Pfizer

Sore arm at the site x 3 days. that evening fatigue, myalgias. at 4 am the next morning awoke with abdominal pain, nausea, then an episode of liquid stool. These continued throughout the next day until the evening of day 2. By morning of day 3 they were gone

Injection site swelling, redness, warm to touch, mildly tender that did not start until today-11 days after injection. I had none of the above directly after or in the 48 hours after the injection. There was absolutely no tenderness to injection site.

Rash throughout scalp, face, neck, ears,torso,thighs,legs, arms, back, itchy throat and ears. Benadryl 50 mg Pepcid 40 mg Prednisone 60 mg The rash started after 1 hour. Took 25 mg benadryl then by 9 pm it got worse, took another 25 mg benadryl without improvement. Continue taking benadryl next day and took pepcid by 12 noon the next day. Following day 22nd December the patient went to hospital ER at 1200 noon. There got prescribed 60 mg prednisone PO with benadryl 50 mg and pepcid 20 mg. Received instructions to continue taking same dose for another 4 days.

Axilla lymph node swelling with tenderness and soreness 6 days post vaccine. No other symptoms. Initial symptoms after receiving the covid vaccine was slight numbness and tingling of left arm where injection was. This resolved within the first hour. However, did have some left neck soreness and ache, as well as injection site soreness in left arm for three days

I got my left arm pit, lump on it, I have bigger than 1 cm 2 lumps, hidradenitis/Pain under my arm; Patient received Pfizer Covid-19 Vaccine who is a nursing mom; Patient received Pfizer Covid-19 Vaccine who is a nursing mom; Mastitis; I got Myalgia all over the body, especially on my shoulders and back; I had chills but my temperature was normal; This is a spontaneous report from a contactable physician (patient herself). This physician reported information for herself (mother) and baby. This is the mother case. A 40-year-old female patient received her first dose of bnt162b2 (BNT162B2, also reported as Pfizer Covid-19 Vaccine, lot/batch number and expiry date were not reported), via an unspecified route of administration on 20Dec2020 18:30 at single dose for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient informed that she got in her left shoulder and left arm pit, lump on it. It was bigger than 1 cm 2 lumps, hidradenitis under her pits arm same size on 21Dec2020. She also reported that she was nursing mom to her self-kid which is 16 months old. She had Mastitis right now (20Dec2020) and informed that she hadn't it her life before. She got her vaccine on Sunday (20Dec2020) in night. She started to have pain under her arm on monday afternoon (21Dec2020) and then since yesterday (20Dec2020) she had mastitis. The mastitis in the right side, lump and the in the left side, which was the site of the vaccine. She never got a fever but got myalgia all over the body, especially on her shoulders and back and also she had chills but her temperature was normal. The outcome of events was unknown. Information on the Lot/Batch Number has been requested.; Sender's Comments: Based on the close temporal relationship, the association between the event mastitis with BNT162b2 can not be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2020520371 Fetal case

Patient immediate burning in her shoulder. Puncture site found to be too high for deltoid. Contacted Pfizer and IM/ID physician. Will re vaccinate in 5 days. Arm very painful, lump under acromion process. Feels like bursitis.

One week post Injection, on 12/28, I noticed a hard lump on my left clavicle (about 1.5 inches in size)-same side as injection. It was painful and partially mobile. No other symptoms other than those of headache a few days prior mentioned below. I went to urgent care on 12/29 where CXR and soft tissue ultrasound were ordered. CXR normal. US 12/30 showed cluster of lymph nodes in that area. Lump appears to be smaller this week and not painful. Also, I developed a severe migraine on 12/26 (5d post vaccine). So severe that it was debilitating which is unusual for me. It lasted approximately 36 hours.

Hives, wheezing,SOB,itching, Tingling in tongue initially. 01/05/2021 Fever 100.8, headache and joint pain Treated with Albuterol inhaler and Benadryl 25mg x2

Angioedema; This is a spontaneous report from a contactable Other Health Professional (patient). A 40-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EL1284, intramuscular in the right arm (also reported as right shoulder), first dose on 22Dec2020 00:30 at a single dose for Covid-19 immunization. The patient's relevant medical history included severe reaction to some animal dander and pollen, severe reactions to poison oak, possible drug induced reactions (unspecified) post C-section, mild rash with influenza vaccine this year (2020) (with no other hx of adverse reaction to a vaccine); had allergies to pollen, mold, some animals. The patient previously took influenza vaccine (split virion, inactivated) and experienced rash. The patient had no covid prior vaccination nor was she tested post vaccination. Adverse event reported was angioedema on 24Dec2020 with outcome of recovering. Systems started appearing on 23Dec2020 evening with slight rash and fluid collection under right eye. Developed more rash on 24Dec2020. In the evening to early morning of 25Dec2020, symptoms worsened significantly. Rapid swelling to face occurred. Swelling was concentrated around eyes and cheeks the most. Both right and left side of the face and neck were affected. However, the right side face had a more pronounced reaction. MD ordered oral prednisone and Benadryl as treatment plan. Also, ordered episode-pen for a worst case scenario. Symptoms have been improving under treatment but still persist some. The events were reported as non-serious. The adverse event start date was 24Dec2020 (as reported). The event resulted in doctor or other healthcare professional office/clinic visit.; Sender's Comments: There is a reasonable possibility that the event angioedema was related to BNT162b2 based on known drug safety profile and temporal relationship. 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.

Rash on legs and arms developed 12-24 hours after vaccine administered. Lasted one day. Treated with OTC medication.; This is a spontaneous report from a contactable consumer. This consumer reported for a 40-year-old female patient (no pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730) on 23Dec2020 at single dose in left arm for covid-19 immunization. Medical history was not reported. Concomitant drug was Spironolactone in two weeks. It was reported that patient experienced Rash on legs and arms developed 12-24 hours after vaccine administered on 23Dec2020. Lasted one day with outcome was recovered. Treated with OTC medication. Patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient not been tested for COVID-19. No Allergies to medications, food, or other products. No follow up attempts are needed. No further information is expected.

Top of Right shoulder has been very soar and painful. This is week 3 of symptoms. My range of motion is limited and I have swelling on the top of my shoulder as well. Can hear popping and clicking in my shoulder when I try to do range of motion as well.

Very fatigue the next day after vaccine. I had whole body tiredness. My arm was very sore and started about 3am . The site was fine but the deltoid and tricep muscles were very sore.

I received the vaccine at 1050hrs on 12/16/20. At around 0900hrs on 12/18/20, I began to experience severe fatigue. At ~1330 on the same day, I had a mildly elevated temperature - normal baseline for me is 97.6, with that reading at 99.4. Due to the fatigue, I slept from 1400 hrs until 0500 on the following day, 12/19/20. No other symptoms to report besides a tender injection site for the first 48 hours.

Warmth at injection site Warm all over body Itchy tingling on my lips. Same feeling I have when I eat shrimp.

Received vaccine in left arm the morning of 12/23/2020. Developed itchy palms and rash on torso the evening on 12/25/2020. Took Benadryl at onset. Did not seek medical attention. Reported incident on 01/06/2021. Rash almost gone, remaining only on left hand and very faded.

Patient became anxious, felt her throat closing and pressure in her chest. Pulse rate increased. Rash noted initially on arms, chest, and back. Palms of hand became very red. Shortly after, she became hoarse, and hives were noted on chest and neck.

Weak, nausea, hives, high fever 102.9 for 16 hours, chills, joint pain (arms, hips, legs and back), symptoms improved after 32 hours. Loss of voice at 42 hours but has since came back.

hsv-1 outbreak; sore arm redness and bruising at site; sore arm redness and bruising at site; sore arm redness and bruising at site; This is a spontaneous report from a contactable physician. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL1204), intramuscular into the left arm on 23Dec2020 at 18:00 as single dose for COVID-19 immunization. Medical history included herpes simplex 1 (HSV1) from an unknown date. The patient's concomitant medications were not reported. Prior to vaccination, the patient had not been diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. There were no allergies to medications, food, or other products. On 27Dec2020, patient experienced HSV-1 outbreak and sore arm redness and bruising at site. This was elaborated as 4- 5 days post vaccine, there was marked HSV-1 outbreak, different than typical outbreak and that was not responding to valacyclovir hydrochloride (VALTREX). There was also sore arm redness and bruising at site. The events were not serious. Therapeutic measures were taken as a result of the events as aforementioned (valacyclovir hydrochloride). The outcome of events, HSV-1 outbreak and sore arm redness and bruising at site was not recovered.

a red area at the injection site /growing red spot at injection site; raised area at the injection site/It was raised; irritated area at the injection site/really irritated; sore arm/arm it would wake her up with pain; itching /painful itchy growing red spot at injection site; normal pain at the injection site; there was an induration there; This is a spontaneous report from a contactable physician reporting for herself. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunization. Medical history and concomitant medications were reported as none. Caller was a ER Physician who received her COVID 19 vaccine last Monday 21Dec2020, and was reporting adverse event at injection site. She reported a red, raised, irritated area at the injection site, stated "thought I got bit by something" and didn't link it to the vaccination, originally. She took Benadryl, treated it like cellulitis by using a heating pad, and applied cortisone. She stated it was persistently getting worse, even seemed worse last night. She had been taking pictures of the skin reaction and wanted to know if there was a way to submit those for follow-up/monitoring. It was also reported painful itchy growing red spot at injection site was reported as worsened. Caller had the vaccine 10 days ago, which was last Monday. She didn't notice at first. She had the normal pain at the injection site. She woke up 3-4 days later, and she felt like she got bit by something. It was a little red. It was painful, itchy, and really irritated. She paid attention to it 3 days ago. She thought this wasn't right. When sleeping on that arm it would wake her up with pain. So she would switch sides. She started taking pics of it yesterday. The redness is getting bigger. She was an Emergency Medicine Physician. She didn't have a prescribing doctor. She got it at (Institution name). She noticed it was there when she first got the shot. It felt like a normal flu shot, and she was fine. She worked out the next day. She had a sore arm like usual with any type of a shot a Tetanus shot or something. She didn't notice anything out of the ordinary until later on, and there was an induration there. It was raised, red, and kind of warm. It was painful and itchy at the same time. It was almost like if a tag in the back of clothes were rubbing it, and she couldn't move all day. There would be an irritated area there. It is getting bigger. Now it was starting to go around her arm. It was not terrible debilitating. She was not allergic to anything. She has put cortisone cream on it, but it didn't change anything. Then, last night, she tried cortisone cream and Neosporin a little later. She then put a medium hot heating pad on it for a nice chunk of the night. It was growing near her lymph nodes now. She said the vial size looked to be about 10 mL. It was a small vial. The nurse did say she could get one more dose out of that vial. She did take Benadryl to sleep at night. So she didn't feel like it was an allergic reaction. Benadryl-Unysom expiration- May2022 Lot: 20E330 Cortisone: Lot: 11885 The Cortisone's lot number was imprinted, and hard to see. The outcome of the events were not resolved.

Burning when the medication was injected; Injection was given under the shoulder bone instead of the deltoid muscle; This is a spontaneous report from a Pfizer-sponsored program. A contactable healthcare professional (patient) reported that a 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EK9231), via an unspecified route of administration under the shoulder bone (arm), on 30Dec2020, at a single dose, for COVID-19 immunization. The patient's medical history included use of multivitamin for a healthy lifestyle. The patient's concomitant medication included ongoing unspecified multivitamin. The patient received the COVID-19 vaccine this morning (30Dec2020) as she works in a COVID unit. The injector put it under her shoulder bone and not in the deltoid muscle; injection was given under the shoulder bone instead of the deltoid muscle. The patient complained of it burning - started when the medication was injected. The patient also asked if this was good enough and if it will it be effective. The patient was recovering from the event.

Red, raised, itchy bump at the insertion site that is warm to the touch. I am now over 48 hours since getting the vaccination.; Red, raised, itchy bump at the insertion site that is warm to the touch. I am now over 48 hours since getting the vaccination.; Red, raised, itchy bump at the insertion site that is warm to the touch. I am now over 48 hours since getting the vaccination.; Red, raised, itchy bump at the insertion site that is warm to the touch. I am now over 48 hours since getting the vaccination.; This is a spontaneous report from a non-contactable nurse who reported for herself. A 40-year-old female patient received first single dose of BNT162B2 (Pfizer/BioNTech Covid-19 vaccine, Lot number: EL0140) intramuscularly at right arm at 10:00 AM on 29Dec2020 for Covid-19 immunization. The patient received the vaccine in hospital. The patient had a history of hypothyroidism and had known allergies to sulfa. Concomitant medications in two weeks included Levothyroxine, amlodipine, losartan, drospirenone, ethinylestradiol betadex clathrate (YAZ), tizanadine, montelukast sodium (SINGULAIR), terbinafine (LAMISIL), cetirizine hydrochloride (Zyrtec). At 12:00PM on 29Dec2020, the patient developed red, raised, itchy bump at the insertion site that was warm to the touch. No treatment was received. The events had not resolved at the time of reporting. The reporter considered the events were non-serious. No follow-up attempts are possible. No further information is expected.

Developed chills, fever (102), headache, body aches, back pain, sore arm at injection site. I had covid March 2020.

Severe muscle pain, that went into back, and all the way down to fingers of left hand. Swelling at injection site, and then swelling and tingling in left hand. and head ache. Symptoms didn't subside until day 3. Still have pain in left arm that radiates down to elbow. All other symptoms subsided.

Patient describe itching of back. Red, slightly raised rash noted across shoulders. Administered 25 mg Benadryl PO. Patient waited additional 20 minutes. Rash persists. Patient described sensation of slight itching on legs. Denies and shortness of breath or itching of throat. Patient advised not to drive if she felt any sleepiness. She verbalized understanding.

After 10 mins of shot had hot flash, nagging headache, nausea in waves. Driving home more hot flashes and nausea, pain in left hip. Got really sleepy. Had problems with left hip, problem getting out of car very stiff. Couldn't stand on the left leg. Had stinging with every step. Burning sensation in the hip. Right arm started having nagging pain with tingling, took Tylenol. Tried to get out of bed, left hip felt like something was poking with fire. Saw bumps on hip, left back. Upper arm was still having tinge. Took Benadryl. Next morning woke up with lesions on left hip, some ruptured that felt like acid and then form a scab. The right arm started with the lesions. Went to urgent care. Dr. diagnosed patient with shingles. Patient questions the Shingles at her age. Pt was given Valtrex for the shingles.

Localized swelling/redness/warmth/soreness that started on the day after vaccine. I thought it was just a normal vaccine reaction because I have had those in the past. It seemed to get a little smaller and less red/warm in the next few days but then started to get more red and swollen in the past 24-48 hours. It has been a week since the vaccine. It is itching some now for the past 2 days as well.

On Monday January 4th I received my Covid-19 vaccine at work, at 410pm. That evening went uneventful. The following day, Tuesday January 5th I woke up with a sore right arm and a slight headache. The headache increased in intensity throughout the day, developing also body aches and a fever of 100.4. The symptoms seemed to improve slightly after taking Tylenol. The next day, Wednesday January 6th I felt much better, the body aches were almost gone, I had no fever and no headache. When I got home from work I noticed hives all over my arms, anterior and posterior neck - going into the hairline, face, especially around my mouth, chest, abdomen, upper and lower back. The affected areas were itchy and I also felt a slight burning/stinging sensation on my neck. Even though I did not notice any hives on my legs, my right ankle was itchy, as well. I took Claritin 10 mg and I did not notice much difference. When I woke up today, Wednesday January 7th the hives were still present on my arms, chest, abdomen and back and they looked like dissipating. It is currently 6:12 pm on January 7th and my hives are almost gone

Around at 7AM when I arrived at work I started feeling chills, took temperature 99.5F that is already elevated for me. About 9:30 my temp was 101.8F and they sent me home. I just had the chills and fever. I got home and developed a headache and around 1PM I started feeling really dizzy. The temperature did not subside and the next day I woke up and I couldn't function, I felt really dizzy I kept laying down and drinking water, I could not keep anything down my stomach did not feel well. I felt like I had to vomit. When I sat down in the toilet then my ears started ringing pretty bad all of a sudden I could not hear anything and I passed out in the toilet. My husband found me and tried to wake me up. After that I still feel dizzy. I did not have any appetite either. I could barely hold water. The next day I was not as dizzy but my stomach was still upset but I could hold some soup down but then started with diarrhea. Employee health kept calling me everyday and I did the the telehealth appt and I also had a little bit of a rash in my chest that appeared all of a sudden red like a streak. The dizziness I had for the first 4 days, diarrhea did not come until the 3rd day and I had it for 2 days and my temperature was back to normal on the 4th day. Everything started to get better (my stomach stopped feeling queezy) around the 4th day but still felt fatigued until about 12/29/2020.

Tingling and numb face and lips mostly on right side of face, right ear pain, right jaw pain, right side headache, sore arm at site, nausea, dizziness, lethargic

low-level headache (was able to go to work, but a bit miserable), tired/run down-lasted several hours (no more than 10) arm pain (at injection site)-it is a bit warm to the touch and a small bruise- still occuring (approximately 12 hours after it started this morning)

Red bumps and itching to arms, legs and belly; Red bumps and itching to arms, legs and belly; This is a spontaneous report from a non-contactable Other HCP (patient). A 40-year-old female patient received the first dose of BNT162b2 (Lot number: EL1284), via an unspecified route of administration at left arm on 05Jan2021 12:00 at single dose for covid-19 immunization. Medical history included Allergies to medications, food, or other products (unspecified allergies). The patient's concomitant medications were not reported. The patient experienced red bumps and itching to arms, legs and belly at 12:30 on 05Jan2021. The patient received the Benadryl as treatment. The events resulted in Doctor or other healthcare professional office/clinic visit. The patient was not pregnant at the time of vaccination. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.

Employee woke with sensory disturbance on left side of face itchy sensation, left eyelid and bottom lip droop, left ear pain. She was ordered steroids by her PCP.

Patient received dose #2 at 2:35 pm, at 2:45 pm onset of severe pruritis, shortness of breath with rapid onset of dyspnea. Epinephrine Injection, USP Auto-Injector 0.3 mg administered. Code blue called. This occured in hospital setting, emergency department responded to vaccination clinic. Oxygen therapy, Methlyprednisolone 125 mg IV push, Diphenhydramine 50 mg IV push.

Acute allergic reaction Tongue swelling Facial swelling Throat swelling Rash on throat and chest Redness in throat Diaphoresis Momentary loss of consciousness

Fever, muscle/body aches. Stiff neck Arm VERY sore. Woke up the night after receiving with cold sweats and arm throbbing (like someone punching repeatedly in the arm) and sensitive to tje touch. Arm painful for 3-4 days

Hive, itchy rash 1 week after the injection which has continued despite mutiple doses of benadryl, claritin, and loratidine; Hive, itchy rash 1 week after the injection which has continued despite mutiple doses of benadryl, claritin, and loratidine; This is a spontaneous report from a contactable nurse. A 40-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular in right arm, on 18Dec2020 at 09:00 ( at the age of 40 years-old) as a single dose for COVID-19 immunization. The patient was administered the vaccine at a hospital. Medical history was not reported. Prior to the vaccination the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. There were also no other medications taken in the last two weeks. On approximately 25Dec2020 (reported as one week after vaccination on 18Dec2020), the patient experienced hives and itchy rash. The patient was not hospitalized for the events but received treatment with diphenhydramine (BENADRYL), loratadine (CLARITIN) and generic loratadine. clinical outcome of hives and itchy rash was not recovered: the patient reported that the hives and itchy rash continued despite multiple doses of BENADRYL, CLARITIN, and loratadine. Since the vaccination, the patient has not been tested for COVID-19. Information on lot/batch number has been requested.

Initial itching at injection site, observed and returned to work. Came back ~30-40 minutes later with itchiness in throat and hives to arm. Given Benadryl PO and observed for extended period of time. Symptoms not resolving. Patient transferred to Emergency Department for further care. At that point observed to have full body rash, SOB. Given Epi while in ED. Developed tachycardia, hypotension. Treatment continued.

Headache (4/10) and body aches (5/10) pain respectively began at about 18 hours after injection. Body and head aches, particularly joints and back, continue and have worsened at 30 hours out. Mild-mod soreness at injection site (4/10)

Shot was given lower in arm than it should have been. There is a hard, warm and red bump where given. Its starting to get itchy as well.

11:30 SHOT GIVEN, BY 11:40 FELT TINGLING IN LIPS AND THROAT AND HEART RATE 125 (MY RESTING HEARTRATE IS 68), BY 11:45 TIGHTNESS IN CHEST AND NECK, HEARTRATE STILL 125 RANGE, NOON: BP 154/75 (MY NORMAL IS 96/58) AND HIVES 12:10 BENADRYL (25MG) GIVEN 12:25: BP 163/78 AND ALL OTHER SYMPTOMS STILL PRESENT 1:00 SECOND BENADRYL (25MG) GIVEN 1:11: BP 158/78 1:45 HEARING TURNED MUFFLED MOVED DOWNSTAIRS TO ER SECTION AT HOSPITAL GIVEN STEROIDS, PEPCID AND WATCHED FOR ADDITIONAL TIME ON 1/9/21: STILL ON BENADRYL AND STEROIDS: WOKE UP AT 8:00 AM SORE ARM AND SLIGHT HEADACHE, 9:00 RED SPLOTCHES ON FACE, NECK AND CHEST, 11:30AM ON 1/9/21: TIGHTNESS IN CHEST AND NECK CONTINUING STEROIDS AND BENADRYL

1/6/21: left arm soreness and decreased range of motion around 5pm. lower extremity weakness and pain, skin sensitivity (feeling like a sunburn when touched) chills and fever (100.4) around 8pm. 1/7/21: fever (101.1), headache, dental/jaw pain around 2am. Nausea started around 6am. Fever lasted all night till around 10am. Blood pressure 138/85 and resting HR 125 and fever started again around 12pm. Chest tightness during exhalation around 2pm. Went to the Emergency Room around 2:30pm. Fever and headache returned around 8pm and gone by 10pm.

Approx 12 hours after injection fever (t-max 101.3), chills, body ache, head ache, skin ache, and fatigue lasting approx 24 hours. Severe fatigue lasted 48 total hours. Fully back to normal 4 days after vaccine. These were severe symptoms, but those that were expected. I only report here because I didnt know how else to make side effects known, in case this is still being followed.

Immediate redness/burning of the injection site. Progressed to itchy throat/tongue and hoarse voice with persistent wheezy cough after 5 min Progressed to itchy/burning/red face/chest/ears after 10 min. Wheeled to the emergency department 20-25 minutes after injection. Had to have benadryl, solumedrol, pepcid, zofran, and an epinephrine injection to stop the anaphylaxic reaction.

Patient received Pfizer-BioNTech COVID19 Vaccine on 01/08/2021 at 1426. Given the patient's medical history, the patient was required to stay for observation for 30 minutes. Within the first 15 minutes, the patient began to experiencing itching. Initially, there was concern that she was reacting to the bandaid (history of latex allergy). The bandaid was removed and staff confirmed the bandaid was LATEX FREE. Per protocol, the patient was administered diphenhydramine 25 mg po x 1 dose. After 15 minutes, the patient's itching continued and she started to develop a skin rash on her chest. Diphenhydramine 25 mg po x 1 dose was repeated and the decision was made to take the patient to the Emergency Department in a wheelchair. Documentation from the Emergency Department Provider: 40 y/o F who comes in from the covid vaccine clinic for a possible allergic reaction. Initially thought to be to latex but then we found out she was not given a bandaid with latex so we assume it is the vaccine. pt had a rash and scratchy throat and initialy felt improved with the benadryl, pepcid and steroids but after about 2 hours had recurrence of her sx. She was then given IM epi. She has now been observed for four more hours and is still feeling well. Will d/c to home with steroids and an epi pen and epi traning. Given return precautions and f/uw ith PCP. .

believed it was injected incorrectly because she didn't have pain in her deltoid but she did have all the pain inside her shoulder, like in the bursa; received the first dose 17DEC2020 / received the second dose 4JAN2021; anterior medial shoulder joint/shoulder pain/pain in shoulder after second dose of COVID 19 vaccine; can't actively use shoulder / can't move her arm; weakness in her hand; bone pain; This is a spontaneous report from a contactable healthcare professional (HCP) reporting for herself. A 40-year-old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EJ1685, expiry date not provided) via an unspecified route of administration in the left arm on 17Dec2020 13:30, and the second dose (lot number EK9231, expiry date not provided)via an unspecified route of administration in the left arm on 04Jan2021 13:30, for COVID-19 immunization. There was no relevant medical history. The patient's concomitant medications were not reported. The patient experienced anterior medial shoulder joint/shoulder pain/pain in shoulder after second dose of the vaccine on 04Jan2021, and couldn't actively use shoulder. She believed it was injected incorrectly because she didn't have pain in her deltoid but she did have all the pain inside her shoulder, like in the bursa, and she couldn't move her arm and felt weakness in her hand. She noticed the pain and all other symptoms immediately when they were injecting it. She told the nurse who said she was tensing up. The events were considered medically significant by the patient. She also reported experiencing bone pain, unable to put in sutures at work. She was taking 600mg Ibuprofen and 1000mg paracetamol (TYLENOL) every 6-8 hours. The events were not resolved. The pain had gotten worse. The other symptoms were persisting.; Sender's Comments: Based on the compatible temporal association, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Patient states on 01/09/2021 had soreness to the injection site. Felt " discomfort but not pain" . Described discomfort as constant. The next day on 01/10/2021 at about 8am, the discomfort started to radiate down to her left armpit area and left lateral breast area. Denied redness or fever but did state area was " swollen" . Stated affected areas felt " hard but it was probably because there was swelling". Patient states she had full range of motion to left arm, no numbness or tingling to left arm or hand. No complaints of shortness of breath , chest pain, or rash.

2 days after receiving the 2nd dose Of vaccine, redness, itchiness, and tiny blisters were noted about 1inch around the injection site.

The person administering the vaccine did not go deep enough into the muscle and the vaccine accumulated in the subcutaneous fat layer. I had a hard, red, hot spot under the skin that night and continued to spread out very slowly over the next day being hot to touch and very red. I massaged the area with my hand for the next two days and the hard spot where the vaccine was got a little softer but is still there. I haven't had any other reactions except the redness and hot to touch. I'm concerned that since the vaccine was not administered correctly that I will not get the full immunity expected by the second dose. I do have pictures I took of my arm if needed.

0808- shot 0812- face got extremely red and hot- burning from inside out 0816- nausea 0829- started to feel chest get tight and began wheezing 0850- went home - itchy on chest stomach, back, and chin/throat. Still very red. 0915- took Benadryl did breathing treatment- cold pack to face 1015- itchy- less- headache, no wheezing no nausea- fell asleep 1215- woke up- chest tight- did breathing treatment- headache 1515- took another 25mg Benadryl Slept most of day til next morning. Went to work 12/29/21 at 6am by 12 feeling really under the weather and tired. Went home took Motrin600mg and went to bed . 12/30 went to work back to normal

This is the 2nd vaccine for the patient. She was not given another lot# for this vaccine. Patient reports nausea, feels like throat is closing, change in her voice (hoarse), patient reports a metal taste in her mouth. Flushed cheeks, facial swelling and whole body was red and flushed, reddish spotting. Also reporting headache. She is still reporting the abnormal taste and headache.

shoulder injury following vaccination. suspect SIRVA. Extreme shoulder pain started a few hours after vaccination and developed loss of range of motion, weakness, inability to lift arm, tingling and numbness down the length of arm. Severe pain prohibiting ADLs; needing assistance with every day functions. Pain is incrementally improving but after 4 days still without recovery. Suspect nurse placed too high, injecting into bursa instead of deltoid muscle. RN seemed concerned after injection. She also was not sitting during injection, increasing the likelihood of injecting too high.

Auditory & visual hallucinations; Auditory & visual hallucinations; tachycardia; extreme panic; confusion; felt like skin was on fire/pulsating; felt like skin was on fire/pulsating; severe pain especially at knees/hips/base of head and neck; severe pain especially at knees/hips/base of head and neck; severe pain especially at knees/hips/base of head and neck; uncontrollable vomiting; bad chills and fever; bad chills and fever; insomnia; felt as if she had been given drugs; This is Spontaneous report from a contactable Other Healthcare Professional reported for herself. This 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EK9231), via an unspecified route of administration on 04Jan2021 14:30 at single dose on right arm for COVID-19 immunization. Medical history included COVID prior vaccination and latex allergy. There were no concomitant medications. No other vaccine in four weeks. The patient previously had allergic to diazepam (VALIUM), clonazepam (KLONOPIN), ondansetron (ZOFRAN) and lorazepam (ATIVAN). The patient experienced auditory & visual hallucinations, tachycardia, extreme panic, confusion, felt like skin was on fire/pulsating, severe pain especially at knees/hips/base of head and neck, uncontrollable vomiting, bad chills and fever, insomnia. She felt as if she had been given drugs. All of the events happened on 05Jan2021 01:30 and resulted in Doctor or other healthcare Recovering professional office/clinic visit. No treatment received for the events. No COVID tested post vaccination. The outcome of the events was recovering.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Auditory hallucinations and Visual hallucinations cannot be totally excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

About 12 hours post vaccine I experienced headache, fatigue, muscle aches, and chills. About 48 hours post vaccine developed rash - raised red swollen area around where the vaccine was given. The area was hot to the touch and very itchy. Currently great than 72 hours post vaccine and rash is still there and still hot and itchy.

24 hours later sever dizziness; Injection site soreness; Internal itching; This is a spontaneous report from a contactable Other HCP. A 40-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), intramuscular on 04Jan2021 10:00 at single dose for COVID-19 immunisation. Medical history included diabetes mellitus from an unknown date. Anatomical location was left arm. The patient experienced internal itching on 04Jan2021 10:15, 24 hours later severe dizziness on 05Jan2021, injection site soreness on 04Jan2021 10:15. The patient underwent lab tests and procedures which included covid-19 test on 05Jan2021 (unknown result). The events outcome was unknown. Information on the Batch/Lot number has been requested.

Palpitations, anxious, no temperature but my body feels really hot in the inside, very bad pain under the arm pit close to my breast on the arm of vaccine, weak ,lightheaded, sweating, headache,

Employee's arm is red/sore (big/hive) with a black/ bluish bruise, evolving cellulitis. Started on Keflex 500 mg PO Q8hr x 10 days. Had a temp of 103 on 1/4/21 but resolved by 1/8/21.

Employee's arm is sore 3 days after vaccine. Arm is red with a bruise that is black/bluish, with evolving cellulitis. Provider prescribed Keflex 500 mg PO Q8hr x 10 days. Had a temperature of 103 on 1/4 but resolved on 1/8.

Patient had her second dose of the Pfizer vaccine Friday, 1/8/2021 at 10:30am. She has had the expected fatigue, muscle aches, headache, chills. however, she had also developed significant swelling in her left armpit and the swelling has spread into her left chest wall and down into her left ribs. It has also become painful. It?s very painful to lower her arm against her body, to raise her arm above her shoulder, to lift anything, even a bottle of water. It?s also painful to take a deep breathe right in the area on the left chest where the swelling is and into her ribs under her armpit. The area doesn?t seem to be significant red or warm. It is very tender to touch and the swollen area is firm. It has not responded to ice or NSAIDS. Her shoulder and arm do not seem to have any swelling."

Headache- severe x 4 days High Fever (103) (6 hours post injection begain, lasted 1. 5 days) Myalgia Pain - bone, and muscle Vomiting Nausea Agitation Diarrhea Inflammation, edema, heat firm induration at injection site

Headache unable to improve with medication, body aches, fever up to 101, 3.5" nodule of erythema, warmth, pain at injection site.

Sore injection site. Injection was given via tuberculin syringe and did not penetrate the muscle, it was subcutaneous. My dose was a waste and I may not have immunity due to operator error.

swelling to left arm with lymph nodes swelling; mild headaches, body ache lasting more than 48 hours left arm cellulitis on steroid and antibiotic

Pt developed itching and a rash on her arm approximately 2 hours post vaccine. colleague self medicated with Benadryl 7 hours post vaccine. symptoms resolved and colleague reported to work the following day without issue

Prior to 1st Covid vaccination the patient reported a history of mast cell syndrome resulting in numerous anaphylactic events. The patient had been consulted by her immunologist to proceed with vaccination and due to her history she was observed for a period of 30 minutes. Upon returning for her 2nd vaccination she reported that she experienced some skin manifestations (hives) but no anaphylactic reaction resulting in difficulty breathing. She stated that she had discussed this again with her immunologist and she wished to proceed with the 2nd dose and she was prepared to receive EpiPen if necessary if reaction develops. Within 10 minutes of the vaccination she felt flushing sensation and then itching all over and her "throat closing up". She was quickly administered 0.3 mg IM epinephrine and IM diphenyhydramine with some improvement in her symptoms. While being transported to the ED an additional 0.3 mg dose of epinephrine was administered. The emergency department also administered the following treatments: famotidine 40 IV x 1 dose, methylprednisolone 125 mg IV x 1 dose, racepinephrine nebulized x 1 dose. The patient was ultimately discharged approximately 2 hours later with return to her baseline condition.

Rash appear on my arm that Sunday. The rash was all over my body. I was on heavy Benadryl for about 1 week.

ABOUT 40 MINUTES AFTER THE SHOT I STARTED TO ITCH THAT PROGRESSIVELY GOT WORSE. BY THE TIME I MADE IT OUT TO MY FIRE ENGINE I WAS RED AND BLOTCHY ON MY CHEST AND BACK THAT STARTED TO GO UP MY NECK. ONE OF MY FIREFIGHTERS GAVE ME BENADRYL IM IN THE RIGHT ARM. THE ITCHING STAYED THE SAME FOR ANOTHER 10 MINUTES UNTIL IT STARTED TO GET WORSE AND MOVE DOWN MY SIDE, STOMACH, LEGS AND ARMS. I THEN STARTED TO DEVELOP BUMPS AND REDNESS TO MY NECK AND BEHIND BOTH MY EARS AND BOTH MY FOREARMS. IN THE ARM WHERE I RECEIVED THE VACCINE IT TURNED RED WITH SOME SWELLING AND BUMPS. MY PARAMEDIC THEN GAVE A DOSE OF EPI 1:1,000 IM ON THE LEFT ARM. ABOUT 1 HOUR LATER THE MAJORITY OF THE BUMPS AND ITCHING WENT AWAY. ABOUT 10 HOURS LATER THE REDNESS AND SWELLING ON THE LEFT ARM WHERE I RECEIVED THE VACCINE WENT AWAY.

Employee had first Pfizer COVID-19 vaccine on 12/16/20 at hospital. She developed an erythematous indurated firm wheal at injection site post-vaccination that lasted for 2 weeks. Evaluated in EH clinic on 12/28/20 and referred to PCP for treatment. Prescribed antibiotics and resolved without complications.

I noticed a rash on both arms at the antecubital fossa on 1/10/21. The rash is red, tender to painful and warm to the touch., slightly itchy but painful when itched. I did not notice the rash anywhere else that day. I feel warm in the face and ears but temperature has stayed between 98.3-98.9 since vaccination was administered. I noticed raised red bumps from my olecranon to mid forearm on the ulnar side of both arms but moreso on the right arm.

itching (benadryl did not relive) strange dark rash/bruising or lesions on left side of body- including lower extremity. Painful.

Patient experiencing moderate-severe body aches, chills, feeling of burning all over skin, skin flushing, nausea, headache, dizziness, near syncope, and bouts of being tachycardia. acetaminophen 1gm q6 hours x 4 doses for 2 days ondansetron 4mg x 1 dose

soreness at the injection site; This is a spontaneous report from a non-contactable other healthcare professional (patient). A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ek5730), via an unspecified route of administration at the left arm on 06Jan2021 17:00 at a single dose for COVID-19 immunization. The patient medical history was not reported. The patient was not pregnant at the time of vaccination. Concomitant medications included ascorbic acid (VIT C), ergocalciferol (VIT D), glucosamine and curcuma longa (TURMERIC). The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient experienced soreness at the injection site on an unspecified date. The patient assessed the event as non-serious. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.

heaviness on the one/left side of her body; left ear pain; left side of tongue is sore; pain that went down from her neck to her abdomen; pain that went down from her neck to her abdomen; injection pain on left arm.; This is a spontaneous report from a contactable nurse (patient). A 40-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EJ1686, expiration date not reported), intramuscular on the left arm on 05Jan2021 at 15:00 to 05Jan2021 15:00 at SINGLE DOSE for Covid-19 vaccine. Medical history included allergies, gallbladder problems, and had a little diarrhea. Concomitant medications included famotidine (PEPCID) for any potential allergic reaction, and diphenhydramine hydrochloride (BENADRYL) for allergies, all are ongoing. On 05Jan2021, the patient experienced left ear pain, left side of tongue is sore, pain that went down from her neck to her abdomen, injection pain on left arm, and on 06Jan2021, heaviness in one/left side of the body. The patient is most concerned with the pain she is experiencing. The patient was calling about Covid vaccine and got her first shot yesterday, on 05Jan2021, around 3pm. The patient stated that they had her stay about 30 minutes to make sure no major side effects. She had gone home and noticed that her tongue on left side was swollen and persisted into the evening and had a little diarrhea. She was experiencing left ear pain and decided to lay down. She stated that when she laid down noticed that she had pain that went down from her neck to abdomen, that when she woke up this morning that she had pressure on left side of her body and everything else had gotten better. She clarified that it was not swollen but sore. She stated that the diarrhea is not related to the Covid vaccine but is because she had gallbladder problems, her gallbladder was taken out before the vaccine. She stated not pressure just heavy and that the arm was regular injection pain. She stated that the shooting pain in ears is continuous like she was getting an ear infection. She stated that the symptoms are all on her left side, she clarified pressure on left side as heaviness. Stated that the allergies were diagnosed way before Covid vaccine. The patient wanted to know if other people have experienced these side effects. She stated that left side of tongue swollen resolved overnight because she did not wake up with it. Later she clarified that her left tongue was sore. Resolved completely. She stated left ear pain started last evening, that it comes and goes. Stated that the pain that went from neck to her abdomen started yesterday evening and stopped yesterday evening. Stated her left arm is sore. Stated it is sore if she touches it and is okay if she is just sitting there. She stated that she took diphenhydramine hydrochloride 25mg in case her tongue was swollen and she was having a reaction. Stated that she took two acetaminophen (TYLENOL) before she went to bed. The outcome of the events of left ear pain and injection pain in left arm was not recovered, while pain that went down from her neck to abdomen recovered on 05Jan2021, heaviness in one side of the body recovered on 06Jan2021, the rest of the events recovered on an unspecified date. The seriousness of left arm injection pain was not provided, reporter assessed other events as non-serious. The causality for the event of injection pain to left arm was related to the suspect drug, causality for other events was unknown.

Fever, chills, body aches, headache, redness, swelling and hot to touch at injection site. Ibuprofen after vaccine given. No problem until following day, late morning. Ibuprofen and tylenol alternating. Swelling and redness at injection site have increased daily.

Hives, red swollen itchy bumps on left ankle foot and mid leg. Various hives and pumps that would pop up on hands and elbows, and right foot that would itch and come and go, but the bumps on the left leg wont go away. I have taken benadryl (2 adult tablets each night), hydrocortisone cream, alcohol rub, and still hasn't gone away a week later. Headache for 7 days. A little dizziness.

Body chills, extreme fatigue, arm soreness at injection site; Body chills, extreme fatigue, arm soreness at injection site; Body chills, extreme fatigue, arm soreness at injection site; This is a spontaneous report from a contactable Nurse (patient). This 40-year-old female Nurse reported for herself received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number: Elt9899/expiration date: unknown), via unknown route of administration, on 17Dec2020 at 07:45 PM (at the age of 40 years old) as a single dose in the left arm and the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number: Eh9899/expiration date: unknown), via unknown route of administration, on 07Jan2021at 06:30 AM (at the age of 40 years old) as a single dose in the left arm for COVID-19 immunization at hospital facility. Relevant medical history included asthma. The patient did not have any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included Albuterol inhaler. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 07Jan2021 at 03:00 PM, the patient experienced body chills, extreme fatigue, arm soreness at injection site. No treatment was received for the events body chills, extreme fatigue, arm soreness at injection site. The outcome of the events body chills, extreme fatigue, arm soreness at injection site was unknown. Since the vaccination, the patient had not been tested for COVID-19.

Patient had regular soreness, redness of injection site. Fever, chills, fatigue hours after vaccine. Patient experienced syncope the morning after vaccination for about 15 minutes. Having bruised head and left eye.

HA, fatigue, pain at the injection site and nausea. Treatment include: Tylenol, hydration and tums the next day. Outcome complete resolution of symptoms on day 3.

"after my 2nd shot i got a swollen area, with some redness which according the email was normal but what concerned me was alot of itching to the site which is still there along with the redness and swelling."

Fever to 99.8; muscle aches; Headache; sore arm for days; This is a spontaneous report from a non-contactable nurse. A 40-year-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration from 28Dec2020 12:00 to 28Dec2020 12:00 at a single dose for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient previously took chlorhexidine and experienced allergies. The patient experienced Fever to 99.8 body, muscle aches, Headache and sore arm for days, felt like being punched repeatedly in the arm; all on 28Dec2020. The outcome of the event was recovered on unspecified dates. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

My right temple started to get sore to the touch, I?m about day 3 post injection. It is fine unless I touch it, but if I do bump it or make contact with it, it hurt like the area was very bruised or recently injured. The pain has improved but it is still very sensitive. I didn?t think it was related to the shot, but I could not recall any injury. I can function like normal. My dr suggested I do a round of steroids, but to contact her immediately or go to ER if it worsened. I am to follow up with her in 2 weeks.

Migraine the day after initial injection (12/24/20). Lasted in to the morning of the 2nd day post injection (12/25/20). Mild to minimal nausea off and on the day after injection. Extreme left arm pain from that injection day through the 4th day post injection (12/27/20). After 2nd dose - bruised arm at injection site. Left arm pain not as severe as 1st injection. Headache more mild.najsea a bit more noticeable off and on. Wheezing and nasally. Muscle aches.

102 F fever through 1 gram acetaminophen (104.6 prior to medication), extreme body aches and headache, overwhelming fatigie, and diapohretic x 2days. Swelling of arm from elbow to axilla during same. Unable to work during symptoms. Moderate fatigue, body aches, headache, and site tenderness persist to date of reporting.

STARTED ON 1/15/2021 4PM WITH NUMBNESS, TINGLING RIGHT UPPER EXTREMITY, AXILLLARY EDEMA AND INDURATION WITH SEVERE PAIN AND ELEVATED TEMPERATURE IN AREA, DIFFICULTY WITH ADDUCTION OF ARM, PAIN RIGHT SHOULDER WITH SWELLEING AND RIGHT TORSO PAIN,

During the Covid vaccine observation period the patient complained of hoarseness, itching and throat swelling. The patient had history of chronic urticaria and prior to receiving her vaccine had taken benadryl, ranitidine as well as an OTC antihistamine at home. She was escorted via wheelchair to the ED, BP 151/102 and pulse 101 in ED, pt noted to have blanching hive-like rash on her chest as well. Received Epinephrine 0.3mg, prednisone 60mg PO x 1. Pt was monitored for 3 hours and discharged to home.

I started to get a painful rash on my left torso and at first thought it was a bug bite but then after 48 hrs it got worse and more painful and I realized it was shingles. I have never had shingles and I am healthy and young and so I thought it might be related to getting the vaccine- Maybe COVID vaccine induced it or made me susceptible. I am nursing a 4 month old to give more information.

at the injection site, it is raised, warm and red; at the injection site, it is raised, warm and red; at the injection site, it is raised, warm and red; This is a spontaneous report from a contactable other health professional (HCP). A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on her right arm, on 06Jan2021 at a single dose for COVID-19 immunization. Medical history was reported as none. There were no concomitant medications. Patient received the first vaccine 2 days ago (06Jan2021) and last night (07Jan2021) at the injection site, it is raised, warm and red. She has had no other symptoms and no fever. She was asking if it is normal for it to take time to occur and for how long will it last. On 08Jan2021, it was reported that she did see that it was normal but was asking if it is normal 48 hours later. Otherwise, she was completely fine. She works as a technician at the hospital. She just took a picture of it so she can keep track of it. The outcome of the events was unknown. Information on the lot/batch number has been requested.

3.5 hours after injection all of a sudden HR was at 161; Muscle pain around injection site and some fatigue, but not bad.; Muscle pain around injection site; Muscle pain around injection site and some fatigue, but not bad.; I was warmflush feeling; When HR jumped to 161 she had a weird sensation run down both of arms; This is a spontaneous report from a contactable consumer. This 40-year-old female (no pregnant) patient received first dose of BNT162B2 (lot# EL3249) on 08Jan2021 02:30 PM on arm Left for COVID-19 immunization. Medical history was Type 1 IDDM (Diabetes), Anxiety/Panic Disorder. Concomitant drug included desvenlafaxine succinate (PRISTIQ), Clonazepam, insulin lispro (HUMALOG), cetirizine hydrochloride (ZYRTEC), all received within 2 weeks of vaccination. Past drug was Allergies to levofloxacin (LEVAQUIN). It was reported that 3.5 hours after injection (08Jan2021 06:00 PM) all of a sudden HR was at 161, patient layed down and it came down a little to 115-125, for 4-5 thereafter it stayed around 110-115, and after about 6 hours it returned to normal. She was warm flush feeling but without a fever. When HR jumped to 161 she had a weird sensation run down both of arms but is subsided with kaying down and HR coming down a bit. No toher bad issues since. Muscle pain around injection site and some fatigue, but not bad. Emergency room/department or urgent care visit. Treatment: EKG, CXR, Labwork, very brief monitoring of HR/BP. Outcome of the event was recovered. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No follow-up attempts are needed. No further information is expected.

1/1/21 sore throat lung pain in back . F/U with Dr antibiotic Amoxicillin Strep diagnosis, swollen pressure in lungs, antibiotic has provided some relief to lungs but pain continues, feels lungs are fatigue and worked. 20 days swollen throat has continued, and small rashes with no itch come and go on eyelid, chin, shoulder.

Fevers; chills; body aches; headache; sore arm; on 22Dec2020 12:00 at first single dose; then on 08Jan2021 at second single dose; on 22Dec2020 12:00 at first single dose; then on 08Jan2021 at second single dose; This is a spontaneous report from a Non-contactable nurse. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685) via intramuscular into left arm on 22Dec2020 12:00 at first single dose; then on 08Jan2021 at second single dose for covid-19 immunization. No covid prior vaccination. The patient known allergies included Cytotec, peanuts, lentils, peas, chick peas and other medical history included Asthma, migraines, kidney stone. There is no other vaccine administered in four weeks. Other medications in two weeks included multi vitamins, vit B2 and magnesium. On 09Jan2021, the patient experienced Fevers, chills, body aches, headache, sore arm and no treatment involved. No covid tested post vaccination. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.

temperature elevated (99.8, 101.8, 101); at the injection site (upper left deltoid) she was experiencing very small redness and a sharp shooting pain; at the injection site (upper left deltoid) she was experiencing very small redness and a sharp shooting pain; She is very achy; shooting pain all the way down from her left upper deltoid to her middle and ring finger on left hand; This is a spontaneous report from a contactable nurse (patient). This 40-year-old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EJ1686) intramuscular, in left deltoid, on 11Jan2021 at 10 AM, COVID-19 immunization. Prior vaccinations (within 4 weeks) or on the same day: none. Medical history included ongoing asthma diagnosed at childhood, ongoing diabetes diagnosed in her twenties, she was overweight, about 7 or 8 years ago she ended up having cellulitis due to the nurse not using aseptic technique but not due to a vaccine, she was diagnosed with COVID on 18Dec2020 (she was off quarantine as of 28Dec2020, going back to work on 31Dec2020). When she was diagnosed with COVID, it caused an asthma exacerbation and she needed a 5-day oral burst of 40 mg prednisone. Concomitant medications were none. On 11Jan2021 the patient experienced temperature elevated, at the injection site (upper left deltoid) she was experiencing very small redness and a sharp shooting pain and she was very achy. Her temperature started last night (11Jan2021), temperature was 99.8. She tried to hydrate. She also had a temperature at 6 AM on 12Jan2021 morning. On 12Jan2021 she had temperature of 101.8 and this was after taking antipyretics 6 hours before. Then, on 12Jan2021, her temperature was 101. She was on the phone with her primary care provider and she was told to take more antipyretics. She just took more antipyretics. She stated it felt almost like they hit a nerve when administering the vaccine since she was experiencing shooting pain all the way down from her left upper deltoid to her middle and ring finger on left hand. She believed, based on anatomy, that there were nerves going right there. She knew she was overweight but her upper arms were not that bad. She tried to take a shower to cool herself down. She received the vaccine through pharmacy since she was working at a long term care facility around COVID. Pharmacist came to the long term care facility where she works to administer the vaccine. The events did not require ER visit. Relevant tests: none. Fever outcome was unknown. The other events had not yet resolved. Sharp shooting pain came and went. The reporter considered all the events serious as medically significant and related to BNT162B2 vaccine.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer 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 woke up at 2:45am with chills, a bad headache, sore arm at test site and nausea. I took extra strength Tylenol and went back to sleep. The following day, I continued to have the headache and fatigue. I took Tylenol and/or Advil all day to keep the headache at bay and also needed a nap. Today, I feel much better.

Experience skin nerve pain all over my body; Experience skin nerve pain all over my body; Extreme cold sensation after bowel movements; This is spontaneous report from a contactable other HCP (patient). A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number not provided), via an unspecified route of administration on 04Jan2021 10:15 at single dose for covid-19 immunization. Patient is not pregnant. Medical history included severe post concussion syndrome (5 major concussions), anxiety, depression, raynaud's syndrome, pineal gland cyst (last MRI Oct2020 reveal cyst was 12mm). The known allergies included Cipro, sensitive to many food, high allergy to mold, grasses, trees. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), fluoxetine hydrochloride (PROZAC), rizatriptan benzoate (MAXALT), montelukast sodium (SINGULAIR), levocetirizine dihydrochloride (XYZAL) , lactulose (LACTUL), ongoing medications included mometasone furoate (FLONASE), budesonide (BUDESONIDE), olopatadine (OLOPATADINE), ipratropium (IPRATROPIUM) , fremanezumab (AJOVY), allergy shots. 48 hours after injection on 06Jan2021 13:00, patient began to experience skin nerve pain all over body accompanied with extreme cold sensation after bowel movements, has been 6 days and getting worse. She will be going to urgent care tomorrow. She was between primary care physicians until 13Jan2021. Patient didn't receive treatment for the adverse events. The outcome of events was not recovered. Information about lot/batch number has been requested.

Employee reported flushing, itching and burning sensation noted to her cheeks, nose, chin, and chest within hours of receiving 2nd dose of vaccine. She stated that she has continued experiencing it intermittently, has taken Benadryl at night time, and is planning on trying Zyrtec.

Shingles: Redness and tenderness in right eye area at 7:00 PM on 1/14/21, later that nigh (approximately 11:00 PM) experienced sharp pain behind right eye. On 1/15/21 bumps in right eyebrow and itchiness on right side of scalp. on 1/16/21 developed redness in right eye. Pain behind right eye and itchiness persisted for >5 days. Went to Urgent Care on 1/20/21 and shingles suspected. Referred to confirm diagnosis. Antiviral pills and drops prescribed, as well as steroid drops.

Broke out in a rash on neck and torso. Body aches and headache as well. Treated with Benadryl and Prednisone

It looked like a spider bite that was about about 8 inches in Diameter.. The area was really hot and swollen Rash on chest . that was similar to chicken Pox

1/22 @ 15:00-low grade fever, chills, body aches, headache 1/23 @ 17:30-noticed swelling in left armpit and Red circle around injection site

No symptoms or reactions immediately. Injection site was very sore the following day. Followed by body aches, chills, headache, muscle and joint pain. Tired.

Twelve minutes after receiving the vaccine injection, patient reported tingling in both arms and across her upper back. She had taken a dose of Benadryl, 50 mg p.o. prior to coming to the clinic, due to her prior history of allergies. Her blood pressure was checked in left arm, 134/94. She denied chest pain, SOB or feeling of swelling in tongue or face. After the tingling sensation, she began to experience pruritus of her arms, back and scalp. Visual inspection revealed no visible rash or hives. When she began rubbing on her left arm to relieve the itchy sensation, the area of rubbing became erythematous. She was observed for 45 minutes after the injection. Symptoms did not progress and she was discharged from the clinic. Phone follow-up 24 hours later: pruritus has resolved. She took 2 more doses of Benadryl 50 mg p.o. yesterday, at 2 p.m. and 11 p.m. Only symptom reported today is sleepiness.

right abdominal vesicular rash with erythema, pruritits for 8 days turning into dry scaly skin (not painful)

I begin to lose consciousness; I felt lightheaded; My face and ears got red and I begin to feel warm; My face and ears got red and I begin to feel warm; Then My whole body felt really weird; my lips went numb; Afterwards for approximately 4 hours I could barely talk or open my eyes; Afterwards for approximately 4 hours I could barely talk or open my eyes; I got red rash on my neck and chest; I felt so weak, I could not move my body!; This is a spontaneous report from a contactable Other HCP reporting for herself. A 40-years-old female patient received the second dose bnt162b2 (BNT162B2) vaccine , intramuscular in the left arm on 18Dec2020 12:15 at single dose for Covid-19 immunisation . The patient medical history and concomitant medications were not reported. On an unknown date the patient received the first dose of the vaccine. The patient experienced got red rash on my neck and chest on 18Dec2020 12:15 with outcome of recovering , felt lightheaded on 18Dec2020 12:15 with outcome of recovering , face and ears got red and begin to feel warm on 18Dec2020 12:15 with outcome of recovering , then whole body felt really weird on 18Dec2020 12:15 with outcome of recovering , lips went numb on 18Dec2020 12:15 with outcome of recovering , begin to lose consciousness on 18Dec2020 12:15 with outcome of recovering , afterwards for approximately 4 hours could barely talk or open my eyes on 18Dec2020 12:15 with outcome of recovering , felt so weak, could not move my body on 18Dec2020 12:15 with outcome of recovering. The patient was hospitalized for one day for all the reported events. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 18Dec2020 . The patient received Epipen injection, steroids, saline & Benadryl as treatment for the reported events. Information on the Lot/Batch Number has been requested.; Sender's Comments: Based on the compatible time association, the reported events are possibly related to suspect BNT162B2 administration. 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.

Right arm injection site pain/swelling/red circle. Right Axillary lymph node swelling in arm injected. Headache, tiredness, muscle pain, chills, fever- T max. 101.8, feeling unwell.

Localized injection site irritation. Skin is red and hot at injection location. Symptoms increased on Sunday -- injection was Friday.

Itching; headache and body aches; headache and body aches; chest tightness; had hives; Vertigo; Nystagmus in her eyes; passing out; vomiting/puke when vertical; Dizziness; tingling and numbness in throat and lips; tingling and numbness in throat and lips; tingling and numbness in throat and lips; tingling and numbness in throat and lips; heart rate 125; BP of 170/100; throat tightness; This is a spontaneous report from a contactable consumer (patient). A 40-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=El1283) via an unspecified route of administration at left arm on 08Jan2021 11:30 at single dose for covid-19 immunization. Vaccine was administered at hospital. Medical history included ongoing autoimmune disorder. The patient had known allergies to Amoxicillin and wasps. No family medical history relevant to events. Ongoing concomitant medication included hydroxychloroquine sulfate (HYDROXYCHLOROQUINE) for autoimmune disorder, celecoxib (CELEBREX) for autoimmune disorder, oral dimenhydrinate (DRAMAMINE), oral fexofenadine hydrochloride (ALLEGRA) and oral famotidine (PEPCID). No other vaccine in four weeks. The patient previously took flu vaccine (Expiry Date: Nov2020), tetanus vaccines for immunization. At 11:40 on 08Jan2021, the patient had tingling and numbness in throat and lips, heart rate was 125. By noon had hives and blood pressure (BP) of 170/100 (normal BP was 96/58 and heart rate was 65), chest tightness and throat tightness, the patient was given Benadryl (50mg) and monitored. No change so walked to emergency room. Given intravenous Benadryl and steroids then released the same day on 08Jan2021. The patient woke up on Saturday and shortly after hives came back, itching, chest tightness, headache and body aches. Saturday night on 09Jan2021 she went back to hospital due to continued reaction from 09Jan2021 06:00 pm until 10Jan2021 04:30 PM. The patient was admitted for heart testing then released on Sunday afternoon simply due because each doctor said they didn't know what to do. The patient slept from late Saturday night to Monday (except testing and eating at hospital), on 11Jan2021 around noon the patient took a shower and hives, itching and tingling all came back. Completely started over with reaction and started dizziness. On Tuesday 12Jan2021, primary care physician (PCP) for tests. Chest tightness started subsiding but very dizzy, puke when vertical. Wednesday: rheumatoid doctor. The patient had extreme vertigo. Other reported events: passing out, vomiting. Nystagmus in her eyes was very strong so that she got very dizzy. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care or Hospitalization. Adverse event start time also reported as 11:45 am. The patient underwent lab tests and procedures which included blood pressure 170/100 on 08Jan2021, blood test and electrocardiogram (EKG) with unknown results, heart rate: 125 on 08Jan2021. Normal BP was 96/58 and heart rate was 65. Heart and lungs examination with clear result. The patient had no Covid prior vaccination. Nasal Swab of Covid tested post vaccination on 05Jan2021 with a result of negative. Heart rate 125 recovered on 12Jan2021. BP of 170/100 recovered on 12Jan2021. Chest tightness sometimes she has episodes. She cannot walk without assistance. She stated she currently was 100% dependent on someone else. Throat tightness recovered on 11Jan2021. Outcome of other events was not recovered. She was treated at hospital with Oral and IV Benadryl and IV Steroids on 08Jan2021. On 09Jan2021 she was administered Oral Prednisone, Oral Diphenhydramine HCl (BENADRYL) and Oral Acetaminophen(Tylenol). Steroids switched from prednisone Oral to dexamethasone Oral twice daily. On 13Jan2021 she started on ondansetron (ZOFRAN) 4mg 3xday Promethazine (Fenagrin) 25 mg once at night. Information on Lot/Batch has been requested.

beginning around 8pm on 1/20/21 (day of vaccine), chills. woke up around 2am on 1/21/21 with nausea, feeling warm -- temp of 100.7; chills, fever, and nausea all morning of 1/21/21; fever and chills continued through 1/22/21 around 11am. Treated with Tylenol and Zofran. On 1/22/21 noticed lymph node swelling on arm where vaccine given. Neuropathy 1/22/21. Treated wtih ibuprofen 600mg TID. Lymph node remains swollen as of 1/25/21. Lymph node is hard.

pain in injection site. I noticed today that my skin had peeled away at the injection site after my son pointed it out. There is a large square and of skin peeled away. The skin is also discolored.

I received the 2nd dose of the vaccine on Monday 1/4/2021 at 1600. Over the afternoon and evening I developed arm pain at the injection site. Since there were no other side effects in the morning, I returned to work for my regularly scheduled shift on 01/05/2021 at 0545. At approximately 0615 I began to get body aches and restlessness. At approximately 0725 in addition to the body aches and restlessness, I began to get severe nausea, weakness, light-headedness, headache, profuse sweating, and severe chest pain and shortness of breath. Because of the severity of my symptoms my manager immediately told me to go to the ED and a fellow co-worked brought me down via wheelchair. In the emergency department I was assessed and worked up and after several tests and xrays I was given a diagnosis of adverse reaction to drug/vaccine. I was discharged to home at approximately 1130 on 01/05/2021. Upon arriving home I continued to have body aches, and then developed chills, shaking and fever of 101.00. All of this combined became unbearable and I had to take 500mg of Tylenol at 2230 on 01/05/2021. On 01/06/2021 I still felt horrible with body aches, fever, nausea and fatigue. My weakness, fatigue are still present today 01/07/2021 at 0945.

On 1/20/2021, approximately 2.5 hours after my second dose, I had nausea with dry heaving and started having intense, crushing pain in my CTL back (with the worst of it being in my thoracic and lumbar areas). *The nausea and subsequent dry heaving subsided within 6-8 hours with prescribed anti nausea. *The back pain only intensified, with me finally calling my doctor who recommended contacting ONE Parkview. This back pain continues today (1/26/2021). On 1/21/2021, in the early hours of the morning, I woke to hives over my entire trunk, left arm (injection site), and left thigh. *This subsided in maybe 10 or so hours with antihistamines. On 1/23/2021, at approximately 1100, I felt heat in my left arm. This coincided with a heavy feeling in my left arm. When examined, I noted that my upper arm was slightly swollen, blotchy, and had a reddened rash approximately 4x4 inches. Minor itching. *The swelling subsided by 1/25/2021, but the heat and reddened rash continues today (1/26/2021).

1. ALL started around 4:00pm on 1/24/21-Severe muscle aches, fever (100.8), severe headache, chills, sore throat, nausea 2. Noticed rash on 1/15/21-Rash on right side on stomach, side, and around back

Rashes to upper body anterior and posterior; Generalized body pain; chest pain; This is a spontaneous report from a contactable Nurse (patient). A 40-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK5730), intramuscularly in left arm on 01Jan2021 06:15 at single dose for COVID-19 immunization. Medical history was none. Known allergies: No. Other medical history: No. The patient was not pregnant. Concomitant medication in two weeks included colecalciferol (VITAMIN D). If other vaccine in four weeks: No. The patient experienced rashes to upper body anterior and posterior, generalized body pain, chest pain, all on 12Jan2021 17:00 with outcome of not recovered. No treatment received for the events. If covid prior vaccination: No. If covid tested post vaccination: No. AE was not resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.

36 hours after the injection I developed large red, warm and painful area at the injection site. 24 hours after that I was experiencing fever and chills again. I also started to vomit

Later on the day of vaccination I started feeling fatigue & pain on the site of the injection. I had continues fatigue & muscle pain this lasted about 5-6 days. On 12/28/2020 I started noticing that I developed shingles on my right side of forehead also experiencing pain till current. I saw my doctor on 12/28/2020 & prescribed medication.

woke up during the night after her second dose (dose given on Friday) with joint pain (around midnight or shortly after); joint pain; intense fatigue; muscle aches; arm was sore at the injection site; This is a spontaneous report from a contactable other healthcare professional (patient). A 40-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration (left arm) on 08Jan2021 (11:00) at single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 (lot number: EH9899) on 18Dec2020 (02:45 PM) via an unspecified route (right arm) for Covid-19 immunization. The patient's medical history included drug allergy (reported as known allergies: Cephalosporin (mild reaction of hives one time after having taken it with no issues for years-pending clarification)). There were no concomitant medications. The patient was not diagnosed with COVID-19 prior to vaccination. The patient reported that she woke up during the night after her second dose (dose given on Friday) with joint pain (around midnight or shortly after [09Jan2021, 12:15AM]). The entire day after her 2nd dose (during the day Saturday) every joint in her body ached and she experienced intense fatigue. There were also some muscle aches in her shoulders and her arm was sore at the injection site as it usually is after a tetanus shot (she stated she had soreness in her arm the day after the first injection but no other adverse events after the first injection). She did not seek medical treatment and did not take any over the counter medications to alleviate the symptoms as she does not typically take medications unless absolutely necessary. By the next day (Sunday), she was much better and had only slight joint pain remaining in her neck. By the following day (Monday;11Jan2021), all symptoms had resolved. She further stated that the symptoms experienced for one day did not make her regret getting the vaccine and she continue to strongly recommend the vaccine. The outcome of events was recovered on 11Jan2021. The patient has not been tested for COVID-19 since the vaccination.

About 20 minutes after receiving her 2nd dose of vaccine, the patient developed tingling lips (no apparent angioedema), itching and warmth of the face and chest. Her face and upper chest did appear flushed. She was administered Benadryl, and her symptoms resolved after half an hour.

Patient is a healthcare worker who received the first dose of the COVID-19 vaccine. Later that day, patient had excessive fatigue and some site injection pain. The next morning patient has loss of consciousness witnessed by husband. At the same time patient was drooling, not speaking clearly, and then eyes rolled back in her head, and passed out for a few minutes.

On 1/22, I noticed a painful red itchy bump on my left foot. Another bump appeared on my right index finger the day after, and then another bump appeared today 1/28 under my right arm. They are getting larger, more painful and swollen, itchier, and seem to be filled with white pus. The one on my left foot has burst.

Went to hospital in middle of night when resting heart rate was 136/ woke up in middle of night with racing heart/was 133; chills; fever; body aches; swollen axillary lymph nodes; rash on shoulder, armpit and back close to the vaccine site; bad headache; This is a spontaneous report from a contactable nurse. A 40-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular (left arm) from 13Jan2021 10:45 to 13Jan2021 10:45 at a single dose for covid-19 immunization. Medical history included asthma and hypothyroidism. Concomitant medication included beclometasone dipropionate (QVAR) and levothyroxine. The patient also has allergies to Codeine and Azithromycin. The patient took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 23Dec2020. Information on the lot/batch number has been requested. It was reported that the patient went to the hospital (Emergency Room/Urgent Care) in the middle of the night when her resting heart rate was 136 on 13Jan2021. She had fever, chills, body aches. She woke up in the middle of the night with racing heart. Was 133 in the hospital, they gave her 2 liters of fluids which eventually brought it down to 105. They ran a lot of test and ruled out anything else. On Jan2021, they also found swollen axillary lymph nodes. It's now 48 hours later, still have a fever, HR finally is below 100, she now has a rash on her shoulder, armpit and back close to the vaccine site and she have a bad headache. The outcome of the event fever was not recovered while recovered with sequel on unspecified dates for the other events.

Shingles involving R. flank, with first lesion presenting 15JAN. Treated with valacyclovir, amitriptyline, prednisone. Treatment still ongoing on 29JAN

The muscle at the injection site was sore. It progressively got worse over about 12 hours and the next morning I could barely lift it equal to my shoulder. The soreness was manageable and it was gone by the next morning.

I received 2 dose on 1/26 at 8:40 a.m. About 4:30 p.m. I start feeling a throbbing pain at injection site. I around home about 6:00 p.m. immediately I start having chills, fever, muscle ache , nausea , and headaches. I could not sleep all night I was back and forth with chills and fever up to 102 for two days. On third day I felt better but headache and nausea linger still.

approximately 10 minutes after vaccine patient had shortness of breath and felt wheezy. She also had intermittent itching and chills. Rapid Response team notified and she was observed for an additional 30 minutes with improvement in symptoms. She was dismissed at 1000 to home

patient developed itching and rash on chest and neck with some throat tightness. RRT called and she was transferred to the ER

Approximately 15 minutes after vaccine patient began feeling flushed, but denied any rash or respiratory issues. Patient chose to leave facility and went to a store where she purchased Benadryl and took 25mg orally. Patient returned to site where vaccine was given (which is also her place of employment). Nurse evaluated patient and rash noted on chest. Blood pressure elevated to 220/115 and heart rate 120. Physician evaluated patient. EKG performed and patient found to have sinus tachycardia. Benadryl 25mg and Kenalog 40mg administered intramuscularly. Blood pressure came down to 150/104 which patient reported was close to her recent baseline as she recently had a medication adjustment. After approximately 15 minutes patient no longer felt flushed. Patient was instructed to take and additional dose of Benadryl 50mg orally that evening and a Prednisone dose pack was prescribed.

Day 2 after injection just injection site pain and tired. Severe hips/knees/ankles/wrists/back pain on day 5 and 6 after injection and calves pain and tightness.

Patient c/o slight numbenss at the injection site and to the back side of the arm along with feelings of queasiness. Ears were flush, no redness noted at the injection site or arm after fifteen minutes. Pt was able to lift her arm and hold it without any difficulty. Pt reported not eating anything this morning before recieving the vaccine. Pt allowed to lie down and monitored for 15 more minutes. Pt verbalized that she felt better after the additional 15 minutes, ears were with in normal color.

Pt received her first pfizer vaccination and after approximately 10 minutes, pt started itching throughout her entire body and burning to her perineal area. SQ Epi given on scene and IV benadryl given in route by EMS.

PT presented to ED complaining of fever (TMAX 102), frontal headache, chills, high heart rate (MAX 153), injection site pain PT took Tylenol at home, presented to ED r/t high heart rate

Throat itchy, felt like right side of throat swelling, dizzy, skin hot. Seen by doctor in vaccine clinic who held me for one hour. Took Benadryl which helped reduce throat itching and feeling of swelling in throat.

I experienced red, irritated eyes following the vaccine. Also experienced a blister likely chemosis which lasted approx 1 day.

Localized allergic reaction. Itchy, red, hot to touch over injection site. Mild pain. No ROM restrictions. Growing in size on 2/1/21.

Systemic: Rash (other than injection site)-Medium; Systemic: Other- half face swollen several hours later; symptoms lasted 1 day.

severe chills, body aches, joint pain, small patch of hives by left shoulder. Took Tylenol and Advil

Patient administered 2nd dose of Pfizer COVID vaccine on 1/25/2020. Six days later the patient developed generalized hives treated with over the counter antihistamine (benadryl). The next day patient again had hives, trouble swallowing, and difficulty breathing. She presented to an Emergency Department and was treated with epi IM and oral antihistamines (H1 and H2). Discharged to home on prednisone 40 mg PO QD x 3 days and then 20 mg PO QD x 2 days. Patient again had trouble breathing 2/1/2020 and returned to the ED. Patient 10 weeks pregnant.

Have had a lot of swelling or inflammation in both of my knees since a week after first dose injected and have pain with it - unable to stand too long because of the swelling and pain ongoing for 3 weeks now without improvement Came on out of the blue because Endo not normally have this issue.

Two days post-injection patient developed a red rash across the neck that has not subsided. Patient States that rash is flush red and itchy since time of the injection.

myself the patient i had the first covid Pfizer vaccine on 01/04/21, symptoms started on monday nite 1-04-21 feeling very fatigue and tired, on 01-05-21 felt just a little tired and fatigued had no rash mark, on 01-06-21. i threw up and just a bit tired. After a few days i fully recovered from the first dose of the covid 19 Pfizer, When i received the Second dose of the Pfizer on 01-29-21 that nite i started with a massive headache n chills, on 01-30-31 the entire day had diahrea severe chills massive headache and sweats.On 01-30-21 thru today 02-02-21 i have a round circle rash with heat and bump underneath it each day the rash is bigger were the right arm had the covid Pfizer vaccine injected on 01-29-21.

Pfizer-BioNTech was administered at 4:19 pm, she was advised she would need to wait 30 for any adverse reaction. At 4:25pm patient started to fee palpations, braking out with redness on her chest and her left arm where the vaccine was administrated. Epinephrine 0.3 mg auto injector was given in her right thigh by the doctor. We then called 911 to transport her to the emergency room.

tip of nose still funny feeling; Slight dry cough; clearing throat; hoarse voice; pins and needles on face; numb face; Red spots on nose and legs; mottled leg color but looked like a flat rash; mottled leg color but looked like a flat rash; This is a spontaneous report from a contactable nurse (patient). A 40-year-old female patient (not pregnant) received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EL1283 and Expiration Date unknown) via an unspecified route of administration on 19Jan2021 07:15 PM (vaccine location: Right arm) at single dose for COVID-19 immunisation. Previous vaccine included first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EJ1685 and Expiration Date unknown) via an unspecified route of administration on 31Dec2020 11:30 AM (vaccine location: Left arm) at single dose for COVID-19 immunisation. The patient's medical history included asthma, chronic migraines from neck injury, increased weight, known allergies to Reglan. No covid prior vaccination. The concomitant medications was reported as pregabalin (LYRICA), cefixime (FLEXERIL), sertraline hydrochloride (ZOLOFT), omeprazole (PROTONIX), sumatriptan succinate (IMITREX).On 19Jan2021 08:00 PM, patient experienced pins and needles on face. Then numb face. Red spots on nose and legs. Then mottled leg color but looked like a flat rash. Next day (20Jan2021) tip of nose still funny feeling. Spots remain. Slight dry cough, clearing throat, hoarse voice. Events resulted in Emergency room/department or urgent care. Treatment information included IV fluid, Benadryl, pepcid, steroids.The outcome of events was recovering after treatment given. No follow-up attempts are possible. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

EE states she received Covid vaccine on Wednesday 1/27/21. She had to call off work on Thursday (1/28/21) due to headache, general body aches and nausea. Came back to work today (1/29/21) and came to EH with c/o uppder body aches, intermittent headaches and a rash to back, chest and bilateral underarms. EE afebrile at this time. EE medicated with Benadryl PO, as per standing order.

The employee received both Pfizer covid vaccines (12/17/20 - R deltoid and 1/7/21 -L deltoid per report). The employee reports taking only OTC Claritin the day of vaccination for both covid vaccines per employee report. The employee offers no other recent illness, no new medication regimen, nor change in overall health. The employee reports two small "hive" spots noticed on her R buttock on 1/12/21, 5 days after the second covid vaccine. Since 1/12/21, the employee has a described flat, red, non-itching rash extending from her R buttock to her R groin and flank, extending to the R breast. The redness has extended across her abdomen and now includes involvement on the left, from the L axillae to the L groin. Newest spots per employee include now her left wrist and two spots on her left upper arm.

Swollen face, eyes lids, nose and lips. Received the vaccine on 1-11-21. Experienced left arm numbness and pain on site. Numbness subsided and pain was minimal. Went to bed and work up around 6am to face, eyes, nose and lips swollen. Barely unable to open eyes. Immediately contacted employer employee health and contacted PCP. Appointment scheduled with PCP. PCP assessment completed. Recommended prednisone for swelling. Unable to take because of previous reaction. Recommended for Benadryl to be taken every 4-6 hrs and also Ibuprophen

12/30/2020: COVID Vaccine Pfizer-BioNTech dose 1 of 2 left arm. Acute onset left shoulder/arm pain 1-2 days later without inciting event (no trauma, no sports/weights), progressively worsening to severe next 2 days with onset of numbness and paresthesias in left upper arm and hand by 1/5/2021 seen at urgent care with dx: Cervical Neuropathy. Follow-up cervical MRI 1/22/21 without significant canal or foraminal impingement. Seen by Neurologist 2/3/2021, at that time pain improved and localized to left shoulder joint area radiating under scapula and paresthesia resolved to numbness. Physical exam findings: Absent triceps reflex, Left FDI atrophy, left hand finger extensor weakness, left abduction limited to 90 degrees. Dx: Neurologic Amyotrophy (Parsonage Turner Syndrome); Complication of COVID vaccination. Plan: EMG, NCS, Left shoulder MRI, labs pending. PT OT ordered. Rx: Nortriptyline, Medrol Dosepak. F/U 2-3 months with neurology.

Shingles: Approximately 3 hours after receiving vaccine, experienced redness and tenderness under eyebrow of right eye.; Tenderness under eyebrow of right eye/pain behind right eye that did not go away for more than 5 days; Shingles: Approximately 3 hours after receiving vaccine, experienced redness and tenderness under eyebrow of right eye.; This is a spontaneous report from a contactable healthcare professional (HCP). A 40-year-old female patient received first single dose of BNT162B2 (Pfizer- BioNTech, Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration (vaccine location: right arm) on 14Jan2021 16:00 for COVID-19 immunization. Vaccination facility: Hospital. The patient had no relevant history. The patient was not pregnant at time of vaccination and at the time of reporting. The patient had no known allergies. The patient did not have Covid prior vaccination. Concomitant medication (other medications in two weeks) included multivitamin (unspecified). There was no other vaccine in four weeks. On 14Jan2021 19:00, the patient experienced shingles: approximately 3 hours after receiving vaccine, experienced redness and tenderness under eyebrow of right eye. Experienced pain behind right eye that did not go away for more than 5 days. Sought medical attention and ophthalmologist diagnosed shingles on 20Jan2021. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, and Emergency room/department or urgent care. Treatment for the adverse events included antiviral medication and steroid drops. Patient was not Covid tested post vaccination. The patient had not recovered from the events at the time of reporting. Information about lot number and expiry date for the suspect product will be requested in follow-up attempts.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events herpes zoster, eyelid pain and erythema of eyelid cannot be excluded. The information available in this report is limited; information on previous occurrences of shingles, if any, would aid in case assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.

With the 1st dose I had myalgia, arthralgia and pain at the injection site which began the next morning when I woke up at around 10:00 am and lasted 48 hours. For the 2nd dose, the reaction was more profound. I had pain at the injection site within 6 hours of the injection and by the next day around 11:00 am I woke up with myalgia, arthralgia, fever of 101.2 F, fatigue, headache, and sore throat. Symptoms lasted for 4 days and I missed 2 days of work.

45 minutes after administration pt became nauseated, tachycardic, numbness and tingling hands and feet, progressing to the knees. Injection site warm, BP 132/96. On exam, oropharynx mild erythema - no edema and no stridor. Lungs CTA. Cor - S1 S2 slightly rapid. Abd soft, non-tender, positive BS. No rashes. Gave Benadryl 50 mg and prednisone 20 mg. BP 110/72. HR 72. O2 Sat 98%. Temp 98.3F.

Pfizer-BioNTech Covid-19 vaccine EUA. 3 x 3 inch red welt, hot to touch at injection site. Fever of 101.5 beginning 19 hours after injection. Fever ongoing 48 hours after injection (has not ceased as of yet). Body aches, especially lower back, swollen lymph nodes throughout entire body, chills, lethargy, lack of appetite, dizziness, mild headache. There is a large swollen lump under collarbone about 4 inches and is raised from skin. Also pain under left armpit. Since this occurred over the weekend, I plan to follow up with primary care doctor Monday.

15 minutes after injection, I saw white spots and felt dizzy. The white spots in vision occurred on and off for the following 24 hours. Injection site warm to touch (compared to other arm) but without redness.

25 minutes after her vaccine, patient's tongue and lips started tingling. She said they were not swollen but she definitely had a tingling feeling. She felt as if she had difficulty swallowing and had some hives on her back. These symptoms all resolved after 3 hours. She never had trouble breathing and was able to eat her dinner.

hard time catching her breath; throat felt a little tight; her throat felt a little tight, and she found it hard to swallow; little nervous; very lightheaded; her husband told her she looked very pale; her heart rate jumped to over 150, according to her (company name) watch; she had pins and needles up and down her entire left arm; her left arm initially felt almost totally numb from her shoulder to her finger tips, and then she felt pins and needles down the entire length of her arm.; maybe a nerve was hit when the COVID-19 Vaccine was administered in her left arm; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the first dose of bnt162b2 (Lot Number: EK4176), via an unspecified route of administration in left arm on 25Jan2021 12:50 at single dose for covid-19 immunization. Medical history included coeliac disease from Mar2013 and ongoing. There were no concomitant medications. She said initially she was OK after she received the COVID-19 Vaccine. She said after about 5 minutes in from receiving the COVID-19 Vaccine, she had a hard time catching her breath, and her throat felt a little tight, and she found it hard to swallow. She said she thought she was nuts at first, and was a little nervous for a minute. She said the staff at the vaccination center made people wait 15 minutes after receiving the COVID-19 Vaccine before being allowed to leave. She said she actually spoke to the vaccination center staff while she was waiting for the 15 minutes to go by. She said she didn't say anything to the staff because she thought she might be crazy. She said she scheduled her second COVID-19 Vaccine dose, and after the 15 minutes went by, she left. She said her husband had drove her to and from the COVID-19 Vaccine facility location. She said 5 minutes into her car trip after leaving the facility, she became very lightheaded. She said her throat began to feel tight again (saying the throat tightness was worse than what she first experienced at the convention center), and she kept trying to clear her throat. She said her husband told her she looked very pale. She said her heart rate jumped to over 150, according to her Apple watch. She said she had pins and needles up and down her entire left arm. She clarified her left arm initially felt almost completely numb from her shoulder to her finger tips. She said she thought that maybe a nerve was hit when the COVID-19 Vaccine was administered in her left arm. She clarified the numbness improved in her left arm, but she still has a pins and needle sensation down the length of her left arm. Patient asked if it is OK for her to received the second COVID-19 Vaccine based on what she experienced after the first COVID-19 Vaccine dose. Reported if she would have been driving the car after she received her first COVID-19 Vaccine dose, she would have had to pull over on the side of the road because of the side effects she was experiencing. Reported the side effects she experienced in the car after leaving the vaccination facility, resolved after a couple minutes, with the exception of the pins and needles and numbness in her left arm. She said the pins and needles, and numbness in her left arm improved, but was still present. Reported she had a well visit not too long ago, and her blood work was perfectly fine. The outcome of the events Peripheral nerve injury, Pins and needles, Numbness of upper extremities was recovering, other events was recovered on 25Jan2021.

The day after vaccine administration, pt experienced an injection site that was raised, red, itchy and warm. She contacted per PCP and he said the rxn was secondary to the vaccine administration. He recommended she receive the 2nd dose of the vaccine in the opposite arm. 1 week later she still had a knot at her injection site but it was getting smaller daily.

Patient experienced tachycardia, chills, and itch within 15 minutes of observation. No treatment was given. Patient was observed and later discharged

Hives, on right shoulder and right hand, given 50 mg Benadryl. Client went back to work after Benadryl was given and vitals remained stable, hives did not continue to spread.

I had Chills, low grade fever, site sorness, arm stiffness, worsened joint and muscle pain and fatigue for 3 days

blurry vision, kaleidoscope vision accompanied by a headache - entire body soreness, soreness at injection site

Raised rash on face; Raised rash on face and injection site; flushed feeling face; chills; Body aches; brain fog/ overall not up to feeling like myself; This is a spontaneous report from a contactable nurse reported for herself. A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on the right arm on 22Jan2021 15:00 at a SINGLE DOSE for covid-19 immunisation. Medical history included rheumatoid arthritis from an unknown date and unknown if ongoing and cerebrovascular accident from an unknown date and unknown if ongoing. The patient previously took morphine and experienced drug hypersensitivity. On 23Jan2021 10:30, the patient experienced raised rash on face and injection site, flushed feeling face, chills, overall not up to feeling like myself, body aches and brain fog. No treatment was received for the events. The outcome of the events was recovering. Information on the lot/batch number has been requested.

Rash on my upper back; sore/tender armpit on injection arm.; This is a spontaneous report from a contactable other healthcare professional (patient). A 40-year-old female patient received bnt162b2 (Lot: EL0142), via an unspecified route of administration on 07Jan2021 (dose: 1) at 04:00 PM single dose (Left arm) and then on 28Jan2021 (dose: 2, Lot: EL3246) at 03:45 PM single dose for COVID-19 immunization. Medical history included allergies: Sulfa. Concomitant medications included omeprazole, fexofenadine hydrochloride, hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ), iron, fish oil, vitamin D and probiotic. The patient previously took azithromycin (ZITHROMAX) and experienced drug allergy. On 19Jan2021, the patient experienced rash on upper back and sore/tender armpit on injection arm. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Treatment was not received for the adverse events. The outcome of the events was not recovered.

Headache Extreme; fatigue; Pain at injection site; armpit and breast (all L) Ncek pain; armpit and breast (all L) Neck pain; armpit and breast (all L) Neck pain; This is a spontaneous report from a non-contactable Other HCP (patient). A 40-year-old female patient received the 1st dose of bnt162b2 (BNT162B2) at single dose on 19Jan2021 15:00 for an unspecified indication Covid-19 immunisation. Medical history included irritable bowel syndrome (IBS), asthma, allergies to sulfa. Patient was not pregnant. The patient had not experienced Covid-19 prior vaccination. The patient's concomitant medications were not reported. No other vaccine was received in four weeks. On 20Jan2021 the patient experienced headache extreme, fatigue, pain at injection site, armpit and breast (all l) neck pain. No treatment received. COVID was not tested post vaccination. The outcome of events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Pain at site of injection upon waking the next morning and in shoulder area. About 15 hours after vaccine. Began to feel moderate body aches all over body with a headache. Began using restroom repeatedly with significant back pain and spasms. Muscle aches and pain continue. This reaction is after the 1st dose and I have had Covid July 2020.

Pain at injection side for a week. Fevers for 2 days up to 103.9. Fever stayed around 102.5 despite taking IBU every 5 hours. Severe fatigue. Then on day 3 had severe nausea.

Swelling of hands, fingers; rash and redness on forearms/red rash; Face swollen; Very hot.; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 02Feb2021 at 03:15 (at the age of 40-years-old) as a single dose for COVID-19 immunization. Medical history included obesity from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient's concomitant medications included pantoprazole sodium sesquihydrate (PROTONIX) for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took amoxicillin/clavulanic acid (AUGMENTIN) and dextropropoxyphene napsilate/paracetamol (DARVOCET); both from unknown dates to unknown dates for unknown indications and experienced allergy. On 02Feb2021 at 15:45, the patient experienced swelling of hands/fingers, rash and redness on forearms/red rash, face swollen, and very hot; all reported as serious of being life-threatening. The events required a visit to the urgent care (physician's office). The patient was treated with epinephrine (EPIPEN) and unspecified medications at the urgent care after emergency medical services were called. The clinical outcomes of swelling of hands/fingers, rash and redness on forearms/red rash, face swollen, and very hot were recovering. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Right arm injection site swelling/red circle/pain; Right arm injection site swelling/red circle/pain; Right arm injection site swelling/red circle/pain; Right axillary lymph node swelling; Tiredness; Headache; Muscle pain; Chills; Fever; Feeling unwell; Received the first dose of vaccination on 21Dec2020/second dose on 22Jan2021; This is a spontaneous report from a contactable nurse (patient). A 40-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK9231; Expiration date was not reported), intramuscularly on the right arm on 22Jan2021 (16:00) at a single dose for COVID-19 immunization at the workplace clinic. Medical history included hypertension; obstructive sleep apnea; had used continuous positive airway pressure (CPAP); obesity; polycystic ovarian syndrome; and had COVID-19. Concomitant medications included spironolactone, ethinylestradiol, ferrous fumarate, norethisterone acetate (JUNEL FE), metformin, acacia senegal, ascorbic acid, betacarotene, calcium carbonate, calcium pantothenate, calcium silicate, cellulose microcrystalline, colecalciferol, croscarmellose sodium, cyanocobalamin, dextrin, dl-alpha tocopheryl acetate, ferrous fumarate, folic acid, gelatin, glucose, hypromellose, lecithin, macrogol, magnesium oxide, magnesium stearate, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, silicon dioxide, starch, thiamine mononitrate, titanium dioxide, zinc oxide (ONE-A-DAY WOMEN'S), vitamin D, echinacea, cranberry, melatonin and black elderberry. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730; Expiration date was not reported) intramuscularly on the right arm on 21Dec2020 (when the patient was 40 years old) for COVID-19 immunization. The patient was not pregnant at the time of vaccination. On 22Jan2021 (16:00), the patient had received the second dose of vaccination of BNT162B2 when the first dose was received on 21Dec2020. On 23Jan2021 (13:00), the patient had right arm injection site swelling, red circle and pain; right axillary lymph node swelling; tiredness; headache; muscle pain; chills; fever; and was feeling unwell. The patient did not receive any treatment for the reported events. The outcome of the events was recovering for 'right arm injection site swelling, red circle and pain', 'right axillary lymph node swelling', 'tiredness', 'headache', 'muscle pain', 'chills', 'fever' and 'feeling unwell'; and was unknown for 'received the second dose of vaccination of BNT162B2 when the first dose was received on 21Dec2020'. The patient had not been tested for COVID-19 since the vaccination.

About 12 hours after the vaccine I developed headache, fever 100.5, nausea and vomiting, and red rash across my chest up to my neck and under both breasts. All symptoms but the rash improved the following day. I went to have my 8 week pregnancy US 6 days after this second vaccine dose and there was no fetal heart rate. The baby measured 8.7mm and there should be a heart rate when the baby measures >7mm. I had all of my pregnancy symptoms up through the day of the vaccine and then they disappeared the day my vaccine symptoms improved. I do not have a history of miscarriage.

Injected arm started throbbing. Woke up out of sleep twice that night to take NSAIDS to try and make it bearable. Still 3 weeks later not able to push or pull with arm, drive care, or lift with left arm-including taking off shirt, without pain. Able to pinpoint exact place injection was given and pain associated when pushing spot. Taking NSAIDS all day long to be able to move. Finally after 2 1/2 weeks made general physician appt because it is crazy how long and how bad my arm hurts. At that time still not able to lay on left arm or lift over head. Have been to chiropractor 3 time to help relieve shoulder/muscle pain.

Swelling of hands and fingers. Forearms radshy. Face was red, swollen and rash, looked like I had a sunburn I was so red. I was very hot.

red rash came up on her chest; upper chest muscles just below her collar bone. the pressure of the water hitting her was painful; Diarrhea; pain and stiffness in her chest that extended across her shoulders; can't seem to regulate her body temperature; laboring to breathe; joint pain; pulse and it had dropped down to 40; She has a history of tachycardia, but her pulse kept reading normal; muscle pain; inflammation; she woke up and she was itchy around her left forearm. She was really itching; couldn't really taste, things didn't really taste right to her; immediate soreness in arm; she has pain that extends up into her neck; Nausea; hasn't had much of an appetite; sweating; left hand swelling; hives on forearm; gastrointestinal issues; Fever; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is the first of two reports. A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL8982), intramuscular at left arm on 21Jan2021 15:38 at a single dose for COVID-19 immunization. Medical history included Tachycardia (started about 4 years ago), Hypertension (started about 4 years ago) and Essential tremor from 2020 (she has been having symptoms for a while; finally, during the summer of 2020, she was diagnosed through a neurologist) and anxiety, all ongoing; pain, back problems and sleep disorder.Concomitant medications included ongoing Tizanidine as muscle relaxant for back problems, ongoing Metoprolol tartrate for hypertension and tachycardia, Primidone for Essential tremor and ongoing Clonazepam for essential tremors, to help her sleep, and also for anxiety. No prior vaccinations (within 4 weeks). The patient got the first COVID vaccine dose. Afterwards, she went to school and it "was downhill from there". 5 days of persistent symptoms including sweating, muscle pain, joint pain and left hand swelling. It was further reported that she had to wait 15 minutes and then she drove home which is about a 35-minute drive. So about 45 mins after receiving the vaccine, she noticed her tongue, it was more on the right side of her tongue, she can't explain the sensation. She couldn't really taste. Things didn't taste right to her. This lasted 24 hours. She woke up the next day, 22Jan2021, feeling not quite right. She took some Tylenol that morning and went on into school. She took some ibuprofen in the middle of day, it wasn't a big deal. She has a history of tachycardia, but her pulse kept reading normal. She had a drink she was drinking from lunch and she ended up having the remainder of it the last few hours of that day. At about the end of her workday, around 15:30 she was finishing the Cdrink off and she said to herself "oh that taste like a regular drink again". This tongue sensation/lack of taste resolved. At that point, she got really excited because she thought this was all that she would experience with the vaccine. She was grateful she had the chance to have the vaccine. She mentions her arm was very sore right off the bat. She experienced immediate soreness in her arm right after receiving the COVID-19. She thought when they were injecting her, it hit her bone. In fact, she joked about this with the person administering the vaccine. The person at the facility told her to rub it, it actually helps with that. This kind of soreness didn't seem like a major problem. She was still experiencing this soreness. If she is sitting on the couch sideways, with her side of her arm against the couch, she has pain that extends up into her neck. It was pretty painful. Friday, 22Jan2021 (24 hours later after receiving the vaccine), by the time she got home from work, she was really sore. She had some real muscle pain around her hips and upper thighs, both of them. The soreness extended across. It was like she had inflammation that started flaring up. She felt pretty sore that evening. It wasn't like a normal muscle soreness. She went to bed because she was pretty tired. The next morning (Saturday, 23 Jan 2021), she couldn't get off the couch. She had such bad muscle and joint pain. She slept off and on, the pain was pretty bad. Her whole body had so much stiffness and inflammation. Every muscle and every joint just hurt. She confirmed that she hasn't been able to regulate her body temperature. This has been going on since Saturday evening (23Jan2021). She stated that this wasn't normal for her. She does take medications to lower heart rate but she hadn't taken it. She was talking to her best friend about how she had been sore and slept all evening. She checked her pulse and it had dropped down to 40. Her O2 level was at 92. She didn't think it was that big of a deal. Her best friend was kind of freaking out about it. She had such pain and stiffness in her chest that extended across her shoulders, it made it difficult to breathe. She was laboring to breathe. She checked her pulse thinking maybe she was feeling anxious about it and her HR was up, but it wasn't. She states happened so bad yesterday, yesterday was worse than before. She got up on Sunday morning, 24Jan2021, and took a hot shower. When the water from the shower head hit her chest, clarified as her upper chest muscles just below her collar bone, the pressure of the water hitting her was painful. However, she was able to get up, she was moving around. Still the whole time. she had this fever-ish feeling. Her kids were telling her that they were sweating because she had the house at 76 degrees. Monday morning, 25Jan2021, she woke up and she was itchy around her left forearm. She was really itching on Friday night, but she didn't think anything about it. When she took a hot shower yesterday (25Jan2021), a red rash came up on her chest and it looked like she had hives on her forearm. She didn't know if the hot water flared that up, but she doesn't have any allergies. She also had gastrointestinal issues. She has had some nausea that has lasted the entire time since she received the vaccine. She clarifies the nausea has came and gone. She hasn't had much of an appetite. They thought she had a fever yesterday at school. It was 99. something but she had already taken Tylenol a couple hours before and she was sweating so much. She states she has also had diarrhea the last few days, clarified as the last 2 days (24Jan2021). She has already spoken to someone to report her symptoms but wasn't sure about and had question about getting the second vaccine dose. She reported having gone to Urgent care where she was told she had Post covid vaccine syndrome and that she shouldn't have a problem with the second dose. She explained she went to the urgent care yesterday, 25Jan2021. She called her doctor that morning and was told to continue to treat her symptoms and take ibuprofen and Tylenol but if she got worse, to go to urgent care. So, she went to the urgent care (Product information for the Tylenol and Ibuprofen she has been taking (Ibuprofen: UPC/NDC: not provided when probed. Lot: P142385 Expiry date: Apr2023 and Tylenol: UPC/NDC: not provided when probed. Lot: P121664 Expiry date: Sep2023). The nurse just explained (Name Withheld) was having the same exact symptoms as the patient, except it was (Name Withheld) second dose. Her symptoms were identical to the patient. The patient wasn't initially sure if it was from the vaccine or if it was her anxiety. The patient didn't feel anxious and her heart rate wasn't up. The patient told she didn't think anxiety caused her to feel like she had a fever. The school nurse looked it up and found out more symptoms kind of wax and wane. Her symptoms got much worse. On 25Jan2021, Test: Rapid COVID-19 test Result: Negative. The event immediate soreness in arm was not recovered; event couldn't really taste, things didn't really taste right to her recovered on 22Jan2021 and nausea recovered in Jan2021; and unknown outcome for the other events.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021101606 same reporter/drug, similar events, different patient

Dose number 1 start of drug 08Jan2021/Dose number 2 start of drug 25Jan2021; Rash at injection site, upper back, back of knee on right leg; generalized itching all over; This is a spontaneous report from a contactable 40-year-old female other healthcare professional reporting for herself A 40 years old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9262) on an unspecified date at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medicao history included allergies to Latex, peniccillin, Tomatoes, and Pineapple, diabetes mellitus and hypertension. The patient received first dose of BNT162B2 (Lot number:EJ1685) on 08Jan2021 intramuscular on left arm. Concomitant medications were not reported. On 26Jan2021 the patient experienced rash at injection site, upper back, back of knee on right leg and generalized itching all over. The patient did not received treatment for the events. The patient also experienced inappropriate schedule of vaccine administered as second dose was administered 17 days after first dose with outcome unknown. The patient had not yet recovered from other reported events.

Fainted twice! Causing massive head trauma & wounds. It happened 35 hours after the vaccination & I was given no warning that this could happen.

In monitoring area shortly after vaccination, patient reported to EMS observation staff she was experiencing "lip tingling." In speaking with staff during assessment, patient's symptoms progressed to c/o lower lip swelling and trouble swallowing. Redness and swelling noted around mouth and nose. IM epinephrine administered at 18:08 and 911 called for transport to hospital.

Days 1-2 after injection: tightness and ache in chest, collar bones, and ribs. Day 3: rash in left armpit Day 4: rash grew, swollen lymph node in left armpit noticeable Day 5: swelling and rash receding, still notable

had second dose of COVID vaccine on 1/8/2021, notes initially with rash and swelling of face which went away when she got home. Since then, patient has had HA but noticed swelling to left shoulder on 1/9/21. neck: 3 cm x 3 cm left supraclavicular lymphadenopathy with tenderness to palpation give ibuprofen 600mg PO x1 and discharged with Ibuprofen

1st dose Vaccine 1/9/21; 2nd dose vaccine 2/14/21; developed hives/rash 2/15/21, resolved with Benadryl; developed chest pain, SOA, HA, jaw/teeth pain , and nausea 2/17/21; seen at Clinic 2/17/21 and sent to ED same day for eval; was d/c'd home from ED 2/17/21.

Sever joint pain, headache Hives on the backside of not of my legs with itching that turned into large welts a few hours later that then turned into 2 large welts on the side/back of my upper thighs. 2 days later and ever since I have severe nerve pain that is constant and is affecting my ADLs.

24 hours post vaccine, developed bilateral eye swelling, itchy ness full body and right orbital pain along with the feeling of my heart racing. Swelling lasted 9 hrs, self medicated with Zyrtec (Benadryl makes my heart race) . Tylenol 1000mg every 4 hrs for headache pain. Headache is still present daily. Switched to 800 Motrin every 6 hrs. Headache and lower extremity muscle pain, as well as nerve twitches and cramping still occurring 8 days post vaccine.

Flushing/sweating, right-sided warmth (right arm at injection site). Patient has a history of anxiety and hypertension. Initial BP 161/102 (pulse 102); final BP 132/88 (pulse 95). Benadryl PO given.

Pt pre-medicated with benadryl prior to ariaval. Pt started getting pruitis 10 mins after administration. pt given benadryl and predisone in ED. Pt improved soon after

Lymphoid under left day swollen and bruised. 2 inches under vaccine site was swollen, red and hot to touch. Now bruising down the arm to her elbow. Last Lymphoid behind her left knee was swollen and enlarged.

Started with discomfort on arm where the vaccine was administered. When I got up to take acetaminophen, I felt very dizzy, nauseous, stay up, couldn't talk, after I drank cold water, I started with profuse sweating followed by chills, also had lower abdominal pain and pain on the left side of the chest. I went to the bathroom and did not have diarrhea. I was finally able to get up with help from my wife. Slow walking. The event lasted about 15 minutes. Since then I've take acetaminophen every 4 hrs.

Large red rash similar to COVID arm side effect appeared at the injection site. This was almost a week later.

Evening of vaccine starting around 3 pm I had Diarrhea, Nausea, Headache, & Fatigue. Over night I had chills so possible fever but I did not check it. Next morning woke up with Full Body Aches, Very Fatigued, Headache, Injection Site Pain and Swelling.

Following the injection, after approximately four hours later I began to feel some slight disorientation and tiredness. Later the same evening I experienced brain fog and confusion for the next several days as well as a terrible headache. Additionally my tongue felt tingly. All of these symptoms passed within several 3- 4 days following the vaccination. injection site discomfort was also a symptom.

Pain at the site of injection; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 40-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL 3247), via an unspecified route of administration in left arm on 26Jan2021 12:45 PM at single dose for COVID-19 immunization. The patient's medical history included seasonal allergies. The patient had no allergies to medications, food, or other products. Concomitant medications included azelastine hydrochloride/fluticasone propionate (DYMISTA) and cetirizine hydrochloride. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. On 26Jan2021 16:00, the patient experienced pain at the site of injection. The event was considered as non-serious by the other healthcare professional. The patient did not receive any treatment for the adverse event. The outcome of the event was recovered on an unspecified date in 2021.

The day of the vaccine my left arm was in pain. The pain continued to get worse the next day. I was unable to touch or move my arm without intense pain. It felt as though my arm had been stabbed. A week later I noticed a patch of hair loss on my scalp. I went to a dermatologist and was diagnosed with alopecia. There is no family history of alopecia and the only thing I can think of that could have triggered my immune system to start attacking itself is from my bodies response to the vaccine.

light headed; woke up with hives on my neck; This is a spontaneous report from a contactable Other Health Professional (patient). A 40-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number PAA15 6651), via an unspecified route of administration in left arm on 03Feb2021 09:00 at single dose for Covid-19 immunization. Medical history included allergies to medications, food, or other products: Penicillin. Pregnant at the time of vaccination: No. Facility where the most recent COVID-19 vaccine was administered: Workplace clinic. Prior to vaccination, was the patient diagnosed with COVID-19: No. There were no concomitant medications. Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. List of any other medications the patient received within 2 weeks of vaccination: None. The patient previously took erythromycin and experienced Allergies: erythromycin. The patient experienced light headed and woke up with hives on her neck on 04Feb2021 06:00 with outcome of recovered in Feb2021. Since the vaccination, has the patient been tested for COVID-19: Yes. The patient underwent lab tests and procedures which included BinaxNOW Covid-19 Ag Nasal Swab: negative on 05Feb2021 and negative on 08Feb2021. No treatment received for the adverse event. AE was not resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.

I received the first dose on 12/30/20 and the 2nd dose on 1/20/21. I started have an allergic reaction after eating walnuts on 1/30/21. I have never had reactions to nuts before. I had swelling, itching and rash on my face. I took Benadryl and after 32 hours, my symptoms improved. I have since avoided tree nuts. I have also been having wrist and finger "tightness" in both hands since 2/10. and it seems to wax and wane. Both hands feel stiff. Prior to the vaccinations, I have had no health conditions. I have an appointment w/ my PCP later in the month.

My face began to itch around 9 pm last night. I woke this morning with a slightly swollen face and extremely itchy face even my ears. I took a antihistamine which has helped but it still itchy. It?s currently 1 pm the following day after the first dose

During the observation period after the vaccine, at the 5-6 minutes time frame, my heart was pounding like palpitations. My arm was warm up to my chest. EMS was called. They took my vitals signs. All of my vitals were normal accept my pulse was elevated 113 and then it finally came back down to 108.

Her hand is a purple color; Her skin feels like a BP cuff is on it; entire left arm is swollen and red; entire left arm is swollen and red; Her entire left arm, which is the arm that received the vaccine is swollen and red. It feels like the circulation is being cut off; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the 1st dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Lot number: EL8982 and Expiration date: 31May2021), via an unspecified route of administration at the left arm on 21Jan2021 at a single dose for covid-19 immunization. The patient's has no medical history. There were no concomitant medications. On 22Jan2021, her entire left arm, which is the arm that received the vaccine is swollen and red. It feels like the circulation is being cut off. It hasn't been seeming to get better. The first time she noticed it was the morning after the vaccine. Her entire arm was swollen. She thought it would dissipate. At times it has kind of gotten better, but then the swelling keeps coming right back. Like right now her arm was uncomfortable in her coat. On an unspecified date, her hand was purple color. Her skin feels like a BP cuff was on it. She has not had treatment for it. The outcome of the events was not recovered.

patient experience swollen neck, itching, and elevated heart rate. she was administered 1/2 iv dose of benadryl by local emt. Symptoms resolved.

pain at injection site, myalgia, severe headache, joint pain x 3 weeks, psoriasis flare, carpal tunnel syndrome flare, chills, menstrual spotting, ovarian cyst

rash appeared in both upper arms/the rash had extended to the rest of the arms/ both legs also displayed the rash; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9262), via an unspecified route of administration in left arm on 25Jan2021 14:30 at a single dose for COVID-19 immunisation. The patient has no medical history. No allergies to medications, food, or other products. Patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. On 25Jan2021 21:00, a few hours after receiving the vaccine, a rash appeared in both upper arms. By the end of the day, the rash had extended to the rest of the arms. After 36 hours of receiving the vaccine, both legs also displayed the rash. The event was reported as non-serious. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse event. The outcome of the event was not recovered.

Patient describes hives over anterior neck and chest approximately 1-2 hours after receiving the injection. The rash lasted about 3-4 days and then resolved.

Headache; pain at injection site; This is a spontaneous report from a contactable consumer (Patient). A 40-year-old female non-pregnant patient received first dose of bnt162b2 (formulation: Solution for injection, Brand: Pfizer, Lot number: unknown) via unspecified route of administration at 12:15 on 27Jan2021, on left arm at single dose for COVID-19 immunization. The patient medical history was not reported. The concomitant medication included CELEXA (celecoxib), NEXIUM (esomeprazole sodium) and ZYRTEC (cetirizine hydrochloride). It was reported that on an unknown date in Jan2021 at 07:00, the patient experienced headache and pain at injection site. The events were reported as non-serious by the reporter. The patient had not diagnosed with COVID-19 prior to vaccination and since the vaccination. It was reported that patient had no allergies to medications, food, or other products. The outcome of the events was not recovered. Information on the lot/batch number has been requested.

Near injection site is raised, red rash near injection site. Red marks above and below injection. Very hot to the touch.

Patient had 2 minutes left on her 20 minute post-vaccination observation and began to complain of metallic taste, tongue feeling wierd and facial itching; no SOB, no rash or redness noted; Vitals were WNL, given Benedryl 50 mg chewable and drink of water; at no time did client c/o or appear SOB, pO2 remained at 99% and vitals remained WNL; continued observation for an additional half hour and c/o subsided; client released to home.

Once injected, I felt a Swooshing in my brain, immediate numbness in my arm and fever in fifteen...nurse had me lay down for ten mins. Still felt weird and numb in arm, she said it was normal and sent me to leave. Tem mins into my car ride home my left cheek starting tingling and going numb. The nerves in my left leg began tingling all over. By the time I got to the hospital, I had similar symptoms of Temporary paralysis on left side yet my limbs were still functioning. When I left the hospital a few hours later, I was like 50 percent numb on my left side, all test results showed everything was good, blood, EKG and cat scan. I felt like I'd been injected with novacaine all over the left side of my body and I was in the stage where it is starting to wear down with tingling and itching on my hand leg and cheek on my left side. My back on left side and neck locked up. The numbing in my face took two weeks to decipate. While exercising never agitation occurred and felt like nerves were firing for two weeks. Severe ear nerve pain occured within first week. Followed up with personal doctor had mri of brain w/ and without contrast and that looked good. I am pretty healthy, maybe a few extra covid lbs. EKG good, CT scan good, blood work good. I am waiting to see neurologist for more testing. There is still random tingling in and out, very faint on left side of my body only. Use of my left hand feels

Dizzy Friday when given shot, Chills and fever Friday night, upset stomach, headache, low grade fever on Saturday, upset stomach, headache, lowgrade fever on Sunday, Swollen lymph nodes, rash on chest/shoulders/upper back and chills Monday, Rash spread to torso, arms, legs and neck, eyes burned and left ear hurt, chills, fever was 104, resting hear rate was 120 bpm

Rash from latex: Rx steroid ointment for earlier unrelated rash, Benadryl Wine flush/congestion: nothing Face swelling/redness/shortness of breath: Benadryl

I developed a very bad migraine about 4 hours after getting the vaccine that lasted all night and the next day my arm was very tender where I got the shot. The adverse side effect I'm most concerned about developed 2 days later. I noticed it hurt to turn my head and realized I had a lump on the right side of my neck sort of under my chin but a little to the right of that. It's making my throat hurt even though my throat itself is fine and the pain from this knot is radiating up to my right ear. I'm sure it's a swollen lymph node. I've had swollen lymph nodes before with strep throat but never have they hurt as much as this is and I've never had just one lymph node swell until now. I got the shot on a Saturday and this symptom began on Monday. I've been dealing with it for 3 days now, so if it's now gone in 2 more days I'll be going to my doctor for evaluation. I just wanted to report this and I was also wondering if this reaction has anything to do with the brain tumor surgery I had for an acoustic neuroma brain tumor and they put a metal plate in my head that my body had a bad reaction to causing hives, itching, and a lot of extra pain and irritation.

Histamine reaction: red, hot sweaty cheeks that became a little puffy; slightly itchy lips; red splotchy patches on parts of my legs, chest, feet (mostly toes), and hands (mostly fingers). Started with my cheeks within minutes of the shot, got worse over the next hour. It took about 4-5 hours to dissipate. But even the next day, I have been a little itchy.

I woke up on 2/27/2021 with a red rash on my neck, chest, stomach, back, arms, legs, bottom and pelvic area. I called the on call physician. Took over the counter Benadryl. The rash cleared up on Monday, 3/1/2021. Still feel itchy on 3/1/21, 3/2/21, 3/3/21, 3/4/21. Used over the counter hydrocortisone cream.

Pt. c/o itching of eyes, abdomen, behind ears and sore throat. Denied SOB or chest pain. Hx of anaphylaxis to TDap and NSAIDs. Pt stated felt similar to other reactions in past. 0917 BP 175/112 and 0927 170/105. Pt. states forgot to take BP meds. 0921 Benedryl 50 mg IM given per Dr. orders. Pt. observed for 20 min and reported all symptoms subsided. Pt. released to home driven by spouse.

Fevers ranging from 99-103 daily for 3 weeks now, headache x 3 weeks, body aches, nauseous x 3 weeks, facial rash/flushing daily the past week 2 weeks from last dose. Severe fatigue unable to do my daily activities, missed work and sought care by pcp. Trying to see immunology at where vaccine was administered and Getting the run around by everyone.

Within 5 min I had hives and facial swelling. I was given Benadryl and 20 min later I had body shaking/tremors

Headache since about 15 minutes after injection. Injection site pain started about 10 minutes after injection and stopped after day 2. Tiredness started a few hours after injection and got better after day 4. Muscle pain and chills started the same day and stopped on day 4. Injection site swelling started on day 2 and went down on day 4. Injection site redness started as pink but is now purple. Nausea started within 10 minutes of injection but went away the same day. Feeling unwell started the same day of the injection and has been ongoing off and on since. My whole arm felt swollen on Saturday. The same day, I started noticing blood blisters on my fingertips on my left hand. More and more have shown up since then.

Fast onset of Tiredness occurred at 11:00pm until 11:00am.. Sore arm at injection site lasted for 4 days. Trouble breathing, felt like a weight on my chest and it was difficult to speak lasted for 90 minutes.

I started to itch all on my legs at first and when I would scratch the itch, I would get hives and bumps in that area. Itching spread to arms, head and back. I would itch at random times and random spots on my body. Itching became worse after my second vaccine on 3/2/2021.

A few hours after receiving my 2nd dose vaccine I got sores on my tongue. The following day I felt very fatigued, had a low fever for a couple hours, sore neck and shoulder to the injection site, sore throat, headache, light sensitivity and hazy/foggy feeling. I also had a finger feel sore and inflamed for about 5 days. It has been 1 week now and I still have major fatigue, headaches, brain fog, morning sore throat and just a feeling of ?not well?. I try to workout, but after I get so fatigued I can?t perform regular daily tasks. I have been so foggy, I can?t help my kids with their school work.

1. Joint pain start 02112021 end 02222021 2. Skin rash and itchy start 02182021 and faded overtime. 3. Pregnant 02172021?miscarriage 03072021

Received COVID Vaccine Dose #1 Friday morning around 8am. Pain at injection site was manageable. Friday evening I began to feel achy. Went to bed and woke up around 1am Saturday with a fever (101.5), muscle aches and chills. I also had a headache but headaches are more common for me so may or may not have been related to the vaccine. Fever subsided with ibuprofen. Continued to take ibuprofen every 6 hrs throughout the day on Saturday. By Sunday, I felt fine. FYI I did have COVID back in December.

About 10 minutes after receiving the vaccine, the back of my neck started tightening badly and started getting uncomfortable. My throat then started to get dry and began breaking out with a rash on my neck and chest. This lasted about 30 minutes before the symptoms started to cease (in total 45 minutes after receiving the vaccine). Within 2 hours after receiving the vaccine, all symptoms had subsided. Treatment - at the vaccine clinic, EMTs observed me and took my vital signs. My blood pressure was slightly elevated, but did not require medical treatment. They continued to monitor me with the recommendation that I use my EPI-pen if symptoms got worse and instructed me to seek emergency medical treatment if symptoms got worse. No further treatment was sought out as symptoms all started to improve.

Left arm pain between elbow and wrist, extreme nausea, pounding headache, dizziness, blurry vision, rash on face, extreme fatigue

Mild shoulder muscle soreness at site injection day of 2nd dose; next day, lymph node (underarm) was noticeably swollen to the size of a small orange - symptom began to subside by morning of 3/15/21.

Patient reported "my throat is closing up", then devoped generalized pruritis, more tightening and dyspnea. Epinephrine 0.3IM and EMS called. She refused transport. She called her primary care office who also urged her to go to ER 15 minutes later symptoms recurred along with anxiety EMS administered Epi IM, benedryl and solumedrol IV. She then refused transport again and departed. 10:22 - 114/81 P-111 02 98% 10:31 137/70, 102, 99% 10:40 130/80, 106. 98%

injection site that was raised, red, itchy and warm; injection site that was raised, red, itchy and warm; injection site that was raised, red, itchy and warm; injection site that was raised, red, itchy and warm; knot at her injection site; This is a spontaneous report from a non-contactable pharmacist. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot EL9262, first dose (at the age of 40 years), intramuscular on 28Jan2021 at single dose for covid-19 immunisation. COVID-19 vaccine was administered at hospital. The patient medical history and concomitant medications were not reported. It was unknown if the patient was pregnant at the time of vaccination. On 29Jan2021 the patient experienced injection site that was raised, red, itchy and warm. One week later she still had a knot at her injection site but it was getting smaller daily. It was unknown if treatment was received for the events. The patient contacted per PCP and it was explained that it was secondary to the vaccine administration. It was recommended to receive the 2nd dose of the vaccine in the opposite arm. The events were non serious with outcome of recovering. No follow-up attempts are possible. No further information is expected.

fine maculopapular rash on right side of face, onset ~4-6 hours after vaccination, not painful or pruritic

Full body hives. Started on my right arm, then spread throughout the day. Still have some hives on my head, face and legs. Very itchy, warm to the touch.

Strong muscular pain in the arm, almost mobile since the date of the second vaccine dose. It has been almost three weeks with an aching arm.

Red rash on chest. Got the same rash when I got Covid back in January. I feel very light headed and tired. Sore arm. Took 2 Tylenol. Nothing has helped .

Saturday, March 13 I started experiencing burning on my stomach and back. Sunday morning, March 14 I noticed a rash on the right side of my stomach and side body. I went to the nurse practitioner at CVS minute clinic on Monday, March 15 who diagnosed me with shingles. I was given an anti-viral medication to take 3 times a day for 7 days. I continue to experience burning on my stomach and back. Although I have had chicken pox as a child, this is the first time I have had shingles.

I received my second dose of the COVID vaccine on 3/5/21. The symptoms began on 3/7/21 with pain in my upper left arm. The next following night, I was awakened by sharp pains from the top of my left arm to my fingers. Even the back of my left arm is swollen. It even traveled down my back. I went to urgent care on Sunday 3/9/21 to see what had happened. A CNP said it seems musculoskeletal and the pain radiated from the injection site. I've taken Tylenol, Ibuprofen, been prescribed muscle relaxers and steroids to numb the pain but it doesn't work. This is still occurring to this day.

BlurredVision, Dizziness, Myalgia, Arthralgia, Fever, Angioedema, INJECTION SITE PAIN, SWOLLEN GLANDS Narrative: Other Relevant History:

I received the 2nd shot out of the Covid 19 series on Wednesday March 10th. I had severe left arm pain where I received the shot, could not even sleep on it and/or lift it. The following morning I woke up to go to work and throughout the day the symptoms progressed.it began with slight dizziness, headache, fatigue, nausea, chills and fever for the 24hrs following -- I ended up taking Tylenol Extra Strength for relief of the headache/fever. Exactly 6 days later I felt an itching on my wrist that later progressed to "Covid Arm" swelling at the site of injection, onto an upper body allergic reaction with hives then later to lower body as well. it has been relieved with Benadryl nightly.

Within 2 to 3 minutes after the shot, I experienced swelling in my throat. My glands were sore. I was monitored for 30 minutes by the nurse and as the symptoms were not getting worse she suggested I drive home and take Benadryl. It was a 45 minute drive. Halfway home (about one hour after my shot) I started experiencing itching, swollen tongue, swollen lips. I took 62.5 mg of Children?s Benadryl and met up with my husband and he drove me to the ER, arriving at about 10;15. After being there about 15 minutes some of my symptoms started going away. At about 11 a rash appeared on my chest. The ER doctors gave me Pepcid 10 mg around 1130 or so. They just charge me and recommended I follow up with my allergy doctor.

diffuse rash on body with hives on chest, back and bilateral arms - Benadryl for three days and rash resolved - rash has recurred three weeks later with rash on chest, back and bilateral arms - second rash has not resolved

I began to feel very itchy all over my body within 30-60 minutes, I felt swollen in my hand, feet, tongue, my mouth and throat felt itchy, the itching got so bad that i had hives in some places such as my forearm and legs and skin just felt like it was on fire, I had issues breathing and felt as though someone was sitting on my chest, i have been shortness of breath since and have trouble catching my breath.. This was all that same night. The next day I had the same issues adding the sore arm of the injection site and feeling very tired all day. the next day from there am I am feeling better but am still experiencing shortness of breath, I am using my inhaler, I am still itchy but not as severe as the first night or next day. The arm tenderness has gone unless you touch the injection site and am no longer feeling over tired.

severe body aches; slight fever; chills; severe diarrhea; dizziness almost fainted; fast heart beat; headache; pain in the injection site; This is a spontaneous report from a contactable consumer (patient). This 40-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown), via an unspecified route of administration in the right arm on 26Feb2021 09:30 at a single dose for COVID-19 immunisation. Medical history included allergies: dairy. Concomitant medications included ergocalciferol, retinol palmitate (VITAMINS A & D), apple cider vinegar (APPLE CIDER VINEGAR), cranberry, and allium sativum (GARLIC (DEODORIZED). Patient is not pregnant at time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Feb2021 14:30, on the first day, patient experienced moderate headache and pain in the injection site. On 28Feb2021, the second day, patient experienced severe headache, severe body aches, slight fever, chills, severe diarrhea, dizziness almost fainted, fast heart beat. Patient is recovering from the events. No treatment was received. Information on about lot/batch number has been requested.

Received vaccine around 11:40am. Around 7pm same night on 3/19/21 noticed rash to tops of both feet, with mild swelling and itching to feet and lower legs. Took 2 benadryl and went to sleep. Woke up this morning with facial swelling, eyes swollen shut. Took Claritin and states improved greatly. Reports itchiness in throat but denies difficulty breathing, throat swelling, chest pain or shortness of breath. Rash on feet/legs was gone when she woke up, still has itchy sensation to body but no rash. Patient reports improving symptoms at time of evaluation in Urgent Care, but would like to report side effect/reaction.

About 30 minutes after getting the vaccine I was driving home and suddenly felt like I was losing consciousness. It lasted for a few seconds and then the feeling went away. I called 911 because I didn't know what was happening and other than a bit of an elevated heartrate I was ok so I deferred the option to go to the hospital. At the time that the paramedics were checking on me, one of them noticed a red area on the inside of my right elbow. I hadn't noticed it until then, but it could have been there and I just missed it. After about 2 days the rash appeared on my left inner elbow. It didn't really itch but it was painful and felt very dry and irritated. I was told it looked like eczema so I began using eczema cream. It has seemed to help a little. I have never had eczema prior to this. I contacted my doctor and he said he had no way of really knowing if it was an allergic reaction.

body aches; prickly skin; Intense pain at injection site and in right shoulder traveling down to elbow. Unable to raise arm overhead.; Intense pain at injection site and in right shoulder traveling down to elbow. Unable to raise arm overhead.; Intense pain at injection site and in right shoulder traveling down to elbow. Unable to raise arm overhead.; Chills; fatigue; general malaise; This is a spontaneous report from a contactable Other HCP, the patient. A 40-year-old non-pregnant female patient first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Lot Number: UNKNOWN), via an unspecified route of administration, in the right arm on 03Feb2021 at 12:00 PM (at the age of 40-years-old) as a single dose for COVID-19 vaccination. Medical history included patient was diagnosed with COVID-19 (prior to vaccination). Since the vaccination, the patient had not been tested for COVID-19.The patient had no Known allergies. Concomitant medications included multivitamin and magnesium supplement. On 03Feb2021 at 16:00 the patient expereinced Intense pain at injection site and traveling down to elbow. Unable to raise arm overhead. Chills, body aches, fatigue, prickly skin, general malaise. No treatment was received for the events. Outcome of the events were recovered on an unspecified date. Information on the lot/batch number has been requested.

Approximately one week after receiving my first dose of the COVID19 Pfizer vaccine, I experienced soreness, redness and itchiness at and around the injection site. All three symptoms lasted 3 days and then cleared. The itchiness was treated with a topical cortizone cream which did provide relief.

The Chief Complaint is: 40 y/o F with history of allergic rhinitis including systemic reaction to skin testing years ago presents for COVID vaccination. She and I discussed getting vaccinated with her history a few weeks ago and I recommended vaccination. She reports that today she is in previous good health but 15 minutes after vaccination she started to feel itching all over her body which was rapidly followed by throat itching and difficulty swallowing. She was taken to the treatment area of the vaccination center and evaluated. - Pruritis, flushing, sclerae injection after COVID vaccination with PFizer vaccine. May be allergic or due to complement release. Treatment course - took patient back to the treatment area and administered 0.3mg epinephrine with rapid improvement in symptoms and signs and minimal side effects. Follow up BP lower, flushing improved, sclerae improved and throat symptoms improved. Called 911 for EMS response to observe her in the ED will complete VAERS and contact patient by phone for follow up

Had localized itch on back prior to vaccine. Within days or at most a couple weeks of receiving the second dose of my vaccine I started to have symptomatic dermatographia with scratching that manifested as follicular urticaria. This became more widespread where ever I was itchy and scratched. Im being treated with antihistamines and it is improving but not resolved.

Nurse injected but needle may have not been at 90 degree angle and more toward 45 degrees. there was some bleeding from site immediately upon removal of needle and some palpable swelling in sub dermal tissue thereafter. The question is whether this was fully injected into sub cutaneous tissue, partially into sub q and partially into muscle, or into muscle tissue. The patient was informed of possibilities and was to call if any further swelling, bruising or pain. I will follow up by phone on 24 march 21.

Pt presented to the medical tent with complaints of tingling in her tongue. States has long history of allergies, has 2 epi pens with her and premedicated herself prior to coming to the vaccination site with 50 mg of PO benadryl at 1100. As pt was monitored she developed a rash on neck that was splotchy, flat, red. Tongue tingling stopped and moved to her fingers. BP was 152/90, other VS were WNL. Seen by MD on site. 1252 pt was feeling better, rash gone, all tingling gone. Pt left on own from vaccine site.

After 12 days, I am still experiencing a lot of tenderness in my arm. It is slightly red and swollen at the injection site and I have overall felt rundown for 12 days now.

Rash started on stomach near belly button, over 24 hrs spread to my neck, face, ears, now starting up my arms.

Patient presented with tightness in chest after 1st dose of COVID vaccine. Patient has history of severe allergic reactions to vaccinations. Administered 50mg of Benadryl PO. Patient condition worsened rapidly with hives and anxiety. 911 contacted for transport. 0.3mg Epi administered in right deltoid. Epi began working quickly. Care transferred to EMS and transferred to Hospital.

Worse asthma than usual for several hours, but not so bad that I had to use my rescue inhaler. At noon I had severe pain the entire length of my right arm, and I felt drowsy so I fell asleep for several hours and the pain in my arm was moderate and restricted to injection sight when I woke up. I went to bed at 10 pm and woke up at 1 am with diarrhea. I spent the the next hour having a few diarrhea bowel movements. On 3/20 my right arm was still in moderate pain and injection site was swollen and red. At 8 am I woke up with a headache and so I went back to bed. By afternoon I had the chills and went to bed for another nap and when I woke up the chills were gone. On 3/21 my right arm still had moderate pain. On 3/22 I had another bout of diarrhea for one bowel movement, and my arm pain was still moderate. On 3/23 the swelling and redness at the injection site went away but the area is still slightly tender to the touch on 3/25. On 3/25 at 1 am I was in bed trying to sleep, but I kept having intense dizzy spells that lasted 3-4 hours.

Swelling/soreness at injection site. Diarrhea beginning the morning after injection and lasting into the evening. Treated with over-the-counter medications (Ibuprofen and Imodium)

One week after my first dose, my arm got swollen and itchy at the injection site. It lasted several days.

03.15.2021 1:40 vaccinated 1:55 left site, returned home ~3:00 began itch around waistband. Aleve for back. 3:30-4:00 symptoms undeniable: itch on neck, face, trunk, lips tingle/swell, lump in throat. Hoarse. No hives. 4:00 Claritin 4:30 talk to Dr take vitals (Sp02 100%, heartbeat normal, BP 131/79, pulse 67, temp normal) 5:15 Benadryl 5:30 itch spreads to whole body, including legs 6:30 talk to Dr Symptoms steady now. 7:30 fall asleep from Benadryl 8:30 wake up for dinner 9:30 laying in bed, breathing becomes shallow. O2 and bpm still normal. 10:00 Talk to Dr. Advises ER if vitals outside of norm. Report to PCP in am. 11:00 breathing normalizes. Sp02 and bpm normal, BP 122/82, pulse 70. Aleve before bed. midnight-1:00 fall asleep 03.16.2021 7:20 Wake up. Water, Wellbutrin, Aleve. Read in bed about an hour until fall back asleep. 11:15 Wake up. Headache. Sp02, bpm, temp, normal. Stay in bed. 12:25 Send report to Dr. 12:30 Get out of bed for first time; coffee, bathroom. Back to bed. 1:10 Spoke with triage nurse. Concern is that lips are still swollen at almost 24 hours. Recommends urgent care for steroids if increased lip/face or respiratory symptoms. Can take Claritin an hour early. 2:30 Get out of bed and shower. Warm to wash, cool to rinse. Got dressed, moved around. Increased itching, skin mottled; still no hives. Aleve. 3:00 Claritin, call from Dr nurse. 3:30 Heat up late lunch, continue to move around the house, answer work questions. 4:30 Upticked symptoms not abating, still mottled skin, lips more swollen. Harder to swallow and dry cough starts, worse when talking. Take vitals: Sp02 and bpm normal, BP 107/83, pulse 73 5:00 Leave for urgent care; BP there 159/71, pulse 79, temp normal. No steroids. Referral to allergy/immunology. Prescription H2 inhibitor, switch to Zyrtec in am. 6:40 Pepcid. Back in bed. 11:30 Benadryl, Aleve. 12:40 Sp02, bpm normal 1:15 Fall asleep 03.17.2021 8:55 Wake up. Water, Wellbutrin, Aleve. 9:30 Sp02, bpm normal. Get up for Pepcid, Zyrtec, bathroom then back in bed. 11:20-11:40 Dozed off, woken up by heart symptoms. Palpitations, panic feeling. Sp02, bpm normal 12:45 Dr called. Allowed to switch back to Claritin tomorrow. Recommends Benadryl more often. Allergy: 504.842.6742 Dr 3:00 Aleve. BP 117/80 pulse 75 4:15 Benadryl 8:20 Hoarse again 9:20 Pepcid. Itching increasing as Benadryl wears off. 10:20 Benadryl 10:30 BP 103/77, pulse 73. Sp02, bpm normal, PI 2.5% 11:45 Aleve 12:00 itching increasing as move around/get ready for bed 1:15 Fall asleep 12.18.2021 6:30 Benadryl. Tired, itch still present (improving), headache. Fell back asleep 7:30. 8:55 Water, Wellbutrin, Aleve, Claritin, Pepcid. Fell back asleep until 11:30 11:45 Sp02, bpm normal, PI 8.0 2:00 Finished shower, didn't worsen itch. 2:45 Aleve 6:00 Been "on" for work about 4 hours. Exhausted. Nauseated. Verge of collapse. Most itching is face/scalp and clothing seams. Lips almost normal though. 8:00 Meds definitely wearing off; face/lips symptoms increasing again. 8:30 Benadryl. Throat symptoms. Swollen lymph nodes. 9:15 Pepcid. Slight cough returned. 10:30 BP 120/85, pulse 80 (was just moving around quickly), Aleve. Itching better, throat/lymph nodes painful 12:45 Benadryl. Ibuprofen. Neck muscles hurt too. 1:15-1:30 fall asleep 03.19.2021 9:00 Water, Wellbutrin, Aleve. Throat still swollen. Itch primarily face/head, back of thighs. 9:15 Pepcid, Claritin. Sp02 normal, bpm low (51-53 back in bed), PI 4.1 3:15 Aleve. Lump in throat still impacts swallowing. Eating makes me hoarse. Neck muscles hurt. 11:00 Pepcid 12:15:Benadryl, Aleve. BP 109/76, pulse 69 2:30 fall asleep 03.20.2021 10:00 Water, Wellbutrin, Aleve. Lips swollen again. 10:15 Pepcid, Claritin 11:25 Symptoms: itching better, mostly gone from body (remains on head). Headache. Throat/neck improved. Lips still swollen. Sp02, bpm normal. PI 10.2% 6:00 Aleve. Itching only head/face. Throat/neck still symptomatic. 11:30 Aleve, Pepcid. Sp02 normal, bpm 70s. 12:15 Benadryl 1:20 Throat sore but no lump. Lymph nodes returning to normal. Still some itch head/face/neck. 1:45-2:00 fall asleep 03.21.2021 7:00 Claritin, back to sleep 11:00 Aleve, Pepcid, Wellbutrin. 5:00 Aleve 11:10 Pepcid, Benadryl. Mild itching. No lump. Throat still slightly sore. BP 113/77, pulse 69 12:20 Aleve 1:15-1:30 fall asleep 03.22.2021 9:45 Water, Wellbutrin, Aleve, Claritin, Pepcid 5:50 Aleve 10:00 Pepcid 12:15 Aleve. Minimal, occasional itching. Lips almost normal. Sp02 normal, bpm 70s 03.23.2021 9:45 Water, Wellbutrin, Aleve, Claritin, last Pepcid

Felt slight swelling in left armpit exactly one week after the vaccine (3/25). On 3/26 swelling was mildly painful and the place of original shot was red and slightly raised.

First 24 hours: Large red raised hot-to-touch bump at injection site (applied ice pack) Severe pain from site up back of neck and down to fingers Low grade temperature 99.9° Next 24 hours: Still have large raised red hot-to-touch bump at injection site but now site is very itchy (applied ice pack) Pain has dulled but still present Fever gone Sore throat and slightly swollen tonsils

4 hours after the shot, I noticed that my left eyelid was a bit swollen. No pain or itchiness. Not sure when it began to swell. I didn't think much of it, until about 2 hours as I could feel that it was more swollen. I was with friends, they recommended benedryl. So, went and talked to a pharmacist. On the way there, back began to feel itchy (similar to when I have broken out in hives in the past when an allergic reaction starts). Pharmacist recommended 25 ml of liquid benedryl every 4-6 hours and increase to 30 ml if swelling remains. After 1-2 days, if still present to go to doctor. I already have a doc office visit early Monday morning.

Rash on thighs, arms and ankles developed 12 days after 1st dose and subsided 1 week after presentation.

First pregnancy, due date 8-11-2021 Adverse effects: - mild headache for 1-2 hours (went away after taking Tylenol) - sore arm at site of injection

After receiving the vaccination the patient presented about 10 to 15 minutes later with a spotted purple-red rash on the inner aspect of the forearms. This was the only symptom reported at this time. The patient was monitored for about 45 minutes. During this time the patient reported having a racing heart and some mild dizziness. As time passed no worsening of the rash was seen or reported. After sitting calmly for a period anxiety symptoms also subsided. After making sure the patient was able to walk and function normally she was instructed to get immediate medical attention if there was any worsening of symptoms or if there was no improvement.

On 3/10/2021 Migraine headache started at 6:15pm Ear ringing (tinnitus) started at 7:00 pm 3/11/2021 Additional hearing muffled was was noticeable 3/16/2021: severe migraine, throwing up, nauseous 3/17/2021: facial rash prominent **hearing loss deemed permanent, ringing continuous

Signs/Symptoms: Macular rash on face, upper arms and chest; "tickling" in throat. Treatment: Benadryl PO @ 14:10.

Two days after vaccination patient developed new onset itchy, raised rash over the left arm, chest, face and neck. Clinical signs consistent with eczema/contact dermatitis/atopic dermatitis, but patient does not have a history of these disorders. No shortness of breath, diarrhea, fever, vomiting or other signs of anaphylaxis.

Left Eye swelling; Severe Itching all over; Severe Headache; Stiff neck; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient she received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6198) via an unspecified route of administration in the left arm on 26Feb2021 at 16:30 (at the age of 40-years-old) as a single dose for COVID-19 immunization. Medical history included variable immune deficiency, asthma, and eosinophilic esophagitis (EOE). Allergies to medications included amoxicillin, erythromycin, clindamycin, ciprofloxacin (CIPRO), sulfamethoxazole/ trimethoprim (BACTRIM), and oxycodone/ paracetamol (PERCOCET). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications were not reported. On 26Feb2021 at 17:15, the patient experienced left eye swelling, severe itching all over, severe headache, and stiff neck. The patient was not treated for left eye swelling, severe itching all over, severe headache, and stiff neck. The clinical outcome of left eye swelling, severe itching all over, severe headache, and stiff neck was not recovered.

2:15pm Pt stated she felt dizzy and nauseated. Pt was alert and oriented. Warm and dry to touch. B/P @ 128/75 p-89 Code assist Team called and was taken to Adult walk in Clinic.

At first my arm was sore at the sight. I was very tired. Then three days later I noticed a rash on my right under arm. It was red and itchy. Then it went to my right right under arm red and itchy. Now its on my legs small spots red rounded from the top of my leg all the way down to my foot on both legs

Period started early and was heavier and lasted longer than normal. Also developed rash on arm near injection site. Both resolved within 7 days.

swollen, hot, itchy welt at injection site >48 hours after injection; symptoms reduced 3 days after injection and disappeared about 4 days after injection; was 23 weeks pregnant at time, estimated date of delivery is July 24, 2021

Anaphylactic shock. Tongue, Hands and feet swelling. Hives all over body, skin felt like it was burning from itching so bad. Inside of mouth and throat itching. Chest felt like someone was sitting on it.

Patient received vaccine and within 5 minutes began feeling itchy all over and reported shortness of breath and reported throat was beginning to feel tight. Epi-Pen administered per RN at 1046. BP was 100/62 HR 70 bpm, oxygen saturation 99%. Nasal canula applied at 1048 due to decreasing oxygen saturation. Oxygen saturation promptly returned to 100%. Stat team called and responded, patient taken to ED at 1055 with resolving symptoms, decreased anxiety, and no shortness of breath with an oxygen saturation of 100%.

Redness at the injection site 9 days after dose 1; This is a spontaneous report from a contactable other health care professional (patient herself). A 40-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Ek4176), via an unspecified route of administration in right arm at the age of 40-years (non-pregnant at the time of vaccination), on 03Feb2021 at 02:30 PM at a single dose for COVID-19 immunization. The patient's medical history was reported as none. The patient had no known allergies. Concomitant medications included desogestrel, ethinylestradiol (VELIVET), loratadine, pseudoephedrine sulfate (CLARITIN-D), and cyanocobalamin (VITAMIN B 12 [CYANOCOBALAMIN]). The patient received other vaccine in four weeks was reported as no. Prior to the vaccination, the patient was not diagnosed with COVID. On 13Feb2021 at 08:45 AM (9 days after dose 1), the patient experienced redness at the injection site. The patient did not receive any treatment for the event. The outcome of the event was not recovered. It was also reported that post vaccination, the patient had not been tested for COVID.

sore arm where shot was given; nauseous; shortness of breath; tongue tingly; right Eye bothersome; metallic taste; elevated heart rate; headache; This is a spontaneous report from a contactable consumer (patient). A 40-year-old non-pregnant female patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number: EL 3257, Expiration date: unknown) via unspecified route on 30Jan2021 01:30 PM, in the left arm, deltoid at a single dose for COVID-19 immunization. The patient's relevant medical history included asthma and seasonal allergies. Concomitant medications included Nortriptyline, oxcarbazepin, montelukost. It was reported that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that the patient did not have COVID-19 prior to vaccination or tested since the vaccination. On 30Jan2021 at 02:00 PM the patient experienced very sore arm where shot was given, nauseous, shortness of breath, tongue tingly, right eye bothersome, metallic taste, elevated heart rate and headache. It was unknown if the patient had received any treatment for the events. Outcome of events was not resolved.

On 3/29/2021, I noticed a red spot on my arm near the injection site, but forgot about it. Today (4/1/2021), I noticed a very large red blotchy area on my right arm - it appeared to have spread from the original red spot. The area is approximately 17cm by 6cm in a parallelogram on my arm. It is mildly itchy and sore but otherwise painless.

According to the patient, she experienced severe red and hot rash and hive all over her body. She had discomfort breathing and had to go to ER for treatment. She is currently taking loratadine and Benadryl to help treat the rash.

Pt. developed severe red rash on face, neck, and chest within five minutes of vaccination noted by two volunteer doctors on site at clinic. Pt. also c/o anxiety. Doctors on site administered Benadryl 25 mg po @1105. 1110: BP 153/98, Pulse 109, O2 sat 98%. Moved pt. to cot and continued to assess. No hives, itching, or swelling noted. 1120: BP 143/86, P 97. Pt.'s rash, flushing, and anxiety improved. 1130: BP 139/81, P 81. Pt. continued to improved and deny lightheadedness or SOB, left vaccination site @1150.

Anxiety induced reaction to vaccine, felt heart rate / beat higher than normal, white in face, nausea, vomitting in bathroom, dizzy, requested 911, left with paramedics

15:21-REceived vaccine injection L deltoid. 15:30-Arrived in observation area, reported onset of H/A, LUE pain and warmness, numbness of left UE and LE and dry eyes.Dr. present. 16:09-VS: 175/69; HR 80; SpO2 98%. 16:14-Epinephrine 0.3mg L lat thigh per Dr. 16:19-VS: 184/91; HR 74; SpO2 98% 16:40-VS stable, pt W/O discomfort. Released home per Dr.

12:32 (aprox) patient entered observation area 12:39 patient reported feeling dizzy; juice & crackers provided. 12:46 patient reported rash and itching to face, neck back. Mild rash noted. Moved to triage area for medical consult. Dr. responded 13:18 VS-130/74, HR 95, SpO2 97% on RA 13:19 Pt. given Zyrtec 10 mg p.o per Dr. and monitored 13:40 Rash resolved, patient without complaint; released home per Dr. 13:40

First, it feels like I was punched in the arm (at the site), but without a bruise to show for it. Second, my equilibrium is off, not like I can't get up walk around my apartment. No, this more like if I'm walking it will feel like the ground has moved not me. So, I need up walking sideways or hitting a walk. If, I'm standing I have to grab on to something because I feel like I'm going to fall down if I don't. It lasts for a few minutes m, about 5 minutes is the longest.

she felt like she had been in a car accident. My entire body was sore; I was very hungry - ate three breakfasts and a big lunch and was still starving; I had a 101 temp; chills; extreme joint pain; muscle aches; dizziness; exhaustion; she felt off; unusual hair loss; This is a spontaneous report from a contactable consumer (patient). A 40-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in Arm Left on 05Mar2021 17:15 (Batch/Lot Number: EN6198) as SINGLE DOSE for covid-19 immunisation, 40 years old at doctor's office/urgent care. Medical history included coeliac disease, sjogren's syndrome, hypersensitivity (known allergies), all from an unknown date, and Covid-19 from Nov2020 (First, I had a mild case of COVID in Nov2020 and recovered fully). No other vaccine in four weeks and not other medications in two weeks. Patient is not pregnant. The patient's concomitant medications were not reported. On 06Mar2021 09:00, the day after first vaccine, patient had a 101 temp, chills, extreme joint pain, muscle aches, dizziness, exhaustion. The following morning on 07Mar2021, she felt like she had been in a car accident. My entire body was sore, she was exhausted, and she was very hungry - ate three breakfasts and a big lunch and was still starving. The following week (Mar2021) she felt off and experienced some unusual hair loss. She does not feel comfortable taking the second shot. Patient was asking some guidance on whether to take the second shot. Treatment was not given for the events. Outcome of the events was recovering.

ON THE EVENING OF 3/30/2021 SHE DEVELOPED LETHARGY,BACK PAIN , HEADACHE, FEVER , CHILLS, ACUTE RIGHT ARM PAIN AND LUMP ON SITE OF VACCINATION, WEAKNESS AND NAUSEA.

After 1st dose - slight soreness at injection site, no other symptoms After 2nd dose - after 4 hours, extreme fatigue, whole body soreness, injection site soreness, after 12 hours, all of the above, after 24 hours, all plus injection site swelling and redness, 36 hours, only more injection site swelling and more redness, 48 hours, more swelling and redness, and now itchiness

Injection site pain beginning same day and lasted for about 5 days. Trouble sleeping the same night. Headache, diarrhea, and general not feeling well began the day after and lasted for 2 days.

Dizziness, tingling and itchy skin, swelling and tingling of lips and tongue, slight throat swelling. Treated at home with 50 mg Benadryl every 6 hours, Pepcid, and Predinsonl (steroid pack).

Site: Pain at Injection Site-Mild, Systemic: Headache-Mild, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: arms and hands and at bedtime cant sleep due to pain and numbness

NUMBNESS AND TINGLING OF LEFT ARM, SHOULDER, FACE, AND TONGUE. NO SWELLING DIAPHORESIS, CHILLS, SOME ITCHING AT 5:10 PM

About 90 minutes after the shot, my face swelled up and had hives. My left eye would not open all the way. I had hives on my back, chest and both arms. I got the symptoms under control after 9 Benadryl pills. 2 days after the shot - my lymph nodes swelled up in my neck and on my left clavicle. I did not treat these. 3 days after the shot, out of nowhere, my left cheek swelled up and there were hives and my eye was half swollen shut. Symptoms were under control after 2 Benadryl pills. My lymph nodes remain slightly swollen, but not as severe as on Day 2.

Tingling toes started around 12:50-1:00 pm Heavy feeling in chest about 20 minutes after injection Heaviness in both arms within 30 mins after injection Pressure in chest next morning Burning, intense itching , hot inflammation around injection site next morning

Pfizer-BioNTech COVID-19 Vaccine EUA Symptoms: injection site pain, tiredness, headache, muscle pain, chills, nausea, feeling unwell Outcomes: since I didn?t feel well I rested on 4/7 and lost my consciousness at around 6pm on 4/7 and fell down to the front on floor. When I wake up, I found the I got injuries with my lip and teeth. My upper front teeth was broken.

2/9 vaccine #1 around 0930. Around 5pm notice neck was itchy, red and ?hot? feeling. Over the next few weeks the neck got a more widespread redness, the creases of my elbows became red and itchy then behind my knees became red and itchy. 2/23 I noticed the rash has spread to my truck and was starting to itch on my shins. Called dermatology clinic. 2/24 Derm appt #1- saw the NP. She thought it looked like a viral rash. Started oral steroids 60mg x3 days then tapered down over 10 day period. Ordered Triamcinolone cream for topical treatment and Zyrtec twice a day, 25mg hydroxyzine at night for sleep 3/2- vaccine #2 due... was told to hold off until the rash cleared just to make sure 3/7- itching and redness returned to neck and spread to truck. 3/9- Derm appt #2. Noted the rash had changed in appearance and biopsied arm. Received a steroid shot, Ordered pepcid twice a day, Allegra twice a day. 3/17- severe redness (the most extreme pic), burning and itching. It felt like a terrible sunburn with itchy hives under it. I can?t even begin to describe that pain. Called the Derm clinic. They ordered clobetasol ointment and go see Dr the next day. 3/18- biopsy with no eosinophils and only extreme inflammation. Received a loading dose (2 shots) of dupixent. 3/25- reddness and itching return to neck and shoulders/trunk. 3/26- Called Derm. Ordered a 40mg steroid taper that will last 20 days total. 4/1- Dupixent shot (2mL) 4/6- Appointment with Dr. Ordered Singulair and keep other taking medications. Lab work ordered.

I am experiencing a lot of arm/shoulder pain a week after the shot. The pain was very acute right near the injection site the day after the shot, which I expected. But then I started to notice more pain in my upper arm, farther away from the injection site. A week later, I still have a lot of pain throughout my arm, between my shoulder and my elbow.

sore arm- lasted about 3 days redness, hot spot at injection site- developed within an hour and lasted 2.5 weeks hardness at injection site- developed within hours of being administered, still there at almost 3 weeks pain/tingling in arm developed within hours, lasted for a week headache- developed in both my husband and myself within an hour or so after injection, lasted until the next day massively aching joints- developed the next morning, lasted 3 days

Acute onset large clot and profuse first time nose bleed (posterior potentially from sinuses which hurt), petechiae

10 mins after injection, developed tingling in mouth and lips, tightening in throat, blotchy chest and neck. arrived to obs, 1830 bp 140/69 hr 95 rr 18 sats 96%, feeling hot. water and apple juice given, started feeling relief and blotchy neck and chest improving. 1838 bp 112/66 hr 97 rr 18 sats 95% on ra. 1847 bp 118/67 hr 67 rr 20 sats 99% on ra, blotchty areas resolved, and facial/mouth tingling resolved as well as throat tightness. escorted to exit with no further issues. instructed on benadryl once home.

Rash on arm that was hot, sore, itchy. Started very small and spread over the course of 3 days. Eventually was my entire upper arm. I took benedryl 2 tablets and 800mg ibprofeun.

Patient received Pfizer COVID-19 vaccine on 4/6/2021. Patient reports the following adverse reactions: facial swelling, lips swelling, reddness, small hives. Patient was given 25mg Benadryl PO per protocol. Dr was made aware. Monitored patient. Patient started to experience some throat tightness but no shortness of breath or difficulty breathing. Spoke with Dr again and gave patient 0.3mg Epinephrine in right deltoid. Dr came down to clinic as patient was going to ED per car with her sister driving. In the ED , patient was treated for anaphylaxis at hospital and stayed overnight (epinephrine, solumedrol, pepcid x2). After discharge on prednisone 40mg daily x5 days, patient came back with hives and was readmitted and treated overnight with pepcid/benadryl expect to be discharged again today.

The night of my vaccination I spiked a fever of 104. It stayed high for three days - even with Tylenol and Ibuprofen I could not get it below 100. It finally broke on the fourth day. My other symptoms lasted longer. I had terrible muscle pain and joint pain, fatigue, headaches, swollen glands, swelling and a rash at the injection site, strange bruising on my other arm, and a sore throat that made swallowing difficult. I am now nine days post-vaccine, and my only lingering symptoms are a sore throat, laryngitis, and a cough. I am healthy and have never before reacted to a vaccine. This was a terrifying and *lengthy* reaction.

Wed Mar 31 - day of shot Stiff neck on side of shot Sore arm on shot site Heavy period w painful cramps for two days Swollen, painful lymph node in neck on same side as stiff neck and same side as shot - visit to chiropractor following day where it was numbed with bengay type product and vigorously rubbed. As of Saturday, Apr 10 pain and swollen lymph node still present but pain significantly less.

both ears have a red flaky rash with small white bumps. Skin in dry to the touch and very itchy. rash has lasted 6 days at time of reporting

Systematic outbreak of maculopapular rash noted in clusters over most of body. Very itchy Onset of rash was on day 4-5 of receiving vaccine. Onset was not immediate. Still presenting hives 1 week after outbreak.

muscle aches, total body soreness, tenderness at injection site, chills/low grade fever, armpit/breast area soreness. Headache. Fatigue. Lasted over 24 hours without improvement. 4 days later - feeling almost better

Red raised areas that start at left eyebrow and go into hairline. Red raised bumps throughout scalp on the left side. Left swollen lymph node behind ear that is continuing to swell. Pressure from lymph node swelling now felt near left eye. All bumps can be itchy at times.

Shingles (not the first occurrence of shingles for this patient. However, the most adverse case - extreme burning, itching and pain)

I received my first Pfizer COVID vaccination on 3-1-2021. Seven days later I had a Shingles outbreak, which I've never had before. My doctor advised that I should continue to get the second vaccination as it's a two step process, which I did on 3-25-2021. I'm now experiencing numbness and loss of sensation that started in my foot and hand which has now progressed up my leg to my hip and from my hand up my arm. My doctor ordered a MRI scan which showed lesions on my spinal cord. Based on the results of the first MRI scan my doctor has ordered a second scan (showing more of the spinal cord) and a brain scan. She has also scheduled me an appointment to speak with a Neurologist to try to determine the cause of this. I can't help but feel that this vaccine was the cause of this as it all started shortly after I was given my first dose.

Only mild injection site discomfort following first dose. Fatigue and left arm pain within 6 hours of second dose; dizziness, body aches, moderate muscle pain, joint pain, chills, swollen lymph nodes starting 8 hours after second dose. Pain lasted 24 hours. Fatigue lasted 72 hours. Muscle pain, joint pain and body aches were managed with 800 mg Ibuprofen prn.

Pfizer-BioNTech Covid-19 Vaccine Received vaccine Monday morning- no issues until Wednesday other than slight arm pain at the injection site. Wednesday morning, woke up with chills, sweating, vomiting, and a headache. Chills, sweating, tiredness were strong for 8 hours, lessened over the next 12 hours. Headache increased and remained present until Friday afternoon.

Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild

itching - on face, no rash noted. Onset of symptoms - under 1 hour. Patient reported itching to face. No redness or rash noted anywhere on face. Benadryl 25mg PO given. No other issues noted. Stable to release home.

4/8/21-Very stiff neck, pain level 8. Hard to move. Improved the following day. Did not take NSAIDS. Developed constipation. Developed a migraine (to be expected) 4/10/21-developed "Covid Arm" rash. Raised red itchy rash. 4/11/21-rash grew to size of silver dollar, didn't respond to topical hydrocortisone, took benadryl. 4/12/21-rash has settled down some but is still present. Having continued issues with constipation (was not an issue until the vaccine). Period is late, not at risk for being pregnant.

Since approximately 3/29/21 I have been developing many red raised rashes on my legs, mainly, but also on my arms, hands and sole of my right foot. Some of the rashes are painful, some are puffy. I've been taking an antihistamine once a day. I have taken photos, which I can submit if they would be helpful.

Small rash in numerous areas on both legs and abdomen. Larger bumps on both elbows, both legs, feet and abdomen. Itchy.

Approximately 48 hours after receiving Pfizer Covid-19 mRNA vaccine, patient starting immediately throwing up with diarrhea and then developed chest pain and breaking out into hives, then her face started swelling on R side, phlegm in her throat, rashes on her feet; had full blown panic attack once she saw the face swelling; was too nervous to use her epinephrine pens. Took Xanax, Zyrtec and Benadryl.

Within minutes of receiving the injection I experienced waves of dizziness to the point of almost passing out, rapid heartbeat, full body hot flashes, sweating, hand tremors,, dry mouth Observed for 30 min and released with no intervention. Waves of vertigo continued throughout the day, but are decreasing in frequency but not intensity as days go on. Within an hour of injection psoriasis on left leg flared and was raised, red and extremely itchy through Sunday, 4.11.21. Severe headache through end of day on 4.9.21. Treated allergic symptoms with 10ml Benadryl every 5 hours for 2 days, Ibuprofen PRN for pain. All symptoms subsided except for headache and dizziness/vertigo but appears to be decreasing in frequency but not intensity.

Swollen lymph nodes in armpits, breast, torso, groin over 15 in total appearing over 10 days. Fatigue lasting a few days. Chills for one night on the 4th day. Rash that was a cluster of red marks on lower back about half dollar size lasted for a few days. Most lymph nodes have gone down but some still noticeable.

Client received the Pfizer COVID 19 vaccine on 4/10/2021 at 9:24 am, in left arm. Per Client on 4/10/2021 started experiencing symptoms of left armpit pain, like a "chafing" feeling, burning, soreness and painful to touch. Per Client still having symptoms, took Tylenol for pain and no follow up with PCP as of today. Client admitted after taking Tylenol pain in left armpit has decreased. PHN suggested to the Client if symptoms continue to persist should follow up with PCP, or with worsening symptoms go into urgent care, emergency room or call 911 for medical emergency. Client verbalized understanding information provided by PHN.

Approximately 24 hours after receiving the Pfizer Covid vaccine, I experienced hot/cold chills, clammy face and lips. I noted that I had pink/red allergic marks on both legs. I mentioned it to the nurse today as I was receiving my 2nd dose and filled out report.

I went to pharmacy to complete my Pfizer vaccination series. After my vaccination was complete, the vaccinator removed the needle and noticed I was bleeding considerably. She asked if I was on blood thinners and I told her I was not on any medication. The bleeding stopped and I went to sit in the waiting area. A few minutes later she came and told me that the syringe was empty and I would need a second shot. She did not explain how she knew it was empty. She administered the second shot, I waited the required amount of time, and then I left. I am reporting the error related to the presumably empty syringe.

I couldn't sleep the night of the day that I got the vaccine due to body aches and chills, and general feeling of discomfort. The next day I had a low fever that lasted the entire day, along with the body aches, chills, headache, nausea and soreness around the injection site -- basically, I felt flu-like. The fever didn't break until the following night around 1:30-2 a.m. -- so, 24 hours after symptoms started, and heading into the second day following my vaccination. I noticed the lymph nodes in both arm pits were painfully swollen, as well, which was not a side effect that I was warned about, so it freaked me out. The node in my left arm pit -- the arm where I got the vaccine -- was more swollen and painful than the right arm. And that swelling did not leave until three days after my vaccine. In short, I was feverish and ill the night I got the vaccine, and all of the following day after getting the vaccine. I still felt nauseated and had a headache two days after my vaccine -- which is when my lymph nodes in my under arms were also noticeably swollen and painful -- but the fever was gone. Three days out from the vaccine, the flu-like symptoms were gone, except for headache and fatigue. All told, I missed two days of work, and was "down for the count" feeling sick for three days.

Have developed large red welt at injection that has been spreading slowly and continuously over past 30 hours. Started approximately size of dime, is larger than a quarter after 30 hours. Red in color, hot, swollen. Left ear is starting to get swollen and painful on inside - due to swollen lymph node under ear.

ItchiNg - symptoms resolved - No tx ment- Did not reach out to a provider TX: NonE For meds, PMoD Itching 1st day of vaccination and resolved iN less than 24 hours

Rash on entire body mainly torso. Extra sensitive gums that bled when teeth were brushed. Rash on inside of both lips and in the back of my throat. Diarrhea, body aches, vomiting, mild fever, splotchy skin,

Rash on the inner arm where vaccination was given. Starts at the wrist and extends almost to the armpit. Red, flat, small and blotchy. It also itches. Came on within 24hrs of shot.

All day: mild fatigue, mild soreness and occasional itchiness at site of vaccination Evening: moderate nausea after eating, moderate abdominal pain, moderate chills and feverish feeling, moderate fatigue No medications taken to treat symptoms; symptoms treated with rest.

I have been experiencing these symptoms for three days now. -moderate dizzy spells/vertigo -severe headache -severe fatigue -sore arm in injection site -swollen lymph nodes -tingling in tongue -achy muscles/joints

SYMPTOMS BEGAN 40-45 MIN. POST VACCINATION AFTER LEAVING FACILITY. CLIENT REPORTS NUMBNESS/TINGLING BEGINNING IN LEFT ARM , PROGRESSING DOWN ENTIRE LEFT SIDE, UP RIGHT SIDE TO LEFT SIDE OF FACE AND HEAD, THEN DOWN RIGHT SIDE OF ENTIRE BODY , PROGRESS UP TRUNK. DIFFICULTY SWALLOWING DEVELOPED- "THROAT FELT SWOLLEN" NO DIFFICULTY BREATHING. NO HIVES OR OTHER RASH NOTED. NUMBNESS/TINGLING CONTINUES TODAY. THROAT SWELLING SLIGHTLY IMPROVED, CAN SWALLOW VERY SMALL BITES OF SOLIDS, AND LIQUIDS. LAST EVENING HAD CONTACTED PCP WHO ADVISED BENADRYL, WHICH SHE TOOK A DOSE 4/14/21 EVENING, AND AGAIN 4/15/2021 12:00PM. ONLY OTHER SYMPTONS VOICED IS MILD SITE TENDERNESS.

pain in left arm started approximately 6-8 hours after receiving the vaccine. The pain was much higher 24 hours later, and I found it difficult to move my arm in any direction. The pain was mainly muscular, involving movement. Only slight pain when touching the location where the shot was administered. The pain did not subside until at least 48 hours later. After 48 hours a new symptom began. I am now experiencing extreme fatigue. The fatigue continues today, so it has lasted at least 3 days. I am a runner and normally do not have this kind of heaviness. I have been unable to run since receiving the vaccine.

Onset 12 Apr 2021, pt developed pruritus and rash under arms axilla, posterior arm, back. Self treated with OTC Benadryl and OTC topical steroid. Provider adjunct management with TRIAMCIN ACET 0.1 % topical cream, antihistamine, lotion, and emollient.

Within a couple minutes of getting the shot, I could feel that my body was reacting. I started itching around my shoulder and chest area on the same side the shot was administered. Then my scalp and face stated itching. I decided to take two children's benadryl chewables (25 mg total) that I had in my purse. I notified the person watching us and he sent a supervisor to talk to me. I stayed about 45 minutes. They kept checking on me. I was itching all over and we all agreed that I needed more Benadryl but also that I shouldn't drive home after taking the full adult dose. I decided to go home and then take some more Benadryl once I got home. My throat was starting to get tight, but it wasn't awful. I took another 25 mg of Benadryl when I got home, for a total of 50 mg. After about 15 minutes, the itching went away. I had to lie down about 30 minutes later when the Benadryl made me sleepy. I didn't have any more serious issues after that.

My husband noticed a red patch had formed at the injection site on Tuesday the 13th. I hadn't noticed it at all because it wasn't itchy or bothering me in any way. I would say it has gotten a little itchy since last night and looks a little splotchy. It's minimally itchy though & I have been able to avoid scratching it. I looked it up and saw that it is a common side effect with Moderna but since I got the Pfizer vaccine, I figured I'd report it.

Immediately after vaccine pt began feeling lightheaded, shakey legs, chest tightness and warmth. Denies tunnel vision, hearing changes and shortness of breath. Pt transported to obs at 1743 via wc. Around 1749 pt states she feels cold, lightheaded when sitting up and persistent chest tightness. Pt declines call to EMS and EMS transportation. She does agree to drive herself to urgent care for further evaluation. Pt states she feels safe to drive. Pt released by self at 1803. Vitals as follows: 1744 BP 134/90 HR 64 SPO2 100; 1749 BP 135/78 HR 65 SPO2 100; 1756 BP 155/87 HR 74 SPO2 100

dizziness, nausea, flushed skin, mild urticaria to arms and back. headache as well sx onset less than 5 min post vax EMS called and trasnported to ED no meds given on site no resp distres

Seconds after injection my left arm had an icy numb sensation from injection site to my fingers. Today Three weeks later I experienced same icy sensation plus numbness/weakness, decreased sensation in fingertips. 2. Still have bad Headaches still after 3 weeks 3. Extreme Fatigue still after 3 weeks 4. Last few days, three weeks after shot, I have worsening/ Increased joint pain, spiky pain in joints, chills and entire body aches like I have the flu. No fever, no runny nose, etc. Just the body aches, joint pain like people experience with the flu. 5. Decreased mental sharpest last 2 weeks since shot. 6. Light headedness, dizziness. 7. Immediately after shot I experienced metal taste in my mouth. Since the shot, I still experience occurrences of metal taste every day. 8. Today experiencing slight numbness in right foot. 9. Swelling in fingers

Site: Pain at Injection Site-Medium, Systemic: Visual Changes/Disturbances-Severe, Additional Details: Pt said her arm was sore for two days and also her Left Eye Burned and felt like acid was in her eye for about 90 second time periods about 3 episodes a day for 2 days.

Body aches, chills, fatigue, headache, and eye pain for 24 hours. Arm soreness at the site for 3 days, followed by swelling and itch on entire upper arm where vaccinated. Swelling and itch lasted for 10 days.

Within 15 minutes after vaccination "flushed with noted erythema of face/ant chest with complaints of itchiness of face/chest, with tachypnea, wheezing and reported sensation of throat swelling w/ shortness of breath."

March 24 - normal bloodwork April 5-7 heavy menses. First menses postpartum while exclusively breastfeeding. Delivery date 12/28/2020 April 10 noticed petechia and abnormal bruising but with high energy April 13 - second COVID shot. April 13 - nose bleed with continued petechia and abnormal bruising. No other symptoms

At approximately 6pm on 4/16/21, I began feeling as if I were in a fog (second dose of COVID-19 vaccine received at 10:30am previous day). I began to feel weak and tired; all I wanted to do was lay down. I laid in bed and took my temperature via ear. 100.8 in the right ear and a reading of 101.2 in the left ear (I've not had a fever since maybe 12 years of age). I was also experiencing a headache (back of head) and neck discomfort. I felt hot, specifically ears and face. I took 400mg of ibuprofen at approximately 7pm and 1000mg of acetaminophen at approximately 10pm. by 10:30 my temp was 98.9. I woke up at 1:30am on 4/17/21 and was completely drenched I sweat. I assumed this was from the fever break but I woke up again at approximately 4am drenched again. After waking and getting up around 8am on 4/17/21, I felt great; back to normal. I went about my day. I woke again around 1:30am on 4/18/21 with a sore neck and the back, lower area of the head hurting (this wasn't the same feeling as having a stiff neck or laying in an awkward position). When I sat up, I felt some sore, throbbing on the top of my head which then subsided. I woke again at 4:30am with the same issue. I was also, again, completely drenched in sweat but no fever this time that I am aware of. My pajamas were soaked. I felt some relief with the head and neck discomfort when I got up at 6;30am. As I type this now, my head and neck feel basically normal. I also wish to report that in addition to injection site soreness which I think is always to be expected, I have been experiencing quite a bit of soreness and discomfort under my left arm. It runs down my left side from my arm pit to the side of my left breast. This area has been sore and tender since the evening of the day I received the shot (4/15/21). I'm assuming this could be due to stolen lymph nodes which I was told by a health care professional, could be a side effect of the vaccine.

Immediate headache that lasted 5 days although I took ibuprofen, fatigue, nausea, joint pain in left arm, back, hip, knees . Itchy left arm about 2 days after that has continued to this day.

Patient reported feeling numbness to her hands and red patches appeared on her face and neck. Patient was assessed and symptoms were monitored. After an additional 15 minutes of observation, the numbness to the hands and the red patches on face and neck disappeared. Patient left vaccination clinic in stable condition.

I had fever between 101-103 F; severe muscle and joint pain for 36 hours; severe muscle and joint pain for 36 hours; I had a migraine-like severe headache; couldn't stop vomitting; had a rash on my upper left arm; This is a spontaneous report from a contactable consumer (patient). A 40-years-old female patient received second dose of bnt162b2 (BNT162B2, Formulation: Solution for injection,Lot Number: Er2613), on 25Mar2021 10:30 at a single dose and first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot Number: En6199)on 03Mar2021 03:30 both via an unspecified route of administration, administered in left arm for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included Vitamin c and vitamin d. No allergies to medications, food, or other products were reported. No covid was diagnosed prior to vaccination. On 25Mar2021, 09:30 PM the patient experienced fever between 101-103 f, severe muscle and joint pain for 36 hours. The next 2 days she had a migraine-like severe headache, couldn't stop vomitting, also had a rash on her upper left arm. The patient underwent lab tests and procedures which included pyrexia: 101-103 f. No covid test was done since the vaccination. She was treated with 1000 mg tylenol for 2 days and 2 pills of excedrine. The outcome of events was unknown.

There?s a swollen area between my neck and top of my shoulder. Is uncomfortable when moving a specific way.

I started with hives all over my back, buttocks, arms and legs early Thursday morning. They got worse Friday and still all weekend I?m finding more hives show up. I?m taking Benadryl around the clock and using hydrocortisone cream.

Soreness/swollen lymph node under left arm pit the morning after injection along with swollen arm at injection site. Soreness/swollen lymph node is still there 1 week later and has not gone down.; Swollen arm at injection site; Soreness/swollen lymph node under left arm pit; This is a spontaneous report from a contactable consumer (patient). A 40-year-old non pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EP7534), via an unspecified route of administration in the left arm on 23Mar2021 at 10:30 (at the age of 40-years-old) as a single dose for COVID-19 immunization. The patient medical history included asthma. The patient had allergies to medications, food, or other products which included, shellfish, penicillin, biaxin, ceclor, sulfa, Cephalosporins. Patient reported that she took concomitant medications in two weeks as Mirabegron (MYRBETRIQ). The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. On 24Mar2021 at 07:00 patient experienced Soreness/swollen lymph node under left arm pit in the morning after the vaccination along with swollen arm at injection site. Patient stated that the Soreness/swollen lymph node is still there 1 week later and has not gone down. The patient not had covid prior vaccination; not tested covid post vaccination. The patient did not receive any treatment for the events. The outcome of events were not recovered. No follow-up attempts are possible. No further information is expected.

Initial soreness at injection site. 12 hours post injection, chills, feverish, weak, and extreme fatigue, no appetite

I was diagnosed with shingles two days after the first shot with symptoms beginning 6 hours after the first shot.

Injection site was sore for 4-5 days, the usual soreness post-vaccination, resolving; suddenly, 6 days after vaccination, pt experienced a new pain (tenderness) and warmth to the same site; now it hurts constantly and is unrelieved by Tylenol; no visible or appreciable swelling/erythema upon exam;

Shingles - I received the Pfizer vaccine on a Wednesday afternoon and by Monday I developed a rash and throughout nthe week it was a burning sensation and turned into blisters and went to the Doctor and she diagnosed me with shingles / herpes zoster

Starting around 6pm - pain at injection site, severe chills, muscle pain, joint pain, and extreme fatigue. Symptoms continued through 1/27 and around 6am started to feel nausea.

hives in throat (20 min post vaccine) 20 min-4 hours post vaccine shortness of breath body itching throat feeling constricted Sore throat continues as of today

Pfizer-BioNTech COVID-19 Vaccine EUA: patient reports throat tightness, mild pain with swallowing (but able to swallow), flushing, and blotchy skin on forehead, cheeks, and neck after vaccination. Vital signs: blood pressure 146/93 mmHg (repeat 136/100 mmHg), pulse 74 beats per minute, oxygen saturation 98% on room air. Patient denies chest pain and shortness of breath. Administered oral diphenhydramine and left vaccination clinic stable with symptom improvement and drinking fluids without difficulty.

I have a rash on my stomach and skin sensitivity all across my left side. This started on April 20, 10 days after inoculation. I have not deviated from my normal routines in any other way than receiving the vaccine. The rash is small and the pain is minimal, it feels like the kind of pain that directly precedes a muscle spasm, only it's been constant since onset. I am not personally concerned, but wanted to add to all data that is being collected.

Patient did not report symptoms until I called about coming in to receive 2nd COVID vaccine. Stated her cheeks got very hot, facial flushing on the way home from the clinic after sitting in the clinic for 30 mins on 4/2/2021

Hives/rash, mostly on left arm but also right upper arm, right thigh, some just red and slightly raised, some scaly in texture, the latter of which were itchy

First shot of COVID-19 vaccine was administered on left arm. Hives /red bumps appeared on right forearm over 3.5 hours after the shot was administered. Diphenhydramine was administered after hives appeared and resolved within about 30 minutes of administration.

I developed shingles 20 days after I received the first Pfizer shot. It began on April 15 as a few spots on my mid back which looked like pimples. The next day the rash had spread and I thought I had gotten bit by a spider. The following day the rash was inflamed and the pain was excruciating. The next day I was diagnosed with shingles.

Injection site pain/ soreness 4/21 11:00pm Headache 4/22 2:00pm Fever 4/22 9:00pm Increased heart rate 4/22 9:00 pm

Patient was initially seen on 4/16 in the ED and discharged after complaints of myalgias. She was tested for COVID and discharged home and instructed to take acetaminophen. On 4/20, she returned to the ED with continued complaints including abdominal pain, nausea, and diarrhea. She also complained of dizziness when she stands, and that her skin and eyes were jaundiced. The patient was hypotensive and was not responding to IV fluids. She was started on vasopressors. She was found to be in acute liver and kidney failure. She was emergently intubated and ended up being transferred to hospital. Due to the nature of her condition, the above therapies were continued and CRRT was started due to acidosis. A bicarb drip was started and was continuous. Arrangements were made to transfer the patient to hospital once stable enough. It was thought that she was in HLH. She was also empirically started on hydrocortisone, later changed to dexamethasone. She was started on antibiotics - cefepime, Flagyl, and vancomycin. She has now been transferred to hospital. Outcome unknown at this time. 4/22

-LIMP ARM WITHIN 30 MINUTES OF VACCINATION -LEFT ARM, NECK, AND FACE SWELLING WITHING AN HOUR OF RECEIVING VACCINE - LASTED FOR 6 DAYS -UNABLE TO MOVE LEFT ARM, RAISE IT, OR LIFT ANYTHING FOR THE PAST 18 DAYS -UNABLE TO GRASP OBJECTS WITH LEFT ARM FOR THE PAST 18 DAYS -UNABLE TO SLEEP ON LEFT SIDE - CAUSES EXTREME PAIN -TINGLING AND NERVE SHOOTING PAIN ON LEFT ARM FROM FINGERS TO NECK, FRONT AND BACK CHEST LEFT SIDE -MUSCULAR NODULE DEVELOPED ON LEFT SHOULDER UP TO MY KNECK - CAUSING SEVERE EAR PAIN -EXTREME FATIGUE - LETHARGIC FOR THE PAST 18 DAYS -SEVERE JOINT/PAINT THROUGH OUT ENTIRE BODY -LOST OF TASTE -NIGHTSWEATS FOR PAST 18 DAYS -FEVERS RANGING BETWEEN 99.0 - 103 F FOR PAST 18 DAYS -NAUSE FOR PAST 18 DAYS -LOST OF APPETITE -DIARRHEA AND LOOSE STOOLS FOR THE PAST 8 DAYS (NO BLOOD) -BRAIN FEELS FOGGY ALL THE TIME - FEELING AS IN A DAZE FOR PAST 18 DAYS -SHORTNESS OF BREATH - JUST FROM WALKING OR MOVING AROUND -SKIN IS SUPER SENSITIVE AND ITCHY -UNABLE TO DRIVE BECAUSE OF THE FATIGUE AND UNABLE TO USE LEFT ARM. -UNABLE TO WORK - RELYING ON OTHERS TO TAKE CARE OF ME.

pt reported generalized pruritus after receiving 2nd dose of pfizer vaccine, vital signs stable, pt given 50 mg Benadryl po, pt reported decreased sensation of pruritus after receiving Benadryl po

Generalized itching feeling after receiving second dose of Pfizer vaccine, water given, 50 mg po Benedryl given at 10:15 am, VS as follows: 10:15 HR 88, R 20, 188/80, O2 96%; 10:22 HR 85, R 19, 173/108, O2 96; 10:37 HR 75, R 20, 160/106, O2 99%

throat constriction, dryness, scratcy/itchy. facial itiching, head, arm, back itching, eye swelling, overheating, tachycardic. epinephrine administered, 911 called, ambulance taken across the street to ER for observation. steroids given. further benadryl taken at home. symptoms started 10-15 minutes post injection. I am allergic to PEG, my allergist put me on a pre dose of anthystamines & steroids to lessen or prevent reaction so overall reaction was fairly mild but epi was the only thing left to give as I had already had 400mg hydroxyzine, 40 mg pepcid x3, 28mg medrol x5 during the 24 hours prior to my vaccination.

A little more than an hour after receiving the shot My body broke out in hives all over it. My skin was red and splotchy everywhere. My skin was in credibly hot to the touch and tingly. It remains that way for around two hours while I tried to contact a doctor or nurse. I was advised by the nurse to take an Antihistamine Which I did and Within about 40 minutes all of the symptoms were resolved. 48 hours later all of the symptoms returned and I again took an antihistamine and they resolved. 11 days after the second reaction all of the symptoms returned again. This time I did not take an antihistamine and they resolved on their own within an hour. Eight days after the third reaction all of the symptoms returned again. I did not take an antihistamine and they resolved within an hour.

The day of and day after my arm was sore at the injection site and hard to lift. I also had a headache. Both went away after 2 days. However, 9, days later I noticed red spots on my thighs that were itchy. As the day progressed they got worse and bigger and itchy. They were red raised lesions. I woke up in pain and noticed the spots all over my thighs; buttox and my lower lip became very swollen. I went to the hospital they said it was an allergic reaction to something. I had not done anything out of the ordinary in the last couple weeks other than the 2nd dose of the vaccine and a spray tan. They gave me Benadryl and steroids

Immediate temperature fluctuation, fogginess, it lifted fast and was able to drive home. About 30 minutes after I was home hives on my scalp, they disappeared in about an hour. 6 hours after the vaccine my hands broke out, and then I checked the rest of me, my chest was sunburn red, which is usually my first symptom when I?m having a reaction. I took an antihistamine and it all calmed down. No hives today, but I?m itchy. Pretty wicked headache. The antihistamine is almost out of my system.

Rashes/hives around trunk (belly and chest) appeared the day of vaccination. Still present today (April 24) - 3 weeks post vaccination. It is a little itchy and appears worse at night.

anaphylaxis; rash/hives on face; rash/hives on face; progressed to swollen lips, tongue; progressed to swollen lips, tongue; cough; throat irritation; wheezing; This is a spontaneous report from a contactable consumer (patient). The 40-year-old non pregnant female patient received first dose of BNT162B2 (Pfizer Covid-19 vaccine, lot number: EW0150 expiry date unknown) via an unspecified route of administration on Left arm as a single dose on 06Apr2021 09:30 AM. Medical history included asthma, known allergies: Biaxin, albuterol, xopenex, apples, pears, stone fruit (peaches, plums, apricot, etc), almond, hazel-nut. Concomitant medications included Zyrtec, Nasonex, Flovent, Singulair and Zoloft. On 06Apr2021 10:00 AM, started with rash/hives on face, then progressed to swollen lips, tongue, cough, throat irritation/swelling and wheezing. Initially treated in emergency room (ER) for anaphylaxis then released. Within 30 minutes, symptoms returned and was treated ER for anaphylaxis and was admitted for observation. She was discharged in the morning of 07Apr2021, but had to return to ER that evening, and was discharged in the morning of 09Apr2021. She was treated with Epinephrine, Benadryl, steroids and Pepcid. She did not receive any other vaccine in four weeks prior to the suspect. The patient was not suffering from covid prior vaccination. On 06Apr2021, she was tested through Nasal Swab for Covid and results were found to be negative. The outcome of events was recovering. No further information was available.

lost my consciousness; My upper front teeth was broken; fell down to the front on floor; injuries with my lip and teeth; injuries with my lip and teeth; chills; headache; nausea; injection site pain; muscle pain; unwell; This is a spontaneous report from a contactable consumer. A non-pregnant 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered on left arm on 06Apr2021 17:30 (Batch/Lot Number: EW0151) as single dose (at the age of 40 years old) for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported. The patient previously took BNT162B2, dose 1, (lot number=EN6204), on 13Mar2021 04:00 PM, administered on left arm for COVID-19 immunisation. The patient stated, "I got various symptoms such as chills, headache, nausea, injection site pain, muscle pain, unwell, and one day after getting the shot (on 06Apr2021 20:00) and on 07Apr2021, I lost my consciousness and fell down to the front on floor and it caused injuries with my lip and teeth. My upper front teeth was broken". The patient received no treatment. The patient was rushed to the emergency room and physician was visited. The outcome of the events was not recovered.

The morning following vaccine left arm was in extreme pain. Could not move it and bruising formed at injection site. Brushing continued to spread. Monday morning pain had receded, and the bruise had stopped growing.

Day 2-4 sore arm, redness at injection site, arm hot to touch, swelling in upper part of the arm Day 10: redness at injection site reappears, arm hot to touch, swelling in upper part of the arm, headaches, upper back pain, chills

Vaccine was improperly administered into shoulder joint rather than deltoid muscle below the joint. Sharp shooting pains at the time of vaccine continuing to this hour. Severe pain and inflammation. Unable to move arm in shoulder joint. Radiating pain across left back and neck, arm, and hands.

On Thursday I present a rash at the level of the trunk and back similar to measles, no fever or any type of symptoms, only the rash, sensitivity in the area of ??the rash and a little itching ... even today 04 / 26/2021 I continue with the same rash despite having taken medications such as steroids, anti-allergies, even ivermectin prescribed by my primary doctor.

First dose given 03/17/2021: momentary adverse reaction: racing heartbeat. Second dose given: 04/08/2021: no immediate adverse reaction other than soreness at injection site & general feeling of unwellness. Days after, tingling in the fingers…until the 17th, rib and back pain began. Pain radiated and worsened over the next two days. Was seen by PCM 04/20/2021, sent for XRAY, CAT scan, and ER, immediate diagnosis of Pulmonary Embolism in the right lung, as well as lung infarct in lower portion.

Generalized itching w/o hives, HX of asthma. Feels seasonal allergies are getting worse. No airway edema. Given 25mg PO Benadryl. Pt states she usually takes 50 -75mg at home and request that but is driving home, denied by medical team. Feels symptoms have resolved @1140. Reports "tingling" all over body from anxiety.

weird feeling, itchy all over mostly arms. increased phelgm with throat / tongue/ swelling; anxious.

Patient stated she took the vaccine on Monday 4/5/21 @1600 and within 10 minutes she felt her arm started to go numb and it was swollen (face and neck), radiating back pain and a nodule in neck and pain shooting all throughout the arm, loss of appetite, n/v, sob (no chest pain), lethargic, fever (ranging from 99-103), diarrhea developed within the last week, lost a sense of taste, headache, she can move arm but she's in a lot of pain.As of 4/22/21 patient is just experiencing shooting arm pain, nausea, fever, lethargic, SOB (patient feels exhausted when moving around the house), and started to experience some itchyness as of this morning. Patient took tylenol at least 6 times since she took the vaccine, she stated it helps with the pain but once it wears off the pain comes back. Advised patient to continue with the tylenol/ibuprofen for the fever and pain, and benadryl to help with itchiness or she can apply benadryl cream/hydrocortisone to help. Also advised her that if her sob continues and it gets worse to seek medical attention (ER or urgent care). 4/25-Patient continues with fever, negative for Covid test, continues with loss of taste, recommended for her to see primary provider.

Pfizer-BioNTech COVID-19 Vaccine EUA Day 1 Arm sore at injection site. Day 2 Chills and fever overnight, with intense body aches and soreness. Fever and aches all day. Managed with ibuprofen. Fever and chills again at night. Day 3 Still very sore and tired but better than the day before. Bruise at injection site, and rectangle under it on left arm - a red rectangle that felt warm and hurt like a bruise. Broke out in an itchy rash that evening, in my back and neck. Red small itchy bumps. Did have chills and fever in the night, but not as bad as the first two nights. But after the fever broke got a SPLITTING headache in the night. Day 4 Not as sore during the day. Took a shower in the afternoon and the rash spread all over neck, chest, and back, down towards waistline all around. Called doctor. Said to take benadryl, and come into the office if rash continues/spreads. Go to ED if tongue or throat swell. Day 5 Still tired and sore, but much better. Green bruise at injection site, and red rectangle that is warm and sore under it. Rash is less red or itchy, but small bumps still present. Red rectangle on arm started to itch around 7 and got bumpy. Took benadryl to manage the itchy rash again.

Radiating very red painful rash. Began at the hips, went down legs, then arms, torso and face. Hands and feet. Left large bruises. Rash diminished to small spots with prednisone/benadryl. Have photos.

Fatigue, chills 4/26-4/26 Injection site soreness 4/26-4/27 Swollen lymph nodes right under arm 4/27-ongoing

Body aches, slight fever of 99.4 degrees F, fatigue for 24 hours. Vivid dreams for 2 weeks. Soreness in arm that received vaccine for 4 days.

I have a pea sized nodule elbow my AC joint with swelling surrounding the strain the same side I received my injection on. I received both injections on the left side.

Pt experienced itchiness on limbs and chest 10 min after vaccine administration. 50 MG Benadryl Lot #080010 Given L arm. BP 122/84

Patient reported feeling itchy and "on fire" inside shortly after getting her vaccine. She said it took 5 doses of Benadryl to stop the reaction. Then her chest got tight later that day. She did not go to a doctor or seek emergency help. She said her autoimmune condition was already flared when she received the vaccine, and getting the vaccine made it flare up even worse. She denied hives, but she did say she developed a rash on her back. She came in today for her 2nd dose, but I advised her to try to talk to her doctor(s) about the reaction and see if they would be able to give her the 2nd dose since they would be more equipped to handle a potential anaphylactic reaction. She said she has not seen any of her doctors since the pandemic started, but that she would try to reach out to them.

Injection site pain; Nausea; back pain; lymph node in underarm of injection swollen; lymph node in underarm of injection pain; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received a second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6201) via unknown route of administration on 18Feb2021 05:00 PM at single dose in left arm for COVID-19 immunisation at Hospital. Medical history was known drug allergies to Bactrim. Patient was not pregnant at time of vaccination. No other vaccine in four weeks. Concomitant medication included in two weeks lorazepam. The patient previously took first dose of BNT162B2, (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9261) on 25Jan2021 (at 40-year-old age) 09:00 AM for Covid-19 immunisation. The patient had experienced injection site pain, nausea, back pain, lymph node in underarm of injection swollen and painful on 18Feb2021 08:30 PM. No treatment for adverse events. No COVID tested post vaccination. Outcome of events was not recovered. No follow-up attempts are possible. No further information is expected.

Pain at injection site approximately 4 hours after injection Fever (101) and chills approximately 8 hours after injection Extreme exhaustion approximately 24 hours later

Moderate itchiness of the entire arm that received the injection. Itchiness is very distracting and is preventing me from being able to concentrate on my work. All I can do is scratch. Minor itchiness of lower left leg and left side of face. All the itchiness is on the left side of the body. No visible rash. Injection site is not swollen. No other symptoms. It's been four hours since the injection.

severe under arm rash; used hydrocortizone to manage symptoms, started on Tuesday, has not yet gone away

cortisone 10, Claritin, Benadryl gel., Calming lotion, xyzal, and aloe Vera plant nothing seem to help the itch in my face. my rash starting with my face without have itch all over my body my, my face is the worst part. I got my second shot and my face feels painful and more itch now and nothing helps.

Patient received vaccination at location listed and came into her pharmacy the day after vaccination to report a red, swollen area around the vaccination site. It is about 3 inches wide, lower than deltoid region of the arm, almost halfway between the shoulder and elbow. It is more posterior, warm to the touch. The patient also reports numbness in her left hand shortly after vaccination and sudden leg numbness day after vaccination that recovered. Informed patient to contact location that gave vaccination but clinic is closed for the weekend. Also encouraged patient to seek medical attention as soon as possible. She was considering an emergency room visit or contacting PCP on Monday, unsure of outcome.

general itchiness; throat tightening; dizziness; This is a spontaneous report from a contactable Physician reported for a consumer (patient). A 40-year-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6198, Expiry date was not reported) intramuscular at left arm on 25Feb2021 at 09:30 am (age at vaccination was 40 years) at a single dose for COVID-19 immunization. Medical history included HTN. The patient had known allergies to Penicillin and vancomycin. Concomitant medication patient received within 2 weeks of vaccination included duloxetine (DULOXETINE), gabapentin (NEURONTIN), verapamil (VERAPAMIL) and naproxen (NAPROXEN). The patient received shot and shortly after on 25Feb2021 at 09:45 am, the patient felt general itchiness and throat tightening and dizziness. The facility where the most recent COVID-19 vaccine was administered was other. The patient did not receive any other vaccines within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient received Epinephrine x2 steroids, Benadryl, famotidine now sxs improved. The reporter evaluated the patient in the emergency room. The outcome of all the events was recovering.

Vomiting, headache, chills, body aches, fatigue, redness around injection site, sore arm. All lasted about 12 hours, except red arm. Still large red circle.

Injection site swelled to golf ball size day 2, red and firm. Day 4 it grew to softball sized. Day 5 it is smaller (baseball sized), lighter in color and less firm.

Chills, sweating, body aches, headaches, blotches (rash), itching, vomiting, fatigue, constantly sleeping, joint pain, nauseous, swollen lymph nodes, sore throat

Right arm & side numbness, pins & needles feeling Lost of strength in right hand Itching sensation on right side of neck

Extreme body aches, headache, extreme chills, fever, numbness in fingers and toes, dizzy and light headed, lasted for about 5 hours. then broke out into hives or rash on neck and chest, underarms, hips and upper thighs that are starting to subside 3 days later.

After receiving the first dose in my left arm, I immediately thought it was more painful than I anticipated. When I sat down to self monitor, I felt tingling sensations in my left arm. I assumed it was just a normal reaction. I never had any injection site issues, no swelling or inflammation or pain at the site. No redness. Each day after the dose, I have a throb in the same area with shooting pain and tingles. The throb is about 6 inches below the injection site. The throb starts there and then radiates a tingling feeling outwards. It occurs randomly throughout the day. It hasn't stopped since the first dose. I had the second dose in my right arm because of this. It didn't hurt as much as the left injection and have had no issues in my right arm. Besides these symptoms, I was tired for the first day with a headache and general body aches.

Had generalized itching on back and arm (bilateral). Given Benadryl 25 mg PO x1, ice pack applied with little relief, given another Benadryl 25 mg PO x1. Reported relief after 10 min. Stable, released from vaccination site.

Three hours after receiving my first Covid vaccine, I suddenly got two large bumps on my tongue. About a minute later, I couldn't speak clearly. Next, I got extremely dizzy, to the point I couldn't stand up. After that, I got a rash across my chest, then my shin started tingling. Finally, my scalp started tingling as well. This went on for about 10 minutes and then each symptom went away, one by one, until I was completely fine, as if it never occurred. I had not gone anywhere or done anything out of the ordinary that day besides drive from my home office to the fairgrounds for my shot and then came straight home. I don't know if I am supposed to get my second shot on 5/17/21, as my doctor told me I need to talk to the CDC.

Sensitivity and itching back of hands Sunday 5/2 morning. I thought it was insect bites or dryness. Used lotion to treat. Got worse overnight. Monday 5/3 reported to work at 16:00. rash had started to spread back of hands, wrists, forearms (both arms). Eczema looking rash just beneath injection site left arm. By 18:30 rash seemed to ?explode? left work abruptly because the soles of my feet had an unmanageable itch. Went to clinic and took my socks off in the car, by the time I arrived to clinic neck looked like I had a sunburn, hot to touch and I was unable to stop scratching. Was given 60mg of prednisone, and 7 more doses. Took 60mg this morning around 08:00 am, went to work. Started to develop rash again on face and palms of hands and treated with Benadryl and OTC cortisone cream. Left work abruptly at 15;30, rash was spreading from cheeks, forehead, neck and anything that was under clothes clinging my body (groin, buttocks, breasts, upper shoulders and collar). Took a shower with no soap and 20mg of prednisone at 16:00 to calm my skin down, and will continue taking Benadryl. Bad behind knees, any place my skin bends. Pretty much sucks.

shingles type blistering, weeping, oozing and kind of on fire type of feeling; shingles type blistering, weeping, oozing and kind of on fire type of feeling; shingles type blistering, weeping, oozing and kind of on fire type of feeling; hives and a rash that continues to get worse; hives and a rash that continues to get worse; When clothes touching it hurts, it is very uncomfortable; injection site soreness; This is a spontaneous report from a contactable registered nurse, the patient. This 40-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151; Expiration Date: 01Jul2021) via an intramuscular route of administration in the left arm on 14Apr2021 09:00 (at the age of 40-year-old) as single dose for COVID-19 immunization. Medical history included anxiety depression. Concomitant medication included bupropion hydrochloride (WELLBUTRIN XL) taken for 15 years (2006) and ongoing for anxiety depression. The patient did not have any allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Apr2021, the patient experienced some expected injection site soreness. On Friday evening 16Apr2021, the patient broke out in hives and rash that continued to get worse. The patient described the hives started on right side of neck and now is on her face on the right side and neck, on left breast and right lower abdomen which spread around the back down on the leg and on the left bikini line on the groin. She stated now it is like shingles type blistering, weeping, oozing and kind of on fire type of feeling. It is mostly on the right side and there are some spots on the left. When clothes touching it hurts, it is very uncomfortable. She had a friend/physician to call in for her for oral steroids but don't seem to be doing much. The patient clarified the oral steroids as a MEDROL Dose pack, methylprednisolone 4mg tablets, and she only one full-day worth so far, she took all 6 tablets for yesterday (19Apr2021) and has taken one tablet so far today with doses being titrate down daily. It is not any worse than yesterday, but it has not started getting any better either. The patient stated that she has nothing on the left arm where she got the injection, no rash on left arm. Her second dose is scheduled 05May2021 and she does not know if she should get it. The clinical outcome of the event injection site soreness was resolved on 16Apr2021 while the events "hives and a rash that continues to get worse", "shingles type blistering, weeping, oozing and kind of on fire type of feeling" and "When clothes touching it hurts, it is very uncomfortable" were not resolved.; Sender's Comments: Based on temporal association, a contributory role of BNT162b2 to the events of broke out in hives and rash, blistering, weeping, oozing and kind of on fire type of feeling 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.

Initial Response - Redness, Tenderness, and Swelling at Injection Site that Continued Growing in Size Over the Next Weeks; Secondary Response - Rash that Presented First as One Raised Itchy Spot on Day 2 Following Injection; the Rash Progressed to Resemble Poisoin Ivy Over the Next 2 Weeks Before New Areas Near the Original Outbreaks Appeared that Resemble Classic Drug Reaction Appearance (Similar to Ringworm)

Chills, headache, muscle soreness (back & armpits), mild fever, soreness at injection site, metallic taste at back of throat, slight cough, itchiness in nasal cavity, occasional sneezing

About 5 minutes after the shot I felt pain in the area where they put the shot. About 15 minutes later I started to feel disoriented, lightheaded and felt like I was going to lose consciousness and I felt my heart racing. When they took my blood pressure it was 148/80. Then I started to have difficulty breathing. They took me to the ER in the same facility but the symptoms had resolved I believe because I drank plenty of water while I had the symptoms.

Feet swollen and red spots on the bottom of feet. Looked like broken capillaries. Toes where swollen and a little darker in color. Did not hurt or cause any pain.

Developed bumpy itchy rash on both wrists, right wrist/arm worse than left. Some areas appeared like heat rash bumps and others as hives. Spread over several days up towards elbow. Seemed to start to go away a few days before Second Dose.

Raised bumps ONLY in the tattoo areas near where the vaccine was given. They have been there for a few months now and are not going away. Reaction to the ink?

I began feeling chills around 9pm and continued until bed, woke up several times in the night in puddles of sweat, all parts of my body were hot to the touch. Also had pain under my left armpit, like there were marbles underneath my skin, I'm assuming lymph node swelling, also same feeling in my right groin. Headache and general body ache all over. Fatigue. Slept until around 11am next morning, May 4. Took Advil and felt somewhat better until evening of May 4, when I started chilling again and armpit soreness and headache. Took more Advil and went to bed. Better next morning May 5.

hives on multiple areas of her body which worsened and began to blister and ooze; hives on multiple areas of her body which worsened and began to blister and ooze; rash on her neck; soreness on her left/injection arm; This is a spontaneous report received from a contactable nurse. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 14Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 16Apr2021, she developed a rash on her neck and had expected soreness on her left/injection arm. She stated the next morning (17Apr2021) she had hives on multiple areas of her body which worsened and began to blister and ooze. She reported they were similar to a shingles rash. She started a methylprednisolone (MEDROL) dose pack on 19Apr2021 and stated the rash continued but had not worsened. Outcome of neck rash was not resolved. Outcome of other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

symptoms started last night around 6pm; headache, fever, chills, bodyaches and left arm pain at injection site. Taking tylenol. She reports taking tylenol at 2am, she had covid March 6 and took first dose of moderna vaccine yesterday per the recommendation of her doctor. She tested positive for antibodies prior to vaccine. 5/3-Placed follow up call on 5/3/2021 at 1203 hours: Pt reports she is feeling ok now, but her ADEs was really bad and this made her hesitant to go get her 2nd dose. Adv pt her symptoms are common ADEs that usually occurred with post-vaccination, and it is not a contraindication from getting the second dose. Pt also reports that her MD also advised her to go get the second dose. Advised pt that every person is different, whether she'll experience any ADEs with her 2nd dose is not know. Advised pt if she experience any ADE with second dose to call back and report.

Herpes zoster symptoms start around April 17th. Diagnosed on the 30th and was prescribed with IC Gabapentin 100 MG. Was given an OKAY to take the second dose of vaccine (taken on May 2nd) and have not been having much side effect. The Herpes zoster symptom has been almost cured now on May 7th.

4/8 negative rapid covid screen for work. 4/9 845 received shot, 1200pm begain with moderate dry hacking cough, injection site pain, muscle aches. 4/10 symptoms more severe. 4/11 rapid covid test negative, worked as a hospice nurse. 4/12 coughing more severe, telehealth visit with PCP, nebulizer treatments xopenex and budesonide ordered. 4/13 symptoms unchanged. 4/14 attempted to go back to work rapid covid test positive. PCR nasal swab performed at pharmacy. 4/17 results from PCR come back positive for Covid 19. 4/18 hospitalized with COVID pneumonia. Discharged from Hospital 4/25

diagnosed in-clinic with shingles; This is a spontaneous report from a contactable other hcp (patient herself). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL8982, expiration date not reported), via an unspecified route of administration, administered on the right arm on 14Jan2021 15:00 (at the age of 40-years-old) at a single dose for COVID-19 immunisation. Medical history included asthma (allergy-related asthma), drug hypersensitivity (Penicillin allergy), allergy to animal (pet dander), seasonal allergy (hay-fever), and seasonal allergy (pollen). The patient was reported to be taking other medications (unspecified) in the last two weeks prior vaccination. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. On 26Jan2021 09:30, two weeks following the first dose vaccination, the patient was diagnosed in-clinic with shingles. The event resulted to a physician office visit. Patient received anti-viral medication as a result of the event. The outcome of the event was recovered on an unspecified date. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Considering a plausible temporal relationship , a possible contributory role of suspect vaccine BNT162B2 to the reported event shingles cannot be completely 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.

First day, arm soreness. Second day (today), constant diarrhea (about once an hour on empty stomach, water consistency, large quantity from 9am to 3pm so far and showing no signs of slowing down), nausea, lethargy, itching on left arm. No fever. Nothing life threatening (*knock on wood*). Didn't see this listed on the website's side effects, so I am filling out this form.

Pain/itching behind right arm/shoulder two days later; 6 days later rash appeared on right chest; 8 days later diagnosed with shingles

Chills, tired, body aches, loss of smell, fever, rash on hands and thighs, stomach aches, no appetite, on day 10 and still not feeling 100%.

Area where shot was administered is inflamed and red, with a raised large circle about the size of a can. In talking to a nurse it appears the shot was not put in the right location. It?s below the top of the arm muscle and was not injected all the way, which means I may not have received the full vaccine.

rash on legs from hip through mid calf. Both sides. Onset was roughly 4-5 days after first vaccine shot.

Developed a rash on both of legs; Rash showed up on her arm at the "location that I got the vaccine as well"; This is a spontaneous report from a contactable consumer (patient). A 40-years-old female patient (at 40 years ) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: unknown) via an unspecified route of administration, administered on arm on 12Apr2021 as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 12Apr2021, at night, the patient developed a rash on both of legs. She also stated that the rash showed up on her arm at the location that she got the vaccine as well, but she stated that the rash has already gone away. she did take pictures of it. The patient was due for her second dose on 03May2021 and would like to know if she was still okay to get it despite the side effects she experienced. Response was the patient knows the contraindications to receiving a dose of the vaccine. Also let her know that rash had been reported as a non-severe allergic reaction to the vaccine. The outcome of the events was reported as recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

4 days after the vaccine was administered the patient reported to the vaccine site. She reports and shows approximately 20 areas of bruising on multiple parts of her body. All are isolated to her extremities and she reports no pain associated. I completed this for her as we had an interpreter and the ability to do so in a timely manner. She has been instructed on how to access the VAER's system for further reporting.

Light-headedness, "adrenaline"-type rush; warm and tingling sensation on right side of face; pulsing sensation at injection site. Occurred about ten minutes after injection. Intensity greatly diminished after about ten minutes, but slight light-headness lasted for about 45 min- 1 hour.

40 y/o female presents with c/o localized rash to the left deltoid near the site of injection in observation 10 minutes after receiving the first dose. The rash progressed with itching to the upper/lower extremities and back. Patient denies swelling, difficulty breathing, cough. Patient received 10 mg of IM Dexamethasone to the right deltoid and was transported to due to history of adverse reaction with Benadryl

Two days after receiving first dose, my face started itching. Over the course of the next few days my face became red, patchy, flaky and my neck had a rash as well. Went to clinic and prescribed oral steroids. Face cleared up but neck persisted. Went back to clinic 1 day after receiving second vax and was prescribed topical steroid cream for my neck. Neck cleared up and then a week later face started flaring up again. Went to clinic and suggested hydrocortisone for face. That got better and been about a week and a half but still experiencing mild flare ups of face, neck, and now hands. Cannot think of anything else I could be reacting too. Also been taking an oral anti-histamine every day since day three post first vax.

scratchy throat; flushed feeling; beginning of hives (raised welts); This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm left on 28Jan2021 14:00 (Batch/Lot number was not reported) as single dose at the age of 40-year-old for COVID-19 immunisation . Medical history included congenital heart defects, Eegs allergy. The patient's concomitant medications in two weeks were none. Patient was not pregnant. Prior to vaccination, the patient was diagnosed with COVID-19. The patient previously took phenergan, demerol and hydrocodone and experienced drug hypersensitivity. No other vaccine in four weeks. Within 5-10 minutes the patient experienced scratchy throat, flushed feeling and beginning of hives on 28Jan2021 02:15. Patient received treatment with Benadryl for the events. COVID was not tested post vaccination. The outcome of events was recovered in 2021. No follow-up attempts are possible, information about lot/batch number cannot be obtained.

Fever of 101.5, chills, lethargy, and body aches on 5/6-5/7. Widespread petechiae on arms and legs beginning the morning of 5/10 and spread through the evening of 5/11. Slight tachycardia at rest. 110 bpm. No other symptoms. No treatment given.

Large hard bump on day 1, day 2 it became smaller but more spread out and red. Hot and itchy from day 1. Taken benadryl both days. Slight improvement.

About 8 or 10 hours later, I woke up during the night with severe chills and a fever. I was taking Tylenol every four hours, but it wasn't helping at all. I was also nauseous. All of that lasted for about 21 hours, then they decreased and lasted like another day. I was having hot flashes. My left knee randomly gave out a few weeks after that and my left armpit was really itchy. It was the sickest I've felt in my entire life. I spoke with my doctor and she prescribed nausea meds.

On March 7th I broke out in a rash on the inside of my arms and on my legs. At first I thought it was something like bug bites, but the rash nor the bumps ever cleared up. I went to the dermatologist and we did a thorough history of my symptoms and exposure. She took a biopsy of one of the bumps and the lab work indicated that it was consistent with Lichen Planus. Because it was so close to the date of my vaccine, she recommended that I report this as a possible VAERS.

I have had hives every day. They started two or three days after. They have not gone away. Nothing new has changed in my life. There is no new laundry detergent. These hives are like what I get when I have mushrooms. I have never gotten hives otherwise.

Dose 1 - soreness at injection site; mild fatigue for a 3-4 days, swollen lymph nodes under left armpit about 5-7 days after the dose was given that lasted for 4-5 days. Dose 2 - mild swelling and soreness at injection site beginning in first 24 hours after dose given; active chills for about 30 min beginning just shy of 12 hours after dose was given; nausea and vomiting that last 24 hours after symptoms began; intermittent neck and head pain (sometimes sharp/severe head pain) over first 24 hours after symptoms began; dull headache with light and noise sensitivity between 24-48 hours; backache for 2-3 days; fatigue for first 24-48 hours. Dose given on Tuesday afternoon and worst symptoms experienced Wednesday, feeling slightly better by Thursday morning but milder symptoms described above returned midday. Friday, I was cautiously returning to very light activity around the home and without previous symptoms, but refrained from being up and about too much, as I would feel off and slightly light headed. As of this morning (Saturday), only soreness/light swelling at injection site and slight lymph node pain remain.

About 24 hours after my second shot severe pain in back an lower extremities. Lasted at the severe level for about 12 hours. Mild pain continued for 2 weeks like sciatica nerve pain in both legs. 2 and a half weeks later pinched nerve in back . L5 to S1. Disc degeneration found but unexplained why the pain started at time of shot.

then itch was mild for 1 hour/Started itching all over the worst was behind; itching all over the worst was behind my eyes deep in sockets; Sharp pain both arms 1 min.; left arm was swollen; This is a spontaneous report from a contactable consumer (patient). A 40-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 30Apr2021 at 11:15 (at the age of 40-years-old) as 1st dose, single for COVID-19 immunisation. Medical history was reported as yes but not specified. The patient's concomitant medications were not reported. On 30Apr2021 at 11:15, the patient experienced sharp pain both arms for 1 minute then itch was mild for 1 hour. Started itching all over the worst was behind her eyes deep in sockets that lasted 2 days, had to take diphenhydramine (BENADRYL). Left arm was swollen that night and lasted 2 days. On day 3, she was still itching but not as bad. Therapeutic measures were taken as a result of all events. The outcome of the events was recovering. No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.

A few hours after patient received vaccine, she felt pain in her arm, swelling and redness. She iced her arm. She had swelling in her arm for 2 days. Pain lasted for 3 days. She took some Tylenol to help with the pain the second day. She is worried about the abnormal marking on her arm that has not gone away yet.

Metallic taste in mouth about 20 minutes after receiving the vaccine Sore at injection spot in left arm and almost a numbness in left arm. My left arm feels fuzzy. The rest of me is fine right now.

Hot, itching ears outside and inside starting at 4:00pm. Followed by itchy mouth, racing heart, and all over skin itching. I took an extra Claritin at about 4:15. Then around 5pm I had a sudden feeling of an allover body sensation like a surge of electricity or drop in blood pressure, and had ringing in my ears and slowing of thoughts and movement and awareness. Went to the ER. Still itchy and ears were red. About 2 hours later all itching was gone and ears were no longer red. Stayed at the ER until 7:40pm.

5/15/2021: Pain around the injection site. Chills, muscle pain, and fever over 101 degree . Taken acetaminophen twice. 5/16/2021: Urinary tract infection. Healthcare provider prescribed nitrofurantoin for 5 days.

Generalized pruritus; rash on left deltoid; This is a spontaneous report from a contactable other HCP (patient). A 40-years-old non-pregnant female patient received bnt162b2 (BNT162B2, Solution for injection) dose 2, via an unspecified route of administration on 16Jan2021 at 12:45 PM on right arm (Batch/Lot Number: EL3246) as SINGLE DOSE for COVID-19 immunization. Medical history included Sjogren's syndrome, osteoporosis, renal tubular acidosis and lactose allergy. The patient previously took bnt162b2 (BNT162B2) dose 1, via unspecified route of administration on 28Dec2020 at 02:45 PM on left arm (Batch/Lot Number: EK5730) as single dose for COVID-19 immunization. Concomitant medication received within 2 weeks of vaccination. The patient experienced generalized pruritus and rash on left deltoid on 18Jan2021. The events were reported as non-serious. COVID-19 vaccine was administered in 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 and since the vaccination, the patient has not tested for COVID-19. The patient did not receive treatment for the events. Outcome of the events was not recovered. Follow-Up (15-Apr-2021): Follow-up attempts are completed. No further information is expected.

Muscle aches; tiredness; injection site pain (left arm); swollen and painful lymph nodes in left armpit and left side of neck; painful lymph nodes in left armpit and left side of neck; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EW0172), via unspecified route of administration in left arm on 30Apr2021 16:30 at age of 40-year-old at single dose for COVID-19 immunization. Medical history included allergies, arthritis. Prior to vaccination, patient was not diagnosed with COVID-19. Patient was not pregnant at time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EW0158) in Apr2021 05:45 PM in Left arm for COVID-19 immunization. The patient received medications within 2 weeks of vaccination included ibuprofen. The reported event included muscle aches, tiredness, injection site pain (left arm), swollen and painful lymph nodes in left armpit and left side of neck. Adverse Event start on 30Apr2021 07:00 PM. Seriousness criteria was reported as non-serious. No Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect. Since the vaccination, the patient had not been tested for COVID-19. No treatment received. It was unknown if patient recovered from events. No follow-up attempts are needed. No further information is expected.

Throat tightening & pain with swallowing, itching, irritable/aggitated, hot. Purposefully tried to avoid EPI this time. Took oral hydroxyzine and decade in. Waited 1hr in observation. No changes, willing to send me home.Developed vomiting & diarrhea in the night, still itchy, throat still hurts.

After 2nd dose of COVID-19 Vaccine received 4/23/2021 the following symptoms appeared: 12 hours post-dose: Fever (101.2F) Chills Headache Body aches (muscle, joint and low-back pain) Lethargy 48 hrs post-dose: Pain, swelling, and itching in Left armpit (same side as injection)

8 hours after the shot was received, started with headache, overnight moved to horrible chills, full body aches, lasted about 15 hours. More importantly, ~40 hours after the shot (got it at noon on a Friday, started middle of the night on a Saturday); woke up from full body hives. The hives were in sheets, incredibly itchy, in places all over my body (back, feet, arms, neck). They lasted in that intensity for another ~24 hours; then settled a little bit, but very itchy hives have continued to break out in patches all over my body (face, armpits, ankles, legs, lower back etc). They last for several hours, then die down (on own or by using OTC ointments) and pop up in another location. Extremely itchy bumps, but not painful to the touch. It has been about 5 days of steady state and now just starting to see fewer patches.

hives; This is a spontaneous report received from a contactable other health care professional, the patient. A 40-year-old female patient received first dose of BNT162B2 (BNT162B2) (Lot/batch no: = EN6208) via an unknown route of administration on 14Mar2021 at 11:30am for COVID-19 immunisation. Medical history and past drug history were not reported for the patient. The patient received Lo Lo Estrin FE Birth Control, QD within 2 weeks of vaccination. Allergy to Vicodin was 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 and since the vaccination, the patient has not been tested for COVID-19. The patient's Lab Tests were not reported. Patient experienced hives all over my low, mid and upper back as well as back of neck. The patient described the hives as raised, warm and painful to the touch similar to a severe sun burn. The patient could not lay or apply pressure to the area. After 48 hours the hives first began to subside. No therapeutic measures included the use of a handheld massager on her back and neck, the same areas where hives developed. The clinical outcome for the event was reported as recovering/ resolving. No follow-up attempts are needed. No further information is expected.

menstrual irregularity: much heavier period.; much heavier period; joint pain x 2 weeks; psoriasis flare; Carpal Tunnel Syndrome Flare; condition aggravated; Fatigue; chill; myalgia; injection site pain; This is a spontaneous report from a contactable healthcare professional (other HCP; Patient). A 40-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EJ1685; Expiration date was not reported), via an unspecified route of administration, administered in the left arm on 28Dec2020 10:15AM (at the age of 40-years-old) as first dose, single for COVID-19 immunisation. Medical history included Gilbert's Syndrome, Psoriasis and Carpal tunnel syndrome; all from an unknown date and unknown if ongoing. Concomitant medication included amoxicillin sodium, clavulanate potassium (AUGMENTIN) taken for an unspecified indication, start and stop date were not reported (reported as second dose only). Patient was not pregnant at the time of vaccination. No other vaccine was given to patient in four weeks. Patient was not COVID positive prior vaccination and has not been tested for COVID post vaccination. The patient has no known allergies. On 28Dec2020 22:00, the patient experienced menstrual irregularity: much heavier period, joint pain x 2 weeks, psoriasis flare, carpal tunnel syndrome flare, fatigue, chill, myalgia and injection site pain. The events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events was not recovered. The patient was given with the second dose of BNT162B2 on 19Jan2021 10:00 AM. No follow-up attempts are possible. No further information is expected.

Shingles on left-side of face, on V2 dermatome. blisters appeared on eye lid, lips, upper lip, temple area, nose

got vaccine at 6, rash started 9pm at home. Rash on neck, both legs bottom legs, more on left, some swelling

broke out in canker sores all over mouth again; Slept 17 hours q day; severe fatigue; Sinus and ear pressure; Sinus and ear pressure; Generalized aching; break out in canker sores all over my mouth; sore muscles all over; joint pain; mild itching to upper torso, breasts and under arms; low grade fever; chills; face became pink and warm; felt burning sensation throughout my body; This is a spontaneous report from a contactable nurse (patient). A 41-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in deltoid left on 03Feb2021 12:00 (Batch/Lot number was not reported) as 1st dose, single at age of 40-years-old for covid-19 immunization. Medical history included Asthma, 3 herniated discs in neck, hx of pneumonia, hypertension (HTN). Known allergies included: Ceclor, PCN, Doxycycline, Bactrim DS, Codiene, berries and anaphylaxis to Latex. Concomitant medications the patient received within 2 weeks of vaccination included: lisinopril; hydrocodone bitartrate, paracetamol (HYDROCODONE/ACETAMINOPHEN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Adverse event started on 03Feb2021 14:00 PM, within first 24 hours the patient experienced mild itching to upper torso, breasts and under arms, also had low grade fever and chills in this time. Within first 24 hours, face became pink and warm, and felt burning sensation throughout her body. At this point the patient took Pepcid and Benedryl and it seemed to control symptoms. On 09Feb2021, the patient begun to break out in canker sores all over her mouth, total of 5 (the patient did not have a canker sore since high school), began to develop sore muscles all over and joint pain that progressed to severe by 12Feb2021. Worse in mornings. Got a flu and covid test (Nasal Swab). They were negative. 17Feb-20Feb2021 severe fatigue and cont. Joint pain. Slept 17 hours q day. Sinus and ear pressure. Generalized aching. The patient did not get 2nd vaccine. 01Mar2021 broke out in canker sores all over mouth again. Took 4 days to resolve. The patient was still having significant joint pain throughout her body, worse in mornings. The patient never had this before vaccine. Events resulted in disability or permanent damage. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the event canker sores was recovered, of other events was not recovered. Follow up needed, further 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.

Dark bruise (larger than a golf ball) at injection site. A few hours after the shot, extreme soreness in arm to the point of being unable to lift for 24 hours after the injection. Extreme muscle ache, skin aches and extreme fatigue for almost two full days after receiving shot.

Right after vaccine injection site was extremely itchy. After a few minutes of vaccine my whole body was itchy . Left arm was extremely sore warm to touch and bruised 45 minutes after vaccine I bleed as if I was getting my period (Bright red blood) spotted until the next day then it was done. I was due for my menstrual cycle on 05/22/2021 which never came I am regular on my cycle. Topical rash on neck developed after 24hrs , redness, itching and burning

Patient received her first Covid 19 Vaccine. She has history of allergic reactions after flu vaccines and has several seasonal allergies. She states that she spoke to her allergist prior to receiving the vaccine and was advised to receive the vaccine. At 12:30, Patient reported itching on her arms and itching in her throat. Patient developed a cough. No hives, no difficulty breathing, No SOB or No trouble speaking. No visible rashes. Patient given fexofenadine 60 mg per standing order at 12:40. Patient was monitored for 30 minutes following medication and reported a relief in the itching in her throat. She still had some itching in her arms. Patient states that she is feeling much better Patient was instructed to proceed to the nearest ER or call 911 for worsening symptoms or difficulty breathing. She will also contact her allergist regarding instructions for the second Covid vaccination. Understanding verbalized.

About 20 minute after vaccine was administered I felt a subtle numbness feeling to the right of my mouth. Then it was felt on most of my right cheek. It lasted the whole day and the next morning it was mostly gone. Since then my right eyelid and under eye have been a little red which isn't normal for me. Some tingling in right leg felt as well. Mainly concerned about the face sensation and not sure if I should proceed with second shot.

One week after 1st covid vaccine pt. c/o itching and rash on right lower jaw, worse at night, helped with OTC cortisone cream. After 2nd covid vaccine, itching and rash got worse, spread across face and to back of neck. Rash "comes and goes", is worse at night and pt. gets short term relief w/the cortisone cream. Takes Depakote for a seizure condition and has contact allergies to plants and animals; is otherwise healthy. Has not sought care from her PCP because of cost. Advised on other OTC measures and if not improved, to see her PCP for eval. She feels it is not a serious condition but wanted to report it.

I was diagnosed with shingles on 5/20/21. I was prescribed valtrex and gabapentin. I am still in the middle of my treatment.

TINNITUS bilateral, loud, persistent Joint soreness Foggy thinking Pain at injection site Headache Weird twinges all over body randomly

Ovarian cyst; irregular spotting; Severe headache; injection site pain; Carpal tunnel Syndrome flare; Carpal tunnel Syndrome flare; Psoriasis Flare; myalgia; fatigue; joint pain x 3 weeks; This is a spontaneous report from a contactable other health care professional (patient). A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: EK4176, Expiration Date: not reported), via an unspecified route of administration, administered in left arm on 19Jan2021 at 10:00 (reported as 10:00 AM) (at the age of 40 years old) as second dose, single for COVID-19 immunisation. Medical history included Gilbert's Syndrome, Psoriasis, and Carpal Tunnel Syndrome, all from an unknown date. Patient was not pregnant and has no known allergies. Prior to vaccine the patient was not diagnosed with COVID-19. Concomitant medication included amoxicillin, clavulanate potassium (AUGMENTIN [AMOXICILLIN;CLAVULANATE POTASSIUM]) reported as "2nd dose only" taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines in 4 weeks. The patient was previously given the first dose of BNT162B2 (Lot number: EJ1685), via an unspecified route of administration, administered in left arm on 28Dec2020 at 10:15 AM (at the age of 40 years old) as single for COVID-19 immunisation and experienced menstrual irregularity: much heavier period, joint pain for 2 weeks, psoriasis flare, Carpal Tunnel Syndrome Flare, Fatigue, chill, myalgia and injection site pain. On an unspecified date, the patient experienced Ovarian cyst, irregular spotting, Severe headache, injection site pain, Carpal tunnel Syndrome Flare, Psoriasis Flare, myalgia, fatigue and joint pain x 3 weeks. Treatment was received with current treatment for Ovarian cyst. Events resulted in Doctor or other healthcare professional office/clinic visit. After vaccination, the patient has not been tested for COVID-19. Outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.

After the 1st shot, I had 2.5 weeks of severe fatigue, my femurs deeply ached, and crushing headache. after the 2nd shot, I had fatigue but on 1/30/2021 I was woken up by hives. I took Benadryl and they went away. On 1/31/2021 I was woken up by hives again and 4 hours later, my throat began to close up and my stomach was crampy. I went to the ER and rec'd epi, Decadron, & Pepcid to great relief. However 2/1/2021 my throat began to close up again and I went back to the ER and they just gave me Decadron. I now have to see an allergist and take Xyzal 20 mg/day, Pepcid 80 mg/day, and Singulair 10 mg/HS to keep the hives and throat closing from coming back.

After receiving the shot on 5/24, I broke out in red itchy bumps all over my body. It looks as if I had been bitten by a bunch of mosquitoes. I called my doctor and was told to use Benedryl cream. I have these itchy bumps on my legs, knees, arms, back, stomach, and breasts. I'm using the cream and taking Benedryl orally to help get rid of this issue.

After receiving vaccination, patient was reported to have fainted, with a potential seizure, and fallen over resulting in injury to head and laceration to forehead. Pharmacist was notified in which patient was immediately placed in laying position with elevation to her head and support to neck. Patient reported nausea, confusion, attempted to vomit without success. Patient was able to report name when prompted. 911 was called, fire service and ambulatory service arrived for further assessment. Patient was deemed safe without necessity of going to emergency room.

My first shot came with full body hives, sweats, and I slept for three days straight. Felt normal in a little over a week. My second shot, I work up the next morning with one of the worst headaches I've ever had. I started to develop a fever. 101.5. It spiked at 102. The fever was off and on for three days. I couldn't stop sleeping. I could only stay awake for a couple of hours at a time. That lasted for four days. Now today marks the two week anniversary and I can only stay awake for six or seven hours at a time, then I'll sleep for seven or eight, and repeat. I am SO tired I can barely function. I talked to a doctor friend who suggested I file a report here. I don't have health insurance and can't go to the doctor.

Hives within minutes of the injections; Chills; massive headache; back pain; This is a spontaneous report from a contactable consumer. This 40-year-old non-pregnant female consumer (patient) received bnt162b2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration, administered in arm left on 04Feb2021 at 03:00 PM (Batch/Lot Number: Ec3247) in hospital as SINGLE DOSE for COVID-19 immunization. Medical history included known allergies: mushrooms, break out in hives on morphine and oxycontin. The patient's concomitant medications were not reported. The patient previously took morphine and oxycontin, experienced urticaria with both. No other vaccine reported in four weeks and two weeks. The patient experienced hives within minutes of the injections, chills, massive and back pain on 04Feb2021 03:15 PM. The patient underwent lab tests and procedures which included COVID tested: negative in 2021. The patient was treated with Benadryl and Tylenol. Outcome of the event was recovered on 10Feb2021, side effects last about 5 days. No follow-up attempts are possible. No further information is expected.

Very unusually heavy period; painful lymph nodes in armpit and under arm of right side where shot was administered; painful lymph nodes in armpit and under arm of right side where shot was administered; This is a spontaneous report from a non-contactable other hcp (patient). A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on an unspecified date (Lot Number: Unknown) as 1ST DOSE, SINGLE for covid-19 immunisation. Pregnant at the time of vaccination was No. No known allergies. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history was none. The patient's concomitant medications were not reported. After 1st shot, the patient experienced painful lymph nodes in armpit and under arm of right side where shot was administered. This pain started 5 days post vaccine and lasted 3 weeks! The patient also experienced very unusually heavy period as well. The adverse events resulted Doctor or other healthcare professional office/clinic visit. Treatment received for the adverse events included Advil, counseling. The outcome of events "painful lymph nodes in armpit and under arm of right side where shot was administered" was not recovered, the other event was unknown. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The events were reported as non-serious. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Vaccine was administered by a clinician. The patient left the vaccination table and walked down to the observation area. When in observation, the staff was alerted that she has had a reaction to her first shot of the Pfizer vaccine, which comprised on whole body itchiness and some hives. Denied any trouble breathing. The patient was itching all over and wanted to be evaluated at the hospital. The patient was not given any medication by EMS personnel.

I had the typical sore arm after the short for approximately 72 hours. The worst of it, the first 24. I did get some intense diarrhea as well for a few days but as I'm near my period, I haven't any idea if it's due to that. On the 27th of May in the evening, I noticed my lymph nodes visibly swollen out of nowhere by my clavicle and they were incredibly painful to palpate. Upon going to the ER they noted that my lymph nodes in my throat were also swollen but not painful. This being a new thing to me, I called the nurse line who advised me to go to the ER. The ER said I didn't have cancer (not helpful) and would not talk about any side effects. I got a Covid test (negative). They sent me home and told me if I have issues breathing or anything, to return. 5/28 I started developing some nausea, congestion, headache, and fatigue, and I have lacked appetite all day. Around 6 pm I developed, so far, one hive on my abdomen.

On the night of the second dose (Saturday), I started feeling soreness on my entire back. This soreness lasted all Sunday. Taking ibuprofen, resting and laying down on a warm pad helped. The night of the Sunday to Monday was not comfortable, as the pain continued. On the Monday, the pain was gone, but I felt somewhat tired. I was able to work (on a computer), though. This is when the rash started on my face. I had what looked like an allergic reaction (at least, it manifested itself like when I get bitten by a mosquito and react badly). This first started on my forehead, above my right eye. It looked like a circle of 2cm in diameter. I also felt and saw some rash above my 2 eyebrows. What was interesting was also the rash I experienced on the back of my head. This lasted about 2 days. So, I took some Zyrtec. The rash on the front of my face then went away. The one on the back lasted a little longer. But then the rash went down the exterior of my left forearm, and to the stomach, also on the left side. This lasted a few days too. Taking Zyrtec again helped. Today, 1 week after the second dose, I still have marks from the rash on my belly, but the itchy sensation is gone.

I noticed severe itching on my left upper thigh with bumps and after this shot; itching has spread to face and arms; This is a spontaneous report from a contactable other health professional (patient) reported for herself that a 40-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL0140), via intramuscular route of administration, administered in right arm (at the age of 40 years) on 08Jan2021 as 1ST DOSE, SINGLE for COVID-19 immunization. Medical history included sinus tachycardia, panic disorder, depression, chronic fatigue syndrome, PCOS and allergic to Penicillin. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included Metformin 500mg, Metoprolol 50 mg, Paroxetine 50 mg and Vitamin D, which were received by the patient within 2 weeks of vaccination and all were taken for an unspecified indication, start and stop date were not reported. The most recent COVID-19 vaccine was administered at nursing Home/Senior Living Facility. On an unknown date, 2 weeks or so after first shot, the patient was noticed severe itching on my left upper thigh with bumps and after this shot, itching has spread to face and arms. Clinical course was reported as: On 20Jan2021, Joint and muscle pain and extreme fatigue that started on days 3+ (slept over 20 hours day 4, plus 12 day 5 and still exhausted). Congested with runny nose and itchy eyes and just generally feeling ill. 2 weeks or so after first shot, she noticed severe itching on her left upper thigh with bumps and after this shot, itching spread to face and arms. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient been tested for COVID-19. The patient underwent lab tests and procedures which included sars-cov-2 test/ oropharyngeal swab test: negative on 01Feb2021. Patient did not receive treatment for the adverse event. The case was considered as non-serious as per reporter. Outcome of the events was not resolved. Follow-up attempts are completed. No further information is expected.

Patient stated that she broke out in all over rash the next day following her COVID vaccine of Pfizer. I advised her to take Benadryl and use hydrocortisone cream. I also told her that if it got worse or did not get better to seek care from a doctor.

I developed severely blotchy skin on my inner right thigh on Friday evening (5/28/21). It would not clear up and was subcutaneous (not chafing). It was a little sore to the touch in places. I did a Google search and was alarmed when one of the first things to pop up was possible clotting. I had also been experiencing strange heart fluttering/palpitations and my chest felt tight, like I couldn't take a deep breath comfortably. My husband brought home some chewable low dose aspirin. I took approx. 600mg (per directions - it said take 4-8 tablets every 4 hours). I took 8 tablets. Within 15 minutes the blotchiness started to fade in my leg, and within on hour it was 90% better. It was 100% better by the next morning. I have since been taking one low dose aspirin per day as a precaution. Heart palpitations also stopped with the aspirin. I emailed my doctor at the time of the event but have not heard back, as it was a holiday weekend. I chose not to go to the ER since the symptoms subsided, but I still worry and plan to see my doctor about this event. The heart palpitations were NOT a tachycardia event. I am all too familiar, and this was entirely different with chest tightness also noted.

April 15- second Covid shot April 22 - first big vertigo spell. Deafness then ringing in right ear April 23 - mild ringing in both ears and thumping, pressure in head May 4th - very noticeable ticking in right ear May 9th - felt sick, off, hard to take a deep breath, pounding head, fullness in ears, ringing, emotional May 11th - ENT visit. Ears clear, hearing fine May 18th - May 23- off and on headaches, difficulty breathing May 24th - Headache that didn?t go away with medicine. Fullness in ear. Nausea May 25th - Sleepless night, stiff neck, very full head. Medicine providing no relief(Excedrin, Sudafed, Flexeril) can feel fast heartbeat, ringing, and pulsation in ears, stiff jaw May 26-28 - light head congestion May 29- headache returns May 30- head congested even after Sudafed. Ears feel ?wet? hard to take a deep breath, lots of yawning. Flushed face and blotchiness on neck. May 31 - Difficulty breathing, ringing in both ears

Patient started with tongue tingling, felt her jaw getting tight and redness to her chest. Patient given Benadryl in COVID pod as well as an Epi Pen. Patient transported to ED and given IV solumedrol and Pepcid. Racemic epi and neb given as well. patient symptoms have since improved.

Rash over entire body -3weeks and counting, swelling of lips in the morning 2 days, swelling of left ankle every night -3 weeks and counting

Looks like small hives; Rash all over my sides, stomach, too potion of thighs. Started about a week and a half after my last dose. Started out on my right rib cage and then moved through rest over the next week.; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the second dose of BNT162B2 (PFIZER COVID-19 VACCINE), via an unspecified route of administration, administered in left arm in Apr2021 (Lot Number: Ep7533) at the age of 40 years as single dose for Covid-19 immunization. Medical history included hyperthyroidism. Concomitant medications included levothyroxine sodium (SYNTHROID). Historical vaccine included the first dose of BNT162B2 (lot number: Er8735) administered in left arm on 31Mar2021 at the age of 40 years as single dose for Covid-19 immunization. Patient was not pregnant. There was no other vaccine in four weeks, no Covid prior vaccination, no known allergies. Patient experienced rash all over her sides, stomach, too potion of thighs. Started on 01May2021 04:00 PM, about a week and a half after her last dose. Started out on her right rib cage and then moved through rest over the next week. Went to care spot where they couldn't make any connection to things and gave her an oral steroid to take daily for a week, which didn't help. Ae resulted in doctor or other healthcare professional office/clinic visit. No Covid was tested post vaccination. Outcome of events was not recovered.

blurred vision/After my 2nd dose my vision is substantially worse, to where I cannot drive even 3 days later; huge lump under where she received the vaccine; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), 1ST DOSE, single on 23Apr2021 (Batch/Lot Number: EW0170) and 2ND DOSE, single on 14May2021 (Batch/Lot number was not reported), both via unspecified route at 9:50 am, arm left for covid-19 immunisation. Medical history included does wear glasses and mild psoriasis (just uses something topical if she has a flare up) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient historical vaccine includes: flu vaccine from unspecified date for immunization. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient is calling about the Covid 19 vaccine. After she received her first Covid 19 vaccine on 23Apr2021, she had blurred vision starting on Sunday, 25Apr2021. She called the pharmacy and was told that blurred vision was a rare side effect and her vision should clear. She received the second Covid 19 vaccine on Friday, 14May2021 and she experienced the blurred vision again except this time she can't see anything unless it's about 2 inches from her eyes. She doesn't have a job she has to go to but she is a stay at home mom and she home schools her children. She can't even see the text in books. She can't drive, not even to the grocery store. She is asking how long is this going to last. Her arm has a huge lump under where she received the vaccine. The lump is still there from the first vaccine and she has another lump from the second vaccine. Her left arm now has 2 lumps. She thought that might be an allergic reaction but the same lady gave her both injections and stabbed her pretty hard when she gave the Covid 19 vaccine. The pharmacist did tell her she can get blurred vision with any vaccine but she always gets her flu vaccine and she's never had blurred vision before. She received her second Covid 19 vaccine on Friday, 14May2021 in the left arm. She can't find the vaccine record card, she had two vaccine records card because she forgot to bring the first vaccine record card to her second appointment. The NDC for the second vaccine is on her receipt. NDC 59267-1000-01, Lot/Expiry not known for second dose. First Covid 19 vaccine information is in the suspect product field. She received her first Covid 19 vaccine on Friday, 23Apr2021 and she had blurred vision on Sunday, 25Apr2021. She thought at first it was pink eye or conjunctivitis because her vision was blurry and she thought, what did her children bring home to her. Her eyes weren't pink though. She called the pharmacist and he told her it was a side effect. Her vision did get better about a week before the second Covid 19 vaccine but it wasn't completely back to normal. She received the second Covid 19 vaccine on 14May2021 and she experienced more blurred vision on Sunday, 16May2021 but it's much worse and it's not gotten better. She's trying to read from her coffee machine and she can't even see what it says. This can't be normal. Does she need to see an optometrist? She reports she could still drive after her first Covid 19 vaccine because the blurry vision wasn't that bad but this time it's scaring her a little bit. She reports she does wear glasses but only for night time. Her pupils don't dilate well so she tries not to drive at night.The reporter added that around 48 hours after my first dose I began having blurred vision, it got slightly better before my 2nd dose, however, it did not get completely better. After my 2nd dose my vision is substantially worse, to where I cannot drive even 3 days later. The outcome of the event was recovering for blurred vision and not recovered for the other event. The patient was did not required emergency room and physician office visit. Follow up attempts are needed. Further information has been requested.

Sore arm at injection site; This is a spontaneous report from a non-contactable consumer (patient). A 40-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number and Expiration date were not reported), via an unspecified route of administration (administered on the left arm) on 02Mar2021 (at the age of 40-years-old) as 1st dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient has not been diagnosed with COVID-19. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. The patient has no other medications in 2 weeks. The patient experienced sore arm at injection site on 02Mar2021. No treatment was received for the event. Since the vaccination the patient has not been tested for COVID-19. The outcome of the event was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

I woke up on the 4/13/2021 with hives all over my body I did not know what it was I had no pain at injection site I felt fine I went about my business the next day I felt like there were ants crawling under my skin by Thursday the feeling of heat kept rising in my skin i would look and it would be hives the following the bloody noses began every three days i get nose bleeds. the hives has gotten worse I am now taking 6 Benadryl's a day just to avoid itching my skin off I went to medical facility where i received 2 steroid injections. The dr does not know what to do, I had to go to the hospital to cauterize the inside of my nose they could not figure out the cause. I had a stroke back in Oct and I thought maybe something was going on but the Dr said it was not associated. Ever since I received the shot I have not been the same. Right before the hives appear, it feels like the stinging burning feeling right after someone slaps your skin. This lasts for 30 seconds. My skin is dark but my skin turns red with the hives. They gave me Zofran for the nausea, they also gave me a nose pincher thing that I use when I have nosebleeds. Also, I thought it was allergies but I have congestion that have no diagnosis. It is hard to breathe. I feel like I have Covid but I do not. The doctors say I have insomnia, I have headaches due to the congestion. I also feel tired. I have dizziness that feels like I am on a merry go round that I can't get off. Walking up stairs exhausts me which is unusual because I am a physically fit individual. I have had to take a lot of days off from work due to these side effects. Taking as many Benadryl's as I do causes drowsiness and I am a single mother of 4, I cannot be drowsy.

On 1/27/2021, I woke up with a rash on my left arm where the shot was. I called the insurance company for a telemedicine doctor as I do not have PCP. I went to the store right afterwards o get a Benadryl cream. The doctor called me in the afternoon. by the time he contacted me the area had already began to heal. The doctor looked and it and could see that it was red and bumpy, he prescribed prednisone, I did not pick up the RX because it was healing and I did not think I needed. The doctor was not certain if the rash was caused by my allergy of bandage glue or the vaccine. It cleared up a day and a half.

she got COVID exactly 8 days after the shot; COVID arm/It was described as a big, giant, red circle and giant lump in that circle; COVID arm/It was described as a big, giant, red circle and giant lump in that circle; COVID arm/It was described as a big, giant, red circle and giant lump in that circle; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered on the left arm on 26Apr2021 18:35 (at the age of 40-years-old; lot number: EW0170, expiration date not reported) as first dose, single dose and via an unspecified route of administration, administered on the left arm on 17May2021 18:35 (at the age of 40-years-old; lot number: EW0182, expiration date not reported) as second dose, single dose both for COVID-19 immunisation. Medical history included ongoing asthma (had since she was a baby), ongoing Epstein Barr (has since she was 16 years old), allergy, penicillin allergy (this was found out when she was a little kid. She has also been taking Tylenol as treatment for the event) , and antacid therapy. Concomitant medications included cetirizine hydrochloride (ZYRTEC ALLERGY) taken for hypersensitivity from an unspecified start date and ongoing; diphenhydramine hydrochloride (BENADRYL) taken for hypersensitivity, start and stop date were not reported; and esomeprazole magnesium (manufacturer unknown) taken for antacid therapy, start and stop date were not reported. The patient previously took amoxicillin and experienced drug hypersensitivity (reported as this was found out when she was a little kid. She has also been taking Tylenol as treatment for the event). The patient reported that her mom and dad had COVID in Dec2020. The patient did not receive any other vaccines within 4 weeks prior and on the day of administration of the COVID vaccine. The patient experienced covid arm/it was described as a big, giant, red circle and giant lump in that circle on an unspecified date on May2021 and she got covid exactly 8 days after the shot on 04May2021. Reporter who wanted to report a side from COVID vaccine after the first dose. She explained she got something called COVID arm. It was explained she went and got the second dose yesterday (17May2021) and told them about it. The facility told her to report this as it doesn't happen often with the Pfizer vaccine. The first dose was given on 26Apr2021 and she got COVID exactly 8 days after the shot, almost 2 weeks in. It was described as a big, giant, red circle and giant lump in that circle. She didn't know what was going on so she looked it up and the pictures she saw looked exactly like what she had. The article said that most people got it 8 days in after the vaccine. She brought it up when she got her second dose because it is not even gone yet. She clarifies the redness went away a day or 2 ago but the lump is still there. Because of that, the second was done in same arm but on the side of her arm and not in the lump. The second dose was administered closer to the arm pit instead of where the lump is. Regarding the lump, it isn't as big, it is on the verge of going away. She was warned that this could happen again since she had the first reaction. Both shots were given on the left arm. She did pretty must everything she was told to for treatment; she put ice on it and took paracetamol (TYLENOL). Yesterday when she got the second shot (17May2021), she was given a topical cream to put on incase it happens again. Reporter asked if this happens again should she call to report it. It was explained she could call us back to report or include this on the paperwork she maybe be sent regarding the event reported and she agreed. Patient took paracetamol (TYLENOL) and put ice on her covid arm as a result of the events reported. Events did not result to emergency room or physician office visit. The outcome of COVID-19 was unknown, vaccination site lump and swelling was recovering, and vaccination site redness was recovered on an unspecified date.

violently vomiting; nauseous; losing weight; my labs are a mess; losing hair; short of breath; dizzy; I have never felt so awful for so long.; can barely eat; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Right on 16Mar2021 09:00 (Batch/Lot number was not reported) at single dose for COVID-19 immunization. Medical history included Lupus, Postural orthostatic tachycardia syndrome (POTS), depression, Axial Spondyloarthritis, Degenerative Disc Disease. Concomitant medications included unspecified medications, the patient was on quite a few, she didn't fit. The patient's known allergies Ambient, augmentin, doxycycline (not anaphylaxis). No other vaccine in four weeks. Vaccine 16Mar2021, day after she started violently vomiting. She had vomited al-most every day since, she was nauseous 24/7, she can barely eat so she was losing weight and her labs were a mess, she had to get IV Iron yesterday (19May2021), and she had a ton other GI tests coming up. She was losing hair, I'm getting barely any nutrients. She was now short of breath and dizzy too. She had never felt so awful for so long. Adverse event start date was 17Mar2021. Adverse event start time was 07:00 AM. Adverse events resulted in Doctor or other healthcare professional office/clinic visit. The patient received treatment for the events included intravenous Iron, tried different medicine, lots of appts. No covid prior vaccination. No covid tested post vaccination. The adverse events did not result in death, did not cause/prolong hospitalization, was not life threatening, disabling/incapacitating, congenital anomaly/birth defect. All events considered as serious due to being medically significant. The outcome of the events was not recovered. Information on the lot/batch number has been requested.

Generalized fatigue; Injection site soreness; Severe headache for 3-4 hours a few hours after injection; Slight chills; Fever; This is a spontaneous report from a contactable non-healthcare professional reporting for a patient. A 40-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205) via unspecified route of administration in right arm on 16Mar2021 at 16:15 (age at vaccination 40-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 had known allergic to seasonal, pet dander, mold and dust. Medical history included severe asthma. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included SINGULAIR, LEXAPRO, SYMBICORT, VENTOLIN and allergy medication. On 16Mar2021, at 18:00 the patient experienced severe headache for 3-4 hours a few hours after injection, slight chills and fever. On 17Mar2021 patient experienced generalized fatigue and injection site soreness. The patient did not receive any treatment for the reported events. The clinical outcome of severe headache, slight chills, fever, generalized fatigue and injection site soreness was recovering at the time of reporting. No follow-up attempts are possible. No further information is expected.

pain in my right boob; maybe it is swollen; aching in my upper right arm; burning pain in my joints of the vaccinated arm; extreme tiredness; all joints in my arm began to sting; extremely nauseous; sweaty; light-headed/mild dizzy spells; unable to think clearly; sudden down in blood sugar; foggy-headed; This is a spontaneous report from a contactable consumer (patient). A 40-years-old non-pregnant female patient received bnt162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; Lot Number: EN6200), dose 1 via an unspecified route of administration, administered in Arm Right on 02Mar2021 13:30 as 1st dose, single dose for COVID-19 immunization. Patient did not receive any vaccine in four weeks and not had COVID prior vaccination. Medical history included high blood sugar, asthma, scarlet fever survivor and patient had known allergy to latex. Concomitant medications included cinnamomum verum (CINNAMON TABLETS), quercetin, rhodiola rosea (RHODIOLA), and st johns (as reported). On 02Mar202 01:30, within 1 minute after vaccination, patient experienced all joints in arm began to sting. and was extremely nauseous, sweaty, light-headed, and unable to think clearly- very much like experiencing a sudden down in blood sugar. The doctor had patient to drink water and eat fruit. Patient reported it took about 15 minutes to be able to think clearly and was foggy headed for at least 24 hours. On 03Mar2021, (the after) patient experienced burning pain in joints of the vaccinated arm, extreme tiredness, and mild dizzy spells. On 05Mar2021, 3 days (yesterday) after vaccination, had pain in right boob and patient think maybe it was swollen as well as aching in upper right arm. Patient reported it still hurts today. Patient not tested COVID post vaccination. The patient underwent lab tests and procedures which included blood glucose: high. Therapeutic measures were taken as a result of extremely nauseous, sweaty, light-headed, and unable to think clearly- very much like experiencing a sudden down in blood sugar with water and fruit. The outcome of the events reported as recovered with sequelae (Recovered with lasting effects). No follow-up attempts are possible. No further information is expected.

Mild metal taste in mouth approx. 1 minute after shot was administered; Soreness in left arm, around site injection started approximately 6 hours after administration; spread to about 3 inches outward around from site of injection; Migraine started around 24 hours after shot was administered, with pain concentrated behind right eye; Fatigue; ended up sleeping nearly 12 hours; This is a spontaneous report received from a non-contactable consumer or other non hcp. A 40-years-old non pregnancy female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EW0186), via an unspecified route of administration in Arm Left on 28May2021 15:00 (age at vaccination 40years old, No pregnancy at time of Vaccination) as single dose for covid-19 immunization. Medical history included lactose intolerance from an unknown date and unknown if ongoing. Prior to vaccination, the patient was diagnosed with covid-19. Concomitant medication(s) included Vitamin C, Vitamin D, Calcium Citrate, Iron taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination the patient was not diagnosed with covid-19. The patient received other medications in two weeks. On 28May2021 21:00 the patient experienced mild metal taste in mouth approx. 1 minute after shot was administered; dissipated a few minutes afterward. Soreness in left arm, around site injection started approximately 6 hours after administration; spread to about 3 inches outward around from site of injection; no swelling. Migraine started around 24 hours after shot was administered, with pain concentrated behind right eye. Fatigue; ended up sleeping nearly 12 hours. After 42 hours, migraine has gone away; remaining symptom is soreness - now reduced to half the area and still concentrated around site injection area. Patient was not received treatment for the events. Since the vaccination, the patient has not been tested for covid-19. The clinical outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.

Pt reported difficulty breathing, swelling of face and throat, dizziness and weakness, pain, swelling and redness at injection site, sore throat, swollen lymph nodes, pain/tightness in chest, shortness of breath, headache, body aches, muscle aches, upset stomach, nausea, brain fog, fatigue, dizziness, and vertigo for six days after vaccination.

I had an allergic response that included itchiness, watery eyes, congestion... then settled into bronchitis. I still have the bronchitis.

I have a strange full arm rash/stripped skin discoloration on my right arm. It appeared two weeks after the shot and is still present. It does not itch and is not irritating. It looks like a series of stretch marks almost. It is slightly fading from an angry red to a lighter brown. My body had a very bad reaction on the next day after the second shot. I anticipated that reaction, but not this skin discoloration / rash. I do not think it is going to go completely away. It is very strange.

anaphylactic shock (fully body hives/extreme swelling of faces, neck, and limbs/ full body rash/painful itching/ feeling like a very intense burn) has lasted for 5 days causing hospitalization (has not gone away yet)

Symptoms are ongoing 8+ weeks post vaccine. I have had two doctors visits and numerous blood tests. All normal. I was perfectly healthy prior to this other than a vitamin D deficiency that is now within the normal range. No known prior COVID exposure/infection. Have been maintaining a small, strict family bubble since March 2020 - working from home, home schooling my son, no travel or even going into stores. I had the normal/expected next day reaction to the 2nd shot - extreme fatigue, body aches, headache. I rested for the full day on Saturday and felt better /normal by Sunday morning. However, by late Sunday afternoon, new symptoms came on. They started out on the left side of my body and then grew from there in the days that followed. First it was pain behind my left knee that radiated down to my ankle and later upward through my left thigh, hip, entire arm, and shoulder. From there, it progressed to all over pain in my joints on both side of my body and almost daily headaches - typically around the base of my skull. I am also experiencing prolonged periods (days and sometime weeks at a time) of constant muscle tension/soreness in both arms and legs and intermittent tightness in my chest. However, the pain has remained most intense/pronounced/persistent on my left side and a couple of different times in the last 8 weeks I've had bruising on my left foot and ankle. As a result of all of this, I am fatigued most days and it is all inhibiting my ability to function normally. I don't know whether it is related to the vaccine or not, but I know it isn't normal. My quality of life and ability to function as I typically have has decreased dramatically in the last 8 weeks and I am very worried and I don't know what to do. If someone can please contact me and advise whether they have received any similar reports and provided direction on some type of specialist or test that might be able to help, I would be forever grateful as I am scared and my primary care physician has basically just said I need to wait it out.

My first dose on may 18th 2021. Side effects hit me 45 minutes later. Head ache, chills like flu, my felt hot like I was on steroids. No fever. pain in arm where I recieved the shot, loss of appetite, weakness in my body. Body ached to the point I cried. It lasted for 5 days.

speech difficulties (couldn't think of words, slurred words); Blurry eyesight; fever; clammy skin; headache; fatigue; itching skin; loss the ability to focus eyesight on phone, computer screen or books.; This is a spontaneous report from a Non-Contactable consumer (patient). A 40-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL3302), via unspecified route of administration in the Left arm, on 25May2021 at 10:30 AM, as a single for COVID-19 immunisation. Medical history included Hypothyroid. Concomitant medications included armour, liothyronine and spironolactone. The patient had no known allergies. On 25May2021 at 02:30 AM, the patient experienced Blurry eyesight, fever, clammy skin, headache, fatigue, itching skin, speech difficulties (could not think of words, slurred words), loss the ability to focus eyesight on phone, computer screen or books. 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 and Since the vaccination, the patient had not been tested for COVID-19. The patient was not tested for COVID-19 post vaccination. The patient did not received treatment for the events. The outcome of the events was recovered with lasting effects. No follow-up attempts are possible. No further information is expected.

Facial hives Eye lid swelling Symptoms began at 630pm 2 25 mg tablets (50mg total) taken orally at 7pm Symptoms resolved within 4 hours

The evening following the 2nd dose of covid 19 vaccine my arm was sore and I was tired. That night it progressed into a fever of 104, severe body aches in almost all my joints, headaches, bradycardia and body chills. The fever was minimal reduced by switching Tylenol and Ibuprofen every few hours to about 102. Fever, chill and body aches started to subside in about 24 hours. Today I have sore throat, pressure/fluids in ears, slight chest pains and bradycardia, light headache and swollen lymph nodes in throat , inject site is still sore but most bothering is dizziness that is setting in.

About 15 days after receiving first vaccine I developed what I thought was a rash. It turned out to be guttate psoriasis, which is a different form of psoriasis than I previously suffered from. Saw a dermatologist after both vaccine injections and treated with a course of oral steriods. When it came back after the second round of steriods, we began treatment with Otezla 30mg 2x/day.

patient had tingling on face starting on 6/3/21, on 6/4/21 broke out in rash, on 6/5/21 rash broke open to open sores\ 6/10/2021 diagnosed with shingles

Fever over 103°, chills, severe headache with light sensitivity, rash halfway down my arm on the arm where injection was given

pain at injection site; Fever; exhaustion; This is a spontaneous report from a contactable consumer (patient). A 40-years-old female patient received the second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 09Mar2021 15:00 (Batch/Lot number was not reported) (at the age of 40) as single dose for covid-19 immunisation. First dose was received on 16Feb2021, left arm, 02:45PM. No other vaccine was received in four weeks. No covid prior vaccination. No covid tested post vaccination. Medical history included asthma, iodine allergy. Concomitant medication included gabapentin taken for an unspecified indication, start and stop date were not reported. The patient experienced pain at injection site on 10Mar2021 13:00, fever on 10Mar2021 13:00, exhaustion on 10Mar2021 13:00. No treatment received. The outcome was not recovered. No follow up attempts are possible. Information about Lot/batch number cannot be obtained.

Patient received second dose of Pfizer COVID 19 vaccine 15 days after the first. No reported unexpected side effects the night of or day after vaccination received. Only reported side effect of mild arm soreness.

06/02/2021- Immediately (under 5 minutes) - Mottled skin on both legs, upper and lower (last 45 minutes), Extremely dizzy and lightheaded. Face went dumb 4 hours after vaccine, both legs turned bright pink like sunburn 10 hours after vaccine. 06/03/2021 - Broke out in hives on inside of arms. Lasted 3 days and no longer there 06/08/2021 - Metrorrhagia (my period was not due for 10 more days, I am always exactly regular for my whole life) 06/08/2021 - Hypoglycemia (Multiple episodes since vaccination, Bloodwork showed one episode of 56 mg/dL) No history of diabetes. Hypoglycemic episodes still happening as of 06/13/2021 when blood sugar was 72.

Left arm pain radiating to should and scapula. Unable to lift arm above head without having pain. Tingling in finger tips that come and go. My body doesn't feel the same after my second dose of the vaccine.

On the third day after receiving my 2nd Pfizer vaccine I broke out in a vesicular type rash in the V2 dermatome. I was prescribed Valcyvlovir 1gm TID after being diagnosed in the ER the same day. The next day some more blisters broke out in the same dermatome above my left eye off to the corner, my left nostril, left lip, and left side of bridge of nose. I also have increased pain in my left tooth in the incisor section. I followed up with the eye doctor.

Symptoms - Right eye swelling on June 10, rash on right side of face on June 11, swollen lymph nodes on June 12, face tingling on June 15. Initial Diagnosis - Stye on June 13 Later Diagnosis - Shingles on June 16 Initial Treatment - Prednisone and Clindamycin Later Treatment - Valacyclovir

Site: Redness at Injection Site-Mild, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Additional Details: The Patient fainted after receiving the covid vaccine. EMS came and attended to the patient. She left the store with her husband.

i have been having a pain in my left arm where the shot was given. i didn't have any pain right after the shot. it has all started in april

Emotional disturbance (exceptionally bad PMS), suddenly onset of acne, bright pink spotting in the middle of period. It appears to be a hormonal fluctuation. This patient has never experienced mid-cycle spotting before.

Rash on face and chest; periodic numbness and tingling in left side of face/cheek is ongoing still/Numbness and pins and needles feeling in left side of face and cheek; Numbness in left side of face, tongue and throat; Numbness in left side of face, tongue and throat; Numbness in left side of face, tongue and throat; This is a spontaneous report from a non-contactable consumer (patient) reported for herself. A 40-year-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EW0172, Expiration date: unknown) via unspecified route of administration, administered in left arm on 05May2021 at 16:30 pm (age at vaccination was 40 years) as first dose, single dose for COVID-19 immunization. The patient did not have any medical history. The patient had known allergies to penicillin and carmel color, eggs, pistachios. Concomitant medications the patient received within 2 weeks of vaccination included ergocalciferol (VIT D), ascorbic acid, beta vulgaris root, iron amino acid chelate, rosa canina fruit, rubus idaeus leaf (IRON SUPPLEMENT WITH VIT C & HERBS) and Multi Vitamin. The patient previously took amoxicillin, erythromycin, z-pac, codeine and experienced drug allergy. The facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. 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. On 05May2021 at 16:45 pm, the patient experienced numbness in left side of face, tongue and throat, starting 15 minutes after the shot. Throat and tongue were back to normal after 24 hours. Numbness and pins and needles feeling in left side of face and cheek continually for 3 weeks, periodic numbness and tingling in left side of face/cheek was ongoing still. Rash on face and chest began 48 hours after shot and lasted 3 days. The device timestamp and device date was reported as 07Jun2021. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse events. The events were reported as non-serious. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.

Blisters; itching; pain on left hand; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: Er8732; Expiration date was not reported), via an unspecified route of administration in the left arm on 07Apr2021 (at the age of 40-years-old) as first dose, single dose for COVID-19 immunization. Medical history included arthritis, colon polyps, PTSD, ADHD, bulging disc and depression; all from unknown date and unknown if ongoing. Concomitant medications included hydrocodone and zolpidem tartrate (AMBIEN); both taken for an unspecified indication, start and stop dates were not reported. The patient previously took metoclopramide (REGLAN) and experienced drug allergy. The patient was not pregnant at the time of vaccination. No other vaccine was received by the patient in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19. On 08Apr2021, the patient experienced blisters, itching and pain on left hand. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care visit. Treatment with steroids pills, steroids shot and 4 creams were taken as a result of the events. The outcome of the events was not recovered. The patient was vaccinated with BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: ew0161; Expiration date was not reported), via an unspecified route of administration on 27Apr2021 (at the age of 40-years-old) as second dose, single dose for COVID-19 immunization.

Mild soreness of injection site, only lasted a day.; This is a spontaneous report from a non-contactable other HCP (patient herself). A 40-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9264) via an unspecified route of administration, administered in Arm Left on 29Jan2021 18:30 (at the age of 40-years-old) as 1st dose, single dose for covid-19 immunisation. The patient's had no medical history and no known allergies. The patient's concomitant medication included bupropion in two weeks 75 mg two times a day (BID) for an unspecified indication. The patient had no other vaccine in four weeks. The patient had no Covid prior vaccination. On 30Jan2021, the patient experienced mild soreness of injection site, that only lasted a day. The patient tested for covid post vaccination, covid test type post vaccination nasal swab, a polymerase chain reaction (PCR) test done on 31Jan2021 which showed negative result. The patient did not receive treatment for the adverse event. The outcome of the event was recovered on 30Jan2021. No follow up attempts are possible. No further information is expected.

circular rash m/spot at the site; pain to the site; excruciating pain to the entire left arm and neck; excruciating pain to the entire left arm and neck; This is a spontaneous report received from a contactable nurse. A 40-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no. EN6198) via an unspecified route of administration in the left arm on 06Mar2021 at 09 15, as a single dose for COVID-19 immunisation. Medical history included asthma and migraines. Concomitant medications included TYLENOL, SYMBICORT, albuterol (UNKNOWN MANUFACTURER UNKNOWN), ZYRTEC taken within 2 weeks of vaccination. The patient had allergies to aspirin and NSAIDS. Prior to vaccination, patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested positive for COVID- 19. On 17Mar2021, the patient experienced pain at site and excruciating pain in the entire left arm and neck, also noticed a circular rash m/spot at the site on 18Mar2021 which got larger on 19Mar2021. The clinical outcome of vaccination site pain, vaccination site rash, excruciating pain to the entire left arm and neck was not recovered. No follow-up attempts are needed. No further information is expected

reproductive organs, bleeding that consisted for 2 weeks straight and now spotting 3 weeks out of 4 weeks; intense pain in reproductive organs; Bloating; now growths (possibly cervical polyps); dull achy sore pain where the shot was administered; tingliess in her fingers on that arm; This is a spontaneous report received from a contactable consumer (patient). A 40-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown, NDC 59267100002) via an unspecified route of administration at left arm on 13Apr2021 12:00 (40-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history included depression and ADHD. Concomitant medications in two weeks included dextroamphetamine hydrochloride; alprazolam; sertraline hydrochloride (ZOLOFT); hydroxyzine hydrochloride (VISTARIL). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) at left arm on 23Mar2021 11:00 (40-year-old at time of vaccination) for COVID-19 immunization. Patient did not receive any other vaccines within 4weeks prior to the COVID vaccine. Event start date was reported as 14Apr2021 15:00. Patient has had a dull achy sore pain where the shot was administered ever since she received the last shot. She also has tingliess in her fingers on that arm. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. No treatment was received for these adverse events. The patient also reported intense pain in reproductive organs, bleeding that consisted for 2 weeks straight and now spotting 3 weeks out of 4 weeks. Bloating and now growths (possibly cervical polyps)- visting OBGYN for follow up. The adverse events resulted 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 has not been tested for COVID-19. The case was serious, medically significant. No therapeutic measures were taken as a result of the event "dull achy sore pain where the shot was administered" and "tingliess in her fingers on that arm". The outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

5 days later developed rash and still lump at injection site. In day or 2 following injection, arm was sore, some flare up in systemic fibromyalgia pain.

Small, itchy bumps on forearms and shins. Less severe on upper arms and thighs. Leg rash ended after 5 days. Arms still affected.

hives Tx: EDvisit, given benadryl Received vaccine 12/22, noticed hives arm/Flank 12/25 Allergy evaluation - recommend 2Nd dose with increased 30 min of monitoring time Dose #2 given 1/11/2021 - NO adverse reaction. First dose ReactioN , WAs not considered allergic

petechia all over her legs and a large bruise on her abdomen; Petechia all over her legs and a large bruise on her abdomen; Caller states she gave birth to her son 28DEC2020, and she had been exclusively breastfeeding; Had her first period post partum and it was extremely heavy and atypical; states it was more bleeding than like a period; This is a spontaneous report from a contactable consumer (patient) reported for herself that: A 40-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown; formulation: solution for injection; expiration date: unknown), via an unspecified route of administration in left on 17Mar2021 17:15 (at the age of 40-year-old) as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history included COVID-19 from Mar2020 to an unknown date. The patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown; formulation: solution for injection; expiration date: unknown), via an unspecified route of administration in left on 13Apr2021 10.30 as second dose, single dose for COVID-19 immunisation. The vaccine was not administered at the facility. additional vaccines administered on Same date of the Pfizer suspect was None. The patient did not receive any other vaccines within four weeks prior to the vaccination. prior vaccinations the AE was reported as none. Patient do not have any illness at time of vaccination in medical history and no history relevant to family. The patient relevant tests were reported as none. The patient stated that she wanted to report an adverse side effect that she had to the vaccine. It was a leading hypothesis for the cause with her haematologist based on the timeline and having no past medical history. The patient concomitant medications were not reported. The patient stated that she got the first vaccine of Pfizer on 17Mar2021. and she stated on the weekend of 05Apr2021, she had her first period post-partum, and it was extremely heavy and atypical. Patient states that she gave birth to her son on 28Dec2020, and she had been exclusively breastfeeding on 05Apr2021. She stated that were the first abnormal thing that happened. She stated that on weekend of 10Apr2021-11Apr2021, when she did not know what they were yet, she got petechia all over her legs and a large bruise on her abdomen on 10Apr2021, but she did not know what meant yet. She stated the bruises and petechiae cleared up with treatment, exact date was unknown. The patient stated the bruises were big, and they recovered after a week or two. She stated they were not normal bruises where she would hit something and be like ouch. Caller states she went to the Urgent Care for petechiae. The patient underwent lab tests and procedures which included sars-cov-2 antibody test (IVG Spike Protein and Nucleocapsid): positive on an unspecified date, indicate that she has probably had COVID, sometime in the past, only time would have been March 2020 when the pandemic started, she had symptoms that weren't reported as symptoms yet and she was traveling in India at the time. States she doesn't know what strain it may have been. States she tested for antibodies because she was interested to see how the steroid was affecting her response to vaccine. The outcome of the Caller states she gave birth to her son 28DEC2020, and she had been exclusively breastfeeding and had her first period post-partum and it was extremely heavy and atypical states it was more bleeding than like a period was recovered on 07Apr2021 and other events was recovered on 11Apr2021. Information on the lot/batch number has been requested.

Diagnosed with shingles aprox three weeks after second vaccine given. Shingles like back pain in same dermatome 1-2 days after vaccine given. Resolved and rash appeared May 6 in same dermatome with reappearance of same pain.

Developed a swollen lymph node under right arm.; itchy throat; Started with itchy nose; cough; nausea; headache; Temp 99.5.; heavy chest; hard breathing; Body aches occurred overnight; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL22613), via an unspecified route of administration in the right arm on 18Mar2021 at 10:45 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, depression/anxiety, and heart burn. Concomitant medications received within 2 weeks of vaccination included levothyroxine (MANUFACTURE UNKNOWN), fluoxetine (MANUFACTURE UNKNOWN), norgestimate and ethinyl estradiol (TRI-LO SPRINTEC) and omeprazole (OMEPRA), all for unknown indications from unknown date. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9263), via an unspecified route of administration in the right arm on 25Feb2021 at 12:00 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 18Mar2021 at 16:00, the patient experienced itchy nose and throat that developed into cough, nausea, and headache. Temp 99.5 and developed into heavy chest and hard breathing. Body aches occurred overnight and into the morning of 19Mar2021. Coughing, nausea, and body aches continued, and developed a swollen lymph node under right arm. The patient did not receive treatment for the reported adverse events. The clinical outcome of itchy nose, itchy throat, headache, temperature 99.5, heavy chest, hard breathing, swollen lymph node under right arm were recovering, and body aches, nausea, cough was not recovered. No follow up attempts are needed. No further information is expected.

30 minutes after receiving vaccine my arms abdominal and legs began itching and had red patches like hives. I ignored this and continued working. Then insides of my ears began itching. I told the pharmacy techs that were qt my place of work administering the vaccine. They gave me 50mg of benadryl, at that time my eyes had begun to itch and started coughing. Pulse rate was 160. No shortness of breath and no tongue swelling. They offered an epipen but as a nurse myself I declined and wanted to wait to see if benadryl would be effective. I was monitored for an hour. By the end of the hour I was not coughing, my eyes and inner ears had stopped itching and my pulse was back below 100. I still had hives and moderate itching to my body which resolved about 2 hours after taking benadryl.

Low grade fever; Arm soreness with some numbness around the injection site; Arm soreness with some numbness around the injection site; Nausea; Elevated heart rate; This is a spontaneous report from a non-contactable consumer (patient). A 40-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown), via an unspecified route of administration on 03Feb2021 (at the age of 40-year-old), as unknown, single, in left arm, for COVID-19 immunization at Workplace Clinic. The patient's medical history included glaucoma, bipolar disorder, corticosteroids allergy, and COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Feb2021, patient experienced arm soreness with some numbness around the injection site, nausea, and elevated heart rate. Patient received Ibuprofen as a treatment medication. The patient had COVID prior vaccination and was not tested COVID post vaccination. The patient underwent lab test and procedure which included heart rate: elevated, on an unspecified date in Feb2021. The clinical outcome of all the events was resolving. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Itchy rash just near injection site on left arm 6 days after second dose; Itchy rash just near injection site on left arm 6 days after second dose; This is a spontaneous report from a non-contactable other hcp (Patient). A 40-year-old non pregnant female patient received of second dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 29Jan2021 (age at vaccination: 40-Year-old) as single dose for covid-19 immunization. Medical history included hypertension, hashimotos thyroiditis. Concomitant medication included metoprolol (METOPROLOL) taken for an unspecified indication, start and stop date were not reported, levothyroxine (LEVOTHYROXINE) taken for an unspecified indication, start and stop date were not reported, bupropion hydrochloride (WELLBUTRIN) taken for an unspecified indication, start and stop date were not reported, curcuma longa (TURMERIC [CURCUMA LONGA]) taken for an unspecified indication, start and stop date were not reported. The patient previously took first dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 08-JAN-2021 for covid-19 immunization. No known allergies. No Covid prior to vaccination. On 04Feb2021 at 16:00 The patient experienced itchy rash just near injection site on left arm 6 days after second dose. The patient underwent lab tests and procedures which included sars-cov-2 test: negative. The outcome for the event was not resolved. No follow-up attempts are possible, Information about batch/lot number cannot be obtained. No further information is expected.

Approximately 3 days after the 2nd dose - Slight symptoms of hemorrhoids; however, this one was not as severe as after the first dose. This only included slight discomfort/itching. I only had to use 1 or 2 treatments of Tucks before the symptoms disappeared (last about a day or two). No medical treatment was sought for either the first or second occasion. Ongoing - Starting perhaps a month after my 2nd dose, I've begun having mucus build up in my sinuses. In addition, I frequently experiencing a "tickle" in my throat that triggers coughing. The sinus build up happens throughout the day and is usually resolved by "snorting" and either spitting out (or swallowing) the mucus. I haven't kept track of the color, though. This is something very abnormal for me, as I've never had sinus build up (except for sometimes during allergies or colds). I have not had an allergy issue or cold leading up to or during these issues. Also, the "tickle" in my throat that triggers coughing, happens intermittent, maybe once or twice a day. It can trigger coughing fits of varying lengths. Both the sinus build up and throat tickle are ongoing. I have not yet sought medical treatment as they don't really impact my day to day; they are just things that I've noticed happening now (that did not occur prior to the vaccination). I'd like to mention that I did not experience any of the typical "flu-like" symptoms immediately after receiving either COVID vaccine dose. I was prepared for and expected to get sick. However, I had no typical flu-like adverse reaction at all within 48 hours of receiving either dose.

12 hrs post injection: facial flushing, prickly feeling all over body/skin, nausea, body aches, racing pulse 24 hrs post injection: persistent facial flushing/rash, facial blotches & bumps, upper back and neck aches, head ache, fatigue, right thumb joint pain 48 hrs post injection: right thumb/pinky joints painful & stiff 3 days post injection: both thumbs and most fingers painful & stiff (consistent for 1 month, sporadic to present) 1 week post injection: Noticed occasional low-grade fevers (99-100 degrees), continues to present 3 week post injection: Developed head pain in/around temples, sides of forehead, and scalp. These are sudden bursts of pain/ache and occasionally persistent throbbing. Veins on side of forehead are swollen and bulging. Stiff and painful neck and SI/lower back that would cause me to wake during sleep. Nausea, fatigue, and head pains continued. Occasional sore throat. Temples and scalp tender to touch and hurt when chewing or talking. Other veins throughout body appear more visible. 8 weeks post injection (present): Symptoms continue to include Rosacea flare up and everything listed at 3 weeks post injection to include sporadic pain in thumb and finger joints.

Experienced injection site swelling, heat, and pain 2 days after vaccination. Still has not resolved.

The day following the shot I had a very sore arm (which was to be expected) this went away in a day or two and felt completely fine after. On day 9/10 following the vaccine, I woke up with severe pain in the same arm at the injection point and pain with mobility of the same shoulder. Later the same day I unexpectedly began my menstrual cycle. It was 7 days early. It's never early, ever. My cycle is down to the day and regular, always. No usual menstrual cycle indicators/symptoms prior to it beginning either. The day after my cycle started, I noticed my heartbeat was pounding very loudly at night in bed, this lasted for 3 days with moments of minor chest tightness in the center of the chest, which was concerning, I almost opted to go to ER. this sensation subsided on the 4th day and has not returned.

Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Chills-Mild, Systemic: runny nose and eyes-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: onset of adverse effects started about 30 minutes after vaccination

Patient received her vaccine at noon on 6/28/21. When she woke up in the morning on 6/29/21 she stated that her body had broken out in hives. The hives were noticed from the neck down to the pelvis. She said that the rash was not on the legs or arms and it was localized to the trunk of the body. She did not report trouble breathing and stated that the rash was just itchy.

Shingles on face near mouth, on the right side.; This is a spontaneous report received from a contactable consumer, the patient. A 40-year-old non-pregnant female 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 18Mar2021, at 11:30 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included bipolar I disorder, type 2 diabetes mellitus, generalised anxiety disorder (GAD) and chronic bronchitis. The patient had history of allergy to penicillin. Concomitant medications included aripiprazole (ABILIFY), quetiapine (SEROQUEL), clonazepam (KLONOPIN) and lamotrigine (LAMICTAL), all for unknown indications from unknown dates. 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 19Mar2021, at 09:00, the patient had shingles on her face near mouth in the right side. Therapeutic measures were taken as a result of shingles included valacyclovir (VALTREX). Adverse event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event shingles was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.

(Athletic 40 yr old female endurance athlete, 115lb, no prescription meds or hormonal birth control). Have confirmed HLA-B27 antigen disorder (autoimmune eye issues, not in flare, not on meds). Also have chronic history of low-ish iron/borderline anemia. MILD case of blood spots / petechiae rash on both lower legs & forearms 48 hours after both pfizer vaccines, deep muscle aches, one severe nosebleed (nosebleeds are chronic, but had been under control for some months). Feeling of blood pressure surges in large muscles, esp lower legs. Petechiae resolved in one day and did not worsen. Nosebleed clotted normally in 5min. Consulted with family dr over telehealth & followed up with routine yearly cardio exam. No concerning pulse, headache or chest pain, did not feel need for urgent care. Normal athletic function recovered in 3 weeks, yearly physical vitals were normal 1.5 month later.

Hives all over joint areas of the body; Stomach ache; Itching; This is a spontaneous report from a contactable consumer, the patient. A 40-Year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613) via an unspecified route of administration on 21Mar2021 at 12:30 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history included ulcerative colitis. The patient was allergic to doxycycline. Concomitant medications included LIALDA for unknown indication from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced hives all over joint areas of the body with mild itching and stomach ache after the meals on 21Mar2021. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No treatments were taken for any events. The therapeutic measures taken for the events was unknown. The clinical outcome of the events hives, itching and stomach aches were not resolved at the time of this report. No follow-up attempts are needed. No further information was expected.

Dose 1- 03Feb2021 and Dose 2- 19Mar2021; Sore arm at injection site; Swollen lymph node left armpit; sore underarm; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via unspecified route of administration in the left arm on 19Mar2021 at 12:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic back pain (chronic lower back pain) and latex allergy. Concomitant medications included oxycodone and acetaminophen (MANUFACTURER UNKNOWN) and etonogestrel; ethinyl estradiol (NUVARING) from unknown date for unspecified indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via unspecified route of administration in the left arm on 03Feb2021 at 16:00 (at the age of 40-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 vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 20Mar2021 at 21:00, patient experienced sore left arm at injection site, swollen lymph node at left armpit, and and sore underarm .The patient received first dose on 03Feb2021 and second dose on 19Mar2021 (Inappropriate schedule of vaccine administration). 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 treatment for the reported events. The clinical outcome for sore left arm at injection site, swollen lymph node at left armpit, and and sore underarm and inappropriate schedule of vaccine administration was unknown. No follow-up attempts are needed. No further information is expected.

injection site still swollen, red and itching frequently; injection site still swollen, red and itching frequently; injection site still swollen, red and itching frequently; This is a spontaneous report from a contactable consumer, the patient. A 40-years-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6207) via an unspecified route of administration in the left arm on 14Mar2021 at 09:45 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patients medical history included systemic lupus erythematosus (lupus SLE as reported). The patient had no known allergies to medications, food, or other products. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 14Mar2021, the patient experienced injection site swelling, red and itching. The patient reported that 1 week later, injection site was still swollen, red and itching frequently. Therapeutic measures were taken as a result of events and included treatment with ice packs and ibuprofen. 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 vaccination site swelling, vaccination site erythema and injection site itching were not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.

I started getting a red dry itchy patch on my right side about a week and a half after my first shot, that's the only shot I ended up getting. I then got like more spots and began to have extremely breasts. I also got itchy spots under my arms and into my arm pits and onto my back. I was extremely itchy it woke me up in the middle of the night with the itchy red spots. I had a DRs appointment at the Clinic and my dermatologist said that it was very similar to what she was seeing on her other patients post vaccination. She put me on a strong round of Prednisone on 4/26/2021 as well as a steroid cream. She did biopsy of the rash. The prednisone helped the rash go away it worked very well, I was hoping that would be it then the rash came back with a vengeance. It was mostly around my breasts, under arms and on my back. It also sprung up on my feet as well at that point. I saw an Immunologist and he said he did not know if it was a COVID rash. They sent my biopsy all over the place to get thorough analysis. They said it was an allergic reaction of some kind. I did use a low allergen wash and detergent for my clothes. Another Dermatologist called me and brought me in, they decided it was very likely that it was psoriasis rosacea and likely from the COVID vaccine but could not track how long it takes to go away. I was advised against getting the second vaccine due to my reaction.

Swelling , sick and in bed, then found a large rash on left breast, small boil , covid arm, chills low energy for 4 days

About a few weeks after, I started having some severe eczema and contact dermatitis. I had itching especially in my hands and feet. It's always somewhere itching on my body. I have taken different kinds of allergy medications, Benadryl, Xyzal, prednisone and steroid cream. The Benadryl helped a bit but it made me too tired to continue taking it. The Xyzal was not very helpful. The prednisone alleviated my symptoms completely.

burning sensation through my body; shakes; jitteriness; lightheaded; exhaustion; injection site redness and soreness; injection site redness and soreness; This is a spontaneous report from a contactable consumer (patient). A 40-years-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: EL9264 and Expiration date: unknown), via an unspecified route of administration, in left arm on 07Feb2021 (at the age of 40-years-old) as dose 2, single for Covid-19 immunization. Facility where the most recent covid-19 vaccine was administered was hospital. The patient medical history was not reported. Concomitant medication included escitalopram oxalate (LEXAPRO) taken for an unspecified indication, start and stop date were not reported. Historical vaccination included dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: EL3249 and Expiration date: unknown), via an unknown route of administration, in left arm on 17Jan2021 at 09:30 (at the age of 40-years-old) as dose 1, single for covid-19 immunisation and experienced injection site irritation. Patient had no allergies to medications, food or other products. The patient did not receive any other vaccine 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 07Feb2021 (at 09:45), the patient experienced after 2nd dose burning sensation through her body followed by shakes and jitteriness and lightheaded. Then exhaustion. 2 days later still had injection site redness and soreness. The case was assessed as non-serious. It was reported that " Was treatment received for the adverse event: Unknown". Outcome of the events was resolved on an unspecified date in Feb2021. Follow-up attempts are completed. No further information is expected.

1st occurence: Left collarbone, shoulder and armpit pain. Burning/ throbbing pain that lasted 12 hours. Nothing helped - OTC pain relivers, heating pad, BIO-Freeze, Cold pack, hot shower, cold shower, movement Extreme pain that caused sleeplessness 2nd Occurrence on 6/25/2021 Same symptoms as above - nothing helped. Extreme burning/ throbbing pain left side of face was swollen and skin near collar bone was swollen - this lasted 2 days after pain stopped Still experience soreness in shoulder

Extreme body and joint pain three days after vaccine. Throbbing in legs, aching in arms, hip and shoulder pain. Doctor prescribed pain medication and muscle relaxer to try to help. I then had a leg ultrasound, hip MRI and was put on a steroid pack for inflammatory response. My psoriasis which was dormant flared and I have had to see the dermatologist who will be ordering blue light therapy to control the inflammation. Currently on anti-inflammatory medication to help with the pain however I haven't been able to workout or be as physically active as I was prior to the second dose vaccine.

Not sure if this is related to the vaccine but 6 days later I woke up drenched in sweat.; Rash like area; with raised bump on buttocks; It seems to be a shingles outbreak; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female 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 18Mar2021 at 15:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not have allergies to medications, food, or other products. Concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 24Mar2021 (6 days after vaccination), the patient woke up drenched in sweat and had a rash like area with raised bump on buttocks, that seemed to be a shingles outbreak. The patient was not sure if that was related to the vaccination. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcomes of the events drenched in sweat and had a rash like area with raised bump on buttocks, that seemed to be a shingles outbreak were unknown at the time of this report. No follow-up attempts are needed. No further information is expected.

Headache; sore arm; fatigue; developed shingles; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: En6206) via an unspecified route of administration in the right arm on 13Mar2021 at 12:00 (at the age of 40-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have allergies to medications, food, or other products. Concomitant medications received within 2 weeks of vaccination included ibuprofen (ADVIL), multi vitamin (MANUFACTURER UNKNOWN), sambucus nigra (ELDERBERRY), sertraline hydrochloride (ZOLOFT) and clarithromycin (CLARITIN), all for unknown indications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: En6200) via an unspecified route of administration in right arm on 20Feb2021 at 12:00 (at the age of 40-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 vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 20Mar2021 at 00:00, the patient had experienced headache, sore arm, fatigue and developed shingles 9 days after on an unknown date in Mar2021. The patient underwent lab tests and procedures, which included COVID-19 virus test via nasal swab on 23Mar2021 and the result found to be negative. The patient was treated with Valtrex for the reported events. Adverse events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events headache, sore arm, fatigue and shingles was not resolved at the time of report. No follow-up attempts are needed. No further information expected.

The second injection hurt really badly immediately, as I was getting the injection and in the moments after and continued hurting badly for almost two weeks after, and now I have this pain that feels like an overuse injury in my shoulder and it radiates into my collarbone and neck area and sometimes down into my arm as well. I can?t sleep or carry bags on that side. I don?t have insurance so I don?t know who to see about it but I?m worried that the needle missed the muscle and hit something in my shoulder.

40-year-old female with history of occasional headaches and Hashimoto?s thyroiditis (euthyroid not on medication) who presented for evaluation of a new purpuric rash on her gluteal region of unknown duration. Twenty days prior to presentation, she received the second dose of the Pfizer?BioNTech BNT16B2b2 mRNA vaccine, reporting mild fatigue and myalgias lasting 2 days post injection. She developed a purpuric rash on her buttocks that was consistent with Henoch-Schönlein purpura. Rheumatology, hematology, and fertility doctors agreed the rash was consistent with early-stage HSP triggered by Pfizer?BioNTech BNT16B2b2 mRNA vaccination. Given lack of systemic involvement, she was asked to monitor symptoms. Rash resolved within a week.

My arm swelled like a big knot, bruised and hardened. I felt woozy and out of it like not alert for 3 days already i would also sweat and feel weak like passing out, i had fever spikes of 100 degrees for 3 days and had to take tylenol plus had headpain, confusion. I felt nsuseated. I had flu chills in the first 24 hours and aches for 3 days the wooziness and disoriented effects lasted 5 days and came in waves. I took tylenol and stayed home from work

experienced itchiness around her legs; her arm felt heavy; This is a spontaneous report from a contactable consumer or other non hcp. A 40-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), Dose 1 via an unspecified route of administration, administered in Arm Right on 09Feb2021 16:00 (Batch/Lot Number: EM9809) as DOSE 1, SINGLE for Covid-19 immunization. Medical history included allergy, heart burn, she is allergic to Shellfish, she is allergic to eggs, she is allergic to nuts, she is allergic to Penicillin from an unknown date and unknown if ongoing. She provided relevant family history as heart issues and diabetes. Concomitant medication included Escitalopram oxalate (LEXAPRO); Bupropion hydrochloride (WELLBUTRIN) taken for unspecified indication; Famotidine (PEPCID [FAMOTIDINE]); Omeprazole (PRILOSEC [OMEPRAZOLE]) taken for Dyspepsia. The patient experienced Itchiness around her legs on 09Feb2021 17:15, Her arm felt heavy on 09Feb2021 16:45. Patient took Benadryl for therapeutic measures as a result of experienced itchiness around her legs, her arm felt heavy. It was reported that, she had her first dose of the covid vaccine at 4PM yesterday then at 5:15PM or 5:30PM she started feeling itchiness around the leg and felt a heavy arm. She took Benadryl and felt better. The product is the Covid 19 Vaccine. Patient clarified that her First Dose was on 09Feb2021 4PM, then at 5:15PM she started to notice the itchiness around both legs. The heaviness was in the Right Arm and started around 4:45PM, she adds that she feels the heaviness in the same arm that she received the injection. She took the Benadryl around 6:15PM. Patient stated that the vaccine Lot was on a sticker posted on the card. Her scheduled second dose is on 02Mar2021. Patient stated that she has had no positive covid test or positive antibody test prior to the vaccine. She has had no other vaccines on the same day as her covid vaccine and no vaccines in the last 4 weeks. She did not have to have any visit to the ER or physician office. Patient stated that she was just a little afraid to get the second dose and wants to know if it was okay. Outcome of the event experienced Itchiness around her legs was recovered on 09Feb2021, and not recovered from her arm felt heavy.

Patient had vaccine Tuesday 7/6 around 6pm. Rash present on arm, neck and face Wednesday night. Patient visited emergency room Friday 7/9 because rash was still present. Emergency room diagnosis was Hypersensitivity Reaction. Was prescribed Benadryl 50mg and Prednisone 50mg.

redness, itching, swelling lasting for two days around injection site 8 days after vaccine; redness, itching, swelling lasting fortwo days around injection site 8 daysafter vaccine; redness, itching, swelling lasting fortwo days around injection site 8 daysafter vaccine; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER- BIONTECH COVID-19 mRNA vaccine, Lot Number: EN6206) via unspecified route of administration in the right arm on 09Mar2021 at 14:30 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The medical history included rheumatoid arthritis. The patient was allergic to penicillin and clindamycin. The concomitant medication included adalimumab (HUMIRA). 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 didn't receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 17Mar2021, 8 days after vaccine, the patient experienced redness (vaccination site erythema), itching (vaccination site pruritis) and swelling (vaccination site swelling) that had lasted for two days around the injection site. 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. No therapeutic measures were taken for the adverse events. The clinical outcome of redness, itching and swelling were recovered on 19Mar2021. No follow-up attempts are needed. No further information is expected.

HAS RASH TO RT ARMPIT, NECK, CHEST AND LT WRIST. DENIES ANY DIFFICULTY BREATHING OR SWALLOWING. ADVISED TO USE COOL PACK AND BENADRYL FOR COMFORT AND CALL PCP TO SEE IF CORTISONE SHOT OR OTHER TX NEEDED. GO TO ER IF SX WORSEN/JAW

1- Heart palpitations that started slowly the day after the first shot, then increased significantly after second dose. Heart palpitations are extremely frequent. Twice an hour is the least frequent. 2- Shoulder pain within a day of the first dose, the left shoulder joint and muscles were very sore and unable to use fully, still sore but have retained use.

7/8/21: Around 4:30pm became flushed and hot. 30 minutes later minor wheezing followed by itching on neck and upper back. Took 2 Benedryl and symptoms resolved. 7/10/21: Began experiencing tightness in chest, difficulty taking a deep breath. Asthma hasn't been this bad in well over a decade. Albuterol provided only short term relief. Benedryl provided more relieve and for longer period but symptoms persisted. 7/14/21: Met with doctor. Switched from Allegra to Zyrtec. Added Qvar on top of Symbicort. Will have checkin in a few days. If there's no improvement, the plan is to start prednisone.

DVT left saphenous vein and left common femoral vein. Redness and tenderness inside of left thigh x 2 days. Got an ultrasound 1/29/21 that confirmed DVT. Treatment: eliquis x 3 months and for as long as I'm on tamoxifen. If discontinuing tamoxifen, daily aspirin recommended.

Patient stated that 3 days after her vaccination she had increased pain, swelling and redness at the injection site that grew and became larger now extending all the way to her elbow. She went to see a doctor and was diagnosed with cellulitis and prescribed dicloxacillin 250 mg q 6 hours x 7 days. Patient just started taking medication today on 7/17/21

Full body rash, legs, arms, stomach and back.; shortness of breath; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 8732) via an unspecified route of administration in the left arm on 25Mar2021 at 14:30 (at the age of vaccination 40-years-old) as a single dose for COVID-19 immunisation. The patient medical history included asthma, GERD, gastritis. The patient previously had drug allergy while taking amoxicillin (MANUFACTURER UNKNOWN), omeprazole (MANUFACTURER UNKNOWN) and advil (MANUFACTURER UNKNOWN). Concomitant medications included famotidine (PEPCID), paracetamol (TYLENOL), vitamin D (MANUFACTURER UNKNOWN), prenatal vitamins (MANUFACTURER UNKNOWN) since an unknown date for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 30Mar2021 at 17:30, the patient experienced full body rash on legs, arms, stomach and back and shortness of breath. The patient had received BENADRYL (MANUFACTURER UNKNOWN), CLARITIN (MANUFACTURER UNKNOWN) as treatment for the events. The adverse events resulted in emergency room/department or urgent care. The clinical outcome for the events rash and shortness of breath were recovered with lasting effects at the time of report. No follow-up attempts are needed. No further information is expected.

Red swollen area around injection site irritated; Red swollen area around injection site; Swollen injection site; Red swollen area around injection site itches; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER2613), via an unspecified route of administration in the left arm (at the age of 40-years-old), as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had no known allergies. Concomitant medications were not reported. 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 01Mar2021, as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient had not been diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 28Mar2021 at 13:00, the patient experienced red swollen area around injection site. Developed about a week after the injection. It was also itchy and irritated. The patient did not receive treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of red swollen area around injection site, swollen injection site, red swollen area around injection site itches and red swollen area around injection site irritated was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.

About a month after the vaccine, I had an autoimmune flare, my flare's look like circular patches of hair loss. I saw my dermatologist and she treated with a cortisone injection on my scalp. Since March, I've had them once a month to stimulate the hair growth again. My hair is not fully grown back but it takes time.

Rash appeared on trunk 7/20/21. Care chat with provider diagnosed as shingles. Provider recommended reporting just in case there was a connection.

bright red rash; sore area on right arm; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727) via an unspecified route of administration in the right arm on 24Mar2021 at 20:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were reported as "too long to list-can provide a list if contacted directly". The patient had history of known allergies to adhesives. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202) via an unspecified route of administration on 03Mar2021 at 13:45 (at the age of 40-years-old) as a single dose for COVID-19 immunisation and cefprozil (CEFZIL) on an unknown date for an unspecified indication and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 29Mar2021, the patient firstly had noticed bright red rash and sore area on her right arm near the injection site, but it was very small and it became larger on 01Apr2021, measured approximately 17cm by 6cm in a parallelogram at the time of reporting. 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 the reported events. The clinical outcomes of bright red rash and sore area on right arm were not recovered. No follow-up attempts are needed. No further information is expected.

2 episodes of shingles on my right upper arm. First episode was 2/26/21, second episode was 7/4/21. Both episodes cleared after 10 day course of valacyclovir HCL 1gm

Systemic: Hypertension-Medium, Systemic: Tachycardia-Medium, Additional Details: Pt felt a burning sensation right away and stated that their heart was racing. I checked BP several times and the range was between 130-158 / 70-90. Pt went to urgent care & MD monitored until BP & HR was normal. They are unsure if this was vaccine related or nerves. Pt was instructed to rest at home today & is feeling better but noted that she felt itchy when she first woke up this AM but it has since passed.

Mixed connective Tissue Disease; Started with a rash on the back and arms in February and and March and then in April I had a Thyroid Ablation; This is a spontaneous report from a contactable nurse (patient). A 40-years-old female patient received bnt162b2 (BNT162B2, brand: Pfizer) at the age of 40-years-old, dose 1 via an unspecified route of administration, administered in Arm Right on 21Jan2021 14:00 (Batch/Lot Number: EL8982) as DOSE 1, SINGLE for covid-19 immunisation. The patient was not pregnant. Medical history included Graves Disease. No other vaccine in four weeks. No Covid prior vaccination. Concomitant medication included atenolol (ATENOLOL) taken for an unspecified indication, start and stop date were not reported. Reported adverse event: Started with a rash on the back and arms in Feb and March and then in April in 2021, the patent had a Thyroid Ablation. Developed Mixed connective Tissue Disease on 03May2021. She understand this was not related to the thyroid disorder and was just curious if anyone else has reported a new diagnosis of MCTD. Is very rare and she had no reason to suddenly have it. But its been confirmed through an ANA test for RNP antibody. The patient underwent lab tests and procedures which included ANA test: rnp antibody on 2021. No treatment received. The event outcome was not recovered. The report was provided as serious due to Disabling/Incapacitating. Ae resulted in: Emergency Room Visit/ Physician Office Visit. Covid test post vaccination: Nasal Swab on 05Apr2021 was Negative.

Patient calling for Chronic COVID-19 Vaccine, Arm Pain, and Skin Problem (burning senstion- upper extremeties ) Symptoms started x1 month. Symptoms include: Received covid-19 vaccine. Patient has had a burning sensation since in arm since vaccine. States sensation has been spreading to the rest of her body. Patient Has not attempted treatment at home.. Pertinent negatives include: Afebrile. HISTORY OF PRESENT ILLNESS Patient is a 41 y.o. female who presents regarding a potential concern for an adverse reaction to the COVID-19 vaccine. Second Dose in Series: Vaccine was obtained from the clinic/location: on the date of: May 14th and approximate time of 2:30 Vaccine was administered to patient's: Right Deltoid Vaccine manufacture was: Pfizer No Previous Reactions to other immunizations Known COVID Exposure since receiving vaccination?: No Patient notes the following symptoms: Headache, Localized injection site pain and Myalgias Patient is a 41-year-old female presenting with multiple different symptoms post COVID-19 vaccine. Patient reports that has any burning sensation in her vaccine arm. She reports that it almost feels like it is on fire or sunburn. Patient reports that at times the sensation travels to different parts of her body. She also reports that she had neck pain, Back pain, and upper chest discomfort. That time she reports that she has some numbness and tingling bilateral to her upper extremities. She denies any weakness. She denies any level of consciousness changes. She denies any trauma. She does not a family history of stroke or neurological problems. She also reports that she has had a change in her menstrual cycle. She reports that she is had 2 menstrual periods in the month of May and also in June. She also reports mild headache. She also reports that her eyes seem a little dry and feels as though her vision may be getting worse. 1. Adverse effect of vaccine, initial encounter At this time due to multiple different neurological symptoms and unable to do a good thorough neuro exam I would like her to be seen in person for further evaluation. Patient was educated on worsening symptoms and reasons to go to the emergency room right away such as any signs of the stroke which we discussed speech changes, numbness or tingling down one arm. Patient was agreeable to plan of care and is going to reach out to her primary care doctor. Called PCP office to let them know my recommendation for appointment as soon as available This visit was completed via health visit and 11-20 mins was spent as part of care with patient.

Night of injection I nearly fainted-very odd experience. It was awful. Next day was 101 fever, but as expected from vaccine reactions. Two days later extreme itching all over that lasted about a week. My scalp still itches daily seven weeks later. At about two days also my second toes on both feet (closest to my pinky toes) starting hurting. Next day my second finger on my left hand (closest to my pinky finger) starting hurting. Those still bother me but not as intense. In those next few weeks, I had heart flutters and general fatigue. The heart flutters weren't bothersome. At around July 2nd/4 weeks post second vaccine, I got intense stabbing pains in my chest area. So bad that if I didn't currently have bad health insurance, I would have gone to emergency room. I had the stabs of pain the next evening too. Fatigue worsened since those initial stabbing pains and has not been my usual normal since. Messaged doctor. He said he had a couple other patients wtih same issue and theirs went away. Heart has felt heavy since. It did seem to get better for about a week and then came raring back and had more stabbing pain episodes for a few days. ONe of which was when i was just simply taking my dog on a walk (not laying down which usually provokes it) It is worst when I am laying on my left side or laying back. Sleep was miserable for a week as I had to prop myself up on three pillows to even get remotely comfortable. I haven't been able to do anything that seem to get my heartrate over 100. I notice the extra heaviness in chest hurts when I go on a lenthier walk. During all of this I had several times where I typically would have gone directly to Emergency Room. I didn't go because of my bad health insurance currently from losing my job in last year. So please don't lower the severity of it because I didn't go to the emergency room. I have chronic condition, but my heart has never been effected/never had heart issues.

Starting on 12/24/2021 I broke out in rash on right side of torso and neck and arm, I also developed blisters in the roof of my mouth, all this was happening on right side only. Lasted about 2 weeks and all side effects subsided at that point. Called doctor for consultation on 12/25/2021.

Arm pain at injection site; Fever 100.8 max; Nausea; Vomiting; Diarrhea; Fatigue; Body aches; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 3248) via an unspecified route of administration in the arm right on 30Mar2021 at 09:15 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was allergic to clindamycin (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via an unspecified route of administration in the arm right on 09Mar2021 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Apr2021, the patient experienced arm pain at injection site, fever 100.8 max, nausea, vomiting, diarrhea, fatigue and body aches. 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 events. The clinical outcome of the events arm pain at injection site, fever 100.8 max, nausea, vomiting, diarrhea, fatigue and body aches were not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.

Shingles on right side of lower torso; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the right arm on an unknown date in Mar2021 at 13:30 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history of the patient was not reported. The patient did not have allergies to medications, food, or other products. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Mar2021, 04Mar2021, 14Mar2021, 22Mar2021 the patient underwent nasal swab test for COVID-19 and the result for all the test was negative. On 05Mar2021 the patient experienced shingles on right side of lower torso. 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 adverse event. The clinical outcome of the event shingles on right side of lower torso was resolved on an unknown date in Mar2021. No follow-up attempts are needed. No further information is expected.

Racing heart; Dizziness; Headache; Hives; Mild throat swelling; This is a spontaneous report from a non-contactable consumer, the patient. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot m100003243928, first dose) solution for injection intramuscular in the left arm on 29Mar2021 at 10:15 (at the age of 40-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included known allergies: shellfish, soy, nuts, sunflower seeds, sesame, mustard, bananas, apricots, peaches; and COVID-19 on an unknown date. Concomitant medications included salbutamol sulfate (PROAIR DIGIHALER) and over the counter allergy medication. Lab test on an unknown date included COVID-19 was positive. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 29Mar2021 at 10:30, the patient experienced racing heart, dizziness, headache, hives, mild throat swelling. Treatment for the events racing heart, dizziness, headache, hives, mild throat swelling included diphenhydramine (BENADRYL), epinephrine (EPIPEN), and inhaler. The outcome of the events racing heart, dizziness, headache, hives, mild throat swelling was recovered in 2021. Since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.

Patient called the day following her second Pfizer vaccination and said the injection site was red and felt a bit of a lump at the site. I counseled her to use a cold compress and take ibuprofen for pain if needed. I told her she could take a benadryl tablet too and see if that helped.

Patient noticed that she had bruising on both of her lower legs. From knee down to her ankles. Made Dr appointment with cadiologist.

Deep Tissue pain in site injection 3 months after vaccine - Pain strong enough to wake me in middle of night

Patient stated that 4 or 5 hours after receiving the vaccine she started feeling itchiness in her body. She has spots on her body that look like mosquito bites. She is still having this reaction.

I have a weird tightening on the right side of my face. My right eye lid is droopy all the time and the right corner of my lip always pulls up, its kind of the opposite of bells palsy and the mornings are much more prominent. I have had occasional chest pain and R arm tingling when this first started. My vision is fine but my eye is very irritated and watery.

Red rash on the abdomen, spread to the back, arms, and legs.; The spots are red and slightly raised.; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO153) via an unspecified route of administration on 09Apr2021 at 15:00 (at the age of 40-years-old), as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not receive any medication 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 16Apr2021, seven days after receiving the first dose, the patient experienced a red rash on the abdomen. It gradually spread to her back, arms, and legs over the course of the next two weeks. The rash was not itchy, but the spots were red and slightly raised (no blisters). The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measure was taken as a result of red and slightly raised rash and included treatment with steroid cream. The clinical outcome of the events red and slightly raised rash on the abdomen, back, arms, and legs was not resolved at the time of report. No follow-up attempts are needed. No further information is expected.

Left arm soreness.; Red mark about the size of a dime around the injection site.; the injection site had a bit of a burning or stinging sensation; my arm was just sore; Menstrual spotting; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that. A 40-years-old female (Non-pregnant) patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL3248), dose 2 via an unspecified route of administration, administered in Arm Left on 25Mar2021 10:00 as (At the age of 40-years) DOSE 2, SINGLE for covid-19 immunisation. Medical history included intermenstrual bleeding from an unknown date and unknown if ongoing patient have a recent history of spotting. No Allergies to medications, food, or other products. Concomitant medication included oxymetazoline hydrochloride (CLARITIN ALLERGIC); triamcinolone acetonide (NASACORT); desogestrel, ethinylestradiol (VELIVET); ascorbic acid, betacarotene, biotin, calcium phosphate dibasic, calcium stearate, chromic chloride hexahydrate, copper sulfate, ferrous fumarate, folic acid, magnesium oxide, manganese sulfate, nicotinamide, panax ginseng, pantothenic acid, potassium chloride, potassium iodide, pyridoxine hydrochloride, retinol, riboflavin, sodium molybdate, sodium selenate, vitamin b1 nos, vitamin b12 nos, vitamin d nos, vitamin e nos, zinc oxide (CENTRUM ACTIVE); calcium carbonate, colecalciferol (VITAMIN D 2000) all are taken for an unspecified indication, start and stop date were not reported patient received within 2 weeks of vaccination. Patient was not pregnant at the time of vaccination. No covid prior vaccination. No covid test post vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not diagnose with COVID-19 Prior to vaccination Patient did not been tested for COVID-19 Since the vaccination. No Allergies to medications, food, or other products were reported. The patient previously took first dose of BNT162B2 (Lot number: EN6203) on 03Mar2021for COVID-19 immunization. On 25Mar2021 10:30 patient experienced Left arm soreness. Red mark about the size of a dime around the injection. May be a half hour after the injection, the injection site had a bit of a burning or stinging sensation but that lasted a version short time. Then later in the afternoon patient arm was just sore. It was reported that the date when patient first became aware of adverse event was 25Mar2021. It was reported that On Mar2021 patient experience Menstrual spotting, starting sometime the day after or days after his second dose (I'm not sure of the exact timing in relation to my vaccination). It was reported that patient had recent history of spotting so didn't think much of it. However, the spotting has been consistent since then and grown increasingly heavier. It was reported that patient read an article today that heaver menstrual cycles or spotting may be a side effect of vaccination. Facility where the most recent COVID-19 vaccine was administered was Workplace clinic. Reporter considered all event was not serious. Patient did not receive any tenement for the events. The outcome of event menstrual spotting was not recovered, and outcome of all other events was recovering. No follow-up attempts are needed. No further information is expected.

Large bumps around injection site; Large bumps around injection site with itching; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 05Apr2021 at 09:30 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any medication within two weeks of vaccination. The patient previously received morphine (MANUFACTURER UNKNOWN) and pethidine (DEMEROL) on an unknown date for unknown indication and experienced allergy. 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 05Apr2021 at 11:15, the patient experienced large bumps around the injection site and itching. The patient did not receive any treatment for the events large bumps around the injection site and itching. The events did not result in doctor or other healthcare professional office/clinic visits, and the emergency room/department or urgent care. The clinical outcome of the events large bumps around the injection site and itching was not recovered at the time of the report. No follow-up attempts are needed. No further information is expected.

Soreness and swelling at injection site; Soreness and swelling at injection site; Red spot at exact injection site; Soreness in lymph nodes at arm pit.; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female 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 on 26Mar2021 at 15:15 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history and 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 for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021 at 23:00 the patient experienced soreness and swelling at injection site (7 days after the first injection), red spot at exact injection site and soreness in lymph nodes at arm pit. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the adverse events. The clinical outcome of the events soreness and swelling at injection site, red spot at exact injection site and soreness in lymph nodes at arm pit were not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.

Mild to severe lingering pain at the injection site and up into left shoulder.; Mild to severe lingering pain at the injection site and up into left shoulder.; This is a spontaneous report received from a contactable consumer (patient) via COVID-19 Adverse Event Self-Reporting Solution. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration, in the left arm on 02Apr2021 at 13:15 (at the age of 40-years-old) as a single dose for COVID-19 immunization. Medical history included allergy to nuts and grass. Concomitant medications included ibuprofen (MANUFRATURER UNKNOWN) from an unknown date and for unknown indication taken within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 02Apr2021, the patient experienced mild to severe lingering pain at the injection site and up into left shoulder. Patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of mild to severe lingering pain at the injection site and up into left shoulder was resolving. No follow-up attempts are needed; information about lot number cannot be obtained.

Arm was very hot to the touch at the injection site; Sporadic low grade fever; No energy.; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0161), via an unspecified route of administration in the right arm on 25Apr2021 at 13:30 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient did not receive any concomitant medication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613), via an unspecified route of administration in the right arm on 30Mar2021(at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Apr2021 at 13:00, the patient reported that her arm was very hot to touch at the injection site (vaccination site warmth) for more than four days at the time of reporting. On 26Apr2021 at 13:00, the patient also experienced sporadic low-grade fever and she reported that she had no energy. The clinical outcome of all the events arm was very hot to touch at the injection site (vaccination site warmth), sporadic low-grade fever and no energy were resolving at the time of this report. No follow-up attempts are needed. No further information is expected.

Effect On Ears - Evening of 3/13 tinnitus became louder and came in waves. - Tinnitus increased over the next couple of days to louder, constant, high-pitched buzzing, louder than TV and sound machine. - Feeling of fullness/pressure in/around ears. - Pain/discomfort in/around ear. - Sensitive to loud and high-pitched sounds, incl. kids, TV, music, dishes, loud talking. - Occasional popping in ears. - Occasional itching in ears. - Multiple sounds in ears (buzzing, tone), some times sound travels. - Tinnitus aggravated with exercise, hot showers, long exposure to sound (for example, low music, ocean waves, driving). Allergy shots cause flare ups with multiple symptoms (none of this happened prior to vaccine). - All symptoms above are new. Prior to vaccine I had a low baseline T that was easily ignored and only heard when silent. - Most symptoms eased after 10 - 12 weeks, but tinnitus (louder than pre-vaccine tinnitus) continues, as well as flare ups of all ear symptoms. Other Side Effects - GI: Significant loss of appetite, weight loss, stomach cramping, nausea, spit out food because of off taste, loose stool / diarrhea. All improved after 3 weeks. - Tremors / Shaking. Improved after 3 weeks. - Intense anxiety/depression began 3/14, including tightness in chest, difficulty breathing at times, increased heart rate, sleep disturbances, troubled thoughts. Eased after several weeks. Emotional upset from situation continues but at more appropriate level. - Pain/pressure (all over or shooting) in head and face, some times on one side of face, temples, forehead, base of neck. Eased after 1-2 months. - Prickly & numb sensations on face, similar sensation in toes and fingers a few times. Eased after 1-2 months. - Head fog. Eased after 1-2 months. - Fatigue. 3/26 Took walk and felt as though recovering from flu (heaviness in chest), unable to work out for 2 weeks, resumed since with less frequency & more modifications (continues like this). - 1-2 days after vaccine sore arm, aggravated arthritis and interstitial cystitis. - Other misc things experienced during the first 2-3 months post vaccine: neck and back pain, vision issues (trouble focusing, not as clear, floaters), hair loss (hair dresser noticed 3/23), increased pain in legs/veins, leg cramps.

12/24/20- tenderness, swelling at injection site for 1 week; 12/30- flu like symptoms, dizzy, weak, headache, muscle pain, nausea, vomiting. Seen in ED on 1/3/21 with reports of all over body numbness, shortness of breath, cough, sore throat, unable to eat/drink. EMS reports patient went unresponsive at home, but was doing purposeful movements. Respiratory panel which included COVID, Flu, was resulted as not detected. CXR, CBC, Comprehensive metabolic panel, Urinalysis. Patient diagnosed with COVID-19; Cough; Shortness of Breath; Nausea and Vomiting; generalized body aches. Discharged home with prescription for Tessalon 10mg capsule - Take one every 8 hours and Zofran 4mg PRN every 8 hours and follow-up with primary And follow up with primary care MD.

Taste buds went numb, metallic taste, slight swelling of throat, itchiness all to upper body, joint pain, and pain at injection site. Lasting about 12 to 24hours. Antihistamines treated at home.

The next day on 12/19 I was super sore. On 12/20 really bad joint pain and I had rash located on my face and chest. I went to PCP on 12/21 seen PCP given EpiPen.

Developed shingles on 12/23/20- went to urgent care on 12/24/20, was given Prednisone and Acyclovir prescriptions. Rash sites dried on 12/28/20.

41-year-old female HCW who received Pfizer BioNTech vaccine (Lot # EK5730) on 21 Dec 2020 in her left upper arm. No other vaccines were received that day. She reports a sensation of warmth and tenderness locally right after vaccination. On the evening of vaccination, she noted a small area of redness and swelling at the vaccination site. She denied anything out of the ordinary with regard to vaccine administration, except the vaccine might have been given "a little lower" than usual. She did not experience any respiratory, CV, dermatologic, or gastrointestinal signs/symptoms during observation post-vaccination or during the next several days. Post-vaccination day (PVD) one, patient noted some tenderness, warmth, redness, and some bruising surrounding the vaccination site. (SEE PVD 1 Photo); local reaction gradually resolved (SEE PVD 7 Photo) and currently, all that remains is a big bruise. On the evening of 26 Dec, patient reported having some "congestion" and took some Nyquil. She reports a good night's sleep, but upon awakening, she noted mild shortness of breath and she "couldn't open" her eyes due to swelling. She also noted her bottom lip and tongue were swollen and she experienced a tight feeling in her throat and chest. She also reports mild swelling of her hands. She denies hives/urticaria, wheezing, stridor, dysphagia, loss of consciousness, or gastrointestinal-related symptoms. Patient self-treated with oral Benadryl, Pepcid, and Zyrtec, as well as using her Albuterol inhaler. After 2 hours, her symptoms had not improved, so her spouse took her to the Emergency Room. In the ER, she was placed on a cardiac monitor, and shortly after arrival, she received IM Epinephrine (x2), followed by IV Solumedrol. She was observed for 8-10 hours and discharged home with a 5-day course of oral steroids. She was diagnosed with "anaphylaxis" and instructed to follow-up with her Primary Care Provider. Since discharge, she has continued to note some facial swelling, and on 29 Dec, she was having problems breathing for which she used her inhalers, and symptoms resolved. On the day of vaccine receipt, patient reports feeling well prior to vaccination. She denies previous vaccine reactions. She denies any exposures that might have been potential triggers to her reaction on 27 Dec – "the only thing different was the vaccine"

20 Minuets after injection hot air, red , moved across face, neck. 1 hour after injection. high BP chest heavy face and nose itchy @ 3:15 pm Benadryl 25 mg IM + difficulty swallowing.

Immediately post-vaccine, face felt hot and tingling, lasted 45 minutes. Nausea 12/26-12/27. Rash on flexural of both arms, started with just left then progressed to both arms 12/27; achy feeling still; "gross feeling;" swollen lip with blister, started 1/3; left supraclavicular lymph node swollen

"Pfizer-Bio-Tech COVID-19 Vaccine EUA" Provider contacted an individual in regards to an individual who received the Covid-19 Vaccine on 12/19/2020. The individual reported sand paper face rash and full swollen face that started 3 days after receiving the vaccine (1/1/2021). Individual reported that she had Botox and facial fillers on 12/15/2020. This event was an unwitnessed by the staff at Health Department. The event was reported to Epidemiologist.

Fatigue; Myalgia; Injection site pain; Headache (frontal)/Worsening headache; Joint pain; Chills; Nausea; Vomiting; Worsening headache w/ photophobia; Subjective fever; This is a spontaneous report from a contactable physician (patient). A 41-year-old female non-pregnant patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=59267-1000-1 /EH9899), via intramuscular on 28Dec2020 09:45 at single dose on her right arm for Covid-19 immunization. Medical history included psoriasis. The patient had no known allergies. Allergies to medications, food, or other products was none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination. It was reported that 6h after administration on 28Dec2020 16:00, the patient experienced fatigue, myalgia, injection site pain; 10h after (in addition to above) on 28Dec2020, the patient experienced headache (frontal), joint pain, chills and 12-28h after (in addition to above) in Dec2020, the patient experienced nausea, vomiting, worsening headache w/ photophobia, subjective fever, joint pain. The patient was not received any treatment for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19, since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovering.

Itching that began localized to the injection site then spread all over the body. Feels like a burning sensation as well and an itch you can't scratch; Itching that began localized to the injection site then spread all over the body. Feels like a burning sensation as well and an itch you can't scratch; Itching that began localized to the injection site then spread all over the body. Feels like a burning sensation as well and an itch you can't scratch; This is a spontaneous report from a non-contactable nurse (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Dec2020 at single dose for covid-19 immunization. Vaccine location was right arm and it was the first dose. The facility type vaccine was hospital. The patient medical history and concomitant medications were not reported. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient stated itching that began localized to the injection site then spread all over the body. Felt like a burning sensation as well and an itch you can't scratch on 29Dec2020. Patient received Benadryl as treatment for the adverse events. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was not recovered. The events were reported as non-serious. No follow-up attempts are possible; Information about batch/lot number cannot be obtained.

I received the vaccine on 12/23/20, and the reaction popped up around new years. On 1/1/21 an area on the skin became bright pink, medium hard to the touch and very warm compared to the skin around it. The area got larger and continued to spread over about two more days. Today is 1/6/21 and the skin is back to normal. I did not get a fever, chills, or any other symptom of note.

hives; intense itching; headache; injection site is red and raised and itches intensely.; injection site is red and raised and itches intensely.; injection site is red and raised and itches intensely.; This is a spontaneous report from a contactable nurse. A 41-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular in the right arm, on 28Dec2020 at 08:45 (at the age of 41 years-old) as a single dose for COVID-19 immunization. The vaccine wad administered at a hospital. There were no other vaccinations given within 4 weeks and no other medications were taken within 2 weeks. Medical history included allergies to penicillin and shrimp. There were no concomitant medications. The patient previously took codeine and experienced an allergy. On 28Dec2020, the patient experienced hives, intense itching coupled with a headache, injection site is red, raised and itched intensely. The clinical course was as follows: Within 3 hours of receiving the vaccine she developed hives and intense itching coupled with a headache. She reported that the hives come and go and have covered pretty much her entire body in waves of occurrences. The injection site was red and raised and itched intensely. It has been 48 hours since and still there are hives. The patient was not hospitalized for the events. Treatment included diphenhydramine (BENADRYL) however she stated that it does not seem to affect the hives or address the itching. The clinical outcome of the events: hives, intense itching coupled with a headache, injection site is red, raised and itched intensely, was not recovered. The patient was not tested for COVID-19 after receiving the vaccination. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

vaccine site was pink, warm, indurated (size of tennis ball); vaccine site was pink, warm, indurated (size of tennis ball); vaccine site was pink, warm, indurated (size of tennis ball); vaccine site rt deltoid began to itch and had red blotches; vaccine site rt deltoid began to itch and had red blotches; Headache; low grade fever; sore throat; This is a spontaneous report from contactable healthcare professional . A 41-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at a right deltoid on 16Dec2020 11:00 at a single dose for COVID-19 immunization, at a hospital. Medical history included seasonal allergy. No known allergies to medication, food or other products. The patient's concomitant medications were not reported. On 19Dec2020 16:00, day 3 post vaccine, the patient experienced headache, low grade fever, and sore throat. On 27Dec2020, day 11, patient experienced vaccine site right (rt) deltoid began to itch and had red blotches. On 28Dec2020, day 12, the patient experienced vaccine site was pink, warm, indurated (size of tennis ball). Treated with paracetamol (TYLENOL), topical/oral diphenhydramine (BENADRYL) and topical 1% hydrocortisone. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not received any medications within 2 weeks of vaccination. The patient was tested for COVID-19 with via rapid test and PCR with nasal swab, both negative on 22Dec2020. The patient recovered from the events, headache, low grade fever, and sore throat on 24Dec2020, day 8 post vaccine and the rest of the events on 30Dec2020, day 14. Information about lot/batch number has been requested.

24-48 hrs site red, swelling, pain, sore arm, severe fatigue, hive to arm and neck of injection site, 48-96 nausea and diarrhea X24hrs, severe migraine, improving fatigue and hives. treated with rest, advil , and Benadryl

woke up 1/6/21 @ 4am with chills and nausea. Took a Zofran. Awoke again at 5am with fever of 100.6 F. Fever did not respond to 600 mg ibuprofen. Later that day developed headache and body aches. Pain at injection site present as well.

fatigue - onset about 1230, I usually don't take naps but I took a 4 hour nap that day headache - onset about 1230, lasted the rest of the day and intermittently the next few days injection site pain x 3 days - moderate, pain would wake me in my sleep if I rolled onto affected side

Fever, chills, body aches, ( muscle and joint pain), pain at injection site, nausea, 1 episode of vomiting, abdominal pain

Dizziness light headed, itchiness on head, ears felt hot and red, elevated BP and elevated HR Narrative: Tool Prednisone, Hydroxazine, and Zyrtec- all previously prescribed medications for general allergies.

STARTING ON 12/24/2020 I developed burning and itching in both feet and along both deltoids. This resulted in raised red pruritic wheals. I dosed Benadrly and used hydrocortisone cream to the area. Throughout the night, the rash appeared on both thighs, knees, back of the arms and along the back of the lower legs. Again raised pruritic wheals. It would improve with anti-histamine use. this continued until 12/29/2020. No persistent symptoms. There are no other changes in medicine, OTC medication use, no changes in foods/soaps etc.

site red, swelling, pain, hives, nausea, diarrhea, severe fatigue, severe migraine, hives to arm and neck side of injection 24-96hrs. Treated with rest, advil, Benadryl

Hives, sneezing, anaphylaxis, wheezing, itchy throat, stuffy, started in evening, hives first then itchy throat, probably about an hour, as that got worse throat started swelling. Took 50mg prednisone 2 benadryl and albuterol inhaler. Breathing got better and hives went away but still had swollen throat and took pepcid. Headache afterwards but that's typical of an allergic reaction. I can't be sure it was from the vaccine or not but nothing I did yesterday would normally trigger that reaction

I initially developed 3 small red raised bumped on my R arm around Day 9 after the injection . One on forearm, one near antecubital, and one at inner upper arm. The bumps did not itch or have any drainage. The area increased in size, remained red, and had a central clearing, as if the skin came off the surface. The skin is now dry and cracked. I applied hydrocortisone 1% OTC on Day 7 and it caused a burning sensation to the area. The lesions are still, red, dry, no scabbing noted.

0930 vaccine, and at 1030am (1 hour after vaccine injection) pt experienced red, hot rash from left deltoid injection site up to her neck. Pt states that she took Benadryl at 1230 and this rash and redness is now resolved.

Symptoms - ? EE reports pain at injection immediately after injection. EE reports ?nickel size? knot on her arm almost immediately after, worsening to 2x2 size this morning (1/8). 1/7 morning: body aches, chills, feelings of unwell. Unsure of fever as she has been rotating Tylenol and motrin. EE reports she saw RN at campus this morning for inspection of injection site. Home remedies? - ice pack to injection site and rotating Tylenol (last dose 20:30 1/7) and motrin (last dose 23:00 1/8) Any improvement? ? mild improvement Recommendation? EE encouraged to continue to ice injection site and to rotate Tylenol and motrin. EE encouraged to continue to monitor symptoms and to call vaccine support with further questions and/or concerns. EE denied history of COVID-19 exposure without proper PPE and denied recent travel. EE educated to manange per Illness in the Workplace Policy. EE encouraged to fill out V-safe. EE verbalized back understanding and denied further questions at this time.

Lethargy onset approximately 4 hours after dose. SOB while supine. 1 day later continued lethargy and orthopnea, plus imms site soreness.

site swelling, itching along upper extremities, shoulders, and upper back. Itching treated with Benadryl x 2 doses with positive results

Employee received Pfizer COVID-19 vaccine and subsequently developed full body itching and reported feeling like tongue was swelling. Patient was given 50 mg PO Benadryl. No improvement patient was escorted to ED by RN for evaluation

Got vaccine at 1:15. At 1:27. Became very hot, red rash all over, tachycardia . I alerted the nurse and at that time my watch was beeping afib.

sand paper face rash and full swollen face; sand paper face rash and full swollen face; This is a spontaneous report from a contactable other healthcare professional (HCP). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot#: EH9899) via intramuscular on arm left as the first dose on 19Dec2020 at single dose for COVID-19 immunization. The patient had Botox and facial fillers on 15Dec2020. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown whether the patient was diagnosed with COVID-19 prior to vaccination. And it was unknown whether the patient had been tested for COVID-19 since the vaccination. The patient had sand paper face rash and full swollen face that started on 01Jan2021 (also reported as 3 days after receiving the vaccine). The events were reported as non-serious. It was unknown whether treatment was received for the events. The outcome of the events was unknown.

PT had aa mild reaction with hives and itchy skin on her upper chest and face. No airway or breathing involvement. Pt given 25mg Benadryl, symptoms began to resolve after 30-40 min.

on day 3 after injection severe pain in left arm and weakness unable to raise arm at shoulder; on day 3 after injection severe pain in left arm and weakness unable to raise arm at shoulder; on day 3 after injection severe pain in left arm and weakness unable to raise arm at shoulder; numbness in extremities; numbness and tingling in extremities, tingling in extremities more so in left upper extremity then left foot, then right hand; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), via an unspecified route of administration (Left arm) on 27Dec2020 14:30 at single dose for Covid-19 immunization. The patient's medical history included connective tissue undifferentiated (disorder), cervical radiculopathy, and Covid-19. No known allergies. Concomitant medications were unspecified; the patient received other medications within 2 weeks of vaccination. The patient was diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported numbness and tingling in extremities more so in left upper extremity then left foot, then right hand on 27Dec2020 (16:00). The patient also noticed slightly on day of injection then on day 3 (30Dec2020) after injection the patient had severe pain in left arm, weakness, and unable to raise arm at shoulder. The adverse events resulted in Emergency room/department or urgent care. The patient was treated with prednisone. The outcome of events was not recovered. The patient has not been tested for COVID-19 since the vaccination. This case is non-serious.

chills & shivering; high fevers (peaked 102.7); tachycardia (noted to be 148 standing, 120's at rest in supine); headaches; nasal/sinus congestion; fatigue; dehydration; dizziness; sore throat; GI issues; Sore arm; This is a spontaneous report from a contactable other hcp (patient). A 41-year-old female patient received first dose of BNT162B2 (COVID-19 vaccine, lot number EK5730), via an unspecified route of administration on 28Dec2020 11:00 at single dose on left arm for COVID-19 immunization. Medical history included COVID-19, hyperthyroidism, Grave's Disease, benign PVCs (Premature ventricular contractions), PACs (Premature atrial contraction) from an unknown date and unknown if ongoing, allergies, Penicillin allergy, allergy to pineapple, kiwi and pomegranate, and NUMEROUS environmental allergies (dust, weed, pollen, trees, animals. it's a long list) from an unknown date and ongoing. Concomitant medication included cetirizine, fluticasone, propylthiouracil. The patient previously took clindamycin and methimazole and experienced drug allergy. On 28Dec2020 the patient experienced sore arm (like flu vaccine) the day of the vaccination. Early the following morning (on 29Dec2020 04:00) developed chills & shivering. Progressed to high fevers (peaked 102.7), tachycardia (noted to be 148 standing, 120's at rest in supine), headaches, nasal/sinus congestion, fatigue, associated dehydration & dizziness. Subsequent sore throat & GI issues. Symptoms lasted 4-5 days. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient was not pregnant at the time of vaccination. The patient underwent lab tests and procedures which included covid test type post vaccination (nasal swab): negative on 02Jan2021, body temperature: high fevers (peaked 102.7) on 29Dec2020, tachycardia: noted to be 148 standing, 120's at rest in supine on 29Dec2020. No treatment received for the adverse events. The outcome of the events was resolved on an unspecified date.

Abdominal cramping; Diarrhea on 30Dec pm over night; Injection site soreness; Arm pain; General aches; fatigue; This is a spontaneous report from a contactable healthcare profess. A 41-years-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EH9899), intramuscular on 29Dec2020 14:45 at a single dose for Covid-19 immunization. Medical history included colitis ulcerative. Concomitant medications included infliximab (REMICADE), calcium D, sertraline hydrochloride (ZOLOFT), and probiotics. The patient previously took ampicillin sodium (OMNIPEN) and BACTRIM DS and experienced allergies. On 30Dec2020, at 04:45 PM, the patient experienced abdominal cramping and diarrhea on pm overnight, injection site soreness/arm pain, general aches and fatigue. The patient did not receive any treatment for the events. The patient has no Covid prior to vaccination and did not take Covid test post vaccination. The outcome of the events was recovering.

Had chill soon after the injection and about 5 minutes later had slight nausea, I was told to stay 15 more minutes for observation . About 30 minutes or so after the injection, I had sever nausea. The person at the observation sent me to ER for close monitoring . After couple hours of sever nausea My body started itchy for few hours without hives. In ER, prescribed zofran but didn?t take it. Stayed ER for few hours and I was released

c/o feeling flushed within 15 minutes of being vaccinated. Blotchy rash noted to chest and neck. No SOB, no hives, no airway involvement. Transported to ED and al symptoms resolved upon arrival without intervention.

Rash & UrticariaPruritus Narrative: Developed urticaria (welt) over the vaccine site hours after receiving vaccine. mild tenderness, then rash after several hours and became itchy. Employee is concerned about the level of protection (antibody titer produced)because allegedly given subcutaneous rather than intramuscular

COVID-19 Vaccine (Pfizer) EL3302 Exo 05/21. Itching and redness (flushing) on chest, stomach, legs occurring 10 minutes after receiving vaccine. Face was flushed red no itching. Initial BP 152/99 HR 84. Benadryl 50 mg PO and famotidine 20 mg PO administered. Patient reports similar reaction following the first dose of the vaccine - COVID-19 Vaccine (Pfizer) EL0140 Exp 03/21; itching resolved without medication the first time. Patient reports that this reaction is slightly worse than previous reaction to the first dose. At 3:48pm, BP 151/87 HR 82 O2=96%. Patient itching and redness on chest and flushing of face dissipating by 3:45pm. Patient clinically stable. Patient dismissed from clinic at 3:54pm.

I received my first vaccine 12/22/2020 at 3:45pm. My right arm was sore like I would have expected and everything else was fine, until 12/31/2020. My left upper thigh had a burning feeling around the outer part and in the goin on that thigh a painful lymph node. That afternoon I had a burning sensation on my left butt cheek. When I looked I noticed a very small rash with blisters. I waited through the weekend because I knew the OBGYN was not open. I called first thing Monday morning and made an appointment as soon as they could see me which was the next day (1/5/2021)at 3:30pm. The doctor took samples and sent them to the lab for testing. The test was positive for shingles. I am now taking valtrex for shingles.

Pfizer BioNTech Covid 19 vaccine EUA- Symptoms started at 2100 on 1/5/21 and ended 0800 01/07/2021-- fever 101.3, body aches, chills, extreme fatigue, sore throat, dizziness, sinus congestion , abdominal pain, tender lymph nodes in neck HA and pain at injection site.

41 Y female who presents to the Emergency Department for evaluation of her rash. The onset of rash was gradual beginning 2 days ago with progression since that time. The rash began on the abdomen 2 days ago and 1 day after her second immunization with Pfizer COVID-19 vaccine. The rash over the next 24 to 48 hours spread to the back, the chest, the arms, and inguinal folds, and popliteal areas. This morning she woke up with itching and hives on her scalp. She has used Benadryl with some relief. Patient denies shortness of breath, chest pain, nausea, or vomiting.   There is no lip swelling or itching, tongue swelling or itching, sense of throat closing, or shortness of breath. There is been no nausea vomiting, no palpitations.   She has no hx of similar previous allergic reactions. She denies exposure to new medications, shampoos, detergents, soaps, lotions, sprays or allergens.

Approximately 5 minutes after receiving vaccine, tongue began to swell with itching to lips and cheeks and stiffness to jaw. Notified vaccine team. Received Benadryl IM with return to baseline and transported to the ER for monitoring. Received 4 days of Prednisone and Pepcid PO.

palms of hands started to swell and itch. diaphoretic, then neck started to itch. extended to throat leading to difficulty swallowing

Patient developed an itchy rash on her arms and stomach the day after receiving this vaccine. She took Benadryl for two days, and it was gone. She had no other symptoms.

Upon resting in waiting area after administration of vaccine, I began to notice left-sided facial numbness, extending to left shoulder / pectoris area. The symptom was mild throughout, did not get any worse. However, the symptoms have not subsided and I have continued to experience mild facial numbness (left). Yesterday, 01/07/21, I had an intermittent episode of tingling and left sided weakness which lasted a several hours in the afternoon. In addition to facial numbness, I also experienced left upper arm soreness, especially at site of injection. I also had a mild headache which lasted a three days.

Made felt dizzy, disoriented :15 minutes :50 minutes face, chest and neck became blochey with redness and heart beat was racing or elavated heart rate nd took benydrol after became back of hands and face became flushed red again and took more benydrol and next day face and cheeks was still blouchey and red. Hot flashes and chills .

Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; This is a spontaneous report from a contactable Nurse (patient). This 41-Year-old female Nurse (no pregnant) received first dose of BNT162B2 (Lot number: EJ1685) on 04Jan2021 09:00 AM on Left arm for COVID-19 immunization. Medical history was migraines. Concomitant drug was not reported. Known allergies: amoxicillin, cefaclor (CECLOR), ciprofloxacin hydrochloride (CIPRO), erythromycin, Zithromax. Patient experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days following injection on 05Jan2021 00:30 (reported as 04Jan2021 12:30 PM) with outcome was recovering. Treatment: Medication for nausea (zofran). Covid test post vaccination on 06Jan2021, result unknown. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Not any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Follow-up attempt are not possible. No expected further information.

24 hours after the injection I had a sore arm, developed slight body aches and headache. Since the injection I had been getting headaches almost daily, mostly on my right side of my head. On Dec. 5, 2021 I noticed I was getting a sore eyebrow. Later that evening ok noticed swollen lymph nodes throughout my scalp, face, ear, jaw, neck and chest. My eyebrow also started to swell and was slightly pink. When the swelling was worse the next day - I went to urgent care and saw A doctor that diagnosed me with facial cellulitis. After a couple days my eye was not getting any better and started to itch severely. Called to urgent care over the weekend and takes to one of the providers who said to use cold compresses and elevate my head as much as I could. On Dec. 11, 2021 I called back to the provider I had seen on Dec. 6 - he told me he believed I had developed shingles and to go to the eye doctor that day. I saw a doctor on Dec. 11 & was diagnosed with shingles. They started me on antivirals along with the antibiotics they had prescribed on Dec. 6.

Itchy skin rash in elbow crease, torso, groin area and legs that started exactly after 48 hours of receiving the vaccine from the left elbow area (where the vaccine was administered) and gradually spread to other body parts over the next couple of hours. Has not resolved with over the counter oral anti-histamine and topical over the counter steroid cream as of 1/13/21.

positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; After the shot i have headache, sorethroat, cough and cold till this date; After the shot i have headache, sorethroat, cough and cold till this date; After the shot i have headache, sorethroat, cough and cold till this date; After the shot i have headache, sorethroat, cough and cold till this date; A 48-years-old non-pregnant female patient, receivedBNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, in left arm, on 18Dec2020 (at the age of 41 years-old) as a single dose for COVID-19 immunization. The vaccination was administered at a pharmacy/drug store. Medical history was not reported. Concomitant medication included sertraline hydrochloride (SERTRALINE HYDROCHLORIDE). The patient had not received any other vaccines within four weeks prior to the vaccination nor received any other medications withing 2 weeks prior. It was reported that the patient had been tested for COVID-19 prior to vaccination and was negative. On 18Dec2020, the patient experienced itchy sore eyes one hour after vaccination, sore and itchy arm for 5 days, headache, swollen sore throat, tiredness all 5 days after. The patient was not hospitalized nor received treatment for the events. The clinical outcome of the events of Itchy, sore eyes 1 hour after, sore and itchy arm for 5 days, headache, swollen sore throat, tiredness all 5 days after, was not recovered., the outcome of the COVID-19 positive was unknown. It was reported that the patient tested positive for COVID-19 via nasal swab, post vaccination on 31Dec2020. No follow-up attempts possible. No further information expected. Lot/batch number was not provided and unable to obtain

The vaccination was given at 1802. At approximately 1804 the patient stated she did not feel quite right and something may be wrong. She stated she was feeling all warm. She was complaining of mild heat or burning traveling from the vaccination arm, across her chest to the other arm and down her torso. Did not complain of any breathing difficulties or other symptoms. Her heart rate and respirations were normal. Upper extremities were examined for redness or hives - none found. The heat flash lasted about 2 minutes then she stated she felt normal. She was observed for another 20 minutes. She was examined again before leaving and no signs or symptoms were noted at that time. She felt normal before leaving the clinic.

SkinRash, CoughWheeze, Rash, UrticariaPruritus, throat swelling not characterized by anaphylaxis Narrative: Report one hour following Vac #2, she felt a difficulty in swallowing. She did not go to ER, took benadryl x 4 days and used albuterol inhaler for the wheezing.

Started having itching after vaccine. Taken to ER. Broke out in full hives. Was given IV Benadryl and steroids.

Employee received first vaccine 12/22/21. Developed hives on neck and face later that day. Took Benadryl routinely and Prednisone 10mg daily for three days with resolution of symptoms. Patient has a history of hives after flu vaccine, antibiotics, and childhood vaccines. Had second COVID vaccine 1/12/21. Developed hives on neck, arms, chest, and back. Also had a mild headache and nausea on 1/12/21 which have resolved. Is again taking Prednisone and Benadryl. Patient did not seek medical help. She has Prednisone on hand for these reactions since they are common for her.

Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Rash (other than injection site)-Mild; symptoms lasted 0 days

01/08/21 reported around 3:30pm sick to stomach, 01/09/21 04:00am noted redness to right arm at injection site.

Pt Complained of numbness/tingling around the mouth . Red rash . Tenderness on the injection site/lower arm for 5 days.

sore arm on the same day , fatigue, next day woke up with swollen lymph nodes on my right arm same place where injection was given , still sore and pain full to touch and headaches .

Systemic: Rash (other than injection site)-Medium, Systemic: Fever-Medium, Systemic: Felt itchy all over body, no visible hives, flushed-Medium; symptoms lasted for 1 day

severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath.; severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath.; severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath.; severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath.; severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath.; severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath; severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath; This is a spontaneous report from a contactable nurse (reporting for herself). A 41-year-old non-pregnant female patient received two doses of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), both via an unspecified route of administration in the left arm, the first dose on 16Dec2020 09:00 (lot number: EH9899) and the second dose on 08Jan2021 07:15 (lot number: EL0140), both at a single dose for COVID-19 immunization. Medical history included ongoing anxiety, from an unspecified date. The patient had no known allergies. Concomitant medication included escitalopram oxalate (LEXAPRO), acetaminophen (MANUFACTURER UNKNOWN), naproxen sodium (MANUFACTURER UNKNOWN), ibuprofen (MANUFACTURER UNKNOWN). 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 and since the vaccination, has not been tested for COVID-19. On 09Jan2021 at 01:30 AM, the patient experienced severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath, all of which were reported as being life-threatening. The patient went to the Emergency room due to the events. Therapeutic measures were taken as a result of the events and included: methylprednisolone sodium succinate (SOLUMEDROL) 125 mg, famotidine (MANUFACTURER UNKNOWN) 20 mg and diphenhydramine hydrochloride (BENADRYL) 50 mg. The clinical outcome of severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath was recovering.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Severe aches, chills, headache, stomach cramps, nausea, vomiting, diarrhea, sweats, eye pain, fatigue, skin sensitivity. Treated with Tylenol and CBD lotion. Mostly resolved within 36 hours of onset.

Within ten minutes, I had a massive headache and the roof of my mouth went numb. Within one hour, I had severe bruising, dark purple, the size of a half dollar, that JUST went away and I am due on 1/17/2021 for my next vaccine. I had no pain, only dark purple bruising and swelling. The headache and mouth issue went away after three days.

Day of vaccine, patient started feeling fatigue, malaise, site pain & swelling, joint pain all over, profuse sweating w/no fever, chills, all over inflammation & swelling, hives upper extremity, petechial rash, and the next day after the vaccine, the patient started experiencing swelling in R-axilla (lemon size). 3 days after vaccine all symptoms have resolved except swelling in right axilla.

Received second Pfizer vaccine on 1/13 at 7pm. Woke with headache and injection site pain on 1/14. As day progressed, fatigue, joint pain, mm aches increased. Fatigue, headache, injection site pain and swelling, new or worsened joint and muscle pain

Symptoms - ? Patient reports she woke up on 1/14 with pain to injection site and sore L arm. At approximately 0400 + chills, HA, body aches, and nausea without emesis. + fever (Tmax 100.3), Patient reports yesterday took motrin/tylenol around the clock. Today (1/15), Patient reports no fever today but ?brain fog? and feelings of fatigue. Patient reports last dose of motrin 600 mg at 08:00. Patient reports she called off work yesterday due to not feeling well. Last day of work and shift - ?Tuesday, January 12th Home remedies? - Tylenol, motrin, rest Any improvement? ? mild improvement Recommendation? Patient encouraged to take ibuprofen and acetaminophen as outlined in the TCH Medical Directive. Patient encouraged to continue to monitor her symptoms and to contact the Vaccine support line with additional questions and concerns. Patient reports she called out of work yesterday, next scheduled shift Monday (1/18). Patient educated to manage her RTW according to the TCH Illness in the Workplace policy. Patient verbalized back understanding and denied further questions at this time.

Dizzy at work around 4pm. Tightness in chest worked its way down to stomach - felling queasy and sick to the stomach. When driving home from work, she instantly felt really hot and had a lot of flushing that felt like a hot flash. Hot all over. Had to pull over and take off layers of clothes. Sat with the air on in the car. Burning sensation when she got home felt like brillo pad was used on face. Burning sensation on cheek all the way down to chin. Face was really on fire. Today, the burning sensation have gotten better, but her cheeks still have prickly, tight sensation. Headache at 8pm yesterday when she was trying to go to bed at the back of the head. Felt like a lot of pressure.

*Rash ,whelps and swelling on bilateral arms from the shoulder area to hands. *Rash ,whelps and swelling on bilateral legs from upper thighs down to feet *Severe Itching Received the vaccination on Wednesday, January 6, 2021. Symptoms started on Saturday, January 9, 2021 around 1pm. Symptoms intensified as the days went by. Went to Urgent Care on Monday, January 11, 2021.

Inject site pain; muscle/joint pain; muscle/joint pain; fever with temperature of 99-100.6 [units unspecified]; under arm lymph node pain; headache; This is a spontaneous report from a contactable healthcare professional. A 41-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as COVID-19 vaccine; lot number: EL1284; expiration date: unknown), intramuscular left arm on 08Jan2021 08:45 AM at a single dose for covid-19 vaccination. Medical history included asthma, allergies, high blood pressure and gastric sleeve. Concomitant medication included albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]), beclometasone dipropionate (QVAR), mometasone furoate (FLONASE), aminobenzoic acid, calcium pantothenate, cyanocobalamin, nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride (B-COMPLEX), cyanocobalamin (B-12), colecalciferol (D) and macrogol 3350 (MIRALAX). The patient previously took vancomycin but had allergies. The patient received the first dose of bnt162b2 (BNT162B2 reported as COVID-19 vaccine; lot number: EK5730; expiration date: unknown) intramuscular left arm on 18Dec2020 07:45 AM at a single dose for covid-19 vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient received the most recent COVID-19 vaccine in a hospital. The patient experienced inject site pain, muscle/joint pain, fever with temperature of 99-100.6 [units unspecified], under arm lymph node pain and headache on 09Jan2021 23:30. The events were considered as non-serious. The treatment the patient received for the adverse event were acetaminophen (TYLENOL), fluids, ice packs and magnesium. The patient has not been tested for COVID-19 since the vaccination. The patient underwent lab tests and procedures which included temperature was 99-100.6 [units unspecified] on 09Jan2021. The outcome of the events was recovering.

Fatigue; Dry mouth; Low grade fever; Chills; Headache; Itchy rash at injection site; Itchy rash at injection site; Soreness at injection site; This is a spontaneous report from a non-contactable nurse (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685), via an unspecified route of administration on 31Dec2020 12:45 at left arm, at single dose for covid-19 immunization. Medical history known allergies: penicillin, chocolate from an unknown date. Concomitant medication included acetylsalicylic acid (ASPIRIN) and Birth control pills. The patient previously took erythromycin and known allergies: Erythromycin. The patient was not pregnant at the time of vaccination. The patient experienced fatigue, dry mouth, low grade fever, chills, headache, itchy rash at injection site, soreness at injection site on 31Dec2020 15:00. No treatment was received for all events. The outcome of the events was recovered on an unspecified date. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect. No follow up attempts are possible. No further information is expected.

I started itching while being monitored post vaccine administration within the 5 minutes of the vaccine being administered. The itching was everywhere including my tongue and throat, since this is my workplace and I was working I had to go home and was given Benadryl to take upon arrival, the Benadryl did not help so I did a virtual visit with a physician who recommended that I increase the dose of benadryl at the same time I called my PCP to inform them of the issue they ordered, Atarax 25 mg every 6 hours plus taking an over the counter antihistamine.

I received my second dose of Pfizer's Covid vaccine on 1/9/21. The person who gave the vaccine administered it SQ, not IM. I did develop a cellulitis like reaction to the area. The redness began almost immediately following the vaccine, however, the following 2 days the area grew larger and hot to touch. The area currently is red and itchy, however, swelling and warmth is gone. My concern is the efficacy of the vaccine since it was not given IM.

Within 25 minutes of receiving the vaccine, my left arm became very heavy and there was a tingling/neuro sensation in left wrist/hand. A pressure began in the anterior of my throat which increased gradually. I sought treatment in our Urgent Care just after noon that same day. The Provider monitored my vitals which were good and administered liquid Pepcid. Said Provider chose not to give Benadryl as I had taken Zyrec that morning for my allergies. I was discharged from the Urgent Care and went back to work at 1245. At 1730 hours, I had a slight headache above my right eye and extreme right-sided jaw pain with tooth sensitivity. These lasted for only 10 minutes. At 1830, the anterior and bilateral portions of my throat began to feel "prickly" and I developed a wheeze. I used an albuterol inhaler to relieve the wheeze successfully. At this time I also developed an itchiness throughout my whole body, worse on left side than right side. I took 100mg of Benadryl with no relief. At 0300, I took another dose of 100mg of Benadryl with no relief. I also took an itch pill/antihistamine of my husband's which provided no relief. At 0800, I took 20 mg of Zyrtec. At 1030, I took 100mg of Benadryl. I continued to use Benadryl throughout the day, every 4-5 hours. At 1800, I had a fullness in my throat, a tightness in my chest and my left shoulder blade felt almost numb. I also had a hoarse voice which passed by the next morning. The chest tightness was intermittent over the next day or two. On Friday, the itchiness had improved some but was still prominent. I continued to use Zyrtec and Benadryl throughout the day. My Primary Doctor called in Prednisone if needed. By Saturday morning, I felt MUCH better. Today is Sunday and I am no longer itching and I feel so much better today.

1/17/2021 2:42 pm gave vaccine 1/17/21 2:54 pm itchy throat on outside was upset and we opted for 25mg Benadryl as a precaution. BP 112/72. Reported itchy back. Checked back, unremarkable. 3:30, no issue ? she went home. F/u 4:30 - no issues

Started with aches, pain and headache on 1/14 pm. By 1/15 am temperature had spiked to 106 but was responsive to acetaminophen and remained high until 1/17 am. patient is continuing to experience aches and pain still 1/18. Face was swollen and red until 1-17 pm. Lymph nodes in neck, collar bone and armpit on right side were swollen and sore. About 3 inches below actual injection site an area 1x2 inches is red and hot to touch still on 1/18

I felt off/not myself for about 30 hours after the second dose. A migraine for 48 hrs. a red welt on my arm at the injection site, I found it 1/13 it was small and got bigger overnight. I took Benadryl on 1/17 and it got smaller. the morning of 1/18 it was back just as big as before the benadryl. It is about 5 inches accross and 3 inches up and down

Soreness/pain in the injection site starting 3pm on January 8, 2021 until January 10 at 11am. I cannot lift the affected arm but still can do light activities like eating, writing, typing, etc. Chills and fatigue starts saturday January 9 at 7pm until January 10 at 11pm. I took tylenol starting January 8 for the pain until pain is gone and took Theraflu starting January 9 until sunday bedtime at 11pm. Bedrest and increase fluid intake one of the interventions, besides medicines.

COVID positive 11/27/20. Oxygen saturation dropped to 90% with exertion and 94% resting. Also had chest pain and sinus tachycardia. Received first COVID vaccine 12/18/20.Developed continuous vomiting 1.5 hours later then muscle aches and cramps as the day went on. Symptoms were gone later the next day except site soreness. Developed SOB and wheezing on 12/24/20. Went to ER - no treatment. Called her pulmonologist and increased diltiazem for the weekend. Called cardiologist 12/28/20 and was put on Corlanor. Took care of acute issues, but still had some SOB and palpitations.

Fatigued; Sore in her throat; Lost her voice (hoarse); Reddish nose; Intermittent coughs; she went to work to a COVID unit which she usually didn't do; described her symptoms as a chest cold; Feeling strange like coming down; swelling and soreness in the injection site for a day or two; swelling and soreness in the injection site for a day or two; This is a spontaneous report from a contactable nurse reported for self. This 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) via unspecified route of administration on 07Jan2021 13:30 PM at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not provided. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) for COVID-19 immunization on an unspecified date. On 07Jan2021 after second dose vaccination, the patient started experiencing swelling and soreness in the injection site for a day or two. On 08Jan2021 the next day, she went to work to a COVID unit which she usually didn't do. On 08Jan2021 the next day after her shift at 15:00 PM, she started feeling strange like coming down. On 09Jan2021, she felt totally fatigued. The symptom that bothered her the most is the sore in her throat which has gone 10Jan2021, she said she lost her voice (hoarse). She was also experiencing a reddish nose and intermittent coughs. She described her symptoms as a chest cold. The patient also stated she didn't have fever or chills. She's afraid she might be sick. The outcome of event the sore in her throat was resolved on 10Jan2021. The outcome of other events was unknown. Information about lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported chest cold 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.

5 minutes after vaccine- hot/dizzy, lasted less than 1 minute. Right side neck pain/ache, left arm pain/ache- lasted less than 5 minutes. 30 minutes after vaccine rash, itching- lasted 2 days. 1 hour after vaccine- severe headache lasted 4 days. 4 hours after vaccine- ears/throat itching. Took Benadryl 50mg, Tylenol 1000mg, Albuterol Inhaler 2 puffs, and Famotidine 20 mg 4 hrs after vaccine.

10 minutes after vaccine administered was lightheaded, heart rate increased. This lasted no more than 2 minutes and resolved on its own with no further recurrence. A few hours later developed rash to upper body (chest & back areas). Treated rash with antihistamines (Benadryl, Pepcid), Zyrtec. Rash resolved after 7 days, then flared after allergy medications stopped. Rash completely resolved at 16 days post vaccine.

5 days after my injection, I noticed a raised, bumpy area on my L upper arm. At this time, I did not equate this with my injection since it was 5 days later. But on day 6 in the AM, the area on my L deltoid was visible and red in the mirror. It took my husband and I a few minutes to put together that this was the site of my injection. Throughout the day, the area was raised, red, and itchy- but not intolerable and I did not take any medication. I did put some hydrocortizone ointment on the area this PM (still day 6 post-injection).

Roughly 2-3 minutes post injection as I was sitting in the designated waiting area, (as instructed by the nurse to sit there for 15 minutes post injection to assure no adverse effects) I began to get very short of breath, I felt that I had to take my mask off to breath properly. ( I did not remove my mask) My heart then started to race and I felt a warming, tingling feeling throughout my body. I felt a little hot and light headed. I stayed sitting in my chair, tried to take some deep breath, and everything went away. This lasted about 30 to 60 seconds. I did NOT report this to anyone there, as I was unsure if I was actually having a reaction or not. Since it went away on it's own, I did NOT report it to anyone. I stayed for about 15-20 minutes post injection and then I left and drove home. I did feel tired and my arm is sore at injection site, but other than that, no other effects.

Got vaccine on 1/16/2021 at 8:03 am only had left arm pain site of vaccine given later in the day started having Headache, Body aches, Fever, Fatigue. Sunday 1/17/2021 left arm pain where vaccine given, headache, fatigue, minor body aches. Monday 1/18/2021 only headache, fatigue, minor left arm pain where vaccine given.

Itching all over began night of and continued for almost two days after vaccine. Mild symptoms, didn't need Benadryl or anything.

Mild skin rash/welts on face. 1cm sized itchy swelling on bottom lip. puffy eyes (mild) mildly scratchy thoat. Mildly scratchy eyes. Was better by morning and gone by the next evening. Did not take Benadryl.

22 hours after the second dose started to have an allergic reaction, hives all over back and chest and neck. Took benedryl and pepcid at home OTC. The next morning woke up with hives, flushed feeling, and chest/throat tightening. Went to the ER was administered iv medications. Went home. 4 Hours later started again with chest and throat tightening and swelling of the eyes. Kept having break through reactions when medications were wearing off. The ER md that I saw called in some home medications that I started taking. Pepcid and Prednisone. 7 days later still having to take benedryl and pepcid due to eye itchiness and swelling.

At about 4:30am on 12/24/20 she woke up with an itchy throat and hives all over body. Took 50mg Benadryl and symptoms cleared up in 3 hours. Developed hives again that evening. Took Benadryl 25mg and resolved. This has continued to occur approximately once daily with relief of Benadryl 25mg. Was advised by Dr. that this could be from an allergy to the filler.

Decided to get second vaccine 1/11/21 even though she was still getting hives from 1st dose. Developed swelling on inner canthus L eye. Saw Dr. 1/14/21 and famotidine was ordered. This reduced hives. In 1/16/21 developed swelling of R inner canthus. Took Benadryl and famotidine hs on 1/17/21. Took famotidine 1/18/21 before work, but developed hives under arms and tongue began to swell that evening. Took another dose of famotidine. Tongue improved within 40 minutes but L side of face began to swell. Took Benadryl 50mg. Facial swelling improved but did not go away. Called Dr. this am and was ordered a Medrol dose pack. If this is not effective then she will be referred to Dr., allergist.

On Jan 12, the patient developed positional vertigo and nausea as well as sore arm. Vertigo resolved when she fell asleep. Vertigo returned on Jan 16 and17. Diarrhea occurred 6 times on Jan 17. The patient noticed significant diffuse loss of hair from January 16 to 19. She continues to have some nausea.

5 minutes after vaccination, recipient became flushed, red in face, felt hot. Reported to observation RN that she began feeling short of breath. RN administered Epinephrine in left thigh. Patient escorted to Emergency Department for further evaluation approximately 10 minutes later due to recurrence of symptoms.

at 6:00 pm I had diarrhea and the pain in my left arm started and I tooke tylenos 350mlg. I had a headache in the middle of the night. today i woke up with a lot of pain non my left arm and shoulder and iI put Cbd pain cream all over my arm and tooke paracetamol 650 mlg for pain.

Patient got her 2nd dose of Pfizer covid vaccine on 1/8. On 1/11 she had intermittent chest pain that lasted a few days and started to notice small purpura rash on left breast. She didn't think much of it but noticed the same type of rash on her pant line and then right thigh. On 1/15 she called Occupational Health who advised her to go straight to the ED.

"Pfizer-Bio-Tech COVID-19 Vaccine EUA" Physician contacted staff in regards to an individual who received the Covid-19 Vaccine on 12/19/2020. The individual reported sand paper face rash and full swollen face that started 3 days after receiving the vaccine (1/1/2021). Individual reported that she had Botox and facial fillers on 12/15/2020. This event was an unwitnessed by the staff at County Health Department. The event was reported to Epidemiologist.

sore left deltoid; mild muscle aches; mild neck/joint pain; mild neck/joint pain; tired; This is a spontaneous report from a contactable nurse. A 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL1283), via an unspecified route of administration in the left deltoid, on 09Jan2021 (at the age of 41-years-old) at a single dose for COVID-19 immunization. Medical history included hypertension (HTN) and COVID-19. The patient was not pregnant at the time of vaccination. The patient had no known allergies. Concomitant medications, taken within two weeks of vaccination, included amlodipine besilate (NORVASC), ascorbic acid (vitamin C; MANUFACTURER UNKNOWN), ergocalciferol (reported as: vitamin D; MANUFACTURER UNKNOWN), zinc (MANUFACTURER UNKNOWN), and magnesium (MANUFACTURER UNKNOWN). Other concomitant medications included unspecified daily multivitamins (MANUFACTURER UNKNOWN). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EK5730), intramuscularly in left arm, on 19Dec2020 at 07:00 (at the age of 41-years-old) for COVID-19 immunization and experienced sore left deltoid (Day 1), body aches (Day 1), headache (HA) (Day 1, 2, & 3), all over body aches (Day 2), fatigue (Day 2, 3, & 4), chills (Day 2), myalgia/muscle ache (Day 3), all over joint pain (Day 3), lower/upper extremity (LUE) pain (Day 4), and muscle and bone pain (Day 4). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced sore left deltoid, mild muscle aches, mild neck/joint pain, and tired on 09Jan2021. The events were reported as non-serious. The events occurred on day 1 after vaccination and by day 2, the patient felt great with no side effects. Therapeutic measures were taken as a result of all of the events, which included paracetamol (TYLENOL) and ibuprofen (MOTRIN). The clinical outcome of sore left deltoid, mild muscle aches, mild neck/joint pain, and tired was recovered on 10Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.

Really bad headache; Really itchy/itching in her upper body and in legs, like a rash; Rash/itching in her upper body and in legs, like a rash; Mottled skin; This is a spontaneous report from a contactable nurse reporting for herself A 41-years-old female patient received bnt162b2 (BNT162B2; Lot #EL3249) vaccine , in the left arm on 11Jan2021 13:00 at single dose for Covid-19 immunisation . The patient medical history was not reported. There were no concomitant medications. The patient experienced really bad headache on 12Jan2021 with outcome of unknown , really itchy/itching in her upper body and in legs, like a rash on 12Jan2021 with outcome of unknown , mottled skin on 12Jan2021 with outcome of unknown. Unknown treatment was given for really bad headache The reported events were considered Important Medical Events.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the events headache, pruritus, rash and livedo reticularis 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. 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.

itching; palpitations; back ache; had an allergic reaction; full blown hives; rash on her face, ears, legs and arms; fever; tired; sore throat; swollen lymph nodes; chills; This is a spontaneous report from a contactable nurse (patient) via a Pfizer-sponsored program. A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EJ1685, expiry: Mar2021) intramuscularly on 19Dec2020 at a single dose for covid-19 immunisation. Medical history was reported as none. The patient's concomitant medications were not reported. On 20Dec2020, the patient experienced fever, tired, sore throat, swollen lymph nodes and chills. On 08Jan2021, the patient experienced rash on her face, ears, legs and arms. On 09Jan2021, the patient had an allergic reaction and had full blown hives. It was also reported that the patient experienced itching and back ache on an unspecified date. The patient also experienced palpitation on an unspecified date and she went to the emergency room in which she was prescribed with lorazepam (ATIVAN). The patient was also treated with naproxen (ALEVE) for fever and back ache, steroid (unspecified) for allergic reaction and hives, TRIAMCINOLONE cream for the rash and HYDROXYZINE for the itching. Outcome of the events fever, tired, sore throat, swollen lymph nodes and chills recovered on 21Dec2020 while for the events full blown hives, itching, had an allergic reaction, rash on her face, ears, legs and arms, palpitations and back ache was unknown.

Diffuse rash and left supraclavicular lymphadenopathy; Diffuse rash and left supraclavicular lymphadenopathy; This is a spontaneous report from a contactable other health professional (patient). A 41-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot:EL0142) via an unspecified route of administration into the left arm on 09Jan2021 08:45 at a single dose for covid-19 immunisation. Medical history was reported as non. The patient's concomitant medications were not reported. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot:ES1685) via an unspecified route of administration into the left arm on 19Dec2020 08:45 at a single dose for covid-19 immunization. On 09Jan2021 20:00, it was reported that the patient experienced diffuse rash and left supraclavicular lymphadenopathy. It was also reported that the events reported was treated with loratadine (CLARITIN). Patient was not pregnant. Outcome of events was not recovered.

Several toes on my right foot and one toe on my left became purple in color and looked like "COVID toes."; Stiff Neck noted in correlation with discoloration; This is a spontaneous report from a contactable Nurse reported for herself. A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), intramuscular at right arm on 28Dec2020 15:30 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Medical history included Factor V, Behcet's disease, Hypertension, and allergy to PCN. Prior to vaccination, the patient was not diagnosed with COVID-19 The patient's concomitant medication was not provided. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's past drug history included steriod Injection to left shoulder 23Dec2020. On 09Jan2021 11:30, Approximately 12 days after receiving vaccine, several toes on my right foot and one toe on my left became purple in color and looked like "COVID toes." I was seen in the ED, unsure of what is causing this, will be seen by MD next week. Lighter purple on second day, seems to be resolving. Stiff Neck noted in correlation with discoloration. Adverse event resulted in: Emergency room/department or urgent care. No treatment received for the events. The patient underwent lab tests and procedures which included Nasal Swab 2019 Novel Coronavirus SARSCOV-2 by PCR was negative on 09Jan2021. The outcome of the events was recovering.

hand was hurting so bad/feeling more pain in her hands; hurting down into her breast; feeling weakness; joint hurting; fever; chills; whole body aches; restless; joints and muscles were hurting; She saw really bad redness and it was increasing in size; It was swollen and warm to touch; It was swollen and warm to touch; she has had horrible feelings; inappropriate schedule of vaccine administered (first dose on 21Dec2020, second dose on 09Jan2021); inappropriate schedule of vaccine administered (first dose on 21Dec2020, second dose on 09Jan2021); Cellulitis; This is a spontaneous report from a contactable Nurse (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on 09Jan2021 at 10:30 a.m. at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history and concomitant medication were not reported. The patient received first dose on 21Dec2020 (lot number: EJ1685) on left Arm. Patient received second dose of the Pfizer COVID19 Vaccine on 09Jan2021 at 10:30 a.m. and until 11 that night she had no symptoms. She started feeling weakness and joint hurting. After midnight she had fever, chills, and whole body aches. She was restless. All her joints and muscles were hurting. The chills were really bad. She was taking Motrin 200mg and she took three pills at the time, so she took high dose kind of. It didn't get better until Monday, 11Jan2021, at around 1:00PM. It was She stayed home. She has heard from so many people that the second dose gives this kind of symptoms. She was already prepared with the medication. She knew the symptoms would get better. She didn't just right away go to the doctor. For two days she was running all the symptoms. Patient commented also that the last two days she has had horrible feelings. She didn't pay attention to the arm. With any shot, pain is normal. She was getting better with the other symptoms, but was feeling more pain in her hands. She saw really bad redness and it was increasing in size. It was spreading. When moving her arm, it was radiating under the arm and to the side of her breast. Then she felt really bad and came to work. She showed it to her friend and it was spreading and hurting. It was swollen and warm to touch. She went to Urgent Care downstairs. On 12Jan2021 at 10:50AM she went to Urgent Care and was diagnosed with cellulitis in left upper arm. Antibiotics were prescribed as treatment. She informed took vitamins. At the time of the reporting event outcome was unknown. Information on the Batch/Lot number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162BB2 on reported events 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.

Chills; Headache; Site pain; Body ache; This is a Spontaneous report from a contactable Nurse (patient). A 41-years-old female patient (no pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) , intramuscular on 09Jan2021 08:45 (lot number EL0142) at the second single dose, intramuscular on 21Dec2020 11:15 (lot number EH9899) at the first single dose for covid-19 immunisation. Anatomical location was left arm. Medical history reported as none. The patient's concomitant medications were not reported. The patient experienced chills, headache, site pain, body ache on 09Jan2021 21:00. The patient underwent lab tests and procedures which included Covid testing viral RNA: negative on 04Jun2020 via Nasal Swab. The outcome of events was unknown.No other vaccine in four weeks; No covid prior vaccination; No covid tested post vaccination

LUE pain; bone pain; mialgia/muscle aches; all over joint pain; fatigue; chills; sore Left deltoid; body aches/all over body aches; Headache; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EK5730), intramuscular on 19Dec2020 07:00 am at single dose at left arm for covid-19 immunization. Medical history included hypertension, covid-19 (prior vaccination). No known allergies. Concomitant medications in two weeks included amlodipine besilate (NORVASC), ascorbic acid (VIT C), ergocalciferol (VIT D), magnesium chloride (MAG), zinc and daily multivitamins. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, patient had not been tested for COVID-19. The patient experienced sore left deltoid, body aches, headache all on 19Dec2020 16:00, all over body aches, headache, fatigue and chills all on 20Dec2020, mialgia/muscle aches, fatigue, headache and all over joint pain all on 21Dec2020, headache, LUE pain, muscle and bone pain, fatigue all on 22Dec2020, patient finally felt better with decreased symptoms on 23Dec2020. Outcome of all events was recovered on unspecified date. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care. Patient received paracetamol (TYLENOL), motrin for events.

Fever, body aches, fatigue - all lasting 12 hours, then resolved. Also having cellulitis to injection site, started with adverse symptoms, still having & redness is getting larger now (55 hours after injection)

I got my 2nd vaccine on 1-14-20 at 9am. About 6 hours later I had severe headaches, fatigue, muscle pain, also pain at the injection site. i felt very tired. The next day I had severe headaches, muscle pain and fatigue and took Ibuprofen as pain medication. My headache went from a severe to moderate. All the rest of days continued with headaches.

Employee developed severe left upper extremity pain immediately after she received the COVID Pfizer vaccinedose #2 on left arm on 1/6/2021 at 11:15 am. The pain persisted and increased in intensity despite the use of topical and oral anti inflammatory medications. She was evaluated by an orthopedist on 1/18/2021 who performed various imaging studies and diagnosed the acute condition as left subacromial bursitis and tendinitis secondary to vaccine infiltration in the left shoulder bursa. The employee informed employee health director on 1/20/2021 and evaluated on same day. On physical exam, she had marked tenderness on the left arm at site of injection and moderate decrease range of motion of the left shoulder. She has been prescribed physical therapy sessions of left shoulder for eight weeks and is continued on daily analgesics. SARSCov-2 Ab IgG test done on 1/20/2021 is negative She will follow up with her orthopedist for further diagnostic tests and treatment.

Patient reported to having generalized Itchiness in back, and breast with hives after receiving first shot of vaccine.. After 21 days the patient came to the clinic for the second shot, but she still presented symptoms of the adverse reaction. Dr recommended to do not received the second shot. The patient went to the ER to get a second opinion. After having Talked with Dr, he agree with Dr for to not give her the second shot. Dr. from emergency department proceed to give her Medrol dose pack, Allegra and Zyrtec to relieve the symptoms.

Severe bilateral upper and lower extremity itching, ear and facial itching. no rash. Treatment: Continued taking Benadryl 25 mg every 6 hours until 9PM on 1/12/21. One dose of Prednisolone 15 mg @ 330 AM on 1/12/21 and Decadron 16 mg @ 300 PM on 1/12/21. Symptoms resolved at 1/12/21 around 8 PM. Outcome: no other reactions

Pfizer COVID-19 Vaccine EUA. At 1317 (18 minutes after vaccine administered) Patient observed to have rash to chest and neck. Patient stated she felt "warm in her neck and inner thighs". Rash progressed to ears and face. Patient stated she was having "tingling in the mouth w/progression to her face and eyes. Patient taken to triage area for observation, VS Q 5 mins. Patient noted to have tachycardia PR 103 and elevated BP 178/100 on initial VS. Pulse rate decrease after 5 minutes to 95. BP remained elevated. Patient placed on gurney in recumbent position and water given. Patient given a mirror to view face and patient stated " my face is swollen slightly". Absent selling to lips or tongue. EPI pen 0.3mg/0.3ml auto injector administered at 1339.patient transported to site ED for further evaluation. O2 applied enroute to ED at 4L/min via NC when patient stated she felt a little lightheaded. Patient care transferred to ED and report given.

Hives started on my chest, they were very sensitive, first noticed when my chest felt raw from my shirt. Hives went up from my chest to my neck and eventually to my face. About 30 mins after hives started, my breathing became labored. I took 3 Benadryl and was preparing to give my self an EpiPen injection. Benadryl was enough to slowly bring everything back to normal. This began around 6:00 pm, Benadryl was taken around 6:45, by 9:00pm I was completely normal for bed.

Nausea, vomiting, and body aches within 3 hrs of injection. Swelling and pain at injection site. Cellulitis at injection site, L armpit, L breast, lymph nodes, L shoulder. Prescribed antibiotics and instructed to take OTC NSAIDS and Anti-hystamimes. If symptoms don't abade seek further treatment, possibly IV antibiotics.

For informational purposes, to hopefully add to current research:. Dose 1: administered in the am-lightheaded, tired, sleepy began after an hr or so after administration and continued throughout the day, blood pressure increased significantly after a few hrs (151/94); was much better the following day, only feeling tired and having pain at site of vaccine/upper arm. Dose 2: administered in the pm- lightheaded slightly for the first hr, more dizzy after 2.5 hrs, blood pressure ok, but severe headache; woke up with chills 2-3x that night, woke up with headache still, no fever, joints aching more than usual in spite of taking lots of ibuprofen; slight upper arm pain. Headaches have continued and my typical joint/back pains seem to be a lot worst and not really responding to ibuprofen. May be coincidence, maybe not. Thank you.

Felt dizzy and light headed immediately following injection Had flu like symptoms from 1pm through 9pm I took 1,000 mg Tylenol at 5pm Developed generalized, all over body severe itchiness at 9pm Took Benadryl at 11:45pm Woke at 6:00am on 1/23/21 with continued all over body itchiness, although more mild/moderate Reporting at 6:55am on 1/23/21

Rash on lower legs and feet. No pain No itching No swelling on feet Some swelling on right Started in last 24 hrs. Seeking treatment.

L arm pain and swelling at injection site. Upper body aches unable to sleep. Lasted about 12-15 hours was gone about 27 hours after injection. Fatigue and feeling flush then chilled very mild. No fever

Sharp pain at bridge of nose that became a tightening across entire face and forehead, rapid heartbeat, nausea, numbness in lips, sinuses pushing on roof of mouth, difficulty swallowing for about 15 minutes about a half hour after taking vaccine. Then about 6 hours same symptoms but without rapid heartbeat, swallowing issues were worse, took Benadryl, after about an hour symptoms lessened and I fell asleep. Next morning roughly 13 hours later would randomly have tightness in face and under chin. Lasted off and on all day.

I began feeling a sore, scratchy throat, a headache and localized redness and swelling at the injection site about 6 hours after receiving my vaccine. The next morning, about 18 hours after receiving the vaccine the injection site redness had extended to about 2" and had become painful. At about 22 hours after injection I began having a significant headache, chills, elevated temperature of 100 degrees, body aches, exhaustion and overall unwell feeling. This feeling persisted through the remainder of the day. By 46 hours post vaccination the redness and swelling had grown to about 3" and now had a strong red center, was hot and hard to the touch. I was still having chills, temperature stayed around 99 degrees, still felt tired and had headache. At about 66 hours post injection I have sinus congestion and the swelling and redness at the injection site is about 3 1/2" and swelling without redness now extends about 2" past the redness down my arm.

following the 1st dose on 12/29/2020- soreness and swelling at injection site followinf the 2nd dose on 1/19/2021- swelling and pain at injection side, right axilla severe pain, flu like symptoms, nausea, headache. migrane developed on day 3, on day 4 hives and pruritus all over the body, swelling of hands and feet, on day 5 the symptoms worsened despite medicating with OTC benadryl 50mg every 6hrs. Contacted PCP and was prescribed prednisone 20mg daily with some improvement. day 6- today rash still present, pruritus present, weakness, dizziness, shaky. unable to work or drive.

Day 1: Moderate Headache, chills, low fever, moderate joint pain and body ache, and injection site pain and swelling Day 2: chills, low fever, moderate to severe joint pain and injection site pain, severe fatigue Day 3: mild to moderate joint pain, mild to moderate body ache, moderate to severe fatigue, malaise Day 4: moderate to severe fatigue, malaise, mild body ache Day 5: moderate fatigue, malaise, mild body ache Day 6: moderate fatigue, malaise, mild body ache

Following the 1st dose- arm soreness and pain at injection side. 2nd dose- axilla pain on the right, flu like symptoms, headache, joint pain followed by migraine headache on day 3 post second dose. On Saturday day 4 hives, itching all over the body. Treated with oTC Benadryl 50mg q 6hrs. On day 5 the rash was more severe. Contacted PCP and was prescribed prednisone 20mg daily. Day 6- today, rash slightly improved but still present and itchy. Feeling weak and dizzy.

Status post vaccine #2 Pfizer covid vaccine. R arm r preast started itching approx 7:45 . 8:16 Took own allegra, increased pruritis 8:40 called 9111 employee taken to clinic treated with benadryl and zyrtec, MD next day told to take allegra and Pepcid. 1/14 employee returned to work. Started Diarrhea on 1/15. Had intermittent diarrhea since then, still has pruritis. all over. Taking allegra and pepcid. benadryl at night. Employee Advised to contact allergist for appointment. Advised to contact MD again because of the persistent itching.

Throat, ears and nose itching; Nose running; Throat tightening; This is a spontaneous report from a contactable consumer. A 41-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK5730/expiration date) dose number 1 via an unspecified route of administration on 22Dec2020 17:00 at a single dose on the right arm for COVID-19 immunization. Medical history included allergy to NSAIDs. The patient previously took buproprion and experienced allergies. No other vaccine was received within 4 weeks. Concomitant medications included sertraline hydrochloride (ZOLOFT), lisdexamfetamine mesilate (VYVANSE), and clarithromycin (CLARITIN). The patient experienced throat, ears and nose itching, nose running, and throat tightening on 23Dec2020 01:00. The patient received Benedryl and Prevacid taken at home for the events. The outcome of the events was recovered.

Approx 15 minutes after receiving the vaccine she started c/o lip abd facial itching. She was given Benadryl 50mg Im to L Deltoid. She said within 5 minutes she was feeling better already. She called a friend that is a nurse practicioner to come and pick her up. no other problems noted

20 min after injection left arm/hand swelling. Hand swelling/difficult to bend fingers. Waited 30 min, offered benedryl, went home and rested. Arm hand still swollen on 1/25/21 but not as severe

Approximately 10 mins post injection I had intermittent abdominal cramping which I didn't initially associate with the injection, 30 mins post injection after obs period I felt dizziness. Chills within an hour, accompanied by sweating. Continued to work through it because otherwise felt okay. Dizziness subsided shortly after additional antihistamine and Pepcid. Approximatley around 7 pm my face start burning and itching, I had a diffuse red rash all over my face and my torso. I took 50 mg of Benadryl and rash resolved. It was not hives, almost appeared as flushing, Over the weekend I had fevers, chills but nothing that prevented me from my daily life. I however, have felt since my 2nd vaccine throat irritation, and itching, sweating. I am just continue my Zyrtec and regimen I took several years ago when I had this type of immune response. I didn't bother with MD, I left a message with nurse.

About 45 minutes to an hour after the administration of the vaccine m, my cheeks became red, hot, and swollen. There were also hives. I took Benadryl which stopped the spreading but it did not go away. I had shortness of breath, and by about 6:00 it was hard to breath when lying down. I did an albuterol treatment with my nebulizer. It helped but it took much longer than usual. There were was about 30 minutes that I found my epipen and was going to the ED if it got worse. My breathing improved. The red changed to pink but was still swollen and tight 7 hours later. The second one of Benadryl helped get rid of most of the pinkness. When I woke up this morning, I had a little bit of a wheezy cough that I didn?t have yesterday. My daily Zyrtec and singular helped that a little. I have new hives along my jawline this morning that are very minor but they do itch. The redness and swelling was similar to reactions I?ve gotten when I drink a beer or have eaten soft shell crab, but typically Benadryl will clear that up and it doesn?t linger for so long. This was more aggressive. My side effects at this point are minor, but I have a call in to my allergist to see if I should be doing anything different and questions about the second dose.

Two days after my second COVID vaccine I felt pretty bloated although my fatigue/chills/aches from the previous day had subsided. That night I got hives on my neck, shoulders, chest, breasts and upper abdomen. They were not itchy and went away without treatment that night but I got up in the night to go to bathroom and had small amount of blood from rectum. The blood from rectum and bloating has continued. It is only a small amount of bright red blood but has occurred about 5 times since that second dose of vaccine.

Patient reports that within 1 hour of receiving the first dose of vaccine, she developed redness on bilateral arms that extended from her shoulders down to her hands. Her arms also itched towards the top, near her shoulders. Also reports feeling an odd sensation on her back, had coworkers lift her shirt and they saw a "spiderweb-like" pattern of redness on her back. Patient also reports she had to take Zyrtec and Benadryl. No other rashes or reactions reported.

symptoms: exhausted/run-down, headache, some nausea, rash (red, itchy, sore) at injection site, not sleeping well treatment: resting, sleeping, acetaminophen, drinking fluids all symptoms started approximately 24 hours after the shot was administered. symptoms have not resolved as of typing this at 2117 28January 2021

40 min after vaccine, noticed that her throat red, hives, flushed, elevated heart rate to 120s-130s. Took Tylenol and Benadryl which improved. Mild lip tingling. Symptoms now resolved. She believes the heart rate was due to "anxiety" After the first dose, only felt flushed.

15hrs post injection, muscle aches, joint pain; 15hrs post injection, muscle aches, joint pain; injection site pain 12hrs post injection; intense chills/shivering 12hrs post injection #2; This is a spontaneous report from a contactable nurse. A 41-year-old non-pregnant female patient received the second dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL3248 and Expiration Date: Apr2021), via an unspecified route of administration in the left arm on 15Jan2021 at 12:00 at 41-years-old at a single dose for COVID-19 immunization in a hospital. Medical history included asthma from an unknown date and unknown if ongoing, gastrooesophageal reflux disease (GERD) from an unknown date and unknown if ongoing, thoracic outlet syndrome (arterial/neurogenic) from an unknown date and unknown if ongoing, Allergies to Iodine based contrast from an unknown date and unknown if ongoing, sulfonamide allergy from an unknown date and unknown if ongoing. The patient previously received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) for COVID-19 immunization on 28Dec2020 at 12:00 at 41-years-old and experienced no symptoms (first dose; Lot number: EJ1685, EXP: Mar2021, vaccine location: left arm). Concomitant medications included gabapentin (MANUFACTURER UNKNOWN), levocetirizine dihydrochloride (XYZAL), omeprazole (PROTONIX); all taken for an unspecified indication from an unspecified date to an unspecified date; within two weeks of vaccination. On 16Jan2021 at 00:00, the patient experienced: injection site pain 12hrs post injection, intense chills/shivering 12hrs post injection #2. On 16Jan2021 at 03:00, the patient experienced: 15hrs post injection, muscle aches, joint pain. Therapeutic measures were taken as a result of intense chills/shivering 12hrs post injection #2: relieved by 500 mg of paracetamol (TYLENOL) upon onset of chills (as reported). The clinical outcome of the events was recovering (as reported). 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 has not been tested for COVID-19.

Full body rash; trouble clearing throat; felt like there was something stuck in throat; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL3249), intramuscular (right arm), on 13Jan2021 09:45, at single dose, for covid-19 immunization. Medical history included allergies: sea salt, hypothyroidism, anemia, asthma, and seizures (when younger). Concomitant medications were not reported. The patient previously took tramadol and hydrocodone and experienced allergies to both drugs. The patient experienced full body rash on 13Jan2021 10:15 (also reported as about 30 mins after vaccination). On 13Jan2021 10:15 (also reported as about an hour after receiving vaccination), the patient had trouble clearing throat and felt like there was something stuck in throat. The patient has been taking Benadryl and Motrin for these adverse events. The patient had no other vaccine in four weeks, had no other medications in two weeks, had no Covid prior vaccination and, had not been Covid-tested post vaccination. The outcome of the events was recovering.

245 pm Rash on lower arm 600 chills 700 leg cramps significant to make muscle fasciculations 900 bowel dysfunction Following day, flu like symptoms, chills, aches, etc Rash still has not gone away I have had abdominal cramping and significant pain. It has worsened to resemble the pain I had prior to my hysterectomy and endometriosis ablation/scar tissue removal.

"Pfizer-BioTech COVID-19 Vaccine EUA" Received 1st dose of vaccine in left arm at 10:28 a.m. Drove home and at 4:00 p.m. face, forehead, and neck turned bright red, facial tightness, feeling like face was on fire. Heart rate recorded between 112bpm and 115 bpm and began having shortness of breath. Then began feeling nauseous, eyes were itchy and had a headache. Took 10 ml Benedryl @ 4:40 p.m. and drank some water. 7:00 p.m. still have slight facial and neck redness and headache.

weird taste (bitter) in her mouth; Lymphadenopathy; significant myalgias; injection site soreness; This is a spontaneous report from a contactable physician (patient). A 41-year-old female patient received the second dose of BNT162B2 via an unspecified route of administration on 11Jan2021 at a single dose as Covid vaccine. Medical history and concomitant medications were not reported. The patient previously had her first dose of BNT162B2 on an unspecified date as Covid vaccine. The patient experienced significant myalgias and injection site soreness, both on 11Jan2021; weird taste (bitter) in her mouth and lymphadenopathy, both on 13Jan2021. The patient received her second Covid vaccine on Monday and was having a weird taste in her mouth (weird taste as bitterness). She has significant myalgia that resolved and injection site pain (injection site pain as soreness) that was resolving. She looked it up and could not find anything. She wanted to know if this was something that they were getting a lot of. The outcome of the event significant myalgias was recovered with sequelae on 13Jan2021 while of the rest of events was recovering. Information on the lot/batch number has been requested.

Elevated blood pressure, fever, malaise, headache, dizziness, loss of appetite, abdominal pain. all of these symptoms came on gradually and worsened 20 hrs after vaccination. symptoms lasted a full 48hrs for me and slowly dissipated over the following days. Itching at injection site started 72hrs after and has now ceased

8 hours post injection: fever (101 tmax), chills, headache, injection site soreness. Fever, chills, headache resolved 36 hours post injection. Approx 90 hours post injection wheal lesions on R arm appear (not on injection site) ,red/warm to touch, swelling to injection site, decreased ROM to RUE.

Fever and chills, fatigue, body aches, headache, weakness, vomiting, pain at injection site and back pain, joint pain, that started approximately 10 hours post injection and lasted for approximately 36 hours.

Itching on arms and chest began Jan 30 approximately 4pm. Got progressively worse throughout the night. Hives covered 95% of body, including eyes which began to swell shut. Took 50mg Benadryl with little relief. Went to Urgent Care and was given: 01/31/2021 0836 famotidine (PEPCID) injection 40 mg 40 mg Intravenous 01/31/2021 0836 diphenhydrAMINE (BENADRYL) injection 25 mg 25 mg Intravenous 01/31/2021 0836 methylPREDNISolone sodium succinate (Solu-MEDROL) injection 125 mg 125 mg Intravenous 01/31/2021 0840 EPINEPHrine (EPIPEN) injection 0.3 mg 0.3 mg Intramuscular Raised lesions started to flatten 1.5 hours after medications were administered Dx to home with prescription for Epi Pen, prednisone PO 60mg 1dose/day and instructed to continue taking 50 mg Benadryl q4-6 hours and Pepcid OTC 1 dose per day. Instructed to follow up with PCP in 1 week.

At the 8 to 10 minute mark: Could not stop coughing Lips burning and itching At about 20 minute mark: Still coughing Swollen mouth Lips burning and itchy - took Flovent inhaler and drank water About 45 minutes Same and worse , nurse gave me 25 mg of Benadryl After about 20 minutes coughing reduces, Swelling reduces but still itchy in moisture Still swollen at about 30 minutes of the Benadryl and the nurse gave me another dose of Benadryl. Symptoms started to get somewhat better I was very tired from the Benadryl Next day my mouth was still swollen Next day chest was very very tight and took inhaler constantly Third day after vaccine had an asthma attack, hadn?t had an asthma attack since I was in middle school. Dr prescribed prednisone and to take Zyrtec along with my inhaler I cannot return to exercise until 10 days after the start of prednisone

have limited use in my L hand; numbness down the L side of my body into my L foot; experiencing a major flare-up of my condition; low-grade fever (between 99-100); severe muscle & joint pain; severe muscle & joint pain; existing nerve impingement affecting the left (L) side of my body & both sides of my face; decreased concentration & executive functioning; GI upset; anticipated some inflammation response to the vaccine; feel sick; This is a spontaneous report from a contactable other-HCP (patient). A 41-year-old non-pregnant female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 30Dec2020 at 18:00 at single dose in right arm for covid-19 immunization. Medical history included Ehlers-Danlos syndrome hypermobility type, IgA deficiency, cervical radiculopathy, spondylosis of cervical region, chronic hypertension, fibromyalgia, androgenic alopecia, seasonal allergies, and known allergies: gold, nickel. The patient's concomitant medications were not reported. The patient previously took prednisone and experienced allergies. The patient reported that she anticipated some inflammation response to the vaccine from 04Jan2021. Briefly, she started to feel sick around 04Jan2021, by 10Jan2021 was experiencing a major flare-up of her condition requiring additional medication and time off from work. She had had a low-grade fever (between 99-100) from 04Jan2021 for 7 days, severe muscle and joint pain from 04Jan2021. She had existing nerve impingement affecting the left (L) side of her body and both sides of her face from 04Jan2021. Beginning 12Jan2021 she had limited use in her L hand, numbness down the L side of her body into her L foot. This was most likely due to significantly increased levels of inflammation as a result of the vaccine. She had also had GI upset, decreased concentration & executive functioning from 04Jan2021. It was unknown if the patient received treatment for the events. The outcome of the events was not resolved. The events resulted in doctor or other healthcare professional office/clinic visit.

Visible rash on left arm forearm, appeared approx. 1 week after second injection. Not relieved with OTC Zyrtec or Benadryl cream

Two hours post injection, developed numbness, tingling, extreme cold in hands and feet with fatigue. Slept for 3 hours, awoke feeling better. 14 hours post injection developed severe body aches, chills, fever, numbness in hands and feet, severe abdominal pain and cramping, and a rash on arms and abdomen.

red and hot area approximately 2 1/2 X 1 1/2 inches distal to injection site; red and hot area approximately 2 1/2 X 1 1/2 inches distal to injection site; Severe pain from neck to hand, shoulder blade to chest (right side); Severe pain from neck to hand; severe pain from neck to hand, shoulder blade to chest (right side); unable to lift arm above shoulder; second dose received on 12Jan2021; first dose received on 18Dec2020; Chills; fatigue; hive; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), intramuscular (right arm) on 12Jan2021 (14:00) at single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 (lot number: unknown) intramuscular (right arm) on 18Dec2020 for Covid-19 immunization. Medical history included "known allergies". The patient's concomitant medications were unspecified (received in 2 weeks). The patient was not diagnosed with COVID-19 prior to vaccination. The patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Jan2021 (pending clarification), the patient experienced chills, fatigue, and hive. On 13Jan2021 (07:00), the patient experienced severe pain from neck to hand, shoulder blade to chest (right side) and unable to lift arm above shoulder, and hive. On 14Jan2021 (pending clarification), the patient experienced red and hot area approximately 2 1/2 X 1 1/2 inches distal to injection site. There was no treatment received for the adverse event. The outcome of events was not recovered. The patient has not been tested for COVID-19 since the vaccination. Information on the Batch/Lot number has been requested.

high platelets; fatigue; sharp muscle pains in hands and elbows; Headaches; nausea; Canker sore on my tongue; had a sizable bruise; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at left arm on 09Jan2021 11:45 AM at single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. Patient is not pregnant. Patient previously took the first dose of BNT162B2 at single dose for COVID-19 immunization. Patient have had a lot of fatigue, sharp muscle pains in hands and elbows at day 9 post injection (17Jan2021). Patient was now developing a Canker sore on her tongue as a fellow coworker had the same reaction (Jan2021). Patient have high platelets and have had a sizable bruise for 9 days. Headaches and nausea were present at three hours post injection (09Jan2021). AE resulted in doctor or other healthcare professional office/clinic visit. No COVID prior vaccination. No COVID tested post vaccination. covid test type post vaccination included Nasal Swab on 12Jan2021 with test result of Negative. No treatment received for the events. Outcome of the events was unknown. Information on the Lot/batch number has been requested.

Patient reported to vaccine clinic to receive second dose of Pfizer Covid vaccine. First dose received on 1/12/2021 without any problems or reaction. Patient reported history of anaphylaxis to shellfish so she was asked to wait 30 minutes post vaccination for observation. Around 15-20 minutes after receiving vaccination, it was noted patient was rubbing her throat. RN at vaccine clinic asked patient if she was ok and she reported she was fine, she thinks it is in her head. RN noted she continued to rub her throat and asked her to describe what it felt like. Patient felt sensation of tickle in her throat and asked for water. Patient also noticed began to itch all over. Patient provided water and 25 mg PO Benadryl. Patient noted it felt like her throat was starting to close and her tongue felt it might be swelling. Epinephrine 0.3 mg IM was administered at 12:07 and patient arrived in ER at 12:08. Patient received another dose of IV benadryl and famotidine and kept for observation. She was discharged home after a couple of hours.

Pt. developed faint itchy rash of upper chest and upper arms, no respiratory symptoms, no C/O throat closing, etc.

Pt. C/O Throat tightening soon after receiving the vaccine, denied difficulty breathing, no impairment of her airway, complaint improved with swallowing water. She also developed an itchy rash (very faint) on left arm. which resolved over about 10 minutes.

Injection site pain; headache; muscle pain; chills; fever; This is a spontaneous report from a contactable Other HCP reporting for self. A 41-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1283), via an unspecified route of administration on 18Jan2021 09:30 at single dose for COVID-19 immunization. Patient received first dose of bnt162b2 on 31Dec2020. Medical history included Fatty liver and vertigo. The patient's concomitant medications were not reported. Patient had allergies medications. The patient experienced Injection site pain, headaches, muscle pain, chills, fever on 18Jan2021 16:00. Outcome of events was recovering.

Approx 7 days post vaccine, I developed a small jelly bean sized lump near my left clavicle. Im not sure when it appeared, but I noticed it on 1/20/22 in the evening due to pain in that location and on the front on my shoulder near injection site. My seatbelt was rubbing on it.

1st adverse event - Pain at injection site that started approx. 8hrs after first vaccine injection 2nd adverse event (main concern) - Pain at the left fibular head. This pain was noticed as soon as I woke up on Sat. 1/9/21 @ 7:30am. The pain was intense & constant. It felt as if the fibular head was bruised, but there was no bruising & no possible injury to that site. The pain subsided by the time I woke up on Thursday, 1/14/21. No pain in this area since 1/14/21.

Around 7:00pm, approx. 7hrs after receiving my second vaccine my left arm (the arm I received my injection in) was extremely sore. As the evening progressed so did my discomfort & pain. By the time I went to bed I wasn't able to raise my left arm above my waist. When I woke up @ 5am my joints were achy & I had a headache. Both of my feet were freezing. Throughout the day on Tuesday, 2/2/21 my arm around the injection site continued to hurt & was fevered. I kept a headache all day. Today, Wed. 2/3/21 my left arm remains extremely painful in my upper arm. My left arm is swollen, red & fevered. There is a large 4.5in x 4.5in red, swollen, fevered area around the injection site. This is extremely painful & uncomfortable. I am worried the injection may have been administered subcutaneously instead of intramuscularly & may not be as effective as it should be. I spoke with the coordinator of ocupation health (who performs the vaccinations at my workplace). She advised me to submit this form.

Sore arm x 48 hour, I applied ice and it resolved. Starting at about 30 hours after the shot I started feeling itchy in my upper arms, shoulders and scalp. I started getting small rashes on my upper arms, and large hard welts all over my scalp. I took 50 mg of Benadryl orally and the symptoms resolved by 6 am the following day.

fever (highest 100.8), severe muscle pain, joint pain, jaundice (I have Gilbert's sydrome), axillary and cervical lymphadenopathy on L side, headache, restless leg, nightmares

Soreness in arm at injection, 24 hrs; Day after debilitating lower back pain; Day after debilitating lower back pain which moved down towards buttocks & legs by 3rd day.; Day after debilitating lower back pain which moved down towards buttocks & legs by 3rd day.; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL3302), via an unspecified route of administration on 18Jan2021 09:30 AM at single dose on the right arm for COVID-19 immunization. Patient is not pregnant. Medical history included psoriasis, hypothyroidism and insomnia. Patient has no known allergies. No COVID prior vaccination. Concomitant medications (Other medications in two weeks) included levothyroxine, trazodone (reported as "Trazadone"), phentermine and ergocalciferol (VIT D). No other vaccines in four weeks. Facility type vaccine was Workplace clinic. The patient experienced "soreness in arm at injection, 24 hrs. Day after debilitating lower back pain which moved down towards buttocks & legs by 3rd day. Pain in walking, sitting & movement", all on 19Jan2021 11:00 AM which resulted in Doctor or other healthcare professional office/clinic visit. Treatment was received for the events, also reported a s "Call into pcp but was not helpful". Outcome of the events was not recovered. Patient was not tested for COVID since the vaccination.

typical site reaction at the time of injection/The spot was raised and turned bright red; typical site reaction at the time of injection/The spot was raised and turned bright red; typical site reaction at the time of injection/my arm was sore; I felt lethargic; hot to the touch; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EK9231) intramuscular on 08Jan2021 10:30 AM at single dose on the left arm for COVID-19 immunization. Patient is not pregnant. Medical history included unknown allergies(reported as "Known allergies: yes"). There were no other medical history. No COVID prior vaccination. Concomitant medications (Other medications in two weeks) included ibuprofen (ADVIL [IBUPROFEN]), fexofenadine hydrochloride (ALLEGRA 24 HOUR), diphenhydramine hydrochloride (BENADRYL) and montelukast sodium (SINGULAIR). No other vaccine in four weeks. Facility type vaccine is Hospital. The patient had a typical site reaction at the time of injection on 16Jan2021 09:00 AM. The spot was raised and turned bright red, and her arm was sore. The patient felt lethargic. After a few days those symptoms went away. The spot on her arm disappeared. Eight days later, the spot on her arm reappeared. It was bigger, bright red, and hot to the touch. Patient's arm felt sore again and she had lethargy again. A doctor confirmed it was not cellulitis. No treatment was given for the events. The events resulted in Doctor or other healthcare professional office/clinic visit. Patient was not tested for COVID-19 since the vaccination. Outcome of the events was recovering (as reported).

Temporary nausea, significant fatigue, Muscle pain, Joint pain Redness, pain and swelling still remains at site of injection Pain on top of head, but not necessarily a fullbown headache

experienced a bad headache; had arm pain in the vaccinated arm (left), only when lifting my arm; This is a spontaneous report received from a contactable consumer (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247, expiry date: unknown), via an unspecified route of administration in the left arm, on 19Jan2021 13:00, at single dose, for COVID-19 immunization, at workplace clinic. There were no medical history and no allergies to medication, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since vaccination. The patient was not pregnant at the time of vaccination. Concomitant medication included vitamin c, colecalciferol (VITAMIN D), vitamin b and ibuprofen (ADVIL). The patient did not receive other vaccines within 4 weeks prior to BNT162B2 vaccine. On 20Jan2021 at 08:00, the patient had a bad headache and had arm pain in the vaccinated arm (left), only when lifting her arm. The headache went away during the evening without treatment. The patient did not take any pain relief medication. No treatment was given for the events. The patient recovered from headache on the evening of 20Jan2021 and recovered from "had arm pain in the vaccinated arm (left), only when lifting my arm" on an unspecified date. The events were assessed as non-serious. No follow-up attempts are possible. No further information is expected.

RASH NOTED IN BILAERAL AXILLARY REGIONS. NOTICED THIS MORNING. CONCERNED BECAUSE JUST RECEIVED 1ST COVID INJECTION 5 DAYS AGO. RASH DOES ITCH AT TIMES. DENIES ANY OTHER AREAS OF BODY INVOLVEMENT. RASH COMES AND GOES. DENIES NIEW SOPAS OR ALLERGENS. NO SHORTNESS OF BREATH, SENSATION OF TONGUE OR THROAT SWELLING.

Generalized itch while being observed after vaccination. No hives or rashes seen. Resolved with dose of benadryl.

0945 pulled into medical site @ clinic . States she received vaccine @ 9:25 an waited 15 minutes after receiving the vaccine & was cleared to leave. After she left the site she started feeling hot, c/o itchy rash on left side of neck, and feeling hot and shaky. EMS on site to evaluate patient. 9:47 gave Benadryl 25 mgm PO 10:10 symptoms resolved. Doctor notified. Patient instructed to take Benadryl 25 mgm when she gets home and to notify her PCP regarding additional f/u. Patient left site @ 1020.

Two days after injection, I had a large (baseball size) knot form at the injection site. The knot was hot to the touch and very sore. Lasted about 3 days.