Pfizer

I have had a fever ranging from 100.1 to 100.5 since 7 pm on the day I received the 2nd dose vaccine on 1/4/2021. Symptoms include extreme body aches, joint aches, and headache. Today is 1/6/2021 my temp at 7:30 am was 100.3. I have had to miss work yesterday and today so far.

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.

On day 1 after the vaccine the employee began having muscle aches and sore joints. By day 4 she felt like she had an improvement in symptoms. On day 6 the same symptoms reappeared and the employee was tested for COVID (negative PCR). She reports that all of her joints in bilateral upper and lower extremities are extremely sore, she noted that "even her toes were painful". She is unable to take NSAIDS because of a history of anaphylactic reaction to Motrin in the past.

INJECTION SITE REDNESS, NAUSEA, FEELING UNWELL, HEADACHE, FAST HEART BEAT, SLIGHT ITCHING, DIZZINESS, TIREDNESS, MUSCLE PAIN, CHILLS ALL BY 13:30PM AND LASTED FROM 1.04.21 AND CURRENTLY ON 1.06.21 STILL TIRED, DIZZY, HEADACHE, CHILLS AND ITCHY BUT IS BETTER THAN ON 1.04.21.

Dizzy right after vaccine, foggy increased through evening, tired in the evening of injection, muscle aches, headache, and nausea about 2am, fever 99.8 at 1pm on 1/6/21. All these symptoms still persist now 5:40pm 1/6/20

Joint PAIN -upon awakening the next day I had severe neck and bilateral hip pain. It hurt to hold my head up and even lay on a pillow. Took 800mg Advil prn for about 4 days. Tonsillitis- Right tonsil was inflamed and sore . This started 5 days after the vaccine and lasted 3 -4 days. Used warm water rinses and gargled with Listerine As I am a Nurse with Rheumatoid arthritis , I know there is not much info about subjects with my underlying conditions . I just wanted to report that it did cause a flare in my symptoms but it lasted less than a week. I did hold my Humira for one week after the vaccine as I know it is a "t-cell " inhibitor and I wanted a good result from the vaccine. I had my second shot today and can update you as to how things go

Severe fatigue, headache, joint pain, fever. Started around 0700 next day of injection and these symptoms lasted 24 hours. Took Tylenol, Ibuprofen for fever. Even with these two onboard, continued low grade temp.

17 hours after vaccine, developed gradually worsening fatigue, myalgias, arthralgias, chills, sweats, malaise, and fever up to 103. Sxs peaked at approx 24 hrs post vaccine administration, resolving nearly completely by the following morning. Would have reported via v-safe but had no info to access the app.

Chills, extreme weakness, and excruciating bone and muscle pain, diarrhea lasting 48 hours. Improved with Meloxicam. The keratitis flared up. Developed keratitis after the first dose on 12/17/2020. Lot EK5730. The keratitis presented with dry eyes, photophobia and reduced reading ability. I am treated with steroid drops and artificial tears.

dizziness around 8:00pm, fatigue, severe headache, neck & shoulder pain, body aches, joint pain, nauseous, mild shortness of breath

COVID vaccine #2 given Thursday January7th 12:30. Body aches and chills started Friday January 8th approx. 1700. Worsening symptoms through the night. Fever and slight cough on Saturday morning with body aches, joint pain and chills.

She experienced head ache, neck pain, sinus pain, weakness, aches, very short of breath on exertion and when wearing a mask. Aching in left arm, in chest and in right arm pit. Very dry eyes and bloodshot. Sweating and very warm. Temperature 1-11-21 96.2°F

Muscle and joint weakness with chest muscle pain x 5 days hurts all over and worse when gets up and moves. Diarrhea started 1-5-2021. No fever 97.7. Off work for 4 days. Using heating pad and inhalers. Has appointment with provider 1-5-2021 and 1-7-2021. Test for COVID on 1-7-2021 and negative Symptoms resolved 1-9-2021 and returned to work on 1-11-2021

Pain at injection site; Tiredness; Headache; Chills; Joint pain; Fever; Felt paralyzed at one point; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: K5730, via an unspecified route of administration from 29Dec2020 16:15 at a SINGLE DOSE for covid-19 immunization. Medical history included migraine with aura. Concomitant medication included gabapentin, pravastatin, estradiol, diphenhydramine hydrochloride (ALLERGY), and ascorbic acid, calcium pantothenate, colecalciferol, cyanocobalamin, nicotinamide, pyridoxine hydrochloride, retinol, riboflavin, thiamine hydrochloride, tocopherol (VITAM). The patient previously took amoxicillin and had allergies. On 30Dec2020 15:00, the patient experienced pain at injection site, tiredness, chills, joint pain, fever and felt paralyzed at one point. The outcome of events was recovering. No follow-up attempts possible. No further information expected.

Dizzy Clammy Heavy legs Frequent PVC on monitor Irregular heartbeats Headache Tightness in throat and chest

developed more severe arm pain, headache, rigors, muscle aches- lasted approx 3 -4 hour- took tylenol, used heating pad

achy knees/ achy joints/ achy right elbow; Headache; her temperature was 96, but not a fever; Achy back; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received second dose of BNT162B2 (Batch/lot number: EJ1685, Pfizer product), via an unspecified route of administration in in left arm on 06Jan2021 at single dose for COVID-19 immunization. The patient's medical history was not reported. The patient was receiving concomitant therapy. The patient previous received first dose of BNT162B2 on 08Dec2020 and experienced left arm a little sore at the injection site. The patient experienced achy knees/ achy joints/ achy right elbow, headache, her temperature was 96, but not a fever, achy back, all on 07Jan2021. She got her 2nd vaccine (COVID-19 Vaccine) on 06Jan2021 and this morning, the longer the morning goes on, she felt achy, has a headache, feels like she has a fever but does not. Had temperature taken this morning going into work and it was 93. Just now, her temperature was 96, but not a fever. She stated that this was nothing major, but the information she received said to call and report anything. First temperature taken this morning was from a forehead thermometer. The type of thermometer used for her second temperature this morning was not provided. She was a secretary for environmental services at the hospital she works at. She stated that she thought she could go to work and had to leave. She was going to bed as soon as she hangs up. Height: she used to be 5 feet 8 inches. She was counting on feeling better by tomorrow. She further described her achy feeling as her joints are achy including her knees, back and her elbow, but only her right elbow. She received the injection in her left arm. All she wanted to do now, was to crawl into a warm bed. She stated that she was fine after the first shot. Her arm was a little sore and that was it. She had her first COVID-19 Vaccine injection in her left arm. The soreness at the injection site lasted 2 days and then recovered completely. She did not provide her concomitant medications, stating that she took the same medications that she usually took and had not started anything new. She stated that she was 60 and has the what she had, but she did not have anything of concern; further stating that she had no breathing difficulties or anything like that. The patient underwent lab tests and procedures which included body height: 172.72 cm, body temperature: 93, body temperature: 96, all on an unspecified date. The outcome of events was not resolved.

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.

left neck moderate to severe pain; pain started radiating down her left arm and down left leg; weakening her joints on those extremities/ shoulder pain; This is a spontaneous report from a contactable other healthcare professional reporting for herself. A 60-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number: EK5730, expiry date: unknown), via an unspecified route of administration, on 16Dec220, at a single dose on arm right for COVID-19 immunization. Medical history included diabetes mellitus 2, hypertension (HTN), migraines, back pains, hypothyroidism, and allergies to latex and kiwi. The patient received the vaccine at a military base. She did not receive other vaccines in four weeks. The patient was not pregnant at the time of vaccination. She had no COVID prior vaccination and was not tested for COVID post vaccination. Concomitant medications included unspecified medications; she received other medications in two weeks. The patient previously took gabapentin and topiramate (TOPAMAX), in which she experienced allergies. On the second day after receiving the vaccine, 18Dec2020 04:00 AM, the patient started feeling left neck moderate to severe pain, and the pain started radiating down her left arm and down left leg, weakening her joints on those extremities. This continued severely for 3 days. At this time, she continued to feel mild left neck, shoulder and arm pain intermittently. She could not report this immediately due to not having her vaccine documents which she forgot at her workplace as she proceeded to vacation. She had paused in getting the second dose that was due on 07Jan2021, waiting to hear from Pfizer. The patient received NSAIDS and Muscle relaxant medications as treatment for the reported adverse events. Outcome of the events was recovering.

1/13/21 had pain in R arm and employee woke up 1/14 with cramping, chest pain and feeling of heaviness from belly button down to the legs. Advised to go to the EC for evaluation. Update 1/15: Seen in ED and had EKG with inverted T wave. Still has heaviness in legs. Will get a referral to cardiology after speaking with PCP.

Patient reports chills, fever, muscle aches, headache, 100.1 within 24 hours. Also report loss of appetite, fatigue.

Employee reported chills, muscle aches, headache, pain at injection site, fatigue, nausea, pruritus, and pressure on her upper back. She reported feeling anxious when she laid down. She went to see her doctor last week and was treated with benadryl.

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.

1) I sat for 30 minutes after shot since I have a mild shellfish allergy. When I stood up, I was briefly dizzy but only for a few seconds at most. 2) By the time I reached my car, I had developed a mild headache which lasted until around noon the next day. The headache was not severe. 3) Shoulder that received the shot was sore for about two days.

Initial symtom of warm flush (head to toe), followed by added symtoms over course of next 5-10 min: light headed, dizziness, pale, tachycardia, scratchy throat, heaviness in chest, tightness in throat, spike in blood pressure (initial 144/88, 168/96, 152/87, 146/84-final). Monitored symptoms 45 min to one hour. Temp 97.3. Symtoms lasted approx one hour, then began improving, with exception of light headedness and general malaise and fatigue for 4 hrs. Additional event at approx 10 hours post vaccine: excruciating upper arm pain (left shoulder to elbow), felt "down to the bone". Unable to move arm and very painful to touch. Took 600 mg ibuprofen. Severe pain lasted approximately 3-4 hours (unable to sleep). Then became moderate soreness at injection site x 8 hrs. Mild soreness x 12 hrs, no pain 36 hrs after vaccine. Continued fatigue and malaise for 3-4 days after vaccine.

limping one side of foot; wanted to pass out; numbness to right side of face; every muscle in her body hurts; stomach is cramping; This is a spontaneous report from a contactable consumer. A 60-years-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0140) , via an unspecified route of administration on 04Jan2021 at the first single dose at Arm Left for covid-19 immunisation . Medical history reported as none. There were no concomitant medications. The patient experienced wanted to pass out, numbness to right side of face, every muscle in her body hurts, stomach is cramping on 08Jan2021, limping one side of foot on 11Jan2021. The outcome of event wanted to pass out was unknown; outcome of event numbness to right side of face, stomach is cramping, limping one side of foot was not recovered; outcome of event every muscle in her body hurts was recovering;

6PM DAY OF SHOT ITCHING IN EXTREMITIES LOWER LEGS AND ARMS JUST ABOVE WRIST. PAINFUL LOWER BACK PAIN. TOOK TWO BENEDRYL AND SYMPTOMS RESOLVED BY AM. 1/16 HAD SYMPTOMS OF AN ON-COMING COLD, SLIGHT SORE THROUGH, SINUS PRESSURE AND FELT WARM. NO TREATMENT OTHER THAN FLUIDS AND REST AND RESOLVED BY MORNING. 1/17 AND 1/18 ONLY SYMPTOM MILD FATIGUE

within 36 hours of second dose patient developed fasciculations of the right lower eyelid, which have persisted ever since

received 2nd dose at 7pm 1/18/21. woke up tuesday with sore arm went to work and while working afternoon progressed to chills and total body aches. temp 101 through evening up and down after motrin to next day Wednesday. wednesday had some chills but during night into Thursday had joint pain no fever. woken up thursday with joint pain and headache no fever.

Within an hour of the vaccine face was hot and muscle in face were painful in the jaws, sinuses up in nose felt weird and dry like menthol. Put ice on face. Took Tramadol. Having fatigue. Next day felt better, then started having brain fog difficulty remembering, vision is blurry, no energy and feel exhausted.

chills; fatigue; deep muscle aching in both arms; fever ranged between 100-101 F; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231), via an unspecified route of administration at left arm on 08Jan2021 at 09:30 at single dose for COVID-19 immunization. The patient medical history included seasonal allergy from an unknown date and unknown if ongoing and COVID-19 from Oct2020 (as reported: "I had been diagnosed with COVID-19 on 21Oct2020 with symptoms onset on 15Oct2020") to an unknown date. The patient's concomitant medication included cetirizine hydrochloride (ZYRTEC ALLERGY), aspirin, calcium/cholecalciferol (CALCIUM + D3), docusate. The patient previously took COMPAZINE and BACTRIM DS and experienced allergies. The patient reported that on 08Jan2021 at 21:00 developed chills, fatigue, deep muscle aching in both arms and fever ranged between 100- 101 F. On 09Jan2021 at 09:00 he felt fine, until approximately 17:00 and again developed chills, muscle aching and fatigue. On 10Jan2021 at 08:30 all symptoms were gone and never returned. The patient underwent lab tests and procedures which included SARS-COV-2 test: positive on 21Oct2020. The patient outcome of the events was recovered on 10Jan2021 at 08:30.

INJECTION 1===back ache, heat from waist down to top of knees, no fever INJECTION 2===rash on top of both legs- no fever

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

Temperature 101.7; Back pain/pain in her back; Right upper jaw pain that felt like sinus; Heart rate 130's; Oxygen Saturation dropping; Headache/head felt like it would explode; Ringing in the ears; Thighs are burning; calf pain/Calves were sore in back; Calves were sore in back and felt like DVT; Chest pressure; she sound like a hypochondriac; flu like symptoms; can barely walk; Nausea; Shivering; weak; felt miserable; dry hives; This is a spontaneous report from a contactable Nurse reporting for herself. A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Batch/lot number: EL1283, Expiry Date: 30Nov2021, intramuscularly into right deltoid on 11Jan2021 07:15 at single dose at the hospital for Precaution as frontline healthcare worker. Medical history included Wolff-Parkinson-White (WPW) syndrome from 2000, heart surgery in the past on unknown date, had surgery that was in 2000. Years of chest pain and PVC after that; allergic to Sulfa with hives: One time she mixed it up with a medication of her sons and took it by mistake and did not realize it and she did not have any reaction, she has not had in years. It was an injection and she doesn't have the name, lot or expiration. Family medical history included Mother was diabetic and sister was prediabetic and was 61. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (Lot E49899) on 18Dec2020 at 10:30 am injected in Right Deltoid for COVID-19 immunisation and experienced shivering; same body aches, she took TYLENOL; had major headache all night long, all over her head; It was a pressure headache; Someone gave her MOTRIN and within 3 hours she was totally fine. The patient stated she received the Pfizer COVID vaccine second dose on 11Jan2021 and has had problems since then. She has been miserable, took paracetamol (TYLENOL), headache, have ringing the ears, head was exploding, back aches, calf pain, temperature at 8 am 101.7 and 101.7 at 10:40 on 12Jan2021, feeling very weak, nausea, dry hives, Right upper jaw pain that felt like sinus, all in Jan2021. Her heart rate was in the 130's at 3:30-4:00 on 12Jan2021 and now down to 115-108. Her Oxygen saturation has been 91-95 %. She just had a miserable night (Jan2021). She had this pressure in her chest. Her heart rate was 130 and O2 was 93%. Her O2 saturation last night (on 11Jan2021) was 91-94%, mostly about 93%. Chest Pressure began around 3am on 12Jan2021. She called healthcare provider and was waiting to get advice from them if she needs an EKG. She was still having a little bit of mild pressure. She noticed that her oxygenation was 93% when this was happening. It went up to 95% for a second last night. Her heart rate was now between 112-115. When she walked, it went to 125-130. It started around 3:30-4:00 this morning (on 12Jan2021) and was mildly improved. she was feeling the chest pressure back pain had lesson, but had pain in the upper jaw, flu like symptoms on 12Jan2021. she said she could not get out of the bed right. She did have a heart surgery in the past, her legs were burring, and week. she said after the first dose she did had a reaction but took MOTRIN and went to work the next day. The patient wanted to know about the heart rate being high and ringing in the ears. She wanted to know if it was supposed to drop your saturation and increase your heart rate. Is she just behaving like the norm or should her O2 be much higher. Her first shot was not as bad as this reaction. There was no prescriber. The temperature just began now as she just took it. Oxygen Saturation dropping began when she woke up in middle of night around 3:30- 4:00. She used her pulse oximeter and noticed it then. It was associated with her ears ringing and her head felt like it would explode at 3:30 on 12Jan2021. She felt better with headache but still had it. She was so weak on 12Jan2021, she did not want to go anywhere. Her oxygenation had worsened to 93% on average. She had a headache last time but did not have ringing in her ears. She woke up about 3:30 with it. The headache now was all over head from front to back and comes and goes. Last time she went to work after receiving the first one and today (on 12Jan2021), there was no way she could go to work. She took TYLENOL when she got home because she was shivering and took more at 3:30 because she felt miserable because of her chest. She took 1 gram. Her headache did not go away. She got to sleep after she took the TYLENOL. Her back and jaw was bothering her. It felt like the flu. She had upper jaw pain and pain in her back. She didn't have a good back and just aches. After the first one, it took 10 hours for the shivering to start. This time it was very similar. The shivering started about 10 hours later, at 9pm on 11Jan2021. Back pain starting at 05:00 on 12Jan2021 was stated as being sharp on right side scapula and feel like the flu. It is to the right of spinal vertebrae. She thought she would go to bed and lie down. She has had back pain before. The jaw pain started around 05:00 on 12Jan2021. She felt it in her cheek. It was a little bit better. Nausea started at 11:00 pm on 11Jan2021 and got worse at 03:30 when she got up to go to the bathroom around midnight. She felt like she could vomit and felt better, but she couldn't. Her thighs were burning at 03:30 on 12Jan2020. It was persistent weak and burning. She can barely walk. The areas that have hurt like when you get the flu, she was having now in the same places, so she thought it was from the shot. Calves were sore in back and felt like a DVT (Deep vein thrombosis), started at 03:30 of 12Jan2021 and was still sore. She said she sound like a hypochondriac. It was in back of calf towards knee. She did not think it was a blood clot. It was feeling better. It was still sore but nothing like it was at 03:30. It is just an odd pain. She did not want to leave the house and surprised that her oxygen saturation was low. She just wanted to go back to sleep for a bit. Oxygen Saturation dropping was reported as worsened. The outcome of events Chest pressure, Heart rate 130's, Headache/head felt like it would explode, Right upper jaw pain that felt like sinus, calf pain/Calves were sore in back and Calves were sore in back and felt like DVT was recovering. The outcome of events Oxygen Saturation dropping, Ringing in the ears, Shivering, Back pain/pain in her back, Nausea, and Thighs are burning was not recovered. The outcome of events Temperature 101.7, she sound like a hypochondriac, dry hives, flu like symptoms, weak, felt miserable and can barely walk was unknown. The reporter considered events Heart rate 130's, Temperature 101.7, Oxygen Saturation dropping, Right upper jaw pain that felt like sinus and Thighs are burning were related to BNT162B2. The reporter considered events Chest pressure, Heart rate 130's, Temperature 101.7, Oxygen Saturation dropping, Headache, Ringing in ears, Shivering, Back pain, Nausea, Thighs are burning, Right upper jaw pain that felt like sinus and Calves were sore in back and felt like DVT as serious due to Medically significant.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Syncope,dizziness, head spinning,weakness of arms slurred speech BP 195/105 PULSE 91 Repeat BP 167/92

The patient experienced syncope within 30 minutes after receiving the covid-19 vaccine. At 2:30pm, she felt dizziness, her head was spinning, weakness of the arms, and slurred speech. Her FS was at 108 (Normal), BP 195/105 (Extremely high), Pulse 91, O2 saturation was at 100%. At 2:48PM, her BP lowered to 167/92. At this time, she can smile, she can put her hands up, she can kick her feet and she can opened/closed her eyes. Due to her high BP, Doctor requested that the should go to the ER via the ambulance.

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.

Slight fever, 99.2, with chills and muscle aches. Event occurred about 2:00 am on 01/26/2021. I took a Tylenol went back to bed. No fever upon waking. Minor muscle aches and mild soreness at injection site.

Left arm very painful, pain in my neck left side goes into my chest and back of head left side, dizziness, and horrible fatigue. Feeling out of it.

First vaccine small bruise at her left knee and extreme pain in her neck, shoulder and left arm and missed work. Second vaccine she has 4 bruises and clots on her inner leg from ankle to thigh. So painful she can't sleep and she is having a hard time walking. Her left shoulder is limited due to extreme pain. She sought care from her physician and he is sending her for scans that the facility is requiring a deposit.

C/o muscle aches, calf cramps, (B) feet numbness, cough, nausea, diarrhea, all began after #2 vaccine. No problems with #1 vaccine Tx antiemetic, H2 blocker, anti histamine, Tylenol push fluids

Severe Left Leg, Hip and Lower left leg pain (Sciatic Nerve) it appears the vaccine may have irritated sciatic nerve pain. Left left leg numbness. Decreased mobility, difficulty sitting, walking, and even lying in bed. Started very quickly without andy known injury. Pain continued to worsen. Pain even worse after second injection. Now two weeks after second shot, the pain is going away. It is like the nerve irritation is subsiding. The way the irritation is subsiding makes it seem that the vaccination may have caused irritation to the nerve. After receiving 1st and continuing through the second vaccine, started having severe sciatica pain going down left hip and leg. Left leg pain and numbness. Thought I had done something to damage the nerve. Hurt to sit, hurt to stand and even hurt when in bed. The pain was so severe it caused issues with any mobility. Took Advil, Aspiring, Tylenol and nothing helped. Received second vaccine 1/12/2021 the pain continued and even got worse. It was to the point I couldn't even walk. I couldn't figure out how I had damaged the nerve. I am now thinking it was from the vaccine. I believe the vaccine irritated the nerve. The nerve pain is starting to go away. Normally if you have a sciatic nerve issue, it just doesn't go away on its own. I know there have been reports of severe back and neck pain. I believe it can irritate the nerves which cause severe pain. I wanted this reported in cases others complain of similar issues. The good thing it is improving.

Muscle pain; Chills; Nausea; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration in left upper arm on 11Jan2021 around 3:45-4:00pm at a single dose for COVID-19 vaccination. Medical history included hypothyroidism. Concomitant medication included levothyroxine from 2006 for hypothyroidism. The patient was administered the first dose of Pfizer-BioNTech COVID Vaccine on 11Jan2021 at work. On 12Jan2021, the patient experienced muscle pain, chills, nausea. The outcome of the events was not recovered. The patient underwent rapid COVID-19 nasal swab test and the result was negative on 12Jan2021. Second dose scheduled to be administered on 01Feb2021 with no dose change made. Information on the Lot/batch number has been requested.

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.

Headache; chills; shaking; weakness; tiredness; nausea; Joint pain; muscle pain; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm, on 15Jan2021 at 13:15 (at the age of 60-years-old) at a single dose for COVID-19 immunization. Medical history included arthritis (knees), sulfa drugs allergy, poison ivy allergy (severe), and COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medications included meloxicam (MANUFACTURER UNKNOWN) and furosemide (LASIX). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced headache, chills, shaking, weakness, tiredness, nausea, joint pain, and muscle pain on 16Jan2021 at 13:00. The events were reported as non-serious. The patient underwent lab tests and procedures which included COVID-19 nasal swab: negative (test name: Binex) on 12Jan2021 and COVID-19 test: unknown results (post vaccination) on an unspecified date. Therapeutic measures were taken as a result of the events, which included naproxen sodium (ALEVE); it was reported that the treatment did not work. The clinical outcome of headache, chills, shaking, weakness, tiredness, nausea, joint pain, and muscle pain was unknown. The batch/lot number for the vaccine, BNT162B2, was provided and has been requested during follow up.

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

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.

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.

headache, joint & bone pain, red lump at injection site, injection site warm to the touch, soreness at injection site, some wheezing 40 x 40 mm

Late (11 pm ish) on 1/24/21 severe diarrhea started, lasted through early (8 am ish) on 1/26/21. On 1/25/21 I also had fever (highest was 101.4), chills, weakness, and aching bones. I also had a terrible headache that started 1/20 and lasted until 1/ 28 or 1/29. There was the normal injection site soreness on the evening of the first day.

Dizziness and nausea within 7 minutes of receiving vaccine. 6 Hours after vaccine severe arm pain, sensitive to touch, movement and unable to lift arm beyond 45 degree angle. 17 hours after vaccine chills, fever of 102, muscle aches, severe headache, fatigue. 53 hours after vaccine, fever 101, severe headache, muscle aches, fatigue. Arm pain much less severe.

Right upper arm/shoulder pain, including pain within joint. Limitations to move arm and weakness continue even after 1 month.

Starting about 30 minutes after the injection she had nausea and occasional dizziness. About 12 hours later she began having fever, chills and muscle aches. Fever improved with Motrin.

I had covid Sept 26th 2020.The day after the second shot I had covid symptoms. Seven days later I still have chills,fever,muscle aches and fatigue. I am going for a covid test today.I have missed days of work due to this vaccine.

12 hours after shot, all over body aches, sore arm and shoulder, fever. Shortly after, a headache occurred. The symptoms lasted all day and were mostly gone except for a small headache and fuzzy brain after 30 hours. All clear after about 36 hours.

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.

12/22 Vaccination 4 hours later, chest pain. Felt heavy. Got extremely sleepy. I tried to lay down, episode of syncope. Chest discomfort. ER for observation

Had a very mild case of COVID in November. Slight muscle tenderness for 1 day after first shot. Have had same symptoms as COVID but much worse after 2nd shot. Symptoms started Day 4 after vaccine and continue today. Running fever for 5 days now. Still sick. Flu test was negative although I doubted it was anything else since I rarely get sick and when I do it only lasts a day or two. Will have a few hours where I finally think I am getting better and then another wave hits.

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.

injection site pain; chills; muscle aches; fatigue; Rash on torso, arms; This is a spontaneous report from a non-contactable other hcp (patient). A 60-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19Jan2021 14:30 at single dose in Left arm for covid-19 immunisation. The patient was not Pregnant at the time of vaccination. Medical history was none. Concomitant drug received within 2 weeks of vaccination included Multivitamin. The patient previously received first dose of BNT162B2 on 29Dec2020 03:15 PM at single dose in Left arm for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After 6 hrs on 19Jan2021 21:00 PM, the patient experienced injection site pain. After 12 hrs the patient experienced chills, muscle aches, fatigue in Jan2021. The patient experienced Rash on torso, arms 36 hours after in Jan2021. The outcome was Recovering. No treatment received for events. The events were assessed non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts are possible, information about batch number cannot be obtained.

left upper arm redness and swelling. She reports she got the second Pfizer COVID-19 vaccine on Monday 2/1. She reports the area is red right after the vaccine. She reports she has had increased swelling, redness, warmth. She reports she did have reaction to her first vaccine with redness and swelling, but that occurred 10 days after. She reports she has had some fever and body aches that she associates with having the second vaccine. Constitutional: Negative for chills and fever. HENT: Negative for sore throat. Eyes: Negative for visual disturbance. Respiratory: Negative for cough and shortness of breath. Cardiovascular: Negative for chest pain. Gastrointestinal: Negative for abdominal pain, nausea and vomiting. Genitourinary: Negative for dysuria. Musculoskeletal: Positive for joint swelling and arthralgias. Negative for back pain. Skin: Positive for color change. Negative for rash. Neurological: Negative for weakness and numbness.

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.

positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302), via an unspecified route of administration at arm right on 20Jan2021 at 10:00 at single dose for COVID-19 immunization. The patient medical history included diabetes from an unknown date and ongoing. The patient's concomitant medication included metformin. The patient experienced COVID-19 on 27Jan2021 (she got all the symptoms: sinus, headache, body aches, pain, chills, joint pain, fever). The patient was admitted to emergency room due to the event. The patient underwent lab test and procedure which included blood test and chest X-ray both on an unspecified date and both resulted that "everything was good" values not provided, in Jan2021 body weight: between 114-115 lbs, but probably 110 (lost a lot of weight in the past two weeks because of the virus) and SARS-CoV-2 test (nasal swab): positive on 27Jan2021. Therapeutic measures were taken as result of COVID-19 and included treatment with benzonatate (lot: 7893614, dose: 100 mg; one pill a day), ivermectin (dose: 3 mg, 4 pills a day for 2 days, exp: 28Apr2021), prednisone (dose: 20 mg, 3 tablets once daily lot: 7893618 ), azithromycin (dose: 500 mg, for five days, lot: 7893308). Medications she was prescribed in the emergency room were helping a little bit. The patient outcome of the events was unknown.

Severe chills; joint pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 60-year-old female patient received bnt162b2, via an unspecified route of administration on 30Jan2021 at 04:45, single dose in the Left arm for covid-19 immunization. Medical history included Hashimotos Thyroiditis. Concomitant medication included thyroid (ARMOUR THYROID). The patient previously took Levoquine and experienced allergies. 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 had not been tested for COVID-19. In Feb2021, the patient experienced severe chills and joint pain still 4 days later. The patient did not receive treatment for the adverse events. The outcome of the events was recovering. Information on the lot/batch number has been requested.

on 2/6/2021 woke up in am with headache, chills, temperature . Symptoms continued with chills, sweating, lethargic with muscle aches and pains along with temp. Temperature returned to normal in pm on 2/7/2021. Muscle aches and pains, itchy at injection site and being tired lasted another couple of days. Feeling back to normal by 2/10/2021

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.

About 12:30 AM on 2/14/21, I woke with extreme chills, muscle weakness, possible fever and sweats, joint pains. About 2:30 AM, I took two 325 MG aspirin. About 9:30 AM, I woke again with the same extreme symptoms listed above. I took an additional two 325 MG aspirin. About 4 PM, my symptoms were not as severe, but I was still unable to engage in daily activities, and I took an additional two 325 MG aspirin. Symptoms continued, but lessened, and about 9 PM, I told an additional two 325 MG aspirin and a zolpedim CR to help me sleep throughout the night. I woke about 6:45 AM on 2/15/21, with mild muscle weakness, joint pain, and feeling slow and tired. As of this report at 11:15 AM on 2/15/21, I am functioning at about 80% capacity, some chills and muscle/joint pain.

Sore arm at injection site. Itchy throat and itchy body. Extreme Fatigue. Heavy and fast heartbeat with severe pressure and chest pain. Ongoing muscle and joint pain that moves from location to location. Redness on chest and facial - cheeks.

Day 4 sudden feeling unwell, out of it, severe burning pain throughout whole body, joint pain , headache, cough, fatigue, upset stomach, diarrhea. Subsided in about 36 hours.

lightheaded to the point of nearly passing out; nausea; general feeling of being unwell; lightheaded to the point of nearly passing out; cold sweat; loss of appetite; pain in upper shoulder/back area; pain in upper shoulder/back area; This is a spontaneous report from a contactable consumer (patient). A 60-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL-9265), via an unspecified route of administration on 29Jan2021 12:30 in left arm, at single dose for covid-19 immunization. Medical history included chronic low BP, hypothyroidism, HRT, nasal allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included estradiol, levothyroxine sodium (SYNTHROID), multivitamin NOS (MULTIVITAMIN). The patient previously took amoxicillin; clavulanic acid (AUGMENTIN) and known allergies: Augmentin, being treated for nasal allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced nausea, general feeling of being unwell, lightheaded to the point of nearly passing out; cold sweat, loss of appetite, pain in upper shoulder/back area, on 01Feb2021 06:30. No treatment was received. The outcome of the events was recovering. Since the vaccination, the patient had not been tested for COVID-19.

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.

This is a spontaneous report from a contactable nurse. A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302), other route on the right arm at the age of 60 years, on 02Feb2021 12:15 at a SINGLE DOSE for covid-19 immunisation. Medical history included depression Depression, Hypothyroidism, High Cholesterol, Osteopenia, Occasional vertigo. Concomitant medication included simvastatin (SIMVASTATIN), duloxetine (DULOXETINE), raloxifene (RALOXIFENE), chlorthalidone (CHLORTHALIDONE), levothyroxine (LEVOTHYROXINE) , calcium (CALCIUM), vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]), folic acid (FOLIC ACID), fish oil (FISH OIL), vitamin b12 nos (VITAMIN B12 NOS) , calcium carbonate, colecalciferol (VITAMIN D 2000) and Tumeric. The patient had the first dose of vaccine on 12Jan2021. After the 2nd shot, the patient's arm didn't get heavy, just felt a weakness going from shoulders down to hands on Feb2021. She couldn't move or feel them for 15 min. Slowly she could move her fingers then hands then lift arms. The next day her brain felt kind of fuzzy and still a little "off kilter" on 2nd day (Feb2021). She did not have any anxiety about either shot, even with what happened with the first one. The outcome of the events was recovering.

This is a spontaneous report from a contactable nurse reported for herself. A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE;lot EL3247) intramuscular in right arm on 01Feb2021 at 11:30 am (at 60 years) at single dose for covid-19 immunisation . Medical history included hypertension (HTN) , hypergammaglobulinaemia benign monoclonal (MGUS) , mononucleosis (recent mononucleosis one year before). Patient was not pregnant. Concomitant medication included venlafaxine hydrochloride (EFFEXOR), hydrochlorothiazide/ losartan potassium (HYZAAR), amfepramone hydrochloride (TENUATE). The patient previously took IV dramamine, tetanus and ceclor and experienced allergy. Previously, on 18Jan2021 at 10:30 am (at 60 years) she took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE;lot EL3248) intramuscular in right arm for covid-19 immunisation. Patient took the 1st dose of the vaccine on 18Jan2021 and 2nd dose on 01Feb2021 (inappropriate schedule of vaccine administered). Events were described as follows: next day, on 02Feb2021 at 06:00 temperature of 100.6, arthralgias and myalgias, dizziness. Second day (Feb2021), temp lower but still around 99.8 (normal for her 97.2), vasovagal, dizziness, arthralgias and myalgias. Events were non serious. Patient (a nurse) treated herself with dramamine for the dizziness, Nyquil and Advil. The final outcome of pyrexia, vasovagal, dizziness, arthralgias and myalgias was recovering.

Left shoulder has periodic pain and stinging as if someone with a heavy hand is giving me an injection now. The pain wakes me up at night. Sometimes in the day I feel the pain level at about a 6.

2-19-21 by 8pm full body aches and head ache 2-20-19 12am woke to severe chilling and temp 101.3, 6am temp 100.8, 5pm temp 99.9, 9:30 pm temp 99.7, slept the whole day with continual aches and pains in legs, arms, and back, with a severe headache 2-21-21 6:30am temperature 97.6, improvement in aches, headache gone, slight ache in legs, arms and back, walking better, feel like getting up and doing something

I only had 1 dose on 2/16/2021 and got the reaction 1 week later 2/23/2021.. Not sure if that's possible but wanted to report it anyway. body ache, joint discomfort, migraine headache all day, fever, chills & nausea - this started about 10am on 2/23/2021 and lasted until 2am the following morning 2/24/2021. I took 600 mg of motrin every 6 hrs and 600 mg of tylenol every 4 hrs. I feel fine today

As per Dr: 60 year old woman with history of MVA and back pain presents to office today with left arm pain and discomfort that started three weeks ago and has resolved but left her with tingling sensation in her third, fourth, and fifth digits on her left hand, symptoms started three weeks ago, hours after getting her COVID-19 vaccine. About a week and a half ago she began feeling numbness of her right leg going up to her upper abdomen with progressively worsening symptoms that have stabilized in the past several days. She also feels that her walking is off but cannot quite describe how or when it started. Exam notable for left-sided cervical myelopathy and decreased sensation on her right side up to a mid-thoracic sensory level. Of note she has a first cousin on her fathers side with multiple sclerosis and a more distant cousin on her mother's side with multiple sclerosis. Father with Parkinson's disease. I see that COVID-19 biofire came back positive. In light of this, COVID myelopathy is on the differential

Strong metallic taste in my mouth about 5-10 min after vaccination (lasted about 45 min); morning stiff shoulders and back of neck (still have it but it's better); This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9265), via an unspecified route of administration on 26Jan2021 12:30 at a single dose for COVID-19 immunization. Medical history included PVCs (Premature ventricular contractions), coronary artery disease (CAD) and allergies to NSAIDS, artificial sweeteners, sulfa, and mango. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included nicotinic acid (NIASPAN), vitamin d nos, metoprolol tartrate (LOPRESSOR), omega-3-acid ethyl ester (LOVAZA) and Nexlizet. No any other vaccines received within 4 weeks prior to the COVID vaccine. On 26Jan2021 12:45, the patient experienced strong metallic taste in her mouth about 5-10 min after vaccination and morning stiff shoulders and back of neck (still have it but it's better). No treatment was received for the events. The patient has not been tested for COVID-19 since the vaccination. The patient was recovering from the events.

IMMEDIATE Strange warmth/tingling down left arm and then further down body Dizziness Headache Fatigue brief chills LATER & NEXT DAY Pain left arm Muscile aches, especially legs Brief episode of nausea Slight fever

That evening starting to feel flu like symptoms. Today I feel like I have the stomach flu-body aches, headache, sore arm, nausea, 102 fever, joint pain

My upper arm started feeling odd ... numbness in my left upper arm. I liken the feeling to when I?m having dental work done and my mouth/lips are numb. Through the night I developed some aching in my left shoulder. No treatment. Just an annoying feeling of not being able to feel my upper arm. It feels cold as well.

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.

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.

pain in lymphoma area; pain in lymphoma area; Multiple headaches; neck pain; inner ear pressure; jaw pain; 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: EL3247), via an unspecified route of administration in the left arm on 21Jan2021 at 11:45 (at the age of 60-years-old) as a single dose for COVID-19 immunization. Medical history included type 2 diabetes and overweight, and the patient had no known allergies. The patient was not diagnosed with COVID-19 prior to the vaccination. Concomitant medications included lisinopril, metformin, metoprolol, sitagliptin (JANUVIA). The patient did not receive any other vaccine within 4 weeks of the vaccination. On 01Feb2021 at 09:00, the patient experienced multiple headaches, neck pain, pain in lymphoma area, inner ear pressure, jaw pain. The patient was not treated for the events. Since the vaccination, the patient was not tested for COVID-19. The clinical outcomes of multiple headaches, neck pain, pain in lymphoma area, inner ear pressure, jaw pain was resolving.

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.

Seizure: Sunday 2/28 @noon Migraines: 2/28 post seizure & 3/1 & 3/2 Pre-seizure symptoms: 3/1 & 3/2 ExtremeMuscle&Joint pain, fatigue, Ubrelvy 100mg 2/28 & 3/2, Ibuprofen 800mg, alt w/Tylenol 2-500mg, Rest/sleep most of days, warm showers, heating pads

Elevated blood pressure, headache (2 days), fever, EXTREME chills/shaking, congestion, loss of appetite, fatigue, could not lift arm.

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

At midnight after the shot I developed 99.9, chills, myalgia, severe migraine and all of it lasted 16 hours. I reported it to the nurse practitioner but did not want to see her because I knew it would resolve. I am a nurse and expected it would improve on it's own and it did. I did take Tylenol for the symptoms when they began. I work in a clinic.

COVID Vaccine Adverse Event Documentation After vaccination with COVID Vaccine Dose #1, patient developed evidence of Immediate (within 4 hours of dose) adverse reaction starting 3/5/2021 2:02 PM. Signs/Symptoms: Dry Mouth, Flushing, Lightheadedness, Nausea/Vomiting and Other (see comments) Reaction Comments: Skin blotchiness, dizziness, shaky, responsive but limp Treatment Administered: Cold Compress and Sips of Water Treatment Comments: Crackers, put in supine position Disposition: Home Disposition Comments: Next vaccine should be supine when receiving it. Additional Documentation: Pt became faint immediately after vaccine, warm, shaky and went limp I her chair but was responsive. BP: (!) 150/94 Pulse: 75 Supervising Provider Notified of Reaction: MD

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

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.

Starting about one hour after the injection, my left shoulder began to hurt a little bit. As the day progressed the pain increased substantially into my shoulder. It then started to hurt on the left side of my neck. I took Tylenol before bed, 500 mg is all I can take. This pain kept me awake all night and this morning I am not able to lift my arm up or down or sideways without pain, quite a bit of pain. Today is Sunday and I do not plan to seek medical care unless it continues to worsen. I will probably talk with my medical provider tomorrow if this continues.

Almost immediate discomfort at injection site, followed by sore shoulder (left) and neck pain as well as headache for 24 hours. One week later, severe joint pain for 48 hours.

Since the week after the first Pfizer vaccine, I began struggling with symptoms of diabetes. I experienced extreme thirst, frequent urination and I lost 17 pounds in the 3 weeks following the first dose. I never associated it with the vaccine, initially, because I never heard of any side effects like increased glucose, and my dad and sister have type 2 diabetes, so I was altering my diet, but the symptoms did not subside. I proceeded to get the second vaccine and that?s when I knew something was seriously wrong. That afternoon my blood sugar was 528, my vision was blurred, and I experienced a strange feeling in my heart. I was diagnosed by my GP with diabetes, and put on medication (Metformin and Glipizide). I proceeded to see an endocrinologist, I was put on insulin and after additional blood tests was diagnosed with Latent Autoimmune Diabetes , and Premature Atrial Complexes.

Injection site pain, muscle pain, could not raise arm up high, chills, whole body ached, joints hurt, weak, mild consistent headache, nausea, skin sensitivity, feeling like a bad case of the flu for 30 hours. Getting better by Sunday evening. Still not 100% as of Tuesday. Slight headache comes and goes like a sinus infection would feel like.

Sore nipples and armpits for several days then today light vaginal bleeding I am in or done with menopause and have not had a period for several years

On day 2 of the second dose, had soreness, pain and swelling to injection site, also fever of 100.3, chills, body aches and weakness On day 4 after second dose had severe back pain, painful to walk, despite taking Motrin. Went to doctor and had MRI done. Then by early February started having insomnia, hard time falling asleep and staying asleep . I feel the second dose of vaccine might have caused my immune system to become over active. The back is now ok after rest and physical therapy but the insomnia still persist.

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.

Approximately 10 hours after the vaccine, I awoke with pain in all the joints in my body. I took Ibuprofen and went back to sleep. When I woke up later I felt better but was tired and achy for the next 24 hours. I continued taking Ibuprofen So adverse event lasted approximately 48 hours

2:30 pm pain in left breast and arm pit. Around 3:30 pm slight headache lasting until 6:40 pm. 12:50 am woke to hot sweating and cold lightheaded and dizzy, nauseous and dry heaves. Rash on shot spot and surrounding area. Skin peeling at bandage area. 11:00 am shot area sore. Bandage area still a rash and slight peeling of skin.Dizziness is gone and nausea is gone. No headache

My tongue swelled slightly and the right side of it became numb. This lasted for 30 minutes. If it had gotten worse I would have gone to a hospital but it went away. Also, starting around 8 PM on Thursday and lasting until Saturday evening, my hips and lower back were extremely stiff and achy.

INJ. PAIN 3/11/2021 TIREDNESS 3/12 &13/2021 HEADACHE 3/11 & 12/ 2021 MUSCLE PAIN 3/11 & 12/2021 CHILLS 3/12 & 13/2021 JOINT PAIN 3/11/12/13/2021 FEVER 3/12/13/2021 102.5 & 100.2 FEELING UNWELL 3/12/13/2021 I JUST KEPT TAKING TYLENOL TILL I FELT BETTER. I AM FINE TODAY. 3/14/2021

Fever, nausea, whole body aches, pain in arm, armpit, back, chest, dizziness, palpitations, headache.

Normal side effects except extreme pain at back and left kidney. Felt like I had been kicked in the kidney by a mule. Lasted Wednesday through Friday. Could not get comfortable.

A few days after the vaccine on that Wednesday I began having pain in the upper shoulder and back area which persisted to a heaviness in my chest going into Thursday. Thursday night I woke up in the middle of the night to the feeling of not being able to breathe. I laid awake for a while but dosed back off and it happened again a little later. It felt as if someone was sitting on my chest which prompted me to go to the ER the next day. Various test were done and I was admitted in the hospital for further observation. After admission I developed a massive headache which lasted from that Friday afternoon until that Sunday. I was released on that Sat and the symptoms seemed to be getting better and by that Sunday evening all symptoms had subsided.

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.

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.

I started throwing up and had diarrhea by around 10 pm, did that about 4 times, my stomach was so bloated, it was weird. The next day, couldn?t get out of bed, all I had yesterday was diarrhea and felt like someone kicked me in the ribs. Today I am having a hard time taking a deep breathe or coughing without my ribs hurting so bad. My stomach feels better. Haven?t eaten anything, I am more concerned about under my breast hurt so much when I take a deep breathe or cough. I haven?t gone to doctor because I just wonder if it hurts so much there because if the vomiting

Severe joint pain to knees and hands lasting now into 3-4 weeks. Knee pain now gone, hand/joint pain remains. I think the hand/joint pain may be getting better?

Muscle fatigue was noticed around 5pm, took a 500mg Tylenol and laid down. Went to sleep. Muscle fatigue continued throughout the night and into next day (FR 3/19/21), continued to take 500mg Tylenol every 6 hours, slept through Noon on Friday, felt better laying down throughout rest of Friday/Friday night. Symptoms gone about 2:30am SA 3/20/21

I felt fine when I woke up. My left arm was very sore which also was the case after first vaccine. Around 10 am I developed chills and just did not feel great. My husband took my temp and the highest it got was 102.6 which is high for me since my baseline is 97.6 or so. I did not have a great appetite and felt very stiff when I moved around. I pushed fluids and took 3 naps Saturday. I have a low grade fever of 99 today but feel much better. Did take 2 naps and slept well last night. Took Advil with each meal and doing so today.

I called My primary care doctor on Thursday afternoon the 14th to see what they thought. They said I should go to ER. I called my Psychiatrist and his Nurse said call my regular primary care doctor. Since then I?ve been icing my back, knees, ankles and shoulders.. I?ve been taking ibuprofen and acetaminophen- Alternately . Resting but the pain only subsided for a few minutes

Due to 4 days progressive worsen skin lesion. Lesion as erythema multiform, generalized on hand, forearm, body and lower leg; Oral ulcer; Chill; Body ache; Joint pain; Joints swelling; Diarrhea; This is a spontaneous report from a contactable other healthcare professional (HCP). A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6201), via unspecified route of administration in the left arm on 17Feb2021 as single dose for COVID-19 immunization. Medical history included hyperlipidemia. The patient had no known allergies. The patient is not pregnant. There were no vaccine in four weeks. Other medications in two weeks included cholesterol med. The previously received the first dose of BNT162B2 on 26Jan2021 12:00 intramuscular at left arm (lot number: EL9262) for COVID-19 immunization. The patient was seen at urgent care on 04Mar2021 due to 4 days progressive worsened skin lesion. Lesion as erythema multiform, generalized on hand, forearm, body and lower leg from 28Feb2021 (12:00 AM). Patient presented with chill, body ache, joint pain, joints swelling and diarrhea since second dose of vaccine on 17Feb2021. She also has oral ulcer at the same time when rash started on 28Feb2021. Vital sign was stable, no shortness of breath (SOB) and no chest pain. Events resulted in Doctor or other HCP office/clinic visit. The treatment for the events included Hydroxyzine 25 mg prn. It was unknown if patient had COVID prior vaccination or if COVID tested post vaccination. The outcome of the events was not recovered.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Erythema multiforme cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

By eight pm my left arm started hurting. At 2:30 am Sunday morning it was hurting so bad it woke me up. I could not raise my arm up past 6 inches. My left arm and side down to my waist was hurting. I took some Ibruprofen. Used a heating pad on my shoulder. Finally got back to sleep for a few hours. When I woke around 7:30 am, most of the pain had moved under my arm and to the front of my shoulder. I sat in my hot tub (100 degrees) for an hour and took more Ibruprofen. I was able to raise my arm up about half way. Was very tired. Went back to bed around 10 am and slept until 2:30. Had a headache and fatigue. Napped off and on the rest of the day. Today I can raise my arm all the way up, slowly. It is still painful to do so. The headache and fatigue are minimal.

8.5 hours after vaccine injection, I suddenly began experiencing fatigue and extreme joint and muscle soreness. Initially I noticed my knees hurting with radiating pain up into my thighs. My head hurt, particularly at the back of my skull, near my neck. My neck muscles were sore, as were BOTH shoulders - my right shoulder (injection site) was only slightly sorer than my left shoulder. I called a 24/7 nurse associated with insurance company to ask if ibuprofen or tylenol were acceptable treatments for my symptoms. She told me I could take either and alternate if I felt I needed to maximize relief. I noticed the joins in my toes and fingers were hurting. It was frightening to experience tightness in my chest and back muscles. I never felt like my lungs were compromised, there was just a heaviness as the muscles seemed constricted. I felt a slight rise in my heart rate and experienced a few palpitations mostly because I kept pondering how much worse my symptoms could get. I was a little cold, so I decided to go to bed after drinking extra water (also a suggestion from the nurse). I slept for a few hours 10:00 PM - 4:00 AM then got up and called an advise nurse to report that my joint and muscle pain were not subsiding. She encouraged water and more painkiller. As the day wore on, I felt less achy and more shaky/jittery. My thinking was somewhat unclear - I felt a little dizzy, out of balance, off-kilter and brain "foggy." As I write this 36 hours after my injection, my symptoms are subsiding. Where I felt a little chilled during our cool and rainy afternoon, I now feel a wave of heat sort of traveling through my body. It isn't a fever - just an odd sensation that something is still going on.

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

Started out with mild muscle pain with certain movement. Effects ability to drive and work. Saw Dr on 3/16/2021 Steroid cream, tylenol, and Xrays done. Informed that they might need to do an MRI. At this time she does not feel like it is getting any better. Sometimes hurts more than other times depending on activity, feels heavy and week. Can feel it poping and grinding with movement.

At about 3:55PM my left arm, where injectiion was administered began tingling from upper arm to fingers. Pain to the back of my neck, a flush of warmth to my upper body and difficulty breathing. Felt like a truck ran over my chest. I was weak, dizzy and nauseous as well. The tingling sensation also affected both my legs. The RN took to their infirmary area and began taking my vitals. Vitals seems normal, Blood Pressure and Pulse were high. I am asthmatic but did not bring my inhaler with me. Because of my difficulty breathing, they decided to inject me with Benadryl which is all they had. After about twenty minutes, my breathing started to calm down and blood pressure began coming down as well.

Received the first vac on 3/12 at 8:30 a.m.. I started feeling achy and tired by 4pm. By the next day, I had diarrhea and stomach upset starting by mid day. Since then, I have had daily diarrhea, lethargy, weakness, off and on headache, body aches (especially joints) and overall feeling of unwell.

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

After I left the facility, driving home I notice that my back was starting to hurt, so I turned on the heat on my back . When I got home, I had difficulty getting out of my car. I sat in a chair and within the next few minutes I was not able to stand. My husband had to come help me get up and stand, there was pain across my lower back like pin needles and up part of my spine. I took Motrin and it helped it subside somewhat not much. The second day it continued but later started to ease a little but I was not able to walk upright. Third day, 3/24, it is starting to ease up and I am able to walk upright, there is still discomfort. I have contacted my physician to report the issue.

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.

Extreme exhaustion, chills, muscle aches, brain fogginess, headache - all the symptoms I experienced when I had COVID-19 in early November 2020. All symptoms improved within 18 hours except headache, which lasted for 36 hours. Headache was also a lingering effect after all other COVID-19 symptoms subsided when I had the virus, as well.

Day 1 muscle stiffness lower back and slight fever, tired. Day 2 bone, muscle pain moved to right hip, sore to touch, tired. Day 3 bone, muscle pain moved upper back, tired. Took aspirin. Day 4 bone, muscle pain more extreme, tired. Took aspirin. Day 5 extreme pain in hip and ribs, sore to touch hard to breath, fainted, tired. Took tylenol. Pain went away

neurothopy for 1-2 days; bone pain; Exhaustion; 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 MRNA VACCINE) via unspecified route of administration on unspecified date at age of 60 years old at single dose for COVID-19 immunisation. Patient had chemotherapy for ovarian cancer in 2020. Concomitant medications were not reported. Patient experienced exhaustion, bone pain, neurothopy for 1-2 days post first vaccine. Event took place after use of product. Outcome of events was unknown. Information on the lot/batch number has been requested.

this was my 2nd dose. late afternoon & was feeling unenergetic. late that eve I felt achy, took 400mg ibuprofen before going to bed around 11pm. by 1 am on 3/24 I was running a fever, shivering & my inj arm was very sore/felt heavy. Took 400 more ibuprofen, fever reduced before too long. Also felt slightly nauseous during the night & into the day of 3/24. around 2 pm got a bad headache. more ibuprofen, still felt a little nauceous, tho that subsided in early a.m. 3/25. Also was coughing quite q bit most of 3/24, but that may have been due to allergy stuff. experienced some mild diarrhea on 2 occassions 3/24. Symptoms are fairly well abated by 10a.m. 3/25.

Approximately 28 hours after administered: extreme fatigue, mild chills and muscle aches. Chills subsided in 4 hours, muscle aches in 6 hours.

On 3/18 Started out with arm and shoulder feeling hot. Then Excruciating pain in shoulder and all down the arm from 3/19 and still continuing today 3/27. Took Tylenol and used ice on shoulder and arm. Had a massage and stretching done on 3/23 didn?t help much. Contacted my doctors office on 3/23 and have an appointment for 3/31. The symptoms I?m feeling is that of SIRVA. Went to urgent care on 3/26 and was told that ?that is a symptom of the vaccine, give it another day?. Told them it was over a week and the pain I?m feeling is nerve pain. I was told there was nothing they can do for me there. Still feeling the pain today. Still icing and using Voltaren gel to help with inflammation.

Pain in left arm for about 30 min. followed by numbness in hand, then ring finger fingertip completely white that lasted about 10 min. Once color returned I soon became dizzy and weak feeling in my legs followed with vomiting. I then felt a little better with mild light headedness.

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.

I have taken Pfizer-BioNTech COVID-19 Vaccine EUA Three days later I have muscle pain, ear infection, headache, stomach very up set, feeling not well

Felt fine after injection; waited 15 minutes felt fine. Got up at 4 am to assist my mom in using the bathroom and everything was spinning in the room. I sat down on floor for about a minute and thought it passed, stood up and took two steps, and from what I?m told I went flat down on the ground without trying to even break my fall. I was out cold. Taken to hospital where I had four ct scans, numerous xrays done; all okay minus pulled muscles/ligaments and possibly some fractures in my foot. I had surgery on it in January and they couldn?t tell if it was old or new fractures.

Pain at injection site, extreme back and body aches, headache, dizziness, low grade fever. Ibuprofen & Acetaminophen As of 4:00pm on following day of injection, reactive symptoms still occurring...

Muscles around hip replacement were affected for 2-3 days. Sore muscles in the buttocks, hip and quad. It only affected this site. It went away but I found it odd. I got the usual bit of nausea, wooziness, fatigue and sore arm, but those were expected

her arm was extremely sore; unable to move left side of neck/unable to move arm; She felt unwell like she had the flu/sick; nose running; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198), an unspecified route of administration, administered in left arm on 25Feb2021 (at the age of 60-years-old), as single dose for COVID-19 immunisation. Medical history included lupus from 2018 to an unknown date, Cushing's syndrome from 2018 to an unknown date and ongoing Hashimoto's disease. The patient had also allergies. Concomitant medications included ibuprofen (ADVIL). Patient reported that within 2 minutes of getting the vaccine her nose was running. Two hours later she started to feel unwell. Her nose was still running. She was not sure if this was from the vaccine or because of her allergies. She felt unwell like she had the flu. She was sick and progressively getting worst. She was having reaction to the injection. On 26Feb2021 she woke up around 3:00 am and was unable to move the left side of her neck or her left arm. She still has some neck stiffness. She had small incidences for 3 days after. She felt paralyzed. She was unable to move her arm because it was completely painful. She didn't panic that her arm was extremely sore. She was able to move it. Caller added that she though she had Covid when she got the vaccine and didn't know it. She was sent t an EMS station to be tested. She was given the rapid test on 03Mar2021. Within 15 minutes she was told the result was negative. They sent out another test the same day. On 06Mar2021 she received negative results. She was scheduled to get the second dose on 18Mar2021 at 11:00am. The outcome of events 'she felt unwell like she had the flu/sick' was not recovered, nose running was resolving, unable to move left side of neck was resolved on 28Feb2021, unable to move arm was not resolved, the outcome of other event was unknown.

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.

That night felt tired with chills and body aches. The next day I had a fever of 102.2, horrible body aches, joint pain, chills, headache, nausea, zero appetite, fatigue. Felt like a bad flu. By Monday the fever was gone but was very weak, nauseous, with joint pain. Didn?t feel like myself for several days-almost a week.

Headache chills fever upper respiratory cough, muscle aches, earache, stomach ache, pain at injection site and itching

I had every single side effect listed. Severe headache starting almost immediately, lasting 5 days. Fever of 102, gradually coming down, over 5 days. Severe dry coughing, lasting 6 days and continuing. Severe muscle aches, lasting 6 days so far. Diarrhea lasting 1 day. Nausea, lasting 3 days.

dramatic increase in Rheumatoid Arthritis symptoms; This is a spontaneous report received from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, in Feb2021 (reported as "last month"), as single dose, for COVID-19 immunisation. Medical history included ongoing rheumatoid arthritis. The patient's concomitant medications were not reported. The patient previously took tofacitinib (XELJANZ XR) for rheumatoid arthritis. The patient reported that she missed two weeks of XELJANZ XR last month (Feb2021) due to receiving COVID-19 vaccine. She said she experienced a dramatic increase in rheumatoid arthritis symptoms (unspecified date) as a result of this but she feels like overall Xeljanz XR is managing her rheumatoid arthritis well. The outcome of the event was unknown. No follow-up attempts are possible. Information on lot/number cannot be obtained. No further information is expected.

I was doing my HIIT workout as always (I am 60 and in good physical conditioning) and got bad hip pain on my left side. I stopped and saw my chiropractor and just took it easy from doing HIIT for awhile.

The day after the vaccination, there was pain on my left side (my vaccine shot was in my right arm). By Saturday 3/27/21 (day 4), a localized rash appeared on my left side (midriff area) which looked like herpes blisters. The area was sensitive to touch and painful. The pain had spread to my left back area. Started 1000 mg Valacyclovir 3 times a day on 3/30/21, after I saw the doctor and she confirmed it was probably shingles. The rash and sensitivity/pain are still present today, 4/2/21, on day 10 after the vaccine.

Site: Pain at Injection Site-Mild, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Fever-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Hypotension-Mild, Systemic: Shakiness-Mild, Additional Details: Patient reported vitals from ER BP=107/70, Liver tests were off due to dehydrated per ER , had fever ,sweats then chills and Headache followed by fatigue for a few days. Patient did notify her PCP

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.

On Saturday, April 3, 2021 clientt received her first dose of Pfizer COVID vaccine (LOT # EW0150, EXP 7/2021) at approximately 2:00pm. After vaccine was administered, client was to wait in the Observaton Area for 30 minutes due to Penicillin and sulfa drug allergy. At 2:09pm, client walked up to EMT and stated she was "feeling light-headed." Client was advised to sit in the anti-gravity chair and was given a bottle of water. Upon assessment by EMTs, client's last meal was at 12:30pm. Client also stated to EMTs she felt light-headed right after receiving the vaccine. At 2:13pm, the client stated the back of her neck felt "a little tight" and stated she had a headache. At 2:15pm vitals were taken: BP: 130/76, Hr: 57, RR: 15, O2 sat: 97%. Lead PHN was notified and advised client to be watched for an additional 30 minutes. Vitals at 2:20pm: BP: 128/78, HR: 59, O2 sat: 98%. Vitals at 2:25pm: BP: 128/70, HR: 59, O2 sat: 97%. At approximately 2:40pm, client stated her light-headedness and tightness on the back of her neck completely subsided. Patient was alert and oriented x4 during entire interaction. No further interventions indicated. Client was educated by Lead RN & EMT on signs and symptoms of adverse reactions and when to go to the ED/call MD. Client was also encouraged to sign-up on v-safe. Client was able to ambulate with EMTs to her car with a steady gait at approximately 3pm.

Sore left arm at injection site; Tingling feeling on forehead; Slight headache; neck pain; This is a spontaneous report from a contactable Pharmacist. A 60-years-old female patient received BNT162B2 ( BNT162B2, Formulation: solution for injection, Batch/Lot Number: EL3247) first dose via an unspecified route of administration, administered in left arm on 18Feb2021 9:15 as single dose for COVID-19 immunization. Vaccination administered facility Workplace clinic. The patient medical history included Osteoporosis; irritable bowl syndrome. The patient concomitant medications included : Citracal; Centrum; Vit D (ergocalciferol); Colace; Evening Primrose (oenothera biennis), ascorbic acid, biotin, calcium carbonate, calcium pantothenate, calcium phosphate dibasic, chromium picolinate, colecalciferol, copper sulfate, cyanocobalamin, ferrous fumarate, folic acid, magnesium borate, magnesium oxide, manganese sulfate, nickel sulfate, nicotinamide, panax ginseng root, phytomenadione, potassium chloride, potassium iodide, pyridoxine hydrochloride, retinol acetate, riboflavin, sodium metavanadate, sodium molybdate, sodium selenate, stannous chloride, thiamine mononitrate, tocopheryl acetate, zinc oxide (CENTRUM ENERGY). On 18Feb2021 10:00 patient experienced with sore left arm at injection site (vaccination site pain), tingling feeling on forehead, slight headache, and sore neck on left side. The outcome of the event was recovering. Follow-up information was received on (25-MAR-2021): No new medically significant information was received on this case.

12-48 hrs post vaccine: nausea, fever, headache, muscle aches, malaise; took tylenol; 48-96 hrs post: malaise; 5th-10th day post: coronary vasospasms, malaise, arrhythmia; took nitroglycerin patches, nitro bid paste; 11th day: met with rheumatologist, started medrol dose pack, improved spasms for a short time, 13th day: afib symptoms and Apple Watch reading noted by patient; 15th day spasms began again and increased symptoms of afib: saw doctor in office for EKG showing afib; met with cardiologist ordered increase in diltiazem and second medrol dose pack; first 48 hrs on second dose pack improved spasms, by 3rd day spasms significantly increased and constant afib w headache, dizziness, malaise. Visited ER, admitted. cardio version. Reduced dilitiazem, reduced ramipril, increased isosorbide. Continued symptoms with waxing and waning of spasms and atrial fibrillation . Although this is a pre-existing chronic condition, Afib without relief is not normal. Spasms without resolution not normal nor have I experienced an episode of this duration ever.

Sharp stabbing stomach pain without nausea or diarrhea. Burning, achy joint pain followed by chills, fever ,headache and general weakness. Lack of appetite due to stomach pain. Continued for 48 hours. Slow improvement on 4/4. Still having moderate, intermittent stomach pain and now diarrhea. Poor appetite, feel flushed, without fever. Still headache,weakness and fatigue

Even though taking Tylenol - had fever the next day that became increasingly higher. Highest Fever 101.5 first day after with bad chills all day, achy joints, dull headache and no energy. Low grade fever 100.5 second day after with Dull headache and low energy.

Woke up at 2 AM with severe chest pain, no dyspnea, but she felt like she was going to die. Chills, back pain (from the front of the chest to the back), slight nausea. Sore arm the next day, chest continued to hurt over the next 24 hours, developing lower right groin pain ~ 32 hours after injection onset. Diaphoretic 36-48 hours afterwards, severe abdominal pain when waking up in the morning . 53 hours s/p injection, pt now feeling queasy.

Received shot on Friday afternoon. On Saturday morning had sore arm at injection site. Then developed very achy shoulder, with ache spreading up neck and down back on left side. Some fatigue as well. Aches dissipated after a couple of hours, but fatigue continued and worsened on Sunday and continued into Monday. Also on Monday, woke up nauseated, and it continued, on and off, throughout the day until bedtime. Nausea gone on Tuesday, but still a bit more tired than usual.

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.

I didn't even feel the shot, but there was soreness up my arm, across my shoulder and up the left side of my neck in the occipital region. There was no redness, rash nor was it hot to the touch. It was still painful for about 3 days and I took Ibuprofen as directed by my doctor (via telehealth), but stopped taking it. Today, even turning my head is really painful and I still have a headache. It isn't throbbing or debilitating, but it's there. I am getting my 2nd dose on 4/14/21.

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.

~12 hours after vaccination, began experiencing chills, lower back pain, bilateral side/abdominal cramping (gas-like), and rapid heart rate with elevated blood pressure (normal 120s/80 but up to 146/84), was advised to come to EC for evaluation but patient declined

tightness in chest; Headache; dizziness; shortness of breath; nausea; itching; severe pain in both knees; numbness in both thighs; 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), dose 1 via an unspecified route of administration, administered in Arm Right on 21Mar2021 14:30 (Batch/Lot number was not reported) at the age of 60 years old, as single dose for covid-19 immunization. Medical history included sleep apnea, history of breast cancer left side lumpectomy, chemotherapy, radiation, asthma, osteoarthritis, vestibular disorder, allergies to unspecified medications and food, and GERD (gastrooesophageal reflux disease). The patient was not diagnosed with COVID prior to vaccination. Concomitant medications included lisinopril (LISINOPRIL); hydrochlorothiazide; hydroxyzine; and meloxicam (MELOX); all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 21Mar2021 03:00, the patient experienced tightness in chest, headache, dizziness, shortness of breath, nausea, itching, severe pain in both knees, and numbness in both thighs. The events resulted in: doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The events were treated with Benadryl, solution medrol pf, sodium chloride. The patient has not recovered from the events. The patient has not been tested for COVID post vaccination. The events were reported as non-serious. Information on the lot/batch number has been requested.

Sickle cell crisis; She said she was unable to touch her collar bone because of the pain; pain along her heart, collar bone area, and ribs; Hot flash on the left side of her head preceded the headache; Headache; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received first dose of BNT62b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in left arm on 12Mar2021 (Batch/Lot Number: EN6206) as single dose for covid-19 immunisation. Medical history included sickle cell anaemia diagnosed when she was a baby from an unknown date unknown if ongoing. The patients concomitant medication included unknown injectable medication the patient stated she was given injectable medication for 2 tests, 1 on 23Feb2021 and 1 on 26Feb2021. She said she didn't know the name of the medications given to her and the tests were ordered by her cardiologist. There was no 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). The patient experienced sickle cell crisis on 18Mar2021 headache on Mar2021, she said she was unable to touch her collar bone because of the pain on an unspecified date, pain along her heart, collar bone area, and ribs on an unspecified date, hot flash on the left side of her head preceded the headache on an unspecified date. The patient was hospitalized for sickle cell crisis from 19Mar2021 to 20Mar2021. The patient was still had sickle cell crisis pain along her heart, collar bone area, and ribs. She said she was unable to touch her collar bone because of the pain. She said she also had a headache. She clarified the headache started a couple days after she had the COVID-19 Vaccine. She said a hot flash on the left side of her head preceded the headache. She said she still had a headache, and some days her headache was better. She said yesterday (24Mar2021) her headache was so strong. She said the headache was on the left and back side of her head, but particularly strong on the back side of her head. The patient went to the Emergency Room after midnight on 19Mar2021. She said she spent the night at the hospital as an inpatient, and then was discharged by Saturday (20Mar2021) afternoon, around 14:30-15:00. She said she was given Morphine for pain, and was on an IV, and took her regular medicines. She said she did not know the name of the IV fluids that were given to her. The patient underwent lab tests and procedures which included cardiac stress test and electroencephalogram result was unknown. The outcome of event hot flash on the left side of her head preceded the headache was unknown and outcome of all other events was not recovered, Information on the lot/batch number already available. Further information has been requested.

Stiff and Severe lower back and left hip pain, unable to stand up without significant difficulty. I am a runner and since the injection, have barely been able to get out of bed or chair or to walk. Today is Sunday and have started being able to move somewhat,

Almost immediately felt flushy and a bit hyper and then started to develop numbness (not pins and needles) of the front of my face. Somewhat milder than for the first dose, both of my upper arms started to feel discomfort within a few minutes. The numbness dissipated within an hour and a half, by which time I started to feel achy and have some of the common side effects. Next day was very achy and did not have much stamina. Was feeling much better in the morning of 04/11/2021. In the evening of 04/11/2021 started to feel some numbness in my nose again.

approximately 12 hours after vaccination 4/10 woke up with severe muscle aches, arms, shins, ankles and headache. Also felt nauseous. In morning had very slight fever and sore throat. Overnight on 4/10 woke up with extreme tightening feeling in center of chest Today 4/11 have rash on arm where I received vaccination in an area that covers an oval about 5 x 8". Took Ibuprofen in am for pain then tylenol for slight fever and pain. have marked rash to see if it spreads.

Extreme pain from top of left shoulder to the elbow. Unable to stretch, scratch my neck, wash my back or put on my seatbelt. The are aches so much that I can not sleep at night. I am unable to lay on my left arm. I have a large hard lump on my left arm at the injection site. Weakness in left hand. Unable to raise my arm to remove my shirt. The pain seems to be getting worse. Left inner leg bruises and pain.

Brain fog and memory loss, since vaccine 1st dose, 04/07/2021 On 04/08/2021 I woke up to find my left eye with filled with blood over most of the sclera. Severe joint pain. Muscle pain, and lethargy. Extremely forgetful with new onset 04/07/2021. Eye pain left eye. L eye hemorrhage is not resolved yet.

Systemic: Headache-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Additional Details: Patient said she experienced left side numbness, slurred speech, severe neck pain, and a headache. She said she had stroke like symptoms but after being hospitalized for 3 days and having a CT scan performed stroke was ruled out.

I experienced muscle and joint aches, headache and overall malaise. Approximately 14 days after the first vaccine , started having vision deficits in my left eye out of the blue. I experienced a fuzziness and haziness in the vision of the left eye and pain above the left eye brow. Was seen urgently in the eye clinic on 3/29/21 and had a battery of tests - a swollen and inflamed left optic nerve was observed and some deficits to vision and peripheral vision. Had second vaccine on 3/31/21 and eye seemed to get worse. Seen by Optical Nerve Specialist on 4/5/21 and had battery of tests and optic nerve worse. Dr. diagnosed as ischemic optical neuropathy likely due to giant cell artritis (GCA). I had urgent/emergent temporal artery biopsy on 4/6/21 to determine if giant cell artritis. Received results from biopsy on 4/13/21 and negative for GCA. Saw Optical Nerve Specialist on 4/14/21 and diagnosed with ischemic optical neuropathy but cause can not be specified. Optic nerve is still swollen and vision impacted. I am to return to clinic in 8 weeks and see if improvement. I have never had any issue like this in the past.

chills, joint pain, muscle aches, low-grade fever, fatigue starting at 4:00 pm 4/12/2021 through 2:00 am 4/14/2021 diarrhea 4/14/2021 6:00 am - 2:00 pm

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.

One week after receiving the first vaccine, I developed severe headaches. I got my booster 21 days later. One week after receiving the booster, I started having severe headaches, severe neck, back and abdominal pain. I went to the ED the morning of 3/5/21, was admitted to the hospital and release on 3/8/21. It is in the H&P from Health facility.

In addition to common symptoms listed on the CDC website ( soreness in arm, muscle and body aches, fatigue) I experienced tingling and numbness in hands and feet, and tingling in the face. It got progressively worse over the next few days, and started getting better each day after Sunday 4/11/20. I went to my doctor?s office yesterday, and since he was not available, I saw the nurse practitioner. She checked me out and did a needle test as well. She said that although this is not listed on the common side effects, that it appears to be a side effect. She said since I am getting better each day, it will likely resolve itself in a week or two. She feels that my nerves are inflamed. I was not prescribed anything, and since I do take a dose of gabapentin each day, this should help.

Pt was given second dose of vaccine on 0412/2021. She developed severe pain of forearm and wrist. She had applied ice to site and today noticed a bruise on her inner wrist (4 x 2 inch). Denies taking any blood thinner and denied trauma. No warmth or pain at this time. She took 800 mg Ibuprofen night before vaccine for back injury. She applied ice to site. PCC: Advised to FU with pcp, urgent care or ED for cbc and coags. Although Pfizer vaccine has not been known to cause clotting issues and sx could be unrelated it is best to r/o. Caller will be going to home on Friday and said she might wait to fu with pcp there.

Felt fine until 11 hours after 2nd shot, then felt like I was hit by a truck so went to bed. Could not sleep all night because bones started to ache terribly...felt like my bones were going to explode, which seemed like a very unusual reaction. Halfway through the night, got nauseous. Later in the night got stuffed nose and headache. Woke with headache, body aches, fuzzy head and had fever up to 101.5 all day. Took a Tylenol in the morning and drank a cup of coffee and lots of water which made headache disappear. Finally took a Motrin at 6pm and started feeling much better by 9pm. Slept well. By 7am next morning, was 100% fine albeit tired.

ueststarted to develop high heart rate and hypertension....150/100 initially. started hypertensive therapy. after second shot on April 8, (Thursday), BP went to 155/108. had an irregular heart rate...and constrictive feeling around my neck. thyroid lab studies were abnormal. my

Bruising; Soreness and pain in left arm at site; Soreness and pain in left arm at site, under arm pit; Soreness and pain in left arm at site, under arm pit and around breast; This is a spontaneous report from a contactable other 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 26Jan2021 (Batch/Lot Number: EL9261) as single dose for covid-19 immunisation (age at vaccination was 60 years). No other vaccine in four weeks and other medications in two weeks were reported. No Known allergies and no other medical history were reporter. Historical vaccine included dose 1 via an unspecified route of administration, administered in Arm Left on 05Jan2021 at 07:45 AM, (Batch/Lot Number: EK4176) as single dose for covid-19 immunisation (age at vaccination was 60 years). Following mammogram 26 days after (as reported) second dose the patient experienced bruising and soreness and pain in left arm at site, under arm pit and around breast on 19Feb2021 at 16:00. The patient recovered with lasting effects. No treatment was received for the events. No covid reported prior vaccination. Covid wasn't tested post vaccination. The patient underwent lab tests and procedures which included mammogram: unknown result. Outcome of events was recovered with sequelae on an unknown date in 2021. No follow-up attempts are possible. No further information is expected.

Patient received Pfizer for her first dose on 3/17/21 and a moderna for her second dose on 4/8/21. She states at the 24 hour mark of receiving the moderna she experienced extreme joint pain and swelling. She states she has not been able to work when I called to check on her on 4/13/21.

Extreme muscle soreness, low grade temp. Within 30 hours excessive vomiting started & continued for over 12 hours, resulting in dehydration, leading to trip to ER.

13 hours after receiving 2nd vaccine, woke up with chills, shaking, extreme muscle aches, headache and sinus drainage; 13 hours after receiving 2nd vaccine, woke up with chills, shaking, extreme muscle aches, headache and sinus drainage; 13 hours after receiving 2nd vaccine, woke up with chills, shaking, extreme muscle aches, headache and sinus drainage; 13 hours after receiving 2nd vaccine, woke up with chills, shaking, extreme muscle aches, headache and sinus drainage; 13 hours after receiving 2nd vaccine, woke up with chills, shaking, extreme muscle aches, headache and sinus drainage; This is a spontaneous report from a contactable consumer (patient). A 60-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ER2613), via an unspecified route of administration, administered in arm left on 28Mar2021 at 12:00 as single dose for COVID-19 immunization. Medical history included breast cancer from 2013 and blood cholesterol increased. The patient had allergy to sulfa. The patient previously received first dose of bnt162b2 (lot number: EN6202), in left arm on 07Mar2021 at 15:30 as single doses for COVID-19 immunization. Concomitant medication(s) (received within 2 weeks of vaccination) included atorvastatin, colecalciferol (VITAMIN D [COLECALCIFEROL]), ascorbic acid, betaine hydrochloride, boric acid, calcium carbonate, calcium citrate, calcium lactate, calcium pantothenate, calcium phosphate, citric acid, colecalciferol, copper gluconate, cyanocobalamin, folic acid, fumaric acid, magnesium aspartate, magnesium oxide, malic acid, manganese aspartate, menaquinone-7, nicotinamide, oxogluric acid, phytomenadione, pyridoxine hydrochloride, riboflavin, silicon dioxide, sodium molybdate, sodium selenite, strontium chloride, succinic acid, thiamine, zinc picolinate (OSTEOPRIME ULTRA). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 29Mar2021 at 03:00, the patient experienced 13 hours after receiving second dose, woke up with chills, shaking, extreme muscle aches, headache and sinus drainage. The patient did not receive treatment for the events. The outcome of events was recovering. No follow-up attempts are possible. No further information expected.

Pain in left shoulder/ arm started approximately two hours after vaccine. Pain Consistently getting worse into Wednesday evening to where I was having trouble moving my arm up down behind me a crossed my midsection and out away from my side, pain getting worse intoThursday morning. Called off work Thursday/Friday. Other symptoms subsided after 48 hrs but not the pain in Site area and shoulder. Saturday not improving went to clinic in afternoon.

appendix had ruptured; diagnosed with appendicitis; could barely stand; I felt tired; sore arm; entire intestinal tract and stomach became hard; extended and felt like it was on fire and was extremely painful; vomiting along with diarrhea; vomiting along with diarrhea; pain and burning in my stomach and back; pain and burning in my stomach and back; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in left arm on 29Mar2021 12:15 (Batch/Lot Number: EP6955) as single dose (at the age of 60-year-old) for COVID-19 immunisation, administered at Pharmacy or Drug Store. Medical history included known allergies: Sulfa drugs, aspirin cordisone. Patient had not COVID prior vaccination. Patient was not pregnant. Concomitant medication(s) included thyroid (ARMOUR THYROID) taken for an unspecified indication, start and stop date were not reported. The patient previously took aspirin [acetylsalicylic acid] and experienced drug hypersensitivity, cortisone and experienced drug hypersensitivity. No other vaccine in fourweeks. On 29Mar2021 19:30 the patient experienced she felt tired, sore arm, entire intestinal tract and stomach became hard, extended and felt like it was on fire and was extremely painful, vomiting along with diarrhea, pain and burning in my stomach and back. On 31Mar2021 the patient experienced appendix had ruptured, diagnosed with appendicitis, could barely stand. The patient was hospitalized for appendix had ruptured and diagnosed with appendicitis for 2 days. The events were considered serious as per hospitalization, disability, life threatening. Therapeutic measures were taken as a result of appendix had ruptured and diagnosed with appendicitis: appendectomy. COVID was not tested post vaccination. Course of events was as follows: She had the shot on 29Mar2021 at 12:15, 4 hrs after she felt tired and had sore arm. 7 hours after, her entire intestinal tract and stomach became hard and extended and felt like it was on fire and was extremely painful. 4 hrs later she started vomiting along with diarrhea. The vomiting continued non stop along with the pain and burning in her stomach and back. On 31Mar2021 morning the pain settled into the right lower stomach and became so painful she could barely stand. She went to the ER and was diagnosed with appendicitis. She had surgery that night and found my appendix had ruptured. The OR nurse told he she was the 2nd lady that day who's appendix had ruptured after having their First COVID vaccine and there had been others. She believed this was absolutely the direct result of the vaccine. She queried why were we not warned of this violent side effect of the vaccine. The outcome of events was recovering.

Three hours after receiving the 2nd dose, right arm begin to ache. Felt ache down the arm into the hand and fingers. Body aches and chills through out the night ache across the shoulders, neck and up toward the base of the neck and lower back. Next day symptoms were slightly worse I developed a slight headache became very listless had to go to bed. Friday night, the injection site arm developed a red rash that was warm to the touch.

left side headache, left eye pain, severe vomiting, full body pain, neck pain, chills as of Sunday some had subsided but not all. tylenol of no use!

Dose 1: Redness, swelling at injection site, Headache, dizzy, nauseous, fever over 100 degrees F. Everyday or every other day. Diarrhea, muscle aches, joint aches, neck pain, fatigue all lasting 2-3 weeks. Still had 100 degree fever the night before Dose 2. Told nurses at Super Station about all the side effects from first dose and they had me take a Benadryl before 2nd shot, stay 30 min. for observation, then they told me to take Tylenol when I got home, which I did. Taking 2-3 more over the next day or so. Did not get redness or swelling at shot site, did have headache, fever, fatigue, muscle and joint pain, but much more muted than with the first dose with no medication. I continue to have a fever of 100 degrees about every 2-3 days. Some days I have diarrhea or feel headachy and have to be in bed most of the day. Usually fever is first symptom on those days. It's been 3 weeks since last dose and my fever was 100 yesterday and spent 15 hours in bed.

I experienced the known, Headache, body/joint pain, injection site pain....what followed was severe abdominal pain followed by frequent diarrhea & high levels of gas. This started approx 10 hours after my second injection(on Wed 4/14/21)and lasted until midday 4 days (Sunday 4/18/21). I did not run a temperature. After waiting for it to go away (48 hours), I called COVID-19 line and they said to go to BRAT diet. I did that & added Pedialyte to replenish electrolytes & help with the extreme fatigue(over and above my usual MS fatigue). I also treated the extreme gas with gas-x chewable tablets. The diarrhea was like prepping for a colonoscopy, nothing stayed in my system & the stools were very loose & yellow in color.

Received the shot about 1:30. Everything was fine. By evening, the arm was sore and left armpit hurt. Went to bed about 10. Woke up about 1:30/2:00 with left arm hurt a lot. Took Advil and went back to bed. Woke up at 4 am to get ready for work and felt awful. Noticed was out of breath on short horizontal walk from bedroom to bathroom, chest tight, acting like an asthma attack. Took a puff of albuterol inhaler and went back to sleep. Got up just before 7, still sore to breath. Grabbed oximeter (being asthmatic, I have one) and noticed )s level down to 94/95 when normally it reads 98/99 on this one. Called allergist to cancel allergy shot scheduled for that morning. Took another puff of albuterol. (Waiting to see if need nebulizer.) Breathing becoming easier and reading now about 97/98 with pulse lower, more normal. Lungs a bit touchy this time of year anyway. And I have had allergic reactions in the past take place as an asthma attack. (For instance, if I eat a small quantity of something with yellow dye 5 in it, I will notice that my breathing is more difficult.)

My shoulder joint began to hurt about four hours after my vaccination. I couldn't raise my left arm. My shoulder felt stiff and like it was out of joint. It was extremely painful to move it and I couldn't raise my left arm, I thought maybe the injection had been given too high on my arm and caused SIRVA

The following morning,, back pain/sciatica began after waking. As the day went on, it got worse. Night-time ... difficult to sleep. Next morning (today) very painful ... difficult to stand (at times) and sit. All similar to my back condition in December that I thought was under control. Taking over the counter medications haven't helped yet. Alternating heat / ice / bacx-brace.

her MS started to flare; I have a lot of numbness and tingling in my left side; it's still a little tingling; I have a lot of numbness and tingling in my left side; it's still a little tingling; I had 3 days of sheer misery I couldn't use my left side as I am left handed; it made it kind of difficult; I couldn't hold anything in it, if I wanted to put my hand back; I could not even grab my head up to put it off; I have been not feeling that good; shot I went to home I had gastro intestinal problems; This is 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 in arm left (reported as "Left shoulder") on 31Mar2021, at the age of 60-year-old (Batch/Lot number was not reported, it was reported that "it says Pfizer and then 8733") as single dose for covid-19 immunisation. Medical history included multiple sclerosis (MS) and she had the GA (gallbladder atony) thing it was awful she mean anything she ate or drank, right to the toilet. Concomitant medications included ibuprofen (ADVIL) taken for an unspecified indication, start and stop date were not reported and Vitamins. Consumer stated, she had the COVID-19 shot last Wednesday 31Mar2021 and she have MS so what it happens was she have got the shot she went to home she had gastro intestinal problems she had she could not get off the toilet for a while and then her MS started to flare, So she have a lot of numbness and tingling in her left side and it's still a little tingling but she had 3 days of sheer misery. She couldn't use her left side as she was left handed so it made it kind of difficult and she live alone. The reporter wanted to know that it was as potential side effects, she was just glad they didn't go full blown affect because they are miserable. When paraphrased the above concern, Consumer stated, No she was starting to get a lot better because she would be really going to say it if it didn't come, because she was not going to stand it but 3 days she couldn't use it at all, she mean she couldn't hold anything in it, if she wanted to put her hand back and probably feel she could not because she was not she could not hold anything she could not even grab her head up to put it off, as she said she had the GA thing it was awful she mean anything she ate or drank, right to the toilet. Consumer stated, No she haven't talked to anybody like any she have been not feeling that good, the first thing she had blown up in because when she had MS it starts to flare she don't she actually want to do is laid down and sleep. For treatment, consumer stated, no treatment, she stayed home, she just rested that's it, it's like her left side is affected her left leg was affected and her arm is affected all the left side is numb and tingly, so she don't like to do anything she don't like to walk anywhere, it's not good. Consumer stated, she just wanted to let us know in case anyone called us with and MS. Date for second shot of COVID-19 Vaccine is "21Apr2021." The outcome of the event "tingling" was recovering; of the other events was unknown. Information about lot/batch number has been requested.

Patient received her second Pfizer COVID vaccine yesterday. She reports today she has a sore arm (no redness, warmth or swelling), a headache, feels tired, and has some muscles and joint aches. She is using Tylenol (advised to not exceed 3000mg in 24 hours), gatorade, water, rest, and ice. She questioned how long these symptoms will last and was advised that generally they lessen within the first 24-36 hours. She was advised to call if she did not start to feel better within that time frame.

RhA flare to hands and knees, mid back felt like hives without redness. Took Tylenol PM and worked in side prone position for a few hours, then took normal Night time pills and another Tylenol PM around 8PM. Woke up feeling great!

3-12-21 5 minutes after eyes began to feel warm/hot latsted about a minute 3-13-21 Early afternoon neck and shoulders began to ache followed sharp pains to my right eye and right foot 3-14-21 Morning began to feel a tingling sensation throughout whole body.. Pins and needles. 3-17-21 Went to primary physician. No knowledge of this side effect left with no real information and or treatment. 4-22-21 Symptoms have subsided, but still very present and activates upon anxiousness do to condition of sensations.

The day following the vaccination, I had a fever, intense chills, and a mild headache. I have had an upset stomach since the second vaccination, with intermittent stomach pain. Last night (04/22/2021, starting around 7:30 PM), I had intense lower abdominal pain, loose stool, vomiting, and an intense chill. The symptoms came on suddenly (over the period of a half hour). After vomiting, I was seized by sudden, intense, lower-back pain immediately followed by full-body tremors. The tremors started with my legs, then went to my hands and finally my arms. I have never had a problem with tremors or seizures before. The back pain and tremors fully subsided after 10 minutes. I did not visit a doctor, since it is doubtful that they would definitively blame the Covid vaccine, and I would be stuck with a large hospital bill. However, the symptoms were too peculiar to be attributed to a random illness. I do believe they are a side effect from the second vaccine dose. This morning I feel tired and am a pound lighter, but I am quickly recovering.

Injection site pain, extreme tiredness, ?hangover? headache/awful headache, joint pain, 101 degree fever, feeling unwell, no appetite (but not nauseous) X 1-1/2 days Sore arm/difficulty raising arm X several days; tolerable

Severe dizziness, rare front or left headache with pain, pain in both eyes and left eyelid tremor, diarrhea, muscle and joint pain, stiff fingers, feet and leg muscles, rash all over the body, fatigued and shortness of breath, tiredness.

On 3/15/2021 my neck and scalp began to itch/hurt. . On 3/18/2021 my scalp broke out in rash consisting of blisters that wept and formed crusts. On 3/19/2021 I was diagnosed with shingles and started on an anti-viral medication and gabapentin.

Four days after I felt a sore area on my shoulder. Next morning I had a rash on my shoulder and down my arm. The worst areas were my shoulder and inside elbow. It was like a burn. Felt and looked like a motorcycle muffler burn I once had. I waited it out and it began to hurt less and itch. After 6 days it is only a pink area where it was broke out.

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.

Fever, chills, muscle aches, malaise, site pain extending down arm and into shoulder, headache, nausea. Adverse events lasted 2 days. Treated with tylenol.

Exactly ONE WEEK after I had the 2nd dose of Pfizer, both my arms began to tingle and hurt by 2 pm on a Monday. Within a few hours, this spread to my entire body; every joint and muscle was in severe pain and discomfort. I went to bed around 5 pm and had the chills, but no fever. I continued with this pain for Monday night and could barely sleep. It continued but not as severe on Tuesday and Wednesday. By Thursday, I forced myself to take a shower. By Thursday, the pain in the upper body was gone, but I still had severe pain in both lower legs from the knees down. It was unbearable if I stood for more than 20 seconds, however, if I lifted each leg and then alternated legs, the pain would go away. This felt like enormous pressure in my legs and at one point, I thought maybe I had blood clots, but my legs were not red or swollen. The lower leg pressure finally went away on its own by Sunday, April 25th, 2021. At no point did I have a fever and I could get some relief by taking Ibuprofen, but not a lot of relief.

Within an hour, dizziness. That night, fatigue, pain in arm, bad,bad headache, neck ache. Fever around 100 degrees. Morning after, bad headache, fever over 100 but less than 101. Within 24 hours, headache, shoulder, back, neck ache. Fever with Tylenol 101.6. Sore throat. Possible swollen glands. Waiting to see if better at 48 hrs.

Beginning a few days after my first injection, I began feeling joint and muscle pain in my lower body only: hips, glutes, quads, calves, inner thighs, pelvis (not knees). Sore as though I had undergone a heavy exercise workout the day before. This continues today, though seems to be easing somewhat (I am 4 weeks post second vaccination). It has not inhibited my energy level or mobility. Taking an Advil/Aleve relieves the symptoms. This may NOT be related to the vaccine at all; however, I do have degeneration in my hips, and it seems as though the vaccine has targeted inflamed areas in my body.

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

On 4/18/2021 ~0800, pt's husband reported that pt described feeling like "felt like bones are broken". Today (4/19/2021), pt's husband reports that this morning pt was sweating to the point where she was dripping wet and her temp was slightly elevated Temp 99.6, and feeling fatigue. Pt's husband reported that pt took 2 tablets of 500 mg Tylenol ~1430 today (4/19/2021). Recommend that pt keep hydrated and rest. Counseled on the importance of making sure pt does not take more than 4,000 mg of Tylenol per day to avoid liver injury. 4/20-Completed up call on 4/20/2021 at 11:47am: Pt reports she feels much better today, only have a little achiness and fatigue. Recommend to take Tylenol PRN and to stay hydrated

Have had had pretty constant headaches and neck ache. it has been a week today and still happening. Our Medical Director where I work (Rose Research Center) suggested I report it.

Had prior pain from shoulder blade up to neck and ear. Lasted 3-4 days. Had been increasingly Itchy. On 4/23/2021, rash on shoulder neck. Went to dr rash not there. Treated for shingles. Rash reappeared later that evening. Husband received vaccine same date/time. Being Treated for shingles. He reported his event

Both times like mini version of covid which I had a year ago. Now right side of my neck hurts and still inflamed. Feeling extremely fatigued. Headaches. Exhaustion; Both times like mini version of covid which I had a year ago. Now right side of my neck hurts and still inflamed. Feeling extremely fatigued. Headaches. Exhaustion; Both times like mini version of covid which I had a year ago. Now right side of my neck hurts and still inflamed. Feeling extremely fatigued. Headaches. Exhaustion; Both times like mini version of covid which I had a year ago. Now right side of my neck hurts and still inflamed. Feeling extremely fatigued. Headaches. Exhaustion; Both times like mini version of covid which I had a year ago. Now right side of my neck hurts and still inflamed. Feeling extremely fatigued. Headaches. Exhaustion; Both times like mini version of covid which I had a year ago. Now right side of my neck hurts and still inflamed. Feeling extremely fatigued. Headaches. Exhaustion; Exhaustion; This is a spontaneous report from a contactable other hcp (patient). A 60-years-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 20Jan2021 (Batch/Lot Number: EL9262) as SINGLE DOSE in left arm, dose 2 via an unspecified route of administration, administered in Arm Right on 15Feb2021 09:45 (Batch/Lot Number: EN6201) as SINGLE DOSE for covid-19 immunization. Medical history included arthritis, joint stiffness, back pain, arthralgia and unknown date, Allergic to insect stings. Concomitant medication included acetylsalicylic acid (ASPIRIN); paracetamol (TYLENOL). The patient previously took Augmentin and experienced drug allergy. On 16Feb2021 the patient experienced both times like mini version of covid which patient had a year ago. now right side of my neck hurts and still inflamed, feeling extremely fatigued, headaches, exhaustion (suspected covid-19) The outcome of both times like mini version of covid which I had a year ago, now right side of my neck hurts and still inflamed, feeling extremely fatigued. Headaches, exhaustion was not recovered.; Sender's Comments: The contributory role of the suspect BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 20Jan2021 (Batch/Lot Number: EL9262) to reported events is probable.

Diffuse muscle pain and fatigue over a 4 week period which led to an ER visit on 4/21/21. Final diagnosis was nontraumatic rhabdomyolysis and patient needed to be treated with IV fluids

1/11/2021: Within 40 minutes of receiving 2nd dose Pfizer vaccine, began having tingling bilateral arms proximal & distal. Following day, developed a temperature to 102F which remained x4 days. Since this time, has had continued tingling of the arms & low grade temperature (99F) & has begun having weakness of her upper extremities only with hypersensitivity to heat, as well as touch, but interestingly having decreased sensation to touch of her fingers, feeling as though she wears gloves, with no weakness anywhere else on her body. She has also beginning to develop a sense of decrease cognition. She has been seen by Neurology who felt this was a neurologic hypersensitivity reaction. Initially when she began having complaints following injections/day 1, she was given Benadryl with no improvement beyond causing her to sleep. Since this time she has also been placed on prednisone with no interval improvement. Relates no cutaneous lesions beyond mottling of her arms/no frank urticaria dermatitis etc., and has had no GI complaints or cardiovascular sequela. 4/19/21: This 60 y.o., female is referred by MD for evaluation of bilateral hand pain, weakness and numbness starting shortly after the 2nd dose of her COVID vaccine (5 her). The patient has generally been in excellent health. On Monday, January 11th at 9:20 a.m. she received the 2nd dose of COVID vaccine (Pfizer), in the left deltoid. She had no immediate reaction but while driving about 45 min later developed numbness and tingling bilaterally in her face, lips, tongue and hands. She awakened at about 3:00 a.m. with fever of 102, no abnormal sensations in her face but pain, redness and sensitivity in both hands. Systemic symptoms resolved in several days. Hand symptoms have continued to date. Pain can range as high as 8/10. She has marked sensitivity such that if she or someone else touches her hands it is extremely painful. She sleeps with opera gloves to protect them. She has not had neck pain but has developed grip weakness and has to use 2 hands to hold a cup of coffee. She has never had adverse reactions to vaccines in the past. She has had no immunologic disorders. She initially saw Dr. who tried a short course of steroids without benefit. She took gabapentin 200 mg followed by 100 and slept for hours without a change in the pain. NSAIDs have been ineffective. No other medications have been tried. She has had nothing to suggest a symptomatic COVID infection. 4/23/21: The patient continues to have bilateral hand sensitivity and temperature lability. The EMG showed diffusely slow sensory conductions, consistent with the non correctable low temperature of her hands. Motor conductions were notable for slowing in the right median motor with drop in amplitude proximally but with waveforms that did not suggest conduction block. All motor terminal latencies and F response latencies were normal. Overall the study is probably normal within technical limitations but if necessary should be repeated in about a month with her hands warmer. The nortriptyline was just approved yesterday and the blood tests 2 days ago. She will start the nortriptyline over the weekend and let me know if it is tolerable or effective. She will get the blood work done early next week and I will review the results with her. HISTORY: This patient with bilateral hand dysesthesias and temperature lability following COVID vaccination comes in for neurophysiologic testing. Notably the nortriptyline was just approved and she has not yet started taking it. Similar the blood test were just approved 2 days ago and she will have them drawn next week. Her symptoms have not changed since he was here last.

pt said her arm hurt immediately after taking the vax and she experienced strange pains in random spots. She got home and was very dizzy. She was stiff and achy. Today she woke up feeling wiped out, very fatigued. She has a slight fever, chills and pains. She has taken 2 Bayer aspirin.

terrible pain that would surge from low level to unbearable over 5 days (headache, eye pain, neck and shoulders, lower back, throat), sensitivity to light, dizziness, ringing in hears

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.

real tired; legs felt heavy and aching; legs felt heavy and aching; I have a MTHFR mutation; This is a spontaneous report from a contactable other health professional (patient). A 60-year-old female patient (not pregnant) 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 an unspecified date (at the age of 60-year-old, not pregnant), at single dose, for COVID-19 immunization; and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6198 and expiration date not provided), via an unspecified route of administration, in right arm, in Mar2021 15:45 (at the age of 60-year-old, not pregnant), at single dose, for COVID-19 immunization. Medical history included MDD (major depressive disorder), allergies to IV contrast dye. No other vaccine in four weeks. No COVID prior vaccination. Concomitant medication included sertraline. The patient previously took oxycodone hydrochloride;oxycodone terephthalate;paracetamol (PERCOCET) and ketorolac tromethamine (TORADOL), both had allergies. The patient stated the first dose made her real tired, and after 2 weeks her legs felt heavy and aching (but no redness or swelling). Patient had a MTHFR mutation (Methylenetetrahydrofolate reductase gene mutation) so she was scared about clots. After the 2nd shot on 04Apr2021 patient feel better. Patient thought COVID is in our bodies already and the shot just stimulates antibodies which somehow create the clotting. No treatment received for events. No COVID tested post vaccination. The outcome of the events was recovered. Information on the lot/batch number has been requested.

DVT blood clot; ankle was still swollen and uncomfortable; ankle was still swollen and uncomfortable/discomfort; nights were the worst for the pain; pulse ox was low; d-dimer was very high; fainted; Fracture of ankle/two fractures on her ankle; severely nauseous; Vomiting; Diarrhea; deathly sick; This is a spontaneous report from a contactable consumer, reporting for herself. A 60-year-old female patient received the first dose of the bnt162b2 (BNT162B2; Lot Number: ER8727), via an unspecified route of administration in the left arm on 26Mar2021 at 14:00 at a single dose for covid-19 immunisation. Medical history included osteoporosis at least 10 years, terrible nausea, mild case of covid from Nov2020 to an unknown date. There were no concomitant medications. The patient previously took alendronate from 2008 to an unknown date and experienced very sick, nausea, diarrhoea and zoledronic acid (RECLAST) from Dec2017 and experienced nausea and vomiting. On 27Mar2021 at 2:00, the patient experienced deathly sick, fainted, fracture of ankle/two fractures on her ankle, severely nauseous, vomiting, and diarrhea. On an unknown date, the patient experienced dvt blood clot, ankle was still swollen and uncomfortable/discomfort, the nights are the worst for the pain, pulse ox was low, and d-dimer was very high. The event, deathly sick, was life-threatening. The clinical course was as follows: the patient had the first dose of the vaccine on 26Mar2021 at 14:00 in the afternoon in her left arm. Twelve hours after the first dose, later in the night about 02:00 AM she woke up deathly sick; and severely nauseous. She remembered she was going to the bathroom then she must have fainted because they were taking her to the hospital. She went to the ER and they found she had a fractured ankle. She was not admitted to the hospital. She was in the ER from about 03:00 AM to noon the next day. There must have been something in there; she knew there must be something in the vaccine because of her reaction. Adds a few years ago, something like this happened before. She had osteoporosis and had similar reactions with other products she had tried for osteoporosis; she had terrible nausea. The other products she tried included: in 2008 she took alendronate, it made her very sick but not as severe as this time, she never fainted. She had nausea and diarrhea. Then in Dec2017 she had zoledronic acid. She went for an infusion at the hospital then went shopping, and was fine until the early morning, when she woke up with nausea and vomiting. In the ambulance, they gave her ondasetron (ZOFRAN) for the nausea so the vomiting stopped. With regard to her ankle, first they thought it was a DVT blood clot. They did the xray and saw actually two fractures on her ankle but she does not need surgery. She saw the orthopedic doctor the other day and he said her ankle was healing but she still will have no weight bearing for 6 weeks and she was in a boot. Adds her ankle was still swollen and uncomfortable. She hated to take medications and they gave her oxy but she didn't want to take it. She was taking ibuprofen but that messed up her stomach. The nights are the worst for the pain and discomfort. Doctor at the hospital and primary care agreed she should not have the second dose. She did have mild case of COVID in Nov2020 and they are hoping she had antibodies from the infection and the first dose. Her primary care doctor was reviewing the blood work she had done at the hospital and told her they were surprised the hospital didn't admit her for observation because her pulse ox was low and there was another test that she was questioning because the d-dimer was very high. They did a chest x ray with unknown results. The doctor was questioning why they didn't do something else to rule out a blood clot. Therapeutic measures were taken as a result of the events, deathly sick, DVT blood clot, fainted, fracture of ankle/two fractures on her ankle, severely nauseous, vomiting, diarrhea, ankle was still swollen and uncomfortable/discomfort, nights were the worst for the pain, pulse ox was low, and d-dimer was very high. The clinical outcome of the events, deathly sick, fainted, severely nauseous, vomiting, diarrhea, was recovered on 27Mar2021. The clinical outcome of the events, DVT blood clot and nights were the worst for the pain, pulse ox was low, and d-dimer was very high, was unknown. The clinical outcome of the event, fracture of ankle/two fractures on her ankle, was recovering. The clinical outcome of the event, ankle was still swollen and uncomfortable/discomfort, was not recovered. No follow-up attempts are needed. No further information is expected.

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.

First symtom occurred after shot while driving home: I can only explain it as as 'rush' in my head; some kind of dizziness I've never had. 1:30 am on 2/28/21: Chills and fatigue. The next day and since then I have had: extreme fatigue, malice, headache, extreme joint pain, dizziness. I still have it today on 5/2/21. I cannot search for a job, I feel debilitated.

Pfizer-BioNTech COVID-19 Vaccine EUA: patient with seizure disorder reports seizure one day following vaccination. No loss of conscioussness or speech. Seizure reported as arm weakness, incontinenece, and vomiting. Afterwards rested all day and able to eat and drink. Patient also reports fatigue, myalgias, arthralgias, and nausea. Symptoms improving and no additional seizures documented.

Intense increase in volume of ringing in my ears sometime around my second dose. I have had mild tinnitis for >5 years, but sudden increase in volume (and absolute volume) of ringing was noticeable. Whereas previously I had to concentrate or focus to hear it, it is now loud and intrusive-- much harder to ignore, much more disruptive to sleep, thought, etc.

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

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

sickness to her stomach; fibromyalgia flared up; heaviness in the muscle of her arm; vomiting; 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: EN6206), via an unspecified route of administration in left arm on 08Mar2021 at single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis, fibromyalgia, diabetes diagnosed almost 10 years before, obese, knee replacements 10 years before on both knees, and Sjogren's disease. Concomitant medications included loratadine from 13Mar2021, hydrochloorthiazide for Sjogren's disease from little over a year before, fluoxetine, cetirizine hydrochloride (ZYRTEC) for years like 20 years for asthma, and montelukast sodium (SINGULAIR) for years for asthma. Patient previously received varicella zoster vaccine (shingles shot) 2 years before. The patient experienced sickness to her stomach, fibromyalgia flared up, heaviness in the muscle of her arm and vomiting within 24 hours after the vaccination. After the 1st dose she was really sick and it affected her fibromyalgia and rheumatoid arthritis and she was just a mess and ended up vomiting and this took about three days which was normal. Patient was on a lot of medicines that counter act anything the Pfizer COVID Vaccine could do to her regarding side effects and thought the vaccine was too much for her body. Patient took several different asthma medicines and made the reported event not as severe. Outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.

PT STATES SHE HAS 'TINGLING TO BOTH FEET AND RT HAND. ALSO HAS WEAKNESS TO BOTH LEGS FROM VACCINE. HAS SEEN A NEUROLOGIST AND HAD MRI X3 - NEGATIVE.

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.

Muscle fatigue, joint pain, extreme fatigue, whole body in pain and fatigued 24/7 now a month later and is worse than ever. No treatments yet

started scratching and now the holes are open on areas to her chest; stated that the left side of her face is hard as a rock; Has rash on left side of face down to chest with blistery spots; could not breathe/cannot catch her breath every now and then; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 60-year-old, dose 1 via an unspecified route of administration, administered in right arm on 17Apr2021 (Lot Number: EW0171) as single dose for COVID-19 immunisation. Medical history included high blood pressure; and bad feet since 2004. The patient's concomitant medications were not reported. The patient had first vaccine on 17Apr2021. On 18Apr2021, she had a reaction, could not breathe. She cannot catch her breath every now and then and had to use the Epipen. Has been using nebulizer. Has more Epipens in case something else happened. Stated that she has a rash on the left side of her face down to her chest with blistery spots and that the left side of face was hard as a rock on 19Apr2021. Stated that the rash was worst on her chest. Has put some cream on the rash but it burns. Had a pain cream called Volten that she put on it because the rash was painful but that made it worst. Stated that she started scratching and now the holes are open on areas to her chest on 21Apr2021. Stated that she had to wear low shirts because her shirts were rubbing her chest. Stated that she was told by her doctor not to take the second shot that was scheduled for 17May2021. Stated that she has scheduled doctor's appointments that were fine. The patient wanted to know if she could get something in writing to submit with her passport stating the she could not have the second shot. The outcome of the event could not breathe/cannot catch her breath every now and then was recovered with sequel, and for the rest of the events was not recovered.

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.

Entire body ached in muscles; Did not feel well at all; This is a spontaneous report from a contactable consumer (patient). A 60-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9267, expiration date not reported), via an unspecified route of administration in left arm on 23Feb2021 at 13:30 (age at the time of vaccination 60-year-old) as a single dose for COVID-19 immunization. COVID-19 vaccine was administered in hospital. Patient had a medical history of bronchitis and Raynaud. The patient received thyroid medications within 2 weeks of vaccination. Patient did not receive other vaccine in four weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior vaccination. The patient did not undergo COVID-19 test post vaccination. The patient had no known allergies to medications, food other products to his knowledge. On 23Feb2021 (the same day of vaccination) at 20:00, the patients entire body ached in muscles and did not felt well. Reportedly, for three full days my entire body ached in my muscles. Did not feel well at all. The patient did not receive any treatment for the events. The case was assessed as non-serious as per reporter with no seriousness criteria like results in death/life threatening/cause/prolonged hospitalization/Disabling/Incapacitating/Congenital anomaly/birth defect. The outcome of the events was recovering.

Adverse Event - Shoulder Pain since date of the vaccination, hurts all of the time, shoulder so sore, can't sleep on right side. No treatment - Taking Advil for pain (doesn't really help). Will talk with MD at next MD appt. June 1, 2021 Outcome - Right shoulder pain continues

Immediate feeling of pain that shot down arm of left arm ("tendonitis-feeling") after receiving vaccine. Developed odd lower back and abdominal cramping 4 days later accompanied with loss of appetite. Provider thinks possible colitis but unsure.

pain in her right arm; there is pain in her right breast and under arm.; there is pain in her right breast breast and under arm; there is pain in her right breast breast and under arm; This is a spontaneous report from a contactable consumer. This consumer (patient's husband) reported for 60-year-old female patient (reporter wife) that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection) On 07Apr2021 administered at right arm as a single dose for COVID-19 immunization. The past medical history and concomitant medication was not reported. On 07Apr2021, patient had experienced pain in her right arm where she received the vaccine. Patient reported that she could hardly lift up the arm because of the pain, there is pain in her right breast breast and under arm. The patients second dose was due today 29Apr2021 but she did not want to get it because of the pain. Patient is going to see an MD tomorrow for treatment. The clinical outcome for the events were unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

light headed/dizzy; shortness of breath; chest pain; headache; her arm bothered her for couple of days; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 60-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 22Apr2021 (Lot Number: EW0172, Expiry date: Unknown) as single dose for COVID-19 immunisation. Medical history included stroke from an unknown date and unknown if ongoing, Cancer; Variant Cancer with Vitamin D from an unknown date and unknown if ongoing, thoracic aortic aneurysm from an unknown date and unknown if ongoing, heart Surgery from an unknown date and unknown if ongoing, seizures from an unknown date and unknown if ongoing, anaemia from an unknown date and unknown if ongoing, problem with my stomach from an unknown date and unknown if ongoing, lost my gall bladder from an unknown date and unknown if ongoing, reflux from an unknown date and unknown if ongoing, thyroid cancer from an unknown date and unknown if ongoing. The patient previously took cipro 1a pharma and experienced hypersensitivity before, it stopped her heart, demerol and experienced hypersensitivity, it made her throat close up and Pneumonia vaccine in the past, made her swell up all over her body. Patient had Gastric Bypass before heart surgery. Patient can only take Acetaminophen. Patient cannot take anything with Naproxen in it. So, patient do not know if that matters with this vaccine or not. So, just thought and will let you know. Patient cannot take pain killers because patient raise her grandson. Concomitant medication(s) included topiramate (TOPAMAX) 100 mg taken for seizure, start and stop date were not reported; atenolol (ATENOLOL) 100 mg taken for an unspecified indication, start and stop date were not reported; calcium carbonate, colecalciferol (CALCIUM WITH VITAMIN D 3) taken for osteopenia, start and stop date were not reported; cyanocobalamin (B-12) taken for anaemia every 2 months, start and stop date were not reported; benzethonium chloride, ethanol (PENTAL COL) 20 mg 3 times a day for Problem with my stomach, start and stop date were not reported; pepsin (PEPSIN) 20 mg taken for an unspecified indication, start and stop date were not reported; fluorometholone (FLUROMET) do take 1 or 2 Over the Counter pills. I take Fluromet if that is needed when I have migraine, that's not everyday and 2 more over the counter taken for migraine, start and stop date were not reported; diphenhydramine hydrochloride, paracetamol (LEGATRIN PM) taken for restless legs, start and stop date were not reported; rivaroxaban (XARELTO) for Antithrombin 3 blood clotting disorder, start and stop date were not reported; pamabrom, paracetamol (BACKAID) taken for an unspecified indication, start and stop date were not reported; levothyroxine sodium (SYNTHROID) taken for thyroid disorder, start and stop date were not reported; hctz (HCTZ) 12.5 mg taken for heart, start and stop date were not reported; ascorbic acid, betacarotene, biotin, calcium, chlorine, chromium, copper, cyanocobalamin, dl-alpha tocopheryl acetate, folic acid, iodine, magnesium, manganese, molybdenum, nickel, nicotinamide, pantothenic acid, phosphorus, phytomenadione, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, silicon, thiamine, vanadium, vitamin d nos, xantofyl, zinc (CENTRUM SILVER +50) taken for an unspecified indication, start and stop date were not reported; duloxetine hydrochloride (CYMBALTA) 60 mg twice a day taken for an unspecified indication, start and stop date were not reported. On an unspecified date, the patient experienced lightheaded/dizzy, shortness of breath, chest pain, headache and her arm bothered her for couple of days. She states the paramedics made her stay for about 30 minutes to monitor her. Consumer stated, she was going to check with her Cardiologist and if he says that's okay patient was going to take the other shot. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.

24 hours after second shot I had a sever migraine, nausea, pain in joints/bones, and fatigue. My lungs also had a minimal amount of pressure/discomfort

Severe joint pain, mild nausea, lethargy, and Headache for 5 days. The headache still mildly persists and I have no history of headaches.

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.

This is a spontaneous report from a contactable consumer (patient). This 60-year-old female (no pregnant) patient received 2nd dose of BNT162B2 on 14Apr2021 03:45 PM on Left arm at single dose for covid-19 immunization. Medical history was Myasthenia Gravis. Past drug was allergies to Z pack. Historical Vaccine was 1st dose of BNT162B2 on 24Mar2021 03:45 PM on Left arm for covid-19 immunization. No other vaccine in four weeks. Other Medications in Two week included Olmesartan, Calcium. On the second day of the second dose of Pfizer (15Apr2021), she had the expected side effects, such as chills, muscle pain during the day. But, around 11 p.m. she suddenly started having abdominal pain, then throwing up, cold sweats, shivering, dizziness. She was taken to ER that night. The ER doctor did a CT, lab work but didn't find anything remarkable, so she was sent home. The next day (16Apr2021) she found blood in the toilet when she had bowel movement, so she went to see family doctor. He confirmed it's blood. He then set up an appointment for her to see a specialist the next Monday, since it's Friday afternoon. The bleeding got worse at night (16Apr2021), so she went to that ER again. She was then admitted to the hospital due to the big drop of red blood cell count. Later, the specialist did a colonoscopy on her and the result showed ischemic colitis. She was released from the hospital on 18Apr2021. This is very surprising to her as she had never had GI problems before. Events results in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization (2 days). Outcome of the event was Recovering. No covid prior vaccination. No covid tested post vaccination. Information on the lot/batch number has been requested.

Joint pain lasting 30 days, rash on ALL parts of body starting one week after 2nd dose STILL active, itching, painful. Steroid pack and cream used with no results.

starting 1st day of injection pain at injection site and radiating up to shoulder with swelling around the site area. Nausea . starting days 2 & 3 pains increased up further on left side of the arm to neck (left side only) , switched from taking Ibuprofen 800mg throughout the day after day 3 - 4 body aches and pains in left leg/thigh muscles , switched to Tylenol 1000mg everyday from day 1 rubbing down multiple time daily with rubbing alcohol , nightly alcohol with Epsom bath soaks. pains for about 2 weeks before relief. May 11 no pain just still tiredness . Yesterday and today believe all resolved .

Numbness; Headache; Dizziness; extreme fatigue; muscle aches; she saw white flashes in front of the eyes; She got some bumps that are itchy on the ankle; Bell's palsy; facial paralysis; Lyme disease/had a bunch a symptom and flare up; Lyme disease/had a bunch a symptom and flare up; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 15Apr2021 12:00 (Batch/Lot Number: EW0158) at single dose for COVID-19 immunisation. Medical history included High Blood pressure, Chronic Lyme's Disease, Rocky mountain spotted fever, Psoriasis. She had Bells Palsy with her Lyme's disease 15 years ago. She also added that she was diagnosed about a year with rocky mountain spotted fever. Lyme's disease and rocky mountain spotted fever are both tick born diseases. She also had Bells palsy with the rocky mountain spotted fever. She had mild psoriasis, once a year she got little spots on both arms little patches of skin that were scaly, other then shots been. Concomitant medications included routine blood pressure medication .Patient stated she reported the side effects to the nurse on the other line. she wanted to know if you have information on the vaccine given to individual with Lyme disease. she received the first shot of the Pfizer COVID-19 shot on 15Apr2021. she had a bunch a symptom and flare up. she had facial paralysis which began 24 hours after receiving the vaccine. she worried about getting my second shot. Patient also wanted some clarification on the reported Bell palsy post vaccination. Patient stated that she was calling about the covid vaccine, she had had chronic Lyme disease for a long time and when she got the vaccine it triggered a lot of old symptoms. She was trying to call doctor and health department. She was scheduled for the second dose on this coming Monday 03May2021. She wanted to question if there was research on people with Lyme's diseased. The symptoms she experienced was bells palsy, noticeable numbness in lips to nose to cheeks that occurred about an hour and a half after shot, the bells ballsy was in the center of her face clarifying on both sides of the face. She spoke for a living and her face went numb that didn't make sense. She also still had a headache for 2 weeks every day, she saw white flashes in front of the eyes, some dizziness, extreme fatigue, and muscle aches. She also went to the chiropractor once a week for back pain and it hadn't been helping. The Chiropractor said that a bunch of patients have been complaining since the shot that the chiropractic wasn't working as well. She got some bumps that are itchy on the ankle, no bugs are outside yet, it's a couple itchy bumps, she didn't know if it's related. Patient clarifies that the bumps she had was 1 on ankle and 1 on hip, and 1 below belly button, it started a couple days ago. No follow-up attempts are needed. No further information is expected.

Since having COVID in November 2020 still experiencing shortness of breath and ringing in ears. After the shot , Felt fine first day, next morning woke up nauseous and dizzy, achy in muscles , especially in legs, pain in knees. Worsen shortness of breath with even short distances . Ringing in ears louder and high pitched. Brain fog. Each day the symptoms got worse, more intense. By the 8th day, pain in muscles so bad , had to be helped to walk or use a cane. Breathing was gasp for breath within short distances.Stayed in bed for several days and muscle pain got better. Breathing got better.

Joints are very painful. My shoulders hurt and rec cortisone shot and doing pt. My knees I was hoping it would go away but m y knees are very sore. They started hurting the night after the shot. I could barely walk. That night. They started to get somewhat better with rest and Wishing it would go away but it is not. So I have an apt for my knees now This is crazy. I use to walk everyday for 3-4 miles and I can?t barely make it to a car or down the steps.

With the 1st shot arms got heavy; Couldn't move arms for about 4 min; The next 2 days I felt like an oven door was opened inside me. Very hot inside but outside body was cool; This is a spontaneous report from a contactable 60-year-old female (Nurse). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot no: EL1283) via intramuscular administration, administrated in right arm on 12Jan2021 11:15 AM, as single dose and second dose (Batch/Lot no: EL3302) via other route administrated in right arm on 02Feb2021 12:15 PM as single dose for COVID-19 immunization. The patient medical history included depression Depression, Hypothyroidism, High Cholesterol, Osteopenia, Occasional vertigo. The patient concomitant medications included Simvastatin 40mg, Duloxetine 30-60mg, Raloxifene 60mg, Chlorthalidone 25mg, Levothyroxine 0.88mcg, Calcium 600mg with 500IU Vitamin D, Folic Acid 400mcg, Fish Oil 1400mcg, B12 5000mcg, Vitamin D 2000IU and Tumeric 1000mg. The patient had second dose on 02Feb2021. After the first dose patient experienced patient arms got heavy and then pateint couldn't move them for about 4 min. The next 2 days patient felt like an oven door was opened inside. Very hot inside but outside body was cool, no redness or sweating. patient 2nd shot on arms didn't get heavy, just felt a weakness going from shoulders down to hands. Couldn't move or feel them for 15 min. Slowly patient could move fingers then hands then lift arms. The next day patient brain felt kind of fuzzy. Still a little "off kilter" on 2nd day. Patient did not have any anxiety about either shot, even with what happened with the first one. (patient the one reporting - it says patient from a healthcare professional reporting for a patient and patient couldn't change it). Prior to vaccination, was the patient did not diagnose with COVID-19. Since the vaccination, the patient had been not tested for COVID-19. The outcome of the events was recovering. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021136873 Same patient, same drug, different vaccine date

incredible chest pressure; shortness of breath; anxiety; chest started hurting; pain across her breasts; concentration levels are off; but being that sick makes her so weary.; She goes to the bathroom 12 times a night to urinate; body aches; feet hurt/top of her feet hurt really super bad/legs hurt; pressing under her arm and she had pain really bad there; pain went around her back /whole back started hurting; This is a spontaneous report from a contactable consumer (patient). This 60-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration administered in right arm on 27Apr2021 (Batch/Lot Number: ER8731) as single dose for COVID-19 immunisation. Medical history included ongoing congestive heart failure, diabetes, high cholesterol and high blood pressure. Concomitant medication(s) included aripiprazole (ABILIFY) taken for an unspecified indication, start and stop date were not reported; atorvastatin calcium (ATORVASTATIN CALCIUM) taken for an unspecified indication, start and stop date were not reported, noted as on of the 2 new heart medication; and another unspecified heart medication. No other vaccine within 4 weeks. The patient received the first dose of the COVID-19 vaccine on 27Apr2021, then 2 days later on 29Apr2021 she developed side effects of body aches and couldn't get comfortable sitting, laying down, or standing, and her feet hurt, the top of her feet hurt really super bad and her legs hurt. She stated she was feeling "fair to partly cloudy" and "this is just beyond anything". She stated she literally didn't want to exist anymore the pain was that horrible, that when she was experiencing adverse effects she couldn't get comfortable in any way, nowhere to go, nothing to do, no warm bath, no hot warm or cool compresses, it was just her whole body. She said there was nothing that would help and she just didn't know if she could do that again. She only had relief through paracetamol (TYLENOL) and she took so much that she felt her liver was in jeopardy. She stated it was a really bad experience. The patient was also having incredible chest pressure and shortness of breath, onset date unspecified. She had a diagnosis of heart failure/a history of congestive heart failure, with the body aches she was having, she thought she was going into heart failure. She did call an ambulance twice (maybe 29Apr2021 then 01May2021; she didn't remember exactly which days) and the emergency medical technicians (EMT) took an EKG each time. The first time she called the ambulance the EMT's offered to take her to the hospital. Her EKG did look abnormal but it could have been attributed to her history of heart related issues or anxiety. The second time her chest started hurting it was hard to distinguish between pain and pressure. There was definitely pressure. There was also pain across her breasts (onset date unspecified) and underneath her arm (on 29Apr2021; initially she was pressing under her arm and she had pain really bad there), she was questioning her lymph nodes. Then the pain went around her back and then her whole back started hurting and her whole body was hurting, onset date 29Apr2021. She had never experienced anything like this before, as stated. She also reported that her concentration levels were off (onset date unspecified). She couldn't listen to music or do anything like that. She spoke with her doctor but being that sick made her so weary (onset date unspecified). The patient reported she didn't know if her symptoms were because of the COVID-19 vaccine or because of her new heart medication, but she said it's stupid to think her symptoms could be caused from her new pills. Her doctor wanted blood work on 27Apr2021 primarily because of all the medical diseases she had. She's guessing maybe blood work would give her an indication of why the vaccine made her feel the way it did. She went on 05May2021 to get bloodwork. She went to the bathroom 12 times a night to urinate (onset date unspecified) and she asked her doctor to put her on Lasix so she could just get the urine out. The doctor told her that her heart and her lungs sound good. The patient asked if she should still get the second dose of the vaccine as she was worried that the symptoms could be worse after the second dose. She was supposed to return for her second COVID-19 vaccine on 14May2021, but she was not going (though she knew she needed to get the second dose), she did not want to get it. The events body aches, feet hurting/legs hurting, pain underneath her arm, back pain, were ongoing but lessened in severity. As of the time of reporting, she had started to feel better, these events (body aches, feet hurting/legs hurting, pain underneath her arm, back pain) were resolving. The outcome of the other events was unknown.

I began experiencing severe muscle pain and stiffness near the injection site beginning 8 days after vaccination. Pain is in my shoulder and bicep and radiates all the way down my arm and up to my neck. I experienced moderate muscle pain for about 24 hours beginning about 8 hours after vaccination with both doses (first on was April 24), but that resolved both times and did not return after the first vaccination. When I was receiving the injection on May 12 I felt a sharp pain deep that radiated to my back as the injection was given. I did not have that experience with the vaccination on April 24.

Nausea; High fever 101; Mussel aches; 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: EN6200], as first dose via an unspecified route of administration, in left arm on 14Mar2021 at 01:00 AM (at the age of 60-years-old) as single dose for COVID-19 immunization. The patient's medical history included diabetic, ulcerative colitis and non alcoholic steatohepatitis (NASH) also the patient was allergic to Morifine. The patient was diagnosed with COVID-19 prior to vaccination. The patient received prescribed medicines (unspecified) within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 15Mar2021, the patient experienced high fever 101, muscle aches (reported as mussel aches) and nausea. The patient did not receive any treatment for the reported events. The clinical outcome of the events high fever 101, muscle aches and nausea were resolved with sequelae. No follow-up attempts are needed. No further information is expected.

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.

bulging veins in wrists and hands; experiencing side effects with her veins looking like they are bulging in her legs, feet and ankles at first and they are now spreading to her hands.; Neck pain; Caller states the Vitamin E supplement that she takes can have a blood thinner property so she is not sure if that could have caused her reaction; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 17May2021 (Batch/Lot Number: EW0183; Expiration Date: 31Aug2021) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included hypersensitivity and arthritis. Concomitant medication(s) included D-flame, Vitamin E, daily dose. The patient she has been experiencing side effects last night with her veins looking like they are bulging in her legs, feet and ankles at first and they are now spreading to her hands on 17May2021 22:00 and this morning the veins in her wrists and hands are bulging as well on 18May2021. She takes a daily supplement something like a multivitamin and she would like to know if the ingredients in the supplement could have caused an interaction with the vaccine? She states the Vitamin E supplement that she takes can have a blood thinner property so she is not sure if that could have caused her reaction. Ingredients of the supplement include holy basil 250 mg, turmeric 100 mg, ginger 100 mg, green tea 100 mg, baikal skullcap 50 mg, bromelain extract 100 mg, resveratrol 10 mg, berberine 5 mg and boswellia 100 mg. States the dosages provided are for two capsules and she only take one so it would be half. She said she really had bad neck pain last night on 17May2021. It was severe but went away after dinner. It was last evening, and she noticed it around 10:00pm. Took Tylenol before bed. She had nuclear stress test result unknown on 05May2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of event for bulging veins in wrists and hands was not resolved and for rest of the events it was unknown. Follow up needed, further information has been requested.

aching all over; her arm hurt very bad where she got shot, right arm, "her arm was killing her; shooting from her arm up to her neck; chills; feeling really unwell; heart started beating a little bit fast; shortness of breath; tiredness; headache; muscle pain; joint pain really bad; really weak; Back Pain; Throat Hurting; injection site pain; 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: EP7533), via an unspecified route of administration in the right arm on 12May2021 08:30 (at the age of 60-year-old) as single dose for COVID-19 immunization. Medical history included allergic to dye (last time she had black dye, her head was itching and burning like fire and her head is still red and her hair is falling out by handfuls), back injury ongoing since 2004, and ongoing diabetes mellitus that started 14.5 years ago. The patient was tested negative on the COVID Nasal swab on 08Nov2020. The patient was hospitalized for 7 days for COVID-19 from 07Feb2021 or 08Feb2021 when she had "diarrhea coming out both ends", and when she had come home, she had on/off head spinning for 2 weeks and in a month her head stopped spinning. She waited 90 days before getting the vaccine. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not enrolled in a clinical study or a program. Concomitant medications included naproxen (NAPROSYN E) taken as needed for back pain. On 12May2021, the patient experienced injection site pain. On 13May2021, she started experiencing aching all over for about 8 hours and has been hurting all morning from 08:00, "her arm hurt very bad where she got shot, right arm", "her arm was killing her; shooting from her arm up to her neck", tiredness, couldn't hardly walk legs were hurting started today worse, headache, muscle pain, really bad joint pain, chills, feeling really unwell, really weak, heart started beating a little bit fast and shortness of breath. she has no swollen lymph nodes. She stated her back wasn't hurting yesterday and now today (13May2021) she has back pain so much so that she can't hardly get out of bed. She also stated throat hurting. She reported that the persistent/significant aching all over for about 8 hours & "her arm hurt very bad where she got shot, right arm" were serious due to disability/incapacity. If it keeps up like this, she doesn't know if she will take the second one. She is scheduled for her second one on 02Jun2021. Later, she stated, "I was aching about 8 hours. After that I think I had took a Tylenol" but she can't be sure. The clinical outcome of the event "aching all over" was resolved after 8 hours on 13May2021 around 16:00. The clinical outcomes of the events chills and heart started beating a little bit fast were resolving, the events injection site pain, "her arm hurt very bad where she got shot, right arm", "her arm was killing her; shooting from her arm up to her neck", tiredness, headache, muscle pain, joint pain really bad, really weak, throat hurting were not resolved, while the events feeling really unwell, shortness of breath and back pain were unknown. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.

60 y/o female with past medical history of HTN who presents with leg left numbness post vaccination. Patient states that this is her second vaccine in the two-dose series. Patient states that she had fever, weakness and right arm difficulty moving 8 days post vaccination, lasting 4 days. Patient states that she received the first vaccination to the left arm and experienced the symptom of difficulty moving post vaccination to the right arm. Patient states that she received todays vaccination to the left arm. NP and Paramedics at patient side. Patient was able to stand and sit in wheelchair without difficulty. Patient was able to ambulate from wheelchair to cot without difficulty. Within in 2-3 mins patient states that numbness to left leg improved. NP questioning if numbness was due to the way that patient was sitting post vaccination. Patient able to move all digits of her left foot, normal color and temp of left lower extremity. No swelling visualized. Patient initial vitals with hypertension noted, 170/77 BP R arm, 80 HR, 98% RA, 12 Resp. Patient monitored for blood pressure normalization. Patient BP decreased to 151/79, which is described as normal for patient. Patient able to ambulate without difficulty and states that she feels better and ready to go home. Patient discharged in stable condition with numbness resolved. Patient aware that if symptoms worsen or persist, to seek further medical care.

Very bad muscle aches; Fatigue; headache; Fever of 102; Sweats; Uncontrollable chills; This is a spontaneous report received from a contactable consumer, the patient. A 60-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: Unknown, Dose number: 2) via an unspecified route of administration in the left arm on 10Mar2021 at 10:30 AM (age unknown at the time of vaccination) as a single dose for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient medical history and concomitant medications were not reported. The patient past drug history included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: Unknown, Dose number: 1) via an unspecified route of administration in the left arm on 17Feb2021 10:30 AM as a single dose for COVID-19 immunization. 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. Approximately 10 hours after the second dose on 10Mar2021 patient started having uncontrollable chills and fever of 102. A couple of hours after the chills had subsided, but she started having headache and very bad muscle aches. It continued all night into the morning. Therapeutic measures included Advil for headache and muscle aches. The muscle aches, fatigue and low-grade fever continued for 4 days after the second dose. Patient still continued to struggle with fatigue and started having sweats. The clinical outcome of the events sweating and fatigue was not resolved and for the events muscle ache, headache, fever and chills were resolved on 14Mar2021 (reported as 4 days after second dose). Information about lot/batch number cannot be obtained. No further information is expected.

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.

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

Severe joint and muscle pain and weakness throughout the body, especially in the right leg and right knee.; Severe joint and muscle pain and weakness throughout the body, especially in the right leg and right knee.; Weakness throughout the body, especially in the right leg and right knee. Unable to lift right foot from floor; Unable to sit and stand back up; Unable to sit and stand back up; Severe pain in the neck starting at the base of the skull and lower back; Weakness throughout the body, especially in the right leg and right knee. Unable to lift right foot from floor; dose number=1/administration date=03Feb2021,dose number=2,administration date=17Feb2021; dose number=1/administration date=03Feb2021,dose number=2,administration date=17Feb2021; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL9267), via an unspecified route of administration in left arm on 17Feb2021 at 04:00 PM as 2nd dose, single for COVID-19 immunization. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EN5318), via an unspecified route of administration in left arm on 03Feb2021 at 04:00 PM as 1st dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient had no known allergies. Patient did not receive any other vaccine in four weeks. Patient did not receive any other medications in two weeks. Patient was not pregnant. On 20Feb2021 at 03:00 AM, patient experienced severe joint and muscle pain and weakness throughout the body, especially in the right leg and right knee. Unable to lift right foot from floor. Unable to sit and stand back up. Severe pain in the neck starting at the base of the skull and lower back. Symptoms have been persistent for close to 3 weeks. No treatment was received. The outcome of the events off label use and inappropriate schedule of vaccine administered was unknown and outcome of the other events was not recovered. No follow-up attempts are possible. No further information is expected.

experienced the same excruciating pain in my right knee this time; two Baker's Cysts were visible, one in each leg, only visible on the back of my right knee, but no trace of any blood clots; This is a spontaneous report from a contactable consumer (patient). A 60-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number: unknown) via an unspecified route of administration, administered in left arm on 13Apr2021 at 07:00 (at the age of 60-year-old) as 1st dose single and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number: unknown) via an unspecified route of administration on 04May2021 (at the age of 60-year-old) as 2nd dose, single both for covid-19 immunization. Medical history included undiagnosed arthritis. The patient did not receive any other concomitant medications within 2 weeks of vaccination. The 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. On 13Apr2021 at 20:00, patient started experiencing the events. It was reported that, for twenty days, patient needed help to accomplish anything. On the 21st day, patient went out but the steps were extraordinarily painful in left knee. Her plan was to wait it out until she had the 2nd dose on 04May. Again, six days later, patient experienced the same excruciating pain in right knee this time. Two doses, both knees, unbelievable pain. The patient finally went the ER on Friday, 14May2021. After the first dose, patient suspected a Baker's Cyst. After the second dose, it measured the size of a golf ball cut in half. Trusted her research skills, she confirmed what she already knew, with an MRI scheduled and two ultrasounds done on both knees, two Baker's Cysts were visible, one in each leg, only visible on the back of right knee, but no trace of any blood clots. The patient underwent lab tests and procedures which included MRI: unknown and ultrasounds done on both knees: two baker's cysts were visible, one in each leg: size of a golf ball cut in half on an unspecified date. The adverse event resulted patient to visit the Physician Office Visit and Emergency Room Visit. The patient received treatment for the adverse event. Therapeutic measures were taken as a result of both events and treatment included with 10 mg Prednisone. Since the vaccination, patient has not been tested for COVID-19. The outcome of events was unknown. Follow-up attempts are needed; information about lot/batch number can be obtained.

Fever; Body ache; Headache; Chills; Muscle ache; 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: EN6199), via an unspecified route of administration in the left arm on 16Mar2021 at 09:15 hours (at the age of 60-years-old), as a single dose for COVID-19 vaccination. The patient took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN5318), via an unspecified route of administration in the left arm on 24Feb2021 at 14:00 hours (at the age of 60-years-old), as a single dose for COVID-19 vaccination. Medical history reported as none. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. Concomitant medications included Lipitor (MANUFACTURER UNKNOWN), for an unknown indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 16Mar2021, around 12 hours post injection, the patient experienced headache which progressed to chills and body ache or muscle ache that lasted all day. On 17Mar2021, the following night, the patient experienced fever up to 104F that lasted for few hours. The patient was treated with Tylenol for fever on an unknown date. The clinical outcome of the events chills, body ache, muscle ache headache and fever was reported as resolving. No follow-up attempts are needed. No further information is expected.

I was unresponsive, he could not wake me up; Had pain in my neck on the same site of the shot; Had pain in my neck on the same site of the shot.; Nerve pain; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), first dose via an unspecified route of administration, administered in left deltoid (left arm) on 17May2021 (at the age of 60-year-old, Batch/Lot Number: EW0177) as a single dose for Covid-19 immunization. Medical history included the patient had a child arrhythmia; she believed it was from 1996 but it pretty much controlled and prior to vaccine. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. This report was not related to a study or programme. The patient stated that she had a concern because she took the first COVID vaccine on the 17May2021 and she was due to get the second one on the 07Jun2021 however she had some concern today. The patient stated that she had some changed episode of reactions on 17May2021, she started having pain, after she took the first one, on the same day, she had pain in her neck on the same site of the shot and had some effect of pain, a nerve pain and it had devastated to the back of her neck where she had her thick neck and she had to use warm pack on the back of my neck. It would be about 4'O clock in the morning which would be on the 18May2021 her husband was observing her because he is a nurse and he could not wake her up, he tried everything possible to wake her up and he attempted to perform cardiopulmonary resuscitation (CPR) on her, so she was concerned about putting herself again such an event taken place. The patient went to the emergency room. They took her to the emergency room however she got her name administered in 'first a clinic' and he was able to stabilize her. The patient went to the emergency room and when she got there it was like a concerning so when she got there, she was not seen by the doctor because she was feeling little better but the context person, and they did concern that some of the episode she had, she saw the effect after COVID vaccine, she was concerned because she was due for the second vaccine and this was the first episode which she had, and she was concerned whether not should, she take the second shot, she went on her and she reported. The patient could not get this anyone, all she got was the worst. They took her to late but whatever she never got a chance to speak with anyone in her life, you know she do consult with her doctor has followed her so she was concerned now that she would have a second shot, she did not know if she could really take it. When concern confirmed the patient stated that she did have adverse reactions to the Covid-19 shot. The outcome of the events was recovering. Information on Lot/Batch number was available. Additional information has been requested.

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.

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

aches and pain in the left side of body that went away; aches and pain in the right side of body; pain in right and left side joints,elbow,knee,wrist,shoulder; right arm and forearm pain; its effecting my gripping power; This is a spontaneous report from a non-contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number and expiry date was not reported), dose 1 via an unspecified route of administration on 19May2021 as, single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On unspecified date in May2021, 1week after vaccination the patient experienced aches and pain in the left side of body that went away. From the second week patient experienced right side of body pain in joints at the wrist, shoulder, elbow joints, now it's started in her right knee. She states right side is very different symptoms, it is problematic, but improving, she don't think it's going away anytime soon. Patient stated If her body has not returned to normal, it's also in the forearm, its effecting her gripping power and she was concerned about getting the second shot before this resolves. it's gonna take a while, she hoped to delay the second dose to the 4th week. She stated it was weird because her body was split in two, on left side one week and then the right side started and it was so different, it seems to be all in her right arm until today it started in knee. She felt vaccine was working and her body reacting to the first dose, don't want to make things worse, just curious about the switching side, starting in one side and then going to the other, it was isolated on one side and then switched to the other side. The side it started on was not the side she got the shot. It's like some one drew a line down the middle of the body, and one week was on one side and then the next week the other side. Patient enquired whether will it be effective if she delays second dose to the fourth week". The outcome of the event aches and pain in the left side of body was recovered on unspecified date of May2021. The outcome of the event aches and pain in the right side of body, arthralgia, pain in extremity, grip strength decreased was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

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.

significant aches; pain in her hips after the first dose/ Joint pain; after the first vaccine, she couldn't stand up straight, she was walking like a monkey; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EM9809), via an unspecified route of administration, administered in Arm Left on 24Feb2021 (at the age of 60-year-old) as 1st dose, single dose for COVID-19 immunization. Medical history included covid-19 from 21Dec2020 to 11Jan2021, lower back pain (had lower back problem for years), herniated L2 and L3 from 2015, had sciatica on left, but sciatica was lower back and down leg (never joints and hips). The patient's concomitant medications were none. The patient previously received hep B shots (HEPATITIS B VACCINE) for Immunization (had Hep B shots, all vaccines as a child) and flu shots (INFLUENZA VACCINE) for Immunization (flu shots every year and had the herpes). Patient did not have any history of all previous immunization with the Pfizer vaccine and not received any additional vaccines administered on same date of the Pfizer suspect. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. Patient did not have family medical history relevant to adverse events. On an unknown date in 2021, patient experienced significant aches, pain in her hips after the first dose, after the first vaccine. It was also reported, she couldn't stand up straight and was walking like a monkey. The patient experienced joint pain. Her doctor didn't believe that it gave her joint pain. She got a new doctor and told him about the right side which she never had any problems before. He said, "maybe you are overcompensating". The patient had lower back problem for years. It was good to hear that it can cause joint problems. Her doctors did not believe her. Doctor gave her tramadol which takes the pain away for 1 day but that was it. Further stated, received both doses of the Pfizer covid vaccine. Since receiving the Pfizer covid vaccine, had significant aches and pains in joints. The aches and pains began after the first dose of the covid vaccine. The first dose was not so bad, she felt like maybe it was from the rain. This all started the next day after her first dose, she went to work and it was raining bad, and she told the secretary her hip joints were hurting and she cannot stand up straight but she thought it was the rain and she had turned 60, she thought she would just had joint problems, but she had no problems until the day after the first vaccine, she could not stand up straight, she was walking like a monkey. Everything seemed to be fine, it was easing up. The patient went to Doctor for the first time, he gave her Tramadol, too, and it took away the pain for one day. She had a herniated L2 and L3, she was unsure which was torn. This was diagnosed in 2015, she's been going to Pain management since at least 2017. She never had joint pain in hips ever, especially on the right side, she always had sciatica on left, but sciatica was lower back and down leg, never joints and hips. She had Hep B shots, all vaccines as a child, even had flu shots every year and had the herpes, or whatever one if you had chicken pox as a kid, now you'll get it, she had that as a series, 2 or 3 shots, and had no side effects. The patient used to go to gymnastics when she was little and has two herniated discs and a tear in the back, which was why she goes to pain management. Clarifies she had a herniated L2 and L3, she was unsure which was torn. This was diagnosed in 2015, she was been going to Pain management since at least 2017, but never for hip/joint pain and swelling, like since the COVID vaccine, and also, she had COVID in December and January, maybe she shouldn't have got it, she was hearing the antibodies were good for a year, maybe it was too much on top of her having COVID. She was intelligent and was thinking perhaps she gave herself too much dose, she already had antibodies, the doctors said to get vaccinated even though she had COVID, they did not know how long the antibodies last, they said maybe 3 months, but she got the COVID vaccine within the three-month time, so she was unsure if that was the reason why this happened. There was no investigation assessment and Relevant tests. The patient not visited emergency room and physician office due to the events. Therapeutic measures were taken as a result of significant aches, pain in her hips after the first dose. The outcome of event ache and pain in hip was not recovered while unknown for other.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021642671 Same reporter/ drug,different patient

After 18 hours of 2nd dose. Symptoms: cold, temperature degrees from 37.8 C to 39.9 C. 6/8 around 12:00AM, I had headaches, muscle pain, shortness of breath, cough, muscle pain, weakness, dizzy. Sleeping until 1:00pm on 6/9. The body temperature was down to 37.8C?but still dizzy and no energy at all. I feel better today, and body temperature has down to 37.4, and the shortness of breath is getting better, but not as normal, and had cough sometimes, but not too bad.

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.

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.

After her second COVID-19 Vaccine, she had a really bad flare up of rheumatoid arthritis; This is a spontaneous report received via pharmacy. A contactable consumer (patient herself). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0162/Batch number was not reported), dose 2 via an unspecified route of administration, administered in arm left on 13Apr2021 (at the age of 60-years-old) as 2nd dose, single dose for covid-19 immunisation. Medical history included rheumatoid arthritis from 2003 and ongoing (she also has a pre-existing condition of arthritis). The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0162/Batch number was not reported) dose 1 via an unspecified route of administration, administered in arm left on 23Mar2021 (at the age of 60-years-old) as 1st dose, single dose for covid-19 immunisation and xeljanz xr for rheumatoid arthritis (reported she continued to take her Xeljanz XR 11mg while she took the Prednisone 5mg tablets, providing the Xeljanz XR 11mg). The reporter stared that for after patient second COVID-19 Vaccine, she had a really bad flare up of rheumatoid arthritis. The reporter wanted to know if her rheumatoid arthritis would be a contraindication in getting the booster third dose of the Pfizer BioNTech Covid-19 Vaccine. Warm transfer from Pharmacy, with a patient who takes Xeljanz XR 11mg. 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. Reviewed and clarified the transferring agent's report details with the caller. 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. She said she had to get her second Pfizer BioNTech COVID-19 Vaccine at the University of (withheld) because the store she received her first Pfizer BioNTech COVID-19 Vaccine at said she missed her second vaccine appointment time. Rheumatoid Arthritis Flare Up Treatment: Stated 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). No relevant tests were performed. Therapeutic measures were taken as a result of after her second covid-19 vaccine, she had a really bad flare up of rheumatoid arthritis (rheumatoid arthritis). The reporter stated the event result in Physician Office visit. The outcome of the event was resolving.

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.

The jab was administered directly into my joint approximately 1 inch from the top of my left shoulder which, at the time, I did not realize was the wrong place. That evening I was up all night in a great deal of pain from my shoulder and directly across my should blades. It has now been 2.5 months and I still have limited movement in my left arm and still experience a sharp pain when I move my arm in certain directions. Hoping this will eventually go away. I did not have any trouble with the 2nd jab which I had administered into my right arm and in the correct place approx 3 inches below the top of my shoulder.

her hands started sweating again; After getting her second, some of her symptoms started to dissipate and her inflammation markers are coming down; After getting her second, some of her symptoms started to dissipate and her inflammation markers are coming down; This is spontaneous report from contactable consumer. This contactable consumer (patient's husband) reported for 60-year-old Female (patient) that who received first dose 23-MAR-2021 14:40 BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number ER2613 expiry date was unknown) at arm, second dose on 29Apr2021 (Age at vaccination 60-year-old), at arm left (Lot number: ER8736 and expiry date was unknown) via an unspecified route of administration as a single dose for COVID-19 immunisation. Medical history included covid-19 from an unknown date in Jan2021 to an unknown date got the covid infection in Jan2020 and is a long hauler, hyperhidrosis from an unknown date and unknown if ongoing her hands would sweat, but after having covid they stopped sweating, arthritis from an unknown date and unknown if ongoing has a lot of inflammation of her joints. Concomitant medication(s) included prednisone (PREDNISONE) taken for rheumatoid arthritis from Jan2021 to an unspecified stop date. She was given prednisone 5 mg for the inflammation and was on it when she got her first Pfizer covid vaccine. After getting her second, some of her symptoms started to dissipate and her inflammation markers are coming down and her hands started sweating again. On an unspecified date in 2021 patient experienced after getting her second, some of her symptoms started to dissipate and her inflammation markers are coming down (therapeutic response unexpected), after getting her second, some of her symptoms started to dissipate and on an unknown date in Apr2021 her inflammation markers are coming down and her hands started sweating again. The patient underwent lab tests and procedures which included inflammatory marker test: 2, inflammatory marker test: 8, rheumatoid arthritis: negative. Outcome of the events her hands started sweating again recovering, symptoms started to dissipate, and her inflammation markers are coming down (therapeutic response unexpected), after getting her second, some of her symptoms started to dissipate and on an unknown date in Apr2021 her inflammation markers are coming down was unknown.

Injured shoulder; She has chronic fatigue syndrome (CFS) for many years and has had bad flare ups; Tendinitis in her shoulder/which "hurts quite a bit"; Tendinitis in her shoulder; Wort headaches that "she ever had".; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose of BNT162B2 (Formulation for injection; Batch/Lot number: unknown) via an unspecified route of administration on 07May2021 as single dose for COVID-19 immunisation. Medical history included chronic fatigue syndrome from an unknown date and unknown if ongoing for many years. The patient's concomitant medications were not reported. On an unspecified date of May2021 patient explained chronic fatigue syndrome (CFS) for many years and has had bad flare ups. She added she also has tendinitis in her shoulder, which hurts quite a bit. She mentioned 2.5-3 weeks post vaccination she had her CSF flare up and the worst headaches that she ever had. She added she will be consulting her neurologist on the 17th (failed to confirm the month), which will approach the 42 days mark post vaccination. She explained she would like to wait for this consultation before getting the second dose. She asked if the second dose can be administered beyond the 42 days. Upon follow up, she also reported that, her shoulder was injured and at the very least has tendonitis. She was 32 days out from receiving the first injection, but she wanted to know if it's okay to get the second shot to complete the vaccination series. The outcome of the events was unknown. Follow-up (08Jun2021): This is a follow-up spontaneous report from a Pfizer sponsored program Support via consumer (patient) which included new information such as: She is 32 days out from receiving the first injection, but she wants to know if it's okay to get the second shot to complete the vaccination series/ she has had chronic fatigue syndrome for years, but she had a bad fare up. Her shoulder is also injured and at the very least has tendonitis" No follow-up attempts are possible; information about lot/batch number cannot be obtained.

On the morning of April 8, 2021, dull, achy lower back pain woke me up and did not subside throughout the day. The next morning, April 9, 2021 (2 weeks to the day of my 2nd Pfizer vaccine dose), I noticed a few spots on my lower left to middle torso. The pain was increasingly unbearable. I immediately suspected possible shingles and went to ER where I was diagnosed with shingles. I was prescribed a 10 day dose of antiviral acyclovir along with Percocet. As of this date, despite various OTC remedies as well as completing all medications prescribed, I still have inflammation, pain that intensifies throughout the day, as well as periodic numbness, primarily on my left side (which was the site of the original shingles attack).

couldn't lift arm or lay on it; red hematoma at injection site for weeks; burning from head to toe; Arm hurt; Neuropathy and Small Nerve Fiber Neuropathy; worst headache; This is 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 on 05May2021(at age of 60 years old) (Batch/Lot number was not reported) as 1st dose, single for Covid-19 immunisation. Medical history included Hashimoto's, Fibromyalgia, Small Nerve Fiber Neuropathy, surgeries for defective veins and valves, poor circulation problems and kidney infection 10 years before shortly after undergoing cath lab procedure. The patient's concomitant medications were not reported. Consumer call with questions regarding " I had side effects after the first dose of the vaccine. Should I get the second dose?" Side effects included "worst headache on 05May2021 for 2 days continued for weeks, couldnt lift arm or lay on it, red hematoma at injection site for weeks, burning from head to toe." Caller also reported that her arm hurt after the vaccine. Also reported she had to receive prednisone (her doctor put her on steroids) after first vaccine dose, also reported that her doctor gave her Methylprednisolone, which she took for 6 days, the medication did help somewhat with her symptoms, specifically, the burning from her neuropathy, headache and she couldnt lift her arm, the medication was not a miracle drug, but she did have some relief. She tapered the medication, she had less relief of her symptoms. The symptoms have subsided somewhat and it has taken several weeks. Caller just wanted to ask a medical professional if that ingredient (propyl ethlene glycol as provided and spelled by Caller) contributes to Small Nerve Fiber Neuropathy, Patient reported she went on vacation in January of 2020, after returning home she was very sick but was never diagnosed with Covid-19. Caller reported that she had some type of neuropathy that had come back after she got the first vaccine, she had a splitting headache within 30 minutes of getting the vaccine, and it was really bad, for two days after the vaccine. Caller was concerned to take the second vaccine, because of her previous bad reaction, and her doctor told her to take her second dose and Second dose of vaccine scheduled for 10Jun2021, 36 days after the first dose of vaccine. Outcome for events was recovering. Information regarding the lot/batch number has been requested.

Completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose 03/02/201pfizer,Lot#EN6205 2nd dose: 03/23/2021Pfizer,Lot# EN6208 Diagnosed covid positive:06/22/2021 Exposure:Unknown Symptoms:Fever,fatigue,muscle aches,nasal congestion.

Patient having worsening tingling and numbness of hands and feet. Patient also having weakness of all extremities

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.

One month after my second dose I felt aching in my shoulders and neck area. The symptoms were similar to those I had when I had a minor heart attack in 2015. I went to the emergency room and after many test it was determined I had pericarditis.

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.

Within 4 hours of receiving the vaccine, I developed chills and an fever of 101.5. I had muscle aches, pains, stomach upset, and nausea. At night I had difficulty breathing so I had to take extra medicine for my asthma. My temperature had went down to 100. I had severe body pains, abdominal pains, and vomiting. I was told to take Tylenol and stay hydrated by my doctor. He sent me to ER on March 11th. I went to ER and they ruled out a Covid or flu infection and any other infections. They said it was caused by the vaccine. They administered IV fluids, pain medicines, and vomiting medicines. 9 hours later after waiting, I decided to leave the ER and continued with taking pain and vomiting medicines. The symptoms lasted for 16 days. I met with my PCP and decided to get the 2nd shot three weeks later. I got similar symptoms as 1st shot with 2nd dose. Off and on I have been having adnominal discomfort. I have been having a hard time swallowing and chewing food. June 2nd I seen my PCP, and he said there was a problem with food processing into my stomach. He sent me to a gastroenterologist on June 22nd and they are scheduling a procedure to take a look into my esophagus and stomach to see the issue.

4 Days after 2nd injection I woke up having pulsing in my ears, I was very lightheaded and nauseous as if I was having motion sickness at 11 a.m. I checked my blood pressure and it was extremely high, Over the course of 15 minutes, I got a pain in my shoulders, and could barely walk. I check my blood pressure again it was 180/120. My stomach was upset and I had to crawl to the bathroom, too dizzy to walk. I checked my blood pressure again and it was 178/130. My head was pounding and I was losing my ability to walk. I was taken to the Emergency Room, I wasn't sure if this was a stroke or Heart attack, or neuro problem. I was admitted for two nights and released on January 19, 2021. I still had extremely high blood pressure and motion sickness. The hospital did several tests and ruled out a heart attack and stroke. As of today, I am still undergoing treatment for high blood pressure. I had no issue with this before the vacine

Acute onset of myalgia, polyarthraglia, cramps, weakness, stiffness, fatigue, edema, decrease mobility of small joints of hands, feet, wrists and ankles. Difficult to write and grasp items starting a few days after the first dose. Symptoms increased after second dose and continue to persist.

24 hours post vaccine developed fever (101); Nausea; lack of appetite; muscle aches (entire body); Fatigue; This is a spontaneous report received from a contactable health care professional, the patient. A 60-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: FR2613) via an unspecified route of administration in the right arm on 19Mar2021 at 16:00 (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 sulpha. The concomitant medications included losartan (MANUFACTURER UNKNOWN), felodipine (MANUFACTURER UNKNOWN), omeprazole (MANUFACTURER UNKNOWN), CRESTOR and CARVIDEX; 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 was tested for COVID-19, but the result was unknown. On 20Mar2021 at 16:00, the patient experienced fever of 101 (units unspecified), nausea, lack of appetite, muscle aches (entire body) and fatigue. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient was treated with TYLENOL for the reported events. The clinical outcome of the events fever, nausea, lack of appetite, muscle aches and fatigue were resolved on an unknown date in Mar2021. No follow-up attempts possible. No further information 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.

Fever; Body aches; Shakes; Fatigue; Joint pain; Headache; Weakness; Chills; Sore arm; Nausea; Stomach cramps; Diarrhea; 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: unknown), via an unspecified route of administration in left arm on 19Mar2021 at 15:45 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had only known allergy with z-pak. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. Concomitant medications included atorvastatin calcium (LIPITOR), estradiol (ESTRACE), simvastatin (ZOCOR) and multivitamins, all for unknown indication received within 2 weeks of vaccination and was unknown if ongoing. The patient experienced fever, body aches, shakes, fatigue, joint pain, headache, weakness, chills, sore arm, nausea, stomach cramps and diarrhea on 20Mar2021 at 06:00. The patient did not receive any treatment for 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 fever, body aches, shakes, fatigue, joint pain, headache, weakness, chills, sore arm, nausea, stomach cramps and diarrhea was resolving at the time of reporting. Information about lot/ batch number cannot be obtained. No further information expected.

Pfizer-BioNTech COVID-19 Vaccine EUA: After receiving dose 1 on 5/19/21 & 2nd dose on 6/9/21, I noticed daily, low-grade headache and continued muscle soreness in my left arm at the injection site that was used for both vaccines. I had frequent flushing/burning in my cheeks. As of 7/1/21, these symptoms linger but are becoming lesser. I treat the headache as needed with OTC ibuprofen. Note: When I contracted & was treated for Lyme's disease in or @ 2010, I had severe daily headaches for 1 year & then they went away. The covid vaccine side effects seem to be similar to the Lyme disease side effects.

TSH reading of zero; Subacute Thryoiditits Inflamed painful thyroid; elevated t4; Subacute Thryoiditits Inflamed painful thyroid; Subacute Thryoiditits Inflamed painful thyroid; Extreme fatique; headaches; muscle aches; feeling like i have the flu; This is a spontaneous report from a contactable consumer. This 60-year-old female consumer (patient) reported for herself that. A 60-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 24Apr2021 16:30 (Batch/Lot Number: EW0171) as DOSE 2, SINGLE, dose 1 via an unspecified route of administration in in Arm Left on Apr2021 16:30 (Batch/Lot Number: ER8737) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included patient had Subacute thyroidities at age 47. Concomitant medications included progesterone (PROMETRIUM [PROGESTERONE]) and estradiol both taken for an unspecified indication, start and stop date were not reported. The patient previously took cipr for allergy. It was reported that on 14May2021 patient experienced Subacute Thryoiditits Inflamed painful thyroid, TSH reading of zero (medically significant), elevated t4, Extreme fatigue, headaches, muscle aches, feeling like she have the flu. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient did not test for COVID-19. Outcome of the events was not recovered.

This is a spontaneous report from a contactable consumer or other non health care professional. A 60-years-old female patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection, Lot Number: 9W0187), intramuscular, administered in upper Arm Left on 17Jun2021 14:15 (Age at vaccination: 60 years) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that she don't know if she has high blood pressure or diabetes at that time. Patient did not received any vaccinations prior to COVID vaccine. It was reported that she haven't took any medicine since Thursday morning (further not clarified). On 17June2021 the patient experienced fever went highest as 104 but it's down to 101 today, lot of pain, headache, muscle ache, tiredness, chills, joint pain, Feeling unwell, severe nausea, pain in her ear, severe vomiting, really draining she haven't eaten anything since Thursday at 6 pm, everything keeps 'coming', diarrhea, pain in 'neck area'. Consumer stated that I don't have my, the card with me, I am downstairs on the couch I don't have the card in front of me and I don't have enough energy to go upstairs to get it. Consumer stated, "I got the Pfizer shot (COVID Shot) on Thursday and Thursday evening I have been having the problems and it's still going today 20Jun2021 and I got the call from the pharmacist and he concerns about the side effects, I am not sure what caused all of this 'up again', I was fine before the shot and now that evening different things started happening, not feeling well." Patient did not had swelling. Consumer was suggested to share information and a safety report will be filed by the call handler which is going to be forwarded and if consumer want to speak to someone then call back attempt can be done in order to get a person. The patient underwent lab tests procedures which included body temperature was 104 , body temperature was 101 on 20Jun2021. Patient did not received any treatment for the events. last night something to control diarrhea Ammonia AD, that was the only thing that she took, to stop the diarrhea. But the pain was still there, diarrhea stopped. The patient was recovered from diarrhea in Jun2021,Outcome of Lot of pain was not recovered ,the outcome of the rest of the events was unknown.. Consumer was informed about the role of Pfizer Medical Information and offered the number. Information on the lot/ batch number has been requested.

Itching on the arm (started within the first hour) and sore and my arm felt heavy (injection site arm). Hard to lift my arm. I noticed my fingers were swelled up. The itching never has gone away. I still get it. The swollen fingers took about two weeks to go away. I hadn't been able to take my wedding rings off. Heaviness didn't go away. When I got the second shot that got worse (heaviness). March 28 was date of second Pfizer vaccine - LOT# ER8730. The itching felt more prominent and I couldn't scratch by that time so I would try to rub it lightly to calm it. I would put warm compresses on my arm jus to fall asleep. I went to the doctor - I had to see a resident doctor in the office - that might have been 6/2/2021. He prescribed me to take two Aleve's morning and night. And he prescribed a muscle relaxant and Naproxen but none of that worked. I can't extend my arm unless I use my other arm to do it. It wakes me up at night. They also prescribed physical therapist and I had my second Physical therapy appt yesterday but it just hurts - they have scheduled me for12 sessions. I had realized there was a lump on the arm on the first week of May. Now the lump is bigger and you can feel hardness inside. Doctor could see it. The lump is a little lower to the right of the injection site. If I put my three middle fingers together it kind of covers the size - so it's the width of three finger. And that hurts - it wakes me up at night even if I'm not sleeping on it. I'm usually pretty tolerant of pain and I don't usually have time to go to the doctor but this is how bad it hurts - I had to go to the doctor. My physical therapist says they have had patients come in with those same symptoms after their vaccines. I also get lightning bolt pain on the left side of top of my hand - on my left hand. It feels like a neurological issue.

Worst part so far is inability to sleep, feels like heart racing since at least 07/06/2021 around noon or 1:00; many many feelings like heart flip flops during same period - these things are continuing. injection site still hot, red and swollen and painful. Had fever 100.4 to 101.6 for twelve hours, head and body aches, joint pain - the fever and aches and pain started subsiding today. - the fever, aches and pains I understand are fairly common. Really had not expected the feeling that my heart is racing and flip flopping or the inability to sleep - may have got two hours last night - so that is why I am reporting. Not planning to seek medical care unless it continues another night or two.

Feels like Covid pneumonia all over again; Feels like Covid pneumonia all over again; Feels like Covid pneumonia all over again; Sore arm; Extreme chills; Body and muscle ache; Body and muscle ache; Diarrhea; This is a spontaneous report from a contactable consumer (patient herself). This 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and Lot number EW0182), via an unspecified route of administration in left arm on 10May2021 10:45 as single dose for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Patient medical history included COVID-19. Concomitant medication included (paracetamol) TYLENOL. Patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), via unspecified route in left arm on 19Apr2021 24:00 (Batch/Lot number EW0171) as single dose for COVID-19 immunization. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 11May2021 23:00 the patient experienced with felt like COVID pneumonia all over again, sore arm, extreme chills, feels like ice in blood, Body and muscle ache and diarrhea. Treatment received was reported as no. The outcome of events was recovering.

I got my first dose of the vaccine on the advice of my Rheumatologist. I have not been able to see him yet. Two days after the first dose my left arm was really bothering me. My arm was red below the injection site and it was hot, raised up and painful. I couldn?t sleep on that side. I was very tired that week. I used antibiotic ointment and alcohol pads with a cold washcloth. I went back to the pharmacy. It looks better now after eight days. It is a little splotchy now, but the pain has gone down. I have also had more joint pain since I got the vaccine but that may be because I have not had any Embrel for two weeks. It feels like my Rheumatoid Arthritis is flared up.

presented with appears to be (clinically) brachial plexitis left shoulder pan, left arm weakness responded partially to steroids responding to PT

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.

Inflammation throughout body. Tennis elbow, shoulder pain, wrist pain. All of which I have had in past but did not have at time of vaccine. All came on again at once 2 weeks after 2nd dose

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.

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.

rheumatoid arthritis; was really sick and it affected her fibromyalgia; she was just a mess and ended up vomiting and this took about three days; feeling sick; This case has been considered invalid initially upon follow up information case was processed as valid file The initial case was missing the following minimum criteria: Other-Info not qualifying for AE reporting Medical Information. Upon receipt of follow-up information on (20Apr2021), this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer. This consumer reported similar events for 2 patients. This is 1st of two reports. This 60-year-old female consumer reported for herself that: a 60-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EN6206, Expire Date: unknown) via an unspecified route of administration, in the left arm on 08Mar2021 as dose 1, single and bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: ER8734, Expire Date: unknown) via an unspecified route of administration, in the left arm on 29Mar2021 as dose 2, single for covid-19 immunisation. Medical history included ongoing Diabetes, Sjogren's disease, obese and knee replacements like 10 years ago on both knees and she did not know the exact dates of the knee replacements. Concomitant medications included loratadine taken for rash from 13Mar2021 and ongoing; hydrochlorothiazide taken for sjogren's syndrome, fluoxetine taken for antidepressant therapy; montelukast sodium (SINGULAIR) taken for asthma, cetirizine hydrochloride (ZYRTEC ALLERGY) taken for rash. No additional vaccines administered on same date of the pfizer suspect. The patient did not receive any vaccines within four weeks prior to the vaccination. Caller stated she had a reaction to the Pfizer COVID vaccine and had the 1st dose on 08Mar2021 and after the 1st dose she was really sick and it affected her fibromyalgia and rheumatoid arthritis and she was just a mess and ended up vomiting and this took about three days which was normal. Stated after the 2nd dose within 24 hours she started feeling sick again on 30Mar2021 and she could not move and ended up throwing up and got a rash that appeared on her left arm; stated she had both doses of the Pfizer COVID Vaccine in her left arm and the rash was a little above where the vaccine doses were administered. Stated she had the 2nd Pfizer COVID vaccine on 29Mar2021 and had been coming in and out of feeling good and bad since then and for the rash she had, she used the Triamcinolone Acetone cream and the rash seems to subside and then flares back up and when the rash flares back up she got sick again. Stated the Triamcinolone Acetone cream is 0.1% with lot 0LT0435, expiry date Sep2022 and NDC number. Stated the rash has gotten larger than when it first appeared and when it did flare it itches and was hot and she also has Sjogrens disease in that rheumatology thing and has had the shingles shot 2 years ago; stated she had no name of the shingles shot to provide but had it 2 years ago in September and it was at Walgreens. Stated she just got over this weekend and was sick on Friday, was ok on Saturday and then on Sunday she could not move and was sick. Caller stated the 1st dose of the Pfizer Vaccine was administered on 08Mar2021 with lot EN6206; 2nd dose administered on 29Mar2021 with lot number ER8734; states the patient card has no expiry date or NDC written on it; stated she has had no treatment for the reported events and had not gone into the HCP office but wanted to. Stated her husband got nervous when he looked on the site and saw there were problems with the Pfizer COVID Vaccine in Israel about bringing up shingles in people and he read this in an article; caller stated her husband was concerned about her and thought maybe she had shingles and caller stated this was not shingles and she had the shingles shot and this did not look like shingles to her. Caller stated her husband himself had shingles and he got a little nervous and she herself was going to go to urgent care and did not feel like going that route; stated she had no other treatment. Stated she was having a bad reaction and sees enough doctors and went often enough if this was a real problem she would bring it up and the further away from testing the longer the distance was between her feeling ill; no further details stated by the caller. Stated she took quite a bit of medications and takes Hydrochlorothiazide for her Sjogrens disease and began taking that a little over a year ago and takes 300mg once per day by mouth. Stated she was on an antidepressant and takes Fluoxetine 60mg once per day by mouth and all the names of these medications a was going crazy in her head; stated she began taking Fluoxetine about 10 years ago. Stated she was on a lot of medicines that counter act anything the Pfizer COVID Vaccine could did to her regarding side effects and thinks the vaccine was too much for her body; no further details provided by the caller except she states she took several different asthma medicines and made the reported event not as severe and the rash was not as severe. Caller clarifies to state the medications she took for asthma that made the reported events less severe are Zyrtec 10mg tablets and she took it once per day and had been on it for years like 20 years; she takes Singulair 10mg once per day and had been on that for years and had two new medications just prescribed to her that was Loratidine 10mg once daily that she started taking on 13Mar2021 and then clarified this was the only new one prescribed and she also used nose sprays; no further details provided by the caller. Caller asks that based on what she had told medical, was she doing the right things for this and was she treating this the right way by letting it run its course; caller aware that Pfizer cannot offer medical advice or treatment recommendations and she was referred to her HCP. Adverse events not required in a visit to ER or MD office. Outcome of all events was unknown. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021076803 same reporter/drug/event, different patients

I woke up around 2:30 in the morning of the 18th and I was having pain that went across my shoulders. In half an hour, it was going down both arms, up my neck and in my jaw. I started having chest pains. I went to the ER and they sent me to another hospital where they gave me blood thinners. They think something affected my heart or I had a blood clot. I was discharged two days later and was given an MRI of my heart. They determined that the lining of my heart was swollen. I am now on blood pressure meds and cholesterol meds and am not allowed to spike my heart rate for the next 3-6 months. The doctors believe it was caused by the vaccine.

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.

Symptomatic, started on 7/9/21 with cough, runny nose, muscles aches, nausea, loss of smell & taste, sore throat, nasal congestion, fever, headache, fatigue abdominal pain, & ear ache.

Hands and feet were burning, very painful and felt locked up. By the end of the day the extreme pain had subsided but now, hands, feet, ankles, back and arms hurt. So much so it?s keeping me up at night. Prior to the shot I did have hand pain due to RA. But not like this. Shooting pains start from wrists and go down into palms. Those come and go. Mornings are terrible. The pain is getting worse. Taking over the counter pain pills reduces the pain a little bit.

Pain at injection site; extreme back and body aches; headache; dizziness; low grade fever; Body aches; This is a spontaneous report from a contactable other health care professional. A 60-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8733), via intramuscular route of administration in the right arm on 30Mar2021 at 15:15 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medications were included levothyroxine sodium 12mcg (MANUFACTURER UNKNOWN) taken from unknown date for unknown indication; duloxetine hydrochloride 20mg (DULOXETINE HCL), estradiol; estriol (BIEST) 4(80/20) unknown units, progesterone (Prog 80) (MANUFACTURER UNKNOWN) and prasterone (DHEA) 8mg/g (MANUFACTURER UNKNOWN) taken as hormone replacement therapy from an unknown date and multi vitamin (unspecified) taken from unknown date for unknown indication. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 31Mar2021, at 03:00 the patient had pain at injection site (vaccination site pain), extreme back and body aches, headache, dizziness, low grade fever. The patient did not receive any treatment for the adverse events. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of pain at injection site, extreme back and body aches, headache, dizziness, low grade fever was recovering at the time of this report. No follow-up attempts are needed. No further information is expected

pain in injection side; cherry angioma; fatigue; muscle weakness; chills; fever; diarrhea; skin rash (urticaria); on day five start of abdominal pain; 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 no: EN6205) via an unspecified route of administration in the right arm on 13Mar2021 at 11:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included cholinergic urticaria, lactose and fructose intolerance. The patient's allergic history included rhinitis, animal fur, mites, dust, NSAIDS (Nonsteroidal Anti-Inflammatory Drugs) causes urticaria. 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 vaccination, the patient was not diagnosed with COVID-19. On 18Mar2021, the patient experienced abdominal pain. On 20Mar2021 at 10:00, the patient experienced pain in injection side, fatigue and muscle weakness, chills, fever, diarrhoea, skin rash (urticaria), cherry angioma. Since the vaccination, the patient had been tested negative for COVID-19 on 21Mar2021. As a corrective measure the patient received cetirizine for all the events. The clinical outcomes of the events, pain in injection side, fatigue and muscle weakness, abdominal pain, chills, fever, diarrhoea, skin rash (urticaria), cherry angioma were recovering. No follow-up attempts are needed. No further information is expected. Amendment: This follow-up report is being submitted to amend previously reported information: Patient's Postal Code added, Verbatim was updated for medical history. Relevant Med History Rhinitis was deleted as it is the reaction of animal fur, mites, dust allergy, Lab data "Rapid Diagnostic RNA test" deleted as it can be combined with PCR (Nasal Swab), Vaccine Facility Information added.

Painful blisters and rash on left side, starting as small boils, diagnosed as Shingles, after second vaccine.; Painful blisters and rash on left side, starting as small boils, diagnosed as Shingles, after second vaccine.; Painful blisters and rash on left side, starting as small boils, diagnosed as Shingles, after second vaccine.; Sore, reclarified as left arm after the first and second vaccine; Fever, after the second vaccine; Muscle pain, after the second vaccine; Itching, left arm at the injection site, after second vaccine; Left side of body aching, after the second vaccine; This is a spontaneous report from a contactable consumer (patient). A 60-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8735, Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 03May2021 17:00 (at the age of 60-years-old) as dose 2, single for covid-19 immunisation in pharmacy. No vaccines administered on same date of the Pfizer suspect. The patient did not have prior vaccinations within 4 weeks. The patient did not have any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. Medical history included glucose tolerance impaired from 2020 and ongoing (patient stated probably last year), blood cholesterol increased from 2020 and ongoing (patient states at about the same time as diagnosed with prediabetes). Family medical history was none. Concomitant medication(s) included naproxen taken for arthralgia from an unspecified start date to 10May2021; valaciclovir hydrochloride taken for herpes zoster from 12May2021 and ongoing. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8729, Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 11Apr2021 17:45 (at the age of 60-years-old) as dose 1, single for covid-19 immunisation in pharmacy and experienced she fell in the office and she had knee pain, Sore, reclarified as left arm after the first and second vaccine. On May2021, the patient experienced, muscle pain, after the second vaccine, itching, left arm at the injection site, after second vaccine, left side of body aching, after the second vaccine. On 04May2021, the patient experienced sore, reclarified as left arm after the first and second vaccine, fever, after the second vaccine. On 10May2021, the patient experienced painful blisters and rash on left side, starting as small boils, diagnosed as shingles, after second vaccine. The events resulted in physician office visit. Patient stated she was not sure if she had to call, but she still was in pain, and she wants Pfizer to know, so she can help other people. Patient stated she had her second dose of the vaccine and then the following day she was sore in morning. Patient stated she had a fever for 3 consecutive nights. Patient stated because she had normal effects, the vaccine was probably working. Patient stated on the third night she had muscle pain. Patient stated her left side of her body was aching and she used a pad on it for the muscle pain. Patient stated on 09May2021 or 10May2021, she had blisters that were painful on her left side. Patient stated that the blisters were diagnosed as Shingles. Reclarified, patient stated she had a video visit with her primary care doctor. Patient stated that and she noticed the rashes and blisters on the left side of her body. Patient stated they started as small boils and then blistered. Muscle pain started probably on morning of 05May2021 or 06May2021. Itching, left arm at the injection site, after second vaccine started on 05May2021 or 06May2021 and confirmed the itching is not like it first started. Left side of body aching, after the second vaccine started on noon of 05May2021 or 06May2021. Patient stated when she went to the urgent care for her knee pain, they gave her Naproxen Patient stated she stopped taking it when the rash and blisters appeared. Patient was thinking she was allergic to the medications, not the shingles. Patient stated she has high cholesterol and diabetic medications that she doesn't take. Patient stated she checks her blood sugar, and they are normal. Therapeutic measures were taken as a result of muscle pain, after the second vaccine with a pad on it and Motrin. Patient stated that when she takes Motrin it helps with the pain, but then it comes back when the medication wears off. The outcome of the event sore, reclarified as left arm after the first and second vaccine was recovered on an unspecified date of May2021. The outcome of the event fever, after the second vaccine was unknown. The outcome of the events muscle pain, after the second vaccine and itching, left arm at the injection site, after second vaccine was recovering and not recovered for other events. Information about Lot/Batch number is available. Further information has been requested.

Headache; Chills; Fatigue; Muscle ache; generalized weakness; unable to stand for minimal amount of time due to chills and generalized weakness; This is a spontaneous report from a contactable Nurse, the patient. A 60-year-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 on 27Mar2021 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included AFib, rheumatoid arthritis (RA), migraine, asthma, congestive heart failure (CHF), prosthetic heart valve, allergies, hyperlipidemia and pacemaker. Concomitant medications included warfarin (MANUFACTURER UNKNOWN), digoxin (MANUFACTURER UNKNOWN), verapamil (MANUFACTURER UNKNOWN), abatacept (ORENCIA), prednisone (MANUFACTURER UNKNOWN), leflunomide (LEFL); all from unknown date for unspecified indication. The patient had known(Unspecified) allergies to medications, food or other products. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6199), via an unspecified route of administration on 06Mar2021 at 15.45 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 29Mar2021 at 06.30, the patient experienced headache, chills, fatigue, muscle aches and unable to stand for minimal amount of time due to chills and generalized weakness. 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 headache, chills, fatigue, muscle aches and unable to stand for minimal amount of time due to chills and generalized weakness was not resolved. No follow-up attempts are needed. No further information is expected.

The morning following vaccination, the patient reported pain and heaviness in middle portion of her left arm (the arm that received the vaccine). The patient stated that the pain was fairly localized around the elbow area, with the area of the pain starting about six inches below the elbow and stopping about six inches above the elbow. The pain made normal activities uncomfortable and became more intense as the day progressed. The patient also reported noticing occasional shooting pains originating at her shoulder and traveling down her left arm. She did not mention any systemic signs or symptoms nor did she report any areas of redness or swelling. After about a week of the elbow-area pain, the patient sought care at an urgent care provider who ordered x-rays of her arm, which did not show any detectible damage. After that visit, the patient saw her primary care doctor for the arm pain as well as for routine care. The patient noted that the provider suggested possible nerve involvement due to the vaccine and/or its administration and mentioned to the patient that the arm pain should improve over the next few months. The patient regularly sees her primary care doctor and a cardiology due to poorly controlled hypertension.

Pain seems to be in shoulder area and bicep area; aching/ stabbing pain; Bump reappeared with red itchy rash; Extreme pain and mobility issues with left arm that lasted from time I received vaccine but really worsened on 4/2/21./ Could not even lift my arm any distance from body in any direction; mobility issues/ did not had full mobility; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient (not pregnant) received the first dose of BNT162B2 via an unspecified route of administration on the left arm on 30Mar2021 at 12:30 (Lot Number: EN6208) at the age of 60-year-old as single dose for COVID-19 immunization. Medical history included allergies to medications and food. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included estradiol, antihistamines, vitamins and progesterone. The patient experienced extreme pain and mobility issues with left arm that lasted from time received vaccine but really worsened on 02Apr2021. On 04Apr2021, the patient went to urgent care. Went again to primary care doctor 4/8/21. It was gotten better each day but still did not had full mobility and had some pain. The patient could not event lift arm any distance from body in any direction. Extreme pain on scale of 1-10, a definite 10. Aching, stabbing pain. Bump reappeared with red itchy rash on the 07Apr2021, but was not severe. And improved today the 10Apr2021. Still not able to fully extend arm up above head. Pain seems to be in shoulder area and bicep area. At 2nd application, they prescribed Prednisone as treatment for events. The events resulted in doctor or other healthcare professional office/clinic visit. The outcome of events was recovering. No follow-up attempts are needed. No further information is expected.

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.

Sore arm; chills; body aches; pain under left arm pit; headache; This is a spontaneous report received 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: EL3247), via an unspecified route of administration in the left arm on 31Mar2021 at 10:00 (at the age of 60-years) as a single dose for COVID-19 immunisation. The medical history of the patient included high blood pressure. The patient did not receive any concomitant medications with in 2 weeks of vaccination. The patient had no known allergies to food, medications, or other products. The patient previously received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: EL3247) via an unspecified route of administration in the left arm on 10Mar2021 at 10:00 (at the age of 60- years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 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 31Mar2021 at 17:00, the patient experienced the events sore arm, chills, body aches, pain under left arm pit and headache. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit. The patient did not receive any treatment for the reported events. The clinical outcome of the events sore arm, chills, body aches, pain under left arm pit and headache was not recovered at the time of the report. No follow-up attempts are needed. No further information is expected.

3/23 Arthritic flare up w/ painful numbness. NSAIDs, Voltaren, referred to Rheumatologist, Physical therapy.

pain/heaviness in left arm; pain/heaviness in left ram; pain/heaviness in left arm; sweats; chills; diahrea; Weakness; nausea; fatigue; low tolerance to sound and light; low tolerance to sound and light; vertigo; feeling cold; headaches; muscle/joint pain in all extremities; muscle/joint pain in all extremities; diminished sense of taste; blurred vision; confusion; mood changes; increased sleep; physical agitation; difficulty breathing; Aggravation/exacerbation of underlying neurological/ pulmonary conditions; Pain in injection arm persists; This is a spontaneous report from a contactable consumer or other healthcare professional (patient). A 60-years-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EL9261) via an unspecified route of administration in Arm Left on 29Jan2021 07:00 (age at vaccination 60 years old, Pregnant at Time of Vaccination No) as single dose for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing, hypothyroidism from an unknown date and unknown if ongoing, vertigo from an unknown date and unknown if ongoing, migraine from an unknown date and unknown if ongoing None in past 5-6 years, arthritis from an unknown date and unknown if ongoing, affective disorder from an unknown date and unknown if ongoing, nervous system disorder from an unknown date and unknown if ongoing. The patient had unknown allergies Darvon. 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. Concomitant medication(s) included umeclidinium bromide, vilanterol trifenatate (ANORO); levothyroxine sodium (UNITHROID); valproate semisodium (DEPAKOTE); paliperidone (PALIPERIDONE). All taken for an unspecified indication, start and stop date were not reported. The patient had historical vaccine of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EK9231) via an unspecified route of administration in Arm Left on 07Jan2021 17:00 (age at vaccination 60years old, Pregnant at Time of Vaccination No) as single dose for covid-19 immunisation. Since the vaccination, the patient had not been tested positive for COVID-19. The patient experienced after second dose pain/heaviness in left ram, sweats, chills, diahrea, nausea 3 days. Weakness and fatigue for 3 weeks, low tolerance to sound and light, vertigo, feeling cold, headaches, muscle/joint pain in all extremities, diminished sense of taste, blurred vision, confusion, mood changes, increased sleep, physical agitation, difficulty breathing. These lasted 5 weeks. Mood changes, breathing difficulties, vertigo, muscle and joint pain persist. Aggravation/exacerbation of underlying neurological/ pulmonary conditions. Pain in injection arm persists on unspecified date. Therapeutic measures were taken as a result events which included injection of a medication with high NSAID levels. AE resulted in Doctor or other healthcare professional office/clinic visit. The clinical outcome of the events was recovered with sequelae in 2021. No follow-up attempts are possible. No further information is expected.

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.

Endorses significant painful swelling of multiple joints including hands, wrists, legs, ankles, decreased mobility of the small joints of her extremities. Symptoms worsened after the second dose of the vaccination. Since then, her symptoms have worsened. Endorses hand swelling daily, worse overnight and in the mornings. States that she wakes up with her hands paralyzed into a claw position, painful, right worse than left. Endorses fatigue, myalgias, weakness. States her fingers feel that they are on fire. Is starting to drop things -having difficulty with sustaining grasp and having difficulty writing.

Epiglottis; Developed tightness in my throat; Chills; Muscle aches; This is a spontaneous report from a contactable consumer. A female patient 60 years old female received BNT162B2 (PFIZER-BIONTECH COVID-VACCINE, Formulation was Solution for injection, Lot Number: EW0180), dose 2 via intramuscular in left arm on 08-Jul2021 11:30, DOSE 2, SINGLE as single dose for COVID-19 immunization. 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. The patient medical history and concomitant medications were not reported. The patient previously took first dose BNT162B2 (PFIZER-BIONTECH COVID-VACCINE, Formulation was Solution for injection, Lot Number: EW0180), dose 2 via an unspecified route on 17Jun2021 01:30, DOSE 1, SINGLE as single dose for COVID-19 immunization. On 10Jul2021 04:00 AM patient developed tightness in her throat, and it felt like her airway on the right side was closing. This was after developing chills and muscle aches that began early on Friday morning, approximately 15 hours after her second Pfizer shot. She went to the emergency room and was diagnosed with epiglottis. She received two shots of epinephrine, an IV and CT scan and prescribed antibiotics, a steroid and antihistamine. She had only mild side effects after the 1st shot sore arm after the first shot. Patient was allergic to penicillin only. The outcome of all events were recovering. Information on the lot/batch number has been requested. Follow-Up (19Jul2021): Follow-up attempts are completed. No further information is expected.

For 3-4 days following the 2nd dose of Pfizer vax I experienced almost non-stop munchies. Munchies as in canabis type. I could not find a full button on my appetite. It clearly effected my metabolism in some way. Then about 2 1/2 weeks later, my left wrist, where I have mild carpel tunnel grew a ganglion cyst ( confirmed with chiropractor ) It's still there. I got the shot in my left arm. I've had carpel tunnel for over 30 years, and never had a ganglion cyst anywhere on my body in my life. Since then I have gained at least 10 lbs and feel like I could sleep for hours. My mood is fine, but my head thinks my pillow is a standing invitation.

flu like symptoms Sunday morning, knees hurt - by Sunday afternoon every thing hurt so bad I was crying and it was indescribable. Monday I was some better - not sure if would have been able to drive to work, Tuesday better - Wednesday all good.

Knee pain 10+, flu symptoms, body hurt all over - unable to really describe it other than I hurt all over and it's indescribable. Spoke to internist and orthopedic doctor once I felt better

Tiredness; muscle pain; chills; joint pain; Headache; Fever; injection site pain; Nausea; feeling unwell; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old 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 arm left on 03Apr2021 at 17:30 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. It was reported that the patient had no allergies to medications, food, or other products. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. Concomitant medications included progesterone (MANUFACTURER UNKNOWN), dextromethorphan hydrobromide and guaifenesin (ROBITUSSIN DM) and azithromycin (MANUFACTURER UNKNOWN) started on an unknown date for an unknown indication. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 04Apr2021 at 6:00, the patient experienced tiredness, muscle pain, chills, joint pain, headache, fever, vaccination site pain, nausea and malaise. 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 tiredness, muscle pain, chills, joint pain, headache, fever, vaccination site pain, nausea and malaise were recovered on an unknown date in 2021. No follow-up attempts are needed; information about the lot number cannot be obtained.

Right arm sore; left knee/shin/calf pain; left knee/shin/calf pain; left knee/shin/calf pain; 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: ER8736) via an unspecified route of administration in the arm right on 30Apr2021 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included levothyroxine sodium (LEVOTHYROXIN), rabeprazole (MANUFACTURER UNKNOWN) and losartan (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication. The patient previously took Avelox, penicillin and sulfa on unknown date for 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 01May2021 the patient experienced right arm sore, left knee, shin and calf pain. The patient stated that she had right arm sore but was not bad. However next morning she woke up with left knee/shin/calf pain and she could not put weight on it throughout the day and night. She further stated that her knee and shin got better on second day morning but calf was still stiff and sore. The clinical outcome of the events right arm sore, left knee pain and shin pain and calf pain was unknown. No follow-up attempts are needed. No further information is expected.

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.

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.

Felt as if my legs were far more heavy when climbing stairs or walking; 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: En6204) via an unspecified route of administration in the left arm on13Mar2021 at 11:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8734) via an unspecified route of administration in the left arm on an unknown date, as a single dose for COVID-19 immunisation. Medical history included cancer in left breast from an unknown date. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in 2021, after the first dose of vaccination, the patient felt as if her legs were far more heavy when climbing stairs or walking and on an unknown date after the second dose of vaccination, the patient's legs felt super heavy so she weighed herself to make sure she had not gained weight. The patient had not gained any weight. Then her right leg felt horrible behind the knee area and on 01May2021 at 21:00, the patient felt her knee area give out and she grabbed the edge of the checkout conveyor belt area. The patient's right leg still felt horrible and she couldn't walk the same as prior to the vaccine. The patient's legs had no problems and she walked fine and her legs did not feel as if steel weights. The clinical outcome of the event felt as if my legs were far more heavy was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.

Headache; Tiredness; Muscle pain; Chills; I am so painful in my joints, all muscle ache; I was so tired and weak; I am not feeling well; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received second dose of bnt162b2 (PFIZER COVID-19 VACCINE, Solution for injection, Lot number: EW0167, Expiration date: Aug2021), via an unspecified route of administration, administered in Arm Left on 20May2021 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included diabetes mellitus from 26Apr2021 to 26Apr2021. Concomitant medications included metformin, lisinopril and glipizide. Historical vaccine included first dose of BNT162B2 (Lot number: EW0171) via an unspecified route of administration, administered in left arm for COVID-19 immunization. Patient got the vaccine second dose and patient was not feeling well. patient got the vaccine in the morning and midday patient was having like headache, tiredness, muscle pain and last night, patient was not shivering but patient was feeling chills inside her body like patient was under the layers of blanket, but patient did not have fever. My temperature patient kept taking it was last 98 to 97.9 something like that. Patient kept taking her temperature, but patient so painful in her joints, all muscle aches. Patient was so tired and weak on an unspecified date in 2021, for headache patient have taken Tylenol (Treatment) it comes in and goes. The outcome of the events headache, tiredness was not recovered while unknown for another events. Information on Lot/Batch number was available. Additional information has been requested

inapproriate schedule of vaccine administration; Shingles; Fever; chills; muscle aches; fatigue; This is a spontaneous report from a contactable consumer or other non hcp. A 60-years-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, dose 1 (Lot Number: er8731 expiry date was not reported) via an unspecified route of administration at arm Left on 16Apr2021 16:00 as a single dose, dose 2 (Lot Number: ew0182 expiry date was not reported) via an unspecified route of administration arm Left on 16Apr2021 (inappropriate schedule of vaccine administration) as a single dose for covid-19 immunization (age at vaccination:60-year-old). Medical history included appendicitis, hysterectomy, gallbladder disorder from an unknown date and unknown if ongoing. Concomitant medication(s) included levothyroxine sodium (LEVOXYL), ginkgo biloba (GINKO [GINKGO BILOBA]), magnesium (MAGNESIUM) taken for an unspecified indication, start and stop date were not reported. The patient previously took sulfa [sulphanilamide] and experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. on 24May2021 12:00 the patient experienced shingles, fever, chills, muscle aches, fatigue. Therapeutic measures were taken valacyclovir as a result of shingles, fever, chills, muscle aches, fatigue. Outcome of the events was not recovered. Follow-Up (12Jul2021): Follow-up attempts are completed. No further information is expected.

~20 mins (0852) after receiving the 1st dose of Pfizer vaccine, complained of itchiness on her back, legs. She denied swelling of throat/tongue, difficulty of breathing. BP 190/93, O2 sat=96. 25 mg. Benadryl given x1 at 0853. 20 minutes later, verbalized persistent itchiness on her back and left foot. A second dose of Benadryl 25 mg. given at 0913. 10 minutes later, verbalized she's "feeling good". Patient advised to get clearance from her PCP regarding the second dose of the Pfizer vaccine.

muscle pain; This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer (patient) reported for herself. Report 1 of 2. A 60-years-old female consumer received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6204, Expiration date: unknown) via an unspecified route of administration, administered in right arm on 17Mar2021 (age at vaccination 60 years) as dose 2, single for COVID-19 immunization. The patient's medical history included breast cancer survivor (survivor for 14 years and stated she was not taking anything for that) and immunocompromised person (she had an auto-immune disorder). The patient's concomitant medications included infliximab (REMICAID) taken for autoimmune disorder (she initially started therapy with Remicaid in Sept2019. She had to change her remicaid infusion and pushed that back a week because they said the remicaid and Pfizer COVID vaccine should not be close together), ascorbic acid, ergocalciferol, folic acid, nicotinamide, panthenol, retinol, riboflavin, thiamine hydrochloride (MULTIVITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;FOLIC ACID; NICOTINAMIDE; PANTHENOL; RETINOL; RIBOFLAVIN; THIAMINE HYDROCHLORIDE]), fish oil and calcium carbonate, colecalciferol (VITAMIN D 2000) taken for an unspecified indication (she began taking those for years but has no idea for how long). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6202, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 24Feb2021 at 16:30 pm (age at vaccination 60 years) as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. No additional vaccines were administered on same date of the Pfizer Suspect. The patient had received both dose of the Pfizer COVID vaccine and was tested and did not have any antibodies present. She asked about information for immunity of the Pfizer COVID Vaccine if she did not get immunity to it. After testing she asked if she had immunity to the Pfizer COVID vaccine and after testing had no immunity from the Pfizer COVID Vaccine. The caller wanted to know whether Pfizer had any studies specific for immune compromised individuals like her. On an unspecified date in Mar2021, patient experienced muscle pain for a little bit of time. She stated that the muscle pain began after the 2nd dose of the Pfizer COVID Vaccine and the pain was not that bad and it was not like she took anything for it and it did not interfere with anything and the pain resolved and it lasted a day and a half and thought it was from working out or something she did but then thought it was probably the vaccine and realized it came on suddenly while she was at work, stated the muscle pain began the day after the 2nd dose of the vaccine 24 hours after the 2nd dose. The patient underwent lab test which included Antibody test: negative (she did not have immunity from the Pfizer COVID vaccine) on 28Jun2021. She took both Pfizer COVID shots but she still had no antibodies for the SARS-COV-2. There was a product compliant. The outcome of event was resolved on an unspecified date in 2021.

Injection site pain; Tiredness; Headache; Muscle pain; Chills; Nausea; Feeling unwell; 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: EW0161) via an unspecified route of administration in the arm left on 27Apr2021 at 13:45 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient received unspecified medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01May2021 at 09:00, the patient experienced injections site pain, tiredness, headache, muscle pain, chills, nausea and feeling unwell. The clinical outcomes of the events injections site pain, tiredness, headache, muscle pain, chills, nausea, feeling unwell were recovering. No follow-up attempts are needed; No further information is expected.

Vertigo; Diarrhea; Brain fog; Muscle pain; Headache; Tiredness; 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: Ew0164) via an unspecified route of administration in the left arm on 22Apr2021 at 15:15 (at the age of 60-years-old), as a single dose for COVID-19 immunisation. Medical history included polycystic kidney disease, dry eye, iritis and uveitis. Concomitant medications included fexofenadine hydrochloride (ALLEGRA) of dose 180 milligram (mg), irbesartan (MANUFACTURER UNKNOWN) of dose 75 mg and valaciclovir (MANUFACTURER UNKNOWN), all from unknown dates for unknown indications. The patient past drugs included paracetamol (TYLENOL), topiramate (TOPAMAX), penicillin (MANUFACTURER UNKNOWN), latex and cefalexin (KEFLEX). The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ep6955) via an unspecified route of administration in the left arm on 29Mar2021 at 16:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 23Apr2021, next day of vaccination, the patient experienced muscle pain and headache and on an unknown date in Apr2021, the patient experienced tiredness for three days then felt fine until brain fog started on 8th day after vaccination on 30Apr2021 at 12:00. On 02May2021, 10th day after vaccination, the patient experienced diarrhoea and on 03May2021, 11th day after vaccination, the patient experienced vertigo. The clinical outcome of the event tiredness was resolved on an unknown date in Apr2021 where as the outcomes of the events muscle pain, headache, brain fog, diarrhoea and vertigo were not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.

Reports the following symptoms: Left shoulder pain, diarrhea, nasal congestion, sore throat, cough, Itching all over body, scalp pain and tenderness. 12/28 Began feeling better, mild cough persists. 1/4: Feels as though she has "bad flu" fever of 101 F.

Patient describes feeling feverish, joint aches in elbows and knees, body aches, red rash at knees and elbows and arm pain at injection sites. This is the 2nd dose, patient reports no adverse reactions on the first dose.

Headache; muscle aches and pains; feels like she is getting a fever; thinks she is having the chills; feeling a little warm/ She is cold, too; 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: EK9231) intramuscular on left arm, near the top (in the muscle), at single dose for vaccination on 29Dec2020 at 12:45 pm at 61-year-old. Medical history included: hay fever allergies, allergic to prochlorperazine maleate (COMPAZINE). Concomitant medication was not reported. No additional vaccines administered on same date of the Pfizer vaccine. On 30Dec2020, the patient stated her headache started about an hour and a half ago. She started having the muscle aches and pains when she woke up this morning. She felt like she was getting a fever, but she was at work and couldn't take her temperature. She was feeling a little warm, she was cold, too. She was having the chills. The patient confirmed all of these symptoms just started happening this morning (30Dec2020). No emergency room nor physician office visited. No relevant tests. Action taken for BNT162B2 was not applicable. Outcome of the events was not resolved. It was reported as non-serious.

couldn't lift my head off my pillow; severe pain in neck; squeezing on a nerve; had soreness in my arm; This is a spontaneous report from a contactable nurse, the patient. A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 18Dec2020 (at the age of 61 years old) as a single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. On 18Dec2020, the patient experienced soreness in her arm that was gone by the next day. On 23Dec2020, while driving home, she felt severe pain in neck. She almost felt like something went up in her neck and started squeezing on a nerve. It proceeded to get bad so she took muscle relaxants. Christmas day was horrible, she couldn't lift her head off her pillow. The pain came from up head, under her clavicle and down her back. Her pain started getting better, but then next morning it up started again. The only way she's able to get some sleep is to take Flexeril, 800mg of Motrin and applying moist heat. The clinical outcome of severe pain in neck, squeezing on a nerve, couldn't lift her head off her pillow was unknown, and for event had soreness in her arm was recovered on 19Dec2020. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Headache, Myalgia, Arthralgia, Chills, Fatigue, Injection Site Pain Narrative: Adverse reaction lasted 3 days, employee did not report to work on day 3 after vaccine.

muscle pain in left shoulder blade and under left breast; rash which resembles shingles without blistering; redness on left should blade and over left breast

01/08/21 02:30am on set of headache, 01/08/21 05:15am nausea Headache, called in for work due to this being so bad, 01/08/21 08:54am hip pain/throbbing, took motrin. reported difficulty to bear weight, stayed in bed all day. 01/09/20 01:00pm reports much improved continues with slight pain today, but able to ambulate and function without problems.

First dose given 12/18/20 with expected muscle stiffness soreness later that evening and the next day. Dose two given on 01/07/21 with onset of shaking chills on 01/08/21 at 2:00am, ensuing fever max 101.7 degrees Fahrenheit, at 4:00 am noticed redness of eyes, face flushed with burning feeling, headache, dizziness, blood pressure of 184/96 and heart rate of 153. This required medical evaluation and treatment with IV fluids and Toradol for resulting headache. Patient also self administered 1000mg oral Tylenol prior to ER evaluation.

Headache, Myalgia, Arthralgia & Fever Narrative: Missed work following vaccine administration second dose due to headache, fever, myalgia, arthalgia.

Slight headache the night I received the dose, shot site redness and muscle pain for 2 days after receiving dose

Myalgia, Fever chills, fatigue Took a couple of days off from work, laid in bed x2 days and let it run it course.

Arm pain post injection Severe pain in shoulder joint, down arm, pain elbow, pain firearm and hand on left side. Diagnosed as reactive arthritis due to vaccine

Myalgia, Fever, fatigue, chills Narrative: 6-8 hours after the vaccine had chills and body aches. This lasted until the next day - 24-30 hours. She also developed a low grade fever to 100 degrees. Symptoms resolved by Thursday 1/7.

Headache, Myalgia & Fever Narrative: missed two days work following second dose of vaccine due to flu like symptoms

Initially mild nausea, moderate abdominal cramping for 30 minutes then severe watery diarrhea and moderate to severe abdominal cramping with moderate chills lasting 6 hours. Any fluids taken ran right through me. 4 lb weight loss and muscle cramping from dehydration. 12 hours after symptoms started I was able to take fluids and eat crackers. 24 hours after start felt shaky with mild abdominal soreness but improvement progressed and by 28 hours after start if symptoms felt normal other than I felt like I did 100 sit ups!

Headache for3 days Nausea for 3 days Muscle weakness for 3 days. Joint pain for 3 days. Red rash at injection site. Swelling at injection site. Diarrhea for 2 Days

trouble lifting things like my tea kettle; lot of pain in right elbow; bad neck and shoulder pain; bad neck and shoulder pain; sore right arm similar to after a tetanus shot; This is a spontaneous report from a non-contactable nurse (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot number: EL1284, intramuscular on right arm from 05Jan2021 09:45 to 05Jan2021 09:45 as single dose (first dose) for COVID-19 immunisation. Medical history included none. The patient's concomitant medications were not reported. On 05Jan2021 at 03:00pm, the patient experienced sore right arm similar to after a tetanus shot. On 06Jan2021, the pain in upper arm gone but by afternoon but the patient got bad neck and shoulder pain on right side that she treated with heat and Advil. On 07Jan201, neck pain still present and by late afternoon, the patient got a lot of pain in right elbow. On 08Jan2021, the patient still have the neck to shoulder pain in addition to the right elbow pain. It feels like she sprained her elbow and was having trouble lifting things like my tea kettle. The outcome of the event sore right arm/pain in upper arm was recovered on 06Jan2021; having trouble lifting things like my tea kettle was unknown; while the other events were not recovered. Treatment has been given for the event bad neck and shoulder pain. Since the vaccination, the patient has not been tested for COVID-19. No follow up attempts are possible. No further information is expected.

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

Pfizer-BioNTech COVID-19 Vaccine EUA. //Symptoms began 12 hours after with increase soreness at injection site radiating up and down arm and up into neck ; Body aches especially lower back developed within 24 hours with a severe throbbing type headache and ringing in the ears. Elevation of temperature by 1-2 degrees normal for me runs 97 degrees F and was up to 99 degrees F. Headache intensified with movement(ex. .bending over ,etc) Treated arm soreness and lower back with heat compresses... elevated temp and headache with rest and a lot of water. It is now over 48 hours since vaccination and all symptoms are subsiding but still present with temperature normal for me and no arm soreness. Scheduled day off from work day after vaccination but also a second day due to the severe headache mostly.

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

"Pfizer-BioNTech COVID-19 Vaccine EUA", Injection site pain, Severe tiredness, mild headache, muscle pain, fever, loss of appetite, HR in lower 90's, pulse OX in low 90's.

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.

Received Vaccine on 1/2/2021 at 10AM , at 3PM employee felt itchy, took a nap, and at 8PM she had a circular redden skin rash on her arms, legs, and torso. Temperature: 99 degrees. Employee took Tylenol and Claritin for rash, complained of diarrhea, vomiting, and weakness of both knees within 24 hours all symptoms were gone.

Was cold, took a shower, got out , couldn't get warm. Freezing and shaking, nausea, tingling in left side of face, joint pain, headache and neck pain. Lasted about 3 hours, shaking stopped but had chills that lasted all night. The next day, no appetite but when she ate something, she vomited. Worse things were shakes, headache and neck pain and vision. . Had vision problems. Eyes were swollen and jittery and hard to focus. The swelling went away but still unable to focus. Everything has gone except vision issue.

24 hours after my 2nd vaccine I had symptoms of severe fatigue and body aches. I had a low grade fever and headache. The following morning I had pain in my left axilla, low grade fever, headache and body aches. I left work early because of severe fatigue and was out the following day for symptoms due to covid vaccine.

Though I had pain and soreness in the arm after both the shots I am left with a residual weakness and ache in the arm almost a month later. I find I am not able to lift items that I was able to lift last month and there is a lump in my left upper arm that is new as well.

Could not raise right arm above shoulder. Extreme fatigue. Sneezing with first shot. Sneezing, aching in joints., headache, chills with second shot.

Joint pain (all joints felt like they were on fire - different than usual arthritis pain - could barely walk or hold a cup of water due to pain), significant fatigue (barely able to get out of bed) recurrence, brain fog recurrence, headache , muscle pain, I felt almost like I did when I had COVID - starting to subside now 4 days after vaccination

The first thing I had nausea and stomach pain (for 2 days) in the AM and then it went to achy, joint hurting and headache. It was not like I could not work or anything, it was just there. On the 9th day I woke up with fever and chills and a super bad headache and I felt so bad I could not even go seek medical care, I finally went after 3 or 4 days feeling like that. At the walk in clinic they tested me for flu, covid and strep and on the rapid the result was negative but when done the PCR it came back positive (around 12/29/20). I did not have any respiratory issues on this one. I do remember having diarrhea.

STarted having nausea around 10am on 1/21/21, then at noon started having chest pain and a migraine. Went home early from work. As of 1/22/21 0830, still has chest pain but not as intense and it radiates to left shoulder and towards back (advised employee to have this evaluated)

I was at work yesterday morning and began to feel shaky. Progressed to both hands trembling; legs feeling weak and wobbly. Could not perform my work duties. Progressed to Rigors. Lasted at least 3 hrs in it's severest form. Now, 24 hrs later I still have some hand tremors, and legs are weak. Shoulder, knees, hips achy. I'm very fatigued. Right arm soreness @ injection site. All events were reported. I was sent home from work, had to be driven home. I rested, slept and hydrated the remainder of the day. Did not go to work today.

Had when I woke up at 6 am set on Jan 22, 2021 still ongoing Sore throat, severe headache, nausea, muscle ache, light headness, dizzy. January 22, 2021 temp 100.1 tympanic

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.

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.

No problems with first vaccine. Started having severe head aches 2 days after the vaccine. Back Ache after 5 days on the right side. Throwing up 6 days after for 3 days. Went to the hospital 10 days later for four days was taken by ambulance because she was to ill to drive.

Approx 18 hours after the vaccine: Cold and hot flashes with chills (no fever) weakness, fatigue, slight left arm ache, loss of appetite, insomnia, body/joint aches. I took a couple of Aleve tabs 24 hours after the vaccine and then switched to 500 mg Tylenol 30 hours after the vaccine, with no relief of symptoms from either meds. I've been sleeping (taking 2 hour naps) and called off of work (I work in home health). Today, 1.27.21 I feel better, still having 'hot flashes' and some chills (again, without fever). I feel tired, slept last night for 12 hours (no further insomnia). I am eating, but really have no appetite.

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.

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.

Pain in shoulder joint starting the morning after I received my first dose. Continued till date of my second dose and got worse after 2nd dose given in same arm due to medical recommendation for better vaccine response. Have pain on lifting arm. Can?t raise it more than 75 degrees without great pain. Trouble pulling or pushing with that arm or carrying heavy things. Have not had issues with this arm before vaccination.

This is a spontaneous report from a contactable physician (patient). A 61-year-old female patient (not pregnant) received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number: EL3294 and Expiration Date unknown) via an unspecified route of administration on 11Jan2021 07:15 AM (Right arm) at single dose for COVID-19 immunisation. Previous vaccine included first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number: EK5730 and Expiration Date unknown) via an unspecified route of administration on 21Dec2020 03:45 PM (Left arm) at single dose for COVID-19 immunisation.No covid prior vaccination, no covid tested post vaccination and no known allergies.Other medical history included thyroiditis and scleritis The concomitant medications included Levothyroxine, Vitamins, paracetamol (TYLENOL), Pepsid, Melatonin. No other vaccine in four weeks. Patient experienced, fatigue, left under eye bruise, right eye injection, joint swelling, gum bleeding with brushing on 13Jan2021 08:00 AM, resulted in Doctor or other healthcare professional office/clinic visit. The outcome of events was not recovered with unknown treatment.

Headache/Could not pick my head up; All the muscles in my shoulders and my back were tightened up/muscles are still tight and at all the way to my neck; Muscle pain; muscles in my neck are all tied up between my shoulder blades, my shoulders all was shrugging and I could never release the muscles back that is what I felt like.; Could never release the muscles back that is what I felt like/My muscles never acted this way; This is a spontaneous report from a contactable nurse (patient). A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number, expiration date unspecified), via an unspecified route of administration on 31Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Nurse reported that she had severe side effects but not an allergic reaction. She had the vaccine on Thursday (31Dec2020) and by Sunday (02Jan2021), she had a horrible headache, all the muscles in her shoulders and back were tightened up. And all the week long, she kept trying to keep care with hot packs and cold packs and Advil and Maxalt and all kind of things but could not. Yesterday morning (as reported), she lifted nothing heavy, did nothing different at all and she could not pick her head up. Patient had to seek for medical attention just at her doctor's office not at the hospital. She had to have somebody and take care of muscle pain. She still have the muscle pain she do have to go back but they did give a muscle relaxant. Patient reported that she never had a reaction ever like this. Nurse further stated that she didn't do anything as a precursor before the vaccine or after the vaccine. The muscles in her neck were all tied up between her shoulder blades, and her shoulders all was shrugging and could never release the muscles back that was what she felt like. Nurse stated that she just have to take the second shot, that was just the first one. Somebody told her that she have to report it because it took her off the work for two days. And her muscles were still tight and at all the way to my neck and still have headache. She had a shot on 31Dec2020, and symptoms started on the 2nd. Patient reported that she never had such kind of pain before and her muscles never acted this way. She was advised by her healthcare provider that there were side effects and this one she consider severe. She was advised to continue to take the second one. Outcome of the events headache/could not pick my head up and all the muscles in my shoulders and my back were tightened up/muscles are still tight and at all the way to my neck were not recovered; outcome of the rest of events was unknown. Information on the Lot/Batch number has been requested.

alost fainted- very pale, then tachycardia, high blood pressure, diarrhea. This reoccurred i waves over the next week. Also fatique,, muscle and joint pain. for 6 days also had sever headace, numbness in face and lips, spasm of left eyebrow. Mised wek of work, ended up in Emergency room. Had negative covid test. sent home. Was fatiques and dizzy and brain fog for next three weeks. Took a month to feel rigtht.

Metallic taste in her mouth. Violent shaking for 11.5 hours and pulled muscles in her stomach and back. Injection site hot. Fingers on that side were white Dizziness. H/A. Vomiting

12 hr after vaccine, sore arm, a little achy. 15 hrs after vaccine (11 pm) and through the night, felt very cold and had difficulty getting warm, headache, all body achy, unable to get into any comfortable position and very limited sleep. By 24 hr after vaccine and continuing until 40 hr after, nausea most of day, severe muscle pains, headache, difficulty moving from pain and general weakness, head swimming sensation. felt like skin crawling sensation all over. By 48 hrs, much less headache and nausea, able to eat, still had skin crawling sensation and achy but able to walk around a bit, not able to go outside. By 58 hr after (at time of report), just weak all over feeling, head fuzzy but better. Treatment: ondansetron x 2 doses (at 24 hr and 20 hr), Nurtec x 2 doses at 15 hr and 20 hr), Acetaminophen 8 hr x 2 doses (at 36 hr and 48 hrs)

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.

(This is a duplicate entry. I mistakenly entered that patient received the Moderna vaccine, but she in fact received the Pfizer.) I got the 2nd dose of the Pfizer vaccine late last Wednesday afternoon (1/20). Before the 2nd dose, I premedicated (as instructed by my medical office) with Benadryl 50mg and Pepcid 20mg (for the histamine blocking effect) since I had terrible itching for about 36 hrs after the 1st dose; but the itching didn't begin-after the 1st dose-until about 8hrs after the shot & became intense 2 more hrs later. I had itching the night of the 2nd dose that kept me awake part of the night but was FAR less intense than after the 1st dose. I came to work Thurs not feeling ill--just cold and tired all day (I attributed to the cold weather and not sleeping well). Thurs about noon I began feeling ill--like I was coming down with the flu; I went home after my shift and found my temp to be 100.4. Shortly thereafter it was 100.9. I thought it would pass by morning so I just showered, drank fluids, took Tylenol and slept. By 0200ish Fri 1/22 I still had a fever of 100.9 (even with Tylenol on board), a bad headache, sinus congestion, and significant neck and back pain so I called out for work. I continued to treat the fever and by noon Fri the fever finally had resolved-along with the head, neck and back pain. I've been fine since.

Slight fever/ her temperature usually runs 97 and currently is 99.4; joint pain because her hips hurt/ her hips were really sore; Chills; Arm pain; Headache/ pain at the base of the head/ pain in her head; Neck pain; Shoulder pain; pain everywhere; 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 VACCINE, lot number: EJ16R6), intramuscular in the left arm on 17Jan2021 09:30 at single dose for COVID-19 prophylaxis. The patient medical history was not reported. There were no concomitant medications. The historical vaccine included the first dose of BNT162B2 on 26Dec2020 at her 60-year-old for COVID-19 prophylaxis. The patient was a physical therapist (non- Healthcare Professional), she received the second dose and was having almost every side effects. She experienced arm pain started night around 17Jan2021 17:00; headache, pain at the base of the head, neck pain, shoulder pain, pain everywhere on 17Jan2021; chills that she couldn't get rid of on 17Jan2021 19:00; slight fever, and overall feeling tough, joint pain because her hips hurt on 18Jan2021. At 17:00-19:00 on 17Jan2021 and stated that she could not tolerate her head being upright. She stated that she went to bed at 19:00. Pain in her head, neck, and shoulders is a little better because she can actually sit up now and hold her head up. She said that her temperature usually ran 97 and currently was 99.4. She said that she did not take her temperature on 17Jan2021 and did not get up until 13:00 and stated that she took it when she got up on18Jan2021. She noticed joint pain when she got up on 18Jan2021, her hips were really sore. Chills started at night, when she went to bed she had the chills around 19:00 17Jan2021. The outcome of pain in her head, neck, and shoulders was recovering, of the other events was not recovered.

lost 22lbs; teeth hurting; can't eat; sores in mouth; cold chills; Headache/it's mainly in the back of her head; Diarrhea; Throwing up/threw up 4 times; low grade temp of 100; This is Spontaneous report from a contactable consumer reporting for self. A 61-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), via an unspecified route of administration in Right arm on 14Jan2021 10:00 at single dose for covid-19 immunisation. Patient received 1st dose of bnt162b2 on 24Dec2020, Lot number: EL0140; She only had a little aches with the first dose. States that she has had Covid before. There were no concomitant medications. She got the 2nd covid vaccine and felt like she got Covid all over again, diarrhea, throwing up, cold chills, and headaches started on 15Jan2021 at around 2:00AM, low grade temp of 100 on 15Jan2021, then she got sores in her mouth and now her teeth hurt. States that maybe it's from the fever. States that she can't eat because it hurts. She lost 22lbs because she couldn't eat. She has been gargling with half warm water and half peroxide. States that she threw up 4 times, but she doesn't even remember how many times she had diarrhea. After she was done throwing up she finally sat down and took her temperature, so it was probably around 4:00-5:00 AM. States that she still has a headache; it's mainly in the back of her head. Outcome of event diarrhea, throwing up, low grade temp of 100, chills was recovered, of headache was recovering, of can't eat and lost 22lbs was unknown, of others was not recovered.

FATIGUE, SORENESS AT INJECTION SITE, MUSCLE ACHES, DIZZINESS, LIGHT HEADEDNESS, MUSCLE AND BODY ACHES

I experienced muscle aches the spread across my entire back starting at about 8 PM on 2/4/21. At 2:30 AM on 2/5/21, I passed out three times after rising from the toilet, resulting in a split lip. I was covered with sweat the third time I "came to" and soon got the chills.

Mild headache that evening, arm slightly sore during the night and the next day. Frontal headache and muscle aches the next day on 1/22/21. Some fatigue and nasal congestion that next day as well. Some fatigue and headache on 1/23/21. Took Tylenol once on 1/22 and 1/23.

I am not sure this is what i shoud be filling out - just wanted to report what seemed like pretty bad symptoms on first dose by all info i have found. The actual shot was given by another facility than listed previously. I recieved the first dose of Pfizer at Health Dept . No other location information was provided by them. When i got the shot, a blood vein and possibly a nerve was hit. The nurse did everything properly i think to correct and notify other RN. It caused immediate pain in left fingers and arm felt heavy. That continued for days, but not too bad and injection site itself really was not very sore. My concern was how sick I felt starting within 6 hours of the injection and how long it lasted. I had pretty much instant nausea- no vomiting- mild but persistant, severe fatigue and general overall uneasy/sick feeling. Joint pain started within the 6 hours, along with a few odd pains in neck and right abdomen. Was extremely chilled for hours, pretty bad tension /tight feeling headache, jittery feeling and foggy. I took a 500mg Tylenol about 8 hours after the shot, and it helped to relieve most symptoms to a degree that was nagging, but tolerable. I pretty much went through this for about the next 3 days and off/on to the 5th day

Pt stated -Onset 12-16 hours post injection of shills, headache, body ache, joint pain and fatigue. The symptoms lasted a day and resolved.

Body aches; fever(100.1); chills; runny nose; cough; headache; fatigue; neck pain; head congestion; This is a spontaneous report from a contactable nurse reporting for herself. A 61-year-old female patient (non-pregnant) received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL9261), via an unspecified route of administration on 20Jan2021 at single dose on left arm for COVID-19 immunisation. Medical history included Irritable Bowel Syndrome with Constipation (IBSC), anxiety, allergies, Known allergies: sulfa. Historical vaccine included 1st dose of BNT162B2 (lot: EL1284) on 28Dec2020 at 14:00 via intramuscular at single dose on right arm for COVID-19 Immunization. Concomitant medication included celecoxib (CELEXA [CELECOXIB]), montelukast sodium (SINGULAIR), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), lisdexamfetamine mesilate (VYVANSE) and linaclotide (LINZESS). The patient experienced body aches, fever (100.1), chills, runny nose, cough, headache, fatigue, neck pain and head congestion, all on 21Jan2021 at 14:45 with outcome of resolving.No treatment was received for the events. This case was reported as non-serious.

Initially after injection I felt as if a rapid heart beat (but 60 minute pulse count was no more than 80 and was regular). Discomfort in arm began, progressed to inflammation and difficulty in movement of arm especially to lift arm. Used Tylenol or Motrin PRN for relief as well as heating pad intermittently. After 1/23 injection discomfort seemed to lessen but on 2/9 (4 days before second injection due) discomfort still persists. Due to persistence of symptoms seen in Urgent Care diagnosis Adhesive Capsulitis of right shoulder and acute pain of right shoulder. Treatment, Physical Therapy and Ibuprofen. Unable to use steroids due to diabetes. Follow up scheduled 2 weeks 2/16/2021.

From charting for point of care services before EMS transport: Chief Complaint: Immunization Visit: Client received Pfizer Vaccine at 11:30am. At 11:32 am client reports "throat feels a little funny" and Chest tightness. No difficulty breathing reported. Lung sounds clear bilaterally per RN at 11:38am. Pt reports that her throat still feels funny after administration of benadryl by RN. Epi was administered at 11:40am by RN. EMS arrived at 11:42am. Client has is now complaining of jaw pain. Reports shoulder pain ( residual from recent accident). Vital signs obtained by RN Her husband was present when EMS arrived and will follow client to the hospital.

On 2/5 am felt dizzy and nauseated. On 2/6 am felt dizzy and nauseated On 2/7 had child, abdominal cramping and pain , Temp 99.3 On 2/8 stomach uncomfortable, fatigue and muscle aches. 2/9 feel tired

Injection Site Pain, tiredness, headache severe, muscle pain, chills, joint pain, fever, nausea, feeling unwell, cough

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.

Left thumb and all the way to the wrist sore, inflammation, very painful, sore, tender, stiff. on a scale of 1 to 10 on pain, it is an 8. Keep thinking it will get better each day but it is not getting better.

Developed generalized rash over body, more pronounced on knees and lower legs. Rash remains now but is lighter. Significant L knee pain.

Patient was administered vaccine at 11:00 AM in the left deltoid muscle IM. Patient reported feeling chest tightness, heaviness as if someone was sitting on her chest, pressure on her chest, and found it a little hard to breath at 11:10 am. Patient had a history of congestive heart failure and suffers from anxiety, but wasn't sure if the chest pain was due to her past medical history or the vaccine. At 11:17 am the chest pain remained the same. At 11:30 she was still feeling chest pressure and her right arm was feeling weak. At 11:30 Heart rate was 56, Blood Pressure was 138/72, and respiratory rate was 12. EMS was called at 11:35. Patient was taken to the hospital once EMS arrived.

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

Around 1 am on 1/29/2021, hot flashes, fever 99, & a little bit nauseas this lasted 48hrs. My legs felt weak & shaky legs and fuzzy head. I feel with no energy. This symptoms are still going on.

Around 2am on 1/8/2021 I woke up having chills, nauseas, fever, dizzy felt like I was going to faint, foggy head, very fatigue, shaky weak legs & body aches. The chills, body aches, fevers & dizziness were under 48hrs. The other symptoms lasted till 2 days before I got my second dose. Tight Chest going on but I think it might of been anxiety. Phone consult with doctor and prescribe some steroids.

I want to report to Pharmacy and/or CDC what I have experienced with both shots (separate arms). In both cases, my upper shoulders into my neck hurt and tighten the day after the shot. The following day it was gone but it returned on or around day 4 and it has not gone away. I have seen my medical doctor, acupuncturist, chiropractor and a massage therapist. My doctor believes the shot activated some sort of chemical tendonitis. I took my second shot last Friday, in the other arm hoping it was simply coincidental, but I am having the same experience. I wanted to know who I should call to report this and was curious if anyone else has experienced this challenge. Thank you.

patient reported: Mild headache after the vaccine, Headache resolved after 1-2 d After 2 days of vaccine she started feeling right leg heaviness (whole leg) , she was dragging when she walks But no visible swelling, pain, redness per patient, She states at that time she was able to stand and move leg fine but only when she walks she needed to drag No facial weakness , upper extremities symptoms . Had slurry speech intermittent for 1 week after vaccine (Currently none) Lasted for 2 weeks, then resolved completely. after that no symptoms at all. Now Waking fine, no facial weakness, no extremities weakness She did not call us at that time as she thought it is side effect of covid vaccine and thought it would go away. When she went for covid vaccine #2, they said she needs to contact primary care physician due to some symptoms after first vaccine,. then she called us for an advise. by the time she called, no symptoms of neurology. MRI brain: did not show any abnormalities Discussed with local Infectious disease specialist: not sure those were vaccine related or not, recommended to report.

Right side upper arm ache spread to right side of neck and into headache at back and top of skull. Persisted through night and spread down into right side of neck to left arm ache. Throat became red and right, then left side of tonsil became pus filled. Chills but no fever. Fatigue every day. Took 2-3 hour naps every couple of days and slept 8-10 hours through the nights. Headache off and on for 10 days. Throat remained red, becoming most sore late afternoons, voice hoarse. On and off drippy nose. On the 13th day I felt normal energy level in the morning but today, my 15th day at nearly 3pm, my normal energy is waning and throat becoming sore again.

Pain on right-side of back all the way to front of chest and under breast and part of right shoulder. Week prior felt sensation of "pins and needles" on back. Patient reports 1 blister spot on chest. Patient went to urgent care and was diagnosed with shingles. Doctor prescribed Valtrex and Ibuprofen.

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.

arm/joint pain, vomiting chills low grade fever overnight, headache. Severe pain in shoulders, hips and lower back lasted 3 days. lymph nodes in armpits very sore. headache lasted 2 days. vomiting lasted 8 hrs. fever(99-101) lasted 2 days. had 3 minor breathing incidents which was alleviated by using rescue inhaler(albuterol) Called in to Health Service and messaged primary care, was advised to take advil, tylenol, lots fluids and get tested for COVID19.

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

The next day, when I woke up I was unable to stand on my left leg. Pain in the posterior knee. Felt like I was walking through mud. Joints were all loose. Just a really bad left knee pain. They a lower extremity doppler to that leg - to look for blood clot and that was negative. Physical therapy - taped my knee; pain was so bad I had to stay home a couple of times. My hands (both) were so painful. Like I had frostbite. Occupational therapy did hand massage and paraffin for the pain. And isotoner glove at night and that helps with the buzzing. I am 2 months out today from the vaccine and I'm starting to feel like normal. Took two months to fade away. It may have been because I was still having COVID antibodies. COVID antibodies on August started at 6.95. I'm not totally recovered right now but I'm close to normal. Doctor visit - January 29, 2021 and February 5, 2021.and February 19th. They put me on high dose of Steroids - 20 mgs Prednisone daily and another round of blood thinner -ELIQUIS mg which helped me with pain and joints.

Severe neck soreness and tenderness 2/27 & 28, took Tylenol Rash& Itching at injection area. 2/27 4:00pm. Itching stopped 2/28 however the rash is still present on 3/2. Took Benadryl.

First headache, vertigo, dizziness, nausea, neck tension, left arm weakness. Progressed in the course of several weeks to both legs weakness, and then the right arm, tension in the jaw and the face (altered facial sensation). Poor balance. Symptoms continue getting worse. Unable to work.

still have sore muscles in my shoulders; still feeling bad with all the above symtoms; 23Jan2021 went to get covid test but due to blood in my nose received antibody test which was neg; bad headache; winded; vomited; diaherra; coughing/cough; large clots gushed from my rt nostril went to er stopped bleeding after 2 hrs; large clots gushed from my rt nostril went to er stopped bleeding after 2 hrs; This is a spontaneous report from a contactable other hcp (patient). A 61-year-old female patient received their first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1283, expiry date not reported), via an unspecified route of administration on the left arm on 20Jan2021 18:45 at single dose for COVID-19 immunization. Medical history included diabetes mellitus and high BP from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine, losartan potassium and sodium fluoride (CREST CAVITY PROTECTION). The patient previously took septra and experienced allergies. The patient reported that on 21Jan2021, they woke up and brushed their teeth then at 6:40am blood with large clots gushed from their right (rt) nostril. The patient went to ER and stopped bleeding after 2 hrs. On 22Jan2021, the patient woke up with bad headache, winded, vomited, diaherra (as reported), coughing. On 23Jan2021, they went to get covid test but due to blood in their nose, they received antibody test which was negative. On 24Jan2021, the patient was still feeling bad with all the above symptoms. Then on 25Jan2021, they went to ENT doctor who cauterized their nose and stated that since antibody was negative to take the maderna vaccine since they have no antibody in their system, the Pfizer vaccine did not work. From 26Jan2021 to 13Feb2021, the patient felt same started feeling better 14Feb2021 but still have sore muscles in their shoulders and cough. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative on 23Jan2021. The action taken in response to the event(s) for bnt162b2 was not applicable. Therapeutic measures were taken as a result of epistaxis and clot blood which include the doctor cauterized their nose. The patient recovered with sequel from the events.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the epistaxis and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including CBC and coagulation panel, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

I have neuropathy symptoms, sore joints and muscles believed due to Tacrolimus. I see a neurologist later this month. Following the first Covid vaccine, these symptoms increased. I was unsure whether this increase was due to the vaccine. However, following the second vaccine, my symptoms increased again and are substantially more severe than they were prior to the vaccine. I am also having increased pain in the area of my liver following both doses.

110/68 97% pulse83 Left arm injection. Client reports heaviness in right arm pressure in her chest almost immediate 10:10 108/68- pulse 96 pso2 97% right arm heaviness- chest pressure resolved. Client declined ER visit and requested to leave, spouse present will drive client home.

I felt a shooting pain immediately from my arm into my shoulder area, and then felt itching and had a slight rash on chest area. When checked to be released, upon mentioning the rash, they checked my blood pressure, which is normally in the 90-100/68-70 range (low!) and it was 138/80. Sounds normal, but I?ve never had a blood pressure reading that high! I felt ok enough to leave with my husband, but later got dizzy, nauseous and throughout the day my joints (neck, shoulders, arms and legs) got increasingly painful, to the point where I could barely climb the stairs that night without assistance. Note: I run 5K every other day and bike or walk on off days, so I?m pretty active. I took Tylenol and went to bed early and was stiff, but better the next morning. Made myself get outside for a light run and was basically fine (albeit very tired) the next day. First day was a little scary though.

Unsure if this reaction could be Osteoarthritis because it is "symmetrical, definitely a trend of RA"; Unsure if this reaction could be Osteoarthritis because it is "symmetrical, definitely a trend of RA"; Excruciating joint pain in my body; 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 and expiration date were not reported) on 11Feb2021 at a single dose, with route of administration unspecified, for COVID-19 immunization. Medical history included Sjogren's autoimmune syndrome. The patient's concomitant medications were not reported. In Feb2021, the patient had excruciating joint pain in the body. The patient was unsure if the reaction could be osteoarthritis because it was "symmetrical, definitely a trend of RA". The outcome of the events, 'excruciating joint pain in the body', 'osteoarthritis' and 'RA', was unknown. The patient was due to receive the second dose of vaccination on 04Mar2021. Information about lot/batch number has been requested.

Tongue swelled and then went numb - like novacaine had been shot into it, throat swelling by 6 PM, took a big swig of Benadryl, went to Fire station, transported by ambulance to ER, blood pressure got way too low on ambulance ride, difficulty breathing/taking air in, IV applied - hospital by 6:30 PM, breathing still difficult, blood pressure better until it dropped again, IV given and monitored. Stable and discharged around midnight. Friday - Tuesday - very tired, heavy arms and legs, sore throat and tongue, limited to soft, bland. foods.

Day after 2nd vaccine had aching in all joints, chills with low fever, headache lasting 24-48 hours. Hip pain continues worsening with walking and standing over time. Hips started to ache after first vaccine but didn't realize it was attributed to vaccine. Started taking fish oil and Glucosamine tabs for joints. Hip pain after 2nd vaccine increased and continues today. Went to Internal Medicine clinic to be seen on 1/25/2021. Xrays, UA, ANA, CBC and CMP were done. Xrays show mild degenerative changes to hips bilaterally. ANA elevated at 2.1. Everything else within normal limits. Physician then added RA, C- Reactive Protein and Sedrate, all coming back WNL. Will be making appointment with Rheumatoidologist.

After 1st dose : Fatigue/tiredness/lack of energy for 1 day. After 2nd dose: Fever of 101 - 102.6 for 3 days. Hips achy. I have a total knee replacement of my R knee. That became warm to touch, painful and very stiff. The knee surgery was 3 years ago. I was prescribed MOBIC for the knee by my surgeon when I reported the issue.

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.

Begin 4 days after first vaccine on 3/9/2021- First significant increase in thirst; Extreme chills and fever rapidly spiking to 101.5; decrease to about 100 after a few hours and held steady through early morning; decreasing to my normal (97''s) next day; Significant headache from below forward head to left and right side of neck (eustachian tubes and mandibles and lymph nodes) eye pain; vomiting (limited); leg muscle pain/. No injection site reaction 3/11 feel great

Already described people - excruciating pain in my right shoulder arm & elbow causing nausea. Shot given in left arm. I?m at home so far nothing dead or hospitalized thank you

He received his 1st COVID-19 vaccine around January 24th and 30 minutes later developed mild lip edema, itching of the skin Nose and ears. A day after injection patient had Benign fasciculations

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.

Pfizer-BioNTech COVID-19 Vaccine EUA. injection site pain, tiredness, headache, muscle pain, chills, joint pain, fever, nausea, feeling unwell

Sore left upper arm by 5pm, 3-13-21. Very tired, muscular aches whole body, chills/feverish, headache overnight to present, nausea. abdominal cramping and diarrhea x 2 days. Feels like 'the flu'.

Friday evening I was tired and slept a lot. When I woke up on saturday I had pain in my muscles and neck and in my shoulders. I was not hungry and I had a fever(101.2). I slept until 1pm and I started getting nauseous. I never got up off the couch saturday. Pain in left arm/shoulder blade went away around 5pm Saturday. I still had a slight fever and headache saturday evening. Sunday I felt better but I still had a slight fever and headache but felt generally much better. Monday I had no fever no headache, and a little aching in my right arm at the injection site.

My joints swelled which includes knees, shoulders, severe pain in lower back, shoulders, knees. Couldn't do anything. It was a problem. Considered going to hospital for pain on second dose as i ran out of pain pills due to this episode

nausea; chills; diarrhea; bad chest pain could barely breathe; bad chest pain could barely breathe; left arm where the injection was given was very painful from the injection site to her wrist and; left arm where the injection was given was very painful from the injection site to her wrist and; can barely lift her arm over her head; increase in her blood sugar; arm pain; This is a spontaneous report from a contactable consumer (patient herself). A 61-year-old female patient, not pregnant, received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9265), via an unspecified route of administration in the left arm, on 02Feb2021 14:30, at a single dose, for covid-19 immunization. Medical history included diabetes, high blood pressure, and sciatica. Concomitant medications included insulin glargine (LANTUS); metformin; hydrochlorothiazide; candesartan; glipizide (GLIPIZIDE XL) and; colecalciferol (VITAMIN D [COLECALCIFEROL]) - all taken for unspecified indications with start and stop dates not reported. The patient previously received sitagliptin (JANUVIA) and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. The patient did not have Covid prior vaccination. The patient received the vaccine in a public health clinic/veterans administration facility. The patient received the Pfizer vaccine dose 1 on 02Feb2021. The patient experienced nausea, chills, diarrhea and bad chest pain could barely breathe - these have passed. Her left arm where the injection was given was very painful from the injection site to her wrist and she has been alternating ice pack/heat pad and taking Tylenol 650 mg for the pain. She can barely lift her arm over her head. She also noticed an increase in her blood sugar and her blood was really dark - she stated this was unusual. She asked if there was anything she can do or take that might decrease her arm pain. All the adverse events happened on Feb2021 and resulted in doctor or other healthcare professional office/clinic visit. It was reported that the patient had not recovered from all the adverse events at the time of the report. No treatment was received for all the adverse events, except for "left arm where the injection was given was very painful from the injection site to her wrist" (alternating ice pack/heat pad and taking Tylenol 650 mg for the pain). The patient has not been Covid-tested post vaccination.

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

At about exactly 12 hours after receiving the vaccine. I was sitting in my living room watching TV and a sudden severe pain shot through my chest and followed by tightness and difficulty breathing. It was immediately accompanied by a pain between the shoulder blades, cold sweat, nausea, then neck pain and faintness along with the uncontrollable need to move my bowels which was in diarrhea form and continued 3 times within 20 minutes with the other symptoms. After about 5 minutes of receiving the onset of the initial shocking pain, the intensity of the chest pain left but the tightness remained and faded but would return and then subside again every 10 minutes. I went to the emergency room at 11:20pm discharged at 2:50am on 3/19/21.

I had significant chills (causing strong body shaking) starting 3 hours after the shot, followed by 36 hours of intermittent fever combined with chills, fever was high but not measured. I was very weak and at times was unable to get out of bed or stand. I had significant joint and overall body pain, at times unable to stand up straight. As this subsided about 36 hours I remained quite weak. On the night of 16 March I was woken up at 1 am with a very severe headache. I took Tylenol and 5 hours later still had the headache - it subsided after about 8 hours. I additionally had stomach cramping but no vomiting or diarrhea, and had no bowel movements until the episode cleared up. During the 4 days that this occurred I tried to keep well hydrated but still had quite concentrated strong urine. I took Tylenol periodically throughout the 4 days, not starting until after the injection was administered. I still feel a little loss of balance/brain fog and have recurring headaches (not migranes).

Around 7 hours after the shot the left side of my neck hurt a little along with a little sore throat. That evening, I was really tired with body aches. That night I had deep body aches and vomited. I also had a slight headache and coughing. The worst part was the extreme body aches. I felt like I had been hit by a truck. On Saturday (shot was on Thursday), I?m better but my body is sore and I don?t have much energy.

Severe headache; chills; muscle aches; arm and neck pain; arm and neck pain; This is a spontaneous report from a contactable consumer (patient herself). A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN9581), via an unspecified route of administration, on 10Feb2021, 04:00PM as single dose in the right arm for COVID-19 immunization at Hospital. Medical history included gastroparesis, gastroesophageal reflux disease (GERD), memory loss. Allergies to medications, food, or other products was reported as yes. The patient was not pregnant at time of vaccination. Prior to vaccination, the patient had been diagnosed with COVID-19. No other vaccines have been administered within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. The patient experienced severe headache, chills, muscle aches, arm and neck pain on 11Feb2021 12:00 PM. No treatment received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected

Fever as high as 100.7, muscle aches, headache severe, fatigue moderate to severe, Three asthma attacks. One was severe taking 2 hours to resolve. Worse on 3/20 than today on 3/21. I?ve taken 2 Tylenol and used my rescue inhaler 4 times. The inhaler improves my breathing, but I don?t feel normal yet. Oxygen saturation between 93-96%. If still experiencing symptoms will call PCP and/or go to urgent care. If I?m still coughing I will have to reschedule a hematologist appointment.

16.5 hrs after injection stomach cramping and diarrhea every 2 hrs x 3. 24 hrs after injection chills, fever (99.1), joint pain, fatigue.

Patient reported to nurse after receiving first dose of Pfizer that 3-5 minutes later her left side of neck/throat felt tight and tingled. Nurse alerted Doctor and myself to assist patient. We arrived to patient's car in front of garage at 10:55 AM and walked beside car as the husband pulled forward to park. Patient stated she received her vaccine about 10:45 and then as her husband started pulling forward, she told him about her symptoms. Dr. assessed patient and stayed with patient until 11:13AM. Patient left in passenger seat with her husband driving stating that she no longer felt the tightness in her neck or throat.

States tenderness to top of left rib below arm pit that started around 2/24/21 and went to PCP on 3/3/21 for evaluation. Reports bloodwork ordered. States she has been getting progressively worse with complaints of bilateral hip pain and discomfort to upper and lower back. Reports she had chills on 3/19/21 but no fever and has been in contact "daily" with PCP.

After waiting 20 minutes, noted some back pain, tightness; on oxygen at home; cannister almost empty. VSS ; uncertain after called about whether to be evaluated/go home; refused ED at that time. Decided if could get in car comfortably would go home, if not, to ED for evaluation. More chest tightness as tried to get in car, decided to go to ED for evaluation; again called.

Pfizer-BioNTECH Covid-19 Vaccine EUA Upper arm ?shoulder pain. Shaking chills, Body aches. Started at 1 a.m. on 3/23/2021. Tylenol 1000mg taken at 5a.m . Chills and muscle aches lasted until 12 noon. Deeling tired and very mild muscle aches continue. Tylenol 1000 mg taken at 4pm.

Pfizer-BioNTech Covid 19 vaccine The night of the vaccine March 11th , I had fever of 100.8, chills, headache, muscle aches, sore throat, joint pain that lasted until Tuesday morning, March 16th. I had no symptoms on Tuesday & Wednesday, but developed hives on my ankles Thursday afternoon exactly one week after the Covid 19 vaccine. When I got up Friday morning I was covered in hives on my legs, arms and abdomen. The whelps were raised and itchy and appeared to be spreading. I went to my HCP and they administered an intramuscular steroid shot and advised me to take Benadryl as needed

BP dropped to 70/40; seizures; She did fall into a cabinet; bruised up; inflamed; back was on fire; if she moves her head quickly, she can feel like she will have a headache, hangover; could not walk; Trouble walking; Funny taste in mouth; Pain/ felt achy; tingling sensation from head to her to spine/ hands tingling/ it was also in her abdomen area and in her leg; Back pain; Could hardly move; could not stand up; autoimmune response; delayed allergic reaction; tweaky muscle/ pulled a muscle in her back; pain at the top of her head down to her hip; pain at the top of her head down to her hip; having trouble holding her urine; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID19 VACCINE, Solution for injection, lot number: EL9266), via an unspecified route of administration in the left arm, on 05Mar2021 1:45 PM at a single dose for COVID-19 immunization. The patient did not receive any vaccines within 4 weeks prior to receiving the BNT162B2. Medical history included allergic reaction, autoimmune disease, brain barrier fever, epilepsy, encephalitis and meningitis. She had epilepsy as a child. She gets epilepsy when she gets sick. The last 4 times she got sick she had a seizure. The last seizure was 1 year ago (in 2020). She may have had COVID, but she got really sick and had a seizure. She is not sure if it was COVID or not. If it was the flu, she does not want that again. She had ataxia and ended up in hospital two times but did not stay. Prior to this, she did not go to hospital for 30 years. She was unable to walk, her gait was real bad. The neurological disorder messed her up for a while. Concomitant medications were not reported. It was reported that the patient received the PFIZER-BIONTECH COVID19 VACCINE first dose and experienced autoimmune response. After the vaccine, she had pain and tingling sensation from head to her to spine (05Mar2021), BP dropped to 70/40 (06Mar2021), seizures (06Mar2021), and delayed allergic reaction (Mar2021). She wanted to know if she should take the second dose or not. She also wanted to know if that would be considered the anaphylactic reaction. It was also reported that the patient experienced funny taste in mouth, back pain, hands tingling on 05Mar2021. The patient further explained that when she got the shot, she had a funny taste in her mouth. It started immediately after she got the vaccine and it lasted 30 minutes. She mentioned this to the people at the facility, but they said she was crazy and no one else has mentioned this. She thought they would be interested, but they did not care. About 20 minutes later she had a tingly sensation. It was in the back of her head that developed into a stingy, painful, heat, funny type feeling. It was all the way down to her back. She later further explained the back of her head was tingling (05Mar2021). Like were the cerebellum is to spine. This sensation is still there, but better. After she felt this feeling her back then started hurting. She bent over and her back went out. She felt achy. She already had what she called a tweaky muscle (05Mar2021). She had pulled a muscle in her back, but it was nothing that had caused a problem. After getting the COVID vaccine it triggered an immune response in her body. She started to have pain at the top of her head down to her hip (05Mar2021). She bent over and she could not stand up (05Mar2021). Her husband had to help her put her pants on and sit down due to this. She started to have horrible back pain (05Mar2021). She could hardly move (05Mar2021). She was having trouble walking (05Mar2021). She was having trouble holding her urine (05Mar2021). On Saturday evening (06Mar2021), her blood pressure started dropping and she later had a seizure. After the seizure occurred it seems like everything got better and she did not have any trouble since. It was very scary. She mentioned she was in the bathroom and there was a tub full of water. She had a hard time already getting to the bathroom. She was in a lot of pain. The amount of pain she had she thinks affected her blood pressure. She had pain in the back, middle of her back. It started at her head, back of head, down her spine, came down to her back and hips. She was hurting a lot and having a terribly hard time getting around. She could hardly walk. She was going to the bathroom because she felt like she had to go. Her husband was helping her sit on the toilet. When she stood up it was like her blood pressure dropped, she almost went headfirst in the tub full of water, but her husband caught her, laid her down, and had a seizure. This was a very unnerving feeling. The seizure did not last more than a minute, maybe two at the very most. The seizure occurred probably around 6PM or 7PM. It did not last long at all. She woke up on the floor. She had been sitting and she thought she had fallen off the toilet. However, her husband had to remind her that a few things happened in between. She almost fell in the bathtub and she has glass doors. She mentioned she felt as clarified and confirmed sped up. She did fall into a cabinet and is bruised up from that seizure (06Mar2021). She is sore from the pain from that. Still inflamed (06Mar2021) possibly due to the seizure. Like she has ruminants of what occurred to back of head, cerebellum. Before she had the seizure, her blood pressure had started dropping. It started dropping in the evening around 5PM or 5:30PM. Mentioned she is a little confused about the time onset because she was hurting so much and bad all day. She does not take any pain medication. She has an autoimmune disease and it is difficult for her to take medications. On top of that, if she wanted to take an Aspirin she was told she should not take one. She was informed she was trying to promote an auto-immune response to the vaccine. As the day ran on, she was in a lot of pain. She had been in pain since Friday and was trying to deal with that. The patient further stated her blood pressure is back, no illness. After the seizure her blood pressure went back to normal and at this time it is perfectly fine. The back pain she experienced went from the brain down to her backbone. The pain is gone. It started to go away after the seizure and by Sunday 07Mar2021 it was totally gone. At first it was like she could not walk (05Mar2021). It was like she/her back was on fire (05Mar2021). The patient also mentioned if she moves her head quickly, she can feel like she will have a headache, hangover. She feels it in her back. She feels like she is near recovery, and this is a feeling she does not thing will stay. She further went on to say her hip where she fell is a different story. However, this is associated to a fall and not a vaccine. She was having this problem when she had the vaccine, but the vaccine caused it to be more and extra aggravating. She later added, when she first got home along with head tingling her hands were tingling as well. When her brain and hands were going through this tingling sensation, she started to notice the back trouble and it was also in her abdomen area and in her legs causing trouble walking (05Mar2021). The events did not require a visit to the emergency room or physician office. Outcome of the events trouble walking, could not walk, tingling sensation and hangover was recovering. Outcome of BP dropped to 70/40 was recovered on Mar2021. Outcome of seizures recovered on 06Mar2021. Outcome of funny taste in mouth was recovered on 05Mar2021. Outcome of back pain was recovered on 07Mar2021. Outcome of bruised up was not recovered. Outcome of the remaining events was unknown. The patient provided an unrelated causality between the vaccine and event fall. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the current available information, the event Fall is most likely related to an intercurrent or underlying condition which is not related to the suspected drug.

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.

I started developing painful nodules upper neck(right), around outside ear(sright) lower jaw line. Being a nurse I thought I was breaking out as the days went by I noticed it was Shingles.

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.

Rheumatoid arthritis/Rheumatoid arthritis attack; herpes outbreak- blisters in her mouth; wound on leg started to get worse, leaking a lot of fluid; back is hurting; felt like a tetanus shot in her arm; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EM9809), intramuscular in left arm on 10Feb2021 14:30 at single dose for covid-19 immunization. Medical history included high blood pressure, rheumatoid arthritis and kidney issues. Concomitant medication included insulin. The patient had the first COVID-19 vaccine. She had a lot of issues wrong with her, however she did not have them hit her at the same time. It was currently the 9th day since she had her first shot. About 4 or 5 days into it, the wound on her leg started to get worse. She had rheumatoid arthritis and she had an RA attack. She had herpes, but she did not had an outbreak in a couple of years. She got blisters in her mouth, and this also hit her. She explained everything hit her all at once. She was now on antibiotics for each one of the things. Her doctor figured out that her body just couldn't handle it. She clarified putting the vaccine into her body, she couldnt fight off everything. Like whatever in in the vaccine and how the vaccines works, her body was just not strong enough to fight off everything at the same time. The patient did not went to the emergency room. It was reported that the patient would receive her second dose on 03Mar2021. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.

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.

Tinnitus moderate to severe onset about 24 hours after vaccination. High pitched ringing both ears. Occurred with a low grade fever, chills, and muscle aches. One alleve (naproxen sodium) pill to address symptoms did not impact tinnitus.

Swelling of throat and neck pain, shortness of breath, headache progressed for 1 hour after shot. Went to ER at Hospital. Took 25 mg Benedryl, declined prednisone, but left ER 2 hrs later with prescription for epipen and prednisone. Took Zytec at home and slept. Symptoms were gone next day.

Injection site pain and redness, tiredness, splitting headache, muscle ache, chills, joint pain, intermittent fever, loss of appetite

pain / swollen area where injection given. joint pain in every joint in my body - never had this before vaccine. Facial muscel spasms; both eyes and left side of cheek area. Never had this before.

Hit with heaviness limbs; whelps all over body arms legs stomach back groin; pain in joints; felt like fire ants; chills; no energy; tightness in chest; This is a spontaneous report from a consumer reported for herself. An 61-year-old female non- pregnant is unknown female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6198), via an unspecified route of administration on Left arm on 02Feb2021 17:45 at single dose for covid-19 immunisation. Medical history included COVID-19, Congested Heart disease, and Penicillin allergy. The patient's concomitant medications were not reported. The patient experienced Hit with heaviness limbs pain in joints whelps all over body arms legs stomach back groin felt like fire ants chills no energy tightness in chest on 22Feb2021. Received Inhalers for breathing and steroids. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient diagnosed with COVID-19; Since the vaccination, the patient not been tested for COVID-19. The seriousness was reported as non-serious. The outcome of the events was "Recovering".

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

Dizzy; Medicine taste in her mouth; Head and neck pain; Head and neck pain/pressure in the face and back of the neck/pressure in jaw and neck; Pressure in the face and back of the neck/pressure in jaw and neck; Pressure in jaw; Pressure in the face; Heaviness in her legs; Cold symptoms in her chest, almost like bronchitis; Cold symptoms in her chest, almost like bronchitis; Throat started getting scratchy/scratchiness in her throat; Itchy in her ear; Phlegm feeling in her throat; Allergic reaction; Getting twitches and surges/felt surges in her leg, like adrenaline shooting through her with no letting up; Tingling in her mouth near her lip and her foot and then in her hand; Tingling in her mouth near her lip and her foot and then in her hand/jolt in her left leg; Not well/feeling of unwell; Spaciness/doesn't feel like herself/feels off/Is in a fog/fogginess; Her mouth is shaky/shaking; Unsteady; She feels like she has a lot of adrenaline; Felt cold; Muscle weakness; Getting twitches and surges; Laborious to walk; Itchy sensation; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6201; Expiration date was not reported) on the right arm on 08Mar2021 (08:30) as a single dose, with route of administration unspecified, for COVID-19 immunization at the hospital. Medical history included being allergic to sulfa drugs and x-ray dye; and had seasonal allergies. Concomitant medications included paracetamol (TYLENOL) and vitamin D3. The patient previously took doxycycline, and was allergic. On 08Mar2021, the patient had cold symptoms in her chest, almost like bronchitis; throat started getting scratchy/scratchiness in her throat; itchy in her ear; had a medicine taste in her mouth; head and neck pain; pressure in the face and back of the neck/pressure in jaw and neck; heaviness in her legs; and phlegm feeling in her throat. In Mar2021, the patient had an allergic reaction; getting twitches and surges/felt surges in her leg, like adrenaline shooting through her with no letting up; had tingling in her mouth near her lip and her foot and then in her hand; tingling in her mouth near her lip and her foot and then in her hand/jolt in her left leg; not well/feeling of unwell; spaciness, did not feel like herself/had felt off and was in a fog/fogginess; mouth was shaky/shaking; was unsteady; had felt like she has a lot of adrenaline; had felt cold; muscle weakness; was getting twitches and surges; was laborious to walk; and had itchy sensation. On 09Mar2021, the patient was dizzy. The events resulted into physician's office visit. The patient's blood test, electrocardiogram (ECG), electrocardiogram (EKG), "two other panels", metabolic and all tests showed everything was normal on an unspecified date. The outcome of the events was unknown. The patient's second dose of vaccination was scheduled on 29Mar2021.

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

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.

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

felt like I was going to hit the floor; Lightheadedness/Dizziness; jerking/involuntary jerking, quenching, it was kind of weird; body jerking; feeling weird/felt like she was not herself/ she felt her body was trying to fight off something; heaviness in her legs; felt pain in her face; flinching; This is a spontaneous report from a contactable consumer(patient). The 61-year-old female patient received first dose BNT162b2, via an unspecified route of administration on 04Mar2021 (Lot Number: EN6205) as single dose for CIVID-19 immunization. Medical history included blood pressure issues from 2010 and ongoing, ongoing sinus issues which was diagnosed in 1973 or 1974, hypoglycaemia, reaction to tetanus shot several years ago. The patient's concomitant medications were not reported. She received postnasal drip started on 02 Mar2021 or 03 Mar2021 before the vaccine. She got the first Covid shot on 04 Mar2021. She wait 30 minutes because had reaction to tetanus shot several years ago. She had flinching, jerking and feeling weird 10 minutes after vaccine on 04 Mar2021. She and husband in holding area waiting. One time jerk so bad felt that she felt she had to lay down. She felt like she was not herself like she was out of body like there and she was not (AS REPORTED). She had a weird feeling after vaccine, she felt her body was trying to fight off something, felt like little bit out of body feeling, felt like she was going to hit the floor on unknown date. She felt lightheadness on 04 Mar2021. They checked her pulse and there was nothing with her heart rate. She does not know if it was an anxiety attack or not. She was nervous about getting the vaccine because it was so new. She felt this way for four days. On the fourth day that she felt she was coming around and on the fifth she felt herself. She has other underlying health issues and does not want the virus. She had heaviness in her legs, felt a pain in her face both on 04 Mar2021. The doctor wanted to rule out if she was having a stroke. She went to the ER, the ER kicked her out and did not find them. Her BP was 130/60 on 09Mar2021. They did blood work and an EKG(Electrocardiogram). They ruled out stroke. The doctor stated that the allergies could have made her feel dizzy but did not know about the twitching and jerking. She has lightheadness and dizziness because of other health reasons like sinuses, blood pressure and low blood sugar which these were before the vaccine. She had the normal EKG on 09 Mar 2021. There was unknown treatment received for events. Outcome of heaviness in her legs was recovered on 06Mar2021, of felt pain in her face, feeling weird, Dizziness was recovered on 07Mar2021, flinching, jerking was recovered on 04Mar2021, of felt like I was going to hit the floor was unknown. Case was assessed as serious.

Immediate strong metallic taste that has not gone away. High fevers 103, chills and shaking, fatigue, muscle aches and nausea.

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.

Stiff arm today. However, patient received second Pfizer COVID vaccine 14 days after first dose instead of 21 days after first dose.

Dizziness, nausea, sleepiness, fog brain, temperature of 96-96,4 (taken with more than one thermometer), throbbing pain in left arm traveling to neck.

rheumatoid arthritis which has flared up following vaccination.; This is a spontaneous report received from a contactable nurse (patient). A 61-year-old female patient received BNT162B2 (Pfizer BioNTech COVID-19 vaccine, Formulation: Solution for injection (batch/Lot number: unknown), via an unspecified route of administration on 26Feb2021 at single dose for COVID-19 immunization. Medical history included blindness. Concomitant medications was not reported. Her next dose was in 2 days. The patient reported that she was ok the first few days after vaccination then experienced side effects including joint pains, the patient had numerous autoimmune diseases, specifying one of the as rheumatoid arthritis which has flared up following vaccination. The outcome of the event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of RA flare due to temporal relationship. However, the reported event may possibly represent intercurrent medical condition in this patient. There is limited information provided in this report. 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.

feels tired; muscle ache; joint ache; fever (up to 100F).; This is a spontaneous report from a contactable consumer (patient herself). A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at age of 61-years, at single dose on 22Mar2021 for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that she received first dose of pfizer covid vaccine yesterday (on 22Mar2021). Today (on 23Mar2021), she felt tired, muscle ache, joint ache and fever (up to 100F). The patient underwent lab tests and procedures which included body temperature was up to 100F on 23Mar2021. Events outcome was unknown. Information on the lot/ batch number has been requested.

ears plugged and ringing; ears plugged and ringing; tongue sore; chills; muscle aches; weakness; joint stiffness; nausea; sharp pains in stomach and breasts; sharp pains in stomach and breasts; tightness in chest; fatigue; dizziness; impaired mental clarity; 102 fever/99 degree fever; This is a spontaneous report from a contactable consumer (patient). A 61-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in the left arm on 15Mar2021 at 18:00 (06:00 PM) (Batch/Lot Number: EN6208) at the age of 61-years-old as single dose for COVID-19 immunization; administered to the patient in public health clinic/administration facility. The patient had no other vaccine in four weeks. The patient had no COVID prior to vaccination. The patient's medical history included known allergies (unspecified). The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 in the left arm on 22Feb2021 at 07:30 PM (lot number: EL9266) at the age of 61-years-old for COVID-19 immunization. The patient experienced 102 fever the night of 16Mar2021 (also reported as 16Mar2021 at 06:00 AM) with chills, muscle aches and weakness, joint stiffness, nausea, sharp pains in stomach and breasts, tightness in chest, fatigue, dizziness, and impaired mental clarity. On 17Mar2021, the patient experienced ears plugged and ringing, weakness, tongue sore, and impaired mental clarity. The patient had 99 degree fever during the nights of 17Mar2021 and 18Mar2021 thus far. The patient did not receive treatment for the events. The patient has not been tested for COVID post vaccination. The outcome of the events was recovered with sequelae (reported as recovered with lasting effects).

swollen ankles noticed at bedtime when removing shoes, slept & woke up normal, after 3 hrs being up swelling again (but less) the following day no swelling, but noticed rash on stomach that lasted 2 days then was normal.

On 3/30 PM, I experienced very severe nerve pain in lower extremities and muscle weakness that last over 48 hours. I was initially very unstable walking for first 24 hours. Symptoms were very similar to severe reaction in 2018 with yellow fever vaccine (Sanofi) but not as severe. Home treatment with Aleve 200 MG every 3 hours. Recovery on 4/4

High fever for 2 night in a row (in excess of 103), nausea, headache, sore muscles and joints, sore teeth, red inflamed area of vaccination about the size of an orange lasting 5 days., dizziness, unproductive cough, extreme tiredness for 3 days and lingering for 5 days.

On days 2 and 3 post vaccination I was achy and sore in my joints more than usual. I assumed it was just two bad arthritis days until on day 4 I felt back to normal level of more tolerable pain.

Heavy arms feel, dizzy observation. Patient states she has high blood pressure; no meds given/patient states feeling fine

Really sore arm, neck, shoulders & back, headache and fever for 2 days so far. Taking tylenol & advil.

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

Beginning at 2:10 am on 3/31, right arm from shoulder to fingertips was in acute pain for 2 hours then pain reduced for 1 hour and then acute pain repeated for 2 more hours from below the shoulder to the palm of the hand. Pain eased for 1 hour then acute pain repeated for 2 hours from mid-bicep to mid forearm. Pain eased for 1 hour then acute pain repeated for 2 hours from 3 inches above the elbow to 3 inches below the elbow. The left shoulder area has continued to be sore for 11 days and the entire right arm has been sore for 11 days.

Every joint in her body is aching since Sunday including her jaw; 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), dose 1 via an unspecified route of administration on 11Feb2021 (Batch/Lot Number: EM9809; Expiration Date: 30Jun2021) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient had every joint in her body is aching since Sunday including her jaw (21Feb2021). Tylenol only helps somewhat and she cannot keep taking it. She was not sure if it could be something else she needs to investigate. The lot number is printed on a sticker and it is very small. she has probably shrunk over the years that happens. The outcome of the events was not recovered.

Chief Complaint rash History of Present Illness Rash on L back/hip x 1.5 weeks red bumps, at low back, buttock and back of thigh, last new lesion 2 days ago pain on the L thigh discomfort on the back of knee and back of thigh h/o shingles in 20's h/o zoster vaccine 2019 immunosuppressed for RA, PA no itchying still developing more spots no fever gardens but hasn't done anythign to trigger back/leg pain

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, aches, joint pain, headache, nausea, chills, injection site pain up to shoulder, weakness, tired, diarrhea Took Tylenol to sleep, most symptoms lasted from lunch time to bed time. About 12 hours. Today, lingering tiredness, and aches.

Muscle and joint pain with weakness in left arm. The left elbow joint pain was so severe I was unable to flex my elbow to touch my face for over a week. Also, have continued joint pain in my hips and back. The symptoms were expected but have continued for over 2 weeks. The side effects after my first dose ( chills, muscle aches , headaches, fatigue and pain in my left arm) resolved completely after 72 hours.

swelling of tongues and upper inside plate; upper inside palate in her mouth was also kind of swelling; upper lip tingling/numbness and swelling of tongues and upper inside plate; muscle soreness near the injection site; injection site was painful; couldn't move her arm behind her or up and was limited with that arm; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 22Mar2021 10:15 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included she was in generally good health besides being hard of hearing and she got hit by a car at age 2 and after she got older her HCP said she would be completely deaf by age 60 and she was now classified as being profoundly deaf. There were no concomitant medications. She had never gotten the flu shot in her life. The patient experienced had muscle soreness near the injection site, injection site was painful, couldn't move her arm behind her or up and was limited with that arm on 22Mar2021, numbness and swelling of tongues and upper inside plate, upper inside palate in her mouth was also kind of swelling and upper lip tingling, all on 22Mar2021 19:00.There was no treatment received. She had physician office visit to ask the HCP to see if there was anything she can take before she takes the 2nd dose to prevent this. The clinical course was reported as follows: She had the 1st dose of the Pfizer Vaccine on 22Mar2021 at 10:15am and for the most part where the injection site was and some in the muscle it was very painful and she was told this is very common; the vaccine was given in her left arm into the muscle and the injection site was painful for a while and then the muscle below it felt painful and throughout the day and yesterday she couldn't move her arm behind her or up and was limited with that arm on 22Mar2021. Today the pain was getting better and the muscle and injection site still are kind of sore but she was sure that would get better in time. Around 7:00pm(22Mar2021 19:00) in the evening she had another reaction that was not listed in the severe reactions and that was she had some numbness and swelling in her tongue and then the upper inside palate in her mouth was also kind of swelling and her upper lip was tingling; states this swelling and tingling began on 22Mar2021 and was not ongoing fortunately she slept sitting up and did not want to lie down and suffocate herself; when she woke up at 4:30am the swelling and tingling went away so she does not know what time the symptoms went away because she was asleep. She had no treatment and tries to avoid medicine as much as possible and did not go to the emergency room but following yesterday she went to the walk in clinic last night because she wanted to ask the HCP to see if there was anything she can take before she takes the 2nd dose to prevent this, and the HCP said there is nothing he can do. Case were assessed as non-serious by reporter. Outcome of muscle soreness near the injection site, injection site was painful, couldn't move her arm behind her or up and was limited with that arm was recovering, of other events was recovered in Mar2021. Information on lot/ batch number has been requested.

Pfizer Covid-19 VAccine, mRNA, LNP-S, PF, 30 mcg / 0.3 mL dose. Carton, 195 Multi-dose vials. REACTIONS: Day #1 April 8th. Soreness, tenderness, mild headache, feeling unwell. Day #2: Very sore, tenderness, Headache, feel unwell. (Note: Was not able to lift my Left arm fully this day.) REDNESS at muscle injection site Did Not appear until Late evening, about 8pm on Day after vaccine given. Day #3 (date of this report): Still tender, Redness, Arm more mobile, able to lift up after late evening of Day #2. I'm taking MOTRIN IB tablets - 2 tablets every 8 hours. It was really for some slight nerve pain in my Rght thigh area, But ti has helped with Soreness, and diminished redness at injection site of the vaccine. RE: FACT SHEET for Pfizer Vaccine. Lists "Risks of Vaccine, Side Effeects.) Here is my List; Day #1: Injection site pain, tiredness, headache, muscle pain, feeling unwell. Day #2: Injection site pain; tiredness, headache, muscle pain, injection site Swelling, Injection Site Redness. Day#3: Site pain; Swelling , Redness.

RA flare started the morning after I received the vaccine. I had been in remission for a while but the day after I received the vaccine I noticed a lot of pain in several joints especially, my back, right elbow and both hands a fingers. I also noticed a lot of fatigue which usually accompanies my RA flares. I will be seeing my Ruematologist on Monday, April 12, 2021 to discuss what to do to get the flare under control.

Day following receiving 1st vaccine dose I experienced major aches throughout entire body, all joints, which did not dissipate until following day. Felt very fatigued throughout day as well. Slight headache.

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.

A strange headache with occasional twinges in my head, body aches and fatigue had been gradually developing during the day on Saturday. I took two Tylenol Saturday afternoon, which seemed to help. An area in my left armpit became extremely painful to the touch (possibly lymph node?) beginning Saturday night at 8:30 pm. I went to bed and woke up at 10:30pm with all the same aches and pains and felt slight chills. I took two more Tylenol and felt good enough to go back to sleep. Armpit pain persists as of now, Sunday morning, but other side effects are mostly gone.

I experienced a slight headache sore arm and elevated blood pressure after the shot. My blood pressure is usually very well controlled. On Monday the 29th, at about 3:30 pm, I started to slur my words. At first we blamed it on the Novocaiine earlier in the day, but I had been talking fine after it and had had it many, many times before and it was worn off. We called my doctor's office after my right arm and leg became very heavy and awkward. They told me to go to the nearest hospital. When I got there, I presented ass a full stroke. I was very hard to understand and my mouth drooped and I had very little use of my right arm and leg. They ran tests, but could not give me the medication because I was already on Eliquis. They thought they saw a small clot very high up. I was hospitalized over the next four days and improved my speech dramatically after a bad headache on March 30. The doctors go back and forth to whether it was a Acute Ischemic Stroke, which is what my paperwork says and a complex migraine. I do not experience migraines or anything like this ever before. I did not have a real headache on the 29th. Since my symptoms, right arm and leg difficulties are still here, my Doctor believes it was a stroke. I have an appointment with a Neurologist and I have to have another MRI. I am going to Physical Therapy. My Doctor told me to fill this out, she thinks it may be from the vaccine.

slight effects for 3 days mostly just a bit loopy, then basic flu like symptoms low fever, aches, headache, tired. But after the first week and continuing to no (3 weeks later) sore muscles, esp thighs, upper arms and neck. achy but also sore to the touch.

Received vaccine on 04/07/2021 at 07:47 AM; Presented at ED on 4/08/2021 at 8:29 am and received prednisone 60 mg and diphenhydramine HCl 50 mg: chest tightness and throat swelling that began yesterday afternoon. She explains that she has h/o anaphylaxis to flu vaccine. She got the first dose of Covid19 vaccine yesterday, she did premedicate with benadryl. She was monitored on site for an hour and felt some left neck pain and jolt of pain down left arm, but it resolved and she went home. Shortly after, she began feeling like she was having asthma attack, wheezing, chest pressure and throat swelling. She used inhaler and took benadryl. Last dose of benadryl at midnight, took Zyrtec D at 7am this morning, last nebulizer and symbicort at 6:30am. She states she still feels chest tightness and throat swelling. She feels like her tongue was very swollen but improved after benadryl. States her voice is different. Feels a little harder to swallow but she is able to drink fluids. She took pantoprazole this morning. States this does not feel like her usual asthma. Rates chest tightness a 4/10 on pain scale, states it feels like something is sitting on chest or squeezing chest. States it does feel a little better in anterior chest now, but she feels it on lateral lower chest still. Denies h/o cardiac issues. Denies h/o MI. No jaw or arm pain at this time. Discharged from ED at 9:27 am and reported to ED at 10:03am on 4/08/2021. Received famotidine 20 mg and discharged home at 1206pm on 4/08/2021 with prednisone, Pepcid, EpiPen

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

very mild tremor in my right index finger/ finger underwent stronger and more pronounced tremors/the neuropathy was more pronounced; an increase in foot spasms; discomfort in my feet concurrent with an improvement in sensation in my arches; a bit more stiffness and achiness in my knees; have noticed an increase in foot spasms and discomfort in my feet concurrent with an improvement in sensation in my arches; This is a spontaneous report from a contactable consumer. A 61-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number-UNKNOWN), via an unspecified route of administration on 04Mar2021 as single dose for covid-19 immunization. Patient relevant medical history included diagnosed with breast cancer three years ago and have some chemo-induced peripheral neuropathy in her hands and feet. The patient's concomitant medications were not reported. Since getting her first shot on March 4, patient have noticed an increase in foot spasms and discomfort in her feet concurrent with an improvement in sensation in her arches. She also had several instances of a brief, very mild tremor in my right index finger, which was where most of the residual neuropathy in her hand resides; when the neuropathy was more pronounced, that finger underwent stronger and more pronounced tremors, whereas what patient had this month is negligible. Patient also had a bit more stiffness and achiness in her knees (both of which have recovered from traumatic injuries), which had mostly leveled off before my second shot but then regained some severity after the second, which was on March 23. (Yes, a 19-day cycle my shots were administered by Hospital. It was unknown if the patient received any treatment for the reported adverse event or not. It was unknown that patient was tested for COVID-19 after the vaccination or not. The outcome of the events was unknown. Information about on Lot/Batch number has been requested.

Anxiety thanks to crowds and fleeting initial dis-organization at the vaccine facility. Sore arm the evening of the injection and the next day. Joint/muscle aches and pains nights the 10th and 11th that interrupted sleep; took acetaminophen. Aches during the day and tired the 11th, 12th and 13th (so far). Strange taste in mouth, upset stomach 12th and 13th (so far). Not looking forward to second dose though happy to have started process.

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

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.

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.

! day after the second dose patient developed sore throat, mouth sores, body aches and swollen joints. She initially had a fever that resolved.

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

Received shot around 1:10pm, a few hours later around 4pm felt tired. Pain at injection site lasted a few days felt like a bruise. Around 8:30pm lips became bright red, felt like there were sores on the roof of the mouth that were painful and interfered with eating for 3 days after shot ate soft foods, eyes really dry, extremely thirsty for about 2 days after shot. On 4/3/21 around 9pm took a 25mg tablet of Benadryl and that helped a little bit with the symptoms. On 4/13/21, 10 days after the shot, felt extremely fatigued, body and joint aches intense, nauseated, headache lasted a couple of days. By 4/16/21 felt better and was able to go to work in retail.

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.

test positive for COVID 19; test positive for COVID 19; coughing; Muscle aches; Fatigue; Sore throat; 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 (BNT162B2, Solution for injection, Lot Number: EL3302), via an unspecified route of administration, administered in Arm Left on 16Jan2021 10:30 as single dose for covid-19 immunisation. Medical history included high blood pressure, migraines, inflammatory arthritis, penicillin allergy. Concomitant medications included eszopiclone (LUNESTA) (MANUFACTURER UNKNOWN); valsartan (MANUFACTURER UNKNOWN); sumatriptan succinate (IMITREX) (MANUFACTURER UNKNOWN). On 8Feb2021, the patient experienced coughing, muscle aches, fatigue, sore throat. On 23Feb2021, the patient experienced test positive for covid 19. There was no direct adverse reaction from the vaccine, but I did test positive for COVID 19 on 23Feb2021 (yesterday) with symptoms of coughing, muscle aches, fatigue and sore throat. The patient underwent lab tests which included sars-cov-2 test: negative on 19Feb2021 and sars-cov-2 test: positive on 23Feb2021. The patient did not receive any treatment for the events. The clinical outcomes of the coughing, muscle aches, fatigue, sore throat, test positive for covid 19. No follow-up attempts are possible.

This is a spontaneous report from received from contactable consumer. A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EP7534), via an unspecified route of administration on 24Mar2021 via an unspecified route of administration in top of left arm as single dose for covid-19 immunization. Medical history included Salpingo-oophorectomy (resection to remove an ovary and fallopian tube) in Mar2016 and an operation in 2016 for diverticulitis. Concomitant medications were not reported. There were no allergies to medications, food, or other products. No known allergies. No, she says this is her first vaccine, she has never even had the flu vaccine. Caller clarifies she is talking about the Pfizer BioNTech vaccine. Later in the call clarified as the COVID-19 vaccination. She is calling to report that she contracted COVID. She says she is so discouraged, she did everything right and she ended up getting COVID, she was shot in the arm, her family forced her to get it, 7 days later she was sick, so sick Wednesday(31Mar2021)/Thursday(01Apr2021), positive on Saturday (03Apr2021). She says she is been googling this, it has only been only 6 months, less than 6 months in. On 30 Mar2021, patient had experienced ill, Sneezing, coughing, choking, coughing up phlegm, Fever, Chills and aches. Patient says she did not get her second shot, she is supposed to go for it on 14Apr2021 but she suspects she had to get tested before she gets the vaccine. She says she does not know what to do. She says she is isolating herself and has her own bathroom. She says her card has a patient number and an ISS number. She says she is got this vaccine for society to get this vaccine rolling so we can be whatever the word is, for social status, to be in the cool club. Patient says she had no tests since she does not have a primary. The adverse event was not resulted in emergency room. The patient was resolving from the event COVID. At the time of reporting the outcome of the events were unknown. Additional information has been requested.

Fatigue 4/16/2021-4/18/2021 Pain on left side of neck and behind ear 4/17/2021, 8:00AM-2:00PM Fog-Brain 4/17/2021, all day Low grade Fever 4/17/2021, 1:00pm-middle of the night when I woke up sweating, 99 degrees during the day time hours Took no fever reducing medications during this time.

her left arm was a little bit sore after she got the COVID-19 Vaccine; 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), (Batch/Lot number was not reported),via an unspecified route of administration, administered in the left arm on 12Mar2021 08:40 (at the age of 61 years-old) as single dose for covid-19 immunization. Medical history included tinnitus from Nov2020 and would get headaches, she had anxiety, panic attacks and insomnia. She had high blood pressure; last visit to her doctor was in Jan2021 and her EKG was fine, and her blood pressure was down. She said her doctor wanted to wean her off of her old blood pressure medicine before starting any new medication). She also had AFib (atrial fibrillation), left ventricular muscle thickening and enlarged right atrium. She reported that she was getting herself a new heart doctor and neurologist. She was also sick in Mar2020, and the doctor was not sure if she had the COVID-19 Virus. She said she quarantined for 16 days, and then found out she was negative for the COVID-19. She said after that, she couldn't leave her house without having extreme anxiety and panic attacks. She said her blood pressure would reach 200 during those times. The patient's concomitant medications were not reported. The patient received her first dose on 12Mar2021 and had no symptoms, except that her left arm was a little bit sore after she got the COVID-19 Vaccine. She said the soreness started late in the afternoon, or early evening. She said her left arm soreness maybe lasted through to the next day, and the left arm soreness was only for a day. The outcome of event was recovered. The event did not require visit to an emergency room or a physician's office. Information about lot/batch number has been requested.

Started with slightly sore arm, and a headache, headache got worse, took advil, didn't sleep well, severe headache, muscle and joint pain, took more advil. Morning, felt like a flu, slight fever, body aches, joints, major pain trying to lift left (shot) arm. Not severe enough to seek medical attention.

Severe left chest back and shoulder pain lasting more than 2 days; Severe left chest back and shoulder pain lasting more than 2 days; Severe left chest back and shoulder pain lasting more than 2 days; high BP; fluid around heart; elevated D DIM; 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 VACCINE) (brand: Pfizer BioNTech, lot: EN6199) in left arm on 06Apr2021 06:30 PM at a single dose for COVID-19 immunization. Facility type vaccine was Pharmacy or Drug Store. Medical history was not reported. Patient was not pregnant (AS REPORTED) at the time of vaccination. Concomitant medications were unspecified. No other vaccine in four weeks. Other medications in two weeks was yes. Patient used to receive Wellbutrin and experienced allergies. Historical vaccine included the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: ER8733) in left arm on 17Mar2021 05:00 PM at a single dose for COVID-19 immunization. Patient experienced severe left chest back and shoulder pain lasting more than 2 days accompanied by high blood pressure (BP), fluid around heart and elevated D DIM on 07Apr2021 05:30 AM. Adverse events (AE) resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). The outcome of the events was recovering. AE treatment: Ultrasound, CT Scan, morphine. If COVID prior vaccination was no. If COVID tested post vaccination was no.

having a stroke; I began to experience numbness on my entire left side, left arm; hand weakness, left leg weakness; trouble walking/stumbling; speech problems; slurred speech; fatigue; injection site pain; nausea; pain in my left hip; 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: ER8727), via an unspecified route of administration, administered in left arm on 29Mar2021 16:30 at single dose for COVID-19 immunisation. The patient's medical history included chronic fatigue syndrome, fibromyalgia, sulfa allergy. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered was Pharmacy/drug store. 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 and has not been tested for COVID-19 since the vaccination. The patient experienced immediate fatigue, injection site pain, nausea, along with pain in her left hip the day after her first Covid vaccine on 30Mar2021 05:00 (Tuesday). The injection site pain resolved after a few days, but she continued to be exhausted and nauseous all week. On 02Apr2021 (Friday), she began to experience numbness on my entire left side, left arm and hand weakness, left leg weakness, trouble walking, speech problems, having to really think about her words (her daughter-in-law was typing this as she could not), slurred speech, stumbling. Her family was concerned she was having a stroke on 02Apr2021 05:00, but have no drooping in her face. She was so scared that she will not be getting her second vaccine. She have not gone to a doctor, as she do not have insurance. The symptoms were continuing. No treatment was received for the adverse events. The outcome of the event 'injection site pain' was recovered; the events fatigue and nausea was not recovered; and unknown for the rest of the events. Events were reported as non-serious. Information on lot/batch number was available. Additional information has been requested.

muscle aches in neck on left side, and general muscle aches all over. These were whose on the second day after the shot. On day 3, all muscle aches were gone.

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.

Sore shoulder for three days-no treatment Bodyaches- for three day-Tylenol, rest, water Headaches- for three day-Tylenol, rest, water Slept all Saturday following, most of Sunday, Some of Monday Insomnia Sunday night about four hours, Monday about two hours. Internal external mouth sores. Still healing from outside sores Brain Fog. Took about three weeks for brain fog to go away from first to second shot. Still have brain fog from second shot which what I am reporting on here.

This was my second COVID dose, it felt completely different from the first one, which was given at a different pharmacy. When it was being injected, it felt like the vaccine was pooling in my arm and the injection took much longer than the first one. My arm felt heavy within 30 minutes of getting the vaccine. About two hours later, I could not lift my arm more than 10% without terrible pain. I could not sleep even taking Advil. After three days, the intensity lessened some, but I still cannot lift my arm certain ways without a lot of pain and it is keeping me awake as it just aches. I cannot lay on that side either, as the pain becomes intolerable.

DAY ONE April 15, 2021. On Thursday April 15th at 10:00 a.m. I received the first dose of the Covid 19 vaccine. They gave me the shot in my left arm. Within about 5 seconds, I started feeling nauseated and light headed like I was going to pass out. I asked to just sit there for awhile because I did not feel stable to stand up and go to the waiting area. I stayed seated for about 1-2 more minutes then the paramedics took me to the Medical area in a wheelchair. The paramedics checked my vitals. My blood pressure was 135 over ?? I don't remember. I told the medic my BP is normally 98/58. She said my BP was elevated. My pulse was in the high 80's. My temperature was 98.6 and my oxygen was 100. I started getting pain and pressure going up the back of my neck, into my head, eyes and ears. It was very painful and throbbing pressure. I felt dizzy and really high. It felt like I was floating on the top of the ceiling and the people were off in a distance. I was really woozy. I then got diarrhea. The nausea continued but I did not throw up. At times my thinking was spacey, so I talked to the paramedic to help me stay grounded. I narrated what was happening in my body. They did a glucose finger prick test because of my spaceyness, but it was normal. It was like my whole system was freaking out. I was there and then not there, feeling like I was floating. These symptoms continued for about 90 minutes and getting worse. The paramedics offered me to go to the hospital, but I thought eventually I would be fine. I did not want to go to the hospital and have a huge medical bill. At around 90 minutes, I started having pain in my heart left side, under my left breast on my left shoulder. The paramedics did an EKG and did not find anything but some irregular heartbeats. The heart beats felt like BA BOOM, then my heart would do a cartwheel. BA BOOM and another cartwheel. At this time, my husband arrived and took me to the hospital emergency room because the pain in my heart was getting worse. I stayed in the hospital emergency room until around 5:00pm on April 15th. They did another EKG and some lab work and did not find anything but low thyroid. I continued to feel drunk, nauseated, pain pressure and throbbing in my head neck, ears and eyes, diarrhea, and like I was High and going to pass out. The chest pain in my heart was off and on. It felt like muscle cramping in my heart, under my left breast and the left shoulder. I also got a pain in my left groin area, then behind my left knee. It was a sharp and throbbing pain for about an hour in each location, but eventually went away. While in the Emergency room, they tried to give me Ativan. I asked what it was for and they said Anxiety. I said I wasn't anxious; I was just having a reaction to my first Covid 19 vaccine. I said I did not want it because my body was already struggling to handle the Covid 19 vaccine. They said the doctor prescribed it. I said I had not seen a doctor, and they said it is protocol. The nurse then came in and wanted to give me a shot for nausea and I said no, I don't want any more chemicals in my body, it is really having a hard time already with the Covid vaccine. I went home, was wiped out, still feeling drunk/woozy/high, also nauseated, diarrhea, very dizzy, had a hard time walking. The pain, throbbing in my head, neck, ears and eyes was still there. By this time, I could not find clear thoughts, and could not make sense of things. I was very agitated and at the same time exhausted and only wanted to sleep. DAY TWO April 16, 2021 I woke up with a smashing head ache, neck ache, back ache and general feeling like Crap. The nausea and diarrhea were still there and had woken me in the middle of the night. I felt like a truck had hit me. I stayed in bed all day and tried to eat and drink as much as I could. I drank a lot of water that day. I felt horrible, but was able to stand without feeling like I was going to fall over. Had trouble finding clear thoughts at times. Still felt out of it and had chest pain off and on. Also had the BA BOOM heart beats and cartwheels in my heart. DAY THREE April 17, 2021 Very similar to day two. I felt weak, nauseated, diarrhea, pain all over, jittery, not able to have clear thoughts at times. It felt like my body was still on RED ALERT!!! I also had very shallow breathing on day 2, 3, 4 and 5. It tired me and I panted just getting up to go to the restroom. I am able to eat fine and keep food down. BA BOOM hear beats and cartwheels in my heart have lessened. DAY FOUR April 18, 2021 I felt a little better and made the mistake of thinking I was getting over the reactions and did too much. Shortness of breath. DAY FIVE April 19, 2021 I feel horrible again, Nausea is really strong as well as the diarrhea. I am feverish, sweaty and shaky. Shortness of Breath. Tight in my chest. I just took my temperature and it is normal, although I am hot, sweaty, feel feverish and shaky. I am exhausted. The headache is still here as well as the pains in my neck, ears and eyes. The aches in my body are still here. I have no energy. A wave of emotions is also here and I am weepy and crying. This is no fun. I am able to eat food OK and drink lots of water to counteract the diarrhea. DAY SIX April 20, 2021 Shortness of breath, very tight in my chest, having to take Benadryl and use my rescue inhaler to keep my breathing open. Feverish, chills, shakey, hot. Temperature 97.0 Blood pressure 90/66 Pulse 70. I feel like crap, just wiped out.

Yellow mucus / vomiting/ diarrhea 15+ / headache/ body ache/ stomach ache / can?t smell / can?t eat / lower back is hurting

Tingling and burning on 4-17-2021, on upper lefthand side of back. Burning, stinging pain on 4-18/2021 and 4/19/2021, same area. Rash broke out and it was diagnosed as shingles on 4-20-2021.

severe allergic reaction to the vaccine; sore arm; neck pain; getting lots of saliva; tongue started swelling; rapid breathing, couldn't control her breathing; heart rate it got faster; started getting confused; shaky; wheezing; swelling of her throat; blood pressure dropped; This is a spontaneous report form a contactable consumer reporting for herself. A 61 years old female consumer received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; NDC number 59267-1000-01) on 29Mar2921 at 14:15, in left upper arm, for COVID-19 immunisation. No other vaccines were given on the same date or within 4 weeks. Medical history included allergic to hamsters (she found out that this one had the Chinese Hamster Ovary cells and she knew she had problems with those things), allergic to prednisone (crazy rash, itching), allergic to a lot of different things, sinus infection. Family history included allergy (the whole family had allergies). Concomitant medications included unspecified antibiotics for sinus infection (but it had cleared up by then) and unspecified allergy shots (but not a vaccine). The patient just wanted to report that she had a severe allergic reaction to the vaccine on 29Mar2021. Symptoms began minutes after getting vaccine. The patient experienced getting lots of saliva started with a couple of minutes of getting the shot, tongue started swelling, rapid breathing, couldn't control her breathing, heart rate it got faster, started getting confused, shaky, wheezing, swelling of her throat, blood pressure dropped, all on 29Mar2021. On 30Mar2021 the patient experienced sore arm and neck pain but she thought that was more of a vaccination saying it was working. Clinical course of the events included the following information: the patient had to stay for a while since she had allergies normally. She started getting lots of saliva and she thought that was her body saying, she did something, not a big deal. Around 15 minutes, she was at a grocery store, she started walking around, her tongue started swelling, rapid breathing, she couldn't control her breathing and heart rate, it got faster. She started getting confused, shaky, it wasn't too good. She made her way back to the place where the injections were done, they were trying to get her to use her epinephrine (EPIPEN). She took a diphenidramine (BENADRYL) while walking around looking for her husband and then took another and was wheezing. She thought BENADRYL would have helped. She should have taken her EPIPEN looking back, she thought BENADRYL would help. They heard wheezing, they contacted the other pharmacist, who contacted EMS then they came and took her to the emergency room on 29Mar2021 in the afternoon. When she was wheeled in, the doctor met her in the hall and he said they could give her a steroid shot. The patient stated she was allergic to prednisone, she got a crazy rash, itching, it's not just prednisone, it's an allergy. She got the shot at 14:15 and she was at the hospital by 15:00. The patient thought she was there for 5 hours and then she was sent home. Her blood pressure dropped. The only one she saw was 114/39 but her husband saw it went even lower than that. At the emergency room, they had the automatic thing strapped on so they watched her until it started going back up again. The vaccine shot was probably the easiest shot she had ever had. She had never had any problems. She did not research it very well in the beginning because she thought they should be good. The patient was told to not get the second vaccine. The events also required physician office visit. Allergic reaction symptoms resolved on 29Mar2021 but the swelling of her throat and heart rate lasted about four days, until 02Apr2021. Neck pain resolved on 01Apr2021. Sore arm resolved on 03Apr2021 or 04Apr2021. Blood pressure dropping resolved on an unspecified date in 2021. Information on the lot/batch number has been requested.

I had done some weight lifting on Wednesday morning, the day before dose 2. May have aggravated a nerve in my back but had no sensation of this until acute pain from mid upper back across shoulder and down right arm. Began exactly 12 hours post vaccine. And woke me from deep sleep. Could not get relief for several days until I contacted provider and was given Flexeril and Aleve. Could not lay down or sleep due to position of nerve in my back. (Vaccine administered in Left arm. ) Have never had a problem previously like this in my back. I exercise regularly. I surmise that if this nerve was aggravated, the inflammation induced by the vaccine made this worse where no vaccine and I would not have had a problem. Friday followed with typical side effects of lethargy and tiredness. Experiencing slight mobility issues in right arm post 13 days vaccination.

Pt received vaccine without incident and left facility. Her angina/chest pain began enroute to her house. She returned and reported to Med Observation 1 at 1205. Vitals HR 62 BP 137/77 O2 sat 97% on RA L sided chest pain 6/10 Pt states L sided chest pain radiates to L posterior back " it feels like someone is sitting on my chest" Her pain is very similar to her "angina pain". 1210 HR 63 BP 127/75 O2 Sat 97% one sublingual nitro given of patient's own medication. 1215 BP 157/69 HR 62 96% on RA Pt states pain is 4/10 second sublingual nitro given. 1220 BP 156/77 HR58 100 % on RA Pain rates 2/10 pt does not want to go to ER 1230 convinced pt she should go to ER, 911 called. chest pain remains 2/10 1240EMS arrives for transfer BP 161/73 HR 61 97% on RA chest pain 2/10 Left facility via EMS at 1250.

After the vaccination, I experienced pain and tingling/numbness in upper arm radiating to under the arm. Throughout the day and into the night I had pain, redness, itching and swelling at injection site. The next day (21st) a hard lump developed under the skin where I had the injection. I also had a headache and muscle aches. I didn't take any medication for the pain and discomfort as I was told it was beneficial to let the reactions occur without drug interaction or interference.

Heart started racing right after injection. Pharmacy monitored my heart rate until it came down to a normal range - 20 minutes. Very sore arm, severe chills and body aches started that evening. 28 hours later, still have chills, body aches, bad headache, neck pain.

I woke with a migraine headache on the 2nd day after my vaccine and the migraine lasted 28 days in a row, 24 hrs each day. I lost my appetite which led to a 30 lb weight loss, I was dizzy, and fatigued. Furthermore, I was given tramadol, but it did not help and contributed to the dizziness so discontinued that after 1 week.

Severe fatigue onset 5 hours following injection. 24 hours after, developed migraine, fever, chills, vomiting and diarrhea last app. 24 hours. Day 3 and 4 severe fatigue, body and joint aches, migraine, mild nausea.

4/22/21, 7pm ET: Chills, fatigue 4/23/21,1pm ET through 4/24/21 10am ET: Chills, fatigue, slight fever (99.8º), nausea, muscle aches, headache,

Sore arm and neck on the injection side of body.; Sore arm and neck on the injection side of body.; This is a spontaneous report from a contactable Other HCP. A 61-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9261), dose 1 via an unspecified route of administration, in left arm on 07Feb2021 13:30 (at 61-years age) as single dose for covid-19 immunisation. Medical history included diabetes, hypertension, obesity, arthritis, copd and patient was allergic to bactrin, perfume. Concomitant medication(s) included doxepin (DOXEPIN); dapagliflozin propanediol monohydrate (FARXIGA); metformin (METFORMIN); temazepam (TEMAZEPAM); dulaglutide (TRULICITY). The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.on 08Feb2021 04:00, The patient experienced sore arm and neck on the injection side of body.No treatment received for reported adverse event. The outcome of the event was resolved.

she could have partially had a stroke; She woke up and her left hand and arm were numb; left arm hurts a couple of days ago; Her hand is now cramped up, and she cannot bend it, almost like someone who has cerebral palsy.; she could not use her left hand; Her hand is now cramped up, and she can not bend it, almost like someone who has cerebral palsy./all her fingers are cramped and she cant open them and her hand is in a brace; radial nerve palsy; This is a spontaneous report from a contactable consumer or other non hcp. A 61-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: EN6198) via an unspecified route of administration, administration in left arm on 19Mar2021 as SINGLE DOSE for covid-19 immunization. Medical history was not reported. There were no concomitant medications. On 01Apr2021, she woke up and her left hand and arm were numb. She went to the hospital, and they told her she could have partially and had a stroke. Three days after receiving the first dose of the Covid vaccine, she could not use her left hand. Her hand was now cramped up, and she could not bend it, almost like someone who had cerebral palsy. She stated that after the first dose her left hand went numb, and she went to the hospital and was diagnosed with radial nerve palsy. She stated that all her fingers are cramped, and she can't open them, and her hand was in a brace. She stated that she would have to do physical therapy. It was her left hand, the same arm that she got the first dose of the Covid vaccine in. She could not move her left hand. She was really annoyed about it, and she was scared. The patient stated that she had a grandson and a daughter. This vaccine was the best possible way to prevent Covid. She had always got vaccines. Upon follow-up received on 09Apr2021, she was calling about the Pfizer Covid vaccine. She does not have a ride to get her second dose of the Covid vaccine on Saturday morning. She does not know the name of the facility where she was supposed to go. She was asking for help with an (cab service). She thought she was calling her county. She would call her county and ask for help with a ride. She had a reaction after her first dose of the Covid vaccine. She received the first dose on 19Mar2021. She does not know if it was because of the Covid vaccine. She was asking if she should get the second dose of the Covid vaccine in the same arm as last time. She wanted to get the second dose of the Covid vaccine in the same arm as last time, so that she does not mess up the other side of her body. She was asking what was going on with her arm. She was asking if thaws had anything to do with the Covid vaccine. Upon follow-up received on 09Apr2021, she scheduled second dose due on 10Apr. Her left arm hurts a couple of days ago, it ended her going to the hospital. She called to ask if it had something to do with the Covid vaccine. The event hypoaesthesia, cerebral palsy, muscular weakness, muscle spasms outcome was reported as not recovered. The event cerebrovascular accident, pain in extremity, radial nerve palsy outcome was reported as Unknown. The action taken in response to the events for bnt162b2 was not applicable. Therapeutic measures were taken as a result of her hand was now cramped up, and she cannot bend it, almost like someone who had cerebral palsy. (cerebral palsy). Follow-up (09Apr2021): This follow-up spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that: New significant information.

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.

Severe joint pain whole body 4/23,4/24 Headache-still have Heart palpitations 4/23 Muscle pain 4/23,4/24 Dizziness -still have

Client received vaccine Wednesday morning. Client started to feel weak the next afternoon. Got out of vehicle and almost fell due to leg weakness and had an abnormal gate. After 20 minutes had passed, symptoms got better. A couple hours later that day it happened again, but this time with arm weakness and hand fell at side. Client then went to ER. Had CT scan and MRI which showed client had a small clot causing a small stroke. Client had no risk factors for a stroke. Not a smoker, no high blood pressure, and good cholesterol. Doctors were unaware if the stroke was correlated with vaccine or not. Primary care physician is running labs to see if there is a clotting disorder.

Severe joint pain through entire body.; Muscle fatigue; lethargic; Severe headache; Top lip swelled; left eye mild swelling; Temperature of 100°; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in the left arm on 17Mar2021 at 14:00 (Batch/Lot number was not reported) at 61-years-old as a single dose for COVID-19 immunization. The patient did not receive any other vaccine within four weeks of the suspect vaccine. The patient was not tested for COVID post vaccination. The patient's medical history was reported as none; no allergies to medications, food, or other products. The patient did not have COVID prior to the vaccination. There were no concomitant medications. The patient previously took bnt162b2 for COVID-19 immunization on 23Feb2021 (Dose number=1; Vaccine location=Left arm; Administration time=13:30; Lot number= Unknown), hyaluronic acid (JUVEDERM) in Jan2019 (location=under left eye), hyaluronic acid (JUVEDERM) (location= top lip) on 02Feb2021. On 23Mar2021 at 05:00, the patient experienced: severe joint pain through entire body, muscle fatigue, lethargic, severe headache, top lip swelled (where she received hyaluronic acid filler on 02Feb2021), left eye mild swelling (at the hyaluronic acid filler injection site from Jan2019), temperature of 100°; all assessed as non-serious. There was no therapeutic measures taken. The clinical outcome of the events was recovering. The batch/lot numbers for the vaccine, bnt162b2, were not provided and will be requested during follow up.

when woke up today 4/27/21 at 7am, exhausted, muscle ache, headache, fever 101.3, foggy brain, 2 new symptoms that I didn't get with first vaccine: VERY thirsty, bloodshot eyes

passed out; tunnel vision; "jerking movements" of her upper extremities; left arm was tingling/left pinky and ring fingers felt nerve tingling sensations; then the back of her throat had a chemical taste and tingling; then the back of her throat had a chemical taste and tingling; BP was 164/94 while lying down; continued to have pain in her left arm and across the left side of her chest and left-sided back shoulder; continued to have pain in her left arm and across the left side of her chest and left-sided back shoulder; continued to have pain in her left arm and across the left side of her chest and left-sided back shoulder; tongue was tingling and felt swollen with an altered chemical taste for 2 days; tongue was tingling and felt swollen with an altered chemical taste for 2 days; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 12Apr2021 11:00 (Lot Number: ER8734) at the age of 61 years old as single dose for covid-19 immunisation. Medical history included Low thyroid, kidney infections, skin rashes, high cholesterol, food sensitivities. Concomitant medications in two weeks included liothyronine sodium (CYTOMEL); levothyroxine; vitamin b complex (VITAMIN B); levoglutamide (L GLUTAMINE). Facility type vaccine was Pharmacy or Drug Store. No other vaccine in four weeks. On 12Apr2021 11:00, within 1st min of vaccine, the patient's left arm was tingling, then the back of her throat had a chemical taste and tingling, then tunnel vision, then that was the last thing she remembered until she heard her partner saying, "Are you ok?" The patient said to her she thought she fell asleep. She was an RN and said that the patient passed out for about 15 seconds and had "jerking movements" of her upper extremities before she woke up. The staff and medic helped the patient to the floor where she rested for 20 min with her legs elevated on chair. BP was 164/94 while lying down, pulse was 74. The patient returned home and continued to have pain in her left arm and across the left side of her chest and left-sided back shoulder for most of the day. Also her left pinky and ring fingers felt nerve tingling sensations for the rest of the day. Her tongue was tingling and felt swollen with an altered chemical taste for 2 days. No treatment received for the events. No covid prior vaccination and no covid tested post vaccination. The outcome of the events was recovering.

soreness at injection site; fatigue; joint pain; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient (not pregnant at time of vaccination) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Apr2021 at 14:15 (lot number: ew0162) on the left arm as single dose for COVID-19 immunization. Medical history was not reported. Concomitant medications included ibuprofen (ADVIL [IBUPROFEN]) and loratadine that received within 2 weeks of vaccination. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Mar2021 at 14:15 (lot number: er2613) on the left arm as single dose for COVID-19 immunization; and on 19Mar2021, patient experienced injection site pain and soreness, fatigue, extreme thirst. Patient previously also took codeine family and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 10Apr2021, patient experienced soreness at injection site, fatigue, joint pain. There was no treatment received for the adverse event. The outcome of the events was recovered on unspecified date. No follow-up attempts are needed. No further information is expected.

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

The vaccine (Pfizer, 2nd dose) was administered too high on my shoulder and entered into the bursa, which was much more painful than the first vaccine had been. The pain in my left shoulder worsened over the next several days and I lost range of motion in the joint. I could tell the bursa was inflamed because I once had a shoulder injury in my right arm that felt and acted exactly the same. It has now been three weeks since my second dose and I am still experiencing some inflammation/limitation in my left arm, though I expect it will heal over time.

reported to ER with 1 day history of change in status of left arm weakness/imbalance with walking. Within 1 day symptoms were improving by time of presentation to ER. Ultimately was admitted and found to have an area of 1 to 2cm area of acute infarction in right posterior frontal lobe found on MRI after initial CT scan and other labs were normal.

around 2nd day have burning feeling in all my joints, migraine, upset tummy, and extremely tired. This went on for a few days. I called my health care provider since I was feeling so bad. I called on Friday and heard back on Monday. Things had gotten a lot better. Now since then my right shoulder hurts, and it never did before, When I move it it hurts, putting pressure on makes it hurt, I think it was caused by the shot. I have a apponitment with my doc on Tuesday to let them check it out. It has not gotten better and seems to be slowly getting worse, pain will go to my elbow and up my collar bone. I have never had this type of pain or issue before the shot.

Extreme muscle pain in my hips,knees,groin,and lower back. Basically the lower extremities of my body. I kept thinking that it would go away after a couple of days. It?s been almost three months. I also have stiffness in my neck and shoulders many days. But the lower extremity pain is every day, all day. It is difficult to go up and down stairs.

Hot and cold chills diarrhea started March 9, 2021 for 3 weeks now my loose stools is loose and I am having diarrhea never had a bowel problem before until i took The Pfizer vaccine on March 9 it is now May 5 and I still have the problem and weight loss Doctor is sending me for more testing because I never had a problem before to find out why this is happening to me it Hass to come from the vaccination shot that?s when everything started happening to me

Almost fainted from struggling to breathe; abdomen swell quite a bit; nerve burning/nerve pain; Diarrhea; Losing some weight; Almost fainted from struggling to breathe; This is a spontaneous report from a contactable consumer (patient). A 61 Years female (no Pregnant) patient received 1st dose of BNT162B2 (Lot number: EN6208) Intramuscular on 25Mar2021 at single dose on Left arm for covid-19 immunization. Medical history was not reported. No other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications that the patient received within 2 weeks of vaccination was Vitamin C and D and a multi vitamin. Past drug included Allergies to Codeine, Cipro (Cipro gave me central nervous system toxicity). Patient stated that I could immediately taste the shot. Two hours into receiving the shot I could feel it attack my right side. Almost fainted from struggling to breathe. It made the right side of my abdomen swell quite a bit to the point where I felt I almost needed to ice it. It also gave me nerve burning. It has been 3 weeks and I still have some nerve pain from it. Diarrhea. Losing some weight. Unsure if I dare get the second dose. No treatment. Outcome of the event was unknown. Prior to vaccination, patient was not diagnosed with COVID19. Since the vaccination, patient had not been tested for COVID 19. No follow-up attempts are needed. No further information is expected.

After the 2nd COVID 19 vaccine shot, the tingling and numbness at the tips of my fingers and toes become worse the next day. I am now also experiencing severe joint pain, and muscle spasm during sleep at night.

About 1 week after my second COVID19 vaccine, I began to experience pain in my left hip area. It feels like a bruise but there is no visible bruising. It has not resolved.

Second vaccine given at 1627. 1700 pt. Stating having tingling lips and feeling shaky. Taken to sit in observation area to sit and VSS BP178/92, HR 92, sat 98%. Benadryl, 25mg PO given with water. VSS 1705 BP191/88, HR 90 and sat 94%. 1710 162/91, 90, 99%, 1715 158/91,93,96%Patient put on cart with knees up and cont. To complain of dizziness and left neck stiffness. 1720 166/83,85HR,99% 1725 154/83, HR85, 99% 1728 157/91, HR 86, 98% 1732 156/94, HR 86, 99% 1737 175/87, HR 86, 99% Took patient into wheelchair, complaining of head spinning 1741 184/72, HR 90, 97% 1747 155/87, HR 90, 98% 1751 187/91, HR 95, 95% Patient was going to attempt to go to car, but continued with dizziness; EMS called. 1756 182/84, HR 97, 99% EMS arrived at 1800; took down history 1800 182/91, HR 99, 99% Patient transferred to cart and taken to hospital. Patient alert/oriented x3, anxious for the entire encounter.

Cough; Shortness of Breath; Fatigue, Chills, Muscle or Body Aches, Headaches, New loss of taste or smell, Congestion or Runny Nose, Diarrhea; Vomiting. Prednisone (DELTASONE) 10 mg tablet; Take 2 tablets (20 mg total) by mouth 2 (two) times a day for 4 days-Azithromycin (ZITHROMAX) 250 mg tablet; z pack. 500 mg day one 250 mg day 2-5. -Albuterol HFA (PROVENTIL;VENTOLIN) 90 mcg/actuation inhaler; Inhale 2 puffs every 6 (six) hours as needed for wheezing for up to 7 days.

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.

Feeling like maybe there is something wrong with her spleen; The pain is in the left side of the back kind of by the lungs; She has been sick; Her mental status was also affected; What scared her was not feeling like she was getting enough oxygen; Nausea; Body pain/flu-like body pain in her muscles over her shoulders; Out of it; Pain in her back where her lungs are; Problems breathing/Her breathing still almost feels labored; Hot and cold sweats; Dizzy; Shaky; Weak; Tired; Headache; Anxious; Fever; Itchy; Arm hurt; This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer. A 61-year-old female patient received first dose BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Left on 09Apr2021 13:00 (Batch/Lot Number: TW0151) as SINGLE DOSE for covid-19 immunization. Medical history included cancer, pneumonia, pain in her lungs, smoker and arthritis. The patient's concomitant medications were not reported. The patient experienced what scared her was not feeling like she was getting enough oxygen on an unspecified date, problems breathing/her breathing still almost feels labored on 11Apr2021, arm hurt on 09Apr2021, pain in her back where her lungs are on 11Apr2021, hot and cold sweats on 10Apr2021, dizzy on 10Apr2021, shaky on 10Apr2021, nausea on 13Apr2021, body pain/flu-like body pain in her muscles over her shoulders on 11Apr2021, out of it on 11Apr2021, weak on 10Apr2021, tired on 10Apr2021, headache on 10Apr2021, anxious on 10Apr2021, fever on 10Apr2021, itchy on 09Apr2021, feeling like maybe there is something wrong with her spleen on an unspecified date, the pain is in the left side of the back kind of by the lungs on an unspecified date, she has been sick on an unspecified date, her mental status was also affected on an unspecified date. Patient had the first dose of the Covid Vaccine on 09Apr2021 and gradually her arm hurt, she had hot sweats, she felt dizzy, was shaky, had nausea, and had body pain. The one thing she is concerned about was she had pain in her back where her lungs are and she was having problems breathing. She has a little bit of that still. She has also been out of it. Her breathing still almost feels labored, and this past weekend she thought she would go to the emergency room. Her main concern is this awful pain in her back while she was having problems breathing and getting enough oxygen. She felt weak, dizzy, and shaky. She got scared. She has been sick, she had cancer a long time ago. What scared her was not feeling like she was getting enough oxygen. The pain is in the left side of the back kind of by the lungs. It goes directly from the front to the back. On Monday it started feeling better. Today it is so much better. She will feel like she is not getting enough oxygen or giving a full breath and then this in her back. She remembers having pneumonia years ago and having pain in her lungs. That's why she knows the pain is in the back of her lungs. She has to say she is a smoker. She slowed down and couldn't smoke this week or during that. She kind of quit, that's her reality now. The pain comes and goes throughout the day but it is not as bad. She didn't have this shortness of breath and other things until a couple days after she got the vaccine. It gradually came up on her. She was not having trouble breathing, it was more slightly labored. It was not profound, just there. Sometimes when she is speaking after a while she gets tired and will have to take a moment and take a deep breath. It is so much better. She called her primary care physician and was anxious, and all he said was she would feel effects for 2 weeks. He wasn't very helpful. Her arm hurt the day that she had the shot. Even today there are little bits of pain but very light. 09Apr2021 through 11Apr2021 was when everything really hit. It was hard to lift up her arm. It was a little pain, it was no big deal. She would have the AC on and blast it when she had the hot and cold sweats. She was using napkins because she was sweating profusely. It felt like she obviously had a reaction to the vaccine. It's normal she guesses. She didn't expect it for the first dose. The 11th, 12th, 13th, and 14th it was really bad. Her whole body was sweating and would get wet. She'd be hot and then cold. She was anxious because she was having problems breathing. She still gets a little bit of hot and cold sweats, but nothing compared to what she went through. As the days go on she is slowly getting better. She was dizzy not just during the day, at night she couldn't sleep because of it. She has gradually gotten better. Yesterday she tried to do some gardening but felt so weak she had to come back inside. When she gets up she feels weak and a little bit of lack of air. She has labored breathing. She was real itchy. The shakiness, dizziness, and anxiety all came on and were horrible. She doesn't know if the nausea was because she couldn't eat and had to take her regular medication. It was very light nausea. She had flu-like body pain in her muscles over her shoulders. Her headache was major too during all of this. The headache is something that comes and goes still. It is a weird kind of headache. She had a fever and got like flu all over body pain. She doesn't know how to explain how she felt out of it. She doesn't know if it was the fact she was so sick. She had a feeling of did she do that. She couldn't make decisions. She would need to take the garbage out and go back to the garbage and think what did she come here for. Her mental status was also affected. The weakness gradually got really bad, and she still hasn't recovered from it. She still feels weak and tired when trying to do things. She was tired the day after she got the vaccine. The first day she thought it was nothing and she was fine. Gradually it got real bad when she was sick. She didn't feel that flu-ish feeling but was weak and tired. She got dizzy and she had the brain fog thing. She was having really bad headaches during the same time. The weakness and tiredness go hand in hand. She takes a mineral for her thoracic spine, but she takes that more for elderly arthritis. She doesn't have any conditions that she thinks played a role. She has been feeling like maybe there is something wrong with her spleen. Took Tylenol for her fever. Mentioned fever would go away and come back. The patient underwent lab tests and procedures which included body temperature: 102, 99 and 100.1 (unit unspecified) all on unspecified dates. Therapeutic measures were taken as a result of fever and itchy. Outcome of the event problems breathing/her breathing still almost feels labored, arm hurt, pain in her back where her lungs are, hot and cold sweats, dizzy, out of it and headache was recovering. Outcome of the event fever was recovered on 13Apr2021, itchy was recovered with sequelae on 14Apr2021, body pain/flu-like body pain in her muscles over her shoulders was recovered on 16Apr2021, nausea was recovered on 16Apr2021, shaky was recovered on 19Apr2021. Outcome of the event weak and tired was not recovered. Outcome of all the other events was unknown.

Patient started having numbness and joint pain in her left arm within one hour of administration. By that evening, she had pain in all her joints. Joint pain lasted 3-4 days. She had vertigo when standing. Experienced confusion and forgetfulness for 24-36 hours.

It seems like it took a long time to complete administering the vaccine. I felt almost faint than I heard/felt a "pop". The next day the soreness from the arm migrated to the back/top of the left shoulder, then up the left side of the neck then up to the ear. The pain/soreness then come over to the front of the should down under the clavicle bone. The pain/soreness is still present today with mild headaches.

Mild/moderate loss of bladder control Off balance Injection site pain Headache/ stabbing pain in left temple area,a little in the right temple/"spacey" feeling Lower back pain/General muscle weakness Chills/ low grade fever Nausea Congestion/cough Lasted 24-48 hours

Lower back discomfort/mild joint pain Mild injection site pain Large swelling/redness at site for a week Mild/moderate loss of bladder control Vertigo/nausea Lethargy Chills/fever 102.9 Congestion/cough Headache Unwell for about 24 hours

bled a bit; pain in left finger joints/ joint aches; sudden heaviness in arm; chills; severe fatigue; over all unwell/uneasy feeling; Nausea started about the 5th hour; feeling feverish, but never had a real fever; odd little pains in the left side of her neck; tension type headache; foggy; blood vein and possibly a nerve was hit; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient (pregnant: No) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration in left arm on 03Feb2021 (lot number: EL9265) at 10:00 at single dose for COVID-19 immunisation. The relevant medical history included arthritis, breathing issues - asthma/copd still being tested, hypertension, liver issues and known allergies: Ct contrast, Dilaudid, Flagyl combined with doxycyline or cephlexinc. Concomitant medications were reported as none. At injection, a blood vein and possibly a nerve was hit. She felt the nurse followed all proper protocol for finishing the injection and notifying RN in charge. On 03Feb2021 at 2:00 PM, the patient had immediate pain in left finger joints and sudden heaviness in arm within a couple of minutes. It bled a bit. She was still having some issues with the hand, but the injection site was fine. She was concerned about the number of symptoms, the severeness and the length of time they had lasted. This was very worrisome and unexpected from all other accounts by others and everything she had read on the first vaccine. She was feeling 'off' within 2 hours, by the 4th hour She had developed chills, severe fatigue and over all unwell/uneasy feeling. Nausea started about the 5th hour and she started feeling feverish, but never had a real fever, odd little pains in the left side of her neck, but that subsided. Developed tension type headache, joint aches, foggy. This continued for about 4 1/2 days. Unable to function without Tylenol every 5hr. Therapeutic measures were taken as a result of the events. The outcome of the events was recovering. Follow-up attempts are completed. No further information is expected.

The soreness in my neck and arm seemed to be the only issues for the first two weeks. Then I began to have dizzy spells. These dizzy spells seem to come and go all day long. The sound going into my ears sounds as if I am under water.

slight cough, lips tingling right after shot, then back pain and discomfort, headache 4 hours later, then next morning - extreme fatigue, nausea, then through the day - brain shut down, slept all day, extreme pains throughout body like being stabbed and twisting the knife, convulsion like movements from pain, couldn't eat or drink. Didn't feel better until next morning. That was the worse experience I've ever been through. This was my second vaccine. I reacted to the first vaccine also, but not with such pain.

Global myalgia X 5 days, fever (next day -101, day after that - 102.8), night sweats X 2 nights, and arm pain 5 days (even with total relaxation of deltoid during injection). I have had since the injection, and still have, severe anergia, weakness and fatigue.

She got her vaccine, no reaction to the arm, no arm pain, nothing. Then that evening 3 hours later she could hardly walk when she stood up. Her right side of her body starting from hip to inner thigh and stabbing pain in her groin area with any step she took. Firing pain to her hip and inner thigh. She was limping that evening and went to bed, and when she woke up with stabbing pain in her hip and groin area and unable to walk at all. She had to scoop around in her office chair as she is OK to sit, but when she takes her first step on the right side has the stabbing pain until her body (warms) up for at least the first several steps at least. She did go to her doctor and he prescribed Diclofenac sodium 75 mg twice daily for the inflammation and should go away within a week or two, but it has been almost a month and the symptoms have not gone away. Her hip area has gotten much better, however, her groin area has gotten worse. It's at the point that she can walk, but she grimaces and hurts once she's able to get up and walk. In the right groin she can distinctly feel the sharp stabbing pain as she walks. Again, as long as she's sitting she is okay, but upon trying to walk the first 5-6 steps it is painful. The longer she walks the pain diminishes more. She did not have these symptoms prior to the vaccine. She did not fall or do anything to injure herself. She is now going to restart taking the medication he prescribed to her. First vaccine had foot pain on the right side that went away by the next day.

ED Note: "presents to the ED via RRT from pre-op after having a left SI injection with complaints of a stroke alert. at 1132 this morning. Per NP from pre-op, the pt received the injection without issue. After the injection she was developed groin numbness, which progressed into a headache, and chest pain. She then became aphasic, with left sided weakness and numbness. BS was 154 at that time. Per husband at bedside, the pt had numbness and tingling after injection but was otherwise at baseline. While the pt was getting dressed, the husband went to get the car. He notes the pt is on Xarelto secondary to PE and has taken it as prescribed. He denies any missed doses but states he is unsure of what time the last dose was. He states that the pt has no lasting deficits from her prior stroke. Of note, the pt is able to respond by nodding yes or no but is unable to speak. Pt able to write on a white board. She states she was taken off the Xarelto 3 months ago. The pt states she is unable to talk. She endorses left arm and leg weakness. The pt states she has a prior stoke years ago with weakness but has no lasting deficits. " Admitted to the hospital Diagnoses: -Dysphasia -Small vessel cerebrovascular disease -Bereavement -Vitamin-D deficiency

Extreme fatigue; body aches; joint pain; This is a spontaneous report from a contactable A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19. VACCINE, solution for injection, lot no: EN6203), dose2 at Right arm on 20 Feb 2021 at 03:45 PM as single dose for COVID-19 immunisation. Medical history included IBS, Szogrines syndrome and fibromyalgia. Concomitant medication included Omeprazole, bupropion, duloxetine, anastrozole. Historic vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19. VACCINE, solution for injection, lot no: EL9264), dose1 intramuscular at Right arm on 30Jan2021 at 03:45 PM for COVID-19 immunisation. The patient did not receive covid prior vaccination and was not tested covid post vaccination. There were no known allergies. On 22 Feb 2021 at 12:00 AM, patient experienced Extreme fatigue, body aches joint pain. The outcome of events was reported as not recovered. No follow-up attempts are needed. No further information is expected.

pulled a muscle under her left breast; 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 on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE (at the age of 61 years old) for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The consumer received the first dose of the Covid vaccine and is scheduled to receive the second dose today at 1 p.m. On unspecified date, the patient pulled a muscle under her left breast. Outcome of the event was unknown. No follow-up attempts were needed. Information on Lot/batch number cannot be obtained.

Fever, severe muscle pain, severe joint pain. Gradually increased from 4/14 and peaked about 4/22 , continued, and then abated about 5/4. Voltaren and Vicodin on the worst days, but pain was still severe. Pain lasted about 20 days.

Pt reports after receiving her vaccines and for the past 3 weeks she is still in a lot of physical pain, difficult to walk, and lots of muscle and joint pain in the side she received the vaccine. She has not been able to sleep and her brain feels foggy, states the her memory has been affected severely. Pt also reports still having diarrhea, vomiting and coughs sometimes. At time of call pt also reports she is feeling shaky. Pt states all these symptoms she is experiencing is all because of the vaccine. Pt reports she took Tylenol, and did not help. Pt reports that she called her MD today and was told she should still get her second vaccine.

This was reported to this writer. The patient lost consciousness immediately after the injection. Laid on floor by daughter. There was no head trauma. EMS was called and assumed care. Patient's legs were elevated. Laid on floor for 10 minutes. Conscious and able to answer questions from EMTs, with daughter interpreting. Patient was eventually assisted to a wheelchair and wheeled into the observation area. There was leg weakness with transfer. While in the post vaccination observation area, patient was talking, drinking water. Appeared stable. 15 minutes from EMT arrival, they left. Patient able to stand and walk with stable gait 45 minutes following the incident. Taken home by daughter.

Nerve pain down left leg; back pain that goes down left leg; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number ENG6199) via an unspecified route of administration on 27Mar2021 at 10:00 (at the age of 61-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included high blood pressure. 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 amlodipine besilate (NORVAC), daily multivitamin, "estradiol and prog" from unspecified dates for unspecified indications. The patient previously received dose 1 of BNT162B2 (lot number ENG202) on 06Mar2021 at 10:00 as a single dose for COVID-19 immunization. On 29Mar2021, the patient started with back pain that went down the left leg; "nerve pain down left leg." The patient visited a doctor for the event. The patient underwent lab tests and procedures that included X-rays and "possible MRI." The outcomes of back pain that went down the left leg and nerve pain were not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.

Moderate to severe muscular pain starting in upper thighs bilaterally and spreading to entire thigh over the course of several days. I am a fit woman who walks 3 miles 3-4 times a week. I did not participate in any activity that would have caused this issue. Several of my colleagues that were vacinated. In December and January have also been complaining of unusual muscle and joint aches so I thought I should report.

Patient has had Bells Palsy 2 times prior. 1976 H1N1 vaccine / 2009 after having been infected with H1N1. No Fever at all during 14 days May 12- facial pain, body aches, head aches. May 15- all symptoms continued facial swelling, loss of feeling to touch of face. Pain traveling down neck. Left side of face dropping. Hands very cold and cramping. May 17 - body aches and headaches leave. All other symptoms and facial pain continues. Tingling of skin on knees begins. May 21 - knees and thighs begin to feel numb and tingly. This feeling of not right continues to increase and spread. May 24 - all facial pain increased. Legs and arms tingly and numbing feeling unsteady. May 25- flushing and rash appears. Arms are heavy and all other symptoms continue.

Woke up at 5am on 5/7/21 with severe lower abdomen/back pain & severe cramping; took Ibuprophin & used heat pad. Pain subsided by noon but still slightly sore when, got up & moved around that day then I went to bed that night still slightly sore. Woke up again at 6am with severe pain like morning before; took Ibuprohin and heat pad. Tried to get up around 8am but had to return to bed by 10am. Pain got worse to point where I could not breath with SEVERE cramping in lower back/abdomen. Called for EMT to transport to ER. Was given muscle relaxer OTW ER. After about 1 hr in ER was given another muscle relaxer and pain med (Morphine). (NOTE: this form will not allow use of Continuation Pg)

chills; I had chills, muscle aches and ran a temperature between 101.7 and 100.1 for 30 hours; ran a temperature between 101.7 and 100.1 for 30 hours; This is a spontaneous report from a contactable consumer (patient) A 61-Years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: en6210) on 17Feb2021 at 02:30 at single dose via an unspecified route of administration on left arm for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 (lot #: en5318) on 27Jn2021 at 02:30 am on left arm. On 17Feb2021 at 12:00 am the patient presented chills, muscle aches and ran a temperature between 101.7 and 100.1 for 30 hours. No treatment was administered for the events. The patient recovered on an unspecified date. Follow-up attempts completed. No further information expected.

Lots of systemic Sx- Mild H/A; myalgia pretty strong; injection site pain; Fatigue; Poor appetite; This is a spontaneous report from a contactable consumer (patient). A 61-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 05May2021 at 15:45 (at the age of 61-years-old) as unknown, single for COVID-19 immunisation. Medical history included hypertension (HTN), hypercholesterol, hypothyroidism and possibly cephalosporin allergy. The patient's concomitant medications were not reported. On 06May2021 at 11:00, patient experienced lots of systemic Sx (symptoms)- Mild H/A (headache), myalgia pretty strong, injection site pain (unlike from past vaccines like flu and TPD), fatigue and poor appetite which lasted nearly entire next day after 3:45 pm shot. Patient reported it prevented her from attending to normal activities. No treatment was given to the patient. Patient did not have COVID prior and post vaccination. Outcome of events was recovered on an unspecified date. Information on lot/ batch number has been requested.

Fever 101.5; headache; back pain; hip pain; dizziness; nausea; arm pain; This is a spontaneous report from a contactable consumer (patient, self-reported). A 61-year-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL 9269 and Expiry date: unknown), dose 2 via an unspecified route of administration, in the left arm, on 06Feb2021 at 11:30 (age at vaccination 61-year-old), as single for COVID-19 immunization in the hospital. The patient's medical history included psoriasis, fibromyalgia and vitamin b12 deficiency. The patient had drug allergy which were contrast media allergy, vancomycin allergy. The patient concomitant medications included amitriptyline, vitamin B12 NOS, vitamin D NOS taken for an unspecified indication, start and stop date were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL8982 and Expiry date: unknown), dose 1 via an unspecified route of administration, in the left arm, on 17Jan2021 at 11:30, as single 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 was not tested for COVID-19 since the vaccination. On 06Feb2021, the patient experienced fever 101.5, headache, back pain, hip pain, dizziness, nausea, arm pain. The patient underwent lab tests and procedures which included body temperature 101.5 on 06Feb2021. The outcome of the events was recovering. Follow-up attempts are completed. No further information is expected.

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

Patient became rigid and fell down and could not get up, she can no longer stand unassisted. She has become incontinent and now has to where a diaper, and leans to her right side while sitting and standing. She cannot focus for very long. And she becomes rigid and stiff for periods of time. She is no longer able to bath herself or care fir her basic needs. Even with intense therapy hasn?t reached her baseline.

Severe pain in upper neck, left shoulder, left arm; Severe pain in upper neck, left shoulder, left arm; Severe pain in upper neck, left shoulder, left arm; pain to left shoulder and left arm where the shot was given/Severe muscle pain on injection arm; Left wrist ache; was not sleeping; severe muscle pain; This is a spontaneous report from a contactable consumer or other non hcp. A 61-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 03May2021 10:00 (Batch/Lot Number: EN6208) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included nerve injury from an unknown date and unknown if ongoing, intervertebral disc operation from 2019 to an unknown date, nuchal rigidity (Can't turn neck to the left past a certain point) from an unknown date and was ongoing. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2m (Lot number: EN6198) on 12Apr2021 (at the age of 61-year-old) for covid-19 immunisation; the past drug includes naproxen which worked well. The patient developed pain to left shoulder and left arm where the shot was given a week later/ Severe muscle pain on injection arm, on an unknown date in May2021, severe pain in upper neck, left shoulder, left arm on 07May2021, experienced left wrist ache, was not sleeping on an unknown date in May2021. It was reported that patient used ice packs on it and taking Naproxen around the clock, but nothing touches it. Starts to feel like she was getting better, but really was not. The patient had no cold or flu symptoms. It was reported that patient visited chiropractor on 01May2021 for this crick in her neck. States she did not have COVID arm and did not have redness or swelling on the injection arm. It was also reported that patient had severe muscle pain on an unknown date in May2021. The patient has been taking Naproxen (Kroger brand, Formulation: 220mg caplets, NDC: 30142-617-90, Lot: 9ER0418, Exp: Dec2020) at a dose of three caplets in the morning. A couple of nights did two caplets 12-14 hours later; Lidocaine Patches (NDC: 0603188010; Lot: 74098; Exp: Jun2017; Formulation: 5%, 700mg patches) at a dose of patch on last night where the main part of the pain was at, which was the injection site, put one patch on the left arm and one patch on the upper part of the left shoulder near her back, left patches on overnight, about six hours. The outcome of the events pain to left shoulder and left arm where the shot was given/Severe muscle pain on injection arm, Severe pain in upper neck, left shoulder, left arm was not resolved, left wrist ache was resolved on May2021 and was not sleeping, severe muscle pain was unknown. No follow-up attempts are needed. No further information is expected

severe pain down her both legs and the pain has not gone away; she also had back pain but it's a little bit better; she had nerve pain; I have the usual fever and you know feeling like I had the flu on Sunday the day after I had the flu on Sunday the day after I had the second vaccine.; I have the usual fever and you know feeling like I had the flu on Sunday the day after I had the flu on Sunday the day after I had the second vaccine.; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), via an unspecified route of administration on 17Apr2021 (at the age of 61-year-old) as 2nd dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot no.: EN6204) on 27Mar2021 (at the age of 61-year-old) as single dose for COVID-19 immunization and she experienced a slight pain (minimal) down in both of her legs, pain from the vaccine, nerve pain and could barely walk. Then she received the second dose on 17Apr2021 and the next day (18Apr2021), she started experiencing a severe pain down her both legs and the pain has not gone away, she also had back pain but it's a little bit better, during the call she mentioned that she didn't have muscle or joint pain, that she had nerve pain. She has gone to many doctors, her life is affected negatively, she said that they should care people better. She would like to know why she is experiencing this pain. The patient also had the usual fever and flu on Sunday (18Apr2021) after she had the second vaccine. Therapeutic measures were taken as a result of the events which included Advil and Tylenol. The outcome of the events was unknown. Information on the lot/batch number has been requested.

Tinnitus; hearing loss; Gout; Dry heaves; extreme abdominal cramping; Chills/Fever; Chills/Fever; Body Aches; Slept most of the day; Extreme sore arm; Quarter size hard lump X3weeks;; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 61-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 1 via an unspecified route of administration, administered in the left arm, at age 61 years, on 03Feb2021 (Batch/Lot Number: EL9269) as 1st DOSE, SINGLE for COVID-19 immunisation. Relevant medical history includes hypertension, asthma, glaucoma and cataracts, and blood clot from unspecified dates. Prior to vaccination, the patient was diagnosed with COVID-19 on unspecified date. Concomitant medications included chlorthalidone; apixaban (ELIQUIS); losartan; and verapamil, all taken for an unspecified indication, start and stop date were not reported, received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient previously received ciprofloxacin (CIPRO) and vancomycin on unspecified dates and experienced known allergies. On 03Feb2021 14:00, the 1st day, patient experienced extreme sore arm; quarter size hard lump X3weeks. On 04Feb2021 14:00, second day, patient experienced chills, fever, body aches, slept most of the day. On 05Feb2021 14:00, third day, patient experienced dry heaves for 2 hours followed by extreme abdominal cramping that required the patient to lay flat for the whole day. On 06Feb2021 14:00, fourth day, patient woke up to gout in his right big toe that lasted for a week. On 08Feb2021 14:00, sixth day, patient had tinnitus in both ears and hearing loss. ENT doctor prescribed oral steroids w/ taper and when that didn't work. Patient went through 4 torturous treatments where ear drum was initially punctured and shot of steroids was inserted through the hole. That didn't work either and around the time of reporting, patient was told that she have permanent hearing loss and the tinnitus has not gone away. She is now looking at needing hearing aids and will not be subjecting herself to the second dose. Hospitalization prolonged was not involved. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered was at a doctor's office/urgent care. The outcome of the events was not recovered.

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.

Patient stated she felt some pain in her back at first, then when down to her left leg. She stated her left leg has been hurting since the first shot. She felt muscle pain and sensitive to the touch to he left leg. She was advise to seek medical treatment for a doctor.

"Ten hours after vaccine, general fatigue, 16 hours post injection, severe shivering, chills, muscle pain, and fever. Followed by headache, backache, weakness."

Tingling/numbness and weakness of left arm from biceps to wrist... on and off throughout the day... when the tingling feeling happens my arm gets weak and I cant lift things safely and my hand grip is weaker. the tingling sensation is like "falling asleep" limb.

she started to feel fatigued; like she was coming down with a cold; pain below her left shoulder bladShe also had a pain below her left shoulder blade. Stated it became so painful she couldn't stand.e; a pulled muscle; Her blood pressure was elevated at the hospital at "over 200"; numbness; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received second dose of bnt162b2 (Pfizer-Biontech Covid19 vaccine, Solution for injection, Lot Number: EW0168 and expiration date not reported), via an unspecified route of administration on right arm on 21May2021 at around 16:30 (at the age of 61-year-old) as 2nd dose, single dose, for covid-19 immunization. Medical history was not reported. The patient's concomitant medications were not reported. It was stated she was very healthy. Patient previously took First dose of bnt162b2 (Pfizer-Biontech Covid19 vaccine, Solution for injection, Lot Number: EW0176 and expiration date not reported), via an unspecified route of administration on right arm on 29Apr2021 for covid-19 immunization. Patient experienced Sore arm after first dose of vaccine which was recovered on 01May2021. On 22May2021, Saturday around 14:00, Patient felt fatigue and felt like she had a cold coming on. She also had a pain below her left shoulder blade. Stated it became so painful she couldn't stand. Stated at night she took some Tylenol. She said that she changed positions a lot while sleeping and had difficulty doing so that night. Her daughter called to see how she was doing and made the caller go to an Urgent Care. Patient stated she went, and they checked her vital signs. The Physician's Assistant talked with her and prescribed her a muscle relaxer and Ibuprofen. While the patient was driving to get her prescriptions, she noticed that the pain was traveling down her left arm as well as some numbness. Her daughter told her that this was a sign of a heart attack in women. She said her daughter was a nurse and was upset that the urgent care did not do an EKG or listen to her heart. The patient went back to the Urgent Care; they said her EKG was abnormal and wanted to send her to the Emergency Room. The caller signed a form refusing the ambulance and took herself to the Emergency Room. The Emergency Room did 2 EKG's, blood work, and a CAT scan of the patient's brain. Everything resulted as normal or near normal per the patient. Her blood pressure was elevated at the Emergency Room, the first one was over 190, the second one over 200 per the patient. She stated that was why they did the second EKG and stated they told her both those EKG's were normal. Patient said that the Physician's Assistant at the Emergency Room told her that her heart was okay. She got home from the Emergency Room around 01:00 on 24May2021. She slept some after taking a muscle relaxer and Ibuprofen. She did not pull a muscle or anything. Stated the only thing she could think of was the vaccine. Patient asked if anyone else had reported having this issue after the second dose. A friend of hers had flu like symptoms after the second dose; no identifying information provided by the patient. She took care of her grandkids but had not been able to do so. Her daughter has had to find someone else to care for them. Patient asked how long may this last. Her HCP had just retired, and she had a new one who works out of withheld. It was stated that the pain below her shoulder blade comes and goes. Rates it as a 7-9 on the 1-10 pain scale. The outcome of the event numbness was unknown. Patient recovered from events other on an unknown date May2021. Follow up attempt completed. Additional information has been requested.

4/24/21 At about 6pm I started to feel pain on right side from groin area down to my legs by the next morning I was not able to walk. The pain would radiate and it was a stabbing pain around the groin area. I started to walk and it would numb out. The next morning I called the emergency line and the doctor assure me it would be a reaction and it shouldn't take more than a few days. after a week he prescribed medicine for inflammation they didn't work another week later I was prescribed Gabapentin 300mg 1x a day

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.

Headache; Chills; Muscle aches; Tiredness; Sore at injection site; 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 17Mar2021 at 13:00 (at the age of 61-year-old) as a single dose for COVID-19 Immunisation. The patients medical history included high BP and diabetes Type 2. The patients concomitant medications included atenolol (MANUFACTURER UNKNOWN), spironolactone (MANUFACTURER UNKNOWN), losartan (MANUFACTURER UNKNOWN) and metformin (MANUFACTURER UNKNOWN) for an unknown indication from unknown date. The patient did not have any allergies to medications, food or other products. The patient did not receive any other vaccine within four weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced Headache, chills, muscle aches, tired and sore at injection site on 17Mar2021 at 15.00. The patient did not receive any treatment for the adverse events. At the time of report, the clinical outcome of the events Headache, chills, muscle aches, tired and sore at injection site were recovering. Information about lot/batch number cannot be obtained. No further information is expected.

Around 7:00-8:00 that evening, approximately four hours after recieving the vaccine, I started having shooting pain in my head. It was mild at first, then harder and more frequent as the evening went on. It did that until late the next morning and was completely gone by around noon. This wasn't a 'headache' or migraine. It was shooting pain like none I had ever had in my head. I had a knee revision years ago and it also affected the knee through the night with that same type of pain. I wasn't as concerned about the knee, but, the head was concerning. I didn't report it because I didn't know I had to register to check in.

ALS; Profound fatigue; weakness; joint pain; Difficulty getting up from a crouch position; This is a spontaneous report from a contactable nurse reported for herself. A 61-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 02Apr2021 11:15 AM(Batch/Lot Number: EP7533) as 1ST DOSE, SINGLE for covid-19 immunization, at the age at vaccination of 61 years old. Medical history included Damage from spinal cord tumor at C2, s/p resection, s/p ablations for cardiac arrhythmia, amyotrophic lateral sclerosis, Allergies. The patient's concomitant medications were not reported. The patient experienced ALS, profound fatigue, weakness, joint pain and difficulty getting up from a crouch position, all on 03Apr2021 with outcome of recovering. Reported Event: Profound fatigue, weakness and joint pain. Difficulty getting up from a crouch position to the point that she googled 'how to get up off the floor'. She was worried she had Amyotrophic lateral sclerosis (ALS.) This progressed to having difficulty getting both up and down, even from a chair. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The event ALS was serious as medically significant. No treatment received for events. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the available information, the Company considers the reported event ALS is unrelated to bnt162b2 vaccination, but more likely due to underlying or inter-current medical conditions. The patient has medical history of amyotrophic lateral sclerosis. 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 has been diagnosed w/ Polymyalgia Rheumatica.; This is spontaneous report from a contactable other-HCP. A 61-year-old female patient received the second dose of BNT162B2 (Lot Number: EW0161) at single dose for COVID-19 immunisation on 15Apr2021 at 02:30 PM. Relevant history included HTN, Hypothyroidism, HLD, Hyperglycemia, Vit D Deficiency, Radiculopathy Lumbar Region. Relevant concomitant drug included ascorbic acid, retinol, tocopherol (OCUVITE), Enalapril 5mg, Vitamin D3 50000 IU, Atorvastatin 10mg, Bisoprolol/HCTZ 10/6.25mg, levothyroxine sodium (SYNTHROID) 200mcg. Past drug included NKDA (as reported). The patient previously received the first dose of BNT162B2 (Lot Number:EP7534) at single dose for COVID-19 immunisation on 18Mar2021 at 02:30 PM, without side effects after 1st vaccine. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Approx 7-8 hours after 2nd vaccine (as reported), the patient started to experience intense leg and arm cramps and pain in her joints with a 10/10 pain level. She needed assistance getting into an upright position. The pain continued to worsen. She was put on Meloxicam without relief. Then Prednisone 10mg was started which had significantly help with her symptoms. She still had some pain in her knees. Patient had been diagnosed with polymyalgia rheumatica. The patient visited the doctor or other healthcare professional office/clinic due to the events. The outcome of events was resolving. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the temporal relationship, the reasonable possibility of an association between 'polymyalgia rheumatica' with symptoms of 'leg and arm cramps' and 'pain in joints' and suspect product cannot be ruled out. 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 received first Pfizer COVID vaccine dose at approximately 0800 on 5/27/2021. Injection administered in left deltoid. Pt states that she took two Tylenol before going to bed the night of 5/27/2021. Felt fine prior to going to bed except for injection site pain. She was awakened by chest pain, muscles pain, joint pain and swelling and malaise at 0200 on 05/28/2021. She states she did not have a fever and felt cold but no chills. States the chest pain lasted about 30 minutes. Unable and afraid to go back to sleep after this episode. Joint and muscle pain resolved after about 2 days.

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.

Cough This is a new problem. The current episode started in the past 7 days (x3 days. Possible covid exposure to covid 2 weeks ago. Had had both covid vaccines. Seen at clinic this week and started on antibiotics for bronchitis. Did not get tested for covid and wants covid test.). The cough is productive of sputum. Associated symptoms include headaches, myalgias, shortness of breath and wheezing. Pertinent negatives include no chest pain, chills, fever or sore throat. Associated symptoms comments: Decrease in taste. N,V,D.. She has tried a beta-agonist inhaler (antibiotics, phenergan) for the symptoms. Her past medical history is significant for COPD. Vomiting This is a new problem. The current episode started in the past 7 days (x3 days). There has been no fever. Associated symptoms include abdominal pain, coughing, diarrhea, headaches and myalgias. Pertinent negatives include no chest pain, chills or fever. Risk factors include ill contacts (No traveling.). Treatments tried: phenergan. The treatment provided mild relief.

Immediately after the shot, my shoulder became very painful. I noticed that the band-aid from the injection was located very high on my arm, right at the shoulder joint towards the back. My arm stayed painful, and I couldn't sleep. I couldn't move my arm normally. I read that arm pain was a normal side effect, so I waited. After 7-8 days, on April 3, I went to the urgent care for a virtual visit. I was seen by a PA. She had my husband rotate my arm in several ways, and it would move normally except if directly out to the side and up over my head. I couldn't raise my arm past horizontal, and my shoulder was very painful. She recommended Ibuprofen, ice, and movement. I did those things, but my arm still was not able to move normally. It felt stuck when I tried to raise it. I went in on April 30 for an in-person visit with my doctor. She examined my shoulder and recommended physical therapy and that I see an orthopedist. I had some difficulty getting authorizations in place in a timely manner, and eventually was able to see an orthopedist for a virtual visit on June 1. He recommended physical therapy and to call back for an MRI if it doesn't resolve after 6 weeks. I had my first physical therapy appointment with a clinic on June 8. I am currently doing daily PT and seeing the PT weekly.

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.

Firs stop shot 3/27/2021, second 4/17/2021Lightheaded, accelerated INR of 4.7within 48 hrs. Of first shot.Low grade fever on and off sometimes accompanied wit chills. Increasing fatigue and leg weakness, eventually shortness of breath, pain in center of chest when breathing, couldn?t lay down due to pain in neck and chest, diagnosed with pericarditis May 31 2021. Out of work since may 28 2021

she was working in the garden and she hurt her arm. She pulled a muscle in it. It was her right arm where she had gotten the shot; I got both shot on right arm because I used right arm and I wanna workout the stiffness of the shot right arm.; sore arm/sored and painful arm on the same site where the vaccine was administered; injection site magnetic; sore muscles; sore arm/sored and painful arm on the same site where the vaccine was administered; This is a spontaneous report from a contactable consumer. This 61-year-old female consumer (patient) reported for herself that she received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EM9810, and Expiration date: 30Jun2021), via an unspecified route of administration, administered in right arm on 19Feb2021 (at the age of 61-year-old) as 2nd dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Previously the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL9262, and Expiration date: 31May2021), via an unspecified route of administration, administered in right arm on 29Jan2021 as 1st dose, single dose for COVID-19 immunization. The patient was wondering if anyone had complained about their injection site being magnetic. Her girlfriend said that she heard that it was magnetic. Caller could stick a magnet on her arm, and it sticks there. It was weird that her arm was magnetic since the shot and it was not magnetic before. The patient was concerned as the magnet sticks on the same arm where she got the shot. On 02Jun2021, the patient had her injection site magnetic, sore arm/sored and painful arm on the same site where the vaccine was administered, and sore muscles. The patient reported that she got both shot on right arm because she used right arm and she wanted to work out the stiffness of the shot right arm. She got shot just she worked, she got both shot on right arm 3 weeks apart and her right arm got sored and right arm had been magnetic you can stick a magnet on her right arm. A week and half ago (on an unspecified date), she was working in the garden and she hurt her arm. She pulled a muscle in it. It was her right arm where she had gotten the shot. Her arm was so bad that she was not able to use it properly. She went to the doctors and they wanted to make sure her rotator cuff was connected so she could lift her arm up. Her arm was still sore, and they put it in a sling. It had not been recovered. She could lift it up, but it was sore than normal. The patient wondered if they put metal (that could possibly contribute to its magnetic properties) in the shot and it goes on my arm, that's why it was not recovering. She also wanted to know if this (a probable magnet presence in the vaccine) was the reason why her arm was sore. She was wondering since her arm was not feeling well, she wondered if they connect since her arm had been sore for so long. The patient had been informed that there was no metal on the shot. The patient got both shot on right arm because she used right arm and she wanted to workout the stiffness of the shot right arm. The patient was given with muscle relaxant (as treatment) and she took muscle relaxant but as per patient it was waste of time, it did nothing. The patient stated, "I put give on one minute I better look for cream waste of time. I thought to release that waste of time nothing work, its only things feel good, live things let it rest." Upon addressing Medical Inquiry, she also reported that one of her girlfriends had experience the same side effect where a magnet was sticking on the same arm where they got the vaccine. Unspecified muscle relaxant was given as therapeutic measure as a result of sore arm/sored and painful arm on the same site where the vaccine was administered and sore muscles. The outcome of the events injection site magnetic, sore arm/sored and painful arm on the same site where the vaccine was administered, and sore muscles was reported as not resolved. The outcome of the event "she was working in the garden and she hurt her arm. She pulled a muscle in it. It was her right arm where she had gotten the shot" and "I got both shot on right arm because I used right arm and I wanna workout the stiffness of the shot right arm" was unknown.

Started with left wrist, then left knee pain. Shooting pains in knee. Then the next day went to my right hip and down leg into foot. Continued to get worse until I couldn?t longer walk on it. After second shot it was again worse but is now continuing to get better. I?m walking with a limp but not using crutches any longer. Attending physical therapy. Pain is much better but still there.

Patient stated that she received a lot of pain in shoulder and thigh. Heart complications. Rumbling in chest.

After the first shot on 03242021 I experienced overall fatigue. Though I drove the 30 minutes to the first shot, I could not drive the same distance to the second due to fatigue. After the second shot, the fatigue worsened. Pain in my joints and muscles increased. My inability to walk beyond a few steps resulted in my using a cane at all times. My grip worsened and I dropped most objects I picked up. The pain had continued to increase throughout my body. I could not sleep, I became depressed. My thought processes became confused and my memory cloudy. I spoke to the Rheumatologist on June 3 out of concern and he scheduled Xrays. By 06232021 the confusion symptom started to wane.

About 4:00 pm, pain in my back and then it kept getting worse and worse and I was feeling nausea and was in a lot of pain. Husband came home and took me to urgent care. They gave me a shot there, and it was a pain reliever, which relieved it and I think the kidney stone passed at that time; Toradol injection. After that I had to strain my urine and got some of the stones and took them in the lab to test it.

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.

Patient awoke from pain from shoulder down to forearm at 9am the morning after her vaccine. She described it as "absolute misery" and she had less than 5% range of motion in her arm. She was transported to a hospital where she was released on 6/26/21 at 4pm. She said she also experienced minor nausea.

Severe shoulder pain and upper arm pain. Restricted range of motion. Prior to vaccine had zero issues with shoulder. Arm was sore and kept getting worse each day...shoulder pain began around day 3. Continually got worse. Affected sleeping, anything to do with arm and shoulder usage, woke me up twice a night. In the morning when I got up, pain so severe I could not lift shoulder out of position without assistance. Pain was all day and all night. Pain is severe up still and range of motion affected.

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.

I felt severe back pain that moved from my back to my thigh and back again for 1 week on my left side of my body; I felt severe back pain that moved from my back to my thigh and back again for 1 week on my left side of my body; I felt severe back pain that moved from my back to my thigh and back again for 1 week on my left side of my body; This is a spontaneous report from a contactable consumer (reporting on herself). A 61-years-old Non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number and expiry date was not reported) via an unspecified route of administration, administered in Arm Left on 26Jan2021 14:30 as dose 1 single for COVID-19 immunization. The patient medical history was not reported. Concomitant medication(s) included apixaban (ELIQUIS) taken for an unspecified indication, start and stop date were not reported; hctz (HCTZ) taken for an unspecified indication, start and stop date were not reported; metoprolol (METOPROLOL) taken for an unspecified indication, start and stop date were not reported; potassium chloride (K+10) taken for an unspecified indication, start and stop date were not reported. On 29Jan2021 12:00 the patient experienced she felt severe back pain that moved from her back to her thigh and back again for 1 week on her left side of her body. Patient visited physician office and received treatment for adverse events. The outcome of the events was not recovered. Follow-up attempts have been completed and no further information is expected.

felt paralyzed; hip pain; It's red and swollen.; It's red and swollen.; If she touches it with her fingers, it hurts; I'm in pain I cannot walk; had mild muscle spasms; was in horrible pain; Gout around ankle on left foot; my legs were shaking; spasms in legs; This is a spontaneous report from a contactable consumer. A 61-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection; Batch/Lot number: unknown), dose 1 via an unspecified route of administration on 11Jun2021 as 16:00 Hr as Dose 1,Single for COVID-19 immunization. The patient medical's history and concomitant medications were not reported. The patient reported that has developed gout and would like to know the number of cases of gout flare ups associated with the Pfizer COVID-19 vaccine, also stated that she wanted to know what the vaccine does to your body, what should she do about the gout flare up, and if she should call her doctor for a prescription for this problem or if Pfizer can provide her with a prescription to treat this side effect. She states that many people have experienced gout flare ups after receiving the Pfizer COVID-19 vaccine. She states that she has never had gout before in her life but after receiving her first dose on Friday 11Jun2021 that evening she states, I felt like I was being terrorized, my legs were shaking, spasms in legs, hips hurt a lot the next day this was gone. But the gout started and now she was in so much pain that I'm so furious, I'm in pain I cannot walk, it feels like needles, it's all flared up and has gout around the ankle on her left foot. She has never had gout before. She is in such pain. She can't walk. She can't step down on her foot. There are cases of gout flare-up with the vaccine. She wonders what the vaccine does to your body. She knows that it changes the DNA of the body. What does she do with the gout flare-up. It was 2 days ago when the adverse events started. She got her vaccine on Friday at 4:00. Towards the evening, she had mild muscle spasms. The next day, she could not walk. This was on Saturday. For 2 days, she was in horrible pain She has never had gout. Her mother had gout, so she knows what it is. The patient read online that gout is a side effect to the vaccine. They administer the vaccine all over the place. They push it all over the place. You can't go anywhere without getting that damn vaccine. Gout around ankle on left foot was around the bone in the back around the ankle. It's red and swollen. If she touches it with her fingers, it hurts. If she steps on it, it's like she's walking on needles or nails. It's absolutely horrible. It's disgusting they don't disclose this information regarding the vaccine. She kept putting it off. Her son informed her that he would not visit unless she got the vaccine. She does not trust vaccine companies. She had hip pain also but that is gone now. The pain was in both hips. The gout is really severe now. Mild muscle spasms both legs were affected. She felt like she was shaky. She didn't feel sturdy on her legs. Her legs were weak. She mentioned to her husband that she felt paralyzed. The muscle spasms improved but she has recovered with lasting effects. She came down the stairs at 12. She's in that much pain. Pfizer must make sure the drug is okay before they administer it. She feels like we're guinea pigs for some experiment. People who are not vaccinated are walking around without masks and people who are vaccinated are the ones wearing them. Now she finds out people who got the vaccine are more susceptible to getting Covid but with milder symptoms. The outcome of event gout around ankle on left foot was not recovered, spasms in legs, hip pain, horrible pain was recovered and outcome for other events was unknown and had mild muscle spasms was recovered with long lasting effects. Information on Lot/Batch number has been requested.

This is a spontaneous report received 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: EN6205) via an unspecified route of administration in left arm on 05Mar2021 at 10:15 (at the age of 61-year-old), as a single dose for COVID-19 immunisation. Medical history included high cholesterol. The patient did not have any allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient had received unspecified other medications within two weeks prior to the vaccination. The patient had COVID-19 nasal swab test on 15Mar2021 and resulted negative. On 12Mar2021 at 17:00, the patient experienced an ear ache, headache, tiredness, muscle pain, chills, not feeling well and had high blood pressure. The events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown if the patient received any treatment for the reported events. The clinical outcome of events ear ache, headache, tiredness, muscle pain, chills, feeling unwell and high blood pressure was resolving at the time of this report. No follow-up attempts are needed. No further information is expected.

seeing black moving spots in my right eye; jaw & neck are achy on my right side; jaw & neck are achy on my right side; This is a spontaneous report from a contactable consumer (patient). A 61-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: ER8737), via an unspecified route of administration, administered in arm left on 19Apr2021 at 13:45 (at an age of 61-years-old) as dose1, single for covid-19 immunization. Medical history included hysterectomy on an unspecified date in 2011. Patient was not diagnosed with covid-19 prior to vaccination. Concomitant medications included Calcium (MANUFACTURER UNKNOWN), via an unspecified date on an unspecified date at unknown dose and frequency for unknown indication; levothyroxine, liothyronine (NP THYROID) (MANUFACTURER UNKNOWN), via an unspecified date on an unspecified date at 60 mg, unknown frequency for unknown indication; vitamin d3 (VITAMIN D3) (MANUFACTURER UNKNOWN), via an unspecified date on an unspecified date at unknown dose and frequency for unknown indication; cyanocobalamin (VITAMIN B12 AAA) (MANUFACTURER UNKNOWN), via an unspecified date on an unspecified date at unknown dose and frequency for unknown indication; fish O (MANUFACTURER UNKNOWN), via an unspecified date on an unspecified date at unknown dose and frequency for unknown indication. The patient previously took ampicillin for hypersensitivity and experienced allergy. Patient did not received any other vaccine prior four weeks of vaccination. On 20Apr2021 at 17:00, the patient experienced seeing black moving spots in my right eye since tuesday evening and jaw & neck are achy on my right side. Since vaccination patient not tested for covid-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the seeing black moving spots in my right eye, jaw & neck are achy on my right side were not recovered. Batch/Lot number was obtained. Further information has been requested.

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.

Hives on left wrist; started feeling a little funny when she first got the vaccine; Felt really tired; Raspy voice; This is a spontaneous case from a female contactable consumer (patient herself). A 61-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- ER8736) via an unspecified route of administration in left arm on 10May2021 as dose 1, single (at the age of 61-years-old) and received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EW0173) via an unspecified route of administration in left arm on 07Jun2021 as dose 2, single for COVID-19 immunization. Vaccine was not administered at Military Facility. Patient history included ongoing seasonal allergies, hypertension, benign tumor in breast (found at 16 years old), type II diabetes from 2014, thyroid, non-smoker, fibroid tumor (surgically removed in 2003), anemia, overweight (but was losing weight) parasites, hay fever. In early 2000s, her glucose was 80 which was normal. UTI infections for which patient took ciprofloxacin in the past. Patient experienced typical dizziness from the Ciprofloxacin. Patient was allergic to trees, foods and cats, dust and grass that is freshly cut, beef, corn, strawberries, ragweed and blooming flowers/plants. Her allergies have tremendously improved the older she has gotten. In the 1990s, they were really bad. She was eating scallops and other seafood. She knows she was getting contaminated food. She picked up these parasites which eat the glucose and other nutrients out of her body. She went from one doctor to another, only 2 doctors found the parasites. These parasites are microscopic and some of them could be pinworms, but also could look like hookworms, pinworms, and different types of parasites. She believed she developed Type II Diabetes because the parasites were eating glucose and nutrients out of her body. She was previously eating well, three meals a day. She confirms she was diagnosed for diabetes in 2014. She was severely anemic in 2003. She knows if the anemia goes on for 6 months, she can have vital organ failure. She had not been tested lately for anemia. Patient family history included patient said her brother was allergic to the penicillin family. Her brother had Covid. He tested seventh in the county for Covid last year. He also took the vaccine this year. The concomitant medications were not reported. The patient stated when she first got the vaccine, she started feeling a little funny. She broke out in hives on her wrists about an hour after both injections. She clarified that the hives were only on the wrist of the arm where she got the vaccine. When she tried to tell people she broke out in hives immediately within an hour after receiving the vaccine, people were doubting her. She makes the comment that we all have a different chemical make-up and she is allergic to a lot of things. She did have a reaction. The reactions that she mostly had were that she got tired and she did get hives around her wrist. She comments that she has had hives around her wrist before, but mostly it had been a reaction to food that she was allergic to. She had been tested by allergists with standard tests. She explained they used to do injections and now they do the back test. She had broken out in hives around her wrist before, this was not the first time. She had 3 other health conditions that gets her attention. Patient was not sure if the stress and the spike in her blood pressure could have anything to do with the hive breakout or if it was an anaphylactic reaction. When she came down with the second tumor, she became severely anemic and she gained 100 pounds. She clarifies the tumor was the size of a golf ball, 3.5cm fibroid. She became severely anemic and had a hemoglobin count of 7.6. She told to the healthcare team she suspected a tumor. Instead of listening to her, she was tested for diabetes and other things, and were not on the right track. Those tests were coming back negative. So, she did gain a lot of weight and she is taking the weight off, but it had took a long time. Her underlying conditions could have led to her death, and her doctors did not get her to any other professionals. The hives on her wrist started again a day before (07Jun2021), but she actually broke out in hives the first time after the first injection. Patient stated the first dose was in the beginning of May, about 3 or 4 weeks ago. She later confirmed the first dose was on 10May2021. She confirmed she broke out in hives the same day she received her doses, within the hour. She confirmed the hives were on her wrist of her left arm, where she had the injection. She confirms there were no hives on the right wrist. The hives were still ongoing today, but they were going down. She can still see the hives and feel the bumps under her skin. However, they looked like they were going down. She has had hives before so she knows what they were. Patient stated she felt really tired and she woke up in hives. She had a little bit of a raspy throat. Her throat did not hurt, but her voice was a little bit raspy a day before (May2021). However, she also had seasonal allergies. Her allergies were bad in April and May and also bad in September and October. So, one part could be the allergies. However, she thought it was strange she broke out on the same arm where she had the injection. The adverse events did not result in physician office or emergency room visit. Patient did not receive any treatment for the adverse events. The outcome of the event hives was not resolved while of the other events was unknown. Information on Lot/Batch number was available. Additional information has been requested.

About 6:30 PM, I was watching TV, my chest started pounding hard and my pulse rate went up. It's usually low. It kept creeping up to 130 and 140. I went to ER. I called my doctor on video chat. I told them where I was going to - pulse was 157. I was talking to her for awhile and it started going down and I sat for about an hour and half. It stayed at 100 for a long while. I went back home. At 11:00 pm, it was finally back to normal. I had a few palpitations ever since. They come and go. But usually that doesn't happen because that is what my Atenolol is for. Next morning, I woke up with slight fever and went to 101 and big body aches. The next day, Sunday, I woke up feeling great. Monday hit and I wasn't feeling right. My lower legs were weak as all get out. I was getting nauseated and weak and shaky getting ready for work. Arm was getting a little weak too. That whole week I wasn't feeling good - those symptoms would happen again in the morning and as the day progressed the symptoms would get better. Morning time was back to the weakness and shakiness and fatigue again. I was off the whole week of work. The following week, I drug into work - I still wasn't feeling well. I am definitely better now finally. No treatment other than rest. The doctor told me to get on the treadmill - I couldn't for the first two days and so I started though the next day (third day of the week I was off) and it helped. Every now and then I do still feel my heart still flutter. I'm 99% better.

Patient is a 61 year old woman with no PMH who presents as a new pt for side effects after the Covid-19 vaccine. She received Pfizer vaccine on 4/1 and began having fatigue, soreness at the site of the injection, muscle spasms and cramping in her R arm and legs worse w/ sitting or reclining. Symptoms are improving but not gone. She has no weakness. She is problems driving and works from home. She is taking Advil and tizanidine and biofreeze. CK was wnl. She did not have reactions to other vaccines.

high fever; trembling; pain when breathing; bone pain; severe sweating; nausea; diarrhea; weakness; loss of appetite; back pain; stabbing pains in my lungs; headache; 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: Ep6955), via an unspecified route of administration in the right arm on 23Mar2021 at 11:00 (at the age of 61-years-old), as a single dose for COVID-19 immunisation. The patient did not have any allergies to medications, food or other products. Medical history included scleroderma and crest syndrome. Concomitant medications included losartan (MANUFACTURER UNKNOWN), carvedilol (MANUFACTURER UNKNOWN), aspirin (MANUFACTURER UNKNOWN) and isosorbide (MANUFACTURER UNKNOWN); all for unspecified indications from unknown date. The patient did not receive any other vaccines within the four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 24Mar2021 at 03:00, the patient experienced high fever for 3 days, trembling, pain when breathing, bone pain, severe sweating, nausea, diarrhea, weakness, loss of appetite, back pain, stabbing pains in my lungs and headache. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the reported events. The clinical outcome of high fever for 3 days, trembling, pain when breathing, bone pain, severe sweating, nausea, diarrhea, weakness, loss of appetite, back pain, stabbing pains in my lungs and headache were not recovered. No follow-up attempts are needed. No further information is expected.

Severe headache; Joint pain; Muscle pain; Fever of 103; Severe chills; Weakness; Still dizzy; 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 25Mar2021 at 16:00 (at the age of 61-years-old), as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not had allergy to any medications, food, or other products. Concomitant medications included melatonin (MANUFACTURER UNKNOWN) and diazepam (VALIUM); both taken for unknown indication on an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 26Mar2021 at 06:00, the patient experienced severe headache, joint and muscle pain, weakness, fever of about 103 (unknown units) and severe chills for 24 hours. The patient still felt dizzy and weak 2 days later. 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. Therapeutic measures were taken for the reported events and included treatment with TYLENOL and ibuprofen (MANUFACTURER UNKNOWN). The clinical outcomes of the events severe headache, joint and muscle pain, fever of about 103 and severe chills were resolving, while that of the event dizzy and weakness were unknown at the time of report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

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.

Continued GI symptoms; bloating; no appetite; smells not present or identifiable; Increased back pain; runs; This is a spontaneous report from a contactable consumer (patient). A 61-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0162) via an unspecified route of administration, in the left arm on 16Apr2021 12:00 (at age of 61-year-old) as dose 2, single for covid-19 immunisation. Medical history included ongoing (hypertension) HTN, chronic severe l side spinal pain s/p T10-12 laminectomy, fusion and graft from r hip. Had colonoscopy/endoscopy on 27May2021with polyp removal and some gastritis. Although she continued with the symptoms, weight loss, and weird smells. Known allergies were not reported. The patient's concomitant medications were not reported. List of any other medications the patient received within 2 weeks of vaccination was yes but not specified. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EP7534) via an unspecified route of administration, in the left arm on 23Mar2021 12:45 (at age of 61-year-old) as dose 1, single for covid-19 immunisation. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination the patient had been tested for COVID-19. The patient did not receive any vaccines within four weeks prior to the vaccination. On 20Apr2021, the patient experienced continued GI symptoms, bloating, runs, no appetite, smells not present or identifiable. Increased back pain after Feb surgery. Seriousness criteria not reported. Adverse events resulted in doctor or other healthcare professional office/clinic visit. Patient had received treatment for event was increase pain medication and contacted GI docs. Outcome of all events was recovered with sequelae in 2021. Follow-up actions are needed. Further information has been requested

Tingling /Paresthesia hands, feet, face, mouth. stabbing nerve pain in chest, crawling sensation in back, muscle spams and cramping in hands and feet, muscle weakness lower arms and legs, overall weakness, fatigue and lethargy. Also developed UTI feelings, however tests show I do not have a UTI.

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.

Patient received the first dose of the Pfizer COVID-19 vaccine on Wednesday, June 30. She reports that 2 days later, on Friday, July 2, she broke out in a rash from head to toe that lasted about a week. She reports the rash was itchy and started to blister the following day, on Saturday. She also reports she had body aches that made it difficult to walk, as well as fatigue, joint swelling, and nausea. She contacted her rheumatologist about the reaction and was instructed to take prednisone 10 mg for 2 days. She reports this helped, and the rash subsided. Her rheumatologist recommended against taking the second dose of the vaccine. Her primary care physician agreed.

7/11/21 Awakened by a sharp pain in lower right side at 8 am. increasing gastrointestinal upset throughout the day and into the evening along with an unquenchable thirst despite drinking a lot of water. 7/12/21 mid morning began to experience my allergic reaction to ingesting artificial sugar: metallic taste in mouth, very dry mouth, despite drinking water, tingling of mouth and tongue and subsequent swelling. Skin on lips began to peel off with tongue pressure. a second dose of advair was necessary and I was prepared to use rescue inhaler. some of these symptoms subsided around midnight, which is when i noticed a smell in my nose that was very like nail polish remover. 7/13 skin hyper-sensitive to temperature

I began allergy shots for fire ants and on the second shot, I started developing rare tingling and numbness in the buttocks and severe musculoskeletal pain as well as extreme fatigue. Allergist said they have never seen this. Could Covid Vaccine make immune system overrespond to antigens?

extreme pain on left sideof neck; pain extended to ear; pain on occasion moved to lower jaw; tenderness in theneck; 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: EN 6205) via an unspecified route of administration in the left arm on 11Mar2021at 12:00 (at the age of 61-years-old), as a single dose for COVID-19 immunisation. Medical history included hashimoto thyroid. Concomitant medications included Levothyroxine sodium (UNITHROID) from an unknown date for unknown indication which was received within 2 weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER6201) via an unspecified route of administration in the left arm on 18Feb2021 at 16:00 (at the age of 61-years-old), as a single dose for COVID-19 immunisation. The patient had a history of allergy to eggs and corn. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. The patient was not diagnosed with COVID-19 prior to vaccination. On 25Mar2021 at 08:30, the patient had experienced extreme pain on left side of her neck, at the base of her skull and was not relieved with ibuprofen. The pain extended to her ear and on occasion moved to her lower jaw. The following day, the pain was only at the base of her skull but on both left and right. By the 3rd day, the pain had moved to the right side primarily and on the 4th day to the right side only, radiating to the right ear, but later in the day back to left centre of her neck. For the entire 4 days, she struggled to use the muscles in her neck at times. At other times she felt she was straining the muscles. Stretching helped, when she could isolate the muscle. At times she found relief with ice or heat, at other times ice or heat caused more distress. she still had tenderness in the neck, but the pain had dissipated. Adverse events resulted in a visit to the doctors or other healthcare professional office/clinic visit. The patient received ibuprofen and treatment from a chiropractor for the reported events. The clinical outcome of the events extreme pain on left side of neck, pain extended to ear, pain on occasion moved to lower jaw and tenderness in the neck was resolving at the time of this report. No follow-up attempts are needed. No further information is expected.

tired and exhausted; Panic/anxiety; Panic/anxiety; feels like her ribs are killing her; Back hurts; Arms hurt the front of her breasts; Her feet, ankles, calves and back hurt; Bones feel hurt; injection site is just sore; Lethargic; When I get up it actually hurt to walk all my ankles on my feet now; the site is very red and very sore and swollen; I had all kind of things going on but did not feel as weak as I felt the next couple of days; I still was not feeling right/I just did not feel well; Joint pain/Joint were bothering; Chills/extreme chills to my bones; body and muscle aches/Pain in my muscle; the site is very red and very sore and swollen; body and muscle aches; Slept the entire week/she just wanted to sleep; Touching of my skin it hurts; Everything was irritating her/it's irritating, wearing cloths irritated, the sheet irritate it, my thigh, joint, hip, knees, shoulder, the back of my arm, elbows, forearm; This is a spontaneous report from a contactable consumer or other non hcp. A 61-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EN6206), via an unspecified route of administration on 12Mar2021(at 61-years-old) as single dose for covid-19 immunization. Medical history included , thoracic outlet syndrome She had a pectoral flap moved up to her chest , thyroid disorder, autoimmune thyroiditis, renal stone removal from 08Feb2021 to an unknown date She had a kidney stone removed and had complications with that and he called the other day and said she has a UTI, which is a reoccurring , ongoing urinary tract infection , heart valve replacement from an unknown date and unknown if ongoing , coronary artery bypass from an unknown date and unknown if ongoing , coronary artery disease from an unknown date and unknown if ongoing. Concomitant medication(s) included ranolazine (RANEXA) taken for an unspecified indication, start and stop date were not reported; semaglutide (OZEMPIC) taken for an unspecified indication, start and stop date were not reported; metoprolol (METOPROLOL) taken for an unspecified indication, start and stop date were not reported; aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) 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; levothyroxine sodium (EUTHYROX) taken for an unspecified indication, start and stop date were not reported; empagliflozin (JARDIANCE) taken for an unspecified indication, start and stop date were not reported. The patient previously took Percocet [oxycodone hydrochloride; oxycodone terephthalate; paracetamol] for cardiac operation, warfarin. The patient reported that she had the first dose of the vaccine on 12Mar2021. It started about 3 o'clock in the morning (13Mar2021). She was experiencing something she had never experienced before. Later that night and more towards the morning she had joint pain. She noticed this first in her ankles and feet, she only noticed that because she had to go to let her dog out. Then the next day, she had pain in her muscle she had chills to the bone, and she just started with body and muscle aches and that was all last week and she slept the entire week. She had the chills really bad. The site was very red and very sore and swollen. She was like that Saturday, joint pain and chills and then she called a friend of her who got first shot but she got Moderna and she said she had symptoms similar to that (hence submitted as split case), said that was not big deal, that means it working so she was like okay. Then on Sunday she still was not feeling right. She got up and took Xanax. She took her normal medication. She took Xanax for anxiety (Intent: Treatment) and took 5 mg percocet (Oxycodone) for joint pain in order to function, get up and get around and do stuff with her husband who was only home on the weekend. So anyhow she did that on Sunday. She ended up coming to bed early and she fell asleep and the entire week last week she did not do anything she just stayed in bed and she just felt very lethargic. The patient actually fell asleep trying to talk to her husband on the phone, she means on video chat because we video chat every night while we he was awake. So, she thought she was just tired, so she stopped video chat with him and just started talking to him every night and this was last week, and I was really tired. She was in her bed. She had one of the beds where pop comes up and legs come up because she had underlying condition. A big deal underlying condition and all last week she stayed in bed all week and she just slept and when she gets up it actually hurt to walk all her ankles on her feet now. It feels like just touching of her skin, this was been going on since yesterday maybe Friday, just touching of my skin it hurts, it was irritating, wearing cloths irritated, the feet irritate it, her thigh, joint, hip, knees, shoulder, the back of her arm, elbows, forearm, and just tried to massage them and just tried to get through it yesterday. The patient took yet again an anxiety medication within addition to my other medication. She took anxiety medication and an Oxycodone. So that she can go to viewing her husband's friend passed and people were like what's wrong with you, you look like you could fall asleep. They did not stay long, came back home and climbed back in bed and that was where she was all day yesterday. She had not taken anything thus far and literally the sheets she got up last night and as she tried to slide out of bed, it literally hurts rubbing the sheet back of my leg and then getting up out of her bed going in into the bathroom because she had other issues, bladder issues. So, this morning she still had some issues and her husband said could it be the result of the covid, the vaccine you got, and she said you know what I never even thought of that, so she started reading some paperwork and it was like joint pain. She was like well she got more than joint pain or muscle pain that she got joint muscle and chills. She was still feeling the same way. Her back hurts just lying on the bed and hurts. When she gets up to move it feels like her ribs are killing her, her arms hurt the front of her breasts. This was something new and prolonged. Walking to the kitchen her feet, ankles, calves and back hurt and her nightgown is hurting her skin. Her bones feel hurt, and her calves hurt. The injection site was just sore. The patient did not have chill at the time of report but jacked up the heat in her house. The patient normally keeps it at 68 all year around whether a heat or cold she turned up the heat and stayed in bed and at the time of report she was under sheet blanket and heavy comfort. The patient asked could any of this related to the shot. It was reported that she tests her own INR and it went down to 2.2, it was up to 2.8 and for some reason it dropped down to 2.2 in middle of the week and I am due to test tomorrow and for some reason the doctor called but that his test was done before she got the shot. The patient stated that she supposed to figure out the drug interaction, possible drug interaction maybe as she takes other drugs. The patient reported that she still experiencing symptoms and it could be due to the Pfizer vaccination. The patient asked that how long can she expect these symptoms to last. She asked if the symptoms reported in the clinical trials with people with underlying conditions. The patient underwent lab tests and procedures which included international normalized ratio: 2.2 it was up to 2.8 and for some reason it dropped down to 2.2 in middle of the week. The patient received treatment. The clinical outcome of the events tired and exhausted, panic/anxiety, back hurts, calves and back hurt, bones feel hurt, lethargic, when i get up it actually hurt to walk all my ankles on my feet now, touching of my skin it hurts, irritability, the site is very red and very sore and swollen was unknown whereas the remaining events was not recovered. No follow-up attempts are possible. No further information is expected

Forehead lips numb; Aches in neck; Aches in shoulders; Forehead lips numb; This is a spontaneous report received 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: ER8732) via an unspecified route administration in the left arm on 25Mar2021 at 14:00 (at the age of 61-year-old) as a single dose, for COVID-19 immunisation. Medical history was not reported. The patient was allergic to naproxen. The concomitant medications included unspecified blood pressure medication, zinc (MANUFACTURER UNKNOWN) and colecalciferol (VITAMIN D3) all taken unknown indication from unknown date. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 26Mar2021 at 05:30, the patient experienced forehead lips numb, aches in neck and shoulders. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for events. The clinical outcome of events forehead lips numb, aches in neck and shoulders were not recovered. No follow-up attempts are possible. 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

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

Dupuytrens contracture; she developed three hard cysts in the palm of her right hand; injection site pain; her arm will start bothering her; her right arm is hurting where the injection site is; This is a spontaneous report received from a contactable consumer (patient) reported for herself. A 61-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0169, Expiration date: unknown) via an unspecified route of administration, administered in right arm on 23Apr2021 at 10:00 am (age at vaccination was 61 years) as dose 2, single for COVID-19 immunization. The patient did not have any medical history. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6204, Expiration date: unknown) via an unspecified route of administration, administered in right arm on 26Mar2021 at 15:00 pm (age at vaccination was 61 years) as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. No additional vaccines were administered on same date of the Pfizer suspect. The patient was calling about the COVID 19 vaccine. She believed she had a side effect resulting from the COVID 19 vaccine about 3 weeks after she received the second dose. Three weeks after receiving the second dose of the Pfizer BioNTech COVID-19 vaccine, just overnight the patient developed three hard cysts in the palm of her right hand/three hard cysts in her right palm. The cysts showed up overnight. She went to two doctors, her primary care physician and her hand doctor and both diagnosed her with Dupuytrens contracture. She wanted to know if that was an immune response and if that diagnosis had been reported by others who received the Pfizer BioNTech COVID-19 vaccine. After receiving her second dose of the Pfizer BioNTech COVID-19 vaccine on 23Apr2021 caller has been experiencing injection site pain that comes and goes (on/off) and wanted to know if there was any information about the injection site hurting for as long as it has. She received the response which stated that how long side effects last (v3.0) in general, local side effects; the ones you get on the arm where you got the shot were mostly mild-to-moderate in severity and resolved within 1 to 2 days. Side effects after your second shot may be more intense than the ones you experienced after your first shot. and attached VR - section safety long how potential AE will last and referred to HCP, as Pfizer is unable to make treatment recommendations to individual patients. She wanted to add that randomly out of nowhere, in her right arm where she got the COVID 19 injection, right where the shot went in, was still bothering her. She would not even be thinking about the COVID 19 vaccine and her arm would start bothering her. Her arm was sore at the injection site the day after the vaccine but like right now while on the phone, her right arm was hurting where the injection site was. She thought that also began with the second COVID 19 vaccine. At her primary care doctor, she had an exam. At the hand doctor she had an exam and a hand x-ray. She asked whether that was an immune response to the COVID 19 vaccine and were other people experiencing that or heard of that. The event three hard cysts in the palm of her right hand/ three hard cysts in her right palm required a visit to Physician Office. The adverse events did not require a visit to Emergency Room. The outcome of the events was not resolved. Follow-up attempts are completed. No further information is expected. Follow-up (01Jul2021 and 06Jul2021): New information received from a contactable consumer (patient) reported for herself included: Updated the details of the events, details of first and second dose of vaccine, details of vaccine supplemental form and details of follow-up attempts.

Back ache; Finger stiffness; Headache; Nausea; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old female patient received second 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 09:00 as a single dose (at the age of 61-years-old) for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA vaccine; lot number: UNKNOWN) via an unspecified route of administration as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 27Mar2021 at 17:30, the patient experienced back ache, finger stiffness, headache, nausea, fatigue. The events resulted in a visit to the doctors or other healthcare professional office/clinic visit. The patient received treatment from a chiropractor for headache. The clinical outcomes of back ache, finger stiffness, headache, nausea, fatigue was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.

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.

A 61-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) via an unspecified route of administration in the left arm on 25Mar2021 at 13:30 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included atorvastatin 20 mg (MANUFACTURER UNKNOWN), amlodipine besilate (NORVASC) 5mg and magnesium 400 (MANUFACTURER UNKNOWN) (unit unspecified) for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EL3247) via an unspecified route of administration in the left arm on 04Mar2021 (at an age of 61-year-old) at 11:30, as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 25Mar2021 at 13:30 (immediately after vaccination), the patient experienced change in saliva flow. On 26Mar2021 at 06:30 (in the next morning), the patient experienced 103.1 F temperature, muscle ache and joint ache. The patient did not receive treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events changes in saliva flow, 103.1 F temperature, muscle ache and joint ache was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.

Severe pain in arm one weekafter.; chills within 16 hours of shot lasting 18 hours.; fever within 16 hours of shot lasting 18 hours.; severe muscle aches within 16 hours of shot lasting 18 hours.; This is a spontaneous report from a non-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: unknown), via an unspecified route of administration in left arm on 21Mar2021 at 1200 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. The patient medical history included allergic to codeine. Concomitant medications were not reported. The patient previously received a first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown), via an unspecified route and site of administration on an unknown date as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had not been tested for COVID-19 since the vaccination. On 22Mar2021, at 1500, the patient experienced chills, fever and severe muscle aches within 16 hours of shot which lasted for 18 hours. The patient also experienced severe pain in arm after one week on 29Mar2021. The adverse event did not result in a doctor or other healthcare professional office/clinic visit. No treatment was received for the adverse events reported. The clinical outcome of the events chills, fever, muscle aches and pain in arm were recovering at the time of report. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

feeling extremly over tired; muscles ache; 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: UNKNOWN), via an unspecified route of administration in the left arm on an unspecified date at 15:00 (at the age of 61-years-old), as a single dose for COVID-19 immunisation. Medical history included diabetes. The patient had received other unspecified medications in two weeks of vaccination. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in Mar2021 at 15:00, the patient reported that for the last 2 days feeling extremely over tired and muscles ache. The patient reported that doesn't know if the problem was a result of the vaccine but wanted to check if it could be. The patient did not receive treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events extremely fatigue and muscle ache was unknown at the time of the report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Headache, chills, body/muscle aches, fatigue, cough, congestion. I rested the whole day, drank plenty of fluids, ate what I could. The next morning I woke up and I was fine

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: ER8733) via an unspecified route of administration in the left arm on 30Mar2021 at 11:00 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history included peripheral neuropathy, hypertension and migraines. The patient had history of allergies to lisinopril, amlodipine and Percocet. Concomitant medications included gabapentin (MANUFACTURER UNKNOWN), clonidine (MANUFACTURER UNKNOWN), ASPIRIN, vitamin b1 (MANUFACTURER UNKNOWN) and vitamin D3 (MANUFACTURER UNKNOWN) for an unknown indication and from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 the patient experienced Inflamed left toe joint within 24 hours of vaccination. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with foot wrap and foot boot. The clinical outcome of the event inflamed left toe joint was not resolved. No follow-up attempts are needed. No further information is expected.

I had arm soreness in the same area as the injection the next morning. I tried to use a little bit of ibuprofen and acetaminophen and it didn't help at all. And there was muscle stiffness. It got worse the next day, and the next day and the next day. I kept trying to treat it with the ibuprofen and acetaminophen. They told me to use Naproxen. My arm was still sore all the way down. A month later, it slowly started with a dent in my arm - it was going across the arm starting with the site and then to the front of the arm. It really dented in. I called the doctor and to get in to the doctor it took awhile - it may have been in March or late February when I finally got in. I tried to keep treating it with Naproxen and acetaminophen. I couldn't push or pull anything with it. I was in a lot of pain. I work in caregiving - with 20 years with special needs who are self sufficient - I don't do lifting at work. I drive them to appts and help them get meals. It was continuous pain from the time of the vaccination. I couldn't use my arm at all. I finally had physical therapy - shortly after my doctor visit (in March) was the first session. I did physical therapy for 6 weeks and it cost over $900 and I couldn't afford anymore. The pain subsided if I rotated heat and ice and heat and ice. If I feel the site or push on it - it still has pain in it. I had extreme pain still on February 5th (Pfizer - Lot EL9264) when I received was second dose and I had them put that injection in the left arm and that had no problem whatsoever. At physical therapy - they gave me at home exercises to keep working the arm using the instructions they gave me. I still have the dent in my arm. That hasn't gone away. My right arm is nice and round like a muscle should me - but there is a dent like someone has deflated the muscle. I have a lot less pain and I can use the arm now but there is still pain and there is still the deflated dent area.

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.

Progressive discomfort and decrease in range of motion in the left shoulder. Diagnosed of adhesive capsulitis of the left shoulder in May 18, 2021 at Hospital Currently undergoing physical therapy started in early July with some improvement

Patient reports having shooting arm pain up her left arm and neck the day after her vaccination. Difficulty sleeping and pain in her arm.

After receiving the vaccine a few moments later i instantly started to have this metallic taste in my mouth and that has not gone away since receiving my vaccines. I also was very fatigue the following 3 days after the vaccine. I am a very healthy person and about 2 weeks later I started to feel pain and soreness throughout my body, mostly my joints. It got to the point that I had to visit my chiropractor just to feel a little relief.

arthritis; Shingles; I noticed a rash on my front trunk; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 61-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955), dose 2 via an unspecified route of administration, administered in Arm Right on 07Apr2021 (at the age of 61-years-old) as a single dose for covid-19 immunization. Medical history included breast cancer, ongoing arthritis diagnosed about 10 years ago. The patient's concomitant medications were not reported. The patient did not have any allergies. The patient had no other vaccine within four weeks and no other medications received within 2 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 07Apr2021, the patient returning from receiving 2nd dose, she noticed a rash on her front trunk (left side). It extended to her spine. She went to an Urgent Care facility on 08Apr2021and was diagnosed with shingles. She had shingles between the first and second doses of the vaccine, states on the online report she did not include something she should have, wanted to add that she has arthritis, diagnosed about 10 years ago. Is not reporting any additional events. The adverse event resulted her to visit emergency room/department or urgent care. Therapeutic measures were taken as a result of rash and shingles with Valtrex as an antifugal and gabapentin for pain. Outcome of the event rash and shingles was resolving and for other was unknown. No follow-up attempts are needed. No further information is expected.

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.

surgeries and a neck fusion. The patient received unspecified concomitant medications within 2 weeks of vaccination. The patient had no allergies to medications, food, or other products. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the right arm on 12Mar2021 at 19:00 (at the age of 61-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 at 06:00, the patient experienced above moderate pain throughout her back and neck areas, specifically where she had a previous back surgery and the pain was much more significant in the areas where she had screws in the back. The back pain had lasted roughly for 48 hours. On 02Apr2021, the following day, the patient had headaches which had lasted a little over 48 hours. 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 back pain was resolved on 03Apr2021 and of the neck pain and headaches was resolving at the time of this report. No follow-up attempts are needed. 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.

I am still having muscle and joint pain.; I am still having muscle and joint pain.; Hips shoulder Achilles arms; 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 on an unknown date in Feb2021 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had previously taken Phenergan, and experienced drug allergy. Any other medication taken within two weeks of vaccination was not reported. Prior to vaccination, the patient was not diagnosed with COVID -19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Feb2021 the patient was still having muscle and joint pain, hips shoulder Achilles arms. The events resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the events. The clinical outcome of the events still having muscle and joint pain, hips shoulder Achilles arms was not resolved at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Approximately 12 hours after injection, sudden onset headache, went to bed and woke a couple hours later with severe back pain, neck pain, deep muscle ache in legs, low grade fever. 24 hours after injection, some decrease in pain with Tylenol, diarrhea, fatigue, general malaise. Loss of taste, loss of appetite . 48 hours post injection- subsiding muscle aches, other symptoms on going, 72 hours post to present, diarrhea, loss of appetite

9 DAYS POST VACCINATION EXPERIENCED SORE THROAT, MILD DRY COUGH, CHILLS W/O FEVER, GENERALIZED FLU LIKE MUSCLE ACHES.

Arm was sore for about three days. On 12/21 evening, had headache, some lightheadedness and severe back muscle ache. On 12/22, had stomach upset, extreme fatigue, nasal congestion. On 12/24, had diarrhea. Fatigue continued until at least 12/29.

Left deltoid was sore initially, then pain progressed upward into left neck up to just under left ear; Left deltoid was sore initially, then pain progressed upward into left neck up to just under left ear; Also felt a little stiffness in that neck area; This is a spontaneous report from a contactable nurse, the patient. A 62-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number EH9899) via an unspecified route of administration, in the left arm, on 19Dec2020 at 07:00 AM (at the age of 62-year-old) as a single dose for COVID-19 immunization. Medical history was none. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination included fish oil (OMEGA 3 FISH OIL), calcium carbonate, colecalciferol (VITAMIN D 2000). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Dec2020, at 08:00 AM, the patient experienced left deltoid was sore initially, then pain progressed upward into left neck up to just under left ear, she also felt a little stiffness in that neck area. The neck pain lasted 24 hours. The events were reported as non-serious. The patient did not receive any treatment for left deltoid was sore initially, then pain progressed upward into left neck up to just under left ear, she also felt a little stiffness in that neck area. The clinical outcome of the events left deltoid was sore initially, then pain progressed upward into left neck up to just under left ear, she also felt a little stiffness in that neck area was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.

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.

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

Feeling unwell; Headache; Tiredness; Muscle pain; Chills; Nausea; Injection site pain; had been asleep most of the whole day; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiration date: Arp2021), via an unspecified route of administration on 30Dec2020 at single dose at right arm for Covid virus. Medical history included blood thinner treatment. Concomitant medication included ongoing apixaban (ELIQUIS) for blood thinner treatment. The patient previously took coumadin, warfarin. Patient received the Covid-19 vaccine yesterday. She had been asleep most of the whole day (Dec2020). She had injection site pain, headache, tiredness, muscle pain and chills. She thought she was going to work but that didn't work. She was currently taking Eliquis. She had been on coumadin and warfarin before. She looked at the different medications that needed to be reported. She would also call her physician and make her aware. The start date for "Injection site pain" was 30Dec2020. The start dates for headache, tiredness, muscle pain and chills all were 31Dec2020. The patient also experienced nausea, feeling unwell on 31Dec2020. Investigation assessment was no. The outcome of the event "Injection site pain" was not recovered. The outcome of the other events was unknown.

Pfizer-BioTech COVID-19 Vaccine EUA 24 hrs post vaccination I started feeling fatigued, muscle and headaches which seemed to move around my body for about 24 hrs. At one point it seemed to settle into my hand. Knuckles swelled arthritis like. When walking up stairs I had significant muscle weakness in my legs and exertional dyspnea. Eyes felt "feverish" but had no fever. The next morning while trying to do a routine workout the same thing happened. It was a significant change to my normal condition. The dyspnea was the most concerning. The body aches settled into my lower back. Fatigue was moderate-moderately severe. As the day went on things waxed and waned. By the end of 72 hrs. most symptoms subsided. Friday 01/08/2021 I had a completely normal workout, no exertional dyspnea, fatigue subsided, no body aches. Back to normal. I would consider the symptoms to have been Moderate+.

Tested Positive for COVID-19/nausea, occasional dry cough, neck and lower back soreness, and sore throat; Tested Positive for COVID-19/nausea, occasional dry cough, neck and lower back soreness, and sore throat; Weakness/generalized weakness; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received first dose of BNT162b2 (Pfizer, Lot number: 5730), via an unspecified route of administration at right arm at 22Dec2020 21:00 at single dose for covid-19 immunization. Medical history included Mayonaise allergies. The patient's concomitant medications were not reported. The patient previously took codeine and experienced allergies. At 31Dec2020 06:00, the patient experienced Weakness, nausea, occasional dry cough, generalized weakness, neck and lower back soreness, and sore throat which has now dissipated. Tested Positive for COVID-19 on 02Jan2021 (also reported as 01Jan2021, pending clarification). The covid test type post vaccination was Nasal Swab, Covid test name post vaccination was COVID-19 PCR ROCHE c6800(NTX), RNA SARS CoV2 TGT1, PAN SARS RNA TGT2. No treatment received for events. The events result in Emergency room/department or urgent care. The patient was not pregnant. The outcome of the events were nor recovered.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded. The case will be reassessed if additional information becomes available.

Back pain; Muscles felt really tightened up and stiff when getting out of bed and throughout the day (worst complaint); slight nausea/nausea; slight fatigue; slight headache; slightly stiff neck; right arm pain; The muscles knot up under her rib cage/muscle tightness; This is a spontaneous report from a contactable other health care professional. A 62-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL1284), intramuscularly in the left arm on 29Dec2020 at 06:30 at a single dose for COVID-19 immunization. Medical history included Hashimoto's thyroiditis from an unknown date and unknown if ongoing. Concomitant medications included ergocalciferol (VIT D), levothyroxine (MANUFACTURER UNKNOWN); both taken for an unspecified indication from an unspecified date to an unspecified date. The patient previously took sulfamethoxazole and trimethoprim (BACTRIM) and experienced allergy from an unspecified date to an unspecified date, influenza vaccine (FLU VACCINE) for an immunization on an unspecified date (received within two weeks of vaccination). The patient experienced the following events and outcomes: muscles felt really tightened up and stiff when getting out of bed and throughout the day (worst complaint) (non-serious) on 30Dec2020 at 07:00 with outcome of not recovered, slight nausea/nausea (non-serious) on 30Dec2020 at 07:00 with outcome of not recovered, slight fatigue (non-serious) on 30Dec2020 at 07:00 with outcome of not recovered, slight headache (non-serious) on 30Dec2020 at 07:00 with outcome of not recovered, slightly stiff neck (non-serious) on 30Dec2020 at 07:00 with outcome of not recovered, right arm pain (non-serious) on 30Dec2020 with outcome of unknown, back pain (non-serious) on 31Dec2020 with outcome of unknown, the muscles knot up under her rib cage/muscle tightness (non-serious) in Dec2020 with outcome of unknown. The patient received the COVID-19 vaccine on 29Dec2020 at work, and she had been experiencing adverse events since. The worst side effect she was experiencing was muscle tightness. At the time of the report, the patient got up at 09:00, and her "back was killing her." The patient was achy. The patient would tighten up really tight under both rib cages, and it made her nauseous. The patient had been taking ibuprofen (ADVIL) and ibuprofen (MANUFACTURER UNKNOWN since she received the vaccination. The patient received the vaccine in her left arm, but her right arm hurt the next day. The next day after that (30Dec2020) she woke up and the right side of her back around the kidney area hurt. It was the right side lumbar. The next morning after that, "her entire back was killing her down the middle of her spine. From her head all the way down." Since then, it came and went. The patient could not say if it was persisting, improving or worsening for any of the symptoms. "It just grabs her." The day before the report, the patient thought she was doing better. The patient cleaned the house, and then sat down to eat. The past two nights, it had "hit her really hard during supper time." Both of her sides of her back would tighten up; "tense up like waiting for an impact before a wreck." The patient's back would seize up. The patient could not get comfortable; and would start pacing. Then, she would try to lay down. Last night, it took a half an hour to loosen back up. "It knots up like crazy. It was bad enough, she thought she was going to pass out." The patient did not know if it was the combination of eating supper or what. The patient thought if she got up that maybe she would feel better. The patient started pacing around. The patient went outside because she thought maybe fresh air would help. When it would tighten up under her rib cage, it made her nauseous. The patient did not know if it was a "vagus nerve thing or what." The patient was close to throwing up. The muscles knot up under her rib cage. The patient's back felt like she fell off a horse. It was weird to her that her left arm never bothered her. "Nothing stays the same." Sometimes it was her entire arm or part of the arm that hurt. Like on top of her forearm. The patient thought she was doing good and then it would come back. When she moved her arm upward, she felt it. The patient said she could deal with the arm pain. It was the knotting up pains that were the worst. The patient tried calling an institute (name withheld) because it happened while eating dinner the other night. The institute (name withheld) "nurse was useless." The pain was across her sacroiliac area. The patient had been "living on Advil and ibuprofen for her back pain." The patient had been taking them together. The patient worked nights, and she was planning on going to work the night before the report, but she had to text her boss and tell her she could not come in. The patient was in good health; had perfect blood pressure and her sugar was normal. The patient was not diabetic. The patient's labs were always normal. The patient was really dreading that second shot. "The flu shot kicked her butt for a couple of days, but this was way worse." The patient started reading up on the COVID vaccine, and it said usually younger people had severe side effects. That old people have less of a response. The patient did not know why she was experiencing such side effects. At the time of the report, it was day 7 or 8, and she was still feeling bad. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.

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

Confusion, Headache, Myalgia, fatigue, chills Narrative: Felt "loopy" with sharp vision initially. Over 3 day period developed varying degrees of chills, headache, muscle aches. Fatigue on first day.

Early morning Friday 01/08/21, moderate pain at injection site, PO Tylenol 1000mg, @ 0615, heading into work. Then @ 1030 feeling tired, neck & shoulder pain, chills, headache, right ear pain, slight sore throat, PO Motrin, 400mg moderate relief. Total of 30 hrs of recurring symptoms, alternating Tylenol & Motrin throughout. Started to feel better Saturday afternoon 4-4:30p

Eight hours after vaccine I developed terrible chills fever, terrible myalgia and weakness . The pain was terrible as was the fatigue and fever . I used Ibuprofen. 48 hours later I felt almost completely normal- no pain etc . Then 56 hours later resumption of chills fever for 4 hours . At 64 hours and after ibuprofen feeling better

Patient's reaction(s) noted during COVID vaccine observation period: Pain on left side of neck (same side as injection site) ) and waves of nausea. Actions Taken: VS taken and WNL. Pt states the nausea is resolving and she feels comfortable just going home.

Chills, dizzy (nearly fainted), headache and joint (hip) pain. All symptoms manifested approximately 21 hours after injection

pateint received vaccine and about 15 minutes later felt a heaviness in her arm and some pins and needles sensation in hand, arm and left leg. NO rash, no itching, no notable other side effects; denies palipations, shortness of breath, no pain , no hives, no cough or swelling

some congestion that just came on; her arm was really aching after the injection; she started coughing; voice was hoarse; light wheeze; soles of her feet were hurting; pressure in bilateral groin; aching all over; very tired; balance issues; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231) intramuscularly in left upper arm on 05Jan2021 at single dose for covid-19 immunisation. The patient got her Covid vaccine yesterday (05Jan2021) around 11 or 11:30 am in her left upper arm. She had bilateral breast cancer and had lymph nodes removed in each arm but more removed from her Right, so she got the vaccine in the left arm. She also had some skin cancers removed, one would not heal properly on her left arm and formed a blister, and her dermatologist popped it and put a band aid on it. The vaccine was given 3 inches above it. The patient's concomitant medications were not reported. The patient experienced pressure in bilateral groin, aching all over, very tired and balance issues on 05Jan2021; light wheeze on 06Jan2021. Seriousness for these events was medically significant. The patient stated she had some congestion that just came on. She felt fine yesterday (05Jan2021) right after getting the vaccine, that at work she did notice that there was something different feeling in the left side of her groin. She was not in direct patient care. She noticed on her left side in the groin, something felt different, then yesterday evening (05Jan2021) after work she was really tired in the evening, aching all over last night, even the soles of her feet were hurting, woke up like her balance was off, she would walk one way and go another, states it is not like an orthostatic issue, that she knows what that feels like. She stated that in her inguinal area she could feel pressure, bilaterally. Her arm was really aching after the injection. Her breathing, heard a light wheezing, was clearing her voice, and then she started coughing, voice was hoarse. The outcome of events pressure in bilateral groin, very tired and light wheeze was not recovered; of events aching all over and balance issues was recovering; of other events was unknown.; Sender's Comments: The reported events bilateral groin, aching all over, very tired, balance issues and light wheeze were possibly related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), due to temporal relationship. 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.

About 10:30 pm, 1/11/21, became very cold teeth chattering headache, sharp pains in muscles then aches, uncomfortable to touch skin. Took 2 acetaminophen, lots of blankets, able to sleep. No fever, woke up with same symptoms but milder.

Body aches; fever; chills; diarrhea; headache; joint pain; nausea; fatigue; This is a spontaneous report from a contactable other HCP (patient). This 62--year-old female HCP reported for herself received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: unknown), via intramuscular route of administration, on 07Jan2021at 02:00 PM (at the age of 62 years old) as a single dose in the left arm for COVID-19 immunization at hospital facility. Relevant medical history included chronic Fatigue. The patient have known allergies to Sulfa. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included liothyronine sodium (T3), levothyroxine sodium (T4), progesterone, estradiol, estriol (BIESTROGEN), testosterone, colecalciferol (VITAMIN D), calcium, zinc sulfate (XINC), ascorbic acid (Vitamin C), magnesium. The patient previously received the first dose of BNT162B2 (lot number/expiration date: unknown) on 17Dec2020 at 10:30 AM (at the age of 62 years old) as a single dose in the left arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 07Jan2021 at 10:00 PM, after the second dose, the patient experienced body aches, fever, chills, diarrhea, headache, joint pain, nausea, fatigue. No treatment was received for the events body aches, fever, chills, diarrhea, headache, joint pain, nausea, fatigue. The outcome of the events body aches, fever, chills, diarrhea, headache, joint pain, nausea, fatigue was recovering. Since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Almost immediately after the injection, I noticed a metallic taste. It was mild enough that it did not interfere with the taste of foods or drinks. It was noticeable whenever I had not had anything by mouth for a while. This lasted for 2 to 3, maybe 4, days. Soreness at the injection site, and stiffness of the arm, began the evening after the injection. Warming applications and moving the arm relieved these symptoms. They were gone the next day.

Advised received first covid vaccine 12/21/2020 w/o issues. Received 2nd Pfizer vaccine on 1/11/21. Within minutes her tongue was tingling with sensation of feeling full-felt funny. 30 min later had frontal/jaw headache. 60 min later chills with goose bumps all over while working (works as resp technician at NMCP). While walking to car, her upper arm and front of thighs hurt as if exercised too much. Self treated with Advil and tylenol. --- Next day 1/12 0100am awoke with severe bilateral shoulder joint pain extending to shoulder blades, stabbing abdominal/stomach pain, nausea, urge to vomit. she returned to sleep but awoke 6am with nausea and severe diarrhea and fatigue. She c/o nasal congetion, sinus fullness and severe post nasal drip x 24 hours. S/s persisted and left work early now with severe bilateral ankle pain. She was off Wed/Thursday. Wed 1/13 her shoulder pains eased but now with severe back pain. Wed evening noted tongue swelling sensation again (has pictures) and took oral benadryl and ice chips. She went to sleep. Thursday 1/14 bilateral knee pain/joint with increased nausea again - treated with zofran. Friday 1/15 returned to work, pain in knees made gait wobbly = treated with advil. Notified ID MD and director on tongue swelling and constantly trying to clear throat = sent to ER where treated with oral decadron and M Toradol for pain. She was sent home with prednisone dose pack and compazine. Recommended f/u with HCP for further testing to r/o possibility of a mast cell disorder of familial hypertrytassemia due to her history of multiple allergies/insect allergies--

Second dose of Pfizer vaccine was administered too early, at day 15. Individual is reporting muscle pain, fever, and headache

2nd dose next day had nausea in am since subsided. chills muscle aches and swelling soreness at arm site present @ this time.

Jan 12, 11:30am - Dizziness, headache, muscle aches, weakness, cold feeling, flushed. Temperature = 102.4 F. Had to leave work. Slept for 18 hours, Symptoms continued for 48 hours.

Feel like , I have a cold or allergies, Lower back pain, Abdominal Pain One Knee was shaking right after vaccine Full body pain daily mostly in the lower back

Left arm sore 2 days, 3rd day left neck, shoulder, arm , shoulder blade pain. Symptoms have not resolved 1/18/2021, not as painful now advil and massage therapist therapist treatment

I had my first vaccination on 1/11/21 at HD. The reaction was typical- significantly sore red inflammed arm over deltoid muscle that resolved after 3 days. Second dose given 21 days later- some swelling and soreness, low grade fever. Then 3 days later, I awoke, turned in bed and experienced an intense shearing pain in my neck and arm. The pain was the worst ever felt, and was not improved with NSAIDS, Acetaminophen, Hydrocodone, or Tramadol. I went to an urgent care center on 1/16 where a tentative diagnosis of sprained neck was made. The sypmptoms continue with slight improvement with steroids, and a muscle relaxant. I am concerned because I understand that covid itself can impact the nervous system considerably. I am awaiting improvement in symptoms and if none seen then I will see my primary care MD

Pfizer -BioNTech Covid-19 Vaccine EUA After the vaccine I developed headache, low grade fever, muscle ache, stiffness and nausea. This felt positive for the first 3 days until the symptoms did not leave and remained for 9 days post vaccination.

fever of 100.5; severe muscle and joint aches for about 24 hours; severe muscle and joint aches for about 24 hours; severe headache; This is a spontaneous report from a contactable consumer. A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: E11283), via an unspecified route of administration on 07Jan2021 06:30 at a single dose for covid-19 immunization. The patient's medical history included osteoarthritis from an unknown date and unknown if ongoing. Concomitant medication included aciclovir sodium (ACYCLOVIR [ACICLOVIR SODIUM]), famotidine (FAMOTIDINE), hydroxychloroquine (HYDROXYCHLOROQUINE), escitalopram oxalate (LEXAPRO), rosuvastatin calcium (ROSUVAST) , cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]). The patient previously took cipro [ciprofloxacin hydrochloride monohydrate] and experienced drug hypersensitivity, vioxx and experienced drug hypersensitivity, ees and experienced drug hypersensitivity. On 07Jan2021 at 18:30, 12 hours after the injection, the patient experienced fever of 100.5 with severe muscle and joint aches for about 24 hours. Then the fever subsided and had severe headache for 24 hours. All the events recovered in Jan2021.

Bruise in arm; I lost some weight; This is a spontaneous report from a contactable Consumer. This consumer reported for herself that the 62-year-old female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on unknown date at a single dose for covid-19 immunisation. Medical history included "I went to the doctor because I wasn't feeling well just little congestion inside my lungs." Concomitant medications included "Yes, Antibiotics, I was worried I didn't think about it since I think about it yesterday, wow is this going to effect the vaccine (further not clarified)." Consumer stated, "I have a question I received the First shot (clarified as Covid 19 vaccine) here 20th of this month I get my second but 7th of this month I didn't even think about it I went to the doctors even though I was negative and they put me on antibiotics is that going to interfere with the vaccine. Consumer stated, "I guess no, I had no side effects, I got a bruise in my arm and that was all." Consumer stated, "120 pounds, I lost some weight." Consumer stated, "I just had my blood count checked that's all." The outcome of the events was unknown. Information on the lot/batch number has been requested.

Pain in all over bones started at 11pm continued all over 24 hours. Bilateral arms still painfull for 48 hours. Took extra strength tylenol and advil did not help very much.

Starting on the 16th of Jan I became very sick to my stomach.This lasted the the AM on the 18th no other syptoms present. I left work at 8:00am on the 18th with no fever ( I checked three times during the midnight shift ) I went home to bed and woke up at 6:00pm with 100.8 fever ( I never run a fever ) had fever chills and joint pain in the upper body no respiratory issues .Within 48 hours the fever was gone as well as the chills but I continued to be sick to my stomach for another two days.I wanted to report this delayed reaction because of my underlying HIV and given the fact no individuals with HIV were included in the initial study. I tested negative with the nasal swab test on the 20th.

joint pain; bad back spasms in the middle of the back radiating up through right should to right arm; Sweating; arm pain; she couldn't do anything with her right hand. She "couldn't open a soda can, the next morning couldn't get socks on, hand wouldn't work, and had a difficult time writing or typing".; arm shoulder blade rib cage are sore; arm shoulder blade rib cage are sore; This is a spontaneous report from a contactable consumer (patient, healthcare tech in the ER). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on Jan2021 at single dose for COVID-19 immunization. Medical history included spondylosis. Concomitant medications were not reported. patient calls today to report symptoms following administration of the covid vaccine. Caller reports that she got the vaccine on Friday. Reports that on Saturday she started to have joint pain everywhere on Sunday she felt a little better. Reports that on Monday she got up and had really bad back spasms in the middle of the back radiating up through right should to right arm. She went to work, only worked for 2 hours and then checked into the ED. They did an EKG because she was sweating and was with arm pain. They did X-rays and gave her steroids and gave her a pain shot stating it didn't do anything, states they put her on steroids to come home with, muscle relaxers to stop spams. Reports that on Monday night she couldn't do anything with her right hand. She couldn't open a soda can, the next morning couldn't get socks on, hand wouldn't work, and had a difficult time writing or typing. The spasms won't stop, everything; arm shoulder blade rib cage was sore. Went back to the ER on Tuesday, they did a thoracic and cervical MRI, nothing looked different or wrong. they told her to stay on steroids and keep taking muscle relaxers, with ibuprofen and Tylenol. She also asks, what should her do, and if her history of spondylosis triggering this reaction. Patient was recovering from joint pain, was not recovered from bad back spasms in the middle of the back radiating up through right should to right arm and arm shoulder blade rib cage are sore. Outcome of the events was unknown. Identification of the case safety report serious was No. Information on the Lot/Batch number has been requested.

Unable to get out of bed: She is so sleepy and has no energy; Wiped out of energy; lots of flatulence; Chills; Joint pain; Lower GI symptoms; she is also feeling cold; This is a spontaneous report from a contactable nurse (patient). A 62-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, LOT#: GL3248 (Caller said that the G may be an E.)), via an unspecified route of administration in the left arm on 07Jan2021 at second single dose for working with cancer patients. Medical history included ongoing diabetic and ongoing hyperthyroidism, both diagnosed about 6 years ago and were under control. There were no concomitant medications. Historical vaccine included BNT162B2 on 18Dec2020 for working with cancer patients (First dose, lot number: EJ1685, injection in the left arm). On 11Jan2021 the patient had chills, joint pain, and lower GI symptoms. Her lower GI symptoms included diarrhea. Then caller clarified that it was not diarrhea but the urge to go. The stools were solid. She also had lots of flatulence. She was also wiped out of energy, around like 2 PM on 11Jan2021 she went up a flight of stairs and was so exhausted. The patient is a nurse. She was in her office that day and had to literally lay on the floor because she was so wiped out of energy. She left work early and went to bed. Then the next day 12Jan2021, she was unable to get out of bed the whole day. She is so sleepy and has no energy. She went to bed last night at 08:30, but is still so sleepy. Today she is feeling better, but still had lower GI symptoms. She was also feeling cold, which she normally is always hot. She was having to put 5 blankets on her. Outcome of the event chills was recovered on 12Jan2021, of events joint pain, lower GI symptoms, wiped out of energy, unable to get out of bed was recovering, of events flatulence and feeling cold was unknown. The reporter considered the event chills, joint pain, lower GI symptoms, wiped out of energy, unable to get out of bed as serious (disability) and related to BNT162B2.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported chills, joint pain, lower GI symptoms, wiped out of energy, unable to get out of bed and the administration of the COVID 19 vaccine, BNT162B2, given the plausible temporal association. 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.

1/14 am. General malaise and fever shortn of breath, cough sneezing body?s aches joint pain ongoing for last 10 days Still low grade fever 99.8 and cough headache body aches weakness fatigue short of breath

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.

arm soreness, joint pain, chills, fatigue x 48 hours headache start at same time but has gotten worse on day 3 post vaccine and not relieved by acetaminophen

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

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".

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.

migraines; arm is sore where the injection; she could hear like blood going through her, and if she moved it got faster and faster; Chills; muscle aches; not feeling well; Headache; fever; This is a spontaneous report from a contactable consumer (patient). A 62-years-old female patient received bnt162b2 (BNT162B2, manufacture: Pfizer), via an unspecified route of administration on 21Dec2020 by injection once to right arm (Lot Number: EJ1685) at SINGLE DOSE, via an unspecified route of administration on 11Jan2021 (Lot Number: EL3302) at SINGLE DOSE for covid-19 immunization (reported as healthcare worker, medical receptionist). Medical history included Other Conditions No. There were no concomitant medications. The patient experienced fever on 11Jan2021, headache on 12Jan2021, chills on 12Jan2021 23:30 , muscle aches on 12Jan2021 06:00, not feeling well on 12Jan2021 , migraines and arm is sore where the injection on an unspecified date. The caller had her second vaccine (later clarified as COVID vaccine) on 11Jan2021, and had the same symptoms as on the first one. They were not as bad, and she thought the first one was pretty bad. She previously reported her symptoms with the first vaccine. Symptoms with the second were fever, headache, chills, of course, and muscle aches, her arm weighs a ton, and not feeling well. Fever was noted when she was sleeping, it is now 99.6, but it was was 103. Headache was noted in the early morning, it was not a normal headache, it was the worst thing, and she is prone to migraines, but this was not even like that, she could hear like blood going through her, and if she moved it got faster and faster, one time, she stood still and it was like ahhh! Chills started about 11:30 last night, they went away this morning, about 11AM. Muscle aches started at 6AM yesterday, and are finally gone, as of probably about 9AM, they are fine now, just her arm is sore where the injection was. Not feeling well started yesterday and is getting better. First dose was 21Dec2020, she previously provided lot EJ1685, confirms both were Pfizer vaccines. The outcome of the event fever, not feeling well was recovering, headache recovered on 13Jan2021, chills recovered on 13Jan2021 11:00, muscle aches recovered on 13Jan2021 09:00. No follow-up attempts possible. No further information expected.

Early afternoon - Tiredness- 7-8 pm Fever of 99; Muscle/joint aches/pains; Upset stomach; stuff nose Later in evening - hives Next morning - swollen lip on left side (had derm filler on 1/21/2021) Took Tylenol and Benadryl

(Friday)Immediately after the injection-dizziness, vertigo, tunnel vision, blurred vision, pin point pupils, unable to talk, headache, facial and lip numbness, numbness traveled down the right side of my body (side of injection) trembles, weak legs, very weak all over. EMTs were called but I didn't go to the hospital. My son picked me up and took me home because I was unable to drive. On the way I experienced loss of vision and speech for about 5 minutes. When I got home, my legs were so shaky that I had to have help walking. I started getting severe chills that took 3 hours to get warm (2 heavy blankets, space heater, and heating pad). I was very fatigued and felt bad the rest of the day. (Saturday)The next day I had flu-like symptoms; headache, joint aches, chills, nausea, extreme fatigue. Sunday was better but still had to rest most of the day because when I would stay up for over 30 minutes, the symptoms would return. Monday- stomach cramps, headache, fatigue but went to work (30 minutes late due to stomach) and left 30 minutes early.

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

101.5 fever for approx. 30 hours; severe headache with light sensitivity for days 1-5; severe headache with light sensitivity for days 1-5; muscle cramps; joint pain; nausea; extreme fatigue lasting several days.; This is a spontaneous report from a contactable Other Health Professional (HCP) (patient). A 62-year-old female patient (pregnant: No) received the second dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Lot number: EL0140), via unspecified route of administration on left arm on 12Jan2021 at 10:00 AM at single dose for covid-19 immunisation. The relevant medical history included Rheumatoid Arthritis, Asthma, Hypertension, Multiple allergies, Peripheral Neuropathy, degenerative disc disease, known allergies: Sulfa drugs; Tetracycline; Nsaids; Aspirin; Ioxinol; multiple pollens & molds; capsicum, peppers, black tea, black cohosh, and more. Concomitant medications included valsartan (DIOVAN), adalimumab (HUMIRA), leflunomide, hydroxychloroquine phosphate (PLAQUENIL), montelukast sodium (SINGULAIR) and levocetirizine dihydrochloride (XYZAL). The patient previously received first dose of BNT162B2 at the age of 61 years old on 22Dec2020 (first dose, Lot number: EL1283, 03:00 PM, Left arm) for covid-19 immunisation. The patient experienced 101.5 fever for approx. 30 hours; severe headache with light sensitivity for days 1-5; muscle cramps, joint pain, nausea, and extreme fatigue lasting several days on 12Jan2021 at 04:00 PM. No treatment received for the events. No covid prior vaccination and no covid tested post vaccination. The outcome of the events was recovering.

chills day 1 and 2; tiredness; headache; muscle pain; joint pain; feeling unwell; dizziness; weakness; sleeplessness; sinus unable to drain, feels like sinus infection but no fever; This is a spontaneous report from a contactable health care professional (patient). A 62-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL1283) in the hospital, via intramuscular route of adminsitration on 08Jan2021 at 15:00 at a single dose on the left arm for COVID-19 immunization. Medical history included Diabetes, High blood pressure, Osteoporosis, Hyperlipidemia, GERD, Diverticulosis and allergies to soaps, shampoos and lotions all from an unknown date and unknown if ongoing. Concomitant medication included metformin (manufacturer unknown), losartan (manufacturer unknown), ezetimibe (manufacturer unknown), esomeprazole (manufacturer unknown), dulaglutide (TRULICITY) , hctz (manufacturer unknown), denosumab (PROLIA), Alive multi vitamin (as reported), vitamin d3 (manufacturer unknown), ascorbic acid, colecalciferol, copper gluconate, cyanocobalamin, durapatite, folic acid, glucosamine hydrochloride, magnesium oxide, manganese sulfate, phytomenadione, sodium borate decahydrate, zinc amino acid chelate (BONE UP), alpha-amylase swine pancreas, cellulase, lipase, protease nos (DIGESTIVE ENZYME) and curcuma longa rhizome (TURMERIC CURCUMIN [CURCUMA LONGA RHIZOME]). The patient had no other vaccines in four weeks. The patient did not have COVID-19 prior to vaccination. It was reported that the patient had chills day 1 and 2, tiredness, headache, muscle pain, joint pain, feeling unwell, dizziness, weakness, sleeplessness and sinus unable to drain, feels like sinus infection but no fever all on 08Jan2021 at 19:00. The patient took Advil, Mucinex and Walphed as treatment for the events. The outcome of the events was not recovered. The patient has not been tested for COVID-19 post vaccination.

Patient with headache, muscle aches, nausea. then developed palpitations and dull constant nonexertional chest ache for several hours resolved with fluids and Tylenol/motrin.

lower left side back pain; received the first dose of the Pfizer COVID 19 vaccine on 15Jan2021 at 12:53PM in the left arm/ she noticed a sore arm right afterward; rash; This is a spontaneous report from a contactable consumer reporting for herself. A 62-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982, expiry date: not reported), via an unspecified route of administration, on 15Jan2021 12:53PM at a single dose on the left arm for COVID-19 immunization. The vaccine was administered at a hospital. It was not administered at a military facility. The patient did not receive other vaccines within 4 weeks prior to receiving the Pfizer vaccine. Medical history included allergies/allergy from childhood 4 years old, back problem from 2001, back surgery in 2015, vaginal dryness, high cholesterol, depression, acid reflux, surgery in 2015, physical therapy, and allergy to mold, dogs, roaches. She has multiple allergies from childhood including allergy to mold, dogs, and roaches. She also mentioned she has had back problems since her first surgery in 2015. All of these predate treatment with Pfizer COVID 19 vaccine and Lipitor. She got to where she couldn't stand up straight, but she went to physical therapy. She had surgery in 2015. She had a problem in 2018 and they gave her shots and that helped. Family history was none. Concomitant medications included estradiol (ESTRING) (for three years) for vaginal dryness, fish oil (taking for three to four years) for high cholesterol, paroxetine hydrochloride (PAXIL) (taking for 20 years) for depression, cyamopsis tetragonoloba gum (BENEFIBER FIBER SUPPLEMENT) (using for a year), vitamin d3 (VITAMIN D3) (using for five years; she used to be on calcium but it can cause heart problems so her doctor told to take Vitamin D), dexlansoprazole (DEXILANT) (taking for five years) for acid reflux, (ALLEGRA) (taking for 5 years ) for allergy, (QNASL) (using for 3 years), allergy shots (used forever) for allergy and stool softener (taking for 5 years) to "keep things moving"; all were from unspecified dates and ongoing. The patient previously took atorvastatin (LIPITOR) for high cholesterol from 2017 to 2017 and experienced back pain from 2017 to 2017 (recovered). She also previously took calcium. The patient experienced "received the first dose of the Pfizer COVID 19 vaccine on 15Jan2021 at 12:53PM in the left arm/ she noticed a sore arm right afterward" on 15Jan2021, lower left side back pain on 20Jan2021, and rash on an unspecified date in Jan2021. The patient called to report a problem with her lower back after receiving the 1st dose of the vaccine. "I've had surgery and a couple of shots, the CAT scan kind. I have been fine for a while, just had a sore arm and yesterday I noticed a problem with my lower back and thought it may have been because I painted, but it is still bothering me. I remembered when I went on Lipitor I started having problems with my back about 3 weeks in, same deal. The doctor took me off and I went back on a month later and I started having problems again. Because I don't know if it was the vaccine, I am wondering if I should get the second dose." She clarified she received the first dose of the Pfizer COVID 19 vaccine on 15Jan2021 at 12:53PM in the left arm. She noticed a sore arm right afterward which lasted at least 48 hours. Then on 20Jan2021, she noticed lower left side back pain. Mentions she thinks it is at the L4 or L5 and this is the same place she had a shot there in 2018 for back pain and previously had surgery on that location in 2015. With regard to Lipitor, she is unsure of the exact year, but states it was probably back in 2017. After taking Lipitor she noticed her back pain coming back. Her doctor took her off of Lipitor for a month and it got better. Then he put her back on Lipitor and she had the same back pain problem. She stated that she is unsure if she will take the second dose and asked with regard to her back pain should she take the second dose. Outcome of "received the first dose of the Pfizer COVID 19 vaccine on 15Jan2021 at 12:53PM in the left arm/ she noticed a sore arm right afterward" was recovered on 18Jan2021, outcome of lower left side back pain was not recovered, while outcome of rash was unknown.

Called PCP, from the note: I got my shot on Jan 19. But last Friday I have been down with a horrible flu. I'm wearing diapers because of uncontrollable diarrhea. I can't leave my sofa to walk over to my desk because I'll be so out of breath. I have a cough that produces a pink or gold Phelm I have dry mouth. I have no appetite I'm so weak and have lost 15 pounds. Don't know what to do. My next Covid is shot is feb 11 Called employer on 2/3/21 but hung up. Tried calling multiple times to follow up. In triage she stated she had a COVID test scheduled and had spoken with her PCP. COVID test through PCP: 2/4/21 She passed away the night of 2/4/21

heart rate of 160; severe nausea; arm soreness; muscle soreness in left arm; general fatigue; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1283), via an unspecified route of administration on 21Jan2021 13:00 at single dose in left arm for COVID-19 immunisation. Patient age at time of vaccination was 62 years. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EK5730) administered on 30Dec2020 at 01:00PM and the patient said she did not have a reaction after the first vaccine. The patient received no concomitant medications. She stated that she had no other recent vaccinations or new medications. One thing that may be important is that she did do a 7 day detox that ended the Sunday before her second vaccine dose, so her body was pretty much having no impurities in it, and she has been eating clean since then, maybe having something foreign put into her body set it off after detox. The patient experienced arm soreness and general fatigue on 21Jan2021, and on 22Jan2021 at 01:00 she experienced severe nausea and heart rate of 160 (which was reported serious as medically significant). Patient reported that after her second dose of the COVID-19 vaccine she had a significant side effect that didn't happen until 10-12 hours after getting the vaccine. She did not have a reaction after the first vaccine. After the second injection her arm was sore, and she had general fatigue. She had the second dose injected Thursday at around 01:00PM, then at one in the morning her heart rate was 160, and she had severe nausea. She was that way until 08:00AM. Her heart rate was 120 probably by 09:00AM, then came down to 100, she has never had anything like that before. Her arm soreness was a deep muscle soreness to her left arm. The fatigue was a couple hours later after she got the second dose of the vaccine. The nausea started at 01:00AM, and lasted until six to eight, she did no treatment, and it improved and is still gone now. For her heart rate of 160, she had no treatment, though she probably should have gone to the hospital, but it came down. She usually runs a heart rate of 60-70, it went back to normal Friday, probably in the afternoon on the 22nd, about 12 hours after that started. The patient stated that she feels this is medically significant for her heart rate to be that high. She had contacted her primary care physician (PCP), but they didn't call her back for 4-5 hours, by then she was fine. She doesn't think that this was treated well by her PCP, and that they should have done an electrocardiogram (EKG) and follow up labs, she is changing her PCP as a result of this. She is concerned about the people who will be getting their second dose, she has been helping with these, they have patients that are over 100, they wouldn't survive that rapid heartbeat. The outcome of arm soreness/muscle soreness and fatigue was unknown.; Sender's Comments: The reported event of heart rate increased was likely causally related to the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) due to temporal relationship. 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.

Moderate to severe fatigue; moderate nausea; slight joint pain; Vomiting; Dose 1 administration date 21Dec2020, Dose 2 administration date 07Jan2021; severe underarm pain; moderate chills; shaking; severe migraine-like headache; This is a spontaneous report from a contactable other health professional reporting for herself. A 62-year-old female patient received the second dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, lot number: EK4176), via an unspecified route of administration on 07Jan2021 10:30 AM at single dose in Right arm for COVID-19 immunisation. Medical history included IV dye allergy and Allergy when on antibiotics from an unknown date. Concomitant medication included acetylsalicylic acid (ALKA SELTZER) received within 2 weeks of vaccination. The patient previously received the first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, lot number: EL0140) on 21Dec2020 10:30 AM in Right arm 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. The patient experienced vomiting 12 hours after second injection on 07Jan2021 at 10:30 PM, then severe underarm pain and moderate chills and shaking 14 hours after, then severe migraine-like headache and slight chills 22-26 hours after. Moderate to severe fatigue, moderate nausea, slight joint pain for another 2 days, on 10Jan2021. Third day after injection was slight nausea and moderate fatigue. Fourth to sixth day after injection was slight fatigue. Since the vaccination, the patient has not been tested for COVID-19. Treatment was not received for the adverse event. The outcome of events was recovered. The case was reported as non-serious.

Severe body aches, headache, pain under arms, pain at injection site and could not lift arm for 26 hours

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.

01/07/2021 Started having low back pain on right low back took Advil on the 01/08/2021 horrible pain the radiates around pelvic area and across the whole lower back, called off work and went it to Physician in the afternoon. Examined for Muscular Cellular was prescribe Flexeril 10mg once a day at bedtime, Naproxen 500mg twice a day. Took them about three days was able to go back to work.

Fever, headache, dizziness, muscle and join pain/aches - at time severe, hives, nauseous/stomach ache similar to indigestion, loss of appetite, injection site pain, fatigue

I woke up with runny nose and constant sneezing, muscle aches and pains. Fever 103 and chills and uncontrollable vomiting. Suspects cerebral edema because of head ache and vomiting. Took 8 mg of dexmetholzone and Zofran. Neither were helpful. I took a shot of emetrex in case of a migraine. Vomiting has stopped but fatigue and weakness persists.

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.

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.

Pain in left back/rib cage radiating to front of chest. No blistering rash yet. Patient also reports itching and burning sensations in affected area. Patient went to urgent care (2/25/21) and was diagnosed with shingles. Patient was prescribed valtrex.

persistant nausea/nausea become much worse on day 4; fatigue; slight appetite loss; unable to eat normally; lost much weight; This is a spontaneous report from a contactable consumer reported for herself. A 62-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE;lot EM980) , on 04Feb2021 at 16:00 (at 62 years) at single dose in left arm for covid-19 immunisation . Medical history included glucose intolerance. Patient was not pregnant.Concomitant medication included atenolol and calcium/ergocalciferol (CALCIUM/VITAMIN D). The patient previously took sulfamethoxazole/trimethoprim (BACTRIM) and experienced allergy. On 08Feb2021 at 08:00 (as reported) the patient experienced persistent nausea, fatigue, slight appetite loss, unable to eat normally and lost much weight, all non serious. Events were described as follows: patient had persistent nausea. The first few days she had the expected side effects of fatigue and slight appetite loss. The fatigue resolved on the second day, but the nausea become much worse on day 4. She had been unable to eat normally since then and had lost much weight that she cannot afford to lose. She kept hoping that it will go away, but it was 8 days after her shot and she still had nausea (as reported). Anti nausea medicine was administered, no treatment given for the other events. Patient recovered from fatigue in Feb2021; outcome of the other events was not recovered.

body ache, head ache, nausea, diarrhea, weakness, muscle pain, moving body pain, food intolerance, thirst, shaking, feeling of crawling out of body. Lasted 3 1/2 days. Last 2 days shaking and crawling out of body feeling was not present. Diarrhea only day 1. Nausea lasted 1 1/2 days. Day 4 no adverse effects remained. Not certain if the above was related to vaccine but timing seemed to match.

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.

4 inch area at injection site hard, red, hot. Extreme fatigue. Slight fever. Muscle and bone ache. Rash and itch on abdomen. Itch at injection site. Symptoms slowly decreasing over time, but not yet gone.

WITHIN MINUTES OF THE SHOT, FELT LIGHTHEADED & DIZZY. AFTER 40 MINUTES, EXPERIENCED LIP TINGLING, ITCHY/SCRATCHY THROAT, ITCHY SKIN, A COUPLE OF STRAY HIVES. ALL OF THESE SYMPTOMS WERE MILD, AND PASSED AFTER A COUPLE OF HOURS. THE NEXT DAY HAD A VERY BAD HEADACHE. ABOUT 18 HOURS AFTER THE SHOT BECAME ILL WITH FLU-LIKE SYMPTOMS. HEADACHE, CHILLS, MUSCLE ACHES, LOW GRADE FEVER, CHEST TIGHTNESS/PRESSURE, HEAD & CHEST CONGESTION. ALL RESOLVED JUST ABOUT 48 HOURS AFTER THE SHOT.

Developed the following approx 15-17 hours after injection: Low grade fever 100.2 Muscle and joint ache Fatigue Headache Took two Tylenol which brought fever down and slept. Took two more Tylenol at bedtime and felt normal the following morning.

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.

On day 10 I woke with achey shoulders, neck and hands. Later in day had mild chills and overall aches and by evening had 101.5 temp and flushing of face along with mild headache. Tylenol taken along with warm shower and early bed. Woke in am with mild headache, loss of appetite. Felt better by 11am and after a cup of tea. By afternoon I felt 100% back to normal. No rashes or even a sore arm post vaccination in the days prior to this event on day 10.

8:00 am 3/3/2021 had severe muscle and joint aches. Area of injection was red all around in large area and warm to rich. Was lethargic.

Saturday evening injection sight started hurting. Woke up Sunday morning to nausea, dizziness, chills, muscle and joint pain, headache, tiredness

Significant joint pain; fatigue; left arm pain. - Joint pain lasted 3 weeks from 12/27/2021 - 1/19/2021; Called Dr. - telemed visit - 1/18/2021. I had not recovered from the adverse symptoms of first dose before getting second dose. I had the second dose on January 19, 2021 - had joint pain but I did so much easier than this first dose.

Little chill; tired; felt like I have no energy/ My body feels so weak; slight pain on left arm/ my hand started to pain a lot; I couldn't even touch my own self it was so sensitive; may be I'm inflamed; nausea; severe pain/ my waist my back is so painful; My body feels so weak; my fingers and hand; It triggered the shingles pain in my back; It triggered the shingles pain in my back; had no appetite, I didn't eat; She just checked her pressure and its was 130/80, and now, because of the pain, it went up a little bit; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982, expiration date: May2021), via an unspecified route of administration on 22Jan2021 at single dose for COVID-19 immunization. Medical history included shingles which she contracted in 2019, about one and a half years ago, it was a shingles on her back and lower back which she stated were the worst place for shingles has attacked, it left her with severe pain in both legs; diabetes; and high blood pressure. Concomitant medications included losartan, atenolol (a beta-blocker), and metformin for diabetes. The patient took the vaccine on 22Jan2021 and after about 2-4 days (Jan2021), she had a little chill and got very tired. She had to take care of herself. She was very tired not realizing it was the shot she took. She also felt like she has no energy. The patient was working from home but a lot of times, she was lying on the couch. Over the weekend (Jan2021), she had a slight pain on left arm. About a week or 8-10 days later (2021), she got very tired and couldn't even sit up. Her body was not itself. She started to feel like a bus rolling over her, like somebody took a baseball bat and beat her really bad. The patient uses her arm a lot and her hand started to feel a lot of pain. She couldn't even touch herself; it was so sensitive. She took paracetamol (TYLENOL) but it didn't work. She had celecoxib (CELEBREX) an anti-inflammatory, she thought she was maybe inflamed, but it didn't work. She had some diclofenac cream, she rubbed it, but it didn't work. The patient had shingles about a year and a half ago which was very bad. She just felt weak and didn't feel like herself anymore. She had a little bit of nausea and her whole body was really terrible. When she had the shingles, it left her with severe pain in both legs. She saw a neurologist and told her that she would have to take pregabalin (LYRICA) and it would go away. So, when she had severe pain last week, she took pregabalin but it didn't help. The patient took half of acetaminophen, oxycodone (PERCOCET) as she was not the person who takes pills, but it didn't work. Her body was so severe on Friday, it was not going away, the pain was there 24 hours. The patient has been experiencing this for 8-10 days now. She took one PERCOCET on Friday and had a slight relief and didn't took anything again. She kept rubbing the diclofenac cream, but it was not much of a relief. This morning, she has to work, she was sitting so she took PERCOCET. She is getting her second shot on Friday, 12Feb2021. She asked how she will feel after the second dose if she felt that way after the first dose, if the first shot was adequate, and if she should take the second dose. She stated that she didn't want to take the second dose. Her body felt so weak including her fingers and hand. It triggered the shingles pain in her back and felt like she was beaten up by someone. She has to lie down for the pain in her back. She also mentioned that she couldn't sit for so long as her waist and back were so painful. She was lying on a heating pad and ice and nothing was working. She even has a hard time getting up. She thought what happened was it triggered the shingles pain in her back and also left her with a problem under her feet. The shingles left her with some kind of damage when she took the shot. It was really bad. Her son was a physician and was concerned because last week, it got so bad, she didn't come out, she was in bed and bedridden from Friday to Sunday. She had no appetite, she didn't eat. The only thing that the patient had was diabetes and high blood pressure, but it was under control. She just checked her pressure and its was 130/80, and now, because of the pain, it went up a little bit, but before my pressure was like 120 something, over 68 or 72 it was always around the 60s and 70s. Since she was having this, it was a little high. The outcome of the events was unknown.

The first reaction - 15 minutes after the vaccine - I felt really dizzy and loopy. She told me, I think you better sit back down. I felt better after sitting there for 30 minutes after. I didn't get dizzy again. I finished my workday. Next morning, I woke up with a fever 100.8 (about). I woke up with sore muscles - I tend to get sore muscles easily but I felt more sore than normal and I had a headache. Fever stopped after 24 hours. Note: I also get dizzy really easily - and so it isn't difficult for something to make me dizzy. I also felt really tired. And over the weekend, I felt nauseated (not initially but over the weekend.) And that lasted until about midday Monday (over the weekend) to be getting better . I took Tylenol and I rested. That helped with the symptoms.