Pfizer

Some swelling of arm; Rash developed 5cm x 4cm at injection site; Chills and shivers; Bronchospasm cough; Bronchospasm cough; Mild eczema flare ups, itchiness and sores; Mild eczema flare ups, itchiness and sores; Mild eczema flare ups, itchiness and sores; Spasm; she has a lot of allergies; This is a spontaneous report from a contactable nurse. This 60-year-old female nurse (patient) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Dec2020 to 23Dec2020 at 0.3 mL single on left deltoid to prevent getting the COVID vaccine, for protection. Medical history included ongoing asthma diagnosed in her mid twenties, in the 80s, she had asthma when she was a child, then it stopped and resurfaced in her mid twenties, ongoing eczema diagnosed years already, a long time ago and unspecified allergies with medications. There were no concomitant medications. She received the vaccine on 23Dec2020. She has a lot of allergies in Dec2020, and had some side effects, and she got through it ok. Her side effects were some swelling of arm, a rash developed, like 5cm x 4cm at site of injection, chills and shivers, and a bronchospasm cough on 24Dec2020. Arm swelling event started 24 hours later, no more, it was stable for 24 hours, and the 3rd day, went down, was a little raised, the next day was flat but still red. She had recovered completely. The 4th day was a good day. The patient stated she had some allergy shots she had to go through before, this was no different. Rash was no more, it was gone by 27Dec2020. She was still able to go to work. Chills and shivers started 24 hours later, and took for 48 hours intermittently, she had since recovered completely. The patient stated this was all nothing different than getting like the flu shot. Bronchospasm cough event only took another 48 hours, the difference was, even when she calls it bronchospasm, it was close to when she had an asthma attack, but no chest tightness, shortness of breath, she just would cough, spasm in Dec2020 and stop. She had recovered completely. The patient stated she had no symptoms at all before the vaccine, she was healthy, she made sure nothing was going on, that she was not tired, had no cold, she took no medications for this, as she wanted to know how her body reacted and if it can handle it. They says it was ok to take paracetamol (TYLENOL), but she did not, but the second dose she would, now that she knows and she was comfortable through it. She did have some mild eczema flare ups, itchiness and sores that came up in Dec2020, but nothing to run to the hospital to the doctor for. Clarifies this occured after she received the vaccine. The outcome of the event allergies, mild eczema flare ups, itchiness and sores were unknown. The outcome of rash at site of injection was recovered on 27Dec2020. The outcome of other events was recovered in Dec2020. The causality between Pfizer COVID vaccine with some swelling of arm, rash developed 5cm x 4cm at injection site, chills and shivers, bronchospasm cough was related (Source of assessment: Primary Source Reporter, Method of assessment: Global Introspection). Information on the lot/batch number has been requested.

Felt mildly fluish by end of working shift (1130 pm), arm became more sore, unable to lay on it in bed. Woke up in middle of night with body aches , chills and headache. By 10 am felt increase in flu like symptoms, mild nausea, swollen glands, mouth cold sore and red hot face. Temp was 101.2. All joints hurt, general malaise.

hand was swollen and itchy on the same arm where the injection was; back of hand was swollen and itchy on the same arm where the injection was; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), via an unspecified route of administration (Deltoid Right) from 26Dec2020 15:00 at single dose for Covid-19 immunization. The patient's medical history included chronic pain and insomnia. Concomitant medications included hydrocodone and temazepam. The patient reported, "On 26Dec2020 I got my first immunization for COVID and today (30Dec2020) I woke up and the back of my hand was swollen and itchy on the same arm where the injection was". The patient further stated "It never have happened before I don't have any reaction at the injection site but it was kind of odd that it kind of showed up on the back of my hand, it feels like an allergy kind of thing." The patient tried the Voltaren Gel to try and get the inflammation down, but it didn't help, and she took some Benadryl it doesn't seem to help much. The patient's next shot is due on "12Jan2021". The outcome of events was unknown.

Patient reported soreness/painful up into clavicle area of right side where injection occurred. Patient also reports swollen and painful lymph nodes on right side where injection occurred.

Looked like an encephalopathy; Face was all swollen; Head swelled; Glands swelled; Fatigue; Headache/ So much pain in my head; Couldn't talk; Complete brain fog; nausea; This is a spontaneous report from a contactable nurse. This 60-year-old female nurse (Patient) reported that received bnt162b2 (BNT162B2, Pfizer COVID-19 vaccine), via an unspecified route of administration on 30Dec2020 at single dose for covid-19 immunisation. Medical history included Atrial fibrillation, Chronic Lyme, Lupus and Autoimmune. Concomitant medications included Metoprolol at 12.5 mg for Atrial fibrillation and acetylsalicylic acid (BABY ASPIRIN). No diabetes, no hypertension. None of the usual common diseases. Registered Nurse stated, "I received vaccine this past Wednesday. I was just talking to a couple of my colleagues and honestly I received the vac. at work. I did not really read through the paperwork and was 'weird' sharing reactions to the vaccine which for me was pretty bad reaction and thought like I need to go through your paperwork and report it. So I thought I should call and just give some information. The usual fatigue which I go to after being normal, my arm was not sore. However, as the week progressed into Friday I had a constant headache but it was manageable and then by Friday night my glands swelled, my nerves behind my ears, my neck and I was extremely fatigued, bad headache and went to bed and I had not gone out and finally I got out today I spoke with my Physician yesterday. What happened it looked like an encephalopathy but my head swelled, my face was all swollen, complete brain fog, fatigue and I couldn't talk. I was in so much pain in my head resulting in (incomplete sentence)." Lab work included the only thing is the PCR swabbing. No blood test. Registered Nurse further stated, "I don't know if that is important. But I will tell you and if it is you can send me the questions. I do have a history of Autoimmune. So my Physician thought that this was just like an enhancement of like my bodies reaction I have Chronic Lyme and I have lupus like my ANA has always been stressful. But we think that it is a family thing. No treatment for the Lyme. I did a lot of antibiotic and a lot of naturopathic stuff but that is in the past. But anyhow for anything else what I did was when I got the injection they said try and just take Tylenol not Ibuprofen but there was no way I was going to make it through with just that . So I took Ibuprofen. I called my Physician yesterday morning because I was not sure about what was is happening and I thought it might be secondary sinus infection or something else going on and it reassured me that it is definitely due to the vaccine. He said it is just your body's reaction, take the Ibuprofen, hydrate. Had me take what I had in my house Tigan for nausea. So I was extremely nauseous from the severity of the headache." Registered Nurse stated, "I just wanted to let you know what happened and the intensity of what it was because normally I would expect a headache. But this was a 'go dated'. Registered Nurse stated, "I guess the only question that I have is so do my work has this question and I was going to call my doctor tomorrow may be might know it better. I know that I have to take the second dose. But I understand the second round can be worse than the first. Is there anything that they are recommending that I can do may be prior to ease the reaction?" The outcome of the events was unknown. Information on the Lot/Batch number has been requested.; Sender's Comments: The reported clinical manifestations including swelling face and head swelled, which was suspected as encephalopathy by the reporting nurse, was probably related to the bnt162b2 (BNT162B2, Pfizer COVID-19 vaccine), due to temporal relationship. The subject's underlying Chronic Lyme, Lupus and Autoimmune were likely the risk factors to 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.

Woke up morning after 2nd dose of COVID-19 vaccine with noticeable left armpit swelling (noticed while applying my deodorant for the day). Swelling was the size of large lemon. Smaller amount of swelling noticed in right armpit, also. Vaccinations had both been done in my LEFT arm and greater swelling was in left armpit. Had fever, chills and headache this same day requiring me to take round the clock doses of Tylenol. By the following day, fever and chills were gone but swelling of armpit still present. Swelling is slowly diminishing but still present by day 3, as I send this notification.

1/1/2021: soreness at site 01/08/2021: headache,malaise 01/09/2021: redness & inflammation, hot to touch, swelling 3" x 3", small raised blisters. 01/11/2021: symptoms are subsiding; pink, warm to touch, swelling 2" x 2", blisters fading

The day after my arm was very soar for at least 48 hours, no fever just laying around. I had low energy for about three weeks and I'm just now feeling better. Around the 26th my lymph nodes swelled up (three of them) . I called my PCP, he told me to take Tylenol is painful and to put warm compress if they were uncomfortable. They are still there, they don't hurt or painful.

At 4hrs post vaccination experienced extreme muscular pain between shoulder blades. The following week, as far as I can recall, I began to have tingling from the right shoulder blade down to my hand. I thought I may have a pinched nerve and went to the walk in clinic to be seen by the nurse practitioner that is in the same office as my primary. She examined me and thought it sounded like a pinched nerve and said I was swollen in the area of complaint. Cervical and thoracic x rays were taken (normal) and was told to take Flexeril and steroids. Pain was getting worse and primary told me to begin taking Meloxicam and have physical therapy. I have been doing both beginning 1-11-2021. Pain continues with no improvement. Do not know if my symptoms are caused from the Covid shot, but just seemed to me that it was quite a coincidence that muscle pain began on the same day as receiving the shot.

Right after shot body felt on fire, within 5 minutes tongue start swelling, face, neck and injection site red, BP went to 170/120, very fatigued and throat closing.

Received dose 1 of Pfizer Covid vaccine on 12/22/20, reported she noticed small bump on the side of her neck the next day or so. No systemic symptoms. Did not seek treatment/evaluation. Received second dose (lot EK9231) on 1/13/21 and reports that the bump is tender and has gotten bigger.

Swelling to left axillary lymph node; This is a spontaneous report from a contactable nurse (patient) reported for herself that a 60-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1685) via an unspecified route of administration at left arm, on 17Dec2020 16:30 at single dose for COVID-19 immunization. Medical history included cherries and peach allergies. Patient was not pregnant at the time of this report. Concomitant medications were not reported. The nurse received the vaccine at Hospital. She reported swelling to left axillary lymph node since 17Dec2020, no treatment received, event was not recovered at the time of this report (09Jan2021). Nurse denied having COVID prior vaccination. She had tested COVID through nasal swab post vaccination which revealed negative on an unspecified date. She did not receive other vaccine in four weeks, she had the second dose of BNT162B2 (Lot number EK9231) via intramuscular at left arm on 06Jan2021 01:45 PM at single dose for COVID-19 immunization. Outcome of the event was not recovered.

Day 1-3: had headache, generalized itching and swelling of the right side of the face and eyelid. Took Tylenol Day 6: diagnosed with Bells Palsy by PCP 1/8: went to doctors for evaluation by PCP of symptoms currently patient still experiencing swelling of the right side of face and slight itching

right deltoid pain, fatigue, headache, neck pain, low back pain, right axillary lymph node swollen/discomfort

Very swollen and erythematous arm; Very swollen and erythematous arm; chills; severe neck pain; myalgias; This is a spontaneous report from a contactable nurse reported for herself. A 60-year-old female patient (not pregnant) received first dose of bnt162b2 (Lot number: Ek5730), via an unspecified route of administration in left arm on 22Dec2020 11:30 at single dose for COVID-19 immunization. Medical history included covid-19 from an unknown date and unknown if ongoing (COVID prior vaccination: Yes). There were no concomitant medications. The patient experienced very swollen and erythematous arm, chills, severe neck pain, myalgias, all on 22Dec2020 14:00. The adverse event was not resulted in a visit to doctor or other healthcare professional office/clinic or Emergency room/department or urgent care. No treatment given. The outcome of events was resolved. Facility type vaccine: Hospital. No other vaccine in four weeks. No other medications in two weeks. No COVID tested post vaccination. Not known allergies or other medical history.

arm pain; light headedness; abdominal pain; swollen, tender lymph node left axillary area; swollen, tender lymph node left axillary area; This is a spontaneous report from a contactable nurse (patient). A 60-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE; lot number: EK4176; expiration date: unknown), via an unspecified route of administration left arm on 08Jan2021 08:30 at a single dose for covid-19 immunization. The patient medical history was not reported. The patient has no known allergies. There were no concomitant medications. The patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE; lot number: EK5730; expiration date: unknown), via an unspecified route of administration left arm on 18Dec2020 10:30 at a single dose for covid-19 immunization. The patient experienced arm pain, light headedness, abdominal pain and swollen, tender lymph node left axillary area on 08Jan2021 04:00 PM. The patient received treatment for the adverse events includes acetaminophen (TYLENOL) and ibuprofen (MOTRIN). The outcome of the events was recovered on in Jan2021.

Had normal site pain, fatigue and began running fever of about 100.0 the evening of injection however the fever has continued x7 days, getting as high as 101.9. I began noticing soreness in the lymph nodes in my neck and underarms on the evening of 1/25 and that lasted until midmorning of 1/27.

FLU LIKE SYMPTOMS STARTED 3AM 1/29/2021 WITH GENERALIZED BODYACHE, LEFT AXILLARY PAIN, TENDER LEFT CERVICAL NODES, HOT AND COLD FLASHES AND HEADACHE. NASAL CONGESTION.

Moderate Swelling and pain under right axilla Redness swelling at site Nausea Aches Abdominal pain Headache

6 hours after vaccination: vaccination sight soreness and swelling - still have this symptom 3 days later 12 hrs after vaccination: Nausea, vomiting, headache, body aches, fever (100.7 at peak), chills. Lasted approximately 36 hours. 48 hours after vaccination: vaccinated arm has tingling sensation and weakness when raised, armpit lymph nodes tendor/sore - still have this symptom 3 days later. Took Aleve to alleviate symptoms. It lessened them somewhat but I was still not able to function fully for several days.

Radiating pain the first night in the arm and in the muscle behind her breast. Continual head ache with fatigue and sore throat swollen glands since the vaccine in the evenings.

Swelling of face & throat; rapid heart beat Hospital I received, a steroid shot & Hydroxyzine pill and Rex?s + contact regular doc 3 Rx-1) 40 mg Prednisone for 4 days 2) Hydroxyzine 25mg as needed 3) Epi pen RETURNED TO ER 2/5/21 same symptoms after taking prednisone; told to take Hydroxyzine even though I have no rash & rare itchiness. ON GOING SYMPTOMS; UNRESOLVED

Swollen glands; severe headache; muscle pain; extremely tired; body hurts; This is a spontaneous report from a contactable consumer (patient). This 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number El3248/expiration date: unknown), via unknown route of administration, on 09Jan2021 12:30 PM (at the age of 60 years old) as a single dose on left arm for COVID-19 immunisation for COVID-19 immunisation at a Public Health Clinic/Veterans Administration facility. Relevant medical history included breast cancer last year. The patient had no allergies to medications, food or other products. Relevant concomitant medications were not provided. 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. It was reported that the patient experienced swollen glands, severe headache, muscle pain, extremely tired, body hurts on 14Jan2021. The outcome of the events swollen glands, severe headache, muscle pain, extremely tired, body hurts was not recovered. No treatment was received for the events. Since the vaccination, the patient has not been tested for COVID-19.

high fever/100.1 degrees Fahrenheit/100.8 degrees Fahrenheit/99.8 degrees Fahrenheit; arm swelling; arm was very sore; headache; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249) via an unspecified route of administration in left arm on 20Jan2021 15:15 at single dose for COVID-19 vaccination. Medical history included ongoing coeliac disease diagnosed four years ago in 2017, allergic to dairy and corn, COVID in Nov2020. There were no concomitant medications, no other recent vaccinations and had started no new medications. The patient had a reaction with a high fever, a headache, and her arm was very sore after vaccination, that were similar to how she felt when she had COVID in Nov2020. The patient's arm was swollen and sore that evening on 20Jan2021. Her first fever was yesterday morning on 21Jan2021, probably at about 10:00AM or 11:00AM, and at that time it was 100.1 degrees Fahrenheit then later in the afternoon at 02:00PM it was 100.8 degrees Fahrenheit. She took Tylenol, applied cold moist cloth, drank lots of liquid for treatment, and she did sleep. Tylenol was clarified to be generic pain reliever, Acetaminophen 500mg. Acetaminophen 500mg, EXP Apr2021, LOT P114992, UPC: 1191717759. Her temperature improved after taking this medication, and it was 99.8 degrees Fahrenheit before bed. She hadn't taken any Acetaminophen this morning on 22Jan2021, but she took two tablets the first time yesterday on 21Jan2021 and then one tablet right before bed. She didn't go to the doctor for this. The outcome of events was unknown.

her face got swollen; lymph node right there it was extremely swollen and very tender and very painful; She had a lump at the site of the injection; chills; headache; flu like symptoms; This is a spontaneous report from a contactable consumer. A 60-years-old female patient received the second dose of bnt162b2 (BNT162B2; Lot # EL8982) vaccine , via an unspecified route of administration on 20Jan2021 at single dose for covid-19 immunisation . Medical history included hypertension. Concomitant medication included telmisartan (MICARDIS). On 30Dec2021 the patient received the first dose of BNT162B2 vaccine. The patient experienced her face got swollen on an unspecified date with outcome of unknown , lymph node right there it was extremely swollen and very tender and very painful on an unspecified date with outcome of unknown , she had a lump at the site of the injection on an unspecified date with outcome of unknown , chills on an unspecified date with outcome of unknown , headache on an unspecified date with outcome of unknown , flu like symptoms on an unspecified date with outcome of unknown. The events swollen face and lymph adenopathy were considered important medical Events. The remaining events were considered non serious. The patient stated she got the second vaccine shot of Pfizer on Wednesday the 20Jan2021. She got like a weird side effect like under her armpit it got really swollen and painful, like the lymph node right there it was extremely swollen and very tender and very painful. It still is but not as much. The next day the right side of her face was swollen The patient received Tylenol as treatment for the events. Follow up information has been requested.

Axillary lymph node-grape size, on side of injection site painful, movable and tender 5 days after the vaccine injection. No longer tender but still same size

lymphadenopathy along the left collar bone; This is a spontaneous report from a contactable other hcp (patient). This 60-Year-old female no pregnant patient received,at hospital, the second dose of BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) from lot# EL3246 on left arm on 14Jan2021 07:30 at SINGLE DOSE for covid-19 immunisation . The patient medical history was not reported. The patient's concomitant medications were not reported. No other vaccine in four weeks.The patient previously took ibuprofen and experienced drug hypersensitivity.First dose details : lot number=EK9231,administration date= 24Dec2020,administration time= 07:30 AM,vaccine location= Left arm,dose number= 1.The patient experienced lymphadenopathy along the left collar bone on 16Jan2021 06:00 .No treatment received.Event outcome was not recovered. No covid prior vaccination,No covid tested post vaccination.

Could not raise my arm the next morning with out extreme pain from the site to the arm pit to the neck. Then my arm pit was swollen, hot and the swelling went down my arm. I also had diarrhea, Nausea, slight head ache, chills, body ache with a temp of 101.5. Went to the doctor yesterday because of my armpit swelling, hot to touch and it had a red band. She said where they gave it was not in a muscle. It was given sub Q & that it went into my lymph gland and leaked down my arm to swell. Right now I just have on and off nausea , pain in my lymph glands in my arm pit. The swelling and pain has gone down and the other symptoms have faded away.

For about 24 hours soreness in left arm near injection site, more swelling and a lump under left arm and burning sensation under left arm and chest area where I typically have swelling and numbness due to lymphedema post mastectomy. Resolved within 24 hours with no treatment.

2MIN AFTER DOSE DIZZY, VERY CONFUSED, SLIGHT CHEST PRESSURE, 30 MIN LATER SLIGHT SWELLING OVER EYELIDS, 1 HR LATER STILL VERY CONFUSED IN A FOG. VERY CONGESTED , SNEEZING, ITCHY EYES, STUFFY EARS, VERY CONFUSED. STRANGE FEELING INSIDE MY BODY - TINGLING . FEELING OUT OF BODY .... NOT MY SELF ...ITCHING. VERY CONFUESED AND VERY DIZZY FOR ABOUT 4 HR... SEVERED HEADACHES. NAUSAUES. 6 HRS LATER SWOLLEN FACE RIGFHT SIDE.

facial swelling, facial stinging, flushing approximately 45 minutes after vaccination. Persisted ~12 hours

This is a spontaneous report from a contactable consumer. A 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL1283, subcutaneous on 20Jan2021 15:00 at SINGLE DOSE for COVID-19 immunization. Medical history included diabetes, anaemia, blood pressure, cholesterol. Patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EU9899, in the left arm on 30Dec2020 15:00 at SINGLE DOSE for COVID-19 immunization and experienced swelling and redness at the site. Concomitant medications included liraglutide (VICTOZA), labetalol (LABETALOL), diltiazem (DILTIAZEM), valsartan (DIOVAN), rosuvastatin, metformin, aspirin and iron. The patient thinks that it wasn't given to her intramuscularly. This is a potential inadvertent subcutaneous administration of the BNT162B2. This patient received her second dose on 20Jan2021 on the side of her arm and reported that it was swollen, red, and hot, but has gotten 100 times better' over the last 6 days since administration. She was asking for efficacy of the incorrectly administered dose. It was further stated that in the middle of the night, her arm was red almost like a little bullseye and she said that she was getting burning, and pins and needles down her arm, and a fullness in her hand like her hand was swollen. She said that she still kind of feels it. As the days progressed on day 2, 3, and 4, the swelling got more intense, the circular red swollen area got worse to the size of like a small baseball. She was feeling okay other than that. Today was day 6 and it was not as red and was more black and blue, swelling went down 80 percent, she still feels a little bit of the pins and needles and the fullness in her hand. She said that there was like a big knot that was very hot. It was a hard like knot at the injection site. The injection site was really big, round, hot, red, and had a knot that lasted; adds it is still there but 99% better; and she had tingling down her arm with pins and needles in her hand. She noticed it was little red a couple of hours, like 8 hours later; but by the next day it was circular, more red, swollen, itchy, and burning down her arm. By the third day, the site had a big, red, hard knot; still burning down her arm and with pins and needles down her arm. She added that her hand felt like a fullness in her hand filled with fluid. By Friday the swelling at the site was gigantic. The site swelling is improved but the redness was more of a black and blue now. Her arm has been very dark red, discolored, swollen, painful and has nerve pain described as "hot tingling down the arm like pins and needles" to her hand. She states that she has a very large knot at the injection site. This was in her non-dominant arm. She spoke with two of the pharmacists that she works with and they looked at her arm and both felt like she may have received the injection subcutaneously instead of intramuscularly. The outcome of events was not recovered. No follow-up attempts are possible. No further information is expected. Information on the batch/lot number has been obtained.

This is a spontaneous report from a contactable consumer. A 60-year-old female patient started to receive bnt162b2 (manufacturer unspecified), lot number: EL4238, via an unspecified route of administration in the left arm, on 21Jan2021 15:00 at SINGLE DOSE for COVID-19 immunization. Medical history included arthritis. Patient's known allergies are Penicillin, Peanut and Dairy. Patient was not pregnant at the time 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 hasn't been tested for COVID-19. There were no concomitant medications. The patient's whole/entire arm was killing her; she was hurting across her shoulder blades down to fingers. Her elbow and wrist were hot and she was feeling a tremble in hand which she has never had before. She later added that her joint in elbow and shoulder was now reaching down to her arm. She couldn't even wear her watch today to her work, it felt swollen, like there was liquid in it. She also can't lift her arm, move and the pain was like going into her back. The patient was taking Aleve and Advil and "it doesn't take away all but it takes away enough that she can function." She also bought a topical ointment to help numb the area and she was wearing a pain patch on my back. The outcome of events was reported as 'not recovered'. No follow-up attempts are possible. No further information is expected. Information on the batch/lot number has been obtained.

Eyelids and face swollen, itching on the jaw, tingling sensation and possible stomach upset and some shortness of breath.

Swollen and very sore lymph glands in left armpit/chest with pain/tenderness on the underside of arm where injection was given; ice was used to reduce swelling and was alternated with heating pad. soaked in warm bath with epsom salts. relief was finally achieved by taking 1 Aleve liquid gel capsule - 220 mg. Swelling and pain began within 24 hrs after injection and pain increased intensely by hour 36. Some tenderness to touch still in lymph glands in armpit/chest and to underside of arm. minimal tenderness at actual injection site - no more than normal for a injection.

Pfizer. My right hand was swollen up like a catchers- mit. Very painful in thumb joint at a level 10. Was swollen for 5 days, then fever chills, body aches (fever 0f 100.2) Right hand was so painful was intolerable, truly had to wait for it to pass, nothing helped except for soaking in Epsom salt bath, which was short live. Have had arthritis in this thumb but not for approximately 8 years. Entire hand was swollen and not useable.

Left upper abdominal pain after receiving COVID vaccine radiating to left jaw rapid response, had patient remove mask and reported facial drooping. Transferred to ED for acute, painless, unilateral facial paralysis with no forehead sparing most likely secondary to Bell?s Palsy. Patient was monitored and discharged with prescriptions for valacyclovir 1000mg tid and prednisone 50mg qday x 7 days

Vaccine given 2/9/21. On the afternoon of 2/12/21 I began to have joint pains in my right wrist. By 2/10/21 in the morning both elbows, knees and wrists were sore. Elbows and right knee felt warm to the touch. Nodules or red spots developed around the joints. I could barely walk or climb in and out of the car, the bed, and had a very difficult time standing up from the toilet or a low chair or couch. No fever, but did have a few chills with teeth chattering at least twice.

SORE ARM, VERY TIRED, SEVERE HEADACHE, SORE MUSCLES ALL OVER, CHILLS, KNEE AND HIP JOINT PAIN, NAUSEA, SWOLLEN LYMPH NODES UNDER BOTH ARMS, FEELING UNWELL

Received Pfizer COVID19 injection at 9:57 am on March 4 at the . As is usual for any shot or IV on me, I immediately tasted something weird in my mouth. It was not as metallic tasting as usual. More plasticy. Shot did not hurt. Was told to stay in 30 minutes waiting area.I did. The taste remained in my mouth. I left at 10:34 am feeling OK, except for weird taste. As I drove off the parking lot, I noticed that my mouth and tongue were tingling, with worst of it on my left side. My throat did not seem to be affected, so I continued driving. Some nasal congestion and coughing. The tingling turned into numbness in my mouth and tongue, all the way back to top of throat. I called my primary care doctor at 12:10 pm and left a message. I received a call back at 2:15 pm from nurse. She told me to take Benadryl and have someone take me to Urgent Care right away to get my vitals checked. I did not take Benadryl, as CDC said it could mask anaphylactic reaction. I called a friend and she took me . I noticed that my lymph nodes in my neck were swelling and painful. We arrived at 2:45 pm. My vitals were checked, heart and breathing listened to and was checked briefly for swelling in mouth and throat. There was no swelling. He said he had never heard of this tingling reaction and claimed it is just a side effect and not a serious reaction and that it would probably last a couple of days. He recommended that I watch for new symptoms and take Benadryl. That was $30. We left at 3:10. We left. I noticed that the numbness was spreading to my lips and up the left side of face and I was getting super tired. Also, my mid to lower back started hurting a lot. I took a Benadryl. 4:30 pm still have same numbness. My eyes got super dry and itchy. My head started to hurt. Some coughing. 5:10 pm dry eye and numbness, more swollen lymph nodes and chills. Pain in calves, upper back, same on both sides. 6:38 weirdly, from the bottom of my thumb to halfway up my arm there is pain. Both arms simultaneously. Worse on the left. 8:11 pm after bundling up and using a heating pad, plus extra heat, chills are lessened. Lymph nodes very sore in neck. Eyes are not quite as dry. Everything else is the same. 8:48 pm jaw really aches. Intestinal discomfort. Going to bed. 10:39 pm pain from jaw extended up into left ear. Upper part of throat hurts. March 5, 2021 4:00 am. Body aches have lessened. Left arm sore at shot area. 5:45 am eyes definitely dry, but not nearly as dry as yesterday. Numbness in mouth , tongue and face has lessened, but still uncomfortably present. Definitely worse on the left side. Little bit of tingling on the left, mostly on cheek from chin to ear. Headache gone. Lymph nodes sore and swollen . 7:00 am went on a walk. Noticed some achyness throughout body. Very tired. 10:51 am The tingling and numbness remain in my mouth, tongue and cheek up to my left eye. Very tired. Lymph nodes still swollen and sore.

Red, itchy, bumpy, swollen rash on right shoulder extending to right breast. Swelling of left hand, stiffness, hard to move fingers, same rash as above between fingers.

I received vaccine. Noted at the 30 minute post wait vaccine site feeling a very slight like it was hard to take a deep breath 15 minutes after receiving the vaccine. I took my pulse. It was 90. I did not tell the medical monitor people. My husband drove me home after the 30 minute watch period was up. At 1:15pm I gave myself an albuterol neb to. Post tx home pulse ox was 95% pulse 96. No n/v, no itching. Breathing felt improved . I did a home peak flow reading which was 240. My personal best baseline is 350. I auscultated my anterior chest. Diminished, clear, no wheezing. I sat calmly. My husband noticed the left side of my face was mildly swollen. Amazing! For him to notice! it was very slight around cheek bone to jawline. I sent him to get otc Benadryl. I took 25 mg po . At 2:20 pm Pam was 300 p02 sat 98% pulse 96. Lips felt tingling, no swelling. Speech clear. Swallowing intact Drank water, low sodium soup. 3:30 pm did another albuterol next. Sat 95% after neb . Pulse 89. 20 minutes post neb peak flow reading 320. Started feeling chills. Temp outside a nice seventy degree day. Wrapped self 6 blankets,winter hoody fleece, heating pad and finally fell asleep. Family watched me sleep. Woke up 7pm. Still felt cold. Had fluids, urinated, breathing ok. Went back to sleep. 11 pm woke up, peak flow 300, did neb, took Benadryl wore my cpap machine and went to bed till today.

4 hours after vaccine, had the following Reaction : -Big Chills -Nausea -Small amount of swelling on Face, Ankles, & Wrists -Very tired = fatigue / sleep

Swollen arm,unable to lift,unable to lay on,achy arm and wrist,tingly fingers from 7pm same day til 3:30 next day(Friday March 5)Slept all day,made appointment with Primary, took dosages of Ibuprofen

On the day of the shot, by Noon I could feel the vaccine moving into my throat and my face. My throat and left cheek started to swell and turn slightly red. I took more Benadryl and called my allergist in the afternoon. They told me I needed to get to the hospital for treatment. At the hospital, they gave me steriods, benadryl and Pepcid in an IV. After allowing this to work, they sent me home with a steriod prescription for 60Mg for the next 5 days. They asked me to follow up with my allergist if I had other issues , they also told me that I would not be able to get the 2nd dose of the vaccine. Over the next several days, I continued to have issues with this redness that had grown over my entire face. I looked like I was totally sunburned. I did not feel well, the redness was very hot, and I struggled with some breathing. I made an appointment on Monday morning with my allergist, and they adjusted my allergy medicine and gave me more asteroids for 5 more days. They advised me to use my nebulizer treatments as needed to remove the heaviness in my chest. This redness and swelling has moved around my body, almost as if I can see where the vaccine is at in my body. It went from my head to my chest/back and right arm. Down to my abdomen, and then down below my knees. In the morning, it is usually in my face and then it moves around during the day. I can feel this fluid moving around in my body because the redness brings swelling/fluid. This last saturday 3/6/2021 was horrible, it was in my right ear and right foot. It was very painful and made me very dizzy. I struggled to walk. Then on Sunday morning, I felt fine all day. Today Monday, it feels like it is in my right foot again, but I feel like It is getting better.

swelling, itchy spots: , itchy knot on hip, itchy spots: under breasts, ears, and palms-- swollen lips

FLARE OF A RASH ON MY LOWER LEGS, HIGHLY INFLAMED AND SWOLLEN, DR. PRESCRIBED TRIAMCINOLONE ON 02/12/21. IT IS BETTER BUT NOT GONE AT THIS TIME.

My Arm Pit and my Breast on my right side of my body became so painful as if I had a major injury or surgery. Tylenol and Aspirin could not control the intense pain. The pain was excruciating!! I also had aches, fever, chills and tender lymph nodes in my neck. The excruciating pain last 3-4 days. 7 days later I still have tenderness in my breast and arm pit.

Patient administered Covid Vaccine (Pfizer, 1st dose) at approximately 2:46PM. At approximately 1505 pt c/o nausea and ran outside. Pt awake, alert, respirations easy and unlabored, no distress noted. No vomiting occurred. Pt stated history of throat swelling and facial swelling/rash after PCN. 1510: Pt stated nausea resolved. Pt Diabetic and had not eaten lunch. Juice and crackers given, pt tolerated well with no difficulty. Respirations remain easy and unlabored, no distress. 1517: Pt clearing throat, c/o throat swelling, able to manage oral secretions, speaking in complete sentences. Pt to triage area via wheelchair by RN. BP 171/80 | Pulse 77 | Resp 17 | LMP 02/01/2013 (LMP Unknown) | SpO2 98% 1523: Pt awake, alert, c/o difficulty breathing. RN called for assistance 1526: 911 called. BP 184/84 | Pulse 82 | Resp 20 | LMP 02/01/2013 (LMP Unknown) | SpO2 100% 1528: RN called ED MD, Dr., verbal order received for Epinephrine 0.3 mg subcutaneous one time now. 1530: Epinephrine given per MD order. 1532: EMS crew on scene, Sac City 7, assessing patient, full report given by RN. During transfer of care, pt started shaking, full body, eyes closed, assisted to supine position on gurney by EMS crew, no injuries occurred, very short duration- pt aroused. Pt and her personal belongings to ED by EMS crew.

swollen lymph nodes; tiredness; diarrhea; This is a spontaneous report from a contactable consumer (patient herself). A 60-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3247), via an unspecified route of administration in left arm on 10Feb2021 09:15 at single dose for COVID-19 immunisation in workplace clinic. The patient's medical history included AFib, hypertension, known allergies: TB test (allergies to medications, food, or other products: TB test). Concomitant medications included apixaban, digoxin, metoprolol, enalapril; the patient received all the drugs within 2 weeks of vaccination. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3247), in left arm on 20Jan2021 09:15 AM at single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. On an unspecified date in 2021, the patient experienced swollen lymph nodes, tiredness, diarrhea. The events were considered as non-serious by the consumer. No treatment received for the adverse events. The outcome of the events was recovering.

This patient was vaccinated approximately 1 hour prior to presentation here with her first dose of the Pfizer COVID-19 vaccine. She felt fine right after her vaccination but as she drove to her destination where she was going to take a walk, she started to develop left-sided facial burning and swelling. That prompted her to call her PCP in that office recommended she come back to the vaccination clinic to be evaluated. I evaluated her at approximately 2 PM.. She was feeling well for the most part with the exception of left-sided facial burning and swelling and a little bit of redness over her left cheek. She denied fevers, chills, itching, other areas of rash, difficulty speaking, difficulty swallowing, tongue swelling, lip swelling, wheezing, chest pain, or difficulty breathing. She recalls a penicillin allergy at age 5 or 6 but cannot remember the reaction. She has never reacted to a vaccine before. Initial vital signs included a blood pressure of 134/73, a pulse that was 70 and regular, and an oxygen saturation of 100% on room air. She had normal mental status and her lungs were clear. The left side of her face was slightly swollen over her left cheek as compared to the right with some slight increased flushing on the left side. There was no stridor, she was speaking comfortably, and her lungs were clear with good airflow. Her heart demonstrated S1 and S2 with regular rate and rhythm. I administered 2 doses of Benadryl, 25 mg with each dose about 15 minutes apart with her last dose at approximately 2:25 PM. I rechecked her vital signs at 2:50 PM and her blood pressure was 138/79 with a pulse of 70 and regular and an oxygen saturation of 99% on room air. Her lungs were clear and she was moving good air. I did take a relook at her face which was improved with decreased swelling. At 3 PM, because she was doing much better, I discharged her to home with instructions to use Benadryl 50 mg when she got home and then 25 to 50 mg every 4 hours today. If she develops any respiratory symptoms such as difficulty swallowing, cough, breathing difficulty, swollen tongue or swollen lips, as well as increased facial swelling, she will call 911 to be evaluated. She should not get the second Pfizer COVID-19 vaccine.

As I pulled up for the 15 minute wait period the symptoms started 5 minutes after I received my vaccine. A tingling feeling up my left arm to back of my neck. My neck stiffened and then my throat started to close. Not to where I can't swallow but just like when I eat food that I'm allergic too, it closes up. The nurse that was overseeing me was holding the umbrella over my car window with the rainfall. All of a sudden their was lightning & thunder. The nurse threw the umbrella because she was shocked from the lightning. She started to talk to all the other around her and forgot about me. Since I could still swallow I didn't get her attention. When she returned she asked me the time so I had to pull my phone out. She didn't know the time of my 15 minutes and sent me away. As soon as I got out of the parking area but still inside amusement park, I started to feel my cheeks becoming numb and my right eye was blurry. I quickly moved over to the side lane still inside of amusement park and waited. I called my husband and told him that with the heavy rain I didn't feel safe driving with my right eye being blurry. I waiting another 15 minutes before driving home. That evening the blurriness came back, my eye's & forehead was tender to touch but no headache. Only pressure in my head. My symptoms of closed throat, swollen cheeks, pressure in my head and blurriness continued on Friday, March 12th, Saturday, March 13th, Sunday, March 14th and Monday, March 15th. As of today, no other systems other than feeling my body has inflammation.

40 hours after COVID-19 mRNA vaccination patient awoke in the middle of the night with itch, swelling, rash on left eyebrow. Subsequent 6 days rash developed into typical herpes zoster (shingles) rash localized over left eyebrow.

Could stand, couldn't walk; Swollen lymph nodes in left arm; neck ache; Frontal headache; Heaviness and soreness in arms; Heaviness and soreness in arms; has a sore spot only where the COVID vaccine was; This is a spontaneous report from a contactable pharmacist (patient). A 60-year-old female patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EN9581), via an unspecified route of administration on 04Feb2021 at 10:20 at SINGLE DOSE in left arm for covid-19 immunisation. Medical history included ongoing multiple sclerosis. There were no concomitant medications. The patient previously received the first dose bnt162b2 (Lot: EL3249) on 14Jan2021 for COVID-19 immunisation and experienced couldn't re stand. The patient experienced could stand, couldn't walk on 05Feb2021, frontal headache, heaviness and soreness in arms on 04Feb2021, swollen lymph nodes in left arm on 05Feb2021, neck ache on 04Feb2021 at 22:00, had a sore spot only where the covid vaccine was in Feb2021. Event details: The patient had the second COVID vaccine on 04Feb2021. Was fine that day. Had heaviness in her arm and little bit of headache. Was fine the day of the shot. 04Feb2021, felt a little heavy in the arm where she got the COVID shot. Received COVID vaccine in left arm. Drove home and was fine. Sat down and watched TV and had a frontal headache. Took Tylenol. By the time she went to bed, around 10:00 PM, her neck was so sore to turn from side to side. On top of her arms where shoulder pads would be is there the heaviness was. Both arms became sore. It was manageable and she took Tylenol. Eventually it went away. Friday morning 05Feb2021 when she got up, got to the point where she got out of bed and couldn't get up. There was no possible way for her to get up. Her husband had to buy her a 3-in-1 potty chair so she could just stand and pivot, seriousness was provided as disabling, could understand hospitalization, but confirmed she never went to the hospital. Could not rest that day or go back to the bathroom. Didn't walk anywhere. Was in a chair that she could sleep in. Husband bought her a potty chair. Was able to use the lift on the lift chair later that afternoon. Definitely debilitating. Sister who was an orthopedist nurse had to help her and secured she wouldn't fall. The patient had swollen lymph nodes only in the left arm on 05Feb2021. At time of reporting the patient had a sore spot only where the COVID vaccine was. It was not red. Only sure up underneath and when it was touched. The outcome of events could stand, couldn't walk, heaviness and soreness in arms was resolved on 06Feb2021, outcome of other events was unknown.; Sender's Comments: Based on available information, due to close temporal association, a possible contribution roe of bnt162b2 to the onset of "unable to walk" cannot be excluded. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

pt. called stating she recieved her first COVID vacc. past weekend, now having swollen lymph nodes and trouble swallowing. Pt. was advised to go to UC or ER. Pt. presenting today for Swollen glands (had 1st dose vaccine on Saturday, Monday started having swollen glands in neck

Day 1 (3/7): sore arm, mild headache, fatigue, nausea Day 2 (3/8): more sore arm, mild headache, fatigue Day 3: unable to lift left arm, headache Day 4: sore arm, 3" oval shaped red spot next to shot spot: swollen, raised, itch Day 5: arm better, red spot still itch Day 6: able to lift arm, less sore, red spot smaller, still itch, shot spot still itch too Day 7: arm almost back to normal, red spot diasppeared Day 8: all 10 toes red, swollen, extremely itch, unbearable especially at night Day 9 - 10: different toes itch more each night Day 11 (3/17): visited urgent care - diagnosed fungal infection Day 11: visited Primary Care Physician : referral to visit Podiatrist Day 13 (3/19): visited Podiatrist - diagnosis COVID Pfizer Vaccine side effect, prescription: Betamethasone

Pt was admitted 6 weeks post second covid vaccination with c/o sudden onset of generalized abdominal pain, nausea, vomiting and diarrhea resulting in 2 syncopal episodes. CBC showed leukocytosis with neutrophilia which resolved. She was treated with IV fluids and antiemetics and was discharged on 3/19/2021

The patient's arm was slightly red in color and swollen. When felt, there seemed to be a lump where the vaccine was given after 5 days.

Large swelling in lymph node above left clavicle the size of a 50 cent piece Injection in the left arm Use warm compresses for 3-4 days and it went away

Swollen lymph nodes under arms and in groin, headache, pain at injection site, tiredness, fever, chills, felt unwell

extreme fatigue, headache, nausea, muscle aches, joint pain, low grade fever, chills, swollen lymph nodes in neck and under arm, treatment was motrin 600 mgs q6hrs from 2/18/21-02/22/21 returned to work on 02/23 lymph nodes still slightly enlarged as of today, 03/22/21

Rash and hives, itchy and swollen lymph node on right neck - appeared approximately 24 hours after second dose of vaccine. Received one shot of steroid and prescribed a 6 day dose of oral steroid.

Loss of appetite morning after vaccine, headache, body aches, chills, face flushed. Fever started afternoon. 99.4. Took Tylenol but it gradually rose to 102.3. Took 3 hours for fever to go down. By 5:30 fever was gone & I was feeling better. Next day I felt great but by three days later I had a fever blister & very sore, dry and stuffy nose which lasted two weeks. And headache as well. I?m thinking because of stuffy nose. I did have Covid last March/April 2020 so I have heard that I would have side effects.

About 45 minutes after the injection two large spots on the face had hives, moderate swelling beneath right side of lip, minor swelling beneath left side of lip. Took Zyrtec and symptoms went away.

3-22-21 11AM TC: PT STATES ON '3-19-21 7PM SHE HAD SWELLING OF HER TONGUE AND RT SIDE OF FACE AND NECK; SHE CALLED HER PCP WHO HAD HER SUE HER EPI PEN - THE SWELLING RESOLVED. ON 3-20-21 SHE ALSO HAD A EARACHE, HEADACHE AND BLOODY NOSE. HAS TAKEN TYLENOL.'

Flu-like symptoms: headache, fatigue, dizziness, nausea, swollen lymph nodes, sore arm beginning the evening of injection. All symptoms, except sore arm, gone by morning. No treatment given.

Swollen face; Swollen puffy eyelids and below eye; itchy rash on face,neck, and chest; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration in left arm on 14Feb2021 at 12:30 at single dose for COVID-19 immunization. Medical history included allergies to dust mites, dogs, and corn; Hashimoto's thyroid; and high blood pressure. Prior to vaccination, the patient was not diagnosed with COVID-19. She was not pregnant and did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included fluvoxamine maleate (LUVOX), thyroid (ARMOUR THYROID), and amlodipine. The facility where the most recent COVID-19 vaccine was administered was reported as other. The patient experienced swollen face, swollen puffy eyelids and below the eye, and itchy rash on face, neck, and chest on 14Feb2021 at 17:30. The events resulted in doctor or other healthcare professional office/clinic visit. The patient was told to take ALLEGRA and PEPCID in the morning and CLARITIN AND PEPCID in the evening by the allergist. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered. The events were assessed as non-serious. Information on the lot/batch number has been requested.

Felt abnormal and went to bed. Woke up at 9:35am with 101.7 temperature and called into work to advise I will not be coming in. I went back to bed no food no medicine, Most information I read and was aware is that it would be better with sleep. Only to wake up at 8:30pm with a 102.7 had 500 mg acetaminophen went back to bed. Woke up Thursday morning at 9:45am fever free. Friday afternoon I noticed swelling on my left neck area. Just inside my left clavicle. I made a Dr appointment for Monday and Dr. found several Lymph nodes swollen as well as under my left arm pit area. Due to some chest pain she sent me for a chest x-ray.

Swollen lymph nodes under the arms, joint pain throughout but highly concentrated on the right side of body and arm

I was submitting my events daily on website and two days it tells me my session has expired and won't let me report anything. On Sunday night, March 21st, I started with very painful joint and muscle aches with fatigue. The next morning I felt terrible and could barely function, I had a bought with diarrhea that lasted almost the entire day and had no energy. I developed a large lump on my left clavicle area that seemed to be filled with fluid. My knees I had replaced are still very painful today ( 7 days post vaccine). I phoned my Dr. yesterday and they told me to take 1000mg of Tylenol 3 times a day. I am doing this now for the second day with some relief. I feel this is very unusual to feel this way 7 days after the vaccine. On day 1-2 the only symptoms were a sore arm from the vaccine. Saturday was actually a good day with no symptoms, the other symptoms started on Sunday. I feel like my heartbeat is irregular also but my BP is good. I would like to be able to to report daily on v-safe like I was the first few days.

Initially, mild nausea, immediately (with 15 minutes of administration) . Resolved promptly within 30 minutes of injection. Then, three hours after administration (at approx. 12.30 p.m.), the following symptoms in order of severity: 1. Severe tiredness/fatigue. Lasted 4 hours. Resolved when I took a half hour nap. 2. Sore throat. Still present at 10.30 pm. 3. Swollen lymph nodes (lymphadenopathy). Significant improvement after 4 hours from onset (3 hours after administration). However, still present at 10.30 p.m. 4. Feeling unwell/malaise. Resolved after I took a nap. 5. Dry eyes. I had to remove my contact lenses and put on eyeglasses when I got home at approx. 2pm. 6. Dry mouth. Unresolved, even with drinking a lot of water and tea. Symptoms were fairly severe. I had to leave work and go home to rest. I was unable to drive myself home.

Patient reported facial swelling to the right cheek area and pain around the left eye socket. These symptoms appeared overnight, and the patient first noticed them upon awakening.

At 11:15 am of 3/26/21, after taking a shower, I was applying cream on my neck and I noticed a huge lump on the left side of my neck. Being an MD ( anesthesiologist), I examined the lump and felt like a size of a walnut in a shell. I immediately called my Primary and I went to his office. We discussed about my Covid vaccine. And he requested Chest X-ray. In the future, head and neck CT.

1. Some Swelling and redness at injection site 2. Some lymph node swelling and discomfort under right arm Outcome not known yet, swelling and redness seem to be lessoning.

First dose I was fine,second dose I had reactions next day with face swelling lip swelling tired next day swelling went down then I have big lymph node knots on both sides of neck with chills and fatigue. I am on third day and still have nodes on neck and tired with chills. My eyes fill little swollen also.

Swelling, redness and itching in arm pit of left arm and into lymph nodes. itching only when rubbed.

Swollen Lymph Nodes, chills, headache, nauseous stomach, pain radiating in left boob & left back, and tireness

After typical flu like reaction for 2- 3 days, symptoms of Epstein Barr- extreme exhaustion, muscle weakness and aching, swollen glands and headache started about day 5 and have been severe times one month.

Moderate aches, fatigue and headache for 24 hours followed by lymph node inflammation in left armpit which is ongoing, though improving slightly every day.

she thought she was getting Bell's Palsy; Lymph nodes swelled; This a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 19Mar2021 17:30 (at the age of 60years) as single dose for Covid-19 immunization. There was no medical history; no known allergies. The patient is not pregnant at the time of vaccination. Concomitant medications included colecalciferol (VITA D); ascorbic acid (VITAMIN C); fish oil; ubidecarenone (COQ10); magnesium; and zinc; all taken for an unspecified indication, start and stop date were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that her lymph nodes swelled on the same side where she received the shot. Also, the left side of her checks down to neck and shoulders felt weird, she can't quite explain the feeling; she thought she was getting Bell's Palsy which is one of the adverse reactions. She was alarmed as she was unaware of the swelling of the lymph nodes. The adverse events occurred on 19Mar2021 (16:30). There was no treatment received for the adverse events. The patient has not been tested for COVID-19 since the vaccination. The outcome of events was recovering. Information about lot/batch number has been requested.

fever of 100.1 for 8-9 hrs. day after shot , swollen lymph nodes in right arm pit, slight headache, fatigue, slight cough, 2 days

Severe joint pain (shoulders, elbows, hips, knees, ankles); chills; overall body aches. Lasted a little more than 24 hours, although the severity lessened on the 2nd day. Did not take any medicine to treat symptoms. Resolved by day 3. Enlarged, painful lymph node (right arm pit); lasted 5 days. Dull headache; lasted 3 days.

Swelling right underarm, ongoing; minor body ache throughout and felt like cold coming on, no fever, 12 hours. Did not seek treatment.

Immediate taste of an antibiotic in mouth, numbing of lips and tongue within 3 minutes of vaccine. Slight swelling on right side of face. Reported to primary physician and referred to neurologist. Second dose was canceled.

Cold Feet, Nausea, Vomiting, Diarrhea/abdominal cramps. The diarrhea and abdominal cramps/stomachache are still happening as I write this report today April 5, 2021.

Received first shot on 3/15/21. On 3/25/21, I developed a rash (hives) around 6:30-7pm. After dinner, around 7:30pm I noticed that my lips were swollen and the rash was spreading. Took one Benadryl and waited 1 hour. Condition worsened so left for ER around 8:45pm. Once there, I was diagnosed with an anaphylatic reaction. I was given Prednisone, Pepcid and Benadryl intervaneously. The Benadryl injection caused my throat to close for a few seconds. Things calmed down so we waited an hour to see if I was responding. There was not a lot of improvement so ER doctor decided to use Epinephrine (EP pen injection). After 2 hours of observation, I was set home to follow up with primary care physcian.

3/10/21?first shot. Felt fine. 3/19/21?started to get rash on upper left arm?shot arm. 3-20-21?rash spread to upper right arm and a few spots on my knees 3/23/21?blood draw. Platelets almost doubled since my last count three weeks prior. Increase anagrelide to two pills twice a day. 3/31/21?second dose. Shot again the left arm Felt fine that day. 4/1/21?felt tired. 4/2/21?really feel tired and skin feel tingly like a rash coming on. Had chills. By evening upper arms were red, sore, swollen, rash covered and warm to the touch. 4/3/21---Slept a lot of the day and still in a fair amount of pain. Upper arms and hands red, sore and swollen. Took an over the counter antihistamine Zyrtec, which helped with the swelling. 4/4/21?Continued with Zyrtec 4/5/21?Continued with the Zyrtec. Skin in my arms seems to be ?drying out? a bit and swelling down. 4/6/21?Arms and hand still red but swelling down.

pt says that her right arm became very sore. The muscles in her right knee became sore. Her knee seemed to have locked up. By the next day it became very painful and still. The pain is going up towards the thigh and then going down the calf muscle. Pt has taken Advil and used ice compressions for the pain. She says the pain and swelling seem to be less present today but is still there and will see an orthopedic doctor if she doesn't improve.

anaphylaxis with stridor and diffuse wheezes. No rash, GI symptoms. Received epinephrine, bronchodilators, IV steroids, histamine blockers, epinephrine drip. ICU admission

March 28: Bright red cheeks, extreme thirst, cold sores, severly chapped lips, clammy sweat (continued through entire series of symptoms) March 31 - April 2: Fever, Chills, Excrutiating muscle and joint pain, nausea, severe headache. Unable to function, think clearly, or eat/drink. No vomiting April 2 - April 5: Severe upper stomach pain and burning/soreness under right side rib cage. Uncontrollable watery diahhrea. Unable to eat the first two days of this. Able to drink some. April 5 to current: Still fighting the diahhrea but pain stopped. Have been on the BRAT diet since April 4th. Began taking a prescription from doctor to help with diahhrea on April 8. Still experiencing dizzyness, lack of clarity.

Side of right foot got very red and swollen, then turned to large bruise covering little toe, and part way down foot. Next bruised spread out.

Went to bed and woke up at 4 am to pee. Afterwards I blacked out and work up on the bathroom floor; Anaphylaxis; chest hurt to breathe; Itching in my arms and chest in the evening.; rash; This is a spontaneous report from a contactable healthcare professional (patient). A 60-years-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Left arm on 15Mar2021 at 17:00 (Batch/Lot Number: EP8534) as SINGLE DOSE for covid-19 immunisation. Medical history included Only occasional migraines. Never anything like this and known allergies: Some grasses. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included probiotics (PROBIOTICS) taken for an unspecified indication, start and stop date were not reported; betaine hydrochloride, bromelains, cellulase, pancreatin, papain (DIGESTIVE ENZYMES) taken for an unspecified indication, start and stop date were not reported. On 18Mar2021, at 8pm, the patient reported that "3 days after 2nd shot I started itching in my arms and chest in the evening. Went to bed and woke up at 4 am to pee. Afterwards I blacked out and work up on the bathroom floor. My rash was worse and spreading and chest hurt to breathe and I had bumps on head so we called # and nurse and my husband drove me to (Name). They gave me an IV and epinephrine shot and Pepcid and did CT scan of head and blood work. Diagnosed Anaphylaxis. They sent me home a couple hours later with prescription for Epi pens Zyrtec and Famotidine. Over the course of Friday my rash/hives got worse and spread over my body and my lips /mouth started to swell. I called the nurse who suggested I come back in and they checked by throat to ensure it wasn't closing up and gave me ibuprofen and Benadryl and sent me home. Rash/hives worse and spread all over body and face when I woke up Saturday morning (today). Plan to see specialist Sunday or Monday." The outcome of the events was not recovered. The patient was not tested for COVID-19 after vaccination.

Pfizer-BioNTech COVID-19 Vaccine EUA I had normal pain at the injection site after the shot, which went away after a couple of days. A few days later a different part of that upper arm and shoulder became painful to move certain ways. I saw my primary care physician and he said the shot must have nicked the bursa under the muscle. He diagnosed bursitis and prescribed diclofenac gel.

u1st Pfizer vaccine on 3/17/21 the next day I only has pain with swollen area in left arm around shot location. My 2nd Pfizer vaccine on 4/7/21 the next day around 4pm I started all the symptoms until chills, aches and pains, fever, and nausea, This was severe Thursday evening and most of Friday. Friday night I had swollen lymph nodes in the armpit and near the collarbone on my shot arm. This was very uncomfortable. Saturday the chills, aches and pains, fever, and nausea started to go away. Sunday mostly swollen lymph nodes and aches and pain in joints. Sunday night swollen lymph nodes stared to go down. Monday am still a bit tired but feeling better

4/7/21. Sweating profusely,no fever. 4/8/21 .Swollen left upper arm (2× it's size).Intense itching entire left arm for 24 hours

My arm was sore immediately. As the hours progressed after the shot, my left upper arm became very swollen, hard, and painful enough to wake me in the middle of the night. The hard lump was as big & wide as my right hand and began 2 inches above my elbow up to the place of injection. When my morning alarm went off, I was very fuzzy and extremely weak. I was unable to go to work or remember a lock combination I use every day. My energy began to return the next day enough to work a half day but returned to bed for the afternoon. The tiredness was all but gone by 8:30 pm. Reaction began Sunday morning and was gone by Tuesday night.

Swelling right arm pit, very large size of a lemon, severe pain, resolving with warm compresses after 4 days.As of 4/15/2021 slight persistent swelling. Severe chills, no fever 4/8/2021 thru 4/9/2021, diminishing over time. Severe headaches, starting 4/9/2021, lasting for 6-8 hours, refractive to acetomenaphin, ibuprophen. Continuing through 4/14/2021. Suspected gallbladder involvement.

experienced extreme pain on my inner thigh on my left leg; It was hot to the touch, very red and swollen; It was hot to the touch, very red and swollen; It was hot to the touch, very red and swollen; difficulties to sleep and walk; difficulties to sleep and walk; Superficial Thrombophlebitis; This is a spontaneous report from a contactable consumer (patient). A 61 year old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EL9263, expiry date not reported), at the age of 60 years old, via an unspecified route of administration, administered in left arm on 02Feb2021 09:00 at a single dose for covid-19 immunisation. The patient then received the second dose of covid-19 immunisation on 23Feb2021 08:00 AM (lot EN6200), via an unspecified route of administration, administered in the left arm. Medical history included rheumatoid arthritis and multiple sclerosis, both from an unknown date and unknown if ongoing. The patient was not pregnant at the time of vaccination and the events. The patient no covid prior to vaccination. The patient's concomitant medications were not reported. The patient was not tested for covid post vaccination. Soon after COVID-19 vaccination, on 21Feb2021, patient experienced extreme pain on inner thigh on left leg. It was hot to the touch, very red and swollen causing difficulties to sleep and walk. Patient then saw a vascular doctor for the pain on 16Mar2021 and was advised that patient have superficial thrombophlebitis (since 21Feb2021) and was prescribed to take Xarelto 15 mg for two weeks. Therapeutic measures were taken as a result of the events reported which included Xarelto 15 mg and had a venous ultrasound of area on an unknown date (unknown results). The events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events reported was recovering.

bad case of jet lag; glands under my arms got very sore; lumps under my arms; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 26Mar2021 14:00 (Batch/Lot Number: EP6955) as single dose for covid-19 immunisation at a workplace clinic. The patient's medical history was not reported. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included losartan and sertraline hydrochloride (ZOLOFT). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 05Mar2021 for COVID-19 immunization. The patient also previously took codeine and experienced allergies. On 28Mar2021 08:00, the patient felt like a very very bad case of jet lag. Also, the glands under her arms got very sore and felt like there were lumps under her arms. The events were not treated. The outcome of the events was recovering.

tenderness in lymph nodes under the arm of the arm that received the shot; This is a spontaneous report from a contactable consumer reported for herself. A 60-year-old female patient received second dose of bnt162b2 (Lot Number: ER8732) via an unspecified route of administration in left arm on 29Mar2021 13:15 as single dose for covid-19 immunisation. Medical history included asthma, NAFLD (Fatty liver), high blood pressure, high cholesterol. Patient was not diagnosed with COVID-19 prior to vaccination. Patient not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, with unspecified medications the patient received within 2 weeks of vaccination. Patient received first dose of bnt162b2 (lot number: EN6205) on an unspecified date in Mar2020 10:15 PM in left arm. On 30Mar2021 09:00 AM, patient experienced tenderness in lymph nodes under the arm of the arm that received the shot. The event outcome was recovering. No treatment received. Patient had not been tested for COVID-19 since the vaccination. No follow-up attempts are needed. No further information is expected.

Shingles-left shoulder blade and left breast (vaccine in left arm); began two days after vaccine with tingling on shoulder blade, then red rash, then painful blisters; stinging/stabbing pain; inability to sleep due to discomfort Lymphadenopathy-swelling in my left breast and chest; much discomfort

Following my first Covid 19 Pfizer vaccine 03/11/21: **Note, I went through 1 1/2 days dull ache in arm no concerns > days 2--5 went through a HYPER-WELL (no age aches, prior-hurt finger didn't ache, energy, ladies room habits back to what I reported to daughter "age 20!" for these four days, amazing, enjoyable, then > day 6 very early am woke up with swollen neck lymph nodes half-palm sized rocks on neck, breathing difficulties (lungs not neck), bad dull intrusive headache (different pain from Migraine, or low-hydration pain), cough dry and have called this my HYPER-CRASH because I could barely walk, backward C-shape abdomen hurt (dull ache big always + frequent stabbing pains from below bra bottom line to left abdomen down side then curving to my right across bottom abdomen at both leg-attaches-to-abdomen locations. Difficulty breathing, pain, extreme swelling over upper abdomen when I even drank water to swallow morning Hydrochlorothiazide pill and would stay swollen for 4-8 hours with continued surprise to me gulps of air throughout period, weak, nausea but not vomiting, dizzy, unable to walk more than a few steps at a time, fever taken and wavered from 95 to 99 degrees (my usual body registered 97.8 degrees) but never over 99 degrees, and only over 97.8 degrees perhaps three times very little above it and only for a few hours. >>I went to Urgent Care in person no better at all on 3/24/21/roughly day 12 after vaccine shot 3/11/21 (Urgent Care) which took blood and urine tests determining roaring infection and blood in tests and a CT CONTRAST scan should be ordered by my PCP asap at appt PCP already scheduled 3/26/21 but she couldn't order CONTRAST version the PCP would need to and she prescribed three antibiotics to take over next 2 weeks >> I went to PCP 3/26/21/day 14 after vaccine shot and he ordered CT Scan but insurance required pre-auth and they refused it at first so PCP referred me to GI SPECIALIST who again referred me for CT CONTRAST test, which I did have on Friday afternoon 4/16/21 (Clinic), and I await the results today 4/19/21. Today I continue to have pain abdomen, though softer and throbbing, same C-shaped region, HUGE issue even drinking water with Hydrochlorothiazide pill only for many hours as abdomen swells at bottom bra-line center in a palm size mound for hours, and back hurts badly, solid headache which may be only right side of head more than left but I am taking nothing for any symptoms afraid of GI issue. NOTING AGAIN: Yes I was diagnosed roughly 2015 with a single incidence of diverticulitis/osis by GI SPECIALIST in Town and went through series of Colonoscopies and tests, but tests only determined incidental few polyps removed over all tests and no incidents at all since that. Knowing what I know of my body and health, the trigger seemed to be the first shot of Covid 19 Pfizer vaccination which remarkably seemed to react first with a few days of better health than I have had for decades (eating, moving, energy etc. for my age), where after days of extreme great health and energy (where I went nowhere, and still did not push myself much) my body then crashed to unable to move much or even breath normally for many days after and with a multi-level infection in my gut that needed three antibiotics and after those I still hurt in the same locations. I cannot confidently rule out the Vaccine as the cause, and what I know of my body suggests in fact some "overdrive" function in my system was triggered and then caused the crash that resulted in infection and that continues to interfere with my walking, eating, moving, breathing, and even drinking a small glass of water today. Final note: PCP confirmed I should take the second Vaccine Pfizer shot, which I did on 4/1/21 - same site, Lot #EW0150, after which second vaccine shot I had the same two days of dull arm pain, and I continued to finish the antibiotics until finished (but pain though softer continues to today). I did not experience a #-Days HYPER-WELL episode then HYPER-CRASH after this second vaccine shot, only the arm ache, but throughout was still very unwell (breathing, pain, no activity, weak, unable to eat, swelling, headache, cough intermittent, back hurts, etc.) throughout, and same to this day 4/19/21 as I await CT CONTRAST results. I felt compelled to share I feel this was triggered by the first Vaccine shot, and would not have happened had I not had the Vaccine shot. Thank you.

Sat (4/17): severe chills for two hours starting at 11:55 pm Sun (4/18): woke and could not walk across the room without falling down due to dizziness, was nauseated, strong headache, fever of 102 all day, bedridden Mon (4/19): Fever was reduced but nausea, headache still persisted all day, continued chills. Right middle finger began to swell and turn purple Tues (4/20): Lost feeling/sensation in right middle finger, head feels off, nausea still persists, stomach pains. Called doctor and had televisit with nurse practitioner

Red rash mostly under right eye, but small place under left eye as well. Does not hurt or itch, just swollen and red. Also developed a fever blister/cold sore on upper lip at the same time. It's been about 23 days since first shot and I still have the rash under my right eye, but cold sore is gone. Did not see doctor. Treated cold sore with Blistex and just put vaseline on rash at night.

Cold sores around mouth and chin. Accompanied by severe nausea. They are still breaking out so unsure how bad yet or if hospital is needed.

On 4/10/21 I had fever and severe chills. On 4/11/21 the fever broke. I was fine but weak. On the night of 4/11/21 (9:00pm) fever returned. I took advil and went to sleep. On 4/12/21 I woke up with my arm very swollen and it was hot to touch. By the afternoon I was worse and the area was turning red so I went to the Urgent care and diagnosed with Cellulitis (which I have never had and didn't understand at first what this was about). I was treated and returned to my regular Doctor for follow up. I still have this thing and although it's better it's not gone as of this report and it is causing me distress in typing, cleaning and so on.

6 hours after the injection, i developed lymph node swelling on my collar bone approx. 3 in x 3in area, headache, watery ices and sneezing that lasted 48hours. As of today, April 24th the swollen lymph node is still present

Swollen lymph nodes under right arm 29 to 30 hours after receiving vaccination. Still experiencing swollen lymph nodes 4 days later.

Day after shot (Saturday 10 April) - nausea, headache, 101.5 fever, body aches, arm soreness, tiredness 2nd day after shot (Sunday 11 April) - slight headache, tiredness, red rash around injection site and itching. My arm was also swollen and more sensitive to touch than movement. The itching wasn't bad enough that I needed to take any meds. I just wanted to report this adverse reaction to the second shot.

Swelling lower left arm and hand. Intensified to include entire left arm. Deep bruised ache feeling. Heaviness. Could not fit arm through sleeve. Became difficult to use hand due to swelling. Due to swelling now have carpal tunnel in left hand with numbness & painful tingling.

3/19/21: patient is a 60yo female who presented with complains of facial droop. The sister reports the patient complained about headache in the left temporal area around 8-9pm, reports having the same pain throughout the week but today was stronger, and the sister noticed she had facial droop and was unable to open her left eye. The patient also reports abdominal discomfort the the epigastric region and LUQ that started today and was associated with nausea. She denies diarrhea or fever. Of note patient reports having Covid Pfeizer vaccine yesterday and 5 minutes later being were unable to speak with edema in her lips and tongue, associated with SOB. She was taken to a ER, was given epipen, albuterol, benadril, prednisone and was discharged home at night with improvement on her symptoms. Patient discharge note on 3/22/21: Admitted for facial paresthesias in setting of arnold-chiari malformation, HTN, HLD, after covid vaccine, neuro work up neg, discharged home on 3/22/21.

Adverse event: Pt received first dose Pfizer COVID-19 vaccine on 4/13 at approximately noon. She states later that evening, approximately 6pm, she noticed her right eyebrow and corner of mouth "looked funny", as they did not raise in symmetry with the left side of her face. She denied any other noticeable deficits in the head/neck, upper and lower extremities. Treatment: none Outcome: patient reached out to our facility and asked whether or not she should get the second dose. I described the risk / benefit ratio of not receiving the second dose. Pt states she would research the topic further on her own before making a decision. I advised the patient may report the incident to V-safe as well.

I had all this pain at the injection side; tired; headache; chill; throat pain; fever; nausea; swollen lymph nodes; This is a spontaneous report from a contactable consumer (Patient) reported for herself. A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/expiration date: unknown) via an unspecified route of administration on 23Feb2021 (at age of 60 years) at single dose for COVID-19 immunization. Patient relevant medical history included chronic obstructive pulmonary disease (COPD). Patient concomitant medications were not reported. After receiving covid-19 vaccine patient started running really high temperature and pain at the vaccination side, really tired, headache, chill, throat pain, fever, nausea, Patient said swollen lymph nodes, throat has been sore on unspecified date. Patient stated that run temperature but took Tylenol and it took it down it was high, but I still have the soreness. Patient also mentioned having COVID 19 infection months ago. Treatment received for events was unknown. The outcome of event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Multiple swollen lymph nodes under both underarms and right groin. Also noticed flare up of arthritic pain in left knee

After the first dose, developed a skin rash behind the knee. With the second dose I have a skin rash in multiple places and an inflamed lymph gland under my right arm.

50 year old female had 1st Covid Pfizer vaccine on 3/18/21 and second dose on 4/14/21. Developed mucosal bleed in tongue and lips. Went to the ER on 4/25/21 and found to have WBC 8.1, Hb 10.2, Plt 10K. Peripheral smear showed thrombocytopenia, no platelet aggregates. WBCs were normal. RBCs showed mild normochromic, normocytic anemia. Patient was started on Prednisone 60mg x 3 days. PLT increased to 75K on 4/27/21 and patient was discharged on 4/27. She was seen in the outpatient clinic on 4/29/21, on Prednisone 50mg . Her Prednisone taper is planned at 50mg x 3d, 40mg x 3d, 30mg x 3 days, 20mg x 4 days, 10mg qd then office visit scheduled again to monitor response. Bleeding spot from the tongue, and lips resolved.

One hour post vaccine - severe SOB lasting maybe 30 min, followed by right leg/ankle/foot swelling - not painful, but would not resolve with furosemide 40 mg. Severe Swelling persisted for over 2 weeks before eventually resolving. My concern is I?m due to get #2 vaccine 5/2/21 and am worried about possible blood clot as I have a past history of a blood clot (left leg) 14 years ago.

Caller states the patient had an anaphylactic reaction twice that caused her to go to the emergency room; couldn't swallow; right side of the patient's face swelled up and her lips were numb; right side of the patient's face swelled up and her lips were numb; face numb; hands itching; tongue had swelled up; voice was scratchy; This is a spontaneous report from a contactable consumer, Reporter's sister via Pfizer-sponsored. A 60-year-old female patient received the second dose of BNT162b2 (Pfizer-Biontech COVID-19 vaccine, Solution for injection, Lot number: unknown, NDC number: Unknown, Ex-piry Date: Unknown) via an unspecified route of administration on 01Mar2021 on an unknown ana-tomical location as a single dose for COVID-19 immunization. Caller provided that her sister got the vaccine for COVID Prevention and because the patient has a handicapped, bedridden husband who has MS and is immune compromised, and it was to help prevent him from getting sick. Caller reported that the patient received the product during the daytime, all the women at the patient's job, which was home health payroll, everyone left to get the vaccine during work hours, like in the AM at around lunch time. Patient's medical history and concomitant medications were unknown. Patient has not received any prior vaccinations within 4 weeks. Patient had no other vaccines on the same day as the suspect product. Patient received first dose of BNT162b2 (Pfizer-Biontech COVID-19 vaccine, Solution for injection, Lot number: unknown, NDC number: Unknown, Expiry Date: Unknown) on 08Feb2021 with no reaction. She worked for a health agency and the whole office went and got it. Caller provided that her sister had a reaction the first time, on 03Apr2021, where her sister woke up with itching started in her hands and ended up migrating to her whole body. By morning patient's tongue had swelled up, couldn't swallow and her voice was scratchy, like the caller couldn't understand her sister's speech well. Caller provided that her sister went to the ER and said there was a whole team giving her urgent care, medication, and such. Caller reported that her sister said the ER didn't find anything in her bloodwork, and the caller did not think the patient was being treated for any other medical conditions, and caller did not think her sister is on any medications, but caller said to not quote her on that. Caller knew her sister had a weight problem, but she did not know if her sister needed blood pressure medication or anything. Caller reported her sister said that the bloodwork from the ER did not find any-thing, and the patient was not admitted to the hospital. Caller reported that at this time, her sister's adverse events were no longer ongoing as her sister was given Steroids, like Prednisone, Benadryl and Famotidine, and she took those products as recommended by the doctor. Caller did not know the end date of her sister's events; all she knew was that the reaction initially started on 03Apr2021. Caller stated that her sister was allergic to nothing, and she has never had incidences of itching like that, where the itching was so bad that she was stripping down and the patient's daughter was patting the patient down with witch hazel. Caller stated that ER released the patient and gave her some medications and such. Caller stated that a day or so later, there was a second round of reaction: the right side of the patient's face swelled up and numb and her lips were numb, like when people have a dental procedure. Lips were numb for a while. Upon completion of the medications she was given, the reactions stopped. Patient regularly saw the family doctor. She would go back to see her Doctor on Thursday. HCP Information was unknown to the caller, but caller stated that her sister had been recommended to go to her PCP and get an Epi Pen. Caller stated that knock on wood, so far, her sister was holding her own, and it had not happened again. Caller stated that she was reporting the data that her sister gave to her after having the Pfizer vaccination. Caller stated the patient had an anaphylactic reaction twice that caused her to go to the emergency room. No relevant tests were done. Caller stated that she had the dates that she had her shots and where she had her shot at. Caller stated somebody called and reported it already. Caller stated she was trying to press three but never could figure out which prompts was. Caller stated they said if she called this number, they would tell her at the medical information department if this occurrence has happened to other people, like statistics. Caller stated they tried to call this number, but it was too long of a wait. Caller stated that she did not have the vaccination card, she never asked for them. Caller does not have card with her at time of call for LOT, NDC, Expiry date. Caller stated that she knew that all the COVID vaccines are just in the Emergency Use Authorization stage and in clinical trials, but caller really thought that all manufacturers should be advertising that they would like feedback from patients. Caller has not heard anything from any of the manufacturers saying that people are welcome to reach out and report side effects. Caller states that she only knew to call because she used to be a Home Health Worker, and she thought this is an important data. Caller has never seen on any of her 19 TV channels about calling to report. Caller stated that the girl who first answered her call, read a clinical data sheet about joint pain being seen in 23% of patient's and not knowing a percentage for anaphylactic reactions, caller was wondering if this was true. Caller verified that she just wanted to ask basically that patient was not alone, if other people might have had that happen too. Caller stated that she tried to call, and it would ask another question and it would say press 1 or 2, then it would ask other questions and it would say press 1 or 2, she never got an option 3. Caller asked: how much percentage, has anyone reported this side effects weeks after the second dose. Caller was wondering if this reaction could have been from the vaccine. Investigation Assessment: No. The outcome of the events were unknown. Information on the lot/batch number has been requested.

Anaphylactic reaction; it started like a flushed feeling; She felt woozy; she still feels a little tight in her throat/she does feel tight, scratchy, and hoarse; she still feels a little tight in her throat/she does feel tight, scratchy, and hoarse; she still feels a little tight in her throat/she does feel tight, scratchy, and hoarse; she is just a little uncomfortable, just a little today, not too bad; She adds that she is having a hard time focusing; This is a spontaneous report from a contactable consumer (patient). This 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ER8731 and expiry date unknown, Solution for injection), via an unknown route on 12Apr2021 at 15:05 (at the age of 60-years-old) at single dose on left arm for COVID-19 immunization. Relevant medical history included allergies, asthma, she had anaphylaxis in the past to allergies. (Unspecified allergens). The patient added that she had issues for about a year before her surgeon had to do a surgery on her throat. She added she was fortunate because her thyroid was in her airways 14 years ago and her body exploded with allergies and her throat closed a lot. When the doctor did the surgery, the doctor opened her throat up more so that if she had another anaphylaxis it would not result in death. Concomitant medications was not reported. On the same date, after the vaccination the patient had anaphylactic reaction. She stated that happened 62 minutes, it might have been 64 minutes and also stated a few minutes after 60 minutes. The vaccination facility released her after 30 minutes at 15:35 and when she realized something was happening it was 16:10 when the patient realized what it was that she was experiencing. The vaccine facility held onto her for 30 minutes, so she got the vaccine around 15:05 and they watched her for 30 minutes. She believed it was around 65 minutes later that she started noticing something was happening. The patient started like a flushed feeling. She does not know to describe it, it was like she had a drink or something like she felt flush or something over her system like a wave or something. It was like a strong drink or something. She does not drink a lot but it was like woohooo, a wave of something, and then she felt woozy. It was not too bad at first, she was at a bank drive through and she was not driving. The patient was going to pick something up so she stopped for 5 to 10 minutes. She was on the phone with a friend. She felt woozy. The patient asked her husband to buy diphenhydramine (Benadryl). Her husband called back when she got done at the bank, and she was only 10 minutes from her house. The patient had her EpiPen with her. The patient was feeling better and she still feels a little tight in her throat and the way she explained it yesterday was that it was like someone had their finger down her throat, it was uncomfortable. She was just a little uncomfortable, just a little today, not too bad. She added that she was having a hard time focusing. Today, the patient felt tight, scratchy, and hoarse. It was not like it was last night. The patient did not receive any treatment for the events. Outcome of the events were unknown. Description of Product Complaint: Description of complaint: Consumer reporting an AE for the Pfizer COVID 19 vaccine mentions that they told her not to take the flu vaccine because she would get sick. Her flu symptoms would go on for 2-3 months. If she got the flu shot in September or October, she would not feel well through Christmas. Caller adds that she never got the flu again when she stopped the vaccine. Caller does not know manufacturer, NDC, lot or expiration date for the flu vaccine she had that made her sick Caller does not have any information about the Benadryl - and she does not have the bottle that she took that made her sleepy because she added that the only bottle she had was the one that her husband bought yesterday and it was not opened and she had not taken it. Caller added that she had not taken Benadryl in 14 years since before her surgery. Caller adds it might have been 15 years, she would have to remember that. AE identified after call completed. No NDC, lot or expiration date provided for Benadryl caller took 14 to 15 years ago. Follow-up attempts completed. No further information is expected.

anaphylactic reaction; anti kell antibodies in her blood; nausea; her left and her right hips, both, had severe pain/her right knee joint is in severe pain; she could barely walk and she couldn't bend at all; really weak; had leg aches; she couldn't stay awake/she couldn't sleep again; diarrhea; severe pain at the back of her neck with a headache; severe pain at the back of her neck with a headache; had extreme fatigue; lightheadedness; upper back pain; bloody nose; she couldn't see out of her left eye for about 2 hours; she couldn't breathe; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8731), via an unspecified route of administration, administered in Arm Right on 08Apr2021 10:41 as SINGLE DOSE for covid-19 immunisation (Age at vaccination: 60 years). Medical history included ongoing chronic obstructive pulmonary disease, ongoing chronic kidney disease and Positive ANA. The patient's concomitant medications were not reported. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8727) on 18Mar2021 for covid-19 immunisation and experienced First dose: a little bit of soreness and swelling all on the site. The patient stated that during her second dose last Thursday on 08Apr2021, she had an anaphylactic reaction and she couldn't breathe and long story short she had to go to the emergency room and she was given all kinds of epi shots and treatment and stuff and eventually she had to be kept in the ICU unit. She is not sure why she had such a severe reaction. She wanted to report that since then she has kept track every day on how she has been and she actually thought yesterday was the first day that she had felt better. She had extreme fatigue, lightheadedness, upper back pain and even a bloody nose on 10Apr2021 and also she couldn't see out of her left eye for about 2 hours. Then on 11Apr2021, she had severe pain at the back of her neck with a headache that lasted about 20 minutes and she couldn't move her neck. She had diarrhea and the only temperature she had was on 12Apr2021, it was only 99.5 degrees Fahrenheit, which isn't bad, but she had really bad diarrhea on 12Apr2021 and she took Imodium. She had a headache and slight breathing difficulties and things like that. On 13Apr2021 she had a headache, was really weak, had leg aches, fatigue that was really bad and she couldn't stay awake and her temperature that day was 98.7 degrees Fahrenheit which is normal. Then yesterday, 15Apr2021, she thought she was over all the things and that she was feeling better from the fatigue, nausea (occurred on an unspecified date), lightheadedness but she couldn't sleep again. She didn't sleep since Wednesday morning until last night finally and she only slept for an hour since Wednesday morning. She woke up on 15Apr2021 and had no symptoms except her left and her right hips, both, had severe pain and she could barely walk and she couldn't bend at all. All she could do it take Tylenol and she used a heating pad and the pain was excruciating. She went to bed last night and she did sleep for maybe a total of 2 hours and when she woke up this morning her left hip seemed to be a little better but her right hip is still in severe pain and now her right knee joint is in severe pain too. Other than that, she has no other symptoms just the joint pain. She didn't know it would go on for this long, it has been over a week now and she just wanted to let us know about this. The patient was hospitalized for the event anaphylactic reaction from 08Apr2021 to 08Apr2021. The patient underwent lab tests and procedures which included Blood typing: anti kell antibodies (doctor randomly decided to do a blood typing and they found anti kell antibodies in her blood) on an unspecified date, temperature: 99.5 degrees fahrenheit on 12Apr2021, temperature: 98.7 degrees fahrenheit on 13Apr2021. Therapeutic measures were taken as a result of anaphylactic reaction, dyspnoea, diarrhea and arthralgia. Outcome of the event anaphylactic reaction was recovered with sequelae on 09Apr2021 while outcome of the events nausea, dyspnea, arthralgia, sleep disorder and movement disorder was unknown. Outcome of the event vision impairment was recovered on 10Apr2021 while outcome of the event neck pain was recovered on 11Apr2021. Outcome of the remaining events was recovered on 15Apr2021.

Injection site arm pain for 5 days, followed by pain in left neck and left collarbone lymph node approximately 1 week after injection. 10 days after injection pain in collarbone increased, area tender and discomfort when bending forward and shrugging.

C/o facial fullness, jaw/facial heaviness, dizziness, and slight speech slurring 5 mins after vaccine. No CP, SOB, dyspnea, blurry vision, HA, redness, swelling, rash noted. A&O x 4, able to speak full sentences. VS stable: 88. 97%, 144/86, BS: 116. EKG: NSR. Neuro exam normal, muscle strength intact, facial symmetry, no facial droop noted. Advised pt to transport to hospital but pt refused transport. Observed for total 45 mins.

C/O FACIAL FULLNESS, HEAVINESS, JAW, HEAVINESS, DIZZINESS, SLIGHT SPEECH SLURRING 5 MIN AFTER VACCINE

4/9/21 Pt had URI symptoms. She was seen at a Minute Clinic. Tested negative for Sars-Co-V-2 4/12 Had continued symptoms. Test positive for SARS-CoV-2 4/15 Treated with mAB 4/17 Presented to ED w/nausea and decreased appetite. Vitals stable. No hypoxemia. +electrolyte imbalance K+ was 2.9. Given IFV and K repletion and discharged to home 4/19 Started on Zpack and Decadron as outpt 4/21 Returned to ED with increasing SOB and reported home pulse ox 75-82% w/ exertion. In ED, sats in low 90's. Tachypnea with RR24-28. CTA + for PNA and new PE Discharge summary : Pulmonary embolus Likely secondary to COVID-19 infection; HRT possibly contributing Chest CTA showed a small subsegmental pulmonary embolus in the left lower lobe. Flattening of the interventricular septum possibly indicating acute right heart strain Lovenox 1 mg/kg twice daily in the hospital and transitioned to Eliquis at discharge Patient currently on estrogen placement therapy-discontinued Covid-19 Virus Infection Date of onset of symptoms: 4/9/2021 Symptoms present on admission: Productive cough, dyspnea Date of covid positive test: 4/12/2021 Vaccination status: First dose given on 3/31/2021 Special isolation anticipated end date: 4/22/2021 if symptomatically improving Imaging: Chest CTA with interval worsening of diffuse interstitial infiltrates Oxygen requirements on admission: Room air Current oxygen requirements: Room air Medical therapy: Continue oral Decadron 6 mg daily Consultants following: None Inflammatory markers: LDH 306, ferritin 507, CRP 54.3 and D-dimer 2.07 Disharged on codeine cough syrup and Tessalon for persistent cough

Swelling of lymph nodes in left breast, armpit. Painful to touch, and unable put arm down at side for two days. This did not start until about 2 days after second vaccination. I had no adverse reactions from 1st vaccine. No other symptoms. Went away after 2-3 days of swelling. I took 2 Aleve twice a day for pain. Now it is fine.

Left arm pain starting on 4/26/21 and then redness at the site of injection started that spread outward from there. Was raised, warm, and red. On 5/4/21 slightly pink in color but still mildly warm to the touch and mildly swollen. Still painful on the left deltoid when lifting arm because of the mild site swelling that remains. Swollen lymph node in the left armpit on 4/24 and 4/25 but then resolved.

swollen node, extreme pain in my left armpit, some pressure in my chest as a result of the pain in armpit area

I woke up 4/26/21 with what looked like 2 bug bites on my left cheek. By morning of 4/27/21, it was completely swollen. I experienced itching, pain & vibrating pulses in this area. The swelling enlarged over the next several days. On 4/22/21, I had gone to my annual dermatology appt at Derm. I had to have 2 spots frozen off my face. One on my left cheek & one on my forehead. Since the swelling was occurring near the area I had frozen on my left cheek, I called Dr at Derm & was seen by them for a wound check follow up on 4/28/21. She did not know what it was but did not think it was related to her procedure. She took a culture & had it tested. Her best guess was that it was either an infection or Shingles. Since the results of the culture was going to take several days, she gave me a RX for ValACYclovir. This was just in case it was shingles. Even with this medication, the swelling, itching, burning & pulsating continued. On 5/4/21, I woke up & noticed a significant reduction in the swelling on my left cheek. I also received a follow up message from Dr that the results showed negative for Shingles. However, they have no idea what caused the issue on my left cheek. She recommended that I notify CDC as it may or may not be related to the Covid shot.

blood pressure (BP) went over 269/149, it made my blood pressure go up.; left side of middle back had some excruciating pain; Nauseous; I had a major body ache; it started hurting the minute she put it in my arm/Excruciating pain; pain in the neck down the arm; I had a major body ache; it started hurting the minute she put it in my arm/Excruciating pain; pain in the neck down the arm; I had a major body ache; it started hurting the minute she put it in my arm/Excruciating pain; pain in the neck down the arm; I got a mark on my arm, my arm started swelling; This is a spontaneous report from a contactable consumer reporting for herself. A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EW0164/expiration date: 30Jun2021), via an unspecified route of administration, on 16Mar2021 (at the age of 60 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EN6208/expiration date: not provided), via an unspecified route of administration, on 16Mar2021 (at the age of 60 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION and experienced a headache. Relevant ongoing medical history included Diabetes Type II from about 5 years ago in 2016, fibromyalgia diagnosed about 6 years ago in 2015, and high blood pressure. Concomitant medication included gabapentin from an unspecified date at 600mg 3x/day for fibromyalgia, empagliflozin (JARDIANCE) from an unspecified date at 10mg 1x/day for Diabetes Type II, clonidine from an unspecified date at 30 mg, 2x/day for high blood pressure and labetalol from an unspecified date at 200 mg, 2x/day for high blood pressure. On an unspecified date in Mar2021, the patient experienced her blood pressure (BP) went over 269/149, it made my blood pressure go up, which required hospitalization overnight. Also on an unspecified date in Mar2021, the patient experienced a mark on her arm, and her arm started swelling. On 16Mar2021, the patient experienced major body ache, described as it started hurting the minute she put it in her arm, excruciating pain and pain in the neck down the arm, and she was nauseous. She described that she couldn't get out of the bed because of so much body pain. On 21Mar2021, the patient experienced her left side of middle back had some excruciating pain. The clinical course was as follows: I had a major body ache with the second vaccine. I did not have any problem except the headache with the first one but I took second one on this past Friday, I got very nauseous, it started hurting the minute she put it in my arm, which is on the left side. I got a mark on my arm, my arm started swelling. Saturday morning I couldn't get out of the bed because of so much body pain, Sunday my left side my middle back I had some excruciating pain I rushed to the doctor to the ER, my BP went over 269/149 and they had to give me pain medicine and BP medicine to reduce the blood pressure. I made it to the doctor and I'm getting medicine for the pain. I woke up in the morning there's pain in the neck down the arm and it's aching, the side I got the shot, the side is hurting, excruciating pain in my arm. I had to go to the ER straight to my doctor's office, they wouldn't let me drive or anything straight to the ER where they administered 2 doses of pain medicine and 3 doses of blood pressure, the pain was so intensive it made my blood pressure go up, the doctor said all of this was coming from the vaccine." Relevant lab data on an unspecified date in Mar2019 included blood pressure 269/149. The patient received treatment for the events blood pressure high, body pain, neck pain, pain in arm, and back pain. The outcome of the events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021446955 same reporter/patient/drug, different event in separate dose

Patient developed bilateral cervical lymphadenopathy on 4/21. She was started on Augmentin 4/23 without improvement. At time of my exam on 4/27/21 she had a large right fixed submandibular neck mass. CBC 4/27/21 showed mild monocytosis, and US 4/27/21 showed bilateral hypoechoic LNs (R>L with largest node adjacent to R submandibular gland 3.2cm in size) concerning for systemic abnormality such as lymphoma or metastatic disease. Patient was switched to clindamycin on 4/27/21, but developed drug rash, so was ultimately treated with 10-day course of Augmentin and Bactrim with complete resolution of lymphadenopathy when next examined 5/6/21.

Moderna COVID-19 Vaccine EUA: during telehealth encounter nine days after vaccination patient reports a lump under the collarbone. The provider documented arm redness and a diagnosis of cellulitis and prescribed antibiotics.

SORE THROAT, COUGH, NASAL CONGESTION, LEG SWELLING, BURNING FEELING TO BOTTOM OF BILATERAL SOLE OF FEET

Itching on her hands and her feet; Chills; Clammy; Sensitivity to light; inflammation; Under her eyes it is swollen; She was having severe diarrhea; having severe dry heaves; vomiting bile; It had dehydrated her/lead to dehydration; Her throat closing up and it being sore from vomiting and dry heaving; couldn't swallow to get any fluids in; Her throat closing up and it being sore from vomiting and dry heaving; she was struggling with having a dry mouth; puffiness; Headache; severe muscles aches/Muscles pain; feeling nauseous; Was a little warm on her arms/ it was warm to the touch; it just looked like a bee sting and it wasn't super sore; sensitive to the touch; It had big red spots; had a little tiredness; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 16Apr2021 at 10:00 (at age of 60 years old, Lot Number: EW0ISO) as single dose for covid-19 immunization. Medical history included she had lupus, sjogren's syndrome. The patient's concomitant medications not reported. The patient previously took Pneumonia Vaccine on 04Mar2021 (Anatomical Location: Left arm); took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 26Mar2021 at 10:00 (at age of 60 years old, Lot Number: the lot number starts with ER something and then it ends with a 3) as single dose for covid-19 immunization; took azathioprine for lupus and had allergic reaction; took belimumab (BENLYSTA), subcutaneous from an unspecified date (Lot Number: PV7G; Expiration Date: Jun2023, NDC: 49401-088-01, Number on the side: 0147098) to an unspecified date, self injection once a week for lupus. She gets it through the VA and it is subcutaneous use and the manufacturer is company. she was immunocompromise, she had lupus, so she was off of her medication (BENLYSTA) for a month per the CDC guidelines. She wanted to let Pfizer know that as well. For her first COVID vaccine she was originally scheduled to go 6 to 7 days after she had her pneumonia shot and they told her that she would have to wait 2 weeks before having her COVID shot and she did. Other than that she had followed the guidelines and she had been able to take her regular medications but she had to stop her Benlysta because of her immune system and everything. She had been following through on what the CDC has said. Patient stated that she just did a follow up with her doctor because of what happened after her second Pfizer COVID vaccine and her doctor recommended her to let Pfizer know about the side effects that she was having. On Friday 16Apr2021 she had her shot at 10 AM and it was no big deal, it was a little warm on her arms. She stated that it just looked like a bee sting and it wasn't super sore, it was warm to the touch and sensitive to the touch. It had big red spots and there has really been no change since it began. It looks about the size of a bee sting and it was still there. She had a little tiredness and she was not hungry but when she woke up at 06:40 the next morning (17Apr2021) on Saturday she was having severe dry heaves and vomiting bile and she could not get it under control. It had dehydrated her and she was having severe muscles aches. She had the severe dry heaves and the vomiting that lead to dehydration and then she went to the emergency room and she got replenished and they had given her something for feeling nauseous and eventually she was released 3 to 4 hours later. They gave her pills as well so she was doing well now and she hasn't done anything since she went to the emergency room with the vomiting and feeling nauseous. She went there about 1030 to 1040. Before she went she couldn't stop and she told herself that if it didn't stop on the 5th time then she was going to go to the emergency room and it got really bad so she had to call 911 to come and get her. Then she was having severe diarrhea on Sunday (18Apr2021) and the only way she could stop that was for her husband to pick up antidiarrheal pills. That only went away because of the medicine from the pharmacy. She had the over the counter medicine and she took Imodium. She hasn't been eating a lot so she hasn't had a bowel movement since she took that medication. When she had diarrhea there was no substance, it was very watery. And now today (unspecified date) she was having another reaction that she was seeing and it was just itching on her hands and her feet. She had been continuing to take the Benadryl and something that they gave her in the emergency room and she had taken Tylenol for the little headache that she has had. She had a slight headache and she was still taking Tylenol like they had recommended. This began the same time as she was vomiting on 17Apr2021 when she was going through all of that she had the slight headache. But her biggest concern was during this time when initially on Saturday (17Apr2021), her throat closing up and it being sore from vomiting and dry heaving, she was having the dry heaves her airway closed shut and she couldn't swallow to get any fluids in. Her concern was that the back of her throat was killing her and it was totally closed up so she had to go to the emergency room. She had recognized this because in the past she has had a medication where she had an allergic reaction (she thinks it is the medication that they gave her for lupus because she has been on several different things. She thinks azathioprine but she can't recall exactly but she thinks that might of been the one that did it to her) and it had closed her esophagus up the same way like this. This time it got worse to where she couldn't even swallow water no less a pill. This was on 17Apr2021. When she went to the emergency room they gave her the hydrocortisone to take it down and she actually had felt better while she was waiting for the saline drop. She was able to swallow when her airway was opened again by the time they treated it with the hydrocortisone. Around 16:00 she was better when she left the emergency room that same day 17Apr2021. She doesn't really have a sore throat, it is pretty fine. It seems to be okay she thinks that once the dry heaves and all that stopped it helped to relax that. She was a little raspy from the whole thing and she was struggling with having a dry mouth but that even had been resolved as far as her throat. She had no other reactions than what she explain but she also had a lot of muscles pain but that was to be excepted because it says that on all that she has read. She had had all of the reactions listed except for fever. She had had chills and then when clammy and then was clammy and had chills. She had all of those side effects listed on the sheet and when she went on Saturday following her vaccine to the emergency room most of the side effects were treated in emergency room. They gave her Pepcid, hydrocortisone through her IV and gave her Zofran for the vomiting and they said to keep taking acetaminophen. They gave her cetirizine for allergy or the itching or whatever and they also gave her famotidine which she thinks is Pepcid. Since being off the lupus drug she was getting her symptoms again such as sensitivity to light, inflammation and the dry heaves didn't help so under her eyes it was swollen and she just takes it as it was because she was not on her medication and she had something else injected inside of her. Also, she had Sjogren's disease too so her eyes were already drier than normal and she had had puffiness since 17Apr2021 when she was vomiting. She just wanted to make sure that Pfizer got that information because she didn t see that listed. The only side effect she was related was the swollen glands and she has glands in her throat but she wanted to be sure that Pfizer had that data just in case if it could help someone else. Again, she wants to reiterate that with her first dosage she had no problems. She couldn t even see the mark and all of this is stemming from the second dose of the COVID vaccine. The outcome of the events "Dry heaves, Bilious vomiting, Dehydration, Her throat closing up and it being sore from vomiting and dry heaving, Unable to swallow, Dry mouth, Nauseous" was recovered on 17Apr2021. The outcome of events "Feeling of warmth, Vaccination site pain, Hyperaesthesia, Vaccination site erythema, Tiredness" not recovered. The outcome of the event "Headache" was recovering. The outcome of other events was unknown. No follow up attempts are needed. No further information is expected.

High fever of 107.5 degree Fahrenheit; Dizziness; Nausea; Headache; Fatigue; Joint and muscle pain; Joint and muscle pain; Blurred vision; Persistent cough; My glands started hurting; My ears hurt specially on the right where the shot was given everything is the worse; Sore throat; Jaw pain; my neck under my chin is swollen and painful; my neck under my chin is swollen and painful; Abscess in my gum and swelling and blisters in my mouth; Abscess in my gum and swelling and blisters in my mouth; Abscess in my gum and swelling and blisters in my mouth; This is a spontaneous report from a contactable consumer(patient). A 60-years-old female patient received first dose of bnt162b2 (BNT162B2, solution for injection, Lot Number: EW016) via an unspecified route of administration in right arm on 19Apr2021 at 17:15 as SINGLE DOSE for covid-19 immunization. Patient was 60 years old at the time of vaccination. Medical history included rheumatoid arthritis, COPD, chronic empyema, asthma, chronic bronchitis, gastritis, irritable bowel syndrome, blood pressure high and digestive disorder, all from an unknown date and unknown if ongoing. Concomitant medications included quetiapine fumarate (SEROQUEL), POTASSIUM CHLORIDE, albuterol sulfate (ALBUTEROL), budesonide, formoterol fumarate (SYMBICORT), FLUNISOLIDE, FLUOXETINE, HYDROCHLOROTHIAZIDE, IPRATROPIN, METOPROLOL, MONTELUKAST, PANTOPRAZOLE, FAMOTIDINE and LOSARTAN, all taken on unspecified date for unknown indication. In Apr20, the patient had high fever of 107.5 degree fahrenheit, dizziness, nausea, headache, fatigue, joint and muscle pain, blurred vision, persistent cough, my glands started hurting, my ears hurt specially on the right where the shot was given everything was the worse, sore throat, jaw pain and neck pain, my neck under my chin is swollen and painful, abscess in my gum and swelling and blisters in my mouth. On unspecified date, the patient underwent lab tests and procedures which included body temperature 107.5 degree F, blood test which she does every year and she had a follow up every 6 months. Outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

body aches; Headache; sleepiness; Fatigue; Chills; body temperature: 97.5-98.7; Ear pain; sense of fullness in ears and lymph nodes; sense of fullness in ears and lymph nodes; I feel pretty awful after this first dose.; This is a spontaneous report from a contactable Nurse reporting for herself. A 60-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm left on 03Feb2021 17:40 (Batch/Lot Number: EL9269) as single dose at the age of 60-year-old for COVID-19 immunisation, offered at the health system she works for and administered at hospital. Medical history included ongoing acoustic neuroma on 8th cranial nerve left side, on the side she felt the intense ear pain, diagnosed 2007-2008, thyroid cancer from 2004 and thyroid removed, her hormone levels are normal, COVID-19 in Dec2020. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of BNT162B2. No prior vaccinations (within 4 weeks). There were no concomitant medications. The patient experienced I feel pretty awful in Feb2021 with outcome of unknown, ear pain on 03Feb2021 with outcome of not recovered, sense of fullness in ears and lymph nodes on 03Feb2021 with outcome of recovered on 05Feb2021, body aches on 04Feb2021 with outcome of not recovered, headache on 04Feb2021 with outcome of recovering, sleepiness on 04Feb2021 with outcome of not recovered, fatigue on 04Feb2021 with outcome of not recovered, chills on 04Feb2021 with outcome of not recovered, body temperature: 97.5-98.7 on 04Feb2021 with outcome of unknown. The events did not require a visit to Emergency Room or Physician Office. The course of events was as follows: Patient expected that since she just had COVID in Dec2020, she thought her response to the vaccine would not be severe because she already had some immunity from the infection. The evening of the vaccine, on 03Feb2021, she experienced ear pain and a sense of fullness in her ears and lymph nodes. The ear pain was almost immediate after vaccination. On 04Feb2021, the next day, she woke up with a headache. It was an unusual headache. It did not go away with Tylenol. Then about halfway through the day, she developed significant body aches like when she had COVID. She also experienced extreme sleepiness like when she had COVID too. She took Motrin and had to lie down during her work day. The Motrin did help. Then mid morning 04Feb2021, she got a chill. She couldn't get warm enough. She had no fever. She checked multiple times. Her temps ranged from 97.5-98.7 on 04Feb2021. She experienced fatigue. She did not know the seriousness for any of the side effects she experienced. As of 05Feb2021, her headache has improved. She was still experiencing sleepiness and fatigue. The chills she developed mid day. She had not them right now. She has better and worse moments just like when she had COVID. She was worried about the second one. The patient underwent lab tests and procedures which included body temperature: 97.5-98.7 on 04Feb2021, COVID-19: positive in Dec2020. No other relevant tests. Therapeutic measures were taken as a result of headache and sleepiness. A Product Complaint was filed.

Patient reports after first dose on 4/8/21 they had red rash on left arm, itchiness at site of injection, then itchiness spread over face and body and lasted for one week. Then on 4/28/21 patient had swelling in their thighs and went to the ER and was diagnosed with Urinary Tract Infection. Patient reports after second dose of pfizer on 5/8/21 getting headache, joint pain, fever, cough, itchiness all over body/face, under right armpit. Symptoms started between 4-7pm on Saturday 5/8/21. Patient reports having fatigue on Sunday 5/9/21 and Monday 5/10/21. Patient self treated at home and took tylenol, ketorolac, and benadryl for symptoms.

1st noticed red spots on both arms below the elbows and on my chest on 4/7/21. I had an upcoming appt. w/ a dermatologist on Friday 4/16, so I waited to see him before doing anything. He wasn't sure what it was, but thought with the location it could be Polymorphic Light Eruption. Was given TRIAMCINOLONE ACETONIDE CREAM 0.1% for the itch. On Monday 4/19 I call the dermatologist to ask if Sunlight Eruption would spread and was told no. It had spread to my thighs, calves, feet, back and the rest of my arms by this time and the itching was uncontrollable. On Monday the 19th I started my version of a dose pack with 30 mg of Prednisone for 6 days.

Anaphylaxis (lip swelling, generalized hives, shortness of breath) within 30-45 minutes of vaccine. Because patient has a history of anaphylaxis, she was able to treat it by giving herself epinephrine, oral antihistamines, and nebulizer treatment with levalbuterol every few hours for the next 3 days. She recovered and did not report this until 5/12/21.

severe systemic itching, facial swelling; hives on back; flushing on chest; face; arms; hands; severe systemic itching, facial swelling; hives on back; flushing on chest; face; arms; hands; severe systemic itching, facial swelling; hives on back; flushing on chest; face; arms; hands; severe systemic itching, facial swelling; hives on back; flushing on chest; face; arms; hands; This is a spontaneous report from a contactable consumer (patient). A 60-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 18Mar2021 10:30 (Batch/Lot Number: unknown) as single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient medical history was not reported. Concomitant medications included chlorthalidone; diltiazem; doxepin; famotidine (PEPCID AC); fexofenadine hydrochloride (ALLEGRA). The patient experienced severe systemic itching, facial swelling, hives on back, flushing on chest, face, arms, hands on 18Mar2021 10:45. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, life threatening illness (immediate risk of death from the event). Treatment received for the adverse events included diphenhydramine (BENADRYL) and steroids. The outcome of events was recovered in 2021. Information on the batch number has been requested.

Rash on face; Rash on neck; swollen tongue; swollen lips; swollen face; itchy hands/Itchy; Lip tingling; Swelling of the arms; swelling and tingling; swelling and tingling; This is a spontaneous report from a Pfizer sponsored program support. A contactable consumer (patient) reported that a 60-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6206, Expiry Date of Covid-19 Vaccine: Unknown), via an unspecified route of administration on 05Mar2021 03:00 PM in the left arm at 1st dose, single for COVID-19 immunisation. The patient age at vaccination was 60 Years. Medical history included vertigo, migraines, Sjogren's syndrome (diagnosed about 10 year ago), thyroid cancer, diabetes and high blood pressure. known allergies included Latex, daptomycin, ceftaroline fosamil, doxcycline, fremanezumab-vfrm. The patient had second shingles shot with Shingrex and she got a few chicken pox rash around the shot itself but that's pretty normal, the onset age was 58 years and at the age of 60 years old at the time of the last flu vaccine, and has received multiple flu shots in the past with unknown brand of flu vaccine. On 05Mar2021 03:15 PM, the patient experienced rash on face, rash on neck, swollen tongue, swollen lips, swollen face, itchy hands/Itchy, lip tingling, swelling of the arms and swelling and tingling. The report received as, on 05Mar2021, received her first Pfizer Covid vaccine dose. 10 minutes later patient had an allergic reaction which included swelling of her lips and tongue, rash on her body, and swollen and itchy hands. The patient reported a second reaction on 07Mar2021, which were the same symptoms as the first and then another (3rd) reaction on 12Mar2021. She has been to the ER 3 times and was prescribed oral steroids and was given a steroid injection each time. She feels that each time the steroid injection wears off, the symptoms return. She wants to know how long this side effect could last. The patient had allergic reactions to it and patient as now had three allergic reactions to it and was wondering have you had other people that have had multiple allergic reactions if the steroid they were given has run out. The patient was given Decadron on day 1 and it ran out in a couple of days because it's a short-acting steroid, then they gave her the longer-acting five-day steroid, betamethasone, patient was taking oral, but it's not as good as the beta methasone shot, patient was asking to have we had other people who have needed more steroids even though the shots have stayed in their system. She wants to know if she is going to have more allergic reactions down the road as the steroids' run out. The patient had three injectable rounds of steroid shots on 05Mar2021, 07Mar2021, and 12Mar2021 and had two courses of oral steroids on 05Mar2021 and 12Mar2021. The patient said 10 to 15 minutes after receiving the shot, had lip swelling and tingling, rash on face, then within a half hour started to swell up. The patient stated that at the center where she got her vaccination, they gave her Benadryl but noticed her symptoms getting worse, packed her up in an ambulance to hospital, and there they gave her Decadron and Pepcid and more Benadryl. The patient states it wasn't anaphylaxis but was an allergic reaction. This was on 05Mar2021, right after getting the shot. It is explained the events improved when given the medications at the ER. She still gets a little itchy once in a while but she is on oral steriods and 50 mg of Benadryl every day. This is her third injectable and second round or oral steriods. Caller has not NDC, Lot, or Expiry for those product as they are from the pharmacy. She also has no NDC, Lot, or Expiry for the Benadryl being used, it is also from the pharmacy. The patient informed as, this was her first Covid vaccination and she was not getting the second one. The patient husband and daughter have had their Covid vaccines and had no reactions at all. The patient was not had covid prior and post vaccination. The patient was not received other vaccine in four weeks. Abd received many daily prescriptions and supplements medications in two weeks. Adverse events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of events and treated with Benedryl, Steroids, Pepcid. Outcome of the events itchy hands/Itchy, swelling of the arms, swelling and tingling was unknown, for remaining events outcome was recovering. Follow-up attempts are required. Further information was expected.

Patient reports 7 weeks prior to her 1st dose of pfizer she received a cosmetic filler in her face. on 5/4 the location where the filler was placed began to swell to the size "of a ping pong ball." As of today (5/21) it has still not resolved. Patient is taking oral prednisone.

2.5 days after my second dose, the gum behind my right wisdom tooth & inside cheek became swollen, which I have never experiences. After 2 weeks, my cheek was basically ok & about 2.5-3 weeks the swelling of my gum subsided. I did go to the dentist the weekend after my vaccination & she didn't find any dental issues. I took Tylenol for 6 days, but it was not really helpful, then Advil which reduced the swelling immediately! Also, I used hot/cold compresses outside of my cheek & warm tea bags on my gum.

went in for a CT scan for a fracture and the doctors noticed swollen lymphodes on the left side, went in for another scan last Thursday (5/21/2021) and they were still swollen

tiredness; headache; muscle pain; feeling unwell; swollen lymph nodes; hives with pain in them; pain; I got Shingles; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2 (BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in right arm on 03Mar2021 13:15 (also reported 15Mar2021 13:30) (Batch/Lot Number: ENG198) (at the age of 60 years old) as 1st dose, single for COVID-19 immunisation. Medical history included stage 3 kidney disease and thyroid disorder. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was in doctor's office/urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that patient had other medications received within 2 weeks of vaccination (unspecified). On 03Mar2021, the patient experienced tiredness, headache, muscle pain, feeling unwell, swollen lymph nodes, hives with pain in them, pain and she got shingles. The events resulted in doctor or other healthcare professional office/clinic visit. The treatment received for the adverse event included Valtrex, anti biotic and creme. 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 event shingles was unknown; and not recovered outcome for the other events. No follow-up attempts are needed. No further information is expected.

Really bad stiff neck; lump in the neck/lymph node that is a lump in her neck above the collar bone on left side; body aches/Bones aching kind of like the beginning of COVID; headache; having a fever of 101F; Sick; This is a spontaneous report from a contactable consumer. This female consumer reported for herself that: Serious: No Patient characteristics: Sex: Female Reaction(s)/Event(s): MedDRA version for reaction/event term LLT: N/A Reaction/event in MedDRA terminology (LLT): Medical Information Potential AE Drug(s) Information: Characterization of drug role: SUSPECT Proprietary medicinal product name: PFIZER-BIONTECH COVID-19 VACCINE Active Substance Information Active Drug substance names: PFIZER-BIONTECH COVID-19 VACCINE Narrative case summary and further information: Case narrative: Originating AE Request: REQ-# Attachments: 1 Reporter Subtype: Patient PQC Present: No AE Present: Yes Request Name: REQ-# Product: PFIZER-BIONTECH COVID-19 VACCINE Question: Caller said she has been transferred from hospital and has reported the AEs (possible duplicate AE); Caller got the first dose of the Pfizer BioNTech COVID-19 vaccine on 25Jan2021 3:22PM in (State name). The next day (26Jan2021), she ended up having a fever of 101F, stiff neck, headache, lump in the neck, and body aches. Her fever broke the next day (27Jan2021) and the other symptoms slowly went away also that day. She mentioned that she had COVID-19 in Jul. She got hospitalized because of pneumonia. She got discharged for that then 14 days later she was hospitalized again because of her high grade fever and collapsed left lung. She also mentioned that she has an autoimmune disease "immunoglobulin anemia" and she has infusions once a week with a medication called "Hiventa". She said that she came from a family of doctors and her uncle who is an immunologist recommended her to call Pfizer to see if we do have recommendations about taking the second dose of the Pfizer vaccine considering her conditions. (This REQ pertains to her AEs after her first dose) Request Name: REQ-# Product: PFIZER-BIONTECH COVID-19 VACCINE Question: Caller mentioned that she had COVID-19 in Jul. She got hospitalized because of pneumonia. She got discharged for that then 14 days later she was hospitalized again because of her high grade fever and collapsed left lung. She also mentioned that she has an autoimmune disease "immunoglobulin anemia" and she has infusions once a week with a medication called "Hiventa". She said that she came from a family of doctors and her uncle who is an immunologist recommended her to call Pfizer to see if we do have recommendations about taking the second dose of the Pfizer vaccine considering her conditions. Request Name: REQ-# Product: PFIZER-BIONTECH COVID-19 VACCINE Question: Caller said her uncle who is an immunologist recommends her to go the Emergency Room if her fever breaks to 103F or higher because her lung might collapse. She wanted to know if Pfizer has any recommendations on that. Follow-up (03Feb2021): This is a follow-up spontaneous report from a contactable consumer. This 60-year-old consumer reported for herself that: Patient characteristics: Age at time of onset of reaction/event: 60 Age at time of onset of reaction/event (Unit): YEAR Weight (kg): 58.97 Height (cm): 164 Sex: Female Relevant medical history and concurrent conditions: Structured information (Patient episode name): COVID-19 Patient Medical start date: Jul2020 Patient Medical comments: Verbatim: COVID-19 Relevant medical history and concurrent conditions: Patient Medical start date: 2013 Patient Medical continuing: Yes Patient Medical comments: Verbatim: Connective tissue disease Relevant medical history and concurrent conditions: Structured information (Patient episode name): Gamma globulinemia Patient Medical start date: 2013 Patient Medical continuing: Yes Patient Medical comments: Verbatim: Gamma globulinemia Relevant medical history and concurrent conditions: Patient Medical start date: 18Nov2020 Patient Medical continuing: No Patient Medical end date: 18Nov2020 Patient Medical comments: Verbatim: Bladder surgery Relevant medical history and concurrent conditions: Structured information (Patient episode name): Pleurisy Patient Medical start date: 2016 Patient Medical continuing: No Patient Medical end date: 2016 Patient Medical comments: Verbatim: Pleurisy Relevant medical history and concurrent conditions: Structured information (Patient episode name): Pneumonia Patient Medical comments: Verbatim: Pneumonia Relevant medical history and concurrent conditions: Patient Medical start date: 2016 Patient Medical continuing: No Patient Medical end date: 2016 Patient Medical comments: Verbatim: West Nile Virus Relevant medical history and concurrent conditions: Patient Medical start date: 2015 Patient Medical comments: Verbatim: Sick with all kinds of weird viruses Reaction(s)/Event(s): Reaction/event as reported by primary source: Sick Date of start of reaction/event: Jan2021 Outcome of reaction/event at the time of last observation: UNKNOWN Reaction(s)/Event(s): Reaction/event as reported by primary source: Bones aching kind of like the beginning of COVID Date of start of reaction/event: Jan2021 Outcome of reaction/event at the time of last observation: RECOVERED/RESOLVED Reaction(s)/Event(s): Reaction/event as reported by primary source: Really bad headache Date of start of reaction/event: Jan2021 Outcome of reaction/event at the time of last observation: RECOVERED/RESOLVED Reaction(s)/Event(s): Reaction/event as reported by primary source: Fever Date of start of reaction/event: Jan2021 Outcome of reaction/event at the time of last observation: RECOVERED/RESOLVED Reaction(s)/Event(s): Reaction/event as reported by primary source: Really bad stiff neck Date of start of reaction/event: Jan2021 Outcome of reaction/event at the time of last observation: RECOVERED/RESOLVED Reaction(s)/Event(s): Reaction/event as reported by primary source: lymph node that is a lump in her neck above the collar bone on left side Date of start of reaction/event: Jan2021 Outcome of reaction/event at the time of last observation: UNKNOWN Results of tests and procedures for investigation of the patient: Date: Nov2020 Test: Bloodwork Result: Enlarged red blood cells More information available (Y/N): No Results of tests and procedures for investigation of the patient: Date: Jan2021 Test: Bloodwork Result: Normal More information available (Y/N): No Drug(s) Information: Characterization of drug role: SUSPECT Proprietary medicinal product name: Pfizer COVID-19 vaccine Batch/lot number: EL9263 Dosage text: Unknown strength/volume/dose injection to left arm 15:22 Pharmaceutical form (Dosage form): Injection Indication for use in the case: Vaccination Date of start of drug: 25Jan2021 Action(s) taken with drug: UNKNOWN Drug(s) Information: Characterization of drug role: CONCOMITANT Proprietary medicinal product name: Hizentra Dosage text: 9 grams subcutaneously once weekly Indication for use in the case: Gamma globulinemia Date of start of drug: 2014 Narrative case summary and further information: Case narrative: Submitted by Call Centre 1 Ref: #; ININ: # Selected Report Type: Initial Patient Ethnicity: (Ethnicity withheld) Is the patient also the reporter? Yes Reporter type: Consumer or other non-health professional Reporter telephone: (Phone withheld) Primary / Prescribing Healthcare Professional Info HCP name: Dr. (Name) HCP Occupation/Specialty: Primary Care Physician HCP postal address: (Address withheld) HCP telephone: (Phone withheld) Dates for Sick: (From: Jan2021 To: Unknown) Dates for Bones aching kind of like the beginning of COVID: (From: Jan2021 To: Unknown) Dates for Really bad headache: (From: Jan2021 To: Unknown) Dates for Fever: (From: Jan2021 To: Unknown) Dates for Really bad stiff neck: (From: Jan2021 To: Unknown) Dates for lymph node that is a lump in her neck above the collar bone on left side: (From: Jan2021 To: Ongoing) Is Pfizer COVID-19 Vaccine a Pfizer product? Yes Pfizer COVID-19 Vaccine manufacturer: Unspecified Dates for Pfizer COVID-19 Vaccine: (Start: 25Jan2021 Stop: Unspecified) NDC number of Pfizer COVID-19 Vaccine: Unknown Expiry Date of Pfizer COVID-19 Vaccine: Unknown Other Products: Yes Dates for Concomitant Products Hizentra: (Start: 2014 Stop: Ongoing) Patient History: Yes Patient history: COVID-19 (From: Jul2020 To: Unspecified) Additional Information for Other Conditions: Hospitalized in Jul2020 for this with double pneumonia, left lung collapsed. Because had double pneumonia and collapsed lung she has to see a Pulmonologist for another chest X-ray to see the damage that COVID has done. Patient history: Connective tissue disease (From: 2013 To: Ongoing) Patient history: Gamma globulinemia (From: 2013 To: Ongoing) Additional Information for Other Conditions: 2013 all her cells, everything collapsed: B cells, T cells, C cells were all below average; that's when they realized she had autoimmune disorder Gamma globulinemia and connective tissue disease. Patient history: Bladder surgery (From: 18Nov2020 To: 18Nov2020) Patient history: Pleurisy (From: 2016 To: 2016) Additional Information for Other Conditions: Thinks initially had this in 2016.Hospitalization related to this. Patient history: Pneumonia (From: Unspecified To: Unspecified) Additional Information for Other Conditions: Had pneumonia like 7 times so she is susceptible. Because of this history she has gotten the Pneumonia vaccine and Prevnar 13 vaccine. Prevnar 13 when she was too young, in her 50s like 4-5 years ago because had pneumonia so many times. Prevnar 13:Lot/NDC/Expiry: Unknown, does not have product. She thinks there is a Prevnar 23 now she will have to look into. Patient history: West Nile Virus (From: 2016 To: 2016) Additional Information for Other Conditions: Hospitalized for this. Patient history: Sick with all kinds of weird viruses (From: 2015 To: Unspecified) Additional Information for Other Conditions: Started getting sick a lot with all kinds of weird viruses that she was hospitalized for starting when she moved to (State name) around 2015 Investigation Assessment: Yes Additional Context: This consumer was administered her first dose of Pfizer COVID-19 Vaccine 25Jan2021. She reported before she got Pfizer COVID-19 Vaccine she had history of COVID in Jul2020. After administered Pfizer COVID-19 Vaccine she initially started getting sick unknown date and time, but either around night of 25Jan2021 or 26Jan2021. Sick further described as: started with her bones aching kind of like the beginning of COVID, then really bad headache, then fever. She also had a really bad stiff neck that went away. Fever started at night she thinks 26Jan2021; Temperature reached 101 degrees Fahrenheit; by the next day when she woke up her fever broke. She still had a little bit of a headache. As the day went on all the sick symptoms went away. She still has a lymph node that is a lump in her neck above the collar bone on left side-that is the only thing still ongoing with unknown outcome. The bones aching kind of like the beginning of COVID felt like she did in the beginning when she had COVID in Jul2020. She recovered completely from all the other events on unknown dates. She is not sure if she should call her surgeon about the lymph node that is a lump in her neck. She thought it was kind of unusual to have that kind of a reaction to the first dose of Pfizer COVID-19 Vaccine; she called to ask if these events are normal with the first dose of the Pfizer COVID-19 Vaccine; and if there are recommendations regarding getting the second dose relative to these events. Reporter: Email: Unknown. Primary: Email: Unknown. Pfizer COVID-19 Vaccine: NDC/Expiry: Unknown, this is not on the CDC vaccine record card she was given. Second dose is scheduled 15Feb2021 Unknown if dose will continue unchanged at this point Primary/Prescriber: Email: Unknown. VACCINE SUPPLEMENTAL FORM: Patient Details: Patient Last Name: (Name) Patient First Name: (Name) Address: (withheld) City: (withheld) State: (withheld) Zip Code: (withheld) Phone: (withheld) Patient Age at Time of Vaccination in Years: 60 Pfizer Suspect Vaccine and Vaccination Details: Vaccine Lot Number: EL9263 Vaccine Lot Expire Date: Unknown, not on CDC vaccine record card Time the Vaccination Was Given (24 hour clock): 15:22 Anatomical Location of Administration of Pfizer vaccine considered as suspect: Arm Left For US Only: Vaccination Facility Type: They turned a sports stadium parking lot into a vaccination center For US Only: Vaccine Administered at Military Facility?: No For US Only: Vaccination Facility Address: Facility Name: (withheld) Address: (withheld) City: (withheld) Zip Code: Unknown State: (withheld) Phone: Unknown History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available): None. Additional Vaccines Administered on Same Date of the Pfizer Suspect: Vaccines If applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect: None. Adverse Event (AE) Details: Provide the time of onset of AE(s): Adverse Event: Sick Time of Onset (24-hour clock): Unknown Adverse Event: Bones aching kind of like the beginning of COVID Time of Onset (24-hour clock): Unknown Adverse Event: Really bad headache Time of Onset (24-hour clock): Unknown Adverse Event: Fever Time of Onset (24-hour clock): Unknown Adverse Event: Really bad stiff neck Time of Onset (24-hour clock): Unknown Adverse Event: lymph node that is a lump in her neck above the collar bone on left side Time of Onset (24-hour clock): Unknown Did any AE(s) require a visit to: Emergency Room?: No Physician Office?: No If the patient was hospitalized, how many days was the hospital stay?: Not applicable, not hospitalized. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): None. AE(s) following prior vaccinations: None. Patient's Medical History (including any illness at time of vaccination) Provide other relevant medical history including but not limited to these conditions: diagnosed allergies, compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity: All relevant information documented in formal fields of other conditions. Family Medical History Relevant to AE(s): Father has heart disease; has a defibrillator; pacemaker and celiac disease. Cancer runs in her family. All of her sisters have had breast cancer, all of her cousins have had breast cancer, all 3 of her aunts died of breast cancer; and another aunt died of leukemia myeloma acute. Relevant Tests: She takes care of herself and has mammograms. She had some bloodwork done in Nov2020 before bladder surgery, and that bloodwork showed enlarged red blood cells. They did follow up bloodwork in Jan2021 and everything came back normal with that bloodwork. Because cancer runs in her family so strongly she is under the care of a hematologist and cancer specialist. She has bloodwork done every 3 months because when providers looked at her history and hospital history her bloodwork is all over the place, up and down historically. Is there a Product Complaint: Yes Description of Product Complaint: This consumer was administered her first dose of Pfizer COVID-19 Vaccine 25Jan2021. She reported before she got Pfizer COVID-19 Vaccine she had history of COVID in Jul2020. After administered Pfizer COVID-19 Vaccine she initially started getting sick unknown date and time, but either around night of 25Jan2021 or 26Jan2021. Sick further described as: started with her bones aching kind of like the beginning of COVID, then really bad headache, then fever. She also had a really bad stiff neck that went away. Fever started at night she thinks 26Jan2021; Temperature reached 101 degrees Fahrenheit; by the next day when she woke up her fever broke. She still had a little bit of a headache. As the day went on all the sick symptoms went away. She still has a lymph node that is a lump in her neck above the collar bone on left side-that is the only thing still ongoing with unknown outcome. The bones aching kind of like the beginning of COVID felt like she did in the beginning when she had COVID in Jul2020. Pfizer COVID-19 Vaccine: NDC/Expiry: Unknown, this is not on the CDC vaccine record card she was given. Follow-up (13May2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.

allergic reaction; she couldn't get warm; chills; rash all over; swelling in her arms and legs; diarrhea; Extremely tired; headache; Nausea; her blood pressure was taken and it was 165/40.; her blood pressure was taken and it was 165/40.; throwing up; dizzy; Numb on body on right side; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) dose 1 via an unspecified route of administration, administered in arm left on 04May2021 08:30 (Lot Number: EW0172) as 1st dose, single for covid-19 immunisation. The patient medical history was reported as none. There were no concomitant medications. Patient had investigation assessment. No additional administered vaccines. No Prior vaccinations within 4 weeks. The patient had an allergic reaction to the first dose of the Pfizer covid 19 vaccine and wanted to know if she should take the other one. The patient had throwing up, numb on body on right side, dizzy, nausea on 04May2021; headache and extremely tired on 05May2021; diarrhea on 06May2021; rash all over, swelling in arms and legs, chills on 08May2021; her blood pressure was taken and it was 165/40 mmHg on 04May2021, she couldn't get warm on an unspecified date. Events did not require a visit to emergency room or physician office. The outcome of events rash all over, swelling in arms and legs, chills was not recovered; event throwing up was recovered on 04May2021; numb on body on right side was recovered on 06May2021; events diarrhea, headache and extremely tired was recovered on 07May2021; events dizzy and nausea was recovered in May2021; of other events was unknown.

It was swollen up pretty big/My arm swelled up. It almost looked like I had a big muscle; Feeling really sick; Her arm was hurting/Sore arm; I did have COVID, the virus; Slight headache; Weak; I don't even feel that well right now with the first shot; So I think this was an allergic reaction to the medicine because its not real clear; She was pale and dizzy/kind of dizzy; She was pale and dizzy; Nauseated; She's tired/I just feel tired; I just feel like I am dragging; This is a spontaneous report from a contactable consumer. A 60-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EW0176) dose 1 via an unspecified route of administration in the left arm on 04May2021 (at the age 60 years old), as single dose for COVID-19 immunization. The patient's medical history included patient had a pulled tendon for which she was wearing a boot, hypothyroidism for which the patient was taking Synthyroid since 1991, COVID-19 in Dec2020 and was sick from Dec2020 to Jan2021, it took patient a month to get over it. The patient's concomitant medication included Diclofenac Sodium delayed release tablets 75mg, two times a day for 2 pulled tendons in her foot. On 05May2021, patient's arm was hurting/Sore arm. On 06May2021, arm swelled up, it was swollen up pretty big, it almost looked like patient had a big muscle, feeling really sick. On an unspecified date in May2021, patient did have COVID, the virus, patient was pale and dizzy/kind of dizzy, felt nauseated, tired/ just feel tired like patient was dragging, slight headache, weak, patient didn't even feel that well right now with the first shot and patient thought that this was an allergic reaction to the medicine because it was not real clear. Patient was started on Diclofenac Sodium 75mg two tabs daily- started on Tuesday, the same day she got her Pfizer Vaccine. On an unspecified date, patient had ultrasound of the leg to check for clots, but she did not have any. The patient reported that her arm was still really sore, and she was not as nauseous and pale as she was last night but then was tired and slept all night. She just felt tired. The patient did not receive any treatment for the adverse events. Patient wanted to know if this could be a reaction between the medication (Diclofenac Sodium) and the vaccine and also wanted to know if she was allergic to something in the vaccine and how many days side effects might last, patient did not know anyone who got sick after the first dose. Patient was scheduled for the second dose of the vaccine on 26may2021. Outcome of the pale and nauseated was recovering, patient's arm was hurting/sore arm, arm swelled up, it was swollen up pretty big, it almost looked like patient had a big muscle not recovered was not recovered while for the other events was unknown. Patient reported that her 83-years-old mother got Moderna and her arm was a little sore after the first dose and nothing after the second shot. No follow-up attempts are needed. No further information is expected.

anaphylaxis; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 20May2021 11:00 (Batch/Lot Number: EW0165) as single dose for covid-19 immunisation (age at vaccination was of 60 years). Medical history included rheuatoid arthritis, surgical asplenia. Patient also allergic to Pineapple. No other vaccine was recieved by the patient in four weeks. The patient received other concomitant medications in two weeks. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 30Apr2021 14:30 (Batch/Lot Number: EW0169) as single dose for covid-19 immunisation (age at vaccination was of 60 years). On 21May2021 12:15, the patient experienced short of breath, increasing difficulty breathing, anaphylaxis, in order hoarseness, voice sounds like laryngitis, in order hoarseness, voice sounds like laryngitis, lips tingling, eyes swelling, wheezing, dizziness. Patient took 50mg Benadryl at 12:30 with no relief and went to ER. The ER (emergency room) diagnosed anaphylaxis and started treatment at 13:37. EpiPen, famotidine (Pepsid), SoluMedrol PF was given as treatment. Patient recovered with lasting effects. No covid prior vaccination was reported. Patient was not tested for covid post vaccination. Outcome of all events was recovered with sequelae. Follow up attempts are needed. Further information has been requested.

Lymphadenopathy of axilla, neck progressing to painful lymphadenopathy requiring steroid treatment to improve symptoms

headache; severe rashes in my forehead; bumps puffy face; swollen lymphnodes on the right side; sensitive to touch itching, and burning; sensitive to touch itching, and burning; This is a spontaneous report from a contactable other hcp (patient). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: EN6201), dose 1 intramuscular, administered in Arm Right on 11Feb2021 at 10:30 (at the age of 60 years old) as 1st dose, single for COVID-19 immunization. Medical history included hypothyroidism, mild hypertension, acid reflux 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 was allergic to aspirin, NSAID, shellfish and some other fish. Concomitant medications included atorvastatin calcium (ATORVASTATIN CALCIUM); metoprolol tartrate (METOPROLOL TARTRATE); omeprazole (OMEPRAZOLE); levothyroxine sodium (LEVOTHYROXINE SODIUM) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks. On 25Feb2021, 15 days after the first dose she got a headache, severe rashes in my forehead, bumps puffy face, swollen lymph nodes on the right side only sensitive to touch itching, and burning. The symptoms are beginning to subside now but was scheduled to get her 2nd dose on March 4th. She would like some guidance. The patient was treated with antibiotics. The patient visited physician office due to events. The outcome of the events was recovering. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

The first day when I woke up I had really bad back pain and I was really sleepy. towards the afternoon I became very itchy. The itching and hives would become increasingly worse. I didn't take it for anything. On Saturday I went to work still itching I called the nurse at work on the hotline and explained what was happening. I was told to take Benadryl but could not because it would make me drowsy. I finished work and took the Benadryl after. I also started to break out into hives, the itching was turning into hives. On Sunday I got up for work and the hives were large and like welts. This was all over my body. The itching was still present as well. I was advised to go to an urgent care or a doctor. On Monday morning I woke up and everything was swollen: my face, my lips. I went to the Dr's office where they gave me steroids and an epi pen as well as oral steroids. After the steroids, the swelling went down after a few days. The itching had also ceased. The itching lasted from Friday up until Monday when I got the steroid shot on Thursday.

First, vaccine caused pain. Second vaccine, caused patient pain and to retain fluid. Patient had an MRI of shoulder and culture of fluid. Fluid tested positive for staph.. Patient was given doxycycline for 10 days. Fluid was drained at hospital. Patient was admitted for overnight stay. Patient has incision in front and back of shoulder. She was diagnosed with tendonitis.

painful swelling of one or more lymph nodes; tennis ball sized knot in the arm; achy; pain and slight swelling at the injection site; pain and slight swelling at the injection site; This is a spontaneous report from a contactable consumer or other non hcp. A 60-years-old adult non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection,Lot Number: EN6203 and Expiry date: Unknown), dose 2 via an unspecified route of administration, on 05Mar2021 at 10:45 as 2ND DOSE, SINGLE for covid-19 administered in Arm Left immunization. Medical history included osteoarthritis, fibromyalgia, asthma and allergy to several foods. The patient did not receive any other vaccine in 4 weeks. Patient was not covid positive prior vaccination. The patient previously took celebrex and experienced Celebrex. Historical vaccination included the patient received dose 1 BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number and Expiry date: Unknown), on 06Feb2021 at 10:45 am for COVID-19 immunization . On 05Mar2021 at 18:00, the patient experienced pain and slight swelling at the injection site, tennis ball sized knot in the arm and achy on 06Mar2021 and painful swelling of one or more lymph nodes on 07Mar2021. It was reported that on evening of injection (Friday) the patient had pain and slight swelling at the injection site. The next day (Saturday), she had a tennis ball sized knot in the arm which was slightly achy but not really painful. When she woke up on the second after the vaccine (Sunday) she noticed a somewhat painful swelling of one or more lymph nodes under her left arm extending slightly into her left breast. A hot shower has alleviated some of the swelling and pain so far. she expected this would ease up in the next few days. If it does not, she would seek medical advice. No treatment was given for the events. Patient was not tested for covid post vaccination. Outcome of the events were resolving. No follow-up attempts are possible. No further information is expected

shot entry is the size of an apple; heart palpitations; diarrhea; blisters in her mouth on her cheeks and roof of her mouth on her tongue, the back of her throat and lips; Because of the blisters she had a hard time breathing and couldn't can't eat; had a fever of 102°F; weak; tooth throbbing; body aches; food tasted like crap for anything that she could get into there; Because of the blisters she had a hard time breathing and couldn't can't eat; Her injection arm was "swollen so bad" from her neck to her fingertips. She couldn't lift up her arm because of the swelling; injection arm was "swollen so bad" from her neck to her fingertips; vomiting; lightheaded, dizziness; Migraine headache/migraine; her arms swollen down to her fingertips which she could not sleep on her left side; could not get out of bed; This is a spontaneous report from a contactable consumer (patient). A 60-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 18May2021 (Batch/Lot Number: EWO182) as single dose for COVID-19 immunisation. Medical history included allergic reaction to back yard tree and had sniffles and watery eyes prior to shot. There were no concomitant medications. The patient received her first Pfizer Covid vaccine dose on 18May2021. That evening she began to experience side effects. Her injection arm was "swollen so bad" from her neck to her fingertips. She couldn't lift up her arm because of the swelling. She had Migraine headache and vomiting. At 5 AM the following day 19May2021, she was vomiting, had diarrhea, a migraine, and then developed blisters in her mouth. Because of the blisters she had a hard time breathing and couldn't can't eat, had a fever of 102 degree F, was feeling weak, had to crawl to bathroom. She reported that 24May2021, was the first day that she felt ok. It was reported that her arms swollen down to her fingertips which she could not sleep on her left side, blisters in her mouth on her cheeks and roof of her mouth on her tongue, the back of her throat and lips, stated that she could not go to her dentist appointment the following day because of blisters and her tooth was throbbing on 19May2021. Stated that she had migraine headaches with vomiting, diarrhea, heart palpitations, weak, 102 fever, food tasted like crap for anything that she could get into there. The patient is supposed to go on 08Jun2021 for her second shot and was told that the second is worst than the first. Stated that she refused second shot. Stated that she could not get out of bed. Stated that she has a 7 and 8 year old to take care of by herself. Stated that the shot entry is the size of an apple on 24May2021. Clarified that she had the shot in her left arm. Caller stated that she had the Covid shot 18May2021 and she still does feel well today. Clarified that the blisters all started at the same time. Stated that she has had no heart palpitations since 5am this morning (24May2021). Stated that her fever is 99.9 Caller keeps rambling on; unable to clarify details with each event. Stated that the migraine is now a headache. She wants to know what would happen if she doesn't get the second dose of the vaccine. The patient received no treatment. Outcome of the events could not sleep on her left side, could not get out of bed was unknown; peripheral swelling was recovered with sequelae on 23May2021, vomiting was recovered with sequelae on 24May2021; Heart palpitations was recovered on 24May2021; Fever, migraine, couldn't lift up her arm, hard time breathing was recovering; all other events was not recovered. Follow up attempts needed. Further information is expected

Bright red rash starting to turn purple; raised, angry rash raised, angry rash all overback, chest, abdomen, neck and face.; raised, angry rash all over back, chest, abdomen, neck and face; Swollen right side face including cheek, eye and ear; This is a spontaneous report from a contactable consumer, the patient. A 60-years-old adult non-pregnant female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the right arm on 16Mar2021 at 10:45 AM (at the age 60-years-old) as a single dose for COVID-19 immunisation. Medical history included Lyme disease, PCOS, asthma, rosacea, Hashimotos thyroiditis, diverticulosis, celiac and IBS. Multiple food and drug allergies reported. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 17Mar2021 at 05:00 AM, patient experienced raised, angry rash all over back, chest, abdomen, neck and face. Rash was bilateral and worse on right side. Patient also experienced Swollen right side face including cheek, eye and ear and bright red rash started to turn purple as the day passed. The patient did not receive any treatment for the events. The clinical outcome of rash all over back, chest, abdomen, neck and face, swollen face and red rash was recovering. Information about lot/batch number cannot be obtained. No further information is expected

2nd dose: Stinging a few minutes after shot, I felt really woozy, and then started shaking all over having a hard time processing and talking. Went home the next day (Wed) fever, chills, headache, 24 hours better, returned to work on Thursday, day (2). Day (3), Friday, I noticed a red rash at the site of the injection earlier in the day, but no symptoms, just a little tender. Friday evening I noticed a little SOB, a little burning sensation under my skin on both forearms, and a couple times felt a little dizzy, but I didn't think much about it. Day (4) Saturday morning, I went to spin class, I felt a little off, halfway through spin class I noticed I was struggling with some breathing, thought it was because I was wearing mask, but pushed through. Ran a couple of errands afterwards and then noticed the SOB was continuing, my skin started burning again under forearms and now my legs with tingling into my feet. At this point I decided I probably needed to go home. On my way home my chest started to hurt in the very center of my chest, and slowly felt like some pressure, with squeezing sensation. Then starting at the center of my chest I could almost feel what felt like a numbness creepy from my chest to my throat. I went to the ER. My legs felt really wobbly and had a difficult time walking, and was feeling dizzy. They ran a variety of blood work and tests. They noted my D-dimers were elevated and (4) lymph nodes enlarged. They ran an additional series of test and released me at 10pm with follow-up to cardiologist. I am still experiencing SOB, not as bad, and the burning sensations under my skin.

a week after the 1st dose, i start having a migraine behind my left ear for a while and then it moves at the back of my head and after on the right side. I also have body ache at night and lower back pain. it comes and goes until the time come for the second dose. at first, I simply take tylenol and green tea. After the second dose, the next day, i discover a swollen lymph nod between my neck and my shoulder but closer to my neck area. The following day, I went to my doctor who prescribes a steroid and an antibiotic. However the med is over and i am still having the migraine from time to time and when have it, i also have lower back pain. This week i also feel pain in my ears

She could not sleep the whole night; Right hand is swollen; She has a sprained wrist; Her hand, that is somewhat in pain from the sprain, and is most of the time fine, was in; Her left knee was hurting her a lot worse; Sore arm; First dose: sore arm; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EN6206) via an unspecified route of administration (age at vaccination 60-year) in Left Arm on 09Mar2021 as single dose for COVID-19 immunization. Medical history included accident (The accident was 25 years ago, and they told her that she had shrunk an inch from the accident. It is hard for her to say) and cardiac disorder (Her dad has heart disease) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 09Mar2021 the patient experienced sore arm after receiving first dose; On 30Mar2021 her hand, that is somewhat in pain from the sprain, and is most of the time fine, was in; her left knee was hurting her a lot worse; sore arm; her right hand is swollen and she has a sprained wrist. On 30Mar2021 09:30 she reported she could not sleep the whole night. The seriousness of all the event was reported as non-serious. Her left knee was hurting her a lot worse was recovering. The clinical outcome for all other events was unknown. No follow-up attempts are needed. No further information is expected.

Hypersensitivity; I feel like I have a arthritis like rheumatoid arthritis in my hands; little tender on the arm; little tender on the arm and it is swollen and little itchy; itchiness on the arm; little tender on the arm and it is swollen and little itchy; itchiness on the arm/ feet are swollen; mild chills; body aches; weird muscle; fatigue; Diarrhea; had marking on my legs actually in elbow area; had like ulcers in my mouth; I lost in the meantime, currently now I am 108 pounds; Bone Ache; blistering in the mouth; blisters; sandpaper like rash on the hands and the feet's; mild rash and itchiness on the arm; This is a spontaneous report from a contactable consumer reported for self. This 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 on 17Feb2021 Arm Left at the age of 60-year-old as 2nd dose, single (Lot # EN6201) for covid-19 immunisation. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Anatomical location: Left Arm for covid-19 immunisation. The patient had it, 2nd one was then on 17Feb2021, 10 days later had a guess what you call hypersensitivity because that is the thing can relate to and the they had at the urgent care (emergency room visit) and then the hospital (further not clarified) because had therapy in multiforme. Symptoms on 27Feb2021 and then had gone through an urgent care that following Tuesday and Thursday went back. So, thought it was from that. She had the initial little tender on the arm and it is swollen and little itchy and then had mild chills and body aches initially and did not take, that is better than other people are having with headaches and everything else but it was 10 days later that had this multiforme beginning of this blisters (27Feb2021), sandpaper like rash on the hands and the feet's (27Feb2021), blistering in the mouth (27Feb2021) and had that everything multiforme all over body it is in neck and head. After the 2nd shot on 17Feb2021. She have been mild rash and itchiness on the arm and then little bit of mild chills and mild body ache, it was nothing serious or anything took a steroid and then 10 days later have little bit of sensitivity on index finger and middle finger and then from the next day had marking on legs actually in elbow area, thought it was mosquito bit because of the experienced of itchiness and then it progressed and migrated upward had sandpaper and blisters on face, hands and feet. The rash was on under, it progressed from the ankle and up through the shoulder and had the blister and sandpaper, rash feeling on hands and on feet and then had like ulcers in her mouth. She also had weird muscle and bone aches, body aches and fatigue and diarrhea and everything but she still had she felt like she had a arthritis like rheumatoid arthritis in hands and feet are swollen. She lost in the meantime, currently now was pounds. Treatments included a corticosteroid shot (Further not clarified) and took steroid for the 5 days at the hospital (further clarification unknown) they give her the shot, corticosteroid shot and then took the pills for the 5 days. Outcome of the events was unknown.

I had a headache, chills, and a fever. Then I had tingling in my head. I started breaking out in a rash all over my face, especially on the right side and near my eye. My face swelled up completely. I went to the ER. I was diagnosed with Shingles. I was given nerve pain medication. Later I saw another ER doctor and I was given an antiviral & steroid medication, but I was nervous to take it. I then visited my PCP, where they checked my eye.

Started out as joint pain and heaviness. Progressed to extreme swelling in both hands. Progressed to upper arm pain. Treating with steroids. Treating with occupational therapy. So far refractory to steroids.

really bad flare up of rheumatoid arthritis; she had a fever of 101.5 degrees Fahrenheit; she had chills; After her second COVID-19 Vaccine, she had a headache; After her second COVID-19 Vaccine, she was tired; her hands and feet got real swollen; She said she hadn't felt right; hadn't felt right; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A 60-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EW0162) via an unspecified route of administration in left arm on 23Mar2021 between 17:20-17:30 as 1st dose, single dose for COVID-19 immunization. Medical history included ongoing rheumatoid arthritis (from 2003), she has had rheumatoid arthritis for almost 20 years. Concomitant medication included Xeljanz XR 11mg. On 24Mar2021, patient had fever of 101.5 degrees Fahrenheit, chills, headache, she was tired. On an unspecified date in Mar2021, her hands and feet got real swollen, she had not felt right since she had COVID-19 Vaccine. It was reported that patient received her second shot of Pfizer (COVID-19) Vaccine on 13Apr2021 and experienced really bad flare up of rheumatoid arthritis in Apr2021. The patient stated she got both doses of the Pfizer (COVID-19) Vaccine, and after her second (COVID-19) Vaccine, she had a really bad flare up of rheumatoid arthritis. The patient stated her doctor put her on Prednisone for 2 weeks. Reported she had received her second COVID-19 Vaccine dose right before her 61st birthday. She said she went to her rheumatologist, and her rheumatologist told her she should report her side effects to Pfizer. She said she already reported her COVID-19 Vaccine side effects on V-Safe. Patient took 1 Tylenol (8HR Arthritis Pain Extended Release 650mg, Lot Number: LPA095, Expiration Date: Aug2020) for a fever of 101.5 degrees Fahrenheit. She said the Tylenol helped her fever, providing. Reported the Tylenol 8HR Arthritis Pain Extended Release 650mg was expired, but the product still worked. Patient stated for Rheumatoid Arthritis Flare Up, her rheumatologist prescribed 1 Prednisone 5mg tablet, once a day, for 2 weeks. She said she saw her rheumatologist on 17May2021. She said she completed her Prednisone 5mg prescription, and the Prednisone 5mg tablets were dispensed in a pharmacy bottle, and she didn't have the Prednisone 5mg NDC, Lot, and Expiration Date. Reported she was feeling better now, but wanted to report her Pfizer BioNTech COVID-19 Vaccine side effects to Pfizer, so she could help other people with rheumatoid arthritis. Reported she continued to take her Xeljanz XR 11mg while she took the Prednisone 5mg tablets, providing the Xeljanz XR 11mg (NDC Number: 0069-0501-30, LOT Number: DJ2906, Expiration Date: 31May2022). Reported she was feeling better now, but she was not 100%. She said she could actually walk now. She said she still had swelling in her hands and feet. She said the swelling had improved in her hands, saying she could make a fist now, but she couldn't wear her wedding ring. She her sandals still felt tight on her feet. Reported she was very reluctant to get a COVID-19 Vaccine booster shot in 12 months with her auto immune disease. She said she was not going to get the COVID-19 Vaccine booster, if she was going to have the same reaction she had after her second COVID-19 Vaccine dose. Patient asked if Pfizer had done any studies with people who had rheumatoid arthritis and the COVID-19 Vaccine. The outcome of the event fever, chills, headache was recovered on 25Mar2021 and outcome of the other events was recovering. Follow up attempts are needed. Further information has been requested.

Erratic blood pressure. Decreased heart rate. Weakness. Fatigue, increase in PVC?s. I am an athlete and was simply unable to workout due to response. I did workout the two days after the vaccine and perhaps I shouldn?t have done that. The following week I was exhausted and ended up I?m emergency room with dropping pulse rate and erratic blood pressure, swelling in my face and ankles.

May 1, 2021 ? Received 1st Covid19 shot around 3:00PM at a Pharmacy. No concerning reaction. May 2, 2021 ? Arm a little sore at site of shot. Not a problem. Later afternoon some posterior leg muscle pain. Not severe. May 3, 2021 ? Bowels are hardened and a little difficult to push out. In the afternoon definite pain in various places in the large posterior muscles of both legs. In the evening abdominal cramping. A little tired feeling. May 4, 2021 ? Bowels hardened. Abdominal cramping. Deep specific areas of pain in both my posterior leg muscles including: calves, hamstrings, gluteals ? felt like someone sucker punched me up and down the backs of my legs. Right thigh is going numb while I work. Forearms and hands are going much more numb. Extreme fatigue by afternoon, to the point I had to sleep for a while. Diarrhea by early evening. May 5, 2021 ? Hardened bowels. Pain in legs is less severe but still there plus pains in inner thigh. Slight headache (I very rarely get headaches), extreme fatigue by afternoon, Debilitating, I had to take a nap. Thigh continues to go numb off and on while I work. My forearms and hands are tingling and going numb at times. May 6, 2021 ? I am noticing mild headache comes and goes, am experiencing ringing in head like I had with past concussion. Extreme fatigue by afternoon and have to lie down. My bowels are less hardened but still not regular. Still have deep pains in legs muscles but not as severe. Joints are achy: wrists, elbows, hips, knees. May 7, 2021 ? Same as day before. Also realize my blood pressure is running high. May 8, 2021 ? One Week Since Shot. Have noticed I am not able to focus in on specific things as well as normal. The fatigue is debilitating at times. It is affecting my daily chores. I have definitely gained weight, joints continue to be achy and stiff. Less headaches and leg pains are much less. No more abdominal cramping. Bowels are still a little hard. May 8, 9, 10, 11, 12 ? Still more tired than usual but not as debilitating. Bowels are better. My joints and muscles are still sore but not as bad. I am noticing swelling in my arms and legs and face ? feels like I am retaining fluid. I have occasional periods where I am not mentally focused/ forgetting things/ not as observant. Ringing in head happens from time to time. Blood pressure is higher than normal. May 13, 14, 15, 16, 17, 18 ? No more leg muscle pains but continue to have fluid retention. My joints are more sore than normal. Thigh and forearms are no longer going numb. Still more tired than normal but no longer need naps. Mental clarity is better but still feel ?off.? May 19, 20, 21 ? Exhausted. Completely exhausted. Legs and arms and face swollen. Bowels are hardened again. I feel like I have regressed. No deep muscle pain. Joints are stiff again. Mentally out of it. Not able to intently focus. Blood Pressure is up again. May 22, 23, 24 ? Body edema continues. On Sunday the 23rd my face literally swelled up! I took a benedryl and did lymph drainage massage on myself. It eventually went down after several hours. Never experienced difficulty breathing, my parotid glands did not seem to be swollen. May 25 to June 13 - Some days I feel okay, other days I am having swelling in legs, arms / seems like I am still retaining fluid, still more tired than I was before the Covid shot/ still have times a don't focus in as well as normal / joints are stiff at times from swelling and right thigh goes numb off and on when standing.

Right arm pain, swelling and redness starting 5/28 lasting 3 days. Chills x2 days starting 5/31/21. Constant cough starting 5/31/21 and continues.

Swollen lymph nodes in neck; rash on chin; This is a spontaneous report from a contactable consumer. A 60-year-old non-pregnant female patient received first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot Number: unknown) via an unspecified route of administration in the Arm Left on 13Mar2021at 12:45 PM (at the age of 60-year-old) for COVID-19 Immunisation. Facility where the COVID-19 vaccine was administered was pharmacy or drug store. Medical history was reported as seasonal allergies, high blood pressure, high cholesterol. Concomitant medications were reported as CLARITAN-D, atorvastatin(MANUFACTURER UNKNOWN), propranolol(MANUFACTURER UNKNOWN), losartan(MANUFACTURER UNKNOWN) for unknown indication from unspecified date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not tested for COVID-19. Patient had not symptoms associated with COVID-19. The patient was not enrolled in clinical trial. Information about ethnicity and race is reported. Patient did not have allergies to medications, food, or other product. On 15Mar2021 at 08:00 AM, the patient experienced swollen lymph nodes in neck 2 -5 days after injection rash on chin 2-5 days after injection and the clinical outcome of these events were recovering at the time of this report. The patient did not receive treatment for the events. No follow-up attempts are possible; information about lot number cannot be obtained.

feeling like legs were made of jello.; Very hot; flushed face; weak; Merely nauseated; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203), via an unspecified route of administration in the left arm on 05Mar2021 at 12:45 (at the age of 60-years-old), as a single dose for COVID-19 immunisation. The patient's medical history included hashimoto's thyroiditis. Patient had allergies to penicillin. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) and lisinopril (MANUFACTURER UNKNOWN) for an unknown indication. On 05Mar2021 at 13:30, patient experienced very hot, flushed face and weak and feeling like legs were made of jello. This lasted for approximately 3 hours. On 05Mar2021, patient experienced merely nauseated. On 17Mar2021, patient underwent lab tests nasal swab (PCR) and result was negative. No therapeutic measures were taken for the reported events. The clinical outcome of the events very hot, flushed face and weak, feeling like legs were made of jello and merely nauseated was recovered/ resolved on 05Mar2021. No follow-up attempts are needed. No further information is expected.

When she took her Pfizer vaccine on 5/29/2021, she had a feeling of pressure around her heart that made her anxious on Day 2 and Day 3, Lymph node under her left arm was swollen the size of a credit card for Days 3 & 4 post vaccine. Had a fever on Day 4 & 5 after the Covid Vaccine. Would wake up in the night with her bed soaked with sweat and she would have to change her clothes. She had a horrible smell in her nostrils. Had diarrhea.

Within 1 hour had tightness in her chest, wheezing and her throat started to tighten up; Within 1 hour had tightness in her chest, wheezing and her throat started to tighten up; Pain in the right side of her leg and in her stomach; Caller stated she has been vomiting mainly from the draining that is choking her.; Throat tightened up and glands swell; Barely able to breath, shortness of breath; Pain in right side, below her breast; Within 1 hour had tightness in her chest, wheezing and her throat started to tighten up; She was so sick; Caller stated she has been vomiting mainly from the draining that is choking her.; Headaches; Pain in the right side of her leg and in her stomach; Burning in her chest and throat/ pain was in the right side of the chest; Burning in her chest and throat/ throat has been like its on fire; This is a spontaneous report from a contactable consumer (patient). A 60-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 02Jun2021 (Batch/Lot Number: EW0177) as 1ST DOSE, SINGLE for covid-19 immunisation. Time the Vaccination Was Given: Between 12:00 and 1:00pm. Medical history included when she was a child, she had bronchial asthma. Has not had any problems in years. Prior Vaccinations (within 4 weeks): No, has been years. Has not even had the flu shot in 3 years. The patient's concomitant medications were not reported. Caller stated she had the first dose of the Pfizer covid 19 vaccine and stated she is having a reaction. Caller stated it feels like she has covid. Caller stated she got the vaccine 3 days ago and within 1 hour had tightness in her chest, wheezing and her throat started to tighten up. All she could do was wheeze. Her throat started tightening up and her glands started swelling. Caller stated she then had draining down the back of her throat. Caller reported burning in her chest and throat. Caller reported pain in the right side of her leg on 02Jun2021 and in her stomach. Caller stated she has been vomiting on 02Jun2021 mainly from the draining that is choking her. Caller stated she is still draining but not vomiting. Caller reported she is having headaches. Caller was concerned about what she should do, go to her doctor or go to the ER. Caller wanted to know how long the symptoms should last. Caller stated she is 52 hours out from the vaccine, Throat tightened up and glands swell, Barely able to breath, shortness of breath, pain on 02Jun2021. She was so sick. She was barely able to breathe within an hour and has been in pain. It is now a struggle, with shortness of breath. Her throat has been like its on fire, and lungs filled with a huge amount of drainage in the back of her throat. Is having right leg pain and pain in her stomach. It is not severe pain, but there is some pain there, is having a lot of burning sensation with the drainage. It now feels like she has Covid now. She read in the paperwork that this could not cause Covid. She was perfectly fine when she had the vaccine. She has no allergies. Does not know what to do. It has been 48 hours. She was perfectly fine until an hour later. She contacted the pharmacy and they didn't do anything. She then contacted this number to report this. Her biggest concern was the severe drainage. There were globs of drainage down the back of her throat. Her chest tightened prior to that and she was wheezing. She has not had bronchial asthma since she was a child. Has had no flus, or nothing. Had the pain after the burning in her chest, the pain was in the right side of the chest. Pain in right side of leg: Hasn't stopped completely. Still has pain in the right leg and in the chest. It is barely any better. It is probably because it is in one spot in the calf on her right leg. The pain in the right side, below her breast. The pain seems to be in the right side. Pain in stomach: Seems to be both sides. Has gotten better some, in the stomach. Vomiting: Was vomiting from all the drainage, it was choking her. It started within 2 hours. She is still experiencing the drainage, but not the vomiting. Has also been experiencing headaches. Shortness of breath: Was the same time as the tightness in the chest. It was within an hour after she left. They kept her there 15 minutes and she was fine when she left. Within the hour, she could barely breathe. She didn't know if she should go to the emergency room or if it would get better in a few days. The shortness of breath and wheezing is not worse, but is constant and really hard. Her breathing is really labored. She is not having pain, other than the tightness and wheezing, which she can hear. It is like she had asthma for years, or pneumonia. Outcome of events Wheezing, Chest burning, Throat burning sensation, headache, and Shortness of breath, pain of was not recovered, of Pain in leg, Stomach pain was recovering, of Vomiting was recovered in Jun2021, of others was unknown.

Low fever; chills; severe headache; body aches; sore arm; This is a spontaneous report received from a contactable consumer, the patient. A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: EN6204) via an unspecified route of administration on the left arm on 18Mar2021 at 10:15 as single dose for COVID-19 immunisation. The past drug history included BNT162B2 (BNT162B2); Lot no: EN6202 via unspecified route of administration administered on 25feb2021 as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Medical history included High Cholesterol, heart disease on an unknown date. Concomitant therapies were not reported. The patient experienced Low fever, chills, severe headache, body aches, sore arm on 19Mar2021 after vaccination. No therapeutic measures were taken for the events. The clinical outcome of the events Low fever, chills, severe headache, body aches, sore arm were reported as resolved at the time of this report. No follow-up attempts are needed. No further information is expected.

Patient stated that her face swelled up about 2 hours post vaccine. Client notified me at her appointment of her second dose. Dose was not administered and she was referred to clinic for that dose due to our rural location and lack of emergency services. I called the client to find out how she did with the second dose, she stated they did not administer it. She informed me at that time that she thinks she also had shortness of breath following the first dose while she was driving to work 1 hour away. All symptoms resolved on their own with no treatment.

My hand and fingers were swollen and, unable to stretch fingers; Fingers were very stiff; My hand and fingers were swollen and, unable to stretch fingers; Fingers were very stiff; Mild headache at back of neck; swollen lymph nodes; This is a spontaneous report from a contactable other-health care professional (patient). A 60-year-old non-pregnant female patient (not pregnant at the time of vacciantion) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN5318), via intramuscular route of administration in right arm on 04Feb2021 at 10:00 AM (at the age of 60 year old) as single for covid-19 immunisation. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EK4176), via intramuscular route of administration in right arm on 14Jan2021 at 10:00 AM (at the age of 60 year old) for covid-19 immunisation. Medical history included high blood pressure, high cholesterol, seizures from an unknown date and unknown if ongoing. Patient had no known allergies. Concomitant medications included vitamin c [ascorbic acid]; colecalciferol (D); zinc; elderberry [sambucus nigra]; paracetamol (TYLENOL), high blood pressure med, seizure meds, high cholesterol med. The patient had no other vaccine in four weeks. Since the vaccination, the patient hasn't been tested for COVID-19. On 05Feb2021 at 02:30 AM, patient experienced hand and fingers were swollen and, unable to stretch fingers; fingers were very stiff; mild headache at back of neck and swollen lymph nodes. The patient did not received treatment due to the events. The outcome of events was recovered on an unspecified date in 2021. Follow-up (11MAY2021): Follow-up attempts completed. No further information expected.

Arm & hand numb during night after injection; lymphadenopathy in left armpit (injection given in left arm); This is a spontaneous report from a Non-contactable Nurse (Patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL9261), via an unspecified route of administration, administered in left arm on 02Feb2021 (at the age of 60-years-old) as 2nd dose, single for COVID-19 immunisation. Medical history included allergic to penicillin and Imipramine, and hypertension. Concomitant medication(s) included Elderberry Syrup, Zicam, HCTZ, lisinopril; all for unknown indications from unknown dates and unknown if ongoing. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: Unknown), via an unspecified route of administration on 12Jan2021 as 1st dose, single for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Feb2021, patient experienced arm and hand numb during night after injection, lymphadenopathy in left armpit. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.

Patient reports having a sore arm that is warm to the touch after getting her second Pfizer COVID-19 vaccine. She also reports some continued soreness and itchy feeling in her left arm which is about the size of a hand. She reports that this adverse reaction has improved since it started on 6/23/21 but it is still present ~5 days later. She will continue to monitor, and will report back to us and her primary care physician.

Day of First shot: headache, sore arm, extreme exhaustion, feeling that some virus or illness was coming on, intermittent chills. 36 hours after first shot: sore arm, headache, stomach ache (upper and lower), cramping, swollen gland on front of neck (just one gland). Had all of these symptoms on my second shot too, but not as bad. I did not have a swollen throat/neck gland, BUT had shortness of breath/asthma reaction on my second shot, and chest & sinus congestion. The intermittent asthma/shortness of breath, (haven't had in a long time), was without wheezing. I used my albuterol rescue inhalor and it seems to help me get through these boughts. The asthma came on at about 29-36 hrs and has lasted 6 days so far.

I do not think this is an adverse reaction at all. My lower back started swelling and having pain. My chiro is caring for me. I reported this on my form because it asked for new symptoms. The only reaction I have had is my left arm has remained and still is very painful and the pain is deep into my arm at the exam site. I have not told my PCP.

Loss of smell; Loss of taste; Slightly swollen lymph nodes; This is a spontaneous report from a contactable consumer, the patient. A 60-years old female patient received first dose of BNT162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534), via an unspecified route of administration in the left arm on 20Mar2021 at 16:30 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had allergies to sulfur ingredient. 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. Concomitant medications included vyvanse (MANUFACTURER UNKNOWN), dosage 40mg 1xday for unknown indication, omeprazole DR (MANUFACTURER UNKNOWN), dosage 40mg for unknown indication from unknown date. On 21Mar2021 at 08:00 (as reported), patient experienced loss of smell, loss of taste and slightly swollen lymph nodes. The clinical outcome of the events of loss of smell, loss of taste, slightly swollen lymph nodes were unknown at the time of reporting. No follow-up attempts are needed. No further information is expected.

Reaction on arm; Itchy; Red; swollen arm; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208) via an unspecified route of administration in the left arm on 11Mar2021 at 11:45 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was allergic to Sulfa, eggs and shellfish. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included VIIBRYD, quetiapine (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN) and spironolactone (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 20Mar2021 at 10:00, the patient had reaction on arm on the ninth day following the vaccine. The patient reported that it was itchy, red and swollen. The patient did not receive any treatment for the reported events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events reaction on arm, itchy, red and swollen was resolving at the time of this report. No follow-up attempts are needed. No further information is expected.

Swelling and pain under the arms; Swelling and pain under the arms; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 02Mar2021 at 8:45 as a single dose for COVID-19 immunisation. Medical history included thyroid. Concomitant medications taken within two weeks of vaccination included levothyroxine (MANUFACTURER UNKNOWN), vitamin D3 (MANUFACTURER UNKNOWN), metoprolol ER succinate (MANUFACTURER UNKNOWN). The patient had a history of drug allergy to hydrocodeine. 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 24Feb2021, the patient underwent lab test included a nasal swab and the result was negative. On 02Mar2021, the patient developed swelling and pain under the arms. No treatment was received for the events. The clinical outcome of the events swelling and pain under the arms was resolved on an unknown date. Information about lot number cannot be obtained. No further information is expected.

Patient complained of swollen neck, ear, and jaw tendon. Wanted it to be reported. It happened about 5 days after she received the vaccine.

Swollen lymph nodes : left armpit, breast; right neck above an below collar bone and into armpit. Above collarbone is a hard nodule with swollen line over collarbone that radiates toward armpit; Swollen lymph nodes: Very painful.; This is a spontaneous report received from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208) via an unspecified route on the right arm on 12Mar2021 16:30 (at the age of 60-year-old) as a single dose, for COVID-19 immunisation. Medical history included mitral valve prolapse, Penicillin allergy, Sulfa allergy, contrast agents allergy and shellfish allergy. Concomitant medications included atenolol (MANUFACTURER UNKNOWN), rosuvastatin (MANUFACTURER UNKNOWN), cranberry pills (MANUFACTURER UNKNOWN) and b complex (MANUFACTURER UNKNOWN) for unknown indication from unknown date. The patient previously took cefaclor monohydrate (CECLOR)and cefalexin monohydrate (KEFLEX) for unspecified indication from unknown dates and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. On 15Mar2021, the patient experienced swollen lymph nodes from left armpit, breast, right neck above and below collar bone into armpit (lymph nodes cervical swollen). There was a hard nodule with swollen line over collarbone which radiated toward armpit and was very painful (lymph node pain). The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measure was taken as a result of event and included the treatment with X-ray with CT scan to follow (No details to confirm if patient underwent these investigations). The clinical outcome of events lymph nodes cervical swollen and lymph node pain was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.

Headache; Dizziness; Fatigue; Nausea; Swollen lymph node; Sore arm; This is a spontaneous report from a non-contactable consumer, the patient. A 60-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the left arm on 20Mar2021 at 10:30 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included losartan (MANUFACTURER UNKNOWN), hydrochlorothiazide (MANUFACTURER UNKNOWN) and labetalol (MANUFACTURER UNKNOWN), all for unknown indication within two weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. On 20Mar2021, at 19:00, the patient experienced headache, dizziness, fatigue, nausea, swollen lymph nodes, sore arm. Adverse 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 of the events headache, dizziness, fatigue, nausea, swollen lymph nodes and sore arm was resolved on an unknown date in Mar2021. Information about lot/batch number cannot be obtained. No further information is expected.

In the week after receiving the second vaccine, I developed various joint pains and muscle pains, at times severe. The first event was both knees becoming very stiff and sore. It lasted about 24 hours. A day later, both my hands became swollen and stiff. Ibuprofen seemed to alleviate the problem. Since that time, at approximately 3-4 day intervals I developed pains in hands and knees again as well as ankles, bicep muscles, wrists, and jaw. This has continued for the last 3 months, and is now only in one of the pair of joints at a time, as in just one knee, not both at the same time. My right wrist is most commonly affected.

Patient reported several itchy wheals/hives that started on the writs of the arm the vaccination was given in, and some on the opposite arm. They were limited, not widespread. These began the day following vaccination. Roughly 12 hours post-vaccination she stated she had a severe headache that woke her up. This headache continued 7 days, peaking on day 3. She almost went in for treatment, but did not end up doing so. She also reported swollen, tender lymph nodes in axilla on side of vaccination, as well as a blood nose.

Swelling in glands/lymph nodes; earache (right ear); burning and tightness in chest; burning and tightness in chest; Aches; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 60- years-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ep6955) via unspecified route of administration in the left arm on 15Mar2021 at 15:15 (at the age of 60-years 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 been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced swelling in n glands/lymph nodes, earache (right ear), burning and tightness in chest, aches and fatigue on 19Mar2021. The patient underwent lab tests and procedure which included COVID test (Nasal swab) on an unknown date and tested negative. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive treatment for the reported events. The clinical outcome of events swelling in n glands/lymph nodes, earache (right ear), burning and tightness in chest, aches and fatigue was not resolved. No follow-up attempts are needed. No further information expected.

Headache; Fever; chills; Body ache; Nausea; Swollen armpit; This is a spontaneous report from a contactable consumer, the patient. A 60-years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: EP7534), via an unspecified route of administration in the left arm on 23Mar2021 at 09:30, (At the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, atrial tachycardia, thyroid disease and Hashimotos disease. Concomitant medications taken within 2 weeks prior to vaccination include Levothyroxine (MANUFRATURER UNKNOWN) and Diltiazem hydrochloride (CARTIA) both for unspecified indications. The patient previously received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: EN6203), via an unspecified route of administration in the left arm on 02Mar2021 at 10:00 as a single dose for COVID-19 immunisation. The patient was allergic to codeine and demerol. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient had not received any other vaccines within four weeks prior to the COVID-19 vaccine. On 23Mar2021, the patient experienced headache, fever, chills, body aches, nausea and swollen left armpit. The adverse event had not resulted in doctor or other healthcare professional office/clinic visit/ emergency visit/ department or urgent care. The patient did not take any medication for headache, nausea, chills, fever, swollen arm, general body pain. The clinical outcome of the events headache, nausea, chills, fever, swollen arm, general body pain was recovering at the time of this report. No follow-up attempts possible. No further information expected.

Rash; Swelling on my collar bone; High Fever; Dizziness; Headache; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number: EW0177, Expiration Date was not reported), via an unspecified route of administration, administered in Deltoid Left on 16May2021 (at the age of 60-year-old) as single dose for COVID-19 immunisation. Anatomical site of vaccination was left shoulder. The patient medical history included thyroid. Concomitant medications included levothyroxine (LEVOTHYROXINE); acetylsalicylic acid (ASPIRIN (E.C.), 81mg); metoprolol (METOPROLOL). The patient historical vaccine included first dose of BNT162B2 for COVID-19 immunization. It was reported that, patient stated that she was calling because she had her second shot on Sunday, she had a reaction to the shot which was normal, which was the high fever and dizziness and a headache but today she had rash and it was swelling on her collar bone. She did not know if that was another reaction to that, she knew the rash was normal, but she did not know about the swelling on her collarbone. Patient was asking was that okay or there was something she should do. Consumer stated, she just was wondering about the swelling on the collarbone was that something she need to worry about, or should she just take some like Benadryl or something for allergic reactions to it or what she should do. Events still experiencing includes the rashes and swelling on the collar bone. Consumer stated, just today, she got her blood work done. She did not know it was just her thyroid check and her cholesterol check. The patient underwent lab tests and procedures which included blood test: unknown on 18May2021. Consumer stated, "Rosuvastatin" (Not appropriately clarified hence, not captured in tab). No treatment received. The outcome of the event swelling on her collar bone was not resolved and unknown for other events. Information on lot/batch number was available. Additional information has been requested.

Hi I got my second Covid shot on Saturday July 10. Shot was in the left arm. Severe headache within five minutes like last time. Felt like a migraine. After an hour the worse pain was in my left breast & armpit. My left armpit was swollen significantly & my breast felt like I was punched or stabbed. I couldn?t lift my left arm. I applied heat & ice alternately & took Tylenol. Then whole body ached like the flu. No worries there, it?s the swollen left armpit & pain in breast that is bad. Yesterday it got worse. I continued with heat, ice & Tylenol. I took today off because the pain is severe & I can only lift my arm half way up. The severe pain feels like how you feel after a surgery when pain meds start to wear off. Do you know how long this will last?? Thanks & have a great day.

LA- 1st Covid Vaccine. IMMEDIATELY after Vaccine: Tingling & NUMBNESS to my fingertips. By Nine PM the night of vaccination, arm pain 10/10 with severe swelling, no mobility and feeling of a dislocated shoulder and elbow. Severe pain the next day accompanied by loud "Cracking" of my L Shoulder and L Elbow. Ongoing Shoulder/Arm pain with decreased mobility and numbness to the fingertips along the ulnar nerve & "cracking". Taking Motrin. Rotational shoulder pain. Consult Dr. 4/22/21. Consult Dr. (orthopedics)-- Prednisone prescribed. Pain improved a bit for 4 days- then pain and rotational problems continued. On 07/12: Visit to Dr., Orthopedics at hospital-- 2nd Prednisone dose pack. Continued from 1st page: 2nd Prednisone dosepak prescription. Was told my Dr. that I had probable improper administration (wrong location- too high) of Covid vaccine and severe, prolonged inflammatory response. I have been referred to physical therapy to improve mobility. Physical Therapy will call me for consult. Problem ongoing... I am tired of filling out this form and keeping it on my desktop.

Face bright red & swollen, red rash all over my body, headache, dizziness within the first few hours of vaccination. The first evening my headache got significantly worse. I was extremely thirsty, very tired, nauseous, vomiting, diarrhea, muscle pain, chills, fever, my left arm was very sore & swollen @ the injection site. I slept for longer periods of time than normal, very disoriented & not clear on my thoughts & memory for days after.

hives on my knees; light sensitivity; concentration difficult throughout experience; felt very dizzy; Knees swollen; neck discomfort; headache; area swollen from nose to chin; sore injection site,; fatigue; foggy during day; felt my heart beating hard within 5 minutes of vaccine; my lips were numb; I felt a little trouble swallowing.; Had chills; had swelling around lips/mouth; This is a spontaneous report received from a contactable consumer, the patient. A 60-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no : ER8727) via an unspecified route of administration in the left arm on 24Mar2021 at 11:300 (at the age of 60-year-old), as a single dose for COVID-19 immunisation. The patient had no Medical history. Concomitant medications included with supplements. The patient previously received Sulpha Drugs on an unknown date for unspecified indication and experienced a sulfonamide allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 24Mar2021 at 11:00, the experienced heart beating hard within 5 minutes of vaccine and her lips were numb and she felt a little trouble swallowing, and had chills, and had swelling around lips/mouth. On 25Mar2021, the Patient experienced area swollen from nose to chin and Had headache, sore injection site, fatigue, foggy during day. On 26Mar2021, the patient experienced Fatigue and neck discomfort. On 27Mar2021, the patient experienced very dizzy, Knees swollen and Could not sleep on injection site. On 28Mar2021, the experienced hives on her knees, Light sensitivity and concentration difficult throughout experience. The patient underwent lab tests and procedures, which included Blood pressure on unknown date and resulted normal. The patient called clinic for instructions and receive Benadryl for lips numbness, heart beating hard, trouble swallowing and chills. Patient had called doctor and awaited to call back. The clinical outcome of felt heart beating hard, numb lips, trouble swallowing, chills, area swollen from nose to chin, headache, fatigue, foggy during day, neck discomfort, dizzy, swollen knees, hives on knees, light sensitivity and concentration difficult was not recovered and of the vaccination site pain was recovered on 26mar2021. No follow-up attempts are possible. No further information is expected.

feels hot to touch; Swollen; Having the redness on the arm/tiny redness; Arm feels hard inside like its inside the muscle; Redness on her arm (where the injection was given)/bit of redness, tiny redness, the size of a penny; This is a spontaneous report from a contactable consumer or other non-HCP. A 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0180), via an unspecified route of administration, administered in Left Arm on 27Jun2021 10:00 as DOSE 2, SINGLE (at the age of 60-year-old) for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0180) administered in Left Arm on 06Jun2021 at 12:00 for covid-19 immunization and had a little bit of tiredness and sleepiness. On 27Jun2021 the patient experienced redness on her arm (where the injection was given) and bit of redness, tiny redness, the size of a penny. On 28Jun2021 the patient experienced feels hot to touch, swollen, having the redness on the arm/tiny redness, arm feels hard inside like its inside the muscle. The patient's arm feels hot to the touch and swollen: The next morning, 28Jun2021, in the morning, the caller finds out that her arm is swollen, not the whole arm, but the area where the caller received the second dose Pfizer Covid Vaccine, it was maybe 5 to 6 centimeters that it was swollen. The patient arm feels hard inside like its inside the muscle. Her arm was hard when touching the muscle, will feel hardness inside when touching arm. Her arm feels hot to the touch and swollen: The arm felt hot, warm, and swollen. Her arm feels hot to the touch and swollen: In the night hours, maybe about 2000, the callers arm swelling was already 9.5 centimeters, the swelling grew. All day on 28Jun2021, the caller was putting a little ice pack and wet and cold things onto the arm. Today, 29Jun2021, in the morning the caller finds out the size is the same. Her arm feels hard inside like its inside the muscle: The hardness in the caller's arm muscle is a little less. The caller doesn't feel the big chunk inside of the arm. There is a little less hardness. Her arm feels hot to the touch and swollen: The swelling is the same. The size is the same on the arm. Her Has redness on arm where the second dose Pfizer Covid Vaccine was given: The color is the same on the arm. Therapeutic measures were taken as a result of swollen. The outcome of event arm feels hard inside like its inside the muscle was recovering. The outcome of rest all events was not recovered.

Pain right underarm area; Severe headache; swelling in right underarm area; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) via an unspecified route of administration in the right arm on 25Mar2021 at 15:15 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and did not receive any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: unknown) via an unspecified route of administration in the left arm on 04Mar2021 at 15:15 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Mar2021, the patient had undergone nasal swab test for COVID-19 and the result was negative. On 26Mar2021 at 17:30, the patient experienced pain and swelling in right underarm area and severe headache. The adverse 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 events pain and swelling in right underarm area and severe headache. The clinical outcomes of the events pain and swelling in right underarm area and severe headache were not recovered at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Found a lump on left side of my breast. Diagnostic mammo/ultrasound found a second, more questionable lump in deep left axilla.

New onset eczema- Filed earlier report about being bitten by fire ants two weeks after second covid shot and having anaphylactic reaction with no prior history of insect bite allergies and have been bitten alot including the harvester ant. Now have epipen. Then started fire ant shots in June and developed butt tingling/numbness and muscle and body aches after 2nd fire ant shot. By third shot on on July 1st, I had fatigue, extreme musculoskeletal pain and developed a rash. It was really scary so went to the allergist who referred me to my GP. She thinks it is serum sickness. Saw the dermatologist today about the rash and it started about 3 to 4 days after the third fire ant shot. I have never had eczema in my life either. After three weeks from July 1st, am starting to feel better. Not sure if serum sickness caused by molecular mimicry hypersensitive immune syndrome caused by Covid vaccine or not, but there are a lot of immune mediated things happening to me in less than 3 months. My brother developed pericarditis after the second Pfizer shot and I told him to file a VAERS as well.

swollen lymph node in left shoulder; swollen lymph node in left shoulder that moves and was painful first couple days; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 26Mar2021 at 14:45 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. The patient medical history included GERD, blood pressure high, clot blood and the patient was allergic to albuterol. Concomitant medications included xerolto (MANUFACTURER UNKNOWN), bystolic (MANUFACTURER UNKNOWN) and pantoprazole (MANUFACTURER UNKNOWN) taken with in two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the left arm on 05Mar2021 at 14:45 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 27Mar2021, the patient experienced lymphadenopathy and lymph node pain. The patient reported that she had swollen lymph node in left shoulder that move and was painful first couple days but subsided, still swollen but less so one week later. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events lymphadenopathy and lymph node pain were resolving at the time of this report. No follow-up attempts are needed. No further information is expected.

Swelling in breaststroke and under left arm; Swelling in breaststroke and under left arm; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN8727) via an unspecified route of administration in the left arm on 27Mar2021 at 12:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient was receiving unspecified concomitant medications. The patient previously received penicillin (MANUFACTURER UNKNOWN) and erythromycin (MANUFACTURER UNKNOWN) on unknown dates and experienced drug 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 COVID-19 vaccine. On 31Mar2021, the patient experienced swelling in breaststroke and under left arm. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event swelling in breaststroke and under left arm. The clinical outcome of the event swelling in breaststroke and under left arm was resolving at the time of the report. No follow-up attempts are needed. No further information is expected.

Fever; body aches; rash on chest and stomach; rash on chest and stomach and swollen where rash is; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 31Mar2021 (at the age of 60-years-old), as a single dose for COVID-19 immunisation. Medical history included high blood pressure. 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. The patient did not receive any concomitant medications. Allergies to medications, food, or other products was reported as Bo. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 03Mar2021 (at the age of 60-years-old), as a single dose for COVID-19 immunisation. On 01Apr2021 at 00:00, the patient experienced fever, body aches, rash on chest and stomach and swollen where rash was. The events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events fever, body aches, rash on chest and stomach and swollen where rash was were not recovered at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

In my arm pit of my left arm it swelled up; In my arm pit of my left arm it swelled up and was very painful; Dose 1 Start date: 20210203/ Dose 2 Start date: 20210218; This is a spontaneous report from a contactable other healthcare professional, the patient. A 60-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the left arm on 18Feb2021 at 13:00 (at the age of 60-years-old), as a single dose for COVID-19 immunisation. Medical history included low thyroid. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) on an unknown date for unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 03Feb2021 at 10:45 (at the age of 60-years-old), as a single dose for COVID-19 immunisation (The vaccine was administered outside the range of 19-42 days (15 days) resulting in Inappropriate schedule of vaccine administered and medication error). The patient past drug therapy included lisinopril (MANUFACTURER UNKNOWN) on an unknown date for unknown indication. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 21Feb2021 at 03:00, the patient's arm pit of the left arm swelled up and was very painful. Her doctor put her on steroids and the pain went away but the swelling has not totally gone away and is sometimes painful. The patient went back to her doctor 6 weeks later with the complaint that it was still swollen and sometime painful. The doctor ordered an ultrasound and blood test but all was negative. It was still swollen and sometimes painful that has not gone away yet. On an unknown date, patient underwent lab tests and procedures which included ultrasound and blood test and the results were negative. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of reported events and included treatment with steroids. The clinical outcome of the events arm pit of the left arm swelled up and was very painful was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.

excruciating pain in the bones; sharp neck pain; Headache; sore throat; Difficulty swallowing and breathing; Difficulty swallowing and breathing; Swollen and blistered on the right leg; Swollen and blistered on the right leg; itch and hurt; itch and hurt; This is a spontaneous report from a contactable consumer (patient). A 60-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) dose 2 via an unspecified route of administration in Arm Right on 04May2021 10:00 (at the age of 60 years old) as single for COVID-19 immunisation at Hospital. Medical history included lupus erythematosus, rheumatoid arthritis, fibromyalgia. Concomitant medication received within two weeks included baclofen (SOLOFEN), clonazepam (KLONOPIN), trazodone hydrochloride (TRAZODON) all taken for an unspecified indication, start and stop date were not reported and Plasma Capilar. The patient previously took tramadol and experienced allergies, ultacit and experienced allergies, ultram and experienced allergies. The patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in Arm Right on 13Apr2021 08:00 (at the age of 60 years old) as single for COVID-19 immunisation. Patient did not have COVID prior to vaccination. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced excruciating pain in the bones, sharp neck pain, headache, sore throat, difficulty swallowing and breathing, swollen and blistered on the right leg, itch and hurt on 06May2021 16:00. Event reported as, After three days excruciating pain in the bones. Still sharp neck pain. Headache and sore throat. Difficulty swallowing and breathing. Swollen and blistered on the right leg. They itch and hurt. The pain in the neck is excruciating. Adverse events resulted in emergency room/department or urgent care. Treatment given for adverse events included toradol, sodomedrol, ataraxia, norflex. Patient did not tested for COVID post vaccination. Outcome of all the events were not recovered. Information about/lot batch number is requested.

the aches and pains were severe and affected all of her joints; cramping up in her calves and it hurts; sight issues; She could barely move; arthritis; she has real sensitivity to light; She still has pain in her knees when she walks, it's almost like her knees want to give out. Severe pain in hips; severe pain was also in her back, hips and neck; severe pain was also in her back, hips and neck; aches and pains; Diarrhea; Severe fatigue; a little bit of swelling; pain at the site; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0169; Expiration Date: Aug2021, at the age 60-year-old), dose 1 via an unspecified route of administration, administered in arm left on 27Apr2021 13:00 as dose 1, single for covid-19 immunisation. The patient medical history was not reported. Prior vaccinations (within 4 weeks), adverse events following prior vaccinations, patient's medical history (including any illness at time of vaccination), family medical history relevant to adverse events and relevant tests: none. Caller stated she had the shot and a reaction with the first shot and haven't had the second. She clarified she was referring to the covid 19 shot. On 27Apr2021, she had the first vaccine. The day of the vaccine, she experienced normal swelling, a little bit of swelling (not much), and pain at the site, which was normal. The pain went away but she doesn't know it went away. No treatment received. Then, after a few days, she started out with aches and pains but then it got to the point, the aches and pains were severe and affected all of her joints. She could barely move. Her husband had to help her on and off the toilet and that lasted a good week. She also mentions she had diarrhea. She doesn't know. It was probably a couple days later after receiving the vaccine. She was still having diarrhea, but it had improved. She has been taking Imodium. Patient reported that 2 days after she got the shot, she was severely fatigued and that's when the aches and pains started. Caller doesn't know the exact date. If she stands for more than 5 minutes, she has cramping up in her calves and it hurts. She confirms she has recovered with lasting affects. She adds she also has arthritis which might be a factor. She clarifies the aches and pains started on third day. She believes the third day, she is not exactly sure. The aches and pains got worse. When she says severe fatigue, she means she was in bed all day. Time of onset: She would say the fatigue started the 2nd or 3rd day. She provides the start date as: 29Apr2021. The severe fatigue is better than it was but hasn't gone away. She makes the comment she doesn't know why she reacted so bad to the first vaccine. She mentioned she was supposed to go on 18May2021 and get second shot, but she cancelled it. She explains this is one of the reasons she is calling. She needs to know should she get the second shot. Patient wanted to be protected against covid the best she could, her husband has major heart issues and she can't have him being exposed to the virus and she needs to get a shot. She's scared. DSU agent stated we suggest caller reach out to her primary care provider if she has questions on whether or not to get the second vaccine we wouldn't be able to provide her with any medical advice over the phone. Caller stated her doctor said not to take the second shot because she had such a severe reaction to the first one. Her main problem is that she is having sight issues. She has her husband read off the product information from her vaccine record card because she can't really see it. She has always been near sighted but this is to the point, she has real sensitivity to light, that's her main concern right now. First, she had severe pain and then had sight issues. She explained the sight issues started about two weeks in after receiving the first dose, it was right after the severe pain. It has persisted. She has an appointment on Thursday to see her ophthalmologist. She mentions its hard to get into her ophthalmologist. The severe pain started on the 4th day after receiving the first dose, around 30Apr2021. The severe pain lasted a good week, week and a half. She still has pain in her knees when she walks, it's almost like her knees want to give out. Other than that, it's better. She mentions the severe pain was also in her back, hips and neck. Her doctor prescribed diclofenac, 50 mg. She mentions she can see this dose because its bolded and its bigger. No emergency visit. The doctor said to call and see what Pfizer had to say about the second shot because she is really nervous. The outcome of event a little bit of swelling was resolved, diarrhea, fatigue was was not recovered and outcome of all other events was unknown. No follow-up attempts are needed. No further information is expected.

lymphadenitis; gland swelling; periorbital edema; severe muscle cramping; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via unspecified route of administration, administered in the left arm on 21May2021 08:00 am (batch/lot number EW0161 and expiry date unknown) at 60 years of age as dose 1, single for covid-19 immunization. The patient informed that the facility where the most recent COVID-19 vaccine was administered was in the hospital. Medical history included graves disease. The patient had no covid prior vaccination/was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included levothyroxine for unspecified indication from unspecified. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. In May2021, the patient experienced lymphadenitis, gland swelling, periorbital edema, severe muscle cramping. The events resulted to emergency room/department or urgent care and doctor or other healthcare professional office/clinic visit. The patient was hospitalized for 1 day due to the events. The patient underwent lab tests and procedures which included COVID-19 (BP) (nasal swab) on 24May2021, 01Jun2021, 10Jun2021, 15Jun2021, 21Jun2021, 29Jun2021, and COVID-19 (RAPID) (nasal swab) on 24Jun2021; all negative. The patient received treatment of prednisone w/taper, magnesium. The outcome of the events was not recovered.; Sender's Comments: The contributory role of the suspect product bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), (batch/lot number EW0161 and expiry date unknown) to reported events is possible based on temporal association and known profile of the product.

Patient hospitalized for bacteremia, severe sepsis with acute organ dysfunction within 6 weeks of receiving covid vaccination.

Small bowel obstruction with diffuse bowel and pelvic lymphadenopathy 36 hours after injection; Small bowel obstruction with diffuse bowel and pelvic lymphadenopathy 36 hours after injection; This is a spontaneous report from a contactable physician (patient). A 61-years-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EH9899), intramuscularly on 21Dec2020 12:30 to at single dose on left arm for COVID-19 immunization in hospital. Medical history included crohn's disease. No known allergies. Concomitant medications within 2 weeks of vaccination included estradiol, progesterone, colestipol hydrochloride (COLESTID), ustekinumab (STELARA), cyanocobalamin (B12). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced small bowel obstruction with diffuse bowel and pelvic lymphadenopathy 36 hours after injection on 22Dec2020 22:00 with outcome of recovered in Dec2020. The adverse events resulted in emergency room/department or urgent care, hospitalization for 3 days. Therapeutic measures were taken as a result of event included inpatient observation, nothing by mouth (reported as NPO), intravenous fluids. No COVID prior vaccination, COVID test nasal swab was negative on 23Dec2020 post vaccination. It was not reported as serious.; Sender's Comments: There is not a reasonable possibility that reported events small bowel obstruction and lymphadenopathy are related to BNT162B2 vaccine. The patient had underlying Crohn's disease, which put patient at risk of developing the event. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Immediately after receiving the vaccine, patient developed sensation of throat numbness in the back of the throat. Patient denied SOB, wheezing, throat swelling, stridor, rash, chest pain, tongue swelling. One dose of diphenhydramine 25 mg PO suspension and referred to the Mount Sinai emergency department. Sensation resolved after a total of 30 minutes (10 minutes after receiving diphenhydramine). Vital signs and physical exam were WNL with the exception bilateral submandibular adenopathy. Patient was observed in the ED for approximately one hour with no clinical change and was subsequently discharged home.

pain in her whole arm; numbness in right cheek/numbness in arm/hand; Swollen lymph nodes; This is a spontaneous report from a contactable consumer. A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 30Dec2020 12:12 at SINGLE DOSE at right arm for covid-19 immunisation. Medical history included SVT this was recognized at least 20 years ago, around the age of 30, she started to deal with high blood pressure, allergic to penicillin. The patient's concomitant medications were not reported. The patient previously took codeine, levothyroxine: allergic to codeine, levothyroxine. The patient also previously took Tylenol with Codeine and that was horrible and she can't ever take it again, when she was around the age of 40 years old. The patient received the COVID vaccination around Wednesday 30Dec2020 at 12:12 p.m. She was perfectly fine until late Thursday afternoon 31Dec2020, around 3:30-4:00 pm. She started to have swollen lymph nodes. It was only a little bad at first and then she started getting more and more swelling. She spoke with her facility's RN who suggested she use some cold and warm packs/compresses and also take some Tylenol to deal with it. She has had the swelling for this many days now. It's not bad swelling but she her lymph nodes are still so swollen. She thought it was a regular reaction, but now it's been too long. Her lymph nodes are not swollen humongous. There is no redness. Her lymph nodes are not hard, just swollen. The swelling was a little bit better on Friday and Saturday but yesterday, it started bothering her again. She has had pain in her whole arm on an unspecified date. On 03Jan2020, her face also started to feel funny. She clarifies by "feeling funny", she meant she started to experience numbness in her right cheek, only her cheek, like when one gets a vaccination when they go to a doctor's office/dentist office and it starts working and one can feel it getting numb. She also experienced numbness in her arm. She clarifies when she puts pressure on her arm (like putting her arm on the desk), she feels numb in her hand. She verifies the numbness in both her cheek and arm started occurring on 03Jan2020 around 7-8pm. She is fine today and then she'll start to feel the numbness again in her cheek and arm. She clarifies the numbness comes and goes. It comes in the morning and then goes away and then the numbness starts again. She started to feel numb in her face and cheek, like when one gets a Novocain at the dentist office and it starts working- it's like the same feeling. The outcome of the events Swollen lymph nodes and numbness in right cheek/numbness in arm/hand was not recovered, while unknown for the other event. Information on the lot/Batch number has been requested.

1st day of inj the expected side effect of inj site very sore and fatigue for 25 hours. Day 8 after receiving the vaccine, at 2 PM started with itching of scalp, arms, legs, rash, and abdominal hives. Proceeded to facial swelling and difficulty swallowing, swelling back of neck. Took 50 mg Benadryl w/ some relief. 630 PM symptoms reoccur, took another 50 mg Benadryl with no relief. Symptoms intensified to severe swelling of back of neck with intense pressure base of skull, radiating to top of head. Proceeded to the ER at 830 PM

Lymph node swelling under left arm and aching down left arm and side of chest. Lymph node painful to touch.

On 01/10/2021 started feeling Chills then 102.5 fever lasting 2 hours, took 2 Tylenol and fever went down to normal. Later I realized that I had two swollen lymph nodes on the left side of my neck. Next morning 01/11/2021 at woke up noticed another swollen above the hollow of the clavicle.

fever; nausea; general feeling of unwell; soreness at site; redness; whole upper arm was swollen after the injection; This is a spontaneous report from a contactable other HCP (patient, Respiratory Therapist) reported that a 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE , Batch/lot number: EJ1685) via an unspecified route of administration on 21Dec2020 around 6:00 PM in left upper arm at 0.3mL single dose for COVID Prevention. The patient's medical history was covid at the end of Apr/May2020 with shortness of breath, seasonal allergies and allergies to "some anitbiotics." The concomitant medications was reported as none, received no other vaccines on the same day as the COVID vaccine. The patient experienced soreness at site, redness and swelling, fever, nausea, general feeling of unwell 3 days. Patient stated, "I had covid at the end of April/May with shortness of breath. I thought I would have less reaction from the vaccine. I know someone who was out of work for a while week after the vaccine." States that she read that the 2nd dose is supposed to have worse side effects than the first. If she had bad side effects from the 1st dose, will the 2nd be worse? Also asking if the side effects are the immune system reacting or just an allergic reaction. Patient was anxious about getting her second COVID shot on 11Jan2021. Patient stated that she had all the side effects listed, for three days. Patient stated that she didn't mind the side effects at the time, she had fever, soreness at the injection site, nausea, and a general feeling of unwell, but Patient stated that she could not work like that. Patient stated that her question was, statistically she has read that the side effects from the second shot are supposed to be worse than the first shot, but she was wondering, if she had bad side effects from the first shot, will her side effects be worse after the second, or will they maybe be lessened because she already had bad side effects. Patient reported that she did fill out the VSafe significant because she had to work on the third day after her shot, which was Christmas Eve, and work, was so busy and she did not feel well. Patient stated that she does have two days scheduled off work after her next injection, but it is the third day that she was worried about because she does not want to work feeling like that. Patient stated that the arm soreness started that same day (21Dec2020). At first, Patient reported that the arm soreness resolved, but then she states that it is still a little sore to the touch. So Patient confirmed that it is ongoing but improved. Patient reportsed that the fever started the day after the injection, 22Dec2020 and it has resolved. Patient reported that the last day she recorded a fever was on 24Dec2020. Patient stated that she woke up on 24Dec2020 and her temperature was normal, so she went to work and she did not feel so well at work, but they were so busy that she barely noticed, and then when the Patient went home that night, she took her temperature and it was 100 degrees Fahrenheit. Patient reported that the nausea started on 22Dec2020, which was mild at times, but then she got to where she did not want to eat. Patient reported that the nausea has resolved but she was not entirely sure when it resolved because she had been so busy at work on 24Dec2020, and it was hard to tell what she was feeling because she was non-stop busy that day. Patient stated that she was nauseous for a full three days, and she remembered that she did not eat much on the 24th either. So Patient stated that her nausea may have resolved on the third day after her injection, but it is unknown to her what day exactly that it resolved. Patient was also experiencing the general feeling of unwell from 22Dec2020 for a few days, but stated that by 25Dec2020 she felt okay. Patient also included that her left arm was also swollen, like her whole upper arm was swollen after the injection in Dec2020. Patient stated that she also experienced redness, there was a like a red mark that was further down her arm than the injection site in Dec2020. The outcome of soreness at site was recovering. Patient confirmed that both the swelling and redness had resolved in Dec2020.The outcome of fever was recovered on 24Dec2020. The outcome of general feeling of unwell and nausea was recovered on 25Dec2020.

Was premedicated with Medrol, Singulair and Zyrtec 20 minutes after vaccine developed paresthesias of both sides of lower face, lips and face swelling. This resolved in @ 20 minutes. Next day developed excessive fatigue with difficulty talking and a heavy sensation in the chaste with an event of fullness sensation of the right soft palate and tongue.. This became worse on the second day for which needed treatment with Medrol pack and antihistamins.

Systemic: Anaphylaxis-Severe, Systemic: Fainting, Systemic: Pharmacist submitting: unable to determine if anaphalaxis or panic attack, patient experienced facial weakness, chest tightening, tremmors, inability to breathe, and fainting within 10 min of administ

Received the 2nd vaccine at 10am on 1/11/21 intramuscular in the right arm. At 3pm on the same day, I had a painful swolle lymph node on left side of neck. That same evening I developed pain, swelling, in my right armpit radiating to the right upper breast and down my right arm with a swollen lymph node under the right arm pit. The pain was about a number 7 on a scale of 1 to 10. The pain and swelling still persist today on 1/15/2021 Still painful, especially to touch. Still radiating down the arm. Lymph node still swollen The pain is about a 2 on a scale of 1 to 10

Total body rash with severe ankle and feet swelling and peeling that continues even after getting vaccine more than 3 weeks ago

i1/13/21 at about 2;45 pm, I had my second Covid vaccination. had pain on site on left arm 1/14/21 woke up feeling a little tired, went to work. went home early at 1:30 pm, feeling a little chilly. no fever. 1/15/21 in the morning noted pain on Left armpit ( injection site is left arm), pain from left shoulder blade to right shoulder blade. took advil. In the afternoon, about 4:00 pm, noted some swelling and soreness on left armpit. took Advil.. 1/16/21, Called employee health to report this. Advised to take advil and monitor and call pcp if symptoms persists.

Noticed early this morning a large swollen area above my left clavicle. This was about 36 hours after my vaccination.

Hands are hurting, looks like I have some bleeding under the skin on my left hand, middle finger, hands are swollen and have a spotted look on the underside. Tried taking over counter meds, nothing is helping with pain.

itching of scalp, arms, legs; rash; abdominal hives; facial swelling; difficulty swallowing; swelling back of neck; inj site very sore; fatigue; This is a spontaneous report from a contactable nurse (patient). A 61-years-old female patient (no pregnant) started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EK923) , via an unspecified route of administration on 29Dec2020 09:45 at the first single dose at arm left for covid-19 immunisation. Medical history included known allergies: Sulfa. The concomitant drug was unspecified. The patient previously took cipro and experienced drug hypersensitivity. On 29Dec2020, the patient expected side effect of inj site very sore and fatigue for 24 hours. On 06Jan2021 14:00, the patient started with itching of scalp, arms, legs ,rash, and abdominal hives. Proceeded to facial swelling and difficulty swallowing, swelling back of neck, took 50 mg Benadryl w some relief. 630 PM symptoms reoccurred, took another 50 mg Benadryl with no relief. Symptoms intensified to severe swelling of the back of neck with intense pressure base of skull, radiating to top of head. Proceeded to the ER. The patient received Prednisone 50 mg orally and for the 4 days. The outcome of event inj site very sore and fatigue was recovered on 30Dec2020; the outcome of events was recovered.

Systemic: 6 hours after vaccine lost voice, 8 hours after mouth, tongue, throat itching. next morning had face and lip swelling and tingling. self treated with antihistamines. resolved after 3 days.

Patient's right side of neck starting swelling after 10-15 minutes of vaccination. Patient received Benadryl and the swelling slowly went down. Patient stayed for another 20 minutes for watch and left.

Second, dose 1/16/21 Pfizer LOT: EL3248 Saturday 11:30 am ? Side Effects started about 1.5 - 2 hours after injection (I took 2 Tylenol and took a 3 hour nap) o Tired o Left Eye twitch o Blurred double vision o Headache o Nauseous ? Side Effects started about 5 - 6 hours after injection (I took 2 Tylenol a Benadryl and used my Ventolin inhalator) o Tired o Watering eyes o Sore tongue o Headache o Nauseous o Heavy feeling in chest ? Side Effects started some time during the night after injection o Muscle cramping in both legs and opposite arm of injection site o Low fever 100.3 Sunday side Effects (I took 2 Tylenol and took a 3-4 hour nap) o Tired o Left Eye twitch o Watering eyes o Sore tongue o Excessive thirst o Swollen neck glands o Nauseous (only after eating) o Muscle cramping in both calves o Blurry vision in the evening o Runny nose Monday side Effects (Went to work) o Tired o Left eye lid twitch o Swollen neck glands o Nauseous o Runny nose o Achy body o Diarrhea Tuesday side Effects (Went to work) o Left eyelid twitch o Swollen neck glands o Runny nose o Sore throat o Diarrhea BLOODY Wednesday side Effects (went to work) o Swollen neck glands o Runny nose o Sore throat Note: I have several Allergies that require me to take an allergy pill every day. I also use an inhaler as needed. My symptoms were not any worse than when I have a bad allergic reaction, I have received shots of Epinephrine for my allergies and did not feel one was necessary.

At day 20 after the vaccination I got up in the middle of the night & could barely walk. My knees were very painful 10 out of 10. As the day progressed it got worse & I needed a walker & eventually a wheelchair.

On day 20 after the vaccination my knees starting getting sore- by 3 am I could barely stand on them- as the day progressed I had to use a walker & by late afternoon a wheelchair. The pain in my knees was a 10 out of 10.

Enlarged, sore lymph node right mid clavicle. 0.8mm; sore lymph node right mid clavicle. 0.8mm; This is Spontaneous report from a contactable Nurse (patient). A 61-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot EL1238, intramuscular in arm right on 09Jan2021 13:00 at single dose for covid-19 immunisation. The patient previously received the first dose of BNT162B2 on 19Dec2020 at 10:00 AM, lot number: EH9899, Intramuscular in arm left for covid-19 immunisation. The patient did not receive other vaccine in four weeks. The patient medical history was not reported. The patient did not have covid prior vaccination, and she was not tested for covid post vaccination. There were not known allergies. Concomitant medication included acetylsalicylic acid (ASPIRIN), and colecalciferol (VITAMIN D). The patient experienced enlarged, sore lymph node right mid clavicle. 0.8mm on 11Jan2021 18:00. The patient did not receive treatment. The outcome was not recovered.

unable to work; ESR of 124 mm/hr; CRP of 4 mg/dl; difficulty with ADLs; neck and leg muscle stiffness and pain; neck and leg muscle stiffness and pain; difficulty ambulating; neck and leg muscle stiffness and pain; fatigue; body aches; chills; sweats; This is a spontaneous report from a contactable physician (patient). A 61-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) via an unspecified route of administration at left arm on 18Dec2020 at single dose for COVID-19 immunization. No medical history. The patient's concomitant medications were not reported. Patient had been otherwise well prior to receiving the bnt162b2 on 18Dec2020. Within 72 hours, she experienced fatigue, body aches, chills and sweats since 21Dec2020, though she was able to work Xmas week. On 31Dec2020, she contacted her PCP to report neck and leg muscle stiffness and pain, difficulty ambulating, fatigue, chills and sweats. She had a negative COVID test on 02Jan2021 and essentially negative blood work, other than an ESR of 124 mm/hr and CRP of 4 mg/dl. I had a negative PET scan on 12Jan2021. Currently, she had pain/stiffness in her neck and legs, and progressive difficulty w/ ambulation (both of which are worst in the early hours of the AM), and difficulty with ADLs since 31Dec2020. She had been unable to work since 03Jan2021. Her physician had not indicated or endorsed any relationship between her symptoms and the vax. She forewent dose 2 out of an abundance of caution. The adverse events resulted in doctor or other healthcare professional office/clinic visit. No treatment received. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No medications received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The outcome of the events was not recovered.; Sender's Comments: The events muscle stiffness , neck pain and gait disturbance appeared 13 days after administration of single dose BNT162B2. The Company considers that the events are less likely related to suspect BNT162B2 injection given the weak time association. The detailed clinical course and cause of the events would be helpful for further assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Monday afternoon, January 25, I started feeling achy and chilly. Just not well. I work 5 a.m. to 1:30 p.m. I went straight home from work. I took shoes off and got in bed. I was very cold and felt that the coldness was from inside out especially in my hands. I covered with a sheet and 3 blankets with an extra blanket to my feet and used winter gloves on my hands. I got up at 5 p.m and felt better. Tuesday morning, January 26 at 3 a.m. when I got up to shower, I noticed a soreness and large swelling under left armpit, ? lymphadenopathy. All others symptoms had passed. Continues to be the same on today, January 27. Seeing MD on Thursday, January 28.

12/31/20:left a message saying she got the vaccine 5 days ago and is experiencing severe neck pain that shoots down her neck and back : saw PCP - f/u 1/8/21 :I still have a little neck pain left and my glands are still slightly swollen. Getting my 2nd dose today. I have paperwork from Pfizer that I need to fill out for their data keeping. Pain was excruciating for nearly 2wks and started to settle down a few days ago, where I don?t have to sit with a heating pad or take motrin and flexaril. f/u 1/28/21-"My neck still hurts, worse on certain days, but is bearable. I haven?t had any imaging done and just heard of another person with same symptoms. My 2nd dose was fine. No pain at all, not even at injection site. I will keep you posted if anything changes. I?m hoping it will just go away on it?s own. I?ve heard it takes months". Referred employee back to PCP.

day after shot. Woke up at 3:00 Am with severe pain in my right arm with redness and swelling around the shot area.

Received second dose of Pfizer COVID vaccine on 1/17/2021 at about 10:30 am. Started having soreness in arm, headache, and fever of 99.4 at about 2:30am on 1/18/2021. Side effects persisted all day on 1/18/2021 but relieved with acetaminophen 325mg every 6 hours. All side effects resolved by morning of 1/19/2021. Around 4:30pm on 1/19/21 started having pain in left axilla which was due to swollen lymph node. The pain and swelling progressed over the evening and pain radiated to chest, throughout left arm, and shoulder. All of these side effects continued all day on 1/20/21 but started getting better around 6pm. All side effects resolved by morning of 1/21/2021.

Extremely painful enlarged lymph nodes under right arm. Remain painful 11days later. It is about the size of a baseball.

facial flushing for 1 hour after shot. Redness on nose and cheeks for about an hour. No hives, no itching. Didn't notice until I left the vaccine site and was on the way home in car because covered by mask. Note I am a very fair skin, freckled red haired woman. I was very, very nervous and had gotten myself to the point of tears. Perhaps the flushing was from that. Have had similar flushing when drinking red wine. Swelling in lymph node in supraclavicular area on same side as shot. Has happened with Flu shot once. Slight fever for a short period of time and fatigue. I continue to have slight shortness of breath from having covid on. 4/3/20. Nothing different.

She had significant fatigue the day after the injection along with a sore arm and intermittent headache. Starting about 72 hours after the vaccine she noticed a swollen lymph node at the base of her neck on the side of the injection. The lymph node, sore arm and intermittent headache are still present.

Fever,chills and uncontrollable shaking. Lymph nodes enlarged. Under layers of bedding and couldn't get warm. Fever got up to 102.5 on that Saturday about 25 hours after vaccine. Also, felt weak and very tired. Early Sunday morning about 2am, I woke up to my gown dripping wet from sweating. I changed went back to sleep and woke up again about 7am to the same thing. I did take Tylenol and Ibuprofen for the fever. I spent all Sunday in bed, no more shaking but chills and Fever persisted through out the day. Monday, I felt better initially until about 8 pm and symptoms started all over but harsher because know my Lymphedema flared up

6:00 am next day woke with a really bad backache hard to walk or bend or pick up something. Felt like that all day...very hard and stiff near back middle rib area both sides. Felt better if rested but if got up bad again. Very uncomfortable continued until the following morning. Got up today am 2/14 feel a lot better but slightly still there. Also had lymph node swelled a little in same arm as shot under collarbone. Hopefully my back isn't as bad as yesterday. Had to lay in bed a lot 2/13.

Wokke up around 3:00 a.m. 3 nights after vaccine. Violent vomiting 3-4 times, then diahhrea for about half hour. Thought I had food poisoning. Sever headache shortly after. Sunday, slight fever, listless, some muscle aches, joint pain. Sunday night, headaches returned. Monday, slight fever, muscle aches, swollen lymph nodes under right armpit. Some mild muscle aches and joint pain. Monday night, headache again. Tuesday, same symptoms. Wednesday, some joint pain, swollen lymph node, otherwise fine.

Severe all arm pain for short period of time, chills, headache, fatigue, swollen lymph nodes and continuing nausea.

Mouth and tongue (top and bottom) numb and stinging, facial swelling and red rash - 5 days Fever 101 - 2 days headache - 5 days nausea - still have diarrhea - 6 days Sore and stinging left arm (received vaccine), sore upper and lower back and neck. Felt like I was kicked in those areas - still have Fatigue - 6 days, lessening Toes bright red at the top and are painful, areas on bottom of toe as well - still have

61 yo F with history of bilateral lung transplant 6/23/17 presented to ED on 2/4/21 with chief complaint of worsening shortness of breath, nausea and diarrhea for past week since receiving since receiving COVID-19 vaccine (Pfizer) on 1/28/21. Upon arrival to triage she was obviously dyspneic with significantly low oxygen saturations. O2 sats on arrival were 65%, improved to mid 90's with O2 6 liters per NC. Admitting diagnosis: hypoxic respiratory failure post COVID vaccine. Lab work shows an elevation of the BUN and creatinine at 31 and 1.71 which is slightly higher than her usual baseline levels. BNP is elevated at 2 448 with a mildly elevated troponin. Procalcitonin is also elevated. Patient's white blood cell count is 11.07. Full viral panel including COVID-19 is not detected. All blood cultures and respiratory cultures were negative. Patient chest x-ray shows numerous bilateral patchy opacities which is significantly different from her previous chest x-ray here. Empiric rejection treatment initiated including high dose methylprednisolone, plasmapheresis, IVIG, Thymoglobulin. She continued to decline and ultimately required intubation, proning and paralyzing on 2/8/2021 and then VV ECMO cannulation on 2/13/2021. EGD done 2/14/2021 as unable to pass the TEE probe during cannulation prior day (unable to complete due to abnormal anatomy). Acute pupil exam change in the early am hours of 2/15/2021 prompted urgent head CT which revealed catastrophic brain bleed. Brainstem reflexes were lost soon after. Despite placing an EVD emergently at bedside, brain stem reflexes were not recovered. GOL engaged and patient not an organ donation candidate. Therefore discussion with sister at bedside resulted in decision for cessation of life support. Patient expired shortly after support withdrawn and pronounced dead on 2/15/2021 at 11:11 AM.

Pt stated itchy and swelling face at the time of her first vaccine, She did not report this at the time of the 1st dose and took benadryl when she returned home. Upon receipt of her 2nd dose, she notified the vaccinator, the medical OIC was notified. Benedryl was administered prior to onset of symptoms. Pt was instructed to be observed for 30 mins and observation was notified.

Received first COVID vaccination at 3:50pm and 5-10 minutes later began to experience pain and throbbing in jaw and lower molars. pain began moving forward. tongue began to tingle and mouth went numb. Glands were swollen and pain was experienced in both ears, under both eyes and cheek bones. Also experienced pain in the top and back of head.

Woke up on 02/24/2021 with sweeling under the right arm (between armpit and breast). Swelling is stated to be the size of a softball in diameter. Client was asked to follow-up with her primary care physician.

Had my 2nd vaccine 1/28/21. On 2/3/28, I has rashes, redness & itchiness upper chest. On 2/5/21, My lymph nodes right neck is swollen, also painful mass around 2x3cm below right clavicle near the sternum. I also have flu-like symptoms, body weakness especially lower extremities. Rashes and itchiness upper chest still present. 2/9/21 : Lymph node swelling of right neck & below right scapula still present. Rashes & itchiness upper chest still present but controlled with hydroxyzine tablet. Flu-like symptoms still present. 2/11/21: Rashes & itchiness minimal, less medication needed. Lymph node swelling less, still gets tired easily. 2/19/21: lymph node below right clavicle bigger for 1 day. No more lymph node swelling right neck. Still gets tired easily. 2/24/2021: Lymph node below right clavicle 1x1 in size, not painful.

Pain at the injection site was typical for vaccination and was essentially gone by the next day. Headache started within one hour after vaccination and was severe 4 hours after vaccination. Next day morning I woke up with all my face swollen, runny nose, headache, stiff neck, pressure and pain at the base of the skull, pain and edema behind and below both jaws, pain in the right year and dizziness. Face edema and runny nose subsided 3 days after injection. Stiff neck, pressure and pain at the base of the skull, pain and edema behind and below both jaws, pain in the right year persists 7 days after injection. Dizziness and foggy head became worth 7 days after injection.

Moderate fatigue - unresolved mild headache - unresolved diarrhea - resolved 2/19/2021 joint pain - resolved 2/22/21 increased blood pressure - resolved 2/19/2021 swollen eye lids and upper checks - resolved 2/22/2021

numbness in her lips; swelling in her face; her tongue was feeling funny; her throat was feeling strange; she had itchiness to her right hand; started to develop hives; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 01Feb2021 at 09:00 (at the age of 61-years-old) at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on an unspecified date for COVID-19 immunisation. The patient experienced numbness in her lips, swelling in her face, her tongue was feeling funny, her throat was feeling strange, she had itchiness to her right hand, and started to develop hives on 01Feb2021. The clinical course was reported as follows: Approximately 3 hours after receiving the vaccine, the patient started to experience numbness in her lips, swelling in her face, her tongue was feeling funny, her throat was feeling strange, and she had itchiness to her right hand and started to develop hives. The patient stated that she cannot take diphenhydramine hydrochloride (BENADRYL), but she did take cetirizine hydrochloride (ZYRTEC) to help with the symptoms. The patient was still having symptoms at the time of reporting. Therapeutic measures were taken as a result of all of the events as aforementioned. The clinical outcome of numbness in her lips, swelling in her face, her tongue was feeling funny, her throat was feeling strange, she had itchiness to her right hand, and started to develop hives was not recovered. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Slurred Speech, fever, aches, feet and hand swelling, confusion, headache, memory loss - mostly resolved some memory issues and headache still 2 days later

On day 2, I developed confusion and could not focus making it impossible for me to complete my work at my job. The confusion made driving dangerous. By Friday, I went to my PCP and they noticed that my blood pressure was only 90/58 and they were concerned so she told me that she was calling my cardiologist who said to reduce the dose of my Diltiazem from 180 mg daily to 120 mg daily. She also said to take a few days off of taking the Diltiazem. I have also had a serious increase in Tachycardia. That evening I went to the ED because I was so weak and couldn't breath well. I am also retaining a lot of fluid. The lab work indicated an elevated Pro-B-Natriuretic Peptide level of 227. I am still not well and each doctor I have spoken to said they believe it is due to the vaccine. I do not know if I should take the second dose.

At 0900 this morning my face next to the right side of my mouth started itching. I immediately felt it swell. I looked in the mirror and could see the left lower part of my face (lower cheek by the edge of my mouth) swell and my right upper lip started to swell. I took a Benadryl (25mg oral tablet) and my roommate drove me to the Emergency Room. That area of my face continued to swell and impacted my lower lip as well. My lips were numb and tingling and I could feel my cheek swell more inside my mouth as it was touching my teeth. I was monitored (vital signs and pulse ox) for 90 minutes and received 20 mg of pepcid oral tablet and 10 mg dexamethasone oral tablet- both 1x only.

arm soreness at injection site (both vaccines); fever <100.6F x 24 hours; delayed headache x 3 days; enlarged left breast lymph nodes; This is a spontaneous report from a contactable health care professional (patient) reported for herself. A 61-year-old non-pregnant 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; EL0140, expiry date: unknown) via an Intramuscular on 28Dec2020 at 12:00 PM (at the age of 61-years-old) on Left arm at single dose and second dose (lot number; EL0142, expiry date: unknown) via an intramuscular route on 19Jan2021, at 08:30 AM on left arm at single dose; both for COVID-19 immunization. Medical history included hypothyroidism and hyperlipidemia. Patient received unspecified concomitant medications (Other medications the patient received within 2 weeks of vaccination (unspecified)). Patient had no Allergies to medications, food, or other products. On an unknown date, the patient had arm soreness at injection site (both vaccines); on 20Jan2021, at 05:00 am, patient had fever less than 100.6 F x 24 hours, delayed headache x 3 days for 3 days, enlarged left breast lymph nodes (routine mammogram/sonogram was 2 days post injecting on left arm). No treatment was received for the adverse events. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. On 25Jan2021, patient underwent nasal swab (SARS-COV-2-BY-NAAT) test and resulted as negative. Seriousness of the events was reported as non-serious. Outcome of the events was recovered on an unknown date in Jan2021.

I am on infusion for severe psoriatic arthritis, and was doing well. Two days after injection it was as if the effects of my infusions were cancelled. Extreme widespread stiffness, pain, joint swelling and heat, muscle weakness and pain. I also had swollen lower lip and have had an increase in headaches and nausea. Two weeks after the injection I awoke with my right arm swollen, hard, and itchy. The arm and my lips have resolved, but I am still having all the other problems. I have reported these symptoms to both my primary doctor and my rheumatologist.

Received Pfizer vaccine at the Hospital on March 12, 2021 at 10:05 a.m. No reaction at that time. One hour later my ears and scalp began to itch. I had chills and severe nausea. Severe stomach cramping. Rash covering arms, legs, scalp, back and shoulders, Hives across chest and down both arms. Swelling and hives on palms of hands. Difficulty breathing. Symptoms began one hour after vaccine and continued to worsen. Was treated at Center for allergic reaction. Was given Benedryl and Famotadine, then released.

Around 12;00pm on 3/13 , I felt muscle aches through back, shoulders, neck. Sore at site of vaccine and Headache. I felt tired and rested around 1:00p.m. Took 1 extra Strength Tylenol. Then started getting chills. Felt like I had swollen lymph node on ride side of throat when swallowing and had some pain going up into my ride ear. These symptoms lasted all evening. I didn't feel like eating dinner so rested and took 2 extra strength Tylenol at 9:00 p.m. and went to bed. Woke up early in morning with bad headache so I took another 2 extra strength Tylenol around 6:00am. I finally started feeling better around 9:00am.

Had severe headache, chills, fever, whole body aches, joint pain, swollen arm, very hard lump and hot at injection site. All this started the day after injection .so severe that it felt like I had covid AGAIN! Couldnt eat or hardly get out of bed the day after shot and the second day after the shot I still felt the same but was able to eat . The third day after shot, my fever went away and most of the body aches except I still have the headache and my arm is still hot, and swollen. Just have been taking tylenol this whole time and cold wash cloth for fever and swelling.

A lump developed in the area between my shoulder and neck on the same side as the vaccine was given. Information provided with vaccine provided a link which after review makes me think this lump is a swollen lymph node.

Within minutes of getting the shot in my left arm I started to feel the left side of my neck getting stiff. It felt like the stiffness was creeping up my neck. After about a hour I felt my ear lobes tingling and the left side of my face in the jaw area seemed a bit swollen and felt a little numb. It resolved and I had only a sore injection site the next day and no other symptoms. I'm wondering if I should be concerned about getting the second shot

Pt called clinic stating that 12 hours after getting vaccine she noticed swelling of left breast and left arm. States that left breast noticeably bigger that the right. Almost double the size from the swelling. Left arm having swelling that started on the inner aspect of the upper arm and has spread down to the elbow. Stated it is tender to the touch and having pain in muscle with moving arm. Not hot to touch. No redness, rash, bruising, shortness of breath, or tightness in throat. Offered an appointment for evaluation at the clinic, but patient declined and preferred to continue to monitor at home. Discussed that if swelling increases or persist to contact the clinic fo an appointment.

Swollen and tender axillary lymph node Narrative: Patient received her second COVID vaccine on 3/9/2021 in her left deltoid. On 3/11, patient called the facility to report a "swollen lump" in her left axila, which she had noticed that day (two days post-vaccine). She additionally reported the area to be tender to palpation. The area was slightly warm, but not hot. She denied drainage or fever. She denied any other symptoms other than increased fatigue since vaccine. On 3/16, patient contacted the facility again to relay that her post-vaccine symptoms had resolved. She reported her affected lymph node was still slightly swollen but much improved from initial onset.

bruise to her back; rash on back of neck/rash all over her body; redness; swollen area back of neck/ swollen area to her back; a lot itchier; This is a spontaneous report from a contactable Nurse (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261), via intramuscular on left deltoid on 21Jan2021 at 14:00 at single dose to prevent Covid 19. The relevant medical history included obese from an unspecified date. Concomitant medications were reported as none. The patient experienced rash on back of neck/rash all over her body on 26Jan2021 at 19:30, swollen area back of neck/ swollen area to her back on 26Jan2021 at 10:00, redness on 26Jan2021 at 19:30, bruise to her back on 27Jan2021 at 10:00, a lot itchier in Jan2021. The nurse stated that she wanted to report that she had the Pfizer vaccine last Thursday. Stated that two days prior to the report that a rash started on the back of her neck and stated yesterday it was a lot itchier (as reported). Stated that she got undressed to put her PJs on and noticed that she had a fine raised rash everywhere and it was swollen. Stated that she went through her house to see if there was anything that could have caused it. Stated that she went to that doctor at the time of the report and was started on Prednisone taper. Stated that the doctor was concerned about the Prednisone reducing her ability to prevent antibodies. Stated that the doctor stated that he was unsure if she should get the second dose. Caller wanted to ask questions about these things. Had not started the Prednisone yet. Stated that there was redness to the back of her neck and back. Stated that the swelling was to the back of her neck and back. The events did not require a visit to Emergency Room but required a visit to Physician Office. Prior Vaccinations (within 4 weeks), no other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The event bruise to her back was reported as non-serious, while the events rash on back of neck/rash all over her body, swollen area back of neck/ swollen area to her back and redness were reported as serious due to medically significant. The outcome of the events was not recovered.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported "rash on back of neck/rash all over her body", "swollen area back of neck/ swollen area to her back and redness" and the administration of the COVID-19 vaccine, BNT162B2, based on the plausible temporal association and lacking alternative explanations. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.

1. Started Mar 8: Swollen lymph nodes on the right side behind the ear and at the root of sculp. Painful, in 4 days started fading away, in 6 days no pain , in 9 days completely gone. 2. started Mar 9: High Blood pressure - 167/97; was taken Amlodipine ( 2*2.5 mg); in 4 days it stabilized. 3. started Mar 14: Fever, treated with Tylenol taking every 6-8 hours. on Mar 19 temp is normal. 4. on Mar 18 Dr. took blood and urine tests. No sings of any abnormality. Came to conclusion - should be vaccine side-effect, report to.

Chills; Fever; Pounding headache; Swollen lymph nodes on left side; This is a spontaneous report from a contactable consumer. A 61-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 05Feb2021 09:45 AM (Batch/Lot Number: EL3247), at the age of 61-year-old at the time of vaccination, as SINGLE DOSE for covid-19 immunisation . Medical history included chronic lymphocytic leukaemia (CLL) and former breast cancer. Concomitant medication included tamoxifen 20 mg taken for an unspecified indication, start and stop date were not reported. The patient received dose 1 of vaccine on 15Jan2021 01:00 PM at left arm, lot number: EL1283. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient was not diagnosed with COVID-19. On 05Feb2021 22:00, the patient experienced chills, fever, pounding headache, swollen lymph nodes on left side. The outcome of the events was recovered. The patient took Tylenol as treatment for the events. Since the vaccination, the patient has not been tested for COVID-19.

Patient DOB 5/16/1959 received 1st dose of Pfizer Lot # ER8730 and was waiting in the 15 minute observation section when she stated that she felt "swelling of her face and tingling of her lips." Blood pressure was 196/98, HR 85, O2 97%, Temp 98.1. Patient was alert and oriented x 4. Patient stated that she was very anxious today and has allergies to dairy and pollen. Patient confirmed that her husband was on the way to pick her up and drive her home. EMT administered 25 mg of Benadryl PO at 12:32 pm. Patient observed for an additional 50 minutes until her husband arrived to pick her up at 1:22 p.m. Patient stated that she was feeling better and was able to walk unassisted with her husband. informed patient to go to ER or call 911 if symptoms worsen.

Face Swelling, lips swelling, felt like inside of mouth was thickening. Called doctors office and spoke to oncall doctor. He recommended to take antihistamine. On way home -stopped at gas station and got Benadryl. Took Benadryl twice Saturday and Sunday. Had cold chills and sweating Sunday night. Stomach pain and diarrhea Monday.

Rash on my abdomen and arms started about 5 days after the vaccine. Rash is itchy and looks like raised bug bites. Itching mostly at night. Will break out in different areas on arms from day to day. Abdominal rash remains constant. Started using OTC cortisone to minimize the itch and started taking Zyrtec for the itch. It still remains as of this report and hasn't gotten any better.

Around 11, 11:30 the pain woke me up because it was so bad. It was hot and there was a big lump under my left arm pit (was very tender). I did not go to sleep like that. I did not have any symptoms by the time I went to bed. I also felt hot, and then cold, then hot, then cold, I would feel too hot and then too cold, freezing, I could not keep my temperature under control. I had to call in at work during the weekend I was feeling so bad. I had a lump under my armpit the size of a fist and I could not close my arm completely. It was huge and painful. I decided to go to a clinic over the weekend (unsure if Saturday or Sunday) to seek medical care and they ran some labs and a CBC to check for infection. All results came well no infection. They suggest to keep taking Tylenol. By Monday or Tuesday I started feeling well enough to return to work. The lump was still present and took about a week to go down. The injection site also was sore for a while, about a week also like the lump.

Immediately: headache, left eye pain, nausea, cold sensation and felt ?weird? but thought it was normal and thought I might feel flying for a bit but that it would wear off so I did not report feeling anything at the clinic. I left the clinic and got in the car to drive home and felt a weird feeling in my throat reminiscent of my esophageal spasm and then it felt like someone had their hand on my throat squeezing my throat and felt like I needed to take deep breaths to expand my lungs. Within a minute or two at most, my lips, tip of my tongue, tip of my nose and face beside my lips and under my cheeks started to tingle and go numb. My insides felt swollen. I had a doctors appointment and went there after picking my son up at home. I reported my feeling to my doctor who prescribed a steroid for 3 days and told me to also take Benadryl or Claritin, which I did. However, today is day 4 after my vaccine and today is the first day my insides don?t hurt.

I had swollen and very, very painful - the muscle on top of my shoulder (Trapezius) on the right side and I took Advil late at night time because it was so painful I couldn't sleep. My arm was not sore but that muscle was. That seemed to calm it down (Advil). The next morning, I was very swollen under my right armpit - I figured it was my lymph node. It was uncomfortable and very noticeable - quite swollen for three days. It took about a week to go back to normal. I also had abnormal fatigue and that took longer to resolve - that took about two weeks to be resolved.

On 3/22/21 I experienced several bouts of diarrhea coupled with clammyness/sweating/heart rate of 102. On 3/22/21 and continue to have swelling in my left armpit (Lymph node area), spasms in my left shoulder blade and surrounding soft tissue adjacent to my left armpit and neck area. I have experienced soreness in that arm/shoulder but not at the injection site - overall bicep and clavicle area. I have been able to alleviate symptoms to a degree by taking a tylenol once or twice a day but the pain is limiting some of my daily activities to a degree.

Diabetes; unable to concentrate; arm is killing her; hands are swelled up; constipated; nausea; tightening of chest every so often; acid reflux; hot flashes; sweating; stomach aches; upper abdominal pain radiating to back; severe fatigue; Dizzy/dizziness; stomach feels odd; Headaches; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot Number: EN6198), via an unspecified route of administration, administered in upper left arm on 25Feb2021 9:00 (at the age of 61-year-old) as single dose for virus (COVID-19 immunisation). Medical history included chronic pain, pancreatitis, allergic to medications, old injury in her right arm, menopause and an ongoing mass in parotid lobe discovered in 2019 with CT scan. MRI performed in Mar2020 and CT scan in Oct2020. She stated that they are just watching it because it has not changed. Well defined borders are present, caller stated that doctor was unconcerned. Her mother had heart disease. Ongoing concomitant medications included ibuprofen for chronic pain and gabapentin from 2019 for chronic pain. The patient also took unspecified medication for pancreatitis. She has taken all kinds of stuff after pancreatitis but they do not work. The patient got deadly ill from the flu shot. Unsure of onset age, vaccine/brand name, or vaccination date. She stated that it was before 2003, possibly in the late 1990's or early 2000's. The patient had no history of all previous immunization with the Pfizer vaccine and no additional vaccines administered on same date of the Pfizer suspect. On unspecified date the patient experienced diabetes; on 25Feb2021, the patient experienced dizzy, stomach feels odd, hot flashes, severe fatigue, sweating, stomach aches, acid reflux, upper abdominal pain radiating to back; on 26Feb2021 she experienced tightening of chest every so often; and in Feb2021, she had headache. It was further reported as follows: The patient stated that she took the Pfizer shot, clarified that she received the Covid-19 vaccine, on 25Feb2021, not quite 2 weeks ago. She stated that she had a little bit of a reaction after receiving the vaccination while there, so they were monitoring her. She has been experiencing hot flashes, sweating, and stomach aches for 2 days. She cannot get rid of hot flashes and that she has not had a hot flash in 2 years. She states that she has been down for 2 days with fatigue, that it's really bad. She is inquiring if the side effects that she is experiencing are common side effects and if it is ok to get 2nd shot. Her second vaccine is scheduled for 17Mar2021. She stated that she wanted to take the time to make a report as she is allergic to medications. While inquiring about dates of vaccines and side effects, she stated that she was experiencing tightening of chest every so often. She stated that she only had a few days of stomach pain and she has not stopped eating. She is unable to concentrate (unspecified date) and she has been experiencing headaches, experiencing them twice in 2 weeks. She also reported that she has been having upper abdominal pain radiating to her back. This concerns her, every time she gets it, it scares her. She had pancreatitis when she was 36. It is a nightmare thought. Does this sound like maybe she is possibly starting Diabetes? She reported that this shot has triggered everything. She has an old injury in her right arm. Her arm is killing her, her hands are swelled up, she has acid reflux again, she felt terrible. She stated that the dizziness not as strong as it was at the beginning. The fatigue it comes and goes and that she has spurts where she is energetic. She stated that it's more on than off. She is no longer having stomach aches. She compared the pain to pains of constipation. She also stated that she was constipated after receiving the vaccine on unspecified date. She had nausea at the beginning. The tightening of chest happened off and on, the last day that she experienced tightening of chest was on Sunday. For acid reflux, she is taking Zegerid as treatment, 20mg 20 mg capsules by mouth once daily as needed. She started this on 02Mar2021. She experienced upper abdominal pain yesterday and some this morning, but it was mostly in her back this morning. Her Sweating is off and on. She experienced headache just a couple of times but that she has not had one in a while. She stated that they lasted only an hour or two, and that she does not usually get headaches. She suggested that these may be due to sinuses and weather change. She has been taking Ibuprofen twice a day as treatment. But she normally takes Ibuprofen for chronic pain. Supposed to be 3 times a day but she does not want to take that much. She stated that all of this could also be stress related and that this could also be menopause. The patient recovered from stomach aches on 02Mar2021. The outcome of the events dizzy, sweating, tightening of chest every so often, upper abdominal pain radiating to back, headache was recovering; the outcome of stomach feels odd, hot flashes, severe fatigue, acid reflux was not recovered. The outcome of the remaining events was unknown.

Pasting clinicians note below: Patient is 61 year old female with hx of anaphylaxis presenting for Covid-19 vaccine, Dose #1. She developed itching in there throat within 30 minute waiting period. She was taken to Rapid Response Room. Symptoms progressed from itchy throat, to congestion in throat/upper chest, clearing her throat, watery eyes. Then dry cough. No nausea, no vomiting, no light headed feeling. No facial swelling No hives. OBJECTIVE: Vitals - 154/97, 105, 100%RA Neck - Supraclavicular mild retractions, end inspiratory stridor CV: tachy, regular, no murmur pulm - diminished breathe sounds throughout, no wheezing. Speaking full sentences. Assessment/ Plan: Anaphylaxis to Covid-19 Vaccine: - emergency responders - epi 0.3 mg IM administered to L mid outer thigh at 9:35 am by me - epi 0.3 mg IM administered to R mid outer thigh at 9:41 am because symptoms not subsiding by me -benadryl 50 mg IM x 1 L deltoid by RN 9:45 am - Itching in throat subsided but still retracting and clearing throat so albuterol 3 puffs given at 9:50 am Vitals stable entire time (see midas report) EMS arrived to transport to local hospital.

3 days after completing vaccine series, pt develop right leg pain and swelling, which progressed later on to shortness of breath after a week.

Sore arm for about 3 days. Then a week later I suddenly got cold hands, legs, stiff neck, swollen head, dizzy, multiple bowel movements, week leg muscles, tired. Lasted about 1 hour for initial wave, then was tired and out of commission for about 3 hours afterwards.

Severe itching all over, anaphylactic, took two allergy pills and medical test on music related to the nostril shot of Flonase

After receiving the vaccine on Saturday afternoon, the right arm started hurting(normal side effect) but by late Sunday afternoon (24 hours later) the lymph nodes in my right armpit started swelling. The size of a plum as of Monday afternoon. (48 hours)

Fever (103°) chills and body aches lasting 28 hours, (RESOLVED) swollen lymphnodes armpit has (NOT RESOLVED)

Lips were red and sunburned like with pain. Following day, fever blisters broke out. (common when my lips get sunburned). Treated with Carmex at onset and they went away in a couple days, fairly quickly.

Fever, headache, aching neck, arms and hands. Fingers felt stiff and swollen, hard to move, but still looked normal size. Developed an egg size lump under left armpit that was very painful.

Pt c/o tingling, swelling in right arm, distal edema noted (mild; no SOB, rash, or hives. Benadryl 25 mg PO @1020; 1030 Edema improving, no other s/s. Pt states B/P is normal for her. Pt stayed 1 hour past injection. Edema resolving. Staqtes feeling much better. Tingling resolved. B/PP 100/60.

Dizzy about an hour later. Worked through it. Itching/swelling as in first dose in arm but handled with anti-itch sprays and cremes. In afternoon, nauseated and dry heaves. After 9:00PM, high fever, aches, constant chills throughout the night. Extreme thirst. Fever through the next day and used a COVID sick day. Symptoms gone by morning of 03/27/2021.

Once injection given, felt like Electric shock immediately afterwards, bleed a little, area swelled, painful and turned a purple /black. The next day my neck, shoulder and area where injected swelled and painful. Muscles aches all over. After about 3-4 days leg muscles stopped hurting but muscles in left arm continue to be bothersome, from my shoulder down to my thumb muscle spasms throughout the day. To this day 3/29/21 I continue to have muscle spasms from my shoulder down my left arm.

chills; injection site pain; headache; muscle pain; fever/tiny fever; impacted lymph nodes/lymph nodes are impacted a little bit; nausea/feeling nauseous; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EN6206) via an unspecified route of administration, administered in Arm Left (left shoulder), at the age of 61-year-old, on 03Mar2021 19:00, as SINGLE DOSE for covid-19 immunisation. The patient medical history was overweight, diagnosed COVID last Apr2020 she had it for 17 days and had every symptoms. The patient tried to give antibodies for many months and she was told she had two different kinds of antibodies which prevented her from doing that. The patient has long hauler symptoms which are nerve pain in her thighs and mouth. The patient's concomitant included an unspecified medication (she takes something but not relevant). The patient did not receive any vaccine within 4 weeks prior. The patient previously received shingles vaccine on 14Feb2020 and tetanus shot on an unspecified date (years ago) both given for immunization and her arm hurt/ pain at the injection site (if she touches it, it hurts). On 03Mar2021 at 7PM, after receiving first dose, she felt blah described as she developed injection site pain which is dissipating but still there, headache, muscle pain, tiny fever, impacted lymph nodes, nausea/ feeling nauseous which she didn't have before. The patient can get up and walk around. On 04Mar2021, the patient had chills in the afternoon. It was just a little fever. The patient took Tylenol and Advil in the afternoon and it helped it go away. The patient took one of each. It was reported that the COVID headache is like none other and she had the headache again. For the COVID headache if you take things it doesn't make it go away. When the patient said she had the headache again she meant she had the same headache that she had in April. The events did not require ER or physician office visit. Outcome of injection site pain was not recovered while it was unknown for the other events. The reporter assessed the events as non-serious. Information on the lot/batch number has been requested.

Fatigue; Fever (101.6); Chills; Shakes; Muscle pain; Joint pain; Headache; Foggy head; Loss of appetite; Nausea; Sore arm at injection site (minor); Swollen lymph gland under left arm; Dizzy; This is a spontaneous report received from a contactable nurse (reported for herself). A 61-year-old female patient received second dose of BNT162B2 (Comirnaty, Solution for injection and Lot number: EL3246), intramuscularly to left arm on 12Jan2021 10:00 at a single dose for COVID-19 Immunization. Patient medical history was reported as none. Patient concomitant medications included calcium, ergocalciferol (VITAMIN D), multivitamin and probiotic. The patient previously took BNT162B2 (Comirnaty, Lot number: EJ1685) vaccination, intramuscularly to left arm on 22Dec2020 for COVID-19 immunization. On 12Jan2021 22:00, 12 hours after the second dose of vaccination the patient experienced with fatigue, fever (101.6), chills, shakes, muscle pain, joint pain, headache, foggy head, loss of appetite, nausea, sore arm at injection site (minor), swollen lymph gland under left arm. patient was on bed and felt dizzy after fever broke for about 24 hours. Seriousness was reported as non-serious. Patient received on advil at night for treatment of events. The outcome of events was recovered on an unspecified date. No follow-up attempts are possible, No further information available

Uncontrollable chills for 4 hours until I fell asleep followed the next day by painful swelling under the left arm.

Very painful lump in fat tissue starting next morning. Red spot starting that evening, gradually growing for 4 days. Hot, hard lump and redness still present after 5 days. No irritation/ pain in muscle at all this time. Lump and pain localized in fat tissue only.

I have had symptoms that mimic Breast Cancer Nipple discarge Nipple redness Lymph Node Pain Swelling Discomfort

Swelling/discomfort in armpit of arm corresponding with covid vaccine injection. Although swelling/discomfort continues, it is lessening with time.

Severe abdominal pain, leading to ER visit and diagnosed with Pancreatitis. Severe pain started 30 minutes after the vaccination.

Face swelled almost double in size. Severe headache very fast heart rate nausea diarrhea about 3-4 minutes after leaving the vaccine site. Symptoms begin to decrease then stop within 5 minutes. Face remained somewhat swollen for about an hour. Headache remained for about 6 hours then arm hurt for about 6 hours. Diarrhea remained for 24 hours

Woozy, felt like body was swelling, then numb, then tingling, then like a rag doll. Headache, nauseous. Red rash all over face. Very fatigued. Most of it lasted all day.. Next day, Friday, still very fatigued and a slight headache that comes and goes. Everything else was gone. Had no problems with breathing. No fever. Had no treatment.

on 4/1/2021 my left clavicle was very sore. then noticed it was swollen - looks like lymph nodes. praying & hoping it will go away. other than that, slight headache nite of shot & day after (4/1) was also extremely tired. i did have the covid on 12/9 & it turned into pneumonia.

development of rash on both arms, torso, side of face, right hand - redness, swelling, terrible itching

Her face started swelling and turned red and her throat felt tight.. She was given .3 cc of epinephrine . She felt better then we had to repeat the dose in about 15 more minutes. She could still breath easily but she did not feel better after the second epinephrine shot. She was sent to the ER in an ambulance

Complained of swollen glands, difficulty swallowing and had pursed lip breathing. Vitals= 140/83, Pulse= 69, no O2 obtained. 2nd set of vitals= 136/71, P 67. Gave 50 mg of Benadryl, IM, right deltoid by S. Lisman, RN. Pt took one dose of albuterol inhaler (RX'd to her by PMD). EMS was called and arrived on scene to assess patient. Patient refused transport. Observed patient in observation area of an additional 30 minutes. 1:30-1:45 pm. S. Lisman educated patient on signs and symptoms of worsening condition and when to call 911. Pt advised to accept transport if, signs and symptoms return post Benadryl is no longer in her system.

Did fine day of shot but next morning woke up felt like I got hit by a Mack Truck my left arm that I received shot swelled alot. I not experience that with previous flu shots or my pneumonia shot. I felt weird and sort of sick for 2 weeks.

In order of occurrence: Chills Face and neck hot and itchy, red rash on face Back itchy, red rash across back Head itchy, can't tell if a rash Bad arm pain to touch, not usual shot arm pain, couldn't lay on left side to sleep Cold all night, used 2 blankets instead of usual 1; fitful sleep As if this writing: arm pain better but minor arm redness/swelling; face and neck hot; neck/back/head itchy, rash on neck/back but not as red as yesterday

In order of occurrence: Chills Face and neck hot and itchy, red rash on face Back itchy, red rash across back Head itchy, can't tell if a rash Bad arm pain to touch, not usual shot arm pain, couldn't lay on left side to sleep Cold all night, used 2 blankets instead of usual 1; fitful sleep As of this writing: arm pain better but minor arm redness/swelling; face and neck hot; neck/back/head itchy, rash on neck/back but not as red as yesterday. Feel cold.

In order of occurrence: Chills/Face and neck hot and itchy, red rash on face Back itchy, red rash across back Head itchy, can't tell if a rash Bad arm pain to touch, not usual shot arm pain, couldn't lay on left side to sleep Cold all night, used 2 blankets instead of usual 1; fitful sleep As of this writing: arm pain better but minor arm redness/swelling; face and neck hot; neck/back/head itchy, rash on neck/back but not as red as yesterday. Feel cold. Note that after my shot I was out until about 4:30 pm. While out, I noticed that my face and neck felt hot and my neck was getting itchy, but I did not check it. After returning home, the itchiness, chills. etc. slowly increased until at 6:30 pm I was very

Developed fever up to 102 degrees F as of 9 PM on the day of vaccination, plus muscle and joint aches, chills, and headache. These symptoms continued the next day along with sore arm, and fever went up to 103.6 degrees F. By bedtime on the second day, March 16, fever, aches and pains, and headache were gone. However, I felt very fatigued and I was sweating profusely all night. I had to get up and change soaked clothing three times during the night. Within 3 days, my arm was still very sore and the lymph nodes in the armpit of the vaccinated arm became very sore. I also began having diarrhea several times per day on approximately the third day after vaccination and this has continued to the present.

Fever >101, muscle aches, joint pain, swollen lymph nodes, INCREASED HEART RATE performing normal tasks

About 36 hours after my first dose, I woke up very thirsty and with "gummy," sticky eyes. My moisture-producing glands, particularly my salivary glands were significantly affected and I had, in effect, (drug-induced?) Sjogrens Syndrome. My salivary glands felt uncomfortable, perhaps because they were swollen. The symptoms have diminished somewhat in the past two weeks, but have not resolved. I visited my PCP on 04/02/2021 and she advised to see her again if the symptoms did not continue to resolve on their own. Note that in 2014, I had a similar, but more severe reaction to a single dose of Nitrofurantoin and regained nearly complete salivary gland function after 9-12 months.

back of arm has a bit and has gotten bigger and it was not the injection site where the mark is getting bigger; back of arm has a bit and has gotten bigger and it was not the injection site where the mark is getting bigger; This is a spontaneous report received from a contactable consumer (patient). A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on 09Mar2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was reported that patient had the shot on the 09Mar2021 back of arm has a bit and has gotten bigger and it was not the injection site where the mark is getting bigger. The outcome of the event was unknown. Information on batch number has been requested.

Tiredness started on 4/8/21 at approximately 2:00 pm. Chills and body aches started on 4/8/21 at approximately 5:00 pm. Swelling and soreness of the lymph nodes in the right armpit started during the night of 4/8/21. It is currently 1:55 pm on 4/11/21, at this reporting. The lymph nodes are still swollen and sore. All other side effects were gone as of 4:00 pm on 4/9/21. I have been taking Ibuprofen regularly for the pain and swelling. Swelling has gone down slightly.

Patient received her second Pfizer covid vaccine on Tuesday 4/6/21. She said she had been doing yard work before she came to get her vaccine. After she received her vaccine she felt fine. On Tuesday night she started to feel some itchiness. She said the itchiness got worse over the next two days. She talked to her husband and he advised her to take Benadryl so she took two Benadryl. On Wednesday she had some soreness at her injection site. Very early Thursday morning she noticed a golf ball sized knot in her armpit. She said it was sore and if she rubbed it, it felt like it was pushing into her breast. She said it felt like pressure going all the way to her breast bone and along her esophagus. She ended up calling EMS and her blood pressure was up to 181/107 and had a high heart rate. She said she never had any hives but did have some throat, tongue, and lip swelling and said that her throat felt raw. The EMS gave her 2 nitroglycerin tablets and 5 aspirin. She spent Friday and Saturday in the hospital. She said the hospital did all kinds of cardiac tests on her and everything can back clear besides a leaky heart valve. She said she is feeling much better now and that the hospital was not sure if it was a reaction to the vaccine, something else, or a combination of things that caused it.

Two days after receiving the vaccine, the front of my neck developed a very itchy, warm rash, my lymph glands on the right side of my neck swelled so much that it was difficult to swallow even liquids without pain, and I had a fever of about 100. The itchy area on my neck continued to worsen, and despite the application of OTC anti-itch medications and me taking Benedryl, it got larger and warmer, and the itching became even more severe. At one point my throat was so swollen, I started to think it was closing up and that I'd need to go to the hospital. The discomfort continued into the next day when I contacted Teledoc, and was prescribed an antibiotic, and prednisone, which helped. The itching is still present, but managed by regular spraying of an aerosol cortisone. And the swelling has gone, but there are slight scars like one would get from a scrape. My throat is much better, and my fever is gone.

4/9/2021: mild headache, arm soreness, muscle aches, tiredness and chills beginning about 6pm. 4/10/2021: headache moderate, muscle aches and joint pain moderate; chills, tiredness, diarrhea beginning in the morning and ending early afternoon; 4/11/2021: woke at 5am because left arm (injection site) hurt; arm mildly swollen along with armpit lymph nodes in left arm, tiredness. 4/12 & 4/13: armpit lymph nodes still a little swollen and tender, arm tender, slight tiredness, other symptoms have resolved but lymph node swelling continues

The morning after the second injection, Woke up nauseated, some vomiting, intermittent chills, no fever. All symptoms were gone within 6 hours. Within a few weeks (timeline not exact) a lump was noticed under the left armpit, which remains

Systemic: Lymph Node Swelling-Medium, Additional Details: Pt has experience some lymph node swelling 3 weeks after the first dose. She experience it in her left axillary.

Within 1 hour severe side effects: body aches, cough (dry like asthma) , fatigue, dizziness, chills, nausea, could not sleep, Swelling, warmth, burning swellinge first dose size of 1/2 orange. No fever. Second not as severe as the first. Body aches, muscle pain, dizziness, chills, nausea, painful injection site not as much swelling,No fever. Blood Sugar spikes: 1/31/2021 280, 2/1/21 2112/27/21 319, 2/28/21 418. 9 days after second vaccine. Purple swelling of both feet. cellulitis rt foot pain worse in lt than rt .PCP to ER (soles, top lower legs black): susp tibial artery occlusion lt . Heparin. Farxiga, Ultram, baby aspirin, procardia, metformin.Possible Reynauds.Still pain discoloration and swelling.

Joints aching and sweats Third day back ache and swelling of hands 04-14-2021. Swelling of hands back aches still.

Metallic taste 2 min later. High blood pressure 5 min later. Swollen lymph mode on collarbone 10 days later.

Not sure exactly when this problem began, but definitely after vaccination. Both hands feel very arthritic. Most proximal knuckle of left long finger is visibly enlarged and painful to any pressure. That finger is very uncomfortable almost all the time. Neither heat nor Ibuprofen decrease pain. No specific finger on the right hand is more affected, but that hand is frequently painful and stiff. Again, neither heat nor Ibuprofen have any effect on the pain. I had not noticed these symptoms prior to Covid-19 vaccination.

Largest flare of Rheumatoid Arthritis I've ever had in 8 years. I could barely move fingers on either hand without a lot of pain and could only make half a fist because of swelling. Reaction appeared to involve both hands and left elbow only. It was very sudden and required a visit to the Rheumatologist for relief.

Broke out in itchy, swollen, red rash. Began as single spot on right eyelid withing 4 hours of receiving vaccine. Spread over first week, across temple and forehead and chin, later on belly (which spread to cover 1/4 torso below waist on front side), between legs on both sides at top of inner thighs, latter on outer thighs of both legs. Felt like needles pricking skin if fabric touched skin. Lasted three weeks. However, at three weeks I am sill not over the rash. I can now function normally, even though the skin is still red and slightly itchy. Oddly, the rash was strong on the right side of my body with a fainter mirror image on the left side. I reported all this on the V-SAFE app.

Day after 2nd dose patient developed erythematous rash with underlying edema on legs and back. 7 days later patient developed similar rashes on forearms and arms. Rash is made up of papules with surround erythema/edema (~5cm max diameter) and is pruritic and burning. Associated myalgias and fatigue

I had some site soreness for several days...nothing too bad. Took some Tylenol for it. Two days after injection I got pretty bad diarrhea that lasted several days. I also got the chills/shakes the second night. Then I got a pretty bad Eczema flare...on my breasts. It continues at week two. My left armpit HURT terribly for almost a week. Tylenol did not relieve it at all. I also had quite sore Lymph nodes across my chest/side of neck.

Swollen portions of hands, portions of feet, knees. Inflamed, red, hot, itchy and very, very painful. The issues move from area to area and seem to inflame fatty areas most. I thought this would go away and didn't document with pictures, like I should have. I now have a couple of pictures and will continue to do so. I've tried hot baths, cold packs, hot packs, elevating the area and topical relievers. I couldn't feel the heat of the pain reliever on the affected area. This has been absolutely debilitating and I've had to miss some work because of it.

I had a full blown red rash all over my body; red lesions all over my leg and my back and red marks and scratches all over my chest, my back, legs; it downed the swelling and the itch but I still have red rashes and scratch and red marks all over my body; had a severe reaction; The next day after vaccine I had extreme hives, red welps all over by body from head to toe; This is a spontaneous report received from a contactable consumer. A 61-year-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2; Formulation: Solution for injection), via unspecified route of administration on Left arm on 24Mar2021 12.00 at single dose for covid-19 immunization and second dose of bnt162b2 (BNT162B2; Formulation: Solution for injection), via unspecified route of administration on Left arm on 24Mar2021 12.00 at single dose for covid-19 immunization. Relevant medical history includes Von Willebrand Type 2 bleeding disorder. Concomitant medications include Lisinopril. It was reported that the next day after vaccine I had extreme hives, red welps all over by body from head to toe on 25Mar2021 at 13.00 PM and treated with Prednisone/Atarax and resulted in doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient not diagnosed with COVID-19. Patient weather tested positive for COVID-19 since having the vaccine is unknown. Upon follow up on 31Mar2021, there wasn't side effects with the first shot, it was with the 2nd shot, developing rash on the second day, red rash, welts, swollen, severe scratch marks on chest, swelling on shoulders and welts, arms with welts and scratch marks, and major scratch marks and welts on lakes, and big old red patch on my left calf. The next day went to Clinic and saw a doctor, he couldn't even believe it, he was gasping at what he saw, gave me prednisone for severe allergic reaction, today is the last day of treatment, I started prednisone on Friday and the last day is today. It did take down swelling itching and pain, now I am left with patches, welts, scratches on my chest and red lesions and big red patch on my left calf. Can send pics if you want. I want to know how to get rid of the patches, or when will they go away? can you suggest what I can take? I am going to go to a haematologist next week, because I do have a bleeding disorder. It looks to me like these are going to be the scars and they are not going to go away. It feels like someone took their nails and just scratched., looks like they aren't going to go away. " Response: Spoke from attached document: explained that Pfizer is unable to provide treatment and management recommendations and referred to HCP. Offered to email document for review with HCP, and for links for latest information and reporting. Upon follow up on 31Mar2021, I had my 2nd vaccine of the Pfizer Vaccine on 24Mar2021 and the next day I started seeing a rash, mild rash and then on the 25mar2021 I had a full blown red rash all over my body and red lesions all over my leg and my back and red marks and scratches all over my chest, my back, legs and so I went to my doctor on the 26mar2021 they prescribed Prednisone and so I am on my last of the Prednisone, it downed the swelling and the itch but I still have red rashes and scratch and red marks all over my body, I had a severe reaction." Consumer stated, " I took pictures, so I can send them, so they can see what it did I don't know. Well I wanted to see like what Pfizer can do to help me, this is like not going away any time soon, I going to see another one of my doctor next week." Consumer was informed about the role of Pfizer Drug Safety and permission to probe: consumer stated, " Well actually I'm expecting a call from my doctor, I need to take his call." The outcome of the events for "Urticaria" was "Not recovered", for "Rash", "Skin lesion", "Swelling", and for "Reaction aggravation" was "Unknown". No follow-up attempts are possible; information about lot/batch number cannot be obtained. Follow-up (31Mar2021): New information received from a contactable consumer: New clinical information (Product details, and new adverse event information) added. Follow-up (31Mar2021): New information received from a contactable consumer: New clinical information added. No follow-up attempts are needed. No further information is expected.

anaphylaxis/anaphylactic condition; abnormal heart problems; vocal cord dyskinesia; SOB; extremely red all over body; Abnormal liver enzymes; Hr became Brady with widening if qtinterval; leg cramps; neuro s/s migraine severe; throat closed; Weight gain 15+ lbs on body non pitting edema; non pitting edema; extreme leg pain; breathing problems; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of bnt162b2 via an unspecified route of administration in right arm on 27Mar2021 16:45 (Lot Number: er8733, expiration date was unknown) as single dose for covid-19 immunisation. Medical history included asthma, brain disorder, arthritis, vertigo. Patient had known allergies. It was unknown if patient had COVID prior vaccination. She was not pregnant at the time of vaccination. Patient did not have other vaccine in four weeks. She used other medications in two weeks. The patient experienced anaphylaxis within 5 minutes went home extreme leg pain. Her throat closed and she had short of breath (SOB). She had extremely red all over body. She went back to emergency department (ED). Electrocardiogram (EKG), X-ray and blood work were done. She had c/o leg cramps. Her weight gain more than 15 lbs on body with non-pitting edema. She received treatment for events. She had abnormal liver enzymes, abnormal heart problems and breathing problems. Anaphylactic condition was to step down was on bipap epi (Epinephrine injection) Benadryl 50 mg every 4 hours and intravenous steroids along with fluids. Renal replacement therapy (RRT) called the next day. Patient didn't remember exact cause. Neuro s/s migraine severe Ajovy taken Uberlvy and not else remembered (as reported). Heart issues maintained and pulmonary showed improvement. Ear, nose, and throat (ENT) consult with scope done showing vocal cord dyskinesia. Heart rate became brady with widening if qt interval. She transferred to telemetry 2 d and echo done. Monitor patient for low heart rate 24 hours. Patient released from hospital on 06Apr2021 evening. At home patient continue to have organs change every 24- 36 hours keeping video monitoring and pictures. All events occurred on 27Mar2021 16:45 and resulted doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization/Prolongation of existing hospitalization (vaccine received during existing hospitalization), Life threatening illness (immediate risk of death from the event). The duration of hospitalization was 6 days. Patient tested COVID-19 via nasal swab on 01Apr2021 with negative result. Benadryl 50 mg she had around the clock, steroids and epi used as treatment. The outcome of all events was not recovered. No follow up attempts are possible. No further information is expected.

Six days after my 2nd vaccine I had an anaphylaxis reaction. Out of the blue while I was driving my face started to burn like acid was rubbed on it. It got really hot and turned very bright red. Then my lips began to feel like they had been sunburned badly. Then my forearms both started burning and also turned bright red. I was very anxious. Had two bouts of diarrhea. All this occurred within about a 20 minute time-frame. I chewed up 4 children's Benadryl (50mg) and the redness, burning and anxiousness subsided mostly. My heart rat was still over 100 bpm even after 6 hours. (Usually my HR is 68-70 bpm). I slept for 12 hours and the next day seemed fine. This has occurred two more times since that first time. The 2nd reaction being 5 days after that first one and the 3rd reaction being 5 days after that. Same reaction, same treatment and same outcome.

Anaphylaxis-swelling of eyes, tongue, and injection site, rash/hives, shortness of breath, and dizziness; Anaphylaxis-swelling of eyes, tongue, and injection site.; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unspecified), via an unspecified route of administration, administered in right arm on 05Apr2021 16:00 as single dose for COVID-19 immunization. Medical history included known allergies: yes and hypertension. The patient was not pregnant. Concomitant medications included metoprolol succinate (TOPROL XL), lisinopril dihydrate (LISINOPRIL), and cetirizine hydrochloride (ZYRTEC). The patient had no other vaccine in 4 weeks. On 05Apr2021 16:15, the patient experienced anaphylaxis-swelling of eyes, tongue, and injection site, rash/hives, shortness of breath, and dizziness. The events resulted in emergency room/ department or urgent care. Therapy for the events included prednisone, antihistamine, and intravenous (IV) fluid. The patient did not have covid prior vaccination and was not Covid tested post vaccination. Outcome of events was recovering. Information about lot/batch number has been requested.

Having injection site pain; Nausea; Can hardly hold her head up; She slept all day yesterday, and slept all night; She just gets hot; Feeling unwell; blood pressure was out of control; lymph nodes are not as bad, they are hurting; She is having hot flashes; Tiredness/ she is still tired; Muscle and joint pain; swollen lymph nodes under arm; muscle and joint pain; Chills; Headaches; This is a spontaneous report received from a contactable consumer (patient). A 61-year-old-female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: CR8732 or LR8732) first dose on 03Apr2021 08:30 on right arm at single dose for COVID-19 immunization. Medical history included ongoing High blood pressure (Has had a long time), Breast cancer (Has had 6 years) and covid in Feb2021. History of all previously immunizations was No. Prior vaccincations wtihin 4 weeks was No. AE's following prior vaccinations was No. Concomitant medications included anastrozole (ARIMIDEX, strength 20 mg) for breast cancer (Has not taken the last 3 days, Did not want to take with the shot), bisoprolol fumarate, hydrochlorothiazide (BISOPROLOL HCT) for Blood pressure (States that she was taking 5-6.25mg and increased dose to taking 10 in the morning and 5 at night) and ongoing Vitamins. States that in Feb2021 had Covid and had gotten over that and was discharged. States that she might have had mild Covid and with all of the variances coming out, she wanted to get the vaccine. States that she got her first dose on Saturday (03Apr2021) and didn't know if she hadn't waited long enough. Caller states that she has been having terrible reactions. Has been having injection site pain but even had that with the flu shot. States that she has been experiencing tiredness, headaches, muscle pain, chills, joint pain, and lymph nodes under her arm were swollen where she got the shot. Has also been experiencing nausea and can hardly hold her head up. States that she slept all day yesterday, and slept all night. Woke up this morning feeling a little bit better, then the side effects took a hold of her again. Caller states that cancer meds made her gain weight and hasn't been able to get rid of it. Noticed Tiredness yesterday (04Apr2021) when she woke up. States that she had the vaccine on Saturday the 03Apr2021 at 8:30am, started to have headache that night. States when she woke up yesterday (04Apr2021), she started experiencing all of the other symptoms, tiredness, headaches, muscle pain, chills, joint pain, and lymph nodes under her arm were swollen where she got the shot. States that when she woke this morning, had thought everything was a little better but, then it hit her again. Clarifies she is still tired, and the headache still has not gone away. This morning (05Apr2021) she is having hot flashes, not so much the chills. The chills are still there but not nearly as bad, she just gets hot. She has been experiencing nausea and feeling unwell. States that the lymph nodes are not as bad, they are hurting but, not as bad. States that it is hopefully doing what it is supposed to do. States that she has been taking only Tylenol but has not taking it yet today. States that she is super scared to get the second shot. If this happened with the first shot, is terrified for the second shot. States that she has been taking Tylenol every four hours and is such a lightweight that she has only been taking one Tylenol every four hours. Caller states that she is supposed to be back 24Apr2021 for second shot but does not know if she can go through with it. States that this was recently increased when her blood pressure was out of control when she had gotten Covid. States that she was taking 5-6.25mg and her dose was increased dose to taking 10 in the morning and 5 at night. States that she is not taking as prescribed but she was too chicken to take the 10mg. States she will be back to see her doctor on 16Apr2021. States that she hates taking any medicine. Tests: States that she had bloodwork done Friday (02Apr2021) but has no idea of the results. States she will be seeing her doctor 16Apr2021 to go over the results. Vaccination facility type was Hospital drive up. Vaccine administered at military facility was No. No events required to ER. Caller states she has contacted her doctor to find out about her future vaccination. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

face and throat swelling and redness; face and throat swelling and redness; mild face swelling; lymph nodes swelling in armpits; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received second dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE; Lot Number: ER8737 and expiration date was not reported), via an unspecified route administered in right arm on 31Mar2021 at 12:00 (at the age of 61-year-old) as single dose for COVID-19 immunization. The patient had no known allergies to medications, food or other products. The patient's medical history included ductal carcinoma in situ (DCIS). The patient previously received the first dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE; Lot Number and expiration date were not reported), via an unspecified route of administration, date and dose for COVID-19 immunization. The patient was not pregnant. It was reported that no other vaccine was given in four weeks but patient had received other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination has not been tested for COVID-19. The patient experienced mild face swelling and lymph nodes swelling in armpits on day 1 (01Apr2021) after vaccination. On day 2 and 3 after vaccination, the patient had only mild face swelling. On day 4 (04Apr2021), the patient experienced severe face and throat swelling and redness. The patient rushed to the emergency room (ER) but conditions reduced by 80% by the time of arrival at the ER. The patient took diphenhydramine (BENADRYL) tablets and the doctor prescribed an epinephrine autoinjector (EPIPEN) and told her to keep on hand. From day 5 to day 8, mild facial swelling still exits. On day 9 (09Apr2021), patient had just a trace of facial swelling. It seems like conditions were getting normal. The outcome of the event facial swelling was recovering at the reporting time. The outcome of lymph nodes swelling in armpits and severe face and throat swelling and redness was recovered at the reporting time on Apr2021. No follow-up attempts are possible. No further information is expected.

Noticed swelling in my neck on 5th day after 2nd dose of vaccine, Tuesday April 20th. Was seen in urgent care on Wednesday evening April 22, diagnosed with parotitis and prescribed Augmentin. Continued to worsen, was treated on Friday April 23. I received IV antibiotics while in ER. Am continuing to take clindamycin and metronidazole. Condition is improving.

Upper & lower lip swelling , blisters/cold sore on each side of mouth, few bumps on roof of mouth, severely chapped lips. Lip swelling lasted 5 days, bumps on roof of mouth lasted 1 day, chapped lips lasted 2.5 weeks but are still very dry and blisters/cold sores are not as visible but skin at corners of mouth are red and tender and opening mouth to eat causes discomfort

After 2nd shot within 24 hours my arm swelled up and became itchy , achy and red . As the night progressed it became worse and now 3 days later my arm is swollen, itchy, achy, and red from my elbow up to my shoulder at the place of injection. Went and seen my Dr. today.

I took my temp, which was 100.2; anaphylactic reactions; The neck itching/burning and throat/ear pain got worse; tired; earache; swelling; itching; stinging; peeling; hurt my throat; throat was swelling; couldn't sleep; rash; burning; This is a spontaneous report from a contactable consumer (patient). A 61-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 09Apr2021 09:15 (Batch/Lot Number: EW0158) as SINGLE DOSE for covid-19 immunization. Medical history included Asthma, HBP, High Cholesterol, prediabetes. Known allergies: Penicillin, Sulfa, Peanuts. Concomitant medication(s) included rosuvastatin calcium (CRESTOR) taken for an unspecified indication, start and stop date were not reported; atenolol, chlortalidone (ATENOLOL/CHLORTHALIDONE) taken for an unspecified indication, start and stop date were not reported; metformin (METFORMIN) taken for an unspecified indication, start and stop date were not reported; sertraline hydrochloride (SERTRAL) taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. On 10Apr2021, the patient experienced anaphylactic reactions, tired, earache, swelling, itching, stinging, peeling, hurt my, throat was swelling, couldn't sleep, rash, burning, the neck itching/burning and throat/ear pain got worse. It was reported that 09Apr2021- got her 1st Pfizer COVID shot. Left arm. Felt okay afterward, got a little tired later on. On Sunday, she woke up w/an earache on her left side, which moved down into her neck - near her lymph nodes. Later, her neck started swelling/itching/stinging/feeling warm, and it hurt her throat to swallow anything. She went to get Benadryl and anti-itch creams, but they didn't work. The neck itching/burning and throat/ear pain got worse, and at one point it felt like her throat was swelling and getting narrow, and she wondered if this was one of those anaphylactic reactions. So she took 2 Benadryl, and that seemed to help. That night she couldn't sleep for the neck heat, itching and throat pain. Monday AM (12Apr2021), she took her temp, which was 100.2. She did a Teladoc Zoom so the doc could see the situation, and he said that it could be a severe vaccine reaction, or some kind of infection. He prescribed prednisone & clindimycin. The rash left scars, which are peeling. Ae resulted in: Doctor or other healthcare professional office/clinic visit. AE treatment: Prescription drugs. Outcome of the events was recovering.

Tiredness; Chills; Fever; Doesn't feel good, weak; Lymph node swollen, hurts, can't touch it; Nauseous; Headache; This is a spontaneous report from a contactable consumer (Patient). A 61-year-old female patient received the second dose of BNT162B2 (COMIRNATY Formulation: Solution for injection) via unspecified route of administration as a SINGLE DOSE on 07Apr2021 02:35PM for COVID-19 immunization. The patient had no relevant medical history and family history. Patient received historical vaccine of first dose BNT162B2 (COMIRNATY) via unspecified route of administration in left arm on 17Mar2021 02:35 PM for COVID-19 immunization. Medical history and concomitant medication was not reported. No family history. Patient reported as does not think her medications had anything to do with the events. she takes all the same medications and didn't have any events with the first vaccine. On 07Apr2021 at 14:35 after second vaccine she got headache right after that and still ongoing. On 08Apr2021 lymph node under arm swollen hurts and she can't touch it and still ongoing, she was nauseous around 5 or 6 in evening. On 08Apr2021 2:00 AM she had chills, tiredness, doesn't feel good weak and fever was 100.5 then it went higher and lower. Second shot on Wednesday and she really sick was 25 percent better today. No Prior Vaccinations (within 4 weeks). The outcome of event recovered for Chills, Fever on 09Apr2021, Nauseous on 08Apr0221 and not recovered for Tiredness, Headache, Doesn't feel good, weak, Lymph node swollen, hurts, can't touch it. No follow-up attempts are needed. No further information is expected.

Anaphylaxis- patient unconscious briefly prior to receiving Epinephrine. After injection, patient slightly arousable- transferred to ED via EMS.

Day of shot, extreme fatigue along with slight additional aches, headache as usual. Lemon-sized lymph node outside armpit of shot. On 5/1 noticed a bruise on side of breast and chills. No fever. Hopefully all will be gone soon otherwise will see physician.

Chills; She was feeling achy and fluish; She was feeling achy and fluish; Swelling of left foot/Swelling of right foot; Headache; Fatigue/felt tired; dizziness/Little dizzy; not feeling too good /Feeling hot/like a low grade fever/fever; This is a spontaneous report received from a contactable consumer (patient). A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date not provided), via an unspecified route of administration, on 02Apr2021 (at the age of 61-year-old), at single dose, for COVID-19 immunization. Medical history and concomitant medications were not reported. On 02Apr2021, patient had headache, fatigue/felt tired, dizziness/little dizzy, and not feeling too good /Feeling hot/like a low grade fever/fever. She reported that to her doctor. On 03Apr2021, patient had swelling of left foot. On 11Apr2021, patient had swelling of right foot. On unknown date, patient experienced chills, lasted for a quarter of a day, "Friday". On unknown date, patient was feeling achy and fluish. Patient stated when she took her first dose she woke up and had slight swelling of her left foot (03Apr2021). She reported her foot would go and would elevate it. She then experienced it again on 08Apr2021, 09Apr2021, and 12Apr2021. She also had swelling of her right foot on 11Apr2021. She was wondering if she should get the second dose of the vaccine, scheduled on 23Apr2021. The swelling was mostly in her left foot and it started day after vaccine. With elevation her left foot was better. It went down for a few days and she didn't have any swelling, then it started back again on 11Apr2021 and 12Apr2021, and it was "Saturday" or something then she had it again. She kept it elevated and it would go down some and come back. Her right foot had gone down but her left was still up. Patient was a little dizzy on 02Apr2021 right after the injection. Saturday she was dizzy and then the fatigue set in and that was Saturday and Sunday. The fatigue started leaving. It was worse and then started feeling better. Patient had headache on 02Apr2021. The headache started that afternoon with a full effect the evening of 02Apr2021, 03Apr2021 and the first part of Thursday she felt it then as well. She wasn't so bad Monday as far as the fatigue. She didn't have the fever on Sunday. As far as the fatigue clarified it started that evening of the vaccine. The only thing that stayed was the headache and fatigue. Everything else felt pretty good right after and she was mostly her normal self that Wednesday. Other than that as far as Wednesday she was a little bit fatigued. She tried going to work and worked through it. She was able to sit down here and there when she felt bad. She went to work Saturday and Sunday. It was a lot better. She told her daughter she was not feeling too good and went and laid down and she started feeling hot. It was like, not how a bad fever felt, but like a low grade fever. That evening she had the hotness, maybe later like 1800 or 1900, up until Saturday. It wasn't all day Saturday. It was not like a bad fever, just hot. It went away. She was feeling achy and flu-ish. She laid down and went to sleep and tried to get up the next morning. She took something like paracetamol( TYLENOL) and called the doctor Friday. They told her to use fever reducers because of the fever. When she went in to see the doctor on Tuesday she could do a little with the fatigue and after that would do a little bit and start to felt tired. She would go back and lay back down. She took 3 days off. Other than that it was like having the flu or something. She has had flu shots and had a reaction to it and it would go as time went on. She asked what's going on with this. She had the flu shot 3 different times and only one time had a reaction. She never had swelling or anything, that's what she was concerned about. The reaction to the flu shot was years ago, and she didn't have a foot reaction. The outcome of the event "swelling of feet", "fatigue" was recovering; of other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

She will be deceased, most likely, if she does.; arms really heavy, can hardly lift them; arms really heavy, can hardly lift them; She feels sick and unwell; face little swollen; chest pain; pressure in chest; ears ringing; Difficulty breathing; Migraine headache; heart palpitations; Chills; nausea; really red face, cheeks; back pain a lot worse; very high fever; This is a spontaneous report from a contactable consumer (patient) A 61-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 08Apr2021 (Batch/Lot Number: EL3247) as SINGLE DOSE for covid-19 immunisation . Age at vaccination :61 years. Medical history included ongoing epilepsy (started at 16 years old. Has not had a seizure in years, maybe 20 years) ,herniated disc and chronic back pain from 2003 and ongoing , Heart septal defect (repaired) and seizure disorder.Concomitant medication(s) included carbamazepine (CARBAMAZEPINE)at 200 mg, 1x/day taken for seizure from an unspecified start date and ongoing. The patient experienced "she will be dead, most likely, if she does" on an unspecified date , difficulty breathing on 10Apr2021 with outcome of unknown , very high fever (on 08Apr2021 with outcome of recovering , migraine headache on 10Apr2021 with outcome of recovering , heart palpitations on 10Apr2021 with outcome of not recovered , back pain a lot worse on 08Apr2021 with outcome of not recovered , ears ringing on 10Apr2021 with outcome of recovering , chills on 09Apr2021 with outcome of recovering , nausea on 09Apr2021 with outcome of not recovered , pressure in chest on 10Apr2021 with outcome of not recovered , chest pain on 14Apr2021 with outcome of not recovered , arms really heavy, can hardly lift them (non-serious) on 15Apr2021 with outcome of recovering , really red face, cheeks on 09Apr2021 with outcome of not recovered, face swelling on 14Apr2021 with outcome of not recovered and She feels sick and unwell on 14Apr2021 with outcome of not recovered. Clincal course was reported as follows:On 08Apr2021 she had her vaccine. She is running a fever and has every side effect on the template from the pharmacy. She is not doing good and should probably be in the hospital. She can not drive her self, or have anyone else drive her. She feels really bad and is afraid of a clot. This is from the first shot and she is not getting another. She will be dead, most likely, if she does.She can hardly lift her arms up. She did not see this in list of side effects and doesn't know what that is.She tried to make a claim with Covid compensation number, but was unable to connect with them. Her symptoms started 3 days ago. She did this in case she had to. She read she has to keep her fever down. She just took some Tylenol.She didn't look for few days at the paperwork provided to her after the vaccine. She was seeing side effects and she got nervous, this is why she didn't call earlier.She is having trouble breathing now and has never been so sick. Caller asking how long the side effects last and needs to talk with Medical Information.Her Mother recommended she receive the vaccine and told her of all these people coming across the boarder and that they may bring Covid with them.She had a septal defect repaired in her heart. She doesn't know if there could be something wrong with that, but her doctor and heart doctor said she is fine. They haven't found anything from the testing she had had.Her difficulty breathing is on and off. It started 2-3 days after, and she doesn't know with her heart palpitations and if there could be damage. That's why she called the Covid compensation.The first day, she had a very high fever and headache. She didn't take her temperature, but she knew it was a fever. Today it is not as high as it was, it's not bad.She had a migraine and took something for it and it went away for hours. She took aspirin, Bayer Back and Body, and her fever and headache went away for hours.She experiences heart palpitations. Every time she eats they get worse. She has reported this to her physician. Her Physician said to take Tylenol and gets exercise. She recommended she doesn't lay up and caller thinks she wanted her to go to the hospital. Caller's mother can't drive and her sister is dying of cancer. Caller lives near her mother but she can't drive. She's older and caller can't ask her to do that.Her palpitations are sometimes there.She has a back injury from someone hitting her from behind. It is extreme back pain. It worsens after she gets a vaccine. She gets on the heat pad. She doesn't have anything for it, just some patches.Her ears are not ringing now and might be getting better. She had chills, but they're better today.She had nausea. It's better today. Yesterday, when talking to her doctor caller was advised to exercise. That makes her feel worse. It's not a big thing. She feels sick and unwell.Her face is really red and maybe a little swollen. Her Physician was thorough and she even asked about it, and commented it sure is red.Caller lays in bed and keeps her feet up. She knows she's got to move around, her Physician told her to.Caller is concerned about a blood clot. She is having pressure and pain in her chest. It has been the same. What's new is chest pain yesterday and did not feel bad, but it is noticeable. She hopes it doesn't get worse. What is new is her arms feel really heavy and she can't hardly lift them.Her facial redness worsened with her fever. The Tylenol is working, her fever is going down, but her arms are still heavy, but better.Treatment received for arms really heavy, can hardly lift them and very high fever.Additional information:Vaccination Facility Type: Pharmacy/Drug Store . No COVID Prior Vaccinations

Covid tongue (oral thrush) plus ulcers along with sore throat and swollen lymph nodes in neck. Started two to three days after second vaccination. Typical symptoms fatigue, headache occurred between 24-48 hours of getting the second shot.

Patient came to the pharmacy today and states she received her 2nd dose on 04/28 and after 72h started to feel a lump on left side of neck and and swelling. I explained lymphadenopathy was a rare side effect of vaccine occurring in less than 0.3% o f the population.

Allergic Reaction at testing site transported to ED via EMS from home. Throat and facial swelling , tight breathing Treated with Benadryl and Epinephrine

Pt woke up at 1 am on 5/1/21 and noticed a small red bump on the inside of her arm, between her elbow and wrist. Tuesday morning 5/4/21 patient noticed several blotchy red spots around injection site and now her whole right arm is swollen. She reports a bump at the injection site. It is very painful and warm to touch. Gabapentin 100mg tid started on 5/3/21, Cipro 500mg BID x 10 days started on 5/4/21 and Prednisone 20mg QD x 7 days started today, 5/6/21. Pt also reports having lifted a 70#box of tile that resulted in her "pulling a muscle" in her shoulder/neck area on her right side. She has been icing the site.

Swelling, redness, rash, heat and pain in lower arm below elbow half way to wrist. Awoke with pain Sunday May 2nd and a red spot on forearm about the size of a 50 cent piece. Monday 5/3 started to spread down the side of my arm, I started icing it and it continued to enlarge. Thur May 6, 2021 was the worst day swelling had dropped down in my arm and made elbow swollen and very tender also. Today May 7 my arm is slightly better but still red rash, swollen and hurts.

excessive fatigue went on for two weeks. would lay down for a 20 min nap and wake up 4 hrs later. Swollen glands under my arms. Hot flashes(which I've never had not even when in menopause) Flare up of my arthritis. Headaches. General feeling of malaise.

Arm injection site soreness did not resolve and spread into arm resulting in continued pain for a month after. On May 3 I went to see the orthopedic doctor to discuss the continuing pain from injection. Doctor noted swelling, loss of mobility and administered a cortisone shot to help heal the inflammation. I have started physical therapy on doctors recommendation to regain the lost mobility.

1st and 2nd dose- swollen glands; injection site pain in right arm; 2nd dose- shingles/shingles blisters; felt quite ill/not feeling well; second dose- extreme pain in left hand/sore arm; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in Arm Right on 08Mar2021 (Batch/Lot Number: EN6208) (at the age of 61-years-old) as 2ND DOSE, SINGLE for COVID-19 immunisation. Medical history included breast cancer (2-time breast cancer survivor), had lymph nodes removed, and has low thyroid. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for low thyroid from an unspecified start date and ongoing; ascorbic acid, betacarotene, biotin, calcium, chloride, chromium, copper, folic acid, iodine, iron, magnesium, manganese, molybdenum, nickel, nicotinic acid, pantothenic acid, phosphorus, potassium, pyridoxine hydrochloride, riboflavin, selenium, silicon, thiamine, vanadium, vitamin b12 nos, vitamin d nos, vitamin e nos, vitamin k nos, xantofyl, zinc (CENTRUM SILVER WOMEN 50+) taken for an unspecified indication from an unspecified start date and ongoing; acetylsalicylic acid (BABY ASPIRIN) taken for an unspecified indication from an unspecified start date and ongoing; colecalciferol (VITAMIN D [COLECALCIFEROL]) taken for an unspecified indication from an unspecified start date and ongoing; famotidine (PEPCIDAC) taken for an unspecified indication from an unspecified start date and ongoing; esomeprazole sodium (NEXIUM) taken for an unspecified indication from an unspecified start date and ongoing. Patient previously took shingles vaccine on an unknown date (reported as number of years ago) for immunization, flu shots on an unknown date for immunization and also previously took the 1st dose of BNT162B2 (Batch/lot number: EN6200) (at the age of 61-years-old) on 15Feb2021, intramuscular administered in the right arm for COVID-19 immunisation, and experienced injection site pain in right arm, sore arm and swollen gland. Patient stated having what was considered typical, like a sore arm and did have some swollen glands with the first and second dose. It was also reported that after 1st and 2nd dose, there was injection site pain in right arm. After second dose she developed shingles, or what was later found out to be shingles, she had extreme pain in her hand. She thought it was injured or something, it was very painful. She got shingles blisters on her hand, and then also got some on her arm, the opposite arm as the injection. Her dermatologist and internist verified it was shingles. Her internist said it may have been triggered by the vaccine. She clarified it started in the palm of her hand and then traveled up her arm on the opposite side of the vaccine, she got the vaccine in the right arm and the shingles in the left arm. She felt quite ill as a result of the shingles. Her dermatologist put on Valtrex, three times a day. It helped with the spread; it stopped spreading. Her dermatologist was not associating it with the vaccine, and she was not sure she was either. After not feeling well for several days she told internist and he was confident that the vaccine was what caused the shingles. She doesn't remember for sure the event extreme pain in left hand, but it was within a few days after the 2nd dose. The swollen glands started within 24 hours, as well as, the sore arm. It wasn't anything she didn't expect. Like with the flu shot maybe a little worse, but it wasn't severe. Her sore arm was not ongoing. It recovered completely by the next day. Swollen glands came back when the shingles first happened, but they initially began within 24 to 48 hours, for both doses. After the second dose she took two extra strength Tylenol again on the first night again; she just took it once after the 2nd dose. Pain in the hand was 98 to 95 percent better. Her doctor did whole blood work up (unknown results) just to see her white count (unknown results) to rule out something else. The blisters were too small for the dermatologist to scrape and get a biopsy. She did not get the most current 2 dose vaccine for shingles, she only got one dose and that was a number of years ago, she was going to get it but then COVID happened. The outcome of event herpes zoster and pain in extremity was resolving while for other events was unknown. No follow up attempts are possible. Information about Lot/batch number cannot be obtained.

By 12:50 hands were starting to swell; chest pain; heart palpitations; pulse felt like her heart was racing very hard; non specific interstitial disease in the right lower lobe that could represent atelectasis aspiration organomia; non specific interstitial disease in the right lower lobe that could represent atelectasis aspiration organomia; blood pressure was up; throat felt like it was starting to tighten; eyes itchy; eyes itching much worse; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (COMIRANTY; Solution for injection; Lot number and expiration date: unknown), via an unspecified route of administration in left upper arm on 22Apr2021 12:10 (at the age of 61-year-old) as unknown single for COVID-19 immunization. This report was not related to a study or programme. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Adverse events following prior vaccinations was first time had flu shot made her very ill, next year doctor suggested she should just have half of a shot instead of full shot to see if she tolerated it and she was able to tolerate that. She had not any other problems with flu vaccines in general. Some of the other vaccines, she was just supposed to take Benadryl with them because of some of the filler ingredients people put in things. She had previously had the 1 dose shingles vaccine, but she had gotten probably shingles probably a couple of months after that so they encouraged her to get the 2 part shingles vaccine at a later date and told her to do the pre-medicate routine like Benadryl day before, day of and at least 2 days after shingles vaccine doses and if any major problems call for help. She did not have a noticeable problem from the 2 part shingles vaccine. Some of the times depends on what filler ingredients people use. She was allergic to nutmeg which was used as an emollient oil or it's called Myristicin something or other oil; if something has too high a dose of mannitol it can cause a problem. She has a very long list of allergies and high sensitivities; if it was a high enough sensitivity it goes in allergies list, even though it may not be a true allergy. Family has lots of allergies. Regarding prescribed indication additional details: She had 3 doctors who initially advised her to get the vaccine including her primary care physician, oncologist and haematologist; this was because she was a high risk person because of various health issues. Her haematologist 2-3 months ago when she had her last appointment with him he was saying to get the shot and prescribed the epi-pen at that time; no one was having it yet, but he expected she would have some sort of reaction to it not able to be covered by Benadryl alone. Medical history included ongoing platelet disorder Verbatim: Unidentified platelet disorder, Lots of allergies, cardiac murmur, ongoing asthma, osteoarthritis, glucose tolerance impaired, hypoglycaemia slow thyroid and back and neck pain. Concomitant medication(s) included diphenhydramine hydrochloride (BENADRYL) taken for hypersensitivity (50mg taken as needed), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for hypersensitivity (10mg daily), fluticasone propionate, salmeterol xinafoate (ADVAIR) taken for asthma (250/50 twice daily), levothyroxine sodium (SYNTHROID) taken for hypothyroidism (137mcg-1 tablet daily), methylphenidate hydrochloride (RITALIN) (20mg tablet twice daily), salsalate, colestyramine (QUESTRAN LIGHT) (2-500mg tablets 3 times daily), sucralfate (CARAFATE) (1mg tablet 4 times daily-dosage verified with caller as milligrams and captured as provided), loperamide hydrochloride (LOMOTIL [LOPERAMIDE HYDROCHLORIDE]) (2.5/0.25 takes 2 tablets of that 4 times daily), calcium carbonate (CALCIUM OYSTER SHELL [CALCIUM CARBONATE]) (Alternates dose of 500mg and 1000mg on days takes Vitamin D), vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) (250 mg), vitamin D (50,000 units every other day taken), vitamin B12 (1mg injection every 14 days), clonazepam (KLONOPIN) (2-1mg tablets at bedtime), montelukast sodium (SINGULAIR) taken for asthma (10mg tablets at bedtime) and cefixime (FLEXERIL [CEFIXIME]) taken for back pain, neck pain (10mg tablets 3 times daily as needed). On 22Apr2021, Onset time: She had a note saying her eyes itchy at 12:20, but they were itching before that because she waited long enough to report it; so onset time was less than 10 minutes when her eyes started itching. Then her pulse; she could feel chest pain; heart palpitations; pulse felt like her heart was racing very hard. They did check her pulse while she was in their initial observation and her pulse was only in the 70s, but oxygenation was at 96%.When at doctors office less than 1 hour before that reading, oxygenation was at 98%.Recorded at 12:30 eyes itching much worse, throat felt like it was starting to tighten, heart felt like it was starting to race. By 12:50 hands were starting to swell. She had already been pre-medicated with Benadryl before this before she went down to get the Pfizer Covid-19 Vaccine, she had Benadryl in her system. She had that same morning with her morning meds had taken Zyrtec and Benadryl in anticipation of getting the possibility of getting the Pfizer Covid-19 Vaccine because she has to pre-medicate for vaccines just in case she starts to react in anyway. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Additional Vaccines was not administered on same date of the Pfizer Suspect. Emergency Room taken from the location where vaccine administered-they gave her Pfizer Covid-19 Vaccine shot had her sit for basic observation then sit for extended observation. In that time period telling them her symptoms were going on, increasing. They gave her another 50mg Benadryl even though she had already had 1 before and then called emergency room, took her down, left her in waiting area even though she had heart and chest palpitations. Physician Office seen prior to event on 20Apr2021, seen after event 27Apr2021. Primary Care Physician didn't hear anything in lungs either visit. Not admitted to hospital; seen in emergency room, theoretically she got treated; however her basic blood pressure and stuff even with what they were doing was higher than when she was triaged in the ER; blood pressure was up and something else,oxygenation level moderately reduced from when she came down to when she was just let go; however her symptoms were worse when she was leaving than when she got there. She knows what they gave her while she was there was IV of normal saline, solumedrol and IV Benadryl. Thinks they later gave her Tylenol tablets. Finally got them to do an EKG because kept saying her chest was getting worse but that was several hours after she was back there even though came there having chest pains. In her opinion this hospital was not taking reaction seriously. Not admitted to hospital even though symptoms were worse and blood pressure higher on discharge, well above her normal levels. Currently trying to get them to explain why they took so long to do anything for her. Finally did a chest x-ray on 22Apr2021:discharge papers say abnormal x-ray and they gave a couple of different possibilities as to what that might be so Primary Care Physician wrote a prescription to get a follow-up chest x-ray to make sure that everything is fine and back to normal and not ongoing or progressing or anything because they gave some strange things: what their impressions were: findings: there is non specific interstitial disease in the right lower lobe that could represent atelectasis aspiration organomia. It says the left lung appears clear; cardiomediastinal silhouette is within normal limits; impression restates non specific right findings there is non specific interstitial disease in the right lower lobe that could represent atelectasis aspiration organomia. This was from front and lateral views of the chest x-ray at 19:00pm 22Apr2021. 2 ECGs: She guesses this is what they call EKG not, relevant point is that in the notes there for the records: Says abnormal ECG compared with blah blah blah, hard to find when exactly they wrote this, trying to get the exact wording for each of the two. Machine results CED, which caller explained is what they call themselves now instead of ER, notes for MD interpretation; one done at 17:53 , other at 21:32. They both say there was slightly different readings, however both say abnormal ECG. One of the wordings that is in both. She had no further details to provide regarding relevant testing/investigations. She had to be in the ER back in the room for several hours before they would do the EKG and that's only because she said I have chest pain and standard procedure is to do an EKG, had been back there for hours, they had done no tests, the only thing they did was basic blood panel, had not done a troponin or heart enzymes test, had not done EKG that's why she knows they were not taking her seriously at all; if someone says chest pains and you don't do anything in the standard protocol they are not taking you seriously. On this Monday, 2 days ago she had gone down to pick up the records from the ER to go to Primary Care Physician appointment 27Apr2021, finally actually got to speak to someone who said they would get back to her on 27Apr2021 to look into why the EKG tests were not done for someone having chest pains. That's one of the first things you do for someone having chest pain, no matter what the source. Frustrated with them because they're still not communicating back, they had not taken her seriously while she was there; unknown if they were actually going to be reporting, as they were still trying to convince her to get the second dose of Pfizer Covid-19 Vaccine. If she reacted to the first dose in first 10 minutes, second dose could be much more of a reaction. With the amount of anti-histamines in her system with Benadryl and Zyrtec and she was still starting to react in under 10 minutes. It's possible to be one of the inactive ingredients but she doesn't see anything in the pamphlet provided that she could identify at first glance as being the culprit to the problem other than 2 possibilities: potassium chloride and other is monobasic potassium phosphate. There is a possibility of her having a reaction to those because she was known to react to certain potassium products; sometimes it was the inactive ingredients. She definitely would have wanted to get the second part of the Pfizer Covid-19 Vaccine series until after she was not getting the medical attention she needed after reaction to the first dose. Because ideally you're supposed to have it at the same location, that just made her very nervous at the prospect of worse reaction at location that did not take her serious the first time. She was a big fan of Pfizer thought they do a great job; she had not known it was a 2 parter, not that it should make much difference. When her Primary Care Physician was saying second dose of Pfizer Covid-19 Vaccine was out of the question and she had been saying to people that she did not think it would be prudent to take the second part, they kept trying to say oh you need to get the second part, talk to so and so so they can convince you to get it, and doctor is going no. She reacted to ringers lactate or lactated ringers whatever the name is, her retired nurse sister sat and watched her getting some ringers lactate prior to surgery for her tear duct and saw her starting to break out in red splotches, patient said she was itching. Action taken in response to the events was drug withdrawn. The outcome of the events was reported as unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

hives on her mucous membranes/got a few hives on shoulder; bumps; then itching inside nostril and other mucous membranes/whole mucous membrane area down there still feels sensitive or irritated or something/burning feeling in mucous membranes, itching and stinging; then itching inside nostril; hives/red flushy skin/itching; touches something like the remote, patient felt very cold; itching on forehead and on back and on shoulder and in other places/itching; flushing; At first had a funny taste in mouth right away; did have diarrhea a lot when first got home; By evening face was flush red; face was probably a little bit puffy; even today every so often where hair touches face is sensitive/All openings to body are sensitive; mucous membrane area down there still feels sensitive or irritated; got goosebumps right away; burning feeling in mucous membranes; stinging; severe allergic reaction; This is a spontaneous report from a contactable consumer (patient) via the medical information team. A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: ER8736), via an unspecified route of administration in right arm on 28Apr2021 08:15 (at the age of 61-years-old) as 1 st dose, single for covid-19 immunisation. No prior vaccinations (within 4 weeks). No family medical history relevant to the events. No additional vaccines administered on same date of bnt162b2. Medical history included strong reaction to bee stings, allergies/some nuts, allergies/shellfish, allergies to a sulfa drug, allergies, hives, red flushy skin and itching (noted from all allergies that never had anaphylaxis before but gets hives or red flushy skin and itching from some or all of these). There were no concomitant medications. The patient previously took sulfamethoxazole, trimethoprim (BACTRIM) and experienced allergies. The patient received the first dose of bnt162b2 yesterday (on 28Apr2021 at 08:15) and had a reaction to it. The site of the injection for first dose was fine, nothing around the site. On 28Apr2021, the patient experienced at first had a funny taste in mouth right away (vaccination facility said they had never heard that before; gone momentarily after first dose/went away completely); then itching inside nostril and other mucous membranes (within five minutes of receiving the first dose); by evening face was flush red (coloring part was completely gone away); face was probably a little bit puffy; even today every so often where hair touches face is sensitive and will get itchy again; did have diarrhea a lot when first got home (lasted 15-20 minutes and then it was over); right away had itching on forehead and on back and on shoulder and in other places; whole mucous membrane area down there still feels sensitive or irritated or something. All openings to body are sensitive; continued to have burning feeling in mucous membranes, itching and stinging. Skin was really sensitive, when patient felt warm if pushed up sleeves, arm got a little cool and got goosebumps right away. If the patient touches something like the remote, patient felt very cold, skin seemed very sensitive all over. The patient took temperature to see if had a fever, temperature was 98.6, exactly normal, usually runs lower than that but definitely wasn't a fever. The patient left the vaccination facility after half an hour, nothing seemed life threatening. On 29Apr2021, the patient experienced that even today overnight got a few hives on shoulder, back up by shoulder area on one side and noticed the bumps, felt where the bumps were but they are not as big and they were itchy occasionally but not very itchy. (were better now). The events did not require emergency room or physician office visit. The patient stated that it wasn't anaphylactic reaction. The patient have read online that if have a reaction in less than four hours, it was considered severe. The patient was a little concerned when got the shot and was reassured at the vaccination facility that they had not seen anaphylaxis. The patient was wondering if it was okay to get the second dose or should the caller hold off. The patient asked if her symptoms were categorized as a severe allergic reaction (in 2021) and thereby contraindicate her from getting her second dose. The outcome was recovered from taste disorder and diarrhoea on 28Apr2021, from flushing and swelling face on 29Apr2021, from erythema in 2021; recovering from pruritus, piloerection, skin disorder and sensitive skin; not recovered from mucosal pain, burning sensation mucosal, pain, mucosal disorder and nasal pruritus while unknown for the remaining events.

After vaccine, 2 hours later my eyes, lips were swollen. They said acute dehydration and my heart started pounding wildly. I went home and took Benadryl the next day I had breathing problems, 3rd day woke up with numb arm and went to ER and developed arm and left numbness and tingling that's still there today. I still have swelling in face and tongue and sores in my mouth and I have to ice myself at bedtime. and still wake up with difficulty breathing. I'm scheduled for an MRI because doctors said it's an adverse event to vaccine and I've also had hives. I will probably go back to ER because I'm having asthma issues again. I checked with my doctor about my medical records to know if I should get the vaccine and was told to get the vaccine. I have left side numbness and that's why I'm getting the MRI to rule out everything.

Patient received 2nd Pfizer COVID Vaccine on 05/07/2021 and patient reports two days later she began to feel increasingly short of breath and was found to be hypoxic at 66% requiring increased supplemental oxygen, thought to be due to sudden COPD exacerbation, requiring IV Solu-medrol, Duo-nebs and Albuterol. Required hospitalization for 2 days and discharged on antibiotics and prednisone.

Adverse symptoms: bilateral lower leg / ankle swelling. Pt said that she experiences bilateral leg swelling after immunizations.

body swelling; Swollen joints; Ulcers in her mouth; Migraine headache; Constant diarrhea; Brain fog; This is a spontaneous report from a contactable consumer reporting for herself. A 61-years-old female patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine in Hospital, via an unspecified route of administration, administered in right arm on 20Apr2021 09:00, at 61 years of age, (Batch/Lot number ER8737) as single dose for COVID-19 immunization. Medical history included thyroid disorder from an unknown date and ongoing (she has had it for years), hypertension started about 8 years before this report and ongoing, immunodeficiency from an unknown date and ongoing, her spleen has been removed and she is immune compromised and has had COVID. The patient reported that after the first dose of Pfizer-BioNTech COVID-19 mRNA Vaccine administered on 30Mar2021 at 09:00, she had mild diarrhea, body aches, fever and headaches and she felt she had COVID. The patient's concomitant medications were not reported. In Apr2021 the patient experienced body swelling, assessed as medically significant, swollen joints, ulcers breaking out inside her mouth and a 24 hour migraine headache. Ulcers started about 3 days in from the 2nd dose, they come and go. She keeps them at bay by using Listerine. She understands that whatever is happening in her lower gastrointestinal tract is coming up into her mouth. The patient added she is a neuro-muscular therapist and had an understanding of how her body works. The body swollen started a week after the shot (also reported as immediately after the shot). It continues at the time of the report and it is persisting. The patient stated "she has a little bit of COVID brain". Moreover, the mild diarrhea after the first dose changed to constant diarrhea after the second dose. It is water and with intense cramping and is constant. She reported she is on the BRAT diet. "It won't hold so she is living on Gatorade and white rice". Over the past week, her joints in her hands and in her body have become swollen. Horribly swollen to the point she couldn't get her pants on because her knees and ankles were so swollen. Her hands last week started swelling and the pores around her joints look like blisters. The patient added she has had severe brain fog since an unknown date which was ongoing at the time of the report. The headache has not left as well, the outcome of all the events was unknown at the time of the report. The patient has not been to the Emergency Department or her Physicians office, but was going at the day of the report. No follow-up attempts are needed. No further information is expected.

Diarrhea; Stomach pain; Stiff neck; Vertigo; Swelling of hands and feet; skin dryness and cuts appeared; skin dryness and cuts appeared; She did not have any smell and taste; She did not have any smell and taste; Fever; Chills; Coughing; Her lymph node glands were swollen between her legs; Right arm was of no use it was so painful it felt like it would break off of the shoulder; Nauseous; Dizzy; Difficulty walking; Exhaustion; The moisture in her skin was almost like it was sucked out and lesions started opening up almost like a papercut; Tachycardia/heart beating out of her chest; This is a spontaneous report from a contactable consumer (patient). A 61-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 25Feb2021 11:30 (Batch/Lot Number: EN6198) age at vaccination of 61-years-old at 0.3 ml single for covid-19 immunisation. Medical history included bell's palsy from an unknown date and unknown if ongoing, endometrial cancer from an unknown date and unknown if ongoing, rheumatoid arthritis from an unknown date and unknown if ongoing, drug hypersensitivity from an unknown date and unknown if ongoing (Penicillin allergy), rubber sensitivity from an unknown date and unknown if ongoing, illness from an unknown date and unknown if ongoing (sick for the past 11 years). The patient was not pregnant and was not pregnant at the time of vaccination. Concomitant medications included levofloxacin (LEVOFLOXACIN) 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; cyclobenzaprine (CYCLOBENZAPRINE) taken for an unspecified indication, start and stop date were not reported. The patient previously took sulfonamide and experienced hypersensitivity, mycin [benzathine benzylpenicillin] and experienced hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered: Hospital. On 25Feb2021 at 1230, she was dizzy, nauseous, vertigo, swelling of hands and feet, tachycardia/heart beating out of her chest, difficulty walking, her right arm was of no use it was so painful it felt like it would break off of the shoulder and her left arm was the arm she got the shot in and it had no reaction at all, she did not have any smell and taste, fever, chills, coughing, her lymph node glands were swollen between her legs and the other weird thing is that the moisture in her skin was almost like it was sucked out and lesions started opening up almost like a papercut, skin dryness and cuts appeared, she could hear the noise of it opening up on fingers it was like a popping, she had a stiff neck and like everyone she had exhaustion. The patient experienced stomach pain and diarrhea on 27Feb2021 those are the things she had and her family won't leave her alone, they think she should get the second injection but she is terrified. She has gotten no help from her doctor. No treatments were given for the events. The patient underwent lab tests and procedures which included sars-cov-2 test negative on 28Nov2020 (Nasal Swab). The patent was not recovered from the events. No follow-up attempts are needed. No further information is expected.

As of 6/1/2021, pt presented with 3 weeks progressively worsening dyspnea on exertion and associated lower extremity pitting edema up to hips and was found to have acute bilateral pulmonary emboli, including a large thrombus seen in the left main pulmonary artery. Also admitted to nausea, orthopnea, PND, chronic leg swelling no worse than usual, and a productive cough with creamy white sputum.

That evening when she laid down she had some neck soreness; she woke up she saw the swollen lymph nodes.; She also experienced fatigue; arm soreness; This is a spontaneous report from a contactable consumer or other non-health care profession. A 61-years-old female patient received second dose of BNT162b2 (solution for injection, Lot number and expiration date was not reported), via an unspecified route of administration on 21Apr2021 (at the age of 61-year-old) as a single dose for covid-19 immunisation. Medical history included ongoing lymphadenopathy three narrowing's in her neck and needs to get surgery on it. The patient's concomitant medications were not reported. Historical vaccine include first dose of BNT162b2, via unspecified route of administration on unspecified date (at the age of 61-year-old) at a single dose for COVID-19 immunisation. On 21Apr2021, on evening of same day of vaccination, the when the patient laid down, she had some neck soreness, and the next morning when she woke up she saw the swollen lymph nodes. She still has swollen lymph nodes now. She also experienced fatigue and arm soreness and she just put some alcohol on that and it resolved. Therapeutic measures were taken as a result of arm soreness. The patient was called to see if this is a side effect/ how long it lasts and She cannot get her neck injections or surgery until it resolves. The outcome of some neck soreness and fatigue were unknown, swollen lymph nodes was not recovered, , arm soreness was recovered. Information on the lot/batch number has been requested.

Reaction began within a few hours of vaccination. Patient had fever, chills and diarrhea within a few hours of receiving the vaccine. By 4:30am on 3/31 she could not walk and her legs went numb. An ambulance was called and the EMTs had to carry her out of the house. She was taken to Hospital where they started treating her for an infection but her fever went up over 103F so they ventilated her to try to control the fever. They did blood tests during that time and got the infections disease unit trying to figure out what was causing her symptoms. Doctors diagnosed sepsis. They continued to do blood test and cultures but could not determine the cause. They did MRIs as follow-ups because she was not responding. The fever never went down. She was awake for a few days (ventilator still in) and then started getting worse again. This is about 1.5 weeks post vaccination. They did an MRI and found a bleed on her brain and the infection had spread to her heart valves. Symptoms began within hours of vaccination. She was take to the hospital the morning after the vaccine and never came home. Patient died after 2 weeks in the ICU.

The adverse reaction was swollen left facial gland. I did not seek treatment. I placed a warm compress on my face. I lasted for about 6 hours.

Severe underarm and left breast swelling that lasted 5 days with pain, chills, fever, body aches and fatigue still present 7 days later

bleed on her brain; the infection had spread to her heart valves; she could not walk; legs went numb; sepsis; fever / fever went up over 103 F; chills; diarrhea; This is a spontaneous report received from a contactable consumer. A 61 years old female received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EP7533) on 30Mar2021 (at 61 years of age), in right arm, for COVID-19 immunisation. The patient received the first dose of BNT162B2 vaccine on 09Mar2021 (lot EN6202), at 61 years of age, in right arm. No other vaccines were given within 4 weeks prior to the COVID vaccine. Medical history included connective tissue disorder - scleroderma. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included methotrexate. On 30Mar2021, within a few hours of receiving the second vaccination, she had fever, chills and diarrhea. By 4:30 AM on 31Mar2021 she could not walk and her legs went numb. An ambulance was called and the EMTs had to carry her out of the house. She was taken to hospital where they started treating with antibiotics her for an infection but her fever went up over 103 F, so they ventilated her to try to control the fever. They did blood tests during that time and got the infections disease unit trying to figure out what was causing her symptoms. Doctors diagnosed sepsis. They continued to do blood test and cultures but could not determine the cause. They did Magnetic Resonance Imaging (MRIs) as follow-ups because she was not responding. The fever never went down. She was awake for a few days (ventilator still in) and then started getting worse again. They did an MRI and found a bleed on her brain and the infection had spread to her heart valves. She died on 14Apr2021 after 15 days of hospital care and Intensive Care Unit (ICU) care. The events were reported with a fatal outcome. It was unknown if autopsy was performed. Since the vaccination, the patient had not been tested for COVID-19.; Reported Cause(s) of Death: chills; diarrhea; she could not walk; legs went numb; sepsis; bleed on her brain; the infection had spread to her heart valves; fever / fever went up over 103 F

headache; Hands were cold; Nauseous; Swollen face; This is a spontaneous report received from a contactable consumer (patient) via COVID-19 Adverse Event Self-Reporting Solution. A 61-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Eke199), via an unspecified route of administration, administered in right arm on 12Mar2021 as single dose for covid-19 immunization at the age of 61-years old. Medical history included drug allergy to salidine from an unknown date and thyroid removal 2008/cancer from an unknown date. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19 (Sofia 2) on an unspecified date with unknown results. The patient's concomitant medications included levothyroxine sodium (SYNTHROID), route of administration, start and stop date, were not reported for an unspecified indication taken within two weeks of vaccination. The patient experienced headache, hands were cold, nauseous and swollen face on 12Mar2021, at 16:15. The events were reported as after receiving the vaccine, headache for 2 days, swollen face 1 day; hands were cold for 2 days, and she was nauseous 3 days. No treatment was received for the adverse events. The patient underwent lab tests and procedures which included negative nasal swab on 02Feb2021. The outcome of events were as follow: headache recovered on 13Mar2021, hands were cold recovered on 14Mar2021, nauseous recovered on 15Mar2021 and swollen face recovered on 13Mar2021.

She is worried it is a kind of blood clot.; She is worried it is a kind of blood clot.; Swollen lymph nodes in right leg; This is a spontaneous report from a contactable consumer(Patient). A 61-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 23May2021 as 2nd DOSE, Single for covid-19 immunization. Medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities, obesity. No family medical history reported. The patient's concomitant medications were not reported. Patient previously took historical vaccine of first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number was not reported), via an unspecified route of administration, administered in Arm left on 02May2021 as single dose for covid-19 immunization. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. It was reported that, on 26May2021, after getting the second dose of the Covid vaccine, she had swollen lymph nodes in her right leg. She was worried and asks what to do and She asked if she needs to go to Urgent Care. she is worried it is a kind of blood clot. She asks if Pfizer will call her doctor and then call her. All she had were swollen lymph nodes. They are getting big and big. She confirms they are getting bigger. No relevant tests reported. The outcome of the events was not recovered. Information on the lot/batch number has been requested.

Joint pain; Tiredness; muscle pain; swelling of face; swelling of throat; difficulty breathing; Diarrhea; This is a spontaneous report from a contactable consumer. A 61-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 16Mar2021 at 10:30 (Batch/Lot number was not reported) as unknown, single dose for covid-19 immunization. Medical history included sjogren's syndrome, arthritis, fibromyalgia and systemic lupus erythematosus. Concomitant medications were not reported. The patient did not have any allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine. Prior to vaccination, patient was not diagnosed with COVID-19 and Since the vaccination, patient has not been tested for COVID-19. On 16Mar2021 at 18:30, the patient experienced Joint pain, tiredness, muscle pain, swelling of face, swelling of throat, difficulty breathing and diarrhea. The events were not treated. The patient was recovering from the events. Amendment: This follow-up report is being submitted to amend previously reported information: Relevant Med History 2, the verbatim was updated from Arthritis NOS to Arthritis and Relevant Med History 4, the verbatim was updated from Lupus syndrome to Lupus and Narrative regenerated per original source document. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

nausea, vomiting, diahrea, body aches, low grade temperature, lethargic, yellow cast to my skin transported by EMS to the hospital and was given IV fluids and IV antibiotics Still having liver tests done every two months

hand swelling , difficult to make fist and bend fingers occasional wrist pain still swollen since shot 4/30/21

has a mass under her left arm pit and every time she moves her arm it hurts; has a mass under her left arm pit and every time she moves her arm it hurts; swollen lymph node; it got bigger and got black, that the black and blue is going down but the mass is still there; This is a spontaneous report from a contactable consumer. A 61-year-old female consumer (patient) received bnt162b2 (BNT162B2, Solution for injection) via unspecified route of administration on 07Jun2021 at 09:00 (61-year-old age at vaccination) as single dose in left arm for COVID-19 immunisation. Medical history reported was rash and ongoing thyroid. Patient previously took first dose of bnt162b2 on 12May2021 and experienced had side effects of massive headache and very tired that started the same day in the evening. Concomitant medications reported was levothyroxine sodium (SYNTHROID) as thyroid medicine. Caller stated that against her better judgment and what she went through with the 1st one, they told her not to get this, she got the 2nd dose and now she has a mass under her left arm pit and every time she moves her arm it hurts. Stated it was under her arm pit and hurts pretty bad and she is really worried what the drug did to her. Stated that things are going underreported, and she was really really worried. has a mass under her left arm pit and every time she moves her arm it hurts was reported as worsened. Caller stated she wished she never got it and will tell other people and doctors don't know. Stated she should have taken the chloroquine like they told her to. Caller stated she doesn't know what the hell is wrong with her now and that she was perfectly fine before this. Caller stated she had her 2nd dose on 7Jun2021 and noticed the mass under her left arm pit immediately within a few hours of getting it. stated it got bigger and got black, that the black and blue is going down, but the mass is still there. stated when she lifts her arm and puts it down it hurts pretty bad, and she was very very concerned. Caller provided that she thought it was a swollen lymph node and it was not going away and she felt it was getting worse. Caller stated she got the 1st dose in her right arm at 10am and her 2nd dose in her left arm at 9am. Pure stupidity so she would not get Covid, and she wouldn't have gotten it anyway and would never do it again and she was trying to tell her kid not to do it. Stated she doesn't trust anything that was not really approved, and she knew better. Regarding concomitant medication, Caller stated nothing different than anything else she has been taking. States she takes thyroid medicine and has been taking it for over 10 years and this has nothing to do with that. Caller stated she has a rash and nobody knows where that was from and she was on Dupixent and there is no contraindication with Pfizer according to (Withheld), and (Withheld) told her not to get the vaccine and she should have listened and they put it in writing and she should have listened because of the Dupixent and the rash and that told her oh yes all their patients that are on Dupixent are on the Pfizer as well. Caller clarified that she had the rash and was taking the Dupixent before receiving the Covid vaccines. Caller stated she had Dupoxint and she always gets that had has not had any reactions. States her last dose was the 1st week of May2021. Caller stated she can't take the flu shot and they knew that. Caller states she does not have the NDC, lot, expiry, or doses to provide as it was 20 years ago. Caller received the 2nd dose of the Pfizer covid 19 vaccine on 07Jun2021, mass under left arm pit, turned black and got bigger, the black and blue going down, but lump is bigger. Having a lot of pain, raises arm puts it down hurts pretty bad and very concerned. It's still there feels it's getting worse; her doctor doesn't know. Caller stated, when she put it (her arm) down, it feels like a huge mass under my armpit. she should never have done this. her doctor has heard that you can get swollen lymph nodes, she was not sure this was a lymph node. Outcome of the events was not recovered. Information about the Lot/batch number has been requested.

Huge cold sore on my upper right lip; This is a spontaneous report from a contactable consumer (patient herself). A 61-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EN6203, Expiration Date: not reported) via an unspecified route of administration in right arm on 27Feb2021 18:45 as 1st dose, single dose for COVID-19 immunization. Medical history included known allergies to Penicillin and other medical history was reported as none. Patient did not receive any other vaccine in four weeks and received other unspecified medications in two weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 28Feb2021, the patient experienced huge cold sore on my upper right lip. Patient was treated with Famciclovir. The outcome of the event was reported as recovering. No follow up attempts are Possible. No further information is expected.

Her arm hurts below the vaccination site in her left arm and the center area to an inch above her elbow; Fatigue; A slight cough; Her left arm began to ache and shake/left arm pain; Her left arm began to ache and shake/left arm shaking; She had arm pain when woke up the next day, and the 28th she had slight swelling; This is a spontaneous report from a contactable consumer (patient). A 61-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955), via an unspecified route of administration, administered in left arm on 27Mar2021 (at the age of 61-years-old) as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated on Sunday morning while taking a phone call her left arm began to ache and shake and she had to end the call. Caller states her arm hurts below the vaccination site in her left arm and the center area to an inch above her elbow. Caller states she can't use her left hand too much because it starts to ache and shake, says she was holding the phone talking to someone and after about 50 minutes her arm hurt, then 5 minutes later it started to shake and she had to stop using her hand to hold the phone. She says she had the same problem driving to work last night, she works night, she couldn't use her left arm driving for the trip because it was shaking. then she couldn't do as much of her usual work because it starts to shake and she needs two hands to do her job. She says today she also has a little bit of a cough and fatigue. The patient reported that since it was after her first dose that she had these problems she would like to know if it is safe for her to have her second dose that is scheduled for 24Apr2021. She could use her left arm now and was currently holding the phone in that hand to see if the event reoccurs. She says her arm aches above her injection site to two inches below her elbow, and when it shakes it was like her arm was having a seizure. She was used to having 4 hour phone calls to stay in touch with people and holding a phone for long periods of time was not unusual for her, but her arm could not hold it after that 50 minute call. She had arm pain when woke up the next day, and the 28th she had slight swelling by Saturday afternoon or evening, then she woke up more swelling the next day. She said this was at a mass vaccination site she got her first dose. She had a constant ache, and she hasn't taken any Ibuprofen for it. Since she has been holding the phone this call, it has begun aching more, she has been holding the phone 15 minutes, and it started to ache, but there was no shaking yet. States she is scheduled for the second dose on 24Apr2021. She would like to know if her side effects are normal and if she should receive the second dose. Outcome of the event was unknown. No follow-up attempts are needed. No further information is expected.

Bright red rash, intense itching, skin peeled like from bad sunburn - multiple areas. Hives - abdomen, upper back, forearms and hands. Intense extended itching! Facial, eyelid and neck swelling. Fri May 7th (last area that week) - Face and neck also developed bright red rash and itching. As rash decreased skin felt dry and papery. Did peel /exfoliate. Last area to have response.

chest was real tight and felt like her heart was going to come out of her chest; heart beating really fast and pumping hard; shivers; tired a lot; It could have been swollen for a while, she probably just got used to it; headaches; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EN6201), via an unspecified route of administration, administered in arm left on 16Feb2021 (at the age of 61-year-old) at a 2nd dose, single dose for COVID-19 immunization. The patient medical history was not reported. Family history included patient husband has cancer and had it twice, just finished treatment, heart trouble on her dad's side. He lived to be 90 and had 2 bypasses and had clogged arteries. Patient did not receive any other vaccines within 4 weeks prior vaccinations. The patient concomitant medication included losartan at a dose of 50 mg 1x/day taken for blood pressure high, vitamin D NOS 1x/day, zinc maybe once a week, acetylsalicylic acid (BABY ASPIRIN Chewable) did not take it regularly maybe 2 or 3 times a week; ascorbic acid, cobalt sulfate, copper sulfate, ergocalciferol, ferrous fumarate, magnesium sulfate, manganese sulfate, nicotinamide, potassium iodide, pyridoxine hydrochloride, retinol, riboflavin, thiamine hydrochloride, tocopherol, vitamin b12 nos, zinc gluconate (MULTIVITAMIN (16)) 2 or 3 times a week, once in a while. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: E69262) via an unspecified route of administration, administered in upper arm right on 21Jan2021 at a 1st dose, single dose for COVID-19 immunization, losartan for blood pressure high (has been taking for probably 2 years), patient takes the flu shots yearly. The patient experienced tired a lot, it could have been swollen for a while, she probably just got used to it, headaches on an unspecified date in 2021, shivers on 17Feb2021, chest was real tight and felt like her heart was going to come out of her chest, heart beating really fast and pumping hard on 18Feb2021. Patient stated she is calling regarding the Pfizer Covid 19 vaccine. Patient took that and after watching things and having complications, she got on this one website and it said to call, so she did. It was her heart. After the second shot, that day, there was nothing. Then, patient had shivers the next night and then the next night it felt like her heart was going to come out of her chest. Patient was taking Benadryl because she knew it was an anti-inflammatory. After the shot, patient sat for 10 to 15 minutes, then she was gone. After the second shot, patient had shivers the second night, all night long. Then, the next night, she felt like her chest was just real tight. Patient could tell her heart was pumping hard. Patient thought it was going to come out of her chest. Patient though, she didn't know what to think. It was beating really fast and swollen like it was pumping hard. After that, patient was just tired a lot. Patient is just now getting to where she is not tired like she was. It could have been swollen for a while, she probably just got used to it. Patient did not clarify this statement but did mention swollen in regards to her heart previously. Patient is still feeling tired but feeling a little bit better. Patient was never having headaches, and she started having headaches after. It could have been weeks after but does not know exactly when it started. She has not been having them now for about a month. Younger ones don't need to be taking this. Feels like it affects the heart and with everything else they don't need. Patient had a physical examination. Patient thinks she mentioned to her the bad shivers and the heart thing. She does not know if she told her about her heart coming out of her chest. The patient received Benadryl, Tylenol, Aspirin, Advil as a treatment medication for the events. Outcome of the events was unknown. Information about Lot/Batch number was available. Additional information has been requested.

Arm being swollen but underneath the arm in my armpit I notice it's pretty swollen; Under my arms it's swollen; Arm being swollen but underneath the arm in my armpit I notice it's pretty swollen; Under my arms it's swollen; Arm is sore; Chills; Headache; Fever; Tired; First it started of with I think it was tiredness, 'jerking' and then fever."; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EW0217) via an unspecified route of administration in Arm on 11Jun2021 as second dose, single for COVID-19 immunization. Medical history included Blood pressure high from an unknown date and unknown if ongoing. Concomitant medications included vitamin d, paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported, since patient had the shot. Consumer stated Dose of Vitamin D as it for High blood pressure medicine further clarification was unknown. It was reported that the patient received the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EW0177) via unspecified route of administration on 18th May 2021 as 1st dose, single for covid-19 immunization. It was reported that the patient did not receive any vaccine within 4 weeks prior to the COVID 19 Vaccine. Consumer stated she was calling regarding a side effect that she noticed after she had her shot-on Friday the 11th of this month (11th june2021) and stated she had all the symptoms except for a few started Saturday on 12jun2021, her arm was sore and she had the chills and when she went to bed, had headache. First it started off with she thinks it was tiredness, jerking and then fever and still experiencing. On 13jun2021, she noticed that her arm being swollen but underneath the arm in her armpit she noticed it was pretty swollen under her arms and confirmed the name of the vaccine as Pfizer Covid 19 vaccine and patient stated no treatment was received and took Tylenol before vaccination. Reporter seriousness for all the reported events as unspecified. There was no investigation assessment. The outcome of the events was not recovered.

This morning, approximately 48 hours after her COVID vaccination, patient states she woke up with swelling on her cheek and under her left eye, which progressed to her forehead. She sought medical attention from her PCP's office since she was unsure of what was happening. They told her they felt it was related to the vaccination and prescribed an antihistamine.

Patient presented to the ED immediately after receiving dose 1 of vaccine with anaphylactic reaction. Patient had hives, difficulty swallowing. was given epinephrine, prednisone taper and benadryl.

On March 31 I woke up and had a hard time breathing. My DR told me to go to the ER immediately so I did. So when I got there, I was put on the bypap and had the respiratory issue, my EKG changed where I had heart problems. My liver enzymes were elevated and my kidney enzymes were elevated. I gained 10 pounds of fluid in three days of being in the ER. I went to intensive care for worsening conditions, ended up having severe migraines and not being able to see correctly. They gave me Benadryl 50mg IV along with epinephrine, all within the first two days. I was in the hospital for a week that I can tell you. Within three weeks later my liver enzymes did go back to normal. I did go to my PCD for follow up, I saw an allergist specialist as well. I couldn't walk correctly, and had a hard time breathing as well. It was like all my organs were affected. Even right now I am still fatigued and I only got the first vaccine, back in March. These all are worsening symptoms as well. I also lost my hair as well. All my nails broke, it was just like, everything happening at once.

About 40 minutes after vaccination, started a tingling in the right side of my face tongue and cheek, throat closing, swollen lips and face on right side. Swollen in areas of the right side of my face. I called urgent care who said start Benadryl every for hours. Found I was allergic to polysorbate 80.

Itchiness; redness on arm below injection point; tenderness and around lymph node under arm.; pain under arm; Hard knot at injection site; Hard knot and tenderness at injectionpoint; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in right arm on 18Mar2021 at 12:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and high cholesterol. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN) and rosuvastatin (MANUFACTURER UNKNOWN) taken from unknown dates for unknown indications. Prior to vaccination, on an unknown date, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Since the vaccination, the patient was not diagnosed with COVID-19. On 18March2021, the patient experienced a hard knot and tenderness at injection site; on 19Mar2021, experienced pain under arm; on 20Mar2021, redness below injection point and tenderness around lymph node underarm and 3-4 days later to vaccination, experienced expanded redness on arm below injection point with pain and itchiness. Therapeutic measures were not taken as a result of the events. The clinical outcome for events vaccination site lump, vaccination site tenderness, armpit pain, itchiness, redness and lymph node tender were recovering. No follow-up attempts are possible. No further information is expected.

Injection site pain; Tiredness; Headache; Muscle pain; Chills; Joint pain; Fever; Feeling unwell; Swollen lymph nodes; This is a spontaneous report received from a contactable consumer, the patient. A 61-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 on left arm on 18Mar2021 at 09:45 (at the age of 61 year) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, asthma and food allergy (some food sensitivities). The patient received unspecified medication within 2 weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205) via unspecified route of administration on left arm on 25Feb2021 at 09:45 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Past drug history also included DEMEROL for which patient developed allergy. 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 4 weeks prior to the COVID-19 vaccine. On 18Mar2021 at 15:30, the patient experienced vaccination site pain, tiredness, headache, muscle pain, chills, joint pain, fever, feeling unwell and swollen lymph node. No therapeutic measures were taken in response to the events. The clinical outcome of the events vaccination site pain, tiredness, headache, muscle pain, chills, joint pain, fever, feeling unwell and swollen lymph node were resolved on an unknown date in 2021. No follow-up attempts are needed. No further information is expected.

Discomfort at injection site; Lymphadenopathy; Nausea; Headache; Severe fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 61-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207), via an unspecified route of administration in the left arm on 18Mar2021 (at the age of 61-years-old), as a single dose for COVID-19 immunisation. Medical history included ovarian cancer, diabetes, hypertension and adhesives allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient received unspecified medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 18Mar2021 at 16:00, the patient experienced severe fatigue, headache, lymphadenopathy, nausea and discomfort at injection site. The patient did not receive any treatment for the events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events of severe fatigue, headache, lymphadenopathy, nausea and discomfort at injection site was recovered on an unspecified date in Mar2021. No follow-up attempts are possible. No further information is expected.

On 4/1, 7 days after the vaccine, the back of my head started itching. Then my neck itches. I has some swollen lymph nodes in the back of my neck. On 4/10, a rash began on my left forearm. It was extremely itchy. On 4/11, it was on my left and right forearm and my chest and legs. Since then it has spread everywhere. By spots, I mean it starts as a spot but then turns into a big rash. There was a rash with 2 weeks and 2 days past the vaccine and since then the rash has spread all over my body. It was awful, I did not ever have skin problems. On 4/19, I went to the dermatologist who prescribed a steroid cream. On 5/11, I went to an allergist/immunologist, he also agreed that it was from the vaccine. I have no idea how long this will last since it is in my body. The itching is much more tolerable now. It itches more in the mornings but it is not such a nuisance now. It has gone in some areas but new ones do keep coming. I'd like to emphasize that this still going on. This is a rash that has been going on since it started. Dermatologist

arm puffiness; her left breast was swollen; had a lot of arm aches where the injection site was; Body aches; swelling in her lymph nodes; had some nerve tingling in her finger; Arm swelling; swelling under her left side of the arm, the left armpit; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 61-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL9264, expiry date unknown), via an unspecified route of administration in left arm on 04Feb2021 at 17:30 in the beginning of February (at the age of 61 years old) as single for COVID-19 immunization. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL3302), via an unspecified route of administration in left arm on 14Jan2021 in the middle of January (at the age of 61 years old) for COVID-19 immunization and experienced no reaction. Medical history included headache. No family medical history relevant to adverse events was provided. No concomitant medications were reported. Patient occasionally took Excedrin or Avil expectorant for headaches and experienced no reaction on previous exposure to drug but did not take any prescription medication. The patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient did not administer any vaccine on same date with the Pfizer vaccine considered as suspect. Patient had no problems with the first injection received on 14Jan2021; all the events started after she received the second dose of the vaccine. On 05Feb2021, patient had body aches. 14 or 15 hours after the injection, patient's arm started aching. Patient had a lot of arm aches on the injection site. Patient took Tylenol for the body aches, which lasted a few hours and recovered on 05Feb2021. Patient was having a lingering symptom. On 06Feb2021, patient's left arm, in the armpit, had puffiness, it was not sore in the tissue and she did not know if it is the muscles or tissue. Patient had swelling under her left side of the arm, the left armpit and noticed the lymph node and got scared. Her arm really hurt on the third day and it was worse than the second day. Swelling eventually went down but not completely. She said it stayed the same and she has not noticed any more improvement for the last few months. She kept thinking it would go down more but it was the same. Patient stated that no one would notice the swelling, but she noticed a protrusion when she lifted her arm up. It did not hurt it was just there. When she lifted her arm up, the left arm was noticeably different than the right armpit. Patient's left breast was also swollen with the whole site near the armpit on 06Feb2021. Swelling started to go down but it took days. Patient had some nerve tingling in her finger on the left side and maybe in her arm, which did not last long, and she figured it was from the swelling pushing on the nerves. She did not notice it that weekend, so it might have been a few days after the weekend when she received the second vaccine. Patient had a gynecologist appointment at the beginning of April and gynecologist did not seem to be concerned, he said it could be her lymph node. Patient did not feel like she needed to go see a doctor because most of the swelling had gone down and just the lingering puffiness was still there, and she kept thinking it was going to go away and it just needed a few weeks. Swelling still had not gone down and patient had given it a few months. Events did not require a visit to emergency room or physician office. No relevant tests were performed. Outcome of the events swelling in her lymph nodes was unknown while of arm puffiness was not recovered. Outcome of the events her left breast was swollen, Arm swelling and swelling under her left side of the arm, the left armpit was recovering. Events "had a lot of arm aches where the injection site was and had some nerve tingling in her finger" recovered on an unspecified date.

my face swelled up like a balloon, it turned burnt red, it was burning/redness; my face swelled up like a balloon, it turned burnt red, it was burning; My arms swelled up like balloon; Red rash all over my arm; allergic reaction; her face and ears had swollen up like a balloon; her face and ears had swollen up like a balloon; arms were burning and swelling; arms were burning and swelling; had a rash in the arm and neck; This is a spontaneous report from a 61-year-old female contactable consumer (patient). A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number was not reported) via an unspecified route of administration on 21Mar2021 at 09:30 as 1st dose, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 21Mar2021, patient received Pfizer Covid19 vaccine first dose on Sunday at 9:30 a.m. and 2 hours later at around 12 o'clock she experienced that her face and ears had swollen up like a balloon, arms were burning and swelling, had a rash in the arm and neck, they took her to the ER and gave her Epinephrine and Benadryl. Some doctors advised not to get second one and some others advised it was not an allergic reaction and wanted to know if this was an allergic reaction to the vaccine or not. On 09Apr2021 it was reported that her face was red like someone burnt her. It was burning. She was taken by ambulance to the emergency room. Her face was hot, burning, burnt red like she had been in the sun for 4 days, and became red like she had a third-degree sunburn. They took her to the Emergency Room. She developed bilateral arm swelling 5 minutes after the vaccine. She still has a little rash. Her face was a little puffy yesterday but is better today. She only ate in the morning and didn't eat lunch before the vaccine. About 2.5 hours of vaccine administration later her face started swelling, redness, with burning. Both arms started to swell with a rash developing. Caller has seen two providers who said the symptoms were allergic reactions to the vaccine. She also seen two other providers who said it was not a reaction to the vaccine. Caller asking if she should take the second Pfizer Covid 19 vaccine. Patient is confused about getting second dose. It was reported that my arms swelled up like balloon; Red rash all over my arm and just wanted to know if she should get her second shot and asked whether she was getting the second shot on Monday or not. The clinical outcome of the event her face and ears had swollen up like a balloon, arms were burning, and swelling was resolved, the event had a rash in the arm and neck was resolving and rest of the events was unknown.

Shingles on left side of face under eye down to lip. Swelling. Severe headaches, fatigue and weight loss. shingles has subsided but all other symptoms are still there.

Swollen lymph nodes in the left shoulder area/upper chest, very painful to touch. Still larger than normal, but with no pain. Strange nerve pains, shooting down left arm (only a few times, couldn't wear my fitbit because it seemed more frequent with it on); has settled down since then. I've been in menopause for 14 years with no hot flashes,etc.; I started having hot flashes again after the second shot. I've been more tired than normal and not felt 100% healthy since the second shot.

Anaphylaxis; Rash; urticaria; This is a spontaneous report from a contactable Physician. This Physician reported in response to other health professional letter [sent to physician] via follow-up. A 61-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: ER8732) via intramuscular in the right deltoid on 12Apr2021 (at the age of 61-years-old) as dose 2, single for covid-19 immunisation. Medical history included history of previous allergies to PNC (penicillin), codeine, amitriptyline and latex. Patient received antihistamine for the treatment of allergies. Concomitant medications included trazodone, vitamin C (ascorbic acid), calcium citrate, linum usitatissimum seed (FLAXSEED), topiramate (TOPAMAX), zolmitriptan (ZOMIG), norethindrone (norethisterone), ethestradiol (desogestrel, ethinylestradiol (ETHISTREL)), esomeprazole sodium (NEXIUM), valaciclovir hydrochloride (VALTREX), linaclotide (LINZESS), cyanocobalamin (VITAMIN B12), and colecalciferol (VITAMIN D) all taken for an unspecified indication, start and stop date were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EP7534), via intramuscular in the left deltoid on 22Mar2021 (at the age of 61-years-old) as dose 1, single for covid-19 immunisation and on an unknown date in Mar2021 patient had rash/hives. The patient did not receive any recent vaccines, for any other conditions and for SARS-CoV2 other than Pfizer-BioNTech Covid-19 Vaccine, prior to the event being reported. On 13Apr2021, the patient experienced anaphylaxis with signs and symptoms rash and urticaria. First saw patient on 13Apr2021, 1 day after 2nd dose, she reported rash/hives since 1st dose in Mar. The patient required medical intervention with corticosteroids and antihistamine. It was reported that Pfizer product had a causal effect to the adverse event. The outcome of all the events was recovered in 2021. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event Anaphylaxis, rash, urticaria and the suspect drug BNT162B2.

Swelling, erythema and pain right upper extremity associated with fever, chills, weakness and fatigue. Swelling extends from shoulder to mid humerus and extend from the axilla down to the level of the breast. Large palpable mass adjacent to right breast. Seen in PCP's office on 6/29/21. Started on Bactrim without responce. Currently on Clindamycin

It did not matter where or how hard the doctor hit here right knee; She has complications with having no taste; She was itching on her right arm, wrists and fingers; She was tomato red from head to toe; Her throat and face was swollen; Her right hand and arm was swollen; She began having vagina spasms. She literally felt like half of a fish was inside of her vagina, and it was flopping around.; Her chest felt heavy; Her right knee had no reflex what so ever.It did not matter where or how hard the doctor hit her right knee, it did not move; The bubble blisters on her wrist; She started getting bubble blisters on her arms, fingers, and over her chest, above her boobs; Her left but cheek, back of leg and knee cap all felt numb, but also felt on fire at the same time. It just really hurt; Excruciating pain in her left butt cheek, back of leg, and knee cap; Her urinary tract started burning. She was peeing, and peeing and peeing. She was using the bathroom a lot; her urinary tract started burning. She was peeing, and peeing and peeing. She was using the bathroom a lot.; This is a spontaneous report from a contactable consumer (patient herself). A 61-year-old female patient (self-reported) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 01Apr2021 13:00 (Batch/Lot Number: ER8737) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included allergy to shellfish and allergy. Concomitant medication included estrogens conjugated (ESTROGENS CONJUGATED) taken for an unspecified indication, start and stop date were not reported. She received the first dose of the covid vaccine on Thursday, 01Apr2021. She felt fine over the weekend. By Monday evening, 05Apr2021, she started not feeling very good. She received her covid vaccine in her right arm. Around 1:00, her left butt cheek was in excruciating pain, then the pain spread to the back of her leg, and to her knee cap. Her left but cheek, back of leg and kneecap all felt numb, but also felt on fire at the same time. It just really hurt. By 4:00PM, she was hurting so bad, and it moved to her vagina and left leg. It did not bother her right leg. It was only bothering her vagina, butt cheek and left leg. About 16:00 to 16:30, her urinary tract started burning. She was peeing. She was using the bathroom a lot. Her husband came home around 5:30PM and co convinced her to take a hot shower. By 8:00PM, she could not take it anymore. She sent her husband to go get her something for a urinary tract infection. Her husband got her some cranberry juice, and over the counter AZO medication for urinary tract infection. Her back of leg was hurting. She had her husband look at it, but nothing showed up. She did not know that you could not see a blood clot visually. She laid on the sofa and fell asleep. About 1:00, she woke up itching. She was itching on her right arm, wrists and fingers (medically significant). She went to the bathroom, and woke her husband up because from head to toe she was tomato red. She took some Benadryl and went back to her bed. She was still in pain in her left leg, butt cheeks and vagina. She began having vagina spasms. She knows that what she is about to say sounds gross, but she does not know how else to describe it. She literally felt like half of a fish was inside of her vagina, and it was flopping around. She stayed awake and was worried. She was thinking about going to the hospital. She called her doctors on call number, and her they told her to go see her doctor first thing the next morning. Her throat and face were swollen also. She was still red all over. She has shellfish allergies. Her chest felt heavy also. Her doctor looked her over and checked for a urinary tract infection. She took AZO over the counter medication, so the urinary tract infection did not show up. Her tests did grow cultures, but no urinary tract infection showed up. While she was at the doctor, the doctor checked her reflexes. Her left knee had a reflex. Her right knee had no reflex whatsoever. It did not matter where or how hard the doctor hit here right knee. She saw a nurse practitioner, not a doctor. The nurse practitioner did not want to give her a steroid shot. The nurse practitioner wanted her to hold on to as much of the covid vaccine as possible. The nurse practitioner told her to take four Benadryl's a day until her symptoms stopped. She got about 16 minutes from her doctor's office, and she started getting bubble blisters on her arms, fingers, and over her chest, above her boobs. The bubble blisters lasted for two days. Now she has red spots where some of them were. She went to the doctor on a Tuesday. The bubble blisters did not alleviate until Saturday or Sunday. She was told not to get the second dose of the covid vaccine. Her symptoms after the first dose were scary. Her doctor said that she did not have an urinary tract infection, but her sample grew cultures. Her doctor told her that her urinary tract burning had nothing to do with covid. She is an esthetician, she does facials. She knows of three or more people that are her age, in their 60s that have not had a urinary tract infection for the past 25 years. Those people all had a urinary tract infection after getting the covid vaccine. No further information provided. Her symptoms began on Monday, 05Apr2021. Over the weekend, her arm was extremely sore. Excruciating pain in her left butt cheek, back of leg, and kneecap: Her left but cheek, back of leg and knee cap all felt numb, but also felt on fire at the same time. Began on 05Apr2021. It began as a tingle. She knew that it was hurting a lot. At first, she could not pinpoint what it was. The pain moved to her vagina and left leg: Clarifies that it moved down her left leg, over her vagina, to her knee cap. It kept going and stopped at her other leg. She takes Estrogen vaginally. She states that Benadryl helped slow down all of that down. 08Apr2021 through 11Apr2021, she was recuperating. She has complications with having no taste: She does not taste metal, or anything. She feels like she is having trouble cooking, but her husband tells her that her cooking has been wonderful. The food she makes tastes horrible to hear. She feels like her sense of taste is getting a little bit better. Her urinary tract started burning. She was peeing and peeing and peeing. She was using the bathroom a lot: Began about 16:30. She did not have an urinary tract infection, but her sample did grow cultures. She was prescribed Amoxicillin on 07Apr2021. Her symptoms had lessened by 07Apr2021. She does not know if she needed the Amoxicillin. 07Apr2021 through 09Apr2021, she felt so much better. She was itching on her right arm, wrists and fingers: Began about 1:00 on 06Apr2021. She took four Benadryl a day. The itching was annoying to her in certain spots. The itching lasted through 13Apr2021 or 14Apr 2021, she is not sure the end date. She was tomato red from head to toe: Began about 1:00AM on 06Apr2021. It went away 08Apr2021 or 09 Apr 2021. The redness went away the same time as the swelling. Her throat and face was swollen: Began about 1:00 on 06Apr2021. It went away 08Apr2021 or 09Apr2021. Her right hand and arm was swollen: Began about 1:00 on Apr 06 2021. It went away 08Apr2021 or 09Apr 2021. She began having vagina spasms. She literally felt like half of a fish was inside of her vagina, and it was flopping around: Her vagina hurt before she went to sleep. But the spasms did not start until the middle of the night. The spasms lasted all day, for a good ten hours. The vagina spasms have not happened again. Her chest felt heavy: Began about 1:00 on 06Apr2021. Her right knee had no reflex whatsoever. It did not matter where or how hard the doctor hit her right knee, it did not move: Began Tuesday, 06Apr2021. Now she thinks that her knee is just fine. It was just weird. She started getting bubble blisters on her arms, fingers, and over her chest, above her boobs: The bubble blisters lasted for two days. Now she has red spots where some of them were. The bubble blisters lasted until the evening of 07Apr2021. Most of the bubble blisters have went away. The bubble blisters on her wrist went away around 08Apr2021. Indication was she has three children. One of her children is an extreme democrat. Her other two children are democrats. Her democrat daughter did not have anything to do with her if she did not get the covid vaccine. At her age, she could not risk it. She has a lot of junk going on. She is allergic to everything. She has five bulging discs. Her two republican daughters did not want her to get the covid vaccine, they wanted her to wait and see how it affected everyone else. Her democrat daughter was losing it. Outcome of the event She has complications with having no taste was recovering. Outcome of the event It did not matter where or how hard the doctor hit here right knee and Her left but cheek, back of leg and kneecap all felt numb, but also felt on fire at the same time. It just really hurt was unknown. Outcome of the events she began having vagina spasms. She literally felt like half of a fish was inside of her vagina, and it was flopping around was recovered on 06APR2021. She started getting bubble blisters on her arms, fingers, and over her chest, above her boobs was recovered on 07Apr2021. Excruciating pain in her left butt cheek, back of leg, kneecap and Her chest felt heavy and The bubble blisters on her wrist was recovered on 08Apr2021. Her urinary tract started burning. She was peeing and peeing and peeing. She was using the bathroom a lot was recovered on 09Apr2021. Outcome of the other events was recovered on unspecified date in APR2021. Information on Lot/Batch number was available. Additional information has been requested.

I experienced after my vaccine, I had little swelling, redness and a little tender. I also had a slight headache that came and went. My symptoms cleared pretty fast within a few days.

Event: Malaise was reported as worsened/ Event: soreness under arm down to wrist was reported as worsened.; She was on another medication for nausea; right tonsil area sore; right tonsil area sore/felt like the right of her throat in the tonsil was swollen; headache; Malaise over my body; swelling is affecting her tongue; aching that goes down her neck, across the shoulder blade and down her arm to the injection site; lymph glands feel tighter in her neck; soreness under arm down to wrist; soreness under arm down to wrist; This is a spontaneous report from a contactable consumer(patient). A 61-year-old female patient received first dose bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL9266), dose 1 via an unspecified route of administration, administered in right arm on 08Mar2021 07:20(at the age of 61years) as DOSE 1, SINGLE for covid-19 immunization. Medical history included migraine from an unknown date and unknown if ongoing, ovarian cancer from 1996 to an unknown date, ongoing neuropathy, ongoing complex regional pain syndrome, ongoing dry eye and ongoing fibromyalgia. Years ago she had chemo for ovarian cancer. The chemo triggered migraines. She was on Cisplatin, Bleomycin and VP 16. She was on another medication for nausea. NDC, Lot and Expiry are unknown to caller. She is on disability for several things. She developed migraines, neuropathy, complex regional pain syndrome and severe dry eyes and fibromyalgia after having the chemo and ovarian cancer. Concomitant medications included cisplatin taken for ovarian cancer from an unspecified start date and ongoing; bleomycin taken for ovarian cancer from an unspecified start date and ongoing; etoposide (VP-16) taken for ovarian cancer from an unspecified start date and ongoing. Patient did not receive other vaccination within 4 weeks prior to vaccination no relevant tests were reported patient didn't received other medications. On 08Mar2021 the patient experienced right tonsil area sore right tonsil area sore felt like the right of her throat in the tonsil was swollen, headache, malaise over my body, swelling is affecting her tongue, aching that goes down her neck, across the shoulder blade and down her arm to the injection site, lymph glands feel tighter in her neck, soreness under arm down to wrist, soreness under arm down to wrist , event malaise was reported as worsened event soreness under arm down to wrist was reported as worsened on an unspecified date, she was on another medication for nausea on an unspecified date investigation assessment was not reported. Clinical course of events: Caller received the first dose of the Covid-19 vaccine this morning. On her way home about 30-45 after receiving the vaccine she started feeling like the right side of her throat in her tonsil was swollen. She did not have any breathing problems. She was aching that goes down her neck, across the shoulder blade and down her arm to the injection site. The lymph glands feel tighter in her neck. She has a headache. She feels like she has malaise. She came home and ate. She did not experience any nausea. She did not eat before going to get the vaccine. She asked if this is normal. She did take Tylenol. The swelling seems like it is affecting her tongue. She can tell with her speech. She has a history of neuropathy. She is wondering if this could have hit a nerve. The headache just started in the last hour. She is prone to migraines. When her neck muscles get involved she gets a migraine. They could have accidentally hit a neve. The soreness keeps getting farther down her arm. Therapeutic measures were taken as a result of the events. She was on another medication for nausea. The outcome of the events tonsillar disorder, tonsillar hypertrophy, malaise, swollen tongue, pain, pain in extremity, arthralgia, was not recovered and the outcome of the event headache was recovered and the outcome of the events lymph gland infection, condition aggravated, nausea was unknown. No follow-up attempts are possible; No further information is expected.

Face Swelling; This is a spontaneous report from a contactable consumer, the patient. A 61-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 24Mar2021 at 23:15 (at the age of 61-years-old), as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, diabetes, hypertension, depression, obesity, sleep apnoea, arthritis, glaucoma, psoriasis and rosacea. The patient was allergic to penicillin and sulphadrugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), aripiprazole (ABILIFY), venlafaxine hydrochloride (EFFEXOR), atorvastatin calcium (LIPITOR) and irbesartan (MANUFACTURER UNKNOWN); all for unknown indication from an unknown date. The patient did not receive any other vaccines within four weeks prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 25Mar2021 at 08:00, the patient experienced face swelling. The adverse event resulted in doctor or other healthcare professional office or clinical visit. The patient was treated with BENADRYL for face swelling. The clinical outcome of the swelling face was resolved on an unspecified date in Mar2021. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

One week following after the vaccination, my arthritis has gotten worse. I'm having cramps in my legs. The cramps in my legs had me go to the doctor. Doctor also notice I had more swelling were my arthritis is. I'm started taking the supplements, calcium, potassium, and magnesium, it's a combination to deal with the leg cramps. And the doctor gave me an osteopathic adjustment. The AE are disabling and impairing my function. I am also having muscle cramps in my abdomen.

I went into antiflactic shock, brought over to the hospital, was given intravenous drugs and benadryl. Had to stay for 6 hours.

Ringing in ears; stiff neck; swollen lymph nodes; it is distracting me; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6206), via an unspecified route of administration on the right arm on 22Mar2021 at 03:45 (at the age of 61-years-old), as a single dose for COVID-19 immunisation. Medical history included ascending aortic aneurysm. Concomitant medications were not reported. The patient did not have any allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 22Mar2021 at 03:45, the patient experienced ringing in ears, stiff neck, swollen lymph nodes and distracting. The patient also reported that ringing started 3 minutes after getting shot and it was distracting her. No therapeutic measures were taken as the result of reported adverse events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome ringing in ears, stiff neck, swollen lymph nodes and distracting were unknown. No follow-up attempts are needed. No further information is expected.

This is a spontaneous report from a contactable consumer, the patient. A 61-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) on 04Mar2021 (at the age of 61-years-old) as a single dose for COVID-19 immunization and received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via unspecified route of administration in the left arm on 24Mar2021 at 11:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included obesity, mitral valve prolapse (MVP) and osteoarthritis. 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 had not been tested for COVID-19. On an unknown date in Mar2021, after first vaccine the patient experienced cold sore - left side of tongue for a couple of days. On 25Mar2021 after Second vaccine, the patient experienced cold sore- right side of tongue for a couple of days. The adverse events did not result in doctor or other healthcare professional office/clinic visit. The patient did not receive treatment for the reported events. The clinical outcome of the events cold sore (after first vaccine) and after second vaccine was recovered on an unknown date in Mar2021. No follow-up attempts are needed; information about lot number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021357059 same patient/drug/event occurred in different place

big red lump on side of right foot; Swelling over the bank of the ankle; Big red lump on side of right foot hurts to even touch. Left foot severe pain; Big red lump on side of right foot; Severe foot and leg pain; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient, received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204) via an unspecified route of administration in the left arm on 18Mar2021 at 16:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included arthritis and high blood pressure. The patient was allergic to doxycycline and sulfa drugs. Concomitant medications included meloxicam (MANUFACTURER UNKNOWN), trazadone (MANUFACTURER UNKNOWN), escitalopram (MANUFACTURER UNKNOWN) and buspar (MANUFACTURER UNKNOWN), all for unknown indications from unknown dates. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not tested for COVID-19. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206) via an unspecified route of administartion in the left leg on 26Feb2021 at 16:00 (at the age of 61-years-old), as a single dose for COVID-19 immunisation. On 22Mar2021 at 07:00, 4 days after the vaccination, the patient had severe foot and leg pain. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measure taken as a result of severe foot and leg pain included tylenol (MANUFACTURER UNKNOWN), anti-inflammatory drugs (MANUFACTURER UNKNOWN) and zpak (MANUFACTURER UNKNOWN). The pain eased for a couple of days but then was back again, worse than before. On an unknown date, the patient had a big red lump on side of right foot which hurt even to touch, left foot had severe pain and swelling over back of ankle. The clinical outcome of the events severe foot and leg pain, big red lump on side of right foot which hurts, left foot severe pain and swelling over back of ankle was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.

swollen wrists; swollen hands; swollen knees; red hands; severe generalized reaction of significant swelling at all extremities and face; Upset stomach; loose stool; eye burning sensation; skin peeling in both hands; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204) via an unspecified route of administration in the left arm on 10Mar2021 at 14:45 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. The patient had known allergies to some food (beans, pistachios, lactose intolerant), chemicals (in respirators, formol, latex etc), environmental, (dust, pollen, some trees) and medicine (tetracycline). Concomitant medications included claritine (MANUFACTURER UNKNOWN),vitamin C (MANUFACTURER UNKNOWN) and d3 (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. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient experienced red hands, severe generalized reaction of significant swelling at all extremities and face, upset stomach, loose stool, eye burning sensation and skin peeling in both hands on 10Mar2021 at 14:45. The patient experienced swollen wrists, hands and knees after 19 days after the first vaccination on an unknown date. The patient received treatment for the reported events included claritin and benadryl. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events red hands, severe generalized reaction of significant swelling at all extremities and face, upset stomach, loose stool, eye burning sensation, skin peeling in both hands, swollen wrists, hands and knees were not recovered at the time of this report. No follow up attempts are needed. No further information is expected

Left arm pit swollen and sore; Left arm pit swollen and sore; This is a spontaneous report from a contactable consumer, the patient. A 61-years-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 29Mar2021 at 13:30 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included osteopenia. The patient received other medication within two weeks of vaccination which included Vitamin D (MANUFACTURER UNKNOWN) and a Multi-Vitamin for unknown indication. The patient received vaccine within four weeks prior to the vaccination which included 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 08Mar2021 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 31Mar2021 at 17:00 the patient experienced left arm pit swollen and sore. Adverse event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events left arm pit swollen and sore was not resolved at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained

Swollen armpit on left arm. The shot was given into the left arm; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old adult non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8732); via an unspecified route of administration in the left arm on 25Mar2021 at 14:45 (at the age 61-years-old), as a single dose for COVID-19 immunisation. Medical history included hypothyroid. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) from an unknown date received within 2 weeks of vaccination. The patient was allergic to shellfish, cats and dogs. The patient had not received any other vaccine within four 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. On 27Mar2021 at 00:00, the patient experienced swollen armpit on left arm. 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 the result of adverse events. The clinical outcome of swollen armpit on left arm was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.

Site: Swelling at Injection Site-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Additional Details: patient reports on right arm had swelling as well as right side of face : cheeks, eyes will go to see urgent care

My arm had a rash on it and its swollen. It is always on my arms and my hands. It went up to my throat so, and sick right away after I have this. I mean had really awful for three days.; My arm had a rash on it and its swollen. It is always on my arms and my hands. It went up to my throat so, and sick right away after I have this. I mean had really awful for three days.; My arm had a rash on it and its swollen. It is always on my arms and my hands. It went up to my throat so, and sick right away after I have this. I mean had really awful for three days.; My arm had a rash on it and its swollen. It is always on my arms and my hands. It went up to my throat so, and sick right away after I have this. I mean had really awful for three days.; I had a bad reaction because of any other medication consider allergic to it.; This is a spontaneous report received from a contactable consumer (patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via intramuscular route of administration in Arm Left on 14Jun2021 as single dose for covid-19 immunization. Medical history included blood pressure from an unknown date and unknown if ongoing. Concomitant medication included propanol taken for hypertension, start and stop date were not reported. In Jun2021 patient had her 1st shot of vaccine, 3 weeks ago and just, had a, she thinks, a had a bad reaction because of any other medication consider allergic to it. Her arm had a rash on it and its swollen. It was always on her arms and hands. It went up to her throat so, and she was sick right away after she had this. She had really awful three days after she had the shot. This does not mean that she was having allergic reaction, she stated. She stated she should not get the second shot. Patient stated it started hours after the shot. The person actually right away, I don't know it was the vaccine necessarily or the person giving me the shot but I am wondering if he or his arm, start turning black and blue. She doesn't have the vaccination card. 13Jun, 14Jun I guess she confirmed as 14Jun2021. Consumer stated, her second shot is due. The LOT number for the first dose, this, she can tell this person had very bad handwriting. It's look like EW0101. Treatment taken for Adverse Event with Benadryl, Diphenhydramine 50 mg, Norco 10/325 mg. Therapeutic measures were taken as a result of the events. The clinical outcome of the events was unknown. Information on the lot/batch number has been requested.

Ongoing muscle aches in arm up through neck. Only on the second shot location.. Achiness continuing and persistent 4 months later. And not improving. It's minor but noticeable. Reported initial side effects back in March but this has not gone away. In the neck area it seems as though it may be lymph nodes as well.

Numbness and tingling on lips and tongue, fatigue, throat tightening, back of thigh swelling, feverish, and pain. lasted at least 3 days but resolved. All issues completely resolved in a week.

Kidney pain; Jaw lymph nodes swelling; Jaw lymph nodes pain; Fatigue; Injection arm pain; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Apr2021 at 10:00 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history included diabetic, asthma, high bp (blood pressure high), obese (obesity), arthritis and disc problems. The patient received many unspecified medications within two weeks of vaccination. The patient previously took sulfa (MANUFACTURER UNKNOWN) for unknown indication and experienced drug allergy on unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021 at 12:00 the patient experienced kidney pain, jaw lymph nodes swelling (swollen lymph nodes) and pain (lymph nodes pain), fatigue and injection arm pain (pain in arm). The patient did not receive any treatment for the reported adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events kidney pain, jaw lymph nodes swelling, jaw lymph nodes pain, fatigue and injection arm pain were not recovered at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Severe pain in lymph node(s) under left arm, in arm pit; Severe swelling and pain in lymph node(s) under left arm, in arm pit.; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK6213) via an unspecified route of administration in the left arm on 29Mar2021 at 14:15 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included COPD (chronic obstructive pulmonary disease) from an unknown date and allergy to sulfa's. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) taken for unknown indication from unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 08Mar2021 at 14:15 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021 at 07:00, the patient experienced severe swelling and pain in lymph node(s) under left arm, in arm pit. The patient received shot on Monday and had absolutely no reaction, not even a sore arm, until she woke up on Friday morning. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of severe swelling and pain in lymph node(s) under left arm, in arm pit and included application of heat and massage (as tolerable). The clinical outcome of the events severe swelling and pain in lymph node(s) under left arm, in arm pit was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.

feels crummy; Chills; a little headache; Low grade fever; a lump under her arm/has a lump under her right arm, this is also the injection site arm/swollen lymph node; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 61-year-old female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), via an unspecified route of administration, administered in Arm Right on an unspecified date as single dose for covid-19 immunization (age at vaccination: 61-year-old). Previously the patient received first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), via an unspecified route of administration, administered in Arm Right on an unspecified date as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date post vaccination, the patient woke up with chills in the morning, a little headache and a low-grade fever. The patient also reported that there is a lump under her arm, her right arm, the same arm she received her vaccine in. The lump is not at the injection site, it is under her armpit. The patient also felt crummy. The outcome of the events was reported as unknown at the time of report. Information on the lot/batch number has been requested.

Within a few days of receiving the second COVID vaccine, I developed severe back pain, shooting down my leg and calf. I went from walking 5 miles a day to being unable to walk. I was bent over in pa; Within a few days of receiving the second COVID vaccine, I developed severe back pain, shooting down my leg and calf. I went from walking 5 miles a day to being unable to walk. I was bent over in pa; Within a few days of receiving the second COVID vaccine, I developed severe back pain, shooting down my leg and calf. I went from walking 5 miles a day to being unable to walk. I was bent over in pa; Within a few days of receiving the second COVID vaccine, I developed severe back pain, shooting down my leg and calf. I went from walking 5 miles a day to being unable to walk. I was bent over in pa; Within a few days of receiving the second COVID vaccine, I developed severe back pain, shooting down my leg and calf. I went from walking 5 miles a day to being unable to walk. I was bent over in pa; Within a few days of receiving the second COVID vaccine, I developed severe back pain, shooting down my leg and calf. I went from walking 5 miles a day to being unable to walk. I was bent over in pa; Within a few days of receiving the second COVID vaccine, I developed severe back pain, shooting down my leg and calf. I went from walking 5 miles a day to being unable to walk. I was bent over in pa; Within a few days of receiving the second COVID vaccine, I developed severe back pain, shooting down my leg and calf. I went from walking 5 miles a day to being unable to walk. I was bent over in pa; Within a few days of receiving the second COVID vaccine, I developed severe back pain, shooting down my leg and calf. I went from walking 5 miles a day to being unable to walk. I was bent over in pa; Within a few days of receiving the second COVID vaccine, I developed severe back pain, shooting down my leg and calf. I went from walking 5 miles a day to being unable to walk. I was bent over in pa; This is a spontaneous report received from a contactable other HCP. A 61-year-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9261), dose 2 via an unspecified route of administration, administered in Arm Left on 04Feb2021 10:00 (at the age 61-year-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included thyroiditis (Verbatim: Hoshimoto's Thyroiditis), food allergy known_allergies: Stadol, Demerol, fish. Concomitant medication(s) included levothyroxine sodium (THYROXINE) for an unspecified indication. The patient previously took stadol for drug hypersensitivity, demerol for drug hypersensitivity, bnt162b2 dose: 1 (Lot: EL3248) via unspecified route of administration, administered in left arm on 14Jan2021 at 10 AM 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 was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. It was stated that "Within a few days of receiving the second COVID vaccine, I developed severe back pain, shooting down my leg and calf. I went from walking 5 miles a day to being unable to walk. I was bent over in pain. I spent three weeks being barely able to walk or stand and unable to leave my home. It was another three weeks before I could walk 1/2 mile comfortably. I had difficulty regulating heat and cold, had hyperhydrosis, decreased appetite and lethargy. My knee and calf were swollen and discolored. I went to the ER, Physical Therapy, and finally my MD, who said it was an inflammatory reaction to the vaccine. I still have some hip, leg, and back pain. I had x-rays to confirm it was not a musculoskeletal problem. I did not hurt my back. Pain medication did little to help. Until this time, I had never had an xray. Before this I was in exceptionally good health. I have finally returned to daily walking and yoga. I am a Registered Nurse with 40-year experience and a Doctorate", in Feb2021at 05:00 AM. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 10Feb2021, physiotherapy: unknown on an unspecified date (inflammatory reaction to the vaccine), x-ray: unknown on an unspecified date. Therapeutic measures were taken as a result of events. Outcome of the events was recovering. Follow-Up (30JUN2021): Follow-up attempts are completed. No further information is expected.

Pain at injection site; base of neck hurt; felt a lump near my collarbone, lump was floating and moving, hurt/tender to the touch; collar bone area swollen; This is a spontaneous report from a contactable consumer reported for herself. A 61-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER COVID-19 VACCINE, Solution for Injection, Lot number: EN6205) via an unspecified route in the right arm on 06Mar2021 at 10:00, as a single dose for covid-19 immunization. Medical history included covid-19, allergic to Lipitor, statins, high blood pressure and slightly overweight. Concomitant medications included naproxen sodium (ALEVE), minocycline, VITAMIN C (ascorbic acid), VITAMIN D (colecalciferol) and quinapril hydrochloride (ACCUPRIL). Prior to vaccination, patient was diagnosed with COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, patient has not been tested for COVID-19. On 07Mar2021 (Sunday) at 15:45, patient experienced pain at injection site, base of neck hurt, felt a lump near collarbone, lump was floating and moving, hurt/tender to the touch and collar bone area swollen. Adverse events resulted in doctor or other health care professional clinic visit. Patient went to dermatologist today felt that it may be nothing and was prescribed to minocycline a day for a week. The clinical outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.

Patient mentioned she was in a lot of pain and swelling; Patient mentioned she was in a lot of pain and swelling; This is a spontaneous report from a contactable consumer, based on information received by Pfizer from Amgen (manufacturer control number: US-AMGEN-USASL2021093868). This case was split from master case 2021755177 for a 61 years old female patient taking BNT162B2 and experienced pain and swelling. This non-serious solicited report (USASL2021093868) was reported to Amgen on 16Jun2021 by a consumer from a commercial program (PSP00086). A 61-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 10Apr2021 (age at vaccination was 61 years) as dose 1, single and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 30Apr2021 (age at vaccination was 61 years) dose 2, single for COVID-19 immunization. No historical medical condition was reported. The patient's current medical condition included rheumatoid arthritis. No co-suspect medications were reported. The patient's concomitant medications included diclofenac (topical), calcium, Vitamin D (ergocalciferol), start and stop date unknown, taken for unspecified indication. Concomitant medications included diclofenac, calcium and ergocalciferol (VITAMIN D [ERGOCALCIFEROL]) all taken for an unspecified indication. The patient began etanercept (Enbrel) with Reusable Autoinjector 50 milligram, qwk (lot number: 1104398, expiry date: 31Jan2023) on 02Jun2021 and (lot number: 1121827, expiry date: 30Apr2023), taken for rheumatoid arthritis. The patient experienced ran down leg/then was a few drops on floor, had stomach ache, indigestion, low grade fever while receiving Enbrel, Reusable Autoinjector. On an unknown date in Jun2021, the patient stated that she had a stomach ache after taking Enbrel, had indigestion the day she takes the injection and the day after and for two days she had a low grade fever of 98.8 and 99. The patient stated that her rheumatologist was aware. On 16Jun2021, the patient took her Enbrel injection. The patient stated when she gave her third injection today, the Enbrel ran down leg and then was a few drops on floor not a puddle. She did not remember the status button flashing green the green bars in the progress bar. The patient stated that the AT (AutoTouch) did not alarm or have a red light. She did not feel the needle stick. She thought it was uneven. No treatment information was received. The outcome of the events accidental exposure to product, abdominal pain upper, dyspepsia, pyrexia were reported as unknown. Action taken with Enbrel and Reusable Autoinjector was reported as unknown for the events abdominal pain upper, dyspepsia and pyrexia. The causal relationship between the events accidental exposure to product, abdominal pain upper, dyspepsia, pyrexia and Enbrel, Reusable Autoinjector was not provided by the consumer. Additional information was received on 01Jul2021 reported to Amgen by a consumer from a commercial program (PSP00046b) and involved a patient who stated part of the injection didn't go in, it went onto the floor, stress, flare in her knees/lot of pain, lot of swelling, while receiving Enbrel with Reusable Autoinjector. The patient stated she had five injections of Enbrel with Enbrel AutoTouch and Enbrel Mini Cartridge for treatment of rheumatoid arthritis. She had been instructed to use once a week. On an unknown date in 2021, the patient then further clarifies that she may have more like four and half injections due to she was under a lot of stress, she does not think the injection was level or even. Patient had a death in the family and her daughter had fallen and she was distracted. She did answer a bunch of questions when she stated this and she did contact her doctor and was instructed to take another dose and she just did not. Patient had been able to administer successful injections later, she had no problems with the injector. Patient stated it was a bad day, part of the injection didn't go in, it went onto the floor. The patient then mentioned that she just wants to walk. Patient was having a flare in her knees and that was why she was given the Medrol dosepak (methylprednisolone). Patient also had some diclofenac topical which she would try first. Patient stated she would like to walk and bend her knees. She had a lot of swelling. Patient had a lot of swelling and her doctor said a lot of people that didn't have underlying conditions had pain and swelling. Patient mentioned she was in a lot of pain and swelling. Patient received the Pfizer COVID-19 vaccines. The outcome of the event stress, arthralgia, joint swelling, was reported as unknown. Action taken with Enbrel, Reusable Autoinjector was reported as unknown for the events stress, arthralgia, and joint swelling. The causal relationship between the events stress, arthralgia, joint swelling, and Enbrel, Reusable Autoinjector was not provided by the consumer. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Swelling, and warmth at injection site, right arm; Swelling, and warmth at injection site, right arm; swollen and tender right axillary node under right arm; swollen and tender right axillary node under right arm; This is a spontaneous report from a contactable consumer (patient). A 62-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number ELO140), intramuscular on 22Dec2020 10:30 at first single dose at arm right for covid-19 immunisation . Medical history included breast cancer, allergy to penicillin, levaquin, neosporin, cocoa butter. Concomitant medication included vitamin c [ascorbic acid]. The patient experienced swelling, and warmth at injection site, right arm, swollen and tender right axillary node under right arm on 28Dec2020 16:00. No treatment for events. The outcome of events was not recovered. No other vaccine in four weeks; No covid prior vaccination; No covid tested post vaccination.

1/2/21- 1/5/21 Fever, chils, arthralgias, swollen throat, nausea, BLURRY VISION, RED eyes, white noise in ears, fatigue lacinating pain ankles, knees ,wrist and finger joints; pain along nerves and vessels fingers with right fourth DIP ulnar side small vessel bleed hematoma 4 cm x 4cm swelling; NO trauma sedenatry Saw Urgent care 1/4/21 -with negative covid 19, strep and flu tests said was repsonse to vaccine Saw primary 1/5/21 Dr hopsital, said probably had covid before and was repsonse to vaccine. 1/6/21; all fingers still swollen no pain most other symptoms improving but TIRED

swelling and joint pain in the little finger on left arm; swelling and joint pain in the little finger on left arm; She got a bruise at the injection site; It bled a little bit when she put it in; This is a spontaneous report from a contactable nurse (patient). A 62-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK9231), via an unspecified route of administration on the left arm, on 28Dec2020 at 14:15 at a single dose for Covid-19 immunization. Medical history included environmental allergies, she has allergies and can have an asthmatic attack from cat dander and perfume, blood pressure (abnormal) and sleep (disorder). Concomitant medications included ongoing lisinopril for blood pressure, colecalciferol (VITAMIN D), acetylsalicylic acid (BABY ASPIRIN), paracetamol (TYLENOL). The patient previously took novocaine but was allergic. She got all this information when she got the vaccine on Monday at (place name) in (state name). It tells all the side effects from the first injection. She wanted to report that it is the same arm that she got the vaccine in. She has swelling and joint pain in the little finger on left arm. It says you can have joint pain, but nothing about swelling. She thought she better report it. This was her first shot. She is supposed to get the second one on 18Jan2021. She wanted to make sure she can take it. She received the vaccine on 28Dec2020. She laid around that day. Today is the first day she doesn't have arm pain and swelling at the injection site. It was the first time she has had arm pain. She has never had that with flu shot. The arm pain started within the 15 minutes she was observed. It hurt like hell until that day. She got a bruise at the injection site. It bled a little bit when she put it in. Swelling and joint pain in the little finger on left arm: she doesn't know if it was later that day. She can't remember. She really noticed it yesterday. She has never had joint pain or swelling. She doesn't have any problems with arthritis. Now her little finger is bigger than the rest of her fingers. It hurts because of the swelling. She doesn't want to take anything. It might be fluid. She has a high pain tolerance. She keeps bending it thinking it will get better. It isn't as bad, but its still swelled up. At first she thought it was better, but it is still pretty swollen. To her this is a reaction. She was thinking if she took paracetamol before, it wouldn't hurt as bad, but she can't remember if she took it that morning. She takes 500mg before bed for the heck of it at night. It helps her sleep better. She has allergies and can have an asthmatic attack from cat dander and perfume. They think she was allergic to the preservative in the flu shot, but she has never had any trouble with the flu shot since. She has environmental allergies. They thought she was allergic to Novocaine once at the dentist office. Who knows, it only happened once. She's been to the dentist many times and who knows what they injected and why she reacted that way. She felt like she was going to pass out. They don't give it to her anymore. She doesn't know what was in it. She is worried since this vaccine is emergency authorization. She doesn't want to get the next one and have a worse reaction. She is not sure if she should be worried. The events of swelling and joint pain in the little finger on left arm were assessed as medically significant. Outcome of the event of 'swelling of fingers' was not recovered, the other events were unknown.; Sender's Comments: There is a reasonable possibility that the event joint pain was related to BNT162b2 based on known drug safety profile. Based on the temporal relationship, the association between the event swelling with BNT162b2 can not be fully 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.

Patient 00037022 DOB 03-21-1958 received 2nd dose Pfizer lot EL1284 on 1-6-2021 in left arm. She has not had history of reaction before. Starting from midnight that night she has fever between 100.6-101.2, body aches and stiff neck. She also has swollen left arm pit, head ache, Pruritus breathing. She has a history of afib and last night she had two runs of it and took metoprolol.

Fine pin point rash and itching noted 45 minutes after shot given. Rash noted to neck,spine,hips,upper back,upper chest and bend of both arms.Benadryl 25 mg OTC 1/6/21 and 1/7/21.Itching. Itching decreasing 1/8/21. Having copious side effects also of injection site pain,tiredness,headache,joint and muscle pain,nausea,lymphadenopathy and feeling unwell.1/6/21,1/7/21 but feeing better when tylenol 500mg ing system to relieve aches and pains

About 13 hours after injection I started having extreme chills and shaking. Took 2 Ibuprofen and the chills subsided during the night and then had mild/moderate body aches for about another 12 hours. About 48 hours after the injection the top half of my arm is currently slightly swollen, red and hot to the touch.

some memory loss; locked jaw/unable to open mouth; her arm hurt; pain went in her jaws; she was really scared; Excruciating pain on left ear; swelling in arm; This is a spontaneous report from a contactable other healthcare professional. A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: ES1685, Expiry date: 01Mar2021) via intramuscular (left deltoid) on 28Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. She stated she is very healthy and don't have any medical conditions. She further stated that it was a scary moment, she don't want to take any chances, she was really frightened (28Dec2020). She made a complaint to let know her experience with the vaccine. Her cousin took the vaccine and told her she needed to report these events. The patient stated she experienced side effects after the first dose of the vaccine: Excruciating pain on left ear, locked jaw, her left upper arm was hurting on 28Dec2020. The pain went in her jaws and she was unable to open her mouth on 28Dec2020. She took 2 Benadryl and it relieved her. She saw on television if you experienced any side effects to take Benadryl. She also took Tylenol for the pain. She also had swelling in arm on an unspecified date in Dec2020. She also experienced some memory loss described as short-term memory loss on 30Dec2020. She stayed in bed after the vaccine, she was really scared, and stated she had memory loss and she don't have any memory problems. She was unable to remember if her car was black. She was looking for a white car. She drives a black car. She stayed in bed all day on Tuesday. Patient was asking what will happen if she does not take the second vaccine. The same morning while she was waiting to get the vaccine, a co-worker sent her a video of a woman who had received a COVID vaccine. She does not know which one. The woman experienced Bell's Palsy. The woman was crying and her face was turning side ways. She stated some people were talking negatively about the vaccine. She stated doesn't want her face to be deformed. She stated what are the cons of not taking the second vaccine. Reporter assessed the events as non-serious. Outcome of the events some memory loss and locked jaw/unable to open mouth was recovered on 30Dec2020, outcome of the events excruciating pain on her left ear, pain went in her jaws, her arm was hurt was recovering. Outcome of swelling in arm and she was really scared was unknown.

1st 24 hrs just arm soreness, 2nd 24 hrs itching and fatigue, 48 hrs, anaphylaxis, hives, rash, itching, lymph swelling, chills

Reported PM post vaccine she had fever, malaise, headache, left axilla swelling, "pleurisy" feeling in chest. No sob. Early on 1/8/21 in the AM, had 2 runs afib, that responded to metoprolol. She reported the afib to her cardiologists. Called again on 1/19/21 to report continued fevers, fatigue, body aches, nausea, and chills that caused her to call off on 1/17/21. Ordered COVID-19 PCR.

Once i received the 2nd dose- My arm swollen for 3 days - continue to be red as thought rash going over the top half of arm around the injected area. chills , body aches, fever. stayed in bed the next 3 days. 4 day sweating, and low grade fever , fatigue very weak.

Headache, dizziness, swollen glands chin/throat sore throat and chills. Extreme fatigue. Covid test and ruled out.

Reported PM post vaccine she had fever, malaise, headache, left axilla swelling, "pleurisy" feeling in chest. No sob. Early on 1/8/21 in the AM, had 2 runs afib, that responded to metoprolol. She reported the afib to her cardiologists. Called again on 1/19/21 to report continued fevers, fatigue, body aches, nausea, and chills that caused her to call off on 1/17/21. Ordered COVID-19 PCR.

tongue itching; lips itching; face feels flushed; left hand is tingling or numb (the palm)/left hand that's puffy and tingling; left hand is tingling or numb (the palm)/left hand that's puffy and tingling; left hand is tingling or numb (the palm)/left hand that's puffy and tingling; palm of left hand was itchy; inside of nose; it feels like someone is pinching nose/It's swelling; inside of nose; it feels like someone is pinching nose/It's swelling; face has a rashly feeling; This is a spontaneous report from a contactable consumer reported for self. This 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) via unspecified route of administration on an unspecified date at single dose in left arm for COVID-19 immunisation. The patient medical history and concomitant mediations not provided. The patient reported that she had the vaccine at her work, waited 15 minutes and left the clinic. About 20 minutes then, her tongue was itching, lips were itching; face felt flushed. Face had a rashly feeling. Her left hand was tingling or numb (the palm). Her palm of left hand was tingling and itchy. The inside of nose; it feels like someone is pinching nose. It was swelling. The patient stated "Whenever I get stung by bees, this is how I feel". The patient stated that it was mild. She stated she was having a reaction, but not severe enough maybe it will subside. Her left arm is where she got the injection and it was left hand that was puffy and tingling. The patient stated that she also had N95 mask on and she guess she get that reaction from it. The patient stated that she was just wondering what she should do, if she should just go by some diphenhydramine hydrochloride (BENADRYL). The outcome of events was not reported. Information about lot/batch number has been requested.

Patient was given the Pfizer vaccine at 9:27 on 01/21/21. At about 5 minutes post vaccine she was noted to have some throat clearing but denied any concerning symptoms. At 9:40 she began experiencing fluttering in her chest and at 9:41 she was noted to have some chest tightness and wheezing. She was given Benadryl 50 mg oral at 9:42 but then symptoms began to progress and she started to have angioedema of her upper lip and her hands/arms started itching and she was noted to have some early hives. Epipen 0.3 mg was given at 9:45. She continued to have some swelling of her upper lip and chest tightness and soulmedrol 125 mg IM was given at 9:49 and then she was placed on O2 via NC at 2 L. At 9:50 she stated that her throat swelling was starting to improve and her chest tightness and wheezing was getting better. EMS arrived at about 9:51 and report was given and care turned over to them. They left the clinic at 10:00 without further incident.

Within 10 min after injection had pain in left side of neck and jaw. was given 800mg Ibuprofen and took for a few days. On Jan 6, 2021 supraclavicular swelling occurred near base of neck size of a baseball and lt neck pain. Saw physician on 1/8/21 and have soft tissue swelling

Brain fog; headache; Muscle spasm at injection site; Severe fatigue; joint pain; Driving difficult; Swelling; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249, expiry date not reported), via an unspecified route of administration in the left arm on 08Jan2021 16:00 at single dose for COVID-19 immunisation. Medical history included latex allergy. Concomitant medications included ibuprofen and paracetamol (TYLENOL). The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient previously took first dose of bnt162b2 (lot number: Ek5730, expiry date not reported) in the right arm on 18Dec2020 15:00 at single dose for COVID-19 immunisation. On 08Jan2021 at 18:00, the patient experienced brain fog, headache, muscle spasm at injection site, severe fatigue, joint pain, driving difficult and swelling. It was unknown if treatment was received for the adverse events. Clinical outcome of the events was not recovered.

runny nose; slight cough; Lethargy; very tired; no appetite; Severe body aches; chills; fever; my lymph nodes under my injection arm became swollen and sore; my lymph nodes under my injection arm became swollen and sore; This is a spontaneous report from a contactable other HCP (patient). A 62-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: 0140) intramuscular in right arm on 11Jan2021 15:30 at single dose for COVID-19 immunization. She received the first dose of BNT162B2 (lot number: 0140) intramuscular in left arm on 21Dec2020 16:15 for COVID-19 immunization. Medical history included Sulfa and PCN allergy. There was no other medical history. There was no concomitant medications. There were no other medications in two weeks, no other vaccine in four weeks. The patient experienced severe body aches, chills, and fever starting approximately 8-10 hours after vaccine on 11Jan2021. These symptoms were accompanied by a runny nose and slight cough on 12Jan2021 08:00. Lethargy, very tired, no appetite also on 12Jan2021 08:00. Symptoms resolved with Tylenol, Nyquil, and one day of deep sleep. On the second day (Jan2021), her lymph nodes under her injection arm became swollen and sore. Patient is not pregnant. Events were recovered on Jan2021.

Patient self-reported to the hospital's electronic ADR reporting system. In her own word, "After 2nd dose of Pfizer COVID-19 Vaccine 1/15/21, the injection site became swollen , itchy, and painful. The following day, under my armpit was swollen and painful. This lasted for 5 days".

Woke up at 5am 1/26/21 with Headache, body aches, ax temp 100.4. Left arm pain with enlarged lymph nodes left axillary area. Fatigued. Headache became debilitating around noon. Extra strength Tylenol decreased temperature and body aches but did not help with headache. Fatigued all day. 1/27/21 10amFatigued, headache, body aches gone.

Vaccine given high up on shoulder, not 3 finger widths down. Persistent pain right shoulder and upper arm, positional discomfort. Pocket of fluid accumulation above right clavicle.

Persistent shoulder and upper arm discomfort. Positional discomfort, pocket of fluid above right clavicle. I believe injection was given improperly, too high up on shoulder, not 3 finger widths down.

approx. 15-20 min after vaccine admin, pt c/o "ha, fatigue", evaluation by EMT, vs 158/86 100, spo2 97, p=101, pt reports that this bp is "normal for her", she remained alert aned oriented, progressed to feeling "flushed from head to waist", at 5:05 pm, pt feels that these s/s r/t "very busy all day,this is the first time I have sat down all day", bp 168/95, 103, spo2 96, cool pack applied to back of neck, pt reports increase in feeling , "flushed", 1720- pt c/o "my neck feels swollen, my jaw hurts", denies shortness of breath, or chest pain, no hives observed on head, or abd, pt agrees to more advanced eval at ER, husband notified, 1730, pt experiences dry heaves, no emesis, bp 179/109, Ambulance called to transport to ER, IV initiated by EMT, 1740, pt to stretcher, with ambulance crew, report given, pt continues to deny shortness of breath, and chest pain, she remains alert and oriented.

behind my ear I feel like it's like the gland is swollen; behind my ear I feel like it's like the gland is swollen/saw the swelling and it's painful, pain a little bit, painful; This is a spontaneous report from a contactable consumer (reported for herself). A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date: not known), via an unspecified route of administration in the left arm on 12Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated she had the first dose of vaccine and it was on Tuesday afternoon (12Jan2021) and this morning (16Jan2021), she woke up and felt behind her ear, she felt like it's like the gland was swollen, so she wanted to know if anything to concern about it or she should wait few days or asked if is this normal for the gland could be swollen from an infection but. The further stated she didn't take anything as treatment but stated, its just this morning she woke up and she saw the swelling and its painful, pain a little bit, painful. The outcome of the events was unknown. Information on Lot/Batch number has been requested.

Caller states she received her 2nd dose of covid vaccine on Friday afternoon. Saturday morning she started with Left arm redness, swelling and soreness. Today the redness and swelling measures about 4x6. She also reports noticing a swollen lymph node to her left arm today. She denies fever. She has been taking tylenol and motrin, but has not tried compresses to injection site. She will call her PCP to schedule an appointment for tomorrow.

Headache, NauseaVomiting, Muscle aches ,swelling right side of neck, fatigue, night sweats, fever,. Narrative:

The day of the shot, I was fine. But I went to bed at about 10:00 that night and slept very little. I was chilling so badly that I couldn't get to sleep! When I got out of bed in the morning, I could barely move due to severe muscle pain. I did very little all day, suffering from what felt like the flu: chills, loss of appetite, and "brain fog" such that I couldn't read or think clearly. My head felt warm, but I never took my temperature. The next morning, I noticed hives on my chest between my breasts and around the armpit of my left arm. The following morning, now about 45 hours after my second injection, I still had pink hives, and my left armpit was swollen so that it wasn't concave, as it always is, but convex. Touching my armpit hurt, and I think some gland in it was swollen. Similarly, a gland on the left side of my neck was swollen and painful to the touch. Today, now the fourth day since the injection, the hives have subsided, and my glands are almost back to normal. Overall, I am very glad to have had the opportunity to get the vaccine, but I haven't felt that sick in years.

Swollen lt. arm, severe body aches and pain, headache, excessive sweating for 14 hrs. Missed work on 1/27/2021. 8 hrs.

Swollen lymph nodes in left armpit, some injection site soreness. Lymph node swelling occurred approx 1 day after vaccine

Felt severe muscle pain and aches the next day starting about 2:00 pm . Went to bed about 6:30 that night. Woke up in the middle of night and I could tell I had a "huge lump" in my Lt armpit. The lump is very sore. No redness or hot to touch. I am going to watch it over the next few days. If it gets bigger or red, I will seek medical advise. I am guessing it is a inflammatory reaction to the vaccine and my lymph nodes are inflamed there. No other lymph nodes are swollen any where else.

Hives on torso on day of vaccination (Thursday), Friday, hives on upper left arm (3? diameter) in the evening . Saturday afternoon, both upper arms with the same dimension. Sunday afternoon,torso, both hands, palms , fingers (swelling), wrists. Monday afternoon, front torso. Tuesday afternoon, both wrists, upper right arm. Wednesday afternoon, full length of left arm and upper right arm, both palms. Thursday morning, both palms, left for arm. Thursday afternoon, torso. Friday late evening, torso. Started cortisone cream on Friday, Benadryl on Saturday, switched to Allegra on Thursday.

The left side of my face, ear, throat and teeth hurt; The left side of my face, ear, throat and teeth hurt; pain in neck; pain in left shoulder; The shortness of breath lasted over; My lips were tingly; I could feel the end of my nose. My throat was closing/throat closing a little bit; I had pain in my arm; my muscles ached.; The left side of my face, ear, throat and teeth hurt; The left side of my face, ear, throat and teeth hurt; anaphylaxis; allergic reaction to the first dose of the Pfizer COVID 19 vaccine; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EN5318), via an unspecified route of administration on 22Jan2021 at 10:30 at single dose in left arm for covid-19 immunization. Medical history included drug allergies from an unknown date. There were no concomitant medications. The patient experienced anaphylaxis on an unspecified date in 2021. The patient had a little bit of an allergic reaction to the first dose of the Pfizer COVID 19 vaccine in 2021, it was not severe enough to use an Epipen. The shortness of breath from 22Jan2021 18:00 lasted over a week. Her lips were tingly from 22Jan2021 14:30, she could feel the end of her nose. Her throat was closing from 22Jan2021 14:30. She had pain in her arm from 22Jan2021 11:00, and her muscles ached from an unspecified date in 2021, the left side of her face, ear, throat and teeth hurt (facial pain from an unspecified date in 2021, ear pain from 22Jan2021 23:00, throat pain from an unspecified date in 2021, tooth pain from 22Jan2021 23:00), pain in left shoulder from 22Jan2021 20:30, pain in neck from 22Jan2021 23:00. She did have to take Benadryl for treatment of shortness of breath. She felt better after 1.5 weeks. The outcome of events anaphylaxis, allergic reaction, muscles ached, Facial pain, Throat pain was unknown, outcome of event pain in arm was resolving, outcome of event tooth pain was resolved on 23Jan2021, outcome of shortness of breath was resolved on 01Feb2021, outcome of other events was resolved on 24Jan2021.

01/23 Hives began on thigh and progress to arms, torso, underarms and then both thighs. 01/25 Called dr and had a Telemed call with NP on Tues. 01/26. Predisone and Benadryl was prescribed. Thurs. 01/28 Call to let them know that it wasn?t working. I went into the office for one shot of Solumedrol. This help and they were gone. They gave me second dose of Predisone to take in case it came back and to continue the Benadryl. 02/8 Second vaccine. Hives began that night: arms, torso, thighs, hair. Call the Dr. on 02/10 and suggested I go to an allergist. Went to allergist on 02/11 she said to only take one Predisone, Allegra one am and one at noon, then take zertek at nighttime. The Predisone created a major brain fog, I had to stop. Saw the allergist on 2/18, she agreed to get off the Predisone. 02/11 I passed out in the am and when I woke up with vomit running down my face. Still suffering with hives this entire time. 02/17 my face, lips, tongue started to swell and I had chest pain for 90 minutes. My feel swelled and I have hives so bad on my feet I could not walk or put on shoes. 02/20 Woke up with sweat on my chest. My hands were so swollen I had to have my wedding ring was cut off . 02/21 I went to the Urgent Care and received a shot of Solumedrol. They said this should last me for a few days. 02/21 woke up 3 time throughout the night soaked in sweat.

bulging on her side; pain/It hurts; symptoms of acute pancreatitis; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female consumer received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 05Feb2021 at single dose in left arm for COVID-19 immunisation at the age of 62-year-old. Lot number was EN3318, expiration date 31Mar2021. Relevant medical history and concurrent conditions included ongoing Primary immunodeficiency syndrome, ongoing lupus, ongoing Type 2 diabetes since 2001, sleep disorder. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date at single dose for COVID-19 immunisation (lot number was lot number EJ1686 or EJL1686). Past drug history included HIZENTRA for Immune system disorder (for years). Concomitant medications included ongoing sitagliptin phosphate (JANUVIA) for Type 2 diabetes, ciprofloxacin, trazodone and alprazolam for sleep disorder, methocarbamol as muscle relaxant. On 06Feb2021, the patient experienced symptoms of acute pancreatitis. The patient has spoken to a Doctor and a Nurse practitioner. The patient refused to go to the hospital. She was drinking an incredible amount of fluids, and she was taking stuff for pain. The patient took Tramadol too, but it did not do anything; it did not ease any pain; she did not seem to respond to it. The patient was bulging on her side, it hurt. The patient did not recover from acute pancreatitis, the outcome of other events was unknown.

high heart rate, muscle aches and pains, left arm still hurts, still swollen in areas. My arm flet like it had a fever at injection sight. I was pale in face.

Experiencing swollen, very tender lymph nodes under armpit. Taking Tylenol for pain. Symptoms are getting better.

Onset approx 45 min after injection--swollen eyelids and face, moderate throat constriction and hoarseness, severe fatigue, headache, brain fog for first 20 hrs, then intermittent eyelid and face swelling, hoarseness, fatigue and brain fog for the next 3 days, followed by mast cell activation symptoms of fatigue, puritis, and mild racing heart in the evening for the last two days. For the past 3 years I have been medication free and virtually symptom free. The symptoms of the last few days are consistent with those I had during the years when my MCAD was active. I am concerned that the vaccine has reactivated the hyper-sensitivity of my mast cells.

One day after vaccine severe body aches and sore arm. I had covid 19 in October 2020 and found the body aches after the vaccine to be worse than having the virus itself. Second day after vaccine I noticed lymph node in my armpit to be very swollen. This was the same side of my body the shot was given. I am worried about getting the second dose but I am still going to get it.

I am submitting this as a supplementary report to the report assigned on March 1, 2021. This is day 10 after the vaccine and my mast cell reactivity symptoms have increased by the day--internal and external swelling, flushing, pruritis, wheezing, tightness in chest, as well as pain and pressure in arm pits, groin, and ears. By late afternoon I am severely fatigued, weak, and foggy-headed. These symptoms are consistent with those I experienced during the twenty years when my mast cell disease was unstable. Through identification of my triggers and avoidance of the same, I have been symptom and medication free for the past three years--until taking the Covid-19 vaccine. It appears that the vaccine has reactivated an excessive degranulation response in my mast cells and that response is getting worse as my body responds to the vaccine. I realize that the percentage of persons who suffer from a condition like mine is small, but I would have appreciated having the information that I am submitting to you when I was weighing the pros and cons of vaccination. I know from the twenty years of navigating this disease that there is nothing that can be done at this point other than taking various H1 and H2 blockers. This vaccine appears to be undoing the hard-won level of stability achieved through years of careful lifestyle management.

Within minutes after receiving shot I became completely dizzy, lightheaded and started to faint. EMT came to my aid and took vitals all looked OK. I stayed in place until I felt better about 30 minutes. For the rest of that day and the next day I was extremely tired, a little nauseous, and kind of out of it. The third day I had very sore left arm at site and very sore and tender lymph notes on left side of Arm and trunk. Six days after the shot I came suddenly down with a massive headache and diarrhea. Al has since resolved and I am on day eight.

My left upper arm was red, swollen, knotted for 9 days after my 1sf shot. The knot and swelling has subsided but the area is still red and itching.

2nd dose of the COVID-vaccine administered on the morning of 2/18/21. Within the hour after administration, severe pain on left shoulder (site of administration) was experienced. Swelling, consistent aching pain, and limited range of motion/inability to lift arm over her head. Motrin for 2 days was self administered with improvement in severity of pain but recurred when Motrin discontinued. Motrin was taken as needed thereafter and was the pain continued until 2/26. Employee was followed up on 3/10 and verbalized that the pain had fully resolved. No further interventions.

After 1 hour facial swelling; After 45 minutes cheeks red; After 30 minutes face felt very hot; Stronger pain at injection site than with yearly flu shot; This is a spontaneous report from a contactable consumer (patient, self-reported). A 62-year-old female patient (who was not pregnant at time of vaccination), received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not provided) via an unspecified route of administration, in Arm Left, on 25Jan2021 13:15, as single dose for COVID-19 immunization, at hospital. Medical history included Allergy to All pain relievers and anti-inflammatory drugs and over the counter, allergies to penicillin and Allergies to sulfites all types. Patient was not allergic to Keflex injections, but allergic to the pull form. Concomitant medications included amlodipine, fluticasone propionate (FLONASE), famotidine (PEPCID AC), calcium, colecalciferol (CALCIUM/VIT D) and one a day multi vitamin (within 2 weeks of vaccination). Patient previously took cefalexin (KEFLEX), Bacitracin, Neomycin, Lidocaine, Prednisone; had allergies with these all medications. Historical vaccine included influenza vaccine (FLU SHOT) and had Pain at injection site. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior to vaccination. Since the vaccination, patient has not been tested for COVID-19. After 30 minutes of vaccine, face felt very hot. After 45 minutes cheeks red. After 1-hour facial swelling. Took 1 Benadryl tablet after noticing swelling. Heat and redness then faded. Facial swelling reduced over the next 24 hours without more Benadryl. Stronger pain at injection site than with yearly flu shot, for which patient was not received treatment. Seriousness of the events was reported as non serious. Outcome of the events was recovered in Jan2021. Information on the lot/batch number has been requested.

At time of injection, severe burning, bruising, and then a very large swelling/lump, redness/rash, and pain. At three days post vaccine now and redness/rash almost gone, swelling some diminished but still very present, pain some diminished but still present, and bruising still present.

Exactly 12 hrs after second injection I had 103 temperature, severe shakes and chills. Both knees and arms at the elbows swelled and the elbow and Lymph nodes on my right inner elbow are still swollen. I am just now able to grip anything with my Left hand. I had both vaccines in my right arm. I am predominantly left handed. This has affected my work asin which I am still working full time.

Right hand swelling with no numbness or tingling. Looked in no acute distress. Observed for 30 minutes and discharged home in a stable condition.

Patient has allergies to several medications and keeps epipen on hand with her always. Was asked to sit for 30 minutes after vaccine. At minute 27 she started getting swelling and redness of her lips and face slightly. She normally takes Benadryl when this happens so gave her a Benadryl 50mg one dose. Her throat then became tight in a few minutes and she said that she needed an epipen because she was starting to have a little bit of trouble breathing. Gave epipen and her symptoms resolved within a few minutes. Kept her for 15 minutes. She stated that she knew she would be ok and asked if she could leave. I stated she needed to see the ER if she had any more trouble. I also consulted with her to check with her doctor about getting the 2nd dose because more than likely it's not recommended.

Headache first 30 min, malaise 6-7 hrs after , joints shoulders and hands/fingers x48 hrs moderate /severe then lessening, Swollen Armpit lymph node 3 in x 4 in for 48 hrs then getting smaller . Severe to moderate pain . Congested all days , needed Inhaler first 24 hrs , benedryl and decongestant , naproxen and Tylenol needed all days

Serious swelling and tenderness in arm pit and side, upper back, lymph nodes in neck and back of skull. upper chest and back of neck with horrible headache, Fever of 101.4, chills but major sweating. Ear aches in both ears from headache. Stomach upset for 4 days and couldn't eat. Body aches. Sleeplessness. Very light headed couldn't think for 4 days.

Approximately 15 minutes after vaccination, patient began feeling bumps on lip and swelling under jaw. Soon after, she felt flushed with itching in feet and swelling of feet. I observed a mild redness to face and upper chest. I saw no swelling of neck, lips or oral cavity. I ordered 25 mg. benedryl po be administered at 3:10 PM. A few minutes later, she felt tightness in chest. At that point (3:15 PM) an EMT tried to inject an Epipen but only left the pen in for less than 1/4 second before she withdrew the pen. I then administered another Epipen directly after and the pen was in her thigh for over 3 seconds. The patient was transferred light and sirens to ER. She received no further Epi in the ER and received steroids, benedryl, and famotidine according to the ER Resident. She was doing well 90 minutes after vaccination per Dr.

she felt something in her foot (right foot) under the toes like she had sept on something like the lymph node down there was inflamed; the lymph node under her arm got inflamed; armpit swelling; her eyes was runny, sort of hurting like salt in her eye; her eyes was runny, sort of hurting like salt in her eye; arm was hurting where she got the vaccine in the right arm; she had a mucus plug and was bleeding; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that a 62-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 62-years, via an unspecified route of administration in right arm on 19Feb2021 at single dose for COVID-19 immunization. Medical history included hadn't had her period for 8 years. Concomitant medications were not reported. The patient historically received first single dose of BNT162B2 at the age of 62-years for COVID-19 immunization. Patient received the 2nd dose of the vaccine last Friday 19Feb2021, when she was driving home her eyes was runny, sort of hurting like salt in her eye, it was like that all evening she had to put a patch on her eye to help it. That same evening may arm was hurting where she got the vaccine in the right arm, and the lymph node under her arm got inflamed. The next morning on 20Feb2021 when she woke up she felt something in her foot (right foot) under the toes like she had sept on something like the lymph node down there was inflamed, but that went away. The armpit swelling has continued since the day of the vaccine. Now this morning in Feb2021 she had a mucus plug and was bleeding she haven't had her period for 8 years, every two days she had something new. Patient wanted to know what had been woken up in her body. Consumer added that she read on line that patients should wait for 5months before going to their doctor about the swollen lymph nodes because they might send the person for a test, mammogram and it may say they have cancer, in the clinical trials apparently some patients has issues with their lymph nodes and when they did testing it was found they had cancer, but it was not cancer it was the vaccine. Outcome of the event she felt something in her foot (right foot) under the toes like she had sept on something like the lymph node down there was inflamed was recovered/resolved in Feb2021; of the armpit swelling was not recovered/not resolved; while of remain was unknown. Information on lot/batch has been requested.

Allergic-Anaphylaxis Itching 17 min after administration, redness, rash, chest pressure under heart. Facility called 911 administered Benadryl via IV transported to ER Once in ED given Epipen at 2:21 and Decadron @ 6:05, discharged at 6:60 pm

Pfizer-BioNTech Covid vaccine, first shot developed a blood clot in a superficial vein the day after the vaccine, was diagnosed by a doctor as "superficial thrombophlebitis, pain swelling in leg. Treatment of ibuprofren started. Wondering if I should take my second shot which is scheduled for MArch 26

These started 31 hours after injection. Chills, Headache, low grade fever of 99.9 body aches, sore arm. On 3 rd day after vaccine, injection site became red, hot to the touch and swollen. A separate area from the injection site also became red, swollen and hot to the touch. 4 th day, injection site and random site became more swollen and began to grow together with intense itching. Still hot to the touch and red.

First time outbreak of Herpetic lesion on buttocks- zoster or simplex- awaiting culture. Rx: acyclovir

1st shot: small rash on chest, arms, tummy. slight swelling in face. Congestion. 2nd shot: Major rash chest, arms, legs, tummy and face. Major swelling on face. Horrible congestion.

Pt experienced swelling immediately following injection. Pt was observed for 15 minutes following injection. After 15 minutes, pt left arm was red with a rash approximately 6 in in length. Site was warm to the touch. Pt denies pain or itching and denies any difficulty breathing.

I had arm pain, aches, tired and vomited a few time. I felt weird all over. I had pain in my upper abdomen, legs and lower back. Chills and anxiety. On 2/8, I had a tele visit with my doctor. I took Tylenol as instructed to make sure that I didn't develop a fever. My doctor said that it could be from the vaccine. My left leg and foot were swollen on 2/13, so I called my doctor again and he sent me for a Doppler to check for a blood clot. I saw him on 2/15 in person. I have lower back pain and weakness in my legs at times, but it doesn't prevent me from doing anything. They feel heavy, especially if I walk for an extended period of time.

Patient was found in house by EMS with agonal respirations. Patient was intubated on scene and brought to ER. At ER, patient presented with a HR of 55, BP of 80/43, O2 of 99%, and a rectal temperature of 107.3F. Further work-up revealed thrombocytopenia with a platelet count of 63, WBC of 13.7, and an elevated lactate of 2.2. Imaging shows a kidney stone obstruction of the right ureter. Diagnosis of sepsis was made with patient admitted to the hospital. Repeat rectal temp after acetaminophen suppository and external cooling continues to be 107. Care is ongoing at time of this report.

My arm has remained sore since the shot 4 days ago. Specifically in the armpit but aches all the way down to my hand at time. My armpit is swollen and painful. The pain goes thru my underarm down to my hand. The pain makes it difficult to sleep. Tylenol doesn't take the pain away. At first I thought the pain was a side effect to the initial vaccine, but it got worse as time went on. Finally I researched it on line and saw that lymph nodes have been reported as swelling due to the vaccine.

Triggered Trigeminal Neuralgia symptoms. 5 minutes after injection left shoulder sore. 25 minutes after injection left side of lips became numb. Medics responded, as we were talking, realized numbness had followed the trigeminal nerve back to the ear, and then from the ear, toward the nose. we determined it was not life threatening, and I was asked to contact my healthcare provider. Left lower quandrant of cheek/face was swollen for between 24 - 36 hours. Developed diarrhea 24 hours after injection.

Large lump appeared in left armpit 3 days after Vaccine It is very sore to touch and hurts most of the day. Went to Dr. Told me to keep taking Tylenol and using a pain rub (Hemp Vana) on it. Said it should die down in 4 to 6 weeks.

Sever body aches including to touch skin throughout body. Sever pain shooting through body and muscle. Severe headache and lethargy. Swollen painful lymph node under left arm pit that continues...

Facial swelling, red hot cheeks. I took one Benedryl tablet and heat & redness subsided. 24 hours later swelling was gone.

cellulitis; lymphadenitis; Fever 103; Still swollen from groin area down to knee; This is a spontaneous report from a contactable other HCP (patient). This 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: not reported), via an unspecified route of administration in the left arm on 26Feb2021 at 12:00 PM at a single dose for COVID-19 immunization. Medical history was unknown. Concomitant medications were none. The patient was not pregnant. The patient had no other vaccine in four weeks or other medications in two weeks. The patient experienced fever 103 white posture on knee that turned into cellulitis and lymphadenitis. The patient had IV antibiotics twice within 5 days of vaccine as treatment for events. The patient still had swollen from groin area down to knee. AE resulted in emergency room/department or urgent care. The patient had no covid prior vaccination, no covid tested post vaccination. Outcome of the events was not recovered. Information on the batch/lot number has been requested.; Sender's Comments: The event cellulitis is assessed as unrelated to BNT162B2 based on the information provided. The event onset date is not reported, therefore the drug-event temporal relationship is not clear. In addition, the BNT162B2 vaccine was administered in the arm but the reported cellulitis was at knee area. It is very unlikely that the cellulitis was related to BNT162B2.

Right side of jaw and ear area pain, mild swelling/inflammation. Rear molars would not meet together from inflammation. Hard to chew on the left side. At times feeling like an ear infection which I have not had in over 50 years. It began 3/17/2021 and almost completely diminished on 3/22/2021

Underarm swelling, redness, and pain - in armpit and down inside of left arm. Starting Saturday - started 1 day after injection and has gotten worse each day.

Waited 30 minutes. A little dizzy. Son drove me home. Arrived home 450. 5 pm eyes and cheeks swelling throat felt like olive stuck in it I called Kaiser. Talking to them chest began stinging hurting pressure. Told to call 911. I hung up walked two blocks to urgent care. Chest really hurting feeling dizzy face eyes swelling throat lump getting larger. My breathing rate normal , blood pressure normal , oxygen normal. They took me back gave me epinephrine and depo modral shot in right buttock cheek. After few minutes felt better chest stopped increasing in pain throat started feeling better, face still swollen. Told me good thing I walked instead of waiting for 911. Very scarey. Told to remain up for 24-48 hours give epi if needed again. Taking 180-360 mg 24 hr Allegra daily. I stayed up 36 hours drank water . Told can not take second shot. No vaccines until I get tested for what caused allergic reaction. Today March 23 face still off and on swelling and eyes. Seems when I begin to move around swelling starts again.

2nd vaccine rec'd on 03/20/21. On 03/21/21 still a lot of soreness in left upper arm. On 03/22 PM, noticed the armpit lymph nodes swollen and slightly sore to the touch. Symptoms same on 03/23. On 03/24/21, noticed a red rash on outer part of upper arm to the elbow. Sweats and chills in PM and 2 fever blisters appearing on moth on left side. Morning of 03/25/21, rash worsens, sweats and chills continue. Toward afternoon, lightheadedness and trembling in hands. Felt better after lunch, some lightheadedness, still.

rash; hives; swollen face; congestion; This is a spontaneous report from a contactable consumer (patient). A 62-years-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose, via an specified route administered in Arm Left on 14Feb2021 10:30 AM at single dose, second dose via an unspecified route of administration, administered in Arm Left on 07Mar2021 (Batch/Lot Number: ENG199) as SINGLE DOSE for covid-19 immunisation. Medical history included avn (left hip and both knees replaced), Known allergies: Bee stings, Cats. No covid prior vaccination. Concomitant medication(s) included sertraline hydrochloride (ZOLOFT). No other vaccine in four weeks. The patient experienced Slight reaction from first shot: Rash, hives, swollen face, congestion. 10Mar2021 10:00 PM, the patient experienced same events after the second dose, resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). The patient hospitalized for 1 day. The patient tested Covid post vaccination on 11Mar2021: Nasal Swab with Negative result. The outcome was recovering.

Outbreak of cold sores on chin, otc medicine - abreva or left alone, still ongoing - but usually lasts a week or less.

days after receiving the vaccine my arm had a 1/4 to 1/2 in raised area about the circumference of an orange around the injection site. Was also red and very warm to the touch. Dr ordered Keflex 2x per day. Today, Monday, the swelling is down, less pain an the warm skin has gone away.

About 36 hours after receiving the vaccine, felt extreme tenderness under left arm (pit) and found a lump that felt the size of a golf ball.

I felt fine until 1:30 in the morning. I woke up with a low fever, 99.5, very achy all over (especially the shot arm, my neck and lower back) then noticed a big lump under my left armpit. It is soft and squishy, not hard like a tumor. The fever and aches only lasted one day with Tylenol. The lump is still present.

I received the Vaccine around 11:14 a.m. At around 4:30 my lips started feeling tingling and the roof of my mounth was feeling the same. I did notice that my lips were swollen and my face was swollen slightly. I continued to drink fluids. I did take 50 mg of Benedryl hoping that the tingling and swollen lips would go away. It took almost three (3) hours for my lips to go down a little. I did not take anymore Benedryl. I alerted Pharmacy regarding my symptoms and Dr. via telephone call. I do not plan to take the second dose.

fever, chills, severe headache, body aches, lymph system pain, severe rash and pain - lower extremities, shortness of breath, chest discomfort fever and chills lasted 3 days, all other symptoms lasted at least 2 weeks and rash is still healing after 4 weeks

initially felt light-headed and dizziness, then had flu like symptoms lasting 24 hours. The lymphedema left axillary area lasting about 24 hours after first dose. Had a mammogram in March 2021 and it showed a spot on the left breast.

I had multiple severe side effects the next day and through the night the next day consisting of tiredness, headache, every joint in my body in pain, chills, nausea, flu like illness, swollen lymph nodes in neck and arm pit area. Left arm pit lymph node was swollen to the size of a clementine and very painful. Swelling has gone down but still somewhat swollen and tender in that area 4 days later.

Shortly following administration of 1st dose of Pfizer COVID-19 vaccine, pt reports developing redness and swelling to contralateral side of arm in area of biceps. Reports reaction resolved after one week then recurred one week later with no triggering event or additional vaccine given during that time.

This is not what I would call a side effect but rather an autoimmune reaction. I experienced what I would call pulsing in the lymph nodes, in order left underarm, right underarm, left groin, right groin and my neck, like nothing I have experienced before. It felt like someone was playing Operation and poking and activating them, followed by inflammation of my gastrointestinal system top to bottom with sporadic pains in different areas. I am still recovering a week later. I postponed my second shot until 4/15.

Arm numbness extending to wrist, immediately after injection. 48 hrs. later patient states experienced "upper body" swelling, "heart racing", "throat swelling", "lymph nodes" swelling, "trouble swallowing", "kidney pain"

Initially, upper right arm swelled. Within 36 hours following vaccine administration, every site of bee stings received over the past 10+ years-- on the right side only --swelled or itched or both, as though I had just gotten the same sting in the same location (I am a beekeeper, so had about 10 sites on the right side). Prior sting sites on the left side did not react. [After the first vaccine dose, these same sites had, at intervals, felt like the "pinch" of the initial sting over the 48 hours following the vaccine] Now, 48 hours post 2nd dose, most of the sites have cleared and the itch has ceased completely.

Patient had an emergency room visit and was told that she could not receive the 2nd dose. She had swollen lips the next day along with right sided swelling, especially in her right foot. Blood pressure was high

Swollen lymph node in neck above right clavicle. Woke on 4/7 to bean shaped swelling which is tender. Waiting to see if it goes away within a day or two.

Fever, swelling, arm pain, chills, dizziness, I fell due to body tremors, weakness, when I lay down I felt heavy things on my body, which I tried to remove for approximately two hours.

Itch; Red swelling welt about 4 inch diameter for about 4 days associated with soreness, Like a wasp sting.; Red swelling welt about 4 inch diameter for about 4 days associated with soreness, Like a wasp sting; Red swelling welt about 4 inch diameter for about 4 days associated with soreness, Like a wasp sting; Red swelling welt about 4 inch diameter for about 4 days associated with soreness, Like a wasp sting; This is a spontaneous report from a contactable other Health Care Professional (Patient, self-reported). A 62-year-old female patient (who was not pregnant at the time of vaccination), received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not provided), via an unspecified route of administration, in Arm Right, on 05Feb2021, 03:45 AM, as a single dose for COVID-19 immunisation, at hospital. Medical history included low platelet count and had Known allergies to yellow jacket stings and sulfa drugs. Concomitant medications were not reported. Patient did not receive other vaccine in four weeks of vaccination. Patient did not receive Other medications in two weeks of vaccination. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. It was reported that patient had Red swelling welt about 4 inch diameter for about 4 days associated with soreness, Like a wasp sting on 05Feb2021. Area remained red, but not elevated for 14 days. On day 10 (15Feb2021), it started to itch. No treatment was received for the events. Outcome of the events was recovered on an unknown date in Feb2021 Information about lot/ batch number has been requested.

Extreme Pain in arm, swelling. Pain goes from arm to shoulder. Fingers on left hand tingle and numb.

Swollen face, tiredness, headache, muscle pain, nausea, feeling unwell, Swollen lymph node and vomiting

Adverse Reaction started on Day 5 after Vaccine shot. Sore throat, like a post nasal drip. Next morning Day 6 started to feel very unwell, copious nasal congestion (could not breathe through nose) no fever, slept most of day, 6:00PM fever 99.2 7:00PM loss of taste and smell Fever steadily increases by increments. Very hard to breathe through mouth do use SINEX to relieve congestion Works! Able to sleep Day 7 Fever rises to 100.5 still much nasal congestion (yellow/green mucus) Still quite achy neck and lymph nodes use SINEX again to clear nasal passages Fever continues to Day 8 after Vaccine 2:00PM

1st reaction - Day 1 As I was walking to my vehicle, after waiting my 15 minutes, I had an awful metallic taste in my mouth. I had to spit out the saliva, which helped, but it still lingered for a few minutes. 2nd reaction -Day 1 After several hours, I experienced swelling in my right arm, and diarrhea. I also had insomnia, and slept very little the night of the shot. Day 2 I had loose stools, slight nauseous feeling most of the day. My body odor smelled like onions. I also had bad muscle aches and fatigue. That night, I had insomnia again and slight chills. Day 3 Still had loose stools, fatigue and muscle aches. The onion smell comes and goes. I experienced excessive urination throughout the day (about once an hour, which is not usual for me). Day 4 Muscle aches and fatigue are gone, Day 5 Excessive urination again. Onion smell comes and goes.

First day, just headache. Woke up second day with aching in both arms, third day swollen glands in neck, and an itchy rash on several places -- near my waist, on one thigh, on one forearm

Severe chilling followed by a panic attack. The next day experiencing pain on the outside of the right knee. By 3rd day pain noticed in left and right arms, moving across the top half of the back above the shoulder blades. Excruciating pain by p.m. of the same day preventing me from sleeping. Unable to use arms to get a glass out of the kitchen cabinet. Pain has moved around causing pain and swelling in joints, affecting the right and left arms, wrists, hands, legs. Went to UTC where I was given a steroid shot. The shot lasted about 24 hrs. and right back to the above symptoms. Going to physician today hopefully for some lab work. 11 days of pain!

Tongue n throat felt burning n a bit puffy. Indigestion 4 days everything u eat and all day nagging and down throat but no throw up or major nauseous

injection site pain tiredness headache muscle pain chills joint pain fever injection site swelling nausea feeling unwell swollen lymph nodes dizziness and weakness

Metallic taste in mouth; swollen glands in neck; ringing in ears, chills, fever, nasaeus, pain in shoulders, arms, hands, hips, ankles, terrible headache. I took Benadryl (50 mg) every 12 hours for two days. I'm still not feeling well (swollen glands in neck, ringing in ears, headache, body aches).

Swollen lymph nodes on inside of upper right arm. First began on 3/26/21 and still can't raise my arm without pain as of 4/14/21.

Swelling of lymph nodes, pain at site of injection, under left armpit, along back shoulder blade, along rib cage and up into the left side of the neck.

large painful swelling in left armpit appeared 3 days after vaccination. lump had receded about 90% after 3 days. there is still a small residual lump 13 days after vaccination.

Patient contacted the pharmacy today and indicated she had experienced left lower leg swelling and redness at approximately 11pm on the night of her first dose of Pfizer COVID-19 vaccination. She indicated that she had slept with her legs above her chest and the next morning (April 9, 2021) the swelling had decreased and redness had gone away. She proceeded to go to work. She reports having sharp pains on right side of her chest and the swelling in the legs continued for a few more days. On the evening of April 13, 2021, she began experiencing heart flutters and took a baby aspirin as a precaution. The patient indicated she did not currently have a primary care physician. She was advised to seek medical attention (i.e urgent care center or hospital) by pharmacy staff.

SIRVA Left shoulder large bulge posterior area. Bursa swollen. Spongy on pressure, like a large ball. Initially size of baseball. Has reduced slightly in size. Still prominent. Still visibly present.

Pfizer-BioNTech COVID-19 Vaccine EUA: six days after immunization patient presents with shortness of breath, myalgias, cough, headache, and chest pain. Hospitalized with acute hypoxemic respiratory failure secondary to COVID-19 infection: administered steroids, antivirals, and anticoagulation. Patient currently hospitalized.

March 31 - one hour after shot numbness and tingling in left forearm for 30 minutes or so. April 1 - 9 pm severe muscle pain, migraines, nausea, dizziness, neck pain on both sides. These continued until Monday am April 5. Then the night of April 5th, neck pain on both sides and then under my left ear, down my left neck and all across to my left shoulder, large patch of fluid under the skin and my left underarm is extremely swollen with fluid and a lump in my armpit. April 16th - still have all this fluid and I have a dr appointment on Monday, April 19th to ensure I don't have an infection. I have not had COVID 19 nor have I been exposed. Been very sheltered in place at home since March 2020.

Severe sore throat, nasal congestion and simultaneous nasal issues of nasal liquid spraying , seeping, sneezing, coughing, swollen lymph nodes, Lost hearing in left ear for a day and a half, completely lost voice, muscle aches, body pains, swollen sinuses, restricted throat airway, intense mucus production. Sick for two complete weeks within 8 hours of having second Pfizer covid shot. Low fever at onset and chills. I was completely housebound and isolated during previous 14 months of pandemic and was not sick prior to covid shot. I lost my voice for two weeks. Completely lost voice. My airway/trachea made my sore throat feel deep. I never got anything in my lungs. But I did have heart palpitations on and off. I called the hospital and explained my symptoms and the nurse told me I was having ?an excellent immune response and to be proud of it and not worried.?

I woke up the next day with severe pain in my right hand, opposite of the injection site. I was unable to use my hand. I could move my fingers, but unable to grip. The top of my hand was swollen and bluish in color, eventually turning a light brown, like a bruise. By the 4th day my hand was fine.

Patient presented complaining of worsening SOB over the past 3 days. She reports leg swelling, as well. Patient was found to have a heart failure exacerbation and critically high potassium, prompting admission to the hospital. Patient received calcium gluconate, insulin, dextrose, and Kayexalate.

20 minutes after the Pfizer vaccine injection, I experienced swelling of the interior of my throat and facial swelling at the site of previous Juvederm injections. This persisted for 10 minutes and stopped. 10 minutes after my first vaccine injection, I experienced a mild tingling in these same areas for about 3 minutes.

Sharp pains in chest and back and neck on left side; Sharp pains in chest and back and neck on left side; Sharp pains in chest and back and neck on left side; Tingling in left hand; very swollen and painful lymph nodes under left arm and in neck, and chest area on left side of body; This is a spontaneous report from a contactable consumer (Patient). A 62-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8727), at left arm via an unspecified route of administration on 24Mar2021at 15:00 (at the age of 62-year-old), as SINGLE DOSE for COVID-19 immunization. Patient historical condition included mytral valve prolapse. The patient concomitant medications were not reported. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6203), at left arm via an unspecified route of administration on 03Mar2021 02:45 PM, as SINGLE DOSE for COVID-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. Patient not diagnosed COVID 19 prior to vaccination. On 25Mar2021 19:00, the patient had sharp pain in chest and back and neck on left side; tingling in left hand; very swollen and painful lymph nodes under left arm and in neck, and chest area on left side of body. Occurred 28 hours after injection and again 90 hours after injection. Patient not received treatment for the adverse event. Since the vaccination, patient not been tested for COVID-19. At the time of this report event outcome was recovering. No follow-up attempts are needed. No further information is expected.

Adverse reaction: Sudden severe shortness of breath when I exerted myself, severe constant headache that tylenol couldn't dull, fatigue and weakness, weak shoulders could keep them raised for more than a few seconds, swelling of abdomen, rapid fluid retention, lack of appetite, chest felt constricted, nose bleeds, black sticky stools Treatment: 2 units of blood, ferrouse sulfate IV, saline IV, protonix IV, endoscopy Outcome:health back to normal, after blood transfusion, will continue to take pantoprazole for six weeks and Iron Note: used to have ulcers years ago due to H. Pylori bacterium suspect Pfizer mRNA vaccine interacted with H. Pylori antibodies as has been found in other patients with H. Pylori.

AFTER 11 DAYS, I'VE GOT A STRANGE TEETH ROOT INFECTION (HAD AN URGENT ROOT CANAL TREATMENT) FOLLOWED BY A HERPES ZOSTER OUTBREAK AND A "COVID ARM" WITH REDNESS, SWOLLEN AND PAIN. THE HOTLINE CORONAVAX IN SWITZERLAND, GAVE ME THE ADVISE TO GO TO THE PHARMACY, EXPLAIN MY EVENT TO THE PHARMACIST. HE LOOKED AT MY "COVID ARM" GAVE ME A POMADE AND GAVE THE ADVISE TO GO THE URGENCY IF IT DOES NOT GET BETTER AFTER 3 DAYS. NOW AFTER 14 DAYS, I AM STILL FEELING A LITTLE CRANKY. MY HEALTH PROFESSIONAL DOCTOR WITH HOMEOPATHIC APROACH, GAVE ME THE ADVISE NOT TO TAKE THE 2ND SHOT. WHAT SHALL I DO?

I had the initial body ache that?s been associated with the second vaccine injection, it disappeared after 36 hours, followed by excruciating pain in my right jaw, the lymph node behind my right ear shooting into my right temple. Within a day my right eye was involved. After 2 misdiagnoses, and increased pain and emerging blisters, it was determined that I had shingles (4/18/2021)

First reaction, feet and hands became red and swollen. Then trouble breathing and I began wheezing. The Emt's were called. Dr was the attending. He administered Benidril. After 15 minutes he had an Emt attempt to administer an EpiPen. She partially administered the Epi and pulled it out too soon. Dr. administered a second EpiPen. An ambulance was called and I was transferred to Banner University Medical Center.

My first dose was administered on Mar. 5th, 2021. On March 18th, 2021 I had a spontaneous anaphylactic reaction requiring the use of Benadryl and an inhaler. 40 minutes after second injection (Apr. 2nd, 2021) my face became bright red - which is usually the beginnings of an allergic or non-tolerant reaction to something to which I've come in contact. A Benadryl dose resolved this reaction within 20 minutes. On April 10th I had a spontaneous anaphylactic reaction requiring the use of Benadryl. 12 Days after second dose I noticed my tongue feeling raw and started feeling a UTI beginning. By 14 days after second dose I had approximately 14 pea sized lumps on the back and back sides of my tongue, the gums of my teeth were very swollen and sore. The roots of my teeth ached terribly, chewing was very difficult. My ears were both very itchy deep within. I was seen my my physician on April 20th, 2021 and diagnosed with Candida Overgrowth.

Patient had swelling at site of injection (right arm ), also swelling at left arm ( not as bad as on right arm ), swelling on right leg and left leg (less compare to right leg ), no shortness of breath or hives.

Numbeness in left hand, and fulness in neck, with 15 minutes later adding facial sensation in her left side of face. Waited in waiting area for about an hour, didnt get better hut dodnt get worse. Staff told her to go to urgent care to seek further treatment

Very swollen lymph nodes under right armpit. Felt like it was the size of a watermelon. Doctor checked it and said they did not feel swollen. Today is April 22 and it is still sore. Injection site in not painful though. Also experiencing fatigue

Severe anaphylactic-like reactions to foods started /Throat swelling, closing; Numbness of lower part of face; throat constriction, lasted for 45 minutes; This is a spontaneous report from a contactable consumer. A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6205), via an unspecified route of administration on 03Mar2021 10:00 AM as single dose in right arm for COVID-19 immunisation. The patient's medical history included auto-immune disease, RA, Hashimoto. Patient had no prior allergies except to bee venom. Patient was not pregnant at the time of vaccination. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within two weeks of vaccination. 60 minute after the shot, throat constriction, lasted for 45 minutes. On 20Mar2021, the patient experienced severe anaphylactic-like reactions to foods. Patient experienced throat swelling, closing, numbness of lower part of face which resulted in emergency room visit and physician office visit. Reactions are muted since taking antihistamines but persisted even on 08Apr2021. Adverse events treatment included Allegra, Zyrtec. All allergy tests were negative. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The clinical outcome of the events was not recovered.

injection site pain; injection site swelling; body aches; muscle ache; fever; redness; swelling; feeling unwell; lymph nodes; nausea; This is a spontaneous report from a contactable consumer or other non hcp. A 62-year-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: Batch/Lot Number: EN6207; Expiration Date: unknown), dose 2 via an unspecified route of administration on 06Apr2021 as single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. In Apr2021, the patient experienced injection site pain, injection site swelling, body aches, muscle ache, fever, redness, swelling, feeling unwell, lymph nodes. They are mostly concerned about the lymph node swelling on the same side of the injection site on the left side and concerned about anything which could treat it and how long would it last.The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.

About 35 hours after the 2nd dose, during the night, I woke up with a terrible ringing in my ear. Earlier in the day I did have clogged ears but thought it was due to allergies. The ringing went most of the night but when I woke in the morning, it was gone. At this time however, I noticed enlarged lymph nodes under my injection arm. I still have the enlarged lymph nodes but don't seem to have any other side effects.

cold and hot; gum were bleeding after second dose; felt like she was going to die after second dose; cold sores on lips after second dose; threw up after second dose; soreness after second dose; dizzy and weak after second dose; dizzy and weak after second dose; chills after second dose; sweating after second dose; dry heaving after second dose; nauseated after second dose; dehydrated after second dose; hasn't eaten for 5 days after second dose; This is a spontaneous report from a contactable consumer (patient, self-reported). A 62-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: FR8737and expiry date was not provided), via an unspecified route of administration, in left arm, on 07Apr2021, as a single dose (at the age of 62-years) for COVID-19 immunization. Patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, solution for injection, lot number: EN6201 and expiry date was unknown), via an unspecified route of administration, in left upper arm, on 05Mar2021, as a single dose for COVID-19 immunization. The patient arm hurt after first dose (began immediately and lasted for about 4 days) which was resolved on 09Mar2021. Patient second dose was scheduled on 27Mar2021, but she did not get it till 07Apr2021. It was reported that on 08Apr2021, patient had such an awful reaction to the second dose of the vaccine. She started to get dizzy and weak, chills, everything was a blur, sweating, could not drink threw up if she tried dry heave went back to sleep and slept for 48 hours had just chills the whole time. She was in bed sleeping trying to drink, getting up to go to the bathroom and feeling like she was going to die for the next three days. She was nauseated and is still nauseated and could not drive. She took Tylenol an antiemetic at urgent care that stopped. She took Zofran with the saline solution infusion and she went home and slept. She was dehydrated and had soreness all over. On 09Apr2021, she could not roll over and had a sore on her left butt cheek that was still there cold sores on lips. She thought the sore on her left butt cheek came from laying in bed so much, and it was not in any other space but that one spot almost like she would have gotten the shot there, but she didn't. On 10Apr2021, patient felt like she was going to die, and went to urgent care and asked if they could give her fluids. They gave her fluids and Zofran and that helped a lot. This one shocked the hell out her, she thinks it was her gums that started to bleed on 11Apr2021. She had the best oral hygiene and went to the dentist all the time. She was flosses like crazy. She started to drink a ton of water and has not seen it since. She cannot guess what the reason was. On 11Apr2021, she could function a little and had chills again last night and sweating. She did not have a fever. She ate chicken noodle soup water and a little bit of ginger ale. She started to feel better, but not 100% better not even 90%, not even 80%, but was heading towards the right direction. Patient also hasn't eaten for 5 days after second dose. She experienced cold and hot. She was not complaining at all and she has been sick for days and cannot eat and will throw up but will gain it right back. The dizziness and weakness were subsided. She feels like she is getting beat up but is recovering. Patient thought that vaccine pulled out with a syringe and that's the problem everyone gets the same dose. Patient's weight was 136 or 138 lbs. Outcome of the events nauseated after second dose was resolved on 10Apr2021, and dizzy and weak after second dose was resolved on an unknown date in Apr 2021, and for the events chills and sweating it was recovering, and for all other events, it was unknown.

heart was fluttering and beating out of her chest; Elevated heart rate/The highest was 130; she felt her heart racing; Heart rate goes up and down; could not do anything and was laying in bed or on the couch; white blood cell count is higher than it should be; has allergies to medications but not what was in the Pfizer shot. She adds that maybe she had a reaction to the chemicals in there.; This is a spontaneous report from a contactable consumer (patient, self-reported). A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, solution for injection, lot number: EN6206 and expiry date: was not provided), via an unspecified route of administration, in arm left, on 10Mar2021 at 03:30 PM, as a single dose for COVID-19 immunization, at hospital. The patient was not pregnant at the time of vaccination. The patient was tested for COVID-19, before the vaccination, however, results not provided. The patient has not been tested for COVID-19, after the vaccination. Patient's medical history included breast cancer survivor, chronic lymphatic leukemia. Patient had known allergies with penicillin and sulfa. Concomitant medications included calcium, colecalciferol (D3), macrogol 3350 (MIRALAX), multi vitamin, and ibuprofen (ADVIL DUAL). The patient previously took ciprofloxacin (CIPRO) and morphine: and had allergies with both drugs. The patient reported that on 11Mar2021, her heart was fluttering and beating it out of her chest with elevated heart rate which goes up and down. She also felt her heart was racing. It was very erratic. The highest heart rate was 130 (non-sustained). It was started since morning after the vaccination and was still happening now and wanted to know that it was a normal side effect. She had a cardiac work up and couldn't find anything however, everything was normal. Her heart rate went up to 130, 140, 150 and went to 80. This was happened over a period of 5 or 6 days. She felt like she could not do anything and was lying in bed or on the couch for three days. Her white blood cell count was higher that it should be. She went to her regular doctor who did the EKG, however, results not provided. Further, she went to a Cardiologist and they did another EKG and wore a monitor for a week and did echocardiogram and blood work all results were normal. She was wondering, if this could possibly be a side effect from the vaccine because it did occur in the morning after she got vaccinated. She also reported that she had allergies to medications but not what was in the vaccine and that maybe she had a reaction to the chemicals in the vaccine. She was supposed to get the second shot of vaccine which was scheduled on 31Mar2021 and had concerned about getting the second shot because she had some allergies and now this happened. She was very frightening and thought that she was going to die. It was very scary for her. The product complaint was not reported. The patient did not receive any treatment for the event. Outcome of the event Allergy to chemicals was unknown and for all other events it was recovered on an unknown date in Mar2021. No follow-up attempts possible. No further information expected.

Severe gout like symptoms in left foot big toe joint began 4.5 days after injection. I am currently on day 4 of pain and swelling

Day 1 Fever chills body aches Day 2 Fever chills body aches Day 3 Fever chills body aches, swollen lymph nodes right armpit Day 4 Swollen lymph nodes right armpit Day 5 Swollen lymph nodes right arm pit and swollen lymph nodes in neck near right clavicle

Doppler showed a blood clot; Pain behind her cast; Really bad case of diarrhea; Swelling in her knee; Leg was swelling/right shoe was tight; Lower extremity venous ultrasound right calf vein acute deep vein thrombosis of the right lower extremity involving the popliteal vein; It was tender on her right leg on the left side of the tibia/It is very tender to the touch; Red mark on her leg with a little nodule; Red mark on her leg with a little nodule; Calf pain; This is a spontaneous report from a contactable consumer. A 62-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EP7533; Expiration date was not reported) on the right arm on 30Mar2021 as a single dose, with route of administration unspecified, for COVID-19 immunization at the clinic. Medical history included pain and headache. Concomitant medications included paracetamol (TYLENOL ARTHRITIS) for pain; hydrocodone for pain; amitriptyline for headache; and ongoing paracetamol (TYLENOL EXTRA-STRENGTH) for pain. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6208; Expiration date was not reported) on the right arm on 11Mar2021 (when the patient was 62 years old) for COVID-19 immunization. On 07Apr2021, the patient's doppler showed a blood clot. On 30Mar2021, the patient had a really bad case of diarrhea; swelling in her knee; and leg was swelling/right shoe was tight. On 02Apr2021, the patient had pain behind her cast. On an unspecified date in 2021, the patient's lower extremity venous ultrasound showed right calf vein acute deep vein thrombosis of the right lower extremity involving the popliteal vein; was tender on the right leg on the left side of the tibia that was very tender to the touch; had a red mark on her leg with a little nodule; and had calf pain. The events had resulted into an emergency room visit and physician's office visit. The patient had received treatment for the events, 'blood clot', 'lower extremity venous ultrasound right calf vein acute deep vein thrombosis of the right lower extremity involving the popliteal vein', 'leg was swelling/right shoe was tight', 'pain behind her cast' and 'tender on her right leg on the left side of the tibia that was very tender to the touch'. The outcome of the events was recovered on 30Mar2021 for 'really bad case of diarrhea'; was recovering for 'leg was swelling/right shoe was tight', 'pain behind her cast' and 'red mark on her leg with a little nodule'; and was unknown for all the other events.

Nausea within 45 minutes, stomach cramp ing; within one hour and vomit; fell asleep for 10 minutes felt better then slep for 4 hours; 2am my surgical hand became inflammed and swollen for 4hours

4 days after the vaccine my MG flared up. First I spent about 9 days too tired to get up. Droopy eye lids, double vision, too weak to even drive my car and problems swallowing. But then the heavy duty stuff starts. Swollen glands for 4 days with a rash, along with the Myasthenia gravis symptoms. So I think I am on the way to mend 4 days later and my glands re-swelled up and the rash came back. This happened a total of three times. Now I am at the 30 day mark. Vocal cords keep collapsing causing my throat to close when I speak. My one eye wont even open at this point. I am so weak I am teaching the dogs to use the vacuum plus drowning in mucus. Before I took the vaccine I was almost completely off my medication and now I am taking it every three hours.

Within a minute tasted mentally a bit foggy then fine within an hour. Luis and tongue felt puffy and swollen a bit tingly and irritated. Arm not sore until second day but didn?t run or ice it this time. Day 2 whole body feels puffy like lots of water retention feels like. Tongue and lips still affected

Swollen lymph glands on left side of chest and under left arm. Tenderness for approx. 6 days. Then no tenderness and swelling has gone down little by little. Small hard lump and swelling still evident, left side of chest near sternum on 5-4-21.

3-24-21 - Chills, body ache, stomach pain 3-25-21 - stomach pain continued, nausea 3-26-21 - intense stomach pain, throwing up, nausea, chest pain. Went to ER stomach pain was so extreme. Diagnosed with accurate pancreatitis admitted to hospital. During stay O2 level dropped to 73, extreme pain for multiple days. 21- The form won't let me fill in the hospital info 10 night stay in hospital.

Left jaw is swollen so huge and it's just hard and now it's going into my lip; Lower lip is numb and it's going down into my throat and up in my ear and it's very painful; I am in severe pain; Lower lip is numb and it's going down into my throat and up in my ear and it's very painful; I am in severe pain; Lower lip is numb and it's going down into my throat and up in my ear and it's very painful; I am in severe pain; Lower lip is numb and it's going down into my throat and up in my ear and it's very painful; I am in severe pain; short of breath/I can't breath; am still not well, Bad condition here; am still not well, Bad condition here; dizziness; tired; deltoid starts swelling; lost feeling in my mouth; Left jaw is swollen so huge and it's just hard and now it's going into my lip; my stomach was upset; my jaw was sore; The initial case was missing the following minimum criteria: ICH-unspecified product. Upon receipt of follow-up information on 22Mar2021, this case now contains all required information to be considered valid. A 62-year-old female consumer (patient) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and lot number: EL3302) via an unspecified route of administration on 11Mar2021 in left arm at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. As per the context, it was reported that consumer stated, I took the vaccine (Unspecified Vaccine) the first dose on Thursday and right now my left side, they gave it into my left arm and my left jaw is swollen so huge and it's just hard and just like really hard and now it's going into my lip, my lower lip is numb and it's going down into my throat and up in my ear and it's very painful; she was in severe pain. Consumer stated, I took the vaccine 11Mar2021 and next day i.e. on 12Mar2021 I get up and my jaw was sore and then my stomach was upset and then as the day started on my jaw started swelling really big. I took it on 11Mar2021 and I am still not well, Bad condition here, I have lost feeling in my mouth and I can't breath either. It was the first vaccine and this is the very last I am not taking again. Consumer stated, I had a trip to the emergency room. Regarding lab data, consumer stated, No, they documented how swollen was my jaw was, I didn't know I was short of breath until I start back exercising and then I can't breath in there. Consumer stated, Well I just wanted to know how long this is going to last then because I have lost feeling in my mouth. Consumer stated, I got a vaccine back in March and I called Pfizer then because I had, my deltoid starts swelling and I had to go to the emergency room because that's what the paper says if you have facial swelling. So now my deltoid is still swelling, it will go down some and it will start swelling again, I have got numbness in my lips and my chin, dizziness and it hurts. So, I just wanted to know what you can do for that and along with that if it's normal. Consumer stated, Well I have been on hold for an hour, just to get this number, can't you just type the information in have them contact me. When tried to probe for further questions, Consumer stated, I have already documented and I just need to talk to somebody that know what to do to get my job back, like it was. Consumer stated, I went to the emergency room, the paper that they gave it to me vaccine was (name withheld), it's a drive through and they vaccinated it was the first vaccine I got, and I did not go back and get another one because I haven't recovered from that one yet. My face is out swelling up, my lips numb, my cheeks numb and numb. I am just tired and dizzy. The outcome for the events swelling face, lip swelling, hypoaesthesia oral, pharyngeal hypoaesthesia, hypoaesthesia, pain, general physical health deterioration, malaise, abdominal discomfort, pain in jaw,sensory loss, swelling, dizziness and fatigue were not reported and for the event deltoid starts swelling it was reported as not recovered/not resolved. Information about batch/lot number had been requested.

difficulty breathing chest pain-unable to comfortably lie down swelling of my face and throat fast heartbeat red face bloodshot and swollen left eye-felt something irritating in left eye insomnia-that night only injection site pain tiredness headache chills and hot flashes joint pain nausea dizzy mental confusion After about 20 hours post shot and one I took some allergy medication I started to improve, it took a full week to feel normal.

Ringing in ears have been high-pitched, continual and unbearable. I've never had this condition in my life. Swollen lymph glands, sore throat, body aches and flu-like symptoms have subsided.

To check if it was blood clot; Intermittent long-lasting palpitations; Lymph discomfort in one leg; Severe pain of bones in chest; Joint pains; Severe shooting intermittent head pain; Cold sweat; Felt like she was going to faint; COVID arm popped out; Severe nerve pain behind ear same side as vaccine; Exacerbated back pain; Bad menstrual cramps; This is spontaneous report from contactable consumer (patient). A non-pregnant 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER8727), via an unspecified route of administration in left arm, on 31Mar2021 at 01:00 PM (13:00), as first dose, single, for COVID-19 immunization. The patient's medical history included fibromyalgia, complex regional pain syndrome (CRPS), lymphedema (previously resolved), mild asthma, osteoporosis, herniated discs, allergies, and menopause. The patient's concomitant medications included unspecified vitamins. The patient had no other vaccine in four weeks (however, it was also reported that other vaccine was administered in same date, 31Mar2021; pending clarification). The patient was not diagnosed with COVID-19 prior vaccination. On 03Apr2021 at 02:00 AM, the patient experienced intermittent long-lasting palpitations, lymph discomfort in one leg for which they went to check if it was blood clot. On 03Apr2021 at 02:00 AM, the patient also had severe pain of bones in chest, joint pains, severe shooting intermittent head pain, cold sweat, felt like she was going to faint, COVID arm popped out (nite 8; as reported), severe nerve pain behind ear same side as vaccine, exacerbated back pain, and bad menstrual cramps for 2 mornings 11 years post-menopause. The adverse events resulted in doctor or other healthcare professional office or clinic visit. No treatment was received for the adverse events. The events were considered non-serious. The patient has not been tested for COVID-19 post-vaccination. The patient had not recovered from the events. No follow-up attempts are needed. No further information is expected.

She got her vaccine, and immediately had a sodium taste in her mouth. She has weakness, very hard to breath, her face was swelling and her lymph nodes were swollen, and the sodium taste is getting worse and she can't get it out of her mouth. Her Meniere's medicine is not helping at all, and she is not able to drive. She is really weak and went to the ER twice and they did some chest X-rays that were fine. They took blood and told her that her sodium was fine, and she feels that was wrong it should be low. She has a lot of problems with sodium. The 2nd time she went they did nothing, gave her a nebulous treatment and she could not do that as her throat was swelling up and has had a sore throat since that visit and that breathing treatment. They told her that it was something like her inhaler, and didn't give her anything else. She was then discharged after 3 hours. She is too weak to walk so is in a wheelchair. She is dead tired and has extreme weakness, and the salt taste in her mouth is BAD. The breathing is real bad, and so is the dizziness which is making her Meniere's bad and all she wants to do is sleep from being so tired. She has two bad knees and is able to walk, but due to the pain she has been using a wheelchair. She has an APT on Tuesday with a pulmonary specialist.

A few hours after the vaccine, I started having pain in the lymph nodes under my left arm. The pain was intense for 3 days and just started to lessen. After the 1st dose on 4/19/2021, I started having worsening tinnitus in my right ear. I had it years ago, but was reduced to nothing with acupuncture. The noise in my right ear has gotten worse. It escalated after this second dose of the COVID vaccine. I now have constant tinnitus in my right ear. The sounds range from a siren to a microwave being constantly on.

I've developed skin rashes to several separate events. 04/18/2021 - Accidentally Cut my ankle while working on a fused glass project. Itchy rash developed around the cut. 5/02/2021 Developed a skin Rash on my chest, that was swollen with itchy red welts. 5/11/2021 Developed a skin rash on my neck after having a skin growth removed by my dermatologist. Rash developed after removal and is itchy with raised red bumps.Treated all with topical cortisol. Rashes still persist but do get slowly better with cortisone. Never have had any reactions like this before.

Rash on neck and chest, facial swelling. Symptoms began Friday, two days after injection, are still present now, Sunday, two days after they began.

swelling/soreness of left axillary lymph nodes, starting 2 weeks after 1st dose. Subsided within a few days. Reoccurred starting 3 days after the 2nd dose. Subsided after almost 2 weeks.

Sore arm where injection was given; body aches; muscle aches; headache; dizziness; felt very warm but had normal temp; Stiffness in legs; Slightly swollen arm; severe fatigue; numb toes and left leg-foot below the knee; diaphoresis; This is a spontaneous report from a contactable Nurse (patient herself). A 62-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection Batch/Lot number was not reported), via an unspecified route of administration on Arm Left on 26Jan2021 as 2nd dose, single for COVID-19 immunisation. Medical history included multiple sclerosis. Allergies to medications, food, or other products was reported as none. Concomitant medications were not reported. The patient historical vaccine includes first dose of BNT162B (lot number: EL0140) on 30Dec2020 (at the age of 62-year-old) on left arm for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Jan2021 23:30, the patient experienced sore arm where injection was given, body aches, muscle aches, headache, dizziness, felt very warm but had normal temp, stiffness in legs, slightly swollen arm, severe fatigue, numb toes and left leg-foot below the knee and diaphoresis. The patient was not diagnose with COVID-19 before vaccination and it is unknown if the patient diagnose with COVID-19 after the vaccination. Therapeutic measures were taken as a result of the events with Aleve every 8hrs. x2 and 1 Tylenol x1. The outcome of the events was reported as recovering. Follow-up attempts have been completed and no further information is expected. Information about lot/batch number cannot be obtained.

Axillary adenopathy L, total size of squashed golf ball, painful. 48 hr of fever then chills, headache, fatigue. Elevated resting HR and occasional chest ache. 11MAY reported to Dr elevated HR & chest aches. Continuing and spreading adenopathy L., 20MAY short of breath, cough, chest aches. Nodes swollen above & below L. clavicle. 22MAY headaches, chest pains sharp 4 times. Bed-rested except 30 min. walk until chest pain then sat until recovered then back to bed. Today total axillary is size of squashed baseball beginning impingement of muscles.

She got her vaccine in the left arm, and felt fine. She went shopping in the store and noticed that she was short winded when she was leaving, but felt that it was possibly asthma and left. She had a temperature between 102 and 103 for a couple of days and having fever and chills as well. She continued with the shortness windedness, and had company and on 5/9/21 they left and she started having severe pain, felt like it was either on the right side kidney or the lung, and was spasming horribly and knocking her down with the pain. She went to the ER and they did a CAT Scan thinking it was kidney stones, but told her that she had three blood clots in her lungs, lower base right and lower base left and mid right and part of her lung has apparently died due to this. They put her on blood thinners, Xarelto. She was admitted on 5/10 early morning and released on 5/12/21. The doctor in the hospital said that it did not make sense that she had blood clots in her lungs, but nothing in her legs. She told her that she was short winded, and he told her to report her reaction. Since being home she has been coughing a lot due to possibly the blood clots. She was told that she will be on the Xarelto for a very long time. She was also informed that she had lymph node enlargement as well.

Pt had second dose on 4/1/2021 and tested positive for COVID on 5/18/2021. Received antibody infusion on 5/20. Was admitted to the hospital on 5/21/2021 for pneumonia secondary to COVID-19 infection.

headache, congestion, runny nose, sneezing, burning eyes, watery eyes, higher than normal blood pressure, fever, chills, body aches, shortness of breath, coughing, muscle pain, injection arm pain, tiredness, feeling unwell, no energy, swollen lymph nodes under arm and below ear lobe,

(5/26) received 2nd covid vaccine at facility. Woke up on 5/27 feeling bad, left arm sore with the feeling of a tennis ball in my left arm pit (axilla) and sore or tender to touch. On (5/27) evening slept all night with left arm elevated on pillows. (5/28) Went to Urgent care /known side affect symptom (lymphadenopathy in left arm axilla d/t covid vaccine #2). When asked what I could take as pain tablet; Ibuprofen was recommended d/t trx of inflammation. As you can see from my date of vaccination, I have been reluctant to get this vaccine d/t side affects and my own known medical history. To my knowledge, i have not had Covid and have always worn a mask. So here I am.....

PER PT DESCRIPTION:I got the vaccine around 11 am last Friday. Thanks to you, I was calm and relaxed during the vaccination. I was fine and was able to return home safe. However, at around 5 pm, I felt a sudden pain on my right leg. My leg felt hot, became red, and had a big lump or swelling which was about 10 cm. The leg was not just feeling hot but was also hard like board. And I could not move my leg. I was really scared, and was thinking of calling an ambulance. Thankfully, everything went back to normal after 5 minutes - no pain, no swelling, no reddish color, and I was able to move my leg. However, after 30 minutes, the same thing happened to my left leg. But the pain was a little weaker and I could still move it despite the pain. The left one was not so bad compared with right one. And a few minutes after, my left leg was fine. Everything was okay like nothing happened. I did not notice any mark on any of my legs. However, at around 9 pm, I looked at my leg and I noticed a circular trace/mark which was about 10 cm on my right leg. Please see the photo attached.

headache; fever; chills; arm soreness; lymph node enlarged; This is a spontaneous report from a contactable nurse (patient herself). A 62-years-old female patient (not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6198) via an unspecified route of administration, in left arm on 04Mar2021 at 09:45 (at 62-years age) as 1st dose, single dose for COVID-19 immunisation. Medical history included high blood pressure. Patient had allergies to penicillin, bee stings, codeine, cheese, nuts. Concomitant medication(s) that patient received in two weeks included verapamil (VERAPAMIL ER); fish oil (FISH OIL); alpha lipoic acid (ALPHA LIPOIC ACID); zinc (ZINC). Patient did not receive any other vaccines within 4 weeks previous to the COVID vaccine. Facility type vaccine was Hospital. Patient had COVID prior vaccination. On 05Mar2021 at 01:00, the patient experienced headache, fever, chills, arm soreness, lymph node enlarged. Since the vaccination, the patient was not tested for COVID-19. Patient did not receive treatment. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.

This is a spontaneous report from a contactable consumer (patient). A 62-years-old female patient received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN6198), via an unspecified route of administration on 03Mar2021 (at the age of 62-years-old) as 1st dose, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On unspecified date of Mar2021, patient experienced headache, fever, chills, itching all over and face was swelling. Patient took couple of Tylenol as treatment for headache. No lab work was done. The outcome of all the events was unknown.mNo follow-up attempts are possible. No further information is expected.

For the last three days (starting 5/31), I have had enormously swollen feet. This is very, very unusual for me. I have only had swollen feet like this after long international flights. And the level of swelling was not anywhere near as extensive as this. (I have not travelled anywhere since the start of COVID-19.) This "event" started on Monday, 5/31/21. On day 1, towards the end of the day, I noticed that my left ankle and foot was enormously swollen. There was a clear difference between my left ankle and my right ankle (narrower). And my sandals cut into my foot as they never have. We have a friend who had surgery that removed all her lymph nodes at the top of her leg, so I had seen her lie on her back with her rump against the wall and her feet above her, resting on the wall, to drain out the fluid. So I tried that. I sat against the wall for 1/2 hour to see if the fluids would drain out of my ankles. It helped. I went to bed thereafter and in the morning both ankles were smaller diameter, with the left ankle still a little larger. On day 2, my left ankle was more of a problem and both ankles were significantly swollen. My left calf was also huge. I sat for most of the evening with my feet elevated and it helped a bit. Today, day 3, I decided to see whether exercise would make a difference. Between meetings (four times today), I walked from the second story of our house to the first floor and back up multiple times (10 times, 5 times, 5 times, 3 times). This did not help. In fact, it is much worse on day 3. At the end of the day today, both ankles were badly swollen, along with both calves. My calves are hard with the impact of the swelling.

Neck pain on shot side like whiplash; Finger joints swollen; Full body muscle and joint pain/ shoulder muscle pain; Sinus pain; Injection site pain; Severe temple/forehead headache; Full body muscle and joint pain/ shoulder muscle pain; Strong fatigue; This is a spontaneous report received from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205), via an unspecified route of administration on 16Mar2021 (at the age of 62-year-old) as single dose for COVID-19 immunisation. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot: EL9264), via an unspecified route of administration in the right arm on 23Feb2021 at 11:00 as a single dose for COVID-19 immunisation. Medical history included Arthritis, AVN (Avascular necrosis) left hip, tendonitis, high blood pressure, fibromyalgia. Patient was allergic to Penicillin. Concomitant medication included Ativan, Hydochlorothiazide (Manufacturer unknown), Valtrex, Wellbutrin and Zana (Manufacturer unknown) all for an unknown indication. 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 16Feb2021 at 20:00 hours the patient experienced finger joints swollen, full body muscle and joint aches, Injection site pain, shoulder muscle pain (like sprained), joint aches, neck pain on shot side like whiplash, severe temple or forehead headache, sinus pain, strong fatigue. Patient did not receive any treatment for reported events. Clinical outcome of the events finger joints swollen, full body muscle and joint aches, Injection site pain, shoulder muscle pain (like sprained), joint aches, neck pain on shot side like whiplash, severe temple or forehead headache, sinus pain, strong fatigue was not recovered/not resolved. No follow-up attempts are possible. No further information is expected.

Rash on right side; Some swelling; Itching right arm, right buttock and right calf; Skin pain right arm, right buttock and right calf; Felt like there were bugs crawling around patient; Tingling all over body with pain around body; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in left arm on 12Mar2021 at 10:30 (at an age of 62-year-old) as single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient was allergic to bug bites. She had no allergies that she knew of except when she got bitten by a mosquito, she swelled up also bug bites. She had a reaction to them, spiders, fleas ext. There was no other medical history. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included Calcium (MANUFACTURER UNKNOWN), vitamin D (MANUFACTURER UNKNOWN) and vitamin B12 (MANUFACTURER UNKNOWN) for an unknown indication and from an unknown start date and unknown if ongoing. On 12Mar2021 at 18:00, the patient experienced rash on right side, some swelling, itching and skin pain, right arm, right buttock and right calf, she felt like there were bugs crawling around, tingling all over the body with some pain/tingling around her body. The therapeutic measure was taken for event as benadryl. Events lead to doctor or other healthcare professional office/clinic visit. The clinical outcome of all events was resolved on an unknown date in Mar2021. No follow-up attempts are needed. No further information is expected.

PAIN BASE OF HEAD BACK OF LEFT EAR. LEFT EAR FELT LIKE IT WAS FULL OF WATER. TOOK TYLENOL 500 MG 2-3Xs DAILY FOR PAIN. ON FOURTH DAY WENT TO DR.'s OFFICE. NURSE PRACTITIONER SAID THAT MY LYMPH NODES WERE SWOLLEN IN NECK, THERE WAS ALSO YELLOW , PUSS LIKE SUBSTANCE IN LEFT EAR. SHE PRESCRIBED: AMOXICILLIN 875 MG 2X DAILY FOR 5 DAYS and PREDNISONE 60MG 1X DAILY FOR 3 DAYS PAIN HAS SUBSIDED, FULLNESS IN EAR IS STILL THERE, MY BALANCE IS SOMETIMES OFF

This is a spontaneous report from a contactable consumer. This 62-year-old female consumer reported (for herself). A 62-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6202 and Expiration Date not reported) via an unspecified route of administration on 02Mar2021 as 1st dose, single dose for COVID-19 immunization. The patient medical history included Blood pressure high from unspecified date to unspecified date. The patient concomitant medications included atenolol taken for blood pressure high from Unspecified date to Unspecified date. The patient reported that, she think that she was having side effects from the first COVID-19 vaccine. The patient had the shot on Tuesday, on Wednesday she was fine. On Thursday 04Mar2021, the patient reported that her chest started to feel like, her chest muscles were tired, and It was hard to tell whether it her my muscles. The patient thought she pulled a muscle or something. So, the patient did not think anything of it. On Friday, it got a little stronger and by yesterday, the patient upper chest felt like she had an upper respiratory infection, but the patient had no fever. The patient was able to breath. The patient reported, it hurts quite a bit for her to take a deep breath. The patient had constant aching and pain in the upper chest, it feels like her chest was being punched and the patient thought she was not positive, but the patient think that her lymph nodes were swollen. The patient reported that, it appears like every day, were little stronger. The patient agreed that events have worsened. The patient asked that, was there something that was expected to get worse or get a little bit better and How long this will last. The patient signed up for the disease safe with CDC. All this is in just to report that, she thought she would be given some insight or something. The patient asked Is there something that is expected to get worse or get a little bit better and How long this will last for. Consumer was informed about Pfizer Medical Information. The outcome of events was not resolved. No follow-up attempts are possible. No further information is expected.

Itching of tongue, mouth, throat; Itching of tongue, mouth, throat; Itching of tongue, mouth, throat; lump in throat; 2 asthma flare-ups; face swollen; itching on face, head and around eyes; itching on face, head and around eyes; Occasional waves of feeling very warm; burning feeling around elbows; This is a spontaneous report from a contactable consumer reporting for herself. A 62-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine administered via an unspecified route in left arm, on 07Mar2021 13:30, at 62 years of age, (Batch/Lot Number: EN6205) as single dose for COVID-19 immunization. Medical history included contrast media allergy, asthma, hypertension, hypothyroidism, glucose tolerance impaired (pre-diabetic) and allergy to erythromycin, cefaclor (CECLOR), penicillin, cefalexin (KEFLEX), neosporine, polysporin, sulfa drugs, eggs, tree nuts, peanuts, fish, shellfish, mushrooms, mustard, chocolate, some melons, raw apples (rashes of hives reactions). The patient didn't receive any other vaccine in the four weeks previous to COVID-19 vaccine. The patient received unspecified concomitant medications. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested from COVID-19 post vaccination. On 07Mar2021 at 13:45 the patient experienced itching of tongue, mouth and throat, sometimes lump in throat, 2 asthma flare-ups, face swollen, itching on face, head and around eyes, occasional waves of feeling very warm and burning feeling around elbows. The patient began treatment with famotidine (PEPCID) and diphenydramine hydrochloride (BENADRYL), contacted Doctor's office, then went to ER the day before this report. The physician assistant in ER prescribed 20 mg prednisone daily for 5 days. At the time of the report the reported events had not resolved yet. No follow-up attempts are possible. No further information is expected.

swollen armpit; slight fever and low grade fever; Arm pit is really sore; Caller explains they both have been experiencing having sinus issues, ear, neck, and throat feeling yucky; Her ears, nose and throat are very congested; sore arm; Her ears, nose and throat are very congested; Her ears, nose and throat are very congested; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 05Apr2021 (at the age of 62 years old) as 2nd dose, single dose for COVID-19 immunization. Medical history included sinus allergies from an unknown date and unknown if ongoing (lost her sense of taste and smell, she had symptoms like this before that she attributed to sinus allergies yearly, she had been treated for with antibiotics in the past), colonoscopy, allergy from an unknown date and unknown if ongoing (she has been treated for with antibiotics in the past), obese from an unknown date and unknown if ongoing. She uses a CPAP machine when sleeping. No history of previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. No other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. No adverse events following prior vaccinations. The patient's concomitant medications were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 12Mar2021 as 1st dose, single dose for COVID-19 immunization. The patient took Pfizer covid-19 vaccine as her husband had health issues, she was obese, and she wanted to go out. The patient stated that she received her second dose of the Pfizer-Biontech Covid19 vaccine, yesterday 05Apr2021. The patient reported that she had some of the same symptoms that daughter had, and it made her a little nervous. She also had a swollen armpit on the same side as the shot, arm pit was really sore, tender on that side and had a slight fever, a low-grade temperature, she did not experience after receiving her first dose. The patient reported arm soreness on injected arm and sinus allergy symptoms. She was having a hard time determining if her symptoms are from her vaccination, yesterday, or her exposure to Covid. She wanted to know if having the vaccine can affect the testing for Covid illness. The patient stated that sinus issues and ear, neck and throat congested worsened and feeling yucky, this started Sunday, on 06Apr2021. She was able to breathe through her nose. Her doctor told her to get tested, she was getting ready to call her doctor. She woke up feeling this way on Sunday. She described it as goopy and yucky. She had these before. The reported adverse events did not require a visit to emergency room/physician office. No relevant tests was reported. No investigation Assessment was reported. The outcome of the events swollen armpit was unknown and slight fever and low-grade fever, arm pit is really sore, caller explains they both have been experiencing having sinus issues, ear, neck, and throat feeling yucky, her ears, nose and throat are very congested, sore arm was not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

I did not suffer with constant angina issue before the vaccination. I am experiencing constant ongoing chest pain, which I never had a problem with before as well my throat and neck swelling, causing me to have swallowing problems. I still not get any relief for these issues.

Outbreak of cold sores on lip; This is a spontaneous report from a contactable consumer (patient herself). A 62-years-old female patient received bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: En6201, Expiry date: Unknown) via an unspecified route of administration in the right arm on 08Mar2021 at 09:30 (at the age of 62-years-old) as unknown, single dose for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Patient did not have known allergies. Patient's medical history was not reported. Concomitant medications included vitamin E, probiotic, fish oil (OMEGA 3), dexpanthenol, lidocaine hydrochloride, nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride (B COMPLEX) and vitamin D. Patient does not have COVID, prior vaccination. Patient has not been tested for COVID post vaccination. No other vaccine in four weeks. On 11Mar2021, the patient experienced outbreak of cold sores on lip. Therapeutic measures were not taken as a result of adverse events. The outcome of event was not recovered. No follow-up attempts are possible. No further information is expected.

outbreak of herpes/outbreak of cold sores like herpes; outbreak started last night, and has gotten worse; This is a spontaneous report from a contactable consumer. A 62-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6205, Expiration date: Unknown), via an unspecified route of administration in left arm on 01Mar2021 at 9:02AM (at the age of 62-years) as single dose for covid-19 immunization. The patient medical history included pernicious anemia. The patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine bnt162b2. The patient did not have any adverse events following prior vaccinations. The patient had no previous history of immunization with the Pfizer vaccine considered as suspect. The patient had no relevant family history relevant to the adverse event. Concomitant medications included cyanocobalamin (B-12) injection once a month for pernicious anemia. The patient's last dose cyanocobalamin was in the end of Dec2020. She stated that she though she was behind a little on the doses. The patient stated that she took bnt162b2 vaccine because she didn't have a good immunity. On 04Mar2021, the patient experienced outbreak of herpes. The patient stated that she had vaccine on Monday, 01Mar2021 and wanted to know if anyone had reported an outbreak of herpes following the vaccine. She stated she weighed too much. The patient stated that the outbreak started last night and had gotten worse. She stated that she only gets the outbreaks when her body is under stress, either emotional stress or a sickness. She just wanted to make sure that it's okay to take the acyclovir. Her doctor told her that it was okay to take it, but it's an anti-viral medication, and she didn't want to use anti-viral with the vaccine. The patient stated that the only thing she was been able to find online was not to take the acyclovir before getting the vaccine, and it had been a few days since she got the vaccine. The patient stated she had hit option and had got to safety. The patient stated she had outbreak of cold sores like herpes on 04Mar2021. The patient stated she had the COVID-19 vaccine on Monday, 01Mar2021 and it was the first of the two doses and it was the Pfizer vaccine. The patient wanted to know if anybody was reporting an outbreak of cold sores like herpes following the injection. The patient was informed about the role of Pfizer Drug Safety and Pfizer Medical Information. The patient was provided with the contact number for Pfizer Medical Information. Upon request for permission to probe questions for a safety report, the patient stated that she did not call for that. She stated she called because she thought she had a reaction. The patient provided consent to follow-up. The patient provided her mailing address. She stated that she was at work and could not stay on the phone for so long. The patient stated that it had already been around 25 minutes on the phone. The product details and pharmacy details could not be probed as the patient was unwilling to complete the report. Hence limited information was available over the call. The event did not lead to emergency room visit or physician office visit. The patient did not undergo any relevant diagnostic and confirmatory test for the event. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.

Few days after receiving the vaccine around 4/25, my mother complained to me that she was feeling very weak and tired, she was unable to hold anything down. She also had a rash. She became weaker and weaker so suddenly and unable to even drink protein drinks. She finally went to the ER on 5/4 because she could barely walk, unable to eat anything and was short of breath. They diagnosed her with pneumonia and a possible lung mass. She was diagnosed simultaneously 10 days later with small cell lung cancer however she had no symptoms prior. She received first dose chemo on 5/20/21 and had a reaction to the chemo that the doctor stated was very rare. They then had to try a different type of chemo for second dose 2 days later. She progressively got worse suddenly after chemo dose #3 and was in renal failure the day following chemo completion. She died on 5/27/2021. Her primary death diagnosis was sepsis, pneumonia and small cell lung cancer. I am reporting this for my mother because the vaccine has not been tested on cancer or chemo patients. It can and should not be regarded as coincidental. It needs to be tracked in case there are future reports regarding cancer patients.

In April, I had two raised areas around my bumps which were thought to be lymph nodes. The CAT scan was done and it was not lymph nodes I was told that it could be Cushing's disease. I also had muscle fatigue and general fatigue just not feeling well.

headache dull after second vaccine; Cold sore, on the bottom of her lip, after second vaccine/Cold sore, upper lip, but larger, after second vaccine; This is a spontaneous report from a contactable consumer (patient). A 62-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0164) via an unspecified route of administration, administered in left arm on 23Apr2021(at the age of 62-years-old) as a 1st single dose for covid-19 immunisation. Patient had no medical history and concomitant medications. Patient did not administer any other vaccine prior to 4 weeks of vaccination. Patient did not administer any additional vaccines on same date of the pfizer suspect. Patient had no adverse reactions following prior vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: ER8732) via intramuscular administered in upper left arm on 24Mar2021 around 14:00 (at the age of 62-year-old) as 1st single dose for covid-19 immunisation. Patient informed that side effects occurred after the second dose of vaccine on 23Apr2021. On 25Apr2021, patient experienced a cold sore on the bottom of lip that was for a couple of days. The patient noticed it probably when she got up in the morning and it didn't last for too long. The patient stated that she would get a cold sore, usually, about once a year. On past Monday, 03May2021, patient got a cold sore on her upper lip, but larger and she was on the path to healing and the cold sore has peaked. The patient works in a hospital, reclarified, and the nurses told her that she should, report her event. Patient also had a headache around noon time with this cold sore and she was taking medication. The headache as dull, and it was ongoing and patient took a couple of Motrin which was effective for her headache. Patient stated she usually gets a headache, when she gets a cold sore. Patient was taking a prescription medication for cold sore Cyclovir and it was shortening the length of time for healing and the cold sore was not lasting as long as it normally would, as when she doesn't take the medication. Patient thinks it was unusual that she got both cold sores after the second vaccine. The adverse event did not require emergency room or physician office visit. The outcome of events was not recovered. No follow-up attempts are needed. No further information is expected.

slight swelling of face near eyes; faster heartbeat than normal; redness on one side of tongue; nausea; feeling a bit of tightness in the throat; tightness in the chest; This is a spontaneous report from a contactable consumer (patient). A 62-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 25Feb2021 at 15:30 (at the age of 62-year-old) as unknown, single dose for COVID-19 immunisation. Medical history included diabetes type II, allergies to nuts and cefzil. Concomitant medications included clindamycin HCL, citalopram, rosuvastatin and pioglitazone hydrochloride (PIOGLIT). The patient did not receive any other vaccine in four weeks. The patient did not have COVID prior vaccination. The patient did not test COVID post vaccination. On 26Feb2021 at 03:00, the patient experienced slight swelling of face near eyes, faster heartbeat than normal, redness on one side of tongue, nausea, feeling a bit of tightness in the throat and tightness in the chest. The patient stated none of the symptoms were stopping her from working. The patient took some Benadryl and feeling a bit better. Outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Itching on tongue, throat, asthma attacks, swollen face, redness in face, itching on skin, lump in throat. Initial event(Itching on tongue, throat, skim). The other effects occurred in the days following, some events re-occurring (particularly facial swelling) for over a month.

Systemic: Blood Disorder (diagnosed by MD)-Medium, Additional Details: Patient reported that within 1 hour of receiving vaccine, she noticed leg pain and swelling. She went to the ER where she was diagnosis with a blod clot in the lower leg. The patient was started on a blood thinner (Eliquis) to treat DVT and prevent further clotting. Patient reported that she swelling and leg pain has gone down significantly but she still notes some swelling at the site of the clot.

Hives/Rash; Facial swelling; This is a spontaneous report from non-contactable consumer, the patient. A 62-years-old non pregnant female patient 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 28Feb2021, as a single dose for COVID-19 immunisation. Medical history included osteoarthritis, fibrocystic breast, tonsils surgery, caesarean, myomectomy, sensitivity to dairy/some fruit, feathers/wool/pets and seasonal allergy. Concomitant medications included ALLERCLEAR; glucosamine (MANUFACTURER UNKNOWN); EMERGEN C IMMUNE PLUS; guaifenesin (MUCINEX) all from an unknown date for unknown indication. 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 03Mar2021, the patient experienced hives/rash and facial swelling. The patient was treated with methylprednisolone for all the events. The clinical outcome of hives/rash and facial swelling was resolving. No follow-up attempts are needed. No further information is expected.

Left hard pain in shoulder and scapula, enlarged lymp noded under left arm, 3 growths in breast that were removed and benign and I was clear in October by an MRI prior. Had to have a surgical biopsy as I had a bilateral mastectomy in 2017 and reconscrution and was clear for 4 years. Lost a patch of hair after vaccine on left side of head.

I received my second shot on 4/26/21. On 4/27/21, I visited Dr. to establish care. My blood pressure recorded lower than normal at that visit(I usually have high blood pressure). Dr. ordered blood work. The WBC,RBC & ABS neutrophil were low. The numbers were in the normal range on 6/1/21. Extreme fatigue began by 4/30. My left arm began to swell by the week of May 3-9. I was sleeping all day for 3 wks. I had pain in left arm, shoulder, neck. I've had tightness in my chest. On May 14, when I visited Dr. for a pap, she noted my fatigue as well. At my visit with on 6/28/21, I requested an EKG. It was abnormal, reporting sinus bradychardia. I will see a cardiologist soon.

herpes reactivation; herpes reactivation worsened; this was herpes S1 since it was on her face; broke out on her lower lip and a couple of days later she broke out in the back of her throat next to the uvula; This is a spontaneous report from a contactable consumer reported for herself. A 62-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot Number: EN6208; Expiration date was not reported) via an unspecified route of administration, administered in arm left on 27Mar2021 10:50 (at the age of 62-years old) as dose 1, single and received second dose via an unspecified route of administration, administered in arm left on 17Apr2021 (Lot number: ER8737; at the age of 62-years old) as dose 2, single for COVID-19 immunisation. Medical history included genital herpes that she has had in the past from unknown date and unknown if ongoing. Other medical history or conditions, concomitant products, investigational assessment, test results, history of all previous immunization with the Pfizer vaccine considered as suspect, additional administered vaccines included none. Prior vaccinations (within 4 weeks) were not reported and for adverse events (AE) following prior vaccination, patient stated no not herpes. For family medical history relevant to AE, the patient stated she was not really sure what was relevant to herpes. Patient took COVID 19 vaccine for protection from COVID so she would not have to go to the hospital. No other products taken. On 27Mar2021, the patient experienced herpes reactivation which was reported as worsened, and this was herpes S1 since it was on her face; it broke out on her lower lip and a couple of days later she broke out in the back of her throat next to the uvula. Therapeutic measures were taken because of events. No emergency room visit was done. Clinical course was as follow: The patient calling about the COVID-19 vaccine to report a side effect. The patient saw a nurse practitioner which was an APRN for her side effect. The patient had a herpes reactivation on her face instead of genital herpes that she has had in the past. The patient stated this was herpes S1 since it was on her face. This started the first day that she received the first vaccine, and she broke out on her lower lip and a couple of days later she broke out in the back of her throat next to the uvula. The patient noticed the first day because she knew the symptoms. The patient stated she took ACYCLOVIR, which was recommended, and the herpes reactivation was strong enough it broke out. The patient was treating her symptoms with ACYCLOVIR, 5 times a day which 5 times a day was the maximum. For the second dose of the vaccine, she made sure she had enough to take the extra 5 times a day and she still broke out within hours. She was having to take 5 pills of the ACYCLOVIR to keep her symptoms at bay instead of the normal 2 pills. Relevant tests included none. Clinical outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.

I began with leg swelling in both legs from the ankle to the knee I thought my thighs were swollen but not sure.; Starting today with itchy skin from my both feet to my knee caps.; I am still experiencing Itchy and redness, not sure if red; I am still experiencing Itchy and redness, not sure if red, because of the lighting in my apartment but it is itchy and painful.; This is a spontaneous report from a non-contactable consumer or other non hcp. A 62-years-old female patient received First Dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection,Batch/Lot Number: EK4176) via an unspecified route of administration on 03Feb2021 as SINGLE DOSE for an unspecified indication. Medical history included drug hypersensitivity from an unknown date if ongoing.The patient's concomitant medications were not reported. On the 05Feb2021,patient stated that, I began with leg swelling in both legs from the ankle to the knee I thought my thighs were swollen but not sure. Starting today with itchy skin from my both feet to my knee caps. I went to Clinic and they gave me a prescription for the later pill, I can't remember the name, if it was lasix, patient said yes. Patient stated that, because my legs were swollen, and they didn't see any reason to give me anything else. I am still experiencing Itchy and redness, not sure if red, because of the lighting in my apartment but it was itchy and painful. Is this a side effect. If he gives me an antibiotic is it advisable. The outcome of the events was not resolved on Feb 2021. No follow up attempts are possible. No further information is expected.

Major pain in her joints/bones, in her hands and in her knees, her back, lower back; Major pain in her joints/bones, in her hands and in her knees, her back, lower back; Arthritis; Tiredness; Joint pain in hands and knees (throbbing and stabbing pain; throbbing and stabbing pain; Hands and knees have the most severe pain; Swelling of hands; Harder and harder to walk; Migraine/migraine headache; This is a spontaneous report from a contactable pharmacist. This pharmacist reported for a 62-year-old female patient that received bnt162b2 (BNT162B2 Formulation: Solution for injecction), dose 1 intramuscular, administered in Arm Left on 01Jun2021 13:00 (Batch/Lot Number: EW0177) as DOSE 1, SINGLE for covid-19 immunisation. Medical history was not reported. concomitant medication(s) included estradiol, norethisterone acetate (COMBIPATCH) taken for an unspecified indication, start and stop date were not reported. Patient not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient diagnosed with COVID-19 was no and Since the vaccination, has the patient been tested for COVID-19 was no.The patient experienced joint pain in hands and knees (throbbing and stabbing pain), throbbing and stabbing pain , hands and knees have the most severe pain , swelling of hands, harder and harder to walk, migraine/migraine headache on Jun2021 (Unspecified day) major pain in her joints/bones, in her hands and in her knees, her back, lower back, major pain in her joints/bones, in her hands and in her knees, her back, lower back, arthritis, tiredness on an unspecified date. Caller states she had almost immediately after the shot came a major migraine headache, it didn't last very long, it went away, and since then it comes and goes, but not an every day occurrence. Caller states what is an every day, constant occurrence, which had her concerned, which has been affecting her work, she works on a computer with a keyboard and mouse is there's major pain in her joints/bones, in her hands and in her knees, her back, lower back. Caller states she has arthritis in lower back and have had injections done there so that's no surprise. Caller states she has had some tiredness. Caller states she's constantly working with her hands etc. so her hands get tired. Caller states what she's never had before is this constant throbbing pain, pain in her joints that are in her hands, knees, and she has a constant pain across her back, is that her clavicle the back part? Caller states the upper part of her back where her shoulders connect together, that whole section is a throbbing pain. Caller states her hands and knees are throbbing and in pain constantly, it keeps her up some nights. Caller states she is right now rubbing her knuckles and hands. Caller states she does have a high pain tolerance and she pushes through it until she clocks out. The patient not received treatment for the events. The outcome of the events Major pain in her joints/bones, in her hands and in her knees, her back, lower back, Arthritis and Tiredness was unknown and other events was not resolved.

On 2nd day after vaccine my face was swollen around my eyes and cheeks. Eyes hurt and were red. NO itching or redness on face. Next I began to have pain and tenderness behind my right ear with sharp shooting pains along jaw line and behind R. ear. Loss of sense of smell and taste (has returned but not normal yet). Extreme fatigue, aching joints. Several weeks later I awoke to find my right eye red and swollen. I have been unable to wear contact lens and my eyes have not returned to normal. Ophthalmologist believes some type of inflammatory response or maybe I had COVID 19 virus.

Under arm lymph nodes swollen, breasts swollen and painful, brain fog, headaches, all over body pain, jaw pain, eyesight worse, arthritis pain much worse. Started about three weeks after second vaccine and continues today

Hot itchy lightly bumpy rash started on cheeks, daily progressed to head, neck, chest , abdomen and back, arms and legs x?s 2 weekFace swollen twice size 4/29/21 in am, swelling slowly increased to whole body x?s 2 weeks. OTC Benadryl, cold compresses, baking soda bath Course of Prednisone 60 mg x?s 2 days, 40 mg x?s 2 days, 30 mg x?s 2 days, 20 mg x?s 2 days, 10 mg x?s 2 days, 5 mg x?s 2 days. Some improvement, second course of Prednisone 20 mg x?s 5 days Swelling face, upper arms and abdomen continue, rash on cheeks continue., whole body itching continues.

Swollen, severe pain, red ring around right breast that has a titanium clip inserted. Underarms discoloration from dark to red color with ring. Vulva pain to the touch, groin pain, lower back pain. Stomach aches, swollen hot feet, hot flashes, sweating, heartburn, cheeks on face became flushed first hour after vaccination

Left arm bruised; Left arm swollen; Left underarm swollen; Left underarm painful; Left side to waist swollen; Left side to waist painful; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old male patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727) via an unspecified route of administration in the left arm on 27Mar2021 at 13:30 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included Hashimoto disease, COVID-19, anxiety due to COVID illness and COVID-19 anosmia. Allergies to medications included ampicillin and penicillin. Concomitant medications received within 2 weeks of vaccination included levothyroxine (MANUFACTURER UNKNOWN), citalopram (MANUFACTURER UNKNOWN), magnesium (MANUFACTURER UNKNOWN) and sambucus nigra (ELDERBERRY). Prior to vaccination, the patient was diagnosed with COVID-19 on unspecified date. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. On 29Mar2021, the patient experienced events of bruise in left arm, swollen left arm, swollen left underarm, painful left underarm, left sided swelling to waist, left sided pain to waist. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Treatment received for the adverse events was reported as no. The clinical outcome of events bruise in left arm, swollen left arm, swollen left underarm, painful left underarm, left sided swelling to waist, left sided pain to waist was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.

Lump under left armpit the size of a golf ball; Tender lump under left armpit.; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number ER2613) via an unspecified route of administration in the left arm on 25Mar2021, at 15:00 (at the age 62-years-old), as a single dose for COVID-19 immunisation. Medical history included breast cancer and atrial fibrillation(A-Fib). Allergies to medications included avelox, celebrex, lortab/vicaden, oxycodone/percocet. Concomitant medications received within 2 weeks of vaccination included apixaban (ELIQUIS), propafenone (MANUFACTURER UNKNOWN), pantoprazole (MANUFACTURER UNKNOWN), and atorvastatin (MANUFACTURER UNKNOWN). The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EN6203) via an unspecified route of administration in the left arm on 04Mar2021, at 15:30 as a single dose for COVID-19 immunisation. The patient did not get any other vaccine within 4 weeks of COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 29Mar2021, the patient underwent COVID-19 molecular test and the result was negative. On 27Mar2021 at 04:00, the patient experienced event of lump under left armpit the size of a golf ball and event of tender lump under left armpit. The events did not result in doctor or other healthcare professional office/clinic visit. Treatment received for the adverse events was reported as no. The clinical outcome of event lump under left armpit the size of a golf ball and event tender lump under left armpit was resolving at the time of this report. No follow-up attempts are needed. No further information is expected.

swollen lymph nodes underarm right side; Chills; Head ache; Low grade fever; sleepy; Light headed; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the right arm on 27Mar2021 at 13:45 (at the age of 62-years-old), as a single dose for COVID-19 immunisation. Medical history included Multiple Sclerosis (MS) and high blood pressure. The patient was allergic to medications, food and other products. The patient received an unspecified concomitant medication within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not tested for COVID-19. On 27Mar2021, the patient experienced chills, headache, low grade fever, sleepy and light headed. On 29Mar2021, the patient experienced swollen lymph nodes under arm on the right side. The event neither resulted in doctor or other healthcare professional office/clinic visit nor emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events chills, headache, low grade fever, sleepy, light headed and swollen lymph nodes under arm on the right side was not resolved at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Swelling on Ulnar side of left hand.; blisters on left hand; hard lumps on left hand and wrist; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6207) via unspecified route of administration in the left arm on 27Mar2021 at 11:00 (at the age of 62-years-old), as a single dose for COVID-19 immunisation. Medical history included high blood pressure. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN), evolocumab (REPATHA), losartan (MANUFACTURER UNKNOWN) and levothyroxine (MANUFACTURER UNKNOWN); all from unspecified dates for unknown indications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EM9809) via unspecified route of administration in the left arm on 06Mar2021 at 11:45 (at the age of 62-years-old), as a single dose for COVID-19 immunisation and montelukast (MANUFACTURER UNKNOWN) on unknown date for unspecified indication and experienced drug allergy. The patient had not received 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 28Mar2021 at 09:00, the patient experienced swelling on ulnar side of left hand, five hard lumps on left hand and wrist and blisters on left hand. The patient did not receive any 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 the events swelling, lumps and blisters was recovering at the time of reporting. No follow-up attempts are needed. No further information is expected.

developed a large red and swollen area on the injected arm but not at the injection site; developed a large red and swollen area on the injected arm but not at the injection site; not bend both thumbs for over 24 hours; lost at least 80 percent of my hearing in the right ear/significant hearing loss; tinnitus; This is a spontaneous report from a contactable other healthcare professional (patient). A 62-years-old female (not pregnant) patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: EW0171, Pfizer NTEC), via an unspecified route of administration in left arm on 29Apr2021 at 08:00 as a single dose for COVID-19 immunization (at the age of 62-years-old). The patient medical history and concomitant medications were not reported. The patient had no known allergies. The patient did not receive any medication within 2 weeks of vaccination. 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. Patient stated that after dose two on 29Apr2021, she could not bend both thumbs for over 24 hours. She also developed a large red and swollen area on the injected arm but not at the injection site. This condition lasted 3 days. She then lost at least 80 percent of my hearing in the right ear, the patient developed joint stiffness. As of 23Jun2021 she still had tinnitus in the right ear and still have a significant hearing loss. There has not been much improvement to either symptom since 29Apr2021. The patient did not receive any treatment. The clinical outcome for the events, lost at least 80 percent of my hearing in the right ear and tinnitus was not recovered whereas for events, not bend both thumbs for over 24 hours was recovered on 30Apr2021 and for event, developed a large red and swollen area on the injected arm but not at the injection site was recovered in May2021. Additional information has been requested.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the event: deafness and the administration of the vaccine cannot be excluded.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Face redness, swelling and itching, after second vaccine.; Neck and upper back pain, after second vaccine.; Neck and upper back pain, after second vaccine.; Pain at the injection site, after both vaccines; Left arm: red, warm, hot, redness spreading with localized itching, after second vaccine./Face redness, swelling and itching, after second vaccine.; Left arm: red, warm, hot, redness spreading with localized itching, after second vaccine.; Left arm: red, warm, hot, redness spreading with localized itching, after second vaccine./Body itching; This is a spontaneous report from a contactable consumer. A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0196, Expiry date: unknown, at the age of 62-year-old), dose 2 via an unspecified route of administration, administered in Arm Left on 26Jun2021 17:00 as dose 2, single for covid-19 immunisation. Medical history included blood cholesterol increased, hypertension from 2018 to an unknown date (3 years ago), gastrooesophageal reflux disease from 2019 to an unknown date (2 years ago). Concomitant medication(s) included simvastatin (ZOCOR) from 2018 and ongoing, orally at 10 mg, 1x/day (once a day) taken for blood cholesterol increased; lisinopril from 2019 and ongoing, orally at 10 mg, 1x/day (once a day) taken for hypertension; omeprazole (PROTONIX [OMEPRAZOLE]), orally at 40 mg, 1x/day (once a day) from 2019 and ongoing taken for gastrooesophageal reflux disease (about 2 years ago, when she started using medication). Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0180, Expiry date: unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 05Jun2021 17:00 as dose 1, single for covid-19 immunisation. The patient reported, she had an allergic reaction to the second vaccine. Yesterday, the injection site and half of her left arm, was red, warm, and hot. Some of the redness has spread. Today her face was red and her body itched, but she had no hiaves. Then reports as it has now worsened, and it is accompanied by swelling and itching. Adds that these are specific to her face with the redness. States that she took Xyzal, 5 mg tablet by mouth, every 24 hours. She is not sure of the effect yet, but states that the medication has worked before for her other allergies. The night (3 AM) after the second vaccine, she had pain, specifically to her neck and upper back. She had to take painkillers, and she took both Aleve on Sunday, and Ibuprofen on Monday, and they both were effective. States that yesterday she could not work. The patient experienced pain at the injection site, after both vaccines, left arm: red, warm, hot, redness spreading with localized itching, after second vaccine, swelling and itching, after second vaccine on 26Jun2021; neck and upper back pain, after second vaccine on 27Jun2021; Face redness, swelling and itching on 29Jun2021. Prior Vaccinations (within 4 weeks) was No. Outcome of the events for neck pain and back pain was recovered on 28Jun2021 and for rest of the events it was not recovered.

Puffiness on left side above waist (armpit, face); Headache; Injection site soreness; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6205), via an unspecified route of administration on the left arm on 01Mar2021 at 08:15 (at the age of 62-year-old), as a first single dose for COVID-19 immunisation. Medical history included atrial fibrillation and other heart concerns. Concomitant medication included mtroplol (MANUFACTURER UNKNOWN), spironolactone (MANUFACTURER UNKNOWN), furosemide (MANUFACTURER UNKNOWN), Lsrtn (MANUFACTURER UNKNOWN), Xrlto (MANUFACTURER UNKNOWN), Actomnphn (MANUFACTURER UNKNOWN). The patient did not know whether had any known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 01Mar2021 at 08:15, the patient experienced headache, very minor puffiness on left side above waist (armpit, face), extremely minors injection site soreness only if touched the next day. The patient also reported that headache and puffiness were gone next morning and soreness did not even last the entire day following injection. The patient did not receive any treatment for the reported events. 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 clinical outcome of the events headache, puffiness on left side above waist (armpit, face) was resolved on 02Mar2021 and injection site soreness was resolved on an 01Mar2021at the time of this report. No follow-up attempts are needed. No further information is expected.

I experienced lymph nodes under my left arm and to the back of my left shoulder blade which lasted a couple of weeks. I also developed pneumonia which I did not know I had which resulted in me having a flat lung, right lung base. I do not know if me having pneumonia was in correlation to the vaccine. I do not have the lymph nodes today under my left arm. I still have issues with my right lung which I am currently being treated. I do not have lot# to provide.

Still experiencing inflammatory response like swollen gland in the neck; Joint pain; pain; swollen, tender, colored toe; swollen, tender, colored toe; Swollen knuckles; fever; experiencing swelling to the side of neck; This is a spontaneous report received from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,Batch/Lot Number: EN6199), intramuscular, administered in Arm Left on 06Mar2021 10:00 as DOSE 2, SINGLE for covid-19 immunization. Patient had no medical history or concomitant medications. The patient experienced experiencing swelling to the side of neck on Mar2021 with outcome of not recovered , still experiencing inflammatory response like swollen gland in the neck (lymphadenopathy) on an unspecified date with outcome of recovered , joint pain (arthralgia) and swollen knuckles (joint swelling) on 08Mar2021 with outcome of recovering , pain on an unspecified date with outcome of recovering , fever (pyrexia) on 07Mar2021 with outcome of recovered , swollen, tender,colored toe (joint dislocation) and swollen, tender, colored toe (pain in extremity) on an unspecified date with outcome of not recovered.The patient underwent lab tests and procedures which included x-ray: covid toe on 13 feb21. Therapeutic measures were taken as a result of experiencing swelling to the side of neck , still experiencing inflammatory response like swollen gland in the neck (lymphadenopathy), joint pain (arthralgia), swollen knuckles (joint swelling), pain , fever (pyrexia), swollen, tender, colored toe (joint dislocation), swollen, tender, colored toe (pain in extremity). Follow up (17May2021): This is a follow-up spontaneous report from a contactable consumer.This consumer reported for herself that:she is experiencing inflammatory response like swollen gland in the neck. Batch/lot number EN6199 start date of drug reported as 06 mar2021.Date of first vaccination: Consumer stated it as 13Feb2021 but not clarified.LOT# of first vaccine: EN9581.Further probing could not be initiated as consumer was unwilling to further answer the questions. Hence, other details were unknown and limited information was available over the call. Follow up (17May2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported for herself that included event as reported by primary source was swollen, tender, colored toe on 15Feb2021 with outcome of recovering. Event fever start date reported as 07th mar2021 and end date was reported to be 08th mar2021.Dates for swollen knuckles at the top of her hand reported to be from: 08Mar2021 To: Ongoing.Event: swollen glands in her neck that is painful and sensitive was reported as worsened. Caller mentioned in call about the side effects she has experienced in two days after the first injection she had a swollen, tender, colored toe that was described by the physician as a COVID toe. Caller stated the color has improved but has not gone away. Caller stated she went to see a Podiatrist who took an x-ray to rule out arthritis and confirmed it was also the so called COVID toe. Patient was advised to use a anti inflammatory cream for toe discoloration.Patient stated that this colored toe started after her 2nd dose that is 13th feb2021.

Pt reports that she had a globus sensation and some shortness of breath PRIOR to receiving the vaccine. She was monitored 15 minutes post-injection without incident. When she walked out to the hallway to go home she reported that she felt like she was going into anaphylaxis and a Rapid Response was called overhead. She was complaining of feeling like her hands and feet were swelling and that he voice was hoarse. Her lips were noted to be large and her husband confirmed that they looked larger than normal. She was found to be hypertensive to 196/109 so analyphylactic shock was ruled out and she was not treated with an epi pen. She was transferred to the ER. Exam found scattered wheezing, mildly protuberant lower lip, no tongue swelling, no drooling. She was treated with IV solumedrol 125mg, IV benadryl, IV famotidine, and a racemic epi nebulizer. ENT came and visualized her airway via NPL and found no oropharyngeal or laryngeal edema. She was admitted to the MICU for 48-hour anaphylaxis observation and continued on steroids and anti-histamines. By the following morning she was feeling well.

Chills; Fever; Muscle aches; Headache; General fatigue; Nausea; Lymph node discomfort; This is a spontaneous report from a contactable consumer, the patient. A 62-years-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 02Apr2021 at 12:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included bronchitis asthmatic from an unspecified date. Patient received other medications in two weeks which included fluoxetine hydrochloride (PROZAC) from an unspecified date for an unknown indication. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 12Mar2021 at 12:00 (at the age of 62-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. The patient had no known allergies. On 02Apr2021 at 22:00 the patient experienced chills, fever, muscle aches, headache, general fatigue, nausea and lymph node discomfort. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of chills, fever, muscle aches, headache, fatigue, nausea and lymph node disorder were not recovered at the time of reporting. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

weakness on her left side; her left side and foot feels numb; her heart was off the charts; Feels like from her foot from the ankle down, is swollen on the left side; Felt like her throat was burning down to her chest; anaphylaxis; had a hard time breathing; could not swallow; Ungodly taste in her mouth, god awful taste in her mouth; This is a spontaneous report from a contactable consumer or other non hcp. A 62-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 02Jul2021 10:30 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation . Medical history included cerebrovascular accident from 1995 to an unknown date , surgery from 1995 to an unknown date , splenectomy from an unknown date and unknown if ongoing , urinary tract infection from an unknown date and unknown if ongoing. Concomitant medication(s) included lamotrigine (LAMOTRIGINE) taken for seizure from 2019 and ongoing; modafinil (MODAFINIL) taken for an unspecified indication, start and stop date were not reported; melatonin (MELATONIN) taken for somnolence from an unspecified start date and ongoing; valproate semisodium (DEPAKOTE) taken for an unspecified indication, start and stop date were not reported. The patient previously took amoxicillin and experienced urticaria, heparin and experienced drug hypersensitivity, penicillin nos and experienced drug hypersensitivity, sulfamethoxazole and experienced gastrointestinal tract irritation. The patient experienced anaphylaxis (anaphylactic reaction) (medically significant) on 02Jul2021 with outcome of not recovered , had a hard time breathing (dyspnoea) (non-serious) on 02Jul2021 with outcome of not recovered , could not swallow (dysphagia) (non-serious) on 02Jul2021 with outcome of not recovered , weakness on her left side (asthenia) (non-serious) on an unspecified date with outcome of not recovered , her left side and foot feels numb (hypoaesthesia) (non-serious) on an unspecified date with outcome of not recovered , ungodly taste in her mouth, god awful taste in her mouth (taste disorder) (non-serious) on 02Jul2021 with outcome of not recovered , had to monitor her heart because it was off the charts (cardiac disorder) (non-serious) on an unspecified date with outcome of not recovered , felt like her throat was burning down to her chest (burning sensation) (non-serious) on 02Jul2021 with outcome of not recovered , feels like from her foot from the ankle down, is swollen on the left side (peripheral swelling) (non-serious) on an unspecified date with outcome of not recovered. The action taken in response to the event(s) for bnt162b2 was not applicable. Therapeutic measures were taken as a result of had a hard time breathing (dyspnoea) , had to monitor her heart because it was off the charts (cardiac disorder). Information on the lot/batch number has been requested.

I had the vaccine on 01/14/2021 and a couple of weeks later my hands and legs started to get swollen. My doctor sent me to get some x-rays for my hand and it came back with no arthritis and also an ultrasound for my leg because it hurt and I had an edema and this was to rule out any blood clots. There were no blood clots. A couple of weeks before this I hit my leg with a dishwasher door and it was healed, later my ankle area was sore and swollen. They also did blood work and it came back normal. They just told me to take Ibuprofen 800 for inflammation.

After few days of second dose of COVID vaccine, right cheeks was noted to be swollen and tender to touch upon waking in the morning as if someone placed an apple inside the cheek. Swelling progressed to up to eyes, below lower jaw and near nose. Swelling and pain persisted for 3-4 days and disappeared on its own, I was advised to take only Tylenol and nothing else. After swelling and inflammation on cheeks resolved then occasionally and randomly rashes, redness, small tiny skin eruptions with itching appear above the skin or even under the skin then resolves on their own. Now symptoms are progressing affecting vision and hearing . I could watch TV without glasses but now suddenly they appear blurred. For the last three days, right ear has echo of external sound such as if I am sitting in front of TV it appears sound is echoing in right ear, which is annoying and discomforting.

After the Pfizer injection, I waited for 30 minutes at the hospital. I drove home and began having a terrible headache/migraine (which I do NOT get/have). My left arm was sore which I expected based on family members input. I then broke out with a slight rash on my left arm and then welts began to appear on my left shoulder. I showered with an oatmeal bar to help relieve the itching and reduce the swelling. I continued to drink fluids on Wednesday from 5 to 1030 p.m. The nurse at the hospital that gave me the injection suggested Tylenol and fluids. I did both. On Thursday from 7 a.m. to approx 1 p.m. the headache and pounding remained. I was lethargic and just slept. Very little energy and had sensitivity to light on Thursday. Loss of appetite. This occurred from Thursday through late Saturday afternoon. I also began to have shingles appear/small bumps that have now begun to fade on my left trunk, calf and right calf. They began to appear early Thursday a.m. My headache is now gone as of Sunday 7/25 @ 12:12 a.m.

I had swelling under my left armpit with pain. I didn't associate it with the vaccine and used Ice and heat in an attempt to reduce the inflammation. Went to get mammogram because I thought I had breast cancer. Test came back with an issue so I had to go back in for secondary test. After reviewing the test results the radiologist determined it was a side effect from the pfizer vaccine.

The joint pain and discomfort has continued to get worse; the pain returns when off the steroids; since receiving my 2 covid vaccines I have experienced a Psoriatic Arthritis flare up with significant joint pain; since receiving my 2 covid vaccines I have experienced a Psoriatic Arthritis flare up with significant joint pain; swelling in my hands which was new; The joint pain and discomfort has continued to get worse; This is a spontaneous report from a contactable consumer and a contactable Physician. A 62-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 11Jan2021 (Batch/Lot Number: EL1283) as DOSE 2, SINGLE (at the age of 62 years) for covid-19 immunisation. The patient received first dose of BNT162B2 (Batch/lot number: EK5730), on 21Dec2020 in left arm. Medical history included macular degeneration from an unknown date and unknown if ongoing, chorioretinopathy from an unknown date and unknown if ongoing, ongoing psoriasis, ongoing arthritis. Concomitant medications included etanercept (ENBREL) taken for an unspecified indication from an unspecified start date and ongoing; ascorbic acid, copper gluconate, tocopheryl acid succinate, xantofyl, zeaxanthin, zinc oxide (AREDS 2 VISUAL ADVANTAGE) taken for an unspecified indication, start and stop date were not reported; ciclosporin (RESTASIS) taken for an unspecified indication, start and stop date were not reported; vitamin D (NOS) (VITAMIN D NOS) taken for an unspecified indication, start and stop date were not reported. The patient experienced since receiving my 2 COVID vaccines has experienced a psoriatic arthritis flare up with significant joint pain on 13Jan2021 with outcome of not recovered , swelling in my hands which was new on 13Jan2021 with outcome of not recovered, the joint pain and discomfort has continued to get worse on 13Jan2021 with outcome of not recovered, and the pain returns when off the steroids on 13Jan2021 with outcome of not recovered. Therapeutic measures (steroids and new biologic Skyrizi) were taken as a result psoriatic arthritis flare up with significant joint pain, swelling in my hands which was new, the joint pain and discomfort has continued to get worse, and the pain returns when off the steroids. Patients concern is since receiving my 2 Covid vaccines I have experienced a Psoriatic Arthritis flare up with significant joint pain which I have never had while taking Enbrel the past 15 years. Patient has been injecting about every 10 days and with great psoriasis and arthritis control up until the early Jan2021. Patient had appointment with dermatologist for a regular visit on 13Jan2021 and reported to him She had noticed joint pain and swelling in my hands which was new. Physician suggested continuing the Enbrel every 7 days to see if helped which it did not. Patient was taking Tylenol and Ibuprofen as well with little improvement. The joint pain and discomfort have continued to get worse, and patient has now switched to Skyrizi with little improvement, also have done 2 rounds of Medrol Dose pack with great relief but the pain returns when off the steroids. Patient is now trying maintenance dose of prednisone which is still tweaked. Patient was unsure if vaccine played a part of this Flare. 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. Since the vaccination, the patient has not been tested for COVID-19. The physician feels Pfizer product had a causal effect to the adverse event. Follow-up attempts completed. No further information expected.

tender lymph gland (near collarbone, on same side as vaccinated arm); swollen lymph gland (near collarbone, on same side as vaccinated arm); Nausea; Headache; diarrhea; General tiredness; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 27Mar2021 at 10:45 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Concomitant medications included statin (MANAFACTURER UNKNOWN) 40 mg, multi vitamin (MANAFACTURER UNKNOWN) all from an unknown date for an unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Mar2021 the patient experienced tiredness, and on 01Apr2021 experienced nausea, headache, diarrhea, swollen lymph nodes, lymph node tenderness. It was reported that swollen and tender lymph gland near collarbone, on same side as vaccinated arm. Lymph gland was still swollen - 8 days later. The patient did not receive treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Clinical outcome of tiredness, nausea, headache, diarrhea, swollen lymph nodes, lymph node tenderness was not recovered at the time of reporting. No follow-up attempts are needed. No further information is expected.

swelling all over face, neck, lymphnodes, abdomen, and hands.; swelling all over face, neck, lymphnodes, abdomen, and hands.; swelling all over face, neck, lymphnodes, abdomen, and hands.; swelling all over face, neck, lymphnodes, abdomen, and hands.; swelling all over face, neck, lymphnodes, abdomen, and hands.; Water retention still in hands, neck abdomen breasts, and lymphnodes; This is a spontaneous report from a contactable consumer (patient reported for herself). A 62-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, Lot Number: 6955, expiry date not reported) via an unspecified route of administration, administered in left arm on 25Mar2021 (at the age of 62 years old as reported) as dose 2, single for covid-19 immunization. Medical history included known allergies to insects, bees and penicillin products. The patient was not pregnant at the time of the vaccination and report. The patient had no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not received other medications within 2 weeks of vaccination. The patient previously received Covid-19 vaccine (bnt162b2) for covid-19 immunisation on 04Mar2021 at 2:00pm at the age of 62 years old (lot number EN6204) administered in the right arm. The patient previously took amoxicillin and experienced allergy. On 27Mar2021 12:00, two days after shot, the patient had swelling all over face, neck, lymphnodes, abdomen, and hands. Doctor said to take Benadryl however patient had continued swelling and went back to doctor and was given 5 day methylprednisone. Patient was then still swelling and got steroid shot. One day fine, then back to swelling in all areas. On Saturday, patient had 3 day steroid shot. Water retention still in hands, neck abdomen, breasts, and lymphnodes (since 27Mar2021 12:00). Patient was taking claritin/ benydryl to help with symptoms and worst in the morning when awaken. Patient was sleeping sitting up. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The events were reported as serious medically significant. Therapeutic measures were taken in response to the events which included steroid shots, and antihistamines, along with prednisone. Since the vaccination, the patient has not been tested for COVID-19. The patient had not recovered from the events reported.

could have had COVID that's why I had severe allergic reaction; could have had COVID that's why I had severe allergic reaction; neck was swollen; felt like the back of her eyeballs were poking/feeling of the eyeball outward/like to the front, like they would pop out of her eye; severe headache; lymphadenopathy/appeared neck was swollen, probably lymph nodes, swollen to the back and side; neck pain feeling of the eye ball outward lasted 1-4 days/severe neck pain; ear burning in ear drums/burning in eardrums, both ears; I thought a severe allergic reaction was like anaphylaxis; little reaction on her left forearm, of a rash; bad flu; This is a spontaneous report from a contactable nurse (patient). This nurse reported different events for different vaccine doses for the same patient. This is one of the two reports. A 62-years-old female patient received dose 2 of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine), via an unspecified route of administration on 08Jun2021 at 15:00 (Batch/Lot Number: EW1071) single; and dose 1 via an unspecified route of administration on 19May2021 (Batch/Lot Number: EW0183) single, for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included diphenhydramine hydrochloride (BENADRYL) taken for an unspecified indication from Jun2021 to 09Jun2021. It was reported that with the first Pfizer vaccine dose on 19May2021, she developed chills, had severe headache, feeling of ants crawling in her throat, and shooting pain in the calves and left calf shot down to the big toe, it was shooting pain, but both calves were involved. The patient experienced rash on 08Jun2021; anaphylactic reaction on 09Jun2021; severe headache, 'lymphadenopathy', 'neck pain', 'ear discomfort', 'swelling', 'ocular discomfort' on 09Jun2021 at 15:00; and bad flu in 2021. After what the patient experienced with the first vaccine dose, she was indicated to take Benadryl thirty minutes before the second vaccine. She was however told that it could mask potential side effects. Due to the masking potential, she stopped taking it and reported adverse events. The patient reported lymphadenopathy, headache, neck pain, feeling of the eye ball outward which lasted 1-4 days, and ear burning in ear drums. The patient stated that these (unspecified) stopped on Sunday. Stated that the headache was most severe. Also stated that "I thought a severe allergic reaction was like anaphylaxis". The patient was at another doctor's office and was indicated that she could also have had COVID that's why she had a severe allergic reaction. According to her, she had never been mask less, and was double masking. She works from home. Second vaccination was two weeks post. She could have possibly gotten it, bad flu, that would be the only time she could have. The patient had called on 09Jun2021 as she got her second dose of the Pfizer vaccine on 08Jun2021 and someone was supposed to call her back from the department, whoever handled Adverse Events, but no one ever returned the call or sent an email. She took the first Pfizer vaccine on 19May2021 and had severe headache, feeling of ants crawling in her throat, shooting pain in calves and left calf shot down to the big toe, it was shooting pain, but both calves were involved, and she had spoken to an employee health nurse, who suggested she take a Benadryl 30 minutes before the second vaccine. As they were concerned about the crawling in her throat, they feared anaphylactic reaction to the second, as people said the second was worse, and she called her doctor to confirm, who was also in agreement for her to take it. Her doctor said to take it and take it every 4-6 hours for the first 24 hours, and she had the vaccine on the 8th at around 3PM, and had a little reaction on her left forearm, of a rash. It lasted about 10 minutes and went away. At the vaccine site, they let her go, and she took the Benadryl twice more, her last dose was at 0130. On 09Jun2021, she called Pfizer, who said they don't recommend to take Benadryl, that it could be masking potential side effects that can lead to anaphylaxis, so she stopped taking her last dose at 0130, and at 3PM on the 9th, she had severe headache, neck pain, it appeared her neck was swollen, stated it was probably lymph nodes that were swollen to the back and side, she had burning in her eardrums, both ears, and she felt like the back of her eyeballs were poking, like to the front, like they would pop out of her eye (she thought that was the most predominant symptoms she had). It lasted for 3 days. She spoke to someone on 09Jun2021 in the morning. and stopped taking Benadryl, and they said she would get a call from Pfizer and she thought she would report those side effects after the second dose because they happened in the afternoon, and now she has a day off from work, so she thought to call and say what happened with the second dose. The patient stated that she works from home, but she was not clinical. Confirmed it was the COVID 19 Pfizer vaccine that she received. The severe headache started after 3PM on 09Jun 2021, it was not ongoing and it went away on Sunday, which the reporter provided as "12Jun2021" The patient stated that she has had intermittent headaches ever since, so has recovered with lasting effects, they are not as severe as the original, but she had some lasting effects. The patient was inquiring if she should receive a booster. According to the patient, they were talking about the potential of having to give boosters, and with everything she had been through with the first two (the second was worse than the first), she was ambivalent about getting the booster. Outcome of the event 'rash' was recovered on 08Jun2021; for 'lymphadenopathy', 'swelling', and 'ocular discomfort' was recovered on 10Jun2021; for 'neck pain' and 'ear discomfort' was recovered on 11Jun2021; for 'headache' was recovered with sequela on 12Jun2021; while for the other events was unknown. Seriousness criteria for the severe neck pain was reported as disabling; for the "burning in eardrums, both ears" was not serious; while for the initial headache, to the 12th was severely debilitating, she couldn't do anything, it was horrible, but the lasting effects were tolerable, she took Tylenol and it resolved. For the severe neck pain that ended in the morning and was no longer present (appeared neck was swollen: ended in the evening) seriousness was reported as just mild discomfort, not disabling. For the burning in eardrums that started in the evening, at hour of sleep, at night, was bilateral, burning, inner ear pain, and it was intermittent, and lasted until 11Jun2021, and she went to the ear doctor today, who said her eardrums were ok, but she was concerned, so this was reported as not serious. For the eyeballs poking that happened at the same time as burning eardrums, only at hour of sleep at night, and woke up on the 10th and it was gone, seriousness was reported that since it was intermittent, not disabling, but was annoying. Also stated that it was frightening, but she was worried if it continued, she would go to the eye doctor, but it went away. Causality for the events was reported as follows: severe headache: Yes (Related), severe neck pain: Yes (Related), "appeared neck was swollen, probably lymph nodes, swollen to the back and side": Yes (Related), burning in eardrums, both ears: Yes (Related), and "felt like the back of her eyeballs were poking, like to the front, like they would pop out of her eye": Yes (Related).; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021677809 Same patient, same product, different events/vaccine dose

She noticed swelling on the left side 24 hours later.; Headache; Lump the size of an orange under her right arm; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VAC-CINE, Solution for injection, Batch/Lot Number: EL3247 expiration date: unknown), via an unspecified route of administration, administered in Arm Right on 25Feb2021 14:00 (at the age of 62-year-old) as dose 2, single for covid-19 immunization. The patient did not have any medical history (was reported as none). There were no concomitant medications. History of previous immunizations was not provided. There were no additional vaccines administered on same date of Pfizer suspect. Prior vaccinations within 4 weeks or any adverse events following prior vaccinations. After second dose of COVID vaccine, patient had a giant lump the size of an orange under her arm. It went down from there and felt like when her milk came in after having a baby, but not as bad. Her breast hurt and she could not use the injection arm. She had the second COVID Vaccine on Thurs-day. She had some soreness on Friday (26Feb2021), but thought it was no big deal. By Friday evening, it was not just a little sore. On Saturday (27Feb2021), she looked at it and noticed the lump the size of an orange. The swelling was down to the size of a golf ball. She also had a headache on an unspecified date. Patient was asking if the agent thought she needed to see a doctor. Patient was assuming the lump would eventually go away. It was clarified the lump and swelling began in the right arm. The swelling did spread to the left side, but not nearly as bad. She noticed swelling on the left side 24 hours later. The outcome of outcome of headache was reported as resolving, and outcome of lump the size of an orange under her right arm and swelling was unknown. No follow-up attempts were possible. No further information was expected.

Patient woke up Saturday am and right foot felt like it was sprained, painful at ankle joint, slightly red. Sunday morning, she could not put any weight on right foot, more red/all toes red (except one), redness is traveling down right big toe, right foot appears slightly swollen.

I received my second vaccine uneventfully and approx. 2 1/2 days later I developed a painfully and swollen lower lip , and then it had severe erythema , pain and ulceration . I have never had a cold sore in my life, or shingles . I did receive the chicken pox vaccine in my 30's

I developed a swelling in the right axilla, not a discrete node, but what felt like an accumulation of fluid - lymph perhaps - about the size of a large lemon.

Pounding headache, heart racing to over 145 bps, chest burning and tightness and hard to breath. I was taken to the Emergency Room at Hospital immediately. Reaction occurred within 30 minutes of the injection. An EKG was administered. I was prescribed prednisone and Benadryl. I was diagnosed with Anaphylaxis.

12/22 Vaccine 12/23 ER. Admitted to hospital for 7 days. Dr stated was due to fluid. Radiology stated no fluid present. Couldn't breath. Pulmonologist put on 2nd inhaler. Coughing a lot. Not able to walk more then 6 steps without stopping to catch breath. *Has had 2nd vaccination on 1/13/2020

Injection was administered very high on left arm(at joint level). It felt like a nail went in, and then she pushed in the medicine. Just the injection process alone made me feel ill. So I waited the 15 minutes before I left, until I felt safe to drive. At noon the meds started affecting me, which is what I expected. I've continued to experience arm pain, weakness, armpit swelling and tenderness, arm not wanting to work and posturing. This is day four and its just starting to feel like its coming back "online." Monday I reported to Colleague Health, who advised me to contact my physician, who I consulted via phone this morning. Physician requested I fill out Adverse Event form.

Bell's Palsy; This is a spontaneous report from a contactable consumer. A 63-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, Batch/lot number: ELD14D, via an unspecified route of administration, in left side of arm, on 04Jan2021 at single dose for COVID-19 immunization. Medical history included early breast cancer from 2017 and ongoing. Concomitant medication included tamoxifen citrate 20 mg tablet by mouth once daily from 2017 and ongoing for breast cancer (cancer pill, she has to be on it for 5 years). The patient received the vaccine as she is "with fire department, thought she needed to take it, she had early breast cancer, is around lots of people". On 09Jan2021 the patient was diagnosed with Bell's palsy, assessed as medically significant and in Jan2021 she experienced earache (she thought it was an earache, but it was more than that, but it made her ear hurt, and she has no infection), her mouth was drawled a little, further detailed as numbness and "the eye, it is messing with it, when she is trying to see out of it, she can see, but it's blurry like" and, "where the ear thing is", on the back of the lymph node was real sore and her face was kind of puffy, which is the reason she went to the doctor. The patient had to go to her doctor, he told her she had a reaction to the shot, he called it Bell's Palsy, and said to let Pfizer know. Her doctor gave her something to take for mouth drawled/numbness, which is supposed to help, and she has to go back in a week. The event Bell's palsy outcome was unknown at the time of the report.

Aching, HA and temp of 101.8, fatigue beginning night of 1/15. On 1/16, was fatigued, had swelling of hands and face. Now resolved.

12 hrs after vaccine headache,nausea,achy,sore arm 24 hrs after vaccine fever 100.2, bad chills,headache,body aches,very sore arm 36 hrs after vaccine swollen lymph nodes under rt arm, temp 99.8

The following day after patient received 2nd dose of Pfizer vaccine, the area around the injection was light red, warm to touch and painful. The area was approximately 2.5 inches around. On Sunday 1/10 it was bright red, indurated, hot to the touch and much more painful. It was also painful to move his arm. On 1/13, the injection site was still tender to the touch and his shoulder area was sore with movement. Over the next couple of days his shoulder into his bicep had a dull ache and was very painful to any pushing, pulling or weight bearing. Ibuprofen did help but did not relieve it. On 1/17 patient went to a local urgent care because at that point it was even difficult to sleep due to pain. They diagnosed him with bursitis of the left shoulder due to SIRVA. He was started on a steroid pack and today, day 2 of steroids it feels slightly less painful.

swollen lymph nodes on left side of neck; first dose on 27Dec2020 and second dose on 07Jan2021; This is a spontaneous report from a contactable nurse (patient herself). A 63-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; batch/lot number and expiration date were unknown), via an unspecified route of administration on the left arm on 07Jan2021 at a single dose for COVID-19 immunization. The patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; batch/lot number and expiration date were unknown), via an unspecified route of administration on the left arm on 27Dec2020 at 16:45. Both doses were administered at the hospital. Relevant medical history included non-insulin-dependent diabetes mellitus (NIDDM), hypertension (HTN), hypersensitivity lung disease (HLD), hyperthyroid, and Graves. The patient had no known allergies. Concomitant medications included empagliflozin (JARDIANCE), metformin, methimazole, cetirizine hydrochloride (ZYRTEC), and montelukast sodium (SINGULA). The patient was not pregnant. The patient had no other vaccine in four weeks. The patient had no Covid prior vaccination. The patient received her first dose on 27Dec2020 and second dose on 07Jan2021. The patient had an adverse event on the next eve of the second (2nd) vaccine. On 08Jan2021 at 22:00, she experienced swollen lymph nodes on left side of neck. The swelling was going down incrementally as she took paracetamol (TYLENOL) 1000 mg per oral (p.o.) daily. The patient underwent Covid test via nasal swab post vaccination on 29Dec2020, which resulted negative. The patient was recovering from the event. Information on the batch/lot number has been requested.

right arm sore, 3 days later right arm and hand starting swelling and developed rash with itching, also left hand swelled, with rash and itching. Next day woke up with sore throat and headache, and fatigue. went to primary care doctor was put on prednisone, symptoms lasted for 10 days.

Injection site pain, tiredness, headache , muscle pain, chill, joint pain, nausea, feeling unwell, swollen lymph nodes, difficulty breathing, swelling of face, fast hearbeat, bad rash , dizziness and weakness, intestinal pain. All symptoms lasted 18 days. Was given prescription medication for symptoms by primary care doctor.

Woke up on 1/26/21 with aches which lasted until 1/27/21. After I got up I had loose bowel movements approx. 15-20 mins apart for approx 2 hours. Felt nausea upon waking and for 2-3 hours. Became dizzy about 1 1/2 hour to 2 hours after waking. Duration of dizziness approx 1 hours. Tired all day. 1/27/21 woke up with all symptoms gone. New symptom was swollen lymph gland under right arm and very sore. Duration 3 hours so far. Will call primary doctor.

Patient received her vaccine on Thursday, 1/21/21. From then until Saturday afternoon she had been experiencing extreme fatigue. On Sat. around 5:00 PM she was standing at her flat-top stove cooking dinner. A wave of very extreme fatigue came over her, so she leaned over to turn off the burner. When she did this, she passed out leaning forward with her hand on the burner and touching the frying pan. When she came to, she went to the couch and laid down - not realizing for 10 minutes that her hand and right breast were burned. The resulting injuries lead to her having to see her PCP on Monday, and then a General Surgeon on Weds 1/27/21. Injuries sustained include a second degree burn on her right breast, On the right arm, laterally above the wrist is a small superficial partially healed burn. On the dorsal aspect of the right fifth finger there is a longitudinal burn that goes from the MCP joint to almost the tip of the finger. She has limited range of motion due to discomfort and swelling. The blister encompasses the entire dorsal lateral aspect of the finger. The fourth right finger has a less extensive blistered area on the PIP joint. The burn on the fifth finger is deep second degree.

Intermittent fever; chills; body aches; tiredness; pain and swelling in a axilla area of left arm; pain and swelling in a axilla area of left arm; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EK9231), via an unspecified route of administration in left arm on 12Jan2021 at 07:00 at single dose for COVID-19 immunization. Medical history included hypertension and ventricular septal defect. The patient was not pregnant. Patient has no COVID-19 prior to vaccination. Concomitant medications included aspirin (ASPIRIN [ACETYLSALICYLIC ACID]), docusate sodium (COLACE), losartan, omeprazole and montelukast sodium (SINGULAIR). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EJ1685), via an unspecified route of administration in left arm on 22Dec2020 at 2PM for COVID-19 immunization. On 12Jan2021 at 11:30 PM, the patient experienced intermittent fever and chills, body aches, tiredness, and pain and swelling in the axilla area of left arm. Patient has not tested for COVID-19 post vaccination. The outcome of the events was recovering.

Individual received the 1st dose of the Pfizer COVID vaccine on 12/ 22/20.On the first week of January 2021 she developed left neck and supraclavicular lymphadenopathy. CT scan on 1/13/21revealed multiple lymphadenopathy over the left supraclavicular area. Excisional biopsy of deep neck supraclavicular lymph nodes on 1/20/21. Surgical pathology revealed overall finding most consistent with a reactive lymphoid hyperplasia, etiology unknown. She received her 2nd Pfizer COVID vaccine on 1/12/21. She had slight redness/swelling of her left arm two to three days after vaccine. She developed red, raised itching rash on her trunk on 1/30/21. Rash continues as of today 2/5/21.

Patient reports to me today that she developed increased swelling of feet and ankle the next morning after receiving first vaccine dose. She does have a history of CHF and she did not seek treatment for condition at the time.

back of neck at the spine began feeling odd and maybe the middle of my spine; When I got the shot, I felt something shoot into the arm and it felt a little startling or shocking to the body; feeling numb in my left pinky & a little in the ring finger plus a strange feeling (achy) in right arm/light numbness on outside of my left leg from the knee down to the ankle; feeling numb in my left pinky & a little in the ring finger plus a strange feeling (achy) in right arm/lighter soreness up the outside of my left forearm; The pinkies feel swollen when I bend them; soreness at the injection site; This is a spontaneous report from a contactable consumer (reported for herself). A 63-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL9261; expiry date: not known), via an unspecified route of administration in the left arm on 26Jan2021 15:00 at single dose for COVID-19 immunization; and ibuprofen, via an unspecified route of administration from an unspecified date at 1 dosage form (DF) for an unspecified indication. Medical history included known allergies to some pesticides, herbicides, chlorox, or possibly the products mixed with them/permanent magic markers (mad her lips and face felt numb, could make it hard to breath, almost made her pass out once/made her feel sick in the past); and caused neuropathy up the back of her legs once. The patient is not pregnant. Concomitant medications included lactobacillus acidophilus (ACIDOPHILUS), melatonin, and ascorbic acid (SUPER C). The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 26Jan2021 20:00, after when she got the shot, she felt something shoot into the arm and it felt a little startling or shocking to the body. After 10 minutes, she did not feel it. The patient started feeling numb in her left pinky & a little in the ring finger plus a strange feeling (achy) in right arm. Eventually, she also felt a lighter soreness up the outside of her left forearm. The pinkies felt swollen when she bent them. She felt a normal soreness at the injection site. On 26Jan2021 23:50, she started feeling light numbness on outside of her left leg from the knee down to the ankle. The ankle on the outside felt a fairly pronounced numbness. Also, the back of neck at the spine began feeling odd and maybe the middle of her spine. Although she stated the spine spot had a twinge of pain the night before & in the morning so that might not be the vaccine. The right pinky also started feeling light numbness by 01:00 the next day. The patient took 2 Tylenol and before bed, she took 1 ibuprofen for back of neck at the spine began feeling odd and maybe the middle of her spine and soreness at the injection site. No treatment received for other events. The action taken in response to the events for ibuprofen was unknown. The outcome of the event "when I got the shot, I felt something shoot into the arm and it felt a little startling or shocking to the body" was recovered on 26Jan2021 20:10; while outcome was unknown for other events.

The temperature that the Pharmacist recorded was not correct/transport the covid 19 vaccines had a temperature of 31 to 33 degrees F; The temperature that the Pharmacist recorded was not correct/transport the covid 19 vaccines had a temperature of 31 to 33 degrees F; improper technique; bruising after the first shot because of improper technique; felt hot at the injection site; swelling; tiredness/tired; arm pain; headache; chills; This is a spontaneous report from a contactable pharmacist (patient). A 63-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot EJ1686, expiry date not reported), intramuscular on 02Jan2021 17:00 at a single dose in the left arm for COVID-19 immunization. Medical history included hypertension, known allergies to latex and has covid-19, all from unknown dates and unknown if ongoing. The patient was not pregnant at the time of the vaccination. Concomitant medications included hydrochlorothiazide, potassium chloride, and calcium citrate (CITRACAL). The patient had no other vaccine in four weeks. Patient stated that a cooler used to transport the covid 19 vaccines had a temperature of 31 to 33 degrees F and she was concerned about the vaccines on the bottom of the shipper that were next to the dry ice in the shipper (date unspecified). Patient wanted temperature excursion data for the covid 19 vaccine and stated in Jan2021 she felt hot at the injection site, swelling, tired, arm pain and had bruising after the first shot because of improper technique (02Jan2021 17:00). Patient reported on the first dose having only arm pain, chills, and tiredness, and headache in Jan2021. Patient also stated that the first dose was much better tolerated. Patient stated some of her pharmacist friends have had the same effects from the vaccine. Patient wanted to verify that the vaccine in the syringe is good for 6 hours and that she read Moderna is effective for 1 year and Pfizer is good for 6 to 12 months. She does not think her vaccination of covid 19 was valid because she thinks the temperature that the pharmacist recorded was not correct. Patient wanted to know if she should get tested to see if the vaccine worked. Patient stated that Pfizer is too complex and has too many pieces and states they need to give more information about how to use the thermal shipper. The patient had Covid test post vaccination as nasal swab on (BioReference COVID-19 Nasopharynx) on 26Jan2021 with results as pending. No treatments received felt hot at the injection site, swelling, tired, arm pain, had bruising after the first shot, chills and headache. The patient did recover from the events felt hot at the injection site, swelling, tired, arm pain, had bruising after the first shot, chills and headache on an unspecified date in Jan2021.

Pfizer BioNTech COVID-19 Vaccine EUA left armpit lymph node swelling injection site pain headache nausea joint pain

Left side swelling to include face, arm, hand, trunk, legs and feet. Noted to be +3 pitting edema. On 2/5 @ 1307 start having seizure activity that lasted for over 20 minutes. Per hospital policy code blue was called. This resulted in an ER send out.

strange feeling and some pain began on left side of neck, left ear and went up my whole neck to my face. Unsure what the feeling was then realized it felt numb and swollen. tongue felt thick. kinda of like after being numb at dentist office. I also felt kind of tired. I was afraid my throat was going to close up but it didn't. after 1 hour the feeling began to fade. and then went away.

First vaccine shot - No adverse events. Second vaccine shot - on the next evening (02/18/21), I had a very slight fever lasting just a couple of hours. Later in the evening, I had swelling and pain under my left arm pit lymph node. The pain continues as of this writing. The pain is dull in nature and more sensitive to the touch.

I seemed to have some itching on my scalp, and there was a little rash under my arms, along my stomach area and a little on my face, the same as when I have been exposed to shellfish of some type, I took 2 benadryl that eve and was able to sleep, the itch went away, felt better on saturday by the afternoon started to feel itchy again took another benadryl and that helped. Had some puffiness in my hands and feet during the week, and stiffness not bad. Just wanted to let you know of the reaction.

24 hours after vaccine, developed: Chills - unable to get warm Rash on left arm, middle, chest, stomach, and back One lymph node enlarged under left arm - size of a golf ball, lasted 2 days

Pt complained of throat tightness and being lightheaded beginning at 1127 hours (5 minutes after vaccine). She arrived at emergency/symptoms reporting station at 1129 hours. She denied tongue swelling, denied rash, denied difficulty speaking. No rash was seen by medics either. Pt did not have wheezing or stridor. Medics on scene and student medics under the direction of Medics, placed the patient on the monitor. Her HR was stable in the 70s and her sats were 99-100% on room air, with a strong pulse and RR of 16. The pt became more anxious and demanded that someone assist her with her Epi pen administration. RN explained sxs of anxiety and sxs of anaphylaxis. Pt became agitated and again remained adamant that medics give her Epi. At 1132 hours a student medic under the direction of Medics administered the pts own epi pen to her. Vitals signs after epi were HR of 88, BP of 170/97, RR 22, sats 100% . A transport unit was called as precaution and to potentially transport. Pt appeared to have an increase in agitation as indicated by her speech with medics being short and her stating that she was "irritated" with "everyone talking", that she "can't hear everyone all at the same time", that this is just "too much" and waving her hands in the air. Pt was transported to the ER via Medics for continued care and follow up.

Inflammation on right side of neck throat and back area. Causing choking feeling of right side of neck/ throat for approx. 8-10 hrs. .............Took several days to a gradual subsiding. Pressure felt in back of neck as well.... Same side loud tinnitus in right ear....took a couple days to subside.........during heightened swelling in nick muscles chest/ heartburn. Subsided after a short while.

Systemic: Abdominal Pain-Medium, Systemic: Chest Tightness / Heaviness / Pain-Mild, Additional Details: Patient stated she was experiencing some \"pressure and swelling under her upper ribcage\" and that she has had this reaction in the past when she accidently inhaled some chemicals. Patient was given one dose of Epinephrine IM into her left thigh and felt relief in pressure after 3 minutes. Patient was advised that if she experiences other symptoms to go to the ER.

Low grade fever (100.3) after one week with progressive weakness, fatigue and swallowing dysfunction analogous to exacerbation of her autoimmune disease (LUPUS) which had been in remission (on medication) for 5 years.

This is the 2nd time since my 2nd shot my throat neck glands are big and sore & thyroid is swelled up & sore difficult to swallow. Extreme long lasting exhaustion. Body is weak & sore muscles & joints. I have not been ok since my 2nd shot. I had a hard marble lymph node in my neck after the 2nd shot too.

2/28 6pm face flushed and puffy 10pm anxiety on guard, trouble sleeping 3/1 6am heart rate 108, no temp scratchy throat 10am diarrhea ; unease and rapid heart rate continue 5pm read about adverse events, called doctor, took Benadryl and began to feel better. 3/2 am communicated with doctor and she advised holding off on second shot, next steps tbd

Pt received 1st dose of Pfizer Biontech vaccine. Patient reported history of anaphylactic reactions. Pt told to stay 30 minutes for observation. During observation patient reported feeling itchy. VS taken at clinic and were stable: HR 88, BP 135/66 Spo2 94%. Patient's face was slightly red without edema. She reported breathing okay but felt a little tight in her throat. Sent to ER for management. Per ER note "63 year old female with a complex medical history including lupus, scoliosis, Sjorgen's syndrome, and anaphylaxis requiring intubation presents complaining of itching and dizziness following COVID 19 vaccination with the Pfizer mRNA vaccine...patient's exam demonstrates itchy red welts consistent with urticaria and she endorses a foreign body sensation in her throat. Examination of the oropharynx demonstrates uvular edema without stridor. The patient endorses chest tightness but does not have wheeze on exam...endorses nausea. Diagnosed with anaphylactic reaction. Patient received epinephrine 0.3 mg IM, diphenhydramine 50 mg IV, famotidine 20 mg IV, and methylprednisolone 125 mg IV along with albuterol MDI. Had improvement in symptoms within an hour, observed for 6 hours without recurrence of symptoms and was discharged home. Advised not to receive second dose of vaccine until discussion with allergist occurred.

No issues during 15 minute observation period after receiving the vaccine. So I left the facility to go to my car. Then about 15 minutes later my face started to get really hot with slight swelling. Then after several more minutes throat became tight and started to experience extreme difficulty swallowing. I was still in the parking lot so I immediately went back inside to the vaccination area asking for help. I did not experience any breathing difficulties during the entire time but did experience extreme difficulty with swallowing and throat tightening. The staff did the usual checks. I was not too awarre of all the things they did but I was given a benedryl tablet which I was able to swallow thankfully. I was told my vitals were very high. Not sure of exact times but sometime shortly after the benedryl things started to fell better. The throat/swallowing started to get better. Face burning started to cool. Stayed in this area for about 20 or 30 more minutes and then told I could go with a comment that I should see my doctor about my high blood pressure. Which I explained I do not have high blood pressure and when checked later in the day it was back to my usual 115 - 125 range . I was concerned about getting the second shot later and was told to take a benedryl either just before I get the next shot or right after.?????? After checking the online cdc guidelines that does not jive at all.

Swelling in ankles/feet/calves/upper thighs, shortness of breath, fatigue. muscle soreness all over, joint pain (esp. wrists & knees). Was hospitalized for 3 days 3/20 - 3/23/2021.

classic migraine-type headache 03/05-present overall muscle ache 03/05-present fatigue 03/05-present nausea 03/05-present L foot & ankle swelling 03/06-present

Had Bamlanivimab IV on December 9, 2020 at The County Hospital. On 3/9/2021 had first Covid injection. I had slight headache, sore throat, gland in neck swollen, chills and bad hip pain that started about11:00 am on 3/10/202. Today, feeling some better but very tired.

ADVERSE EVENTS: INJECTION SITE PAIN, TIREDNESS, HEADACHE, MUSCLE PAIN, CHILLS, JOINT PAIN, FEVER (101.9 DEGREE F @ 2 AM 3/11/21 & BETWEEN 100.6 - 99.6 THROUGH THE EVENING 3/11/21), NAUSEA, FEELING UNWELL, SWOLLEN LYMPH NODE. TREATMENT: TYLENOL EVERY 4 HOURS STARTING AT 8 AM 3/11/21. SYMPTOMS SUBSIDED THROUGH THE LATE NIGHT OF 3/11/21 EXCEPT SWOLLEN LYMPH NODE & INJECTION SITE PAIN STILL PERSISTS 3/12/21.

Headache; Swollen lymph nodes on her neck; Dizziness; Her feet felt swollen and she hurt when she would step down; Loss of appetite; She slept all day; Muscle pain; Chills; Joint pain; Fever; Feeling unwell; Injection site pain; Tiredness; This is a spontaneous report from a contactable consumer (patient). A 63-years-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9264B), intramuscular on 01Feb2021 at single dose for COVID-19 vaccination. The patient medical history and concomitant medications were not reported. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3249) on 11Jan2021 for COVID-19 vaccination. Caller was a consumer that was calling about the Covid-19 vaccine and said that she wanted to report her symptoms after the Covid-19 vaccine. Caller reported that she experienced injection site pain, tiredness, headache, muscle pain, chills, joint pain on, fever, feeling unwell, her feet felt swollen and she hurt when she would step down, loss of appetite and she slept all day on 01Feb2021, swollen lymph nodes on her neck and dizziness on 02Feb2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The seriousness was reported as non-serious. The outcome of the events injection site pain, chills, fever, swollen lymph nodes on her neck, dizziness, her feet felt swollen and she hurt when she would step down, loss of appetite and she slept all day were recovered and other events were recovering.

The following day after the 2nd vaccine, I felt a small itching on the left side of my neck/shoulder blade. I didn't scratch but I felt swelling. After softly rubbing my neck, I felt a little bubble as if there was liquid in the bubble area. I thought maybe it was a side effect so I waited a full week. Along with the itching & swelling, there was a small amount of tender pain. The swelling still persists. On the 10th day after the vaccination (March 15th), I saw my doctor. He felt the same area sensation of a bubble around my shoulder blade. So far, there has been no treatment.

Lymph node swelling tender on palpation supraclavicular on the same side Adv that supraclavicular lymph swelling is a normal reaction but may take 10 days (up to a couple weeks) to fully resolve, can uses APAP PRN or warm compresses and keeping hydrated to help, provided phone number to call if issues persist/worsen and PCC/Covid line will check back tomorrow

Received the vaccine on Saturday on Sunday night started getting a headache and woke Monday morning with a headache, a stiff neck and swelling on my left side of my neck, trapezoid and my dowager hump. After 2 weeks most of the swelling is gone just a slight bit. Headaches have been every day until yesterday. Went to dr the following Monday after the vaccine as was give some anti inflammatory shots in my neck as not allowed anything ( cortisone) due to vaccine. Taking Tylenol and Advil and using Valteran. Dr was not sure if from exercise or the vaccine but have been exercising throughout the pandemic. Never had headaches when my neck would bother me only hand tingling and that was not this time. The acupuncturist today said still a bit swollen and tender and feels that it is a combination of the neck and the vaccine as the vaccine attacked my most vulnerable spot. I had a massage today to to try to stretch my neck. Headache is doing better today and I can move my neck more.

Site: Itching at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: swelling and itching at hands-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Patient called from home to report swelling and itching in both hands, nothing currently reported at site of injection, computer would not let me submit without choosing 1 from that category. Pt was directed to take benadryl and to call primary physician. The symptoms happened after patient left the store after her 15 minutes of monitoring.

Pt developed a new onset, acute deep vein thrombosis approximately 6-7 days after vaccination in the R lower extremity with extreme pain and inability to bear weight.

When I first got it, I felt okay, but as I was walking out, I felt disoriented and had to sit down. I was very lightheaded and uneasy. I stayed about an hour because I was scared to drive. I later got chills and fever for about 24 hours. I eventually developed shortness of breath, headaches, dizziness, tightness in my throat, bruising in my legs and painful lymph nodes in my neck and arms. One day, I felt like I was having a mini-stroke. It only lasted for a brief period and then went away. That has occurred multiple times. My doctor thinks some of my issues were due to anxiety, but I don't agree because I'm fine now.

first shot i woke up 7 days later to rash and itchy at site and very Hard...this SECOND shot i got i woke up next day with swollen arm and pain..took benedryl and icepack..will watch it and tell my family doctor. thank you...i did NOT get sick..

Pt started having new onset of left hand swelling of medial pal, and forearm. PT also had weakness, tremors and high blood pressure (159/98). Pt blood sugar was in the 330s; decrease cap refill. Pt states she did not ear or drink much this morning. EMS assist was called. Pt was transferred to Emergency Room

developed a pain under my arm near armpit area on the side of the injection; swollen gland; Dose Number 1 31Dec2020/Dose number 2 17Jan2021; Dose Number 1 31Dec2020/Dose number 2 17Jan2021; This is a spontaneous report from a contactable consumer (patient). A 63-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL8982; expiration date: unknown) at vaccination age of 63-year-old via an unspecified route of administration in the right arm on 17Jan2021 09:15 as a single dose for covid-19 immunization. Medical history included GERD (gastrooesophageal reflux disease), asthma, IBS (inflammatory bowel disease), diverticulosis, osteoarthritis, lactose intolerant, penicillin allergy and hives. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included famotidine and montelukast. The patient received the first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: E1284) at vaccination age of 63-year-old via an unspecified route of administration in the right arm on 31Dec2020 at 15:15 as a single dose for covid-19 immunization. The patient previously took codeine but had hallucination, pantoprazole sodium but joint pain, and diclofenac sodium but had anemia. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the most recent COVID-19 vaccine in a hospital. The patient first dose was on 31Dec2020 while the second dose was on 17Jan2021. It was reported that on 19Jan2021 (About 36 hours after injection), the patient developed a pain under her arm near armpit area on the side of the injection. It appeared to be a swollen gland. It lasted about 2 days and was moderate pain that she treated with 600 mg Ibuprofen. Soreness remained for another day or two after the pain subsided. The events were considered non-serious. The patient has not been tested for COVID-19 since the vaccination. The outcome of the events swollen glands and axillary pain were recovered in an unspecified date in 2021 while the outcome of the other events was unknown.

Herpes outbreak, cold sore & genital. Still have outbreak as of 3/22. I don't have a doctor, so I notified the clinic, made an appt. for 3/30/21. Couldn't get an earlier appointment.

After the 1st shot, I was ill for about a day: extreme fatigue, every joint in body ached, sore throat. After 2nd shot, not symptoms until Saturday. I noticed a swelling between my left breast and my armpit. It developed into a very pronounced lump at my armpit and toward left breast. There was tenderness when I used the arm. As of today, the swelling is down- not quite normal yet- but no tenderness.

After receiving second dose of COVID vaccine, patient began experiencing swelling of face and throat and was taken to ED. Patient reported having similar reactions to vaccines in the past. Patient received 20mg Pepcid PO BID, Loratadine 10mg PO once, and prednisone 50mg PO once in ED and had subsequent resolution of tongue pruritis and improvement in throat tightness. Was discharged with prescription of prednisone.

After second dose of Pfizer Covid Vaccine 2 days following lymph nodes under right armpit are swollen

Swollen and painful lumps in neck, red and tender to touch . Pain with head movement. I noticed mild soreness on Mar.22 and it grew progressively worse, with the height of swelling and painfulness occurring on Mar25. On Mar 26, systems were mush less and almost completely gone by Mar 27.

+Fever blister outbreak (large) upper and lower lips and above and below the lips on right side. Increased lower back pain on right side. Intermittent pains on the right side of my head, face, neck and ear. Lasted Lasted three days. (Of course, the fever blisters are still healing. - Using medications for these. I had them on hand as I frequently get them but this was a very large outbreak.)

7 days after my first vaccine my arm got swollen, a little tender and itchy. I had the typical sore arm immediately after the injection for about 48 hours and it went away.

Adverse systemic events for the duration of March 17-March 27: Swollen lymph glands (mild) Fatigue (severe) Brain "fog" (severe) Sensation of overheating / burning Fever (few mild elevations) Loss of Appetite /Indigestion (resolving as of March 26)

Pain and swelling of the fingers developed after each dose and resolved after about a week. The symptoms returned 3/12/2021 and did not improve.

Enlarged left sided supra clavicular lymph nodes noted 2/6/2021. Hypertensive crisis on 2/11/2021 with blood pressure 202/101 and palpitations with heart rate 113.

Eyes red and itchy, face blotchy and swollen. Scalp itchy and bumpy. Rash across stomach. Chills. Took Benadryl for 3 days.

rash that was all over her body; Extremely red sunburn rash- really bad sunburn, most of it on torso, had it on legs/face was so red like the rough sunburn feeling; Eyelids red, itchy, and swollen; Eyelids red, itchy, and swollen; Eyelids red, itchy, and swollen; Felt dizzy and weak/had less energy today; Dizziness and lightheadedness /felt dizzy and weak; Worst and really sharp Charlie horse between ankle and calf- took forever to walk; Extremely dehydrated, kidneys were showing some damage, creatinine level was really off.; Extremely dehydrated, kidneys were showing some damage, creatinine level was really off.; Extremely dehydrated, kidneys were showing some damage, creatinine level was really off.; Anaphylaxis due to vaccination; Vomited; Major diarrhea; She was so cold that her toes were purple; Blood Pressure so low: 58, couldn't find a bottom number at first but then at the hospital it was 58/38; Face was extremely pale; could not function- she was beyond cold; felt like she was in a bad dream and couldn't wake up, couldn't walk. Feeling like she was getting the flu; could not function- she was beyond cold; felt like she was in a bad dream and couldn't wake up, couldn't walk. Feeling like she was getting the flu; could not function- she was beyond cold; felt like she was in a bad dream and couldn't wake up, couldn't walk. Feeling like she was getting the flu; Too cold to function or do anything; Nauseated- almost like morning sickness/Extremely nauseated/queasy feeling; Nauseated- almost like morning sickness; very extremely tired; creatinine /it was still high; sick; body temperature was low; She thought she was going to die because of the purple toes; but it seems like her nose won't stop running ever since she got it, sore from blowing- looks like Rudolph.; but it seems like her nose won't stop running ever since she got it, sore from blowing- looks like Rudolph.; her body catching up on sleep or she's just tired; This is a spontaneous report from a contactable consumer (patient herself). A 63-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6206), via an unspecified route of administration, on 11Mar2021 as single dose in left arm for COVID-19 immunisation. Medical history included ongoing High Blood Pressure (It's under control now, fairly healthy; diagnosed probably when she started menopause in early 50s), ongoing Anxiety (Diagnosed probably when she started menopause in early 50s), ongoing Sinus headache (Worst sinuses; Takes Excedrin because Tylenol does not have an effect on her), ongoing smoker (Pack a day, but smoking about only about half of it each time. started when she was a teenager. She was without a cigarette for 3 days in the hospital, but when she came home she had to start again), menopause (in early 50s), shoulder- torn rotator cuff-operated in 2018. Family history included cardiac and heart disease, Parkinson's and Frontal lobe dementia (husband). Concomitant medication included colecalciferol (VITAMIN D3) 1000 IU, once a day, by mouth (Taken these for as long as she can remember, they kept advising it, husband takes it for Parkinson's so she just throws one in for her), calcium ascorbate (VITAMIN C) 1000 IU, once a day, by mouth (Started at least 2 years ago, doesn't drink enough orange juice, doesn't do fruits, doesn't get enough Vitamin C), linum usitatissimum seed oil (FLAXSEED OIL) 1000 IU, once a day, by mouth (Started at least 2 years ago, family history of cardiac and heart disease, takes as preventative) for cardiac and heart disease, takes as preventative, fish oil 1000 IU, once a day, by mouth (Started at least 2 years ago, family history of cardiac and heart disease, takes as preventative) for family history of cardiac and heart disease, takes as preventative, hydrochlorothiazide, lisinopril 20/12.5 mg, once a day, by mouth (She has been taking this medication for years, under control with this medication) for High Blood Pressure, lansoprazole from 2020 30 mg, once a day, by mouth (Started years ago) for Stomach pill for acid reflux, duloxetine hydrochloride 60 mg, once at bedtime, by mouth (Started forever ago) for just being achy and anxiety, lorazepam .05 mg, 1 tablet 3 times a day, takes one tablet a day at bedtime, by mouth for Anxiety (Started this a while back- with the heart disease and everything else, gave this to help with menopause symptoms too), meloxicam 15 mg, at bedtime as needed from 2017 for back issues- really sore at times, takes if really stressed or she overdoes it. Patient previously took Tylenol for sinus headache and does not have an effect on her. After the first dose of the vaccine the patient reported that she was extremely tired on 11Mar2021. She was completely nauseated most of the day on the second day. On Saturday, she was extremely nauseated (12Mar2021) with vomiting and major diarrhea on 13Mar2021. By 4 PM that afternoon (12Mar2021), she could not function because she was so cold; she felt like she was in a really bad dream and couldn't wake up. She called on 13Mar2021, her blood pressure was so low-they got 58 for the top number, they were unable to pull up bottom number at that point. patient reported that when the ambulance arrived, they described her face as extremely pale on 13Mar2021; her major complaint was that she was so cold- she has never been that cold in her life. When she got to the ER- they had to use the old blood pressure cuff to get her blood pressure because it wasn't coming up on the machine- the kind where you pump it up and watch the needle, they said it was 58/38. patient states that they asked her about the rash that was all over her body in 2021; caller reports that she did not have a rash when she called at 4 PM. patient describes the rash as an extremely red sunburn rash- like you got really bad sunburn, most of it was on her torso, she also had it on legs on 13Mar2021. patient mentioned she remembers them taking off sock and her toes were purple on 13Mar2021. She also had a red on her eyelids- she described as itchy and swollen on 13Mar2021. patient mentions that unbelievably as sick as she was in 2021, she could understand everything that they were telling her. Treatment was given as they prescribed her Prednisone and Benadryl; she was also hooked up to an IV, and they were trying to warm up her body because body temperature was low in 2021. Discharge paper reads as anaphylaxis due to vaccination on 13Mar2021. patient states that she came home from hospital on Monday, 15Mar2021. patient reports she started a diet. 2nd day (12Mar2021)- From the time she got up, she was too cold to do anything; she couldn't walk and she was feeling like she was getting the flu. Saturday (13Mar2021)- She woke up and had the worst Charlie horse between ankle and calf- took forever to walk Charlie horse off. Really sharp Charlie horse. Even had less energy today. Really nauseated. patient reports that yesterday and today, she is just tired. She doesn't know if it's just her body catching up on sleep or she's just tired; she will find out today when she goes to doctor. Caller mentions that she is normally more active than she feels right now. patient reports her eyes have been itchy and she has a rash on her eyelids. patient doesn't know if it's from the shot; patient mentions that she decided on 01Mar2021 she would start a diet, get healthy, and see a nutritionist. patient reports that initially she didn't think her symptoms were from the vaccine and thought it was that she wasn't eating enough food on Friday. She got in touch with the dietitian. patient reiterated she did not attribute this to shot right away. patient reports that she was wondering if she had asymptomatic covid, and it would have been within a 3-month period that she reacted to the shot. She was not sick if she did have asymptomatic covid. There still trying to figure out why her body had this reaction. patient states that every now and then she was still cold, but she doesn't know if its her imagination and plus it is cold outside where she is. She is still on the cuff on that one. patient describes the nausea she first felt as almost felt like morning sickness on 12Mar2021-that's why she attributed it to her diet. patient mentions that the day she started feeling better, late Sunday afternoon, she wanted salty foods. Anything salty, chips, she just really wanted salty stuff. She was not normally a salt person, but the saltier it was, the better it was. patient reports that when she was vomiting with diarrhea and laying down, she would be throwing up in a towel because she couldn't make it to the bathroom when she was laying, it would just gush. patient describes it felt like her body was going to be locked into the position it was in, she doesn't know how to describe it. patient states that she had vomit on her clothes when she called. patient reports the nausea stopped late Monday and the queasy feeling went away. patient reports she stopped vomiting when they gave her Zofran- they had to give her a couple because she didn't stop throwing up right away. patient reports she was extremely dehydrated and her kidneys were showing some damage; her creatinine level was really off on 13Mar2021. The diarrhea was gone, but now she has a mixture of soft stools and semi formed. It is trying to improve but hasn't yet. patient states that because of her creatinine level, they did want her to drink and she might have soft stools because she was drinking so much. patient reports she knows when her husband put the shirt on her she did not have the rash, but when the ambulance arrived, they said she had the rash. Upon discharge, they told her not to receive any further covid vaccines- she cannot get her second one which was scheduled for 01Apr2021. She started experiencing the really cold feeling on 12Mar2021 after receiving the vaccine. She went to bed at 7, that's not like her, she was usually up all hours of the night. symptoms she was experiencing were beyond typical. patient reports she also felt dizzy and weak on 13Mar2021. She thought she was going to die because of the purple toes in 2021- she knew that was a sign of her body shutting down and she got the most scared. patient mentions she is experiencing a residual side effect from the covid and influenza tests-both were negative on 13Mar2021, but it seems like her nose won't stop running ever since she got it, sore from blowing- looks like Rudolph in 2021. patient reports she feels human today, but she is still sleepy in 2021. She thinks she would feel a whole lot better if her nose stopped running. The tiredness might be from nose blowing and stuff. patient remembers the nurse was thrilled that her toes weren't purple anymore. It started going away when her blood pressure and everything came back up. patient states that she was so scared that she was dying so she remembers everything that happened. patient remembers she was in the ER still when her blood pressure improved. Treatment for her face was so red like the rough sunburn feeling and putting moisturizer on the dried cheeks. patient reports that she doesn't see any patches of red on her. Part of her has a fear that the stuff is not totally out of her system and it will happen again. patient mentions she has heard comments that this was not a typical reaction from the first one and wants to know if it is typical to be that sick from the first dose. patient reports that now her eyes just feel like she's allergic to something. She doesn't know if the redness is from crying now- it was improving, but was still there. Husband has Parkinson's and Frontal lobe dementia and she is his caregiver, she cannot afford to get Covid, she wants to get back to normal. patient reports that she did not take any of her prescriptions the day of the vaccine, she did not want to get a reaction. patient reports she had her shoulder- torn rotator cuff-operated on in 2018. If nose is really stuffed up or allergies, or Fluticasone nasal spray- she can take it 2 times a day, 2 squirts in each nostril, take it as needed. patient reports that she has the worst sinuses- when it gets too bad, she'll go to the doctor and she'll prescribe Flonase, take Metamucil or whatever she thinks will help with sinuses. she still wants to get the second vaccine. patient reports her creatinine came down well enough that she could come home from the hospital, it was still high on 15Mar2021 so they told her to drink lots of water so she does not get dehydrated. Patient was hospitalized from 13Mar2021 to 15Mar2021 for Anaphylaxis, Tiredness, Nauseated, Morning sickness, Vomited, Activities of daily living impaired, Walking difficulty, Flu like symptoms, Pale, Photosensitive rash, Asthenia, Dizziness, Charley horse, Dehydration, Renal disorder, Creatinine low, Cold, Diarrhea, Purple toes syndrome, Blood pressure low, Redness of eyelid, Eyelids itchy sensation of, Swollen eyelid. For rash also patient was hospitalised. The outcome of Vomited, Pale, Photosensitive rash, Dizziness, Asthenia recovered on 13Mar2021, Nauseated, Morning sickness recovered on 15Mar2021, Activities of daily living impaired, Walking difficulty, Flu like symptoms recovered on 17Mar2021, Diarrhea, Cold, Blood pressure low, Purple toes syndrome, Redness of eyelid, Eyelids itchy sensation of, Swollen eyelid were recovering, Tiredness and Creatinine high were not recovered, while remaining events were unknown. No follow-up attempts are possible. No further information is expected.

onset of symptoms of left-sided Bell palsy (twitching, paralysis, lost of taste/sensation of tongue, lid lag etc). I knew I had Bell palsy; Awakened with brief episode (10 min) severe abdominal pain; Severe muscle aches; Head pain; Neck pain; Developed sore on left side of tongue; Neck/mastoid pain; Swollen gland lasted a few days; This is a spontaneous report from a contactable other HCP (patient). A 63-year-old (non pregnant) female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EN6200, Expiry Date: unknown) via an unspecified route of administration in left arm on 24Feb2021 13:30 at single dose for COVID-19 immunisation. Patient had historical vaccine at 63-year-old BNT162B2, lot number: EL9262 at left arm on 03Feb2021 13:30 at SINGLE DOSE for Covid-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient's medical history included penicillin and neomycin allergy. Patient's concomitant medications included ergocalciferol (VIT D), rosuvastatin calcium (CRETOR) (medications the patient received within 2 weeks of vaccination). On 25Feb2021, the patient experienced onset of symptoms of left-sided bell palsy (twitching, paralysis, lost of taste/sensation of tongue, lid lag etc). I knew I had bell palsy, awakened with brief episode (10 min) severe abdominal pain, severe muscle aches, head pain, neck pain, developed sore on left side of tongue, neck/mastoid pain, swollen gland lasted a few days. Event was reported as on 25Feb, patient awakened with brief episode (10 min) severe abdominal pain. Later, severe muscle aches, head and neck pain, lasted until following Wednesday (03Mar). Patient developed sore on left side of tongue, neck/mastoid pain, swollen gland; lasted a few days, then noted onset of symptoms of left-sided Bell palsy (twitching, paralysis, lost of taste/sensation of tongue, lid lag etc). By friday 12Mar she knew she had Bell palsy. Medrol dosepak, OTC pain meds was received as treatment for adverse events. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The outcome of event was not recovered.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of Bell's palsy and other events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including Head CT/MRI and viral serology, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

It was the pfizer vaccine, got a little tingly and light headed which I am accustomed to. I got very tired but I was able to drive home. At home I fell asleep for an hour or two, swelling started in my legs mostly but also arms and all over. They were swollen like balloons and it was difficult to bend the knee. Swelling was visable, white, no redness, Next day my face was swollen and dark bags under my eyes. I have had this swelling before and another bad episode was after surgery with anesthesia. It is still very tight and sore mostly in my knees. Not sure if it is autommune reaction or allergy.

swollen glands plaque in the throat pain in the lower back fever dizziness tiredness nausia poor appetite I didn't go to the doctor because I don't have insurance

March 1 first injection. March 3rd I had an emergency surgery for a knee injury that occurred on March 1, slept most of the day and the entire night without my CPAP. The day after surgery I started experiencing intermittent palpations for several days before subsiding. March 26 had second injection. 2 1/2 hours after injection started experiencing palpations intermittently throughout the weekend and on the Monday morning became lightheaded and dizzy with an increased heart rate (114) and bursts of rapid palpations, & LLE edema. Unsure if the edema was related to the vaccine or the knee surgery. No lower extremity edema was present 2 days post-op. Sent to ER

Patient reports mild facial swelling. No airway impairment, no breathing difficulty. Patient took their own Zyrtec 15ml. No facial swelling noted, no airway impairment. Patient was observed for 30 minutes. Symptoms resolved

On my way home (about 2:45-2:50), I developed tingling in my lips and my ears felt numb. I pulled into the parking garage at a hospital on my way home and by then my knees felt weak and numb too. After waiting a while in the hospital my legs began to swell and my pants felt tight from the knee down. Later the top of my head felt numb but my lips felt better. They administered 50 mg of Benadryl about 6 pm and my leg swelling went down and I felt good enough to go home by 7pm.

Within 15 minutes-Itching mouth, by 30 minutes-face and lip swelling, blood pressure 210/110 for several hours.

Woke up next AM, face was swollen, had low grade fever, face was red and hot. Pt took Benadryl and it didn?t get better, it got worse. Woke up 2nd day and swelling got much worse, and eyes were swollen shut. Went to walk in clinic and got prescribed 50mg prednisone a day. Pt feeling better after 3 days of steroid treatment

We didn't adminster the vaccine at our location, however, she alerted us of her reaction that started immediately after getting vaccine: Per patient:"I had a generalized reaction. My face swelled, turned red, got hot; my throat had some swelling; I had to remove my mask to breathe. I had to stay an hour and a half before they would let me go home. My face swelling diminished over the next 24 hours."

pain; flu-like symptoms/felt like she had a little bit of the flu; she has one area with a "big circle around it and it's hard; she had a little bit of pneumonia; got a fever; felt like she couldn't go to the bathroom, cramps; had trouble breathing; the site was red; swelling/her arm is swelling; it does hurt her, right in that area where the shot was given; arm was sore and achy/her arm started aching; Diarrhea; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 63-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EN6208, expiration date unknown), via an unspecified route of administration, administered in left arm on 22Mar2021 at the age of 63 years old at a single dose for COVID-19 immunisation. Medical history included ongoing pre diabetic, ongoing high blood pressure, ongoing non-alcoholic liver disease, edema, to help her breathe, pneumonia, COVID in 2021, respiratory problems, asthma, little bit of obesity, swelling in her legs, varicose veins. Concomitant medications included benzonatate at 100 mg to help her breathe, azithromycin (six pills of that, 200mg, two one day and one pill a day until gone) for pneumonia. Patient had her second dose scheduled on 12Apr2021. She explained after the shot, her "arm was sore and achy" she said she also had "pain". She added she experienced "flu-like symptoms". She specified these adverse reactions are all gone now but her arm is still "a little sore" and she has one area with a "big circle around it and it's hard". She said it could be "swelling". She asked if her reaction was reported as side effects to the vaccine. She expressed being in a rush and is expecting her daughter soon and asked us to be quick. She said she will also consult with her HCP this afternoon. Patient stated she had the first shot on Monday 22Mar2021 and today and last night the site was red, but today in that area she has gotten a big circle around it and its hard. Patient stated she's had it before with shots and just wanted to make, sometimes she has had to be put on medicine for it, wanted to be sure its healing because it does hurt her, right in that area where the shot was given. She also stated that after she has her second shot on 12Apr2021, she would like to talk to somebody and she would like to be able to have people in her home. She was reporting she had COVID three weeks ago, would she be ok after the 2nd shot to go out? She stated her daughter thinks she needs to wait until the end of April. She verified she did receive the Pfizer BioNtech Covid 19 vaccine. Swelling: Patient stated her arm is swelling. Also stated she always gets that and today there's a circle there and it is red and hard. Also stated occurred after the shot. Patient reported that the shot hurt like heck and she couldn't really tell, she has big arms, she knows it was swollen. Reported she took over the counter medicines, last night she noticed it was a circle and it was hard there. Stated area is not swelling anymore, now just one hard red circle. Red and a hard circle: She also reporting her entire arm ached after the shot, she stated she knows her entire muscle was aching. Stated it was swollen quite a bit but now its just red and a hard circle, and it's ongoing. Arm swelling outcome: Patient reporting yesterday afternoon, she was feeling better, except that one spot. She stated it does hurt when she bends it because she had that one little area that's swollen. Also stated the swelling started later that afternoon after the shot. Reported she went for a walk with her daughter and her arm started aching. It felt like she couldn't go to the bathroom, cramps. It felt like she had a little bit of the flu, and it was from the shot but it only lasted a few days. Stated that part went fast, got a fever, other than that, just the one area on her arm. Stated she doesn't even feel sick from the shot or anything. Stated she had Diarrhea: Stated she had diarrhea in the beginning after the shot then had trouble going to the bathroom. Stated she thinks its because she has IBS and that's how her body is. She doesn't know if that's from the shot or not because that's how her body always is. Pfizer BioNtech Covid 19 Vaccine: Patient stated she doesn't want COVID again. She has respiratory problems anyway, she has asthma and a little bit of obesity. She states she was in fear of herself. She doesn't do well with hospitals and being put under with that medicine. Also stated patient knew COVID causes a lot of people having trouble breathing and she doesn't want to end up on a breathing tube where its breathing for her and she never sees her family again. Caller states it kind of scared her. Patient stated her niece and nephew, whos got it worse. She stated she went to the hospital and haven't been back. She stated she was hospitalized about 2 weeks ago, and that's when she was diagnosed with COVID, before she got the first COVID shot. About the medical history, non-alcoholic liver disease: Stated diagnosed about eight years ago, she would say the same time, about 7 to 8 years ago because she had a virus and when she went in the hospital, the virus had attacked her right kidney and liver. She stated with non-alcoholic liver disease, she is overweight, and that causes her to have issues with her liver. The last few times her liver has been okay. Pre-Diabetic: They have been watching that for a while. Stated she gets edema, swelling in her legs, well, all the time. She has had this the last two years because she is pre-diabetic and a lot of overweight people have that. She also has varicose veins so that doesn't help. Stated that was given those to help break up, because she had pneumonia when she got the COVID and she had a little bit of pneumonia and had trouble breathing. The patient was recovering from arm was sore and achy/her arm started aching, swelling/her arm is swelling and for other events it was recovering.

arm started swell a little bit; woke me up at 5 O'clock this morning in pain; arm started swell a little bit; woke me up at 5 O'clock this morning in pain; shoulder is kind of swollen; shoulder is kind of swollen, it's got big old knot and it's red and it's apparent itchy; shoulder is kind of swollen, it's got big old knot and it's red and it's apparent itchy; shoulder is kind of swollen, it's got big old knot and it's red and it's apparent itchy; arm kind of still stiff and sore; Blood in stool; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER2613 and expiration date not provided) via an unspecified route of administration administered in the arm, on 23Mar2021 as a single dose for COVID-19 immunization. Medical history included breast cancer survivor. The patient's concomitant medications were not reported. The patient stated that she was trying to figure out what to do. On 26Mar2021, her arm started to swell a little bit. When she woke up, it woke her up at 5 o'clock in pain and her shoulder was kind of swollen, it has got big old knot and it was red and it was apparent itchy and she could not scratch it so, she thought about it and she got an ice pack, so she put ice on it. She was holding ice on it now, trying to sooth it. She was wondering where she would go for reaction, she knew she had reaction like this before so she had a side effect from it, and her arm was kind of still stiff and sore. She did not go to the emergency or urgent care because she looked at left and she looked at the right and like she said, it was swollen and she got big old knot and it was red. She also stated that she did not take Tylenol today. She did not know what she wanted to get through to somebody and she needed to speak to somebody on what she needed to do. She also said that on an unspecified date in Mar2021, in her stool, she found some blood. She had another appointment with her "thyroid" (not clarified) and she does not know the results yet. The outcome of the events was not recovered. Information about lot/batch number has been requested.

Patient got an instant reaction after receieving the vaccine. She had an anaphylactic reaction, she stated throat swelled up and couldn't breathe, BP was elevated and she started to experience hot flashes. Pain at the injection site. Patient took a benadryl and about 20 minutes later the symptoms started to subside. No c/o fever, headache, n/v. As of 4/8/21 @12pm patient is not experiencing any symptoms only slight pain at the injection site. No medications were taken as far as Tylenol/Ibuprofen. 4/11-Follow up call -Patient feeling better but is apprehensive taking second vaccination due to anaphylactic reaction from first vaccination, even though she is aware that it is not recommended. No signs and symptoms at this time.

This was my second shot. Just for background, my reaction to the FIRST SHOT was minimal (slight headache) until the 2 WEEK mark (after my checkin) when all of a sudden I had **5 canker sores in my mouth (both cheeks/ NOT cold sores) and also a ** buzzing in my ear. I received my second shot on 3/26/21 .. minimal reaction except sore arm - until 2 WEEKS exactly (again.. and after check in). ****Enlarged inguinal lymph node on right side with pain and sleeplessness. Over an inch... maybe the size of a pecan in its shell?? No sign of infection - as far as I can tell - no urinary burning or pain. no extra discharge, etc.. no cuts. also, continued buzzing in ears and sores on tongue and lips - all at the 2 week mark. FYI, the enlarge lymph node, ear buzzing and multiple canker sores are highly unusual for me!!

ALL joints severe pain, very achey all over, horrible headache, 2 fingers on r hand would not bend, swollen very itchy injection site, nausea, stiff neck. Started Saturday evening (after injection on wednesday) thru following Monday (time of reporting)

Pfizer-BioNTech COVID-19 Vaccine EUA Developed a swollen gland on the left side of neck, headache and runny nose.

Patient developed hives the afternoon she received COVID vaccine. She had a telemedicine visit with this provider on 4/7/2021. She was prescribed Medrol dose pack, was taking Benadryl, and famotidine was added. She developed tongue and facial swelling later in the day, and went to hospital for treatment. Provider does not have above vaccine information as vaccine was not given at facility

2/28/21 Four days after 1st Pfizer vaccine 2/24/21 Severe cramping and swelling in my right leg and ankle. 3/9/21 Work clinic advised to seek medical attention 3/9/21 Hospital Emergency Room Diagnosis: Deep Vein Thrombosis (DVT)- Blood Clot 3/10/21 Thrombectomy Surgery & Released 3/11/21 Swelling in right leg and ankle Returned 3/12-16/21 Readmitted - Blood Clot returned Currently under several doctors care.

Dose 1- Left side of face would be real red when I woke up. Would happen every 2-3 days for 6-10 hours duration. Went in about 2 weeks. Did not hurt, no fever. injection site sore around 4 days when lifting my arm. Dose 2- injection site not as sore. Woke up the next morning with left side of face beet red again. Also left neck/collarbone area lymph nodes swollen. Palpable, not sore, no fever or muscle aches. Face red most of the day. On day #6 woke up RIGHT side of face beet red, and right neck/collarbone lymph nodes swollen. So now both sides are swollen. And beet res on both sides of face. No fever, no muscle aches.

Slight dizziness and mild nausea about 20 mins in length, I sat down and waited for it to pass. That evening I noticed fever sores erupting all around my mouth. I'm trying home remedies for discomfort. No medical attention at this time. Very painful.

Thrombocytopenia AKI (acute kidney injury) Neutropenic fever C. difficile colitis Hypotension, unspecified hypotension type Sepsis

Patient reports mild facial swelling. No airway impairment, no breathing difficulty. Patient took their own Zyrtec 15ml. No facial swelling noted, no airway impairment. Patient was observed for 30 minutes. Symptoms resolved

throat tightness; axillary node lymphadenopathy; myalgia; fever/a high fever of 103; chest wall erythema; This is a spontaneous report from a contactable physician. A 63-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 24Mar2021 (Batch/Lot Number: ER8727) as SINGLE DOSE for covid-19 immunisation. Medical history included leukaemia, seasonal allergy, anaphylactic reaction, drug hypersensitivity. Concomitant medication(s) included fluticasone propionate, salmeterol xinafoate (ADVAIR) taken for asthma from an unspecified start date and ongoing; azelastine hydrochloride, fluticasone propionate (DYMISTA) taken for hypersensitivity from an unspecified start date and ongoing; dasatinib monohydrate (SPRYCEL, NDC: 0003-0524-11) taken for chronic myeloid leukaemia from 2013 to an unspecified stop date; spironolactone (SPIRONOLACTONE) taken for fluid retention from 2017 to an unspecified stop date; mirabegron (MYRBETRIQ) taken for hypertonic bladder, start and stop date were not reported and unspecified medications for leukemia. The patient previously received Epipen for anaphylactic allergies to foods, drug, and environmental allergies. Caller was calling about the Pfizer BioNtech COVID vaccine. She has had a plethora side effects since her second dose 24Mar2021. It all started with chest wall erythema then it moved to axillary node lymphadenopathy the she got a high fever of 103 and then there was myalgia all across her torso, abdomen, and and upper back, she clarifies her trapezius area. She confirmed on 24Mar2021 the chest wall erythema began that afternoon, 24Mar2021. Axillary node lymphadenopathy began Thursday, she confirms 25Mar2021 ongoing improved. The fever began Wednesday, she confirms 24Mar2021 and it was still ongoing. Yesterday she woke up and it was 103 today it is a bit better, it is 101.2. She confirms today it seems to be improved a bit but yesterday she was taking hand fulls of Ibuprofen to try to get it down. The myalgia she noticed Thursday 25Mar2021 and it was ongoing, it was some what improved. She has environmental allergies. She had some throat tightness the day of the COVID vaccine that dissipated late that afternoon and that was for both doses. She carries an Epipen because she has food, drug, and environmental allergies. She has had anaphylactic allergies to foods. She clarified she was far from needing to use an Epipen with the her doses of the COVID vaccine, the throat tightness just dissipated. She does not think an Epipen would have helped a fever and body aches anyway. She said she takes Spironolactone for fluid retention from the Sprycel. She tried to look up to see if there was any interaction between the vaccine and Sprycel but she couldn't find any thing. Her husband was in the pharmaceutical industry as well and they have looked up available information of duration of side effects and they couldn't fine anything and she was just surprised that after 4 days of it she was still waking up with fever and still having myalgia. She was wondering if the agencies had reported or maybe they have not unmasked any data yet of duration of things reported that are listed. It just seemed extremely unusual. Caller reported fever after her second dose of the Pfizer BioNtech COVID 19 vaccine. She said yesterday she was taking hand fulls of Ibuprofen to try to get the fever down. Today the fever was a bit better but it was still ongoing. The outcome of the event fever, myalgia were not recovered, chest wall erythema was recovered on 27Mar2021, throat tightness was recovered on an unspecified date and axillary node lymphadenopathy was recovering. No follow-up attempts are needed; information about lot/batch number cannot be obtained

Lyme symptom flare up including, fever, swollen throat/lymph glands/parotid glands, headache, eye ache, joint inflammation, nausea, malaise, dizzy, lightheaded, shortness of breath. Came on within the first two days, left me bedridden for 5 days. Ran low grade fever off and on and symptom flare ups for the next 20 some days until I began to feel better. Went in to get scheduled 2nd vaccine and was turned away. Asked to return with epi pen in hand and feeling strong.

intracranial pressure; angioedema near her ears and the gland secretes and the passage way swells up; rush of pressure to back of head and the lower part of head; Headache; dizzy/Dizziness/light headed; out of body experience like floating; my arm started to really hurt/Sore Arm; sore to touch; cloudy and pressure in her ears/Ear Pressure; vertigo issues; vestibular migraines; patient can't walk; tunnel vision; eyes felt funny. States like walking through a stream of pollen, not that she had itchy eyes, but it felt like she had been effected by something; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in Left Arm on 01Apr2021 about 13:30-14:00 pm (Batch/Lot Number: ER8737) as SINGLE DOSE for covid-19 immunisation. Medical history included ongoing Hashimoto's disease, Diagnosed 13 Years ago, patient was allergic to penicillin and Avalox (anaphylactic and I am sensitive to medications). Don't know if this happened when she got Hashimoto's, Thyroid, ongoing Vestibular Issues Started 5 years ago. States one doctor thinks it is her bad neck. States when she got old things shifted and changed. One ENT said she has neuritis, where something hit her ear nerve in right ear. States hence that was what the acyclovir was for, when she feels an earache coming on, she takes acyclovir. No previous immunization with the Pfizer vaccine considered as suspect. No Additional Vaccines Administered on Same Date of the Pfizer Suspect. No prior Vaccinations (within 4 weeks). AEs following prior vaccinations: None; reported she hadn't had any flu vaccines in years because of the ingredients. States because of her Hashimotos because of everything with her health it was not conducive. Last one was 2014. Concomitant medications included guaifenesin (MUCINEX) taken for hypersensitivity from an unspecified start date and ongoing; fexofenadine hydrochloride (ALLEGRA) taken for hypersensitivity from an unspecified start date and ongoing; levothyroxine sodium (LEVOXYL) taken for thyroid disorder from an unspecified start date and ongoing; azelastine hydrochloride (AZELASTINE HYDROCHLORIDE) taken for hypersensitivity from an unspecified start date and ongoing; aciclovir (ACYCLOVIR ACTAVIS) taken for ear pain from Mar2021 to an unspecified stop date; naltrexone (NALTREXONE) taken for autoimmune thyroiditis from an unspecified start date and ongoing; alprazolam (XANAX) taken for an unspecified indication from an unspecified start date and ongoing; magnesium (MAGNESIUM) taken for an unspecified indication from an unspecified start date and ongoing; fish oil (FISH OIL) taken for an unspecified indication, start and stop date were not reported; curcumin (TURMERIC MERIVA) taken for an unspecified indication from an unspecified start date and ongoing; 7-keto-dehydroepiandrosterone (7 KETO DHEA) taken for an unspecified indication, start and stop date were not reported; ferritin (FERRITIN) taken for an unspecified indication from an unspecified start date and ongoing; boric acid, zinc sulfate (OPTIZINC) taken for an unspecified indication from an unspecified start date and ongoing; colecalciferol (VITAMIN D [COLECALCIFEROL]) taken for an unspecified indication, start and stop date were not reported; lactobacillus reuteri (PROBIOTICA) taken for an unspecified indication from an unspecified start date and ongoing; calcium saccharate (CALCIUM D GLUCARATE) taken for an unspecified indication from an unspecified start date and ongoing; berberine hydrochloride, coptis chinensis, glycyrrhiza uralensis, mahonia aquifolium, phellodendron chinense, rheum officinale, scutellaria baicalensis, zingiber officinale (CANDIBACTIN BR) taken for an unspecified indication from an unspecified start date and ongoing; cyanocobalamin, folic acid (VITAMIN B12 & FOLIC ACID) taken for an unspecified indication from an unspecified start date and ongoing; alpha-amylase swine pancreas, cellulase, lipase, protease nos (DIGESTIVE ENZYME) taken for an unspecified indication from an unspecified start date and ongoing; pancreatin enzymatic hydrolysate (PANCREATIN ENZYMATIC HYDROLYSATE) taken for an unspecified indication from an unspecified start date and ongoing; levoglutamide (L GLUTAMINE) taken for an unspecified indication from an unspecified start date and ongoing; betaine hcl (BETAINE HCL) taken for an unspecified indication, start and stop date were not reported, Bio Identical Hormone Cream taken for an unspecified indication, start and stop date were not reported. On 01APR2021, she could feel rush of pressure to back of head, tunnel vision, cloudy and pressure in her ears and was dizzy. Hx of Hashimoto's - autoimmune disorder, vestibular issue, concerns with getting the second one (dose). Read about adverse reactions and dizziness was on the list of severe reactions. The instant, within a minute, patient could feel this happening to her, she instantly could feel she becoming dizzy, light headed, out of body experience like floating. (didn't mention this in report) felt like walking on air. While sitting and chit chatting with other people to distract myself. Patient didn't have any anxiety. She will admit she was reluctant to get the vaccine because of my health problems. She was more concerned, she instantly got a headache with the pressure, when she was leaving, she felt her eyes feel weird, almost like an allergy issue, burning, not quite burning either. Kind of like a burning, not quite like a burning, felt like when you walk into the wind that has lots of pollen, that feeling. She didn't walk out side, she was inside when this happened, the pressure was already starting, no headache in front of head, it was in back of my skull, at top of her neck and pressure within the ears and ache and pressure on back of her head. Not dizzy, not like when you are in the hospital and they give she something and patient can't walk, or where you tried to stand and you couldn't , it was more like light headed, like walking on air like. It lasted all yesterday. As the night progressed by 10PM or 11PM her arm started to really hurt, patient took Tylenol and went to bed, took Xanax as she did and slept, woke up fine. This morning it felt like she wanted to have a headache but haven't had it since. It's almost like patient had intracranial pressure, because she had these conditions, so she read a lot. Investigation Assessment was No. States she is calling to report a potentially strange side effect. She states as soon as she got the injection, approximately within one-two minutes, she could feel a rush to the back of her head and the lower part of her head which then made her feel like she had somewhat of her vision clouded, like a tunnel vision. Clarifies her vision was clouded on the sides but she could see forward. Caller states that she was not dizzy like falling over and she does have vestibular migraines and vertigo issues, but she had that feeling of dizziness and when she got up and walked, it felt like she was walking on a cloud. Clarifies she felt a heavy pressure in the back of her head. States as soon as the injection was over, she could feel it. States she is concerned regarding the second dose because of her autoimmune and vestibular conditions. She states is caused immediate pressure in her ears. States that could've affected her and put her into a migraine, she doesn't know. States a friend said jeez you should report that and she read more on the list of side effects and saw something about an allergic reaction and dizziness, and she did have some sort of adverse reaction. States she doesn't know and it is concerning to her. States she is doing fine today, other than a little headache that comes and comes. States it was bizarre with the clouded, not cloudy, but tunnel vision. States she does not want to release any medical records; she declines for now to provide. She states CVS administered it, not her doctor. States she is going to discuss it with him. States she doesn't want to have a worse reaction with the second dose. Caller states a headache is a headache but the pressure she felt within one minute and continuing it concerns her on the second one with the larger dose. States she is also concerned with the second dose if dizziness is a severe allergic reaction, not saying she fell over and wiped out. Patient wondering if that was an allergic reaction. States as the evening went on and she took Tylenol, it improved. States the dizziness improved as the night went on but had a bizarre feeling when she went to bed. States her arm was sore in the evening and is still sore to the touch. Clarifies that her eyes felt funny. States like walking through a stream of pollen, not that she had itchy eyes, but it felt like she had been effected by something. States it was not like a tired and burning feeling, states she can't explain it but something felt like had an allergy type situation if she has a problem with seasonal allergies. Treatment included took Tylenol. States when someone has an autoimmune issue they have a lot of issues regarding the stomach and take a lot of vitamins and supplements. Caller states she wants to report she has a lot of food sensitivities and environmental sensitivities because of her Hashimotos. States anything can set off an immune response. States what happens with that is she would get on her face, angioedema near her ears and the gland secretes and the passage way swells up. States she takes Pepcid AC to treat it. States this did not happen with her first vaccine. States she was very hesitant on taking the vaccine because knows she has these issues and she didn't want to have adverse reactions. States that her reaction to the first vaccine potentially concerns her for the second dose. States going to speak with the medical information department is a good idea. States the location she received her vaccine was very busy. States they did a nice and good job on getting people in. States the girl administering it did good, but she didn't mention unless you knew you had to wait 15 minutes due to possible adverse reactions, they didn't really check on people. States she just had to do whatever and she didn't know whether or not to report it then because she was not in distress. States she thought she just has to get home and drove 30 miles. All events (AEs) did not require a visit to Emergency Room nor Physician Office. The events of Tunnel vision, rush of pressure to back of head and the lower part of head, Headache, dizzy/Dizziness/light headed, cloudy and pressure in her ears/Ear Pressure, was recovered on 01Apr2021, of my arm started to really hurt/Sore Arm; sore to touch was not recovered, of other events was unknown.

Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third night I had a pancreatitis attack.; Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third night I had a pancreatitis attack.; Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third night I had a pancreatitis attack.; Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third night I had a pancreatitis attack.; Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third night I had a pancreatitis attack.; Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third night I had a pancreatitis attack.; Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third night I had a pancreatitis attack.; Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third night I had a pancreatitis attack.; This is a spontaneous report from a non-contactable consumer (Patient). A 63-years-old female patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8732), dose 1st via an unspecified route of administration, administered in Arm Left on 01Apr2021 08:00 as single dose for covid-19 immunisation. Patient medical history and concomitant medications were not reported. On 01Apr2021 11:15, the patient experienced Fever, Bad body aches, bad headache, nausea, diarrhea, lightheaded when standing, weak. On the third night I had a pancreatitis attack. The patient had other medications in two weeks of vaccination. Patient did not took any treatment for adverse event. Patient did not had covid prior vaccination and not tested for covid post vaccination. She did not have any Known allergies and had other medical history. No follow up needed. No further information is excepted.

Since day 3 after the vaccine I have had cramping and twitching in arms, legs, feet, hands. Since Day 7 I have had a tremor in my neck and face. At times my throat /neck feels like it is swollen. I have had tinnitus since about Day 7. I have had no treatment. Drs. do not know what to do.

Went to bed few hours after vaccine woke up with a swollen face and low grade fever . Monday woke up my eyes were swollen shut face was worse went to walk in clinic. And they gave me 50 mg steroids for 3 days . Still puffy for 2 weeks with headache

4/21/2021 Patient was observed post Covid-19 immunization for 15 minutes . During the observation period, she experienced an adverse reaction with the following symptoms: swelling of face and throat. Assessment : Time of assessment 1445. Swelling of lips and nose. Actions taken: Vitals sign taken EMS called at 1520. VAERS form obtained and completed by RN. Hand off to EMS upon arrival at 1530. VS at 1445- BP- 144/90. P- 101, O2- 99% VS taken at 1506- - BP- 165/88, P- 84, O2- 100%, Medications administered: Diphenhydramine (Benadryl) 25 mg capsule, by mouth. Time: 1445 and 1507. Administered by RN x 2 doses. Disposition: 911 called and patient was evaluated, she refused transport to hospital by EMS, she reports that husband will transport her. Observation time increased to 30 minutes Immunizations Administered Name Date Dose VIS Date Route Pfizer COVID-19 Vaccine 4/21/2021 2:08 PM 0.3 mL 2/25/2020 Intramuscular Manufacturer: Pfizer, Inc Lot: ER8735

First 3 days - eyes burning, throat burning, fever, painful lymph nodes under chin, arm pits, chest. Increased tinnitus. As those got better, dizziness increased. As of 4th day and still continuing, have vertigo with visual swirling and intense spinning. Spinning worse when laying down or turning head quickly. I have contacted my doctor to schedule an appt but have not gone to ER

face was swelling, bright red, and very itchy; face was swelling, bright red, and very itchy; face was swelling, bright red, and very itchy; Continued to worsen all day and night. Eyes and lips swelled shut; entire face and neck brilliant red; max amt of itching; neck still red and bumpy; Have been unable to sleep well; This is spontaneous report from a contactable healthcare professional (patient herself). A 63-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3246), via an unspecified route of administration on 04Feb2021 at 15:15 PM (at the age of 63-years-old) as single dose in left arm for COVID-19 immunisation. The patient's medical history included diabetes Type 2, hypothyroid, shingles 10 years ago. Patient had known allergies. Concomitant medications included Synthroid, Rosuvastatin, Metformin, Tresiba and Ozempic. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had no COVID prior vaccination and was not tested COVID post vaccination. On 04Feb2021 at 20:00 by midnight, the patient's face was swelling, bright red, and very itchy. She took one Benadryl. Her face and neck worsened, got into MD in morning. She prescribed Claritin and make appointment with allergist. Patient did both. Events continued to worsen all day and night. Her eyes and lips swelled shut, entire face and neck brilliant red with maximum amount of itching. Patient kept ice on face and neck all night but continued to worsen. She went into hospital Emergency Room at 9:00 AM, received IV Prednisone, Benadryl and one more. Also, prescribed with Famotidine, Prednisone, Benadryl and Tylenol if needed for home. Itching started subsiding, brilliant red remained everywhere, swelling was still significant around eyes and cheeks, neck was still red and bumpy. Patient have been unable to sleep well. She took appointment with allergist 08Feb2021 morning. She wondered if she should take second vaccine and reported that this has been an expensive and emotional nightmare. The outcome of the events was not recovered.

Left eye isn't right; Didn't get second dose of Covid-19 vaccine as scheduled; Everything on the left side of body was going numb/Left nostril went numb/Left cheekbone really tight and numb/Left back side of neck went numb/Left shoulder and arm were numb; Tingling in fingers; Lymph nodes on left side of neck were swollen; Left shoulder and arm were numb; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 63-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: was not reported; Expiration Date: Jul2021) via an unspecified route of administration on 16Mar2021 18:30 as single dose for COVID-19 immunization. The patient medical history and concomitant medications was not reported. On 16Mar2021 the patient experienced everything on the left side of body was going numb, left nostril went numb, left cheekbone really tight and numb, left back side of neck went numb, left shoulder and arm were numb on 16Mar2021, tingling in fingers, lymph nodes on left side of neck were swollen. The patient experienced left eye isn't right and didn't get second dose of covid-19 vaccine as scheduled on an unspecified date. Caller reported that she was supposed to get her second dose of the Covid-19 vaccine on 06Apr2021 but she is waiting to get the second dose. Caller reported that her physician is going to run tests because her symptoms have been kind of bizarre. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

couldn't get out of the bed as the pain all the way down to her back was killing her, like it was paralyzing her; allergic reactions; Swelling in the face; hives on her back; itching that was in her back; Neck and back pain were pretty intense; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number ER8729), via an unspecified route of administration on 02Apr2021 at a single dose for covid-19 immunization. Medical history was reported as many medical conditions, names unknown, just a combination of medical problems. The patient was taking unspecified concomitant medications, some of which were taken in the morning. The patient had the vaccine on 02Apr2021 (reported as "Friday or Saturday") in the afternoon and had a bad adverse reaction to it. The patient had swelling in the face, hives on her back, itching that was in her back, and, allergic reactions on 02Apr2021. Due to these, since she was just in a medical facility, doctor and nurses over there were able to inject her with Benadryl that was a strong dose, in a long needle given into the muscle and stuff. It was good enough that she got up and was sent home. She then seemed to be fine but on Monday, 05Apr2021, she couldn't get out of the bed as the pain all the way down to her back was killing her, like it was paralyzing her. She could not even get out of the bed for like hours. The neck and back pain on Apr2021 were pretty intense, and she does not know where and how it came so she was trying to figure that out and realized she just recently had the vaccine injection. She knew that there could be some kind of reaction, but she was not sure if it were from the vaccine. She wanted to make sure she did not get something serious because she already has rare conditions. She added she did not have any prior treatment for these because she did not even think like this was even a side effect of the Pfizer vaccine but now she was wondering if it was because she had not taken anything prior. She does not know if it was related or not and she was concerned about it. She wanted to know what she could do if these were side effects because she knew there were some people that have something to do with the spinal cord and she was not sure if their symptoms were like hers or not. She wanted to know if she would need treatment for it and if it was an adverse reaction. She added that the swelling in her face and, itching that was in her back went away the same day when she was given the vaccine. The outcome of the events swelling in the face and itching that was in her back was recovered on 02Apr2021. The outcome of the other remaining events was unknown.

Started having left leg pain and swelling 2wks after 1st covid vaccine (3/12/2021) at outside facility. Seen on 4/6/2021 (same day as 2nd vaccine). Dx with acute DVT of Left popliteal vein with extension into left peroneal veins of calf. Denies HRT, smoking, prolonged travel, surgery

Tenderness and swelling of the lymph node in left armpit. Same arm the vaccine was injected into. There is also soreness at the injection site. Fatigue similar to when I had Covid in January 2021

Vertigo; nausea; headache; swollen glands; fatigue; This is a spontaneous report received from a contactable consumer (patient). A 63-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EP7534) via an unspecified route of administration on 21Mar2021 at 14:30 (at the age of 63-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included high cholesterol and allergic to plants and pollen. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications included simvastatin, thyroid (ARMOUR THYROID), progesterone, and estradiol from unknown dates for unknown indications. The patient previously received oxycodone hydrochloride, paracetamol (PERCOCET) and montelukast (SINGULAIR) from unknown dates and experienced allergy. On 22Mar2021 at 16:45 the patient experienced vertigo, nausea, headache, swollen glands, and fatigue. The events were reported as non-serious. The patient was not hospitalized for the events. The patient did not receive any treatment for the events. The outcomes of vertigo, nausea, headache, swollen glands, and fatigue were recovered. It was also reported that since the vaccine, the patient had not been tested for COVID-19. No follow up attempts are needed. No further information is expected.

Two days following my shot I awoke with an all over body rash which was very itchy. I took Benedryl, hoping that would settle things down. It didn?t help. I went to bed that night, and when I awoke the next morning, the rash was even worse and my hands were so swollen I could hardly bend my fingers. The itch was really severe on my hands and feet. My husband took me to the ER, where I was treated with antihistamines and prednisone. I was there for about 3 hours and released with a prescription for another 6 days of prednisone. The rash , swelling and itching began to improve after about 2 days. The ER doctor told me I should not get the second shot.

her throat got swollen; burning sensation at the site; tiredness; achiness all over; her throat got red; could not sallow; her lymph nodes in the neck were swollen, they hurt really bad; Her lymph nodes in the neck were swollen, they hurt really bad; had pressure in the ears; ain in the shoulder, back of the head, in the back and in the neck; ain in the shoulder, back of the head, in the back and in the neck; ain in the shoulder, back of the head, in the back and in the neck; ain in the shoulder, back of the head, in the back and in the neck; This is a spontaneous report received from contactable consumer (patient). A 63-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 27Mar2021 (Batch/Lot number was not reported) as single dose (at the age of 63-year-old) for covid-19 immunisation. Medical history included COVID-19, she was tested positive for COVID in Jan2021. The patient's concomitant medications were not reported. On an unspecified date she experienced burning sensation at the site (that went away), later experienced tiredness, achiness all over, and her throat got red and swollen, could not sallow, she felt like getting COVID again after the vaccine. Her lymph nodes in the neck were swollen, they hurt really bad, had pressure in the ears, pain in the shoulder, back of the head, in the back and in the neck. She wanted to know if she should to get the second dose or not, if she can get the shot in the gluteal or other sites. The event her throat got swollen was considered medically significant. The outcome of Vaccination site burning was recovered, of all other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Body ache; Chills; Fever; Nasal congestion; Itching and rash on my arms and legs, left side; swelling and redness of my face; swelling and redness of my face; Tingling of my face and lip; Itching and rash on my arms and legs, left sid; Mild allergic reaction to the vaccine; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: ER8731) via unknown route of administration on 12Apr2021 at single dose in left arm for COVID-19 immunization. Medical history included ongoing high cholesterol in 2017, high blood pressure in 2010 and ongoing, ongoing prediabetes in 2013, overweight was maybe 25 years in 1996, and scoliosis was discovered when I was age 12 around 1970 (patient was taking pills for all the other things except for overweight), ongoing acid reflux. Concomitant medications included atorvastatin 10 mg, once a day for blood cholesterol increased, amlodipine 10 mg, once a day for high blood pressure, metformin 750 mg, once a day for glucose tolerance impaired, omeprazole at 40 mg, twice a day for acid reflux, solifenacin succinate (VESICARE) single for bladder control. Patient stated, "I got the first dose of the Pfizer vaccine yesterday and I just want to report that I had the mild allergic reaction to the vaccine on 12Apr2021", patient stated, "she got fever, chills and body ache on 13Apr2021 in the middle of the night." patient stated, "when I woke up I had nasal congestion too but that was very mild on 13Apr2021. patient further stated, "The allergic reaction it was mild, it was swelling and redness of my face and also tinging of my face and lips on 12Apr2021. And itching and rash on my arms and legs and my, my side, left side on 12Apr2021". Patient was feeling somewhat better because was taking Tylenol 500mg 2 pill 3 times a day just started today for all events. No hospitalization because of any of the events. The outcome of events pain and nasal congestion was unknown, while for other events was recovering. No follow-up attempts are possible. No further information is expected.

Severe Rt. Arm pain waking up early AM, 12 hours after the shot, with total body weakness, dizziness, flu-like feelings, lasting a full day, had to stay in bed. Then after 24 hours, Rt Underarm Lymph Nodes swelled up with much pain, although Rt Shoulder muscle was better, and I could get out of bed and move around a little the 2nd day. The Rt. Underarm Lymph Nodes are still swollen and painful, after 48 hours.

swollen lymph node after receiving the first dose of pfizer covid vaccine; This is a spontaneous report from contactable consumer (the patient). A 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) via an unspecified route of administration on 21Apr2021 at age of 63-year-old at single dose for SARS-COV-2 immunization. The patient's medical history and concomitant medications were not reported. The patient was calling to report a swollen lymph node (Apr2021) after receiving the first dose of the Pfizer covid vaccine. The patient asked "Is this side effect something to worry about, or is it going to go away?", the response was "Swollen lymph nodes (lymphadenopathy), which generally resolved within 10 days, is likely to have resulted from a robust vaccine-elicited immune response". The outcome of the event was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

1st dose: hives that started 2 days post the injection and lasted 1.5 weeks 2nd dose: hives that started 5 days post the injection and hives are continuing to rise and blister.

Severe sepsis secondary to Covid pneumonia: Patient made nice recovery with the completion of convalescent plasma and remdesivir. Patient will complete 5 more days of oral dexamethasone.

Later that night, on 1/27/21, I felt sick, Nausea, muscle soreness. Next day 1/28/21 went to work with headache, couldn't lift my arm up very swollen. Felt sick got worse felt very hot. Temperature of 104, got sent home from work. Took Acetaminophen and 2 cold tablets fever went down to 101.9. Took cough syrup. Went to sleep. got up next norming arm still very swollen, went to work got sent home no fever but still felt bad, achy muscles and arm still swollen. Stayed home in bed whole weekend. Got headache every day including Monday morning when got up to go to work. Headach on Tuesday also. Felt better on Wednesday. Woke up with headache on Thursday. Woke up with a headache on Friday.

Ongoing Left wrist pain and swelling with axillary lymph node enlargement a couple of days following the vaccine admin. Xarelto 15mg take as directed Xarelto 20mg take as directed

incredibly horrible itching under her Fitbit; whelp; her lips had started swelling; her tongue was tingling; she thinks that it was the beginning of anaphylactic reaction; she was just tired; type 1 hypersensitivity; a little soreness; It was like heaviness on her chest; having trouble breathing; allergic contact dermatitis; This is a spontaneous report from a contactable consumer (patient) and a physician. A 63-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 10:00 (lot number: EP7533) as SINGLE DOSE for COVID-19 immunization. Medical history included ongoing nickel allergy for decades which was under control and panic attacks. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 14Apr2021, it was reported that the patient didn't have any of the normal side effects such as fevers or chills but she was just tired and went to sleep early that night. She woke up on 15Apr2021 at 05:00 with incredibly horrible itching under her Fitbit that she wears to bed. She has a history of nickel allergy and she bought this particular Fitbit on purpose because it doesn't have any nickel in it that touches her skin and she has had no problems all year with the Fitbit. The itching was unbelievably bad and when she took the Fitbit off she had a horrible whelp under a tiny piece of metal that isn't even supposed to touch her skin. She thought well if it has exacerbated her nickel allergy then maybe it is doing something else to her body. On that day (15Apr2021), she thought that she had a panic attack and upon reading some information online, she thinks that it was the beginning of anaphylactic reaction because the symptoms are the same. She was thinking that the vaccine is doing something with her nickel allergy. It had used to be bad until she got it under control and she had it under control for many years. But with the things under the Fitbit she was blaming or associating it with the COVID vaccine so she took it off and then finally fell asleep again. But when she woke up in the morning, just a few hours later (15Apr2021), the bad whelp was still there and then her lips had started swelling and her tongue was tingling so she decided to look some more on google and she thinks that this is another version to an allergic reaction. She has had panic attacks before and she knows what they are now and she has learned through a therapist on how to get past and manage them but this was different for her. It was like heaviness on her chest and it felt like something was on top of her chest and she was having trouble breathing; both on an unspecified date in 2021. Her husband knows when she has a panic attack but this one was different she can't really explain it. She asks, what is the difference between a panic attack breathing and this type of breathing and later mentioned that she also had a little soreness (2021). In addition, the physician also called to report that this patient was complaining about 2 types of symptoms. The first was more an allergic contact dermatitis (2021) which the physician is not worried about. The second was lip swelling and tongue tingling which could be a type 1 hypersensitivity (2021). The physician is more concerned about the latter and would like to know if it is okay to pre-medicate the patient with Benadryl before getting the second dose. The outcome of the event 'she was just tired' was recovered on 14Apr2021; incredibly horrible itching under her Fitbit; whelp was recovering; her lips had started swelling and her tongue was tingling was recovered on 15Apr2021. The outcome of the other events was unknown.

severe right sided facial nerve pain and sensitivity; developed herpes simplex sore on right side of mouth/ cold sore; low grade fever; fatigue; This is a spontaneous report received from a contactable nurse (patient). A 63-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in right arm on 03Mar2021 09:00 (Lot Number: EJ1685) as single dose for covid-19 immunisation; lidocaine hcl and bupivacaine hydrochloride (BUCAINE), both via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) at unknown dosage for numbing the right upper molar area. Patient is not pregnant. Medical history included known allergies to Latex and hypertension. Concomitant medications in two weeks including vitamins. No other vaccine in four weeks. Patient had dental procedure on 06Mar2021 on including Lidocaine/Bucaine injection to numb the right upper molar area. On 08Mar2021 patient developed severe right sided facial nerve pain and sensitivity. On 08Mar2021 patient developed herpes simplex sore on right side of mouth, low grade fever, fatigue. Evaluated by HCP on 10Mar2021 who was going to prescribe steroids but did not due to receiving the Covid vaccine on 03Mar2021. HCP unsure if the herpes simplex, low grade fever, fatigue are due to dental procedure or Covid vaccine. Have been taking Ibuprofen & Acetaminophen. Facility type vaccine at Workplace clinic. Adverse events resulted in doctor or other healthcare professional office/clinic visit. No covid prior vaccination. No covid tested post vaccination. On 16Mar2021, patient stated cold sore symptoms began on 08Mar2021. patient became aware that the facial pain symptoms may or may not be related to the Covid vaccine and/or the cold sore on 10Mar2021 when seeing a physician. The action taken for lidocaine hcl and bupivacaine hydrochloride was unknown. The event outcome for all events was recovering. Pfizer is a marketing authorization holder of lidocaine hcl in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of lidocaine hcl has submitted the same report to the regulatory authorities.

DVT; tingling feeling on my right leg; leg was severely black and blue/black and blue on my right shoulder; very warm; swelling rapidly; sever left arm pain; nausea; Floating Bruising; Charlie horses on right leg calf; This is a spontaneous report from a contactable consumer (patient). A 63-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 20Jan2021 (Batch/Lot Number: EL 3249) as SINGLE DOSE for covid-19 immunisation, at 63 years old. Medical history included caesarean section from 1988, and allergy to animal (Cat and Dog dander) from an unknown date. Patient received the first dose of BNT162B2 via an unspecified route of administration, administered in Arm Left on 30Dec2020 17:00 (Batch/Lot Number: EK9231) as SINGLE DOSE for covid-19 immunisation. There were no concomitant medications. The patient previously took tramadol and experienced drug hypersensitivity (allergies). On 08Apr2021, while patient was reclining in her chair, she felt a tingling feeling on her right leg. She pulled up her pants leg and found her leg was severely black and blue, very warm and swelling rapidly. She went to the ER they did a CT scan and Chest Xray (Apr2021). The ER Doctors (mostly Medical Students at a Teaching Hospital) suspected she had a DVT. Patient was also experiencing severe left arm pain, left hand tingling and severe nausea. They said patient was fine on all accounts and told to get rays of her right leg and for her to follow up with her primary Doctor who is an NP with Hospital. After doing everything as instructed by all the Physicians, 16 days of the bruising and ER visit, patient is still experiencing "Floating Bruising" appearing on her right leg, right ankles and Charlie horses on right leg calf. Today patient now have black and blue on her right shoulder. Patient commented "Someone help me please. This is scary". Events occurred on 08Apr2021 17:00. Treatment was received for the events and required emergency room and physician office visit. Outcome of the events was not recovered.

Swollen face; red rash on face and torso front and back; This is a spontaneous report from a contactable consumer (patient). A 63-year-old non pregnant female patient received second dose of BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL9263), via an unspecified route of administration, administered in left arm on 04Feb2021 09:00 as single dose for covid-19 immunisation. Medical history included Post hemopetic stem cell transplant in 2016 and allergic to Penicillin. Concomitant medication included ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]). Historical Vaccine included first dose of BNT162B2 (Batch/Lot Number: EL3246) in left arm on 14Jan2021 09:00. The patient experienced swollen face and red rash on face and torso front and back on 10Feb2021 12:00. Therapeutic measures were taken as a result of the events with antihistamine said by occupational health nurse. Outcome of the events was not recovered.

I received my first dose of Pfizer COVID-19 vaccine on 04/23/2021. Nine days post-vaccination on 05/02/2021 I developed a cold sore on the left side of my lower lip. Fourteen days post-vaccination on 05/07/2021 I developed a small patch of painful blisters on my right hand, inner area of the knuckle on my ring finger. On 05/09/2021 I went to the walk-in clinic and was diagnosed with shingles and given a prescription for generic Valtrex. I am scheduled to receive my COVID-19 booster on 05/14/2021 and at this point I still intend to get it.

Within 5 to 6 hours after injection, right side of neck, just underneath right ear, started swelling, and significant pain in the right ear has been constant now since the evening of the injection. Swelling of neck has since gone away, however, the pain in my ear has not. Never in my life prior to the vaccination have I had an earache and it was absolutely caused by the vaccination. Concerned damage will be permanent.

swollen lymph node glands size of golf ball very tender to touch; Body aches; Vaccine arm swelling sore and swollen; Vaccine arm swelling sore and swollen; Headaches; This is a spontaneous report from a contactable consumer(patient). A 63-years-old female patient received bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EL9266 ), second dose via an unspecified route of administration, administered in right arm on 10Feb2021 17:15 (Batch/Lot Number: EL9266) as SINGLE DOSE for covid-19 immunization. Medical history included high blood pressure and anemic, both from an unknown date and unknown if ongoing. On 25Jan2021 at 5:30 PM patient received first of Bnt162b2 (lot number=EL9262) in right arm. No COVID was found prior vaccination. Other medications were taken in two weeks but not specified. Concomitant medications were not reported. On 11Feb2021 at 7:00 PM the patient experienced swollen lymph node glands size of golf ball very tender to touch, body aches, vaccine arm swelling sore and swollen and headaches. Outcome of the events was recovering.

I am having trouble walking, especially left foot. I felt I had stroke. I have severe pain in spine, feels like knife is stabbing me up where bra line is. Never had back problems. All my nerves are throbbing, never had before. Feel very, very weak my strength has gone way down. I did not feel like this before this shot. I have extreme pain throughout body. This all started about 20 hours after shot. It?s been 42 days now and I am having so much trouble walking and spine is not the same. I talked with my doctor, she said take Advil, which I did but doesn?t do anything. I went to urgent care, xrayed left foot, Found some arthritis top foot, but I didn?t have pain before there and now underneath my foot is so painful.Blood work was done. Foot gets swollen and has some discoloration. I feel like my body had such a bad reaction and I?m still suffering. I feel so depressed now.

Pt reports facial swelling for 7 days after her dose. Pt did not seek medical attention and let it subside on its own. Pt declined receiving second dose.

Received the Pfizer vaccine on April 13, 2021 (10 am) in the right arm. Woke up the next day with a numb hand. The numbness resolved temporarily, but a few days later experienced numbness and tingling in the entire arm as well as in the 4th and 5th fingers, along with a burning sensation in the right arm. There was also some swelling and fullness in the hand, elbow, and upper arm. Hand weakness and swelling in the lower forearm also occurred. These symptoms persisted intermittently. Went to see my doctor on April 26, 2021. An Upper Extremity Ultrasound was performed to check for blood clots. The result was negative for Thrombus. Advised to "wait and see" regarding the 2nd vaccine and to call if... ...other symptoms developed. On May 1, 2021 had pain in left foot/ankle along with swelling. Additionally, on May 4, 2021 pain and swelling developed in an area on the inside of the upper left leg. Went to the doctor that morning (May 4th). A Lower Extremity Ultrasound was performed to check for blood clots. The result was negative for Thrombus. Was advised to wait with the second vaccine for another week to see if symptoms would resolve. As of May 15, 2021 symptoms continue, with intermittent swelling, numbness, and pain in the hand, elbow and arm. Additionally, I have difficulty using my right hand due to continued weakness and numbness in the hand. Since first seeing my doctor, I have been advised to take Motrin and/or Tylenol and apply heat and/or ice as needed for inflammation and pain. Have been following this regimen for last few weeks with no significant improvement. I have not received second vaccine, as symptoms still persist, and I have concerns that a similar or worse reaction may occur with the second dose.

Pain at injection site and shoulder; difficulty with range of motion; burning sensation in the tricep muscle. Initial ice and ibuprofen. Diagnosis of bursitis 5/11/21; cortisone shot 5/13/21; physical therapy 5/17 and 5/18/21.

My right arm is swollen and tender to touch, pain radiates down arm and up to my neck, I cannot raise my arm, can't lift things, can't bend my arm behind me, its hard to get dressed, my arm is tight and cannot lay on my arm at night. It's gotten worse and I've tried hot and cold compresses and nothing alleviates the pain and it feels like it's in the rotator cuff, also the site itches on occasion. My second dose Pfizer 4/10/2021 Lot #EW0151 and it was done in the left arm and had no problems with it.

Extreme acute swelling of distal joint on index finger right hand; Extreme acute swelling of distal joint on index finger right hand; Pain in all joints of hands; Pain in all joints of hands; tingling of fingers; aching at prior fracture site; This is a spontaneous report from a contactable physician. A 63-year-old female patient received BNT162B2 (BNT162B2, solution for injection, Batch/Lot Number: EP7533), via intramuscular route of administration, in right arm on 06Apr2021 09:15 (at the age of 63-year-old) 2nd dose single for covid-19 immunisation. The. Patient medical history was not reported. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and not tested for COVID-19, since the vaccination. Patient drug history was none. The patient received other medications within 2 weeks of vaccination. Historical vaccine included first dose of BNT162B2 (BNT162B2, solution for injection) via intramuscular route of administration in left arm on 16Mar2021 12:00. On an unknown date, the patient experienced extreme acute swelling of distal joint on index finger right hand, Pain in all joints of hand , tingling of fingers , aching at prior fracture site. This case was serious due to disabling or Incapacitating. No treatment was reported. Outcome of the events were not recovered. Additional information has been requested.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of joint swelling,finger swelling,Arthralgia,paresthesia,bone pain. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate

9:25 tongue had slight reaction, funny taste 10:23Anaphylaxis, took homeopathic Antihistimine, and Benadryl 25mg , Throat & Tongue swelling, funny chemical taste more intense. Tired all day, and pain at injection site. Day #2 Body aches, tired Day #3 Flu like symptoms Day #4 Flu like symptoms and SOB Chemical Taste more intense Day #5 Tongue Throat swelling all week, Benadryl all week. PM Start Prednisone … Day #6 Throat better on the L side. Day #8 Tongue swollen & Chemical taste, throat esp on R, PM go to ER. shakey. Day#8-Day#14 Dry cough, more SOB, same symptoms, continue Prednisone Day #15 Saw Pulmonologist, hot w/ head rush, productive cough for 2wks; Day # 42 Not good, call for current status

5-4-21 about 6 hours after shot, I had an extremely sore left arm and tenderness under the left arm pit. Beginning about 7 hours after shot, I had chills, fever of 100.2, migraine headache and lower back pain. Did not sleep at all through the night. By morning on 5-5-21, all symptoms still present plus feeling dizzy, light-headed and nausea. Stayed in bed all day. By 6 pm on 5-5-21 (27 hours after shot) I had a fast heart rate and heart palpitations. By 8 pm, I had a tightness and pain in my chest. Difficulty breathing, although that may have been my trying to alleviate some of the pain.

/the swelling of her knees had diminished greatly; She was quite swollen; She could feel it a little bit in her shins and ankles, however that pain was not acute, she just felt discomfort.; Sore/ she woke up in agony.; She was up all night Friday night and didn't get any sleep at all; Acute bilateral knee pain/ She could feel it a little bit in her shins and ankles, however that pain was not acute, she just felt discomfort.; She began to feel discomfort in her knees; This is a spontaneous report received from contactable consumer, the patient. A 63-year-old adult female received the first dose of intramuscular BNT162b2 (solution for injection; Lot EW0175 and expiry information not provided) as a single dose in the right arm on 06May2021 at 11:40 (at 63-years-old) for COVID-19 immunization. Relevant medical history included Stage IV cancer survivor, mastectomy with removal of lymph nodes (Feb2020-Feb2020), radiation treatment Apr2020-May2020, infusions (ended in 2020), Breast reconstruction with first Tram flap breast reconstruction 05Apr2021 and Full-blown TRAM flap with muscle and fat from abdomen added to breast 13Apr2021, and pain. Concomitant medications included trastuzumab (HERCEPTIN) from unspecified date for unspecified indication; pertuzumab (PERJETA) from unspecified date for unspecified indication; and hydrocodone bitartrate, paracetamol (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) from 20Apr2021 and from 21Apr2021 for pain. The patient previously received prophylaxis with the flu shot, and the tetanus vaccine with which she experienced sore. The patient reported that she received her first dose of the COVID-19 vaccine on Thursday, 06May2021. The next day, 07 May 2021, she woke up in agony with her knees, the pain was acute, she could hardly bare weight. She confirmed the pain was in her knees, but at times she could also feel it a little bit in her shins and ankles, She did try and treat the pain on Friday during the day, maybe about noon on Friday, she took some over-the-counter ibuprofen 200mg. The patient reported that she does not have pain usually, though was shocked when she took two ibuprofen 200mg tablets and the ibuprofen did not even touch the pain, it had no effect whatsoever. The patient re-iterated that she was administered the first dose of the COVID-19 vaccine on 06May2021 at approximately 11:40AM. Then, the nurse came by, spoke to her, and released her to leave at 11:50-11:55AM. At around 8PM that evening, she began to feel discomfort in her knees. She did not think much of it just through reading info about side effects including achiness and so forth. She went to bed and she slept through the night, which she does not always do. The next day, on 07May2021, she woke up in agony. The patient mentioned that prior to the vaccine, she had been through so many surgeries, so she has a high pain tolerance. The patient explained that she does not even take the pain medication they send home with her. But, with her knees, the pain was acute, she could hardly bare weight. She confirmed the pain was in her knees, but at times she could feel it a little bit in her shins and ankles too, however that pain was not acute, she just felt discomfort. The patient stated that she was up all-night Friday and experienced the pain all day Friday. She told herself to just deal with it and that the pain would get better since she read side effects would dissipate in a couple of days. However, the pain did not, and she was up all-night Friday night and did not get any sleep at all. Saturday morning, on 08May2021, she went to the emergency room (ER). She was seen by an ER physician who immediately put her on IV morphine and steroids and after that, maybe thirty minutes, the pain started easing. She later clarifies she was put on IV dexamethasone and then morphine and ondansetron, stating "maybe that was to wake me up". Caller confirms she has no NDC, Lot number and expiry date for these medications. She confirms she was not admitted into the hospital, she was only there for a couple of hours and then released home with a five-day pack of prednisone. The ER doctor mentioned his colleagues have seen something similar but usually with the second dose. caller explains when the ER doctor examined her, he could see she was quite swollen. She confirms the ER doctor diagnosed her with "acute bilateral knee pain, adverse effects of the COVID-19 vaccine". She came home from the ER and did get some rest. It was to the point now, yesterday she walked around the house and she was not in acute pain at all. She could tell the swelling of her knees had diminished greatly. However, there is still some movement that was uncomfortable, but it was not acute; She confirmed the pain has improved. The patient reported that she did have blood work done in the ER on 08May2021 including C-reactive protein, complete blood count (CBC) with platelet differential, and a comprehensive metabolic panel though results were unknown. The outcome of the events quite swollen/swelling of her knees, sore/ she woke up in agony was recovered on an unspecified date in May2021. The outcome of the events knee pain, discomfort in her knees, feel it a little bit in her shins and ankles, felt discomfort, was recovering. The outcome of the event did not get any sleep at all was unknown. Information on Lot/Batch number was available. Additional information has been requested.

hypoglycemic shock; positive for covid 19; mobility issues; gets out of breath easily; weak; couldn't remember anything which wasn't normal; WBC was elevated; headaches; went sky high into the 500s and they couldn't control it in the hospital; viral pneumonia; renal failure; Her blood sugar was 28; Covid fog; was not eating or drinking; throw up; This is a spontaneous report from a contactable consumer or other non-health care professional (patient daughter) via Pfizer. A 63-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine, solution for injection, Batch/Lot number was not reported and expiry date unknown) via an unspecified route of administration on 25Mar2021 (at the age of 63-year-old) as 1st DOSE, SINGLE for covid-19 immunization. Patient took vaccine as she wanted to fly on an airplane and not worry as heavily. Medical history included ongoing diabetes mellitus, patient had diabetes for at least 5 years, ongoing high blood pressure from an unknown date, reporter think patient high blood pressure was more with her weight because patient was obese. Patient was immunocompromised with her diabetes. Patient had no relevant family medical history. Concomitant medication included ongoing metformin (METFORMIN) taken for diabetes mellitus. Patient has been on it for years. Reporter believed she was on the max dose that she thinks was 2000mg, but could be wrong. Patient was not eating or drinking from 03Apr2021 and did throw up. On 06Apr2021 patient was tested positive for Covid and experienced hypoglycemic shock at 11:00, renal failure and Covid fog. Reportedly, patient also experienced viral pneumonia, mobility issues, gets out of breath easily, weak, her blood sugar was 28, covid fog, couldn't remember anything which wasn't normal, wbc was elevated and headache. The patient was hospitalized for hypoglycemic shock and COVID-19 from 06Apr2021 to 17Apr2021 (11 days), then discharged and was told by her HCP to wait 8-12 weeks before getting second dose of Pfizer covid vaccine. Patient scheduled to receive second vaccine dose 15May2021. Reporter was told that it was a max of 42 days that patient can get the second dose of the vaccine, but that has obviously since passed. They want patient to come in and get a second first shot. When patient was admitted, the doctor thought patient had viral pneumonia already for at least a week, so it would have started about when she got the shot. Patient was better, she was not on oxygen anymore, but she still gets out of breath easily. Patients mobility issues started when she came down with symptoms. Patient had renal failure and was weak. Patient was not eating or drinking. Patient was diabetic and she had hypoglycemic shock which was what put her in the hospital. Reporter thought it was probably a cold or flu or something and Easter happened where she was not hungry and did throw up. Reporter thought it was something she ate that was bad. When she had the hypoglycemic shock reporter could not wake her and patient was in some kind of unresponsive state from 11:00 to about 15:45. Patient blood sugar was 28 when the paramedics arrived. They were able to get her responsive and transferred her to the hospital. They ended up putting her on a dextrose drip because they could not keep her blood sugar up. They put her on steroids and the number went sky high into the 500s and they could not control it in the hospital. There was a lot of stuff that happened. Reporter did not believe that patient has any lasting effects from the hypoglycemic shock. Patient sugar was back to normal and she was on her normal medications. Patient was off insulin which they gave her in the hospital, so that part was okay. Patient was dealing with Covid fog also. Reporter does not know if it has to do with blood sugar or how the virus attacks the body. Patient had multiple MRIs because they were worried, she had a stroke, and she said she could not remember anything which was not normal. Patient not eating and drinking started right before Easter and was much better. Reporter believed that at about 14Apr2021 or so patient started to eat better and have more of an appetite for food. Patient has recovered completely. The reporter did not notice the Covid fog until her mother was in the hospital on 06Apr2021. She does not remember her first week in the hospital, and then even when she was discharged on 17Apr2021 that whole next week she was still very foggy. The reporter would say she was better now. patient talks normally and was back to swearing which is perfectly her. Patient has recovered completely at this point. Patient mobility was better. Patient was not using the walker in the house today, and her balance was better. It was probably due to some of the side effects of the medicines they added like a beta blocker and other things to make sure she was okay. Regarding kidney failure started, reporter stated on 06Apr2021 patient creatinine was 3.99. Patient also had a high D dimer and were worried about her clotting and throwing a PE or something. That was mostly in the first few days around the 6Apr2021, 7Apr2021, 8Apr2021, 9 Apr2021, 10Apr2021 when they were not sure what was going to happen. The following week patient was still at 5 to 6 liters of oxygen, but by Friday night 16Apr2021 she was down to 1 liter of oxygen. Patient did not come home on oxygen. Reporter believed patient kidneys have recovered, but she did not know. The patient underwent lab tests and procedures which included blood creatinine: 1.47 on an unknown date, 0.97 on Sep2020, reporter does not know if it returned to 0.97, but the last number she knows of was 1.47, 3.99 on 06Apr2021, blood creatinine: 1.47 on 17Apr2021. Patient had normal bloodwork in Sep2020 and her creatinine was 0.97. Reporter did not know if it returned to 0.97, but the last number she knows of was 1.47. That would have been when patient was discharged from the hospital. Blood glucose: 500s on an unknown date in Apr2021, blood glucose: 28 on 06Apr2021. On 06Apr2021 patient was tested positive for Covid. On an unknown date patient got CT, high d dimer, CBC, MRI, metabolic function test, white blood cell count, X-ray and Chem 28. Reportedly, bloodwork were done daily in the hospital, and patient has had bloodwork once since she was discharged. WBC was elevated so they did a blood culture to make sure patient did not have an infection. The culture was negative. There were no additional vaccines administered on same date of the Pfizer suspect. There was no prior vaccination within 4 weeks. There were predisposing factors diabetes and immunosuppression. Patient started Tylenol pill on 06Apr2021 after vaccination at an unknown dose. They gave it to her continuously because she had bad headaches. They started her on antivirals and took her off of Remdesivir because of her kidneys. They put her on a different antiviral that the reporter did not remember the name of and a biologic. Home health just discharged patient, and she was still dealing with viral pneumonia and mobility issues. Patient was still on different medicines and she normally was not. The report is related to study or programme. The outcome of the event hypoglycemic shock was recovered on 06Apr2021 and was not eating or drinking was recovered on 14Apr2021, viral pneumonia, mobility issues, was recovering, renal failure, positive for covid 19, gets out of breath easily, weak, her blood sugar was 28, went sky high into the 500s and they couldn't control it in the hospital, covid fog, couldn't remember anything which wasn't normal, wbc was elevated, throw up and headaches was unknown. Follow-up attempts are completed; information about lot/batch number cannot be obtained

On 5/25/21 patient noted arm pit swelling and pain in the arm she received the injection (right). Patient took motrin and applied ice. Symptoms went away for a couple of hours and returned again

felt like Bell's palsy like a paralysis in my face; Swelling in face; This is a spontaneous report from a contactable consumer (the patient). A 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0168) via an unspecified route of administration, administered in Arm Right on 11May2021 10:00 at age of 63-year-old at single dose for COVID-19 immunisation. Medical history included Bell's palsy (reported as "I had in my life I had Bell's palsy"). No other medical history. There were no concomitant medications. On 11May2021, the patient had like some swelling in her face and she was still having it. She had in her life she had Bell's palsy and that was what it felt like, it felt like paralysis in her face (also reported as "felt like bell's palsy like a paralysis in my face") and she wondered if she had to go to the emergency room. No treatment received for the events. No investigation assessment. The outcome of event "swelling in face" was not recovered, the outcome of event "felt like bell's palsy like a paralysis in my face" was unknown.

Usual pain and soreness at injection site which by 2-26 was unusually itchy with red raised area 1 1/2" x 2"; Usual pain and soreness at injection site which by 2-26 was unusually itchy with red raised area 1 1/2" x 2"; Unusual that right arm started to ache and has continued 24 hrs so far with the center of pain being swollen lymph nodes in the right arm pit; Unusual that right arm started to ache and has continued 24 hrs so far with the center of pain being swollen lymph nodes in the right arm pit; Usual pain and soreness at injection site; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received the second dose of BNT162B2 (Lot Number: EN6203), via an unspecified route of administration administered in left arm on 24Feb2021 at 11:45 AM (at 63 years old) as single dose for COVID-19 immunization. The patient received the first dose of BNT162B2 (Lot number: EL9275) via an unspecified route of administration administered in right arm on 29Jan2021 at 09:45 AM (at 63 years old) as single dose for COVID-19 immunization. There were no other vaccines administered within 4 weeks. Medical history included Hashimoto's from unspecified date and unknown if ongoing. The patient previously took tetracycline and experienced known allergies: nausea; ceftriaxone sodium/tazobactam sodium (BACTRUM T) and experienced known allergies: nausea, and esomeprazole sodium (NEXIUM) and experienced known allergies: wheezing with swelling in throat. Concomitant medications included levothyroxine sodium (SYNTHROID), omeprazole, colecalciferol (D3), tocopherol (VITAMIN E), and multivitamin; all from unspecified date for unspecified indication. The patient experienced on 25Feb2021 at 21:00 unusual that right arm started to ache and has continued 24 hrs so far with the center of pain being swollen lymph nodes in the right arm pit and usual pain and soreness at injection site which by on 26Feb2021 was unusually itchy with red raised area 1 1/2" x 2", which were all considered non-serious. It was unknown whether treatment was given for the events. It was unknown if COVID test was done prior to vaccination. No COVID tests done after vaccination. Outcome of all events was unknown. No follow up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021223429 similar report from same reporter