Pfizer

Myalgias starting within 1 hour after vaccination, worsened throughout day that radiated to ipsilateral trapezius and rhomboid areas. Starting around 16 hours after vaccination, severe subjective fevers and chills with severe headache that worsened with lying down. The headache was the most concerning symptom with tinnitus when laying flat in supine. It awoke me from sleep and prevented me from laying flat so I had to sleep upright on the couch. I took tylenol 500mg around 0200 and was able to sleep for a few hours. By 24 hours post vaccine, the headache and fevers/chills significantly improved so I could attend work the next day.

his gums became discolored and turned purple/gums (both sides up and down) remain purple/discoloration to the gums in his mouth; his mouth started hurting; feeling hot; Body aches; Fever; Pain to the gums in his mouth; muscle aches; sore throat; neck pain; This is a spontaneous report from a contactable nurse (patient). A 26-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration to right shoulder on 24Dec2020 11:30 at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. The patient received vaccine on 24Dec2020. He experienced body aches, fever, and feeling hot with onset of about 3-4 hours after he was administered (24Dec2020). Next day (25Dec2020), his mouth started hurting, his gums became discolored and turned purple. Gums (both sides up and down) remained purple. He will be seeing a dentist. He also reported pain and discoloration to the gums in his mouth on 25Dec2020. He had been experiencing some of the regular side effects such as muscle aches, sore throat, neck pain on an unspecified date in Dec2020. Outcome of the event gum discoloration was not recovered, of the events feeling hot, generelized aching, and fever was recovered on 26Dec2020, of the event gum pain was recovering, and of the remaining events was unknown. He reported seriousness criteria as what he thinks to be medically significant at this point; that they could be medically significant. He is scheduled to receive the second dose of the product which at this point he does not plan to change. Dose change is unknown until he determines cause of these events and on what the doctor and dentist he is going to see recommend. He believes events could be caused by the vaccine. Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

He has a 100.0 fever; Cough; Little bit of congestion in his chest; Body ache; Sore shoulder; Joint pain; Muscle pain; This is a spontaneous report from a contactable consumer. A 26-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EJ1685), intramuscular on 21Dec2020 as single dose for covid-19 immunization. There was no medical history and no concomitant medications. The patient experienced body ache on 27Dec2020 with outcome of unknown; sore shoulder on 27Dec2020 with outcome of unknown; joint pain on 27Dec2020 with outcome of unknown; muscle pain on 27Dec2020 with outcome of unknown; he has a 100.0 fever on 28Dec2020 with outcome of unknown; cough on 28Dec2020 with outcome of unknown; little bit of congestion in his chest on 28Dec2020 with outcome of unknown. The patient underwent lab tests and procedures which included fever at 98.9 on 27Dec2020, and 100.0 on 28Dec2020, weight: 315 on an unspecified date. Details were as follows: patient has been experiencing side effects. Per the reporter (wife to patient), he got a little under the weather, body ached kind of like sore shoulder, like joint pain, muscle pain. He did not have a headache. First he had a fever at 98.9, it was okay but this morning as he woke up, it was 100.0 fever. When he woke up, he felt better because he rested, but he woke up with a cough and a little bit of congestion in his chest. Therapeutic measures were taken as a result of the events, and included acetaminophen (TYLENOL). The outcome of the events was unknown.

fever 100.5F, malaise, myalgia, headache, and rigors x 2 days. responded well to acetaminophen and ibuprofen

The morning after vaccination patient developed full body muscle aches, a migraine, and fatigue. Ibuprofen was taken and symptoms lessened over 6 hours, they resolved by 01/10/2021. Patient developed severe nausea the morning after vaccination (this also occurred after the first dose), and patient vomited several times with severe retching for 30 minutes. No medication was taken and symptoms subsided after 6 hours.

Myalgia, chills, low grade fever occurring 12 hours after first injection and lasting for 10 hours after onset. Sx treated with Tylenol PRN

Sore Left Arm, slight muscle aches and lightheadedness that lasted 24 hours after the day the vaccine was given.

1 day after vaccination I experienced muscle pain, weakness, and chills. Symptoms lasted for roughly 1 day.

approximately 12 hours after administration of 2nd dose, fever to 101F, rigors, diffuse myalgias - lasted approximately 24 hours

Whole body burning sensation, chills, headache, nausea, muscle aches and general exhaustion. Improved on second day to only muscle aches, general exhaustion, headache, and nausea. On third day, only mild muscle aches, headache, and nausea. Resolved on fourth day post-vaccine.

On 1/18/2021 around 1am started feeling back pain, then started feeling hot, & then the pain went all over my body I could still move but it was just very painful. It lasted about 12hrs.

Fever 101 degrees Fahrenheit; chills; muscle aches; This is a spontaneous report from a contactable other Health Professional (patient). A 27 years old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142) at his 26 years old, via an unspecified route of administration at left arm on 08Jan2021 19:15 at single dose for COVID-19 immunization. Medical history included depression, bipolar, dental implants, sinus surgery. No known allergies. Concomitant medication included vortioxetine hydrobromide (TRINTELLIX), bupropion (BUPROPION), acetylsalicylic acid, caffeine, salicylamide (EXCEDRIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fever 101 degrees fahrenheit, chills, muscle aches on 09Jan2021 09:00 with outcome of not recovered. No treatment received for the adverse events. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19.

Patient developed low grade fever, mild dry cough, mild sore throat, arthralgia. Symptoms started day after receiving vaccine. Symptoms resolved over 4-5 days, mild cough has continued.

1/12 Sat soreness left side of neck, felt nodule middle and above left collar bone, size of an M&M, firm feels the same from Sat to today Tuesday muscle aches went away after 24 hours

Shivering; muscle cramps; Extreme Neck and back pain; Extreme Neck and back pain; Left armpit pain with tinglingly sensation down left arm; Left armpit pain with tinglingly sensation down left arm; This is a spontaneous report from a contactable nurse. A 26-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL1283, expiry date not reported), via an unspecified route of administration on 11Jan2021 at a single dose in the left arm for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had no COVID prior to vaccination. The patient had no other vaccine in four weeks. The patient had the first dose of bnt162b2 (brand: Pfizer, lot number: Ej1685, expiry date not reported) on 21Dec2020, intramuscular in the left arm for COVID 19 immunization. On 12Jan2021, patient experienced shivering and muscle cramps the first day; extreme neck and back pain x2 days post injection. On third day post injection, patient experienced left armpit pain with tinglingly sensation down left arm. No treatments received in response to the events reported. The patient was not tested for COVID post vaccination. The outcome of the events shivering, muscle cramps, extreme neck and back pain and left armpit pain with tinglingly sensation down left arm was unknown.

Muscle pain; swelling of upper arm; body aches; headache; chills; slight fever; This is a spontaneous report from a contactable consumer reported for himself. A26-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in right arm on 12Jan2021 16:00 at single dose for COVID-19 immunisation. The patient received the vaccine at workplace clinic. Medical history included Penicillin allergy. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced muscle pain and swelling of upper arm, body aches, headache, chills, slight fever on 12Jan2021 23:30. No treatment was received for the events. The events did not result in Emergency Room visit or physician office visit. The outcome of events was recovered. Information on the lot/batch number has been requested.

Chills; flu like symptoms; Nausea; Myalgia; Headache; Fever; This is a spontaneous report from a contactable consumer. A 26-year-old male patient received his second dose of bnt162b2 (BNT162B2 reported as Pfizer BioNtech COVID 19 Vaccine; lot number: EK9231; expiration date: unknown), via an unspecified route of administration left arm on 13Jan2021 20:00 at a single dose for covid-19 immunization. He received his first dose (age of vaccination was 26-year-old) of bnt162b2 (BNT162B2 reported as Pfizer BioNtech COVID 19 Vaccine; lot number: EH9899; expiration date: unknown), via an unspecified route of administration on 24Dec2020 at a single dose for covid-19 immunization. The patient medical history was not reported. The patient's family history included his father has hypertension and hyperlipidemia. There were no concomitant medications. The patient received the vaccine in a university hospital which set up a clinic. The patient reported that he thought he got his second dose last night at about 8 pm and since then in the morning around 8 am, so about 12 hours after he started having flu like symptoms that got pretty bad one point. He took some acetaminophen (TYLENOL) so it has gotten better but he was having myalgia, headache, fever, chills and nausea. The patient further mentioned that first, he started having chills around 8 am in the morning. He had chills before but now he kind of overheated and now he is not under a blanket anymore, so he thinks that is improved. He then started having nausea, then myalgia and then everything kind of got bad all at once. He mentioned that over all everything has improved except the headache. He further added that everything has not gone away complete but improved significantly. Earlier today (14Jan2021) like 2-3 hours ago he would say it was a 7 or 8 on a scale of 0-10 but right now it is about 4 on a scale of 0-10 and that goes for everything. He does not think anything else is confounding, he is not on any medications and has no chronic health problems, there has been no labs drawn. The patient did not visit an emergency room and physician office. The outcome of the outcome of the event headache was unknown while the outcome of the other events was recovering.

Bilateral painful and enlarged cervical, supra-clavicular, and axillary lymph nodes - Onset: 12 hours post-vaccination Duration: >40 hours; Bilateral painful and enlarged cervical, supra-clavicular, and axillary lymph nodes - Onset: 12 hours post-vaccination Duration: >40 hours; Fever - Onset: 6 hours post-vaccination Duration: >40 hours; Generalized muscle soreness - Onset: 6 hours post-vaccination Duration - 30 hours; Headache - Onset: 6 hours post-vaccination Duration: >40 hours; Tiredness - Onset: 4 hours post-vaccination Duration: >40 hours; Injection site soreness - Onset: 2 hours post-vaccination; Start Date/Time:17Jan2021 03:00 PM; Start Date/Time: 31Dec2020 01:00 PM; This is a spontaneous report from a non-contactable healthcare professional (patient). A 26-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3247), via an unspecified route of administration on left arm on 17Jan2021 15:00 at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. The patient had no known allergies. No other vaccine in four weeks. No other medications in two weeks. No COVID prior vaccination. The patient previously took first dose of BNT162B2 (lot number: EL0142) on 31Dec2020 13:00 on left arm for COVID-19 immunization. On 17Jan2021, 2 hours post-vaccination (17:00) patient had injection site soreness; 4 hours post vaccination patient had tiredness for more than 40 hours; and 6 hours post vaccination (21:00) patient had fever for more than more than 40 hours, generalized muscle soreness for 30 hours, and headache for 40 hours. On 18Jan2021, 12 hours post vaccination (03:00), patient had bilateral painful and enlarged cervical, supra-clavicular, and axillary lymph nodes for more than 40 hours. There was no treatment for the events. Patient was not COVID tested post vaccination. The outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Fever; Chills; Headache; Muscle aches; Injection site burning and soreness for 36 hours; This is a spontaneous report from a contactable healthcare professional (the patient). A 26-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EL9262), intramuscular in the left arm on 20Jan2021 10:30 (at the age of 26-years-old) as a single dose for COVID-19 immunization. Medical history included asthma, and the patient was diagnosed with COVID-19 prior to vaccination. The patient did not have any allergies to medications, food, or other products. The patient did not have any concomitant medications. The patient had not received any other vaccine within 4 weeks prior to the vaccine. On 21Jan2021, the patient experienced fever, chills, headache, muscle aches, injection site burning and soreness for 36 hours (as reported). The patient did not receive treatment for these events. The clinical outcome of fever, chills, headache, muscle aches, injection site burning and soreness was recovering (as reported). It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected

Inflammation of previous knee injury; This is a spontaneous report from a contactable other HCP (patient). A 26-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL9261), via an unspecified route of administration in right deltoid on 27Jan2021 around 15:20 at SINGLE DOSE for covid-19 immunisation. Medical history included Prediabetic from Feb2019 and ongoing, obesity from 2021 and ongoing (thought he just turned the corner to obesity this year), previous knee injury. Family history included diabetes only. There were no concomitant medications. Prior Vaccinations within four weeks prior to the first administration date of the suspect vaccine was reported as 'None'. The patient experienced inflammation of previous knee injury on 27Jan2021. He reported onset of inflammation of previous knee injury around 15:35-15:40 which was ongoing. He called to ask if this event was known to be associated with the vaccine; if it was normal, just an inflammatory response of old injuries that was expected or not. Inflammation of previous knee injury: Described as knee was probably about 25% bigger than normal, swollen and painful, ballooned up a bit with swelling. Noted when he started walking back to the vehicle and knee just started hurting real bad to bend the knee; Described as a bad knee, previous knee injury was an old high school injury where he tore the meniscus and a few other things in the knee. The bad knee normally did not hurt or bothered him, but flared up if he got sick. The swelling was only in his knee, not in his throat or anything else. The event did not require a visit to Emergency Room and Physician office. The outcome of the event was not recovered (reported as worsened).

Patient presented with puffy eyes approximately 4 minutes after vaccination. Was alert and oriented to time, person, and place upon questioning and was able to engage in conversation. Parent (mother) of patient was present who gave patient's medical history and reported allergy to grass with similar reaction. Blood pressure was taken and found to be 150/80. Mother reported patient had not taken his blood pressure medicine yet that day but his normal is 115/70 with medication. While nurse was assessing patient's pulse (patient's pulse was WNL at 85) and other nursing staff was obtaining medication to administer if needed after assessment, patient became unresponsive to verbal commands and his upper body became limp. At 1054, a one time, single dose of 50 mg of diphenhydramine IM was given in the left deltoid. On site EMT arrived on the scene at 1055, completed assessment, and confirmed giving diphenhydramine was the best course of action. At this time, 1055, patient became responsive to verbal commands and was oriented to time, place, and person. At 1056 O2 sat was at 97%, pulse 70, and at 1100, BP was 110/70. Patient stayed for observation 30 more minutes and remained stable. Patient and parent were educated on side effects of diphenhydramine, to watch for any returning symptoms of allergic reaction throughout the day, and if/when to head to the ER. Recommended patient not receive 2nd dose of COVID vaccination.

Lower extremity myalgia; Right hip pain; Fever; This is a spontaneous report from a non-contactable physician. A 26-year-old male patient received second dose of BNT162B2 (COVID 19, Pfizer, Solution for injection, lot number: EL324), intramuscular on 01Feb2021 07:00 at single dose for covid-19 immunisation. No other medical history, allergies to medications, food, or other products and concomitant medications were reported. Prior to vaccination the patient diagnosed with COVID-19 was unknown. The past medication included first dose of BNT162B2 (COVID 19, Pfizer, lot number: EK4176), intramuscular on 11Jan2021 07:00 at single dose for covid-19 immunisation. The patient experienced lower extremity myalgia, right hip pain and fever on 02Feb2021 07:00. The patient received acetaminophen as therapeutic measures of events. The outcome was unknown. No follow-up attempts are possible. No further information is expected.

Vaccine was .05 cc injection; 12 hours later - chills, never had a true fever, fatigue, muscle aches, and a headache. That night I went to bed earlier - got 10 hours of sleep and felt worse then when I get sick. That lasted exactly 12 hours. By noon the following day, it had disappeared. Took Aleve. I returned to work the following day.

1/28 - First dose of vaccine received. Arm felt heavy, not sore. Throughout the day, fatigue gradually increased. Before bed time, had cold sweats and shakes. 1/29 - woke up feeling perfectly fine. 2/17 - Second dose of vaccine. Arm felt sore and was sore two days after. From 2/18-2/20, I noticed the effects of the Cymbalta were gradually decreasing and was experiencing side effects (shocks from toe to head every step). Turns out that even with taking my regular dose of the Cymbalta, my body after 2 hours feels like I had never taken it. 2/20 - After experiencing heavy shocks, shaking, and heart racing, I went home after coming into work 3 hours later. 2/21 - Woke up today feeling dizzy, fatigued, and weak. I know that operating a motor vehicle will not be possible for me.

pt is hospitalized 2/21/21; current LP is pending; pt has fevers, occipital pain, malaise, neck pain, vomiting; elevated ESR & CRP; MRI & Ct Scan are negative. infectious disease physician Dr.'s differential diagnosis is: Meningoencephalitis (LP performed and is pending results) Vaccine

Having fatigue, chills, alopecia, arthralgias, N/V, diarrhea, intermittent rhinorrhea and nasal congestion, lower back pain, neck pain for the last 2 weeks

1/8 vaccination 12:30 2 hours later, I got really fatigued; couldn't walk. Quads locked up. Nausea. I couldn't even it hurt. Nausea and vomiting for 7 days. Fever, shivers, chills. That Monday after vaccine, I couldn't even care for patient due to fatigue and nausea. 1/11 urgent care. Covid; negative. Prescribed Ibuprofen and Zofran *quad still hurts.

I had a blood report taken on the 25th of February as a part of my physical. I have never had elevated platelets, but this report showed my platelets at at 499 (130-450 is reference ranges of the lab). A year ago, my platelets were just below the max at 445. Upon discussing with my PA, he didn't feel too concerned, but after asking if the first dose covid shot may have something to do with it, that became a potential etiology. I am very unsure of my elevated platelets is associated with the first dose. Arm was stiff on injection date for approximately 6 hours. Felt slightly flu like symptoms (headache, dizziness, fatigue) that same evening of injection date and felt fine the next morning. Blood specimen was taken on 25th of February 2021. Diet at the time is a ketogeneic diet. I'd like to make it clear I mean no deception and am unsure if there is an association with the vaccine and platelet levels, but my elevated platelets is inconsistent with any other blood report in the past, and the dose 1 covid vaccine was the only "new" thing in my life prior to the blood draw. I figured, better to let y'all know in case it became relevant. Currently on no treatments for the platelets and was told to "not worry about it" which is hard for me to just take.

Rash (red spots, not raised, not itchy) all over abdomen, stomach, a bit on arms, and some on thighs. This rash appeared within a week or so of getting the first dose of the Pfizer COVID vaccine. Over the next few weeks the rash slowly faded (not completely, though). When I woke up the morning after receiving the second dose of the vaccine, the rash doubled in coverage in the same areas of my body. Around the time the rash showed up, I also began experiencing lower to mid-back pain, which grew more severe over time. The back pain is worst in the morning after sleeping, or after sitting/resting for longer periods of time. I've been taking Ibuprofen and Aleve, which helps, as does being active. The back pain did not noticeably worsen after the second dose, but it is just as severe. Currently, the rash has faded (not completely), and my back pain is still quite bothersome.

Two days after second shot Patient experienced: tingling/numbness in both hands; A rash to his face,chin and to both arms; Itching with bumps, swollen fingers and toes; Rash and swelling moves around body with elevated joint/bone pain; fevers on/off. 2/13/21- Went to Urgent Care, given Keflex with no change.2/15/21- Urgent Care second visit, Keflex stopped.2/17/21- Clinic, Benadryl & Tylenol PRN and labs done with no change in rash, Covid test negative. 2/18/21- Dermatology Appointment- Doxycycline 100mg BID, Hydroxyzine PRN, Zyrtec OT, Punchbx left ankle. 3/11/21 - No diagnosis made in Hospital or from follow-up visit with Dermatologist. Continue to have occasional area of transient redness and some numbness and tingling in hands.

On 2/13/2021, I began to experience both enhanced and new musculoskeletal and neurological symptoms that have not completely resolved still, today, 3/16/2021. While I had experienced some slight discomfort and pain of the b/l thumbs 2-3 weeks prior to 2/13, I began to experience increased pain up to the forearm in both arms on that day. In addition to pain, I had large muscular knots in the superior forearms, especially the right arm. The lower right arm felt extremely tight, and I was having difficulty raising the arm and gripping things. This continued for 2-3 weeks on the right arm. During that time, symptoms worsened on the left arm, while improving on the right arm. A week after the initial symptoms my left arm became worse, and I was struggling to lift objects as light as a sheet of paper. I was also having trouble typing at work, dialing the phone, and opening or closing my hand. Just over a week after symptoms began, I left work to determine a cause and solution for my issues. I also began to have tremors, extreme muscle spasms, and involuntary movements around this time for about 2-3 weeks. While the neurological symptoms have mostly subsided, still, today, 3/16/2021, I continue to deal with various inflammatory musculoskeletal symptoms affecting mostly my left arm, but also my right arm. Since yesterday, my left shoulder has begun to have pain as well, making raising my arm and reaching to the opposite side difficult due to pain. I have also had persistent popping of various joints in both arms since the initial symptoms began.

Chills, upset stomach, muscle ache, fatigue upon waking up on 3/16/21. Lasted through the day, remained bedridden for the most part. Symptoms became slightly alleviated at approximately 7:00 PM, did not take pain relievers.

Nausea - lasted about an hour (11:00 am - 12:00 pm) Light headedness - lasted about 15 minutes (10:45 am - 11:00am) Soreness in left shoulder - ongoing (has been sore since 11:00am on 3/16) it woke me up a few times during the night while sleeping.

About three hours after injection, began experiencing extreme fatigue and muscle aches. Shortly after a low grade fever began and has continued through the night with chills, muscle aches, and headache.

ED Note: At 1650, patient was observed following another nurse to the observation area, when he began swaying from side to side, lost consciousness and landed on his right side. This nurse approached the patient while other co-workers were assisting him to a chair. The patient was regaining consciousness. The patient's vital signs were as followed: 112/96, pulse ox 99%, pulse 46. This nurse gave the patient water and the patient was alert and oriented X 3. The patient c/o left knee pain but denied any other symptoms. This nurse again checked his vital signs at 1655: 85/52, pulse ox 100%, pulse 86. At this point, rapid response was called and report was given. This nurse moved the patient to a wheelchair to prepare for transport to the E.R. The patient denied any further symptoms at this time except pain in his left knee. This nurse checked his vital signs at 1658: 102/64, pulse ox 100%, pulse 59. Rapid response arrived and this nurse gave report to them. Patient was transported to the E.R. via stretcher. No further issues noted at this time. Pt reports he has a history of getting nervous and "passing out" when getting blood drawn or getting a shot. Pt stated that when he stood up after getting his covid vaccine he felt lightheaded and passed out. ED staff responded to vaccine clinic At 1658 where pt's VS were as follows: 102/64 HR: 59 Sats 100% At present time, pt reports feeling "totally normal" and does not feel that he needs to stay to be seen in ED. Pt comfortable with being monitored by RN for 10 min. Pt still does not want to be seen in ED, wants to leave. Pt ambulated out of ED without difficulty.

This was my second dose of the Pfizer/BioNTech COVID-19 vaccine. I took some notes during my waiting time following my injection similar to my first dose. Information from my last report can be found using Temporary VAERS E-Report No: 334845. Of note, I did prepare for my second dose by taking Benadryl 50 mg and Airborne Immune-Boost supplements the night before my second dose, so my symptoms were not as severe as last time. 6 minutes: Mild tingling around tongue. This time all around the edges of my tongue, but a lot less bothersome than the first dose. 8 minutes: Weird. Slight itchiness under left half of tongue. Still very mild but less concerning than first dose itchiness on the left and right sides of my tongue. 18 minutes: Itchy on right side slightly, only side noticeable. 20 minutes: Mild warm feeling on left side of top of my throat. Less bothersome than time. 26 minutes: Left throat warm ness resolved, but transitioned to right side of top of my throat. 31 minute: Throat warmness overall resolved, but slightly itchy on edge of right side of my tongue. 37 minutes: Top of throat on right feels weird but not itchy. Warm maybe? 39 minutes: Weird feeling on right side of throat resolved. Symptoms more or less resolved the rest of the day, especially after second dose of Flonase @ 9:00 am. 14 hours later: About to go to bed. Feeling fatigued, similar to my first dose after working out. Took airborne and two Benadryl (25 mg each) before sleeping. 24 hours later: 03/27/2021, feeling more fatigued, groggy, mild headache (mostly at back of my head), and muscle aches around my body. 25 hours later: Groggy feeling and fatigue resolved. Possibly due to Benadryl or vaccine? 32 hours later: Majority of muscle aches resolved. Headache also resolved. Feeling mostly soreness at this point. Drank Airborne @ 10:00 am and 4:00 pm. In between drank plenty of fluids (water, cranberry juice, apple juice, milk). No fever or chills.

Worsening of psoriatic arthritis occurred a couple days after the first dose of the vaccine. The psoriatic arthritis flare last approximately 7 days. The psoriatic arthritis flare included worsening neck pain. Neck pain was mild prior to receiving the vaccine.

Fatigue, lymph node swelling, night sweats and fever, chest tightness, muscle ache and pains (full body). All symptoms persistent and ongoing, beginning after second dose.

WHILE PATIENT WAS WAITING 15 MINUTES, HE STARTED LOSING FEELING IN HIS ARMS AND LEGS, NEXT HE LOST ALL STRENGTH IN ALL EXTREMITIES, STATED PAIN IN ARM AND SIDE OF RIB CAGE, STARTED LOSING VISION TO TUNNEL VISION AND BLURINESS. LIPS APPEARED SWELLING. WRITER CALLED 911 AND GAVE PATIENT EPI SHOT. EMT TOOK TO HOSPITAL

Soon after receiving the vaccine, heart rate increased, and sweating began. Vision then began to fade to white and ears ringing. This persisted for about 15 minutes, improvement began after 5 minutes. After vaccination, patient was very tired. Sore arm for 5 days. Hot/cold flashes days 3-5. Consitent tiredness 5 days. Muscle aches and cramps days 3-5. After 5 days side effects ceased. Concerns about initial effects

Stronger fatigue than normal (given I have narcolepsy) around 24 hours after shot as I couldn?t focus on work even with methylphenidate and felt the need for 2 hour nap. Woke up with low grade fever (~99-100) with fatigue, haziness and mild muscle aches (similar to a cold without the respiratory symptoms). All symptoms subsided a couple hours later (~10pm) and felt completely fine the next day.

severe rhabdomyolysis/urinating the color of Coca-Cola and could not walk/CK level of 209,000 U/L; Pain in my left arm from vaccine started on Wednesday; Wednesday I worked on upper body and arm/chest/back muscle pains began/On Thursday, I worked on legs and severe quad/glute/hip muscle pain began; This is a spontaneous report from a contactable consumer (Patient). A 26-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 23Mar2021 13:30 (Batch/Lot Number: EN6204) as single dose for covid-19 immunisation. The COVID-19 vaccine was administered at Pharmacy or Drug Store. Medical history included reported as none. Concomitant Therapy included multivitamin, joint suppliment. The patient was hospitalized with severe rhabdomyolysis a few days after receiving his first dose of the Pfizer vaccine. He received the vaccine Tuesday 23Mar2021 and went to the gym Wednesday 24Mar2021 and Thursday 25Mar2021. Pain in his left arm from vaccine started on Wednesday and additional muscle pain was induced post workout on both days. Wednesday he worked on upper body and arm/chest/back muscle pains began. On Thursday, he worked on legs and severe quad/glute/hip muscle pain began. Saturday (27Mar2021) he began urinating the color of Coca-Cola and could not walk. Sunday (28Mar2021) he was hospitalized with a creatine phosphokinase (CK) level of 209,000 U/L with no preexisting health conditions that would cause his CK levels to be so extreme. Adverse event severe rhabdomyolysis was started on 27Mar2021 09:00 AM and resulted in Emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). Patient was hospitalized for 7 days. Therapeutic measures were taken as a result of severe rhabdomyolysis included IV fluids. The outcome of the events was recovered.

About two or three days after my second Pfizer vaccination I started to feel some immense pain in my right trapezius. I had difficulty moving my neck for several hours. The pain subsided later that day but I still had adverse effects. I had a numbing and tingling feeling that traveled from my right trapezius all the way down to my fingers. That sensation continued for several weeks (3 or so) until I saw my general physician. She conducted some strength tests and noticed that there was some weakness and lack of coordination on my right side. I was instructed to go get and MRI and the results showed 5 lesions in my brain and 1 in my cervical spine (C2-C3). After many other tests including blood tests and a follow up MRI the neurologist that viewed my case informed me that I showed a strong case of demylination and it looked likely that Multiple Sclerosis. The shot might have caused an immune response which allowed the MS to appear.

from shoulder to shoulder (back only) sunburn-like sensation at level 4 pain. extreme muscle pain and piercing sensation in the muscles behind both the shoulders and the neck. pain level would increase from a stalemate position (pain level 5) to pain level 7-8 while simply moving to escalate to a pain level 9-10 when sneezing, looking right / left or down, or even being in a driving car the pain would occasionally shift from one area to another, but would always remain between the shoulders and neck pain still persists after 6 days and causes simple tasks as easy as getting out of bed exhausting and excruciating

First noticed symptoms after waking up during the night roughly 14 hours after receiving the 2nd dose of the vaccine. Felt EXTREMELY fatigued and my heart was racing. Fell back asleep and woke up again around 8am. Symptoms persisted. Extremely tired and fatigued and heart was beating fast. Resting heart rate of around 100bpm which jumped to 120bpm when I moved at all (including just rolling over in bed). This persisted throughout the day, and I stayed in bed. In the early afternoon (about 24 hours after 2nd vaccine dose) I started to feel aches in neck and back and started a headache. Took my temperature and had a fever (101). Aches/headache continued to get worse throughout the afternoon. Finally around 4:30pm I found my Tylenol and took a dose. This substantially helped reduce all my symptoms; although I was still tired, it was much less than earlier in the day. Took a dose of Advil around 7:30pm and went to bed about an hour later. By morning, my symptoms were practically all gone, I was just slightly more tired than normal that day (2nd day after vaccine). I did not take any more medication.

Long term muscle fatigue/pain. Primarily noticed when doing chest exercises in the gym (I.e. barbell flat bench). Largely only a problem during flat bench, no issues with incline dumbbell press. Pain/soreness is isolated to the medial deltoid where the injection occurred, and only in the left arm where the injection occurred. Only began after dose 2. Noticed the week following the dose, pain persists. No treatment action taken.

Slight chest tightness and very slight difficulty breathing as if he was experiencing allergies; Slight chest tightness and very slight difficulty breathing as if he was experiencing allergies; Slight chest tightness and very slight difficulty breathing as if he was experiencing allergies; fatigue; muscle soreness; injection site soreness; mild nausea; slight nasal congestion; headache; This is a spontaneous report received from a contactable consumer (patient). This 26-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Apr2021 01:15 PM in left arm at single dose (lot number=EN6204) for COVID-19 immunization. Medical history included Attention Deficit Hyperactivity Disorder, Obesity, Temporomandibular Joint Dysfunction, Ocular Migraines. No allergies to medications, food, or other products. Concomitant medications included cannabis sativa. The patient previously received first dose of BNT162B2 (Lot number=ER8730) on 22Mar2021 01:00 PM in left arm for COVID-19 immunization. On 13Apr2021 07:00, the patient experienced fatigue, muscle soreness, injection site soreness, mild nausea, slight nasal congestion, headache. Slight chest tightness and very slight difficulty breathing as if he was experiencing allergies which started 14Apr2021 at around 07:30 am while he was setting up for work and had come and gone. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient did not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. No treatment received for the adverse events. The outcome of events was recovering. No follow-up attempts needed. No further information expected.

Shakes Fever Fatigue Flu-like Symptoms Muscle Aches Mental Fog Soreness at Injection Site All Symptoms Lasted about 8 Hours

Initial event was hives that didn't itch appearing on elbows, they continued to spread for about a day. The doctor said to start Zyrtec, pepcid and ibuprofen. Hours later vomiting, diarrhea, and a blackout followed along with a fever of 102. This time ER gave IV fluids, acetaminophen, ketorolac, ondansetron, and sodium chloride .9%. At this time no mention or notice was made of the hives previously looked at. After this Zyrtec, Pepcid and acetaminophen were being taken regularly. Throughout the rest of that day the hives got worse along with pretty severe angioedema. Also, a feeling of swollowing around a lump in my throat. No change through the night into next day (Friday) for the hives,swelling and lump feeling in throat. Went to walk in clinic where I was prescribed prednisone tapered for 16 days. After the first day of steroids not much change. After 2 there was some improvement. As of today one week after receiving the 2nd dose of the vaccine approximately 90% of the hives are gone, only mild swelling and some muscle fatigue and pain left.

1st Pfizer shot beginning of April went fine. Only a sore arm. 2nd shot this past Saturday was a different story. I got the shot around 3:30 and felt great until about 7. My arm started getting very sore. It got better a little later in the day. Next morning I felt pretty fatigued but nothing I haven?t felt before. Sore arm was still there. Pretty manageable. Had to pick up groceries and that was a mistake. Had to take deep breaths and my knees were in a lot of pain as I got out of the car and walked through the store (I injured them years ago and now have Baker's cysts). Wife brought me home and I had rigors on the ride back. I got home around 11:45 or so and I put on a blanket. I felt so hot I started to get a little bit delusional and very sad/started getting teary. Took off blanket and couldn?t get off the couch or walk without help. Knees now felt like about to fall apart. Wife takes temp shows 107, makes ice bath, I get in and it goes down to 105 a few minutes later. Temp went down to 103 over the next 15-20 minutes and stayed there. Got out with her help and still couldn?t stand up or walk without help. Sat upright in bed rest of the day. Fever ranged from 98-103, mostly 101-103. Took a very cold shower later in the day but temp still stayed in the same range. All other symptoms mentions else stayed the same. I also now had no appetite and felt nauseous. Stomach felt rock hard, and I didn?t feel too with it. Finally fell asleep later at night and woke up feeling way better but still awful. Monday and Tuesday I had to take off work I felt so fatigued. Both of those days I had no fever, it went away from Sunday night into Monday. I can walk by myself now and just feel a little fatigued today. I have my appetite back now and am back to work. I should mention that I took Tylenol which didn?t help. Ibuprofen I took later in the day and that might have helped a little. Took Benadryl later and that helped with sleep.

his arm is sore and tight; his arm is sore and tight; specifically soreness where the shot was.; This is a spontaneous report from a contactable consumer reported for himself. This 26-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Apr2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had the first dose of the Pfizer covid 19 vaccine on 20Apr2021 and his arm was sore and tight, specifically soreness where the shot was. Event outcome was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

A male patient received first dose BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0161 and expiration date was not reported) via an unspecified route of administration, administered in Arm Left (Left Shoulder Side of the Arm s single dose for covid-19 immunisation. Vaccination facility type was other. Reportedly, patient had no history, no other products and no investigational assessment. Patient did not have any family medical relevant history. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. There was no Additional Vaccines Administered on Same Date of the Pfizer Suspect. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Apr2021 evening the patient experienced left arm sore, on 17Apr2021 patient experienced fever, head pounding, Lower Half of Body was Very Sore; Muscle Aches (muscle pain). The patient states he was calling about his first dose, he got the first dose on this past Friday, 16Apr2021 and he was fine that day and then the following day, Saturday night, he had a fever and he still has a fever 4 days later. Is it normal to have a fever after 5 days. The report was not related to a study or a program. Patient took treatment Montrin. Patient did not went to emergency room or physician office, he went to urgent care. The outcome of the event pyrexia is not recovered, left arm pain recovered on 18Apr2021, muscle pain (Lower Half of Body was Very Sore; Muscle Aches) recovered on 17Apr2021 and head pounding recovered on 18Apr2021. No follow-up attempts are needed. No further information is expected.

Gradual stiffness and tightening of both shoulder joints. Reduced flexibility in knees the first night and pain during normal range of motion. 5-minute intervals of paresthesia in both hands and wrists every couple of hours. Nausea the next day.

Flu like symptoms; Headache; muscle aches; nausea; elevated heart rate; This is a spontaneous report from a contactable consumer (Patient himself). A 26-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 16Feb2021 11:30 (Batch/Lot Number: EL3247) as 2nd dose, single for covid-19 immunisation. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1, administered in Arm right (Batch/Lot number: EL3247) on 26Jan2021 12:30 PM as 1st dose, single for covid-19 immunisation. Medical history included none. There were no concomitant medications. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination and did not receive other medications in two weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 16Feb2021 23:30 the patient experienced flu like symptoms, headache, muscle aches, nausea, elevated heart rate. No treatment was taken for the event caused. The patient underwent lab tests and procedures which included heart rate results elevated on 16Feb2021. The outcome of the events were recovering. Follow-up (24Feb2021): This is a follow-up spontaneous report received in response for the first awareness date of the adverse events caused by Pfizer COVID-19 vaccine and the response included with event onset date. (16Feb2021).

A 26-year-old male with no past medical history presents to the emergency department (ED) with an acute episode of chest pain. He reports initially mild dull substernal chest pain for a day prior to an episode of acute sharp chest pain that radiates to his left neck and left shoulder accompanied by diaphoresis leading him to present to the ED. He had received the second dose of the Pfizer-BioNTech mRNA COVID-19 vaccine three days prior to presentation and reported myalgia and weakness beginning within 24 hours of vaccination. His blood pressure on arrival was 126/83 mmHg and pulse was 61 bpm. Electrocardiogram (ECG) on admission showed diffuse upsloping 2mm STE, no reciprocal changes, and PR elevation in aVR. Troponin-I on admission was 6.03 ng/ml prior to peaking at 21 ng/ml while initial CRP was 56.8 mg/L. Transthoracic echo (TTE) showed left ventricular ejection fraction (LVEF) of 55-60% with hypokinesis of the basal lateral wall. Cardiac magnetic resonance imaging (CMR) was consistent with myocarditis showing subepicardial late gadolinium enhancement (LGE) in the basal inferior wall, no edema on T2 sequences, and a mildly reduced left ventricular systolic function with an LVEF of 51%. He was started on colchicine, low dose beta blocker and losartan and improved symptomatically along with resolution of the EKG findings prior to being discharged with plan for close outpatient follow-up and repeat imaging. In addition, a respiratory viral PCR panel was obtained which was positive for Rhinovirus/Enterovirus on nasal swab. Although it is possible that his presentation was secondary to enteroviral myocarditis, the temporal relationship to the second dose of Pfizer-BioNTech mRNA COVID-19 vaccine suggests the possibility of myocarditis secondary to immunologic response to COVID-19 vaccine itself.

fatigue; upset stomach; Muscle ache; Chills; This is a spontaneous report from a non-contactable other healthcare professional. A 26-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6207), via an unspecified route of administration in the left arm on 14Mar2021 at 11:30 (at the age of 26-years-old), as a first single dose for COVID-19 vaccination. The patient's medical history was 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 tested for COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), for an unknown indication from an unspecified date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 16Mar2021 at 08:00 after he woke up, the patient experienced chills, muscle aches, upset stomach and fatigue. The patient did not receive any treatment for the adverse events. The clinical outcome of chills, muscle aches, upset stomach and fatigue was recovering. No follow-up attempts are possible. No further information is expected.

head pressure; Flu like symptoms; Nausea; diarrhea; low grade fever; muscle pain and aches; muscle pain and aches; tiredness; joint pain; headache; This is a spontaneous report from a contactable consumer or other non hcp. A 26-year-old male patient received bnt162b2 (Pfizer Covid-19 mRNA vaccine, Solution for injection, Batch/Lot Number: En620s), dose 1 via an unspecified route of administration, administered in Arm Left on 04Mar2021 12:00 PM as SINGLE DOSE for covid-19 immunization. The patient medical history of covid prior to vaccination was reported. The concomitant medications were not reported. Patient had not taken any other vaccine in four weeks. Patient had not taken other medications in two weeks. On 05Mar2021 at 08:00 PM, patient experienced flu like symptoms, Nausea, diarrhea, low grade fever, muscle pain and aches, tiredness, joint pain, headache, head pressure. No covid was tested post vaccination. No therapeutic measures were taken. The outcome of events is not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained

heart palpitations; fainted while using the restroom and woke on the bathroom floor; more like a sore or a strain; more like a sore or a strain; felt more strange; This is a spontaneous report from a contactable consumer (patient). A 26-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11May2021 at 11:00 (Lot Number: EW0176, expiration date: Aug2021, at the age of 26-year-old) as 0.3 ml, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Apr2021 about 5:00pm (lot number: ER8731, expiration date: Jul2021, at the age of 26-year-old) as single dose for covid-19 immunisation. When he got the first one, he was fine. The day after he received the second shot, he fainted while using the restroom and woke on the bathroom floor on 12May2021 at 07:30, he was on the floor for a few minutes, 2 to 3 minutes. After that there was no other fainting. Patient had been having heart palpitations since the second dose on 13May2021. Did not particularly remember the time, just that it was in the middle of the day. The palpitations were going away and were less prevalent. He went to the Emergency room (ER) this past Sunday night because it was really working up and he couldn't wait to go to the doctor. Physician office was no. Electrocardiogram (EKG) and blood work were done in the emergency room on unspecified date in May2021 and came back normal. He was supposed to meet with a cardiologist next week. On unspecified date in May2021, he still felt kind of like he senses his heart beating but he didn't usually think about. It felt more strange, than soreness. This was all just so new. Thought it was a sign that he was going to recover and it was going to go away. The palpitations were coming on less and less. Was not so much of an irregular heart beat than last week. On unspecified date in May2021, felt like his heart was getting strong. Felt like his heart was making it's way back and was more like a sore or a strain. It had been going down and he was not feeling his heart in his chest. Treatment was no, not this far. There was not prior vaccinations within 4 weeks. The outcome of the event "fainted while using the restroom and woke on the bathroom floor" was unknown, for other events was recovering.

A few hours after getting the 2nd dose, I had the following reactions (I didn't go to the doctor, I'm just reporting what I experienced): *Slight rash consisting of pen-dot sized raised blisters which only appeared on top of a long-healed tattoo I have *Pain all throughout my right jugular (neck) *Sharp pain behind my right ear *Sleepiness *Dizziness *Muscle aches and muscle cramps Most of these lasted less than 24 hours, but the tattoo rash was progressively becoming worse, I managed to get it under control on day 4 by applying hydrocortisone directly over the immidiate area. I still see a few bumps, but it seems to be healing. I didn't do anything differently in my daily routine; nothing changed (ie: same soap, same detergent, no contact with dust or etcetera). The tattoo also contains phosphorus, which might be related to the reaction. The muscle aches and cramps are still ongoing; which is weird considering how I never get either and my daily activities haven't changed.

I began to experience rapid heart rates to the 140s intermittently starting on the Wednesday following my first vaccination. I also had associated neck pain and "pounding sensation" in my neck, chest, and arms. I had difficulty lying flat at night and developed a dry cough. I went to the urgent care on 4/19/21 and was diagnosed with torticollis. No one at the urgent care listened to my heart or lungs. Given that my symptoms had been diagnosed, I delayed seeking further treatment. My symptoms continued to worsen. I had difficulty walking long distances, exercising. I became short of breath easily. I ended up going to my primary care doctor on 4/26/21 for a second evaluation. He was concerned and did an EKG, it only showed sinus tachycardia. He scheduled me for an echocardiogram and put me on a beta blocker (Bystolic) 5 mg once daily. The echo showed EF 47% with global hypokinesis of the L ventricle. Doctor called me into the office as soon as he saw the results, concerned for myocarditis or pericarditis.

I was vaccinated on 4/20/2021. When I woke up on the morning of 4/22/2021, I had a really bad headache, a sore right shoulder. I had problems with my bowels, with intermittent constipation and diarrhea. The headache and bowel issues lasted for a couple of months, but they eventually subsided. The sore shoulder lasted for only a week or so. I called my doctor. I was told the symptoms were pretty standard and that I had no reason to worry.

24 hour history of discomfort between left nipple and costal margin. radiating to back, worsened with position such as lying flat or leaning forward. Diffuse ST segment elevations V3 to V6 as well as 1, 2 aVF. ST depression and subtle PR elevation in aVRort between left nipple and costal margin. radiating to back, worsened with position such as lying flat or leaning forward. 27 yr old with abd and chest pain. ECG only abnormality. Longer time from 2nd vaccination to chest/abdominal pain so ? etiology idiopathic??

day after: all CDC side effects + sore chest + neck pain + sleeping for 16 or more hours 2 days after: all CDC side effects + chest pain + trouble breathing 3 days after: lessening of all CDC side effects to no CDC side effect + trouble breathing through ER prescribed medication (2 inhalers) 4 days - 4 weeks after: intermittent shortness of breath fixed through further prescribed medication (2 inhalers) and steroid given 5+ weeks after: no noticeable side effects

Had symptoms that night but went away by morning except for the muscle pain that targeted an untreated vehicle accident injuries until the following night. Friday night and all of Saturday (almost 2 months later) I've been having a cough, headache, fever, muscle pain, runny/stuffy nose, irritability, and loss of appetite, smell, and changed tastes. I've self-isolated until I can get tested but it feels like the flu. But it's late June.

Dealing with moderate carpal tunnel symptoms, worse on non shot arm (right) mild symptoms in left arm. Shooting pains throughout left and right arm and hand as a result. Pressure and stiffness in right arm almost always.

thinks he has COVID 19 now; Fever; Headache; muscle aches; Chills; Sore throat; Runny nose; Upset stomach; This is a spontaneous report from a contactable consumer. A 26-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on 16Mar2021 (at the age of 26-years-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Patient had no medical history. The patient concomitant medications were not reported. Prior Vaccinations (within 4 weeks) was none. The patient experienced thinks he has covid 19 now on an unspecified date. On 19Mar2021, he started to have a fever, headache, muscle aches, chills, sore throat, runny nose and an upset stomach that are still persisting today. The patient experienced thinks he has covid 19 now on an unspecified date, Adds the patient is really concerned, and thinks he has COVID 19 now. He even went so far as to get an appointment for the test. It was reported that he got the first dose of the Pfizer COVID 19 vaccine on Tuesday 16MAR2021 at unknown time in an unknown arm. Caller added they were wondered with all of these symptoms should he get a COVID 19 test as suggested to call Pfizer. Patient had not visited physician office. Time the vaccination was given was unknown. History of all previous immunization with the Pfizer vaccine considered as suspect was none. The outcome of thinks he has covid was unknown and other events were not recovered.

Sore / achy; Feverish; Chills; red and tender swollen injection site; red and tender swollen injection site; red and tender swollen injection site; Lightheaded; swollen and tender armpit glands,; Elevated heart rate; swollen and tender armpit glands; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old male patient received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: er8735) via an unspecified route of administration on 26Apr2021(at the age of 26 years old) as a single dose, for COVID-19 immunisation. Medical history included COVID-19 on an unknown date. Concomitant medications were not reported. The patient reported that his past drug history included dairy (unspecified). Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient experienced sore / achy, feverish, chills, red and tender swollen injection site, lightheaded, swollen and tender armpit glands and elevated heart rate on 26Apr2021. The patient did not receive any treatment for the events. The clinical outcome of the events sore / achy, feverish, chills, red and tender swollen injection site, lightheaded, swollen and tender armpit glands, elevated heart rate were resolving at the time of this report. 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 email address added, medical history added (known allergies: dairy), treatment received was ticked as No and updated narrative.

Pain in right arm; mild itching all over; neck pain opposite of injection site; joint pain; This is a spontaneous report from a non-contactable consumer, the patient. A 26-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EP7533) via unspecified route of administration in the right arm on 27Mar2021 at 17:45 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Medical history included overweight. Concomitant medications were not reported. It was unknown if the patient had any known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 28Mar2021 at 10:00, the patient experienced pain in right arm, mild itching all over, neck pain opposite of injection site and mild joint pain. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events pain in extremity, pruritus, neck pain and arthralgia were resolving at the time of this report. No follow-up attempts are possible. No further information is expected.

Shortly after receiving the covid vaccine first shot. I began to develop symptoms that I have never previously felt and have sent me to the hospital in the time since. I have developed serious pins and needles sensation in my left foot, and hands. My left foot and leg constantly feel stiff. My left foot constantly feels as though it is buzzing or vibrating. I have received 3 blood test, imaging test, spent thousands of dollars trying to figure out what is wrong with me. The only thing in my life that changed was the covid vaccine. I can no longer work out due to pain in my leg. I am extremly heat intolerant. This vaccine has ruined my life.

experienced Flu; Joint Paint; Fever; Muscle Pain; Headache; Tiredness; Nausea; Arm Pain; Injection Site Pain; He is feeling sick after second dose; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program . A 26-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm on 20May2021 (at the age of 26-years-old) (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on an unspecified date (at the age of 26-years-old) for COVID-19 immunisation. The patient reported that he experienced Flu, Joint Paint, Fever, Muscle Pain, Headache, Tiredness, Nausea, Arm Pain and Injection Site Pain. He had his first shot of the Pfizer BioNTech Covid-19 Vaccine last day 20May2021 (as reported). Caller wanted to know if he would be allowed to take Dayquil to relieve the current side effects he was experiencing. The patient received his second dose last day (20May2021) but cannot recall exact date of 1st. He was feeling sick after second dose. His symptoms were not much different than what was on the fact sheet. He did not wish to report them at all. He just had a question. His symptoms were very typical of the flu with the usual joint pain, fever, muscle pain, headache and tiredness. He took the day off of work. He just wanted to know if he should take Dayquil tomorrow so he could function and go to work. The patient was referred to HCP. Outcome of the events was unknown. Follow-up needed. Information about batch/lot number has been requested.

Still experiencing severe muscle pain in right leg and left arm (arm was vax site); Severe migraine; Flu-like symptoms; Diarrhea; Nausea; Temperature regulation issues; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP 7533) via an unspecified route of administration in the left arm on 04Apr2021 at 17:15 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Information on medical history and known allergies was not available. Information on whether the patient had received any other medications in two weeks was not available. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN 6203) via an unspecified route of administration in the left arm on 13Mar2021 at 13:00 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, it was unknown if the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021 at 08:00 the patient was still experiencing severe muscle pain in his right leg and left arm (arm was vax site), severe migraine, flu-like symptoms, diarrhea, nausea, and temperature regulation issues. The patient did not receive any treatment for the adverse events. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events severe muscle pain in right leg and left arm (arm was vax site), severe migraine, flu-like symptoms, diarrhea, nausea, and temperature regulation issues was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.

March 20 2021 (shortly after 2nd Pfizer COVID19 vaccine March 17 2021, injected into LEFT arm): woke up with burning, throbbing, RIGHT neck, shoulder, RIGHT arm pain for 3-4 hours -- > numbness/tingling RIGHT shoulder to fingertips; dysesthesias to extremes of temperature in RIGHT arm; RIGHT hand>arm weakness and dexterity issues; dizziness with fast lateral movements that occurred a little bit later Pain went away in a few days, but still has residual numbness and tingling (even now) Dysesthesias to temperature lasted a few weeks -- > MRI brain noncontrast March 29 2021 showed lesions c/f MS in the supra and infratentorium -March 30 2021: L'hermitte's sign (shock or vibration) from abdomen to feet when looking down -- > steroids not given initially, as sx on neuro exam felt to be mild -- > MRI C/T spine April 21 2021 with RIGHT C2-C3 nonenhancing lesion; repeat brain showed no enhancement -- > ACE slightly elevated; CT chest without LAN -- > April 23 2021 decided to order IV steroids given mild RIGHT hand weakness, given April 27-29 2021 -- helped, but still has numbness and tingling; it's getting easier to write and use a pipetter, but still some difficulty IMPRESSION: This is a 26 Y man with CIS, one neurological event mostly causing RIGHT hand weakness and sensory sx plus vertigo that happened 3 days after a 2nd COVID19 vaccine. He meets criteria for dissemination in space (spine, brainstem, and PV lesions) but does not meet dissemination in time (no contrast enhancing lesions, no change in brain lesions over 1 month of monitoring). A LP is required to finalized criteria to discriminate between CIS and RRMS. Elevated ACE and ANA are common to see in MS, and I do not think they point to further pathology.

Fever 100-101 F; Chills; Muscle aches; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the arm left on 02May2021 at 13:45 (at the age of 26-years-old) as a single dose 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: ER8737) via an unspecified route of administration in the arm left on 11Apr2021 at 13:45 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03May2021 at 07:00, the patient woke up with chills and severe muscle aches after receiving second dose. On 03May2021 at 09:30, the patient experienced fever 100-101 F which lasted at least until the patient went to sleep that night at 21:00. The clinical outcomes of chills, muscle aches and fever 100-101 F were recovering. No follow-up attempts are needed. No further information is expected.

Patient demonstrated adverse symptoms after covid vaccination manifested by: chills, headache, neck pain/stiffness, eye pressure.

Tachycardia; Intermittent palpitations; Low grade fever/fever; muscle aches; This is a spontaneous report from a contactable physician. A 27-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly in unknown arm on 17Dec2020 at single dose for routine mass immunizations (covid-19 immunization). The COVID-19 vaccine was administered at Hospital. Not a military facility. The patient's medical history was reported as none and concomitant medications was none (he was on no other medications). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced tachycardia, intermittent palpitations, low grade fever/fever all started somewhere in the morning of 18Dec2020 and muscle aches on 17Dec2020. Physician assessed tachycardia and intermittent palpitations as serious due to medically significant. Physician stated that one of his workers had the vaccine and proceeded to have tachycardia and low grade fever. He would like to know if patient should get the second dose. The patient had mostly tachycardia with some intermittent palpitations. Patient was seen in his office on 18Dec2020, and got the COVID vaccine on 17Dec2020. He also reported fever and muscle aches, although the fever was subjective and was not documented. Tachycardia improved and sent him to cardiology on 21Dec2020. It was not life threatening and they did an Electrocardiogram (EKG). His initial heart rate was 130. When he was seen again in their office on 21Dec2020, it was 93, which was baseline. It improved. He never got his temperature. The highest in office was 99.5 degrees Fahrenheit. He had some muscle aches. The physician just sent patient to cardiology because he was having intermittent tachycardia and intermittent palpitations. Two visits to physician office. He was seen on 18Dec2020 and again on 21Dec2020. Relevant tests: they did testing for tachycardia but not related specifically. They did thyroid and EKG in office and he did not know if test were back. EKG was ok. The Thyroid, Complete blood count (CBC) and lipid (all were on an unknown date in Dec2020) were not back and were just done to make sure there were no cardiac issues. The outcome of the events was recovering. The lot/batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events tachycardia and palpitations cannot be excluded. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.

I would like to start out by saying that I am well aware that this vaccine is known to cause side effects and that the benefits of the vaccine far outweigh any side effects induced by it. The reason I am writing this is to provide information that you all can keep in mind as you provide guidance on your recommendations for the timing of when the vaccine should be administered to those who have already tested positive for COVID. I tested positive for COVID-19 11 days prior to getting vaccinated. My symptoms from the virus began on 12/21/20, lasted until 12/26/20 and included: mild headache, fever of 100.3, moderate muscle fatigue, lymphadenopathy, and sinus congestion. I received the Pfizer vaccine on 1/3/21 at 11am and by 2am on 1/4/21 I was experiencing a temperature of 102.5, severe headache, severe muscle fatigue, and painful right axillary lymphadenopathy. Although they had almost completely resolved by 11am on 1/4/20, I would describe these side effects to the vaccine as significantly worse than the symptoms of the virus itself. As someone who has a stronger medical background than the general public (I am a 4th year dental student in a patient-facing role and was encouraged by my school to receive the vaccine despite already testing positive), I understood the likelihood of developing side effects to the vaccine and I am still planning on receiving my second dose in three weeks despite already showing clear signs of a strong immune response to the proteins created by the vaccine. The reason why I am writing this is because there was no guidance on recommending that I wait longer than 10 days between testing positive and receiving the vaccine and I am worried that if the general public is allowed to receive the vaccine at this same time interval, there will be a significant number of people who will have similar side effects (worse than those induced by the virus itself) and they will not only refuse a second dose, but could also vocally discourage many people from trusting the vaccine?s safety and benefit. I obviously don?t know what minimum timeframe should be recommended, but from my individual experience, 11 days was not sufficient. I will be happy to follow up if you would like to know how the symptoms fare after my second dose.

I started to feel achy all over my body. I was having chills as well. I was still able to work throughout the day 1/7/21. I've had a pain in my right arm pit that hasn't gone away. I feel a lump that is moveable and about 1 cm in diameter that is painful constantly and when I message it in my right arm pit. I feel fine otherwise 1/8/21 morning and am still going to work.

Nerve pain left arm to shoulder and ring and pinky finger weakness in l hand and arm pain and heart; concussion symptoms, severe headaches, body weakness and disorientation, lights bright and sensitive. ER visit 1/9/2021 - ER referral to Ortho Spine. Continuing pain radiates to different degrees l arm to hand to include burning shoulder pain, concussion symptoms, severe headaches, body weakness and disorientation, lights bright and sensitive.

Began to feel really cold; Muscle pains; Joint pains; Throbbing headache; Fever of 101.7F; Shivering chills; Second dose of BNT162b2 was given 17 days after 1st dose; This is a spontaneous report from a contactable physician, the patient. A 27-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm on 04Jan2021 11:15 AM (at the age of 27-years) as a single dose (Lot Number EK9231) for COVID-19 immunization. Medical history included asthma and no allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient had previously received the first dose of BNT162B2 via an unspecified route of administration in the left arm on 18Dec2020 12:00 PM (at the age of 27-years) as a single dose (Lot Number EH9899) for COVID-19 immunization. The patient had not received any other vaccines within four weeks prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 04Jan2021, approximately 10-12 hours after 2nd dose of vaccine the patient began to feel really cold, had some mild muscle pains, joint pains, and a headache. Overnight these symptoms worsened to severe muscle pains, joint pains, and a throbbing headache, shivering chills, took a temperature and had a fever of 101.7F. These symptoms did not subside until late the next morning. The headache had persisted. The patient reported taking paracetamol (TYLENOL) 1000 mg, which helped. The outcome of the events feels really cold, muscle pains, joint pains, throbbing headache, shivering chills, fever of 101.7F, were reported as recovering.

A few hours after my second dose on 1/08/2021, I had some adverse reactions that worried me, including arm numbness, tingling around my mouth and cheeks, a splitting headache/blurry vision, joint and muscle pain and dizziness. I called e-medicine and had a video call with a E-Medicine provider who told me to keep monitoring my symtoms and go to the ER if they got worse (fortunately they didn't); however there are some lingering effects. Currently I still am experiencing headaches (around my ears and temple area) with joint pain/body aches and occasional tingling/burning sensations in my fingers and feet.

3 hours after vaccine: beginning of body aches, arm soreness at injection site 10 hours after vaccine: severe body aches especially in lower back and buttocks, pounding headache, skin sensitivity and chills Over night: inability to sleep, tossing and turning, unknown fever but skin felt very hot with all past symptoms 0430 next day (1/11): nausea, dizziness, pounding headache, severe body aches and sensitivity but no chills 36 hours after vaccine: uncomfortable body aches are still present, most of symptoms have resolved 48 hours after vaccine: body aches are slightly noticeable but resolve during the day

injection site pain; tiredness; headache; muscle pain; chills; joint pain; fever; This is a spontaneous report from a contactable Other Health Professional(patient). A 27 years old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EK9231) via Intramuscular on 06Jan2021 18:00 at single dose in the arm left for COVID-19 immunisation. Medical history was none. Concomitant medications were not reported. On 07Jan2021 04:00 PM, the patient experienced injection site pain, tiredness, headache, muscle pain, chills, joint pain and fever. The patient did not receive any treatment. Outcome of events was recovering.

About 8 hours after vaccine administration on 1/15/21 - woke up in the middle of the night with chills, headache, pain in joints and injection site, nausea. Sat up on the side of the bed - passed out and woke up on the floor. Tried to readjust slowly, passed out again. Place ice pack on stomach and behind neck to treatment with legs up. 1/16/21 continued to experience chills, headache despite cool compress and Tylenol 1000mg TID and Motrin 600mg x 1 dose at 1900. Fatigue and body aches throughout the day - very limited on any daily activities. Sweats and joint pain and pain around L arm injection site.

Sunday 1/17/21 at approximately 6pm began with cough, mild sinus headache, mild shortness of breath. Monday 1/18/21 morning around 8am, awoke with headache, continued coughing, began taking Tylenol and taking Vitamin C. Tuesday 1/19/21 morning woke up feeling worse. Pain to bilateral shoulders, body aches, cough and runny nose.

malaise; myalgias; This is a spontaneous report from a contactable physician (patient's parent). A 27-year-old male patient received second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot/batch number and expiry date were unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patiently previously received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) at a single dose for COVID-19 immunization. The patient experienced malaise and myalgias which took place after the administration of second dose. He took Tylenol 6 hours ago, and the symptoms are decreasing. The outcome of the events was recovering. Information on the lot/batch number has been requested.

Headache; Injections site pain; Myalgia; Malaise; This is a spontaneous report from a non-contactable physician (patient). A 27-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular at left arm on 09Jan2021 16:00 at single dose for COVID-19 immunization. Medical history was reported as none and no known allergies. The patient's concomitant medications were not reported. The historical vaccine included first dose of BNT162B2 intramuscular at left arm on 19Dec2020 16:00 for COVID-19 immunization. The patient experienced headache, injections site pain, myalgia, malaise on 10Jan2021 09:00 with outcome of recovering. No treatment received for the adverse events. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19. No follow-up attempts are possible, information about batch number cannot be obtained.

About 12 hours post-injection I began noticing hot/cold flashes and running a fever. Between 10:30pm and noon on January 22nd, 2021 I've experienced continued hot/cold flashes, fever, nausea, muscle aches, injection site pain, congestion, headache, and minor swelling and pain of the lymph nodes in my left axilla area. So far the fever seems to have broken with Tylenol, water, and rest. Still experiencing significant muscle aches, left axilla pain, headaches, congestion, and general fatigue.

Received the first COVID shot on 1-17-21 and began to feel pain in the back of my neck on the right side in the afternoon of 1-19-21. On 1-20-21 I lost part of my taste and neck started to cause headaches. On 1-21-21 symptoms continued to get worse. On 1-22-21 I began to lose control of the right side of my face. Face began to droop and eye was unable to close. I went to the ER on the evening of 1-22-21 and was diagnosed with Bell's Palsy.

Vaccine given 01/17 R-sided neck pain 01/19 Decreased taste, tongue numbness right sided 01/20 Lip and facial numbness right sided 01/21 Droopy right eye and face 01/22 ED on 01/22, given 7 day course of prednisone and valtrex Ongoing right sided facial droop, right sided eyelid droop. Unable to close right eye fully. Eye dryness. Diagnosed with Bell's Palsy in ED, confirmed in clinic

Headache, Muscle and joint pain, Fatigue , Sore throat, Cough, Shortness of breath , Abdominal pain , Facial swelling , Nasal congestion , Diarrhea , Nausea. Benadryl IM, Prednisone tablet, Ventolin inhaler.

1-2 hours following vaccine administration, I experienced moderate injection site pain that limited my mobility with that arm (i.e. pain on shoulder abduction). 18 hours following vaccine administration, I experienced a fever and chills (beginning at 0530 the morning after the vaccine). For the rest of the day, I had mild myalgia, a mild to moderate headache and general malaise that resolved by the following morning (within 48 hours of vaccine administration)

Fever; Chills; Full body aches; Joint inflammation; Headache; This is a spontaneous report from a contactable consumer (patient). A 27-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3302, Expiration Date: 30May2021), via an unspecified route of administration in left arm, on 20Jan2021 at 09:15, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (Lot Number: EH9899) on 30Dec2020 at 09:30 AM for COVID-19 immunization (left arm). The patient had no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in a military base facility. On 20Jan2021 at 06:00 PM, the patient experienced fever, chills, full body aches, and joint inflammation. In Jan2021 (after the vaccine), the patient experienced headache and ibuprofen was received as treatment. No treatment was received for the other events. The events were considered non-serious. Since the vaccination, the patient has not been tested for COVID-19. The outcome of "Headache" was unknown. The patient was recovering from the other events.

Vertigo; 101 F oral temperature; nausea; generalized weakness; rigors/ chills; generalized muscle aches; This is a spontaneous report from a non-contactable Nurse (patient). A 27 years old male patient receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 27 years old on 21Jan2021 09:00 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced Vertigo, 101 F oral temperature, nausea, generalized weakness, chills, rigors, generalized muscle aches. Patient did not have covid prior vaccination and did not have covid tested post vaccination. The outcomes of events were unknown. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.

First night hours after vaccination I had really bad headaches. The next two days all my joints and muscles ached really bad to the point I could no longer stand at work. Those symptoms subsided but now I have chronic fatigue and insomnia.

Having muscle aches, chills, pain at injection site, NO fever. Sx coming on in waves. This is day 3 of symptoms, thinks getting better No redness or swelling around injection site.

The female medical employee, who was administering the vaccination. The Pfizer Vaccination. Opened a shot syringe. That had an empty vile. The syringe did not have the dosage of vaccine. The female medical employee, documented on my immunization card the sticker Lot number #EN6204, but the vaccine Lot Number (the syringe received) was not the Lot Number indicated on the immunization card. Why? The female medical employee, called over the military personnel whom was being the security for the vaccination site. The female military personnel was holding an open unit syringe vile dosage of the vaccine. The female medical employee showed the empty syringe vaccine to the military personnel. She said, "The dosage fell out." The female medical employee, took the open package, of the syringe vile, that contained a measured dose of the vaccine. Which is not considered the full dosage, or considered a safe dosage of the vaccine, because the package was opened. Not in front of the patient. And. Was open, when the military personnel, who was holding this vile, was walking, with the open package, around without proper medical gear. The medical employee. Quickly took out the syringe. Didn't explain which and what that syringe was, and just injected the dosage into my arm. I know, that practice was malpractice. I know I experienced malpractice. And. It's obvious the Government is going to do anything about it. This is not a petty situation. I don't know where that needle from. What has been introduced to that open syringe package. I did experience very bad side affects: headaches, muscle pains, tiredness, fatigue, weakness, low strength, dizziness, partial blindness, overwhelming stress, back pain, joint pain, spinal pain, chills, fever like symptoms, nausea, spontaneous pain, soreness in the arm, swelling throughout my body, difficulty breathing, short breaths.

Headache, swollen muscles, dizziness, blindness, sweating, flushing, feeling dehydrated, weakness, muscle fatigue, eye soreness, sore neck.

I've been experiencing mild, but consistent adverse side effects to the vaccine. This vaccine. Is completely Terroristic. This vaccine is a biological warfare. I've been very active in obtaining vaccinations. Flu shots, up to date with tetanus, and obtaining a second Immunization for chicken pox because I actually received the chicken, but had no vaccination. And. I need the vaccination record for school. So I had to get the chicken pox vaccine. I've been having mild, but very uncomfortable and consistent headaches. My sinuses all over my face are so filled. My eyes are watery, turn red, and at time so painful that it's difficult to open them. I have muscle weakness. I'm always so thirty all the time. My urine smells like uric acid. Has a rancid toxic smell to it. And. My urine is clear. But smells. My skin feels silky. And. the perspiration from my body, smells like formaldehyde. Smells clean, but smells like toxic formaldehyde and dead sticky body residue. The most uncomfortable is the partial blindness. Headaches. Muscle aches. Joint aches. Neck pains. Eye pains. The consistent thirst. I can't go to the doctor because I don't have insure. But. Most importantly. I don't have employment, because of the Government's illegal employment system that accounts for me. I've been unemployed for 6 years. And. Have a private college degree from one of the top Universities in the USA. Also. I've been very active in producing sputum. Flem. My neck is swollen. And parts of my body are swollen. Not severely. But you can see there is minor swelling. All the symptoms I'm disclosing in this report, are minor. But. When collectively experienced. Is unbarable. Extremely Uncomfortable. And. You're expecting me to get another dosage of this experience. Being. 2 months incapacitated. This is even illegally distributed. What the hell. In God's name. Are you people in there doing. And. Why are you people in the Government even able to get away with this.

Muscle fatigue started around 8am. Temperature started to raise shortly after and sweating began. Symptoms stabilized until around 7pm. Severe sweating and chills through the next night. Muscle fatigue continued the next day.

Lightedness, tightness in neck, anterior and posterior aspects without chest pain, without SOB Vital Signs: BP 140/82 HR 67 Resp 20 O2sat 96 Skin Signs: Warm and dry Circulation: Cap refill <2sec Respiratory: Breath sound clear bilaterally Initial treatment: nsg vs, assessment - resp, neurological Physician assessment performed by Dr. at 13:48 PM 13:50 PM Vital Signs: BP 122/82 HR 72 Resp 70 O2sat 97 Skin Signs: Warm and dry Circulation: Cap refill <2sec Wait an additional 15 minutes in observation in addition to 30 min wait observ time Did not have lunch, only breakfast this am - gave him apple jc and nuts as a snack Disposition: Home by Self

Swollen lymph node in neck since March 24th 2021. I have recently been experiencing muscle fatigue/dull aching in my left arm, left side of neck, left shoulder, and upper left back.

Headache (lasting 3 days after), Body aches (lasted 2 days after), Neck Stiffness (lasting 3 days after), Chills (lasted 2 days after), Sweating (lasted 2 days after), Dehydration (lasting 3 days after), Nausea (lasted one day on second day after), Pain at Site of Injection (lasted 2 days after), Difficult Taking Full Breaths Nausea (lasted one day on second day after), Fatigue (lasting 3 days after)

frequent sneezing, runny nose, watery eyes, muscle pains, neck pains, joint pains, dizziness, partial blindness, severe and chronic joint spinal pops, lack of sleep, high stress, fatigue,

first day :Severe exhaustion, Sleep did not remove any muscle pain gained during the day, Tired all the time, urge to vomit, second day: Muscle pain did not go away get tired just sitting in bed third day: more of the same fourth day: muscle pain in legs tired all the time slight cough developed

5 minutes after vaccine there was dizziness which passed after 10 minutes 30 minutes after vaccine there was headache, arm pain, muscle pain all over, fatigue, low grade fever, and sense of taste was altered. A constant metallic taste was in mouth and nothing (mints, brushing teeth, drinking water, etc.) removed it. Metallic taste resolved after 24 hours. Other symptoms lasted about 36 hours.

When I woke up on Sunday, April 11th, 2021 at around 9am, I have felt like my muscles have been ripped apart, I was sweating, I had labored breathing, and I could not get up for the day. I slept all day, feeling like I had the flu, and was sleeping until 7pm that day. I called out of work when I woke up because I knew on Monday I would not be able to make it, as I felt like I was very tired, lethargic, and sore. This feeling was throughout every inch of my body. I also went to take a shower that day and I had a hard time breathing in the shower, to the point where I had to sit on the edge of the tub, just to make sure I would not pass out from lack of oxygen. This was the scariest sickness I have ever had in my entire life. I literally thought I was going to die. Monday came around and I felt even worse, my muscles were sore, I felt extremely tired, I could not do anything, and I was in bed all day. Today is Tuesday, and I have felt a little bit better, but I have missed two days of work because of the effects this vaccine has had on my body. I made a virtual appointment with a doctor on the app on phone and met with Doctor who basically told me that the only thing I could do for myself is take Ibuprofen every 8 hours for the pain and swelling that might occur and drink plenty of gatorade. It is Tuesday, April 13th, 2021 at 11:29pm at night and I still feel the same as Monday, very weak, tired, and sore all over my body. I have never had this with a vaccine before, until I got the COVID-19 one. I have taken the Flu Vaccine, Hep A, Tantnius, Chicken Pox and never felt like I was so tired I could not get out of bed from these vaccines.

NOTE: Taking Tylenol, Ibuprofen, Diphenhydramine HCL, Clear Eyes Eye drops. Have secere bruising of the eyes. Shortness of breath. Muscle Aches. Joint Aches. Congestion. Mucus buildup. Headaches. Brain noble unstable pressure, and heaviness. Unbalanced and unstable proprioception.

I had intense stomach pains, muscle pains for 4 days. Could not get out of bed. Also had a fever. I thought these were regular side effects and eventually got better. Then, about a week later I started getting nose bleeds with blood clots coming out of my nose. These lasted a few more days. This never happened to me before, and must have been a side effect from the vaccine.

On day 3 following, 2nd dose of Pfizer vaccine, he had right sided calf pain. Initially thought to be recurence of strain injury, although no history of trauma or obvious trigger. Pain conitnued to worsen and had different characteristics than original strain symptoms. Continued to worsen to point wher eunable to weight bear and swollen, hot and red. Saw orthopedist who refered to vascular surgeon, and on day 13 was officially diagnosed with large DVT extending form tibeal & peroneal, popliteal up to the femoral veins. Has no known clotting defects. Currently under evaluation with hematologist who recommended anticoagulants for remainder of his life.

Fatigue about 12 hours after administration, lasting 2 days. Body/muscle soreness starting 24 hours after administration,, lasting 12-18 hours. Headaches starting 24 hours after administration, still ongoing after 72 hours.

Day of shot (4/9), experienced a potential vasovagal reaction and bleeding in the arm. 10 days after shot, on 4/19, began to feel very weak and faint, and movement became effortful, along with chills and muscle aches and soreness. This continued into 4/20. Vitals were checked and found to be normal, and by 4/21 symptoms mostly subsided, except for remaining occasional chills and muscle-aches.

fever and body aches starting @ 1 am the next day, including pain in spine and minor headache, felt like shingles lite (without the itching) Then, 11:50 pm next day: itchy bumps began appearing over body, hands and feet itched profusely for 24 hours until benadryl administered, symptoms diminished consecutively each day,

Started 9 hours after shot: intense chills Started 12 hours after shot: 100 F fever, fatigue, headache Following morning: all of the above with some muscle pain 48 hours after shot: still was slightly feverish (99 F) and had headache

Onset: 4/28/2021 Sx: fever, chills, cough, SOB, fatigue, myalgias, h/a, loss of taste & smell, sore through, runny nose & congestion. Brief LOC today with brief mild disorientation and confusion immediately after. Social: no reported exposures Immz: Pfizer #1 = 1/19/2021 & Pfizer #2 = 2/10/2021

Pain developed in shoulder approximately 3-4 hours post vaccination. Progressed to complete inability to move shoulder, extreme pain upon any movement at all. Pain described as severe stabbing, burning pain centered in shoulder joint and deltoid muscle, causing complete incapacitation of left arm. At scheduled Doctor's visit 5 hours later, Advil was recommended. Patient decided to take Tylenol instead to avoid contraindication due to possible immune-reducing effects of Advil during vaccine immune-development time period. 29 hours after vaccine administration, 1000mg of Tylenol brought slight relief; at 35 hours 1000mg Tylenol taken again with similar effect, allowing more comfortable sleep, but shoulder had to remain immobilized to avoid severe pain. At the time of this report, 55 hours have elapsed since administration of vaccine. Range of motion has increased to approximately 3 inches, after which strong pain and tightness occurs. Left arm still largely incapacitated beyond very slight motions like holding light object. Gentle motions of readjustment to sitting and typing on computer still cause pain past limit of range of motion. Shoulder/arm cannot be raised to any meaningful height without pain. Patient tends to bring arm close to body to avoid pain, effectively resulting in frozen shoulder. PLEASE NOTE: Vaccine site was observed to be much higher up on shoulder than dose #1. Patient is concerned vaccine may have been administered into an area that may have caused entry of vaccine into shoulder joint space or bursa, at least 2 inches higher than suggested central deltoid muscle injection site.

Left Arm pain starting around 4pm intensifying until plateauing at midnight, May 3rd going into May 4th. Left Arm pain became much more mild by early morning May 4th before resolving completely sometime overnight between May 4th and May 5th. Stiffness and feeling feverish starting around 11pm May 3rd lasting until around 4am May 4th. Slight nausea while standing up starting around 3am May 4th and lasting until around noon May 4th. All symptoms managed at home.

Similar symptoms to pericarditis, with debilitating pain that was exasperated while lying down; Heart palpitations; left armpit with pain radiating to entire left shoulder through the middle of the neck; low grade fever; severe fatigue; slightly dry cough; This is a spontaneous report from a contactable consumer reporting for himself. A 27-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EV8732/expiration date: not provided), via an unspecified route of administration, on 07Apr2021 at 13:45 (at the age of 27 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included COVID-19 on an unspecified date. The patient did not have any known allergies to medications, food, or other products. Concomitant medication (other medications taken in two weeks) were none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 19Apr2021 at 22:00, the patient experienced similar symptoms to pericarditis, with debilitating pain that was exasperated while lying down, Heart palpitations, left armpit with pain radiating to entire left shoulder through the middle of the neck, low grade fever, severe fatigue and slightly dry cough. The events required a physician's office visit. The patient received treatment for these events. The clinical course of the events was as follows: Heart palpitations originating under left armpit with pain radiating to entire left shoulder through the middle of the neck. Similar symptoms to pericarditis, with debilitating pain that was exasperated while lying down, low grade fever, severe fatigue, and slightly dry cough. Lasted about 30 hours. Discomfort relief, like pericarditis, was only felt when sitting up and propping myself up by my arms leaning forward. Onset was rapid, occurring 13 days after the first dose of the vaccine over a period of 8 hours (palpitations came first, followed by shoulder and neck pain in the morning). Treated with Aspirin at first (low effectiveness) followed by NSAID Advil 7 hours later (high effectiveness, symptom relief was about 50%). High strength Advil recommended by MD. The outcome of the events was recovering. Since the vaccination, the patient had not been tested for COVID-19.

In the 15 minute waiting area patient begin to have seizure activity, then slumped into steering wheel and then went rigid again with seizure like activity. Each one lasted approx. 15 -20 seconds. No medical hx of seizures per patients.

Shortly after receiving the vaccination, the patient began to complain about pain lateral to his vaccination site towards his armpit. I applied a cold pack to the site and the pain resolved itself within 10 minutes.

Began to have pain in hip that progressed to severe pain and parlaying leg and foot; Unable at 2 nd week to stand or walk; Unable at 2 nd week to stand or walk; Began to have pain in hip that progressed to severe pain and parlaying leg and foot; This is a spontaneous report from a contactable consumer (parent). A 27-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on 30Apr2021 at 15:30 (at the age of 27 years) as unknown dose, single for COVID-19 immunization. Medical history included obesity and mental illness. Concomitant medications included aripiprazole (ABLIFY), sertraline hydrochloride (ZOLOFT), metformin, bupropion hydrochloride (WELLBUTRIN), simvastatin and lisinopril. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, it was unknown if the patient was tested for COVID-19. The patient was hospitalized on 27Apr2021 for an unknown reason and began to have pain in hip that progressed to severe pain and parlaying leg and foot on 03May2021. Unable at the second week to stand or walk. These adverse events result in emergency room (ER) or department or urgent care. The patient's hospitalization was prolonged and the patient was disability as a result of these events. It was unknown if the treatment was received by the patient due to these events. It was reported that the duration of hospitalization was 10 days discharged on 07May2021 (also reported as continued, CLARIFICATION PENDING). The outcome of all these events was not recovered at the time of report. Information on the lot/batch number has been requested.

Symptoms similar to a UTI, which started a few days after injection and persisted for a few days. Symptoms subsided on Tuesday (27th), during which I had a fever (~99°F while taking Ibuprofin). Had minor lower back pain (not biased left or right) on Wednesday (28th) which subsided by Friday (30th).

dry cough, runny nose, migraine, dizziness, trouble sleeping, stiffness, weakness in left arm, sore throat,...

fainted; lost consciousness for a couple of seconds; burning pain that felt like needles on his shoulder, left arm and a little on the right side/extremely, burning pains across his back/He had burning pain on his shoulders, very sensitive, felt like a 3rd degree burn; felt like he could not stand and had to go to the floor, struggled to get up; arms were numb; thought he was having a heart attack; left arm weak; skin is hypertensive: back of neck feels like a third degree burn: if he moves the hair on his arms it hurts; left side of face is swollen; left side of face is swollen was reported as worsened.; skin is hypertensive: back of neck feels like a third degree burn: if he moves the hair on his arms it hurts; skin is hypertensive: back of neck feels like a third degree burn: if he moves the hair on his arms it hurts; left arm pain; This is a spontaneous report from contactable consumers (patient reported for himself, patient's mother). A 27-years-old male patient received bnt162b2 (BNT162B2; PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Right on 01May2021 12:00 noon (Batch/Lot Number: EW0170; Expiration Date: 31Aug2021) as 1ST DOSE, 0.3 ML SINGLE for covid-19 immunization, at the age at vaccination of 27 years old. The patient's medical history and concomitant medications were not reported. The patient experienced thought he was having a heart attack(medically significant) on 03May2021 01:00 with outcome of unknown, skin is hypertensive: back of neck feels like a third degree burn: if he moves the hair on his arms it hurts (medically significant) on 03May2021 with outcome of not recovered, fainted (medically significant) on an unspecified date with outcome of unknown, lost consciousness for a couple of seconds (medically significant) on 03May2021 01:00 with outcome of recovered with sequelae on 03May2021, burning pain that felt like needles on his shoulder, left arm and a little on the right side/extremely, burning pains across his back/he had burning pain on his shoulders, very sensitive, felt like a 3rd degree burn (non-serious) on 03May2021 01:00 with outcome of unknown, felt like he could not stand and had to go to the floor, struggled to get up (non-serious) on 03May2021 01:00 with outcome of recovered with sequelae on 03May2021, arms were numb (non-serious) on 03May2021 01:00 with outcome of recovering, left arm pain (non-serious) on 03May2021 with outcome of not recovered, left arm weak (non-serious) on 03May2021 01:00 with outcome of unknown, skin is hypertensive: back of neck feels like a third degree burn: if he moves the hair on his arms it hurts (non-serious) on 03May2021 01:00 with outcome of not recovered, skin is hypertensive: back of neck feels like a third degree burn: if he moves the hair on his arms it hurts (non-serious) on 03May2021 with outcome of not recovered, left side of face is swollen (non-serious) on 03May2021 01:00 with outcome of not recovered , left side of face is swollen was reported as worsened (non-serious) on 03May2021 with outcome of not recovered. The patient underwent lab tests which included computerised tomogram (brain CT): no results, electrocardiogram (EKG): no results, both on unknown date. Reported patient was in pain and his mom and dad didn't know what to do. He had sharp pains. No bruises. He remember lowering myself to fall. He didn't fall. It was a strange thing. When he went to the ER they didn't fine anything. He was still in the same amount of pain. Caller stated her son took the vaccine on Saturday. Thirty six hours later around 1:00am he started getting extremely, burning pains across his back.The patient stated he was coming out of the bathroom and felt like he couldn't stand and he had to go to the floor. He lost consciousness for a couple of seconds. Both arms were numb. He struggled to get up. He sat on the couch and then went upstairs after being in the basement. He had a burning pain that felt like needles on his shoulder, left arm and a little on right side. His skin was sensitive. The back of his neck feels like he has a third degree burn. This morning he went to the hospital. Initially said he fainted but clarified that he was speaking about losing consciousness. He had left arm pain. He thought he was having a hard attack. While at the emergency room today he had labs, a brain CT scan and an EKG. He does not have results to provide. Caller added that his skin was hypersensitive. It was like if he moves the hair on his arm it hurts. His parents noticed he has swelling on the left side of his face. The events require a visit to Emergency Room. No Prior Vaccinations (within 4 weeks). Information on Lot/Batch number was available. Additional information has been requested.

Almost immediately after patient received the second dose of vaccine he stood up and passed out to the floor. He slightly seized for a few seconds until it stopped. When patient came to he stated that his knee hurt but he didnt believe he hit his head and he felt a bit light headed. Patient laid down for a while with us until he started to feel better. His BP was 102/58, but normally runs low. He said that he has passed out before and has been under a lot of stress, also had not eaten that morning before getting vaccinated. His significant other was with him and was planning to drive home. Patient was offered a call to EMS but refused.

Initial symptom was tingling then loss of feeling in both lower legs. Happened a few times over several days. Lasted for several minutes each episode. Also had involuntary muscle tightness and pain in left upper thigh (quads) and left biceps. These episodes also happened several times, but not concurrently.

Bell's Palsy on the right side of my face; muscle weakness around the right corner of my mouth, cheek, and eye.

Moderate aches experienced on the day following vaccination (5/23) beginning in the morning. Two doses of ibuprofen taken in the morning and afternoon. Mild pain experienced in left front armpit, nearly on the left pectoral, on the night following vaccination. On the following morning (5/24), moderate swelling was noticed in the left armpit, extending from underneath the armpit down to the upper lat muscles and up along the left pectoral nearly to the nipple up to just below the left collarbone. Mild pain experienced in the left front armpit as well as on the lymph node under the armpit. No inhibition of arm motion or pain when using arm, but some feeling of discomfort and pressure. Tele-med help was sought which did not recommend any course of action. By the afternoon, moderate swelling was noticed on the left arm, on the bicep and tricep down to the elbow. Ibuprofen was taken at ~3pm with no effect. Medical advice was sought at 7pm and it was recommended to head to urgent care, but all providers in the area were closed. By this morning (5/25), the swelling has reduced significantly and localized to the left front armpit. Mild pain remains, now more localized to the lymph node under the left armpit.

Flared up my chronic lower back pain, which flared up my nerve/sciatic pain. At its worse, it was so bad I couldn?t walk.

Around 2 weeks after my first dose, I started having heart palpitations. The palpitations were on and off for a week and I didn't think of it much. A week after the palpitations started it started happening more frequently and I was feeling light headed and I went to ER. I was diagnosed with SVT and put on metoprolol to control my heart rate. 1 week after I was on metoprolol, I took my second dose. I was feeling a little dizzy after my second dose but it improved after like 10 minutes. I started getting very fatigued and difficult to concentrate after my second dose. I spoke to my doctor and we thought it was because of metoprolol. My cardiologist took me off metoprolol but the fatigue didn't stop and I started having aches in shoulders, arms, neck and back. The aches and fatigue was more severe in the morning. After a week of being off metoprolol I started waking up with chest pain. One day the pain was severe and I had aches in shoulders, arms, neck and back and my heart rate was around 140 so I went to ER. The doctors put me on carvedilol and my heart rate has been controlled but my body aches and fatigue has been going on. The cardiologist and my PCP aren't sure if SVT or the medication is causing my body aches and fatigue. The only other thing I could think of was the vaccine so I wanted to send this report.

27 yo M presents to the ICC c/o a headache and dizziness. States that he has neck muscle stiffness and a squeezing, pressure-type headache that is affecting the top of his head and both sides of his forehead. The lights are bothering him and he is nauseated. Received COVID vaccination 4 days ago. Had a headache yesterday, which was worse than the one he has today. Has not taken any medications for symptom relief because he did not want to mess with the vaccine. Symptom duration == 5 hours. Not worsening. Diagnosed with a tension headache. Treated with acetaminophen 1000 mg. Rated 8-9/10 before taking acetaminophen and 3-4/10 after acetaminophen.

27 year old male with medical history notable for exercise induced asthma who developed fevers, chills, myalgias, and chest pain shorter after second dose of Pfizer. Presented to ED and found to have elevated troponin, initially normal ECG. Admitted to hospital, experienced recurrent chest pain, rising troponin to 23750, and STE on ECG, and was taken to cath lab, with normal left heart cath. Then transferred to heart medical center for further eval and cardiac MRI. Felt by cardiology there to have myopericarditis potentially related to Pfizer vaccine. Cardiology also wondering if possible inflammatory bowel disease might increase his risk of myocarditis, though no established diagnosis (outpatient gastroenterology workup planned).

Joint pain started about 3 weeks after vaccine. First affected joints in both hands and finger, has progressed to knee pain since first noticed. Range of motion in hands is limited due to pain and loss of flexibility. Range of motion in knees is currently unaffected but pain is moderate during daily activities and work. No prior history of injuries to hands or knees.

I am experiencing hot flashes, cold shivers, fever, full-body muscle soreness, headache, and vomiting. Vomiting only happened once during a really bad hot flash. Onset of event was roughly 12 hours after receiving second dose, and has continued through for almost 48+ hours on and off.

gout flair up in right foot; 3rd day after shot, right knee was hurting for several days; This is a spontaneous report received from a contactable consumer, the patient. A 27-Year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207) as a single dose via an unspecified route of administration in his left arm on 12Mar2021at 10:45AM (at the age of 27-year-old), for COVID-19 immunisation. The patients medical history included immune compromised, no functioning pituitary gland. The patient was allergic to iodine. Concomitant medications included hydrocortisone(MANUFACTURER UNKINOWN), levothyroxine(MANUFACTURER UNKNOWN), testosterone(MANUFACTURER UNKNOWN). The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient had not tested positive for COVID-19 since having the vaccine. The patient had not diagnosed with COVID-19 prior to vaccination. On 15Mar2021, the patient reported that he had right knee pain and gout flare up in right foot. It was reported that on 3rd day after vaccination the right knee was hurting for several days and then after 3-4 days later, he could not walk due to a gout flare up in right foot. Therapeutic measure were provided for the reported events with unspecified medications. The clinical outcome right knee pain and gout flare was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.

tiredness; headache; muscle pain; chills; fever; nausea; feeling unwell; All the flu symptoms tiredness, headache, musclepain, chills, fever, nausea, feelingunwell; injection site pain; This is a spontaneous report received from a non-contactable consumer, the patient. A 27-years-old male patient of received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the right arm on 23Mar2021 at 08:00 AM (at the age of 27-years-old) as a single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications was not reported. Prior to the vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient was not allergic to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 24Mar2021, at 02:00 AM, It was reported that the patient experienced all the flu symptoms, injection site pain, tiredness, headache, muscle pain, chills, fever, nausea, feeling unwell. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient received ibuprofen (MANUFACTURER UNKNOWN) and icepack/heated pack as a treatment measure for the reported events. The clinical outcome of flu symptoms and vaccination site pain, tiredness, headache, muscle pain, chills, fever, nausea and feeling unwell was recovering at the time of report. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Long lasting headache, migraine, vertigo, nauseous, unable to concentrate, brain fog, insomnia, stiff neck, head sinus. Has been ongoing for 2 weeks

Very brief period of nausea; Slight drowsiness lingering; Soreness in arm on side that received injection; Soreness in shoulder; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 28Mar2021 at 12:00 (at the age of 27-years-old), as a single dose for COVID-19 immunisation. Medical history was reported as none. Concomitant medications included men daily multivitamin (MANUFACTURER UNKNOWN) and daily fiber supplement (MANUFACTURER UNKNOWN); both taken for unknown indication from unknown date. The patient had no known allergies to medications, food or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 28Mar2021 at 12:15, the patient experienced very brief period of nausea, some slight drowsiness lingering to about 2-3 hours after injection and soreness in shoulder/arm on side that received injection which lasted till approximately 21 hours. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcomes of the events nausea, drowsiness pain in arm and shoulder pain was resolving at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Client received full series of Covid vaccinations, Pfizer vaccines on March 10 and the second vaccine on April 1, 2021. Client then tested positive for Covid with rapid test on 7/13/2021. Also had symptoms of Covid (chills, fever 101, nasal congestion, diarrhea, fatigue, headache, myalgia, sore throat) that started on 7/10/2021. Reported because this is a case of breakthrough Covid illness s/p full vaccination.

SARS-COV-19 Infection. Congestion, Diarrhea, Loss of taste, loss of smell, shortness of breath, fatigue, muscle aches.

Within a few minutes of receiving the Pfizer Covid vaccine the patient passed out. He fell to the floor. Person standing near said it looked like he hit his head on the sign he was next to but when he came to said his head did not hurt just his back and his arm which appeared to have carpet burn/scratch. He said he did not remember passing out only feeling nauseous. After a few more minutes he passed out once more. Firefighter checked vitals and said they were all fine. Patient declined transfer to a medical facility but did have someone come to pick him up. It was recommended to him to be checked at a medical facility but it is unknown if he did.

Heavy sweating; Muscle aches; Chills; Fatigue; Rash; Headaches; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER8733) via an unspecified route of administration in the right arm on 30Mar2021 at 18:30 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Concomitant medications within two weeks prior to COVID-19 vaccine was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021 at 21:30, the patient experienced heavy sweating, chills, fatigue, muscle aches, rash and headaches. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the events heavy sweating, chills, fatigue, muscle aches, rash and headaches were not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.

Numbing and dead arm feeling; arm discomfort; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the arm left on an unknown date in Mar2021 at 18:00 (at the age of 27-year-old) and the patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the arm left on 26Mar2021 at 18:00 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Mar2021 the patient experienced some numbing and discomfort around just the upper left arm area after the first shot, but not nearly as significant as the second shot, and it never came back like it was now (at the time of this report). After receiving the second dose, on 26Mar2021 at 18:00, the patient experienced numbing and dead arm feeling in upper left arm, extending into the armpit area and side of upper left chest area immediately, it went away after 1-2 hours and dead arm/discomfort returned 8-11 days later. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. On 22Mar2021, the patient underwent COVID-19 PCR test (nasal swab) and the result was negative. No therapeutic measures were taken as a result of the events. The clinical outcome of the event numbing and dead arm feeling and arm discomfort was not recovered at the time of report. No follow-up attempts are needed. No further information is expected.

Pfizer-BioNTech COVID-19 Vaccine EUA Fatigue 12/29 in the evening Fever 12/29 starting at 11 pm to late morning 12/30 Light nausea 12/29 from 11 pm to 3:00 am Headaches 12/29 through 12/31 Muscle aches 12/29 through 12/31 particularly lower back I rested and drank so much water and the symptoms went away on their own

Arm pain, muscle aches, headache, chills. Started with arm pain a 6 hours after shot. Developed rest of symptoms overnight.

Fever and myalgias started approximately 36hrs after administration. Fever, myalgias, headache, drenching night sweats continued for over 24hrs until approximately 72hrs post administration.

Congestion; Nostrils are really like dry inside; back was hurting; Body ache; Muscle ache; Sweats; Body fatigue; Sore in arm; This is a spontaneous report from a contactable nurse. A 28-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration on 28Dec2020 at a single dose for COVID-19 immunization. Medical history included antidepressant therapy. Concomitant medication included sertraline hydrochloride (ZOLOFT) as an antidepressant therapy. On 28Dec2020, patient was sore in her arm. On 29Dec2020, the next day patient woke up, she had body fatigue and muscle aches and had the sweats and was fine the next day. On 30Dec2020, Wednesday, the patient's back was hurting and has a body ache. And on 01Jan2021, patient stated she was like super congested. There was no back ache or anything but just has a really bad congestion and stated her nostrils were like really dry inside. Therapeutic measures were taken as a result of congestion, nostrils were like dry inside with spray nose with normal saline and the use of a humidifier. The patient recovered from the event, back pain; has not recovered from the events, congested and nostrils were like really dry; and outcome of all other events was unknown.

Muscle aches, followed by swollen lymph nodes noted in armpit of arm injected with the vaccine. Noted 2 swollen lymph nodes. Low grade fever prior to going to bed. By the morning symptoms had resolved other than swollen lymph node which remained swollen over next few days.

On the day of the vaccine, 1/7 no reaction. The typical slight sore arm on injection site but nothing odd. On the morning of 1/8 I woke up with noted chills and headache. I checked my temp and noticed 100.4* oral temp. I also had back pain, muscle pain, headaches, continued fever (improved with motrin) and chills. My left arm from my shoulder to my wrist was with noted pain/aches, improved with motrin. On the morning of 1/9 I felt much better, did not take any motrin/tylenol and without any fever/chills. Noted improvement of muscle aches in general and arm felt the same as 1/7 (much better!). Noted lymph swelling of my axillary lymph nodes with aching pain. This has not gone away at current but improved with x1 dose of motrin.

Side effects from COVID vaccine: -Chills -Joint Ache -Headache -Fever -Cough -Fatigue -Mild vertigo Occurred approximately 24 hours after vaccination, lasting at least 7 hours until asleep. Symptoms cleared entirely upon waking up the following morning.

Patient presented with myalgias, fevers, and chest pain on 1/10/21 and was found to have diffuse ST elevation and elevation troponin. He was evaluated by cardiology and diagnosed with acute myopericarditis. He was treated with NSAIDs and colchicine. He improved with this treatment and was discharged on 1/12/21 with ibuprofen and colchicine and outpatient cardiology follow up.

Symptoms of 2nd Covid vaccine lot EL 1284: numbness in feet, legs throbbing, muscle weakness in legs, overall tiredness I received my second Pfizer vaccine on 1/12/21 at 12:15 pm. After several hours, I felt weak and tired. By 7:00 pm, I had a migraine that wouldn?t go away and I had muscle ache in my feet and legs. On 1/13/21 I felt some numbness in my feet and my legs were throbbing. By 10:00 pm, both of my feet were completely numb and my legs were throbbing/radiating heat. It felt as if circulation was cut off from my feet entirely. On 1/14/21 I went into work where I?m constantly on my feet. I felt intense muscle weakness in my legs and thighs to point where I could barely stand up. I immediately went to an urgent care where they started me on an Sodium Chloride 0.9% intravenous IV solution drip. They ran blood tests and urine tests to rule out any other causes to my symptoms. All results came back negative. I was told to rest, hydrate, and recover for the next several days. If my symptoms did not subside within the next couple days, I was instructed to go to the ER for further examination.

severe joint aches/ milder joint pain; I also have had nausea without vomiting.; I have also had sinus congestion without drainage; on 17Dec2020 02:30 PM/ second dose of BNT162B2 on 07Jan2021 08:15; This is a spontaneous report from a contactable other health professional (patient). A 28-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19), via an unspecified route of administration at right arm on 07Jan2021 08:15 at single dose for COVID-19 immunization. Medical history included chronic migraine and no known allergies. The historical vaccine included the first dose of BNT162B2 on 17Dec2020 02:30 PM at right arm for COVID-19 immunization and no notable adverse effects. Concomitant medication included ibuprofen; acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN MIGRAINE) and Vitafusion men's in two weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After the second dose, the patient have experienced severe joint aches the first night, and milder joint pain since. The patient also had had nausea without vomiting. I had also had sinus congestion without drainage, all after the second round. The events onset date was 08Jan2021 01:30. No treatment received for the adverse events. The events outcome was recovering. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19. Information on the lot/batch number has been requested.

Tenderness at injection site lasting ~36 hours Noted weakness and loss in dexterity in hand Feeling of swelling in hand Pins and needles sensation in full arm and extending through fingers

According to patient, he received the COVID vaccine on 1/18 and endorsed typical vaccine symptoms (myalgias, fatigue, lymphedema on right axillary, sweats and chills). He was taking ibuprofen for prophylactic symptom relief and was able to attend work the following day. The patient stated to still endorses symptoms of the vaccine days after but did not seek medical attention because he thought the symptoms would resolve. The morning of 1/21, patient sustained constant, nonradiating chest pain located along the sternal that was moderate to severe in nature and exacerbated with deep inspiration that lasted 2 hours. Lying on the side provided minimal relief but the pain was still moderate. Nausea also accompanied the pain but the patient denied any vomiting. Patient decided to go to the ED for work-up. Patient had two further episodes of chest pain and EKG revealed diffuse ST elevations. Troponin level peaked at 3.02. He was diagnosed with myopericarditis and started on colchicine, with improvement of chest pain.

1st shot of Pfizer-BioNTech: 12/29/2020, left shoulder: marginal shoulder pain from 12/29 to 12/31, no further swellings (ek9231) 2nd shot of Pfizer-BioNTech: 01/22/2020, also left shoulder (el3247): less shoulder pain throughout; feeling that it "spreads" from injection side to left side of the neck in the following hour; on the 01/24 in the morning, palpable swollen lymph node with accompanying calor and dolor right on top of the left clavicular bone; 01/25 swelling reduced, calor and dolor mostly gone but lymph node still palpable No additional drugs taken and on a scale of 0 to 10 maybe a 2/10 causing discomfort

Myalgias, headache, subjective fever/chills, nausea. Lasting from 6 - 22:00. Took acetaminophen 325mg at 19:00, which improved symptoms.

developed itchy papule rash back of R hand 12/27/20, on 12/30/20 migrating muscle aches, weakness, fatigue, 1/1/21 itch/pink rash back R elbow and ant. knees; no resp/thrt, no GI ,improved 1/5/21 , now 75% better, tested 31st and 4th negative covid,

Severe headaches, severe abdominal pain, severe swelling and pain in glands under chin, nausea/vomiting, fever chills, hallucinations, confusion, decrease in mental acuity,abortion pain in joints and muscles.

Flu like symptoms, headache, body aches, uncontrollable shivering the night after, muscle fatigue and soreness

Pain in the back that spread to below the front right rib. Pain resulted in shortness of breath and pain on inhalation.

Intense back pain that confined me to my bed. Doctors told me to take Nsaid and my prescription muscle relaxant Flexeril.

COVID-19 Vaccine Reaction Vaccine administered: Pfizer dose 2/2 Patient reaction, action taken, & outcome: 1206 - 2nd Pfizer dose given 1212 - Syncopal w/ fall forward w/ abrasion/contusion injury to left orbital area while walking from vaccination area to observation area. Diaphoretic. Pale. Lightheaded. 1215 - placed on stretcher and brought to triage area. BP 92/55, RR 28, HR 86, SpO2 96. Gave OJ and water. 1220 - BP 94/64, RR 26, HR 90, SpO2 96 1223 - BP 115/73, RR 26, HR 96, SpO2 97 1226 - BP 121/71, RR 20, HR 96, SpO2 96. Sitting EOB. 1335 - BP 98/59, RR 22, HR 85, SpO2 95. Lightheaded again. Gave OJ and laid back down. No longer pale or diaphoretic now, but neck becoming sore. 1240 - BP 114/67, RR 20, HR 80, SpO2 97 1246 - BP 117/67, HR 77 Sitting EOB MD lead at bedside directing care throughout and d/ced patient at 1300 w/ info about concussions and after ambulation.

Was symptom free from Lyme for 2 years. Lyme symptoms flared up day after vaccine and cont in addition to chest pain and breathing difficulties. Heavy fatigue, joint pains, breathing difficulties progressing. Following up with MD this week.

Patient received the vaccine around 11 am. He hadn't been feeling well (headache, dizziness) per report and initially called in to work. He then decided to come to work and was found down in a patient bathroom during his shift on our Facility while taking care of a patient (he was a nurse aid). Patient was coded and the team and was transferred to our Facility ED. He expired 3/3 2112

Full body rash, itchy, pins and needle feeling all over the body. Some joint pain. Noticed the day after the second shot. Got progressively worse over the next day. I Saw PCP Doctor Friday and Dermatologist On Monday. The treatment has been bed rest, 4mg MethlPREDNISolone and Clobetasol 0.05%. Some of the rash is clearing up.

Sore arm at injection site; Joint pain in my knees; Tiredness and fatigue.; This is a spontaneous report from a non-contactable consumer, the patient. A 28-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number EL3247) via an unspecified route of administration, administered in Arm Left on 12Feb2021 at 11:30 (at the age of 28-years-old) as SINGLE DOSE for covid-19 immunization. Facility in which vaccine was administered was a Workplace clinic Medical history included Known allergies: Penicillin. Concomitant medication included paracetamol (TYLENOL). Historical Data includes BNT162B2 Dose 1, Lot number: EL3247, Administered on 22Jan2021 at 12:00, in the Left arm for covid-19 immunization. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 12Feb2021 at 16:00 The patient experienced sore arm at injection site, joint pain in my knees, tiredness and fatigue. The events were considered non serious. No treatment was given for the events. The clinical outcome of the events sore arm at injection site, joint pain in my knees, tiredness and fatigue were recovering. No follow up attempts are possible. No further information is expected.

Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Joint Pain-Mild, Additional Details: Patient passed out hit his head while dropping to the ground. Paramedic was called and came. He was fine after, but called a ride to get him to be on the safe side.

First 48 hours after the shot the common symptoms reported everywhere disappeared. Exactly a week later , sharp stomach pains at 3:00 am. From then on every day for 5 days having gas, bloating, stomach pains after eating. Shortly after, pain began affecting joints and spinal cord simultaneously with the stomach pain.

Significant elevation of troponin of 12; chest pain; Vaccine induced myocardial injury; headache; myalgia; fever; This is a spontaneous report from a contactable physician. A 28-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EN6205), intramuscular, administered in left arm on 24Mar2021 at 1:00 pm as single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication(s) included keppra, lamictal same dose for more than 5 years. The patient previously took bnt162b2 on 03Mar2021 for covid-19 immunization at the age of 28-year-old at 1:00 pm. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient stated 1-2 days after vaccine he developed headache, myalgia, fever, chest pain. Chest pain progressively worsened. He was presented to the hospital 3 days after onset. There was significant elevation of troponin of 12, ECG unremarkable. No prior history of hypertension/ hyperlipidemia or diabetes. On 25Mar2021, the patient was diagnosed with vaccine induced myocardial injury. Treatment for events was inpatient monitoring, Heparin infusion while awaiting results of cardiac work up. Outcome of events was recovering. Follow up attempts are needed and Information on lot/batch number was available.; Sender's Comments: Based on temporal association and profile of the product, the contributory role of the suspect product bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EN6205), to reported events is possible.

Hot flashes, fatigue(lasting 24 hours), drowsiness (slept for 18 hours the next day), lower back pain,

seizures/Convulsions; weird metal or acidic taste in my mouth; felt heavy; feel shaky; back spasms; blood pressure spiked to higher than normal levels; nauseous; weakness on my left side; pain at the injection site; pain at the injection site, my back, and neck; pain at the injection site, my back, and neck; feel super tired; This is a spontaneous report from a contactable consumer (patient). A 28-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 06Apr2021 11:15 (Batch/Lot Number: EP7533) as single dose for COVID-19 immunisation. Medical history included axenfeld reigers, bilateral congenital iris coloboma, bilateral glaucoma, hearing loss. Known allergies: peanut, albuterol, amoxicillin-pot clavulante, doxycycline, fentanyl, levosalbutamol (LEVALBUTEROL), oxycodone-acetaminophin, sedation. Concomitant medications in two weeks: cryofood (unspecific), folic acid, cyanocobalamin (B12), timolol and dorzolamide hydrochloride/timolol, all from unknown date for unknown indication. First, patient had a weird metal or acidic taste in mouth. Following that, patient felt heavy. Next, began to feel shaky having back spasms. His blood pressure spiked to higher than normal levels and started feeling shakey dropped. Patient was laid down by nursing staff and blood pressure dropped. After being laid down, patient started having seizures/convulsions, paramedics were called and patient was given midazolam hydrochloride (VERSED, anti-seizure meds) and was taken to the ER (emergency room). Once patient arrived at the ER, he felt nauseous and was given anti-nausea medication, after about 4 hours patient was released. But he was experiencing weakness on left side and pain at the injection site, back, and neck, and felt super tired. AEs onset at 11:30 of 06Apr2021. Outcome of the events was resolving. Patient had no COVID prior vaccination and had no COVID tested post vaccination.

Onset of arm heaviness 45 min after injection Mild fatigue 4 hours after injection Arm swelled x2 in size, retained small amount of fluid 24 hrs after injection Arm swelling down by half, bruising of underside of arm/armpit 48 hrs after injection Eyelids slightly blue in hue/appearing almost bruised 72 hrs after injection Days 4-6 mild to moderate fatigue, difficulty sleeping Day 7 moderate sore throat

A day after the vaccine I noticed pain in my armpit. I looked at my arm and I have roughly a golf ball sized lump in my armpit. It's pretty tender when I touch or move my arm abruptly. From what I've researched it seems like a fairly normal reaction, but I still want to report it. I've taken ibuprofen and tried icing it to help with the swelling.

Chills, injection arm ache, back ache, headache - symptoms disappeared overnight but lasted roughly 16 hours or so

Patient called two days after receiving the vaccine and state he was experiencing swelling in his legs and ankles (along with fatigue, nausea, and fever)

he had an episode which he states is similar to a TIA (transient ischemic attack); Reports experiencing something similar last may except for 'the paralysis'.; numbness, pain and tightness in his lower half of his body which was more prominently felt on his left side.; numbness, pain and tightness in his lower half of his body which was more prominently felt on his left side.; numbness, pain and tightness in his lower half of his body which was more prominently felt on his left side.; States he felt as though his knee had a tear in it- it felt it was on fire; tightness in left knee; shortness of breath; feeling foggy; headache; balance issue; coordination off; having a hard time to get a sentence out (felt like his motor skills were affected); having a hard time to get a sentence out (felt like his motor skills were affected); confusion; blurred vision; impending sense of doom; post fatigue; his energy doesnt feel up to par; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 28-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 19Apr2021 at 28 years old (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient stated that on 19Apr, he had the first shot of pfizer covid vaccine. This past sunday (25Apr2021), he had an episode which he stated was similar to a TIA (transient ischemic attack). Reported numbness, pain and tightness in his lower half of his body which was more prominently felt on his left side. Stated he felt as though his knee had a tear in it- it felt it was on fire; he experienced burning and tightness in left knee. He also reported having shortness of breath, headache, feeling foggy, balance issue, coordination off, having a hard time to get a sentence out (felt like his motor skills were affected), confusion, blurred vision and an impending sense of doom. Stated this episode persisted for 15 min and then it resolved. Currently he was experiencing a 'post fatigue' and his energy didn't feel up to par. Reported experiencing something similar last may except for 'the paralysis'. Had not followed up with his provider. Patient was scheduled for second shot of Pfizer covid vaccine on 10May, he was asking for information if he decided to delay his second shot past may 10th. He was asking for information on getting the second shot given his recent experience possibly related to the vaccine shot. Was not sure if he should get the second shot. He was asking about side effects for the second shot- if it would be worse. Asking if there were any reports of blood clots with Pfizer covid vaccine. The outcome of the events 'post fatigue' and "his energy didn't feel up to par" was unknown, of other events was recovered on 25Apr2021. Information about lot/batch number has been requested.

Pfizer-BioNTech COVID-19 Vaccine EUA Chills roughly 12 hours after administration. Resolved by the next morning Headache began 15May21 resolved 16May21 Left Hip pain from 16May21-17May21 Pain in outer left thigh 19May21 - ongoing (no redness or swelling) Fatigue: 14May-15May21

On May 13 (3 Weeks after first covid vaccine shot), I started to feel skin pain on the area above right kneecap. Then I felt nerve pain on the same side of leg. May 14 I couldn't sit down as I felt occasional lumbar pain. I even went to orthopedics and they said no trouble found. Skin pain spread through the whole body. May 15 I had second shot of pfizer, still back pain and thigh pain. Skin pain spread through whole body. May 16 I saw red spots begin to surface on the thigh. Skin pain spread through whole body. May 17 red spot became bigger I thought it was rash, pain persists. May 18 the red spots looks out of control, I scheduled the next available appointment for primary care (2days later!) May 19 Just bigger red spots every time I take off my pants. May 20 black bubbles appeared in the morning, and I got to finally go to appointment at noon, diagnosed as shingles.

3 days after 1st shot Severe joint pain (Similar to RA), muscle pain, Headaches that lasted from 4/9/21 to 5/13/21 when I was taken to the hospital where it was found I had a Venous Stroke. Multiple doses of steroid, and Tylenol until the stroke, then I don?t recall what I was given in the hospital but now I am on 80mg of staton, 81mg of aspirin, 1mg of folic acid

On days 1 and 2, I experienced normal symptoms from receiving the vaccine, fatigue, joint and head aches that lasted through the weekend and up to day 5. On day 5, I noticed unilateral lymphedema of my tonsils. On day 7, I went to an Urgent Care but didn't get much treatment. My condition worsened, I was fatigued, no appetite and thirsty. On day 8, I popped a fever of 103. On day 9, it worsened to the point that it was hard to breathe. I went to the ER on 10 and had a full array of tests. I was treated with dexamethasone and a bolus saline IV. My symptoms went away after treatment around day 14, but the lymphedema lingered for awhile longer.

On the day after my first dose, I had the following side-effects / symptoms: Strong headache, muscle aches, fatigue.; On the day after my first dose, I had the following side-effects / symptoms: Strong headache, muscle aches, fatigue.; On the day after my first dose, I had the following side-effects / symptoms: Strong headache, muscle aches, fatigue.; This is a spontaneous report received from a contactable consumer (patient), who reported for herself. A 28-year-old female patient received the first dose of Bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP7534), via unspecified route of administration in left arm on 01Apr2021 at 08:00 AM (at the age of 28 years) as single dose for covid-19 immunization. The patient medical history included asthma and allergies to penicillin and cephalosporin. 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. Concomitant medications were not reported. On 02Apr2021, (on the day following her first dose of covid vaccine), the patient experienced the side-effects / symptoms including strong headache, muscle aches and fatigue. The patient did not receive treatment for the events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered in 2021. No follow-up attempts are needed. No further information is expected.

The day after (5/14) of receiving the second Pfizer dose, I developed muscle aches, fatigue, and swinging fevers. These symptoms were resolved the next day (5/15), but that night I had an intense episode of chest pain that lasted 5-7 hours. These symptoms went away and then returned again for a second time (5/17) around 4am for around 3-4 hours, while flying back. I went to the hospital and had concerns from doctors over my ECG and raised troponin levels. I spent 2 nights in the hospital and was diagnosed with Myocarditis. This was then validated through an MRI the following day. I am now resting at home for 3 months and taking ibuprofen.

Patient went to a different Pharmacy location for his second COVID vaccine dose and reported that weakness in his left arm and pain when elevating it above his shoulder.

The following day after the second shot. I had started to get serious pain in the armpit/swollen lymph node. I have had swollen lymph nodes in the past for certain infections so theres a chance I have a predisposition to getting them, but haven't had an issue in many years. However, I reached out to a friend that works for a company and she said to report this. The deep lymph node in my left armpit is many times larger than the left and I cannot let my arm rest at its side due to the size and pain.

His eyes rolled in the back of his head , became stiff , and was shaking. It lasted approximately 1 minute. EMS was called to check out.

Within a few minutes after receiving my first COVID vaccine I started feeling lightheaded/nausea and then lost consciousness. My wife was with me during this time and stated that I lost consciousness for about a minute. My wife stated that my eyes rolled back in my head, my back arched, and I became rigid. Upon waking up my ears were muffled and my wife stated my lips were blue and my face/arms/legs were very pale in color. Both of my legs and both of my hands were also tingling upon waking up. 911 was called by my wife.

Muscle soreness in left arm; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204) via an unspecified route of administration in the left arm on 10Mar2021 at 13:00 (at the age of 28-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The concomitant medication included TYLENOL and unspecified medications for unknown indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 10Mar2021 at 19:00, the patient experienced muscle soreness in left arm for approximately 24 hours and cleared up the next day. The patient did not receive any treatment for the reported event. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of muscle soreness was resolved on 11Mar2021. No follow-up attempts are needed. No further information is expected.

I started having intermittent numbness, tingling, pain and weakness in my left arm down to my hand about a week after my second Pfizer Covid vaccination. Over several months it progressively was getting worse. I am a nurse in a hospital and after speaking with several colleagues (other nurses and doctors) about what was going on, I went to my PCP. After seeing my PCP, I was referred to a Hand to Shoulder Center. The doctor declared it as cubital tunnel syndrome in which I had an Ulnar Nerve Release Surgery on June 8th. Approximately a week and a half to two weeks after the surgery I started noticing intermittent numbness and tingling to the left side of my lips and left side of my face. Until I started having issues with my face, I didn't even consider the possible correlation with my problems and the COVID vaccines. It it just ironic that I received both vaccines in my left arm and I am having issues with my left arm and the left side of my face. I am still having numbness, tingling and some weakness to my left arm as well as the intermittent numbness and tingling to the left side of my face. Now I was advised by the surgeon that it could take up to a couple of months for my issues with my arm to resolve but when I contacted my PCP regarding an update on my arm as well as to inform her about the concerns with my face, and questioning the possible correlation with the COVID vaccines, she advised me to file a report through VAERS.

lost consciousness; Lightheadedness; Nausea; She stated that my eyes rolled to the back of my head, my back arched, and I became rigid; She stated that my eyes rolled to the back of my head, my back arched, and I became rigid; She stated that my eyes rolled to the back of my head, my back arched, and I became rigid; Face/arms/legs were pale in color; My lips were blue; My hearing was muffled; Tingling in both of my legs and hands; Mouth was also extremely dry; This is a spontaneous report received from a contactable consumer or other non hcp. A 28-year-old male patient received bnt162b2 (COMINARTY, Solution for injection, Batch/Lot number was not reported), intramuscular, administered in arm left on 19Jun2021 17:15 as dose 1, single for covid-19 immunization. Medical history included cat hair allergy. Concomitant medications included probiotics (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at unknown dose and frequency for unknown indication; ascorbic acid (VIT C) (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at unknown dose and frequency for unknown indication; ergocalciferol (VIT D) (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at unknown dose and frequency for unknown indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with covid-19, prior to vaccination and not has been tested for covid-19 since the vaccination. On 19Jun2021 17:15, the patient experienced lost consciousness, lightheadedness and nausea, Patient stated that his eyes rolled to the back of his head, back arched, and it became rigid, face/arms/legs were pale in color, lips were blue, my hearing was muffled, tingling in both of my legs and hands, mouth was also extremely dry. Therapeutic measures were taken as a result of lost consciousness, lightheadedness and nausea, Patient stated that his eyes rolled to the back of his head, back arched, and it became rigid, face/arms/legs were pale in color, lips were blue, my hearing was muffled, tingling in both of my legs and hands, mouth was also extremely dry. The outcome of the events was recovering. Information on the lot/batch has been requested.

about a week after my shot, I started having heart palpitations and fainting spells. It feels like my heart is substantially weaker and its not improving.

After receiving the vaccine, I started feeling hyperaware. For example, my wife smokes but not around me and for the first time, I could smell cigarettes in the car. Also, my dog who is rather clean, I could smell which is not usual. I had back pain. My tongue felt tingly and numb, my blood pressure was at around 150, my heart rate was at around 116. This persisted for about 30 mins or so. I was sent to the ER and was there for about 6 hours. Since the vaccine, I could be doing nothing, and I?d have random bouts of extremely high heart rate. For about a month after the vaccine I had trouble doing even the most mundane tasks. I was first put on metoprolol for about 2 weeks. I was put on a Holter monitor so I had to stop taking it. I was then switched to atenolol which has helped since. After the vaccine, I was going to the bathroom once every 4 days which was unusual for me. It was also yellow which was abnormal for me. I also lost about 20 lbs in this time frame which my doctor credited due to the elevated heart rate. I had to take time off from work because walking from my car to my office was exhausting for me. I was on atenolol which definitely helped but my doctor suggests that I take half a pill. Taking half a pill does not help with the heart rate compared to the original dosage. My most recent episode of elevated heart rate was about 3 weeks ago. I am also on omeprazole which I am not certain if it is helpful. I also am experiencing random muscle pains on the left side of my body. My doctor also credits some of these symptoms to anxiety which I have never experienced before. Essentially, for the first 1-2 months, my heart rate was extremely high but after the atenolol, it has returned to normal. In the ambulance the paramedic noted that when I was lying still my heart rate was normal but when I would move or talk my heart rate would jump up. Also, just to note, after receiving my vaccine I interacted with my cousin who I later found out had COVID.

Patient was given vaccine and less than 5 minutes later patient fell limp into chair, unconscious for less than 10 seconds with his eyes rolled back in his head. While attempting to lay patient on the floor he woke up extremely confused and tried to run away. When he came to, we sat him down and placed him into a seated position with his head down. Temperature was normal however patient appeared very pale and proceeded to vomit. Patient was able to answer his full name, age, and knew where he was. Patient asked us to call emergency services who came promptly. Patient did not leave with emergency services and proceeded to leave the pharmacy, stating that he felt better.

The patient was given the first dose of Pfizer COVID-19 vaccine and was instructed to wait in the waiting area for 15 minutes. After waiting for about 15 minutes, he tried to exit the waiting area, but ended up collapsing. When I went out to examine him, his eyes were open and he was breathing normally, but he was not immediately responsive. I had to ask him if he was OK several times before I was able to get an answer. He appeared to be disoriented, but otherwise appeared fine. My technician helped him to a chair. He was coming in and out of non-responsive/limp state several times before he asked us for a glass of water. I had contacted 911. They came in and examined him. One of the paramedics told me that he appeared to be fine, but they were going to take him to ER. The patient walked to the stretcher outside the pharmacy.

Sore neck; dizziness; pins and needles feeling while standing; Pressure feeling behind eyes; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old male patient received his second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 02Apr2021 at 14:15 (at the age of 28-year-old) as a single dose for COVID-19 immunisation. Medical history included epilepsy and COVID-19. Concomitant medications included valproate semisodium (DEPAKOTE ER) from an unknown date, for an unknown indication. The patient previously took Lamictal and experienced allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 11Mar2021 (at the age of 28-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was diagnosed with COVID-19 on an unknown date. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021 at 03:00 the patient experienced sore neck, dizziness, pins and needles feeling while standing and pressure feeling behind eyes. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events of sore neck, dizziness, pins and needles feeling while standing and pressure feeling behind eyes was recovering at the time of the report. No follow-up attempts are needed. No further information is expected.

left sided weakness; it has weakened his heart; stutter; severe stroke like symptoms; Ventricular tachycardia/help keep his heart rate at bay; Loss of balance; extreme numbness and tingling in left hand and foot; tingling in left hand and foot; oral motor impairment; mouth weakness and not coordinated/mouth is fatigued easily; Issues finding words and trouble speaking; Issues finding words and trouble speaking; Ejection fraction down to 25%; The initial case was missing the following minimum criteria: adverse event. Upon receipt of follow-up information on 28Dec2020, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable other healthcare professional (HCP). A 29-years-old male patient received bnt162b2 (lot number: EJ1685), intramuscular (deltoid left) on 21Dec2020 at 05:30 at 0.3 mL single (first dose) for Covid. Medical history was reported as "none". Concomitant medications were not reported. The patient previously received Flu vaccine in Oct2020 for immunization. The patient is an Occupational Therapist, and he called to report an adverse event that he experienced with the first dose of the COVID Vaccine. He received the vaccine last Monday, 21Dec2020 at 5:30AM before his shift at work, then 20 minutes later, he was having severe stroke like symptoms. He experienced severe left sided weakness, loss of balance, extreme numbness and tingling in his left hand and foot, he had issues finding his words and he couldn't speak, and he had an oral motor impairment where his mouth was weak and not coordinated. The staff at the hospital did a neurological exam on him, and he failed, so he had to go to the emergency room (ER). The patient added that he was already in the hospital when this happened, and the ER doctors suspected that he had a CVA, and they gave him TPA to prevent any permanent brain damage and it worked. The patient then added that due to the shock of this whole event, from everything that happened, it has weakened his heart. Reportedly, he is a healthy 29 year old man, with no preexisting conditions, and he works out, and he has no heart conditions, but he had to get a cardiology follow up a few days after he got the vaccine, because he started going in to Ventricular Tachycardia, which he had never had in his life. So, the doctors at the hospital went ahead and did an Echocardiogram and an EKG, and he was told that his Ejection Fraction is down to 25%. He stated his heart is so weak, that he cannot work right now, but the structure of his heart is fine and has not had any damage. The hospital staff thought that maybe the patient had a chronic heart issue that he just did not know about, and that the stress of this event maybe made it kick into overdrive, but he states that the cardiologist said that was not the case, because the structure of his heart is fine, and the only thing they can see is that the heart is pumping weak. One physician even suggested that due to the shock of the event, he might have Takotsubo Cardiomyopathy, which is a broken heart, but because the structure of his heart is okay, it should be reversible. He stated that he is hoping he will heal up good, because he is young and has no pre-existing conditions. He added that his heart is in such a state right now; he has to wear an external defibrillator. The patient stated that all these happened about 20 minutes after he received the vaccine, and he was admitted to the hospital from 21Dec2020 to 25Dec2020. His neurological symptoms have resolved except that he has a stutter that he did not have before and his mouth is fatigued easily, so he has to slow down when he is eating, but now he can eat regular for the most part. The patient confirmed that he was not specifically prescribed the product; it was administered to him at his place of work, but it was optional. He stated he considered how he is working with COVID patients every day, and given the circumstance, he thought that it would be a best practice for him to get the vaccine. He had not gone to his primary care doctor in a while because he had been fine and healthy, but he called them and found out that his primary care had retired, so he has to find a new one now. Regarding the issues finding words and trouble speaking, he stated that he has improved, but it is still ongoing, he is just stuck in a plateau zone. With the Ventricular Tachycardia, he stated that this is an ongoing issue, as he has to wear the life vest even though he has no need to activate it yet. He did have one minor bought of the VTach, but because he is a therapist, he knows how to take care of it with relaxation techniques, he knows how to manage it. He had one bought of VTach the evening prior, but he was able to get it under control. The doctors have him on medication to help keep his heart rate at bay. He has never had to use medication before and is on the following medications to help keep his heart rate at bay: Metoprolol 25mg one tablet once daily by mouth and Lisinopril 5mg one tablet once daily by mouth. The VTach has improved, it was good enough he was able to discharge home, but it is still a concern. His cardiologist said that, basically his hope, is that once his body recover from the whole shock of everything, then his ejection fraction will heal, and his heart will heal. He again stated that the doctor told him that the structure of his heart is perfectly fine; he has thick walls in his heart, no leaking valves, and the heart was not conducting any abnormal signals. The doctor just said that right now, his heart is super weak and that it is an acute problem. With the Takotsubo Cardiomyopathy, he states that two doctors mentioned this diagnosis, but he confirmed that he was not actually diagnosed with this issue, he was just diagnosed with Ventricular Tachycardia. The outcome of the ejection fraction down to 25% was unknown to the patient at this time as he has not had another EKG or echocardiogram, but the cardiologist told him that the cardiologist expects that this will not be resolved quickly anyway. The patient confirmed that he did not receive any other vaccines on the same day he received the COVID vaccine. The only other vaccine he had this year was the flu vaccine which he got back in Oct2020. He has gone on to his online portal and there are the bloodwork results and all the imaging results on there from his CTs and MRIs, but he did not see the EKG or Echocardiogram results yet. He does not have this pulled up at this time, but he does have access to this stuff and can provide it later, if requested. He is curious about the next steps from here to how his case is processed. He is also curious if this information would help Pfizer make modifications to the vaccine if it is found that a lot of people are having the same reaction as he did. He is also wondering, given his situation, that probably he is not going to get the second dose, for his safety, but he is wondering what percentage of effectiveness the first dose does having just covered. The events left sided weakness, loss of balance, extreme numbness and tingling in left hand and foot resolved on 25Dec2020; severe stroke like symptoms and oral motor impairment; mouth weakness and not coordinated/mouth is fatigued easily resolved in 2020. The events ventricular tachycardia/help keep his heart rate at bay and issues finding words and trouble speaking were resolving, stutter had not resolved while the outcome of the events it has weakened his heart, and ejection fraction down to 25% was unknown.; Sender's Comments: The reported information is unclear and does not allowa meaningful assessment of the case. It will be reassessed upon receipt of follow up information. 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.

Fatigue, Myalgia, Fever - Began in the morning. Fever was relieved with 1000mg Acetamenophen. By the evening, I was started to feel relief from my symptoms. By the next day, I had complete resolution of my symptoms.

Pain and soreness at injection site beginning 5 hours post injection. At 3am on Jan 5th intense chills/sensitivity to temperature, coughing, waves of nausea, headache, and significant joint paint in arms, hands, and knees. Symptoms persisted until roughly 3pm that same day.

Normal after the inj. 8 hours later, arm pain, fatigue. Next day at noon, felt anxious, heart rate 140's, extreme back pain, tachycardia. Lasted 12 hours 140 at rest. Movement 160 rate. Had chest pain. High fever 102-103.

Cervical and clavicular lymphadenopathy on the left side; Some tenderness in neck; This is a spontaneous report from a contactable physician (patient). A 29-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration in left arm, on 17Dec2020 at 11:45, at a single dose, for COVID-19 immunization. The patient had no medical history and no concomitant medications. The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in the hospital. On 27Dec2020, the patient experienced cervical and clavicular lymphadenopathy on the left side (same side as the vaccine shot was received). The patient first noticed some tenderness in neck about 10 days after vaccine was administered. The events were considered non-serious. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The patient had not recovered from the events. Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.

At 12:05am ( about 12 hours after vaccination) I developed severe (worst ever) chills and rigors. Temp was 101.7. I also had moderate nausea for which I took ondansetron. After taking 1000mg Tylenol my temp dropped to 98.4 but then peaked to 100.8 after 6 hours and taking 1000mg Tylenol followed by another fever 6 hours later and a fever of 100.9. I continue to be febrile after 3g Tylenol. I also continue to have dizziness, joint pain, myalgias, and headache.

Chills started around 4AM while sleeping. Joint pain, malaise, headache, and localize pain at site of injection upon palpation upon awakening and still continues at the time of this writing (27 hours post-inoculation). No fever noted (99.3 F at 8AM). ONE Acetaminophen ER 650 mg TABLET was taken at 1PM.

Headache, Myalgia, Then he had lower right body soreness, then 12/29 myalgias and chills; all resolved on day 3 except for headache.

12 hours after second dose of Pfizer vaccine, I began to experience muscle aches that grew in severity over the next 8 hours. I also developed a fever and headache with bilateral eye pain and pressure. I was unable to sleep due to the pain as it was quite severe.

Received around 7-8pm on 12/22. Woke up 12/23 feeling okay, just L arm soreness however as day went on progressively worsening chills, myalgias, malaise, headache, and extreme weakness/fatigue. Lasted 24-48 hours, peaking around 24-36 hours. Necessitated sick call out from work. Of note I had Covid in March and had antibodies prior to vaccination.

Syncopal event following vaccination including head trauma, followed by fevers, rigors, myalgias and tachycardia and dehydration requiring ER visit with administration of IV fluids

Dose 1 (12/16/20 9:30 am): L arm pain, malaise, fatigue, myalgias lasting 48 hours Dose 2 (1/06/21 9:30am): L arm pain, malaise, fatigue, myalgias, severe rigors starting at 2am and lasting 3 hours

Muscle ache; fever; This is a spontaneous report from a contactable consumer (parent). A 29-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported), via an unspecified route of administration on 08Jan2021 at a single dose for COVID-19 immunization in a hospital. Medical history included patient was positive for COVID-19 from Sep2020 to an unknown date. The patient's concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported) on an unspecified date. It was unknown if the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 08Jan2021, the patient experienced muscle ache and fever. The patient was given ibuprofen as treatment for the events. The patient underwent lab test which included COVID-19 test: positive in Sep2020. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on an unspecified date in Jan2021. Information on the lot/batch number has been requested.

I had a sore throat that felt like it was closing off, muscle aches, pains. Received Dose 2 on 01/12/2021.

chills, fatigue, muscle/body aches, no appetite (general flu like symptoms); symptoms lasted for about 10-12 hours

Fever, chills, night sweats, muscle aches, joint aches all started approximately 14 hours after the vaccine (2100, 1/17,2021) and continued for approximately 6 hours (0300). Joint and muscle aches and pains however continued for approximately 24 hours (until 2100, 1/18/2021). Treatment was acetaminophen 1000mg q6-8h with little to no relief of symptoms.

At midnight 1/17/2021I developed severe muscle aches, shivering, chills, and a temperature of 100 F. The pain in my left arm was so severe I could barely move it. This all persisted to the morning of 1/18/2021 after which it resolved. I was unable to sleep at all the nights of 1/16/2021 or 1/18/2021.

Beginning 1/17/2021 at midnight I developed shivering, chills, a temperature of 100 F, and severe muscle aches. My left arm was so painful I could barely move it. This persisted until the morning of 1/18/2021 and resolved. I also could not sleep at all the nights of 1/16/2021 or 1/18/2021.

fever of 101.7; chills/ rigors; nausea; headache; arthralgias; myalgias; severe dizziness; This is a spontaneous report from a contactable physician. A 29-year-old male patient received the second dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL1284), via an unspecified route of administration in the left arm on 08Jan2021 at 29-years-old at 12:15 at a single dose for COVID-19 immunization in a workplace clinic. Medical history included Seasonal allergies from an unknown date and unknown if ongoing. The patient previously received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) for COVID-19 immunization on an unknown date (first dose-Lot Number: EK5730; Vaccine location: Left Arm; Administration time: 12:30). Concomitant medications included fluticasone propionate (FLONASE) taken for an unspecified indication from an unspecified date to an unspecified date; within two weeks of the vaccine. On 09Jan2021 00:30, the patient experienced: fever of 101.7, chills/ rigors, nausea, headache, arthralgias, myalgias, severe dizziness. The clinical course was reported as follows: The patient woke up after midnight with a fever of 101.7, chills/ rigors, nausea, headache, arthralgias, myalgias, and severe dizziness. The patient continued to have fevers, and his last temperature of 100.8 (taken about 36 hours post vaccination). The patient also continued to have a significant headache and dizziness. These symptoms had caused the patient to call out sick for 09Dec and tomorrow 10Dec (as reported). The patient underwent lab tests and procedures which included body temperature: 100.8 on an unknown date, body temperature: 101.7 on 09Jan2021. Therapeutic measures were taken as a result of fever of 101.7, chills/ rigors, nausea, headache, arthralgias, myalgias, severe dizziness; which included: 4g paracetamol (TYLENOL) (1g every 6 hours (Q6)) 800 mg ibuprofen, and ondansetron (ZOFRAN). The patient did not have COVID prior to vaccination; and was not tested for COVID post vaccination. The clinical outcome of the events was recovering.

Headache Chills Nausea Joint paint Muscle pain This all occurred in the early morning after the day of vaccination at approx 2am. Woke up freezing with body aches.

That same type of swelling happened the following day directly at the injection site with minor muscle and joint pain and fatigue. Heat pad applied to lower the swelling./Left forearm swelling; joint pain; minor muscle and joint pain; Fatigue; This is a spontaneous report from a contactable nurse (patient). A 29-year-old male patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on right arm on 12Jan2021 at 15:45 at single dose for COVID-19 immunization. Medical history included shellfish allergy. There were no concomitant medications. The patient previously received his first dose of BNT162B2 intramuscularly on left arm on 22Dec2020 at 09:00 AM for COVID-19 immunization, two weeks later a mass grew within the muscle at the forearm region. No ecchymosis with minor pain. Heat pad applied to lower the swelling. After the second shot on unknown date in Jan2021, same type of swelling happened the following day directly at the injection site with minor muscle and joint pain and fatigue. Heat pad applied to lower the swelling. There has been significant relief with just rest and applications of heat to both locations. Left forearm swelling is almost completely gone. The outcome of event vaccination site swelling was recovered on unknown date in Jan2021. The outcome of rest events was unknown. Information on the Lot/Batch number has been requested.

He woke up twice. He initially woke up at 5 am on (14Jan2021) and that is when he experienced his legs are actually numb. He also woke up sweating; He woke up twice. He initially woke up at 5 am on (14Jan2021) and that is when he experienced his legs are actually numb. He also woke up sweating; He woke up twice. He initially woke up at 5 am on (14Jan2021) and that is when he experienced his legs are actually numb. He also woke up sweating; he fell flat on the floor; felt really tired; arm feels like it was punched by a gorilla/his arm was sore/muscle sore; arm feels like it was punched by a gorilla/his arm was sore/muscle sore; He couldn't hardly move it sore; tingling, kind of like ants crawling up his leg; This is a spontaneous from a contactable consumer (patient). A 29-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1283), via intramuscular route of administration on 13Jan2021 at 19:05 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took Hepatitis B vaccine that is supposed to last for 10 years (which was administered for about three years ago) and flu vaccine. On 13Jan2021, patient received the vaccine and felt really tired, his arm feels like it was punched by a gorilla, it was sore. He couldn't hardly move it sore, like a muscle sore, so he went to bed. His arm was really, really sore, he's just kind of avoided using his arm. He woke up twice. He initially woke up at 5 am on (14Jan2021) and that is when he experienced his legs are actually numb. He also woke up sweating. He didn't know his legs were numb until he literally got out of bed, and he fell flat on the floor because he could not feel them. He went to bed again and woke up at 7:20. On an unspecified date in Jan2021, he feels the tingling, kind of like ants crawling up his leg. It's not as bad as it was, it's like a feeling one gets when sitting on top of your legs. He wanted to know could these be side effects of the vaccine. The patient took Advil for arm feels like it was punched by a gorilla/his arm was sore/muscle sore. The patient underwent lab test which included COVID-19 PCR test with negative result on 10Jan2021. The outcome of the events arm feels like it was punched by a gorilla/his arm was sore/muscle sore, he couldn't hardly move it sore, numbness in leg was not recovered; sweating was recovered on an unspecified date, while unknown for the other events.

General body aches, compressed feeling. chills, second day big headache , cold and hot feeling , pain in lower neck and spine, today minor headache and tired. sore arm all days.

12hr after second dose: increased pain at injection site, but no swelling or redness; headache; Discomfort is a 6/10; gradual onset of soreness raidiating from lymphnodes in neck; gradual onset of soreness in chest/ soreness in bronchi; gradual onset of soreness in back; gradual onset of soreness in hips; gradual onset of soreness in legs; gradual onset of soreness in glutes; soreness in upper lungs; soreness in upper respiratory system; This is a spontaneous report from a non-contactable consumer. A 29-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL3247), via an unspecified route of administration on the left arm from 18Jan2021 at a SINGLE DOSE for covid-19 immunisation. Medical history included major depression, anxiety; increased airway sensitivity due to being former smoker from an unknown date and unknown if ongoing. Concomitant medication included vilazodone hydrochloride (VIIBRYD), loratadine (LORATADINE), theanine (THEANINE). The patient previously received the first dose on 28Dec2020 (Lot number=EK3730). There were no noticable effects after the first dose but 12hrs after second dose (19Jan2021), the patient experienced increased pain at injection site, but no swelling or redness. There was gradual onset of soreness raidiating from lymphnodes in neck, chest, back, hips/glutes, and legs; headache; soreness in upper lungs/bronchii (they are hypersensitive and usually sometimes get sore in reaction to irritants in the air), as well as upper respiratory system, but no difficulty breathing. Discomfort was at 6/10 on 19Jan2021. The outcome of the events was not recovered.

Pain on arm of injection; fatigue; chills; fever; muscle aches; This is a spontaneous report from a contactable other health professional (patient). A 29-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), intramuscular (left arm) on 19Jan2021 17:30 at single dose for Covid-19 immunization. The patient's medical history was reported as none. The patient's concomitant medications were not reported. 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 experienced pain on arm of injection, fatigue, chills, fever, and muscle aches on 20Jan2021 (07:00 AM). There was no treatment received for the adverse events. The outcome of events was not recovered. The patient has not been tested for COVID-19 since the vaccination. This case is non-serious. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.

Approx. 8 hours following injection, on Friday, 2/5 at 3:45 p.m., began experiencing the following symptoms: low grade fever (99.1 F); Left arm numbness and pain from deltoid to fingers; severe joint pain in L thumb, Index, and middle fingers; headache; chills; systemic muscular weakness; dizziness/nausea; extreme fatigue. Symptoms began to abate on Sunday 2/7 at approx. 8 p.m., and had completely abated by Monday 2/8 at 6 a.m.

slight left armpit swelling and pain; slight left armpit swelling and pain; chills and slight aches 12 hours after 2nd injection; chills and slight aches 12 hours after 2nd injection; This is a spontaneous report from a contactable nurse (patient). A 29-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiry date not reported), via an unspecified route of administration in the left arm on 24Jan2021 at single dose for COVID-19 immunization. Medical history was not reported. Concomitant medications were none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. 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 had no allergies to medications, food, or other products. The patient previously received first dose of bnt162b2 (lot number: EK5730, expiry date not reported), intramuscular in the left arm on 04Jan2021 07:45 AM at single dose for COVID-19 immunization. On 24Jan2021 22:30, the patient experienced chills and slight aches 12 hours after 2nd injection. On 25Jan2021, 24 hours after 2nd injection, the patient experienced slight left armpit swelling and pain. No treatment was received for the adverse events. Clinical outcome of the events was not recovered.

Within 5 minutes following administration: - Paresthesia and pain in left upper extremity extending from shoulder to hand Within 48 hours following administration: - Progressive pain in left upper extremity - Greatly reduced range of motion in left upper extremity - Inability to bear any weight in left upper extremity - Large ecchymotic lesion at head of left humerus After 48 hours to current presentation: - Pain in the left proximal arm, left shoulder, left upper back, and left neck extending to the occiput - Painful spasticity in the left proximal arm, left shoulder, left upper back, and left neck extending to the occiput - Pain-restricted impaired range of motion of the neck including flexion, extension, lateral rotation, medial rotation, and lateral bending - Pain restricted impaired range of motion of the left upper arm including flexion, extension, lateral rotation, medial rotation, and abduction - Painful left-sided dysphagia at the level of the cricoid cartilage - Use of left arm impaired versus baseline with no signs of improvement

syncope; pleurisy; difficulty breathing; Flu-like symptoms; fever; chills; muscle and joint aches; muscle and joint aches; persistent headache; This is a spontaneous report from a contactable health care professional (patient). A 29-year-old male patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EK4176) in the hospital, via intramuscular route on 10Feb2021 at 10:30 at a single dose on the right arm for COVID-19 immunization. Medical history included Non-Hodgkin's lymphoma from 2010 to 2011 and allergies to penicillin on an unknown date and unknown if ongoing. Prior to vaccination, was the patient not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient received the first dose of BNT162B2 (lot number: H9899) in the hospital, via intramuscular route at 01:15 PM on the left arm for COVID-19 immunization. Since the vaccination the patient has not been tested for COVID-19. It was reported that on 12Feb2021 at 08:00 PM (also reported as '3 days after injection') the patient experienced flu-like symptoms that included fever, chills, muscle and joint aches, and a persistent headache. On 13Feb2021 (also reported as 'on the 4th day', the patient developed pleurisy and difficulty breathing and had 2 syncope events the morning of 14Feb2021 (also reported as 'on the 5th day'). The patient was taken by ambulance and admitted to ER for further testing. It was determined that all symptoms likely related to the second dose of the COVID-19 vaccine recently received. Pleurisy persists one week following vaccine dose. The patient went to the emergency room/department or urgent care due to the events. As treatment for the event, the patient was monitored and given IV fluids over 12 hour stay in CDU. The outcome of the events was recovered with sequelae (reported as recovered with lasting effects). The events were reported as non-serious.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events due to temporal relationship and current known drug safety profile. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

chills; fever initially 100.6F/Fever returned at 101.1F by about 5pm; aches (injection site); aches (spine); aches (occiput); aches ( hips, knees); This is a spontaneous report from a contactable other healthcare professional (patient). A 29-year-old male patient received 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration in left arm on 13Feb2021 14:30 at single dose for COVID-19 immunisation . The patient medical history was not reported. No allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient previously received 1st dose of BNT162B2 in left arm on 23Jan2021 at 12:30 for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Beginning approx 11 hours post (14Feb2021 01:00) was chills, aches (spine, occiput, hips, knees, injection site), and fever initially 100.6F. Fever reduced acetaminophen over time. Aches continued. Fever returned at 101.1F by about 5pm day after shot. The patient underwent lab tests and procedures which included body temperature: 100.6 fahrenheit (fever initially) on 14Feb2021, body temperature: 101.1 fahrenheit by about 5pm day after shot on 14Feb2021. Treatment received for the adverse event included acetaminophen, water, rest The outcome of events aches (spine, occiput, hips, knees, injection site) was not recovered, the outcome of other events was recovered on an unspecified date of Feb2021. This case was reported as 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. No further information is expected.

Symptoms: extreme muscle pain, tenderness, visible swelling of muscles, headache, fatigue, lower back pain, joint pain, scrotal swelling

fever; fatigue; headache; muscle pain; thirst; insomnia; This is a spontaneous report from a non-contactable other health professional (HCP) reported for himself. A 29-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3247), via an unspecified route of administration in the right arm on 16Feb2021 at single dose for COVID-19 immunization. The relevant medical history included covid-19 (if covid prior vaccination: Yes) from an unspecified date. Concomitant medications included chondroitin sulfate, glucosamine hydrochloride (OSTEO BI-FLEX). The patient previously received first dose of BNT162B2 at the age of 28 years old on 27Jan2021 for COVID-19 immunization (lot number: EL3247, vaccine location: Right arm). The patient experienced fever, fatigue, headache, muscle pain, thirst, severe enough to cause insomnia and interfere with work on 16Feb2021. No treatment was received for the events. The seriousness was reported as non-serious. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.

headache; fatigue; muscle aches; This is a spontaneous report received from contactable consumer, the mother of the patient. A 29-year-old adult male received the second dose of BNT162b2 (solution for injection; Lot EN6200 expiry not provided) as a single dose via unspecified route on 19Feb2021 (at the age of 29-years-old) for COVID-19 immunisation. The patient had no medical history. There were no concomitant medications reported. The patient previously received COVID-19 immunisation with BNT162b2 (first dose; Lot EL9262 expiry information not provided) on 29Jan2021 (at the age of 29-years-old). The consumer reported that the patient had not received any other vaccinations within four weeks prior to the COVID vaccine. The consumer also reported that the patient had no known allergies and was not diagnosed with COVID prior to the vaccination. On 20Feb2021 after his second injection, the patient experienced a headache, fatigue and muscle aches. There was no laboratory testing reported. There was no treatment received for the events. The outcome of the events, headache, fatigue and muscle aches was recovered on 21Feb2021.

Extreme joint aches - my wrist and my ankle - mainly: Extreme tendonitis feeling. Nothing I normally experience. Felt extremely inflamed - I couldn't do push ups. My right ankle swelled up pretty extreme. I had not been running or anything. Sometimes it would hurt my foot, and another day my right wrist would bother me and then the next day the other wrist. My knees bothered me a little bit too. It was an achy, dull pain. My knees sometimes bother me anyway but this was a bit different. I called my PCM - she told me that I could take Motrin or Ibuprofen - and use cold compress or apply heat. My ankle was just one night and it went away the next day. My wrists bothered me for about a full week or so. That was pretty hindering - I couldn't pick up my children. For the first dose - I had an extreme level of fatigue for about 24 hours - the first 48 hours after vaccine. I felt bodily and mentally tired. I stayed in bed and hydrated for two straight days. The second vaccine I had no reaction.

Injection site tenderness, pain, and bleeding; headache, sweating, chills, full-body muscle and joint aches, lethargy, malaise, runny/stuffy nose. Started a couple hours after the dose and continued for two days after.

Immediately after injection, patient got pale and slid down in his chair. Health staff eased him to the ground and he came to in about 30 seconds. He was brought into clinic in a gurney and initially exhibited orthostatic hypotension. After he was given electrolytes and water, he felt much better. He was observed for about an hour and bp was stable so he was released.

Starting the morning after the 2nd shot I began to experience the following... 1. Chills (mild) 2. Muscle Aches (mild) 3. Fatigue (moderate) 4. Arm soreness at injection site (mild-moderate) 5. Dizziness (mild-moderate) 6. Vertigo mild 1-4 had alleviated by the morning of the 12th, however the dizziness has remained, and can be bad enough at times I worry about falling over, turning head rapidly or just standing up or moving quickly can make it happen.

I woke up the next morning feeling run down. Tired, sore, aches and pains. It?s gotten progressively worse everyday since then. Start 4/11 I woke up with horrible hip pain, it?s only gotten worse since then. It?s very painful and the worse of all my symptoms

At around 11 pm the night of getting the vaccine in the morning, I began to feel fatigued, achy, and chills. I went to bed soon after, and started to have a headache. Had trouble sleeping the whole night because of the pain, when I woke up at 6 am all symptoms were worse. These symptoms continued throughout the morning, after a couple hours a new symptom started: a pain in my left armpit and the left pectoral (just part of it closest to the armpit). I was vaccinated in the left arm. This pain grew in intensity. By 11 pm on 4/16 (when I?m filling this out), the armpit pain is sharp. The other symptoms have subsided a bit (headache, chills, aches and fatigue).

Nausea beginning about 6 days after vaccine; repeated vomiting and, for 10 hours, inability to retain even small amount of any fluid without vomiting; vomiting occurred one more time 30 hours after onset after eating small amount of chicken soup; night sweats, chills, and joint pain accompanied vomiting; night sweats and joint pain remain to date, approximately 4 days after onset of symptoms; no diarrhea. Vomiting was far worse than ever experienced in memory, except possibly when having a stomach bug as a child.

Loss of hearing in left ear; Dizziness more than 24 hours after; loud tinnitus; Deep pain in left side upper abdomen/ lower ribcage.; Deep pain in left side upper abdomen/ lower ribcage.; This is a spontaneous report from a contactable consumer (patient). A 29-year-old male consumer received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 16Apr2021 at 14:15 at single dose in left arm for COVID-19 immunisation at the age of 29-year-old. Medical history and concomitant medications were unknown. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 24Mar2021 at 13:00 in left arm for COVID-19 immunisation at the age of 29-year-old. On 17Apr2021 at 16:00, the patient experienced loss of hearing in left ear, loud tinnitus, deep pain in left side upper abdomen/ lower ribcage, dizziness (also reported as more than 24 hours after). The patient was no treated due to the events. On 19Apr2021, nasal swab resulted negative. The patient did not recover from the events. Prior to vaccination, the patient was not diagnosed with COVID-19; since the vaccination, the patient has not been tested for COVID-19. Information on the lot/batch number has been requested.

Fatigue, chills, fever, muscle soreness, and joint pain all over for 24 hours, starting 24 hours after second injection. Laying down was painful due to serve joint and muscle pain in my neck and arms in the last 8 hours. I sat or stood to relieve the neck pain. I took 2 ibuprofen at 9am Saturday to help with the pain. I had fully recovered by 1pm Saturday, the 8th.

I began experiencing chest tightness/pain (initially concentrated on left side) some hours after receiving the vaccine. Two days later, I visited the hospital and all heart/blood tests appeared OK. It is now a week out and chest discomfort continues?it has manifested itself in other parts of my chest as well and is more present at certain times than others (e.g. when taking a deep breath). Minor shortness of breath. My primary care provider advises it may be costochondritis. Note: I had COVID-19 in late March.

Normal side effects (Fever, Chills, Fatigue, Body/Joint Aches, Headache) all on 5/20 only Persistent Cough and Chest Pressure accompanied with Difficulty Breathing started on 5/21 and is ongoing

Foot and ankle inflammation and swelling. It started out with my left foot/ankle but it is now impacting my right foot/ankle also. Currently, it has gotten to the point where I essentially can?t walk. I am having similar symptoms with my knees and right index finger but they are not as severe and not as debilitating. I am currently waiting for an appointment with a rheumatologist.

After a few hours of receiving the vaccine, I could start to feel soreness in my left armpit (lymphnode). This moved to all of left arm even all left side of body. Began feeling very tired. Less than 12 hrs after receiving 2nd dose I had to leave work early. 3:30 am the next morning I had uncontrollable shivers/tremors. To the point where I couldn't stand on my own. I had a fever of 101 degrees. As a result of the tremors I had entire body soreness. Hot flashes; alternating from sweat to freezing. Side effects began to dissipate after a full 24 hours.

tiredness; weakness; headache; muscle pains; feeling unwell; stomachache; heavy breathing; This is a spontaneous report from a contactable consumer (patient). A 29-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 19Feb2021 at 10:45 (Lot Number: EL9266) (at the age of 29-year-old) as single dose for COVID-19 immunisation. Medical history included type 1 diabetes and penicillin allergy, both from an unknown date and unknown if ongoing. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination the patient has not tested positive for COVID-19. Concomitant medications included insulin and sertraline hydrochloride (ZOLOFT), both taken for an unspecified indication, start and stop date were not reported. On 19Feb2021 at 11:30, the patient experienced tiredness, weakness, headache, muscle pains, feeling unwell, stomachache and heavy breathing. No therapeutic measures were taken as a result of the events. The patient outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.

slurred speech; Memory loss; loss of cognitive functions; increased appetite; nausea; headaches; weight gain; unable to stay focused; shortness of breath / difficulty breathing; chest pain near heart; This is a spontaneous report from a contactable consumer or other non hcp. A 29-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0162) unknown dose via an unspecified route of administration in deltoid left on 15Apr2021 at 01:45 (at the age 29 years) as single dose for COVID-19 immunization. Medical history included depression. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination: Allergy medicine, ibuprofen. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 15Apr2021 at 16:00, the patient experienced memory loss, loss of cognitive functions, increased appetite, nausea, slurred speech, headaches, weight gain, unable to stay focused, shortness of breath, difficulty breathing, chest pain near heart. Outcome of the events was recovered with sequelae. No follow up attempts are possible. No further information is expected.

Chest pain. Visit to hospital outpatient. Non specific muscle pain diagnosis. Tylenol Pepcid. I don?t think they took my chest pain and potential link to vaccine as a serious possibility. It started minutes after vaccine as a sensation. Pain onset and increase for hours and persisted for days leading up to visit and after.

Date added: 06/05/2021 at 10:29 AM (MDT) Patient wants to be seen for covid symptoms. Experiencing headaches, dry cough, congestion, only thing he does not have is fever and chills. Been going on for a week now. Started with the COVID vaccine that was received last Friday been sick since last Saturday. onset week ago, 5/28 he received covid vaccination pfizer first dose - from CVS and developed same evening headache congestion now has neck pain for 2-3 days, 3/10, worse with nothing not worse with movement and has full rom, no fever or chills but has dry cough, and congestion and raspy voice, has headache slight headache, back of head 7/10, daily headache for a week now, and has lightheadedness when stands up for a week, headache is worse with activity, and worse when lays down, taking tylenol and ibuprofen and dayquil and nyquil but headache recurs and only slightly improved by medication. has no PCP had covid19 illness July 2020

Approximately 13 days after vaccination, the patient developed headache, fever, chills, myalgias, arthralgias, and neck stiffness. There was no chest pain or shortness of breath. He required hospitalization 6/6/21-6/7/21. He was found to have elevated cardiac enzymes (Troponin). Viral myocarditis vs vaccine associated myocarditis were considered in the differential diagnosis.

My left armpit swelled up to a baseball cut in half size. Very painful to the touch at times.; My left armpit swelled up to a baseball; Second dose on 07Jun2021, first dose received on 24May2021; This is a spontaneous report from a contactable consumer (patient). A 29-year-old-male patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Right on 07Jun2021 14:00 (Inappropriate schedule) (Lot Number: Ew0179) as single dose (at age of 29-year-old) for covid-19 immunisation. Medical history was not reported. Concomitant medications included paracetamol (TYLENOL); celecoxib (CELEBREX). The patient previously took gabapentin and experienced hypersensitivity, pregabalin (LYRICA) and experienced hypersensitivity. First dose of bnt162b2 (BNT162B2) was administered on 24May2021 at 13:00 (at age of 29-year-old) in Left arm for covid-19 immunisation, lot number: Ew0179. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient did not have COVID prior vaccination and also patient was not tested for COVID since the vaccination. Patient stated that on 08Jun2021 08:00 his left armpit swelled up to a baseball cut in half size. Very painful to the touch at times. No treatment was received. Events resulted in Emergency room/department or urgent care. Patient had not recovered from the events.

Directly after administration of the vaccine, the patient started to feel like he was going to faint and became nauseous. I got him some water and when I returned he was slouched in his chair. His leg and arms started to twitch for at least 10 seconds and he was incoherent. After the twitching stopped, he seemed to not have full recollection of the past minute and asked if he had passed out. His shoulder muscles were tight, he felt very warm, and soon after become nauseous but did not vomit. We gave him an ice pack to cool him down in addition to the cold bottle of water. We waited for a friend to come pick him up and during the wait he recovered and was able to hold a conversation, not feel dizzy, and stand up on his own. After 30 minutes of observation, the friend arrived so I walked with him out of the pharmacy to the car.

Pt getting shot felt tingling 30 seconds after then nausea and lightheaded. He got stiff, gasped and passed out. Per pt, he had a "hallucination". Pt experienced LOC for approx 5 seconds, he "took a deep snort" and came back. Pt pale and diaphoretic, vomited and moved to med obs 1. VSS. Resolution of symptoms within 20 minutes, and released.

Patient had a left sided segmental and subsegmental pulmonary embolism, severe back pain, dyspnea, tachycardia and tachypnea, started on 6/24.

Muscle weakness, nerve damage, burning in legs, numbness/tingling in legs, numbness/tingling feet and hands and arms, severe cramping - cannot walk for more than a few minutes. Treatment will involve Solumedrol steroid injections, Tizanidine muscle relaxers, and Meloxicam inflammatory medication.

Day after vaccine, I was sick all day. Hard to breathe; heart rate would shoot up and then come down in one minutes sessions; I had body aches - all over. Doing anything felt painful. Eating was uncomfortable and sitting was uncomfortable. I had some fever. 238.5 Celsius and it got a little worse during the day (and that number is the end of the day). I had some pain in the chest, too - center of chest. I also had a headache throughout the day. I did a televisit (wednesday) and she advised to take acetaminophen for fever. She said my blood pressure was fine and my heart rate was still under 100 most of the time. The next day, everything seemed fine - all symptoms seemed to go over night except heart rate - still was elevated and the difficulty breathing was still there. Even sitting - my breathing and heartrate felt like it was working. Friday, things were mostly similar - heart rate came mostly down. But end of day, difficulty breathing came worse and chest pain became worse and tightening of chest was more intense. No fever after Wed though. I went to see the Urgent Care doctor at Urgent Care. Friday, the second week after the vaccine, the symptoms received. Pain in left arm started (started Tuesday or Wed the second week) and I had chest pain and tightness in the chest and slight difficulty breathing, nausea, dizziness and no fever. ER - on Saturday - 11:30PM - they did more tests - everything heart related came back fine so they ruled out Heart attack; but didnt' know what it was; gave medication for nausea in case it would help. IV medication and then one medicine to drink on the spot. It didn't really help - the symptoms continued and slowly disappeared the next day (the second Sunday after the vaccine). Nothing new since then.

Felt like had torn muscles in shoulder--intense pain / sudden pain; Limited range of motion, withoutany muscles feeling tense or locked up; Sore arm; Pain and sensation continued to worsen in my arm and shoulder, until it spread to my spine; spine hurt more and more; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: En6202) via unspecified route of administration in left arm on 17Mar2021 (at the age of 29-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not tested positive for COVID-19 since the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had not received any other medications in two weeks prior to vaccination. On 18Mar2021, the patient started the morning after vaccine, with just a sore arm (pain in arm). The second day after the vaccine, it felt like the patient had torn muscles in shoulder--intense pain (shoulder pain) and limited range of motion, without any muscles feeling tense or locked up (movements reduced). The third day, pain and sensation continued to worsen in arm and shoulder, until it spread to spine (condition worsened). By the end of the night, arm started to feel okay but spine hurt more and more (pain in spine), feeling like it had a compression injury. It was reported that, the patient that if he had no memory, and someone told he had been in a car accident, or compressed his spine by jumping from 30 feet in the air, he would readily believe it. It was the fourth morning as the patient wrote, and spine still felt same way. No physical activity or other explanation for sudden pain, no prior history of injury/pain for these areas. It was unknown if the patient had received any treatment for the events. The outcome of the events shoulder pain, movements reduced, condition worsened, pain in spine was not resolved and for event pain in arm was resolving at the time of this report. No follow up attempts are needed. No further information is expected

Fever; CHILLS; Cough; Fatigue; Muscle body ache; Headache; Nausea; Vomiiting; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) via unspecified route of administration in the right arm on 23Mar2021 at 09:15 (at the age of 29 years) as a single dose for COVID-19 immunisation. The patient's medical history included pre-diabetic and high blood pressure at family medical history. Concomitant medication included ibuprofen (MANUFUTURER UNKNOWN). The patient did not had allergies to medications, food or other products. 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. The patient had not tested positive for COVID-19 since having the vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3248) via unspecified route of administration in the right arm on 02Mar2021 at 09:30, as a single dose for COVID-19 immunisation. On 23Mar2021 at 22:00, the patient experienced fever, chills, cough, fatigue, muscle body ache, severe headache, nausea and vomiting. The adverse events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not received treatment for the adverse event. The clinical outcome of fever, chills, cough, fatigue, muscle body ache, severe headache, nausea and vomiting was resolving at the time of this report. No follow-up attempts are needed. No further information is expected.

After recieving second dose of Pfizer vaccine, patient developed pchest pain radiating to back the following day. Associated with nausea, vomiting, and chills. Chest pain was also pleuritic. Symptoms improving over the preceding days while in the hospital.

I started having slight heart palpitations last week, and even the first night of my first dose I was having slight chest wall pain but that it went away.

Migraine 1 day after injection; Headache; arthralgias; myalgia; chills; low grade fever; This is a spontaneous report from a non-contactable other healthcare professional (patient). A 30-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Dec2020 at single dose at left arm for immunization. Medical history was none. The patient's concomitant medications were not reported. Patient didn't 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 had not been tested for COVID-19. The patient experienced migraine 1 day after injection, headache, arthralgias, myalgia, chills, low grade fever on days 1-6 post injection which are improving. Patient received Ibuprofen 400 mg daily for events. The report is considered non-serious. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

12/18 VACCINATION 12/19 WOKE UP, HA, FATIGUE, MUSCLE ACHES. 12/20; HA WORSE, SYMPTOMS WORSE 12/21 FELT BETTER 12/22 VERTIGO, FACE IS RED. URGENT CARE. PRESCRIBED NAUSEA MEDS.

temperature up to 99.6 F.; Myalgias; fatigue; This is a spontaneous report from a contactable physician (patient). A 30-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231) intramuscularly at left arm on 30Dec2020 at 07:30 AM at a single dose (dose number: 1) for COVID-19 immunization. Medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered was at hospital. The patient experienced adverse events myalgias, fatigue, temperature up to 99.6 F; all with onset date in Dec2020. The events were non-serious. No treatment received for events. The outcome of events was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.

left sided facial muscle soreness; Arm soreness/by injection in the left arm; This is a spontaneous report from a contactable consumer (patient). The 30-year-old male patient received BNT162B2(COVID Pfizer vaccine, Batch/lot number: EK9231), via an unspecified route of administration on 31Dec2020 at single dose by injection in the left arm for COVID-19 immunization. Medical history and concomitant medications were none. The patient stated that he just got the COVID vaccine an hour ago. Within 20 minutes he developed left sided facial muscle soreness, which was the side he got the vaccine on, and arm soreness, on 31Dec2020. There was no treatment. Outcome of events was not recovered.

Malaise and joint aches for 1.5 days. Right upper axillary (proximal armpit area) lymph node swelling and tenderness for around 3-4 days then gradually less pain with dissipation of swelling over 2-3 days (after initial 3-4 days) before back to normal.

Fever of 101.7F while taking 500mg of acetaminophen every 6 hours. Chills, night sweats, headache, fatigue, backache/myalgias.

Uncertain if truly caused by the vaccine. I had an ACL reconstruction done back in May of 2020. My knee has transient swelling that comes and goes, but is not particularly frequent. 3 days after receiving the vaccine, my knee swelled up and remained swollen for about 7 days. It has since gone back down. I did not have any acute injuries or remarkable events happen during this time other than the vaccine administration. Overall, uncertain if it was caused by vaccine, but it was odd enough to report.

18h: Dissociation (mild), fatigue 24h: nasal congestion, fatigue 26h: fever, chills, headache, nasal discharge and congestion, fatigue, nausea 30h: difficulty sleeping, headache, fatigue, nausea (ibuprofen 800mg, acetaminophen 1000mg, pepto bismol caplets 2) 36h: fatigue, joint pain (hip) 42h: mild fatigue, joint pain (hip)

9 hours post-vaccine, developed rigors, fever to 102.7, myalgia, headache, and nausea. Everything but fever resolved within 18 hours. Fevers resolved by 48 hour mark.

20 hours after injection, I started having progressively worsening severe back pain, neck pain, headache, chills (no fever), skin sensitivity, noise sensitivity, fatigue, and brain fog. 2 days after the vaccine, I had abdominal pain, and cough. All of that is now better except for the cough. It is now 4 days after the vaccine, and it seems the vaccine has triggered an asthma attack requiring inhaled albuterol. My asthma attacks typically linger for a couple weeks after upper respiratory infections, and this feels exactly like that, I wouldn?t be surprised if this asthma attack persists for a couple of weeks.

about 12 hours after the second vaccine dose I had sudden onsets chills with significant rigors which lasted for about 24h. Chills continued after for 1-2 days after this bu the rigors stopped. I had fevers to the 101F range which persisted for about 48h after the vaccine. Also significant myalgias and fatigue. Symptoms partially responded to tylenol and ibuprofen (total of 3.5g tylenol and 800mg of ibuprofen taken over the 48h period).

received vaccine 01/08/21, reported around 02:00PM 01/09/21, onset of chills, muscle aches, fever, did not take temps, flushed feeling, headache, injection site pain, general weakness, fatigue, unable to get up due to weakness. Around 01/09/21 at midnight reported started feeling better. 01/12/21 reports repeat of symptoms like on 01/09/21, however not as bad and did throw up, reported body sweats on this day and only lasted about 4 hours.

In the evening after getting the shot, I started getting chills and became more sensitive to cold temperatures. Many of joints became stiff, some of which made a cracking sound when I flexed them. Several muscles in my arms, legs and back felt sore and weak. After a restless night of sleep, the cold sensitivity is all but gone. Some of my joints and muscles are still a little stiff and sore, but I'm sure they'll be better by the next morning.

About any hour after sore throat left side , headache ,stomachache ,chills, throughout next day swelling in throat neck and face left side very hard and painful to swallow ,eat , drink felt like a golf ball was in my throat. By 3rd barely ate only had soup and a mild case of diarrhea , day face neck throat pain still and swelling , warm wash clothe hot fluids help with pain, 4 day cold things help reduces swelling in face and throat, neck still swollen and a lot more pain in face jaw , neck, still hard and painful to swallow. Current day a lot of pain in jaw neck throat face still only happening on left side of body more pain then before but less swelling neck still swollen a little bit. I tried cough drops soup heat ice and still having pain don?t want to pay for an ER visit found old painkillers haven?t taken yet. How long do symptoms like these last for ? I take medication for ADD and that masks pain to make it bearable. What do you recommend to do if I don?t want to go to the ER ?

2021/01/16 10:00 AM - Numbness in face (lips, jaw, gums) similar to the feeling from localized anesthesia. Also numbness and tingling in left hand. Vision is blurred and spotted vision loss. 2021/01/16 10:45 AM - Numbness in face and hands diminishing. Head ache on right temple. Vision issues persist. 2021/01/16 11:15 - Muscle pain on right abdomen and numbness beginning in feet. Vision issues cease. Headache persists. 2021/01/16 2:15 - All symptoms cease

S/S started approx 16 hours after injection. It started with fatigue and headaches, by 1400 that same day I began to feel chills and the sensation of pressure on my chest grew. I'm currently writing this 48 hours after injection and still experiencing tiredness, muscle pain and slight chills.

feel his chest and neck hurting; feel his chest and neck hurting; feeling really sick; feeling tired; arms hurting; head hurting/ neck and all around head area, hurting real bad; This is a spontaneous report from a contactable consumer (patient). A 30-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: not provided), via an unspecified route of administration on 10Jan2021 at single dose for COVID-19 immunization (reported as "I guess to protect myself from other people, to protect myself"). There were no medical history and concomitant medications. The patient took his first dose on 20Dec2020, 3 weeks from there, he took the second on 10Jan2021 (reported as "it was 10th it was Sunday morning when I took it"). The patient reported that he had his second dose on Sunday morning (10Jan2021) and started feeling tired last Monday (11Jan2021). Then on 12Jan2021 (reported as "yesterday" at the time of reporting), he started to feel his chest and neck hurting. The patient stated that he woke up in the middle of the night (Sunday night) and Monday morning, he was feeling really sick so he called out rest all day on Monday (11Jan2021). Then patient woke up yesterday morning (12Jan2021) feeling good then probably about 6 o'clock last night he started feeling tired, like real bad tired and he got home. Patient lied down and woke up in middle of night, his chest, arms and head were hurting. His neck and all around head area were hurting real bad. The events were assessed as non-serious. The patient does not have the lot number but stated that it was the Pfizer vaccine. When the patient was asked if still experiencing tiredness and chest hurting, he stated "When I started, that was last night on I will go with the 12 before midnight 12 (not clear). Yes right now yeah. This is the first time my chest and my arms and my neck and like all that has been hurting, started last night". When asked for the treatment, the patient answered "I took Ibuprofen to calm it down a little bit. I took Ibuprofen if you count that as a treatment". Outcome of the events was unknown. Information about lot/batch number has been requested.

12 hours after receiving second dose, I experienced intermittent fever/sweating and chills with body aches/joint pain. Started around 10pm 1/24/2021 and symptoms resided around 4 pm 1/25/2021

adverse outcomes: fever, chills, sweats, joint pain, body aches 10:15 PM 1/24/21 - 4:15 PM 1/25/21 treatment: rest, soup, ibuprofen outcome: missed work 1/25/2021, slept all day, felt normal 1/26/2021 and returned to work

Shoulder soreness; This is a spontaneous report from a contactable healthcare professional (patient). A 30-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK4176; Expiration date was not reported) on 07Jan2021 at a single dose on the right arm, with route of administration unspecified, for COVID-19 immunization at the workplace clinic. The patient had no relevant medical history. The patient's concomitant medications were not reported. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EH9899; Expiration date was not reported), intramuscularly on the left arm on 16Dec2020 (when the patient was 30 years old) for COVID-19 immunization. On 07Jan2021, the patient had shoulder soreness. The patient did not receive any treatment for the event. The outcome of the event, shoulder soreness, was recovered on 09Jan2021. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested since the vaccination. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.

Patient received the Pfizer-BioNTech COVID-19 Vaccine EUA at 1100. Patient reported right arm heat sensation, right neck tightness, right facial tightness at 1120 with sensation progressing up arm and across face. Given Benadryl 25mg PO at 11:50 and symptoms resolved after further observation.

Headaches, site pain, neck pain, numbness in arms and fingers on side if injection site. Extreme fatigue.

- Low fever (99.4-99.8 degrees F) during evenings each night after the vaccine, treated with one dose of 500 mg Tylenol - Increased irratibility, anxiety, muscle tension in neck and chest off and on (1 episode lasting about 10 min every 1-2 hrs). Starting occuring ~ 48 hours after receiving vaccine. Current treatment is laying down until the anxiety passes as needed per episode.

Pain in my knees, back, both arms, joints and shoulders. The next 24 hours, the pain peaked but I rested. By the next day I had no pain. No pain relievers were taken. Only rest.

Fever and chills, debilitating headache, weakness and muscle aches, joint pain, nausea, and fatigue. Local swelling and pain at injection site. Also felt unusually anxious, though unsure if that was directly due to the vaccine or to the inability to sleep for a number of days because of the feverish chills. Acute symptoms lasted for 48 hours, and prohibited me from being able to work from home. I still have what feels like a lingering sinus headache (with no actual sinus symptoms) as well as some fatigue. Lingering headache is not debilitating, but it is irritating. Feels a bit like a sensation of pressure in my forehead.

Initially chills and fever. Woke with diffuse, severe myalgia--most severe in quadriceps bilaterally.

11pm on day of (Sunday) vaccination felt soreness in left arm at injection site and in entire upper arm when trying to hold it up. Soreness subsided by noon the next day, Monday. No symptoms on Tuesday until late evening when tongue began to feel sore. On Wednesday morning around 6am, woke up with severe body fever, chills, muscle and joint aches, nausea, headache. Hands and fingers very cold to the touch. Severe fatigue and weakness all day. Sore tongue persisted. No respiratory symptoms present. By Thursday (today), body is still feverish, joint and muscle aches persist, light headache at times. Still fatigued and weak. All symptoms today Thursday are much weaker except for the muscle and joint pain which remains high. The reason I am reporting this is that from what I've read and been told, the delayed onset of these symptoms (almost 3 days) is very unusual, especially because I had little/no symptoms in the first 2 days of the vaccine.

Severe polymyalgias; CPKs very high at 80,000; This is a spontaneous report from a contactable physician. A 30-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Not Provided, second dose) solution for injection intramuscular on an unknown date (at the age of 30-years-old) as a single dose for COVID-19 vaccination. Medical history included Cystic Fibrosis and Autoimmune Necrotizing Myositis. Concomitant medications were unknown. Historical vaccine included BNT162B2 (first dose) for COVID-19 vaccination on an unknown date with no adverse effect reported (tolerated first COVID-19 vaccine). The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Less than 24 hours after second COVID-19 vaccine injection, the patient had severe polymyalgia. CPKs checked very high at 80,000. The patient was currently admitted to the hospital. Unspecified treatment was provided for the events severe polymyalgias and CPKs very high. The outcome of the events severe polymyalgias and CPKs very high was unknown. Since the vaccination, the patient has not been tested for COVID-19. The patient was supposed to get RITUXAN as a regimen for his muscle disorder and was interested in Pfizer checking his neutralizing antibody level both pre and post Rituxan. The patient will receive RITUXAN shortly in the next week. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on chronological connection to the vaccine causality between events severe polymyalgia and CPKs checked very high and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE0 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.

Moderate pain w/ movement in right arm, specifically shoulder joint. First noticed on 3/14/21. Still having symptoms 3/28/21. Plan is to follow-up with PCP if symptoms don't subside in a few weeks.

Right ear hearing loss - 2 days since vaccination until present (4 days since vaccination) Right ear ringing - 2 days since vaccination until present (4 days since vaccination) Right wrist joint ache - 1 day since vaccination until 2 days since vaccination

Possibly a demyelinating neuropathy; I still have intermittent lumbar discomfort; started experiencing tingling sensation (paresthesia) in both legs without loss of sensitivity or strength/mild tingling sensation in my feet and sometimes legs depending on posture; I started having lumbar pain similar to a mild muscle cramp.; back and joint pain/I started having lumbar pain similar to a mild muscle cramp.; back and joint pain; shivers; headaches; This is a spontaneous report from a contactable consumer (patient). A 30-year-old male patient received second dose of bnt162b2 (lot number: el1283), via an unspecified route of administration, administered in Arm Left, on 09Jan2021 11:30 as single dose for COVID-19 immunisation. Medical history included mild asthma, allergies to fur, mites and olive tree pollen from an unknown date and unknown if ongoing. Concomitant medication(s) in two weeks included finasteride taken for an unspecified indication, start and stop date were not reported. The patient historical vaccine included first dose of bnt162b2 (Lot number: ek5730) at 30-year-old on 19Dec2020 08:00 PM at left arm for COVID-19 immunisation. No other vaccine in four weeks. No Covid prior vaccination. No Covid tested post vaccination. A few hours after the second dose, the patient experienced back and joint pain, shivers and headaches for two days. On 19Jan2021 (reported as 10 days after the second dose), the patient started experiencing tingling sensation (paresthesia) in both legs without loss of sensitivity or strength. Also, the patient started having lumbar pain similar to a mild muscle cramp. The paresthesia was somewhat strong for a week and started to very slowly fade away, but the patient still has intermittent lumbar discomfort and mild tingling sensation in his feet and sometimes legs depending on posture. Possibly a demyelinating neuropathy. No treatment AE. The outcome of the events was recovering.

2nd day after vaccine; shoulder in severe pain on same arm as injection; pain caused nausea, dizziness, and buckling over; woke up with pain that never went away; concentrated around past surgery site

At 3pm i woke up very cold. I started to shiver. I added five blankets, put on a beanie, warm socks, turned on heater in my room and was still freezing. About an hour after that started to get muscle weakness. This was my second shot. Whats weird is that inhad covid in late January but i still had these side effects the second shot. First shot, no symptoms

Starting around noon the following day I had muscle aches which spread across right side of my body throughout the afternoon and evening. Around the same time I also experienced fatigue. The morning after the aches and fatigue I experienced nausea after brief periods of physical activity.

Pfizer-BioNTech COVID-19 Vaccine EUA. Experienced low grade fever (99.4), feeling unwell, headache, and joint pain in left big toe. Took 2 acetaminophen 500 mg every 6 hours.

Unusually extreme hematuria w/ the other side effects including mild fever, chills, joint pain, and pain under arms. The hematuria was very dark starting ~ 24hr. after second dose.

Body aches. sharp pain in finger joints. Sharp pain in joints. Pain in bones. Fatigue. Pain at injection site. Swollen painful lymph nodes in the armpit of the same arm of the injection site. Headache after 24 hours. Neckache. Shoulder pain.

At approximately 4:30pm, on the day I got the vaccine, I began to feel the effects of Encephalopathy and Encephalitis, in which I began to feel pressure in my skull, and felt confusional thinking. It became hard to discern my thoughts. I also, began to experience a difficult time with my vision not being able to control what my vision was focusing on, as well as seeing a blue tint in my vision. I am also experiencing mild pressure and aches on the right side of my back and left side of my chest. These effects have been continuous for the last 4 days. To treat these symptoms I have been using natural remedies, and have maintained a stable condition due to that.

First dose: sinus congestion, headache, lethargy, mild fever Second dose: Muscle/joint pain, dizziness, mild fever, headache, excessive sweating while sleeping, fatigue/lethargy

After receiving the 2nd shot, had a moderate headache, significant tiredness, and light muscle fatigue that lasted for approximately 36 hours. No nausea.

pt says he had soreness in shoulders, neck and had a headache. next day the soreness was throughout his body. He had sweating, chills, headache and red blisters on his chest going towards his right arm. pt says he has been taking ibuprofen, Tylenol, and Dayquil the symptoms are getting worse and will contact his PCP.

Headache, chills, fever, stiff neck, sore throat for 8 plus days. Fever 102-103. Rx. Tylenol, Ibuprofen, minimal effect.

Ran a fever that reached 100.8; fever subsided after 16 hours. Chills at the onset of the symptoms (1-2 hours). Fatigue (has not yet subsided). Muscle pain, particularly in the left arm, though was present in the rest of the body. Subsided in the left arm after 16 hours.

took him a half an hour just to get out of bed; Tightness to left trapezius and left side of neck, same side as vaccine; increased pain and decreased range of motion to his neck; increased pain and decreased range of motion to his neck; inflammatory infectious process with atypical organisms; Lymphadenopathy/ compressing the nerves in his neck and causing his pain and decreased range of motion; This is a spontaneous report from a contactable nurse (patient). A 30-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: ER8730) via an unspecified route of administration, administered on the left arm on 31Mar2021 15:00 at a single dose for COVID-19 immunisation. Medical history included ongoing hypothyroid. Concomitant medication included levothyroxine sodium taken for hypothyroid. The patient previously received tetanus vaccine (6 weeks out from his Covid Vaccine) with no adverse events. Patient stated that his side effects began on 01Apr2021. He noticed tightness to left trapezius and left side of neck. This was the same side of the body he got the vaccine on. His symptoms worsened over the next two days. He had increased pain and decreased range of motion to his neck. On Saturday 03Apr2021. it took him a half an hour just to get out of bed. Stated that he went to the Emergency Room at the hospital where he works and they did a series of tests. He had CAT Scans with and without contrast, a MRI, and an Ultrasound. Mentioned later that they also did blood work (Apr2021). The Emergency Room doctor told the caller he was going to have his CAT scan read by a specialist. Caller stated they called him on Sunday 04Apr2021 and said his CAT scan showed an inflammatory infectious process with atypical organisms and Lymphadenopathy. He stated that he read that Lymphadenopathy was a side effect of the vaccine. They told him that the Lymphadenopathy was compressing the nerves in his neck and causing his pain and decreased range of motion. He had been on a week of treatment consisting of pain medications, muscle relaxers, and anti-inflammatory medications. The Infectious Disease was consulted and he was started on a 5 day course of Azithromycin. He was on the third day of this antibiotic per his report. He has a follow up MRI scheduled next Friday. He was calling to report his side effects and also to ask about what he should do in regards to his appointment for his second dose of the vaccination. His symptoms were worsening for the first three days. Since he has been being treated for them they have started to improve slowly day by day. Today he said there was minimal pain and tightness but he was still not back to one hundred percent. He was offered admission to the hospital for pain control after his emergency room visit but he decided to defer it to an outpatient setting. Was not admitted to the hospital. The patient felt that the events 'tightness to left trapezius and left side of neck, same side as vaccine'; 'increased pain and decreased range of motion to his neck' were medically significant and stated they were disabling, at least temporarily. There were no additional vaccines administered on same date of Pfizer suspect. Outcome of the events 'tightness to left trapezius and left side of neck, same side as vaccine'; 'increased pain and decreased range of motion to his neck' was recovering while unknown for the other events. Patient stated that he felt all of his adverse events were caused by the COVID Vaccination he received.; Sender's Comments: A contributory role of BNT162B2 to reported events cannot be excluded based on the temporal relationship. Case will be reassessed if additional information is received. 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.

Given second dose of covid vaccine on friday in the right arm 04/23/2021. The day after the covid vaccine I ran a high fever from about 7:30am until about 9pm on Saturday 04/24/2021. During Saturday I drank lots of water to combat the fever but I noticed blood in my urine. The blood got worse through out Saturday into Sunday and I noticed slight pain in my lower back and lower abdomen. On Sunday morning (04/25/2021) my urine was a dark burgundy color. This was quite alarming as it was very thick and not as light as the day before. I drank lots of water on sunday and made sure to watch my urine. The urine stayed red in color. I called a telehealth nurse on Sunday and they suggested I go to Urgent care in the morning. I woke up on Monday (04/06/2021) with less blood in my urine but still went to urgent care to be safe. At Urgent care I received a Urine analysis. The doctor told me there was blood and protein in my urine. He ruled out a UTI or an STD. The doctor said there may be kidney damage since there is protein present but it cannot be confirmed with the levels. The doctor advised that I continue to drink liquid and watch for worsening signs. The doctor said I should contact him immediately if the blood or pain gets worse. The doctor also stated I should fill out this VAERS form. Today (04/27/2021) there has been less blood in my urine but there is still some pain in my lower abdomen. I will contact the doctor at the end of the week to let him know what has happened to my symptoms, he requested I keep him informed.

Patient called center and reported swelling 3cm below his armpit that appeared yesterday 24h s/p his 1st Pfizer dose. He has a prior hx of COVID-19 infection. The swollen area is approx 2-3"" in diameter, mild discomfort when touched or when moving arm, no fever, no change in color or warmness to touch, skin intact. No visible change in size or pain level over the past 24 hours. RN told client that it is not a known SE and that immediate eval is not needed unless his condition changes. RN advised him to use ice and cold compresses for relief and to outline the area with a marker to allow him to gauge if it increases or decreases in size. RN advised him to go to a UCC or ED if it suddenly gets larger, fever of over 100.4 develops or pain increases in intensity. Pt has a phone appointment scheduled with his outside PCP 4/23/21 to discuss his concerns.

Pfizer-BioNTech COVID-19 Vaccine EUA Started getting a migraine at 0300. Turned worse by 0530. Got a fever ranging from 100.1-100.5 for the majority of the day. Fever dropped to 99.8 by 2000 that night. All day I had muscle tightness and stiffness to the point I could not function for work or move with out being in extreme pain.

Approximately 3-5 minutes post-vaccination, patient was seated, texting a message on cell phone, and fainted. Slumped out of chair face down. Witnessed by several volunteer employees. Not witnessed by pharmacist who had administered the vaccine. Volunteers called for help. Immediately pharmacist responded to patient. Loss of conscious noted. Patient was assessed and gently rolled to back with head support and began to regain consciousness, stiffened arms and legs noted. Patient asked, "Do you have a history of seizure disorder?" Initially unable to respond. Pharmacist requested 911 be called as is looked like a seizure. Asked again, and then patient shook head no and then verbal no. Muscles more relaxed. Stroke assessment performed with arms and legs equal to weight, no facial droop, verbal back to normal. Patient asked if he would like to sit up in chair after about 5 minutes on back. Patient complained of headache but no other injuries. Stated he had no bump on his head. Paramedics arrive in less than 10 minutes from call. Assessed patient. Vitals normal. Skin color normal from pale. Paramedics assumed vasovagal fainting episode. Pharmacist agreed. Patient offered water and consumed 12 ounces. Stayed additional 30 minutes. Stood and sit tested for balance. Left without complaint.

Bleeding in the cough; Rashes; Cough; Tiredness; Muscle Pain; This is a spontaneous report from a contactable consumer (patient). A 30-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided) at the age of 30-years-old, via an unspecified route of administration in left arm on 07Apr2021 at 08:15 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were reported as none. The patient had no COVID prior to vaccination, did not have any other vaccines in four weeks and no other medications in two weeks. The patient experienced rashes, cough, bleeding in cough, tiredness, and muscle pain on 09Apr2021 at 12:00. There was no treatment given in response to the events. The patient was not tested for COVID post vaccination. The outcome of the event was not recovered. Information about the lot/batch number has been requested.

Patient presented with ?5/10? abdominal pain in left lower quadrant approximately one hour after vaccination. Pain was characterized as inguinal and no constitutional symptoms were present. EMS staff as well as pharmacy staff concluded that implication of vaccine was highly unlikely but patient contacted friend to take him to the ER for further evaluation.

Tightness in right inner arm, tricep, neck and shoulder when moving, months after injection. Sometimes sharp pain, similar to nerve pain when moving.

Headache, Dizziness, Shoulder Pain, Arm pain and Stomach pain started 3-4 days after the vaccine and dizziness has affected the daily activities including work. Been happening for 5 days now

Stabbing pains in both kidneys every time I would inhale, stabbing pains in stomach every time I would exhale; lasted approximately 1 hour. Intense throbbing pain in the head. Sporadic pain and ringing in both ears. Stabbing pain in left armpit. Fever dreams / delirium. Chills, fever. Sensitivity to cold. Spasms of abdominal muscles. Spasms and ?tics? of neck and shoulder muscles. Spasms of leg muscles. Nausea. Extreme weakness of upper body.

Immediately after receiving vaccine, patient eyes began to roll. He then started having jerking movements and body stiffness. Patient was lowered to floor. BP 120/90 P64, SpO2 98% on room air. Patient A&O x3 after approx. 1 min. Cool compresses applied to face/head along with fan. BP 130/99, P81, SpO2 99% room air. Patient sat upright. Denies any further complaints and states, "This always happens when I see needles and get a shot." Additional monitoring in recovery. Patient ambulated from facility with mother. No s/sx of distress noted.

Needle broke with first injection attempt, had to get stabbed a second time. Injection site pain, Fever (102), chills, headache, fatigue, joint pain. Started mild chills at 6am, fatigue and headache at 9am, joint pain and fever at 11. Took 1000mg Tylenol at 4pm. Symptoms clear by 10am on 5/12/21

felt a cold and then hot burning mostly at night; like his legs were heavy; bad bruising on the deltoid muscle and bleeding; bad bruising on the deltoid muscle and bleeding; This is a spontaneous report from a non-contactable consumer reported for his son. A male patient in his 30's received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 12Apr2021 (at age of 30's, Batch/Lot number was not reported) as a single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Reporter stated that his son had the first dose of the Covid-19 vaccine on 12Apr2021 and ten days later he presented "something like burning feet, felt a cold and then hot burning mostly at night, felt like he ran a marathon and felt like his legs were heavy". Stated that the side effects resolved after 24 hours. Added that his son was in his 30s. Stated that the vaccine administrator had a poor technique and his son presented bad bruising on the deltoid muscle and bleeding. He had no preexisting condition and would like to find out if this event has been reported. Reporter would like to consult if his son should get the second dose of the Pfizer Covid-19 vaccine if he presented side effects after the first dose. The outcome of the events "Feeling hot and cold/ Heaviness in limbs" was recovered on 23Apr2021. The outcome of other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

heart fluttering; arrhythmias; Fever; chills; intense pressure behind eyes; headache; muscle weakness; fatigue; brain fog; intense body pains/aches; intense body pains/aches - especially at joints (knees, wrists, ankles); heart pounding; insomnia; lack of appetite; migraine with aura; lethargy; This is a spontaneous report from a contactable pharmacist (patient). A 30-years-old male patient received bnt162b2 (unspecified trade name), dose 2 via an unspecified route of administration, administered in Arm Left on 21Apr2021 16:00 (Lot Number: EW0171) as single dose for covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered was Public Health Clinic/facility. The patient medical history was not reported. No known allergies. The patient's concomitant medications were none. No other vaccine in four weeks. No other medication in two weeks. The patient previous received the first dose on 31Mar2021 11:00 (Lot number=ER8737) as single dose at Left arm for covid-19 immunization. The patient had no reaction on previous exposure to vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced Fever, chills, intense pressure behind eyes, headache, muscle weakness, fatigue, brain fog, intense body pains/aches - especially at joints (knees, wrists, ankles), arrhythmias/heart fluttering, heart pounding, insomnia, lack of appetite, migraine with aura, lethargy on 22Apr2021 13:00. The outcome of the events was recovering. No treatment received.; Sender's Comments: The contributory role of the suspect product bnt162b2 (unspecified trade name), dose 2 via an unspecified route of administration, administered in Arm Left on 21Apr2021 16:00 (Lot Number: EW0171) as single dose for covid-19 immunization to reported events is possible based on temporal association and known profile of the product.

4/28 4am Fatigue 8am joint pain 10 am chest pain, difficulty breathing 8pm chills, sweating 4/29 Chest pain 4/30 2am vomite, chest pain, sweating, difficulty breathing. 3am myocarditis.

High Fever (103 +) Chills Body Aches Nausea and Stomach Pain Joint Pain Was unable to eat or drink causing dehydration. Main add to the community if you have stomach sensitivity this Vaccine caused extreme discomfort and feeling of high risk outcome with high temperature and unable to consume fluids

Rash with pain and burning sensation located on the arm in a straight line where vaccinated the night of receiving the vaccine. Began to spread along the arm, but nowhere else on the body and develop blisters and redness. Along with rash was constant pain through the whole arm and pain in armpit where lymph node is located. Went to a healthcare clinic one week later who said it was a possible case of shingles. Took a sample to send to lab. Was prescribed valacyclovir.

Starting 4 days after first shot: Debilitating night sweats for 15 days straight, increased and large bowel movements (6-10 a day), headache, chest pain, abdominal pain, rapid weight loss, irregular appetite. Night sweats stopped abruptly after second vaccine shot. Tested positive for Blastocystis Hominis. Started Metrozinadole 4/22/21, symptoms recurred immediately upon stopping 10 day course and 10 pounds lost in 2 days. Tinidazole take 5/5/21, symptoms recurred. Paromomycin prescribed 5/17/21 in progress.

chills; muscle soreness in my legs; fatigue; mild headache; This is a spontaneous report from a contactable consumer (patient). A 30-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL3248), via an unspecified route of administration, in left arm on 04Feb2021 15:30 (at 30-years age) as 2nd dose single for COVID-19 immunisation and patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number:EL3248), via an unspecified route of administration, administered in left arm on 14Jan2021 16:00 (at 30-years age) as a 1st dose single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient was not allergic to medications, food, or other products. Facility where COVID-19 vaccine was administered was at a workplace clinic. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 05Feb2021 at 3 a.m. the following morning patient experienced chills, muscle soreness in his legs, fatigue, and a mild headache. These symptoms continued intermittently throughout the day ending around 4 p.m. The patient was not tested for COVID-19 since the vaccination. No treatment was received for the events. The outcome of the events was recovered. No follow-up attempts are possible. No further information is expected.

Symptoms were fatigue, muscle aches, and slight chills. Symptoms dissipated the following morning after sleeping

Typical flue symptoms: fever, headache, sweat, shiver, a few phlegms, muscular pains (located in particular in the left arm where the vaccine was injected). This lasted for 36 to 48 hours.

High fever 38.8 degrees in Celsius or 101.84 degrees in Fahrenheit, right arm pain, back pain, bone pain, splitting headache, heart speeding up, diarrhea, fatigue, feeling very irritated. No treatment but drinking a lot of cold water. Body temperature back to normal and feeling much better 2 days after the shot.

bilateral lower extremity muscle "soreness/weakness"; fatigue; mild headache for most of the day (coughing made it worse); bilateral lower extremity muscle "soreness/weakness"; coughing; left arm pain/bilateral arm pain (worse of the left); This is a spontaneous report from a non-contactable physician. A 30-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiration was not reported), via an unspecified route of administration administered on arm left on 04Mar2021 at single dose for covid-19 immunisation (At the age of 30-year-old). Medical history included chronic hives from an unknown date and unknown if ongoing. The patient had known allergies: shellfish from an unknown date and unknown if ongoing. Concomitant medications in two weeks included cetirizine taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks. Covid prior to vaccination was unknown and the patient was not covid tested post vaccination. On 04Mar2021, the patient experienced left arm pain (the day of the vaccine)and that day after vaccine the patient had bilateral arm pain (worse of the left), bilateral lower extremity muscle "soreness/weakness", fatigue, mild headache for most of the day (coughing made it worse). No treatment was given for any of event. The outcome for all the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

after the second dose he went to see his doctor and he was palpitating and this was thought to be caused by a stress response; had trouble sleeping; very fatigued/ really fatigued; vomiting; a drastic increase in eye floaters/a huge increase in eye floaters; but I have been like falling asleep really early and then like popping awake really early.; dry heaving; I was 180, but I lost 10 pounds during all this I am 170 right now; appetite is still poor; This is a spontaneous report from a contactable consumer (patient). This 31-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on 06Apr2021 (Lot number: ER8737), as single dose, at the age of 30 years, in left arm for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not diagnosed with COVID-19 prior to vaccination. The patient had not tested positive for COVID-19 since having the vaccine. On an unknown date after second dose of vaccine patient experienced palpitating and this was thought to be caused by a stress response, had trouble sleeping, very fatigued/ really fatigued, vomiting every couple days, a drastic increase in eye floaters/a huge increase in eye floaters, patient falling asleep really early and then like popping awake really early, dry heaving, patient was 180, but now lost 10 pounds during all this and 170 right now and appetite is still poor. The events were considered as non-serious. Patient was taking Propranolol for the heart palpitation. On an unknown date patient undergone tests which includes Electrocardiogram (EKG), chest scan and had a full panel blood work results of all were unknown. The outcome of all the events was unknown. No follow-up attempts needed. No further information is expected.

After the pt received the vaccine, he asked me for some water because he wasn't feeling very well. I didn't have any on hand, so I offered chocolate. When I came back he tried to reach for it, but was struggling. He dropped it and started making jerking movements and slumping over. I put my hand on his chest to keep him propped up and called for my technician. After a minute or so, he was responsive, but sweating and his skin tone became washed out. I told him he should lay on the floor and prop his feet up on the chair. He said that made him feel better. I got him some orange juice to drink after he got off the floor. He remained near the location for 30mins and then did some shopping to make sure he would be okay before leaving with his wife.

fatigue, headache, body aches, joint aches, fever to 101 degrees, sweats, swollen lymph nodes left axilla

After the first dose the caller's arm was still sore and tight before the second shot; After the first dose the caller's arm was still sore and tight before the second shot; This is a spontaneous report from a contactable consumer (patient). A 30-years-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EP6955), via an unspecified route on 20Mar2021 as 1st dose, single dose in the left arm for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 20Mar2021, after the first dose the patient experienced arm was still sore and tight. After the first shot, the patient had arm soreness but nothing that was different from the reports. The outcome of the events was not recovered. Information on Lot/Batch number was available. Additional information has been requested.

patient reported tightness/stiffness in neck region, tingling tongue, discomfort in back of throat that progressed over course of 30 minutes, administered 50mg diphenhydramine 10 minutes post vaccination, alerted EMS to have patient checked out

Light headedness, weakness, and subjective fever onset during the morning of 6/6 following injection of second COVID-Pfizer vaccine on 6/4 at approx. 4:30 p.m, and the initial even also included minor muscular spasms, headache, heartburn, and abdominal pain. These symptoms worsened throughout the day. My pulse felt weak. My breathing became rapid and shallow, even though it was not difficult to draw breath. The major symptoms on 6/7 were headache, with a sense of my motion being affected. My urine throughout this time was excessively dark, even though I was drinking more water than normal. The following day, 6/8, most of my joints began to heart, and I became very stiff; this sx lessened after taking a long, slow walk. On 6/13 another event involving slowed heart rate, subjectively weak pulse, and shortness of breath ensued. There had been no unusual or excessive physical activity, and as I had not experienced this phenomenon before receiving the second vaccine dose on 6/4, I believe that the 6/13 event was also linked to the vaccination.

Patient went to the ED and presented with chief complaint of 3 days of rib/sternal pain. Patient stated that it began after twisting torso to squeeze between a palette and wall at work. Was moving heavy objects. Patient has been constant. Hard to sleep. Also has some epigastric abdominal pain, discomfort. Took TUMs, not helping much. Taking motrin for rib pain. No cough, shortness of breath, not exertional. Chest is tenderness to palpation.

2:30am cst I woke up in a lot of pain. My whole body was being racked by wave after wave of muscle soreness. Anything that touched my bed hurt. I tried sitting up, turning over side to side, and the pain continued. This was accompanied by a severe chill that caused my teeth to rattle. The apartment was set to 68 which is slightly warm to me. I got up to go to the restroom and my legs grew tired almost immediately. I?ve tried laying back down and getting back up 2 more times. The chill and the pain have continued now for 3 hours and 17 minutes, although the chill has diminished to a mild child instead of severe. No notable fever has been measured thus far.

heartrate was faster than normal; tightness in his chest and left arm; tightness in his chest and left arm; he was kind of laboring to breath; the left side of neck was numb; "pins and needles" sensation from "heads to toes for weeks".; metallic taste; Tired and fatigue; arm soreness; This is a spontaneous report from a contactable consumer (patient). A 30-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Apr2021 (lot number: EW0150, expiration date: Jul2021) as single dose for COVID-19 immunization. Medical history included having issues ever since with certain foods and having that reaction ever so often throughout the week. Concomitant medications were not provided. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Mar2021 (at the age of 30 years old, lot number: EP6955) as single dose for COVID-19 immunization and after the first dose the patient's arm was still sore and tight before the second shot. On 11Apr2021, the patient experienced arm soreness. The patient experienced metallic taste, tired and fatigued on 12Apr2021. On 19Apr2021, patient reported tightness in his chest and left arm, it was in the left side of his chest, he was kind of laboring to breath, and the left side of neck was numb. He reported that the symptoms were cyclical in nature and that the only thing that's changed in his medical history was the vaccine. On 03May2021, he's also been experiencing a "pins and needles" sensation from "heads to toes for weeks". The patient experienced pins and needles for the last three weeks from the top of his head to his toes, in his fingers, arms, and legs that was also reported as worsened. Patient had been having blood work and x-rays on all of this. None of this was happening to the patient before the vaccines. Also, the patient's heartrate was faster than normal on unspecified date (also reported as on 01Apr2021) and he went to the emergency room on the 19Apr2021. The patient's faster than normal heartrate normally happened in the middle of the night and it woke him up between 2:00 am and 5:00 am. The patient had to walk around and do breathing exercises to slow down his heart rate. After the patient's emergency room visit, the faster than normal heartrate happened roughly around noon and then after that first week, it started earlier around 10:00 am or 10:30 am. The patient went to the emergency room and was admitted and discharged the same day. The patient was in hospital from 19Apr2021 to 19Apr2021 for events tightness in his chest and left arm, it was in the left side of his chest, he was kind of laboring to breath, and the left side of neck was numb, heartrate was faster than normal. Lab data included the patient wore a Holter monitor from 05May2021 to 09May2021. The Holter monitor showed that it was collected normal, normal range, and no issues or symptoms. On 19Apr2021, the blood work and chest X-ray done but both was negative. EKG with result of normal on 19Apr2021. H pylori with result of negative on 02Jun2021. Outcome of events metallic taste, tired and fatigued was recovered on 13Apr2021, while of the other events was not recovered.

Severe acute nerve pain, beginning from vaccination site and spreading over the course of several days to shoulders, neck and throat

30 YO M with no PMH who presented on 4/27 with left arm pain after covid vaccine on 4/15. He reports he developed left arm swelling and redness that was progressive following the vaccine. He is now s/p I&D at El Camino on 4/28. Patient with multiple apparent debridement sites 3x around elbow and 1x left deltoid. Continues to have pain and swelling around elbow and in shoulder. No sensation changes, compartments are soft. He was subsequently taken to the OR on 5/4 for debridement with return trips on 5/5, 5/6, and 5/7 with vac placed on 5/7. He tolerated bedside vac change to left deltoid and WTD to 3 sites around elbow. He lives at home alone and is unable to do dressing changes by himself. Wound vacs were placed on all wounds and home health was arranged for MWF visits. In addition, he will follow up in wound care clinic as outpatient. He understands he needs to complete course of oral antibiotics and will have pain meds for vac changes. He was stable upon discharge

Left arm sore, stiff, and tired it led me to believe I was having a heart attack and had to go the ER the doctor at the time stated I didn't have a heart attack nor had any visible signs of heart damage

I was immunized with the 2nd dose of the Pfizer COVID-19 vaccines on May 4th, 2021, and on May 5th started experiencing left shoulder pain radiating to the arm, and upon breathing in pain would intensify. On the night of May 5th pain started to increase and decided to report to the hospital. On May 6th I was admitted to the hospital to further identify what was causing the shoulder pain, deferent test were performed with normal result but upon performing CT Scan, it was identify that I had blood clots on the left lung (pulmonary embolism). Upon several questions asked by the health care team, the doctors at the Hospital stated that the main cause of the blood cloths was the 2nd dose of the Pfizer COVID-19 vaccine due to my healthy status and being the only thing that I had completed different in the days prior to the hospitalization. Due to this I was prescribed a 3 month anti coagulant treatment for the embolism.

14 minutes after the injection, within a 30 second time period, and lasting 8-10 minutes, I was overwhelmed with the following symptoms: Sever Shortness of Breath, Dizziness, Nausea, Blurred Vision, Sweating, Muscle Fatigue, Elevated Heart Rate, and Body Aches. I was immediately monitored and administered a normal dose of Benadryl where I waited upwards of 1 hour for the symptoms to wear off. All remaining minor symptoms were gone by next day. I've developed pin-pointed neck pain limiting my range of motion within 2 days after the injection. Pain still persists today. No other symptoms. PCP recommended against getting the second dose of the vaccine.

It started out as very bad shoulder pain with a bit of swelling, but shortly after I could feel a tightness when my arm was held all the way outward. The next morning, the top of my ring finger felt numb and as the days progressed it moved to the whole finger and the finger tip of my middle finger as well. I have not regained any of feeling that I lost

Injection Site Mild discomfort on 0d . Arthritis Flare up on 7d. Arthralgia, right hand joints swollen, numbness, stiffness. Nerve pain on right arm, left hand joint pain at 8d

Patient states he received his 2nd COVID vaccine last week and the day after he developed a fever, chest tightness myalgias. States that he has a device at home and checks his heart rate and monitors an EKG and states that it told him he had PVCs at that time.

Headaches, myalgias, arthralgias, migratory testicular pain, axillary pain, chest heaviness, and palpitations

My left arm keeps getting bruised and blood clot looking things all over my left arm which is where I got both vaccines. I have had a loss of vision and seeing little black floating dots and have lost over 10 pounds since without working out.

Entire back hurt; Left arm sore; Left armpit swollen a bit; Cold; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 30Apr2021 at 03:15 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient did not receive any concomitant medications within 2 weeks of vaccination. The patient previously took shellfish. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01May2021 at 00:15, the day after shot, the patient experienced that his entire back hurt, on a pain scale it was 6/10, had left arm sore, left armpit swollen a bit and cold most of the day. The clinical outcome of the events entire back hurt, left arm sore, left armpit swollen and cold was resolved on an unknown date on May2021. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

2 weeks after receiving my first shot I started receiving aching chest pain in the upper left portion of my chest near my heart. The aching is not consistent but appears about once a day and may last for several hours at a time. I also started receiving an aching muscular pain in my left rib cage. No bruising or other physical marking. Everything is internal.

Extremely dry skin; Near cracking; Eyes burning; itchy eyes; dry eyes; headache; muscle ache; chills; tired; Sever pain at injection site.; skin warmed; This is a spontaneous report from a non-contactable consumer. A 30-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 06Apr2021 at 08:15 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. Medical history included LASIK(Laser-assisted in situ keratomileusis) eye surgery on Nov2020. Concomitant medications included lifitegrast (XIIDRA) for lasting headaches from dryness on third and last month of treatment. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 10Mar2021 at 08:00 (at the age of 29-year-old) as a single dose for COVID-19 immunisation. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Apr2021 at 13:00, the patient experienced extremely dry skin, near cracking(chapped skin), eyes burning, itchy, dry (similar feel like seasonal allergies) and other typical symptoms like headache, muscle ache, chills, tired, skin warmed and severe pain at injection site(vaccination site). The patient took advil liquid gel 300 mg as treatment for the reported events. It was reported that all symptoms were muted after receiving Advil. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the events extremely dry skin, near cracking, eyes burning, eye itchy, headache, muscle ache, chills, tired, skin warmed and severe pain at injection site were recovered on 06Apr2021, while that of the event dry eyes was not recovered at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

heart arrhythmia; headache; It was from the back of his head down to his spine; heart started hurting; This is a spontaneous report from a contactable consumer (patient) received from a Pfizer-sponsored program. A 30-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0183), via an unspecified route of administration in arm right on 25Jun2021 at 11:30 (at the age of 30-year-old) as a dose 1, single for COVID-19 immunisation. The family medical history included his family has cardiovascular issues on his dad's side. The patient's medical history (including any illness at time of vaccination) included allergic to pollen. The patient's concomitant medications were not reported. 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) was reported as this was his first dose. Additional vaccines administered on same date of the Pfizer suspect was reported as none. Prior vaccinations (within 4 weeks) prior to the first administration date of the suspect vaccine(s) were reported as none. The AE(s) following prior vaccinations were reported as none. Enquired, inbound call received, warm transfer from (name withheld) with DSU, NTID - #, Reportum - #. The caller was transferred from one place to another, CEP 159558. The caller was a consumer who received his first vaccine dose on 25Jun2021 in his right arm, lot: EW0183 or EO183. There is a date on the back of the card that says 03Sep2020. Stated that, the reporter was going to be a healthcare professional (dental hygienist) in a couple of months. It was required for the dental field so he had to get the vaccine. Afterwards the patient experienced a headache and he went to the emergency room. It was from the back of his head down to his spine and he lost control of his knees for some reason. The headache started 2 days prior to when he went to the emergency room on 08Jul2021 in the afternoon. He still has the headache a little bit. It was a little better. After his first dose of the Covid vaccine, his heart started hurting about 10 days later. When he went to the hospital, he started getting heart arrhythmia and was in the emergency room on 10Jul2021 at 22:00. When he went to the hospital on the first day, he was not admitted, he was in the emergency room. It lasted from 10Jul2021, 11Jul2021, 12Jul2021, and part of 13Jul2021. Stated that, he was 80% recovered. The caller reported that, he was supposed to get his second dose of the vaccine tomorrow and asked, was it ok or safe to postpone that dose to a later time or would that cause side effects. He wanted to go to the doctor and find out whether the heart problems were from the vaccine. Stated that, the caller comes on the line. He verified information provided by transfer agent. Stated that, he has a question regarding the timeless between the first and second dose. Stated that, he knows it was supposed to be 2 weeks max. He had an arrhythmia, it was very high up and he ended up in the hospital. The patient was hospitalized for the event arrythmia. The EKG was normal, but to be on the safe side he was hoping to postpone the second dose. He asked whether he can get the second dose after 4 weeks if possible. The AEs require a visit to emergency room was reported as yes and physician office was reported as no. On 10Jul2021, the patient underwent lab tests and procedures which included blood test, resulted as unknown results and EKG, resulted as normal, heart started hurting, resulted as increased. The outcome of the events for heart arrythmia was recovered on 13Jul2021 and for headache was recovering while for the other events was unknown.

After receiving the vaccine, I was instructed to wait i for 15 minutes to ensure there were no reactions. I sat down in the provided chair, put my headphones in my ears, and started my timer on my watch for 15 minutes. after about 5 minutes I began to feel like my injection arm was a little weak, as if perhaps my arm was stiffening from the injection sore. I remember feeling slightly warm and started to read over the COVID-19 Vaccine symptoms sheet and then I blacked out (Fainted). The nurse in the hallway woke me up and was asking me if i was alright and then rushed me in the back room where they tested me and ensured I was ok. I had not eaten anything the morning of the vaccination shot and barely anything the night before. I have been experiencing higher levels of anxiety recently due to pressures of day to day life; school, work, etc. The nurses are thinking it is likely I had more of a reaction to the anxiety and low food or blood sugar (I am not diabetic), than a reaction to the vaccine itself. They did refer to my experience as sounding like Vasovagal syncope. I have never had this experience with any flu vaccine or shots before; I do not have a fear of needles or shots.

Left arm soreness.; Chills and shivering on the night of the vaccine; Severe body aches and back pains; Severe body aches and back pains; Severe headaches; This is a spontaneous report from a contactable physician (patient). A 31-year-old male patient received a single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot# EK923) as the first dose via an unspecified route of administration in the left arm on 29Dec2020 08:00 for COVID-19 immunization. Medical history included test positive for COVID/ diagnosed with COVID-19 from Apr2020. The patient was diagnosed with COVID-19 prior to vaccination. The patient did not have COVID prior vaccination. The patient had no known allergies. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. And the patient did not take any other medications within 2 weeks of vaccination. The patient had COVID test post vaccination in Dec2020(also reported that the patient had not been tested for COVID-19 since the vaccination). The patient had left arm soreness; chills and shivering on the night of the vaccine; severe body aches and back pains; severe headaches; event onset date reported as 30Dec2020 02:00. The patient was tested positive for COVID in Apr2020 and symptoms felt exactly the same. All the events were reported as non-serious. No treatment was received for the events. The outcome of the events was not recovered.

1/5/21 Within 10 min, started hot flash, right side of face was numb but was not paying attention and went to visit his wife and mother in hospital and came back to the clinic. Noted right facial swelling, right leg felt off, no blurred vison, no difficulty with swallowing. Staff walked to the ED. Gave Benadryl IM given, Steroid IM given. Discharged from ED about 1400

within 6-8 hours started with holocephalic headache, myalgia, low-grade temp and chills, nausea and fatigue. Incident last ~ 24 hours then abated with Tylenol and Advil

Fever 100.8, shortness of breath, chills, myalgias, weakness, shortness of breath worse with exertion, chest tightness

Pt report fever of 100.6, left shoulder blade pain and swelling of the left arm pit. Treatment include Tylenol will continue to monitor.

infection of SARS-COV-2; infection of SARS-COV-2; This is a spontaneous report from a contactable healthcare professional. A 31-year-old male patient started to receive received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL0140), intramuscular into the left arm on 18Dec2020, at 10:30 as single dose for covid-19 immunization. There was no medical history and no concomitant medications. The patient experienced infection of SARS-COV-2 on 25Dec2020. Details were as follows: The patient received the first dose of the two dose series. On 20Dec2020, he was exposed to COVID-19. Official positive diagnosis of COVID-19 was made on 25Dec2020. Patient had symptoms of fatigue, joint pain and a small fever on an unspecified date, and had been exposed to SARS-COV-2 on 20Dec2020, and the infection on 25Dec2020. The patient underwent lab tests and procedures which included sars-cov-2 test which was positive on 25Dec2020. The patient was scheduled to receive second dose of the vaccine; he will be out of quarantine around five to six days before that dose. The outcome of infection of SARS-COV-2 was recovering.; Sender's Comments: The efficacy of a drug varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect drug BNT162B2 to the reported events drug ineffective and COVID-19 cannot be ruled out.

Headache & Myalgia Narrative: reports next morning felt like he was "hit by a truck" "severe headache and muscle aches"On 12/31, things didn't get much better. I felt like I had the flu. I woke up in a puddle of sweat but I was freezing, I still had muscle aches and I had a sore throat. Friday was better beside still having a little bit of a sore throat. (symptoms lasted over 48 hours)

14 hours after getting the vaccine, I had rapid onset fever with Tmax 104F, chills, rigors, headache, nausea, and myalgia. This lasted nearly 4 hours and then spontaneously resolved without intervention.

Myalgias, Chills, hyperesthesia, Headaches, neck pains, fatigue, weakness. The day after the second dose.

Fever more than 100.5F; severe headache; body aches/joint pain; body aches/joint pain; chills; left arm soreness; administration date=06Jan2021 dose number=2/administration date=18Dec2020 dose number=1; administration date=06Jan2021 dose number=2/administration date=18Dec2020 dose number=1; This is a spontaneous report from a contactable pharmacist (patient). A 31-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot: EK9231) via an unspecified route of administration in left arm on 06Jan2021 16:30 at single dose for COVID-19 immunisation. The patient received the first dose of BNT162B2 (Lot: EH9899) on 18Dec2020 16:30 at 31 years old at single dose for COVID-19 immunisation. There was no medical history. There were no concomitant medications. The patient was not allergic to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. On 07Jan2021 06:00 AM, the patient experienced fever more than 100.5F, severe headache, body aches/joint pain, chills, and left arm soreness all lasting 12 hours. Dose received on 06Jan2021 4:30PM and side effects mostly subsided by 07Jan2021 430PM. No treatment was received for the adverse events. Events outcome of fever more than 100.5F, severe headache, body aches/joint pain, chills, and left arm soreness was recovering.

severe headache; Fever to 103 Fahrenheit; myalgias; chills; This is a spontaneous report from a contactable Physician (patient). A 31-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 04Jan2021 Intramuscular at single dose on left arm for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 16Dec2020. The patient experienced Fever to 103 Fahrenheit, severe headache, chills, myalgias on 05Jan2021. No treatment was received for all events. There was no covid prior vaccination. There was no covid tested post vaccination. He had no Allergies to medications, food, or other products. The outcome of all events was resolved. information on the lot/batch number has been requested.

Myalgia-Injection Site Pain-Chills-Generalized Weakness-Dizziness upon standing; Myalgia-Injection Site Pain-Chills-Generalized Weakness-Dizziness upon standing; Myalgia-Injection Site Pain-Chills-Generalized Weakness-Dizziness upon standing; Myalgia-Injection Site Pain-Chills-Generalized Weakness-Dizziness upon standing; Myalgia-Injection Site Pain-Chills-Generalized Weakness-Dizziness upon standing; first dose of BNT162B2 on 16Dec2020 12:00, second dose on 05Jan2021 15:00; first dose of BNT162B2 on 16Dec2020 12:00, second dose on 05Jan2021 15:00; This is a spontaneous report from a contactable Physician (patient). This 31-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 05Jan2021 15:00 (lot number: EK9231) at single dose in Arm Left for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was Hospital. Medical history included Migraines. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication received within 2 weeks of vaccination included paracetamol (TYLENOL), ibuprofen (ADVIL) occasionally as needed. The patient previously received first dose of BNT162B2 intramuscularly on 16Dec2020 12:00 at 31-year-old (lot number: EH9899) at single dose in Arm Left for COVID-19 immunisation. The patient experienced Myalgia-Injection Site Pain-Chills-Generalized Weakness-Dizziness upon standing on 06Jan2021 03:00 AM. The outcome of Myalgia-Injection Site Pain-Chills-Generalized Weakness-Dizziness upon standing was recovering. Tylenol, Advil, Bed Rest was received for the adverse events Myalgia-Injection Site Pain-Chills-Generalized Weakness-Dizziness upon standing as treatment. 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.

The evening after the vaccine, Chills, muscle aches and "hung-over" feeling. Approximately 16 hours later, arm pain and swollen lymph nodes in injection arm.

Left elbow tendinitis onset approximately 48 hours after administration. Occurred with first and second dose.; This is a spontaneous report from a non-contactable physician. A 31-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number:EL1284, via an unspecified route of administration on the left arm on 08Jan2021 09:00 at a SINGLE DOSE and (Lot number: EH9899), via an unspecified route of administration on the left arm on 17Dec2020 20:00 at a SINGLE DOSE for covid-19 immunisation. Medical history included none from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced left elbow tendinitis onset approximately 48 hours after administration which occurred with first and second dose on 10Jan2021 07:00 with outcome of recovering. No follow-up attempts are possible. No further information is expected.

Numbness and tingling in left ulnar nerve starting 2 min after injection into left deltoid. 6h after injection began the flu like symptoms: fever 101, systematic joint ache, fatigue, diarrhea, loss of appetite, and sweats. Symptoms lasting for ~38h. Treatment: Tues: nyquil Wednesday: dayquil, advil, and nyquil Thursday by 1030a, 44h after injection did symptoms subsided suddenly.

began severe muscle aches, nausea and vomiting and itching. We went to grady clinic today 1/21/21 and was evaluated/treated. He is feeling a little better today - was given several prescriptions.

Fever (102.4F), chills, arthralgia, myalgia, headache, nausea. Did not resolve until I took ibuprofen 600mg at 17:30 on 1/21/21

With both first vaccine (12/28/20 lot EK9231) and second vaccine (1/21/21), about 12 hours after dose I developed a sore arm, headache, chills, nausea, myalgias, fatigue, sweats. After the first done they resolved approximately 36 hours after the vaccine was administered, or about 24 hours after the symptoms began

Per patient, he developed a fever, myalgia, and headache after first vaccine. Fever and myalgia resolved after a few days, but headache persisted. At the time of the patient's second dose (1/21/21), patient reported that he continued to experience headache

First night after second dose of vaccine significant chills and cold sweat lasting all night. Began to get better by morning. Early morning muscle and joint paint (1/10)gradual began and increased to a significantly uncomfortable level throughout the day (6/10) along with general malaise. Treated with 600mg ibuprofen at 1500 and 2300. Woke with same type of pain on 1/27/21 (3/10).

Swollen lymph node in right armpit.; Tender to touch and doubled in size when compared to left armpit.; This is a spontaneous report from a contactable Other HCP (patient). This 31-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EL3249) at single dose on 15Jan2021 at 02:45 PM on right arm for COVID-19 immunisation. The first dose was on 28Dec2020 at 03:00 PM at age of 30 years old, on right arm, lot number: EL0140. Medical history included Crohn's disease. Known allergies was Tegaderm. Concomitant medications in two weeks included azathioprine, verapamil. There was no other vaccine in four weeks. There was no COVID prior vaccination. There was no COVID tested post vaccination. The patient experienced swollen lymph node in right armpit on 17Jan2021 at 01:00 AM. Tender to touch and doubled in size when compared to left armpit. There was no treatment received. The outcome of events was recovering.

Soreness at the injection site; Pain and soreness in armpits and groin; Pain and soreness in armpits and groin; Headache; Fatigue; Muscle aches; This is a spontaneous report from a contactable other health care professional, the patient. A 31-year old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3248), intramuscular, in the left arm on 09Jan2021 at 08:00AM (at the age of 31-year-old) as a single dose for COVID-19 immunization. Medical history included Penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. Historical vaccine included Dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: 592671001), intramuscular, left arm on 19Dec2020 for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Jan2021 at 18:00 PM, the patient experienced soreness at the injection site, pain and soreness in armpits and groin, headache, fatigue, muscle aches. The patient did not receive treatment for the events. The clinical outcome of the events soreness at the injection site, pain and soreness in armpits and groin, headache, fatigue, muscle aches was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.

I was vaccinates at around 3pm on 02/02/2021. Everything was fine throughout the day and night. On 02/03/2021 at around 1:30pm I started to feel different. At around 4pm I am sick. I have a fever, I feel sweaty, my muscles hurt and I have body aches. I left work at around 4pm

About after a day after receiving the first dose of the vaccine I noticed that I had right knee pain coming from my knee joint. It is at its worst after I keep it in the same position for a few minutes then try to move it. Prior to the vaccine I never had any knee issues and it is only in the right knee

It is been three weeks since my first dose of the Covid Pfizer vaccine (first dose: Jan 14th; second dose: Feb 6th) that I have a painful underarm. I think my symptoms are similar to the one discussed in the following paper. When I stretch my hand, I feel pain in my underarm (left armpit). How can I make sure it is not cancer? Can I do the biopsy test?

Muscle aches; fever; chills; bones hurting; pressure on head; This is a spontaneous report from a contactable consumer. A 31-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) solution for injection (at the age of 31-years-old) as a single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. It was unknown if the patient had any known allergies. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 12Jan2021, the patient experienced muscle aches, fever, chills, bones hurting and pressure on head. It was unknown if treatment was provided for the events muscle aches, fever, chills, bones hurting and pressure on head. The outcome of the events muscle aches, fever, chills, bones hurting and pressure on head was recovered in Jan2021. Since the vaccination, it was unknown if the patient had been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Began feeling body aches and soreness at 9pm. This developed into chills, headache, nausea, body aches, muscle fatigue, shortness of breath overnight. Symptoms slightly subsided by 7am following day.

On 2/7 I woke up with pain in left shoulder. Movement away from body caused intense tearing pain in shoulder and bicep muscle. After 4 days intense pain had subsided. I am still experiencing persistent aching in shoulder upon movement away from body and noticed marked weakness in arm upon exercise.

Symptoms began with fever 102 F, chills, joint aches, and injection site soreness approximately 12 hours after vaccine was received. Symptoms were abated with naproxen and resolved approximately 10 hours after they started.

1145 vaccine administered 1147 patient stood up from chair and then had syncopal episode. Fell face first onto floor. Hit head on wall trim on the floor. Eyes dilated, fists clinched, arms and legs shaking , not responding to verbal cues. Seizure like activity last approximately 1.5 minutes 1150 called 911 1200 ambulance arrived on scene. patient c/o lightheadedness and needing to continue to lay down 1210 transported patient to ER at Hospital

Slept longer than usual; Triceps pain; This is a spontaneous report from a contactable healthcare professional (patient himself, physical therapist) via Pfizer colleague. A 31-year-old male patient received first dose of bnt162b2 (PFIZERBIONTECH COVID-19 VACCINE, lot number: EL9264 and expiry date: 31May2021), intramuscular on 04Feb2021 at single dose for COVID-19 immunization. The patient was vaccinated at a hospital. Medical history and concomitant medications were not reported. The patient previously received hepatitis B vaccine last 12Jan2021. On 04Feb2021, the patient reported that after the vaccination, he slept longer than usual during the night. The patient also reported that he experienced triceps pain (not at the injection site area). Clinical outcome of the event slept longer than usual was unknown, while for triceps pain was not recovered as of time of report.

The patient stated his tongue was tingly within the first 15 minutes after the immunization was given. On-site he was given 100mg of liquid diphenhydramine. He was monitored for 30 minutes with no worsening of symptoms. He stated he was feeling better and left. The pharmacy was alerted on 3/5/2021 of the following sequence of events: The following day the patient stated he was feeling off. He had joint pain and inflammation thru Wednesday March 3rd. On Monday March 1st, he stated he felt short of breath and needed to use his nebulizer. His heart rate was over 100 and he reported having a panic attack due to seeing his elevated heart rate. He was seen for a routine appointment by his PCP on March 3rd and was told to not receive the second dose of vaccine. His parents subsequently informed him that he has a history of heart arrhythmia.

102 degree fever, body aches, severe chills, lethargy, weakness, muscle aches, fatigue, swollen lymph nodes. Rested in bed for 4 days, felt better on the fifth. I feel an onset of similar symptoms today 03/05/2021, 17 days after 2nd vaccine dose.

Extreme migraine, nausea/vomiting, fever/chills, fatigue, muscle soreness, aching of joints, sensitivity to light/sounds, and weighted sensation.

Sore arm at injection site began hours after (nothing terrible). Woke up the next day with mild to severe body aches, muscle soreness, joint pain and pain in my stomach/abdomen. Developed a 101 fever 24 hrs after receiving the vaccine, and continued until this morning (3/16). Vomiting multiple times in the middle of the night on 3/14. The vomiting was only a one night deal, but every other symptom that I experienced has been persistent until this morning. I feel about 80% back at the moment. Symptoms were very similar, maybe even a little more extreme, than the ones I experienced when I contracted Covid months ago, but they didn?t last as long.

Headache, Small fever of 101 degrees, joint aches especially on right side (previous neuro issue side), chills, fatigue. Lasted roughly 2-3 days.

1) Injection site soreness, intensified approximately 3 hours after injection, peak at 24 hours after injection. Resolved approximately 72 hours after injection. 2) Stool consistency was between 5 and 6 on Bristol chart. Bowel movements at 6 times over the course of first day of immunization, approximately once every 1.5 to 2 hours starting close to 3PM (3 hours post-injection). Woke twice from description of bullet point 4 due to bowel movement. Resolved by 24 hours. 3) Muscle pain/tightness in other locations of body, such as upper left thigh, right shoulder, right buttock starting approximately 24 hours after injection. These were not experienced prior to vaccine, although occasional skeletal related pain in right shoulder from prior injury one year prior is reported. 4) Fatigue began approximately 6 hours after injection, drowsiness following where patient was somnolent 12 hours after injection (4 to 5 hours prior to typical sleep time for patient).

Approx 15 mins post injection, right arm heaviness and pain. Then extreme fatigue, vagal stimulus when stood up, vasovagal near syncope, diaphoretic. Approx 18-20 mins after injection throat and tongue tingling and swelling. PO liquid diphenhydramine 50mg given at that time. Then taken to ER for further observation. In the ER, right arm did lock up. No further treatment given.

Muscle and joint pain in my hips. Burning sensation in my legs that lasted about 5 hours through the night

Injection Site pain - 3-31 ~7pm to current (4-2 ~2pm) currently just in left shoulder, lat, left pec and under arm area ribs Tiredness - 3-31 ~8-10pm to 4-1 ~11pm-12am Headache - 4-1 ~7am to ~1pm went away with Advil Muscle pain - 4-1 ~7am to about 4-2 ~1:30am went away over night Joint pain - 4-1 ~7am to about 4-2 ~1:30am went away over night

Fever of 102F lasting ~4h, fully resolving after ~12h. Moderate muscle and joint pain, mild headache treated with acetaminophen, resolving after 24h.

Woke up with large headache and nausea, chills and hot flashes. Severe throat pain and fatigue with chills throughout the day, arm pain and lymph node swelling, joint pain

Severe nausea, mild vomiting, severe aches, severe joint pain, mild dizziness, moderate fatigue, mild fever (101.2F), moderate chills, moderate runny nose

I started getting small red marks on my skin about 3 days after the injection. They are about 8-10 in number now and are on my arms and chest area predominantly. I was also feeling muscle soreness which is a bit better and I still feel very fatigued.

First Dose - 3/15/2021 - No side effects other than a sore arm. Second Dose - 4/5/2021 - Drowsy approximately 11 hours after injection. Body Aches, Chills, Fever began approximately 13 hours after the injection and lasted for 9 hours. Morning of 4/6/2021. Fever and chills have cleared but still experiencing body aches and stiffness.

Pfizer-BioNTech COVID-19 Vaccine EUA About a minute after the shot I experienced dizziness, weakness and a bad headache. I also become very nauseous, had injection site numbness, a tingling feeling in my fingertips, lower back pain/joint pain and felt sick the rest of the day.

Received dose 1 3/17. Felt normal 3/18. 3/19 pm, started experiencing myalgias, chills, fever 100*. Fully recovered 3/20pm, felt well through 3/21. 3/22pm through 3/25 experienced fever, myalgias, chills worse than before. Received second dose in series 4/7/21, ADE currently unknown.

Today, 9 days later I have pain in arm, and numbness in my hands on the side where I got my shot. Neck pain and leg pain on the side that I got the shot. Joint pain on the side where I got my shot.. Slight Cough.

I started developing another rash on my right low back, I had pain in my lower back on the right side and superficially on my stomach (right side). More rash formed, also on the right side of my low back and right side of my stomach. Swollen inguinal lymph nodes on right side. Treatment is valtrex.

On 4/19 he received the first dose of Pfizer vaccine oh 4 PM. Administration of vaccine was uneventful. The next day he noticed sore shoulder at 3 PM on 4/20 he noted he had upper wrist pain that progressed to his right thumb as well as redness with a shiny quality that was consistent with previous gout flares so he took 2 doses of colchicine and 2 doses of Advil which did not relieve his symptoms. A couple hours later he noted hand numbness and tingling as well as feet numbness and tingling bilaterally. The numbness progressed to his extremities with the left arm more affected than the right arm (he received vaccine in his left arm). He had accompanied pain of his extremities and wrists that was described as 10 out of 10. He then felt 2 episodes of chest tightness and difficulty breathing prompting him to present to the strong ED. In the ED his exam was notable for hypertension (240/90), tachycardia, wrist flexion in distress and yelling in pain. His exam also showed bilateral hyperflexion of bilateral wrist with mild swelling and diminished sensation and motor function throughout. He was administered IV hydromorphone, and Benadryl with dramatic improvement in his symptoms. His labs are notable for abnormal electrolytes including magnesium, potassium, phosphorus, calcium and he was repleted with magnesium potassium and phosphorus. He is admitted to ED OBS. overall felt his symptoms were most likely due to gout flare and hyperventilation, not likely related to vaccine.

24-48 hours post injection, pt experienced a sore arm consistent with other immunizations which resolved shortly thereafter. 9 days post immunization, pt experienced pain and inflammation in the area of the injection. Symptoms included radiating pain into the scapular area, mimicking that of a labral tear. Pt continues to experience pain/inflammation at the site of the injection that continues to radiate and feels like a fatigued arm with excessive movement (as of today (Day 14)).

Client reports uneventful night after receiving vaccine. Day two, client noted mild itching before bed. Day three when client awoke, he experienced rash, itching, and pain on the right side of his torso, back, neck, shoulder, and armpit. Day three the client saw his PCP who referred him to a dermatologist, the dermatologist in turn referred him to an immunologist who confirmed the shingles diagnosis. Diagnosis based on assessments of providers - client denies any specific imaging or studies done outside of a bloodwork panel that he reports was all WNL. Client currently reports feeling "about 80% recovered" and still experiences what he described as internal pain, with the outward rash spots drying/scabbing and fall

The BNT 162 B2 vaccine was administered on the morning of Monday January 4th 2021 at approximately 11:08am, via intramuscular route. Within the next 24 hours, I started having myalgia and Paresthesia to my right leg and foot on 1/5/21, this progressively worsened. On the 6th January, the paresthesia worsened and started to occur on the left foot- anterior and dorsal surfaces. In addition, at about 21:45hrs, I started having lower back pain- severe, rated about 6/10 in severity. This progressively worsened to 10/10 in pain severity. On the 7th an, all my symptoms had worsened, despite taking Tylenol. On the 8th January 2021, I started having difficulty lifting my right foot and visited emergency room for further care. At that time I have had a series of investigations and lab work done, in addition to PCP and specialist referral including Neurologist, Physiatrist and for Physical therapy. I am still undergoing physical therapy with improvement in the weakness but I still have persistent and on going lower back pain and paresthesia in my legs and foot three months later.

Body aches, 2 weeks, arthritis medication meloxicam prescribed knee swelling, 8 days, steroid, muscle relaxer, x rays taken.

drooping face; complaining of right facial weakness; has difficulty closing right eye; headache; neck pain; hard to get into sleep last night; This is a spontaneous report from a non-contactable Other-Healthcare professional. A 31-year-old male patient received of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Pfizer, Formulation: Solution for injection, Lot number and Expiration date were not reported) via an unspecified route of administration on 16Mar2021 (age at vaccination 31 years) at single dose for Covid-19 immunization. Reportedly, there were no known allergies to medications, food or other products other medical history. Patient did not have COVID prior to vaccination. Patient was not tested for COVID post vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Patient was complaining of right facial weakness since 04Apr2021 (the day before yesterday), drooping face, has difficulty closing right eye. It was associated with headache, neck pain. The neck and headache pain scale was 7/10 for 4-5 days. It was reported that pain comes and goes. The headache was less when he works and exercise. But the headache was more severe at night. It was hard to get into sleep last night. There was no n/v/c/d, blurred vision, cp, sob, doe, fever, chills, cough, sore throat, runny nose, etc. There was no rash, numbness. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. The reporter assessed the case as non-serious with no seriousness criteria (Seriousness criteria-Results in death/ Seriousness criteria-Life threatening/ Seriousness criteria-Caused/prolonged hospitalization/ Seriousness criteria-Disabling/Incapacitating/ Seriousness criteria-Congenital anomaly/birth defect). No treatment was given for adverse events. Outcome of the events was unknown. Information about batch/lot number has been requested.; Sender's Comments: Based on the temporal association, a possible contributory role of BNT162B2 to the development of drooping face 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.

45 min after the shot my left foot went numb, a couple days later my left hand also went numb. Shoulders and neck became stiff. after 2 weeks numbness started to fade but now have tingling sensation instead and still on going after 5 weeks. Neck pain has still not subsided after 5 weeks. I have been to 5 Dr appointments so far with no conclusion or fix.

Fatigue directly after the shot, developing into chills at 11pm that evening. Injection site soreness. Woke up at 7am (8 hours later) with a low-grade fever (~99-100F), dizziness, nausea, and a terrible headache. Took an Aleve to help. Symptoms mostly went away by 11pm that evening (16 hours later, 48 hours from injection time). All symptoms besides minor muscle aches were gone by the follow morning.

Patient presented to ED with complaint of left arm pain starting today (2 days post-vaccine). Axillary pain, lymph node palpable. Dx axillary lymphadenopathy. Patient received ketorolac 30mg IM x1 and discharged home from ED.

Fever ranging from 101.2 to 101.5 (measured orally periodically) lasting approximately 12-18 hours; associated chills and sweats. Muscle and joint stiffness, soreness, pain. Dizziness.

April 26 2021 10:00 pm onset of noticeable chills 11:00 pm onset of severe chills, difficulty handling cutlery and other small household items precisely April 27 2021 01:00 am woke up with severe headache and neck pain, dehydration, dry mouth, general soreness body wide. Chills were gone by 01:00 am 01:30 am-03:00 am moderate fever, burning up 03:00 am onset of mild nausea, difficulty drinking water to rehydrate 03:30 am onset of severe nausea, unable to drink water or ginger ale. headache subsides to moderate 05:45 am vomited 06:00 am nausea subsides to mild, again able to drink some water and ginger ale. neck soreness mild, rest of body back to normal 01:00 pm headache has subsided to mild and nausea is mostly gone 03:00 pm headache mostly gone, but recurs when standing up or sitting down quickly 08:00 pm mostly back to normal. mild lingering neck soreness In addition, pain at injection site (left deltoid) prevented me from raising my arm above my shoulder from April 26 ~8:00 pm to April 28 ~8 am. Symptoms other than feeling jet lagged were over by the time I woke up again the next day (8:20 am April 28) Light to mild pain using my left arm persisted until the morning of April 29.

2 days after my second pfizer dose, I had residual pain in my armpit on the side ingot the shot. While showering I noticed a large swollen lump under my armpit. Nearly 2 weeks later, the lump is still there,though 90% of the pain is gone. The lump has not reduced in size.

I had a fever reaching up to 104 F. I took Ibuprofen and Tylenol to drop it along with applying wet towels to my forehead and armpits. My fever increased to 104 F 4 times. Vomiting: After the first two fever spikes, I woke up feeling no fever. But, all of a sudden I vomited 5 times. I have had tiredness, muscle pain, and a really strong headache.

bilat wrist pain and swelling started ~2 weeks after 1st dose, recurred 1-2 days after second dose with more prominent symptoms in wrists and also pain and swelling in ankles.

The day after he received the second dose, he developed severe pain and stiffness in the fingers of both hands, which has persisted for 30 days.

Pt received first dose COVID 19 vaccine 3:07pm on left arm and left to pharmacy after 15 minutes observation. Pt came back to vaccine site after pharmacy c/o weakness and numbness in left arm 3:40pm. BP 127/92 HR 77 O2 98 BS83, last meal at around 1pm. NP was on site to evaluate pt. Pt is A&O but lethargic. Pt was able to move his right arm, right leg, and left leg weakly but not able to move his left arm. Both arm appeared to be pale. Sensation intact for all extremities, no facial droop. Pt then c/o SOB. Called ambulance, wife left with pt to medical center.

Started with numbness and tingling throughout both legs and progressively worsening to severe full body burning/buzzing pain. Also experienced dizziness and slight loss of muscle strength/coordination. Difficulty breathing.

Fever, chills, headache, sore arm, swollen arm, lethargy, sensitive and sore skin. These began within 6 hours of the shot and were debilitating for 48 hours. Severe for 49-72 hours and then fever broke and other symptoms gradually subsided over next 48 hours. At some (unknown) time after the vaccine, I developed viral pericarditis. In addition to the above, this manifested in chest pain (no difficulty breathing) which radiated from what felt like the lungs, through my windpipe, into a sore throat, jaw muscles hurting, inner ear and neck soreness. These symptoms lasted after all had subsided and didn?t disappear until 14 days after the 2nd vaccine.

Swollen lymph node in left underarm; Body ache; nausea; lethargy; chills; joint pain; tiredness; headache; This is a spontaneous report from a contactable consumer (Patient). A 31-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 19Apr2021 14:00 (Batch/Lot Number: Unknown) at the age of 31-years-old as single dose for covid-19 immunisation. Medical history included the patient diagnosed with COVID-19 prior to vaccination. The patient's concomitant medications were None, the patient did not receive other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced swollen lymph node in left underarm, body ache, lethargy, chills, joint pain, tiredness, headache, nausea on 20Apr2021 05:00. No treatment received for the events. Since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovering. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Chills; Fever; Really strong headache; Kind of dizzy; felt like he wanted to throw up all at the same time.; Joint pain; not have much of an appetite; This is a spontaneous report from a contactable consumer reporting for her husband. A 31-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 20Apr2021 at 10:00AM in shoulder (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included sinus problems from an unknown date. Patient normally has sinus conditions because of spring. Reporter cannot remember the name of it. Reporter stated that patient was not having sinus problems currently. The patient's concomitant medications were not reported. The patient previously administered First dose of bnt162b2 on 30Mar2021 at 10:00AM in shoulder for COVID-19 immunization at the age of 30-year-old. Reporter did not know which shoulder. Reporter thought it was in patient's left shoulder. Reporter was assuming it was patient's left shoulder because that made since for the drive through clinic. There were no prior vaccinations within 4 weeks and no Family Medical History Relevant to adverse events. Second dose was administered on 20Apr2021 at 10:00AM in shoulder. Reporter did not know which shoulder. Reporter thought it was in patient's left shoulder. Reporter was assuming it was patient's left shoulder because that makes since for the drive through clinic. Patient was having a lot of symptoms. Reporter called the clinic, and the clinic told her that patient's symptoms are okay as long as they do not last longer than 72 hours. The clinic also told reporter that she should call Pfizer to report patient's symptoms. Reporter has some questions. Whenever reporter called the clinic, the clinic gave her two phone numbers, one for Pfizer and one for the FDA. Reporter did not catch if she was supposed to call both numbers. Reporter is asking what the process for reporting is. Reporter is asking which place is more important to report too. Reporter is asking should she also be calling the FDA to report patient's symptoms. The patient experienced chills which began around 2:00AM to 3:00AM, on 21Apr2021. Patient's chills have been constant. Patients chills were still ongoing, they were coming and going. Patient's chills were so bad at first, that reporter was thinking about taking patient to urgent care. Patient went to bed with two comforters on him. Patient had been taking TYLENOL and it was working for his chills and fever. But as soon as the effects of TYLENOL start to wear off, his chills and fever come back. Reporter thought that patient's chills have gotten better since they started. The patient experienced fever which began in the morning of 21Apr2021. Patient still has a fever. TYLENOL was helping his fever. Patient's first fever was pretty intense. Patient's fever was a little bit better now. The patient experienced really strong headache which began in the morning of 21Apr2021. Patient woke up and went to the bathroom. He got a really strong headache, kind of dizzy and felt like he wanted to throw up all at the same time. Reporter thought that patient felt kind of dizzy because of his headache. Reporter made patient some soup at lunch time, and patient was able to eat some soup. He did not have much of an appetite. Patient went and got back in bed. Reporter thought that his headache has recovered completely now. Whenever patient was awake last, he did not say anything about it. The patient experienced joint pain which began around 2:00AM to 3:00AM of 21Apr2021. Patient told reporter that his bones hurt on the inside, reporter assumed that he meant joint pain. Last time patient was awake at 11:00AM, he told reporter that his joint pain was so bad. Reporter also that heard patient tell his manager his joint pain was bad. Patient was sleeping now, he was pretty knocked out. Reporter was unable to ask patient because he was sleeping. Therapeutic measures were taken as a result of chills, fever, really strong headache, kind of dizzy, felt like he wanted to throw up all at the same time, joint pain. The adverse events did not require a visit to Emergency Room or Physician Office. The outcome of events Chills, Fever was recovering, of events Really strong headache, Kind of dizzy was recovered on 21Apr2021, of event felt like he wanted to throw up all at the same time was recovered on an unspecified date, of event Joint pain was not recovered, of event not have much of an appetite was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

he started feeling pain at injection site at arm, fatigued, really tired, sleepy, body aches but no c/o of fever. He complains that his temperature is fluctuating between hot and cold. No c/o sob but he states he has upper back by shoulder blade pain (states feels like someone is stabbing him but it comes and goes). He also states a slight neck pain and c/o his bones are hurting all over. Patient stated he felt nauseous in the morning after breakfast but no longer has that feeling. Patient took Motrin on Monday @6:30am and around 12pm but didn't do anything. Advised patient to take Tylenol as directed, rest up and hydrate and monitor himself. Also informed him if feels any SOB or chest pain to seek medical attention (ER or urgent care).

Patient received vaccine and fainted. He was dizzy, felt hot, was groggy, and side of his neck hurt. He had no previous reactions to any vaccines. We provided water, cool cloth, and called ambulance.

Woke up 2 days after vaccine and had tingling pins and needles throughout all my extremities. Massive tension headache and pressure behind eyes and sinus that has lasted so far for 3 weeks, tinnitus, blurred vision, joint pain, muscle weakness, muscle twitching in face and throughout body, numbness in all my limbs, burning sensations on my neck and back, stomach pain, and heart palpitations that sent me to the ER. When I walk and move my arms I feel weak. The vaccine has effected my nervous system in a terrible way. The ER doctor, ENT, PCP, Optometrist, and Opthamologist told me it was inflammation due to the vaccine. I was prescribed 6 days prednisone, 40mg for 2 days then taper down and they put me in a "let's wait and see" mode. All symptoms have persisted since. I follow-up with a cardiologist on 05/14/2021 and waiting appt for a neuro ophthalmologist.

Got a fever, chills, muscle aches, headache, fatigue. Took Tylenol. Had symptoms through the night, slightly better in the morning. Tylenol seemed to help a little. Gradually better through the day, then worse toward the evening, though not as bad as the first night.

Muscle aches, high fever started roughly 1 day after the vaccination. Fever subsided after about 6 -7 hours.

Patient received vaccine Thursday morning. Later that evening, he started experiencing chills, fever (>101F), and body aches for the next couple of days. Saturday morning, fever continued with body aches throughout the day but other symptoms subsided. Chest pain started Saturday evening but patient was unsure what it was. Saturday after midnight, patient went to sleep and woke up after 30 mins with chest pain, chest pressure, burning sensation in chest, and stiff neck. Patient couldn't lay down in bed and went to ED.

Mild headache; Mild pain in some of the muscles; Mild pain joints of the left hand; This is a spontaneous report from a non-contactable 31-year-old male consumer reported for himself that: A 31-years-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE;Solution for injection ;Batch/Lot Number: EN5318), dose 1 via an unspecified route of administration, administered in Arm Left on 29Jan2021 11:45 as SINGLE DOSE for covid-19 immunisation.Medical history included food allergy from an unknown date and unknown if ongoing.The patient's concomitant medications were not reported.The patient previously took bactrim and experienced drug hypersensitivity.The patient experienced mild headache on , mild pain in some of the muscles mild pain joints of the left hand on 31Jan2021 The events were assessed as serious Non serious by health authority on 31Jan 2021 outcome of events was recovered. No follow up attempts are possible. No further information is expected.

Congestion; fatigue; muscle aches. Tested negative for COVID on April 19, 2021. Previously had COVID in December 2020.

sleepless night; abdomen pain; rash that started on my left ankle and spread onto both feet, legs, and arms/red dots on my extremities; Joint pain that got progressively worse; inflamed bowels; joint inflammation and pain; currently home in the same pain and red dots on my extremities; Henoch schoenlein purpura vasculitis; Stomach ache that got progressively worse as the day went on; This is a spontaneous report from COVAES. This is a report from a contactable consumer (patient). A 31-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 21Apr2021 10:15 (Batch/Lot Number: EW0164) as 1st dose, single (at the age of 31 years) for covid-19 immunisation. Medical history included hypersensitivity to Penicillin. The patient did not receive "any other vaccines" within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient experienced stomach ache that got progressively worse as the day went on (hospitalization) on 22Apr2021 08:00 with outcome of not recovered , sleepless night (hospitalization) on an unspecified date with outcome of unknown, abdomen pain (hospitalization) on an unspecified date with outcome of unknown , rash that started on my left ankle and spread onto both feet, legs, and arms/ red dots on my extremities (hospitalization) on an unspecified date with outcome of unknown , joint pain that got progressively worse (arthralgia) (hospitalization) on an unspecified date with outcome of unknown. The patient went to the ER (emergency room) 2 times in 3 days, then was admitted into the hospital for 5 days of tests and observation. The patient was diagnosed with henoch schoenlein purpura vasculitis (hospitalization) on an unspecified date with outcome of unknown , inflamed bowels (hospitalization) on an unspecified date with outcome of unknown , joint inflammation and pain (hospitalization) on an unspecified date with outcome of unknown and currently home in the same pain and red dots on my extremities (hospitalization) on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included nasal swab: negative on 26Apr2021, sars-cov-2 test: results not on unspecified date. Since the vaccination, the patient has been tested for COVID-19 however, no results were reported. Therapeutic measures were taken as a result of stomach ache that got progressively worse as the day went on. Treatment included Pain medication, diet change/reduction, and observation.

achy joints; mild sore throat; nausea; Fever; chills; shaking; Headache; This is a spontaneous report from a contactable consumer (patient). A 31-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 18Feb2021 11:45 (Batch/Lot Number: EL3247) as age at vaccination of 31-years-old, as single dose, for covid-19 immunisation. Medical history was none; the patient had no allergy. Patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 28Jan2021 03:00 PM (Batch/Lot Number: EL3247) for covid-19 immunisation. There were no concomitant medications. The patient did not receive other vaccine in four weeks and did not receive other medications in two weeks. Starting at 2 AM on 19Feb2021, the patient experienced achy joints then fever, chills, shaking, headache, nausea and mild sore throat were all experienced. Therapeutic measures were taken as a result of the events and included administration of ibuprofen. The patient had not covid prior vaccination and was not covid tested post vaccination. The patient was recovering from the events. Follow-up attempts completed. No further information expected.

pressure headache; tinnitus; hyperacusis; grainy and double vision; photophobia; facial twitching; Pain in back, shoulders and arms; Pain in back, shoulders and arms; Pain in back, shoulders and arms; Burning sensations in back and arms; Muscle weakness in legs and arms; Large rash at injection site; Swollen lymph nodes in both arms; This is a spontaneous report received from a contactable consumer (patient). A 31-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: ER8736, Expiration date: not reported) via an unspecified route of administration in left arm on 23Apr2021 at 10:00 AM (at the age of 31 years) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient medical history included diabetes (controlled) and concomitant medications were not reported. The patient had a history of allergies to Demerol. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EP6955, Expiration date: not reported) via an unspecified route of administration in left arm on 31Mar2021 at 12:00 PM as 1ST DOSE, SINGLE for covid-19 immunisation. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination was reported as Vitamin C, D3. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 26Apr2021 at 07:45 AM, the patient stated that he woke up with pressure headache, tinnitus, hyperacusis, grainy and double vision, photophobia, facial twitching, pain in back, shoulders and arms, burning sensations in back and arms, muscle weakness in legs and arms, large rash at injection site, swollen lymph nodes in both arms. The adverse events resulted in the doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment was received for the adverse events which includes Prednisone. The events were reported as non serious. Outcome of the events were reported as Not recovered.

Upon receiving the second dose of the COVID-19 vaccine, I immediately felt tingling or chills in the arm where the shot was administered. This developed into muscle soreness as I sat through the waiting period before leaving the facility. (For this reason, I had taken acetaminophen at about 8:30 that morning.) I experienced both of these symptoms after my first shot of this COVID-19 vaccine, so these did not concern me. After taking a nap back at my house, I woke up about 3:30 p.m. experiencing some partial numbness in my left arm, which received the injection. It was not inhibitive, but I can somewhat relate it to the neuropathy my mother experienced before being diagnosed with diabetes in 2005. It was a bit like the tingling I first experienced after the injection, but throughout the injected arm. As I continued through that afternoon and evening, my arm kept getting stiffer and stiffer. This prompted me to take my temperature at about 8 p.m. and then again at 10 p.m. Both of these tests resulted in a normal temperature of 98.3 or 98.4 degrees. By the time I was about to climb into bed at midnight, the stiffness had spread to my shoulder joint -- such that almost any movement of that arm elicited some mild discomfort, especially if I leaned against the wall with that shoulder or raised my arm above my head. I took a third dose of acetaminophen. My normal prone sleeping position was not comfortable with this stiffness, so I did my best to sleep on my back. Next, I woke up too hot about 3:30 a.m. (Wednesday, May 26) and could not get back to sleep. Full-body chills set in soon after, prompting me to turn off my ceiling fan. I faced some mild nausea as I attempted to get comfortable in bed again. I suspected I was feverish by at least 4 a.m., but I did not get up to check my temperature until 5 a.m. The thermometer gave a reading of 100.3 degrees, so I took another dose of acetaminophen (my fourth in 24 hours) and tried to go back to sleep.

Inflammation; Chills; Sweats; Fever; Shaking; could not sleep very well and was going in and out of sleep; Dizziness; Unable to eat; Weakness; Shortness of breath; Excruciating hemorrhoid pain; Left arm was really stiff; Left arm gets locked up; This is spontaneous report received from a contactable consumer (patient). A 31-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in arm left on 03May2021 (Lot Number: EW0179) as 2nd dose, single at the age of 31-years-old for covid-19 immunization. Medical history was none. Family medical history included: High blood pressure, diabetes, high cholesterol and heart problems. The patient's concomitant medications were not reported. The patient received 1st dose of bnt162b2 on 12Apr2021 with Lot ER8729, expiration is unknown, injected intramuscularly in left arm. No additional vaccines administered on same date of the pfizer suspect. No AE following prior vaccinations. No other prior vaccinations (within 4 weeks). The patient received the 2nd dose of the bnt162b2, and the next day (04May2021 12:00) the patient had excruciating slowly pain like a hemorrhoid pain. The patient bought hemorrhoid cream. The patient experienced shortness of breath on 05May2021, when he woke up yesterday he had it as well. He could not sleep very well and was going in and out of sleep. He could not sleep because of discomfort for hemorrhoid pain. The patient also had dizziness on 06May2021 12:00, inflammation, chills, sweats, and fever. He said that his left arm (injection site) gets locked up on 03May2021 23:00. He also said that he experienced shaking, weakness and was unable to eat on 05May2021 11:00. When he woke up on 04May2021, his left arm was really stiff. Yesterday, he was not able to eat (worsened). His weight was provided as being between 180-190 lbs. There was no prescriber. NO ER or physician's office required. Outcome for hemorrhoids was provided as both persistent and worsened, of the events shortness of breath, dizziness, weakness, left arm gets locked up was not recovered, of other events was unknown. No follow-up attempts are needed. No further information is expected.

Within a minute or less of receiving the shot, I experienced a rapid and intense onset of blurred vision, lightheadedness, profuse sweating, and extreme numbness all over but especially in my hands and feet. I came close to losing consciousness and was instructed to lay down with my knees bent to increase blood flow. I slowly came to over the course of probably 10 minutes while laying on the ground, but my hands and especially my fingers remained numb for 30-45 minutes while I experienced chills. My left hand and fingers were extremely pale and bluish during this time. I also had minor pains on the left side of my neck and left shoulder blade. Color came back to my left hand and chills subsided around an hour after my shot.

Patient had pain shooting from back to leg. He was unable to walk or work for two days. He had high fever of 102. Pain was said to be an 9/10.

Pain in jaw, head, neck, shoulders, and lower back. Started May 30. Not an injury from trauma. Not from overexertion. Back and shoulder pain subsided about about 5 days, but neck pain and headache continued through Tuesday, June 8. Treated with Ibuprofen and Tylenol with little effect. Went to the emergency room on June 2 at the advice of a physician. No apparent cause. I was given a strong anti-inflammatory that eased the pain slightly. The pain was about 5-6/10 for the duration of the event. Relief only came with a full-body massage from a licensed massage therapist. Still suffering from some jaw pain and minor headache.

Dose 1 - I had increased body wide nerve pain. At that time, they thought I had fibromyalgia and the shot caused a flare up. Dose 2 - I had very severe body wide nerve pain, vertigo, terrible migraines, vision issues, confusion, short term memory loss and grasping for words and increased muscle weakness. It kind of mirrored a stroke. The pain was a 10/10. It was basically like all of my symptoms were getting progressively worse over the weeks. It's gotten better, but the symptoms are definitely still there. My neurologist increased the dosage of a few of my meds. At this time, they're basically managing my symptoms, but we do not have a definite source for the issue. However, the vaccine definitely caused the flare up because nothing else in my life has changed.

On 6/11/2021 after my 2nd injection, I received muscular pains in my left arm. After applying pressure to it, it felt much worse. On 6/13 I went to a walk-in clinic to have it checked out. The NP prescribed 7 days of Naproxen 500mg and to use hot/cold treatment as needed. At the time of this form being filled out, I have a tingling sensation in my left hand and forearm, due to the Naproxen after doing research. The condition has not worsened.

On 6/11/2021 after my 2nd injection, I received muscular pains in my left arm. After applying pressure to it, it felt much worse. On 6/13 I went to a walk-in clinic to have it checked out. The NP prescribed 7 days of Naproxen 500mg and to use hot/cold treatment as needed. At the time of this form being filled out, I have a tingling sensation in my left hand and forearm, due to the Naproxen after doing research. The condition has not worsened.

Shortly after receiving my second dose of the Pfizer vaccine on 30 Mar 2021, there was insidious and unilateral onset of pain of the left shoulder that quickly amplified in severity and intensity. This pain was subsequently replaced over the ensuing days and weeks with progressive weakness, reflex changes, and sensory abnormalities in shoulder girdle musculature and proximal upper limb. The progressive neurologic deficits of motor weakness, dysesthesias, and numbness have persisted. Subsequent tests (MRIs and EMGs) have been ordered to confirm and/or rule out possible causes of the event.

After first shot there was minimal effects, just a sore arm and fatigue. These went away within a day or so. Second shot had immedate fatigue, body aches, and headache within 12 hours. Again these subsided within 48 hours. However within the week I developed a mild red rash across my body from my chest down to my knees, and an ache in my left ankle. I assumed I had twisted the ankle without realizing and the rash had to do with my seasonal allergies. I began taking Benadryl for the rash and rested the ankle, but the rash only slightly faded and while the ankle got slightly better, the ache moved to my right shoulder, then my left elbow, then the left knee, then right knee, then to the joints in fingers on my right hand. Finally mos recently the ache has moved to joints in the left hand. Each time the aches move the previous location feels slightly better but isn't back up to 100 percent. And aches seem to move every 4/5 days. It has now been over a month since the second shot and the joints of my body still feels abnormal and strained. And in the last few days I have developed a terrible headache that doesn't seem to go away.

The patient is a 31 year old kidney transplant recipient who had been in his usual state of health and feeling well over the past months. On May 7, he received the first dose of COVID vaccine and experienced intense myalgias at that time. He recovered, but then around May 17 noted the onset of pain in the R thigh and lower R back and subsequently developed a vesicular rash in this area. He saw his primary care physician who prescribed gabapentin. However his pain worsened and the rash extended and he presented for admission. He was diagnosed with disseminated zoster, was hospitalized from 5/24/21 - 5/29/21 and was treated with IV acyclovir followed by oral valacyclovir.

GOUT ATTACK THAT CAME 1 WK PRIOR WAS HEALING AND RECOVERED 1 DAY PRIOR, AND AFTER VACCINATION, GOUT ATTACK EXACERBATED AND HAVE BEEN PROLONGED OVER A WEEK. STILL IN PAIN.

lower back muscle soreness; fever; chills/chattering teeth; This is a spontaneous report from a contactable other hcp. This HCP reported for himself that a 31-years-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: EL9263), dose 1 intramuscular, administered in Arm Right on 26Jan2021 16:45 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 31Jan2021 19:00, the patient experienced lower back muscle soreness; fever and chills/chattering teeth. Patient was not received treatment for events. The patient underwent lab tests and procedures which included body temperature: 102.3 fahrenheit on 31Jan2021 from 7 pm until 02Jan2021 afternoon,I had a fever, sars-cov-2 test: negative on 01Feb2021. It was reported that on 31Jan2021 from 07:00 pm until 01Feb2021 afternoon, patient had a fever of 102.3 degrees F with chills, chattering teeth and lower back muscle soreness. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been tested for COVID-19. The clinical outcome of all events were recovering. Follow-up attempts are completed. No further information is expected.

"Pt w/ hx of Asthma and Anxiety. No current information regarding pt medications available. NKDA at the time of vaccination. Pt presented for 2nd dose on 7/1. Pt noted that after first dose Pfizer, pt had neck tightness and angioedema. Time course unclear. Pt was administered Janssen IM Left Deltoid 206A21A as an alternative to 2nd dose Pfizer. No reaction noted after vaccination on 7/1."

After vaccine, the patient had a sore shoulder. The pain has not gone away since then. Pt has done imaging that shows likely impingement. Pain has gradually gotten worse overtime, interfering w/ patient's sleep.

uncomfortable; Extreme pain; Couldn't taste cheetos; Pulp in his arm; Worst fever he can imagine; Chills all over; Brain stating out/ his brain goes fuzzy; gutting his stomach; ribs were sore; Almost died; He thought his body went into shock; Numbness; This is a spontaneous report received from a contactable consumer or other non hcp. A 31-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EW0178) via an unspecified route of administration in Arm Right on 19Jun2021 15:00 as single dose for covid-19 immunisation. Medical history included ongoing substance use. Concomitant medication(s) included hydrocodone and unspecified antibiotics taken for an unspecified indication, start and stop date were not reported. The patient received first dose of BNT162B2 (Batch/lot number: EN5318) via an unspecified route of administration in Arm Right on 20May2021 as single dose for covid-19 immunisation. The patient experienced worst fever he can imagine, pulp in his arm, chills all over on 19Jun2021, extreme pain on 20Jun2021, couldn't taste cheetos on 22Jun2021, numbness, he thought his body went into shock, almost died, brain stating out/ his brain goes fuzzy, gutting his stomach, ribs were sore on Jun2021. Caller reported as he got the second Covid Vaccine in his arm. He literally almost died. He went to (withheld), and they said it is normal and he should take some Tylenol. If he can die it is not normal. The hospital didn't want to do anything because they were afraid people would use him as a scapegoat and say if he is incapacitated, they will never take it. He had a bad dose or just had a severe adverse reaction. He had his vaccination card on him. It didn't happen until he had his second dose. He had been shot in the face with a 357 Magnum at point blank range, and this is more painful than that. It is legit more painful. He has never felt worse pain in his entire life. His card says Pfizer Vaccine EW0178. Maybe he got a bad dose. Right now, he has to be careful to not sit in one position because he was very uncomfortable. Further reporter stated briefly extreme pain: They gave him the shot and he went to sleep, and his body was immediately super tender and painful. He thought his body went into shock. He was shot in the face by a 357 Magnum so he knows the feeling. It started at 0000. In the morning he woke up and tried to eat food and couldn't taste Cheetos. He tried to go to the bathroom and peed on his leg twice, he was that kind of numb. The real pain came from trying to just exist. He was so tender that breathing was an obstacle and touching a pillow against his skin felt like getting hit by a bus for the next couple days. He still doesn't feel all that great. He needs antibiotics and a painkiller. He was smoking marijuana because everyone left him in the cold. Pulp in his arm: He could feel like a pulp in his arm where it was worse. It felt like a bullet was put into his arm. It was all pulpy and feels nasty. It was dispersants of coagulation and blood or the medicine and blood or something else. Either way it is gross. He put his hand against it and massaged it and it hurt like hell. The pain subsided. It was like he has PTSD. He had to get that out of his arm. When he gets the pulpy stuff out of his arm the dispersing pain was less and less, but it was still super painful. That was how he woke up initially. It was there only slightly now. Brain stat icing out: He also keeps having his brain static-ing out which was not a good thing. His brain goes fuzzy. He has had no medical tests. The clinical outcome of the events Numbness, worst fever he can imagine, pulp in his arm, brain stating out/ his brain goes fuzzy was recovering and other were not recovered. Information on Lot/Batch number was available. Additional information has been requested.

Pressure, tingling, and numbness in his head and it spread to his arm and leg.; Pressure, tingling, and numbness in his head and it spread to his arm and leg.; Pressure, tingling, and numbness in his head and it spread to his arm and leg.; he was diagnosed with peripheral neuropathy; Pressure, tingling, and numbness in his head and it spread to his arm and leg.; Migraines; Insomnia; Fatigue; This is a spontaneous report from a contactable other health care professional reported via Pfizer sponsored program . A 31-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 13May2021 (Batch/Lot number was not reported) as dose 1, single (age at vaccination 31-year-old) for covid-19 immunisation. Medical history included none. There were no concomitant medications. No Family Medical History Relevant to AE. Prior to vaccination, the patient did not receive other medication within 4weeks. No AE reported following prior vaccination. On 13May2021, Patient started to experience fatigue and that was a normal side effect at approximately 10 am. The tingling and numbness she did not had exact time. While on 19May2021, patient started to have pressure, tingling, and numbness in his head, and it spread to his arm and leg. On unspecified date patient experienced Insomnia and migraines and he went to the doctor for tests to see what was wrong. Everything came back normal. The patient was hospitalized for two nights for the events pressure, tingling, and numbness in his head, and it spread to his arm and leg. Patient visited Emergency Room and Physician Office for the numbness, tingling and head pressure. Therapeutic measures were taken which included, patient has been given ibuprofen. That was what they typically give. It has been diagnosed as a migraine, for tingling given Gabapentin for he was diagnosed with peripheral neuropathy. For Numbness included Pretty much ibuprofen and gabapentin, it's all in one. Fatigue treatment included Gabapentin, they said gabapentin helps and makes sleepy and they increased it today and night because he was having insomnia as well. He was also taking magnesium and vitamin c. The patient underwent lab tests and procedures which included blood magnesium: low, blood test: normal, blood testosterone: low, thyroid function test: normal, vitamin c: low, vitamin d: low on an unknown date. Patient received his normal blood work. His thyroid and other normal labs. No investigation assessment was provided. The outcome for the event Pressure was ongoing it has been off and on recovering, Tingling, and numbness in his head and it spread to his arm and leg was not recovered while Fatigue was recovering, and rest of events outcome was unknown. His second was scheduled for 03Jun2021 and primary care assistant told him not to get the second shot, he only got one dose. Information on the lot/batch, further information has been requested.; Sender's Comments: Based on the information currently available,The casual association between the reported events and suspected vaccine BNT162B2 cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Increse in sense of smell (mostly disgusting odors) for 2 days. Back pain (the whole spine for 3 weeks predominantly in the morning and relieved with daily activity). Chills (3 days) Pain in the site of the injection with a radius of about 8 inches.

Sore throat, extreme fatigue first three days, developed into chest infection, coughing, persistent extreme fatigue. Slight sore muscles. Attempt at physical activity caused near collapse from nausea, and chest pain around heart.

severe cervicle neck pain for 3 weeks including radiculapathy severe headache inter cranial pressure for 2 weeks non stop pressure in head and different parts of the brain due to elevation swollen lymph nodes left side of face correlates to vax in left arm swollen face and neck fluid filled ears and pressure & mastoid bone pressure neasua due to constant feeling of unsteadiness dizziness & vertigo for 7 weeks tingling in each section of brain electrical shock sensations weakness in arms legs hands severe fatigue and malaise lingering severe brain fog peripheral vision blurriness constant tunnel vision spine pain to middle spine after neck pain stopped chest bone pain and tightness heart pressure and pain random joint pain weakness tingling in hands and legs and head stomach discomfort diarrhea for 6 weeks and soft stool ringing in ears occasionally arachnoid cyst found where grinding & neck pain originated radiating into back of head and severe headaches to entire brain or different sections at random

After 2 days receiving the shot - woke up with severe painful swelling in the outer right chest and under armpit area. Swelling continued for multiple days and as of this time is still present but no longer painful.

patient developed cough, fatigue, muscle aches, and runny nose on 7/27/2021. He tested positive for COVID on 7/28/2021

He got a little bit of tingling in his left arm; headache; Muscle soreness in the arm the vaccine was administered; His thumb looks swollen and inflamed; Muscle weakness; Experiencing swelling in left arm/thumb and numbness from tip of thumb to joint on opposite limb of administration.; Experiencing swelling in left arm/thumb and numbness from tip of thumb to joint on opposite limb of administration.; This is a spontaneous report from a contactable consumer (patient) reported that a 32-year-old male patient receives first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685 and Expiration Date 31Mar2021) intramuscularly on 22Dec2020 15:00 at single dose for Vaccination (covid-19 immunization). The patient's medical history and concomitant medications was reported as none. The patient experienced swelling in left arm/thumb and numbness from tip of thumb to joint on opposite limb of administration. Since Wednesday, 23Dec2020, he has been experiencing some numbness in the arm opposite of where the vaccine was administered. He clarifies the vaccine was administered in the deltoid of his right arm, and the numbness he is experiencing is in his left hand. His thumb has been partially numb since last Wednesday. He got a little bit of tingling in his left arm since last Wednesday (23Dec2020).The patient explains on Tuesday, 22Dec2020, when he was administered the vaccine he only had typical side effects that went away within 24 hours. He experienced headache and muscle soreness in the arm the vaccine was administered. Both of these symptoms went away and he has recovered completely. After 24-36 hours, he noticed numbness on hand opposite of the arm where the vaccine was administered. His thumb has been partially numb which has lasted about 6 days. He clarifies the numbness is on the palm side- which he was told was not related to the nerve. His thumb looks swollen and inflamed compared to the other. He also has noticed muscle weakness in the opposite arm. The patient states he can't recall if the numbness occurred within 24 hours but he knows by 24 hours, he did have the numbness. His thumb is partially numb on the side of the palm and up to the middle of his thumb where the joint is.Patient states yesterday the numbness was noticeably worse when he was sleeping. However, today the numbness seems to be back where it was before. He forgets about the numbness since he is not actively doing anything with that particular hand, but he doesn't forget about it completely. The numbness hasn't improved any, it's been consistently there and never went away. While reading off of his card, the patient cannot determine if the Lot number is an F or an E because the number is underlined. He thinks it might be an E. Patient was able to confirm the Lot number begins with an E after looking at the information sheet he was provided. He also sees the product number, CVX 208. Patient states he has no allergic reactions and nothing that he knows of that is an underlying condition. Patient states he hasn't had any testing done in regards to these events. He wanted to talk to the manufacturer and report it to the (Contact center name) first before he schedules something at Urgent Care. He wanted to check and see if what he is experiencing is a lesser known symptom. He couldn't find this information anywhere. The outcome of events, headache and muscle soreness was recovered on 23Dec2020. The outcome of Numbness in hand was not recovered. The outcome of other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Myalgia; chills; low grade fever; headache; This is a spontaneous report from a non-contactable physician. A 32-year-old male patient received the 1st dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown since unable to locate or read the details) via Intramuscular on 21Dec2020 at single dose in the arm right for covid-19 immunisation. Medical history and concomitant medications were not reported. On 21Dec2020, the patient experienced Myalgia, chills, low grade fever, headache. The patient did not receive any treatment. Outcome of events was recovered in Dec2020. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

12 minutes after vaccine had left sided chest pain and mild shortness of breath. In the evening the same day developed chills and diffuse muscle pain. Following was lightheaded, waves of Tachycardia (resting HR 50s would go as high as 120s at rest). Symptoms came in waves of chest pain, SOB, lightheaded and tachycardia throughout. Patient seen in clinic 1/7/2021 with symptoms slightly improved.

With in 12 hours had muscle soreness in right arm, headache. Got weakness in arm for 2 weeks. Shooting pains in arm. Feels like a pinched nerve when the left arm in moved. Numbness in thumb.

Myalgia, Arthralgia & NauseaVomiting Narrative: chills, chest tightness/pain, fatigue. in bed for 2-3 days, off work one day. No previous reaction to dose #1

chills, migraine, cotton mouth, whole body muscle aches, congestion. Was woken up by chills and head. Went to shower and sat in hot shower for 25-30 minutes. got out. chills returned, got back in shower for 10 minutes. took excedrin and then went back to bed with heat blanket.

Myalgia began on 1/9/2021 mid day. Sunday 1/10/2021 at noon fever to 100.7. Symptoms since have resolved with no interventions.

suspected COVID-19; suspected COVID-19; Fatigue; Body aches; Headache; chills; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 04Jan2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable healthcare professional, the patient, from a Pfizer sponsored program IBCC (Inbound Call Center for HCPs). A 32-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK5730), intramuscular in the left deltoid on 15Dec2020 at 21:00 (at the age of 32-years-old) as a single dose for COVID-19 immunization. Medical history included ongoing hypertension from 2009 and COVID-19 from 10Jun2020 to an unknown date in 2020. Ongoing concomitant medications included fosinopril (MANUFACTURER UNKNOWN) taken for hypertension from 2017. The patient did not receive any other vaccines on the same day as the BNT162B2 vaccine. On 19Dec2020, shy of about 96 hours of getting the vaccine, the patient experienced fatigue, body aches, headache and chills. He did not have any fever. The patient stated that he recovered from the fatigue, body aches, headache and chills by 19Dec2020. The patient was fine from 19Dec2020 until 01Jan2021. On 28Dec2020, the patient had a COVID-19 PCR test that came back negative. On 01Jan2021, the patient suspected that he had COVID-19. He had a fever of 103.1 degrees Fahrenheit, body aches, chills like he was freezing to death, fatigue, diarrhea; however, he did not have nausea or loss of taste or smell. He had swollen lymph nodes, but no sore throat and his oxygen saturation was okay in Jan2021. He was also having chest pain but it was more like intercoastal pain. He stated that these current symptoms were significantly worse than the ones he had just after getting the vaccine and felt more like the symptoms he had when he had COVID-19 before on 10Jun2020 (positive IgG for COVID-19-tested in 2020). The patient had a COVID nasal swab (PCR) done at an urgent care (physician's office) on 02Jan2020 or 03Jan2020 and was awaiting the results. The clinical outcome of the suspected COVID-19 was not recovered.; Sender's Comments: A causal association between reported suspected COVID-19 cannot be excluded.

Following the first COVID vaccine dose on Dec/18/2020, I had headaches that started on the third day and ended on the tenth day. The headaches were usually light, unilateral, and alternating from one side to the other. I was usually functional except on the fourth and seventh days where the headaches were moderate to severe, and I took naps to help with the headaches for those two days. I have never had an issue with headaches before, and these symptoms were a new experience for me. I did not take any medications as treatment for the headaches. Following the second COVID vaccine dose on January/7/2021, I felt fatigue and generalized muscle aches within six to twelve hours, and these symptoms lasted for two days. On January/10/2021, when I woke up that morning I again felt light, unilateral, and alternating headaches. In addition, I noticed that I was unable to move the left side of my face. I felt moderate tingling sensations associated with the distribution of the paralysis. When I looked in the mirror, I could quite noticeably see asymmetry in my face. I immediately went to the emergency department at the hospital where my primary care doctor is located. I was kept in the hospital into the next day for observation. After evaluation by a neurology team and an MRI, I was provided with the diagnosis of Bells Palsy. I have never previously been diagnosed with Bells Palsy, and I have never previously had a hospital stay before. The doctors prescribed medications which I am currently taking. As of today January/12/2021, the symptoms have had some improvement, but the symptoms still continue.

I was fine immediately after the shot on Friday 1/8/21. I experienced slight muscle soreness in the left arm near the administration site. At about 8:30PM, I started to get chills and started to have muscle soreness all throughout my body (shoulders, arms, back, legs, abdomen, etc.). I went to bed at about 11:30PM with the soreness and chills. I woke up at about 7AM and the chills had resolved. The muscles soreness and now a headache remained up until about 5:30PM on Saturday 1/9/21. After that, I felt right back to normal.

Site: Pain at Injection Site-Severe, Systemic: Joint Pain-Medium, Systemic: Confusion, Delrium -Severe

12-36 hours after administration consistent fever with tmax 102.6, also with headache, myalgias, chills, and significant fatigue. Beyond 36 hours fatigue and occasional myalgias, headaches persisted.

Developed subjective fevers and night sweats the night after receiving the second dose. Upon waking, I had significant chills, muscle and body aches, and fatigue. These symptoms lasted between 12-24 hours.

20 minutes after shot, had muscle pains, headache, nausea, joint pains, 14 Jan had joint pain and fatigue

Chills; fever; muscle soreness; headaches; swollen lymphnodes; This is a spontaneous report from a contactable healthcare professional. A 32-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot number EV5730, intramuscular in right arm on 17Dec2020, at 12:00 PM (at the age of 32 years old) as a single dose for COVID-19 immunization and the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL 3246, intramuscular in right arm, on 07Jan2021 at 11:00 (at the age of 32 years-old) as a single dose for COVID-19 immunization. The vaccinations were administered at a hospital. Medical history included an allergy to sulfa drugs. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. It was not known if the patient receives any other vaccines within 4 weeks prior to the COVID vaccine. The patient received unspecified medications within 2 weeks (date not reported) of the vaccination. On 08Jan2021 at 00:00, the patient experienced chills, fever, muscle soreness, headaches, and swollen lymph-nodes. The patient was not hospitalized for the events nor received treatment. The clinical outcome of the events of Chills, fever, muscle soreness, headaches, and swollen lymph-nodes was recovering. Since the vaccination, the patient had not been tested for COVID-19.

myalgias; fever; headache; nausea; This is a spontaneous report from a contactable consumer. A 32-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration (left arm) on 08Jan2021 (12:00 PM) at single dose for Covid-19 immunization. The patient's medical history reported as none; no known allergies. Concomitant medications were not reported. The patient previously received the first dose of BNT162B2 via an unspecified route of administration (left arm) on 18Dec2020. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that the day after the 2nd injection 09Jan2021, the patient had myalgias, fever, headache and nausea. It had mostly resolved on the following day 10Jan2021 and completely resolved on 11Jan2021. The patient took Tylenol and Advil as treatment. The outcome of events was recovered on 11Jan2021. The patient has not been tested for COVID-19 since the vaccination.

Myalgias; fatigue; sweats; headache; chills; Fever/T max 102.6; This is a spontaneous report from a contactable physician. This 32-year-old male physician (patient) reported for himself that he received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number= EL1283), via unspecified route at left arm on 08Jan2021 04:45 pm at single dose for COVID-19 immunization. Medical history and concomitant drugs were not reported. Historical vaccine included the first dose of BNT162B2 (lot number= EK5730) for COVID-19 immunization on 18Dec2020 04:45 pm at left arm. Facility type vaccine was hospital. No other vaccine in four weeks. No other medications in two weeks. No COVID prior vaccination. No COVID tested post vaccination. On 09Jan2021 04:15 am, patient experienced fever/T max 102.6, myalgias, fatigue, sweats, headache and chills. No treatment was received for events. Outcome of events was recovering.

Muscle stiffness through out the body, headach/migraine, sore area at injection site with tenderness. All of this was after the second dose.

Unable to move the left side of my face/I could quite noticeably see asymmetry in my face/I was provided with the diagnosis of Bells Palsy; I felt moderate tingling sensations associated with the distribution of the paralysis; Generalized muscle aches; I felt fatigue; Dizziness; This is a spontaneous report from a contactable Physician. A 32-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3246) on 07Jan2021 at 09:00 a.m. intramuscular on left deltoid, at single dose for COVID-19 immunization. Relevant medical history was not reported. Concomitant medications included omeprazole. The patient received first dose of BNT162B2 on 18Dec2020 at 09:00 on left arm (lot number: EK5730) and experienced headaches that started on the third day and ended on the tenth day. Following the second dose on 07Jan2021, patient experienced fatigue and generalized muscle aches within six to twelve hours, and these symptoms lasted for two days. On 10Jan2021, he noticed that was unable to move the left side of his face. He felt moderate tingling sensations associated with the distribution of the paralysis. When looked in the mirror, he could quite noticeably see asymmetry in his face. Patient immediately visited emergency department at the hospital where his primary care doctor was located. Patient was kept in the hospital into the next day for observation (as reported). After evaluation by a neurology team and an MRI, patient was diagnosed with Bells Palsy. He had never previously been diagnosed with Bells Palsy, and never previously had a hospital stay before. It was also informed that patient underwent Nasal Swab for SARS-CoV-2 test on an unspecified date in Dec2020 and on 10Jan2021, both resulted negative. At the time of the reporting, the symptoms continued.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of diagnosed Bells Palsy presented as unable to move the left side of his face/felt moderate tingling sensations associated with the distribution of the paralysis/asymmetry in his face cannot be excluded, considering the plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Large nodule on left side of neck; Lymphadenopathy; Some pain occurs when straining neck, but mostly just very uncomfortable; Some pain occurs when straining neck, but mostly just very uncomfortable; Some pain occurs when straining neck, but mostly just very uncomfortable; This is a spontaneous report from a contactable pharmacist (patient). A 32-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm, on 15Jan2021 at 13:00 (at the age of 32-years-old) at a single dose for COVID-19 immunization. Medical history included penicillin allergy and sulfa allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications, taken within two weeks of vaccination, included ibuprofen (MANUFACTURER UNKNOWN). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on an unspecified date for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced large nodule on left side of neck, lymphadenopathy, and some pain occurs when straining neck, but mostly just very uncomfortable on 16Jan2021. The clinical course was reported as: The patient woke up the morning after being vaccinated and had a large nodule on left side of neck, which appeared to be lymphadenopathy. There was some pain that occurred when straining neck, but patient was mostly just very uncomfortable. The patient did not receive any treatment for the events. The clinical outcome of large nodule on left side of neck, lymphadenopathy, and some pain occurs when straining neck, but mostly just very uncomfortable was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.

Pain at injection site; Severe headache; Myalgias; Fever; Chills; Night sweats; Weakness; This is a spontaneous report from a contactable physician (patient). A 32-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EK4176), via an unspecified route of administration in right arm, on 13Jan2021 at 10:15, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (Lot Number: EK9241) on 24Dec2020 at 12:15 PM for COVID-19 immunization (left arm) and developed pain at injection. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. The facility where the vaccine was administered was in a hospital. On 13Jan2021 at 8 PM after the second dose, the patient developed pain at injection site similar to the first dose but also developed severe headache, myalgias, fever, chills, night sweats, and weakness about 8-10 hours after the injection that lasted throughout the night. The patient was currently more than (>) 24 hours after the second injection and while most symptoms have resolved, the patient still had significant weakness and myalgias. Treatment was received for the events including paracetamol (TYLENOL). Post-vaccination, the patient has not been tested for COVID-19. The patient was recovering from "Myalgias" and "Weakness". The patient recovered from the remaining events in Jan2021.

Bilateral lower thigh soreness starting 2 days after vaccine (12/21/20) subsequently developing into severe bilateral lower thigh pain and cramping 3 days after the vaccine (12/22/20) persisting for approximately 2 weeks. Confirmed as rhabdomyolysis with elevated CK on 12/29/20, and saw physician on 1/2/21, with subsequent downtrending CK but elevated on 1/2/21.

The main side effect I wish to report is severe joint pain in both knees, lower back, and ankles. Started around 3:00AM the night of the vaccine and lasted about 32 hours. I also experienced severe headache, restlessness, a 100.4-101.0 F fever lasting about 16 hours from 3:00 am of the night of vaccine. I did not take any medications. Side effects resolved on their own.

Fever, chills, muscle aches, and headache. Symptoms caused insomnia. No treatment. Symptoms subsided in 16 hours.

About 12 hours after, fever-like systems; joint pain; fatigue; chills; aches; symptoms lasted two days - treated with Advil. Advil helped. It was gone after the two days. Had to talk to my employee to clear me to go back to work.

Sharp pain in my upper back / neck / shoulder area. Radiates from the left side. Pain started at an 8 on a 1-10 scale. Has slowly gotten better (at a 5 pain scale today 2/25).

Joint pain in arm, shoulder, hip, and leg on side of injection site; joint pain in arm, shoulder, hip, and leg on side of injection site; Joint pain in arm, shoulder, hip, and leg on side of injection site; fever of 99.8 F; Headache; Constipation; Sweating, so much sweating; This is a spontaneous report from a contactable consumer (patient). A 32-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration (left arm) on 10Feb2021 (13:00) (at the age of 32years) at single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 (lot number: EL3247), via an unspecified route of administration on 20Jan2021 (12:00PM) (at the age of 32years) for COVID-19 immunization. The patient has no medical history; no allergies to medications, food, or other products. Concomitant medication included vitamin B complex (VITAMIN B) also reported as "B vitamin supplement" taken from an unspecified date. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 10Feb2021, the patient experienced joint pain in arm, shoulder, hip, and leg on side of injection site. The patient woke up with fever of 99.8 F that ended approximately 03:00 PM on 11Feb2021. The patient also experienced headache, constipation and sweating, so much sweating. There was no treatment received for the adverse event. The patient has not been tested for COVID-19 since the vaccination. The outcome of event fever was recovered on 11Feb2021; the outcome of other events was recovered on an unspecified date. This case is non-serious.

At approximately 15:30 began experiencing pain in right hand and wrist as well as headache. Then at approximately 18:00 began noticing decreased feelings in right hand and wrist. By 19:00 lost all feelings in right hand and arm also notable drift on stroke screening. Was seen at approximately 19:30hrs for possible stroke. Released at 23:30hrs after all results were negative for stroke. Still experiencing symptoms until the following morning. From then extreme pain was noted around a 3 inch circle of injection resolving approximately 24 hours later.

Fever peaking at 102 and persisting for around 72 hours, chills, sweating, severe fatigue, severe tightness/aching through neck and shoulders, significant swelling/tenderness in left armpit.

Pfizer-BioNTech COVID-19 Vaccine EUA: patient presents to ED one day after second dose of vaccine reporting polydipsia, polyuria, nausea, vomiting, and myalgias but no abdominal pain. Vitals within normal ranges except blood pressure 127/100 mmHg and pulse 110 beats per minute. Administered antiemetics, analgesics, intravenous fluids, antidiabetic medications and discharged to home in late afternoon. When additional triglyceride results became available patient contacted to go to ED for nausea and other symptoms in setting of elevated triglycerides. Shortly after midnight the next day patient presented to ED nauseated and fatigued. Vitals within normal ranges except for blood pressure 162/96 and pulse 107 beats per minute. Patient admitted with diagnoses of mild DKA and mild pancreatitis. Administered antidiabetic medications, intravenous fluids, antiemetics and discharged the next day with improvement in symptoms and laboratory values.

blacked out; Nausea; chills; sweating; muscle weakness; arm pain; fever; fell; This is a spontaneous report from a contactable healthcare professional (patient). A 32-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EN5318) via an unspecified route of administration on Right arm, at the age of 32-year-old, on 27Feb2021 13:15, single dose, for covid-19 immunisation. Medical history included gastrooesophageal reflux disease. Concomitant medication included esomeprazole magnesium (ESOMEPRAZOLE [ESOMEPRAZOLE MAGNESIUM]) and garlic supplement. The patient previously took amoxicillin and experienced drug hypersensitivity and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EN6198) on 06Feb2021 13:15, at right arm, at the age of 32-year-old single dose for covid-19 immunisation. On 28Feb2021 at 04:00, 15 hours after the shot was administered, the patient experienced nausea, chills, sweating, muscle weakness, arm pain, fever, fell and blacked out twice. The patient did not receive any treatment in response to the events. The patient was not diagnosed with covid prior vaccination and was not tested for COVID post vaccination. Outcome of the events was recovering at the time of the report.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported loss of consciousness 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.

Bruising at injection site arm and back aches for a week. Now I have yellow bruising and two lines of blood under my skin at the bruised area.

Patient had just received his injection and just sat down in the observation area when he had a sudden syncopal episode that was witnessed by other bystanders. EMS responded immediately. Patient was difficult to arouse, with some muscle rigidity. Patient returned to consciousness within 30 seconds. Patient was moved to WC, and still felt syncopal. HR was 62. Patient was laid down. Patient did have a small carpet burn on his right wrist, and some tenderness on his right side of his neck, and tenderness behind his left ear from his mask. After 30 minutes, patient was able to stand and walk without assistance. He was transported to home by his wife. Patient denied need for further medical assistance and would have his wife observe him at home.

injection site pain, tiredness, headache, muscle pain, chills, joint pain, fever, nausea, feeling unwell

About two weeks after first shot, I got shingles. It could be unrelated, but since I'm young, perfectly healthy, not abnormally stressed, and haven't ever had singles before, I thought there might be a chance it is related. I've seen online other young people who are saying that they got shingles after the first shot of Moderna or Pfizer. Maybe it was just a coincidence, but I figured it was worth reporting. It is overall a pretty mild case because I got on the antiviral drugs pretty quickly. Wondering if I should still get my second shot on schedule or wait until my shingles is all cleared. I have asked my doctor and am awaiting a response. I first noticed the symptoms on Saturday (3/20) exactly two weeks after my first shot.

-Onset after 1 hour - light-sensitivity migraine. Children's dose aspirin taken and decreased in severity at 37 hours. -Onset after 4 hours - altered temperature, between 95.9 F - 97.1 F (average is 98.2 F). Ongoing symptom after 96 hours (97.1 F as of typing this, taken on the hour). -Onset after 6 hours - feeling of physical exhaustion without sleepiness. Decreased in severity at 70 hours. -Onset after 18 hours - bone and joint pain, focused in mid-back, shoulders, hips, knees, and ankles. Decreased in severity at 42 hours. -Onset after 21 hours - Decreased mobility in shoulders, hips, and ankles. Decreased in severity at 38 hours.

Auxiliary lymphadenopathy on the left side of the body from March 24 to approximately March 29. Discomfort due to left auxiliary lymphadenopathy in armpit and a visible egg shaped swelling. Mild flu like symptoms of chills and joint aches occasionally from March 25 to March 26.

Tiredness and exhaustion in general/exhaustion/feeling like I am completely drained of energy; muscle and joint pain; muscle and joint pain; Pain in my arms and legs; Pain in my arms, back, and legs; This is a spontaneous report from a contactable consumer (patient). A 32-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EK9231, expiration date not provided), via an unspecified route of administration on 05Jan2021, 10:30 in right arm and then via unspecified route of administration (Lot Number: EL8982, Expiration date not provided) on 25Jan2021, 07:30 in the right arm both for COVID-19 immunization. The patient's medical history included very slight allergy to Kiwi fruit. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient had not been diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 26Jan2021, the patient experienced tiredness and exhaustion in general, performing any physical activity that requires a minor amount of effort leads to muscle and joint pain and exhaustion, while walking around the store pushing the cart has ended him calling out of work sick the next day due to pain in arms, back, and legs as well as feeling like he was completely drained of energy. It was reported that all events listed happened with the first shot and continued after the second dose but more severe. The patient had not received any treatment for the events. Outcome of the events was not recovered.

Fever of 100.1, pain at site of injection, body aches at lower back/upper leg the morning after the shot.

Was feeling fine the day I received the shot, albeit some pain at the injection site. I woke up early the next morning and my left jaw was sore, my left knee was swollen and hurt to move/walk, and the bottom of my left foot felt strange. There is also a very, very dull wave-like ache across the bottom of my front teeth.

Low grade fever, muscle aches, joint aches, headache, nausea, lethargy. Red bump and swelling at the injection site.

The vaccine was at 9am and by 8pm I began having lower back pain. The pain progressed through the night staying mostly central and rated 6/10. I tried to sleep and woke up at 2 am with worsening lower back pain with pain into my flanks and hips bilaterally that was burning in nature and now rated an 8/10. The back pain and right flank pain persisted into the following day and evening. I woke at 3am on Monday morning and was drenched from sweating. At that time I noticed my back pain was 75% better. As I woke in the morning at 7am it was 80% better. I still have some residual central back and right flank pain but it is manageable. At a 3/10.

Approximately 9 days after injection in left arm, started experiencing symptoms in right armpit consistent with swollen lymph nodes including: intermittent sharp stinging pain similar to ingrown hair or inflamed hair follicle, as well redness and dull pain upon palpation. Over several days, swelling has increased significantly and pain has increased a little as well. Today, 14 days after injection in left arm, starting to experience onset of lymph node swelling in left armpit as well. Additionally, starting 9 days after injection, concomitant with lymph node swelling, I believe I have felt slightly fatigued and have felt 1 degree warmer than usual, though not actually feverish. I confirmed a temperature of 98.9F today around 5:45PM, whereas my normal temperature is about 97.7F when measured by the same method.

4/9/21 Patient called to report symptoms that he believes resulted from his 2nd COVID Vaccination. He received his 2nd Pfizer dose on 4/7/21. He states that by the afternoon of the next day he developed severe headache, nausea, and feeling feverish. He states in the middle of the night he started vomiting red-colored vomit which he felt was from blood. He vomited approximately six times over an hour. The vomiting stopped after that. He also complained of soreness at the injection site which spread to shoulder. He rated his pain at that time as a ?7? on the ?1-10? pain scale. As of 4/9/21, he now feels better with no further symptoms other than muscle soreness. RN encouraged patient to follow up with his PCP to let them know about his symptoms including his complaint of bloody vomiting. Patient agreed to follow up with his PCP.

2020-04-05 - Fatigue with some diarrhea (also common with Nivolumab/BMS986016 that I'm also taking) 2020-04-07 - Noticeable malaise and back pain near left shoulder blade 2020-04-08 - Mild rash developing on left side of chest above nipple (same height as back pain) 2020-04-09 - Rash progresses - diagnosed with Shingles via text chat with photos with provider

Developed a medium size knot where shot was given that was hard and sore to the touch. Then also developed the same thing up on my collar bone area (may be a lymph node) that is more sensitive to the touch than my arm. Makes me arm feel somewhat numb and harder to grip at times.

Skin crawling, nerves going out of control, loss of muscle tone. Infections everywhere and cognitive problems haven?t been able to complete one task for 2 weeks. Can?t see properly either

On day 2 after my second shot i had severe joint and back pain. Knees, ancles, wrists of both hands and lower left shoulder. The pain in my knees and ancles seems to have gone away. Still have some light pain on right wrist and currently still continues daily pain on the left wrist and left shoulder.

On April 6 a.m. developed fewer-like symptoms with muscle pain typical foe fewer with these symptoms steadily worsening by evening. Night shower at appr. 9 p.m. caused a feeling of spinal nerve pinch followed by acute pain during certain movements and breathing. Following day (Wednesday) spent in bed taking Ibuprophene thinking is just a nerve pinch. Called virtual appointment tele doctor who prescribed Katorolac which I took from Wednesday night to Thursday morning per prescription with no effects. On Thursday evening called tele doctor again and got Ibuprophene 800 mg prescription. It helped for 20-30 min only. Same evening coughed some blood. On Friday kept taking Ibuprophene for very temporary relieve. On Saturday April 10 was admitted to hospital and was hospitalized with blood cloth diagnosis for 4 days.

Caller stated that she received his first vaccine on 4/13/2021 and on 4/13/2021 member's started having pain to his armpit with tenderness to his lymph nodes. He denies having other symptoms.

On Tuesday, March 30, 2021 a 47 year old male received his first doe of PFizer COVID19 vaccine (lot#-ER8727) at 3:550 PM at the school. At 3:57 PM, the pt came to the Observation desk, and stated, "I don't feel right. I feel like I'm going to pass out." Observation crew assisted the pt to the chair. The pt went completely "stiff". The pt was caught by Observation crew and did not fall to the floor. During this state, the pt had what sounded like snoring respirations. (Continued narrative on pg 3).

Radiating soreness/numbness (whole left arm/injection arm), neck/spine pain (similar to arm soreness) but 'pricklier', traveling pain/soreness (effected right arm), night sweats, dry throat, 'frog' in throat, sneezing, runny nose, stomach discomfort

Intense fatigue, mild headache, body aches (muscular pain and tiredness). This occurred the day after getting the vaccine for only 24 hrs. Today (two days after the vaccine) I feel good.

Once I received the dose my elbow began to hurt. The feeling later continued to my left hand. The elbow pain now feels of burning and stiff. My left hand has swelled and feeling of joint pain. My left hand also is cold to touch. No discoloration.

Patient reports dizziness, sore muscles, headache, and nausea that began at 10:30am this morning after receiving his first dose of Pfizer COVID 19 vaccine. He said between 10;30am and 11:00am his vision became blurred. At 2:30pm when patient called to make report he was still experiencing blurred vision. I strongly urged him to go to ER for evaluation or call his PCP ASAP. He verbalized understanding.

Fever, chills with uncontrollable shaking, whole body muscle fatigue and soreness, swollen lymph node with extreme pain. On 4/16/21 the pain from my left armpit lymph node almost made me vomit. Swelling has persisted through today 4/20/21. Chills started on 4/15/21 and ended 4/18/21. Fever from 4/15/21 to 4/17/21. Treated with bedrest and ice pack / warm compress.

Joint pain, nauseous, fatigue, body muscle aches, night sweats/chills, headache, and tingling over body.

Fever (101.5) for 18 hours. Light fever (99) until 36 hours after first symptom. Shakes and chills. Achey joints. Flu symptoms and weakness. Sluggish 24 hours. Cutaneous hyperesthesia for 48 hours. Chest pain and odd feeling when taking deep breaths until 04/23. Persistent headache until 04/24 evening. Headache persisted over front left eye and back of head.

while the lymph node swollen was declare i also feel some chest pain during the day since the day following the vaccination. it may be due to the swollen lymph node because the injection was on left arm hence the swollen is my left armpit but i have been feeling pressure in my chest and lot of pain coming from the swollen armpit.

Initially he was diagnosed with Bell's palsy/face drooling; did not have a knee reflex or any feeling in his hands; did not have a knee reflex or any feeling in his hands; severe muscle pain all over his body to the extent he can't move; severe muscle pain all over his body to the extent he can't move; This is a spontaneous report from a contactable pharmacist. A 32-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 intramuscular, administered in left arm on 06Mar2021 09:45 (lot number: EN6205) at the age of 32 years old, as single dose for COVID-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing. The patient has no known allergies. Concomitant medication included salbutamol (ALBUTEROL HFA) taken for an unspecified indication, start and stop date were not reported. Initially the patient was diagnosed with Bell's palsy, his diagnosis was changed to rare reaction to a vaccine as per ER report in the hospital. They changed the diagnosis because it was not only his face drooping (reported as drooling) but he did not have a knee reflex or any feeling in his hands, and severe muscle pain all over his body to the extent he can't move. At the hospital they excluded Lyme disease by blood work and stroke and spinal infection by spinal tapping. Then he was discharged. All events occurred on 12Mar2021 at 09:00 AM. AEs resulted in emergency room/department or urgent care. The patient underwent lab tests and procedures which included nasal swab (COVID-19 PCR test): negative on 13Mar2021; and on unspecified date, blood work which excluded Lyme disease and stroke and spinal tapping which excluded spinal infection. Corticosteroid was given as treatment for the events. The patient has not recovered from the events. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available information and an implied temporal association, the reported events are considered possibly related to BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Morning of April 29 ...severe joint point unlike normal related to chronic conditions. Knees and hips of both legs felt and appeared to be swollen. Mobility was limited due to discomfort. Treated with 800 MG OTC ibuprofen 1x and later in evening treated with 1,000 MG Acetaminophen. Pain got to be enough that 1 5 mg Oxycontin was taken around 9pm.

Within 10 minutes of receiving the immunization the patient felt hot, and pain down the back of his head and neck. He stated his chest felt somewhat heavy off and on. He did not have labored breathing. He was given cold compresses, blood pressure was monitored and 50mg of oral benadryl was given.

72 hours after receiving my 2nd dose of the Pfizer vaccine I developed a pain on the right side of my neck, which then led to a headache on the back right side of my head. I began seeing black spots in my vision, which then developed into kaleidoscope vision affecting both eyes but in my left field of view. I took ibuprofen and laid down with a cold compress. The vision issues lasted for approximately 30 minutes. The headache and neck pain persisted until the next morning which was accompanied by vertigo. I then decided to go to the ER and was diagnosed with a migraine with aura. I have never experienced a migraine or visual problems before. The doctor at the ER recommended I make this report in case my symptoms are linked to the vaccine.

Site: Pain at Injection Site-Medium, Additional Details: patient believes it may have been injected too high on first dose. His shoulder still hurts when he raises his arm. He will monitor and get checked by md if needed and notify the pharmacy.

Body ache, muscle pain, stiffness. All over. Difficulty sleeping due to unable to get comfortable yet still tired. Slight/minor headache. Lasted just about one day. Felt fine after about 5:00 pm the day following the shot.

6 hours after shot: fatigue day 1: fatigue, muscle ache across whole body (back, legs, arms) day 2: fatigue, muscle aches, headache, chills day 3: muscle aches, headache, low grade fever (99.6), chills during day, waking up sweating at night, sore throat day 4: muscle aches, headache, low grade fever (99.6), chills during day, waking up sweating at night, sore throat, intermittent thump on chest like missing a breath day 5: sore throat, headache, chills, intermittent thump on chest like missing a breath day 6: sore throat, headache, intermittent thump on chest like missing a breath day 7: sore throat, headache day 8: mild headache

Same day - fever; pain in injection site; mild pain in legs and back; lethargy Next day - extreme fatigue; muscular and joint pain throughout body; headache; worse fever and reddening of face; difficulty moving and walking due to pain; general cloudy feeling; fever delirium 2-3 days after - nausea

Very bad headache, loss of appetite, no energy, very sharp low back pains. all joints sore. was basically in bed all day the next day

Extreme nausea, vomiting, muscle weakness, and headache. Unable to get out of bed for 2 days and not able to work

rhabdomyolysis; This is a spontaneous report from a contactable consumer (patient). A 32-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 02Apr2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient stated, "These symptoms could be unrelated to the vaccine, but I believe they are worth reporting as they occurred after the vaccination." On 16Apr2021, the patient experienced rhabdomyolysis and currently have ongoing muscle pain. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care and hospitalization for 1 day. The outcome of the events was not recovered. No treatment was given to the patient for the events. Information on the lot/batch number has been requested.

After administering the shot I was explaining to wait for 15 minutes, as we were speaking patient stated he was feeling light headed then he slumped forward and became unresponsive for a few seconds during that period he urinated on the chair and floor I had a customer get the pharmacist and the patients wife came to him. The patient remained shaky, as we retrieved a towel and some water for him. The patient remained sitting and resting for about 20 mins during this time we offered to call 911 to which the patients wife stated that something similar to this happened before and declined the call to 911.

I felt very lightheaded and woozy roughly 5 minutes after injection. I was found passed out on the bathroom floor shortly after, with no recollection of entering the bathroom. It was estimated I was out for a couple minutes. I personally wondered if it caused blood pressure to drop, but I had no way to test it and was more focused on sitting up at the time. I stayed in the waiting area until I was confident I was able to walk on my own. A second wave, though less intense, happened roughly 30-45 minutes after the first. I left the store after 2 hours with fatigue, arm pain, and the hand of the opposite arm shaking on its own. The hand stopped shaking roughly 3 hours after the injection. Fatigue was mostly gone in a day. I could not raise my arm above chest height without pain the 1st day. Today is day two and I can raise it up properly again with mild stiffness and slight twinges of pain.

I received the COVID-19 vaccine at 9:30 am from vaccination clinic. I had just recovered from COVID-19 about two and a half weeks prior. I had no immediate reaction. I worked the entire day with no adverse effects other than a sore arm, which I expected. Later in the day at about 7:45 pm I went for a 6 mile run and got home at approximately 8:49 pm. Within half an hour of getting home, I quickly became feverish. The fever continued to rise until I was extremely hot, and hotter than I can ever remember as an adult or child. I did not have access to a thermometer so I cannot reliably report what the temperature was but I am estimating 103. It felt like every part of my body, including my legs, was hot to the touch. By 1 am I had serious chills and was shivering under winter blankets despite an outdoor temperature of 70-80. In addition, I had an extremely elevated heart rate and chest pain. I also had generalized muscle aches all over my body. I did not sleep at all that night. The fever began to slowly dissipate early in the morning but the elevated heart rate continued for approximately 24 hours. The discomfort resulting from my elevated heart rate was substantial and alarming enough that I sought advice from my primary care physician after a nurse at my Occupational Health clinic suggested potentially getting an ECG. Ultimately, by Thursday morning, the symptoms had decreased and I declined any follow up. However, this was the single worst reaction I've ever had to any vaccine and the single worst fever I've ever experienced as an adult or in my memory as a child. Although I am aware that people who have already had COVID-19 tend to have worse reactions to the first COVID vaccine, I am filing this report primarily because of my concern that exercise may trigger an especially severe reaction.

Pfizer-BioNTech COVID-19 Vaccine EUA: one day after vaccination patient brought in by ambulance to emergency department (ED) for generalized tonic-clonic seizures. Patient experienced first seizure and treated, evaluated, and released from ED at another facility. Patient experienced another seizure at home and brought to this facility. Patient experienced a third seizure in the ED, antiepileptic medication was initiated, patient was admitted then discharged the next day stable on antiepileptic medication and follow-up in place. On subsequent follow-up visit with primary care patient reported no seizures but back pain. Found to have a thoracic compression fracture from seizures prior to hospital admission. On neurology follow-up continues to be seizure-free and compliant with antiepileptic medication. Diagnosed with focal epilepsy and will continue to be followed by outpatient neurology.

nausea; Subjective fever; chills; shaking; significant muscle and joint pain; significant muscle and joint pain; fatigue; headache; This is a spontaneous report from a non-contactable Physician (patient) reported for himself. This 32-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9264, Expiration Date: unknown) via an unspecified route of administration, administered in left arm on 28Jan2021 at 09:00 am (age at vaccination was 32 years) as 2ND DOSE, SINGLE DOSE for COVID-19 immunization. The patient did not have any medical history. Concomitant medications patient received within 2 weeks of vaccination included ibuprofen (MOTRIN [IBUPROFEN]), acetylsalicylic acid, caffeine, salicylamide (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;SALICYLAMIDE]) as needed. The patient previously took augmentin [amoxicillin;clavulanic acid] and had allergy. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EK9231, Expiration Date: unknown) via an unspecified route of administration, administered in left arm on 07Jan2021 at 11:00 am (age at vaccination was unknown) as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was Hospital. On an unknown date, the patient experienced subjective fever, chills, shaking, significant muscle and joint pain, fatigue, headache, nausea which started 18 hours after injection. The patient did not receive any other vaccines within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Post the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse event. The outcome of the events was recovering. No follow up attempts are possible. No further information is expected.

The patient fainted and urinated. He said he was feeling pain briefly in his neck. He also said he had pain in his right chest. He laid down for 40 minutes. He did not want us to call an ambulance. He had someone pick him up and he said he was going to the emergency room.

He cant keep anything down and he keeps running to the toilet; Throwing up; Deathly ill; Gave him nausea pills but they're not helping; Sore arm; Cant even keep soup down/still cannot eat.; Can't lift arms and legs; Start passing out; Sick; Progressed into flu like symptoms 3-4 days after the shot; This is a spontaneous report from a contactable consumer reported for her son. A 32 year old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05May2021 at age of 32 year old (Batch/Lot Number: EM4965) at 2nd dose, single for COVID-19 immunisation. Medical history included ongoing shellfish allergy started in childhood. None family medical history included. Concomitant medications were none. None vaccines administered on same date with the Pfizer vaccine. None other vaccinations within four weeks prior to the first administration date of the suspect vaccines. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunisation, after he had the first shot, he was fine other than a sore arm. He had the second dose on 05May2021 and it started with a sore arm and then progressed into flu like symptoms 3-4 days after the shot on May2021. He was actually sick on 05May2021. He says that he cannot keep anything down and he keeps running to the toilet. He has been missing work and he never misses work. He cannot even keep soup down. He checked himself into the hospital and they released him yesterday after IV fluids and they gave him nausea pills but they're not helping. If he cannot keep anything down then he's going to start passing out on 05May2021. He went and had a Covid test a week ago to make sure he didn't have Covid. States he has been throwing up on 05May2021 and deathly ill on 05May2021. States that it started the first couple of days like flu like symptoms that have kept getting worse. States he can't lift arms and legs on 05May2021. She says at the hospital yesterday they gave him anti-nausea pills and hydration. States he still cannot eat on 05May2021. His symptoms began the evening of 05May2021. They have continued to worsen. She wanted him to go be seen at Urgent Care about a week ago; but he just went and got a Covid test. States he has been missing work ever since 05May2021. States that he finally couldn't stand it anymore and checked himself into the hospital yesterday. She says he was admitted on 16May2021, but they discharged him in the evening on 16May2021. AEs require a visit to emergency room. No physician office. He ran tests in the hospital, like blood tests. No specifics or results provided. Outcome of the event cant keep anything down and he keeps running to the toilet, throwing up, gave him nausea pills but they're not helping, sore arm was unknown. Outcome of other events was unknown. Information about Lot/ batch number has been requested

Systemic: Body Aches Generalized-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Tingling fingertips-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: A couple of minutes after the shot, the patient said he had a sharp neck pain. He sat down and then said he felt hot all over except his arms which were tingling/numb. Patient was clearly very anxious and said he felt "odd," and he asked me to call his wife and appeared to be having a panic attack. It lasted about 10 minutes, and at 13 minutes post vaccine, patient said it had passed. He seemed fine when he left after his 15 minutes and said over and over he did not want me to call an ambulance.

bedridden; extreme nausea; headache; bodyache; stiffness; chest pain; dizzy whenever I try and stand/ light headed; can't focus on screen very long without feeling like throwing up; can barely turn neck; bones/joints hurt; bones/joints hurt; no energy; This is a spontaneous report from a contactable consumer (patient). A 32-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EW0191) via unspecified route of administration, administered in arm left on 01Jun2021 at 06:15 (at the age of 32-year-old) as 2nd dose, single dose for COVID-19 immunization. Medical history included allergy to peanuts and shellfish. Concomitant medication was not reported. The patient previously took bnt162b2 (lot number: EW0185) in arm left on 07May2021 at 07:15 as 1st dose, single dose for COVID-19 immunization and experienced bed ridden and fatigue. No other vaccines within 4 weeks prior to the COVID vaccine. On 02Jun2021 at 10:00 (AM), the patient experienced lightheaded, extreme nausea, physical weakness, headache and body ache. It was reported that the patient also experienced stiffness, chest pain, dizzy on same day. Whenever the patient was trying and stand, could not focus on screen very long without feeling like throwing up, always lightheaded, could barely turn neck, bones and joints hurt and no energy. The patient stated he received full-time care while bedridden first day and a half from his partner and continue to receive care daily as he was not able to accomplish much on his own at this point. The patient also stated he did not know if this was a permanent condition caused by the vaccine nor did he know what the extent of any permanent damage was. This was the worst body he had ever felt. The patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination. Patient was not tested COVID post vaccination. The outcome of events was not recovered. No follow-up attempts are possible. No further information is expected.

Dose 1: Zero side effects Dose 2: Fatigue within four hours, migraine headaches to follow periodically for three days, Pain in left shoulder and swelling and redness, Swollen Lymph Node under the armpit, pain followed in shoulder and arm for one week

Severe back and leg pain began after doing daily stretches on 3/26. MRI determined that the minor herniation had ruptured and caused an extrusion. A surgical microdiscectomy was necessary to remove the extrusion.

I received the first covid vaccination in May 5th and a week or so later started getting tingling in my toes that would come and go. I did not tie it to the vaccine at first as it was not a listed side effect I saw. On 5/26/2021 I received the second shot and the tingling spread to more of my toes, and then into my hands a few days later. After another few days my legs became very weak and I went into the Emergency Room where they diagnosed me with Guillain-Barre and my symptoms continued to worsen where I lost all my reflexes and ability to walk as usual

One week after shot developed burning pain in arm and shoulder. The pain lasted two weeks then went away. After the pain subsided weakness in the muscles of the shoulder and arm developed.

Patient was seen by primary care physician and opthamologist. Patient was diagnosed with shingles (also ocular shingles). Patient reported a rash from top of head to eye, and from nose to ear on the right side of the body. He experienced swollen lymph nodes on the right side and eye swelling. He lost half of his vision in the right eye that has still not returned at this time. In addition to the shingles, he experienced an excrutiating mgiraine (10/10 on pain scale) which he described as the worst he has ever experienced. He also expreinced joint pain and fatigue. At this time, he is being treated with a course of valacyclovir.

First of all, does anyone care? Will anyone contact me? I doubt it. That being said, my level of exhaustion since the shot is INSANE. I can barely walk 5 blocks, the more I walk the more tired and heavy my legs feel. I can barely keep my arms up for extended periods. I went to Physical Therapy and my therapist there tried to test the reflexes in my legs and I had NONE. That has never happened to me before. This is because of the vaccine. It?s been a week and it?s only getting worse not better. I almost don?t have the energy in my hands to write this much. Who is going to contact me? Is this going to get better? The gov?t is coercing people to take a vaccine and I want to know who is going to care when it affects me this badly!? Seriously. It?s quite sad. I keep filling this things out and no one contacts me. Should I wait? Go to ER? My doctor doesn?t seem to care much because everyone blindly thinks this vaccine is safe. I?m worried and confused. Thanks for whoever actually read this. I am sure I won?t be contacted.

Left leg numb from the whole left butt cheek down to his knee/ left arm feels kind of numb and a little heavy; Left arm feels kind of numb and a little heavy; Fatigue; Was sleeping a lot; Pain from the shot at the injection site; This is a spontaneous report from a contactable consumer (patient, self-reported). A 32-year-old male patient (age at vaccination: 32 year) received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0217 and expiry date was not reported), via an unspecified route of administration, in Deltoid Left (upper arm), on 03Jun2021, as a single dose for COVID-19 immunization at Pharmacy. The patient's medical history included dysautonomia (he was born with it) and herniated disc. Concomitant medication included acetylsalicylic acid, caffeine, paracetamol (GOODY'S) (powder for headache or something like that, or back pain powder, in the week or 2 before the vaccine. It was like a pain powder that comes in a little pouch instead of actual pill like Tylenol. No further information provided). There was no family medical history relevant to adverse events. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0182 and expiry date was not reported), via an unspecified route of administration, in Deltoid Left (upper arm), on 14May2021, as a single dose for COVID-19 immunization at Pharmacy and no reaction on previous exposure to vaccine. The patient did not receive any vaccine within 4 weeks prior vaccinations, he had never even had the flus shot before. He had never even had the flu either. Investigation assessment was not done. The patient stated he was calling regarding the Pfizer Covid vaccine. He got the second shot 03Jun2021, about 2 weeks ago. The back side of his left leg was completely numb from the whole left butt cheek down to his knee and it has been since he got the second shot. Also, his left arm felt the same, kind of like he has been holding it over his head for a long time, it felt kind of numb, but not really, but kind of heavy. This probably wasn't a common thing, so he wanted to report it. He had some other side effects, but he wanted to give it a little more time to make sure it didn't go away. The patient's left leg numb from the whole left butt cheek down to his knee which started within the next day or 2 and it hadn't gone away. It felt about the same. It felt like it fell asleep, the whole back side area. It was like holding the arm above the head too long where it loses a little blood. It felt kind of cold and stiff and felt a little heavy. It started around the same time as the numbness in the leg, but it may have taken a little bit to notice because he did have the fatigue and was sleeping a lot the first couple days. That might have been why it took a couple of days to really notice what was going on with his arm. It was after the second dose and lasted a couple of days. It has stayed the same. Numbness was 2 inches higher where he has a herniated disc. The patient's had pain from the shot at the injection site on 03Jun2021, which was normal and went away, the heaviness of the arm was still there and was just right at the injection site. It didn't feel any worse than a tetanus shot. It was kind of a longer needle and all, so he expected that to be normal anyway. The soreness went away the second day. The adverse events did not require a visit to emergency room or physician office. No relevant tests were performed. The patient did not receive any treatment. When asked if he had any other concerns, patient stated, not unless Pfizer was going to help with the copay for going to the doctor and clarified that this was not an actual request, says he was joking. Outcome of the event pain from the shot at the injection site was recovered on 04Jun2021 and for the events fatigue and was sleeping a lot it was reported as unknown and for all other events, it was not recovered. Information on the lot/ batch number has been requested.

Severe pain in knuckle joint which causes swelling and pain in index finger on right hand. The pain is still ongoing, been almost 4 weeks. Not getting better even with ibuprofen. Loss of strength and mobility in finger, hard to use pencil or chopsticks. Never had injury there before, only happened after second dose of vaccine.

I had pain in the heart, pain at neck and also pain near spine. I used hot pack relax the pain in the neck but till today i have the pain

Body aches; Chills; Headaches; Fever; Arm discomfort; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) via an unspecified route of administration in left arm on 20Mar2021 at 10:00 (at the age of 32 years-old) as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes. The patient was not allergic 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, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not take any other medications within two weeks of vaccination. On 20Mar2021, the patient experienced arm discomfort. On 21Mar2021, at 20:00, the patient experienced chills, body aches, headaches and fever. It was unknown if the patient received treatment for the adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of arm discomfort, headache and general body pain was resolved on an unknown date in Mar2021. The clinical outcome of the events chills and fever was not resolved at the time of report. No follow-up attempts are needed. No further information is expected.

weak; could not lift my arm up; blacked out and fell to the floor/ Unconscious; lost hearing; started to lose balance and couldn't stand and couldn't walk; started to lose balance and couldn't stand and couldn't walk; started to lose balance and couldn't stand and couldn't walk; very, very pale; zapped of energy; drenched in sweat; neck was burning, like it was on fire; complete loss of body function; This is a spontaneous report from a contactable consumer (patient). A 32-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: EW0180), dose 1 via an unspecified route of administration, administered in left arm on 16Jun2021 12:15 (at the age of 32-year-old), as single dose for COVID-19 immunisation in pharmacy. The patient had no medical history present and no family medical history relevant to AE. The patient had no other products taken. The patient did not receive any other vaccines within four weeks prior to the vaccination. After received the first dose around 16:30 on 16Jun2021, the patient waited there 15 minutes after and was fine. Four hours later, the patient blacked out and fell to the floor. The patient stated he was unconscious for 30 seconds and then snapped back to life, drenched in sweat, started to lose balance, couldn't stand, and couldn't walk. The patient stated he did not have a phobia of getting a needle or anything like that. The patient stated he was not doing anything but eating dinner when it happened. For a minute or two while all this was happening, he states he lost his hearing. Then the patient was able to walk about 25 feet and tried to lean against the wall and then fell to the floor. Patient stated his buddy was there and tried to wake him up. The patient was still thinking in his mind but he didn't know where he was. He had complete loss of body function for about 20 minutes. The patient stated he was then able to lay down, drenched from sweat from head to toe, the cold air outside seemed to help, He stated his neck was burning, like it was on fire. The patient said that everything came out of left field. He seemed fine from 00:15 until 16:30 (on 16Jun2021). He felt zapped from energy, so he went to sleep from 16:45 until 23:00, which he seemed to help. The patient stated he has had nothing like that today, he was just weak and could not lift his arm. His face did get very, very pale when these events happened. He stated everything happened yesterday between 16:15 to16:45. The patient states for 20 minutes he had to lay down and get fresh air and during that time there was a moment he couldn't hear, he thought he had lost his hearing. Patient stated it was very scary and he considers himself a healthy male and tried to do all the right things. He states he did not have a fear of getting the vaccine, then everything hit him really hard. The patient underwent lab tests and procedures which included blood test: excellent. Outcome of the all events was resolved on 16Jun2021while outcome of the event zapped of energy was resolving and weak and could not lift my arm up was unknown.

Bad headache; Bad muscle pain; Cramps; Fatigue; Low grade fever (~102 max); Diarrhoea; Feeling dehydrated; sensitive skin; This is a spontaneous report received from a contactable consumer. A 32-years-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207) via an unspecified route of administration in the left arm on 16Mar2021 at 9:30 (at the age of 32-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma and ADHD (attention deficit hyperactivity disorder). The patient was allergic to penicillin. Concomitant medications included amfetamine aspartate, amphetamine aspartate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), and salbutamol (ALBUTEROL) for unknown indications. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 18Mar2021, the patient experienced headache, myalgia, muscle spasm, fatigue, low grade fever (102 maximum) (unspecified unit), diarrhea, dehydration and sensitive skin. No treatment was received 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 headache, myalgia, muscle spasm, fatigue, low grade fever, diarrhea, dehydration and sensitive skin was recovered with sequelae. No follow-up attempts are needed. No further information is expected.

32 yr male without Preexisting history, observed with stiffening, tonic/clonic response 2 minutes within vaccination; fell out of chair, hit head. Attendee self awoke, alert, oriented x 2 within one minute. EMS called, declined ER trip, monitored and d/c from EMS after speaking with ER MD(phone). Walking independently.

Patient was complaining of dizziness/shakiness 15 minutes after vaccine was administered. He was provided with water, orange juice and granola bars, positioned with his feet up. He was no better after 1.5 hours and 911 was called at that time. EMTs evaluated the patient - he felt dizzy, shaky, pale, hot and clammy. Seated BP was measured at 144/98, standing up at 152/99. He was transported to hospital and admitted for observation. He was provided with food and fluids and experienced an adrenaline rush. Had ECG (normal?) and tachycardia. He was given an anti-anxiety medication and reassurance by medical staff. Discharged at around 9pm on 7/5/21. On checking up with patient 10am on 7/6/21 - he stated the expected muscle aches but otherwise feeling fine.

This is a spontaneous report from a contactable consumer, the patient. A 32-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 22Mar2021 at 10:15 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history of patient included obesity (33.5 BMI with 21% body fat) and allergy to sulfonamide. The patient was allergic to morphine and ondansetron. Concomitant medications included multivitamin supplement (NATUREMADE) received within 2 weeks of vaccination. 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 01Mar2021 at 11:45 (at the age of 32-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 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 22Mar2021, at 11:15, the patient experienced light-sensitivity migraine, bone and joint pain, altered temperature from (95.9 to 97.1) average temperature was 98.2, reduced mobility, and physical exhaustion. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events light-sensitivity migraine, bone and joint pain, altered temperature, reduced mobility, and physical exhaustion were not recovered at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Soreness in body; Congestion in nose; Congestion in throat; Nausea; Itching in random spots on body; Headache; just overall felt terrible.; Soreness in neck area; Soreness in injection arm; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 01Apr2021 at 10:45 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included Localized epidermolyisis bullosa simplex from an unspecified date. Concomitant medications included terbinafine (LAMISIL), ascorbic acid; biotin; calcium pantothenate; cyanocobalamin; ergocalciferol; iron; nicotinamide; pyridoxine hydrochloride; retinol; riboflavin; thiamine hydrochloride; tocopheryl acetate (CENTRUM) all from an unknown date for an unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 the patient experienced soreness in injection arm, side and neck area. On 02Apr2021 the patient experienced a headache and nausea and just overall felt terrible. Over the next few days, soreness in body, congestion in nose and throat, and itching in random spots on body. 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. Clinical outcome of neck pain, general body pain, nose congestion, throat constriction, nausea, painful arm, itching, headache, feeling miserable was resolving at the time of reporting. No follow-up attempts are needed. No further information is expected.

Pt s/p Covid-19 vaccination administration. While this nurse was completing the documentation, the pt slid self to the floor from a sitting position. No head strike or injury occurred. Pt able to stand by himself and sit back in chair where he was monitored for 25 additional minutes. VS obtained and were WNL. Pt stated "I feel okay and this has never happened to me before". Pt denies any health related conditions. Pt was able to ambulate safely and independently out of the facility.

Extreme pain in my left elbow; This is a spontaneous report from a non-contactable consumer, the patient. A 32-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 05Apr2021 at 10:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received dilaudid (MANUFACTURER UNKNOWN) reported as dilauted and morphine (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Apr2021, the patient experienced extreme pain in left elbow. The clinical outcome of the event extreme pain in left elbow was unknown at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

neck stiffness; left thumb joint pain; right arm pain around injection site; This is a spontaneous report from a contactable unspecified health professional. A 33-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EJ1685, expiry date: unknown, intramuscular at the right arm, from 22Dec2020 12:15 at a single dose for covid-19 immunization. The patient's medical history was not reported. Concomitant medication included simvastatin. On 22Dec2020 18:00 (Tuesday night), the patient experienced left thumb joint pain and right arm pain around injection site. On Wednesday, above issues continued. On 24Dec2020 18:00, Thursday, patient had neck stiffness. The joint pain all over was not severe but noticeable. Outcome of events was reported as unknown. There was no treatment or hospitalization involved. This case is non-serious. No follow-up attempts are possible. No further information is expected. The information on the batch/lot number was obtained.

Arthralgia, UrticariaPruritus, NauseaVomiting, stomach cramps Narrative: 12/29 approximately 15 min after vaccination, employee reports onset of "foggy brain", stomach cramps, and widespread itching. He was transferred to the ED. Evaluation revealed no rash and the physical exam was normal. He was treated with 50 mg of benadryl PO and observed in the ED for about 90 minutes and discharged back to work. He was given a prescription for hydroxyzine 25 mg po q 6 hours x 5 days. On 12/30 - he reports his arm is sore and he still feels itchy. Now he has some nausea and his joints hurt. He plans to stay home from work to rest today. He had to leave work early yesterday (works night shift). 12/31 - reports he feels better but still has a headache and feels achy. He hasn't taken the hydroxyzine because his itching is not as intense. 1/4 employee reports his symptoms have improved and has mild achiness, fatigue, and itching which he describes as 1-2 on a scale of 1-10.

I sat in a chair after I received the vaccine. After 10 minutes I stood up and my legs were tingling and felt heavy. I was slightly lightheaded too. I sat back down for a few more minutes and then I went back to work. The the tingling stopped but my legs felt heavy for 3 days. I am feeling normal now. I am aware of orthostatic hypotension and the possibility of it being from sitting in the chair and pinching nerves. I just wanted to report this in case it is a problem.

Symptoms - ? at time of vaccine, pain at injection site, worsening overnight. EE reports arm as feeling heavy. EE reports unable to sleep over night and tossed and turned. EE reports feeling chilled this am and took temperature. Tmax 102.2 taken at 08:45. EE reports + runny nose and congestion. EE denies travel and COVID-19 exposure without proper PPE. Home remedies? - motrin 600 mg at 08:55 Any improvement? ? none at this time Recommendation? After completely algorithm, EE meets criteria to be COVID tested and removed from work at this time. EE provided with EH command center and instructions to notify them need for COVID-19 testing. EE educated to notify his manager. EE verbalized back understanding and denied further questions at this time.

Fatigue, chills, fevers, myalgias, malaise, headache, stuffy nose started about eight hours after vaccination.

No fever, but chills, mild headache, fatigue and generalized malaise with myalgia, mild joint pain. Managed with Tylenol.

Onset of mild headache at approximately 2:00AM on 12Jan2021, with headache getting progressively worse since onset. Onset of chills, body fatigue, and muscle/joint aches at 4:00AM on 12Jan2021. Low grade fever (99 degrees F) reported at 5:00AM on 12Jan2021.

Fever 101.4; Muscle aches; headache; chills; Dose number=1on 17Dec2020/ Dose number=2 on 05Jan2021; This is a spontaneous report from a contactable other healthcare professional (patient). A 33-year-old male patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on right arm at 09:30 AM on 05Jan2021 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on left arm at 01:30 P.M on 17Dec2020 at single dose for Covid-19 immunization. The patient had no allergies to any medications, food, or other products. The patient experienced Fever 101.4 approximately 14 hours after getting second dose. Muscle aches, headache and chills at 11:00 PM on 05Jan2021. All events were reported as non-serious. The outcome of events was not recovered. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine; The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient had not been tested for COVID-19. The outcome of events fever, muscle aches, headache and chills was not recovered. Information on the lot/ batch number has been requested.

After 24 hours post vaccination, I experienced flu symptoms that include mild fever , chills , back and joint pain. The fever and chills lasted for only few hours but the joint and back pain lasted for 48 hours. At the time of these symptoms no medical intervention was required.

Tiredness; Little headache; Muscle and body pain; Muscle and body pain; Fever; This is a spontaneous report from a contactable consumer (patient). A 33-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686) via an unspecified route of administration on 02Jan2021 at single dose for covid-19 immunisation. The relevant medical history and concomitant medications were reported as none. The day prior to the report on 07Jan2021, the patient got side effects of tiredness, little headache, fever, muscle and body pain. He stated that tiredness began in early morning. He was scheduled to receive second dose on 23Jan2021. He asked a nurse to give him something for a headache the day prior to the report. Since 07Jan2021, he was feeling better. Clarified he cannot confirm the name of medication he was given. He was still feeling body pain. At the time of the report, he asked if he needed to go to the clinic. Didn't know if he needed to wait. Clarified he was asking for medication and if he could go to the hospital to ask for medication. The outcome of the event body pain was not recovered, for the event tiredness and little headache was recovering, while other events were unknown.

Woke up with low grade fever 99.9. Felt low back pain, chills, arm pain, and fatigue. Took Tylenol 1000 mg and Naproxen 440mg. Symptoms decreased around 5pm and fever subsided around 9pm.

Nausea; shortness of breath; tiredness; stiffness at the injection site; stiffness at the injection site; This is a spontaneous report from a contactable consumer. A 33-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot numbers and expiry dates were unknown) via an unspecified route of administration on 08Dec2020 for the first dose and on 08Jan2021 for the second dose, both administered in the right arm at a single dose for COVID-19 immunization. The patient had no medical history and no concomitant medications. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2 and did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 09Jan2021, the patient experienced nausea, shortness of breath, tiredness, and stiffness at the injection site. No therapeutic measures were taken in response to the events. Outcome of the events at the time of last observation was recovered. The report was considered as non-serious; the events did not result in death, were not life threatening, did not caused/prolonged hospitalization, were not disabling/ incapacitating, and did not caused any congenital anomaly/birth defect. Information on the lot/batch number has been requested.

I was diagnosed with COVID-19 on 12/7/2020. My course of symptoms lasted 16 days, meaning I started feeling healthy again on 12/23/20. I am a pharmacist with a healthcare system and they have been offering the Pfizer/Biontech COVID-19 vaccine for essential associates. I received by first dose of vaccine on 12/31/20. On 1/1/20 I woke up with very noticeable muscle aches and fairly profound lethargy, which last 18-20 hours. I was not able to do much on 1/1/21 because of the way I was feeling. I'm not sure if this reaction is normal for patients who receive their COVID-19 vaccine close to their illness/infection with COVID-19, which is why I'm reporting this to the FDA.

I had the same symptoms on the dose two, as I did in dose 1, same timeline. My arm got heavier and hurt quite a bit. I was feeling feverish by the end of the day, a slight head ache, clammy, mental fog, exhausted. The following day I had waves of nausea, and each of the previously reported symptoms were stronger. The headache grew stronger and I was relatively useless, feeling very ill. By the next day the 16th most of the symptoms had cleared up. I had a slight headache and felt a bit tired, but much better. By the 18th, I was back to normal with the only symptom being a sore arm.

Got the second dose of the COVID 19 vaccine. The next morning felt mild to moderate symptoms. Later in the day had more intense symptoms including headache, myalgia, and fatigue (needed to lie down). Continued throughout the evening with night sweats. Woke up Sunday morning feeling significantly better but with persistent mild symptoms.

While driving home in traffic from getting the vaccine, I felt a tingling over my whole body and then everything started to spin (vertigo). This lasted for about 10 seconds of severe vertigo and then stopped. I thought that was weird and kept driving (was in stop and go traffic) then about 1 minute later it started again and thankfully I was stopped at the time in traffic. I leaned my seat back slightly and called my wife to tell her where I am. I couldn't pull over because there was a cement barrier on one side and 4 lanes of traffic on the other. I kept on the phone with her for the remained of my drive and it occurred one more time when I was driving home. Once home, a couple more times I felt it coming on but it didn't ever happen again. I took my blood pressure and it was normal, boarderline high when I got home (140/84). The next morning I had a fever and severe muscle aches and body aches which lasted most of the day and then today I've felt totally fine (today being 1/23).

About 10 minutes after getting the vaccine I felt my neck starting to swell or get tight, it wasn't my throat it was on the outside (lymph nodes) I also got very lightheaded. I've had that same feeling swollen lymph nodes on both sides of my neck and being lightheaded ever since. Today (1/24) I started having waves of shortness of breath.

flu-like sxs. joint and muscular pain. abdominal cramping. pins and needles/hypersensitive skin. headache. fever. unable to sleep. sxs had rapid onset appx 12 hrs after dose administration, have continued for 12 hrs to current time.

Left arm pain at rest and with movement; headache; full body myalgias; sore throat; This is a spontaneous report from a contactable physician (patient). A 33-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231 expiration date unknown), intramuscular in left arm on 12Jan2021 at 08:00 at a single dose for COVID-19 immunization. Medical historywas reported as none. The patient had no known allergies. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899) on 22Dec2020 at 12:30 PM for COVID-19 immunization. The patient has not had COVID prior to vaccination. The patient had no other vaccines within four weeks. On 13Jan2021 at 14:00, the patient experienced left arm pain at rest and with movement, headache, full body myalgias, and sore throat. Therapeutic measures were taken as a result of the events and included treatment with ibuprofen. The patient was not tested for COVID post vaccination. The outcome of the events was recovering.

About an hour after I received my second shot I felt extremely hot and my knees and elbows started to hurt. I felt so hot that I walked outside to my car (about .3 miles away) in freezing cold temperatures with no jacket and didn't feel the cold at all. I developed a brain fog shortly thereafter and made several mistakes while performing my job throughout the day. My supervisor provided me with extra strength tylenol and within an hour or so the joint pains subsided. By 7 PM that night I had very bad chills and was shaking under a blanket on my couch. My temperature got up to 99.8 which is pretty high for me. I went back and forth between feeling like I was freezing cold and on fire. I got very little sleep that night and had disturbing dreams. The following morning all my joints hurt and I felt extreme exhaustion. I laid on my couch all day the day after receiving the shot and felt exhausted and and had no appetite. From 6 PM the day of the shot to 9 PM the following day I ate NOTHING and had no desire to eat. As I'm typing this 60 hours after receiving the second shot the joint pain is gone, the exhaustion is gone and my appetite is back to normal. There's a lingering pain at the injection site but otherwise I feel like I did prior to receiving the second shot.

mild dyspepsia; loose stools; Moderate deltoid soreness at injection site; chills; myalgias; hyperalgesia; headache; fatigue; grogginess; This is a spontaneous report from a contactable physician reported for himself. A 33-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0142), via an unspecified route of administration on 07Jan2021 08:45 at single dose in left arm for covid-19 immunization. The patient medical history was not reported. The patient had no known allergies to medications, food, or other products. Concomitant medications within 2 weeks of vaccination included triamcinolone 1% cream and diphenhydramine 2% cream. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685), via an unspecified route of administration on 17Dec2020 05:00 PM at single dose in left arm for covid-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19, since the vaccination, the patient had not been tested for COVID-19. On 07Jan2021 12:00, the patient experienced moderate deltoid soreness at injection site within 2-3 hours; chills, myalgias, hyperalgesia, headache, fatigue, grogginess from 12-36 hours post injection (on 07Jan2021); mild dyspepsia and loose stools 24-36 hours post-injection (on 08Jan2021). The patient did not received treatment for the events. The outcome of the events was recovered in Jan2021.

Individual reported body aches and extreme lower back pain near the spine. Lower back pain was reported to of occurred initially as minor two hours after receiving the injection and got worse. The back pain is still on going in the person and continued for 48 hours. Curious if linked to taking valaciclovir as the person did not recall hurting their back during the course of the day. Individual is in excellent health and physically fit.

Shooting arm pain in right shoulder began 1/23/21 around 11AM and continued for most of the afternoon. 1/24/21 around noon it came back. Monday 1/25 it was getting worse and just began to feel like I tried to lift entirely too much weight for a long time but I hadn't done anything. Tuesday 1/26 the pain was all but gone but returned and was worse on 1/27 and 1/28. On 1/29 it subsided again and I felt fine but on 1/30 and 1/31 it came back with a vengeance and hurt all day on both of those days. On Monday 2/1 it was back to just being sore again and has been the same soreness on 2/2 and 2/3. No more shooting pain just lingering soreness.

flu like side effects; increased temperature (99.9); lower back pain; chills; muscle aches; This is a spontaneous report from a contactable consumer (patient himself) reported that a 33-year-old male patient received his second dose of bnt162b2 (BNT162B2 also reported as Covid vaccine, lot EL3247), via an unspecified route of administration in the left arm on 19Jan2021 09:00 at SINGLE DOSE for Covid-19 immunisation. Medical history included eosinophilic esophagitis and carry an epi-pen for gastrointestinal anaphylaxis, had food allergy to quinoa, shrimp and mango. He had his first dose of bnt162b2 on 29Dec2020 (lot EK9231,) in the left arm. Concomitant medications included pantoprazole, cetirizine hydrochloride, fluticasone propionate (FLONASE) and melatonin. On 19Jan2021 22:00, she had flu like side effects, increased temperature (99.9), lower back pain, chills, and muscle aches. She self-administered acetaminophen and ibuprofen. The outcome of event was recovered with sequelae (Recovered with lasting effects).

chills; generalized mild myalgia; low fever of 37.9C; This is a spontaneous report from a non-contactable Pharmacist (patient). A 33-years-old male patient received the second dose of bnt162b2 (BNT162B2) , lot number EL3302, via an unspecified route of administration from 18Jan2021 at 19:30 (at the age of 33-years-old) in the left arm as a SINGLE DOSE for COVID-19 vaccination. Historical vaccination included bnt162b2 (BNT162B2) COVID-19 vaccination, lot number EK5730 on 28Dec2020 at 03:15 PM, dose number 1. The patient medical history was not reported. There were no concomitant medications. The patient has no known allergies. The patient received the vaccine at a hospital. On 18Jan2021 at 22:00, the patient experienced chills, generalized mild myalgia and low fever of 37.9C. Treatment for the events included acetaminophen 1000mg. The patient underwent lab tests and procedures which included body temperature: 37.9 centigrade on 18Jan2021 low fever of 37.9C. Outcome of the chills , generalized mild myalgia and low fever of 37.9C was recovered in Jan2021. Prior to the vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Reported moderate fever, chills, muscle aches, and fatigue for 2 days following dose 2 vaccination. Then, began complaining of chest pain. EKG abnormal and referred to Hospital for evaluation. Found to have elevated troponins and myocarditis. Then discharged home.

slight concentration issues; mild swelling similar to a histamine reaction; mild swelling similar to a histamine reaction; muscle tenderness; This is a spontaneous report from a contactable consumer (patient). A 33-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number and expiration date not provided), via an unspecified route of administration on 16Jan2021 11:00 at single dose in left arm for COVID-19 immunization. Medical history included mild allergies to pollens, insomnia, ongoing hypertension from years ago. Concomitant medications in two weeks included mirtazapine, ibuprofen. Facility type vaccine was Workplace clinic. No other vaccine in four weeks. On 18Jan2021 13:00, the patient experienced mild hypertension like symptoms, mild swelling similar to a histamine reaction, muscle tenderness, and slight concentration issues. No treatment received for the events. No COVID prior vaccination. No COVID tested post vaccination. The outcome of the events was recovering. Information about batch/lot number has been requested.

On 26DEC ( 5 days after first injection), he started experiencing pain and weakness in the Right deltoid radiating down to the fingertips . Within a week, started feeling similar symptoms in Left extremity. No shoulder/neck pain. Pain starts at the deltoid at the injection site and has caused stiffness, pain, and tightness of the upper extremities alone. Decreased grip b/l. Symptoms have persisted since ( almost a month now) but did seem to resolve while on prednisone, but returned after cessation. No respiratory issues, chest pain, paresthesias, or lower extremity symptoms.

After receiving the 2nd dose (Phizer-BioNTech) on 2/19 at approximately 2:50pm, I felt fine, until the following day, when I woke up on 2/20 at 8:00am. At that time, I felt extremely tired/groggy/fatigued with an intense headache. I also experience some slight muscle/joint pain. Tylenol seemed to help dull the pain, but not fully relieve it. I am not prone to headaches or migraines. I slept for most of the day on 2/20. On 2/21, the headache and muscle/joint pain subsided with the exception of some mild fatigue.

Starting Monday February 22 (six days after second dose), I experienced moderate muscle cramping and soreness in the back of the neck, lower back, and buttocks/legs. I am also experiencing headache, dizziness, and diarrhea, all moderate. Symptoms are temporarily relieved by massage and stretching, but pain is still ongoing. This has persisted until today (Thursday, February 25).

body ache, fatigue, lower back pain. Body ache and fatigue gone after 2 days. Lower back pain on right side remains.

10 to 15 minutes after receiving the vaccination. The patient reported to a pharmacy technician they were feeling unwell. As the patient went to sit down they fainted. Patient was unresponsive for roughly a minute exhibiting tensed arm and neck muscles. Muscles also contracted several times during the episode. Patients eyes were open during the episode but they could not be coaxed to speak signal or blink. Additional patient symptomology as follows: elevated pulse, constricted pupils, flushing/redness in the face & neck. For this reason, medical staff called 911. Patient became responsive and reported losing consciousness and having no recollection of majority of the event. Upon arrival EMT's took over patient care. Patient left with EMT's

Fever and muscle aches began approximately 18 hours after injection, and continued for approximately 18 hours after onset of symptoms.

got my Pfizer COVID vaccine March 30th 2021 @ 9am. 39 hours after my 1st Pfizer COVID vaccine, I woke up at 1 am from bed on April 1. I dry heaved and threw up from 1-5 am. Horrible headache, knees and ankles weak and sore, no appetite, chills, cold sweats, nausea, April 1, 6 am-5 pm I napped with chills and cold sweats.

9:30pm- Muscle fatigue/soreness. 10:30pm- hands and feet extremely cold. Only way to get warm was hot water. 11pm-7:30am 4/4/21- fever, chills, repeat of hands and feet cold. 7:30-ongoing- Clammy skin, muscle weakness, exhaustion.

facial paralysis/facial drooping/facial palsy/eyes started drooping and then mouth started drooping; strange feelings in face; This is a spontaneous report received from a Pfizer sponsored program.This contactable consumer patient himself and a contactable physician psychologist, (parent of patient reported) that a 33-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 1 via an unspecified route of administration, administered in left arm on 21Mar2021 16:15 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. On 21Mar2021 at 07:30 PM, after receiving his first dose, he began noticing facial drooping, which began to intensify, on the right side. He was advised by a medical professional to immediately call an ambulance and he was then taken to an emergency room where received a CT scan and full bloodwork on Mar2021. Luckily, the facial palsy began to subside and he was able to return home after the test results came back and a stroke was ruled out - it was stated that this was some kind of immuno-reaction to the vaccine. He still felt as though his face was still not 100% back to normal and still felt a bit droopy (noticeable in the mirror) yet it does feel better than on 21Mar2021 evening. Patient had a nasal swab on 22Mar2021 with negative result. One of the reporters is a psychologist and reported that her son received Pfizer-BioNTech COVID-19 Vaccine. Psychologist asking about risk of Bell's palsy, incidence, and outcomes and if these patients received their second dose of the Pfizer-BioNTech COVID-19 Vaccine. She read about 7 cases of Bell's palsy in a Dec2020 article in the [Redacted], 4 of them on the Pfizer vaccine. The reporter further clarified and described that at 6pm (2 hours after dose), patient reported he felt fine and was happy he got the vaccine; but then sometime after that, he reported "strange feelings in face" and then eyes started drooping and then mouth started drooping, all on right side of face. They called the university clinic and was instructed to go to ER. Brain scans and blood work were done; they ruled out stroke and said it was a possible reaction to the vaccine. He was discharged at midnight and by then, paralysis was 80-85% resolved. He is an otherwise very healthy young man. The psychologist wanted to know the efficacy after just one dose and stated that a friend suggested to perhaps not get second dose and consider getting a dose of the non mRNA vaccine like Johnson and Johnson. The outcome of the event was recovering. Information on Lot/Batch number has been requested.

Right arm became weak, tingly and cold. Pt became sweaty, flushed and felt a warm sensation come over body. Became dizzy and lightheaded. Pt assisted to floor and then to stretcher by staff. Arrived to med obs with all symptoms resolved except right arm weakness and tingling. Right arm warm to touch. Bilateral hand grips equal. No arm drift noted. No reaction noted at vaccine site. Vitals remained stable during evaluation. Initial vitals as follows; BP 127/78 HR 57 RR 14 spo2 99%. Final vitals as follows; BP 126/80 HR 48 RR 14 spo2 99%. Pt instructed to follow up with physician if symptoms don't resolve within an hour or symptoms get worse. Pt left facility by self @ 1526.

Severe swelling; tenderness and soreness under the left armpit; Severe soreness at injection site (outer left arm); Severe soreness; fatigue; This is a spontaneous report from a contactable consumer (patient). A 33-years-old male 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 18Feb2021 1:15 pm (Batch/Lot Number: EL0982) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications included Nature's Way Alive Max3 Daily multivitamin. The patient had previously received first dose of bnt162b2 (BNT162B2) on 29-JAN-2021 at 1:15 pm (Lot number: EL3246) for covid-19 immunisation. On 19Feb2021 at 12:00 pm the patient experienced severe swelling, tenderness and soreness under the left armpit, severe soreness and fatigue .The treatment for events was unknown. The action taken in response to the event(s) for bnt162b2 was not applicable. Outcome of events was unknown.

Morning of April 4, pt experienced a full aching in his right side (front, below shoulder, above ribs). This went away after a few hours. Around 1 am EDT on April 7, the pain returned, slowly subsiding over the course of 12 hours. Between 6-7 pm EDT on April 7, a new more intense pain started in his mid-back, right side accompanied by shortness of breathe. We took him to the ER where he was diagnosed with three pulmonary emboli. He was given blood thinner tablets and send home with prescriptions for more thinners and pain medications. 1.5 days later, his pain has not subsided. He is also protein s deficient and has fact v leiden (homozygous).

Full body muscle and joint pain, tiredness, easy exhausted. Lasting approx 24 hours. Advil offered limited benefit temporarily

headache; felt warm in the head; aches, particularly in my lower back; chills; I had pain at the injection site; This is a spontaneous report from a contactable consumer (patient). A 33-years-old male patient received second dose of BNT162B2 (COMIRNATY, solution for injection, Batch/Lot Number: EM9809), via an unspecified route of administration, administered in Arm Right on 09Feb2021 at 04:30, at a single dose for covid-19 immunization. The patient medical history and concomitant medications were none. The patient received first dose of BNT162B2 (COMIRNATY, solution for injection, Batch/Lot Number: EL3247), via an unspecified route of administration, administered in Arm Right on 19Jan2021 04:30 at single dose for covid-19 immunization. The patient did not receive any other vaccines in 4 weeks. The patient experienced pain at the injection site on 10Feb2021, after receiving the second dose and would compare the feeling to a bad bruise approximately after 17 hours the patient had chills and approximately after 19 hours the patient started to develop aches, particularly in lower back. The aches were not severe and were more of a nuisance. Approximately after 21 hours the patient, developed a headache and felt warm in the head. The headache slowed her down and was bothersome for the remainder of the day. The headache was almost completely gone when she woke up the next day. My head no longer felt warm when I woke up. Events were not treated. All the events were recovered when she wok up next day.

1 Day after vaccination the injection site was sore. Later that night the rest of the body became sore. 4 days after vaccination the sore injection site stopped, but a headache began at night. 5 days after vaccination I got fever, chills, swollen lymph nodes, red throat, coughing, pain swallowing, and sore muscles. 6 days after vaccination fever was gone, but the rest of the symptoms remain.

My arm was very sore Friday night. Saturday i seemed to be ok and had more energy. Today my back (lower and upper) is very tight and sore.

Jaw pain under left ear. One week after vaccination. The jaw pain comes and goes. The joint is tender to the touch. Hard to open moth wide and can be hard to chew

Patient presented reporting back pain and shortness of breath within 24 hours of receiving COVID vaccine. Patient admitted for workup.

Fever, chills, chest pain, muscle aches, severe headache, nausea, loss of energy. All symptoms lasted for 3-4 hours with chest pain, muscle aches, headache, and loss of energy continuing into the next day.

Patient reported chest muscle tightness on the left side, numbess in the left shoulder and tricep. This was reported about 50 minutes after receiving the vaccine

I began experiencing severe neck pain the morning after I received my first vaccine. The first morning, the pain was so intense that I was unable to lift my head out of bed and consequently had to lift the back of my neck with one hand to sit up in bed. I?d never experienced this kind of neck pain before. The pain level was equally intense over the next several days until I started taking ibuprofen . I even went to the chiropractor to receive an adjustment to help reduce the pain. However, as of today, I am still experiencing significant neck pain that is effecting my activities of daily living.

Patient states that three weeks ago he received dose number 2 of Pfizer covid 19 vaccination. Within the next few days he developed joint pain and swelling both hands and right knee

I got shingles about one month after the second dose. I had severe pain around my spine and back on Friday (4/23/2021) and by the next morning developed red bumps on the left side of my nose that I at first mistook for acne. They produced a very tiny amount of white liquid secretion. The bumps turned darker and I got a red rash on the left side of my nose. The left side of my face as well as the lymph nodes around my collar area swelled up. By Tuesday morning, it spread to my left eye, so I went to the ER where they started me on two new antibiotics. After none of the antibiotics worked, I started an antiviral (acyclovir) and antiviral eye drops and started to improve. The rash and swelling reduced and no new blisters have formed. The doctor and I both thought it likely I had shingles.

Started experiencing back pain around 4/23/21, then experienced numbness in the feet on 4/26, was subsequently admitted to Medical Center on 4/28/21

Pt rec'd COVID-19 vaccine at 817am. He completed his observation time and walked to his car. He started feeling dizzy. Continue to drive to work and began feeling worse. Sudden onset of pain at injection site that began to shoot into his neck and down into left lower extremity. He returned to the vaccine clinic. BP normal, HR 135. C/O severe left jaw, neck and left arm pain. Brief throat itching. Pain waxes and wanes. EMS notified and patient transported to for evaluation. Pt monitored in ED, treated with Benadryl, Morphine, Robaxin and discharged to home . Symptoms resolved in ED.

Approx. 4 days following the 2nd dose of the vaccine I noted significant nose bleeds. 12 days following injection I had intense chest pain and went to the ED. EKG, blood work, and chest x-rays were taken. All came back clear. Blood pressure was 162/96. Chest pain was deemed to be musculoskelatal. Took blood pressure readings 2 days later and it was 155/90. Took regular readings over the following 3 days and it averaged 150/85. Blood pressure remains high and general practitioner will try low dose blood pressure medications.

subacute thyroiditis, hyperthyroid, 2 weeks, fever, increased heart rate, body aches, weight loss, abnormal liver enzymes. Did not improve until prescribed first atenolol and then metoprolol,

Persistent, low to medium grade throat discomfort starting 2/28 and lasting through the present date Persistent, low grade to medium grade soreness in right armpit starting 2/28 and lasting through the present date

Felt feverish symptoms that woke me up from sleep at 2:30 am. Alternation between body chills and sweats. Joint and muscle pain all over my body. Symptoms were resolved for several hours after taking two Advil tablets at about 4:30 am. At about 11:30 am, the bodyaches returned, and were again resolved by taking three ibuprofen tablets at about 12:30 pm. The symptoms did not return.

I'm still having tiredness, headache, muscle pain and joint pain since I got 2nd vaccine on May 7. In addition, I don't know if this is associated with the vaccine but, I start having Sleep Apnea Syndrome 3 days after the 2nd vaccine.

Severe joint pain; Body aches; Diarrhea; Headache; This is a spontaneous report from a contactable Other Health Care Professional (reported for him-self). A 33-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number and Expiration Date was not reported) via an unspecified route of administration in Arm Right on 25Jan2021 15:45, (at the age of 33-years-old) as un-known, single for COVID-19 immunization. Medical history included post-traumatic stress disorder, hypertension both from an unknown date and unknown if ongoing. Concomitant medication(s) included sertraline hydrochloride (ZOLOFT); amlodipine (AMLODIPINE) both taken for an unspecified indication, start and stop date were not reported. Patient did not received 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 tested for COVID-19 since the vaccination. On 26Jan2021 06:00, patient experienced severe joint pain and body aches, diarrhea and headache. Patient did not received any treatment for the adverse event. The outcome of the events was recovering. Information on the lot/batch number has been requested. This follow-up is being submitted to notify that the batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.

spinal cord swelling/ transverse myelitis; multiple sclerosis; lesions in the brain; It was hard for him to walk. He has to hold on to walls to walk.; Patient started to get terrible numbness in his feet. The numbness moved to up his left leg. Patient could not walk because of his left leg numbness.; patient cannot walk; Severe back pain; both feet have numbness and tingling; This is a spontaneous report from Pfizer. A contactable nurse (patient's mother) reported that a 33-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 13Apr2021 13:30 (Batch/Lot Number: EW0153) (at the age of 33 years old) as 1st dose, single for COVID-19 immunisation. Medical history included surgery on his leg (when he was 17) and cold. There were no concomitant medications. Patient had a severe reaction to the covid vaccine. On 17Apr2021 at 08:00, the patient had severe back pain. On Sunday morning (25Apr2021), patient had severe back pain. Patient was a former college athlete. Patient was mentally healthy and physically fit. Patient did not remember getting hurt while playing golf. Patient iced his back and did some stretches. Patient called his friend who is a doctor, and his friend told him he did the right thing by icing and stretching. A few days later, either Tuesday evening, 27Apr2021 or Wednesday, 28Apr2021, patient started to get terrible numbness in his feet. The numbness moved to up his left leg. Patient could not walk because of his left leg numbness. Patient was able to get down a flight of stairs and then called an uber. Patient was taken to the hospital. It was his left foot and left leg initially. Now both feet have numbness and tingling. It was hard for him to walk. He has to hold on to walls to walk (also reported as Patient could not walk because of his left leg numbness. Patient cannot walk. Patient can now only stand if he is holding a wall). He went to the emergency department on 29Apr2021 and got an MRI of back and lower legs, "all was negative for slip disc or spinal cord swelling. Patient had an MRI of his lower back, and legs. The MRI results were that patient had no spinal cord compression that would cause his left lower leg numbness. Patient was admitted to the hospital, to the neurology department, with a consult for a neurosurgeon to see him. The doctors agreed that he had something going on since he had left lower leg numbness. In the course of four days, Thursday through Sunday, patient was admitted to hospital in the neurology unit. Patient was in an overflow area. Several hospitals around that area have closed, so now the hospital is seeing so many more patients, and the hospital is over capacity. Patient was admitted by a hospitalist, and then was referred to a neurology team. The doctors said that that does not explain patient's symptoms, so the doctors ordered a head to toe MRI with contrast. He was admitted to the hospital and continued to have severe back pain then, the doctors did another head to toe MRI with contrast and then they said he has "MS due to brain lesions and spinal cord swelling the length of his spinal cord." They also did a spinal tap. The family kept telling the MDs that he had just received his Pfizer vaccine. The patient denies any weakness or numbness in past 6 months. He continues to have numbness in both feet and now the left leg is always numb. The doctors gave him an outpatient appt at the end of June. It felt like whenever he sits on his foot while watching TV, and it starts going numb. By the time that patient was getting testing done, the nurses covered patient's eyes, and told patient to tell them whenever he could feel it. The doctors and nurses were sticking pens in patient's feet, and patient could not feel it at all. Patient could only feel pressure. On Friday, 30Apr2021, patient had a head to toe MRI with contrast. Reporter thinks that patient got back to his room after the total body MRI about 22:15. The head to toe MRI with contrast revealed that patient had spinal cord swelling, and lesions in the brain. Doctors diagnosed patient with multiple sclerosis. Patient has never had any symptoms of multiple sclerosis. Reporter's husband feels like patient could have transverse myelitis, because some vaccines can cause that. Reporter's husband asked patient's doctor to contact Pfizer to see if there was anything in place about how to treat this. On Thursday, patient's doctor told reporter's husband that there had been no reported adverse effects of spinal cord swelling from the covid vaccine. On Sunday, whenever patient was discharged, patient's doctor told reporter's husband that he was not going to call and report about patient to Pfizer, and that there had already been 45 documented cases. This was a really big red flag to reporter. Patient cannot walk. Patient can now only stand if he is holding a wall. Before this, he was totally healthy. Patient was discharged from the hospital on Sunday. The hospital sent his MRI results, lab work, and spinal tap fluid after his MRI to Clinic. The doctors did the spinal tap on patient to make sure he did not have an infection. Patient did not have an infection. The doctor started patient on Lyrica and some other drug. The hospital told patient to call back in two weeks, because by then they would have stuff back from Clinic, and then he could make a follow up appointment. Upon discharge, patient was told that maybe he could get a follow up appointment in Jun2021. Everything that reporter has read, says that patient's condition needs to be followed up on as soon as possible. Patient cannot walk. This is going to financially cripple patient. Reporter is sure that after this, patient will meet his deductible and is going to have to pay out all of this money to cover his hospital stay and testing. Before the COVID vaccine, patient did not have any problems at all. Patient had to have surgery on his leg when he was 17. Patient has no history of back pain. By the time the doctors and nurses did testing, that was late Friday evening, 30Apr2021 or Saturday morning, 01May2021. By the time that the testing was done, both of patient's feet and left leg were totally numb. The hospital said that patient's symptoms were terrible, and that he had something acute going on. The hospital ran tests on patient. Patient told the doctors at the hospital that he had recently received the COVID vaccine. Patient was never sick he might get a cold every once in a while. Other than that, patient only sees the doctor once a year for a physical. The hospital did preliminary lab work on patient. Patient's vital signs were stable, and he had no fever. After patient received three doses of IV Solu-Medrol, his back pain went away. Patient's doctors felt like patient's spinal cord swelling had diminished. Patient's doctors felt like patient's spinal cord swelling is what cause patient's numbness and tingling. The first dose of IV Solu-Medrol was given sometime on 30Apr2021. Patient received IV Solu-Medrol 1 gram, three days in a row.The doctors said that was all they were going to do at this time. The doctors wanted to wait to see what the lumbar puncture shows (unknown results). Patient was given IV Solu-Medrol while in the hospital. Patient was put on Lyrica and gabapentin. The doctors are hoping that those two medications will make his symptoms go away. Patient used to take a multivitamin for years, but reporter does not know if patient still takes that. Patient is super healthy. Patient was admitted to the hospital on 29Apr2021, and discharged on 02May2021 after receiving his last dose of IV Solu-Medrol. The patient had no COVID prior vaccination. The patient had Nasal Swab (COVID test) on 28Apr2021 and was negative. Event relatedness to Pfizer COVID vaccine: Severe back pain and Patient started to get terrible numbness in his feet. The numbness moved to up his left leg. Patient could not walk because of his left leg numbness. Patient cannot walk. Patient can now only stand if he is holding a wall was related. Reporter stated that she thinks his symptoms are medically significant, but they could be disabling. If the COVID vaccine gave patient multiple sclerosis or transverse myelitis, this could be disabling. The outcome of the event back pain was recovered in May2021; event spinal cord swelling was recovering; events "terrible numbness in his feet. The numbness moved to up his left leg. Patient could not walk because of his left leg numbness and It was hard for him to walk. He has to hold on to walls to walk" were not recovered; and unknown outcome for the other events.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the multiple sclerosis, transverse myelitis and other reported events due to temporal relationship. However, the reported events may possibly represent intercurrent medical conditions in this patient. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including spinal MRI at baseline, 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.

had pretty severe back pain that lasted about 10 days; This is a spontaneous report from a contactable consumer reporting for son-in-law via Medical Information Team. A 33-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on an unspecified date as a single dose for an COVID-19 immunisation. The patient medical history and concomitant was not reported. On an unspecified date after vaccination, patient had pretty severe back pain that lasted about 10 days. Patient had to call out of work for 2 days because of it. Patient was scheduled to get his second dose on Monday (unspecified date). The outcome of the event unknown. Follow-up attempts have been completed and no further information is expected.

About a week or so after my first dose I started having muscle tightness and cramping in my legs and some ?electric? type radiating shots down my left leg starting up in my thigh down to my ankle. I thought it was getting better but then a week or so after my second shot I began having worse leg problems (weakness, pains, pulsing, numbness, tingling). It?s just gotten worse and I?m having tests done and seeing a neurologist.

fever; Chills; Tiredness; Headache; Muscle pains; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 33-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number and Expiration date not reported), via an unspecified route of administration in arm left on 01Feb2021 (at the age of 33-year-old), as a single dose for covid-19 immunisation. Medical history included type 1 diabetes mellitus from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number and Expiration date not reported), via an unspecified route of administration in arm left on 11Jan2021 15:30 as a single dose for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced fever, chills, tiredness, headache and muscle pains on 02Feb2021 03:00. The seriousness of all the events was reported as non-serious. The patient did not receive any treatment for the events. The outcome of all the events was reported as recovering. Follow-up (16Apr2021): 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.

Woke up to pain in my middle spine at 5am. Every time I moved I got a shooting pain up my spine. Went back to sleep for 3 hours and it was gone.

Hyperacusis, Tinnitus, Head Pressure, Neck Pain, Dizziness, Jaw Pain, Gum Pain, Ear Fluttering, Ear pain. Started on 4/17/2021

Little bit headache; Muscle pain; Little bit tired; This is a spontaneous report from a contactable (patient). A 33-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0191), via an unspecified route of administration, administered in Arm Left on 21May2021 (at the age of 33-years-old) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0169) via an unspecified route of administration, administered in Arm Left on 30Apr2021 (at the age of 33-years-old) as single dose for covid-19 immunisation. On an unspecified date in May2021, after second shot, patient experienced feeling like little bit headache and muscle pain. Reported that was not heavy, but just like little bit tired. Patient inquired that he could take pills for the pain, Tylenol or Advil. Patient was not treated for the events. The outcome for the events was unknown.

Inflammation of entire body/ specifically lower body; Headaches; double vision; Low energy; Low sensation; Neck pain; Extreme foot pain; Nervousness; anger; This is a spontaneous report from a contactable consumer (patient, self-reported). A 33-year-pld male patient received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot number and Expiry date: unknown), dose 2 via an unspecified route of administration in the right arm, on 06May2021 at 17:00, as single for COVID-19 immunization in the pharmacy or drug store. The patient's medical history and concomitant medications were not reported. The patient had no allergies. The patient previously patient received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot number and Expiry date: unknown), dose 1 via an unspecified route of administration in the right arm, on 24Apr2021 at 11:00, 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. The patient did not receive any other medications within 2 weeks prior. On 17May2021 at 01:00, the patient had inflammation of entire body/ specifically lower body, headaches, double vision, low energy, low sensation, neck pain, extreme foot pain, nervousness, and anger. The outcome of the events were not recovered. Information on the lot/batch number has been requested.

Second covid-19 vaccine (Pfizer) on 6/1/21 Says about 5 minutes later he got a temporary electrical pain that radiated from the right scapula up into the right scalp Also developed injection site pain, fever, chills, severe arthralgias within the first 24-48 hours Then on 6/4, developed right neck and scalp rash Burning, electrical pain and also some swelling Also on the right anterior neck area Some ear pain No facial involvement Diagnosed with Shingles June 7, 2021.

Nausea; Body ache; Loss of feeling in the left arm; I have numbness and loss of feeling in left arm; Tightening in my fingers.; This is a spontaneous report received from a contactable male consumer (patient). A 33-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0176, Expiration date: unknown), via unspecified route, on 27may2021 over left arm (at the age of 33-year-old) as 1st dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Her second is scheduled on 17jun2021. No other vaccines were taken prior 4 weeks. Family medical history was reported as blood pressure. On 30may2021 at 10:00, 3 days 10 hours after the vaccination, the patient experienced Nausea, Body ache, Loss of feeling in the left arm, numbness in left arm, Tightening in my fingers. The reporter assessed all events as non-serious. She wanted to know if the presented reactions are normal or not. She also asked about the need of meeting a doctor. The outcome of all the events was unknown. No follow-up attempts possible. No further information expected.

REPORTED: ARM SORENESS, BRUISING, LETHARGY FOR 1 WEEK, RADIAL TENDONITIS INJURY REAGGRAVATED, EFFECTS BEGAN WITHIN A FEW HOURS AND LASTED 1 WEEK

mild fever; stiffness (back as well as arms); 2.5 days of fatique; This is a spontaneous report from a contactable consumer or other non hcp (patient himself). A 33-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (at the age of 33 years old; batch/lot number and expiration date not reported) as first dose, single dose and via an unspecified route of administration, administered in the left arm on an unspecified date (at the age of 33 years old; batch/lot number and expiration date not reported) as second dose, single dose, both for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient experienced 2.5 days of fatique, mild fever, and stiffness (back as well as arms) on an unspecified date. No treatment was received as a result of the events. Patient did not seek consult to physician or urgent care. The outcome of event was recovered on an unspecified date. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

After receiving second dose, patient was experiencing sore and achy arms. However, now he's reporting that the pain has gone down to his elbow. He says, it doesn't hurt when he's moving his arm up and down, but is sore when he's pulling on something, such as a door knob

6/4 (around midnight) - fevers (high around 104/105) and chills 6/6 - symptoms subsided in the morning upon rising 6/8 - woke up with squeezing and stabbing pain radiating from left elbow to left wrist 6/8 - went to ER; ECG was administered and came back clean; blood was taken and showed troponin levels to be moderately high; heparin then administered and heart monitor put on; continued to collect blood 6/8 -6/10 - admitted to a different hospital facility for observation; blood collected and heparin continued to be administered; echocardiogram and heart cath procedure performed; no damage or blockages found in heart

Development of cyst-like, ball-shaped protrusion under dermis adjacent to/resting against right, center section of clavicle. Size/circumference of protrusion comparative to dime (coin). Minor tissue irritation and discomfort at location/site of protrusion. Possibly correlated, development of muscle ache in rear and sides of neck, extending to upper shoulder/trapezius.

Muscle twitching at site of injection at both vaccination sites (Dose 1, Pfizer-BioNTech Covid-19 Vaccine Lot# EP7533, left arm, intramuscular). Fasiculations of up to 3 per minute directly located where vaccine was injected. Occurs daily in intervals of 30minutes, up to 4 times per day. It occurs in both arms since it was first noticed on May 24th (38 days after 2nd dose of vaccine). It prevents sleep and causes distress.

Right and left ulnar nerve damage caused upon injection. Found by emg by dr Muscle weakness in legs hands and feet. Numbness of legs hands and feet.

There where times where I felt I was going to pass out; I became very dizzy and fatigued/ light headedness; I became very dizzy and fatigued; Had extreme brain fog and light headedness; Had shortness of breath. Tightness in throat and dry mouth; Tightness in throat and dry mouth; Tightness in throat and dry mouth; I also developed a very strong metal taste in my mouth that lasted for a few weeks; Sometimes I would also get strange sensations or weakness in my muscles with sweats or hot flashes; Sometimes I would also get strange sensations or weakness in my muscles with sweats or hot flashes; Sometimes I would also get strange sensations or weakness in my muscles with sweats or hot flashes; Some days I would wake up feeling like I was intoxicated like a drunk feeling; The feelings also came with extreme anexity and panic although the symptoms themselves could have caused that; The feelings also came with extreme anexity and panic although the symptoms themselves could have caused that; Sometimes I would also get strange sensations or weakness in my muscles with sweats or hot flashes; This is a spontaneous report from a contactable consumer (patient). A 33-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 11May2021 10:15 (at 33-year-old) (Lot Number: EW0182) as 2nd dose, single in arm right for COVID-19 immunisation. Medical history included anxiety, depression, and panic. No known allergies. The patient's concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 19Apr2021 15:30 (at 33-year-old) (Lot Number: EW0171) as 1st dose, single in arm right for COVID-19 immunisation. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient wasn't diagnosed with COVID-19. After about 7-10 days after 2nd dose vaccination he became very dizzy and fatigued, and had extreme brain fog and light headedness. There where times where he felt he was going to pass out. He also had shortness of breath, tightness in throat and dry mouth. He also developed a very strong metal taste in his mouth that lasted for a few weeks. Sometimes he would also get strange sensations or weakness in his muscles with sweats or hot flashes. Some days he would wake up feeling like he was intoxicated like a drunk feeling. The feelings also came with extreme anexity and panic although the symptoms themselves could have caused that. The onset date of events was reported as 14May2021 02:30 am. No treatment received for events. Since the vaccination, the patient hasn't been tested for COVID-19. The outcome of the events was resolving.

Pain in upper part and side by his ribs, into the back; Pain in upper part and side by his ribs, into the back; blood clots in the lungs; Breathing was not normal; It felt like in his back, like the muscles were too tight; This is a spontaneous report from a contactable consumer (patient's mother). A 33-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in arm on 17May2021 (late morning or early afternoon) at age of 33-year-old at single dose for COVID-19 immunization. There was no additional vaccines administered on same date of the Pfizer suspect. Medical history included the patient was diagnosed with COVID-19 in May2021, 15 days before the patient received the vaccine, he was doing very well, it was a light case. There were no concomitant medications. There was no prior vaccinations within 4 weeks. After vaccination, the patient was feeling much better afterwards and felt fine. The patient did not think too much of it. As the day went on, it got worse. The patient had a very serious reaction. The patient had a blood clot in the lungs on 18May2021 and was in the hospital. It was very scary. It was referring to the Pfizer COVID 19 vaccine. The patient received it in (withheld). 15 days before the patient received the vaccine, he did have COVID. The patient's doctor recommended it was ok to go back to work and to have the vaccine. The patient had the vaccine on 17May2021 and by 20May2021, he was in the hospital with blood clots in the lungs. The lung doctor was saying that the blood clot came from the vaccine. The patient had to take blood thinners for 3 months and they are concerned about the long term. The patient was in the hospital for 2 days, in (withheld) from 18May2021 to 20May2021. On 20May2021, the reporter brought the patient home. The patient was in so much pain, reporter took him back in the morning of 21May2021. For event blood clot, it had been 2 weeks. The patient went to work and came home on 18May2021 that day early from work, around 5:00 pm, having pain. The patient called the doctor who said to take paracetamol (TYLENOL) and go to bed. By that evening around 10:00 pm, they ended up taking him to the hospital, where they said he had blood clots. His pain was in the upper part and on the side by his ribs, into the back. The reporter thought at first, it was more to the left but patient was in so much pain, she really could not tell. They said the patient had 2 blood clots, one was on each lung, but they were so small. The pain was so severe. They took the patient to the hospital and he was there 2 days. On 20May2021, they released the patient. When they went to get him on 20May2021, reporter noticed that something was wrong. They gave the patient medication, a prescription pain pill. By the morning of 21May2021, around 06:00, they took him back to the hospital. They did blood work and another CT scan, and said there was no change. When they finally got the patient back into the room, they gave him some type of injection to release the pain. The reporter literally had to call another hospital, who told her to call the nurse supervisor. The reporter was outside calling the nurse supervisor for the emergency room. Then, they said that someone would come out. It had to go that far. After that, when they gave the patient the shot, the pain did subside. When it started to ware off, they gave the patient pain medication. On 22May2021, the doctor called to check on the patient. The reporter was concerned they gave the patient the shot too soon. The doctor said that it would take a while for the medication to take effect. It felt like in his back, like the muscles were too tight and the pain was so bad. The reporter had asked about a muscle relaxer and was initially told to wait until 24May2021 but then ordered a muscle relaxer and it did seem to help some what. On 22May2021, the patient started to feel like there was not any pain and his breathing felt normal. Before that (May2021), the patient's breathing was not normal. It all started happening and could not even explain when. The event blood clots in the lungs required a visit to emergency room for twice, the first time, the patient was admitted to hospital. Treatment included pain medication or muscle relaxers, apixaban (ELIQUIS) after the blood clots. The outcome of blood clots in the lungs and muscles were too tight was unknown, the outcome of rest events was resolved on 22May2021. Information about lot/batch number has been requested.

Dull ache / pain on inner left pectoral muscle for 3-4 weeks after each injection. Approximately 1-2 times per day, during the same timeframe as sore pectoral muscle, noticeable heart "flutter". This flutter was felt almost like heart skipping a beat / irregular heartbeat / heart palpitations for 5-15 seconds, but would resolve.

Extreme muscle pain, muscle spasms, skin pain, eye pain, pupil dilation, headache, nausea, vomiting, extreme dizziness, fatigue, nose bleed, cough

nerve pain in face arms, legs, fingers, and toes; rapid high blood pressure; superficial thrombosis; weakness in limbs/legs give out on me; constant nausea; pain behind eyes; right eye randomly goes blurry; pain and pressure in back of neck and legs; pain and pressure in back of neck and legs; pain and pressure in back of neck and legs; lightheaded/severe light headedness; almost blackout; rapid heart rate; hard to breath; throat swelling; severe pain and burning down full left side of body; severe pain and burning down full left side of body; severe headache; This is a spontaneous report from a contactable consumer (patient). A 33-year-old male patient received bnt162b2 (brand: PFIZER), dose 1 via an unspecified route of administration, administered in arm left on 03May2021 08:15 (Batch/Lot number was not reported, Unable to locate or read the details) as dose 1, single at the age of 33-year-old for covid-19 immunisation. Medical history included known allergies: Penicillin. Other medical history was none. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. Facility where the most recent COVID-19 vaccine was administered: Other. Reported event: within 30 minutes was lightheaded/almost blackout, rapid heart rate, hard to breath, throat swelling, severe pain and burning down full left side of body, severe headache on 03May2021 08:45. 7 weeks later (Jun2021) still having headaches, nerve pain in face arms, legs, fingers, and toes, rapid high blood pressure, superficial thrombosis, weakness in limbs, legs give out on me, severe light headedness, constant nausea, pain behind eyes, right eye randomly goes blurry, pain and pressure in back of neck and legs. The adverse event result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient was hospitalization for 1 day. Events seriousness reported as hospitalization and life threatening. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included Nasal Swab (Rapid): negative on 05May2021. The treatment received for the adverse event included pain medication. The event outcome was not recovered. Information on the lot/batch number has been requested.

Continuous muscle pain, stiffness, swelling in legs, primarily the lower half; intermittent muscle pain in left arm near armpit

Sleepy; Tired; Shoulder pain; This is a spontaneous report from a non-contactable consumer, the patient. A 33-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 24Mar2021 at 10:00 (at the age of 33-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 24Mar2021, the patient experienced sleepy, tired and shoulder pain. The patient did not receive any treatment for events. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. The clinical outcome of the events sleepy, tiredness and shoulder pain was unknown at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

he couldn't stand up anymore; wasn't able to stand up with the muscle pain; couldn't support his legs any longer; fever; muscle pain; a stronger pain in his head; pain in his throat; heart beat was accelerated too much; flu like symptoms; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 33-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0178), via an unspecified route of administration, administered in Arm Left on 07Jun2021 15:15 (at age of 33 years old) as single dose for COVID-19 Immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot no: EW0177) on 17May2021 (at age of 33 years old) at left arm as single dose for COVID-19 Immunization and experienced a lot of congestion, body aches, cough. Caller stated he had side effects to the Pfizer COVID 19 vaccine and went to the ER (emergency room). The patient said he had to go to the emergency room because of side effects he was having to the COVID 19 vaccine. He is asking who will pay for his medical expenses. He experienced fever, muscle pain, a stronger pain in his head, pain in his throat and also his heartbeat was accelerated too much, all on 13Jun2021. Second dose received on 07Jun2021 in the left arm. After the second dose, it was 4 days starting on the 13Jun2021 with flu like symptoms. On the 16Jun2021, he couldn't stand up anymore so he went to the emergency room. He couldn't stand up anymore so he had to go to the emergency room on 16Jun2021. He was discharged from the emergency room. The emergency room ran some tests and told him to take some Tylenol. He had a COVID 19 test and he is expecting a call with the results and the staff at the hospital took his temperature. He explained to the hospital staff that he was having the symptoms that are on the COVID 19 vaccine paperwork and that was the reason for his visit, since he had the two COVID 19 vaccines. He would like to point out that he asked the nurse when he was going to have the second dose, since the first vaccine he was still having side effects, he asked her if he was in danger to have the second vaccine. The nurse told him he was ok to get the second vaccine. The nurse told him he might have some muscle pain but he shouldn't be worried about it. At the emergency room he also had some blood tests. And also they took his pulse and after that the doctor was reading something in English that the interpreter couldn't catch and read. He provided Pfizer with what happened so far since he had the vaccine. He wasn't able to stand up with the muscle pain and he couldn't support his legs any longer, all on 16Jun2021. He would like to know if he's going to get some help with the medical bills. The patient underwent lab tests and procedures which included Blood test: negative, COVID-19 virus test: negative on 16Jun2021. The outcome of the events was unknown. information on the lot/batch number has been requested.

severe chills for 2 hours (onset 15 hours following administration; aching joints; fever (~101 F) persisting for approximately 24 hours; aching muscles; very minor pain to the touch at injection site; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old, male patient received second dose of BNTI62b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955), via an unspecified route of administration in the left arm on 24Mar2021 at 09:00 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. Patient had no medical history. The patient did not receive any other medication within 2 weeks of vaccination. The patient previously received first dose of BNTI62b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3248), via an unspecified route of administration in the left arm on 04Mar2021 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 25Mar2021, the patient experienced chills, muscles pain, joints pain, fever and vaccination site pain. It was reported that patient had severe chills for ~2 hours (onset 15 hours following administration), fever (101 F) persisting for approximately 24 hours, very minor pain to the touch at injection site. No therapeutic measures were taken as a result of the events. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events of muscle pain, joint pain and vaccination site pain was recovered. The clinical outcome of the events chills was resolved on 25Mar2021 and fever was resolved on 26Mar2021. No follow-up attempts are needed. No further information is expected.

Arm pain and fatigue. Waking up with shooting pain in arm. Numbness and fatigue in legs. Persistent fatigue and muscle twitching still two months after injection. In forearms, thighs, calves, buttocks, eye area. Neck stiffness. inflamed lymph nodes. longer recovery times from exercise. mild to moderate chest pain. severe shoulder pain return in left arm after exercise. Occasional

Erectile dysfunction; Insomnia; Increased high anxiety levels; Diminished sex drive; Continuous joint aches; Possible gout build up; This is a spontaneous report from a contactable consumer (patient himself). A 33-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: ER8753; Expiration date: Unknown) via an unspecified route of administration, in left arm on 22Apr2021 17:30 (age at vaccination 33-year-old) as dose 1, single, and patient received second dose via an unspecified route of administration, in left arm on 22Apr2021 (Batch/Lot Number: EW0173) as dose 2, single both for COVID-19 immunization. Medical history included joint injury and back pain from an unknown date and unknown if ongoing. Concomitant medications included fish oil (FISH OIL), ergocalciferol (VITAMIN D [ERGOCALCIFEROL]), loratadine (CLARITINE), fluticasone (FLUTICASONE) taken for an unspecified indication. Patient did the 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 25Apr2021 23:00 the patient experienced erectile dysfunction multiple times Continuous joint aches, insomnia, increased high anxiety levels, diminished sex drive, continuous joint aches, possible gout build up. Patient experienced diminished sex drive leading to erectile dysfunction multiple times continuous joint aches, that previously were not an issue, ever. Patient was hospitalized for 1 day. Hospitalization was not prolonged. The adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Patient had not received any treatment for adverse events. The outcome of all events was not recovered.

Recurrent headache (frontal); local tightening of the muscles deltoids and triceps of the left arm; This is a spontaneous report from a contactable Other HCP. A 33-year-old male patient received second dose of BNT162B2 (BNT162B2, Solution for injection, Lot Number: EL3247), via unspecified route in left arm on 23Jan2021 01:00 as single dose for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. No known allergies reported. Patient previously took first dose of BNT162B2 (BNT162B2, Solution for injection, batch/Lot number Ek9231 and expiration date was not reported), via unspecified route in left arm on 02Jan2021 10:00 as single dose for COVID-19 immunization. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not take other medication in 2 weeks. On 24Jan2021 at 18:00 the patient experienced Recurrent headache (frontal), and local tightening of the muscles deltoids and triceps of the left arm. The patient was not taking any treatment medications. The outcome of both event was not recovered. Follow-up (07May2021): Follow-up attempts completed. No further information expected.

chest pain/experienced chest pain, but it was more like a radiating pain that also effected their neck and arm; chest pain/experienced chest pain, but it was more like a radiating pain that also effected their neck and arm; chest pain/experienced chest pain, but it was more like a radiating pain that also effected their neck and arm; chest pain/experienced chest pain, but it was more like a radiating pain that also effected their neck and arm; patient had some of the symptoms of the myocarditis or pericarditis; patient had some of the symptoms of the myocarditis or pericarditis; This is a spontaneous report from a contactable pharmacist. A 33-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Batch/Lot Batch/Lot number was not reported) via an unspecified route of administration and administered in left arm on 07Jun2021 (at age of 33 -years-old) as first dose 0.3 ml, single dose for COVID-19 immunization get protection from covid 19. The patient medical history and concomitant medications were not reported. Caller was a pharmacist calling on behalf of her patient who received the first dose of the Pfizer-BioNTech COVID19 vaccine on 7 Jun 2021 and experienced chest pain, but it was more like a radiating pain that also effected their neck and arm on the same day of vaccination. The patient came in to get their second dose. patient had some of the symptoms of the myocarditis or pericarditis. He was supposed to get the vaccine on Monday (28 Jun 2021) but caller said she wanted to talk to Pfizer to see if we had any recommendations on getting the second dose with a potential of having myocarditis or pericarditis. The chest pain lasted 3-4 days and was improved. Investigations as the caller does not think the patient had any tests done as he didn't seek any medical attention about this. Outcome of the chest pain was recovered on unspecified date in 2021 and other events was unknown. Reporter seriousness for chest pain but it was more like a radiating pain that also effected their neck and arm as Not serious and assessed as Related. Information on the lot/batch, further information has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Myocarditis and Pericarditis and the suspect drug bnt162b2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of 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.

03/18/2021 My arm turned purple, stomach ache, headache, diarrhea, all of this lasted 13 days. Excessive thirst. Inability to move left arm, arm was weak, arm felt heavier, muscle weakness, problems extending arm. The arm problems still exist. I saw specialist at clinic, an orthopedic surgeon, 05/04/2021, he said I had shoulder impingement and said it was directed to vaccine. I saw PCP on 4 different dates. April, May, June and July.

left upper arm muscle pain, left shoulder pain, some discomfort in left forearm and left elbow, decreased ROM left arm and left shoulder

Light-headedness, dizziness, headache. Feelings of being cold/hot with high lability. Facial pressure. Exacerbating throughout the day and continuing into the following day.

Myalgia (5/10 pain) much more than with a typical flu vaccine. Significant swings in body temperature ranging from chills to sweating for >24 hrs without a definitive fever.

Nausea, vomiting, fevers, chills, myalgias, arthralgias, severe fatigue, severe headache, muscle stiffness, blurred vision, dizziness,

Local injection site soreness (within 1 hour of administration); fever/chills, fatigue, and myalgias (approximately 7 hours following injection). Improved with acetaminophen and ibuprofen. Fever/chills resolved within 12 hours of onset. Myalgias and fatigue resolved within 48 hours of onset.

Symptoms ? EE reports he received his 2nd dose and reported to work from 11:00 PM shift. EE reports pain at this injection site with shoulder pain that worsened as his shift went on. EE reports pain as ?stabbing and sharp.? EE reports he suffers from severe anxiety and takes medication for his anxiety. EE reporting nausea at time of call but EE attributing to his anxiety as he often feels nauseated when he is anxious. ? Last day of work and shift - ? 1/13 Home remedies? - acetaminophen at 11:15 am (1/14/21) Any improvement? ? mild improvement Recommendation? EE encouraged to continue to monitor his symptoms and to contact the vaccine support line for further questions or concerns. EE encouraged to apply cold compress to injection site and neck and to rotate Tylenol and motrin q3h using dosing as instructed in Medical Directive. EE verbalized back understanding and denied further questions at this time.

Instant arm soreness and numbness. Arm muscle pain from about 2pm until about 9pm. Developing fatigue and headache by 2. At 9pm started to have sever rigors and had to move to a bed. Rigors for several hours with fever coming and going. Mild hallucinations while in bed and severe sweating. Woke up with left eye not responding but still had vision. Headache only on left side of head with severe pressure. Right sight felt normal. Right eye normal. Seemed like mix between edema and slight bell's pallsy. Could still move left side mouth and forehead. Eye was not responsive. Eye resolved after 2 days. Return to 100% about 96 hours after dose.

1. Shaking 2. Whole body tingling 3. Left arm tense (injection was provided in right arm) 4. Felt clammy Walked over to hospital attached to the facility and was discharged the same day. All symptoms resolved.

Fever, rigors, chills lasting 12 hours managed with Tylenol, arthalgias and myalgias lasting 36 hours

At 9:55 am patient reported numbness in the left arm, nausea, diminished pulse, hypotension, and back pain. Vitals taken every 5 minutes. Patient received 8L of continuous O2 by face mask. Administered 50mg/mL IM Diphenhydramine to patient at 10:27.

About 1 day after the shot experienced fatigue, myalgias, fever, night sweats, chills, and sleepiness.

-Mild-moderate fatigue -Moderate bilateral upper body soreness, specifically axillary and neck areas with lymphadenopathy -Mild-moderate fever (99.7*F-100*F) -Mild-moderate bilateral upper extremity peripheral hypersensitivity (burning/pain with light touch from elbows to hands)

Shoulder soreness. Left supraclavicular lymphadenopathy. One swollen node was noted about one week after the first dose. The node was mobile and nontender. One day after the second dose was administered on 2/5/21, a second non-tender mobile node was found lateral to the first node in the left supraclavicular region. Supraclavicular nodes on the right were found to be palpable but not nearly as large.

101 fever for 36 hrs, joints pain, head aches, nausea, severe body aches, constipation, cough, disorientation.

Continued pain in shoulder at the site of injection. Small pinching pain. Feels similar to a stained muscle. Has not gone away since shot was given.

Tendonitis, debilitating neuralgias leading to 2.5 weeks of missed work No issues immediately after injection. About 12 hours later had severe arm pain limiting motion in L arm. Slowly improved but never resolved. Started to get worse again on day 7/8 with pain in deltoid, tricep, bicep, forearm. Should pain on day 10 while in bed reaching for covers - limited ability to do normal task (lift arm to turn on turn signal). No improvement with ibuprofen. Right shoulder pain started the following day. Was given medrol dose pack with some improvement for 2 days but bilateral shoulder pain worsened by day 2 of steroids. Heard pop in Right groin while sliding in bed on day 3 of steroids. Painful causing limping while walking for several days. On 1/13/21, severe pain in groin when standing leading to ER visit (Xray negative). MD described as tendonitis of adductor muscle. Pain radiated down leg to knee and to hip. The following day similar pains occurred in the left leg. Pain "bounced" between bilateral upper and lower proximal muscles and tendons. Had stiffening of R arm on 1/15/21 and 1/16/21 associated with numbness in hand. Went to ED again. inflammatory markers were negative. ANA was positive for RNP antibodies but the titer was low. rheumatoid factor low. TSH normal. ED MD said she would call it polymyalgia rheumatica but I was 40 years too young. Bouncing severe neuralgia type pain lasted about 2 weeks. It started to resolve with scheduled naproxen and daily physical therapy multiple times per day. It's 2/13/21 and I am still taking NSAIDs and doing PT and have residual shoulder impingement with upward arm movements, have limited ability to lift objects that I previously could and also have difficulty standing for rounds (critical care clinical pharmacist).

Patient received Pfizer-BioNTech COVID-19 Vaccine EUA at 1324. At 1339 felt tightness in hands, 1350 itchiness/tightness/anxiety, 1430 sore joints. Given Benadryl 25mg at 1350. After further observation, patient felt good and left at 1452.

joint/muscle ache on left arm (site of injection); joint/muscle ache on left arm (site of injection); joint/muscle ache on left arm (site of injection); Swelling of left arm and left armpit (possibly lymph node swelling); Swelling of left arm and left armpit (possibly lymph node swelling); Unable to lift left arm past shoulder; mild fever; full body ache/pain; slight disorientation when standing; headache; fatigue; This is a spontaneous report from a contactable consumer (patient). A 34-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on the left arm on 27Jan2021 17:45 at a single dose for COVID-19 immunization. Medical history included latex allergy. Concomitant medication included influenza vaccine (TRIVALENT INFLUENZA VACCINE) on 11Jan2021. The patient previously received first dose of BNT162B2 on 06Jan2021 for COVID-19 immunisation (first dose at 05:45 PM, left arm). First symptom: headache/fatigue at 3:30 pm on 28Jan2021, sleep at 11 pm. Woke up at 8 am 29Jan2021, symptoms include mild fever (temperature not taken), severe headache, full body ache/pain, slight disorientation when standing. Symptoms alleviated by taking 1 acetaminophen (TYLENOL) pill (extra strength). Symptoms returned at 4 pm, another Tylenol pill taken to relieve symptoms. On 30Jan2021, mild symptoms in the morning including headache, joint/muscle ache on left arm (site of injection). Treated with Tylenol. Swelling of left arm and left armpit (possibly lymph node swelling). Unable to lift left arm past shoulder. On 31Jan2021, persisting mild headache and left arm aches, now able to lift left arm past shoulder, but with some discomfort. Treat with Tylenol. On 01Feb2021, mild headache still persisting, significantly reduced swelling of left arm/armpit. Full motion with left arm without discomfort. Treat with Tylenol. Events were reported as non-serious; did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. The facility where the vaccine was administered was in a Public Health Clinic/Veterans Administration facility. There were no other medications the patient received within 2 weeks of vaccination. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. Outcome of the event swelling arm was unknown while recovering for the other events. Information on the lot/batch number has been requested.

Soreness in the back started on 2/5/2021 and eventually moved to the abdominal area on 2/12/2021. Went to the doctor and got a CT scan and found an Acute right common iliac vein and infrarenal IVC thrombus. Many blood tests were run and no common factors were located to cause the thrombus.

Patient received second dose of Pfizer vaccine at 5pm on 2/18/21 and experienced expected symptoms of fatigue, injection site pain and minor body aches. Patient began to experience difficulty breathing on the morning 2/20, at that time the patient attributed it to asthma. Patient reports that he has not had an acute asthmatic episode in 25 years and has not experienced any respiratory condion like this before. Shortness of breath, chest pain and dizziness increased in the day to follow. On Monday 2/22 at 8:30am patient was seen at family medical facility by Doctor presenting with a 02 SAT of 93%. Covid test was preformed and was negative. Dr prescribed a preventative inhaler and some prednisone and sent patient home. Patient continued to decompensate and at 6pm was seen by previously treating physician, presenting with 02 sat of 91% given a nebulizer and sent home. Patients condition worsened overnight and he was seen in the faility Urgent care at 9am on 2/23. Patient was given a repeat covid test, that was negative , flu test that was negative, and chest xrays that were clear.

Moderate to Severe pain in left shoulder due to improper placement of the needle. Limited mobility due to inflammation and pain.

Slight pain in deltoid muscle when lifting left arm.; This is a spontaneous report from a contactable consumer (patient). A 34-year-old male patient received bnt162b2 (BNT162B2, Solution for injection, Lot number: EN 5318, expiration date unknown), via an unspecified route of administration on the left arm at the age of 34 years old on 28Jan2021 at 10:45 at a single dose for COVID-19 immunisation in the workplace clinic. Patient has no medical history reported. The patient has no allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced slight pain in deltoid muscle when lifting left arm on 28Jan2021. No treatment was received in response to the event. The patient assessed the event was non-serious. The patient has not been tested for COVID-19 since the vaccination. The outcome of the event was recovering.

While I did experience most of the common side effects - headache, chills, muscle aches, joint aches, short fever - I wanted to report a side effect that surprised me. My eyelids became puffy and the area around my eyes was swollen and ached. My eyes were also very sensitive to light. This started on the morning of day 2 and is still lingering, but better, by day 4.

Lethargy; Muscle and Joint Pain; Muscle and Joint Pain; random Tremors; This is a spontaneous report received from a contactable consumer (patient). A 34-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on the left arm, on 31Jan2021 10:45, at single dose, for COVID-19 immunization. Medical history included HIV undetectable. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. The patient has no allergies to medications, food, or other products. Concomitant medication included bictegravir sodium, emtricitabine, tenofovir alafenamide fumarate (BIKTARVY); clonazepam; divalproex sodium (DIVALPROEX SODIUM ER); and lurasidone hydrochloride (LATUDA). The patient did not receive any other vaccines within 4 weeks prior to BNT162B2 vaccine. On 01Feb2021, the patient experienced lethargy, muscle and joint pain, and random tremors. No treatment was given for the events. The patient underwent lab test which included Blood HIV RNA on an unspecified date with result HIV undetectable. The outcome of the events was not resolved. Information on the lot/batch number has been requested.

8 days after the 2nd dose of the pfizer, I started having heart rate increases where my heart rate increased from my normal rate all the way up to 160bpm+. This has continued now for almost 2 weeks and also the start of additional symptoms where I feel flush, my body tingles, chest tightness, heaviness in my legs, shortness of breaths.

Muscle pain and weakness beginning 2/28/2021, hospitalized 3/2/2021-3/8/2021 for rhabdomyolysis (peak CK = 112,000) and severe transaminitis (ALT and AST in the 2000's). No preceding injury or trauma, no drug or excessive alcohol use. By 3/19/2021 patient still unable to get out of chair without using arms, significant proximal mm weakness. Inflammatory markers elevated and CK and liver enzymes still surprisingly high. Re-hospitalized 3/22/2021. Still in hospital, improving, on date of report (3/23/2021).

I got vaccine on Friday3/19/21. Everything was good on Saturday but when I wake up on Sunday morning I realized that my neck is very stiff and I was not able move my neck. The pain was very severe and was predominantly in the area of upper back and right shoulder area. I was on bed whole Sunday. On Monday i had the same issue. On Tuesday I got little improved. On Tuesday I can move my neck left and right with some pain but still I can?t move my neck downward. I call my doctor?s office and they told me to use over the counter pain medication and if I still have pain until Thursday then schedule office visit.

Severe myalgia throughout most of body, difficult to walk quickly or get in/out of car seat. Moderate fatigue. Lasted approximately 2 days.

Almost immediately after I received my dose, I felt very dizzy and began sweating profusely. My vision became very blurry, and I had trouble breathing. No one came to check and see if I was ok. They just waved me out of the building, being terrified of what was going on and what wanting to leave the facility I drove out into the parking lot for the additional assessment. In the parking lot, I continued panting and sweating, feeling as though I was going to vomit. Again, no one checked on me, and I was too incapacitated to "honk my horn 3 times." After the additional 15 minutes, they waved everyone through to leave, so I left. There was no professional around to speak with at this point anyways. Covered in sweat and dizzy. I drove home to go to bed. When I got home about 10 minutes later, my arm where I received the vaccine was already very sore. I laid in bed and fell asleep and continued sleeping off and on for the rest of the day and night. My shoulder was still sore the following morning when I woke up. As the day progressed my fatigue increased (Sunday was not too bad.) Monday (3.22.21) I felt terrible, (headache, brain-fog, bad back pain, bad knee pain, bad hip pain.) My symptoms have persisted all week. I am unsure as to what to do. I do not have a doctor that I regular see. I am afraid to receive another dose and have even worse reactions/side-effects

stiff neck; blood in my stool; had difficulty getting comfortable; increasing neck pain; fever; chills; major fatigue; increasing back pain; unable to sleep due to the pain; This is a spontaneous report from a contactable consumer (occupation: other health professional), the patient. A 34-year-old male patient received second dose of BNT162B2 (COVID-19 vaccine, Solution for injection, Lot number: EM9810) via an unspecified route of administration in the left arm on 12Feb2021 at 09:00 AM as a single dose for COVID-19 immunization. Medical history included 1 kidney stone. The patient had allergies of whey (milk and cheese). Patient had no vaccination prior to COVID. Concomitant medication included Calcium supplement gummies (from two weeks). Patient did not receive any other vaccine in four weeks. The patient previously received the first dose of BNT162B2 (COVID 19 vaccine, Solution for injection, Lot number: EC9261 or EL9261) via an unspecified route of administration in the left arm on 22Jan2021 at 02:45 PM. Since the vaccination, the patient had not been tested for COVID-19. On 12 Feb2021, the patient had no side effects for almost 12 hours (Fri 9am-9pm). After that at 21:00PM, patient had major fatigue, chills, fever as well as increasing back and neck pain. The Patient was unable to sleep friday night due to the pain and on saturday had difficulty getting comfortable. By sunday the back pain subsided but the neck pain and stiff neck remained, patient had difficulty turning the head. The patient continued to have chills and fever. Ibuprofen helped some with the symptoms. By sunday night patient had no major symptoms but had blood in stool on Sunday and Monday. Event blood in my stool was considered as medically significant. Patient had fully recovered in 2021.; Sender's Comments: Considering a plausible temporal association between the event 'Hematochezia' and the suspect drug BNT162B2, a causal relationship cannot be excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.

Systemic: Flushed / Sweating-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Tachycardia-Mild, Additional Details: Patient complain of tachycardia, sweating, left neck soreness, dry mouth and numb tongue approximately 10 minutes after administration. Recovered after 30 minutes. Per patient possibly anxiety induced.

Sore left arm, muscle soreness, fatigue waking up the next day. Around 24 hrs after vaccination, headache started, and lasted for ~8 hours. I took some advil around an hour before the headache stopped (really wish I'd taken it when I first felt the headache). I could feel the muscle soreness go away before the headache did. The headache felt like it moved from behind my eyes to the back of my head. I decided to only eat bits and pieces of stuff when I was feeling my worst because I was concerned that would make me feel nauseated (never did feel that way, so no idea if that made a difference). I drank probably 200oz of liquid throughout the day, but still felt dehydrated, even though I wasn't sweating. Did pee a lot though. Generally it was what I expected, but a friend who works at a hospital said I should report the info.

Approximately 8 min after receiving vaccine patient reports Tightness in chest and limbs, light headed, anxious

nine hours after injections: fever, muscle pain, nausea, chills, joint pain, headache, injection site pain, vomiting, muscle spasms, lymph node appearance in neck, sleepiness, malaise, vivid dreams, unable to sleep well, or function.

I am experiencing swelling in my left armpit (approximately 30 hours after my second dose of Pfizer vaccine). The swelling is causing my left armpit to be tender and is about the size of a golf ball. I am not currently under treatment for this side effect.

When I got the shot I felt okay for the rest of the day, but the injection site on my right arm hurt a bit for the rest of the day. The next morning my right arm still hurt, but it was not worst. However my left hand and left elbow felt very stiff. When I tried to bend my left elbow it hurt a bit. When I tried to bend my fingers on my left hand it hurt very much. I couldn't even make a fist it hurt so much. I kept slowly bending my elbow and bending my fingers until the pain and stiffness would go away. Most of the pain and stiffness went away, but a little still remained. It feels like I have some kind of Arthritis in my left hand and left elbow, but I have never had it before. Since I got the COVID-19 vaccine, every time I wake up I have been experience the same thing.

Vaccine was received Friday around noon. Friday night i had a headache. By Saturday morning I had muscle aches, chills, and terrible headache. Muscle aches, chills and headache resolved by early Sunday morning. Sunday morning around 9am an itchy rash started on the abdomen. Over the course of 30 minutes it moved from the stomach area to other parts of the body (shoulders, back, head, feed, hands, etc, only the face and neck have avoided seeing rash). It pops up and then dissipates and then moves to another area over the course of 30 minutes to an hour. It has been two weeks since the shot and the rash is still present, coming and going, moving around the body. Allergy medication controls the rash, but when the medication wears off the rash returns.

Shingles start to develop on the second day after receiving the 2nd dose of Pfizer/BioNTech COVID-19 vaccine. The Shingles are on the belly and also on the back.

Feeling unwell, dizziness/weakness, muscle pain, and difficulty breathing. Onset of symptoms under 1 hour from time of vaccination. EMS on site monitored patient and later released. No need for additional care or treatment.

Symptoms starting roughly 10 hours after vaccine, and lasting for 18-24 hours: High fever, chills, intense body ache, joint pain (to the point of not being able to move), fatigue, headache, vomiting, diarrhea, abdominal pain, weakness/fainting

Severe body/muscle aches approximately 19 hours after injection, accompanied by minor dizziness. Moderate fatigue. Took Tylenol to relieve side effect symptoms. Mild to moderate shakiness and shaky sensations then set in 24 hours after injection, most noticeable when trying to sleep and waking up.

I had a nasty zit on the back of my neck, popped it, and my immune response was extreme. Initial: Itching and burning through my neck and shoulders, and swollen lymph nodes in neck and collarbone. I began sweating at night profusely and losing weight. I have had a lot of trouble sleeping. These symptoms continued in 24-48 hour cycles of flare ups until 04/19/2021 but finally seem to be abating. Progression: secondary symptoms appeared over the course of the month such as full body joint soreness, weakness, stiffness, stabbing pains (in the neck, arms, chest, and abdomen), blood pressure spikes, dry/sore throat, dry eyes, difficulty swallowing. Symptoms are similar to arthritis or other autoimmune diseases. Night sweats continue but are lighter. Weight loss continues but slower. Sleeping remains irregular.