Pfizer

Last night I broke out into a bunch of itchy spots that resemble hives all over my body. The hives went away in the morning. Just now, 3:57pm today, I have puffy eyes and a swollen throat.

Itching and rash to the injection site, left deltoid. Down left arm shoulder and chest. After a few minutes patient was stable and sent home after monitoring patient. Benadryl was administered at 12:17pm. Patient advised to take Benadryl prior to 2nd dose.

1. 48 hours after the first vaccine dose, she developed a raised, red, bump ~4-5cm area on her back with irregular borders. It was slightly itchy but not painful. 2. The area on her back worsened over the next 2-3 weeks and developed dark black scabs. 3. 24 hours after the second vaccine dose (which was given on 2/20/21), she developed scattered lesions on her neck, hairline, ear, face ? some with blisters, some with scabbed tops. Again slightly itchy but not painful. She also had a transient headache and chills that resolved on their own that same day.

Patient was sitting in the observation area. Patient stated that she was feeling "off" and we helped lower her to the ground into a sitting position. She stated that she felt dizzy and we lowered her onto her back and raised her legs onto a chair. 911 was contacted. Patient remained responsive and was able to answer questions throughout. Patient stated that her shoulder felt like it was burning where she received the injection. She also stated that her face felt numb and her lips felt funny (tingling). Patient was still able to breathe and respond appropriately to all questions. Care was taken over by Ambulance service. After speaking with patients mother later in the day, it was determined patient had a vasovagal episode.

Rashes in the face, ears and the whole body and ichy in the face. Difficult in swollow in the throat. The doctor in the urgent care gave her an injection of Benadryl and an injection of prednisone, and gave her pills of prednisone for 5 days and Benadryl too.

Right arm immediately went numb down its length and immediately noticeably swelled up, from wrist to shoulder. It was hot to the touch. The arm also developed a rash. Patient was monitored by paramedics, who confirmed her pule, oxygen levels and blood pressure were normal. Conditions improved after about a half hour, but did not resolve completely. Arm is still slightly swollen (after providing Benadryl) and is very painful around injection site, 24 hours later..

Patient reported small area of redness and itching on left forearm. Patient also states she went horseback riding yesterday and had a similar rash on right forearm. Patient evaluated by EMT and MD. Blood pressure 128/87. O2 saturation 99%. Patient given Zyrtec X1 po.

Patient referred to clinic for increased bruising. Patient reports heavier menstrual flow, frequent bloody nose recently.

Pain in injection area, sharp pain in underarm area, shortness of breath, chest pain, rapid heart palpitations, dizziness, tiredness,

patient said she started losing vision in one eye for few minutes, and started having numbness or tightness in arms. Paramedics were called and she felt fine after first few minutes

Severe hives on arms, legs, and torso. Elevated temperature of between 99-100 F. Began at 11:00pm on Apr 5, 2021, about 12 hours after vaccination. Hives severity continues to increase on Apr 6, 2021 as of about 24 hours after vaccination. Has not yet recovered. Monitoring.

The teen had a history of autoimmune disorder, alopecia areata for the past 2 years. When received the first dose of pfizer COVID vaccine, she started losing hair rapidly after about 6 to 7 days. She was started on large dose of prednisone 100mg per day after 2 weeks to slow down alopecia. However, in the span of 4 days she lost most of her hair. We are wondering if the vaccine could have exacerbated the autoimmune disorder.

Feeling faint, extreme fatigue, vomiting without nausea (no warning)--foul/sour. Kept complaining that she felt like she was crawling in her own skin, all through her arms and her chest, like an itch from the inside. NO HIVES. No difficulty breathing. Kept her home from school and she slept a lot. Only vomited the one time. She was fine by late afternoon and all symptoms seemed to have resolved by then.

Patient presented for her first COVID-19 vaccine. Approximately a minute after vaccine was given, she was noted to be seated upright in the passenger seat of her car, with head bent forward and eyes open. She was unresponsive, stiff posture, and was placed into a reclined position. She then had some posturing with head turned to the left, no eye deviation or nystagmus, no tonic-clonic movement. Radial pulse was thready, bradycardia was noted, with normal respirations. She was noted to become diaphoretic and pale/ashen color noted to the face and arms. She became responsive within a few minutes, however initially was not able to answer questions clearly. She had no loss of bowel or bladder function. EMS assisted with evaluation. Initial blood pressure 78/31, HR 54, SpO2 100%. EMS then transferred her to the stretcher and she was transitioned from her car to the ambulance. She continued to improve spontaneously with BP 94/61 then 103/60 and HR 86 then 74. SpO2 remained stable at 100%. Skin color improved. She had normal responses to questions, no complaints of headache, dizziness, chest tightness, shortness of breath, numbness or tingling. She had some shaking/voluntary movement of the limbs and body noted, but she could control and stop this voluntarily, no myoclonic or tonic-clonic jerking noted. After syncopal event occurred, mom reported that the patient has a history of syncope routinely with blood draws and vaccines in the past, however this episode was slightly more prolonged and seizure-like activity was different. She has had some jerking movement previously with syncope which lasts 20-30 seconds, different from today's response. No known history of seizure disorder.

Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Systemic: Visual Changes/Disturbances-Mild, Systemic: Vomiting-Mild, Additional Details: Patient started feeling dizzy within 5 minutes after vaccine administration. Patient vomitted once during observation period. Patient also stated feeling ringing in ears and vision darkening right before throwing up. Patient felt better after throwing up. Patient was observed for total 30 minutes.

My daughter has red facial breakout that is tender to the touch and continues to spread. It is now covering her entire face to the hairline and going under the chin. She also has red breakout on the injection site.

Pt mother had given at the vaccination site not at our facility. Our staff administered at the site. Pt developed hives and itching to face only. Denies any s/s of respiratory distress. Only symptom was rash/hives to face.

She developed a rash on both of her legs/thighs about the third week. Her eczema also flared significantly. She had eczema flaring in her right arm, all over her neck, lower part of her face cheeks.

After giving the injection the patient had severe pain at the injection site. A few minutes later she struggled to make a fist with her same hand and reported having pain going up her neck. The injection site did swell up a few minutes after the injection as well and she felt tingling in her hands shortly after. Patient was given 25 mg of benadryl after she reported the tingling in her hands. She did not have any difficulty breathing though. She was able to stand up and walk with her parent to the car and was driven to ER by parent to be checked out.

sx: dizziness, headache, chills, scratchy throat at 11:45am. started to have rash at 11:55am. BP checked q 15 min since sx started with readings of 120/80, 118/80, 110/83 mmHg. patient drank sprite and was given 2 tablets of diphenhydramine 15 mg by mouth. At 12:11PM rash resolved and sx slowly disappearing. Patient left at 12:22PM with little headache.

Fever, chills, muscle pain, joint pain, tiredness, headache, injection site pain, injection site redness, nausea

Swollen face on left side and red bump on face Red rash on left arm site of injection Period went off prior to vaccine and now period has returned. This has never happened before.

pt give vaccine AM of 4/21. woke up 4/22 w/ facial swelling, periorbit swelling and itchines. Similar to sx after allergic reaction to foods, etc. (tho so far less severe). sx improving after zyrtec. no lip swelling, throat itciness, shortness of breath or nausea/emesis. After video visit, to use benadryl as needed and to ED if w/ worse sx, using epipen which she already has.

Pt. received her second Pfizer dose at 3pm. By 11:30pm she had significant swelling on both of her eyes, mouth, and the start of red splotchy skin on arms and legs. We took her to ER. They gave her 50mg of hydroxizine and sent us home. 5min after leaving the ER at 12:30am on 4/23 she felt a golf ball sized lump in her throat and was having difficulty breathing. We brought her back to the ER. At this time they gave her an ekg, and at around 1:30am gave her an epi pin and an oral steroid. Within 5min of the oral steroid and epi pin she no longer had difficulty in breathing and the lump in her throat was gone as was the res splotches. By 5am the swelling in her face had reduced drastically to 90% normal in her left eye and 70% normal in her right eye and 70% normal in her lip. She was released from the ER at 5:45am and went home to sleep. At 11:30am on 4/23 her swelling in her face remains the same and she is complaining of a headache. She was given 50mg more of hydroxizine.

My daughter was given her 2nd COVID shot at approximately 9:00am on 4-16-2021. We waited 30 minutes after the shot. No issues. That evening at approximately 6:00pm, she had a red rash on her upper chest and throat. She stated that she was having a hard time breathing and swallowing. I gave her a Benadryl tablet and watched her for approximately 15-20 minutes. she continued to feel tightness in her throat and said it burned when she swallowed. She confirmed again that she felt her throat was swelling. I drove her to the closest ER located at. My daughter was seen and it was determined that she was having an allergic reaction. DR recommended continue Benadryl tab every 4 hours for the next 12-24- hours. We were discharged to home. I administered another does of Benadryl at approximately 10:15pm. My daughter went to sleep. I woke her up at 3:00am to check on her and she stated she did not have a rash and her throat was fine. She was running a low grade fever of 100.5. I gave her 500 mg of Tylenol for the fever. When my daughter woke later that morning at approximately 8:30am, she still did not have a rash or throat swelling. Her fever was gone.

multiple bruising to right hip, left arm and left leg a few hours after injection, followed by 24 hours later a diffuse hive like rash that resolved after two days.

Red rash starting from left arm between the shoot and elbow in ~5-6 hrs and spread to both arms, legs, face and neck by ~18hrs. Included swelling of face and lips. No breathing trouble or throat swelling. Treatment giving Benadryl starting ~18 hrs. after shoot. 50 mg Bendaryl every 6 hrs. treatment on going today (4/25/21) >72 hrs after shoot. Will continue treatment and observation.

Friday : soreness at injection site,3 hours later severe migraines; fatigue Saturday - severe migraines, fatigue Sunday,- -Vomiting, severe migraines, joint aches Monday - awoke with swollen face - centered around eyes and cheeks area, achy headaches, fatigue - went to ER and received Steroid shot.

11:40: Called to the car, witnessed vasovegal response with tonic / clonic activity. 11:45: BP 89/34 HR 48 sats99% Alert and oriented x3 CO L arm pain 5/10 @ injection site CO nausea. given 25mg Benedryl 11:48: Car pulled to the side 11:52: Ems called and charge nurse notified. 11:55 ems on scene and took over care.

16 yo who received Covid 19 -Pfizer at CVS, on 4/25/21, woke the morning of 4/27/21 with urticaria rash on chest and b/l thighs and presented to pediatrician's office. Rash cleared with use of Benadryl. No swelling of lips, or respiratory symptoms. C/o of local soreness at injection site on 4/26 which was improving on 4/27. No erythema or rash at injection site. No fevers.

Headache about a week, but decreasing during that week, tiredness for about 3-4 days, soreness at injection site about 1-2 days, general itchiness most prominent between 2 - 5 days after, still there but I think that is due to the fact that I scratched it when it was most prominent.

Itchy and slight rash at site of injection in left arm. Then itching and rash appeared on right arm. Then on top of thighs, neck and back, knees and upper torso. Urgent care recommended prednisone and first dose was taken 4/26/21. Symptoms still present but reduced as of 4/27/21.

First experienced heart racing, fatigue, dizziness and heaviness in your legs followed by hives that moved throughout the body including face, hairline, ears, legs, arms for the next 2.5 days.

Site: Redness at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Additional Details: pt left the pharmacy with paramedics

patient developed moderate to severe rash on her face and neck starting 1 1/2 hours after the vaccine. This lasted several hours. The rash came back the evening of 4/27 and on her legs the evening of 4/28.

Developed hives on body the next morning, some spreading to around nose and mouth, improved with Benadryl. Hives came and wetn over 3 days. No other symptoms.

Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: shakes-Mild, Systemic: Shakiness-Mild, Additional Details: pt fainted and had shakes/ convulsions for a few seconds. after 30 seconds pt awake and stated ok , after 30 min pt stated ok after 30 min observastion. mom n dad brought to hospital dad called and said pt was ok . no unusual findings

Patient waited 15 minutes after administration of vaccine. No adverse reactions at that time. Later in the evening, approx 6:30pm, patient's mother called on-call physician and stated she was developing hives all over. "Brief" episode of shortness of breath per mother, symptoms faded after an hour. The next morning, hives returned along with "pimple" like bumps sporadically showing up on the face where the hives where. Patient stated the bumps hurt and are itchy. Benadryl and hydrocortisone cream were recommended. No difficulty breathing or any other sx noted. Will continue to monitor reoccurrence of hives/bumps.

Purple splotches on sols of feet, behind ears, and on armpits. They are extremely painful with and without touch. They do not turn white when touched. I soaked my feet and epsom salt and that didn?t help. I took ibuprofen and that leased the pain but not a lot.

Fainted 48 hours after shot, sweats, slumped over. Luckily I was there to catch her. Complete loss of color. Came on very suddenly. Could have been catastrophic if she was driving.

My daughter developed a rash to her inner arms, inner legs, and hands. Warm to touch. Raised rough textured rash. The skin that is affected is swollen. Benadryl taken orally did not help decrease the rash, nor did topical Benadryl. She also complains of pain to her left leg from her hip to her knee that intermittently bothers her starting 4/30 and still continues to bother her. The day after the vaccine was given she had injection site pain, tiredness, extreme headache, fever of 101.8, nausea, chills, body aches. No swelling or redness to injection site. No lymph node swelling.

Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Tingling at site of injection. Patient was seated after receiving the vaccine and suddenly collasped. Patient maintained consciousness throughout the episode and her symptoms have improved.

At 1045 patient started experiencing eyes swelling and mild hives. 5/1/21 in morning had severe hives head-to-toe and swollen eyes worse. Took Benadryl 2 tabs, which totally resolved symptoms. This morning, 5/3/21, reoccurrence of hives and eye swelling. Taking Benadryl currently to manage symptoms.

Patient reported feeling lightheaded status post first dose Pfizer COVID vaccine (Lot: EW0167, expiration date: 08/31/2021) to medic. Medic noted that the client was CAOx4, her skin was pale, warm and slightly moist, pupils were equal, round, reactive to light and accommodating (PEARRL), respiration rate (RR) was 20. The client's sister stated the client had a history of anxiety and that "she gets this way whenever she gets a shot". Medic walked patient to the zero gravity chair. The client was given water to sip on. At 1213 baseline vitals were taken with client sitting: Blood pressure (BP): 110/82, heartrate (HR): 98, RR: 20, PEARRL. Medic reports she coached the client on her breathing to help alleviate her complaint of feeling lightheaded, mild nausea and anxiety. Client reported she felt anxious prior to her vaccination and that her last oral intake was 15 minutes prior to vaccine. Client denied headache, blurry vision and chest pain. At 1220 a second set of vitals were taken while standing: BP 108/80, HR 86, RR 16, CAOx4. Client stated her symptoms were diminishing. Client's RR slowed down to normal rate and rhythm, vital signs were trending to normal and client was negative for orthostatic pressures. Client was advised to stay for additional 30 minute observation. Client's symptoms resolved completely and she was able to ambulate away from observation site without assistance and with a steady gait.

Two large (approximately 8cm diameter) bright red patches on chest with vesicles and bullae (looks like severe sun burn)

At approximately 1:04pm on 04/30/2021 patient during 10 minute observation had a syncopal episode and fall from standing to floor with loss of consciousness. Trauma assessment found contusion to occipital region of skull. No bleeding, no other trauma findings. Pt moved to wheelchair, and then to cot without incident. Pt AA&Ox4, airway patent, breathing shallow and non-labored. Pulse strong and regular with delayed perfusion. Pt skin pale, cool and dry. Pt eyes PERRL bilaterally. Pt complains of pain 7/10, dull, localized, to the base of skull, and ringing of ears, as well as dizziness without nausea. Pt administered 650ml oral water with improvement to skin and respirations. Vitals and report continued on next page Pt however post oral hydration still stated no change to headache, and new onset tinnitus to left ear. Pt parent was consulted for transport to emergency department for assessment for potential injury post fall, and consented. EMS was contacted, who transported patient to hospital. Vital signs as follows 1312 108/68 93p 14r 98%RA 1323 106/62 82p 17r 98%RA 1335 104/60 74p 16r 97%RA

Petechiae present on the chin and increasing in severity 4 days after vaccination. Started 5/6/21 at 5pm. No prior trauma to area. Spontaneous presentation.

Pt was asked to stay for 30min observation. Approximately 10-15mins post vaccination, client developed hives and began coughing which progressively got worse. Fire/EMS on-site and attended to client. Client was observed for an additional 45mins and given Benadryl. No relief from benedryl and pt transported to ER via squad where she was observed and released. 5/6/21-per mother, the clients pediatrician was notified and advised that the client not receive the second dose of vaccine unless in a controlled environment. Pediatrician. Additionally, client had continued with cough while in school which required a visit to the nurse and use of inhaler times 2.

Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: itching of eyes, feeling warm-Mild

The complaint is characterized as a skin rash. The onset of the symptoms have been rapid and they have been occurring for 3 days. The course has been decreasing (pain had improved by visit on 5/10). The skin complaint is described as moderate to severe. The location is described as on the right side of trunk. There has been associated itching. She has a history of chronic back pain: aches. She said this is occurring as well as the new and worse sharp pain. It was worst last night. She was achy Wednesday morning into Thursday after vaccine. She felt a little better Friday morning, Friday evening she became tired and her back was hurting again. The rash and itching started on Saturday morning, Sunday was worse. There was burning, sharp pains on her side with the rash. Diagnosis of Shingles (B02.9). Started Acyclovir 5%. Apply 3 times daily for 7 days. Follow up in office if symptoms don't subside or get worse.

Patient- Has a mast cell disorder and can react sometimes to meds etc. At the end of 30 minutes, the patient started to get a raised red bump on leg. The Patient took 50 mg diphenhydramine and headed to Dr Office. Physician was waiting, as patient had prearranged.

Sore arm with rash/swelling at injection site, lasted a week. Fever and chills that evening through the night. Extreme fatigue, slept for 18 hours. Abnormal menstruation (spotting for 8 days prior to actual period, started 2 days after vaccine)

Full body rash (scattered over arms/trunk/legs). Unclear if due to vaccine, but figured would report... (Note: child has not had a rash in the prior ?6-7? years)

12 hours post vaccine she had severe myalgia, rash on both arms and legs, headache, nausea, stomach pain, and mild swelling in legs. Over the next 48 hours the rash darkened and spread to the entire body causing pain in her skin. The myalgia became nearly unbearable and both Ibuprofen and Acetaminophen didn't put a dent in the pain. One side of her face swelled so that one eye could only partially open. The nausea and stomach pain worsened so that she couldn't eat. Headache became intense. By 48 hours post vaccine she became delirious - her speech was slurred and difficult to comprehend. She would fall asleep for a few minutes and wake up unaware of where she was or what was happening. She never got a fever but did have chills. Around this time I called a relative who is a doctor to seek advice and Diphenhydramine was recommended. Benedryl helped immensely. 30 minutes after taking it she could speak clearly, was more alert, pain became tolerable, and her appetite returned. Symptoms and swelling returned when the Benedryl wore off so she continued taking it every 4 hours for the next two days until it wasn't necessary any more. The myalgia, stomach pain and headache persisted for 7 days. At 8 days post vaccine (today) a mild headache, mild and intermittent stomach pain, and mild fatigue are her only remaining symptoms. Her pediatrician cannot see her until next week but we have an appt for the 22nd.

anaphylactic reaction; anaphylactic shock; vomiting; broke out head to toe in hives; trouble breathing; face swelling; This is a spontaneous report received from a Pfizer-sponsored program, Support received from a contactable consumer (patient's parent). A 16-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in left arm on 08Apr2021 (Batch/Lot number was not reported) as 1st dose, SINGLE dose (at the age of 16 years old) for covid-19 immunisation. Medical history included asthma from 2018 and ongoing (Has been asthmatic about 3 years and has it under control and hasn't had issues in years). The patient's concomitant medications were not reported. Last time at the doctors office was for her well check in Oct or Nov. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 21Apr2021, the patient experienced anaphylactic reaction, anaphylactic shock, vomiting, broke out head to toe in hives, trouble breathing and face swelling. They are not sure if it (anaphylactic reaction) is related to the vaccine. She does not have any allergic issues of any kind and is not sure if it is from the vaccine. The patient has an appointment with an allergist on 05May2021. The pediatrician recommended she wait to get the second dose until after the mother talked to the allergist. She is scheduled for the second dose 30Apr2021. The consumer stated the daughter will miss her second dose tomorrow. The pediatrician told her to wait until speaking to the allergist. If the allergist clears her, it wont be until 05May2021. How long would it be until she can get the second dose. She is not sure if it is related or not. It was 2 weeks after. She ate some kind of granola bar that may have been the cause. Before she called 911 and they gave her epinephrine, it lasted anywhere between maybe up to 15 or 20 minutes. She went to the emergency room (ER) and had to be observed 4 to 5 hours and then went home. Treatment for the events included Epinephrine, steroids and she believes a dose of Pepcid. She was on steroids for like 4 days. The steroid was prednisone. Outcome of anaphylactic shock, vomiting, broke out head to toe in hives, trouble breathing, face swelling were recovered on 21Apr2021. Outcome of anaphylactic reaction was unknown.

Three days after the vaccine she had a rash that covered 50% of her body. It was blotchy and dark pink. She is non-verbal so we do not know if it was uncomfortable, but she did not scratch at it and seemed otherwise perfectly healthy (no fever or other symptoms). The rash came and went over 48 hours over various parts of her body, definitely lighter and less on the second day before going away completely.

SMALL BUMPS/RASH WITH WHITE HEADS OVER BODY THAT BEGAN ON CHEST AND GROIN APPROX 6 HRS AFTER; PROGRESSED TO ENTIRE BODY WITHIN 24 HOURS- ITCHING. APPEARS AS CHICKEN POX.

At approximately 1:04pm on 04/30/2021 patient during 10 minute observation had a syncopal episode and fall from standing to floor with loss of consciousness. Trauma assessment found contusion to occipital region of skull. No bleeding, no other trauma findings. Pt moved to wheelchair, and then to cot without incident. Pt AA&Ox4, airway patent, breathing shallow and non-labored. Pulse strong and regular with delayed perfusion. Pt skin pale, cool and dry. Pt eyes PERRL bilaterally. Pt complains of pain 7/10, dull, localized, to the base of skull, and ringing of ears, as well as dizziness without nausea. Pt administered 650ml oral water with improvement to skin and respirations. Vitals and report continued on next page

5:40pm Light itching (generalized). 5:50pm Water given per request. Patient stated that she is feeling much better. 5:52pm Patient voiced that she is feeling much better. Mom advised that if patient still feeling symptom to call 911 or urgent care. Understanding verbalized. BP 118/74, O2Sat 99%, HR 81.

Briefly, patient with history of asthma and food allergies, presenting with hives, nausea, and swelling, in setting of receiving Covid vaccine 36 hours ago. Family had given benadryl and zyrtec without improvement, and symptoms were worsening to presents for evaluation. My exam (after Epipen) showed: Gen: nontoxic appearing; HEENT: no lip/tongue/uvular edema, PERRL, EOMI, normal conjunctiva, neck supple without LAN; Card: RRR, no murmur, good perfusion; Lungs: CTAB, good air entry, no increased WOB, no wheezing; Abd: soft, non-tender, non-distended, no masses; Ext: warm and well perfused, moving all extremities; Skin: hives over hands, arms, abdomen, and legs, including between fingers and on soles of feet Patient presenting with allergic reaction after Covid vaccine, could be more benign allergic reaction such as urticaria multiforme, but given constellation of symptoms and history of severe allergic reaction in past, will treat as anaphylaxis. Therefore given Epipen, steroids, and will plan for observation. Observed 4 hours and continued to be well appearing without symptoms of rebound anaphylaxis. Therefore, patient safe for discharge to home with supportive care and PCP follow up. Given Rx for benadryl and steroids, refilled Epipein. Family in agreement with plan and verbalize understanding of signs and symptoms to return to care. Final Diagnosis 1. Anaphylaxis T80.52XA

A few moments after receiving the vaccination, patient fainted and had some tremors afterwards. We picked her up off of the floor and placed her in a chair. She was pale and had some discoloration around her nose area. She was able to speak to us. She felt cold and was sweating at the same time. Her body temp was 97 degrees F. According to her mom, she's had a previous reaction similar to this but not to this extreme with the HPV shot. We called 911 to have her assessed by the paramedics

patient reports numbness of the injection site. Upon performing exercise, patient was able to move her right arm. Ice pack was placed on the site for 15 minutes. patient was fine. and was able to drive home

Nausea; headache; soreness at injection point; fever; runny nose; This is a spontaneous report from a contactable Consumer (patient). A 16-year-old female non-pregnant patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EN5318, Expiration date not reported), via an unspecified route of administration in arm left on 27Jan2021 (at the age 16-year-old), as a single dose for COVID-19 immunization. Medical history 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. Concomitant medications included escitalopram oxalate (LEXAPRO). The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EL3249, Expiration date not reported), via an unspecified route of administration in arm right on 06Jan2021, as a single dose for COVID-19 immunization. The patient did not receive any other vaccine in four weeks before vaccination. The patient experienced nausea, headache, soreness at injection point, fever and runny nose on 27Jan2021. The patient did not receive any treatment for the events. The outcome of the events was reported as recovering Follow-up attempts are completed. No further information is expected.

Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Chills-Mild

6 days following vaccination, patient was exercising for the first time. started feeling dizzy. She had some water and realized that her skin was red. She had a rash on face and puffy lips. Mom came to get her she stood up and was extremely dizzy. Mom did not notice that her lips were swollen but did notice that her skin was rashy and red. Mom, who is a nurse, also thought she appeared pale and diaphoretic. By the time they got the ED she was hypotensive. She got a cocktail of meds in the ED including a couple doses of EPI. She got IV fluids. She started to improve quickly after giving the medications.

Patient received the vaccine at 4:00p. Her mother called us over at 4:05 as Shaelynn was feeling "weird". She began to itch and cough, apparently trying to throw up, felt her throat was itching and swollen. She stated she couldn't swallow and was having a hard time breathing (although she was breathing). We administered an Epi Pen 0.3mg (only one) and called 911. Patient was transported to the hospital by ambulance.

Sore left arm and swollen node (left collarbone area) same side as where vaccination was administered.

Pfizer-BioNTech COVID-19 Vaccine EUA I woke up at about 4:30 AM and couldn?t fall back asleep, I kept feeling sleepy until I would get jolted back awake over and over. My joints were hurting, I had somewhat severe nausea, my head started throbbing. At about 6:40 AM my migraine started, my arm felt hot to the touch, and I got dizzy so I took some acetaminophen. At 10:00 PM I noticed the area under my left armpit was a little swollen and really sore, my throat and right tonsil was also sore and it hurt to swallow. The next day (today) I have another migraine, my throat and left armpit are still sore, and my muscles hurt. I?m getting better though.

Systemic: Dizziness / Lightheadness-Medium, Additional Details: pt chief complaint was feeling dizzy and numbness feeling at site of injection, which was left arm deltoid region. Pt laid on the floor for about 20 minutes and felt better. Was able to get up herself and left the store with her mom. Offered to call EMS but mom and pt declined

Patient experienced minimal sting at time of injection. Observation period of 15 minutes passed and patient then almost immediately experienced vomiting and increased burning in the arm. She was asked to sit near pharmacy for further observation. After another 5 minutes patient's arm turned red from injection site to elbow. She was then allowed to go home with her grandmother. They were given a cold pack for the heat and redness of the arm it was recommended to take Benadryl. Upon follow-up next day patient was doing better was tired but no other side effects.

Excruciating pain shooting down same arm as injection site. The pain lasted between 8 to 10 hours. Ibuprofen would not help the pain.

hives developed in the evening after first vaccination, treated with otc oral benadryl. Hives of scalp, neck, face and shoulders developed after the second vaccination on 5/19/2021, which was partially treated with otc oral benadryl. The day following the 2nd vaccination, the patient developed nausea with vomiting, fever, sweats, shaking and chills for one day.

Approximately 36 hours after second dose, patient complained of sever skin itching. Parent observed raised hives/welts covering torso and limbs. Rash subsided after one dose of Benadryl and did not return.

itchy, then 2 days later broke out in hives on head, neck and face off and on for 2-3 days. took Benadryl2-3 times per day starting 4/30/21

With in 5 minutes patient began having throat itching, tongue tingling, and lips swelling. Face broke out in hives and patient was shivering.

Hives all over head, neck and face started same day as receiving the covid inj. was taking Benadryl and benadryl anti-itch creme. still having 5 days later and brought her in to be seen by provider. provider thought this was very strange reaction as hive were only on the head and neck. provider did take photos for chart. Patient was then put on benadryl, pepcid, zyrtec and a steriod ointment for her scalp.

Two weeks after receiving the covid vaccine (4/26/21), the patient presented to the dermatology clinic with a rash on legs, elbows, and hands. The patient has a hx of eczema and stated she was bit by a bug prior to the rash development. Determined by dermatology clinic rash was related to covid vaccine and was given the following treatment option: cerave OTC itch cream, cetirizine 10 mg BID, famotidine 20 mg daily, hydroxyzine 25-50 mg qHS for sleep.

Broke out in full body hives. Took her to Dr. And they prescribed steroids and strong antihistamines

Patient had second Pfizer vaccine on 5/22/21. She complains of sore arm and raised area like a bump. RN reviewed supportive measures, and to notify provider since area swollen with bump.

delerium; Severe myalgia; full body rash; swollen legs; facial swelling; slurred speech; stomach pain and cramping; nausea; headache; injection for vaccine received same date; injection for vaccine received same date; injection for vaccine received same date; This is a spontaneous report from a contactable consumer (patient). A 16-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in left arm on 15Apr2021 (Lot Number: EP7533, at the age of 16-year-old) as single dose, and second dose via an unspecified route of administration, administered in right arm on 15Apr2021 (Lot Number: EW0171, at the age of 16-year-old) as single dose for covid-19 immunization. Medical history included post streptococcal reactive arthritis and bee sting allergy. The patient's concomitant medications were not reported. On 16Apr2021, the patient experienced severe myalgia, full body rash, swollen legs, facial swelling, slurred speech, delerium, stomach pain and cramping, nausea, headache. Headache and stomach pain have lasted 7 days. Rash and myalgia lasted 5 days. Delerium, facial swelling, leg swelling and slurred speech lasted 12-24 hours and were relieved by Benedryl. The treatment for the event included Ibuprofen, Acetaminophen, diphenhydramine. The injection for vaccine received same date on 15Apr2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient was not pregnant. The outcome of the events severe myalgia and full body rash was recovered on 21Apr2021, for events stomach pain and cramping and headache was recovered on 23Apr2021, for other events delirium, swollen legs, facial swelling, slurred speech, nausea was recovering.

Rash on trunk of body started on 5/17 as small red spots that covered from chest to pubic area and back from neck to lower back. Spots were raised and began itching after a day or so then they got bigger and spread and in some cases peeled. It seems to be getting better as of today 5/30.

SWOLLEN RED ENLARGED LYMPH NODE UNDER LEFT ARM, LASTED 3 DAYS. AND SEVERE MENSTRUAL PAIN SINCE 2ND VACCINE

Client received 1st dose in seriers of Pfizer on 5/18/2021. Client started with itching and hives on 5/25/2021 and treated by parent with OTC ibuprofen and benadryl. No improvement noted and symtoms progressed on 5/26 and 5/27. On 5/27 symptoms worsed with swelling of lips and tongue and finally difficulty breathing. Parent took client to Hospital ER on 5/27 where she was treated with IV benadryl and steriods. Symptoms have not re-occurred. Client given EpiPen and has not used. Parent denies any other ideas of what could have triggered this allergic response.

Received vaccine on 4/29/2021 On 5/2/2021 she developed hives (arms, trunk, legs, back, neck) She tried using cortisone cream on the hives and Benadryl came in to Urgent care on 5/6/2021 due worsening of hives She was given depomedrol 80 mg IM x 1 Pepcid 40 mg prednisone 40mg daily x 5 days Her symptoms improved after injection, she completed the prednisone She returned to Urgent Care on 5/20/21 when hives reappeared on arms she was given depomedrol 80 mg IM x1 started on prednisone again, but longer duration with taper and referred to allergist ***she tested + for SARS-CoV-2 December 2020***

Bleeding & bruising happened instantly as the injection was given. Within 2 minutes (walking to the waiting area) she was feeling dizzy. By the time we sat down she said she felt like she was going to be sick. She began sweating - it was dripping off her head and neck and her eyes kept closing. She was extremely pale and her lips were white. She was like this for approximately 10 minutes.

excessive bleeding immediately the needle was withdrawn. then 9 hrs later when the bandage was being removed patient fainted for 5 mins associated with LOC.

5/28 - swelling of right eyelid, 5/30 - swelling of left eyelid, burning eye pain, itchy, felt dizzy, trouble focusing, fatigue

Systemic: shingles-Medium, Additional Details: shingles behind the eye that has spread to the eye according to mom. is being treated by an eye doctor.

Fever, urticarial rash to face, neck trunk, and extremities, arthralgias and swelling to hands, feet, ankles, left knee and left elbow occurring 4 weeks after vaccine lasting for 4 days in hospital after 2 days at home. still resolving slowly

Patient started having small red bumps on both hands, and both feet and ankles. This progressed from 6/6/21, to spreading up her arms and legs, neck and upper chest over the next couple of days. On 6/9/21 the bumps became very evident that she had hives.

Extreme Hive Break Out for three days. Extreme Lip Swelling. I have plenty of pictures if you want them. We went to Emergency room on Friday and they gave her an IV with Antihistamine and Steroids and Pepcid. She got better and we went home. She broke out again all over her body on Saturday and this time we went to Emergnecy room. They observed her and basically told us when they discharged us to keep her on Benadryl every four hours for the next 48 hours. I think it's important to note that she did test positive for COVID 19 on December 11, 2020 and had a fairly mild case of the virus. ALso, that she has never had this reaction to anything ever before.

hives all over her body; This is a spontaneous report from a contactable consumer (patient's mom). A 16-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in right arm on 22May2021 (Batch/Lot number was not reported) as single for COVID-19 immunisation. Medical history included anxiety and high functioning autism from an unknown date and unknown if ongoing. Concomitant medications included fluoxetine hydrochloride (FLUOXETIN) and hydroxyzine taken for an unspecified indication, start and stop date were not reported. The patient experienced hives all over her body on 22May2021. They look like mosquito bites, but are not, and are on her toes, hands, torso, legs, everywhere. They are little red bumps and itchy. Like dime-sized. Some are dime and some are nickel sized. Hives started about 4, maybe 6 hours after the vaccination. Outcome of the event was not recovered, reported as worsened. Therapeutic measures were taken. She was giving Hydroxyzine and putting on a topical ointment, as Hydroxyzine is an antihistamine, stronger than Benadryl. Event did not require a visit to Emergency Room or Physician Office. Information on lot/batch has been requested.

Attendee received first dose Pfizer vaccine at 10:03 in the Left arm. Lot# ER8737. Attendee was directed to observation area. At 10:10 the observation RN noticed redness in the attendee's left arm. Upon palpation the arm was firm not just directly at the injection site but above and below the site as well. The observation RN did an assessment and noticed that the attendee's tongue seemed to be swelling. Attendee did not complain anything; she was very stoic, did grimace x 1 with palpation of the arm. Attendee's skin was warm and dry. Attendee's respirations were not tachypneic or dyspneic. No difficulty with swallowing or speech. HR: Not done BP: 110/70 RR: Not done Temp: 98.3 10:12 – Benadryl 50 mg was administered orally. 10:15 - 911 was called. The mother seemed upset about 911 being called and so the EOA had the mother feel how firm the attendee's arm was and then the mother seemed to understand why the site team was so concerned about the attendee. The EOA was then informed that the attendee was a current participant in a medical study and received an injection of an unknown medication in the same arm, in the past 24 hours. Medical Group is where she is doing the clinical trial. Neither the parents or the attendee were able to tell the site staff what the study is about or what injection she might have been given in the same arm as the Pfizer vaccine site. 10:20 –EMS arrived and took over care of the attendee. Unsure of time – EMS left as the attendee was having no trouble breathing, swallowing, or speaking and the parents refused transport of the attendee to the emergency room. 10:45 - Care Practitioner educated on home discharge/adverse reaction instructions and attendee. Advised to check on her every 30 minutes and if she developed any other or further symptoms to take her to the emergency room. They were also advised that if she develops any difficulty in breathing to call 911 instead of attempting to transport the attendee to the emergency room. She was then discharged to home with her parents, were she will be monitored by the parents.

After the second dose, she had a sore arm for a couple of days, but then she started having tangling in the arm the injection was given and then the entire arm went numb. There is no feeling in the left arm from shoulder to fingers. And the tingling and weakness is spreading to the left leg. She was completely fine before the shot.

headaches with dizziness; headaches with dizziness; felt feverish; itchiness we're I got my 2nd shot; Diarrhea; stomachache; This is a spontaneous report from a contactable consumer (patient). A 17-year-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 2 (Age at vaccination: 16 years) via an unspecified route of administration, administered in Arm Right on 03Jun2021 12:00 (Batch/Lot Number: EW0179 and Expiry date:Unknown) as 2ND DOSE, SINGLE for Covid-19 immunization. Medical history included allergy of big amounts of biotin. The patient concomitant medications was not reported. Historical vaccination included previously the patient received bnt162b2 (BNT162B2), dose 1 (Age at vaccination (years): 16) via an unspecified route of administration, administered in Arm Right on 13May2021 12:30 PM (Batch/Lot Number: EW0179 and Expiry date:Unknown) as 1st DOSE, SINGLE for Covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 04Jun2021, after second dose, first day diarrhea and stomachache. On 05Jun2021 (2nd day) she felt feverish but was not too bad and also itchiness where she got her 2nd shot. On 06Jun2021,(on the 3-4 day) the patient had headaches with dizziness .The patient did not received treatment for the events. The outcome of the events was resolved on an unspecified date in 2021. Information on Lot/Batch number was available. Additional information has been requested.

increasing pain at injection site; This is a spontaneous report from a contactable consumer. This consumer (mother) reported for a 16-year-old female patient (daughter) that: A 16-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number and Expiry Date was not reported) via an unspecified route of administration, administered in Arm Left on 07May2021 15:45 (at the age of 16-year-old) as second dose, single dose for covid-19 immunization. The patient Medical history included coeliac disease from 2007 and ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number and Expiry Date was not reported) via an unspecified route of administration, administered in Arm Left on 16Apr2021 as single for covid-19 immunisation. On 07May2021 the patient had increasing pain at injection site a month later, started day of vaccine. It was reported that, she put ice on it and she took some Advil. The outcome of the event was not recovered. Information regarding the lot/batch number has been requested.

Dose 1 (box 11) Pain injection site, reaction to previous exposure to vaccine Dose 2 sleep excessive, nausea, headache, feeling unwell, injection site induration, injection site pain

Site: Pain at Injection Site-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Seizure-Mild

Pt began to feel dizzy, warm and faint within 10 minutes of her second pfizer vaccine. Pt did not lose consciousness but was dizzy, clammy, sweaty, pale, faint feeling. Pt responded to commands but felt faint.

After receiving the vaccine she had redness and swollen in her left eye. It started in the corner of her left eye then spreaded to her whole eye which has since then spreading to the right eye, with peeling of the skin. Any exposer to sunlight irritates it. She also has a crusty nose with peeling skin. Have seen a eye doctor it is not pink eye.

Patient began to notice her arm was extremely heavy, red, and swollen approx. 27 hours after the vaccination. Ice and Ibuprofen were used to control the swelling and discomfort.

She got a knot where she got her injection and it was red and burning; it has got a hard knot and it is painful; She got a knot where she got her injection and it was red and burning; it has got a hard knot and it is painful; She got a knot where she got her injection and it was red and burning; it has got a hard knot and it is painful; She got a knot where she got her injection and it was red and burning; it has got a hard knot and it is painful/ got a knot her knot there; This is a spontaneous report received from a contactable consumer (Parent) or other non-non health care professional A 16-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on 08Jun2021 as 2nd dose, single for covid-19 immunisation. Medical history included attention deficit hyperactivity disorder (ADHD. Concomitant medications included methylphenidate hydrochloride (CONCERTA) taken for attention deficit hyperactivity disorder (ADHD), start and stop date were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via a unspecified route of administration (at the age of 16-yesr-old) on 18May2020 as first dose single for COVID-19 immunisation and experienced no reaction on previous exposure to vaccine. it was reported that patient got second dose of vaccine last week on Tuesday, On Jun2021 she got a knot where she got her injection, it was red and burning yesterday on 16Jun2021 and now it has got a hard knot and it is painful on 17Jun2021. reporter wanted to site where the vaccine was injected it has got a knot like a hard knot there and it was burning and red. No treatment was received for the events. The outcome of the events was reported as unknown. Information on the lot/batch number has been requested.

Extreme swelling, redness, and pain of the left arm (where the vaccine was given and around the surrounding area) at around 8:30pm on June 25, 2021. Hive-like appearance for 5 hours that was itchy, and there are two big red circular raised marks currently (June 29, 2021) that are itchy and painful to the touch that will not resolve with Benadryl or acetaminophen.

Patient was originally nervous about the vaccine to begin with. Patient was given the vaccination and sitting their 15 minutes in the waiting/observation area. Patient became nauseous and decided to go to the restroom to possibly throw up. Upon doing so, patient passed out and cracked chin open. Patient was treated by a paramedic already present, so ambulance wasn't called; the offer to call was given to parents. Parents took child to the emergency room of their own accord after patient was sitting up and feeling better, where she was treated and released.

Small red bumpy rash like patch on the inside of right wrist; Small red bumpy rash like patch on the inside of right wrist; This is a spontaneous report received from a contactable consumer, the patient. A 16-year-old non pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205) via unspecified route of administration in the left arm on 09Mar2021 at 10:45 (at the age of 16-year-old) as single dose for COVID-19 immunisation. Medical history included downs syndrome and hypothyroid. The patient did not have any allergies to medications, food, or other products. Concomitant medications included digestive enzymes (unspecified) and levothyroxine (MANUFACTURER UNKNOWN) received on unspecified date for unknown indication and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Mar2021, the patient developed a small, red, bumpy, rash-like patch, approximately two inches by one inch, on the inside of her right wrist, eight days after the shot. Therapeutic measures were taken as a result of adverse event with antibiotic ointment, covered the area . The clinical outcome of small red bumpy rash like patch was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.

At approximately 3-4 minutes after vaccination patient complained burning pain in her arm. Mom notified RN. RN evaluated. Left arm red from shoulder to wrist. Her left arm was hot to the touch. Cold water bottles and then ICE applied to her arm. Mom instructed to call PCP. Mom put a call into PCP. RN noticed patientss chest becoming red. Paramedic requested to evaluate. The RN administered 50 mg PO Benadryl per standing order. By 7:35 pt. arm starting to appear less red and pt. reported less burning sensation. Mom reports pt is doing fine this morning.

Pt began to have symptoms which were thought to be dandruff but after going to dermatologist on 7/2, she has been diagnosed with psoriasis. I am reporting as this is an autoimmune disease with no genetic history. This is the second of three children who have been diagnosed with an autoimmune disorder either during pandemic/vaccination; the other being type 1 diabetes with no genetic history. Confirmed through multiple tests. Other child age was 13 at time of diagnosis . Maybe unrelated but I did believe that any autoimmune diseases diagnosed after a vaccination that is to provide an autoimmune response to a disease should be reported. Will also report to WHO

Started having rash, itchness, and light patches from back to thigh, on random spots. Pt woke up at 4pm on 07/032021 from the back itchness, conditions are getting better but will seek medical attention at a urgent clinic after visiting the pharmacy.

Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Fever-Mild

Received 1st dose at 3pm on 7/7/21. Observed by facility staff for 30 minutes. Felt fatigued, but otherwise no symptoms. On 7/8/21 at 7:45am went for a run outside. Mid-run felt generalized, severe itching and swelling in throat and facial swelling. Returned home within minutes, reported symptoms to me (mom). Called 911. Epi-Pen 0.3mg injection given in right thigh with no effect. Three minutes later, another Epi-Pen 0.3mg injection given in left thigh given. Benadryl 25mg PO given. Attempted 2nd Benadryl dose...unable to swallow. EMS arrived. Taken to ER. Symptoms slowly improved. Solumedrol IV given in ER. Monitored for 2.5hrs then discharged home with Prednisone PO for 5 days.

HIVES, GENERALIZED EDEMA OF FACE AND HANDS, LIP SWELLING ONSET 3 HOURS POST VACCINATION. TX: PO BENADRYL AND PREDNISOLON GIVEN IN OFFICE TODAY (07/08/2021). DISCHARGED HOME WITH RX: PREDNISONE AND HYDROXIZINE. RECHECK IN 24 HOURS.

day after the first Pfizer vaccination (18 hours) Pt is a 16 year old female with history of anaphylaxis and asthma who presents today with allergic reaction after receiving her Pfizer vaccine. Patient states she had her first dose yesterday, but did not have any immediate reaction. This morning when she was running at school she began to notice itching to her face and scalp as well as swelling to her nose and difficulty breathing. Mother gave her EpiPen and Benadryl with significant improvement in her symptoms. No report of nausea or vomiting. No report of abdominal pain. She denies any new foods or shampoos or perfumes. Mom does report concerned that she has a history of rebound anaphylaxis generally 6 hours after the initial insult.

full body onset of hives with severe itching in ears, throat. hives noted to neck, anterior and posterior torso, bilateral lower extremities. Benadryl 25 mg orally given. methylprednisone 4 mg given. Full recovery in 1 hour after medication administration Parent of the patient is a nurse practitioner who managed care in the home setting

Pt reports she was fine the day she received the Vaccine, but when she woke up the next morning she reports her face felt like it was on fire and she noticed it was bright red and covered in Hives. pt went to the ER for evaluation where they administered IM steroids and Benadryl. pt came to PCP office 7/12/21, with some erythema and fine bumps noted to face where the hives had been present. (pt and PCP unsure if ER filled out a VAERS report)

Patient developed hives after second Pfizer Covid 19 vaccine. Reports having taken OTC Benadryl and problem resolved in 2 days.

While completing paperwork in immunization room, patient's mother stated she thought her daughter was starting to react to the vaccine. It appeared patient was starting to pass out so pharmacist and mother lowered her down from the chair to the floor to prevent injury. Patient's pulse was very faint to the touch and patient was difficult to arouse. Pharmacist delegated pharmacy technician to obtain AED. Patient's mother stated patient was beginning to shake and was becoming very hot and sweaty. 911 was dialed. No health conditions or medications were noted that would cause this reaction. Pharmacist was beginning to take BP when EMS arrived. EMS continued taking vitals. BP 100/65, HR 84, SPO2 96%. Patient started to become alert again as vitals were being taken.

After about 1 week after taking her first vaccine, she started to have rashes on her legs along with her feet swelling and hurting. And after her second vaccine which was given on May 15 (Lot # EW0168) her whole body had rashes and her feet pain got worse. Her joints (knee and elbow) started to hurt her too. I took her to her pediatrician and her doctor thought it was an allergy but the allergy medicine didn?t work so we did blood extraction and they said to take her to hospital immediately. After staying for 5 days, the doctors were suspicious with the diagnosis Lupus so they prescribed her Hydroxychloroquine 200 Mg Tablet, Phytonadione 5 MG Tablet, and PresniSONE 10 MG Tablet. Now she is sick at home and taking the medication. She has never been sick or diagnosed with anything before the vaccination. I told the hospital my concerns and everything should be there too.

Systemic: Fainting / Unresponsive-Severe, Systemic: PT FELL AND HAD 2 LACERATION TO HEAD-Severe, Additional Details: PT WAS STILL IN IMMUNZATION CHAIR WITH FATHER AND IMMUNIZER PRESENT AND SUDDENLY FAINTED AND FELL OFF THE CHAIR AND HIT HER HEAD ON THE DR SCHOLLS FOOT SOLE END CAP BEHIND THE IMMUNIZATION SCREEN

Major reaction. Field vaccination by Strike Teams of Department of Public Health. At ~13:01, patient vaccinated with Pfizer COVID-19 vaccine. Within a few minutes of vaccination with Pfizer COVID-19 vaccine, patient showed urticaria + generalized chest pain (6/10) + postural weakness + convulsions. Field RN assessed an immediate, severe clinical deterioration. Epinephrine 0.3mg given by auto-injector to same left arm. Field RN summoned EMS. Field LVN provided postural support and second-eye VS measurement. EMS arrived at ~13:22. Taken by EMS to ED. VS: BP 90/40; HR 70; Pain 6/10 general chest. ? BP 110/60; HR 90. S/S: Physical weakness; ALOC. ? AOx4 upon EMS arrival. Current disposition unknown at time of this report. Department to attempt contact with family or admitting facility.

Migraine with aura; Burning pain along her right side; prolonged nosebleed; bruise developed under right eye; mouth ulcer; Joint pain; Stiffness; Stomach pain; headache; arm soreness; Severe fatigue; This is a spontaneous report from a contactable consumer, the patient. A 16-year-old non-pregnant female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP7534) via an unspecified route of administration in the left arm on 20Mar2021 at 12:00 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. The patients medical history included Bechet's disease. Concomitant medications were not reported. The 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. The patient was not tested for COVID-19 since having the vaccine. The patient experienced normal headache and arm soreness after 48 hours of vaccination and severe fatigue on 22Mar2021 and prolonged nosebleed, a bruise developed under her right eye, mouth ulcer, joint pain, stiffness, and stomach pain on 23Mar2021 and had another nose bleed on 24Mar2021 and migraine with aura and unusual burning pain along her right side on 25Mar2021. The patient did not receive any treatment for the reported events. The clinical outcome of the events headache, arm soreness, fatigue, nosebleed, bruising, mouth ulcer, joint pain, stiffness, stomach pain, migraine with aura and burning pain was not recovered. No follow-up attempts are needed. No further information is expected.

Blisters on elbow that has spread to her legs, ankles and feet; Elbow pain; it looks like she has some red things maybe on her face; This is a spontaneous report from a contactable consumer or other non hcp. A 16-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0180), dose 1 via an unspecified route of administration on 27Jun2021 11:00 (at the age of 16-year-old) as dose 1, single for covid-19 immunisation. Medical history included none. Family medical history relevant to AE included none. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within four weeks prior to vaccination. On 27jun2021, patient experienced elbow pain. Patient woke up with the blisters on her elbow 28Jun2021. Reporter clarified they were covered on both elbows with blistery things. Patient this morning blisters covered new areas and spreading on her arms legs ankles and feet. Reporter said it has worsened because it is now in other places. Reporter said that the actual elbow pain has persisted about the same but the worsened is the blisters in other areas. On an unknown date in 2021, reporter stated that "it looks like she has some red things maybe on her face". Reporter stated that "She had called paediatrician and trying to find recommendations and she can not find anything other than to take Benadryl and Advil, she is trying to find what to do for it, does Pfizer have any recommendations for when the reaction is blisters". The events did not result in emergency room/physician office visit. patient's father and the patient's brother and sister all had the vaccine as well and no one had this reaction. The outcome of the events were not recovered.

Received her 2nd shot at 16:00 yesterday (7/10/2021) *first shot was June 18, 2021 She started experiencing chest pain last night, also complained of shortness of breath when going up stairs She took 1/2 apap tab (strength not specified) for injection site pain (After first shot, she had anxious at the time of the shot; her BP was checked and was within normal limits. Only issue beyond that was redness of her arm). Follow Up call to parent on July 11, 2021: Spoke with mom. She took daughter to the emergency room last night. EKG and chest x ray were both normal, She was given a muscle relaxer in ER with improvement of pain. Child is sleeping but when mom checked on her she said her pain was minimal this morning.

after1st dose broke out in hives all over the trunk of her body and down both forearms; Elevated blood sugars(340), then extreme low blood sugar (58)-Exactly 38 Hours; This is a spontaneous report from a contactable consumer (patient). A 16-year-old female patient (not pregnant) received the first does of BNT162B2 via an unspecified route of administration on the right arm on 19Mar2021 at 08:15 AM (Batch/lot number :EN6199) at the age of 16-year-old as single dose for COVID-19 immunization. Medical history included type 1 diabetes. The patient didn't received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. Concomitant medication included insulin. On 19Mar2021 at 20:15, 12 hours after the shot, the patient elevated blood sugars(340), then extreme low blood sugar (58). On 20Mar2021 at 22:15, exactly 38 hours after 1st dose, broke out in hives all over the trunk of her body and down both forearms. A dose of antihistamine was given and within 1 hour her hives had disappeared with no other symptoms. The events resulted in doctor or other healthcare professional office/clinic visit. Antihistamine was taken as treatment for events. The outcome of hives was recovered on 20Mar2021 at 23:15. The outcome of blood sugar level fluctuation was unknown. No follow-up attempts are needed. No further information is expected.

Her body, was the rash in her legs, by the knee and all joints is given a pain and she have it on the back, her back is all rash, her legs all rash and her face is just swollen.; The rash is stopped right away but her face is still swollen.; She loose 8 pounds within two weeks because of after, she fell sick.; The pain is just after the first vaccine and it gets worse, after the second one.; Her body, was the rash in her legs, by the knee and all joints is given a pain and she have it on the back, her back is all rash, her legs all rash and her face is just swollen.; She loose 8 pounds within two weeks because of after, she fell sick.; This is a spontaneous report received from a contactable consumer. This consumer (mother) reported for a 16-year-old female patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0172) via an unspecified route of administration on 24Apr2021 (at the age of 16-year old) as dose 1, single for COVID-19 immunization. Relevant medical history was reported as none. The patient's concomitant medications were not reported. It was mentioned that patient did not receive other products and no investigation assessment was done. On an unknown date in Apr2021 the patient had a problem with vaccine, reporter just thought that this was because of the vaccine but after the second one it got worse. She had rash in her legs, by the knee and all joints had pain and she had it on the back, her back was all rash, her legs all rash and her face was just swollen. The rash had stopped right away but her face was still swollen. Reporter stated that she lost 8 pounds within two weeks after, she fell sick. Right after her first vaccine, about a week after patient start facing pain in her joints. The pain was just after the first vaccine and it got worse, after the second one. When probed for lab test: Reporter stated, she had not yet got them and was going to go tomorrow, because two weeks ago, the doctor said, it was allergy and was prescribed Zyrtec and Benadryl. It did not work so that was why they going to do blood work tomorrow because she took her again. It was mentioned that patient received Zyrtec one in the morning and Benadryl one in the night but she took like 3 days and it gave her headache (Further not clarify hence not captured as event) so she start taking it the other, she does not take it. The reported took her again and doctor took her blood to see what was wrong because they could not really tell, what could be better. The reporter mentioned that her daughter was a completely normal kid and after this vaccine just everything had become like another world. The split case was identified after the call hence no further relevant information for the patients could be probed. Limited information was available over the call. Follow-up attempts were completed. No further information was expected.

16 year old female with history of juvenile dermatomyositis that was in remission for several years off medications, started having a disease flare that mainly involved her skin (erythematous Gottron's papules and ulcerations) along with mild weakness. The patient is still under evaluation about the extent of her disease flare but was found to have severely worsened pulmonary function testing parameters (reduced DLCO and lung volumes). Treatment is pending the completion of diagnostic evaluation. Muscle weakness is still not prominent but skin findings are more prominent a month after the onset of disease flare.

Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Seizure-Mild, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: IMMEDIATELY AFTER VACCINE ADMINISTRATION, PT FAINTED FOR A FEW SECONDS, STARTED JERKY MOVEMENT. WHEN CAME BACK SHE DID NOT REMEMBER ANYTHING. THEN AGAIN SHE FAINTED TURNED EXTREMELY PAIL WITH EXCESSIVE SWEATING AND FEELING HOT, SHE SEEMED STUNNED GAZING TO ONE POINT NOT ABLE TO TALK OR MOVE. RPH ASKED TO CALL 911 IMM. PT TURNED BLUE WITH VERY LOW PULSE AND SHALLOW BREATHING. RPH ADMINISTERED EPIPEN TO THE UPPER OUTER RIGHT THIGH TO HELP RAISE BP AND PULSE. PUT PT IN SUPINE POS W/ ELEVATED FEET

Fainted, flushed colored skin, breathing limited, tachycardic. EMS called and recommended a doctor visit for the day of. Was not transported to the hospital by EMS personnel.

Patient fainted after receiving dose 2 in Pfizer covid-19 series. According to father, patient turned slightly green, then slid down to the floor from a standing position.

after 15 minutes started to feel light headed, had patient lay down with feet up, VSS - 120/68, pulse 78 strong and regular, Resp 18 non labored, skin warm and dry, sat up to take a drink of water as she was laying back down she started to have mild tremors of both arms and legs and then became rigid, pupils were dilated and non responsive to light, no verbal response, VS continued to be stable, O2 98%. Patient was transported to the local ED. She was started to respond when the ambulance arrived and was able to walk to the gurney.

Patient is a 16 year old female here with mother, complaining of right deltoid pain since MCV4 and Men B vaccination on 07/20. Injection pain up to her neck, later radiating down to wrist. No medication yet.

1.5 inch round raised welt at the injection site; This is a spontaneous report from a contactable consumer, the patient. A 16-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 21Mar2021 at 15:00 (at the age of 16-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medications included ethinylestradiol; norgestimate (TRI-LO-SPRINTEC) and biotin supplement (MANUFACTURER UNKNOWN); both on unknown dates for unknown indications. The patient had no allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 04Apr2021, the patient experienced 1.5 inch round raised welt at the injection site. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of the event 1.5 inch round raised welt at the injection site was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.

had arm pain at injection site; her arm is numb to her hand on injection site side which is the left side.; From the injection site up to her neck is hurting; feels weak and tired; feels weak and tired; she can't feel her hand up to her fingers; This is a spontaneous report from a contactable consumer (patient's mother). A 16-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EW0198, Expiration Date: not reported) via an unspecified route of administration on 12Jul2021 as dose 1, single for COVID-19 immunization (at the age 16-year-old). The patient's medical history and concomitant medications were not reported. The patient experienced had arm pain at injection site, her arm was numb to her hand on injection site side which was the left side, from the injection site up to her neck was hurting, not horrible pain just aching, feels weak and tired, feels weak and tired, she can't feel her hand up to her fingers on an unspecified date in Jul2021. It was reported that, it was patient's first vaccine and getting the second dose on 02Aug2021. The outcome of the events was unknown. Information about lot/batch number is requested.

patient experienced what appeared to be an anaphylactic reaction immediately after receiving the vaccine. Patient's chest became extremely red and splotchy. Patient's blood pressure was slightly elevated. Patient reported no difficulty breathing and no wheezing was witnessed. The doctor remained in the room with this patient and monitored her until emergency services arrived. Patient refused hospital transfer. Patient was alert and vocal during entire incident. Patients mother was shown how to enroll herself and her daughter in V-safe. Patient will remain in clinic for monitoring and will be followed-up with later this evening and tomorrow morning.

Goosebumps, tingling and numbness on the left side of her face and left side of her arm; Goosebumps, tingling and numbness on the left side of her face and left side of her arm; Goosebumps, tingling and numbness on the left side of her face and left side of her arm; Goosebumps, tingling and numbness on the left side of her face and left side of her arm; Pain at the injection site; This is a spontaneous report from a contactable Nurse or Other Health Care Professional. This nurse reported for a 16-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection; Batch/Lot Number: EW0185; Expiration Date: Aug2021) via an unspecified route of administration on 15May2021 (at the age of 16 years) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. No illness at time of vaccination. No family medical history relevant to ae. It was unknown if any AEs following prior vaccinations. Patient was not taken any medications within 4 weeks, prior vaccination. No additional vaccines administered on same date of the Pfizer suspect. No history of all previous immunization with the Pfizer vaccine considered as suspect. The caller stated that on 15may2021, the same day of vaccine in the afternoon after the first dose, patient experienced goosebumps, tingling, numbness to the left side of her face and left arm, and pain at the injection site in her arm. All the adverse events resulted in physician office. Relevant tests were none. The outcome of events was not recovered. Further follow up excepted. Batch/lot number can be obtained.

Systemic: Anaphylaxis-Medium, Systemic: Rash (other than injection site)-Mild, Systemic: Other- wheezing, shortness of breath, coughing-Medium

itching one arm in one spot with brief throat itching. Pt felt much better with parents driving her. Called family on phone daughter doing better went to store

At approximately 49 hours after the first dose, patient experienced unusual sudden tiredness, soreness at the injection site, visibly flushed face and sensation of heat emanating from the face. No treatment was given. All symptoms were resolved within 8 hours from onset.

Pt received injection and 10 minutes mother noticed face was flushed and patient complained of a hot arm at the injection site. Pt appeared with flat red blotches on her left deltoid which progressed to her arms neck and face. No blotches noted on her trunk. Pt was given 50 mg of Benadryl and monitored by EMS and NP for further reaction. Patient denied difficulty breathing or swelling in the oral area. Upon release patients mother instructed to monitor for any worsening symptoms or difficulty breathing. EMT counseled calling (!! if on a major highway and encountered any problems.

Patient received COVID 19 Pfizer vaccine IM in right deltoid and remained on site ot be monitored. 20 minutes later post-vaccine, the patient (accompanied by her mother and aunt) reported feeling itchy around the neck, mouth, and upper extremities. EMS on site assessed the patient, and she (and family) was transported to Hospital.

Approximately 3 minutes after receiving her first COVID-19 vaccination in her left deltoid developed a flat, non-priuritic, erythemic rash along both anterior arms. She denied any airway involvement; on examination her mouth was without edema or erythema. She was breathing comfortably and in no acute distress. She was provided with 50 mg of diphenhydramine at 11:28. She was rechecked 15 minutes and 30 minutes later, during which time her rash faded but did not resolve. She was advised that the CDC's recommendations when an immediate reaction occurs is to not get her second dose, but that she can consider seeing an immunologist/allergist to discuss this more in depth. We discussed that should symptoms worsen, particularly if she develops airway symptoms, she should present to the ER for evaluation. She left the clinic at 12:04 pm accompanied by family in no apparent distress with no further concerns.

Extreme chills, fever (lasted up to 24 hours), exhaustion, huge swollen bump over shot injection site, rash down left arm, swollen lymph node in left armpit where shot was administered

PATIENT HAS A LOCAL REACTION AT INJECTION SITE OF REDNESS IN A CIRCULAR NATURE. PATIENTS BANDAID REMOVED AND CIRCULAR REDNESS GOT BETTER. PATIENT AND PATIENTS MOTHER INSTRUCTED TO GO TO EMERGENCY CLINIC IF SYMPTOMS GOT WORSE.

Hives to arms, trunk and face within 8 hours of receiving vaccine. No swelling to lips or eyes, no wheeze. Hives improved with antihistamines.

On the right forearm, just distal from the elbow on the prone side there is a purple-brown discoloration that is approx 4 cm by 15 cm. The area does not blanch when touched and is not swollen or painful. This is not a typical bruising or discoloration pattern for her. At the right deltoid injection site there is a 3 cm round induration which is slightly red, warm and painful to touch. There is swelling around the red spot which is approx 8 cm in diameter. We are treating the injection site with Tylenol and cold compress. The discoloration on the lower arm we are watching. We will pre medicate with Benadryl and Tylenol prior to next dose.

Started to have typical flu symptoms night of 2nd vaccine, also followed with dizziness, nausea, and lastly small bumps of a rash developed over chest, neck and back.

6 am following day (4/6) after injection on 4/5/21, my 17-year-old daughter complained of sore right arm (injection site), tinnitus, syncope, nausea, fever. Day before had also been treated for vaginal yeast infection. Treated with miconazole and fluconazole (tablet and vaginal cream). Also complained that her ovaries hurt. She self-administered Motrin and applied heat. Went back to bed. Has rested without waking, suspect fatigue as well.

Pt had itching about 50 minutes after getting the Pfizer covid vaccine. Pt waited the time requested and was thankfully still shopping with her mother and brother in the store when the reaction developed. Pt was given 50mg of liquid diphenhydramine. I discussed calling 911 with the family and they said they would prefer we did not if possible. She has food allergies, which were discussed before giving the vaccine and she is used to having reactions, she also knows what anaphylaxis feels like and could tell that was not the reaction she was having. After discussing with the family and consulting with my market direction I decided to not call 911 immediately but let them know that if the diphenhydramine was not helping quickly I would make the call. I observed the patient for 30+ minutes with an EpiPen on my person in case she showed any signs of worsening. She improved visibly while getting drowsy from the antihistamine. After she had stabilized for some time and the patient and her family was also comfortable with her improvement I allowed her to depart the pharmacy with a request to keep her EpiPen close and call 911 if things worsen or the EpiPen became necessary.

About ten minutes after injection, face and ears became flush and throat became itchy. Complained of mild dizziness and growing lump in her throat. Medical staff checked throat, blood pressure, O2, laid her down on cot with feet elevated. After 20 minutes of stable BP called the chief of immunology who recommended she go to Urgent Care for follow up. While waiting at Urgent Care for 30 minutes, her face, tongue, and throat became swollen, hives developed on face, and had increased difficulty in swallowing and felt short of breath. She was taken to a patient room, IV started and Epi-shot was given. Additional allergy meds were given (Benadryl and Solu-Medro). She the. Slept for the next 90 minutes. Swelling decreased and throat felt better. Monitoring for a couple hours and sent home.

Itchy Body, itchy mouth, trouble breathing started about 10:00 am, 10 minutes after getting the shot. Went to Hospital Er and was intravenously given: diphenhydramine 50 mg, ND (0.9 % sodium chloride) bolts 1,000 ml, and methylprednisolone sodium succinate 60mg at 11:19 am. I was also injected with EPINEPHrine 0.3 mg at 11:20 am, and an albuterol nebulizer solution 5mg at 11:18 am. Stayed at the ER until 2:30 pm, got sent home and feel much better now.

I started to feel a slight pressure on the right side of my throat around 1:30 hours after the vaccine was administered. The pressure was drastic, but it slightly relieved after about two minutes. I took 2 benadryl and kept feeling pressure, although it was lessened. After about 2 more hours I took 6 medrol pack 4mg tablets to see if the symptoms alleviated. Around 30 minutes after I took the medrol pack, I felt the same pressure, but on the left side of my neck, and it lessened after 1 minute. I still feel some pressure on the left side of my neck 10 hours after the vaccine was administered. I all took 1,000 mg of Acetaminophen 1 hour after the vaccine was administered to relieve some pain that I was feeling in the vaccination site.

Reportedly had some redness and blotchiness at the time but currently no signs of anaphylaxis with no urticaria, no respiratory involvement, no intraoral swelling or voice changes, no GI symptoms. He is warm and well-perfused although is slightly tachycardic but appears anxious. His reported inability to move her arms and legs does not seem consistent with a neurologic etiology of this complaint and more likely consistent with anxiety/conversion reaction in the setting of a vasovagal episode. Will give zyrtec at mother and patient's request, PO challenge and reassess.

Pfizer Covid 19 vaccine vial was mixed with 1.4 instead of 1.8 ml of diluent. Spoke to patient's mother 04/11/2021 she stated the patient had some itching the night of her receiving the vaccine and that it went away when she took a Benadryl. Provided counseling

Anaphylaxis (hives, oropharyngeal swelling, cough, shortness of breath) 20 mins following vaccine administration. Patient given epinephrine at vaccine site 20min after symptom onset with significant improvement in symptoms including improved pharyngeal swelling and resolution of hives. Patient presented to the emergency department 1.5 hours following onset of anaphylaxis with mild cough and mild pharyngeal swelling for observation.

Heavy sleeping, sore and stiffness in arm that was injected, chest pains and tightness of chest, nose bleeds and severe headaches

Hives to bilateral arm, associated with mild-moderate itching. No SOB, no chest discomfort, no throat, tongue, swelling or hoarseness. Patient stated "I had a localized hive (right arm), when I got my first dose but it disappeared in a couple of minutes without any treatment". History of allergic reaction to "tramadol (breathing problem), benadryl usually helps" Benadryl administered, patient verbalized relief. Pt was advised to go to the nearest ER or call PCP if symptoms persist or get worse. V/S stable. Observation time extended for close monitoring. Family drove patient home in stable condition

She had COVID-19 infection on January 5. She received Pfizer vaccine 3.28.2021 - er8733 lot. she was feeling well prior to the vaccine with no seasonal allergy symptoms. No nasal congestion or itchy eyes. No NSAIDs the day of vaccine. Tired 20 minutes later. She woke up 4 hour later with fever 101. Took Tylenol 5-6 hours later. No ocular swelling at that time. had some nausea that evening and some abdominal pain. No muscle pain. Some chest tightness that evening. The next miring was very hot and nauseated and then vomited. Two days later swelling around eyes, not too itchy. Swelling was more severe in April 4. the swelling is slightly improved over the last week. On April 4, antecubutal fossa were itchy and red. lasted 1-2 days. No runny nose, sneezing or itching. Low grade fever lasted 1 hour. fatigue lasted a few days. No muscle or GI symptoms. No NSAIDs, but Tylenol initially. no sore throat. No mucous membrane involvement. No leg swelling. No change in urine output. No joint pain. No headache. No vision change. No bleeding gums. No hives. No enlarged lymph nodes. No SOB. No chest pain. No change in bowel habits. Energy level good. No night sweats. SAR symptoms well controlled. Mild swelling at left arm injection sight that lasted 1 day. swelling is worse in the AM when waking up; both upper and lower eyelids.

12Apr- Developed full body rash with extreme itching from scalp to soles of feet and palms of hands. - took Claritin and applied Benadryl cream in AM, used Aveno Lotion and took Benadryl in PM. 13 Apr- rash worsened - continued at-home remedies with no relief. Saw PCM and received prescription for prednisone and steroid cream. Unable to get prescription filled and rash worsened. Saw Urgent care in the evening and received steroid injection and advised to continue with PCM instructions when I received prescription. 14 Apr- Rash continued to worsen, lips swollen and blistered, sores/blisters inside mouth and on tongue. Picked up prescription prednisone and cream and used them with no relief yet. Returning to doctor or ER on 15 Apr if it continues.

Brownish purple plaques on dorsal hands. Appears similar to Phytophotodermatitis but history not appropriate. Symptoms started 2 days after vaccine administration, and symptoms are still present at this time.

The rash first started on her hands on 4/2 and was originally attributed to powdered gloves she used during her job at a restaurant. She had her wisdom teeth out on 3/24 and started amoxicillin and steroids for the wisdom teeth on 3/25. She had her first COVID vaccine on 3/30 with arm pain only on 3/31. She was seen in the urgent care on 4/4 . Rash felt to be due to amoxicillin or contact dermatitis (gloves). She stopped amoxicillin. The rash has continued to evolve. Originally maculopapular and only on hands, nby 4/13 there was both a maculopapular rash in addition to urticarial lesions primarily on her lower extremities, but also present on her trunk and in her groin. It is intensely pruritic. It seems to change over time, though the family is not entirely sure about that. Certainly, they describe confluent erythema and swelling over her right ankle the morning of 4/13 which was not present by the time she saw me that afternoon. She has had ankle arthralgias as well. as of 4/16, rash is gone other than feet.

at 1845 patient began to complain of itchy rash on right shoulder, rash spread to her back, I gave 25mg capsule of diphenhydramine that I had in my purse. At 1906 patient began to have facial spasms on the left side of the face with inability to move right side of face with rash spreading to left shoulder then eventually to chest, neck and face. I took the patient to the local ER and they administered 25mg IV diphenhydramine and 125mg IV methylprednisolone at 1948 and monitored her til discharge from ER at approximately 2200. Diphenhydramine and prednisone prescribed with follow up if symptoms returned.

Ms. Young was observed post Covid-19 immunization for 15 minutes. During the observation period, she experienced an adverse reaction with the following symptoms: Facial rash/bilateral checks. No itch. Warm to touch. Assessment : Patient left after check out in while in her car noticed the rash/flushed face on her face. Patient returned at 12:23pm and rash was noticed by RN to be red to the cheeks bilateral and warm to touch. It was noted that rash followed the outline of the patient's mask. Patient reports she has worn the mask before with no issues. Mask no washed in the past 2-3 days per patient. Alert and oriented. Patient reported itchy throat at 12:35. No difficulty swallowing. At 12:51 patient states she no longer has an itchy throat. Rash in still present. Not worsen in appearance. Patient reports no other symptoms. Patient stable and orientated x4. Walked patient out to door at 12:58 and gave Pfizer information sheet along with symptoms to look out for such as worsening in rash, difficulty breathing, swelling of the face and neck, fast heartbeat and dizziness or weakness. Actions taken: Vitals sign taken VAERS form completed Paramedic on site. Vitals Signs at 12:36, BP= 116/64 HR = 76, 02 = 100, Temp: 97.9F (Temporal) ,Vitals Signs at 12:55, BP= 119/54, HR = 72, 02 = 100. Medications administered: Loratadine (Claritin) 10 mg by mouth. Time: 12:25 pm. Administered by, RN. Famotidine (Pepcid) 20 mg by mouth. Time: 12:30. Administered by, RN, Disposition: Reports no further symptoms of adverse reaction after observation for 30 minutes. Discharged home. Instructed to follow up with PCP for evaluation for second dose. Instructed to call 911 for trouble breathing, rapid heart rate, dizziness, swelling of tongue or throat. The Patient was provided with Vaccine Information Sheet and instruction to access the system. Immunizations Administered, Name, Date Dose VIS Date, Route Pfizer COVID-19 Vaccine, 4/19/2021 12:00 PM, 0.3 mL 2/25/2020 Intramuscular, Manufacturer: Pfizer, Inc, Lot: EW0164, NDC: 59267-1000-2.

Unable to fill in lot number as facility kept vaccine card. Day 4 developed a small amount red raised hives on thighs used antihistamine and cortisone. Continued by day 7 hives completely covered thighs, legs, trunk, arms, and face as large red raised and itchy.

Rashes all over the body with medium to large size blots, redness and raised. The skin has a rough texture to the touch. Headaches, tiredness, chills, and light nausea. Lack of air, and chest pressure, with difficulties to swallow.

Patient not seen in office. History obtained via phone from father of patient and patient herself. Very early on 4/19/2021, 8hrs after receiving her 2nd Pfizer COVID-19 vaccination, patient began developing nausea, chills, sweating, fever and malaise. Highest fever was 102.3', with symptoms treated with Advil 600mg. Had x1 episode of vomiting that day, none since. The next day 4/20, patient woke up with new-onset lip swelling, progressing to periorbital swelling and swelling of her facial cheeks & rash. She then began having a cough with some throat tightness with some mild discomfort with breathing in her throat, but no chest tightness or wheezing. Tongue not swollen per patient. Benadryl 25mg PO given multiple times and patient used her Albuterol MDI a few times as well, which helped. She continued to have fevers to 101' throughout the day, treated with Advil again. At night, patient then developed semi-itchy red "hives" on her legs. Per patient, she didn't feel she needed to go to ER for her symptoms or throat tightness/breathing issue. She was still drinking & urinating well and had been consuming light solids foods. The same day 4/20 in the afternoon, patient was prescribed over the phone Prednisone 60mg PO x1 which she first took after 5pm, with tapering dose over the next 4 days, in addition to increasing Benadryl to 50mg PO and starting Qvar 80 MDI BID, while using Albuterol prn. Via phone call to father this morning 4/21, patient reportedly slept well last night and woke up this morning with significantly less symptoms. No longer having throat tightness/breathing issues, with much less periorbital/facial swelling. Still fatigued but no longer having fevers, either.

Bad pain with injection-needle went too deep for teen female. Instant pain afterwards increasing. Next day can't move arm-pain spreading to shoulder and neck

This was 2nd Pfizer Shot/No side effects with 1st Bumps and large rashes all over the body/itching Have it sought dr at this time...OTC meds

She is head to toe covered in a rash and hives. Benadryl is not really helping. From Tuesday the rash spread from her hands and feet to her entire body including her face. She was seen by her Pediatrician yesterday afternoon (Thursday) and she said that the rash/hives do not appear to be affecting her breathing, lungs or airway. Please note, Patient had COVID in late December.

4/18 received COVID vaccine 4/20 developed rash 4/22 was seen in office - full body rash, hives on face

Large hives on arms, legs, chest, back, face, ears, hands, neck, stomach. Itchy and raised hives. Redness on face, neck.

Pt reported mild itchiness on both hands and face , no SOB , reported by mother, supervisor was advised and EMT assesed pt, was advised to go to hospital if symptoms get worse, advised to drink benadryl as needed , BP 127/85 , P - 98 , O2- 97 . Pt. stable, no SOB, not in distress.

One day after the second dose I felt tired, weak, cold, and with a sore arm. After, I took 3 Tylenol capsules to feel better. Today my left arm which I got the vaccine in, feels itchy and my hand is swollen and red. Now my left feet is starting to feel itchy and swollen-red.

She became very red; Dizziness; Vomiting; Diarrhea; Hypotension; This is a spontaneous report from a contactable healthcare professional. A 17-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0158), intramuscular, administered in left arm on 09Apr2021 16:30 as single dose for COVID-19 immunization. Medical history included 3 weeks of urticaria prior to vaccination. The patient has had no COVID history prior vaccination. The patient has not been tested for COVID post vaccination. Concomitant medications included fish oil; diphenhydramine hydrochloride (BENADRYL); cetirizine hydrochloride (ZYRTEC); ibuprofen (MOTRIN), and an unspecified multivitamin. The patient previously took Amoxicillin and experienced drug allergies. After vaccine, the patient became very red, had dizziness, vomiting and diarrhea and hypotension on 09Apr2021. The events resulted in an emergency room/department or urgent care visit and hospitalization for 1 day. Treatment included epi, Benadryl, steroids, Pepcid, and fluid boluses. The outcome of the events was not resolved.

TODAY DEVELOPED A RASH TO BOTH ARMS. WILL GIVE BENADRYL FOR RASH. INFORMED POSSIBLY ALLERGIC TO VACCINE. DENIES ANY TROUBLE BREATHING OR SWALLOWING. SAW NURSE AT SCHOOL.

Right hell swelling, redness, tenderness first noted on awakening 4/27 (3 days post vaccine). Swelling a bit decreased when seen 1500 on 4/27. No fever. Mild pain when walking.

Reported sudden "fast heartbeats with mild chest pain" lasted less than 2 mins with tingling of L arm where she received the injection. Stable, released from vaccination site.

The patient developed a rash approximately six hours after the vaccination. The rash involved mainly her arms and legs and was pinpoint papular in nature. It was very itchy. It became a confluent red patch along both arms and her lower legs that remains itchy today.

Arm pain, slight swelling in injection site area. Swollen lymph nodes on both sides of neck, overall malaise/body aches, fatigue, light-headedness resulting in fainting episode, headache

Rash, full body "measles-like", erythematous patches of about 3-4 mm, itchy appeared >5 hours after the vaccine.

patient developed one large urticaria 2 days after immunization and diffuse urticaria 3 days after immunization

Facial rash, redness, swelling, itching. Started day after vaccination, treated by MD three days after vaccination.

After receiving the vaccine on 4/26, she developed headache and temperature to max 99-100 as well as muscle pain in the arm where she received the vaccine. Progressed to diffuse myalgias on 4/27 and 4/28. Was having a slight cough that is typical for her during this time of year due to allergies, no other respiratory symptoms. Then acutely developed severe jaw pain that radiated to the throat and into her chest when she woke up on 4/29 in the morning. She had 10 out of 10 crushing chest pain.

After a few minutes of receiving vaccine, patient reported dizziness, light headedness, and blurry/dots in vision. She then became more upset leading to hyperventilation and crying. She then said she had tingling in her fingers, which progressed to difficulty moving her fingers/stiff fingers, and coldness and redness in tips of fingers. She then reported she was loosing sensations in her feet and legs. 911 was called. We tried to have the patient take slow deep breaths. We offered an ice pack and water up front and a heat pack for her fingers. Paramedics arrived. Her blood pressure, heart rate, oxygen saturation, glucose were within normal limits. She was given oxygen and the paramedic was able to help her slow her breathing. Her fingers went back to normal and she felt fine before leaving. She did not feel the need to go with the paramedics.

Hours after injection i had a small welp about the size of a nickel now the welp has flattened out and is very hard and the size of a half dollar and bright red and hot to the touch And tender.

Within a couple of minutes of receiving the shot, my daughter felt hotness running down the length of her vaccinated arm and into her hand. Started feeling hot and started to produce a small patch of hives on the outside of the throat and chest. Did vigorous windmill motions with vaccinated arm. She had a feeling of slight unwellness that was followed by a rush of energy. As we leave the store and start to drive home her hives are a little bit worse and she says she feels a little lightheaded and has some heart palpations. But is still reporting a rush of energy. By the time we get home 10 minutes later hives, lightheadedness, and heart palpations have resolved. She feels great the rest of the day. Next day slight redness around the injection site and arm a bit sore. The following day redness is gone but a slight rash is starting to show up around the neck. 5 days later, the rash becomes inflamed, sore, hot and itchy, hives are full upper-body flareups. She takes Allegra 24 for hives control. Rash comes and goes daily. Acts more like hives. Allegra 24 controls hives mostly along with icing. After a few days, the effectiveness of the Allegra 24 is not as efficient with the neck rash. Switches to Zyrtec 24 which seems to provide better relief from both hives and rash around the neck. Sees Dr. April 29th. He advises not to take a second dose of Pfizer at this time and prescribes her an EpiPen.

Patient said she was feeling dizzy, vision was blurry, sweeting. Was able to breath, asked for water which was given to her. She had some rash on the face, provided diphenhydramine liquid 50mg. She was feeling feverish, took tylenol.

Pt has had a rash on neck and face X 3 days. She reports its slightly itchy, swollen and red. Not painful. It started on neck and spread to face. No fever, no trouble breathing. Very slight tight feeling in her throat yesterday with mild difficult in swallowing, but otherwise no issues swallowing/breathing today. Had first dose of covid pfizer vaccine 10 days ago. Has tried benadryl and hydrocortisone (one dose/application each) with no significant improvement.

White blister rash that started at injection site then spread quickly over back, chest, other arm, legs. Light headedness, and tingling and numbness in lips and face. Was given Benadryl 25mg and 2 Tylenol. The rash and numb feeling persisted for 3-4 hours. Several hours later symptoms were followed with a fever and nausea. These symptoms remedied within 24 hours and she was just tired and sore.

Site: Pain at Injection Site-Mild, Systemic: Chills-Severe, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Severe, Systemic: Fever-Medium, Systemic: Headache-Severe, Systemic: Unable to Sleep-Mild, Additional Details: mom called to report adverse reaction to 2nd dose of pfizer vaccine. pt had chills on monday, fever on tuesday, wed morning child passed out in the kitchen mom heard her fall, she did call 911. child was transported via ambulance to strong ER. pt was diagnosied with syncope. pt is now home with mild headache/lethargy and recovering. mom has called pcp waiting to talk to her.

I had administered the vaccine, pt tolerated well, pt given discharge instructions and instructed to wait for 15 minutes at the observation area. As I was waiting for the next patients to arrive, another technician notified me that she had a reaction of vomiting. When asked patient stated after the injection she felt burning from the site to the nape of her neck and while waiting at the observation area she had nausea and went to one of our stations to vomit in the trash. Patient was escorted to our treatment room for vitals and was given a cold pack for the back of her neck. Our Allergist provider was called to assess patient. When I had arrived to the treatment room to observe her, patient stated this was the first time she had this type of reaction. The provider ordered for her to stay and be observed for 1 hour with 15 minute intervals of vitals. The patient had no other reactions and had no pain, vitals were within normal limits.

Patient arrived to post vaccine area after receiving second dose of Pfizer COVID 19 vaccine. Patient reported to post vaccine nurse feeling lightheaded with tongue tingling, headache, nausea and feeling flushed/itchy. Initial vital signs 123/83 85bpm 99% O2. At 1730 patient given 25mg PO Benadryl per standing orders. Patient monitored by post vaccine nurse. Symptoms resolved at 6:15pm, and requested to leave. Last vitals: 117/78 HR 90 O2 99%. Patient had arrived with mother and agreed not to drive. Instructed to call 911/emergency services if symptoms return/worsen.

Severe headache developed on evening of vaccine. The next morning, patient developed an itchy bumpy raised red rash on her Right forearm while at school. Benadryl helped a little. A worsening headache, cough and wheeze started evening 4/27/21. She took Tylenol and used her Albuterol inhaler. She slept poorly due to itch, headache, bad cough & wheezing. On 4/29/21, 4 hrs after taking Benadryl, she developed an urticarial rash on her Left forearm (right arm improved by then). A pruritic, extensive petechial Left-sided facial rash began that evening which worsened the next am and spread to right side of face. Headache comes and goes. Rash spread to upper arms 5/3/21 despite daily Claritin. Facial rash is fading

Red bullet Mark on arm lasted three weeks. Has pins and needles off and on in feet. Losing muscle function in hands that is not going away. Having hard time holding onto objects or writing. Primary doctor referred to neurologist.. waiting for appointment

Pfizer dose #2 yesterday 5/6/21 and had a local rash at injection site. today reporting generalized rash "little spots all over," itchy on arms, feet and back. denies any respiratory symptoms or facial swelling.

The day after vaccine patient developed fever, myalgias, sore throat. Fever persisted 4-5 days. She developed rash on 4/30. Labs done showed low platelets (64k), low WBC with neutropenia. Fever resolved by 4/30 and rash resolved by 5/1/21. Platelets and WBC are recovering.

Eleven days later, she got another allergic reaction with blister on her arm, water filled blister; She got blister on the opposite arm of the injection, on her right arm; Diagnosed her with a skin disease that happens when your immune system is under attack; Her arm is now swollen around the blister; bullous pemphigoid; cellulitis; Had an allergic reaction; Itchiness; They gave her a high dose/received a higher dose of the vaccine; This is a spontaneous report from a contactable consumer. A 17-years-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 10Apr2021 at 12:00 (Batch/Lot Number: ew0153) as a single dose for COVID-19 immunisation. Medical history included asthma seasonal only during allergy season. No episodes this year. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included Multivitamin/women's one a day gummies. The parent reported that her daughter had the vaccine done on 10Apr2021 and she had an allergic reaction that evening, she had itchiness. So, I contacted the pharmacist that she had an allergic reaction and she told me that they gave her a high dose and there were few patients who got the high dose. So, eleven days later, she got another allergic reaction with blister on her arm, water filled blister, I took her to an urgent care and they referred me to a dermatologist that diagnosed her with a skin disease that happens when your immune system is under attack (event captured as per verbatim). So, I went to her primary doctor and her primary doctor has put her on antibiotic because her arm is now swollen around the blister, so now, she is on ointment, antibiotic and vitamin d (treatment) to bring up her immune system and also she has to get her blood work done to check her immune system. She also stated that the reaction my daughter is now having and how her primary doctor is suggesting not to take her second dose because she highly thinks it is an allergic reaction to the vaccine." The outcome of the events was not recovered. Reported Event: Four hours after the injection on 10Apr2021 (Name) entire body began to itch and the top of mouth. The pharmacist was notified and at the time and further explained that (Name) was one of the patients that day who received a higher dose of the vaccine at the time of injection. The pharmacist did not notify me of how high the dosage was. So I cannot put the exact details on this report because I was not given that information by the pharmacist. I suggest the pharmacist be contacted for the exact mistaken dosage. The second side effect was on 21Apr2021 (Name) woke up with a water filled blister on her right arm which ruptured with a yellow liquid. We seeked medical attention on 21Apr2021 and 23Apr2021 from 3 different facilities. The outcome was (Name) being diagnosed with bullous pemphigoid and cellulitis. (Name) was placed on cephalexin 500mg, vitamin d 50mcg/2000 units, mupirocin 2%, and fluconazole 150 mg to build her immune system back up. Did the adverse event result in any of the following?: Doctor or other healthcare professional office/clinic visit Did the adverse event result in any of the following?: Emergency room/department or urgent care What treatment received for the adverse event? Antibiotics oral and ointment as well as vitamin D Prior to vaccination, was the patient diagnosed with COVID- 19?:No Since the vaccination, has the patient been tested for COVID-19?:No Device Date: 24Apr2021 Language: En Report about covid vaccine: Yes Reporting type: AE Reporter type: Patient Age group: Adolescent (12-17 Years) Current age: 17 Current age unit: Years Is pregnant: No Patient occupation: None of the above Covid vaccine details: [{product=COVID 19, brand=Pfizer biontech ew0153, lot unknown=True, lot unknown reason=other, lot unknown reason other=unsure of above question, administration date=10Apr2021, administration time=12:00 PM, dose number=1, vaccine location=Left arm}] Other vaccine same date details: [{other vaccine same date vaccine date=10Apr2021}] Facility type vaccine: Pharmacy or Drug Store If other vaccine in four weeks: No Other medications in two weeks: Multivitamin/women's one a day gummies Adverse event: Four hours after the injection on 10Apr2021 (Name) entire body began to itch and the top of mouth. The pharmacist was notified and at the time and further explained that (Name) was one of the patients that day who received a higher dose of the vaccine at the time of injection. The pharmacist did not notify me of how high the dosage was. So I cannot put the exact details on this report because I was not given that information by the pharmacist. I suggest the pharmacist be contacted for the exact mistaken dosage. The second side effect was on 21Apr2021 (Name) woke up with a water filled blister on her right arm which ruptured with a yellow liquid. We seeked medical attention on 21Apr2021 and 23Apr2021 from 3 different facilities. The outcome was (Name) being diagnosed with bullous pemphigoid and cellulitis. (Name) was placed on cephalexin 500mg, vitamin d 50mcg/2000 units, mupirocin 2%, and fluconazole 150 mg to build her immune system back up. Adverse event start date: 10Apr2021 Adverse event start time: 05:00 PM AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care] If patient recovered: Not recovered If treatment ae: Yes AE treatment: Antibiotics oral and ointment as well as vitamin D If covid prior vaccination: No If covid tested post vaccination: No Known allergies: No Other medical history: asthma seasonal only during allergy season. No episodes this year

Patient felt tired, light headache and developed rash at lower right abdomen. Given Benadryl and monitored 30 minutes. Itching stopped but continue to feel tired.

developed small rash saturday morning given benadryl. alleviated returned in the afternoon second dose of benadryl given , she continued to have itchiness and her face began to swell. was given pepcid, benadryl, prednisone at home, attempted to go to out pt clinic they instructed to go to facility. Facility evaluated her provided with iv forms of benadryl, pepcid, and decadron, itchiness not relieved given vistaril and fentanyl discharged from facility with decadron for 3 days and vistaril. she continues to have hives but they moved down to bilateral arms, provided with anti itch creams and dombeoro soaks. also ice packs to swollen areas.

Evening of 5/6 hives started. Father gave no medications, just watched and waited. Pt went to school on 5/7, came home around 1400, hives noted on neck, arms, legs, groin, back, stomach, all over per father. Father gave benedryl Friday around 10 am, then took to emergency room Saturday morning due to eyes being swollen shut, left arm was swollen hand and wrist. ER gave 2 injections - immediate reacting and long acting, along with 2 benedryl, pepcid. Pt was discharged from ER after about 1 hour. Hives persist today, May 10th. Pt is now on 40 mg 5/9 and 5/10. Hives remain persist on feet and hands today.

She's been itchy every since; Roughness coming up; Rash coming up; This is a spontaneous report from a non-contactable nurse (Other HCP) (patient's mother). A 17-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown, Expiry date: unknown) via an unspecified route of administration on 08Apr2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 10Apr2021, the patient experienced she's been itchy every-since, roughness coming up and rash coming up. Caller states, her daughter got the first Pfizer vaccine on 08Apr2021, she has been itchy every-since, this started 2 days later. Caller spoke to her doctor and he said it's probably a reaction to vaccine. Her daughter has no rash, just itchy skin, the only difference today was it looks like or has roughness or rash coming up. Dermatologist says it's probably from her scratching, and says it makes sense that it's probably the vaccine. The way it looks, he didn't feel it would be a problem to get the second dose, since it occurred 2 days later. Caller asked, was it recommend to get the second dose. The outcome of the event was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained

immediately felt tingling in her arm. About 3 hours later, she started having side effects. As of this report, it has been 28 hours since she received the 2nd dose. Her side effects are at their worse right now. They include: injection site pain, severe lymph node pain in her armpit, feeling unwell, nausea, low grade fever under 101 degrees, muscle pain in arms and legs, chills and sweats, some joint pain. dizziness and weakness and labored breathing.

Immediate sever pain at injection site, immediately followed by flushed face, racing heartbeat, tingling and inching of face, watering eyes, itchy throat that felt like it was closing in, lump in throat, difficulty breathing, unable to speak. Was able to speak after a couple minutes and the other symptoms started to gradually improve at that point. Most of the above symptoms subsided within around forty minutes. The lump in the throat remained for weeks eventually coming and going.

had pain at injection site; fatigue; This is a spontaneous report from a non contactable consumer. This consumer (sister of patients mother) reported for a 17-year-old female patient. A 17-year-old female patient received second dose of bnt162b2 (BNT162B2, Formulation: solution for injection, Lot number: not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, The patient had pain at injection site and fatigue. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.

Started as small red raised bumps on neck. Spread to both lower arms, upper left arm, left shoulder and left underarm. Bumps are itchy. Neck is red and almost large welt like circular rashes.

Patient started on 10 day course of bactrim for UTI on 5/3/21, got covid vaccine 4:30 pm 5/10/21, started to develop pruritic rash on torso 4:00 pm on 5/11/21 - 24 hours from vaccine, spread to face, upper/lower extremities, very itchy. Seen in clinic today 5/13/21. Instructed patient to stop bactrim, put on sulfa on her allergy list. Due to timing of rash with covid vaccine, entering into VAERS.

Per parent report: Friday 4-30-21. Vaccine was given at 1500, at 1730 client displayed a rash on face and chest with extreme fatigue and chills. client took Benadryl. Saturday 5-1-21. Rash gone, but extreme fatigue, crushing pain on chest and pain in arm. continued to take Benadryl. Sunday 5-2-21. Extreme fatigue. continued to take Benadryl. Monday 5-3-21. Still extremely fatigue, DC'd Benadryl. Tuesday 5-4-21. some improvement in fatigue, but experienced some brain fog. Wednesday 5-5-21. attended school where she presented to the health office with medical concerns, see quote taken from an email with the school nurse: "She missed school on Monday and Tuesday due to the reaction. On Wednesday, she presented to the health office with extreme redness to the face and chest. Emergency services was called and she was transported to the hospital. Benadryl was given in the rig to which she responded to well." parent reported that ER doctor ran many tests but did not determine cause. Tuesday 5-11-21. saw Primary Care provider. client is still having significant "brain fog". she is very confused more than half the day, not remembering things or events, and will zone out or fall asleep in inappropriate places with out realizing it.

hives along both arms and chest one hour after receiving injection. Sensation of throat swelling and very slight difficulty breathing. Did not seek medical attention. Took benadryl and symptoms resolved within 40 minutes of taking benadryl

Headaches, dizziness, fatigue, injection site pain starting approximately 10 hrs after injection and lasting an additional 24 hours

5 minutes after receiving covid vaccine shot felt itchiness on injection site, left arm. 5 minutes later felt itchiness on right shoulder and arm. Monitored VS. Pt's mother & doctor at the bedside. 25 mg PO Benadryl given. pt discharged home per MD's order.

Diffuse hives and erythematous rash on arms, neck and chest. She had expected fever and muscle aches for 24 hours after vaccine administration but this resolved.

5/15 developed hives on abdomen, spread over the next 2 days to chest, arms, and face. No cough, wheeze, vomiting, nausea, or fever. No other symptoms

- Pain/tenderness at injection sight for ~72hrs after vaccination -Small red bump (size of quart) at injection site( was gone after 72hrs.) ***- Abnormal vaginal bleeding, heavy bleeding occured, o clots within blood, cramping*** - General malaise

Intense itching of the arm and shoulder. Started approximately 40 minutes after injection. Patient was given Benadryl 50mg and observed for an additional 40 minutes. No trouble breathing and no swelling occurred. Patient is following up with PCP.

Patient was given dose at a vaccination site through County Health Department. Today in clinic she reported an allergic reaction to Pfizer vaccine. Approximately 30 minutes following vaccination had hives. Following morning had swollen lips and itchy throat with continued hives. Symptoms only treated with benadryl and improved. She then had hives again 4 days later. She did not report this to the vaccination clinic.

Linear isolated raised erythematous areas on left arm. Benadryl given at 3:13p. Pt complains of right side of tongue and throat feeling full. Refused EMT, another Benadryl given at 4:05p. No visible swelling upon assessment.

Systemic: Fainting / Unresponsive-Medium, Additional Details: Pt fainted after vaccine, hit head on nearby object. sustained approx 2 cm laceration to scalp with moderate bleeding. applied saline wound wash and gauze. bleeding stopped. VS normal BP110/72, P90,RR14,O297%RA. Pt revived after1-2 min. She sat up and was able to walk. Mom at work. Mom called neighbor to pick up pt. Mom agreed to have FM take pt to ER/urgent care.

Initially developed hives then swelling of lips, face and difficulty breathing with cough (anaphylaxis reaction). Treated by school nurse with epipen then ambulance paramedics arrived and administered nebulizer treatment, IM benedryl, dexamethasone and transported to ER for follow up stabilization. ER administered additional antihistamine. Patient was discharged from ER stable and in much improved condition.

Patient's parent reported that patient started developing a bruise after her 2nd shot of the pfizer vaccine. Her arm was hurting more from the 2nd dose. After checking in with the parent 2 days after the vaccine, parent reported arm improving. Patient's parent denies use of NSAIDs prior to vaccination.

White papule; Scab; This is a spontaneous report from a contactable other hcp (patient's mother). A 17-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0162), dose 2 intramuscular, administered in right arm on 19Apr2021 09:15 as 2nd dose, single for covid-19 immunisation. Medical history included vaso vagal syncope. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8733,) intramuscular administered in right arm on 29Mar2021 16:00 for COVID-19 Immunization. On 26Apr2021, the patient developed white papule which turned into a scab approximately 1 week following second injection, roughly three inches below injection site. Seriousness criteria-Congenital anomaly/birth defect: Yes. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There is no list of any other medications the patient received within 2 weeks of vaccination, no known Allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the vents was resolved with sequel. Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on temporal association, the contribution of the suspect drug to the onset of events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

Patient became light headed and fainted from a seated position about 10 minutes after her first Pfizer COVID-19 vaccination. She doesn't think she lost consciousness. Her skin was quite warm and sweaty after this event. I had her remain laying down on the ground while she recovered and I assessed her symptoms. She felt better almost immediately so I had her move to the pharmacy office for observation for an additional 15-20 minutes. She then reported that she has fainted with shots before and she hadn't eaten anything today. Her mother said this has happened before and drove her home once she felt well again.

Site: Pain at Injection Site-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Fever-Medium, Systemic: JAW AND THROAT PAIN-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium

Less than 1 minute after received the shot, patient became clammy and pale while sitting in chair. Her eyes rolled back in her head and her body went slack. Myself (parent) and the nurse who had given the shot braced her on either side while she appeared to fade in and out of consciousness for several minutes (she seemed to occasionally interact with us, mumbling responses to 'yes' or 'no' questions). The nurse did not want to lower her to the floor, but wanted to keep her propped on the chair. Her head kept rolling to the side. At one point, she began to jerk rhythmically. Just as I was about to bring this to the attention of the nurse, the patient returned to consciousness. Patient was moved to a rolling recliner chair and taken to a recovery area where I (parent) did not see her for another 30 minutes as I was receiving my own shot. The chair she had sat in was wet, but it was assumed this was due to sweat (patient had sweated profusely). On the way out of the clinic, noticing a wet stain on the back side of patient's pants, I asked if she had wet her pants (quietly) two separate times. Patient denied it both times. However, upon returning home, patient confirmed that she had wet her pants. Patient was monitored during the evening for similar adverse events ; none noted. Patient ate lunch approximately 1 hour before receiving shot and was given crackers while at clinic. Patient is a well-hydrated individual, and also drank water while on-site. No fever either before or after shot. A slightly elevated BP the next day (135/83). However, patient complained of headache, fatigue, and pain at injection location; elevated BP may be related to headache and/or ordeal from day of the shot.

Site: Pain at Injection Site-Medium, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: BP 103/65 Pulse 62-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Mild, Systemic: Shakiness-Mild, Additional Details: EMS was called but she went home with her mother and slept the rest of the day, she had a sore arm on Tuesday but was otherwise fine per mom.

Patient fainted and felt hot. Patient fainted within 10 seconds of receiving vaccine. Once patient came to, she sat down for about 15 minutes and felt better. Patient stated she did not eat anything before.

at 7:00pm got hives all over body (arms, stomach, face, neck inside mouth, took Benadryl hives on body went down, the hives inside mouth went away by morning next day.

Vaccine 5/18. On 5/22 4 days after vaccine, she developed right arm swelling and skin discoloration. On 5/23 she went to the ED. Ultrasound revealed acute, occlusive thrombosis of right subclavian vein. She was admitted to the hospital, started on enoxaparin, achieved therapeutic levels. On 5/25 she underwent thrombolysis and venogram and was confirmed to have findings consistent with Paget-Schroetter syndrome. She was discharged home on 5/25 in good condition. Note: she also has known prothrombin gene mutation G20210A that confers an increased risk of thrombosis. She does have repetitive use of the right arm (lacrosse player).

Syncope approximately 3 minutes after shot with resulting head injury. Pt conscious on paramedic evaluation with hematoma on forehead. Unable to walk without assistance. Pt's mother chose to drive her for follow up at ED against recommendations of reporter. Fire Department wheeled pt to personal vehicle. Unknown dispositions/outcome.

PT father states that two days after her second dose Pfizer vaccine his daughter developed allergies in her whole body. Her skin became dry with little bumps all over her body, face, arm, hands and feet. He also states his daughter?s lips, hands and feet swelled up. Also that on her inner thighs and vaginal region her skin was also dry with cuts of dry skin. PT father states his daughter went to the doctor where they prescribed Cephalxin, Triamcinolone and Acetonide as medication. As of today, PT father states she continues with the dry skin and little bumps on her whole body, face and arms. PT father states that for her first dose vaccine, his daughter only had soreness to her left arm.

Site: Pain at Injection Site-Mild, Systemic: mentrual changes-Mild, Additional Details: headaches, no appetite, stomach ache, light sensitivity, fatigue, mentrual cycle distrupted. Patient states she got her period 2 weeks early. She takes an oral contraceptive pill, she did not miss any

2 hrs after vaccine started having chills and fever by Thursday April 22 her legs starting hurting pain moved from toes and all the way up to back then it stated moving to her hands and fingers. got admitted to hospital because they wanted to make sure she wasn't having syptoms of MS they did blood work, MRI, covid test, xrays, lupus test, physical therapy, nerves test, lime disease test and everything came back fine by sunday they sent her home and she started having stomach pains and had to go back to Dr. she has experience hair loss and it started her menstrual cycle early. was having alot of fatigue and its's been a month and she is now finally started to feel a little better but Dr dont know how long it will be before she is fully herself

Sneezing a lot, after the first and second vaccine; Right arm with rising and swelling: described as red in a crescent moon shape at injection area, after first vaccine; red in a crescent moon shape at injection area, after first vaccine; Vaccine poured and trickled out of arm, after first vaccine; Vaccine poured and trickled out of arm, after first vaccine; This is a spontaneous report from a contactable consumer. A 17-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm right on 21Apr2021 (caller states it was the evening) (Batch/Lot Number: EW0161) as 1st dose, single for covid-19 immunisation (Reported as because she is her daughter's mother, and told her daughter to get the vaccine. her daughter's school is making all the seniors get the shot to go back to school). Medical history included Birth control. Family Medical History relevant to AE was No. Concomitant medication included ethinylestradiol, ferrous fumarate, norethisterone acetate (LOESTRIN FE) from Mar2021 (two months ago) taken for birth control. Prior Vaccinations (within 4 weeks), no other vaccinations within four weeks prior to the first administration date of the suspect vaccine. AEs following prior vaccinations was None. Caller states she is calling for her daughter. Caller confirms she is calling about the Pfizer vaccine, confirmed as the Covid 19 vaccine. Caller states that when her daughter went and got the injection, some of the vaccine poured out of her arm, vaccine poured and trickled out of arm, after first vaccine was on 21Apr2021 3:20 pm. Caller states that 3 days later (in the morning), her daughter's arm started to get a rising, later clarified as swelling. Caller states that it was red, in a crescent moon shape, and raised up off her arm at the injection site. Caller states it was really huge. Caller states that she called the pharmacy and she was told to give her daughter Benadryl and Cortisone cream. Caller reports that this treatment was effective. caller then reports that her daughter had lasting effects, clarified as sneezing a lot, after the first injection and then it got more intense after the second injection. The event was not required a visit to Emergency Room and Physician Office. Relevant Tests was None. No Investigation Assessment. Treatment received for the events. Outcome of red in a crescent moon shape at injection area, after first vaccine was recovered on 26Apr2021 (also reported the area is still a little brown spot but not raised up off her arm). Outcome of Sneezing a lot was not recovered. Outcome of the events was unknown. Seriousness criteria is Medically Significant. Information on Lot/Batch number was available. Additional information has been requested.

Bumps on the body( legs, under arms, neck, back, scalp, chest, groin) and extreme itching , inflammation on ears, redness. Itching everywhere, feeling on skin and inside body. Everything was getting worse until medicines started to work.

After receiving the shot she experienced the "Covid's bullseye", a circle on her arm at the site of administration; tired; her arm was a little sore; the girl got a rash of the diameter of a lemon on her inner thigh, next day on both legs; This is a spontaneous report from a non-contactable consumer (patient grandmother). A 17-year-old female patient received second 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 on 20May2021 (age at the time of vaccination 17-year-old) as 2nd dose, single for covid-19 immunisation. Medical history included allergic to sulfa drugs. Historical vaccine includes 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 on an unspecified date as 1st dose, single for covid-19 immunisation. The patient concomitant medications were not reported. It was reported that after receiving the shot patient experienced after receiving the shot she experienced the "covids bullseye", a circle on her arm at the site of administration, tired, her arm was a little sore. On Saturday, the patient got a rash of the diameter of a lemon on her inner thigh, so the reporter told her to only use sunblock, next day (Sunday) both legs were covered in a rash. Reporter looked on the Pfizer's website and saw that rash was reported in 0.001 percent of people who had the vaccine. Also, on Sunday, reporter took the patient to the doctor but he was not there, so she called a service (reporter did not elaborate on this) and a person told them that the rash could be from a serious disease called "petechiae rash" and told them to take patient to ER where she got the shot. Once in the ER, they told them that it was not the serious condition "petechiae rash" but that it was a "rash" and that they had never heard before of anybody experiencing a "rash" after the administration of the vaccine. Reporter wanted to know if "rash" has been reported as an adverse event of the Pfizer's COVID-19 vaccine, how long after the administration of the vaccine appears and how long it lasts. She would also like to know if we can call the facility to let them know that "rash" was reported as a side effect of the vaccine, since she was upset because she does not understand how someone in the ER does not know that "rash" was an adverse reaction and they had them thinking for a couple of hours that patient could be suffering of a serious disease. Reporter does not want someone else to go through this situation. Reporter mentioned that in the ER told them to wait 2 days and give Benadryl to patient, so she wanted to confirm if this was the right treatment for patient and if she should wait those 2 days to see if the rash was gone before she calls the doctor. Reporter wanted to know how long after the administration of the vaccine the rash appears and how long the rash would last. The outcome of the event was unknown No follow-up attempts are possible. No further information is expected.

Cervical lymphadenopathy and macular rash on trunk. Present on 5/2 initially and advancing through end of May. Has follow up scheduled in June.

My daughter has had a full body rash, that nobody can identify, since the shot. They start as little dots and change into circles after a while. She had had chest pains and pressure and is very uncomfortable

Local skin vaccine reaction, delayed. 4 cm x 5 cm. Started day 8 after vaccination and worsened on day 10.

Patient's mother reported bruising, redness at injection site and warmth day 5 following Pfizer covid vaccine dose 1. Mother states no pain upon injection. I advised mother to follow up with primary care doctor to further evaluate her arm. Parent states the arm bled after immunization and believed the injection site to be too low.

Patient tolerated administration of vaccine well and was monitored in observation room by two RN's for 15 minutes and patient felt fine to leave. Patient left room and came back shortly after feeling very fatigued, nausea, and pain in both calf's- L leg worse than R , with red toes. Bilateral pedal pulses +2. Vitals: BP 130/67 HR 92 Sat 95% on room air. Gatorade given to sip on. RRT was ultimately called and patient was taken to ED.

Swelling on the left hand (fingers) - a ring couldn't be taken off. The injection site was red and very itchy - that lasted for about three days. There was a lot of drowsiness; fatigue; upset stomach - lasted about a week. Went to Primary care doctor; he said it was a side affect. He told us to keep an eye on it. The swelling lasted three or four days.

Patient developed a rash on both arms, became itchy, nauseous. Hydrocortisone cream was applied along with a dose of oral Benadryl.

Dose 1, headache. DOSE 2 Five hours later severe headache, extensive heat being generated from head, body not, then followed by high fever 101.8 with heart rate going up to 155, followed by twelve hour later breaking fever. Extensive headache continues. At 24 hour mark hives on face under eyes, big welts and red. Continued migraine. This is not safe!!!!!! I will sue the agency for this product, emergence use yet mandate by colleges and employers. SOMEONE NEEDS TO PAY FOR THIS!!!!! I WILL CONTACT A LAWYER.

Arm hurt; Tired; Rash all over both of her legs; This is a spontaneous report from a contactable consumer (patient's grandparent). A 17-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration in the left arm on 20May2021 16:30 (Batch/Lot number was not reported), at the age of 17-years-old as 2nd dose, single for COVID-19 immunization. Medical history included allergic reaction of Sulphur drugs. The patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 on an unspecified date for COVID-19 immunization. The patient had her second Pfizer shot on Thursday 20May2021 at 4:30, the only side effect she seem to have, was her arm hurt and she was tired and the reporter don't know, her aunt was a pharmacist and said that circle that she developed at the site of the shot, and called it as a Covid bullseye. On Saturday 22May2021, the patient had rash about the size of a diameter of a lemon on the inside of her leg, the reporter didn't think anything out she has been out in the sun so they just observed until Sunday, 23May2021 she got the rash all over both of her leg. Previously she was has an allergic reaction of Sulphur drugs so with this rash all over both of her legs what they did was they called her doctors office Sunday and they haven't answering. They have a service that you can call about medical things, person that answers, there was a woman and said she know nothing about a rash they thought it would may be side effect from Pfizer because the reporter looked on the website and in the website rash was listed, usually rare. The patient does not have anaphylactic shock any of that there was a rash they think it was 0.001 they tried to explain this to the woman and she insisted it was something called Petechiae rash, which is a serious rash. She insisted not take the patient to the urgent care, she said they should take her to the ER and not urgent care, they took her to the ER they said they didn't know, it was definitely not the Petechiae rash which was a released that's a serious problem. They said it was okay to just give her Benadryl which they could have decided to give at home, but they didn't know if Benadryl was okay to take if the patient took the COVID vaccine. They were advised to bring her back to the doctor in 2 days if it doesn't go away. ER said they had never seen anyone who had a rash, they don't know any rash. The reporter tried to tell that it's on the website it's on a Pfizer website and thought she was thinking she should alert them about this because this was a lot of lot of gut ranching and anxiety that if this person calling from the doctor saying that the rash was a Petechiae rash which was a serious blood disease. The outcome of the events was unknown. Information on the lot/batch number has been requested.

I took the vaccine shot on June 2 and I started to have some rashes and allergic reactions on my face on the morning of June 5, on the morning of June 8 I also noticed a series of red bumps on both my arms. I visited a physician at a medical clinic on June 8 and the doctor prescribed me some medications that would reduce the allergic reactions and itchiness. As of right now, June 9 I did notice that some of the rashes on my face is starting to fade but the red bumps on my arm have not gotten better.

Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: PT fainted several minutes after vaccination and fell out of the chair. Pt regained conciousness immediatly after fall but suffered minor injuries to the face and knee (rug burn). She felt nauseous, light headed, dizzy and was pale and had cold clammy skin. She regained her complexion after 15 minutes and rested for 45 minutes before leaving.

Seen in office 06/09/2021 by Dr Extensive urticaria rash, tight throat beginning 36-48 hours after second dose of Pfizer COVID vaccine. Claritin 10mg 2 po qday for 7 days, continue Nexium, Benadryl prn.

Angioedema. Pt with facial swelling and rash. Swelling was mainly to lower part of face, including lips. Also reports numbness of face and numbness to a section of her R hand.

sporadic breakout of hives on face, torso and back for two days after vaccine, itchy throat, responded to Benedryl and Sarna lotion

second Pfizer vaccine vaccine was administered the patient developed a purple petechiae rash started developing on her left hand. NP ordered 25mg of Benadryl to be administered PO for the patient and to stay in observation for the next 30 min. The 30 min were observed by the LVN the patient's rash was clear and patients vitals are as fallowed B/P 116/67 Resp 18 O2 94. The patient said she was feeling well no sighs of SOB .

Pityriasis rosea; This is a spontaneous report from a non-contactable consumer (patient). A 17-year-old female patient received second dose of BNT162B2 on 21May2021 05:00 PM (at age of 17-year-old) at single dose on left arm for Covid-19 immunization. Medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 on 30Apr2021 05:00 PM (at age of 17-year-old) for Covid-19 immunization. No other vaccines within 4 weeks prior to the COVID vaccine. Patient experienced Pityriasis rosea on 23May2021. Patient received Mometasone cream as treatment. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Patient had Nasal Swab on 04Jun2021 with result of negative. The outcome of the event was unknown. The event reported serious. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Vaccine received at 0914, reaction occurred at 1008. Difficulty breathing, swelling to upper and lower lips, throat tightening, audible wheezing, rash to neck and chest. Two doses of Epinephrine and Benadryl given, oxygen administered, EMS called and taking to hospital via EMS at 1027.

Bilateral knee swelling and pain (severely limiting mobility to the point of being unable to walk due to pain/swelling), rash (c/f erythema nodosum) for 2-3 weeks (presented on 6/18/21). Concerning for flare of JIA vs other autoimmune etiology (infectious studies mostly negative, though some studies pending). Diagnostics ongoing.

Systemic: Body Aches Generalized-Medium, Systemic: Hyperventilation-Medium, Systemic: Joint Pain-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Pt began to display symptoms related to anxiety that progressed to hyperventilation/nausea/full on body aches/ pt states she was then unable to move her arms/legs/hands due to body aches. Pt reported that her body was aching and that she was feeling nauseated. Pt's fingers were turning blue due to intense clenching. Paramedics/Ambulance called for so pt can be further evaluated.

Patient's mom reported hives starting around the mouth approximately 30 minutes after receiving the vaccine. By 9 pm that evening, she reports that patient had hives over half her body. She was advised by pediatrician to give benadryl and go to the ER if hives didn't resolved. Hives responded to benedryl. Patient reports feeling fatigue the next 48 hours as well. Patient is now doing fine. No further followup at this time.

Developed pin dot rash on arms that was noticeable on 06/06/2021. Sought medical treatment with doctor on 06/10/2021. Labs drawn and rash identified as Petechiae. Labs showed very low platelets and WBC. Spent day in ED on 06/11/2021 based on lab results. Labs were redrawn evening of 06/10/2021 to confirm initial lab results. Labs repeated on 06/11/2021 in ED. Another set of labs drawn on 06/14/2021. Appt with Outpatient Hematology on 06/16/2021 and more labs drawn. This is an ongoing issue and I am not sure if related to vaccine, but timing seems concerning. New labs drawn today and awaiting those results. She is still under medical care.

The patient had an apparently spontaneous anaphylactic type reaction with facial hives, eye redness and swelling, diffuse hives on trunk, lips, and extremities, tongue swelling, difficulty swallowing, and itchy tongue. The only thing had had had to eat or drink was a cows milk latte with hazelnut 2 hours prior to the reaction. No fever. The family gave her 2 tabs of Benadryl (50 mg total) at home and brought her to urgent care whereupon her hives and tongue swelling had decreased substantially. They showed photos of her face and skin prior to the Benadryl. She was given 60 mg prednisolone and observed for over 30 minutes. She improved substantially and was discharged home with her mother pending results of allergy testing.

Rash & Fever - went to ED. + burning & itching on back. Joint pain in fingers, joint pain rt elbow and wrist. Pain soles of feet. Started one week prior to 5/31/21. Dx'd with macular rash. Elevated C-reactive protein. Elevated sed. rate. Arthraligia of both hands. (Date of visit 5/31/21)

Left arm puritis, site of injection.. 50mg benadryl with improvement. No sob, wheezing, oral/airway swelling

extreme hives on body; first night hard woke up with a hard time breathing; This is a spontaneous report from a contactable consumer (Patient). A 17-years-old (non pregnant) female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot Number: EN5318), via an unspecified route of administration, administered in arm left on 16Feb2021 (at the age of 17-years-old) as single dose for covid-19 immunisation at workplace clinic. Medical history included anxiety. Patient had known allergies as she got a rash from Sulfa drugs. Concomitant medication included (other medication in two weeks) fluoxetine. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Solution for injection) on an unknown date (at the age of 17-years-old) for COVID-19 immunisation. Patient did not receive any other vaccine in four weeks. Prior to vaccination, the patient did not have COVID-19 and the patient not been tested for COVID-19 post vaccination. On 16Feb2021, patient experienced first night hard woke up with a hard time breathing and extreme hives on body on 20Feb2021. Therapeutic measures were taken as a result of the events included Benadryl. The outcome of events was recovered on an unknown date in 2021. Follow-up (13May2021): Follow-up attempts are completed. No further information is expected.

Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Abdominal Pain-Severe, Systemic: Confusion-Medium, Systemic: Fever-Medium

Patient began on June 3rd with pain in her right lower and foot, the leg and foot felt cool to touch and was discolored.

Fever to 101.3 and malaise night of vaccine, "bad cough" on the following day with chest pain which resolved over a few days, then she developed bilateral ankle swelling and pain 80 hours later with a rash and swelling spreading up to her thighs and down through her feet. hands also swelled and turned white (sounds like Raynaud's). knee pain resulting in difficulty sleeping at night. tachycardic on exam. evaluated in clinic on 6/11 and follow up on 6/15. noted loss of appetite for a week and fatigue. Myalgias made ambulation painful. instructed to use NSAIDs and elevation and she improved over the next few days

had the second vaccine, the injection site bled; Sneezing a lot, after the first and second vaccine; This is a spontaneous report from a contactable consumer (mother). A 17-year-old female patient (daughter) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0171) dose 2 via an unspecified route of administration in right arm on 12May2021 at 4 pm (At the age of 17 years old) as single dose for COVID-19 immunization. Medical history was not reported. Concomitant medications included ongoing ethinylestradiol, ferrous fumarate, norethisterone acetate (LOESTRIN FE, Tablet) oral 1 mg/10 mcg monthly for birth control (started two months ago). Historical Vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0161) dose 1 via an unspecified route of administration in right arm on 21Apr2021 (evening) (At the age of 17 years old) as single dose for COVID-19 immunization. No prior vaccinations within four weeks prior to the first administration date of the suspect vaccine. No AE(s) following prior vaccinations. Her daughter had the second vaccine, the injection site bled around 4 pm on 12May2021. When the provider stuck the needle in her daughter's arm it bled for a few seconds and they wiped the blood off with a cotton ball. Her daughter did not see any blood on the Band-Aid. She was sneezing a lot, after the first injection and then it got more intense/worsened after the second injection in 2021. Her daughter's school is making all the seniors get the shot to go back to school. Because she is her daughter's mother and told her daughter to get the vaccine. A visit to emergency room or physician office was not required. The outcome of event injection site bled was recovered on 12May2021; Sneezing was not recovered. Information on Lot/Batch number was available. Additional information has been requested.

Systemic: Fainting / Unresponsive-Mild, Additional Details: PATIENT WAS GIVEN COVID VACCINE AT 9:13AM. Patient was slightly nervous, covid vaccine was adminstered as normal routine. Patient was tense, slight blood at adminstration site. Left arm was wiped with pad, and given band-aid. After 30 seconds patient passed out on chair with faint response. I IMMEDIATELTY called 911 and ambulance came to observe patient. Ptaient became response, mother assured she had "Anxiety" and she left pharmacy.

itching on the hands; blister going in between the fingers; reaction had worsen; This is a spontaneous report from a contactable consumer or other non-health care professional. A 17-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration, in right arm, on 11Apr2021 at 16:30 (at the age of 17 years), as single dose for COVID-19 immunization. The patient medical history included Strong Family History of Rheumatoid Arthritis, states her mother is crippled, immunodeficiency and borderline immunocompromised. Historical vaccine included cervical cancer vaccine. The patient didn't have any history of all previous immunization with the Pfizer vaccine considered as suspect and no additional Vaccines administered on Same Date of the Pfizer Suspect. The patient didn't receive any vaccines prior 4 weeks. The patient concomitant medications were not reported. The patient previously took cancer vaccines and experienced eczema, cancer vaccines and experienced pyrexia, lo loestrin fe for contraception and experienced heavy menstrual bleeding. She has not taken the second dose yet which is more than 21 days. On 1Jun2021, the patient had experienced Itching and blistering on her hands and between her fingers and it mostly started at the palm and she can't stop itching reported as worsened. Reporter wanted to know if anyone else had the same reaction. patient also started on birth control. She had prior reaction from cervical vaccine at 12 years of age, also had eczema at the top of feet and fever. Reporter wanted to know if her daughter can still take the second dose because her high school clinic has schedule for second doses on 24Jun2021. Reporter tried to ask if she could also take the second dose of the vaccine because she is "borderline immunocompromised", but she already had HCP appointments set for her and her daughter and decided shell ask the doctor as well. The events didn't lead to emergency room or physician office visit. No investigation assessment performed. Patient received treatment with Zyrtec, reporter states her daughter called from school and she forgot to take it today at school, it does help somewhat. UPC, Lot, Expiration Unknown. Caller states they tried an itching cream, but it was not the proper one, she thinks it did work but it had an extra ingredient for a feminine product. She wants to note her daughter started on Birth Control, Lo Lo Estrogen, Dosage unknown. Caller states it was strange because she had heavy periods and they are trying to find out if she has fibroids or endometriosis, and the doctor gave her a packet of birth control and when they tried to refill it 3 weeks ago, their insurance didn't cover it so it might be a combination of her stopping that. Caller states she thought maybe if someone else and reported it. Outcome of the events was reported as not recovered. Communication: Caller provided with Report Reference. The caller was provided with the phone number, hours of operation 8am-8pm EST Mon-Fri and 9am-3pm Sat-Sun

Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Visual Changes/Disturbances-Severe, Additional Details: left pharmacy in ambulance, gave iv in ambulane

First vaccine 3/24/21 Second vaccine 4/14/21 In early may, mom can't remember date, patient c/o left leg and foot pain. Went to podiatrist - no diagnosis made - was told to monitor. Mid to late May developed dry cough. Not seen for this. On June 10 taken to ED lower left leg extremely painful and swollen and mom reported discoloration to back of leg. Diagnosed with DVT and put on blood thinner Xeralto and discharged. A week later went to hematologist who said to continue Xeralto and monitor. A week after seeing Dr. and two weeks after initial ED visit, on a Wednesday, patient started to cough up blood. Went back to Dr. and patient was taken off of Xeralto. PE scan ordered. The next day patient developed chest pain and went to ED. PE scan done and diagnosed with two PE's on right lung. Was informed had six blood clots in lower left leg. Admitted to ICU. Was an inpatient for 5 days then discharged. Now patient is taking Lovenox injections twice daily.

On July 10Th the patient had small rash on her abdomen thigh and down her leg. On July 13th the patient woke up and was covered from head tp toe in the rash. under her arms, behind her ears and neck and private area as well.

Red face cheeks; Red face cheeks, slightly swollen, notcaused by sun exposure; This is a spontaneous report from a non-contactable consumer, the patient. A 17-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 27Mar2021 at 09:00(at the age of 17-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 28Mar2021, the patient experienced red face cheeks, slightly swollen, not caused by sun exposure. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of red face and swelling of face was not recovered at the time of report. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

After the shot was administered, patient was asked to sit for 15 minutes for monitoring. Within 5 min after administration, patient said she was feeling hot and sweaty. We provided patient with a cold bottle of water and ask her to take small sips. Also gave her ice pack to apply to get her to cool down. After few more minutes, patient stated that she was itchy and having burning feeling thru her body. We asked the mother to see if she would like us to call 911 but the child told the mother she will let us know if that was necessary. We asked her to sit longer at this point because of how she was feeling. Few more minutes passed by and patient was starting to feel a little better but the burning didn't go away. She tried to take a walk with her mom in the store to see if she can shake it off, but returned after about 10 min stating that when she walks, the burning feeling is getting to be excessive in her feet. So I asked her to sit for few more min and said they are ok to leave when they feel comfortable but if condition worsens, they should go to ER. I told mom to keep very close eye on her and that she should lay down when she gets home. Next morning, I followed up with a phone call. Spoke to patient and she said everything seems fine now and that it started going away after few hours of administration.

Patient seemed to faint / look like they had a seizure, no seizure history, color recovered to face once we laid her down and lifted legs up. EMS was called and assessed patient.

Full body rash that was controlled with Benadryl and prednisone at an outpatient clinic 45 minutes after vaccination. Adverse rash and allergic reaction still present 48 hours later.

100.1 fever at 630pm , swelling of face, chest pain , trouble with breathing , redness of face , and body pain at 8pm ,

Rash at injection site and muscle aches. Was achy on the morning of 1/28/2021 with 'bumps' on the chest area. Achiness resolved on 1/29/2021 but rash continued affecting her abdomen as well.

she was not good with needles, so it was certainly good that it went quicker and less painful than she expected; This is a spontaneous report from a contactable consumer reporting for herself. An 18-year-old female patient received bnt162b2 (BNT162B2, lot number: EL1283, expiration date: not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The vaccine was administered at a school or student health clinic. The patient was not pregnant at the time of vaccination. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She was not diagnosed with COVID-19 prior to vaccination. Medical history and concomitant medication were not reported. The patient was just nervous for a good amount of the time. When she got the vaccine she was overthinking and her left hand began to throb. She was not in pain but just a sinking feeling. She stated that she was not good with needles, so it was certainly good that it went quicker and less painful than she expected. She added that her nurse treated her so well and was so patient with her and she appreciated it so much. Since the vaccination, the patient has been tested for COVID-19: Nasal Swab with result of negative on an unspecified date. No treatment was received for the event. Outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.

Shortly after immunization, patient started to develop a rash around the injection site as well as nausea. Given Benadryl and transferred to the Emergency Department.

chilblains-toes; still bluish/red, but not any worse-we have been making sure her toes are warm and dry; decreased capillary refill; will monitor the next few weeks. f/u w/pcp on 3/22.

An hour after my vaccine I noticed that my arm was red where I got the shot. It got bigger and bigger. The biggest is what it is currently at 8pm on the 22 of Feb 2020.

Patient developed urticarial rash on 3/13/21 which began on her lower extremities and progressed to most of her body by the following day. She was seen on 3/15/21, and had no other symptoms besides the rash and was treated with zyrtec and benadryl but prescribed an Epipen (Auvi-Q) in case of worsening. The next day, 3/16/21 she awoke with swelling in her mouth and worse rash, used her Auvi-Q and called 911 and was taken to ER where she was treated for anaphylaxis with IV solumedrol,, IV fluids and IV benadryl and was sent home on Prednisone and benadryl and Pepcid.

Low grade fever for 2 days after first shot (101) Rash beginning 8 days after shot, swollen and red but not painful at the vaccine site

-pain in right side of entire body, -entire face rash- rash on face- could be from epiduo forte which is used 2x/week for the last 2 months ? -chills

Red itchy, hives, and swelling forearms on left and right side starting just before 4 hours after vaccination. Slight sore throat pain about 4 and a half hours after and last about a half hour. Took two benadryl, feel better now. :)

Patient received vaccine at noon on 3/25/21 and left the pharmacy after waiting 15min with no side effects. Patient called pharmacy at 4:10pm reporting hives, swelling, pruritus on both arms. Patient denied shortness of breath and dizziness. Advised to take benadryl 25mg stat. and to seek emergency care if developing signs of anaphylaxis or if hives/swelling worsens. Followed up with patient at 6:14pm and patient reported a positive response to benadryl (reduced swelling, no more pruritus).

22 hours after receiving my second dose of the vaccine, and I have a slightly red, warm lower right arm. I received my vaccine on my left arm, which is NOT red and warm. It is only red and warm at my incision site along my right ulna from a surgery I had a little over a year and a half ago.

Patient received the 1st dose of the Pfizer Covid Vaccine (Lot: ER8732, EXP: 7/21) on 3/27/21. Shortly after the injection the patient's arm started itching and a rash developed. Patient was dizzy, hot, and had an elevated blood pressure. Patient was transported to Emergency Department by EMS.

Starting on 28th of march on Headache Muscle aches especially at injection site Injection site is hot Tiredness Overall unwell feeling

Adverse event: Hives on whole body Symptoms: itchiness and irritability Time course: at beginning of day until treatment is taken Treatment: Benadryl Outcome: nothing life threatening

Red slightly itchy rash on elbows, inside of mouth felt swollen and irritated, sore throat, arm slightly sore where the shot was given

Acute DVT in left LE. Patient presented to ED on 3/22/21. She had 2 day h/o leg discomfort and leg was taught and painful on the day she went to the ED. Study was limited due to pt lack of cooperation. Lovenox started.

pt was given 1st dose of Pfizer covid 19 vaccine at apporx. 1525hrs on 4/6/21. Approx 5 minutes later the pt starting having a rash that was visible on her chest and was complaining of itching globally. Pt reported no previous allergic reaction to a vaccine in the past. Pt was given an Epipen 0.3mg in the left thigh. Symptoms began to improve and pt was transported to the local hospital via local Emergency Services for further evaluation

Eight days after her injection, Raised bump that looked like two mosquito bites about the size of two nickels pushed next to each other; brief 99-101 F fever that lasted only an hour or two for two consecutive nights. Bump turned flat and area got to be more of a red spot in similar size. Resolved itself in 24 hours after redness. Not serious but worth mentioning because I have read about this fairly uncommon side effect from recent NEJM article, but ghe article stated the effects were coming from folks who had the Moderna shot, and not the Pfizer.

Within 5 mins of receiving the vaccine, patient collapsed, skin turned red, had difficulty breathing and "strange feeling in throat" on her way to the 15 minute observation room. 911 was called and 2 Pharmacists rushed to her and one administered an epinephrine pen. Patient could breathe more deeply after the epi pen administered. One pharmacist stayed with her in case another dose of epinephrine needed to be administered, once the paramedics arrived the pharmacist left the room so they could care for the patient.

woke up next morning with bilateral hand and forearm discoloration and brown macules on lateral aspects of forearms and dorsal hands

Patient with known allergies to PEG. Had a slight reaction of hives following 1st dose. Patient consulted with her PCP and oncologist and her oncologist was adamant that she was to receive her 2nd dose, not an option to not receive despite documented PEG allergy. After receiving 2nd dose approx 5-10 min later in monitoring area reported to EMS RN feeling dizzy, flush, and eye flutter. EMS evaluated, vitals HR 104, RR 21, BP 137/98, PulseOx 97%. RN noted patient was very anxious and this contributed to the patients symptoms. However, the patient did begin developing mild flushing and small red patches on arms, legs, trunk. Hives and flushing resolved within 30 minutes. Approx 45 minutes post reaction symptoms, patient reports feeling better, flushing resolved. Denied wanted further workup or transfer to ER and left with her mother.

Took Benadryl before getting the shot at 2:30pm Allergic reaction resulting in facial and throat swelling, red welts at the back of the throat, wheezing, going unconscious and shaking all within 2 hours of receiving the vaccine Took second Benadryl to try and calm down the reaction (no effect) Epipen was given at the advice of my physician at 6:30pm Was directed to the ER Given medication in the ER Released after 4 hours

PT MOTHER CALLED, SAID AREA WAS LOWER ON ARM THAN FIRST DOSE, ARE WAS RED INFLAMMED TO SIZE OF A HALF-DOLLAR AND HOT TO THE TOUCH

I started having vesicles all over my body less than 24 hours after my first and second dose. I did go to the clinic to get allergic reaction shot.

Two hrs after 2nd dose of pfizer on April 9, 2021, patient experienced the following for the next 48 hours: pain at injection site and redness; fever or 102; nausea; tiredness; chills (lasted 24 hours); headache; and muscle aches all over. All of this was handled through Sudafed Severe Cold tablets as if she had the flu.

Itchy throat, sweaty, "feels like under water", tinglng arm where vaccine was given. Juice provided, monitored and released with Mom. Phone call follow up later that day, she was doing well.

The day after the vaccine was received, the patient noticed arm and face swelling. She also experienced shooting pains and tingling in the same arm she received the vaccination. At work, it hurts when she carries things and has dropped items, which is unusual. Pain is mainly in the shoulder, but sometimes in the forearm. She has tried Tylenol, ice and naproxen with no relief. She received methylprednisolone on 4/12, and now feels that she is having an allergic reaction. Complaints of increased wheezing, shortness of breath and swelling of her skin, she has used her albuterol inhaler at home which has provided no relief. On 4/13 she received albuterol by nebulizer and an IV dose of methylprednisolone at the emergency department. She is going to start albuterol nebulizer at home, continue OTC antihistamine, discontinue the methyprednisolone and start prednisone tomorrow.

Large welts on both legs, both elbows, back of neck, and buttocks. Benadryl given. Lasted approximately 24 hours.

Red and hot rash on left arm, cheek and leg; spread to right cheek, treated with calamine lotion and two benadryl taken. Began day after vaccination.

Rash, red, trunk and neck Prednisone Rx Developed rash four days ago (itchy) No hx of new product/food etc..

patient was given her injection where she developed itchiness of her throat, neck, chest, and abdomen. then she began to get lightheaded. 12:31 BP 192/ 86 HR 85 12:38 BP 179/84 HR 99 she then began to develop a raised macular rash on her chest and neck 12:45 patient given 25 mg of po benadryl. 13:00 BP 150/77 hr 87 oxygen sats of 98% room air patient feeling better rash disappeared 13:07 BP 150/82 hr 78 oxygen sat 100 % room air 13:10 patient was released with her mother and she was escorted to the exit with staff

12 hours after receiving the second dose of Pfizer I felt fatigued and my injection site was red and swollen. 24 hours after the vaccine I was experiencing abdominal cramping, headache, and fatigue. 48 hours after I developed a severe full-body rash/hives/welts. It started as a small patch on my left arm and progressed to my hips, legs, arms, chest, back, and face - my whole body. The rash is extremely itchy and has caused me to bust blood vessels from scratching so hard and frequently. I began rotating Benadryl and Zyrtec, but it seemed to make it worse. I visited the ER in the middle of the night on 4/18 where I was given steroids and Benadryl IM along with Pepcid. The rash went away a few hours after, but has since then reappeared and I am currently running a low grade fever of 100.2. I am taking Prednisone 20mg 3x a day as prescribed by my doctor along with Benadryl 50mg every four hours and Pepcid twice a day. Despite these medications the rash continues to persist.

[April 10; Evening]: Headache with small pounding feeling, a slight fever. [April 11, Morning]: Slight pressure on injection sight, weak limbs, vomiting, fatigue. [April 11, Evening]: Unconsciousness, nausea, delirious, fever. [April12-14]: Extreme Migraines, dizziness, loss of balance while walking, unconsciousness, loss of appetite. Took Pedialyte and liquid pain reliever everyday.

Chills: 13 - 37 hours after injection Sweating: 20 - 37 hours after injection Leg muscle pain: 23 - 26 hours after injection Hard itchy red lump appeared below injection site

Patient had anaphylaxis reaction. Tongue swelling, SOB, rash, Given benadryl. Taken to ED for observation. Epi pen, benadryl, pepcid, and solumedrol administered.

1328 - Father stated daughter didn't feel well - walked to stretcher and fainted. 1330 - Patient awake, VS taken, on stretcher, color improved, talking. BP = 98/53, HR = 74, RR = 22, O2 Sat = 100% 1335 - Patient sitting up. 1340 - Patient talking, drinking soda. BP = 117/76, HR = 80, RR = 22, O2 Sat = 100% 1350 - Patient's color pink, in no apparent distress. BP = 129/71, Hr = 83, RR = 16, O2 Sat = 98% 1351 - Patient ambulated out of clinic with father.

shortly after vaccination patient began to feel light headed and dizzy and became flushed and hot. Patient broke out in splotches over chest. Pt was given 25mg of diphenhydramine. Pt began to feel better after 30 minutes of observation .

1:50 Called into observation room by RN. for assistance with this patient. Pt had Dose 2 of Phizer at 1: 16 pm and was now complaining of nausea and lightheadedness. Pt asissted to floor, legs elevated up on a chair. Pt is alert .He stated, his name is (unlisted). Skin: pale, hands diaphoretic. Immediately, pt 's chest was pounding;HR was elevated , pt's eyes closed and he appeared attempt to answer this RN's questions as to how he feels, however, could not. Would not/could not open eyes. It appeared that he was shaking/mild jerking as with the chills, however, this RN was discerning if it was seizure like activity. Upper body flushed/red. This lasted about 30-45 seconds. Then pt.'s shakiness slowed down, heart pounding resolved and he opened his eyes. Able to squeeze nurse hand. 1:53 pm DPN Came to assist.Ice pack to forehead Pt was still shaky, but now responding. Still w/ complaints of nausea, lightheadedness. 2:05 still lying on floor with legs elevated. 2:10 Sat up for 5 minutes. C/o nausea. Placed in wheelchair. Within 1 minute, pt. Is pale, shakiness returns, and c/o nausea. Returned to the floor , legs elevated and 9-1-1 initiated. HR steady, respirations -steady. MOC now present.Pt. now responding to MOC or RN's commands to squeeze hand or Speak. Eyes closed. HR and RR steady. 9-11 arrived at 2: 15 pm and pt. Left facility with paramedics and MOC.

Neither my sleeping conditions nor diet has changed within the past month. No new medications introduced in years. However I received my vaccine and two mornings after I developed 30+ small red dots scattered over my torso and neck. They do not resemble bites nor do they itch. They calmed in size and redness over 24 hours however the marks are still there. I have no known allergies or sensitivities and my friend had similar spots developed on his arms and upper torso the second morning after receiving the vaccine as well.

bleeding; less soreness at the injection site; This is a spontaneous report from a contactable consumer. An 18-year-old female patient (non-pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8735, expiration date: unknown), via an unspecified route of administration administrated on left arm on 05Apr2021 at 16:00 at the age of 18-year-old at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. No other medications in two weeks. The patient did not have any known allergies. She received first dose of BNT162B2 (Pfizer Covid-19 vaccine, Lot number: EN6204, Expiry date: unknown) via an unspecified route of administration, administrated on left arm on 14Mar2021 at 15:00 (03:00 PM) at the age of 18-year-old at a single dose for COVID-19 immunization. On 05Apr2021 04:00 PM, reported that the 2nd dose of vaccine caused unusual amount of bleeding after needle was removed. The patient had to clean excess blood after the shot. The band aid was soaked with blood. The patient experienced less soreness at the injection site compared to the first vaccine shot. The concern is whether the vaccine was bled out due improper injection. She did not have any other vaccine in four weeks before the covid-19 vaccine dose. The patient did not receive any treatment for the events. She was not having COVID prior to the vaccination, neither was tested for Covid-19 post vaccination. The patient recovered from the events on an unspecified date in 2021.

The first time I had the vaccine my throat started burning and chest tightness I stayed with the nurse for a good half hour and I started to feel better so I left by the time I made it to my car I throw up I decided to go home in about an hour later calm down. The second time I had the vaccine 04/21/2021 my throat was burning my chest was tight I had hives I was vomiting and having hot flashes for a good hour at that point my symptoms were not coming down so I was sent by ambulance to the hospital I have to give him Benadryl on a steroid I was at the hospital for a good five hours my symptoms were gone. The next day 04/22/2021 I had some soreness in my arm my body was sore and I was really tired later that night I started feeling really hot and my legs were stinging and burning I looked at my legs and there was a rash and a rash on my face and a rash on the left arm where I had the vaccine

Patient is a 18-year-old, female. No known medical history. No known allergies. At 3:18 pm, the patient received her first dose of Pfizer vaccine (lot number EW0179, expires on 08/2021) on left deltoid, given by RN. Patient informed RN that she has a history of fainting after vaccines. RN recommended the patient wait in the zero-gravity chair. Patient continued to be A&Ox3, walked herself over to the EMT waiting area with a steady, balanced, and sat down in zero-gravity chair. At 3:20 pm, patient checked in with EMT and stated she feels "fine". At 3:27 pm, while waiting in observation area, patient stated "I don't feel good" and went unconscious. EMT reclined patient into supine position. Patient remained unconscious for approximately 10 seconds. RN called 9-1-1 at 3:28 pm. Patient regained consciousness at 3:28 pm and stated "I need something sweet". At 3:30 pm, the patient's BP 69/44, RR 8/min, HR 63 bpm and weak, skin dry and cold to touch, lips pale and cyanotic. At 3:33 pm, the patient's BP was 87/60. Fire Department arrived on site at 3:34 pm. Patient was transferred to gurney by FD. Patient left facility at 3:34 pm .

full body blistering hives; full body blistering hives; eyes swollen shut; lips started to swell; This is a spontaneous report from a contactable consumer reported for herself. A 18-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, in left arm on 26Mar2021 12:00, at the age of 18 years old (Batch/Lot Number: EN6208) as single dose for covid-19 immunisation, at the hospital. The patient had received the first dose of BNT162B2 on 05Mar2021 02:00 PM from lot # EN6200 in the left arm. Medical history included hypersensitivity. The patient's concomitant medications were not reported. The patient was not pregnant. Patient had not Covid prior vaccination, patient has not tested positive for COVID-19 since having the vaccine. No Covid tested post vaccination. The patient experienced full body blistering hives, eyes swollen shut, lips started to swell on 27Mar2021 12:00 AM with outcome of recovering. The patient was treated for the events with an injection of steroids and Benadryl at ER. No follow up attempts are possible. No further information is expected.

losing vision; almost passing out; After second dose: fever; chills; headache; body ache; pain at injection site; dizziness; This is a spontaneous report from a non-contactable consumer (patient). An 18-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 09Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation, at 18 years old. The patient medical history was not reported. There were no concomitant medications. No other vaccines if four weeks. Patient received the first dose of bnt162b2 at 12Mar2021 16:30, arm left for covid-19 immunisation, at 18 years old. Patient is not pregnant. The patient experienced after second dose: losing vision, almost passing out, dizziness, fever, chills, headache, body ache, pain at injection site on 10Apr2021 00:00 (12AM). Treatment was not given. Outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Patient's mom called saying that about 4 hours post Pfizer vaccine administration of her 2nd shot. She was having red bumps on her arm and small patches on her leg. Mom said she did not have any type of reaction when she received her first Pfizer vaccine. I recommended patient to take benadryl and monitor for any additional signs of anaphylaxis. If rash spreads or other signs such as trouble breath, swelling of face, etc happen she should go to emergency room. I will be filling out the VAERS form as soon as I submit this event.

PMS symptoms (bloating, headache, acne, cramps, tender breasts), delayed or possibly missed period, headache directly after getting first dose of pfizer, sore arm.

Patient developed an exanthem which developed within 48 hours of receiving #1 COVID vaccine. Rash was raised, and pruritic and started near her ankles. It spread to full-body rash within 24 hours, associated with low grade fever, angiodema of her lips. She treated herself with Benadryl , topical hydrocortisone and her daily Zyrtec. She was treated by healthcare professional with oral steroid for a 5 day course

symptom started 4/21, with pain and tightness in the left arm, progressively spreading up the arm over the following 48 hours, and then to the distal right arm, and legs. The leg symptom were present when seen 5 days ago, though were not discussed as Patient wasnt sure if thats what was really starting. This is associated with a feeling of "not being able to feel muc" and "doesn't feel right", as if it "feels foreign... body says this is weird," and feels heavy. Also notes that different extremities feel different - left is worse than right. Seen 5 days ago, and noted to have been advised by hematology to stop eliquis approximately 2 weeks prior to onset of symptom after PE/Renal artery embolism 1/2021. At that visit was referred to ER, where workup for repeat clot was normal (CTA, b/l upper extremities dopplers, head/neck CT, CXR). EKG was notable for Sinus tach and nonspecific T wave abnormalities. Discharged home with close follow up. Since then the intensity of the symptom as worsened and the leg symptoms have gotten more pronounced and consistent with the upper extremities symptom. Today notes new difficulty getting dressedon because clothes were getting stuck/he couldnt pull them down. Also notes when his left arm is touched it causes burning pain that shoots up the arm. Reports headache. 2-4/day, last 30 minutes, 5/10 in severity. Worse with movement of head. Frequent nausea, no emesis. but not specifically associated with headache. No waking from sleep. Since PE, has complains of intermittent left sided squeezing chest pain, which he wonders may be due to his anxiety. Lasts a few minutes Received Pfizer COVID vaccine 3/29, hasnt received 2nd dose yet ROS: general: no fevers or weight loss. CHRONICALLY C/O FATIGUE AND TROUBLE FOCUSING. has had evaluation for executive function difficulty in the past (interdynamics), now purusing evaluation at Neurology and awaiting EEG with this. HEENT: no sore throat. + VISION CHANGES - TROUBLE FOCUSING, but not specifically blurry vision. CV: LEFT SIDED CP, NONSPECIFIC T WAVE CHANGES ON LAST EKG W/SINUS TACH. Pulm: SOB, with walking up and down stairs, since PE. not worsening. No Cough. GI: +NAUSEA, no vomitting, no abdominal pain. No current diarrhea. Neuro: + HEADACHES. + SENSORY CHANGES. + family h/o MS

Red Face. The redness developed 24 hours after first dose Pfizer. (received shot at 12PM Friday, face began to itch noon Sat)There was no associated SOB, DOE, dysphagia, and no enlarged tongue. Face was hot and itching Neg PMH, No Meds NKA, + seasonal allergies. No new exposure history Resolved completely within 24hrs following single dose of Zyrtec .

Patient received vaccine and within 1/2 hour a 1 1/2 red streak appeared on her arm. Within an hour the red marks had expanded to over half her arm down her deltoid down the medial antebrachial section of her arm. She was taken to the emergency department for further evaluation.

Low grade fever 100.4 approximately 8.5 hours after vaccine administered. Severe body aches - complained that bones hurt, especially ribs and legs. Rapid heart beat on. and off for 24 hours. Injection site pain for 30+ hours.

The patient experienced less soreness at the injection site compared to the 1st vaccine shot; This is a spontaneous report from a contactable consumer (parent). An 18-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6204) via an unspecified route of administration, administered on left arm on 14Mar2021 at 15:00 (at the age of 18-year-old) as SINGLE DOSE for covid-19 immunization. The patient medical history was not reported and concomitant medications were not reported. Patient received second dose of BNT162B2 (Pfizer Covid-19 vaccine, Lot number: ER8735) via an unspecified route of administration, administrated on left arm on 05Apr2021 at 16:00 (at the age of 18-year-old) as a single dose for COVID-19 immunization. It was reported that the patient experienced vaccination site bleeding and vaccination site pain after the second dose of vaccine on 05Apr2021. The patient did not have any known allergies. Patient did not had any other vaccine in four weeks before the covid-19 vaccine dose and No other medications in two weeks. On 14Mar2021, the patient soreness at the injection site. It was reported that the, soreness at the injection site was less when compared to the 1st vaccine shot. The patient did not receive any treatment for the events. She was not having COVID prior to the vaccination, neither was tested for Covid-19 post vaccination. The patient recovered from the events on an unspecified date in 2021. No follow-up attempts are needed. No further information is expected.

04/30/2021 Before the vaccine, Patient had a small rush on her face-right cheek. 05/01/2021 12:30 am, the same rush on her face expanded, and appeared a big rush on her left leg. 8:am, her face was warm, swollen, red, and itching. A big rush on her lower and upper back; the rush on her leg expanded and is very red.

After about 6-8 hours I began to have flu-like symptoms such as feeling feverish, feeling achy, & having a headache. I also felt like it was hard to breathe. But, today May 3rd, 2021, 2 days after the vaccine I developed a rash on my left side (vaccine side) from my armpit down to the top of my ribs. It?s red & looks & feels like sunburn.

Bilateral Rash and itching / burning sensation on hands (reported 20 minutes ago, no treatment / outcome determined yet)

Pruritic rash began approximately 5 days after vaccine. Some improvement with Benadryl. Patient denies any other associated symptoms.

Patient had right sided facial redness and itchiness about 20 to 30 minutes after injection, no swelling, no rash, that lasted about 10-12 hours, patient then had right periorbital swelling about 1-2 hours after injection, with slight scleral injection and itchiness of the eye, this lasted about 24 -36 hours then resolved completely Flu like symptoms ( body aches, fever, chills) within 24 hours that last about 36 hours post vaccine

Fatigue and mild severe pain in the right armpit. A little pain at the injection site. Been feeling the armpit pain since the morning after the vaccine.

Redness at injection site (Wednesday-Thursday), swelling at injection site (Wednesday-Thursday), muscle pain (Wednesday-today), hives on left arm (Wednesday-Thursday), headache (Thursday-today), nausea (Thursday-today), vomiting (today) , diarrhea (today)

Patient received her 1st Covid vaccine today, with a known history of anaphylaxis to the flu shot 6 months prior. She was assigned a 30 minute wait time. She received her vaccine at 1225 on 14May2021, and approximately 15 minutes later developed itchiness around her mouth and face. She reported this felt similar to the beginning of her prior episode. Physician and nurse were notified, who evaluated patient. Patient?s airway was clear, respirations unlabored and normal to auscultation. Vitals were within normal limits. EMS was notified, and 50mg Benadryl was given at 1255. At this time patient?s reaction appeared minor and stable, so epipen was at patient?s side however not given yet. EMS arrived rapidly, and repeated eval, confirming same evaluation and history. Patient was transferred in stable condition to the ER for extended monitoring.

Itching; Tongue is numb and tingling; Tongue is numb and tingling; allergic reaction; at the injection site she broke out; rashes on both arms/saw other red dots appear; Rash; This is a spontaneous report from a contactable consumer.A 18-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 26Apr2021 18:00 (Batch/Lot Number: EW0153; Expiration Date: Jul2021) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced rash on 27Apr2021, itching on 28Apr2021, tongue is numb and tingling on 27Apr2021, allergic reaction on 27Apr2021, she thought it was acne at first, but at the injection site she broke out on 27Apr2021, rashes on both arms/saw other red dots appear on 27Apr2021. Clarified allergic reaction as: She thought it was acne at first, but at the injection site she broke out. She has rashes on both arms. Rash seems to be spreading. Really started to show on day two and day three. Hasn't taken anything for it. She tends to break out on her arms, that's just her own body, but she saw other red dots appear that hadn't been there on her arms. She was itching last night and that was new. Is not itching as of now. She went to the hospital and was told to take Benadryl. Clarified she went to the vaccination facility, which was the hospital, and she was asked what was going on. She was not a patient of the ER and was not admitted to the hospital. Forgot to mention her tongue has been numb and tingling for a couple of days. First noticed it when she had something cold, but has persisted even without drinking something cold. Started Tuesday, 27Apr2021, night. Wondering if that is a side effect. Read in the pamphlet it is part of an allergic reaction. Read that rash is a part of a severe reaction.Outcome of all events was not recovered. Therapeutic measures were taken as a result of all events.

Around 18 hours after getting vaccinated. Rashes start to grow. I first discover it at my injected arm and then it spread to my back, another arm. Then, it starts turning red and itching. The rashes slow its growing at around 25 hours after getting the vaccine

Rash over left arm, neck, and face as well as ear swelling in both ears. After taking Allegra ear swelling and much of rash on neck has dissipated, but face and arm still have rash/getting more red.

Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium

Full body rash - itchy, red, painful - spreading over 24 hour period to cover 90% of body. Swollen, red ears, warm to touch

Headache; soreness at injection site; extreme muscle and joint pain; extreme muscle and joint pain; mild fatigue; This is a spontaneous report received from a contactable consumer (patient). This non-pregnant 18-year-old female patient received the second dose of COVID-19 vaccine (UNSPECIFIED TRADE NAME; lot number EW0153) via an unspecified route of administration in the right arm on 15Apr2021 at 08:15 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination the patient had not been diagnosed with COVID-19. Concomitant medications included sulfamethoxazole, methylphenidate hydrochloride, and sertraline, all from unknown dates for unknown indications. The patient previously received the first dose of COVID-19 vaccine (lot number EP6955) on 25Mar2021 at 08:15 (at the age of 18-years-old) for COVID-19 immunisation. The patient had not received any other vaccines in the four weeks prior to the COVID vaccine. On 15Apr2021 at 16:00 the patient experienced headache, soreness at injection site, extreme muscle and joint pain, and mild fatigue. No treatment was received for the events. The clinical outcomes of headache, soreness at injection site, extreme muscle and joint pain, and mild fatigue were unknown. It was also reported that since vaccination, the patient had not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.

Back pain requiring Naproxen, canker sore outbreak in mouth followed by same type of sores in genital area, headaches, spiked temperatures, chills, sweats, body acne, fatigue. Back pain, headaches & fatigue continue today; genital sores and acne improved after several weeks; mouth sores lasted over a month but better now.

Patient given vaccination ID unclear if this was the LOT number. She developed a mild skin rash one day after vaccination, which spread over her face, neck and chest and arms, with lip swelling, but no other oropharyngeal edema. The rash was itchy and pruritic, raised macules that were slightly erythemaic on the face, and sparsely papular on the arms. We prescribed benadryl and prednisone, with instructions to call our service line and also see us in the office on Monday. She had unresolved blood tests, hyperglycemia, which we were trying manage with our staff however she was not adherent to follow up with us due to college coursework. My associate is her primary care attending, and had requested assistance in filling out the VAERS form.

After receiving my shot on 4/22 I started getting singular hive like bumps on my legs and arms, thinking they were big bites I ignored them until they began to form a sort of rash covering my left hand and sporadically on the left side of my body. When the rash formed I went to urgent care on the morning of 5/2, at the urgent care the doctor prescribed me a steroid to help calm the rash down, at this time I was also taking benadryl to help. The next morning, 5/3, Around 5 in the morning my mother rushed me to the ER where they gave me an IV of benadryl, and steroids, and they also have me a shot of epinephrine. This helped the reaction, but I was referred to a dermatologist to see if they could figure out the cause of the ?rash? they did a biopsy and concluded that there was a hypersensitivity reaction such as urticaria and drug eruption.

I got a quarter-sized scaly red patch on my upper left thigh. I?m not entirely sure when it first appeared, but I first noticed it around April 20th, 2021. A couple weeks later, on May 4th, 2021, I noticed small red spots spreading, concentrated in the middle of my chest & branching out. The spots continued to spread & blossom all over my trunk, neck, hairline, arms & upper thighs. It was eventually suggested by a family friend that it was Pityriasis Rosea, which fit all of my symptoms & matched the timeline to a T.

The first dose of the vaccine went fairly well aside from fever, muscle aches, and pain in the left arm at the injection site. The second dose was reportedly worse. The fever ranged from 104.8 degrees Fahrenheit as a high and 102 degrees Fahrenheit being low, which receded after 3 days of care. In addition, chest pains and heart pain started at 8:00pm the day of the vaccination which was completed at 11:15am. Pain at the injection site and overall body muscle aches lasted for 3 days. The heart/chest pains have yet to recede. Instead it is occurring more frequently in ?bursts? of pain with a constant aching sensation.

Per client noticed redness and itchiness on right arm where she received vaccine 1 day after. Per client is resolved on its own, did not take medication for this. Client also reported throat itchiness on day 2. Client denied shortness of breath. Per client took ibuprofen and symptom resolved by day 3. Client stated not following up with provider as it resolved on its own. Medical history of seasonal allergies and takes over the counter medication for allergies and fiber for digestion.

-Bleeding from vagina (I don?t start my period for another two weeks) -Nose bleeds -Heat flashes (feels like a fever) -Gets cold really easily (shivering and chattering teeth) -Large rash on arm -Unable to eat as much -Fainting -Stomach ache -Headaches

burning sensation all over/her skin felt like it was on fire; burning sensation all over/her skin felt like it was on fire; breaking out in hives; This is a spontaneous report from a contactable consumer, the patient's mother. An 18-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot ER8735, second dose) solution for injection intramuscular in the right arm on 03May2021 (at the age of 18-years-old) as a single dose for COVID-19 vaccination. There was no relevant medical history. There were no concomitant medications. Historical vaccine included BNT162B2 (first dose, Lot ER8731) for COVID-19 vaccination on 11Apr2021 with no adverse effect reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 06May2021, the patient was breaking out in hives. On 09May2021, the patient had burning sensation all over/her skin felt like it was on fire. The patient was taken to the doctor (office visit). By Sunday (09May2021), the patient was completely covered and went to the ER (emergency room) where she was treated with IV diphenhydramine (BENADRYL) and steroids. The patient was not admitted to the hospital. The outcome of the events was not recovered. Information on Lot/Batch number was available. Additional information has been requested.

1) Major rash on face, chest and stomach. Very painful, swollen, itchy and uncomfortable. Started day of vaccine. Still present, 4 days later. 2) Lots of vomiting. Started day after vaccine. Lasted 1 day. 3) Abdominal pain. Started day after vaccine. Lasted 2 days. 4) Lots of diarrhea. Started day after vaccine. Lasted 2 days.

within 34 hours of the 2nd dose of the Pfizer Covid shot, patient began to break out in welts/hives behind her knees. She woke up in the middle of the night with her scalp itching and her ears hot as well as the welts behind her knees. Given Benadryl which helped a little for about 2 hours but then the hives just kept spreading and growing into huge swollen itchy patches on her body. By Friday afternoon, she had tried Benadryl and calamine lotion only to have it continue to get worse. We ended up with the Urgent care by 4pm Friday, 4-30-21. They gave her Prevacid and prescribed steroid cream. They told us if it got worse or affected breathing to go ER. We went home and kept taking the benedryl every 6 Hours and using the steroid cream. as one welt would begin to disappear, others would pop up. the steroid cream did not help in that regard. the benedrul would give about 50% relief for about 2 hours before the itching got very bad. Unable to sleep to do anything, we took patient to the pediatrician that Sat morning 5-1-21. She examined her and told her to take Claritin in the morning and Zyrtec at night to help. She was hestiant to prescribe any steroids due to unknown interaction or affects with the Covid shot. She told us to keep checking in with her and also if it got worse or spread to her face/mouth or any trouble breathing to go to the ER. We went home and tried to take an oatmeal bath. It only made things worse. By 10pm that Sat night 5-1-21, the hives had spread to patient's face and lips and were affecting her throat. Her voice got very raspy. we decided at that point to take her to the ER. They started her on steroids that night. She continued taking the steroids for 5 days after that. The steroids did help make her hives go away. However, within 2 days of finishing the steroids, patient noticed that she still did not feel 100%. That Saturday 5-8-21, She began to feel light-headed and off. She also began to feel fatigued. She came home from an errand needing to lay down and feeling dizzy. A few days after that, she began to have gas and indigestion, feeling like something caught in her throat and feeling nauseous. She also noticed that there a few nights in all of this that she would wake up shivering for no reason. The shivering would continue until she woke up in the morning. This report is being filed on 5-30-21. Since her 2nd shot and after the hives, we have been dealing with ongoing dizziness, fatigue, tiredness, lightheadedness and nausea to varying degrees. She has not been able to resume regular activates of being active or working out. WE have been back to the dr.

2 days later, got lip dermatitis, history of lip fillers a few months prior. Did not recur with second injection.

angioedema to lips; generalized hives (legs, arms, back, stomach); This is a spontaneous report from a contactable consumer (patient). An 18-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 27Apr2021 17:00 (Lot Number: ER8736) at the age of 18-year-old at a single dose for covid-19 immunisation. The patient was not pregnant. The patient medical history included mitral valve defect, seasonal allergies and allergies to peanuts, nuts, goldfish and cheez it crackers. Concomitant medications received in two weeks included minocycline; loratadine, colecalciferol (D3) and multivitamin gummies once a day, these medications taken for an unspecified indication, start and stop date were not reported. No other vaccine administered in four weeks. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 05Apr2021 10:30 (Lot Number: EW0150) at a single dose for covid-19 immunisation. The patient experienced angioedema to lips and generalized hives (legs, arms, back, stomach) on 28Apr2021 03:00 and received benadryl 25 mg, then claritin 20mg later in afternoon as treatment. The patient did not get covid prior vaccination and no covid test post vaccination. The outcome of the events was recovered in Apr2021.

36h after "broke out with hives and patches all over the body with extreme itching; 36h after "broke out with hives and patches all over the body with extreme itching; her ears turned red and became very hot, the hives spread to her face and into the throat; her ears turned red and became very hot, the hives spread to her face and into the throat; gastrointestinal issues; very gassy feeling of something stuck in the throat; skaes and shivered out of blue; felt lightheaded and dizzy with extreme fatigue; felt lightheaded and dizzy with extreme fatigue; nausea; This is a spontaneous report from a contactable consumer (Patient's Mother). An 18-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation solution for injection; Lot number was not reported), via an unspecified route of administration, on an unspecified date as 2ND DOSE,SINGLE DOSE for covid-19 immunization. The patient's medical history included Hashimoto's Disease. The patient's concomitant medications were not reported. The patient previously took first dose of BNT162B2 on 31Mar2021 for covid-19 immunization and experienced severe indigestion, vomiting and did not feel well. On an unspecified date (36 hours after receiving the second dose of vaccine), the patient broke out with hives and patches all over the body with extreme itching, her ears turned red and became very hot, the hives spread to her face and into the throat. The patient was prescribed steroid creams, and she self-administered three antihistamines included Zyrtec, Claritin, & Benadryl. The hives went away. After that on an unspecified date, the patient had gastrointestinal (GI) issues, she had very gassy feeling of something stuck in the throat, and had nausea to the point of being unable to eat. Also, she shivered and shakes out of the blue, felt lightheaded and dizzy with extreme fatigue. The patient received treatment with steroid creams, and antihistamines included Zyrtec, Claritin, & Benadryl for the events 36h after "broke out with hives and patches all over the body with extreme itching and her ears turned red and became very hot, the hives spread to her face and into the throat. The caller (reporter) mentioned that she heard that the vaccine causes problems in fertility hence caller asked for information on fertility studies with regards to the vaccine in response she was explained reports on the possible side effects, mentioned no information found for non-reported AEs, and referred to health care professional (HCP) for further guidance. Further, caller asked for information on how to treat or go about with the side in response she was informed that Pfizer was unable to make treatment recommendations specific for individual patients and referred to HCP for further guidance. Again, Caller asked, "how the vaccines work" in response she was explained about vaccine mechanism and CDC information. Caller asked if there was a way to measure the spiked proteins in the body as caller wanted to know how to measure/assess immunity after vaccination in response she was being explained about CDC recommendation, and referred to HCP for further guidance. Moreover, caller asked if there were other proteins in the body/organs/cells that were similar to the spike protein that our body could possibly react to in response mentioned that no information found on body components similar to the SARS-CoV2 Spike Protein, and she was referred to HCP for discussion. Caller complained and mentioned "reporter don't think all this information is being made public, it just seems to me like the issues for the vaccine is much worse for her than as if she got COVID19. Reporter really hope that the Doctors/ CDC / Pfizer and all organizations would reconsider this, especially on the possibility on the issue on the body attacking its own self." The outcome of the event hives was considered as resolved while the outcome of all other reported events was unknown at the time of this report. Information on Batch/Lot number has been requested.

fell straight over on her face, hitting her chin and splitting it open; felt dizzy; cold sweating; panic attack; significant memory loss; mild concussion; dehydration; fell straight over on her face, hitting her chin and splitting it open; insufficient food intake (had not eaten yet); felt more sick then usual; This is a spontaneous report from a contactable consumer. An 18-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8736, expiration date: not reported), via an unspecified route of administration on 14May2021 as single dose for Covid-19 immunisation (Age at Vaccination: 18years). The patient medical history was not reported. Concomitant medications included fluoxetine hydrochloride (PROZAC) 10mg/day (as medications in two weeks) taken for an unspecified indication, start and stop date were not reported. No known allergies and no other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. On 15May2021, the patient felt dizzy, had cold sweating, was scared, and thought she was having a panic attack but felt more sick than usual. On 15May2021, the patient stood up from couch, walked 15 - 20 steps and then fell straight over on her face, hitting her chin and splitting it open; she was conscious when rolled over by her parents but had significant memory loss (knew her name but not her school grade or which classes she was taking). She was taken to the hospital, computerized tomogram (CT) Scan, electrocardiogram (EKG) was normal, and no evidence of seizure were there. On 15May2021, the patient was diagnosed with mild con-cussion and got stitches on the chin as therapeutic measure for her chin splitting. Doctor suggested dehydration may had been a factor, also insufficient food intake (had not eaten yet) (start date: 15May2021). The patient stayed home from school for a week with memory improving each day and still did not remember completely a period of 48 hours starting around time of vaccination however, other symptoms had resolved. The patient had never fainted before. The treatment for rest of events was unknown. The patient underwent lab tests and procedures which included CT scan and EKG both as normal, both on 15May2021. The outcome for mild con-cussion and significant memory loss was recovering; and rest all events were resolved.

On the same arm around the area lower than the armpit towards the breast she felt pain.; On the same arm around the area lower than the armpit towards the breast she felt pain. The caller thinks it was just the lymph nodes; having pain in her left arm, which is the arm she had her COVID vaccine in, under her armpit towards her breast area; This is a spontaneous report from a contactable nurse (parent). An 18-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in left arm on 24May2021 (at the age of 18-year-old) (Batch/Lot Number: EW0179) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The patient had no relevant medical history and no concomitant medications. Historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EW0165) on 03May2021 (at the age of 17-year-old) as 1ST DOSE, SINGLE DOSE for covid-19 immunization. The nurse was calling about her daughter who experienced some side effects after receiving the Pfizer COVID Vaccine on 24May2021. The daughter had the vaccine administered on the left arm. On the same arm around the area lower than the armpit towards the breast she felt pain. The nurse thinks it was just the lymph nodes and nothin to worry about but the daughter wanted to hear that from someone else and not form her. The nurse was asking if this what the daughter was experiencing was normal and was it the lymph nodes. The nurse further reported that her daughter was having pain in her left arm, which was the arm she had her COVID vaccine in, under her armpit towards her breast area and she was wondering if that was normal. The nurse stated that personally she thinks that it was from her daughter's lymph nodes but since the nurse was the patient's mom, she would rather hear this from someone else. The events started on 25May2021. The reporter considered the events as serious medically significant. The patient had not yet recovered from the events.; Sender's Comments: The events Breast pain, Lymph node pain and Vaccination site pain are assessed as possibly related to the suspect bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), based on strong temporal association.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Began with petechial/purpuric lesions on lower legs and feet on 4/19/2021. Patient has had continued crops of lesions appear since that time. Has worsened over time. Was diagnosed with leukocytoclastic vasculitis (LCV). A biopsy was collected on 5/12/2021. Was put on a prednisone taper, showed improvement on high doses but once tapered down, rash returned worse with no resolution. Visited Dermatology 3 times and 2 visits to her pediatrician - has not resolved. Continued worsening over time.

Patient received the 2nd COVID vaccine Pfizer Lot #ER8736 exp. 07/31/2021 on 06/10/21 at 3:15 PM. Client returned to facility the following day, 06/11/21 with her boyfriend who was receiving a vaccine. The client alerted EMT at approximately 4:11 of a "rash on my left leg." RN and another RN responded. The client reported development of rash on her left leg approximately 2 hours following receiving her 2nd COVID vaccine. The client stated the rash was "itchy" and has been getting worse since it first appeared. RN noted hives along her left leg. The client also stated that she developed "shortness of breath" this morning around 10AM. She states this resolved after she "took a nap." The client also reported experiencing chills, body aches, and pain today. The client states she took Tylenol today. The client states she developed a similar rash about 1-2 hours following receiving the 1st COVID Pfizer vaccine on 05/20/21 at 2:51PM. She said the rash following her 1st vaccine was "not as itchy" as the current rash. Vital signs at 16:13 were as follows BP: 132/92, HR 106, Respirations 24. RN explained that our current protocol did not allow for administration of any medications. RN's provided education regarding signs and symptoms of anaphylaxis, when to seek EMS, to follow up with PCP as soon as possible, and V-safe. The client was provided a list of community clinics in the area. RN reiterated if the client experiences shortness of breath to seek EMS. The client voiced understanding of this. Vital signs repeated at 16:18 were as follows: BP 122/86, HR 82, Respirations 20. Client left the premises unassisted with a steady gait. The client was visualized getting into personal vehicle by EMT at 16:32.

First dose 4/10/21 after face flushing and dried and skin tighten, itchy took Benadryl at nite for relief, rashes show on legs and body area. Second dose 5/1/21 after 2 days body hive, face red and dry tighten skin, itchy head flaky. Patches of rashes head to toes and dry skin. Contact allergist recommend taken Benadryl at nite, Zyrtec 1 pill during day.

Patient received IM Pfizer dose in Left arm at 4:10pm and moved to the waiting area. About 5-10 min later she had developed a red, slightly raised blotch area around the injection site and down her left arm. She said it did not itch, but felt warm and slight burning feeling. Patient complained of being hot and nervous, but breathing was normal no chest tightness. We had her get up and go outside (with 2 nursing staff members) to see if fresh air and no mask would help calm her. On coming back in, the rash was still present and a small patch developed on her other arm. WE gave her a cold compress and measured out 75mg of liquid diphenhydramine. She took the diphenhydramine. After about 5min, we saw the rash spread to her chest and connect the upper right and upper left arm area rashes. We then called EMS to come assess the patient. After assessment by the EMT and speaking with her PCP the patient decided not to go to the hospital for observation. Rash was still present 1 hour later when patient left. Breathing remained normal throughout the entire event and no swelling of face/tongue.

Redness and swelling of a previous vaccine injection scar, not related to the Covid-19 vaccine, like the BCG vaccine, which occurred two days after receiving the second dose of the Pfizer vaccine. Pain is experienced upon pressure to the area.

Rash began 2 days post vaccination on the fingers and spread to arms and legs and feet over 1 week. Rash still present 6/14/2021.

Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: After vaccine, pt bled slightly at injection site. She saw the blood and started to feel faint, tingly lips, flushed and then lost color in her face. I instructed her to deep breath and elevated her feet since she felt she couldn't move to be laid down. Finally she was able to stand up, I assisted her to the floor the pharmacy, elevated her feet, and she improved immediately in the supine position w/ feet elevated. She recovered 100 percent without fainting or losing consciousness.

On 6/21/21, patient came into clinic for a nurse only appointment to receiver her Men B vaccine. Her father is a physician in the clinic and he approached his nurse about her coming in. The nurse thought she heard him say, she was coming in for her Covid vaccine too in addition to the Men B vaccine. The nurse prepared both the Men B and Pfizer Covid vaccines and administered. Patient was inadvertently given a 3rd Covid vaccine. She has already received 2 Moderna Covid vaccines on 01/16/2021 and 02/14/2021. On 06/21/21 she developed chills and body aches, on 06/22/21 the chills and body aches continued, on 06/23/2021 the chills and body aches resolved but she has a small localized reddened area at injection site with mild pain.

I had severe itching after wards and woke up the next morning with hives all over my lower extremities. I took Benadryl for the hives and ibuprofen for the body aches. The hives lasted 6 days.

Pt received shot on 6/28/21. Pt's grandmother contacted pharmacy on 6/30/21 stating patient had broken out in hives over her face and hands. Pharmacy advised to start taking Benadryl for the hives and to not get the second shot due to concern the allergic reaction could escalate. Grandma will follow up with pharmacy in 24 hours to update on pt's condition.

Injection site pain.; Tiredness; Chills; Joint pain; Feeling unwell; Muscle pain; This is a spontaneous report received from a consumer, the patient. A 18-years-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: unknown) via an unspecified route of administration in the right arm on 15Mar2021 at 1230 (at the age of 18-years) as a single dose for COVID-19 immunisation. The patient medical history was not reported. The patient was allergic to bactrim. The patient concomitant medications was not reported. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 19Mar2021, at 1600 the patient experienced injection site pain (vaccination site pain), tiredness, muscle pain, chills, joint pain and myalgia. The patient did not receive any treatment for the events and 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 vaccination site pain, tiredness, muscle pain, chills, joint pain and myalgia was recovering at the time of this report. Information about lot/batch number cannot be obtained. No further information is expected.

left arm at the injection sight developed a huge (between golf & tennis ball) itchy bump that was painful to touch; Arm is still a bit tender; This is a spontaneous report from a contactable consumer, the patient. An 18-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208), via an unspecified route of administration in the left arm on 11Mar2021 at 17:15 (at the age of 18-years-old), as a single dose for COVID-19 immunisation. Medical history included asthma. The patient was allergic to dogs, pollen, mould, guinea pigs and dust. Concomitant medication included isotretinoin (CLARAVIS) 40mg; from an unknown date for unspecified indication. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On Saturday, 20Mar2021, the patient developed a huge itchy bump (between golf & tennis ball) on the left arm at the injection sight, that was painful to touch. The arm was still a bit tender and the bump had reduced in size. 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 outcome of the events vaccination site lump and pain in arm was unknown at the time of this report. No follow-up attempts are needed. No further information is expected.

technician administered vaccine, within minutes pt developed stinging/burning in left arm, stated that they could not relax it. pharmacists were notified at this time. Pt skin and face appeared red and pt was in distress. Pt was given cold compress for arm, and advised by pharmacists to wait additional 30 minutes. Pt and mother (a nurse) agreed and agreed to have pt take diphenhydramine. pt was then checked on every ~5 minutes by technician and pharmacist. after ~45 minutes total, pt still complains of burning/arm pain but is able to move arm and denies any signs/symptoms of anaphylaxis. I assessed pt at this time and stated they could stay as long as they wanted, but that they may leave if comfortable to do so. Upon leaving, I counseled pt and mother to watch for signs/symptoms of anaphylaxis and if they develop to go to ER immediately. Also counseled to see a doctor if pain/burning does not resolve within 24 hours. Also counseled could take APAP/IBU for pain in short-term. This was all documented on back of pt's VAR

Shortly after her shot, my daughter had complained to me that her shoulders were itching a bit. On both, her right and left side, where bra straps usually lay, she had a lot of red bumps, some of them looking white. As the days went on this "rash" has seemed to spread to her chest area as well.

light sensitivity; fatigue; increase in hay fever symptoms; post nasal drip, sore throat; injection site soreness; post nasal drip; sore throat + lymph nodes around jaw; This is a spontaneous report received from a non-contactable other health care professional. An 18-year-old non-pregnant female patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection, Lot number: Unknown) via an unspecified route of administration on an unknown date (at the age of 18-year-old) as a single dose for COVID-19 immunization. Medical history included eczema. The patient was allergic to pistachio and had hay fever allergy. The patient previously had taken fluoxetine, retinoids and had experienced allergy. Concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 19Mar2021 at 09:30, the patient experienced light sensitivity, fatigue, increase in hay fever symptoms, post nasal drip, sore throat and lymph nodes around jaw, injection site soreness (24+ hours). Therapeutic measures included extra dose zyrtec allergy pill, ibuprofen and rest. The clinical outcome of light sensitivity, fatigue, increase in hay fever symptoms, postnasal drip, sore throat and lymph nodes around jaw, injection site soreness was unknown at the time of report. Amendment: This follow-up report is being submitted to amend previously reported information: 1. patient's initial added in first name field in patient tab. 2. final sentence updated to No follow-up attempts are possible; information about lot/batch number cannot be obtained. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

I took the first dose of vaccine (lot number EW0196) on 06/16/2021, and I took the second dose of the vaccine (lot number FA6780) on 07/08/2021, The injection site started to swell and be very painful, I also had tiredness and a headache, and I don't really get headaches. The whole left arm was also very painful. This lasted for two and a half days.

Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium

Patient experienced a hive under her right eye and said her throat felt a little tight but had no difficulty with breathing. two doses of 25mg liquid diphenhydramine was administered at 11:40 am and 11:50 am

WHEN PT CALLED SHE STATED SHE WOKE UP WITH HIVES AND SWELLING AT THE INJECTION SITE. THE HIVES WERE SPREADING TO HER TORSO, NECK AND LIPS. SUGGESTED ANTIHISTAMINE AND ADVISED OF A MD VISIT. VAX WAS GIVEN ON THE 10TH, REPORTED HIVES ON THE 13TH. FAILED TO TELL ME THAT SHE HAD JUST FINISHED A COURSE OF AMOXIL WHICH MAY ALSO CONTRIBUTE TO HER CURRENT STATE.

Headache.; Muscle aches especiallyaround the injection site; Injection site feels warm or hot.; Body temperature changes from hot to freezing in seconds.; Tired; feeling unwell; feverish but no fever; This is a spontaneous report from a contactable consumer, the patient. An 18-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 27Mar2021 at 02:15 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had history of allergy to codeine. Concomitant medications included paracetamol (TYLENOL), naproxen (MOTRIN), mepyramine maleate, mepyramine maleate, paracetamol (PAMPRIN), mefenamic acid (ADVIL) and melatonin (MANUFACTURER UNKNOWN) all for unknown indication on unknown dates. 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 28Mar2021, at 12:00 the patient experienced headache, muscle aches especially around the injection site, warm or hot at Injection site, feverish but not fever, body temperature changes from hot to freezing in seconds, tired and overall feeling unwell. No therapeutic measures were taken for the events. The adverse events did not result in doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events headache, muscle aches especially around the injection site, warm or hot at Injection site, feverish but not fever, body temperature changes from hot to freezing in seconds, tired and overall feeling unwell were not resolved at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Itchy tongue, a little hard to swallow for about 30 minutes, progressed to being itchy on entire body. Took loratadine 10 mg at 9:45pm. No more difficulty with swallowing around 10:45pm. Parent assessed possible hives and or swelling of tongue and found none. No itchiness the following morning.

Injection site pain, swelling. On Saturday noticed swelling in underarm and hardening of breast tissues. Went to PCP on Monday 7/19 and was diagnosed with costochondritis and myalgia of the neck, chest and back. Patient given meloxicam and sent home.

My first three days after my shot, I had typical side effects of headache, fatigue, chills, sore arm at injection site and stiff/achy legs. All the side effects subsided after three days except my legs ached along with my arms and shoulders too. The shoulder and arm pain occurs occasionally now...every two or three days for several hours. My leg pain has not stopped. I describe the leg pain as an ache that does not have sharp pain or tingling. It is less intense if I have a sedentary day. On a normal day on a pain scale of 0-10, I rate my leg pain as a 6. Ibuprofen diminishes the pain by a small amount.

Chest tightening; Chills; Heat all over the injected arm; Sweating; Hand shaking (on injected arm); Difficultly breathing; Nauseous; Lingering chest pain; Heat all over the injected arm, chest and head area; This is a spontaneous report from a contactable consumer, the patient. An 18-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP 9655) via an unspecified route of administration in the left arm on 02Apr2021 at 14:45 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. Medical history included multiple allergies and pollen allergy. Concomitant medications included mometasone furoate (FLONASE) and cetirizine hydrochloride (ZYRTEC); both taken for 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 COVID-19 vaccination. On 03Apr2021 at 21:00, the patient experienced chest tightening, chills, heat all over the injected arm, chest and head area, sweating, hand shaking (on injected arm), difficultly breathing, nauseous and lingering chest pain. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the reported events. The clinical outcome of the events chest tightening, chills, heat all over the injected arm, chest and head area, sweating, hand shaking (on injected arm), difficultly breathing, nauseous and lingering chest pain was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.

achy; skin hurts; Tired; sore arm; low grade fever; This is a spontaneous report from a contactable consumer. An 18-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8732), via an unspecified route of administration on the right arm on 24Mar2021 as a single dose for COVID-19 immunisation. It was reported that medical history was unknown. It was unknown if patient has received any other medication 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 on an unknown date as a single dose for COVID-19 immunisation. It was unknown if the patient has any allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 25Mar2021, the patient experienced tired, achy, sore arm, low grade fever and skin that hurts. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care visit. The clinical outcome of the events tired, achy, sore arm, low grade fever and skin hurts was recovered on an unknown date. Amendment: This follow-up report is being submitted to amend previously reported information: Protect Confidentiality unticked in slide 1. No follow-up attempts are needed. No further information is expected.

Site: Pain at Injection Site-Mild, Systemic: Seizure-Mild, Additional Details: PATIENT HAS A HISTORY OF SEIZURES AND AFRAID OF NEEDLES AS DISCUSSED WITH MOTHER PRIOR TO ADMINSTERING COVID VACCINE. Covid vaccine was given as normal adminstration IM. Patient was counseled to wait 15 minutes, after 5-10 minutes patient seized and mother caught her as she fell from cahir. I immediately contacted 911 and gave the mother ice packs

Skin reaction; Swelling of face; Dry skin; Tight skin; Rash on neck; This is a spontaneous report from a contactable consumer, the patient. An 18-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150), via an unspecified route of administration in the left arm on 01Apr2021 at 09:00 (at the age of 18-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 did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Apr2021, the patient experienced skin reaction, rash on neck, swelling of face, dry and tight skin. Adverse events resulted in doctor/other health care professional office/clinic visit. The patient received treatment for the events with prednisone (MANUFACTURER UNKNOWN). The clinical outcome of the events skin reaction, rash on neck, swelling of face, dry and tight skin was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.

Tiny red dots appeared on my stomach after the vaccine; This is a spontaneous report from a contactable consumer, the patient. A 18-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the left arm on 29Apr2021 at 09:30 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not receive any medications within two weeks prior to the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Previously the patient was not on any drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 29Apr2021 at 12:15, after the vaccination, the patient experienced tiny red dots on stomach. The clinical outcome of the event tiny red dots on stomach was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.

Initial bilateral lower extremity pain within 24 hours post-vaccination. Red sores/welts developed on thighs bilaterally, buttocks, and bilaterally on back upper arms. Welts grew in size and pain. No swelling in joints (knee/ankles). Began to have difficulty walking. APAP was taken but did not alleviate pain. Hot water from shower aggravated welts.

Small red rash appeared next to the injection site, my arm was sore. I felt achey, had a headache and a slightly upset stomach. I felt better within 24 hours.

Day 1: pain/swelling at injection site with redness, muscle aches, joint pain Day 2: pain/swelling at injection site with redness, muscle aches, joint pain, headache; worked but with considerable discomfort/strain Day 3: pain at injection site, muscle aches, joint pain, headache, chills, fatigue, feeling unwell, insomnia; unable to work Day 4: extreme muscle aches, joint pain, headache, chills, fatigue, feeling unwell, insomnia, fever, sweating, sore throat, diarrhea; unable to work; attempted to see doctor but was refused care due to "CoVid-like symptoms" Day 5: extreme muscle aches, joint pain, headache, chills, fatigue, feeling unwell, insomnia, fever, sweating, sore throat, diarrhea; unable to work Day 6: extreme muscle aches, joint pain, headache, chills, fatigue, feeling unwell, insomnia, fever, sweating, sore throat, nausea; unable to work; attempted to see care at Urgent Care but was turned away for having "CoVid-like symptoms;" went to hospital per the recommendation of MD and urgent care Day 7: mild muscle aches, fatigue, feeling unwell, insomnia, sweating, sore throat; unable to work Day 8: sore throat, mild fatigue, sweating; unable to work

Tingling in throat after injection, but subsided after 5 minutes. About an hour after injection, I checked injection site and found a half-dollar bill sized red welt that was hot to the touch.

30 minutes after injection, had sore arm, "hurting" while breathing, increased heart rate, increased blood pressure; after arriving at ER, more than 1 hour after injection, had vomiting x 3, hives/welts on chest and arms, fever and chills

Experienced hives and rashes all over body eight hours after the shot and lasted for the whole next day.; Experienced hives and rashes all over body eight hours after the shot and lasted for the whole next day.; This is a spontaneous report from a contactable healthcare professional (patient). A 19-year-old non-pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on the right arm on 31Dec2020 15:30 at a single dose for COVID-19 immunization at workplace clinic. The patient had no known allergies. The patient was diagnosed with COVID-19 prior to vaccination. Concomitant medications included influenza vaccine (FLU) on 17Dec2020 at right arm, and prednisone received within 2 weeks of vaccination. The patient experienced hives and rashes all over body on 31Dec2020 23:45, eight hours after the shot and lasted for the whole next day. Events were reported as non-serious. The patient received diphenhydramine (BENADRYL) as treatment. The outcome of the events was recovered. Patient was not tested for COVID post vaccination.

vaccinated in her arm then was feeling well but had sore arm; This is a spontaneous report from a contactable nurse (reporting for herself). A 19-year-old female patient to received of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose on 07Jan2021 22:45 (lot number: EL1284) and first dose on 17Dec2020 15:30 (lot number: EK5730); via intramuscular in left arm at single dose for COVID-19 immunization. Medical history was reported as none. The patient's concomitant medications were not reported. The patient was vaccinated in her arm then was feeling well but had sore arm on 19Dec2020, comparable to the flu vaccine. The facility where the most recent COVID-19 vaccine was administered was in the workplace clinic. 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 outcome of the event was recovered on unspecified date. No treatment was given to the patient for the event. The event was considered non serious as it did not results in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect.

19 year old female reaction to Covid 19 vac; she is alert and orientated; complaining of rash, difficulty breathing, dizzy, lump in throat, headache, nausea, cough. 1 dose of Benadryl 25 mg given at 1430. Patient states she is medical fragile and has a HX of epilepsy. EMS called at 1500 evaluation mild allergic rxn will transport to hospital for further evaluation.

Swollen for about 4 days; pain and redness in the site; pain and redness in the site; It feels a little hard but it's just blood in that area; This is a spontaneous report from a contactable Nurse. A 19-year-old female nurse reported for herself that received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number Unknown), on 07Jan2021 in the left arm at single dose for COVID-19 immunization. The patient had not any medical history and did not receive any concomitant drugs. The nurse reported that she had got this shot in her left arm and it is not too swollen but it has been swollen for about 4 days and there is still pain and redness in the site as well. It feels a little hard but it's just blood in that area. The nurse took a Tylenol (LOT# EK9231) or 2, but it didn't really do much. At the time of reporting the patient had not recovered. Information about lot/batch number has been requested.

A few hours after the shot I felt fatigued and my arm was very sore. Later in the day around 3:00pm I got chills and muscle soreness throughout my whole body. I then started to develop pain in my chest while breathing and I was having to gasp for air(this was around 5:30pm). My skin (mostly on my back) felt like it was burning and itchy. That lasted the entire night. 24 hours after the injection and I am still feeling tightness in my chest when I breathe, sore throat, and sore muscles.

Soreness in left arm near injection site and slight nausea. Nausea persisted for 6 hours as with the pain in the injection site.

On the day I took the vaccine, my whole left side became sore and numb. The soreness and numbness continued on through the next day. Friday evening, I had the same symptoms coupled with nausea, headache, and chills. Saturday, I continued to have slight soreness and nausea. Today (Sunday), I'm still having a bit of soreness on my left shoulder where I took the vaccine.

erythematous macular rash on R arm, palm. spread to L arm and palm. not pruritic or painful. no other symptoms.

lymph node swelling started at 8hrs after injection; arm swelling and pain began >48hrs after injection and gradually worsening; mild redness to the area as well

Anaphylactic reaction; Throat was swollen shut, couldn't talk or breathe; Throat was swollen shut, couldn't talk or breathe; Throat was swollen shut, couldn't talk or breathe; loss of consciousness; brain fog; headache; fever; severe body aches and joint aches that make movement difficult; severe body aches and joint aches that make movement difficult; severe body aches and joint aches that make movement difficult; persistent chest pain/pressure; low blood pressure; some swollen and tender bilateral lymph nodes in my neck/trapezius/left (injection site) axillary region; fatigue; decreased appetite due to nausea; decreased appetite due to nausea; This is a spontaneous report from a contactable healthcare professional. A 19-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the left arm on 25Jan2021 08:45 at a single dose for COVID-19 immunization at a hospital. Medical history included type 1 diabetes mellitus, Celiac disease, COVID-19, and heartburn. Concomitant medication included insulin lispro (HUMALOG), spironolactone, fluvoxamine, and alprazolam (XANAX XR). The patient previously took gluten, magnesium ,and iodine and experienced allergies. On 25Jan2021 09:00, patient had an anaphylactic reaction. Throat was swollen shut, couldn't talk or breathe, loss of consciousness, brain fog, headache, fever, severe body aches and joint aches that make movement difficult, persistent chest pain/pressure, low blood pressure, and some swollen and tender bilateral lymph nodes in my neck/trapezius/left (injection site) axillary region, fatigue, and decreased appetite due to nausea. Patient had a doctor or healthcare professional visit, went to emergency room/department or urgent care, and was considered life threatening illness (immediate risk of death from the event). Events was treated with epinephrine, diphenhydramine (BENADRYL), paracetamol (TYLENOL) and had oxygen. Patient was not tested post vaccination. The patient is not pregnant. The patient has not recovered from the events.; Sender's Comments: There is a plausible time relationship between vaccine administration and onset of the events in a subject with allergic diathesis. 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.

Swelling and tingling of tongue, rash at vaccination site, hives on chest and neck. Given a steroid and Benadryl in emergency department. Was real eases with a prescription for steroids and direction to continue taking Benadryl.

rashes on arm getting worse and had one on chest and then on legs; I felt like I was gonna pass out and I did it right when I got to my house; I felt like I was gonna pass out and I did it right when I got to my house; She was lightheaded and extremely dizzy; huge headache; arm didn't hurt when she got the shot but 30 minutes later it hurt so bad; throat hurt extremely bad; This is a spontaneous report from a contactable health professional, the patient. A 19-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly in the left arm on 11Jan2021 at 15:00 (at the age of 19-years-old) as a single dose for COVID-19 immunization. Medical history included allergies to latex, oranges, and adhesive. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included amfetamine aspartate/amfetamine sulfate/dexamfetamine saccharate/dexamfetamine sulfate (ADDERALL), hydroxyzine and celecoxib (CELEXA). The patient did not receive any other vaccines within 4 weeks prior to the vaccination. Her arm didn't hurt when she got the shot but 30 minutes later, on 11Jan2021 at 15:30, it hurt so bad. On 18Jan2021 at 15:00 (also reported as the Monday of the vaccination), the patient experienced a feeling like she was going to pass out, at cheer practice, and did it right when she got to her house. She was lightheaded and extremely dizzy the whole time at practice and had a huge headache. Also, when she got to practice at on 18Jan2021 at 15:15, she noticed the rashes on her arm getting worse, and on her chest and then on her legs. Then, on an unknown date in Jan2021, her throat hurt extremely bad, so she gargled with salt water and it felt a little better. The patient was not treated for the events "I felt like I was gonna pass out and I did it right when I got to my house", "She was lightheaded and extremely dizzy", "huge headache", "rashes on arm getting worse and had one on chest and then on legs" and "arm didn't hurt when she got the shot but 30 minutes later it hurt so bad"; and was treated for "throat hurt extremely bad" as the patient gargled with salt water. Since the vaccination, the patient had been tested for COVID-19 via rapid nasal swab on 18Jan2021 with a negative result. The clinical outcome of "I felt like I was gonna pass out and I did it right when I got to my house" and "arm didn't hurt when she got the shot but 30 minutes later it hurt so bad" was unknown; of "She was lightheaded and extremely dizzy", "huge headache", "rashes on arm getting worse and had one on chest and then on legs", "throat hurt extremely bad" was resolving. Information on the lot/batch number has been requested.; Sender's Comments: Considering the temporal association, a causal association between administration of BNT162B2 and the onset of pass out cannot be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. 40.~

Chills; Body/muscle aches; Body/muscle aches; hot flashes; fatigue; malaise; nasal drainage; arm soreness in injection arm; This is a spontaneous report from a contactable other healthcare professional (patient). A 19-year-old female patient received the first 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 16Jan2021 11:00 at a single dose for COVID-19 immunization. Medical history included Acid Reflux. Concomitant medication included valacyclovir [valaciclovir] (VALACYCLOVIR [VALACICLOVIR]) and famotidine. On 16Jan2021 19:00, the patient experienced chills, body/muscle aches, hot flashes, fatigue, malaise, nasal drainage and arm soreness in injection arm. No treatment was received for the events. The facility where the vaccine was administered was in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. No known allergies. Patient was not pregnant. Outcome of the events was recovered on an unspecified date. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Client while being monitored complained of tingle in her tongue and swelling. Injection site red and jaw on right side. Tongue doesn't appear overly swollen . Client c/o more tingle than swelling. EMS evaluated client . Client sent to ER with IV. Client given Solumedrol and Benadryl in ER. Stayed a little over an hour and then discharged from ER.

Soreness at injection site began shortly after injection Fever began at approximately 8:00 pm the day of the injection (2/7/2021) self treated with Acetaminophen tablets Headache upon waking up the next morning (2/8/2021) self treated with Acetaminophen tablets

Site: Itching at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Additional Details: Pateint had taken Claritin 10mg prior to appointment under MD directions*

1530: Approximately 10 minutes after receiving vaccine patient reported having itching to throat, and hands. Patient stated she did have a Depo-Provera Injection after 1st vaccine approximately 3 weeks ago. Pt did state she pre-medicated herself with Benadryl 50mg orally at approximately 1300hrs today. Mom was present with patient while covering physicians and EMS on duty assessed patient. VS:112/82-B/P, 123-HR, 18-RR, SaO2 98% on RA. Allergies: Steroids, fish FMHx: Sports induced asthma and gallstones. 1550: Patient had notable facial swelling eye redness and flushing. 0.15 Epinephrine IM via home Epi-Pen self delivered by patient's mother for increase SOB, and tightness in chest. EMS transport called to transport patient to location. VS:118/86-B/P, 100-HR, 18-RR, Sa02 96% on RA. 1600:Transfer of care to EMS staff assisting in transfer of the patient.

Patient received 1st dose of vaccine a approximately 1435. 1500 approximately 25 minutes post vaccination patient started feeling upper midsternal chest pressure, worsened with swallowing. Patient's skin with redness to upper chest and neck.

Less than one minute after injection into the right deltoid, an area of bright redness appeared superior to the injection site that quickly spread across right shoulder and across front of throat. No breathing difficulty was noted. Lungs were auscultated and were clear bilaterally all fields. However, it was noted that employee had an irreg/irreg heart sounds that was not known of ever before. Employee complained of vertigo and nausea, became pale and weak and was sent to the local ER across street for further evaluation. Lung sounds remained clear during monitoring of employee post vaccination. Mother reports that she had done this before during infant vaccinations but never since. Employee did not report this in pre-vaccination evaluation as she was unaware of it. Mother reports no prior cardiac history of any kind. Mother transported to ER located across street. Outcome is unknown at time of writing.

Patient experienced allergic reaction at 15 minutes post vaccine. Complained of itching on palms and spreading up her arms. Given 50 mg Benadryl immediately. Vital signs were normal and stable: BP = 104/62 to 118/60; P = 75-80 regular rate; T= 98.3; PO2 = 99%. Patient discharged to family member/home at 12:10pm with instructions to contact doctor/clinic to report incident.

Patient received vaccine on 03/16/21 at 440pm, woke up on 03/17/21 with bumps on her left arm where the vaccine was given. She then woke up on 03/18/21 having chest tightness and shortness of breath.

Felt fine the night before. Woke up at 6:00 a.m. with fever, chills, puffy bottom eye lid, watering, irritated eyes, redness and swelling on upper cheeks, swollen at site of vaccination, slight redness at vaccination site, headache, and my body felt heavy and slow. Towards the Evening, I still had symptoms such as redness in eyes, slightly swollen bottom eyelids, redness and swelling in upper cheeks, fever, chills, watering, irritated eyes, headaches, and my body feels slow, but not as slow as in the morning.

Within 12 hours after the injection I was feeling a little dizzy and very warm. I went home and checked my temperature before getting into bed and saw it was 103. I had chills, pain in my arm, very hot to the touch, and could not sleep through the night with the amount of pain and discomfort I was in.

Sore arm, rash that?s made up of a bunch of purple dots all over my left arm around my injection shot.

The next morning after I got the second dose of the vaccine, I felt incredibly ill. Stomach was aching to the point I thought I was going to throw up, my joints were aching to the point it hurt to move, my skin hurt so touch, and I had a slight quick fever. These symptoms lasted all day, but went away the day after (Wednesday 24, 2021).

Rash showed up on left arm about two weeks later and turned out to be viral meningitis that needed a 4 day hospital stay and treatment. It is believed the virus that caused the meningitis was the varicella virus. Rash developed into serious illness over the span of one week.

Patient presented initially with complaint of skin irritation and tingling around neck, and right upper extremity. Patient was moved to observation chair and evaluated by PA-C. Vital signs BP: 130/76 P: 68, R: 14, SPO2 100. Oral Benadryl 50 mg was administer. After 15 minutes of observation the patient began to complain of increased sensation of tingling and irritated skin extending further down right upper extremity, neck chest and lower right extremity. 10 mg dexamethasone was administered IM. Patient care transferred to local EMS for transport to local emergency room.

5 minutes after, I started getting hives - on chest and stomach and back and was spreading onto my legs. One of the nurses at the site, gave me several doses of Benadryl and a Zyrtec. I was there 45 minutes - I kept getting more and more hives and my throat was getting itchy and my breathing was off a little bit. After taking the Benadryl, it started slowing down eventually and I was able to leave in 45 to fifty minutes. My primary care physician told me to take Benadryl before and after getting the second round of the vaccine. I had hives and a small rash on my chest for three days and I had to take Benadryl for those days. I t was extremely itchy. Symptoms resolved by end of day three. There was also a slight tingling in my fingers while I was experiencing the rash.

Sore throat 2 days after vaccine for 2 days, headache after vaccine for 2 days for 1 day, chest pain for a few hours 4 days after vaccine, joint pain for 4 days, body aches for 5 days, blue feet and grey nails for 30 seconds 3 days after vaccine, couldn't walk for 5 days after vaccine, a lot of weakness everyday for 5 days, bruises on both feet 4 days after vaccine for 3 days.

Soreness at injection site which makes it painful to move arm and sleep on arm, headache, tiredness, overall feeling unwell

4.02.21 Patient reported that she developed a rash that she believes associated with the Pfizer vaccine. She got the Pfizer vaccine on 3.31.21 at 6:15pm on the left deltoid. According to her, she developed the rash on the left elbow on Thursday 4.01.2021 at 2am. She took Xyzal and noticed the rash resolved. On 4.02.21, she woke with a rash on the back of the right thigh and elbow. She took cetirizine and the rash resolved.

Following the injection, I made my way to the observation room to wait for 10 minutes. After about two, my left arm began to get extremely hot and I called the nurse in the room over. I began to ask her if it was a normal side effect and began to lose my vision and hearing while talking. I passed out and was wheeling to the side of the room where the doctor was. Upon waking up (after 2/3 minutes) I threw up. The doctor took vitals and such and said everything looked okay. After about 15 minutes I was able to stand and head home.

Site: Redness at Injection Site-Mild, Systemic: Allergic: Rash Generalized-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild

S: Patient began to develop petechiae within about 10 minutes of her vaccination today. She felt well, without respiratory distress or urticaria. Later on, she developed some tingling in the right palm and part of her forearm. Her vaccination was on the left side. There were no visible changes associated with these symptoms. O: I personally witnessed the spontaneous appearance of small petechiae on patient's forearm. She had about 10 of them on either forearm and a couple on her shoulders. No erythema, rash, wheals. BP128/66 P 70 sPO2 100% RR 12 A: I was unsure regarding the importance of this finding, so I called emergency department and conferred with one of the MDs there. We felt that, since the patient was in no distress, and this condition was not getting worse, we would allow her to head home. After a total of an hour of monitoring, no signs or symptoms consistent with anaphylaxis or respiratory distress of any sort had emerged.

Patient was standing in line and started to feel light-headed and fainted. Patient fell to the ground that caused a cut above her eye. Patient was still conscious and aware. Ambulance was called for assistance. Patient received stitches and taken by ambulance to hospital.

Client complained of redness at injection site (left upper arm). No itchiness or swelling at site. Cold pack was applied to site and client was watched by RN for remaining time in observation.

When I first got the vaccine, i got dizzy and sick to my stomach with a headache. I decided to leave after sitting for 20 minutes and go back to work because it got a little better. on tuesday. A few hours later, my chest started to ache and my throat started to hurt. thinking I had asthma due to the heat, i ignored it and used my inhaler. By the next day, I was coughing and it hurt worse. I was still dizzy but worse, felt neasious and had a headache. I used my inhaler twice with no help. My arm started to hurt to move, and my injection spot became a red lump. By Thursday, I could barely take a normal breath. It hurt to walk, talk, yawn, sneeze or anything that lifted my need to breathe above bare minimum. It hurt greatly and I couldn't take a full breath. I felt like my lungs were swollen and my throat hurt to swallow. I was very dizzy and had horrible nausea.

Feeling a bit more sleepier than normal, there is some slight soreness around the site of injection, nothing severe yet

Worsening over 6 days: arm injection swelling and sharp pain (severe, 1st day on: ice pack), headache (severe: advil, tylenol, thera flu), muslce aches all over the body (medium: 2nd day on); tiredness (medium-severe: 1st day on), sore throat (severe: 3rd - 5th day: cough drops); congestion/nasal and chest with cough and yellow mucous and sneezing (severe: 4th day on: nyquil); difficulty breathing (medium: 5th day on); runny nose (medium: 4th day on); temperature (5th day on, highest of 102: tylenol); nausea/vomitting/diarrhea (5th day only: bland food, BRAT diet), swollen lymph nodes (medium: 4th day on). Possible loss of smell and taste but could be due to congestion. Doctor prescribed (and was carried out): antibiotic (Cefdinir, just in case) and steroid shot.

Itchiness occurred on and off after first covid shot in 3/18. Got second covid shot on 4/08 and Itchiness has been occurring all over body and non stop since 4/11.

Site: Pain at Injection Site-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Additional Details: a few minutes after the patient took the vaacine she started getting lightheaded and she came to the pharmacy counter and passed out there. i carried the patient and sat her straight in a chair. i gave her water and orange juice. patient was confused and not aware of her surrounding and said she barely could hear. once she drank the OJ she felt better. took her vitals everything was fine. pt said she felt all good

Rash-Vaccination site; back and chest Denies itchiness or pain Denies chest discomfort Hx of fear of needles Vital Signs: BP 110/60 HR 102 Resp 16 O2Sat 97 Apical 84 Skin Signs: Cool and dry, Rash - blotchy not raised Circulation: Cap refill <2sec Respiratory: Breath sound clear bilaterally Initial Treatment: Full set of vitals, skin assessed by RN and MD Observation Apple juice and granola bar 12:35 PM Vital Signs: BP 100/76 HR 88 Resp 12 O2sat 97 Skin Signs: Cool and dry, Rash - decreasing Circulation: Cap refill <2sec Respiratory: Breath sound clear bilaterally Follow up Treatment: Observation Moved from triage to observation with second set of vitals for additional 15 min. Observed by RN and MD Notes: States she has a fear of needles and that this is not 'unusual' for her. No SOB. Minimal dermatographia Disposition: Home with grandfather (driver)

The day after I got my 2nd shot, I developed knots above my collarbone that you can literally move and grab. It?s big. And my armpit is swollen but I kind of expected that.

Arm it was administered on: Feels sleepy Hurts to move Has itchy hives Feels weird On my other hand/left I have small hives.

Thrombocytopenia, bruising within a week of vaccine. Patient was admitted for 48 hours and discharged. Plan is for her to follow up with PCP and have a CBC rechecked.

Face felt numb at 12pm Lips started feeling weird which they turned out to be swollen 12:37 Mouth started twitching into a smile 12:45pm Face started swelling 1pm Face started becoming red 1:50pm Went to doctor at 1:54pm Low grade fever at 2:10pm Hives started forming on eyes 2:30pm Face still twitching and mouth still stuck unable to open mouth 2:35pm Zertec provided by doctor and swelling went down and was able to open mouth but the involuntary twitch still occurring 2:40pm Mouth has involuntary twitching since April 16 and currently the same as yesterday it?s April 17th

I Received the shot at 10:45am on April the 15th, no side effects except arm soreness afterward. Then at around 7:40pm that same night, I began getting terrible itchy on my face, back, arms, and neck. It worsened and I started having trouble breathing (it felt like my throat had tightened)/a hoarse voice, and my pulse was faster than usual and I felt woozy and tired.. I called a nurse hotline and she recommended for me to be seen at an ER, and I went home to tell my parents and they called a doctor friend, and I was told to take Benadryl and if anything got worse to go to the ER. The next day when I woke up I felt mainly tired and had a slight cough and was scheduled a telehealth appointment, and I am taking Zyrtec 10mg and Pepsin 20mg daily x one week with Benadryl as a back up in case the symptoms flare up, and am advised to go to the ER if the breathing issues return. In terms of symptoms now, I am just a little itchy.

Started with huge swelling and redness on injection sight. Progressed to two rashes on both arms and is very itchy and they progressively get bigger each day.

Patient presented to our primary care office 10 days after her Pfizer COVID booster shot was administered. She started with hives over her torso, arms and legs the day prior which was 9 days after her booster vaccine. Patient was placed on benadryl and pepcid for urticaira. Her symptoms progressed over that day with difficulty breathing, vomiting and syncope. She was taken to the emergency department. She was observed and placed on 5 days of oral prednisone. SHE DID NOT REQUIRE ANY EPINEPHRINE and was observed in the emergency department for hours prior to discharge. Symptoms resolved fully.

Night of vaccination: sweats, fever, headache, stomach ache, injection site pain Day after vaccination: sweats, fever, headache, injection site pain swelling and tenderness, nausea, diarrhea, muscle pain, chills, fatigue

Patient received 1st dose of Pfizer COVID-19 vaccine and was placed in Observation area for monitoring, subsequently left the clinic in stable condition. Patient later took PO Benadryl and had no relief of itching. Patient came back to the Vaccine Clinic and reported to the EMTs on site post vaccination experienced itching, nausea and vomiting x 1, slight mouth swelling and new complaint of chest discomfort. VS: Stable. While walking patient experienced a syncopal episode lasting 2 seconds. Post A&O x 4, pt placed in trendelenburg position, ice applied to itchy areas of neck. VS and O2 sat stable. Visible rash, mouth swelling and itching present. Benadryl IM administered by EMT, patient continued to be assessed for an additional 15 minutes, then complained of more chest pain. VS remained stable, EMTs transferred to ER. Later received epi IM x 1 with relief.

About 3 days after my second dose I received on April 14th, 2021, on April 17th, 2021 at around 11 PM I noticed hives in between my toes, as well as hives going up the arches of each foot and along the outer sides of each foot, as well. They were bright red, and slightly itchy. I put a topical Benadryl on the reaction, however, they have yet to go away, but they have darkened slightly in color and have gotten more itchy as time has passed.

Patient slumped into chair in the observation area. I rushed to her. She was hyperventilating, but not wheezing or making any high pitched sound while breathing. Patient was conscious, and could answer my questions coherently. Patient was told to take off her mask so she can breath more easily. Patient kept saying "I'm sorry" and was told there's nothing to feel sorry for, and we wanted to make sure she was fine. Pulse was slightly elevated. Hands were warm and sweaty. Patient asked for a bottle of water. After drinking some water she felt better. It was likely a panic attack episode. I checked on her five minutes later. She just finished talking on the phone with a family or friend. She was a lot better at this point. She agreed that that was likely a panic attack. I advised her she should be able to receive the 2nd dose later, but should consult her PCP.

Upon crew arrival found 19 YO female in emotional distress. Patient was CAOx4 and stated she was going to pass out. Patient skin was cool, pale and dry. Patient was assisted to wheelchair where vital signs where obtained and monitored. EMS noted patient vomited. Patient told EMS personnel she felt extremely anxious coming into the facility to get the vaccine. Patient denies any SOB, chest pain, and abdominal pain. HR:66 RR: 16 non-labored BP:77/50 . Crew obtained 4 BPs with last know being : 88/58. Patient refused further evaluation at hospital. released after 30mins of observation.

Diffuse ,red, splotchy rash started on left arm (vaccination arm) but not at the vaccination site. Slightly itchy. Then it spread to right arm within 24 hours. Then splotches started anterior neck. No other symptoms. About a week later , splotches still present all the same places and now skin is peeling. Still red in color. Have been using Benadryl and Benadryl cream, moisturizer lotion. I have pictures. Still has skin condition at the time of this report

After injection the recipient felt dizzy, nauseated, and had a burning sensation at site of injection. Patient was transported to the emergency department for evaluation.

Within 5 minutes of receiving vaccine daughter felt something was not right as we sat in 15 minute holding period. She was holding her chest. I advised her to sit and I would get help. as I turned she was standing next to me holding her chest saying she isnt feeling right. they put her on a bed and was looking for a blood pressure cuff. they placed a pulseox on her finger which showed 100. then they placed another clip on her other finger and it showed her heart rate increasing to 138 from 93 in seconds. her face was red her neck was red and she said her heart was racing. they finally found a BP cuff and her blood pressure was 148/94 which they said this was normal. it was not. they they told us to seek medical attention. She continued to complain about chest pain and racing and her face and next continued to be red. the nurse then gave her 50ml of benadryl with no relief. She was taking out by wheelchair to a waiting ambulance then to the Hospital Emergency Room. They treated her with a Steroid and IV. She was released after about 3 hours. we came home and 2 hours later went back to the same Emergency room for the same chest pain and racing at which point she now had a rash on chest and neck. this time they gave her medicine to slow down her heart which made her feel better. she was then released. Since then she continues to have heart papatations and rashes, and a heard time swallowing with a continue feeling something is stuck in her throat.

Systemic: Allergic: Rash Generalized-Medium, Additional Details: Patient had hives on 4/24/21 after receiving vaccine on 4/22/21.

After the Second Pfizer Dose, an hour after my shot I had an allergic reaction. I had a rash and swelling.

Patient presented with a redness and rash at the injection site and above/around the shoulder. Injection site went numb and shooting pain fired from the elbow, down to the fingers. Diphenhydramine (50mg) was provided and patient was observed every 5 minutes for 15 minutes. Numbness turned to burning sensation, then all symptoms cleared out between 5-10 minutes. All symptoms were gone by 15 minutes other than arm soreness from injection.

Swelling of the left hand and appearance of hives all over the body, he started taking benadryl but the hives increased and he switched to Zyrtec. Hives still appear, although in less quantity on arms, legs and back

30 min post vaccine, patient came back in with hives on left shoulder. She received her vaccine in the left arm. She denied any allergies. 25 mg Benadryl given in clinic, patient's symptoms improved in 10-15 min.

I noticed this weird bruise where I got my vaccine and I felt stomach pains and lack of an appetite afterwards.

Client received first COVID vaccine on 04-19-2021 at 10:00 or 11:00 am. Adverse reaction slightly noticed later that day but more noticeable a day or two after vaccination. This is a reaction noticed on chest of a red mark above left breast. This went away but came back with a rash noticed over her body of arms, legs, back and chest. This rash stings, is itchy and has a burning sensation. The rash looks somewhat like hives, but has big red, patchy areas, and warm to touch. Client has taken Benadryl and used Hydrocortisone cream with no improvement. Client has an appointment to see medical provider today (04-27-21).

Client has cerebral palsy and received vaccine during a visit. Client is non-verbal. Saturday evening (4/17/21), Mom noticed rash on daughters legs (groin). She stated it looked flushed red. On Sunday she noticed her face was flushed as well. She gave Tylenol on Sunday at 3:50 pm. Mom has been putting hydrocortisone cream on her face for the past week and states the rash is mostly resolved. Mom states Saturday and Sunday she was very irritable and "moody." She states as of today, 4/28/21 she is not irritable any longer and the redness from her face has mostly resolved.

I got my first vaccine dose on March 21. On March 27, i started developing a rash in my armpit. when i went to the urgent care, i was given a steroid cream to apply to my armpit. within 4 days of using the steroids the rash had went down significantly. Around April 1, i started feeling a burning, stinging, uncomfortable, sensation near my vagina. Shortly after i went to an urgent care, again. When i went to the urgent care i prescribed two other creams, one being a medicated steroid i was told to put around my vagina. After two weeks of still being uncomfortable, i made an appointment with my gynecologist. My gynecologist took cultures, to find that i had a minor yeast infection, which i took monistat for, and it cleared up within a day. The pain was still persistent so I made a follow up appointment with my gynecologist, and she says everything seems to be normal. I?ve seen 4 different doctors who cannot tell me what is medically wrong with me, but i have never had any problems like this before receiving the vaccine.

Reports she had the Pfizer vaccine on Friday, 4/23, hives started on the night of vaccine. Been taking Benadryl, which worked but hives returns after medication wears off. No other reported side effects. Advised to see provider for evaluation and guidance on whether to proceed with 2nd dose.

Per patient, she developed hives within 4 hours of initial dose of Pfizer COVID-19 vaccine. Hives started at some time after she had left vaccine clinic observation area. They first developed on her hand and spread to rest of her body. They lasted approximately 12 hours. No shortness of breath, wheezing, lip/tongue swelling or any other signs/symptoms of allergic reaction. She took Benadryl PO and the hives were gone by the next morning. She did not report this reaction to anyone until she showed up at the vaccine clinic for dose #2 in early April.

On May 1, I developed some symptoms including skin that was sensitive to the touch and was sore/painful and chills. The next day on May 2, I developed a headache, fever, fatigue and some body aches while maintaining the sensitive skin and chills. On May 3, I developed an itchy and red rash on my skin, which I experienced during the first dosage.

5/4/2021 Pt was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening . During the observation period, she experienced an adverse reaction with the following symptoms: very nervous, complains of itching to face and lips Assessment : Time of assessment 1445. Alert and oriented and redness and visible stratching to face and lips. Actions taken: Vitals sign taken VAERS form obtained and completed by RN. VS- BP- 155/83, O2- 100 % at 1445, recheck at 1455- BP- 135/90, O2- 99%, drinking water, 1510- BP- 133/91, P- 72, O2- 100 %, 1522- BP-144/101, 1549- BP- 138/88/ P- 71, O2- 100 % Medications administered: Loratadine (Claritin) 10 mg by mouth. Time: 1505. Administered by RN. Diphenhydramine (Benadryl) 25 mg capsule, by mouth. Time: 1522. Administered by RN. Diphenhydramine (Benadryl) 12.5 ml (25 mg) by mouth. Time: 1445 and 1455. Administered by RN. Famotidine 20 mg 1 Po x 1 at 1518 by RN Disposition: Reports no further symptoms of adverse reaction after observation for 60 minutes. Discharged home. Instructed to call 911 for trouble breathing, rapid heart rate, dizziness, swelling of tongue or throat. Immunizations Administered Name Date Dose VIS Date Route Pfizer COVID-19 Vaccine 5/4/2021 2:35 PM 0.3 mL 2/25/2020 Intramuscular Manufacturer: Pfizer, Inc Lot: EW0167 NDC: 59267-1000-2 Electronically signed by RN at 5/4/2021 4:40 PM Immunization on 5/4/2021 Detailed Report Note shared with patient

The day after I began to feel so dizzy that I could not walk properly. My skin all over my body was red and hot to the touch. I had nausea symptoms and a migraine.

rash all over her body; itchy from head to toe; This is a spontaneous report from a contactable consumer (patient's mother). A 19-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 19-year-old via an unspecified route of administration, administered in left arm on 16Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included allergic to trees, alopecia. No family medical history. No history of all previously immunizations. No prior vaccination within 4 weeks. No additional vaccines administered on same date. No relevant tests. Ongoing Concomitant medications included hyoscyamine sulfate (LEVSIN) taken for abdominal discomfort; fluoxetine hydrochloride (PROZAC) taken for anxiety; cetirizine hydrochloride (CETIRIZIN) taken for allergic to trees. On 17Apr2021 the patient developed a rash all over her body/ rash from top to bottom and was itchy from head to toe. Patient's mother took her to the emergency room and they gave her stuff to take care of it. When in the ER, got two meds for the rash that could be purchased over the counter. They said it was a reaction from the Covid shot, from the body giving something that shouldn't be there. Said if patient had a hard time breathing to come back. She was not admitted. The events outcome was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Hives began appearing between thirty minutes and an hour after injection was given. They were each about the size of a business card and went away a couple days later after Benadryl was taken.

Left arm pit pain Extreme Hypersensitivity all over body, skin burning, blistering and peeling, extreme teeth sensitivity, brain feels swollen hurts.

After receiving my first vaccine on 4/13/21, I had a small asthma attack after about 20 minutes that went away quickly. After my second dose, I started feeling out of control of my muscles almost immediately. I also noticed the injection site was bleeding more than the first shot. 30 minutes later, the shaking became extensive and uncontrollable. I returned to clinic and the paramedics told me I was having an anxiety attack. The shaking continued on and at about 4:00pm I felt that my throat was puffing up. I went to the hospital and they put me on a variety of medications (Benadryl, Pepcid, and methylprednisolone). I felt better soon after. The next morning I have a sore throat, feel feverish and have a headache.

After a few hours of the shot I was really tired and had a headache but I still went to work. Around 3 I started seeing red rashes appear on my chest and when I got off of work around 6 my face and chest were covered in red bumps and rashes.

Bruised almost immediately. Day 2 bruises run along vein lines. I have pictures. The vein bruising (2 veins) are approximately 2 inches per vein.

Just got a rash on my arm, all the way down to my hand and up to my armpit; This is a spontaneous report from a contactable other healthcare professional (the patient, Certified Nursing Assistant). A 19-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 04Feb2021 at age of 19-year-old at single dose for COVID-19 immunisation. Medical history included polycystic ovarian syndrome (PCOS). Concomitant medication included drospirenone, ethinylestradiol betadex clathrate (YAZ) taken for PCOS from an unspecified date. The patient stated she would just like to report a reaction to the Pfizer. She just got a rash on her arm, all the way down to her hand and up to her armpit (Feb2021). The patient took Benadryl, she went to the emergency care last night (05Feb2021). The outcome of the event was unknown. The reporter considered there was a causal relationship between the drug and the event. Information on the lot/batch number has been requested.

Itchy, swollen toes progressed to elbows within the first few days. The rash slowly began reaching her knees, ankles and thumbs. This lasted for about one week. There were days with minimal presence of a rash but then it returned initially on the elbows and the backs of heels/achilles tendons. Over a course of 2 weeks, the rash has flashed up in various areas for a few days at a time. Today (5/9/21) there is swelling and redness on her feet (bottoms and sides) and her fingers. There is a tingly sensation with movement and her skin feels tight to move. She is due to have second vaccine in 3 days.

I have very itchy hands, arms, feet, legs and face and scalp. I can?t get it to stop at all. I?ve taken allergy medicine but it only helps a little.

Patient states she received the first dose of the Pfizer COVID vaccine on 5-5. Patient states she has the feeling of her throat closing on 5-5, but then resolved into a sore throat which has affected her eating. Patient woke yesterday with urticaria allover causing itching and a burning sensation. Patient has been taking Benadryl and using hydrocortisone cream with little relief of itching, but no relief of the urticaria. Patient denies changes in lotions, soaps or detergents. Patient has not eaten anything new. Patient states the only thing different recently was being put on Bactrim and Keflex for an abscess on 4-30. Patient stopped taking the antibiotics yesterday when she saw the rash. Patient received the vaccine at pharmacy.

Per MD note: The rash is starting to resolve. She does not have any itching or any other discomfort. The rash had appeared on her right arm> left arm, both the palms of her hands and the inner thighs.

1:15 Patient left the building after 15 minute wait ,went to eat. Felt chest and throat tightness and burning. Came back to COVID vaccine clinic. Also reported a headache. PSO2 100 %Pulse 72 b/p 128/82, crying ,face red. Skin pink warm and dry. Respirations even and unlabored. Informed her that her vital signs are stable , she can be taken to ER. Wanted to wait and be monitored here. 1:25 PSO2 99% pulse70 calming down called mother to talk. 1:37 PSO2 97% pulse 78 reports chest and throat tightness 1:42 Still reports throat and chest tightness. B/P 132/84 Pulse 76 PSO2 98 does not want to go the ER wants to go home. Informed to go to ER for any shortness of breath or further problems.

Vasovagal Syncope on the 11th, severe hives to follow and fever resulting in emergency treatment via steroids, anti-inflammatories, and allergy medication.

Reported itching and hives at 11:45 am. Gave 25 mg diphenhydramine. Breathing became more distressed and gave 0.3 mg epinephrine in upper left thigh at 12:00 pm. Breathing and itching improved. Paramedics arrived at 12:05 pm and took over.

Left arm hurt at injection site; Whole arm hurt; Left arm hurt at injection site, then whole arm hurt, now it feels weak and numb/Left leg felt tingly now it feels weak and numb; Left arm hurt at injection site, then whole arm hurt, now it feels weak and numb/Left leg felt tingly now it feels weak and numb/Left side of face feels kind of numb; Left leg felt tingly now it feels weak and numb; Left eye is blurrier than normal; Left eye is blurrier than normal; This is a spontaneous report from a contactable consumer (patient). A 19-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EW0170), via an unspecified route of administration in left arm on 26Apr2021 at 16:30 (at the age of 19-years-old), 1st dose, single for COVID-19 immunization. Medical history included left eye was blurry and wear glasses. Concomitant medications included loratadine (CLARITINE), vitamin B complex (VITAMIN B) and ascorbic acid, cyanocobalamin, ergocalciferol, nicotinamide, pyridoxine hydrochloride, retinol, riboflavin, thiamine mononitrate (ONE-A-DAY). Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive other vaccines four weeks prior. The vaccine was administered at public health department. On 27Apr2021 at 6:30, the patient's left arm hurt at injection site, then whole arm hurt, and then it felt weak and numb. On the same day of 27Apr2021 at 6:30, the patient's left leg felt tingly, then it felt weak and numb. Her left side of face felt kind of numb and the left eye was blurrier than normal. No treatment was received for the events. The patient had not been tested for COVID-19 since vaccination. The outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.

About 10 hours after my second dose, I began to have muscle pain. The muscle pain is different than body aches that I?ve gotten with a cold. My muscles hurt and my skin is sensitive to the touch. It feels like the pain goes from the skin to the bone. I don?t know how else to describe it other than feeling like a bad a sinus infection inside of my muscles. I know that?s a weird way to describe it but the pain is kind of indescribable and unique. The pain is worst in my neck and back. My joints also feel inflamed, it?s hard to close my hands into a fist. I spent most of the night freezing cold and shivering (I live without air conditioning). It has been about 35 hours since I received the vaccine. Cold and shivering has subsided but I have have the sweats for the past 8 or so hours. A bit of nausea and stomach pain started about 15 hours after the vaccine.

Rapid heartbeat and allergic reaction/angioedema and new psoriasis flare. Treatment- corticosteroids, antihistamines.

Felt very hot/felt like heat rushed through her body; Very nauseous; Dizzy; Broke out in hives on her arms, chest and back; She still has some arm pain, left arm; Tired; very bad allergic reaction; This is a spontaneous report from the contactable consumers (patient's mother and patient). A 19-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in Arm Left on 04May2021 15:05 (time also reported as "15:00") [Batch/Lot Number: EW0167; Expiration Date: 30Aug2021 (expiration date also reported as "31Aug2021")] as 1st dose, single for covid-19 immunization. Medical history included ongoing ADHD which she had since she was little, 3rd grade, born with only one kidney, anxiety and whenever she has anxiety she does get some hives. Concomitant medications included ongoing methylphenidate hydrochloride (CONCERTA) since she was in grade school, probably 3rd grade for ADHD and birth control pill which the reporter was unsure of the name, she switched to this one about 2 months ago. The patient has no prior vaccinations within 4 weeks. The patient had a reaction with the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine. The patient felt very hot, very nauseous, dizzy, and broke out in hives on her arms, chest and back on 04May2021. She was given Benadryl, anti-nauseous medicine, Zofran, and some Pepcid. The patient felt fine afterwards. The patient's mother wanted to know if her daughter should still receive the 2nd dose on 25May2021. The patient was dizzy and felt like heat rushed through her body, she was nauseous and broke out in hives on her arms back and chest. The patient still has some arm pain, left arm which started on 04May2021, but everyone had that, and it has improved. The patient went to the hospital ER. The facility administering the vaccines had EMS and since she was having a reaction, they didn't give her a choice, they just took her to the ER and was glad they did. The patient was seen in the ER and released after she was observed for 4-5 hours. She doesn't know if it was from anxiety or if it was a reaction, she has concerns about whether or not her daughter should take the second dose. The patient stated that about 5 minutes into waiting her 15 minutes, she had a very bad allergic reaction to the vaccine on 04May2021. She ended up getting sent to the hospital. She explained that the vaccine facility had EMT and police at the site and they are the ones who suggested she be taken to the hospital. She clarified that as soon as she got the vaccine, she got hives on her chest, neck, arms and back. The hives are still going on at this time. She has some anxiety and whenever she has anxiety, she does get some hives, however these hives were different. She was anxious about getting the vaccine - she hates needles, but it was a different kind of hives/kind of feeling. She felt very nauseous, dizzy, and tired on 04May2021. She still feels very nauseous right now. The patient was seen in the ER and released at 8PM, she was never admitted into the hospital (the hospitalization was later verified as an ER visit only). She saw her doctor today. The events required a visit to emergency room on 04May2021 and physician office on 05May2021. The outcome of the events "felt very hot/felt like heat rushed through her body", dizzy, and hives was recovered on 05May2021, nauseous was not recovered, and arm pain was recovering. The outcome of the other events was unknown.

Pt was turned away for their second dose of Pfizer on 4/16. Pt reported that after the first dose of Pfizer on 3/26/21 she had a severe rash to both arms and face 1 hour after receiving vaccine (and after leaving the vaccination site). She took some Benadryl and the rash resolved after 2 days. Patient advised to Follow Up with PCP and allergist. Allergy recorded in medical record at that time.

Area around arm turned bright red and had a burning sensation. Very hot to touch and had a mild itch.

Site: Pain at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe

- threw up at 5am morning after vaccine -rash on face since 05/23 -sore arm since 05/22 -clammy morning of 05/23

had the Pfizer vaccine LOT WE0169 clinic she had in less 48 h generalized hives + swollen joints and fingers as well SOB + chest tightness she was prescribed Benadryl but still after 10 days she is still w same symptoms and hives getting more uncontrolled

Mycelitis occurred in legs after second dose; This is a spontaneous report from a contactable consumer (patient) reporting herself. A 19-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: CVS 5195 and Expiry date was not reported) via unspecified route of administration in left arm on 06Apr2021 at 16:45 (at the age of 19-years-old) as a single dose for covid-19 immunisation. Patient's medical history and concomitant medications were not reported. Patient does not have COVID, prior vaccination and has not been tested for COVID, post vaccination. Patient has previously received first dose of vaccine on an unspecified date. It was reported that, on an unspecified date, patient has experienced mycelitis occurred in legs after second dose and visited emergency room and physician office. The outcome of event was not recovered. No follow-up attempts are possible. No further information is expected.

Site: Bruising at Injection Site-Severe, Site: Pain at Injection Site-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Additional Details: pt complains of numbness/ tingling in arm of injection

Patient reported to pharmacist that a rash appeared on left side of stomach 1 day after vaccine was administered. The rash has since continued to spread across stomach and appear on top of right thigh. The rash is flat and papular causing pruritis. Patient was advised to take Benadryl daily to twice daily to relieve rash. She will wait one additional week to received dose 2 of vaccine (day 28 instead of day 21).

My back felt hot and itchy. I looked at my back and there was a rash all the way from my neck and biceps down to the top of my butt.

Patient cam to Walgreens with her mother for a Covid 19 shot. We administered the Pfizer shot in the left arm and was asked to stay in the store for 15 to 20 minutes to make sure she di not have an adverse reaction. She walked to the front of the store and and started felling dizzy, therefore, mom had patient sit down on the floor. Our store manager noticed she was on floor and cam over to offer assistance. Pt's mom said she pass out and was not feeling good. I was paged and upon going to front of the store saw the patient on the floor. I came up to and ask how she's feeling and noticed she was flushed and warm. An associate got her some water and a chair. Our store manager offered to call 911 and mom did not want an ambulance called and after 15 to 20 minutes of sitting in the chair drinking water, patient was able to leave the store with no assistance. I called to check on Pt at 5:30pm and she was feeling good with no other issues.

Pain in arm; Swollen; Itching; Headache; Nausea; My left nose clogged up; The left side of my throat burns, hurts to swallow and is swollen.; The left side of my throat burns, hurts to swallow and is swollen.; This is a spontaneous report from a contactable consumer (patient). A 19-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection; Lot number and expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 25May2021 16:30 (at age of 19-year-old during vaccination) as a 1st dose, single dose for COVID-19 immunisation. The patient's medical history was reported as none. The patient had received birth control pills within 2 weeks of vaccination. The Patient had not received any other vaccines within 4 weeks prior to the Covid vaccine. The patient had not diagnosed with COVID-19 prior to vaccination. On 25May2021 12:00 AM, the patient experienced pain in arm, swollen, itching, headache, and nausea for the first few days in the night of. On 29May2021 (Saturday, four days later), her left nose clogged up and the left side of throat burns, hurts to swallow and was swollen. Since the vaccination the patient had not diagnosed with COVID-19. The outcome of the events were unknown. Information about lot/batch number has been requested.

blood clots; she did get really sick / she was displaying a lot of symptoms; fever; whole body was aching; fatigue; nauseated; bruises on the legs / now she's getting more / she would say they have worsened; This is a spontaneous report received from a contactable consumer (patient's mother). A 19-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0182), via an unspecified route of administration in arm left on 14May2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously received flu shot and experienced nausea. The patient experienced blood clots on an unspecified date, bruises on the legs, she was getting more, she would say they have worsened in May2021, fever on 15May2021, whole body was aching on 15May2021, fatigue on 15May2021, nauseated on 15May2021, and she did get really sick, she was displaying a lot of symptoms on an unspecified date. Patient started having bruises on the legs and thought that it might be related to blood clots. She mentioned that she also experienced the common side effects but she was not concerned of that as people she knew also had those symptoms but was more concerned about the bruising. On patient's legs, she had a bunch of bruises. Reporter was just really nervous about her daughter's bruises. When patient was working, she was not noticing, but today patient noticed her legs and said reporter it was a lot of them. Patient did get really sick with her first shot, she had a fever, she couldn't go to work the next day. Reporter was not sure if the patient should get the second dose on 04Jun2021. Patient's whole body was aching, she was nauseated, she was displaying a lot of symptoms. Reporter checked online and they said it was a normal thing. Patient came down and showed reporter the bruises. Patient wasn't really paying attention to them. Patient had one or two bruises when she noticed and at the time of the report she was getting more. They had worsened. Patient took ibuprofen (ADVIL) for fever and she felt better. Outcome of events blood clots and she did get really sick, she was displaying a lot of symptoms was unknown, of event bruises on the legs, she was getting more, she would say they have worsened was not resolved, and of other events was resolved.

Hot flashes Red face Feeling like she was going to pass out or throw up if she didn't lie down Fatigue prodome Fast HR feeling episodes

Within 10 minutes of the vaccine, numbness and swelling started traveling up from the injection site to the left side of my neck and jaw/cheek area. By 30 minutes afterward, it had made my whole arm feel numb including my fingers. I took Tylenol and Benadryl and iced the areas. Swelling and numbness persisted for the next 3-4 hours. I was fine the next morning as far as I could tell.

My daughter was fine on the first day. She woke up the next day with a weird headache that her scalp hurt. She went into work and started to feel poorly throughout the day. When she came home, she went to bed at 4:30 pm as she had aches & pains, continued headache, felt nauseous, tired, and noticed her left leg where she had surgery previously was bothering her with pins and needles. I told her to go to bed and she would be fine the next day. On 5/26, her leg was giving her increased problems where she could not flex her foot, nerve pain in her leg along with numbness, and she still had the headache. I told her to call her primary care physician and the nurse had her go the the ER. They ran no tests, but consulted with neuro on call and surgeon who performed surgery on her leg two years ago. She was instructed to follow-up with a neuro and start PT. We got her into a PT. The next day she continued to have same issues, but her leg pain increased. She followed up via phone twice to primary where the nurse told her to go back to the ER. She had blood work, ultra sound and x-ray. She saw neurologist on 6/2 and is scheduled for follow-up with an EMG on 6/14. She has seen physical therapist 6x since 5/26 and still has numbness, nerve pain, etc. The form from neuro office said left foot drop and parathesia. She has had headaches this week including a migraine on 6/8.

Pfizer COVID vaccine administered 04/27/21. Reports that she started feeling unwell almost immediately after injection. Immediate Reaction (onset <5 min) associated with the following symptoms: ? Visible swelling and pain at the injection site ? Increased nasal secretions and eye tearing ? Chills Around 30 minutes after, she had also developed: ? Swelling of the tongue (felt "heavy") ? Flushing, diaphoresis, and nausea, followed later by vomiting ? Dizziness/lightheadedness/weakness ? Dyspnea, wheezing, and cough ? Hives on arms and chest No throat tightening or tachypnea. She did not attempt speech. No one in the clinic took her blood pressure or pulse ox The patient brought her epi pen with her but elected not to use it. Left after 30 minute observation period. Thinks that the people at the vaccine clinic did not recognize that she had hives because of her dark complexion. The people administering vaccines were not medically trained Patient's mom recognized that she was not feeling well when she picked her up. She took benadryl which helped with allergy symptoms. She then developed fever up to 102.3, chills, headache, nausea, and myalgias x 5 days

Started to develop a rash all over my body the day after my second dose. I have been using Benadryl at night and Claritin during the day and also spray Itch relief. Starts to get better during the day but worsens at night especially right first thing in the morning.

Late night on the 12th after feeling bad due to an elevated temperature, I noticed my forehead was sore like it was bruised. When I looked in a mirror, I noticed a red splotch on my forehead that felt slightly raised like it was swollen. Sunday morning I checked and it was mostly gone. It?s now a very pale red almost normal skin color and less sore but still is to touch.

Headache; Nausea; Vomiting; Injection site pain; Stiffness in injection limb; Mild fever (100.2 F); This is a spontaneous report from a contactable consumer, the patient. A 19-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER- BIONTECH COVID-19 mRNA Vaccine, lot number: UNKNOWN), via an unspecified route of administration in the left arm on 17Mar2021 at 14:15 (at the age of 19-years-old), as a single dose for COVID-19 immunisation. Medical history included Idiopathic intracranial hypertension, Tourettes and fibromyalgia. Concomitant medications included naproxen (MANUFACTURER UNKNOWN), TOPAMAX, CYMBALTA, ATIVAN and trazodone (MANUFACTURER UNKNOWN) taken for unknown indications from unknown dates within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination. Since the vaccination, the patient had not tested for COVID-19. On 18Mar2021 at 12:00, the patient experienced headache, nausea, vomiting, injection site pain, stiffness in injection limb and mild fever (100.2 F). No therapeutic measures were taken for the adverse events. The clinical outcome of headache, nausea, vomiting, injection site pain, stiffness in injection limb, mild fever (100.2 F) was recovering/ resolving. Information about lot number cannot be obtained. No further information is expected.

It started with itching with the left side of my scalp, through out the day while I was at work, at night the itching and burning spread down the scalp and into my eye all of the left side. I went to urgent care, the doctor did not know what was happening, they used a topical scalp treatment and cortisone cream for my face. I work at an exotic animal care, we saw a rare case of unknown hair loss on a rabbit so I do not know if that was related. The symptoms went away after 3 days of using the medications.

Redness, swelling, and itchiness surrounding area of the vaccination shot roughly an hour or so after injection (continuing as of the present time, 11:41 PM 6/22/2021)

Pt reported that they developed a rash, throat swelling/closure after the first dose. Pt was presenting for second dose on 6/22. Unknown time course for development/resolution of reaction. Pt also has an allergy to Peanut butter flavor (SOB) and Egg (rash)

Hives was reported as worsened; Hives; This is a spontaneous report from a contactable consumer or other non hcp. A 19-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose1, single for COVID-19 immunisation. The patient medical history includes allergy to Erythromycin. Concomitant medications were not reported. The patient sisters all seem to have an allergy to Erythromycin. On 16Jun2021, the patient experienced hives, Hives was reported as worsened. The consumer who is calling regarding her daughter who received her first dose of the Pfizer COVID Vaccine and is experience hives would like to inquire if the hives are due to the vaccine. Caller states she is trying to figure out if Pfizer has seen this before. She states her daughter's hives showed up a couple days later after she received the vaccine on Monday. Caller states the hives are good sized hives and merging into each. The caller states her concern is if this is a systemic thing, forbearing to an anaphylactic reaction. She states she knows her daughter probably needs to see and HCP for that. No other vaccines were administered on Same Date of the Pfizer Suspect nor within 4 weeks prior to the vaccination. The events did not require visit to emergency room nor physician office. The outcome of the events was not recovered. Follow-up attempts are needed; Information on the lot/batch number has been requested.

Severe arm pain at injection site, sudden onset dizziness about 2 hrs after injection; the next morning, fatigue, aches & pains, extreme nausea, dizziness, passing out upon standing up (lost consciousness twice, resulting in a fall and mild head injury). For several days afterward experienced unexplained depression, not sure if it was related.

After 4 hours from when the shot was administered, I had an extreme itch starting with my head, wrists, and armpits. I began to see rashes and welting. I took Benadryl which calmed it down for an hour. However, that night my vision became very blurry and I was extremely dizzy. The following day, I woke up with hives all over my legs, arms, chest, and back. I took more Benadryl, however these rashes and hives remained a problem all day long. That night, my lips trippled in size and were very swollen. My hands and feet began to burn and rash. I contacted a doctor and was told to to go to the ER if my breathing was compromised. My throat was a little swollen, however it went down and was not as swollen as my lips. By the fourth day, I was feeling better with little to no rashing.

When I use my arm muscles of the arm where I got the vaccine, I get really weird nerve like(?) pain all along my arm. It hurts more so when I pull my arm to the back and when I flex my muscles/grab something tight. It goes away in a few minutes but comes back when I flex my muscles again.

Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: Patient has complained of redness at injection site which has enlarged over the past 2 days from inital injection. Also swelling has occured and she also expressed a tightness in the injection site area. She was advised to take benadryl for the redness and we will follow up with her tomorrow to see if redness has resolved or improved.

3rd visit to ACC secondary to persistently high fevers and diffuse skin rash, swelling over the past 5 days. Patient states symptoms began the day after receiving her 1st covid vaccine. Has been taking steroids, benadryl, and pepcid 2 days prior. Returned to ACC yesterday with fever up to 104.5 and then broke out into a diffuse rash. had swelling around the eyes.

muscle soreness around the injection site.; Headache; Low grade fever; muscle pain; Joint soreness/ Pain; Tingling feeling in both legs; This is a spontaneous report from a contactable consumer, the parent. A 19-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) via an unspecified route of administration on 22Mar2021 (at the age of 19_years-old), as a single dose for COVID-19 immunisation. Medical history included environmental allergy (like pollen and dust). Concomitant medication included unspecified immune-tolerance (MANUFACTURER UNKNOWN) therapy for allergy. Prior to vaccination, it was unknown if patient was diagnosed with COVID-19. Since the vaccination, it was unknown if patient had tested for COVID-19. It was unknown if patient received any other vaccines within 4 weeks prior to the COVID vaccine. On 22Mar2021 (within 24 hours), the patient experienced very common side effects or sequelae like muscle soreness around the injection site, headache, low-grade fever, and more generalized muscle; joint soreness or pain and side effect which was most unusual and disturbing was the tingling feeling the patient had (and was still experiencing without any diminution) in both of her legs. It was also reported that, as per doctor the patient was not experiencing any muscle weakness or numbness, then it was not guillainbarre syndrome (GBS), and she should come back if it worsened, but did not prescribe any course of treatment. Therapeutics measure was taken as a result of events vaccination site pain, headache, low grade fever, muscle pain and joint pain which included the treatment with ADVIL (over the counter nonsteroidal anti-inflammatory drug). The adverse event 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 vaccination site pain, headache, low grade fever, muscle pain, pain, joint pain and tingling were not resolved at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Pt is a 19 y/o F who suddenly endorsed feeling dizzy, hot, short of breathe, and peri-oral itchiness ~ 10min after receiving first dose of Pfizer vaccine (done at 1357). PMHx pertinent for hx of anaphylaxis to bee stings, currently being treated with allergy shots, last injections given 12JUL21. Pt was immediately evaluated, with initial VS done at 1415 with BP 110/70, SPO2 99%, HR of 94, RR >20. Endorse chest tightness. Lungs CTA B/L, pt noted to be diaphoretic. Patient had a near syncopal episode and was placed in supine position and given an epi-pen 0.3mg at 1418. EMS was called. Repeat VS at 1420 found BP of 115/60, SpO2 100%, HR 100, RR >20. Lungs still CTA b/l. Patient endorsed improved SOB and less peri-oral itching. Chest tightness improved, Pt was AOX3. EMS arrived at 1435, pt stable. Transferred pt to EMS.

Red hot and flushed face; Red hot and flushed face; This is a spontaneous report received from a non-contactable consumer (patient). A 19-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration on 22Mar2021 at 13:45 as a single dose (at the age of 19 year) for COVID-19 immunisation. The patient medical history and concomitant medication was not reported. The patient didn't have known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 22Mar2021 at 14:30, the patient experienced red hot and flushed face. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care visit. The clinical outcome of the event red hot and flushed face was unknown at the time of this report. No follow-up attempts are possible; information about lot number cannot be obtained. Amendment: This follow-up report is being submitted to amend previously reported information: narrative lead sentence updates, and The patient didn't have known allergies added as allergies: No, event face red added.

redness on neck and chest; headache; This is a spontaneous report from a non-contactable consumer, the patient. A 19-year-old female patient received BNT162b2 (COVID-19 MRNA VACCINE BIONTECH; lot number: ER8727) via an unspecified route of administration on an unknown date as a single dose for COVID 19 immunization (at the age 19-years-old). Medical history included dysautonomia and autoimmune autonomic ganglionopathy and past drug include amoxycillin. The patient had a history of allergy to penicillin and tree nuts. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. On an unspecified date in 2021, the patient experienced redness on neck and chest and headache. 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 redness on neck and chest and headache was unknown at the time of report. No follow-up attempts are possible. No further information is expected. Follow-up (01Jul2021) Amendment: This follow-up report is being submitted to amend previously reported information: Verbatim in other relevant history tab row 1 and row 2 , updated to known allergies: penicillin and known allergies : tree nuts. Past Drug Event Amoxycillin was recoded to AMOXYCILLIN, not Amoxycillin. Relevant history autoimmune autonomic gangliopathy added. Final sentence should be updated to: No follow-up attempts are possible. No further information is expected. For all events, onset date added as 2021

Site where vaccine was given was super hard, big and bumpy and red and warm; Site where vaccine was given was super hard, big and bumpy and red and warm; Site where vaccine was given was super hard, big and bumpy and red and warm; Site where vaccine was given was super hard, big and bumpy and red and warm; itching; huge bumps all over her arms and legs; left knee was huge and swollen/ ankles were swollen; rash/ rash was all over her arm/ rash was on her feet and legs and ankles; allergic reaction; This is a spontaneous report from a contactable consumer. This consumer (patient's mother) reported for a 19-year-old female patient (reporter's daughter) that who received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0-87) at the age of 19-years, via an unspecified route of administration in left arm on 12Jun2021 at single dose for COVID-19 immunization, in physician office. Medical history was not reported. No other products. The patient historically received flu vaccine and had reactions to it- super sick, a lot of fever, couldn't sleep, talked in her sleep, crying, she would miss school, and right after vaccine she got a bad severe cold and cough, it got super severe and turned into a mild bronchitis and had to take salbutamol (ALBUTEROL), when patient was about 6 or 7 years old. This consumer reported that the patient developed severe reactions which required her to go to the doctor, such as huge bumps all over her arms and legs 12 hours after getting the dose, left knee was huge and swollen, like overexaggerated swelling, the reaction was probably in the joints and really severe; ankles were swollen. Her doctor advised not to receive the 2nd dose as this may be an allergic reaction from the vaccine. Doctor told her not to get the second dose and that the first dose could have been deadly for her. Consumer also reported that on the same day, 12 hours after, around midnight, patient had a rash but her doctor called it something else, and little bumps. The next morning, patient woke up with bigger bumps all over her arms and other parts body. It was on the weekend so the patient did not see a doctor until Monday. The reaction was a little less at that time. The reaction lasted about 7-10 days, patient continued to get little rashes that faded away and then more would come. It was also mentioned that site where vaccine was given was super hard, big and bumpy and red and warm, did not get a rash next to it, but the rash was all over her arm, just not in that area, the mother said the rash was on her feet and legs and ankles. Patient was given allergy mediation to help with reaction but it did not help, she was given cetirizine hydrochloride (ZYRTEC) 1mg/mL oral solution, it did help with the itching but did not help with the rash. Rash result in physician office. The mother wanted to know if these were reported side effects of the vaccine and if her daughter can still get the 2nd dose which is scheduled on 03Jul2021. Lab data included: weight was 138 pounds when she got the vaccine. Outcome of the events was unknown. Follow-up attempts completed. No further information expected.

slight pain/pinching sensation near lymph-nodes on armpit of injection arm; Stiffness/soreness on arm near injection; Stiffness/soreness on arm near injection; This is a spontaneous report from a non-contactable consumer, the patient. A 19-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) via an unspecified route of administration in the left arm on 27Mar2021 at 12:45 (at the age of 19-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medication included norethisterone acetate; ferrous fumarate; ethinylestradiol (JUNEL FE) for an unknown indication from an unknown date. 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 COVID vaccine. On 27Mar2021, the patient experienced stiffness/soreness on arm near injection. On 29Mar2021, two days after injection, the patient experienced slight pain/pinching sensation near lymph-nodes in the armpit of injected arm. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient underwent lab test on 30Mar2021 which included COVID test and the test result was pending. The patient did not receive any treatment for the events muscle stiffness, vaccination site pain and lymph node pain. The clinical outcomes of the events muscle stiffness, vaccination site pain and lymph node pain were recovering at the time of the report. No follow-up attempts are needed. No further information is expected.

Hives, Redness, itchiness Patient feels trouble breathing for 2-3 seconds. After removing her mask she feels better. Pulse 90, 02 98%. Patient transferred to gurney vitals checked. Given oral Benadryl 25mg, Pt provided water and had a few sips. Advised to consult PCP about adverse reaction. Patient stated that she history of fainting and feels nervous about the vaccine. Patient stayed extra 30 mins in the observation area. Patient feels better and left for home with mother.

Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium

Pfizer-BioNTech COVID-19 Vaccine EUA non-severe allergic reactions- facial rash (7/20/21), right auricular pruritus (7/20/21), right periorbital edema (7/19/21), abdominal pain (7/18/21)

Patient has a rash on their calves. Its red and raised. Has put Aveeno anti-itch cream and Neosporin and still looks the same

Skin eruption or rash all over body; This is a spontaneous report from a Non-contactable consumer(patient). A 19-year-old non pregnant female patient bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Solution for injection, batch/lot number not provided), via an unspecified route of administration on an unspecified date in 2021 (at the age of 19 year), as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced skin eruption or rash all over body. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received Prednisone as a treatment medication. The patient was visited to Doctor or other healthcare professional office/clinic visit for the event. The event was resolved on an unspecified date in 2021. The reporter did not consider the event to be serious. No follow-up attempts were possible; information about lot/batch number could not be obtained.

Fever, chills, headache, body aches, nausea, and pain at injection site ( started at 8 pm lasted until 10 am)

she went to bathroom to pee, it was cloudy and had blood in it; she has pain and has urge; she has pain and has urge; Not able to pee; urinary tract infection symptoms including an urge to urinate, blood in her urine and difficulty urinating; urinary tract infection symptoms including an urge to urinate, blood in her urine and difficulty urinating; Left arm was swollen at injection site.; This is a spontaneous report from a contactable consumer. A 19-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0198), via an unspecified route of administration, administered in left arm (unable to confirm if given in the muscle) on 12Jul2021 at 20:20 (at the age of 19 years old) as single for covid-19 immunisation. Medical history included ongoing peanut allergy diagnosed when she was 1 year old. Concomitant medication included ethinylestradiol, norethisterone acetate (LOESTRAN), 1 tablet daily in the morning for 28 days for contraception from Jan2021 to an unspecified stop date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive additional vaccines on same date of the Pfizer suspect. She began to be experienced unconfirmed urinary tract infection symptoms including an urge to urinate, blood in her urine and difficulty urinating on 13Jul2021. She asking have this been reported after receiving the Pfizer Covid-19 Vaccine? She just took it two days ago and woke up not being able to pee and peeing blood and stated that it caused a UTI on 13Jul2021. She has never had one before in her life. This happened the night after she got the vaccine and it may be just a coincidence. Her left arm was also swollen and when she went to bathroom to pee, it was cloudy and had blood in it. She knew it had to be the vaccine because she never had that before. A couple of hours after the vaccine she noticed her left arm was swollen at injection site on 12Jul2021 at 22:00. Yesterday morning on 13Jul2021 at 08:00 she was not able to pee. It improved a bit, but she has pain and has urge. It feels like she just has to pee even though she just peed. She googled it and it said it was a UTI. She has not been formally diagnosed yet. She first stated the peeing blood started on 13Jul2021. At around 1:00 am, there was a little bit of blood when she got up to pee. She did not see any this morning, but does not know how it will be throughout the day. It has improved for now. She would like to find out if this has been reported before. The patient did not visit emergency room or physician office. No relevant tests were performed. The outcome of events was she went to bathroom to pee, it was cloudy and had blood in it, she has pain and has urge was unknown, while with other events recovering. Follow-up attempts are completed; no further information is expected.

tired; stomach pain; swelling at site; itching; body aches; headache; lightheaded; This is a Spontanoeus report from a contactable other HCP (patient) A 20 years old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on 28Dec2020 at 11:00 AM, at single dose on left arm for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. On 28Dec2020 at 11:45 PM the patient experienced stomach pain, swelling at site, itching, body aches, headache, lightheaded, tired. At the time of the reporting the patient was recovering from reported events. No follow-up attempts are possible; information about lot/batch number cannot be obtained, No further information is expected.

Redness and warmth around injection site 5-6 hours after receiving vaccine; Redness and warmth around injection site 5-6 hours after receiving vaccine; soreness 2 hours after administration until currently; This is a spontaneous report from a contactable healthcare professional, the patient. A 20-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EK9231) solution for injection in the left arm on 29Dec2020 at 17:30 (at the age of 20-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included asthma. Concomitant medications included clonidine, lamotrigine (LAMICTAL), ethinylestradiol/etonogestrel (NUVARING) and bupropion hydrochloride (WELLBUTRIN). The patient did not have 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. On 29Dec2020, the patient experienced redness and warmth around injection site 5-6 hours after receiving vaccine and soreness 2 hours after administration until currently. No treatment was provided for the events redness and warmth around injection site and soreness. The outcome of the events redness and warmth around injection site was recovering. The outcome of the event soreness 2 hours after administration was not recovered. Since the vaccination, the patient has not been tested for COVID-19.

Stayed fir Observation for 15 minutes then left. 25 minutes after injection, developed rash and swelling on arm, chest, face with rapid heart rate and shallow/rapid breathing. Called number on vaccine sheet and was sent to ER but was turned away due to over crowding (COVID) and told to go to PCP, which was two hours away. Went to urgent care instead and was immediately treated with steroids and antihistamine.

15 minutes after inoculation she developed obvious cutaneous flushing, pruritus, and hives with no other symptoms. She was initially given 50mg diphenhydramine PO. Approximately 45 minutes later she reported chest pain and her vital signs were checked and she was tachycardia at 102 BPM. Her BP was 128/74. EMS was activated and she was given 0.3mg of epinephrine IM after which her flushing and pruritus immediately resolved. She described continued mild chest tightness but over stated that she felt much better.

palpitations; 3 days straight skin rash with itching on her left leg; muscle soreness on arm of injection site; muscle soreness on arm of injection site; This is a spontaneous report from a contactable other healthcare professional (patient). A 20-year-old female patient received the first dose of bnt162b2 (Covid 19 vaccine, brand: Pfizer) via an unspecified route of administration in right arm on 31Dec2020 10:00 at a single dose for COVID-19 immunization in a hospital. Medical history included GERD and Strep throat, both from unknown dates. Concomitant medication included benzylpenicillin (PENICILLIN). The patient did not receive other vaccine in four weeks. The patient experienced palpitations - 3 days straight skin rash with itching on her left leg, muscle soreness on arm of injection site, all on 31Dec2020 11:00. The events were reported as non-serious. The patient did not receive treatment for the events. The patient had not recovered from the events. Information on the lot number/Batch number was requested.

Muscle aches, headache, and chills for the first 48 hours. After 48 hours, these symptoms ended but rash appeared.

Patient complained of face feeling swollen. Patient asked to look at reflection and patient states face is visibly swollen and cheeks red. Patient given 25mg Benadryl IM in right deltoid. 15 minutes post Benadryl, patient stated that she felt like her tongue was swelling. Patient denies SOB, no wheezing, no stridor. BP 114/78 manual in right arm. HR 74, pulse ox 100% on Room air. SWAT was called and patient went to ED for further evaluation.

Symptoms: hives, chest tightness, felt dizzy Blood pressure taken at 2:05 p.m.- 150/110, 50 mg Benadryl administered BP recheck at 2:10p.m.- 140/90 Symptom improvement at 2:20p.m. Patient remaining in observation for about 30 additional minutes, symptoms subsided, had boyfriend drive her home

side effects started showing up about five hours after time of injection and some are still present currently. These side effects include injection site pain, tiredness, headache, joint pain, muscle pain, and chills. The side effects that are still present are injection site pain and joint pain.

History of peanut allergies; carries EpiPen. Noted within 3-6 minutes following vaccine, had small rash on L inner wrist; arm where received vaccine. Chest appeared bit mottled; no apparent hive. BP 140/100, HR 140, no issues with breathing. After 5-10 minutes, took 25 mg liquid Benadryl; mottling resolved, wrist with same sized rash, L injection site with bit of redness/rash. BP 108/80, pulse 87, pulse ox 99% Taken to ED by w/c for further evaluation.

Started to feel itching and hives on left wrist within a few minutes after vaccine administration. Chest area became red and mottled. Contacted workers and received around 25 mg of liquid Benadryl. Allergic reaction subsided shortly after. Monitored in the hospital Emergency Room for around 2 hours.

Experiencing numbness in lips; Hives after first dose; This is a spontaneous report from a contactable consumer. A 20-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration on unspecified date at single dose for COVID-19 immunization. Patient medical history included severe allergy to grass (carries an EpiPen). Concomitant medications were not reported. The patient experienced numbness in lips and hives after first dose on unspecified date. Patient was not sure if she should get the second dose which is scheduled for 21Jan. Event took place after use of product. Outcome of the events was unknown. Information on the batch/lot number has been requested.

Chills; chest tightness; minor fatigue; joint and muscle pain throughout the body (injection site in upper left arm; shoulder; back; ankles). Injection site soreness began immediately after the vaccine, but is normal for me. Everything else began at time listed on this form (1/25/2021 afternoon) and ended by the following morning. I took one Tylenol to help with the chills and pain about 5 hours after symptoms started and it seemed to help a little.

Red, blotchy face. Red, itchy hands. Hives on hands and forearms. All began approximately 12 hours after getting the vaccine. All side effects went away within 48 hours.

ice pick headache upon injection (3hr duration), nausea (36hr duration), fever 103F (8hr starting at 03:00 of day following injection), throbbing in arm of injection (36hr duration), chills (8hr starting at 03:00 of day following injection)

After the patient received the vaccine, she experienced R check numbness. 1/30(2 days post-vaccine) the pt took Aleve and the numbness went away halfways through the day. 2/1 was first day without numbness. Her face still feels tight on the affected side.

Symptoms started 15.5 hours after injection, I woke up with extreme joint pain and muscle aches all over my body, particularly my left arm (injection site). Every joint in my body was painful even while resting, I was extremely fatigued and could hardly move. I took Tylenol and Advil around the clock for 24 hours and it made the pain bearable, and when I woke up on 02/04/21 I was completely fine, only a slight ache in the middle of my shoulders.

Muscle aches about 17 hours after injection; injection site pain 3 hours after, fever and headache 20 hours after injection

mental fogginess; headache; body ache; 99.5 temp; swollen lymph nodes; sore jaw (from lymph nodes); swollen lymph nodes; sore jaw (from lymph nodes); swollen injection site; severe tiredness; muscle pain; muscle stiffness (neck and upper extremities); This is a spontaneous report from a contactable consumer (patient herself). A 20-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL8982, expiration date was unknown), via an unspecified route of administration on the left arm on 25Jan2021 at 13:45 at a single dose for COVID-19 immunization. The vaccination facility type was reported as the hospital. Relevant medical history included asthma and glucose intolerance; both from an unknown date and unknown if ongoing. The patient had no known allergies. Concomitant medications included metformin and etonogestrel (NEXPLANON) for birth control. The patient was not pregnant at the time of vaccination. The patient had no other vaccine in 4 weeks. The patient had no COVID-19 prior vaccination. On 25Jan2021 at 15:30, the patient experienced mental fogginess, headache, body ache, 99.5 temperature (temp), swollen lymph nodes; sore jaw (from lymph nodes), swollen injection site, severe tiredness, muscle pain, and muscle stiffness. The patient did not receive any treatment for the adverse events (AE). The patient was not tested for COVID-19 post vaccination (pending clarification). The patient was not recovered from all the events.

Rash covering face, neck, and chest. Also had tachycardia. Treated with Benadryl and a steroid injection 30-45 after reaction

itchy all over her body/Itching in face, arms, neck, chest, and armpits.; Hives on face, neck, armpits, chest; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (Parent) reported for a 20-year-old female patient received the first dose of BNT162B2 (Lot/batch number and Expiration date were not provided), via an unspecified route of administration in left arm on 07Jan2021 at single dose for covid-19 immunization. Medical history included High cholesterol, Apricots allergies. The patient's concomitant medications included Birth control, cholesterol meds. She works in a nursing home, she got the Covid-19 vaccine on 07Jan2021, she started getting high and really got itchy all over her body, especially in her face, in her neck, her armpits. Hives on face, neck, armpits, chest. Itching in face, arms, neck, chest, and armpits. The events occurred on 21Jan2021. No treatment received. The patient was no pregnant. The outcome of the events was not recovered. Information on the lot/batch number has been requested.

Received the shot at 2:10. 2:15, she was feeling light headed and tingly sensation in her extremities. She didn't let anyone know at this time. The person observing her noticed she seemed zoned out and asked how she was doing at about 2:17 and learned that her tingliness was turning into numbness of extremities focused on her upper body. She started displaying other symptoms of a minor panic attack. We monitored her for the full 30 minutes, had her walk around, drink water, etc. She claimed that while her numbness wasn't getting better, it also wasn't getting worse. It was starting to itch though, so she was given some benedryl. She then went home for the evening where her roommate could monitor her. Next day, she called in to confirm that her numbness/itchiness had turned into a rash on her chest which has disappeared. But now is experiencing diarrhea, headache, weakness and dizziness. She was informed that these symptoms were within the normal range of immune responses, but that if she was too miserable, she could go in to urgent care for medical assistance. She declined to do so at that time (approximately 11:45 am).

Rash is on my chest and on my upper back; Can barely breath; I can't really eat or swallow because my throat is swollen; I can't really eat or swallow because my throat is swollen; This is a spontaneous report from a contactable consumer (patient). A 20-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 02Feb2021 at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization. Medical history included asthma, diabetes, autism and attention deficit hyperactivity disorder (ADHD). The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. On 03Feb2021, the patient had rash on the chest and upper back; can barely breathe; and could not really eat or swallow because the throat was swollen. The patient did not receive any treatment for the reported events. The outcome of the events, 'rash on the chest and upper back', 'can barely breathe', 'could not really eat or swallow because the throat was swollen', was unknown. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested since the vaccination. Information on the lot/batch number has been requested.

4 hours post-vaccination: pain and soreness in the arm where the injection was given; soreness got progressively worse for 24 hours and then rapidly improved 12 hours post-vaccination: malaise, nausea, stomach pain, muscle aches, chills (no fever), fatigue, headache, and light-headedness onset; symptoms persisted for 24 hours following onset and improved overnight. 24 hours post-vaccination: axillary lymphadenopathy, currently persistent Overall, adverse effects felt like flu-like symptoms or a severe hangover

- Hot and burning internally immediately - Face redness and swelling and all below within the first 30-60 minutes - Rash on both arms, chest, legs - Lips bright red - Itchy - Sweating - Flush - Throat pain and mild swelling

Rash on entire side of my body, itchy, very red. Woke up with it morning after my vaccine, lasted for a week.

anaphylaxis; high blood pressure; elevated heart rate; her throat felt funny, like it was getting tight; very nauseous/sick of her stomach; rash on her chest; She could not swallow; This is a spontaneous report from a contactable consumer (parent of the patient). Information were received also from a Pfizer-sponsored program COVAX US Support. A 20-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL9261), via an unspecified route of administration in the left arm on 05Feb2021 09:30 at single dose for COVID-19 immunisation. Medical history included acne, allergy environmental cats dogs and latex. Adrenaline (EPIPEN) and Corticosteroid were used to treat these allergies. Due to these severe allergies, the patient had to take weekly allergy shots. Got allergy shot the day before the 2nd vaccine shot. Concomitant medication included isotretinoin (AMNESTEEM), buspirone (unknown manufacturer), calcium (unknown manufacturer), azelastine hydrochloride, fluticasone propionate (DYMISTA), gabapentin (unknown manufacturer), melatonin (unknown manufacturer), omeprazole (unknown manufacturer), estrogens conjugated, medroxyprogesterone acetate (PREMELLA), probiotics (PROBIOTICS), fluoxetine hydrochloride (PROZAC) , trazodone (unknown manufacturer), colecalciferol (VITAMIN D), cetirizine hydrochloride (ZYRTEC). The patient previously took clindamycin, bactrim and corticosteroids and experienced hypersensitivity. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL3249) intramuscular in left arm on 15Jan2021 at 11:00AM. It was reported that 15 minutes after receiving her second COVID-19 vaccine dose the patient developed anaphylaxis, her throat started closing up, her throat felt funny, like it was getting tight. A nurse administered her anaphylactic shot (EPI-PEN shot) and was taken to the hospital by ambulance. The patient was monitored in the Emergency Room because her blood pressure and heart rate were up, but the Emergency Room didn't give her any further treatment. The patient was discharged home on 05Feb2021. On Saturday, 06Feb2021, at 4-5AM she developed anaphylaxis again, the patient had the same throat tightening happen again. The mother gave her an Epi-Pen shot (AUVI-Q) and brought her back to the Emergency Room. While in the Emergency Room, the patient was given steroids and Pepcid, and then sent back home. On Sunday, 07Feb2021, at approximately 1:00AM she had the same throat tightening so the mother gave her an Epi-Pen shot (AUVI-Q) again, and brought her back to the Emergency Room. The patient was admitted to hospital and discharged on 09Feb2021 evening (at 16:00). At hospital the patient received some steroid shots in the hospital. The patient was given 3-125mg steroid shots, and 3-40mg steroid shots, every night she spent in the hospital, she woke up with her throat closing and she was administered 125 steroids 50 mg Diphenhydramine (BENADRYL) and 4-5 hours later 40 mg of steroids 20 mg Famotidine (PEPCID) IV. They kept IV fluids. On 10Feb2021 at 7:50AM the patient experienced throat tightness again. The mother gave her some Diphenhydramine (BENADRYL) and steroids which were prescribed at hospital. The patient started a taper dose of Prednisone 10mg tablets. She was to take 2 Prednisone 10mg tablets twice a day for 3 days, then to take 2 Prednisone 10mg tablets in the morning and 1 Prednisone 10mg tablet in the evening for 3 days; then to take 1 Prednisone 10mg tablet twice a day for 2 days, and then 1 Prednisone 10mg tablet daily for 2 days. The patient was prescribed generic Famotidine (PEPCID), 40mg, one tablet, twice a day, and generic Diphenhydramine (BENADRYL) 25mg capsules. On unknown date in feb2021 the patient gets very nauseous when her throat starts to close. She could not swallow and was sick of her stomach. She experienced a rash on her chest. The outcome of the event heart rate increased and blood pressure high was recovered, for anaphylactic reaction and throat tightness was not recovered. For the other events was unknown. The events anaphylaxis, throat tightness, heart rate increased and blood pressure were serious due to hospitalization.

48 horus after second vaccine Right eye periorbital swelling and mild drainge Throat swelling described as feeling like it was hard to swallow - no acute distress Question of increased respiratory rate - normal respirations noted in clinic 2.5 x 2.5 cm nodule, well demarcated and moveable with sudden appearance to forehead Onset of floaters in B/L eyes occurred 4 hours later, after administration of oral benadryl and prednisone Tx: Patient was given Benadryl 50mg orally and Prednisone 60mg orally. Withing one hour throat tightness resolved, respiratory rate reamined normal, left eye swelling was improving and nodule to forehead was decreasing in size. Floaters were persistent. 24 hours later pt reports no recurrence of throat tightness, normal respiratory rate, resolution of left eye swelling, some decrease in size of forehead nodule. Floaters have been persistent and unchanged. *24 hours after second vaccine pt has onset of palpable lymph nodes to anterior cervical chain, single node to left supraclavicular chain and left axillary swelling. This was not considered an allergic reaction and attributed to immune response to vaccine.

About an hour (5:30pm est) after receiving the first dose of the Pfizer vaccine on my left arm (taken Saturday, March 6th at around 4:30pm est) I started feeling itchy all over my body (neck, stomach, sides, thighs) and it looked like a rash (very red) showing me signs of an allergic reaction. The same thing happened throughout the day on Sunday (March 7th) and the rash would get better and then worsen so it was very on and off throughout my entire body. On Sunday evening after I took 2 Benadryls the rash got worse on my right arm and a small area of my left arm (bubbly-like features appeared). I went to sleep after taking the Benadryl and when I woke up the next morning it was completely gone. Then on Monday (March 8th) I was fine all day no signs of rashes or itching and then around 5pm I felt a burning sensation on my face and when I looked in the mirror both of my cheeks and a small part of my forehead were extremely red. I then took 2 Benadryls again and went to bed. Today (March 9th) I do not have signs of a rash and have not felt itchy all day.

15 minutes post injection, pt. c/o "rash & tightness in chest". Evaluated by APN & assisted by POD supervisor RN & assistant pod supervisor RN. Vital signs at 10:52am: 120/80 blood pressure taken manually, heart rate 79 bpm with no irregularity. Benadryl 100 mg administered IM in right VL by APN at 10:56am. Within 15 minutes, patient reported symptoms resolved & rash observed to be improving. Pt. called family member to drive her home. Pt. instructed to call 911 immediately for any worsening of symptoms or difficulty in breathing.

shingles; temporary vision loss; dizziness; Extreme fatigue; body aches; nausea; This is a spontaneous report from a contactable other Healthcare professional (patient herself). This 20-year-old female patient, not pregnant, received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), Lot EL9265,via an unspecified route of administration in the left arm on 03Feb2021 at 02:00 PM (at the age of 20-year old) single dose for COVID-19 immunization. Relevant medical history included suspected allergy to penicillin. Historical vaccine included first dose of BNT162B2, Lot EL3248, on 13Jan2021 at 11:45 AM single dose in the left arm and recombinant human papillomavirus vaccine (GARDASIL) on 15Dec2020 dose 1 in the left arm. Concomitant medication included one a day women's Vitamins. After 2nd dose of vaccine BNT162B2, the patient experienced extreme fatigue, body aches, dizziness, and nausea. She was unable to go into work 2 days after receiving the vaccine due to temporary vision loss because of dizziness. On 21Feb2021 at 9:30 AM, a painful rash on the left side of torso and on spine had shown up. The patient went into her school doctor on 24Feb2021 and was diagnosed with shingles. The patient specified that she have never had this condition before, she was healthy and she did not have any significant stressors. The patient was treated with acyclovir due to the event. The outcome was not recovered for all events. This is a spontaneous report from a contactable Other HCP. This 20-year-old female Other HCP reported herself that: Report about covid vaccine: Yes Reporting type: AE Reporter type: Patient Age group: Adult (18-64 Years) Current age: 20 Current age unit: Years Gender: Female Is pregnant: No Medical qualification reporter: Other Health Professional Covid vaccine details: [{product=COVID 19, brand=Pfizer, lot number=EL9265, lot unknown=False, administration date=03Feb2021, administration time=02:00 PM, vaccine location=Left arm, dose number=2}, {product=COVID 19, brand=Pfizer, lot number=EL3248, lot unknown=False, administration date=13Jan2021, administration time=11:45 AM, vaccine location=Left arm, dose number=1}] Facility type vaccine: Other If other vaccine in fourweeks: Yes Other vaccine 4weeks details: [{other vaccine 4weeks product=Gardasil, other vaccine 4weeks vaccine date =15Dec2020, other vaccine 4weeks dose number =1, other vaccine 4weeks vaccine location=left arm}] Other medications in two weeks: One a day women's Vitamins Adverse event: Extreme fatigue, body aches, dizziness, and nausea following 2nd dose of the vaccine. I was unable to go into work 2 days after receiving the vaccine due to temporary vision loss because of dizziness. On 21Feb2021, a painful rash on the left side of my torso and on my spine had shown up. I went into my school doctor on 24Feb2021 and was diagnosed with shingles. I have never had this condition before, am 20 years old, and am healthy. I do not have any significant stressors. Adverse event start date: 21Feb2021 Adverse event start time: 09:30 AM AE resulted in: [Doctor or other healthcare professional office/clinic visit] If patient recovered: Not recovered If treatment AE: Yes AE treatment: Acyclovir prescription If covid prior vaccination: No If covid tested post vaccination: No Known allergies: suspected allergy to penicillin Other medical history: N/A; Sender's Comments: Based on the available information and known product profile, the causal relationship between the reported temporary vision loss together with the reported dizziness and vaccination cannot be excluded. The case will be assessed further upon receipt of additional 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.

Itchy throat, left arm tingling and sporadic numbness, tingling in both legs, injection sight pain, swelling, and redness, fatigue. All except the fatigue started a few minutes after the vaccine while I was still at the clinic (~1:05pm) fatigue started roughly 1.5 hours after vaccine (~2:30pm)

Patient called pharmacy to repeat fever, chills, migraine for two days, body aches, and injection site pain. Patient was advised to contact her health care provider, telemedicine, or urgent care.

I got Pfizer Lot EN6200 on 02/26/2021 around 3:30 pm in my left deltoid. The 'blister' is on my right hand index finger (measured 9 mm by 7 mm at its widest points, has not changed size or character since appearing) with a fainter in color 'blister' (5 mm by 3 mm at widest) present on my right hand pinkie. No 'trauma' to the site. Nonblanching, two petechiae present within the ring finger's blister, two also present in the one on my pinky. Those petechiae have disappeared in the last two days, but the spots are still present. Red, not warm, sensitive to touch. I had no other symptoms from dose one of the vaccination, outside of a sore arm and some joint pain. Possibly fatigue, but that's likely just me being fatigued as per usual.

Around 1:00pm, a few hours after getting the vaccine in my left shoulder, my left shoulder was extremely sore for about 24 hours. Also I experienced a sore throat around 7:00pm and that lasted overnight and into the morning and then went away during the day.

Hives which started within 1 hour after the first dose of the COVID-19 Pfizer-BioTech vaccine was administered. Hives started on left arm and then spread throughout body, mostly on upper and lower extremities and trunk. Was seen and evaluated by a medical provider (nurse practitioner) 3/16/2021. Patient was diagnosed with urticarial rash (hives) and given prescription for cetirizine 10 mg 1 tab twice per day and Epipen to use in case of anaphylaxis. There were no signs of anaphylaxis at time of exam on 3/16/2021.

About 2 or 3 hours after dose 1 got on legs and arms. NO SOB angioedema, faintness, cardiac sx, N or V. Supervisor called EMS and she was taken to the ER, diagnosed with hives and give an antihistamine only. Did well though some hives lasted for 4 days. After much discussion decided on dose 2. Told to return if any hives or sx. and to check in around 5 pm. When she did had a hivey area covering most of posterior L lower leg. (flat red rash) None elsewhere. Is itchy. No SOB, etc. Lungs clear Pulse about 76. Give Benadryl at 5 pm and less itchy by 6 pm. Plan : Observe at POD until mother picks her up. If any other symptoms will call 911. Take Benadryl every 4 to 6 hours today and switch to a non-sedating antihistamine such as loratadine tomorrow when she works.

Extreme soreness around shot area since receiving vaccine this morning. Brief numbness in legs occurring 20 minutes after vaccine was administered, and lasting for about 5-10 minutes.

One minute after receiving her vaccination, she started feeling itchy nose and her throat, then subsequently started feeling swelling in her town. Evaluation by physician so no swelling of the tongue. Her lungs were clear auscultation bilaterally. Her heart rate initially was in the 130s. She was taken to a private section of the arena and monitored. Her heart rate gradually decrease to the 110s. She remains normotensive. One minute after receiving her vaccination, she started feeling itchyness in her throat, then subsequently started feeling swelling in her tongue. Evaluation by a physician showed no swelling of the tongue. Her lungs were clear auscultation bilaterally. Her heart rate initially was in the 130s. She was taken to a private section of the arena and monitored. Her heart rate gradually decrease to the 110s, then to normocardia. She remains normal tensive. Prior to monitoring, she already taken a 50 mg dose of oral diphenhydramine (which she brought herself). Recommended she switch to J&J vaccination instead of getting the 2nd dose of Pfizer.

Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Hypertension-Medium

Swollen and painful lymph nodes under the arm and around collar bone on the same side as injection. Extreme arm pain at injection site. Vertigo. Sleepiness

Patient felt her throat was closing. She experienced nausea and itchiness. EMS responded and administered diphenhydramine 25mg injection. Patient was taken to hospital via ambulance.

101-102 degree fever, shivers, full body aches, pain in arm at injection site, very painful headache for 2-3 days on and off, nauseous around 5am after receiving injection.

Developed rash on left and right arms during post vaccination observation period. Vital signs stable, no shortness of breath, swelling or dizziness. Vaccine recipient encouraged to be evaluated in ED, declined and left with family member 20 minutes later

On 3-15-21 patient received 1st dose Pfizer vaccine on L deltoid, states that 2 days after the jab she developed a pruriginous rash on ventral aspect of L forearm above wrist area. Rash faded away on its own. Denied SOB, wheezing, cough, facial swelling. denied any rashes on other areas of her body. she did not disclose that rash to us at the clinic. On 04/05/21 she came to the clinic for 2nd jab, on screening and immunization documentation she mark no on "like to speak with health care provider" but prior to HS providing 2nd jab she brought to her attention the previous symptoms. I intervene and discuss with the patient and asked the nature of the previous symptoms. Due to a miscommunication and misunderstanding, on my part, I thought that her rash was initially on site of injection and that it spread distally, discuss with her Covid arm for about 10-15 minutes with patient as I thought initially that it was a COVID arm and proceed to allow 2nd jab and order to keep her in observation for 30'. 2nd jab administered on R arm this time. About 3 minutes after jab, she developed three lesions on forearm, 2 bumps approximately .2 cm diameter, with mild hyperemia on dorsal aspect of proximal forearm which states were itching. Stated one hyperemic non raised lesion on proximal ventral forearm (that latest lesion was not visualized by me). I extended the observation period and at 45' the lesions started to fade away and the "bumps" got smaller. I did a full evaluation of the patient and there was no other skin lesions on rest of her body. she was breathing normally, no wheezings, no laryngeal stridor, no facial/neck/lips/tongue swelling, no complaints of tingling on lips or tongue. She was not on distress. No treatment provided to patient. Patient was discharge home with specific instructions to call 911, go to neares ER, or call the Duty HS if at any point she develops any new symptoms, breathing problems. Around 6:15 i call patient and told me she was doing good, no new skin lesion, no laboured breathing, wheezing, swelling, problems with swallow and that the lesions were gone. Today 4/6/21 I call patient to come to the clinic for re-assessment and there was no skin rashes, no swelling, her exam was completely normal. she complained of tender arm and that previous night she had some mild headache, took tylenol and better. There was no redness around injection site. Patient was discharged with same recommendations provided previously, to call 911, go to nearest ER, or call Duty HS if any new skin lesions, SOB, wheezing, difficulty swallowing or talking. Just spoke with patient via phone today at 4:25 PM and states she is doing well, no rash, no SOB, completely asymptomatic. I understand the magnitude of these events and I have to say the the misunderstanding was all on me and I take responsibility. Here in our clinic we have immunized over 600 patients and no major issues prior to this. I am available to discuss at any time. Thanks,

experiencing passing a ton of clots; I washed my face, it got extremely red; This is a spontaneous report from a contactable consumer (patient). A 20-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported) at the age of 20-year-old, via an unspecified route of administration, administered in the left arm on 19Jan2021 13:00 as single dose for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included lupus and idiopathic thrombocytopenic purpura (ITP). Concomitant medications included mycophenolate mofetil (CELLCEPT), esomeprazole magnesium (NEXIUM), medroxyprogesterone acetate (DEPOPROVERA), and propranolol; all taken for an unspecified indication, start and stop date were not reported. The patient has known allergies to rituximab and amoxicillin. As a woman, the patient was having a lot of blood clots being passed. The patient doesn't get a period because of depo, but for some reason, she was experiencing passing a ton of clots on an unspecified date. Also, after the first dose, when she washed her face, it got extremely red on an unspecified date in 2021 (She did the same in the days before and that didn't happen). The patient underwent lab tests and procedures which included Covid test: negative on an unspecified date. The outcome of the events was unknown. No treatment was received for the events. The patient received the second dose of BNT162B2 on 11Feb2021 for COVID-19 immunisation administered at the left arm. Information on the lot/batch number has been requested.

Client began to notice redness and rash at site of injection. Localized symptoms did not progress after further observation over 30 minutes. Fire Rescue at scene to evaluate patient. Per Fire Rescue, no further evaluation needed, patient released at 4:05pm.

Sore throat lasting over 48 hours, headache that comes and goes, nausea, fatigue, injection site pain

Full body rash, started within 2 or 3 hours after receiving the vaccine. Slight inflammation around the body. Some itchy areas around the body.

allergic reaction; Rash; This is a spontaneous report from a contactable consumer (patient). A 20-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 23Mar2021 (Batch/Lot number: EN6207) at single dose (at 20-year-old) in arm right for COVID-19 immunization. Medical history was reported as none. Ongoing concomitant medication included galcanezumab (EMGALITY injection) monthly; and ethinylestradiol/ norethisterone acetate (HAILEY) daily; both for an unspecified indication from an unspecified date. The patient got the vaccine on 23Mar2021 (Tuesday), then noticed the rash on 24Mar2021 (Wednesday) evening about 9 pm it started in chest and abdomen and over the last couple of days it spread down to some of arms and legs. It's a mild rash over a decent part of her body. She believed it's an allergic reaction frankly. She had been taking diphenhydramine hydrochloride (BENADRYL). She was taking it three times now over the last Wednesday. The rash was still there (persisting).

Fast heart rate/feeling like I was going to pass out; dizzy/heart palpitating/skin sensitivity (my skin would easy become flushed) I received the shot on Wednesday morning, was tired for the rest of the day (normal) and mentally I was healthy/happy. Thursday morning, I started to feel extremely sluggish and I struggled to catch my breath. 1-10 (10 being severe) I would rank this at a 5. Friday morning is when I really felt like an 8 and my listed symptoms weighed me down. I would define these symptoms as episodes. Each episode would last a couple of minutes and I would return to my normal state. I felt an 8 till the following Sunday/ Monday. Tuesday, felt a little better.

Pt. states she received her vaccination on 04/06/2021. She states she was experience soreness at the vaccination site and fatigue for 2 days. Today she is experiencing chest pain on inspiration and was unsure if this could be related to the vaccine. Advised patient to go to urgent care/ED or contact primary care physician

I got a rash like symptom, it looked like mosquito bites ALL OVER my legs and arms. It itches A LOt and ends up red when I scratch. It ended up actually worsening so I went to urgent care and was told that my immune system was just reacting to vaccine. I was prescribed a stronger benadryl .

moderate vertigo (Feeling of spinning, loss of balance, dizziness, lightheadedness, nausea, feeling of floating, feeling of the floor tilting), coldness and slight discoloration of hands and feet

At 5 PM the day after vaccination, began to experience aches and chills which progressively worsened until around 1 AM, then subsided. Headache began around 8 PM and lasted until 6 AM; took one tablet of ibuprofen at 5 AM. Other symptoms included fast heart rate, minor pain at injection site, and head feeling ?cloudy? or ?stuffy?.

patient began having hives that continued to spread and then patient stated lip numbness, patient was given PO benadryl, IM epi, and transported to ED for further monitoring and intervention.

Whole body rash, hives, and itching one hour after receiving vaccine. Whole body is itchy, red, and swollen.

Major dizziness, tightness of the chest, diarrhea, difficulty breathing, rapid heart beat, the symptoms began to show after the vaccination in 4 hours. At first, it was only pain in the arm where the injection occurred. Now, there is also swelling of the arm when the injection occurred.

- Fatigue/Tiredness (Saturday Sunday and Monday) - Fever (Sunday) - Nausea (through sleeping into Sunday) - Headache (All day Sunday) - Extreme Muscle and Bone Pain (All day Sunday, very very mild Monday) - Injection site soreness

I got the shot at 5:05 PM on 4/17/21. My arm was sore and still currently is but is getting less sore. Around 950ish PM my face started to feel a little warm, then about 15 mins later I looked in the mirror and my face was red all over and it continued to get worse. Currently it is 11:20 PM and my face still feels very warm and is a deep red. I would compare it to a bad sunburn. I took my temperature and it was at 99.4.

Rash - both arms, redness to cheeks, history a anaphylaxis. Complaint of difficulty breathing. Hydrocortisone cream applied bilateral arms. Patient took Benadryl 50mg tablet. Onset of symptoms was observed within 60 minutes of vaccine injection. Symptoms improved within 45 minutes.

The day after getting my first dose of the vaccine my ears started to get really itchy. A week later I went to get my ears checked and I have a rash inside both ears.

The patient developed a rash/redness on arm and welts on chest and back 3 days after receiving vaccine.

A mild?severe allergic reaction that caused massive swelling (face, tongue, and neck), severe pain, a rash/hives, shortness of breath, and minor asphyxiation.

April 19 1:05pm: Slight soreness at sight of injection. April 19 5:00pm: Intense soreness at sight of injection. April 19 10:00pm: Intense soreness at sight of injection. Intense ache in whole arm where injection was placed. Mild whole body ache. April 20 7:00am: Intense soreness at sight of injection. Medium ache in whole arm of injection. April 20 12:00pm: Intense soreness at sight of injection. Medium ache in whole arm of injection. Fatigue. Mild headache. April 20 7:00pm: Mild soreness at sight of injection. Note: My menstrual period started at this time. The typical symptoms associated with my period are fatigue and mild headache. April 20 9:00pm: No soreness at sight of infection. A non-painful pimple like sack forms on my gums. This has never happened to me before. April 20 10:00pm: More blood and puss fill the pimple like sack. April 20 10:30pm: Puss filled sack pops and empties quickly. It quickly scabs over. April 21 7:00am: Area where sack is mostly healed. No more symptoms.

Severely sensitive skin all over body to the point of pain, fever of 99.5. No rash or raised bumps at injection site, no early signs of vaccine reaction

Low-grade fever about 8 hours later has rosy red cheeks and felt hot to touch on forehead Took Tylenol after discovering and started to cool down and went to bed and the fever broke when I woke up the next day Sore arm 1 day after, went away after 1 day.

After my first shot I developed a rash all over my body 12 hours after the shot was administered. I had a slight headache and the rash lasted for 20 minutes.

Tingly slightly painful rash in hands at joints, seems to show up more after ive washed my hands or put lotion on (neither of which bothered me before)

Patient had vasovagal episode manifested with shaking and numbness of the upper and lower extremities, skin is warm to touch and flush. Nursing Intervention: Elevate legs on dashboard, apply cold compress on nape, give cold water to drink, V/S taken O2 Sat is 98%, Pulse is 105. Informed patient on what is happening and keep her calm. Continue monitoring. After 30 minutes patient complain of increase shaking and numbness, she said no sensation in all upper and lower digitalis and did stand up to feel her legs and feet. After a while she said she feel dizzy so I sat her inside the car and elevate her legs on dashboard then she complain of SOB. Take her V/S O2 Sat is 89 Pulse is 109. After 5 minutes take her O2 Sat again and its 85 Pulse is 110. Report to my site lead about the V/S and we Administer 8L/min of oxygen. I massage her hand and arms, stay with her. After 5 minutes her O2 Sat went up to 99%, pulse is 93.give her drink and snack. Observe her for another 10minutes, V/S is stable but her shaking and numbness still there. As they leave I advised them to go to the ER if symptoms did not stop or worsen.

Over the days following the vaccine, the injection site swelled up to the size of a softball. The area was extremely tender and hot to the touch. Accompanying this was a fever of about 100 degrees F. Around the fourth day after the vaccine, the swelling started to abate.

small red rash along bilateral jawline that became itchy as time passed. 50mg Benadryl IM administered Right deltoid.

Skin rash on forearm- skin colored bumps, very faint. I had a bit of an itch there and noticed a few bumps however, the itch did not persist. I inspected the rest of my body and I couldn't find any other signs of a rash. The rash is on both arms and is only on the outer part of my forearm covering about the entire area where hair grows on your forearm to give a general idea. The rash spans between my elbows and wrists.

Spreading rash starting at the stomach. Moved down the legs and up around breasts and stops at armpits. Not itchy or painful, just red bumps and blotches.

Starting April 7th, then again April 11th and continuing until the present day, an uncomfortable and itching rash had covered the majority of my body. This led to 2 UrgentCare visits and a course of steroid pills (that helped for a few hours before the rash would start to reappear each day) After completing my second dose of the vaccine on April 25th (Lot# EW0169) around 7pm I woke up April 27th with the rash the completely covered my legs/groin/hip area and started spreading up my spinal and trunk as well as swelling fingers, face and lips, resulting in a hospital visit, more steroids and on the morning of April 28th a new rash began on my trunk, arm, neck and face in addition to the hive-like rash on my legs.

Left arm rash within minutes of receiving vaccine. Then resolved. Headache, dizziness, difficulty concentrating, difficulty focusing vision, right ear pain-intermittent. Shortness of breath-improved with albuterol inhaler. History of asthma.

she felt like she was being stung by wasps at the COVID-19 Vaccine injection site; injection site pain/ bad injection site pain; extremely swollen left axillary lymph nodes; numbness and tingling in her left elbow and left wrist, as well.; numbness and tingling in her left elbow and left wrist, as well.; fatigue; persistent diarrhea; weakness; headache; chills; muscle aches; injection site pain was a burning sensation; it inhibited her left arm movement; left axillary lymph nodes painful; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 20-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248) via unspecified route of administration in left upper arm on 18jan2021 09:20 at single dose for covid-19 immunization. Medical history includes recurring history of croup since she was young with her last croup diagnosis during Christmas of 2018. Concomitant medication reported as COLECALCIFEROL (NATURE MADE VITAMIN D3 2000iu, UPC Number: 3160403183, Lot Number: 2404901 and Expiration Date: Oct2023) continued taking both the first and second Covid-19 vaccine dose. After second vaccine she only took 2 ibuprofen 200mg tablets on first day. The patient historical vaccines included: flu vaccine in mid-Nov2020 and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EK5730, Expiration Date: Unknown) via intramuscular route of administration in left upper arm on 28Dec2020 09:20 at single dose for covid-19 immunization. The patient had Injection site pain, Flu-like symptoms (clarified as flu minus vomiting), Headache, GI symptoms, Weakness, Fever, Muscle fatigue and leg shakiness with the first dose. There were no other vaccines administered within four weeks. On 18Jan2021 she experienced more interesting side effects. She had injection site pain the afternoon of 18Jan2021 by 20:00 that night (18Jan2021), she had laid down in bed, and she felt like she was being stung by wasps at the COVID-19 Vaccine injection site. The injection site pain was not bad but the pain was constant and by the second day the injection site pain had faded. The bad injection site pain clarifying the injection site pain was a burning sensation. She said if she puts her hand on the vaccine injection site now, she can still feel a burning sensation. She said there is not swelling or redness at the vaccine injection site. She said she developed extremely swollen left axillary lymph nodes after her second COVID-19 Vaccine dose. She said the left axillary lymph node swelling was so extreme it inhibited her left arm movement. She said she developed numbness and tingling in her left elbow and left wrist as well. She said the left axillary lymph node swelling has gone down, so the swollen lymph nodes are not impeding her left arm movement now. She said the left axillary lymph node remains swollen enough that her bra hits the swollen lymph node, making the left axillary lymph nodes painful. She said the numbness and tingling in her left elbow and left wrist is less frequent, but not gone. She said her side effects after the second COVID-19 Vaccine didn't improve for probably 4-5 days after they developed. She said the left axillary lymph node swelling has improved marginally, and the vaccine injection site burning sensation is less, but the left elbow and left wrist numbness and tingling is persistent. On 23Jan2021 or 24Jan2021 she developed fatigue, persistent diarrhea, weakness, headache, and very mild chills and muscle aches. She said she had no fever. Her symptoms lasted 2 days and then completely resolved on Jan2021. She said her left elbow and left wrist numbness and tingling is persisting. She said the vaccine injection site still hurts (burning sensation), and her left axillary lymph nodes are still swollen. She said the burning sensation at the vaccine injection site has her concerned. She feels an increase in the burning sensation if she touches the vaccine injection site. The clinical outcome of the event vaccination site pain, swollen lymph node, numbness, tingling, Limb discomfort reported was recovering, outcome of the event burning sensation was not recovered, outcome of event Feeling abnormal and Lymph node pain was unknown and for other events it was recovered on Jan2021. Follow-up attempts are completed. No further information is expected.

Flu-like symptoms; Headache; Weakness; Fever; Muscle fatigue; leg shakiness; GI symptoms; Injection site pain; This is a spontaneous report from a contactable consumer (patient). A 20-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, lot number: EK5730 and expiry date unknown), intramuscularly in left upper arm on 28Dec2020 at 09:20 as a single dose for COVID-19 immunisation. Medical history included a recurring history of croup since she was very young, with her last croup diagnosis during christmas of 2018. Concomitant medications included Vitamin D (Nature Made Vitamin D 2000iu, Formulation: soft gel, Lot Number: 2404901, and Expiration Date: Oct2023) 2 doses daily. The patient did not receive any other vaccines within four weeks prior to the vaccination and no vaccines were administered on the same day of vaccination. The patient received flu vaccine in mid-Nov2020. On 28Dec2020, the patient experienced Injection site pain and on 30Dec2020, flu-like symptoms felt like the flu minus vomiting, headache, GI symptoms, weakness, fever, muscle fatigue, leg shakiness. Reported she had an issue after she received her first dose of the COVID-19 Vaccine. She said she had immediate injection site pain. She said the injection site pain was not bad, but the pain was constant, and by the second day the injection site pain had faded. Reported 2 days after receiving her first COVID-19 Vaccine dose she developed flu-like symptoms. She said she had weakness that lasted 3 days. She said she also had a headache, GI symptoms. She clarified her flu-like symptoms felt like the flu minus vomiting. She said she had a fever, muscle fatigue, and leg shakiness, as well, before she moved into the recovery period on 01Jan2021. She said by 02Jan2021 or 03Jan2021, she had recovered completely, and she had no more symptoms, or fatigue, or weakness. The events did not result in emergency room or physician office. No investigations were done. Therapeutic measures were taken with 2 Ibuprofen 200mg tablets, twice a day, for 2 days and had continued as normal taking Vitamin D (Nature Made Vitamin D 2000iu, Lot Number: 2404901, Expiration Date: Oct2023). Outcome of Injection site pain was reported as resolved on 30Dec2020, and all other events were reported as resolved on an unspecified date in Jan2021. Follow-up attempts are completed. No further information is expected. .

HISTORY OF PRESENT ILLNESS: Patient is a 20 y.o. female with a PMH of has no past medical history on file. is being called today for a vaccine reaction Pt received Pfizer vaccine on 4/6/21. 3-4 hours following the injection - started experiencing itchy raised wheel shaped lesions to arm. Hives gradually spread to both arms, face, neck and are now diffuse to these areas. Denies difficulty breathing, swelling of the face, tongue, or lips, dizziness, increased drooling. No GI or other systemic symptoms. COVID-19 Vaccine Adverse Reaction Screening Flowsheet completed She has been taking Benadryl Q6-8 in addition to Claritin 10 mg daily. Added topical steroids hydrocortisone 2.5% with mild improvements in itching. States that hives have continued to expand despite antihistamines and topicals. Would like guidance re: current management and 2nd dose of vaccine. She does have a hs of hives - triggered by heat. Treated with antihistamine. Also with many seasonal allergies and some food allergies. No known drug or vaccine allergies in the past Takes Claritin 10 mg daily for seasonal allergies No Known Allergies Current Medications Current Outpatient Medications Medication Sig Dispense Refill ? cetirizine (ZYRTEC) 10 mg tablet Take 10 mg by mouth daily. ? ibuprofen (ADVIL,MOTRIN) 600 MG tablet Take 1 tablet (600 mg total) by mouth every 6 (six) hours as needed.. 60 tablet ROS: Per HPI VITAL SIGNS are unavailable for this phone visit. BP Readings from Last 3 Encounters: 04/09/18 103/67 PHYSICAL EXAM is unavailable for the phone visit. Patient was calm. Voice was clear. No signs of respiratory distress, anxiety, or depression. Speech organized. DATA REVIEWED: ASSESSMENT / PLAN Patient was seen today for allergic reaction. Diagnoses and all orders for this visit: Urticaria, acute - Spoke with PCP. Agreed with plan for oral steroids although this is likely to decrease immune response of vaccine Urgent referral to allergy placed RETURN VISIT: As needed I spent 25 minutes with the patient, of which 25 minutes were spent reviewing data, counseling and coordination of care. Specifically we discussed my impression of the etiology of the patient's symptoms, interpretation of test results, management plan, and acute symptoms for which to seek immediate medical attention. I have counseled about COVID19 ? specifically advising on social distancing, hand washing, staying home when sick. I also provided them with the campus resource line Electronically Signed by APRN, April 9, 2021

itchy, hive like rash on the arm of the injection. rash is present on the underside of my upper arm and goes onto my upper ribcage

Intense soreness throughout my whole arm, very congested head, chills, sweating, very sensitive to touch. Lasted for one day.

Low grade fever - 10 hours after vaccine skin sensitivity (not aches) - 10 hours after vaccine both of these were present in first dose but not until 22 hours after vaccination

hives; swollen face; red bumps on her face; eyes were swollen; This is a spontaneous report from a contactable consumer ( Patients Grandmother). A 20-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration was not reported), via an intramuscular route of administration as a single dose for COVID-19 immunization. The patient's medical history included allergy to pencillin. Concomitant medications were not reported. It was reported that consumer calling on behalf of her granddaughter who received the first dose of the Pfizer vaccine on Friday, after 24 hours by Saturday night she had hives, swollen face, red bumps on her face, her eyes were swollen, (all reactions on her face) it was severe for like 2 days and next three days was not so severe and began to cool down after 3 days. She had appointment on 30Apr2021 for next vaccine, is there anything she can do or take prior to the vaccine to prevent it. She had allergy to penicillin she would get hives. last time she had penicillin was about 5 or 7 years ago. Is there any information about getting the second vaccine after side effects after the first dose, A lot of people have a problem after the second dose. The outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Patient developed pain in her arm within a few hours of ingestion. When she woke up the next morning, there was a red lump at the injection site that was firm and painful. Site has continued to be painful to the touch throughout the day. Patient has not tried any remedies at this time, nor has she consulted her provider yet.

Saturday, May 1: - woke up around 9:00am with slight headache, body felt tired and sore like after doing a hard workout, injection site was very sore, took 200mg ibuprofen every 4 hours which eased symptoms - ran 4 miles at 1:30pm and body felt very tired, breathing was fine - no new symptoms until 8:00pm when I started shivering but did not feel cold, shivering stopped before I went to bed at midnight Sunday, May 2 - no significant symptoms, maybe feeling tired still

Pain and swelling at the injection site, Fever, body aches, headaches, and nauseousness lasting a full day after receiving vaccine and following. I didn't take any treatments, just rested and waited it out. Ended up getting better by day two.

Arm soreness, achy body, lightheaded, drowsy, high fever, chills, nausea, increased sensitivity to touch, rash at injection site

My left arm (where I got the injection) is swollen. Under my arm, on the upper left side of my chest is a decently large swollen lump that I believe to be my lymph node. I just got this today, 2 days after my injection, and I haven't had it looked at yet.

Fever and nausea first day after shot. Full body rash appeared second day after shot. No rash or any symptoms after first shot and no known allergies. Currently on day 5 and have a lowered appetite and digestive issues.

Bumpy, red rash covering shoulders, upper back, and part of chest. Some bumps are like small pimples. This showed up 2 days after vaccination. It is so what itchy but not terribly so.

Approx 12:25pm, patient received Pfizer Covid vaccine, assessed by RN at 12:26pm, 12:30pm patient complained of throat tightness, 12:31 patient complained of voice being raspy. Radial HR 120, pupils equal and reactive. Denies nausea. No hives/rash noted. At that time, patient admitted to previously being diagnosed with Paradoxal Reactions to Medications, Anxiety and Depression. Patient takes Zoloft and Elavil, and admits to being anxious. 12:40-12:43pm patient states that she is feeling SOA, throat tightness, dizziness. Respiration unlabored, however patient admits to becoming more anxious. Patient red faced, HR 130's. 12:44pm Epinephrine 0.1mg/0.15mg/0.3mg auto injector given IM to right outer thigh. Patient tolerated well. EMS called at 12:45pm. EMS arrived to assess patient at 12:53pm. Patient walked into ambulance. Patient did not require O2. No hives noted. Denies nausea. Patient transported to ER per protocol for evaluation.

All after second injection: Fever of 100.8. Went down to 99.8 after 4 hours. Took Tylenol to help. Headache 3 hours after second dose, has not gone away. Pain at the injection site, 2 hours after, has not gone away. Chills that started 12 hours after injection. Loss of appetite after 20 hours of injection. Back pain/body aches 8 hours after injection. Some dizziness on and off starting 20 hours after injection. Feeling weak 20 hours after injection.

broke out in hives on arm, torso, face, neck, all over her body, she was taking Benadryl, it didn't go away so three days later the doctor prescribed a steroids and the hives went away

Patient was administered her second Pfizer COVID19 vaccine. Shortly after she became dizzy and a dark rash appeared on her face. There were no signs of itching, swelling or difficulty in breathing. Pharmacy provided patient with 50 mg of diphenhydramine and called #911.

Pt received 2nd dose vax and was in observation area w/ her sister. Pt denied any reaction after first dose, did report hx of asthma.Ten min post-vax, pt called observation nurse (RN) w/ complaint of "lung pain," some SOB and abd pain. Pt had also developed hives on her chest and neck, visible to observation nurse. Pt was transferred to EMT area for assessment and observation. Pt was alert and oriented to place & time and answering qx w/o WOB or apparent distress. However, during assessment of VS, pt developed add'l hives on face, w/ eye swelling. EMTs and charge nurse recommended transfer to ED d/t multiple early sx of possible severe reaction. Pt and parent agreed. Pt transferred to Hospital via ambulance d/t risk for emergent allergic reaction.

Petechiae on hip/upper thigh area. Noticed the afternoon of May 8th. One area has a bruise whereas the other has no pain or bruise- just the red dots. The site with the bruising is tense and my stomach feels bloated. Fatigue is also a symptom I?ve noticed

Rash along neck and collar bone area, described as, "like goosebumps" by patient, and in two areas approximately 3 to 4 inches in length and 1.5 inches wide, each side of neck. Described as painful to touch. no difficulty breathing reported. Occurred on 5/7/21, and two days after second dose. Patient reported no unusual symptoms or reaction after the first dose was received. Advised to monitor, and to go to urgent care or consult with primary care physician if symptoms did not improve, or if any difficulty breathing. Attempted to call patient on 5/10/21 for follow up, and phone was disconnected after call number 1, and left a voice mail on second attempt.

About 4-5 days after my vaccine, I woke up with excruciating burning pain under my skin in my knee that felt like my leg was on fire. It lessened, but a faint pain remained and came and went for the following 24 hours. It went away for about a week, then came back. It is no longer excruciating pain like the first event which I haven?t felt since then, but it comes as a small burning sensation that occurs at random times at completely random parts of my body. It feels almost like a precise, burning nerve pain, but not pins and needles. I have felt it nearly everywhere on my body from literally my head to my toes, and almost everywhere in between. It lasts for no longer than a minute, and it only shows up in one or two areas of my body at once. It comes and goes often, so some days it?s constant and appears nearly all day, but some days I don?t feel it at all or only a small amount.

fever; Body aches; Not feeling well; She had been feeling ok all week, has not felt bad, just felt a little rundown; Sore left arm where injection site was; This is a spontaneous report from a contactable consumer (daughter). A 20-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: EL9269; Expiration Date: 03May2021), dose 1 via an unspecified route of administration, administered in Arm Left on 07Feb2021 at 10:30 (at the age of 20-year-old) as 1st dose, single for COVID-19 immunization. The Patient's Medical History was not reported. Family medical history of the patient was not reported. Concomitant medications were reported as none. The Patient has received prior vaccinations (within 4 weeks), prior to the COVID vaccine reported as none. Additionally, vaccines administered on same date with the Pfizer vaccine considered as suspect was reported as None. Consumer stated that her daughter received the first dose of the pfizer covid 19 vaccine while at school on 07Feb2021. The patient woke up around at 08:00, 15Feb2021 with fever, body aches and not feeling well. She had been feeling ok all week, had not felt bad, just felt a little rundown since around 08Feb2021; but she was a college student so that was not shocking. She had sore left arm where injection site was with onset around 08Feb2021. Consumer wanted to know if those were common to get side effects from the Pfizer COVID-19 Vaccine this long after vaccine or could she (patient) had COVID-19, should they had her tested for COVID-19. Consumer stated, they kind of anticipated side effects immediately following the vaccine; but unsure about side effects that was long after she was administered the Pfizer COVID-19 Vaccine. On 15Feb2021 at 08:00, the patient experienced fever, body aches, not feeling well; on 08Feb2021, felt a little rundown and sore left arm where injection site was. The patient did not require any visit in emergency room or physician office for events. The reporter classified the patient was not hospitalized. The patient underwent lab tests and procedures which included body temperature: 101 Fahrenheit on 15Feb2021 and Saliva tested for COVID-19: negative on Feb2021, Negative for COVID-19 at school every other day. The outcome of the event 'Sore left arm where injection site was' resolved on unspecified date of Feb2021, event 'Felt a little rundown' was with unknown outcome and all other events was not recovered. Follow-up (15Feb2021): This is a follow-up spontaneous report from a contactable consumer. event information and patient information was added. Follow-up (12May2021): Follow-up attempts completed. No further information expected.

exteremely heavy period like never before.period was 20 days early. period started within 24 hours of the time the vaccine was taken. extremely sore and itchy arm even a week after the vaccine. the period side effects of the vaccine are quite common and are not listed as a side effect from the FDA.

Patient reports presenting with flushing and itchiness/rash within several hours of receiving the vaccination. Patient denies angioedema, trouble breathing, nausea/vomiting.

Redness to chest & itchy all over. Pt has history of hives with codeine, tylenol. BP 120/79; HR94; RR 20. Pruritis resolved 20 minutes after Benadryl given

Developed pruritis and rash on forearms. No throat symptoms, chest tightness, shortness of breath, nausea or vomiting. Rash improved and itching decreased without treatment.

Patient developed chills, shaking and shivering about 15 minutes after her shot. No fever. No allergic symptoms such as throat tightness, SOB, itching, rash or hives. No wheezing. Symptoms resolved slowly and progressively over about 50 minutes of observation. She has similar symptoms at home about 24 hours after her first shot. VSS stable throughout. Initial BP 111/72, pulse 102, O2 sat 99%. No orthostasis at dismissal. Nothing to suggest vasovagal or allergic reaction. Likely anxiety reaction

Face is a little puffy, but it feels itchy all over my face. When trying to sleep last night, a little over 12 hours after the shot I had the chills and 3 hours later I woke up with a fever of 101.8. It?s a couple hours later and I still have the fever.

Standard muscle soreness at injection sight then bruises started to appear across my body. I had two appear the day I got the second shot and within 24 hours I had 7 bruises. Wednesday night (48 hours after) I counted 11 bruises. Two on injection (left) arm and most others in the left leg and a few on the right leg. Mostly smaller than a quarter and green in color. One very high on the upper inner thigh started as dark purple about an inch across.

Allergic Reaction itchy (Rash) located on both arms, chest, upper back, and ribs/stomach area about 15-20 minutes after receiving the 2nd dose. Took Benadryl pills (2) and symptoms appeared to clear and get significantly better.

Redness + irritation at injection site lasting 2-3 days, hard lump formed with tenderness at injection site lasting 2+ weeks (ongoing).

Since the 2nd dose of my COVID-19 vaccine, I have been reacting significantly more to mosquito bites. The site of the bite swells large and becomes red. It causes pain at the site of the bite and in the nerves located in the portion of my body I received the bite.

flu like symptoms; really bad injection site burning; really bad injection site burning, stinging, and pain; really bad injection site burning, stinging, and pain.; left axillary lymph node was swollen and painful to the point where it impeded movement; left axillary lymph node was swollen and painful to the point where it impeded movement; left axillary lymph node was swollen and painful to the point where it impeded movement; numbness in left wrist and elbow; This is a spontaneous report from a contactable Other HCP (reported for herself). This 20-year-old female received her second dose of BNT162B2 (Solution for injection, lot number: unknown) via an unspecified route of administration in left arm on 18Jan2021, as a single dose for Covid-19 immunization. Medical history and concomitant medications were not reported. On 18Jan2021 in evening, she experienced really bad injection site burning, stinging, and pain. Also, left axillary lymph node was swollen and painful to the point where it impeded movement. Also, had numbness in left wrist and elbow. A few days after the vaccine she experienced flu like symptoms and the numbness still continued but was better and the left lymph node was still really swollen and painful. The outcome of the event of numbness in left wrist and elbow was recovering. The outcome of the events of really bad injection site burning, stinging, and pain, left axillary lymph node was painful, left axillary lymph node was painful to the point where it impeded movement, and flu like symptoms was unknown. The outcome of the event of left axillary lymph node was swollen was not recovered. Information on the lot/batch number had been requested. Follow-up attempts were completed. No further information was expected.

I developed hives and woke ip covered in them. I ended up in the ER a day after my second vaccine having a severe allergic reaction. I ended up having to visit a dermatologist through an emergency appointment a week after my second vaccine. She diagnosed my hives as a chronic result of my COVID vaccine.

sharp pain; felt like it was stretched tight or stiff muscle; felt like it was stretched tight or stiff muscle; usual arm pain at injection site; Headache; Chills; Fatigue; This is a spontaneous report received from a Pfizer sponsored program. A contactable consumer (Patient) reported that a 20-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/ Lot number and expiration date: Not reported) via intramuscular route of administration in left arm on 23Apr2021 15:25 at single dose for covid-19 immunisation. Medical history included diagnosed allergies, compromised immune status, respiratory illness, chromosomal abnormalities, endocrine abnormalities, genetic / (including diabetes) and obesity. The patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (Solution for injection, Batch/Lot: ED8734) intramuscular (at the age of 20 years) in left arm on 02Apr2021 at 16:30 for covid-19 immunisation and experienced Pain at left arm injection site. The patient experienced the "usual arm pain at injection site which started on 24APR2021 and went away a few days later. On 07MAY2021 having a new pain, that has been persisting since then, it is a sharp pain. On 24Apr2021, the patient experienced headache at 04:00, chills and fatigue at 01:00 or 02:00, Pain in left arm at injection site at 04:00. The patient later stated pain starting at 04:00 pretty similar to normal pain after injection of second dose which was dull and sore and hurt to lift arm. It was the same as the first shot. It cleared up within 3 days. The patient did not notice anything else. Friday, 07May2021, the patient noticed that left arm felt like it was stretched tight or stiff muscle. If patient lifted her arm up in a certain way, very sharp pain near injection site. That has persisted. It did totally go away and restarted as a different type of pain 2 weeks after. After received second vaccine and pain in the injection site. Had sharp sensation near injection site when raising arm. The outcome of usual arm pain at injection site was recovered on 07May2021; sharp pain, headache, chills and fatigue was recovering and felt like it was stretched tight or stiff muscle was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

pain in left arm injection site/pretty similar to normal pain after injection which was dull and sore and hurt to lift arm; This is a spontaneous report from a consumer (patient) from a Pfizer sponsored program COVAX US support. A 20-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: ER8734), via intramuscularly in left arm on 02Apr2021 at 16:30 (at the age of 20-years-old) as 1st dose single for COVID-19 immunisation. Patient medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic, chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. Patient had no family medical history. Patient had no concomitant medications. No adverse event following prior vaccination. Patient was not administered with additional vaccines on same date of the pfizer suspect. On 02Apr2021at 22:00-23:00, patient experienced pain in left arm injection site. As reported, patient had a pretty similar to normal pain after injection which was dull and sore and hurt to lift arm. No ER (emergency room) or physician's office required. The outcome of events was resolving. No follow-up attempts are needed. No further information is expected.

Where the caller had her shot there's a little bit of a bump; hurts to the touch; redness at the injection site/red; This is a spontaneous report from a contactable consumer or other non hcp (patient, self-reporting). A 20-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0172 and expiry date: unknown), via an unspecified route of administration in arm left on 03May2021 13:15 as second dose, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8737 and expiry date: unknown), via an unspecified route of administration on 12Apr2021, as single dose for COVID-19 immunisation and flu shot. On Monday, 03May2021 (Time the Vaccination Was Given: 1:15 pm), the caller received her second dose of the vaccine. The caller wanted to report that she had a little bit of a reaction. Where the caller had her shot there's a little bit of a bump that is swollen, red, and hurts to the touch. The patient was asking is this common. The patient was asking about any other people that got this reaction. The caller has been taking Ibuprofen and icing her arm and it helps but it is not going away. (Ibuprofen: expiration date Nov2021, unknown NDC, unknown lot number). The patient experienced where the caller had her shot there's a little bit of a bump, swollen red on 05May2021. Vaccination facility type was college. The adverse event did not require a visit to emergency room and physician's office. No prior vaccinations within 4 weeks. The outcome of the events was recovering. Follow up- # 1 (06May2021): This is follow-up a spontaneous report from contactable consumer. This consumer (patient) reported that: event details updated. Follow up #2 (06May2021): This is follow-up a spontaneous report from contactable consumer. No new information updated. No follow-up attempts are needed. No further information is expected.

dizziness; seeing spots; rash on face, arms. upper back; This is a spontaneous report from a contactable consumer. A 20-years-old (non pregnant) female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number=PF12EREL9207; Expiration date: UNKNOWN), via an unspecified route of administration in Right arm on 16Feb2021 at 02:30 PM as single dose for COVID-19 immunizations. Medical history includes known allergies to foods-bananas, pineapple. The patient had COVID prior vaccination. The patient previously received the first dose of BNT162b2 on an unknown date for COVID-19 immunisation. The patient did not receive any other vaccines in four weeks. It was unknown if COVID tested post vaccination. Concomitant medication (other medications in two weeks) included ethinylestradiol, levonorgestrel (ALTAVERA) (MANUFACTURER UNKNOWN), sertraline taken for unspecified indication at unspecified dose from an unspecified date and unknown if ongoing. On 16Feb2021 at 11:45 PM patient experienced dizziness, seeing spots and rash on face, arm and up-per back. Patient received benedryl as a treatment for the adverse events. The outcome of the events dizziness, seeing spots and rash on face, arm and upper back was reported as not recovered.

I developed shingles in my ear that led to Ramsay Hunt syndrome with facial paralysis. As an otherwise healthy, 20 year old girl it?s very rare for my demographic and should not have happened

her daughter experienced a swollen lymph node under the left armpit; bruising on the left breast.; she got lymph nodes left side, got it on left hand and lymph node is swollen under armpit; This is a spontaneous report from a contactable consumer (patient's mother) or other non HCP. reported for a 20-year-old female patient (reporter's daughter). A 20-year-old-female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on 19apr2021 as 2nd dose, single for COVID-19 immunization. The patient received first dose of vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER2613, Expiration date: unknown), via unspecified route of administration, on 29Mar2021, at first dose single for COVID-19 immunization. The patient medical history includes acne (from an unknown date). concomitant medications were not reported. On 19Apr2021, 1 to 2 days after the vaccination, the patient experienced a swollen lymph node left side, got it on left hand and lymph node is swollen under armpit, and she got bruises on her breast. The swollen lymph node under the left armpit and bruising on the left breast. symptom resolved in about 3 days, but then recurred about a month later. it was reported that symptom again appeared for the second time, the swollen lymph node under the left armpit and bruising on the left breast are much improved but have not gone away completely. patient did not received any treatment for events. Reporter enquired about the need of a third injection/booster of the Pfizer covid-19 vaccine due to the variants. The outcome of the events was unknown. Information on the lot/batch number has been requested.

throwing up; feels nauseous; fever; rash, growing on the arm she got the covid vaccine; severe cramping; pain; This is a spontaneous report from a contactable consumer (patient). This 20-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (lot number: EW01S5), dose 2, via an unspecified route of administration in the left arm on 17May2021 08:35 (at the age of 20-years-old) as 2nd DOSE, SINGLE for covid-19 immunisation. The patient's medical history was not reported. Concomitant medications were reported as none. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (lot number: EW0167), dose #1, via an unspecified route of administration in the left arm on 26Apr2021 at 08:35 as 1st DOSE, SINGLE for COVID-19 immunization and experienced no adverse effects. After the first dose of the vaccine, the patient reported being fine. After the second dose, on 17May2021, the patient reported experienced severe cramps at 10:00. The patient developed a rash on the same day at 12:00 that is reportedly growing on the arm she got the covid vaccine. At about 23:00, she could not handle the pain and was going to go to the emergency room, but her mother talked out of it and told her to sleep it off. On 17May2021 at 23:30, the patient experienced a fever. And at 00:00 on 18May2021, the patient reported throwing up. At around 02:00 on 18May2021, the patient awoke screaming in pain. It was not a period cramp. She stated she could not tolerate it. She stated the fever comes and goes. The patient mentioned every time she smells food, she wants to vomit. She feels nauseous. The adverse events experienced did not require a visit to the emergency room or to a physician's office. Clinical outcome of the event severe muscle spasms was not resolved. Clinical outcome of the remaining events was unknown.

skin rash, described as hives, that has continued to become worse and "doesn't seem to be going away; skin rash, described as hives, that has continued to become worse and "doesn't seem to be going away; skin rash, described as hives, that has continued to become worse and "doesn't seem to be going away; This is a spontaneous report from a contactable consumer (Caregiver reported for his daughter). A 20-years-old female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and expiration were not reported), via an unspecified route of administration on 18May2021 (at the age of 20 years) at single dose for COVID -19 immunisation. The patient medical history and concomitant medications were not reported. The patient had earlier received first dose of BNT162B2 (Batch/Lot number and expiration was not reported), via an unspecified route of administration on unspecified date as first dose, at single dose for covid-19 immunisation. Reporter (mother of the patient) had called on behalf of his 20 year old daughter, (name withheld), who received the, the patient had a skin rash, described as hives, that had continued to become worse and "doesn't seem to be going away." Reporter stated that he reported her reaction to their dermatologist online and read online that reaction was rare, but some people had experienced it. Re-porter had enquired about for any resources regarding the side effect that she is experiencing. The outcome for both the events was unknown. Information on the lot/batch number has been requested.

blood on the bandaid/Bleeding; feel a little sore/Soreness; This is a spontaneous report from contactable consumers (included patient) via medical information team. A 20-year-old female patient received bnt162b2 (Solution for injection), via an unspecified route of administration, administered in Arm Left on 18May2021 (at the age of 20-year-old) (Lot Number: EW0177; Expiration Date: 21Aug2021) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The patient had no history and concomitant medication. The patient had a quick concern and stated got vaccinated on 18May2021 (today) with first dose and she just looked up at her injection site little there was bit of blood, it was not bleeding but there was blood. On an unknown date in May2021, she had a little bit of blood on her bandage after she got the vaccine, but it was no longer bleeding. The patient did mention a little soreness on same date. Outcome of the events was unknown. Follow up attempts are needed. Further information has been requested.

Severe rash/like little bumps or pimples on both of her daughter's arms. Then, the same little rash got on her daughter's back; It is really itching; Daughter work up and it looks awful like welts; This is a spontaneous report from a contactable consumer. This consumer (patient's mother) reported for a 20-year-old female (reporter's daughter) patient who received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EW0172) via an unspecified route of administration in left arm on 10May2021 (at the age of 20-year-old) at single dose for COVID-19 immunisation. The patient received the first dose of BNT162b2 (Lot number EW0150) on 14Apr2021 (at the age of 20-year-old) and had tiredness. The patient did not undergo any prior vaccination within 4 weeks. The patient had a flu shot and never had a reaction other than soreness at the immunization site. Concomitant medications included vitamins and probiotics. The patient developed a severe rash in what she claims to be a severe allergic reaction 7 days after receiving the Pfizer COVID-19 vaccination. She had just broken out with it. It started 2 to 3 days before like little bumps or pimples on both of her arms at around day 7. Then, the same little rash got on her back. Then, today, her daughter worked up and it looks awful like welts. It looks like welts like maybe she got into poison oak. It was on her face, back, and really bad on her arms. It was just huge welts. It did look worse. Her daughter was really itching. They are going to treat it like chicken pox. It was just a little bit, it did not really bother her daughter, but it looked awful. She was going to give her Benadryl and do an oatmeal bath and calamine lotion. The reporting consumer added she would also ask the pharmacist what else they recommend. The events were serious as medically significant. Outcome of the events was unknown.

Site: Pain at Injection Site-Severe, Systemic: pain radiating from shoulder-Severe, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)

She was shaking really bad at 1:00 in the morning; Her daughter felt like she couldn't move; She didn't sleep very much; She started not feeling well/ She really didn't feel good; Chills; Hands were very cold/ hands were freezing and finger nails purple; Fingernails were purple; Body aches; Heart was racing very fast./Her heart was beating really fast.; Low grade temperature of 103.2 F/ temperature was 101.5 F/ Fever; Arm sore and lumpy under arm pit/ It really felt lumpy under her arm pit.; Sore arms/she couldn't touch her arm pit because it hurt so much; She said her lymph nodes under her right arm seem like they are feeling better- before, she couldn't even put her arm down because they hurt so bad; She felt so sweaty; This is a spontaneous report from a contactable consumer (Patient mother). A 20-years-old female patient (daughter) received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: ER8733, Expiry date: Jul2021) via an unspecified route of administration in right upper arm on 20May2021 13:30 as SINGLE DOSE for covid-19 immunization. Medical history and concomitant medication was not reported. Patient historical vaccination was Flu vaccine on an unknown date in Sep2020 for immunization and first dose of BNT162B2 lot Number ER8733, Expiry Date: Jul2021 on 29Apr2021 at right upper arm for COVID-19 immunization and patient experienced little sore arm but it was no big deal. On 20May2021 patient experienced sore arms, had chills, her hands were very cold and her fingernails were purple. For a 3 hour period she had low grade temperature of 103.2F. Her heart was racing very fast. The mother gave her Tylenol in 15ml liquid form at 04:00 am and the temperature went down to 2 degrees. Her heart was still racing very fast at 5am. 3 hours later at 08:00 am her temperature was 101.5 F more Tylenol was given but her heart was still racing fast. Later that day it settled down. Her temperature went down to maybe a hundred and heart rate was slowly settling down. The mother said that it was really scary. They had call the doctor on Friday and talked with the nurse two times and the nurse said that they never heard anyone experienced a fever that high with the vaccine. She is asking if this was normal and if anyone has experienced this before. She is asking if ever there would be a third or booster dose, can her daughter take it after experiencing side effects after the second dose. She went back this past Thursday 20May2021 around 1:30pm for the second dose and she felt fine. About 10 hours later that night, she started not feeling well. She had gotten her second dose 3 days before and had a low grade fever, body aches, chills and didn't feel well for 24 to 48 hours. She started not feeling well and started getting chills. She was shaking really bad at 1:00 in the morning. She really didn't feel good. She took her temperature and it was 100.5. Her hands were freezing and her finger nails were purple. Her hands were cold and she was getting a fever. She guesses that can happen. Lasted a little longer from 1:00 until about 3:30 in the morning. Caller was up with her the entire night. Her fever went up to 103.2. Her heart was beating really fast. Caller was getting really scared and was thinking about taking her to the emergency room. She thought this was really weird. She gave her Tylenol trying to hold off. She was trying not to give her too much because there are dozens of interactions. She needed to give her something. Within an hour, it brought her fever down about 2 degrees and was then around 101.5. Her heart rate was still pretty fast. Was still a bit concerned but was glad her fever went down. Other than that, she seemed fine. Her daughter was drinking a lot of water to keep hydrated and was peeing a lot because she was drinking so much water. She seemed okay after that but her heart was still beating faster. Her daughter got up, she didn't sleep very much, and got up around 8:00 am, about 4 hours after taking the Tylenol. She didn't have a high fever but it was still around 101. She gave her more Tylenol and her heart was still beating fast. Reporter did not time it to see how fast it was. She could just tell that it was beating fast, like she was doing aerobics or something. Her daughter got the shot in her right arm. It really felt lumpy under her arm pit. Caller had read that some people get that, their lymph nodes get inflamed. Consumer only gave those 2 doses of Tylenol, her daughters fever got better. Her heart rate went back to normal and she seems fine now. She said her lymph nodes under her right arm seem like they are feeling better- before, she couldn't even put her arm down because they hurt so bad. She does seem to have improved; This was last Thursday and this is Tuesday. She did call the doctors office and talked to the nurse who said she hadn't heard of a fever that high. Said that sometimes when people get a fever, their heart rate can increase and that it is not unheard of. She didn't think that she had to be seen because she was improving. It bothered her the next few days. She heard on TV that kids were getting heart inflammation. Heart beating really fast: Reporter felt her wrist and felt her heart beating really fast. Lasted a little longer, until about 3:30 in the morning. Her daughters heart was beating so fast, it felt as if she were exercising but, she was sitting still. Her daughter seems fine now and caller has been checking her every day. Arm sore and lumpy under arm pit: This happened the next morning, Friday. Her daughter felt like she couldn't move and wanted to take a shower. She felt so sweaty and she couldn't touch her arm pit because it hurt so much. Reporter had read that some peoples lymph nodes get inflamed. It seemed better as the day went on. Treatment: Had only 2 doses of Tylenol. Her daughter doesn't swallow pills, so she had given her Children's strength Tylenol that is for children ages 2-11. She had only given her 15ml, which for her wasn't a lot. It says it's for up to 80 pound kids. Gave her 15ml at 04:00 am and it did bring it down 2 degrees. She gave her the same dose at 8:00 am. It wasn't even an adult strength dose. Fever: Her daughter's fever went away. She went back to bed, she had only slept from 05:00 am to possibly 08:00am, and didn't even sleep well then. After the second dose of Tylenol, her daughter went back to bed. Later in the afternoon, when her daughter got up, it seemed like she had a fever but a low grade fever, probably around 100. She hasn't seen it go back up. It seemed like it had settled down. Caller has been checking every day. Chills: Occurred after the second dose, maybe about 10 hours after on 20May2021. Called the CDC yesterday but was not able to talk to a person. She left some messages with the vaccine adverse something but no one ever called her back. Tests: She hasn't had any blood work done recently. She had her yearly check up last September. Adverse Event: Fever, body aches, chills, shaking really bad about 1:00am. had called the doctor's office and talked to the nurse twice. Was told that if she had swelling in throat to go to the ER. Prior Vaccinations (within 4 weeks): No, her last vaccine was the flu vaccine last September. Outcome of the events sore arms, Chills, Hands were very cold/ hands were freezing and fingernails purple, Fingernails were purple, Body aches and She started not feeling well/ She really didn't feel good, Her daughter felt like she couldn't move, She was shaking really bad at 1:00 in the morning, she didn't sleep very much, Arm sore and lumpy under arm pit/ It really felt lumpy under her arm pit. and She felt so sweaty was unknown and Heart was racing very fast./Her heart was beating really fast and fever was recovered on an unknown date, She said her lymph nodes under her right arm seem like they are feeling better- before, she couldn't even put her arm down because they hurt so bad was recovering. Information on Lot/Batch number was available. Additional information has been requested.

on and off for a week after my vaccination my arms would turn red and become very itchy; on and off for a week after my vaccination my arms would turn red and become very itchy; This is a spontaneous report from a contactable consumer (patient). A 20-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (at 20-years age) as UNKNOWN, SINGLE DOSE for covid-19 immunisation. Medical history included pulmonary valve stenosis, mitral valve incompetence, aortic valve incompetence, eczema mild eczema (almost never flares up on my forearms I believe these recent rashes were caused by the vaccine) from an unknown date and unknown if ongoing. Concomitant medication(s) included fluoxetine hydrochloride (PROZAC) for unspecified indication; desogestrel, ethinylestradiol (APRI) taken for contraception (birth control), within 2 weeks of vaccination. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. On an unspecified date, the patient experienced on and off for a week after my vaccination my arms would turn red and become very itchy. It was not constant and it was mitigated by soothing moisturizer. No treatment received for the events. Outcome of events was resolved on an unspecified date. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Hives; Itching of hands/wrists; This is a spontaneous report received from a contactable consumer, the patient. A 20-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via unspecified route of administration in the left arm on 15Mar2021 at 16:30 (at the age of 20-year-old) for COVID-19 immunisation. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via unspecified route of administration in the left arm on 22Feb2021 at 16:30 for COVID-19 immunisation. The patients concomitant medication included birth control pills. The patient was allergic to peanuts and tree nuts. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccine within 4 weeks prior to the vaccination. The patient experienced hives and itching of hands/wrists on 16Mar2021 at 23:30 hours. The patient did not receive any treatment for the adverse events. At the time of report, the clinical outcome of the event hives and itching of hands/wrists were not recovered. No follow-up attempts are needed. No follow-up information is expected.

The patient presented with hives after vaccination. The clinical lead gave 25mg Benadryl and monitored the patient for an additional 30 minutes until at baseline.

stomach hurting; started not feeling good; nauseated; headache; coughing; sneezing; cold-like symptoms/cold; nose got itchy/eyes got itchy; difficulty breathing/having trouble breathing; feels weak/has no energy; She experienced chills about three hours after the vaccine.; abdominal pain; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A 20-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EW0191; Expiration Date: Sep2021), via an unspecified route of administration, in Left arm on 22May2021 at 11:30 (at the age of 20-years) as single dose for covid-19 immunization. Medical history included ongoing acid reflux in the stomach; was diagnosed about one or two years ago. The patient did not receive any vaccinations within 4 weeks prior to the administration of suspect vaccine. The patient's concomitant medications included ongoing Tri-lo-sprintec (started taking it to regulate her cycle as she had an irregular period; she started this birth control 2 or 3 years ago). On 22May2021, the patient waited 15 minutes after the shot and felt fine, but later on that day (a couple of hours after) she got chills (about three hours after the vaccine). She stated she had normal side effects and did not think anything of it. On Sunday (23May2021), she had difficulty breathing (trouble breathing) and felt weak (feeling very weak and has no energy). She voiced it's hard for her to wear a mask. When she had to put a mask on it really felt like she could not breathe, and the air feels stuffy especially if she wears a mask; every couple of seconds she had to wear the mask under her nose because she could not breathe. Caller stated that she did not have this problem before receiving the COVID vaccine. On Monday (24May2021), she felt like she was coming down with a cold. Caller stated that she thought that might be her trouble breathing was from her cold-like symptoms, but she does not think it was, because she was not experiencing any cold-like symptoms on Sunday and was only having trouble breathing. She experienced coughing, sneezing, itching eyes/nose, chills, and headache. On Wednesday (26May2021), she started feeling nauseated (got very nauseous), not feeling good, she was getting a headache and had caught a cold. Caller stated she did not know if it was from vaccine shot but her eyes got itchy, her nose got itchy, and she kept sneezing and coughing. Yesterday (26May2021), the chills went away, she has not had any chills today, but she does not know if she will have any from this point on. She believed that she has recovered with lasting effects. Caller stated that not feeling well was ongoing and persisting, but then stated that she feels it was worsening. Yesterday, she just felt nauseous, today she woke up with her stomach hurting very badly and abdominal pain; her weakness has continued. Yesterday she took pantoprazole for the abdominal pain and Tylenol for the pain and headache. She stated that she had a slight headache that is now coming and going, clarifies that it is persisting. Caller thought the reason that her stomach is hurting was because of her stomach acid problem. She deals with a strict diet that she must follow for things she was not supposed to have. Since she had the COVID shot, she believes it was affecting the acid problems in her stomach. Caller clarified that she was calling to see what she should do, if she should go see a doctor or if this is normal. The outcome of events Dyspnoea, Asthenia, Sneezing, Headache, stomach hurting, Itchy was not resolved. The outcome of events of Nausea, started not feeling good, Cold like symptoms was resolving. The outcome of events chills was resolved with sequel on 26May2021, and Cough resolved with sequel on 25May2021. The outcome of Abdominal pain was unknown. Information on Lot/Batch number was available. Additional information has been requested.

Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Hypertension-Medium, Systemic: Hyperventilation-Medium, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Shakiness-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic: Visual Changes/Disturbances-Severe, Systemic: Weakness-Medium, Additional Details: Patient was given the vaccination and she moved from the immunizing chair to the waiting area. While in the waiting area, the patient passed out briefly (less than 15 seconds), revived and was complaining of blurred vision and that her brain felt "funky." She then broke out in full body hives and was administered 2x25mg benadryl tablets orally. 911 was called. Patient then began complaining that her face and body felt numb and tingly all over. Paramedics arrived and took patient to the hospital.

After first shot I just had soreness in my arm. Before my second shot on 5/13 I had gotten my period 5/3. It had been tappering off by the time I had my second covid shot. When I had received my second vaccination I had zero symptoms except for a sore arm. Thought it would be the same as the first vaccine. Except that I had had my period for over a month now and my suspicions are due to the vaccine. I had to call my OBGYN about it and they also didn't know what to do. They suggested getting off of my pill for a week and see if it would "reset" anything but instead my body was reacting the same as it did when I was on my birth control. Yes, I have been on my birth control this entire time which is why it is so abnormal. The bleeding is not crazy heavy but enough to wear I would need a tampon some weeks and it likes to disappear and then reappear so I never know whether it is fully over or not. I have read other women having these issues but it only lasting a total of 2 weeks and mine has been happening since 5/13.

Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Chills-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Headache-Medium, Error: Booster Given Too Early, Additional Details: GIVEN 3RD DOSE IN ERROR. INITIAL SX: FATIGUE, HA, CHILLS, THROAT DISCOMFORT. DELAYED RESPIRATORY SYMPTOMS DEVELOPED OVER WEEKEND

I was vaccinated on Tuesday, felt normal reaction. Woke up Saturday morning with excruciating pain from my right armpit to the bottom of my rib cage. Pain was worse every time I inhaled. My breast on the right side swelled up and became red splotchy and hot. Had fever symptoms for 2 to 3 days afterwards. The excruciating pain in my chest and rib cage subsided within 6 to 8 hours. However the swelling in my right breast and redness did not subside for about three days.

Had some crazy nosebleeds beginning 4 days after my first dose. I ended up pulling a gigantic blood clot out of my nose during the first one. It was terrifying. I?ve had 6 nosebleeds since my first dose and I?ve never had issues with nosebleeds before. They last a long time too and each one comes with a clot. I also have bruises all over my legs and that have appeared randomly and if I get cut I take forever to stop bleeding.

Skin rash and ankles and hands; This is a spontaneous report from a contactable consumer (patient). This 20-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 14May2021 at 16:00 (at the age of 20-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history included hypothyroid. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID) and "BCP." The patient did not have any known allergies. On 16May2021 at 10:00 the patient experienced skin rash on ankles and hands. The event was reported as non-serious. The patient was not hospitalized for the event. The patient did not receive any treatment for the event. The outcome of skin rash was recovering. It was also reported that since the vaccination the patient was not tested for COVID-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

PT STATED 30 MINUTES AFTER RECEIVING HER INJECTION THAT HER ARM WAS GETTING ITCHY. SHE WAS TOLD TO STICK AROUND LONGER SO THAT WE COULD MONITER HER SYMPTOMS. PT STAYED AROUND FOR 20 MORE MINUTES WITH MORE ITCHING OF THE ARM AND NO OTHER SYMPTOMS. INSTRUCTED HER TO TAKE BENADRYL INCASE IT WAS AN ALLERGIC REACTION. SHE WAS COMFORTABLE GOING HOME. SHE CALLED LATER TO NOTIFY ME THAT HER FACE WAS SWELLING. I INSTRUCTED HER TO SEE A DR ASAP.

Pain, itching, and redness of left upper arm; numbness of entire arm. Improved with Benadryl 25 mg and Triamcinolone 0.01% cream. 2 days later (6/13/21) developed redness with itching and burning of the entire left breast, upper mid chest and throat. Resolved 6/17/21 after adding Prednisone to Benadryl 25 mg and Triamcinolone cream.

I was extremely itchy for 7 days, exactly. I tried taking allergy medication to relive the itching, which kind of worked, but ultimately my skin felt so irritated that I had to remove all of my clothing and lay in the bed and sleep for days, which is a weird remedy, but that was the only thing that relieved my skin irritation. A week to the day of my first dose, I felt completely fine, had no more skin irritation and was essentially back to normal.

asymmetrical rash about 5 inches in width and to 4 inches in height around both left and right breast just above the nipples. Went to Urgent Care for medical treatment. The doctor advised against future vaccine or second shot

Within a few hours of the 2nd injection, pt developed hives on her left arm. Within 24 hours, hives had spread to her arms and neck, and she developed sharply demarcated, erythematous macules in bilateral axillae. She went to Urgent Care the day after vaccination, was diagnosed with pityriasis rosea and prescribed topical and oral steroids, which she did not take. She was seen in a virtual appointment 5 days after the vaccination by myself her PCP, with persistent urticaria, diagnosed with an allergic reaction to the vaccine, encouraged to take the oral prednisone prescribed in Urgent Care to reduce the duration of symptoms.

2 weeks following vaccine developed pruritus, jaundice, fatigue, headache, elevated liver enzymes and cholestasis found to have moderate acute cellular rejection on liver biopsy in addition to cholangitis/peri-cholangitis, being treated with high dose steroids and antibiotics

Itchy all over my body/ My neck was so itchy; My skin felt like it was on fire; Burning and itchiness; Had hives all over my body; Mysterious rash with red bumps.It appeared on my thighs, calves, arms, chest, face, neck, and stomach; Petichae bruises /bruises on my body and other mysterious bruise; Severe allergic reaction; It also gave me my period which I haven't had in a year due to PCOSThis occurred for around 2-3 weeks.; This is a spontaneous report from a non-contactable consumer or other non hcp (patient). A 20-years-old non-pregnant female patient received bnt162b2 (Formulation: Solution for injection, Batch/Lot Number: ew0185), via an unspecified route of administration, administered in Arm Left on 21May2021 12:15 (at the age of 20-years-old) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included Polycystic Ovarian Syndrome. Concomitant medication included amitriptyline. On 24May 2021 the patient experienced itchy all over her body/ her neck was so itchy, her skin felt like it was on fire, burning and itchiness, had hives all over her body, mysterious rash with red bumps.it appeared on her thighs, calves, arms, chest, face, neck, and stomach. On an unspecified date in May2021, the patient experienced petichae bruises /bruises on her body and other mysterious bruise, severe allergic reaction and it also gave her period which she haven't had in a year due to PCOS this occurred for around 2-3 weeks. The patient reported that 3 days after first vaccination she started to get itchy all over body her skin felt like it was on fire and she laid in bed with ice cubes on it. Cold showers helped to ease the burning and itchiness. She had hives all over her body and a mysterious rash with red bumps. It appeared on her thighs, calves, arms, chest, face, neck, and stomach, her neck was so itchy that she accidentally scratched off a birth mark. The doctor told her to take Benadryl and applied Benadryl cream both of which did not help. She ended up at the ER where she was prescribed me 40 mg of Prednisone to take for 5 days. The rash went away as soon as she took the meds. A few days after that she got Petichae bruises on body and other mysterious bruises. She went in to see her primary care doctor who told that she had a severe allergic reaction and that it's unsafe for her to get second dose. She also got her period which she haven't had in a year due to PCOS. This occurred for around 2-3 weeks. Therapeutic measures were taken as a result of itchy all over my body/ my neck was so itchy, my skin felt like it was on fire, burning and itchiness, had hives all over my body, mysterious rash with red bumps.it appeared on my thighs, calves, arms, chest, face, neck, and stomach. The events were considered as serious (medically significant). The outcome of the events patient experienced itchy all over my body/ my neck was so itchy, my skin felt like it was on fire, burning and itchiness, had hives all over my body was resolving, for the event mysterious rash with red bumps.it appeared on my thighs, calves, arms, chest, face, neck, and stomach the outcome was resolved on May2021, for rest of the events the outcome was unknown. No follow-up attempts are possible. No further information is expected.

15 minutes after injection patient developed a rash that continued to spread. Itching but patient denied shortness of breath, swelling to lips. Patient treated with diphenhydramine 25 mg /10 ml by mouth at time 15:05. Patient symptoms resolved and discharged home after observation.

Anaphylaxis (raised heart rate, rash, nausea and vomiting, swollen lips and throat) difficulty breathing - anaphylaxis under control Cause may be a salad Breathing still doesn?t feel normal

Site: Pain at Injection Site-Severe, Systemic: enitre arm pain to the point of TEARS and unable to use arm day 2-Severe, Systemic: Headache-Severe, Additional Details: Day of Vax = Arm pain in upper arm..but NEXT DAY = entire Arm pain / unable to move it arm at all with Severe Migraine (" I get headaches but never migraines") ...pain level enough to make me cry.

hives that have formed all over her body including her face; Rash; Fever; This is a spontaneous report from a contactable consumer (patient's mother) or other non hcp. A 20-years-old female patient received second dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Expiry Date: unknown, Batch/Lot number: EN0202), via an unspecified route of administration on 13Jun2021 as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection; Expiry Date: unknown, Lot number: EN0185), via an unspecified route of administration on 23May2021 as single dose for COVID-19 immunisation. Caller states that she took her daughter to the urgent care and was surprised that the PA that saw here didn't give her a shot of cortisone or steroid. The PA stated that the shot would take away from the effect of the vaccine. Caller wants to know if she should get a cortisone shot or not. Caller was provided the following information from the attached document: People with a weakened immune system, including people receiving medications that weaken the immune system, may have a lower response to the Pfizer-BioNTech COVID-19 Vaccine. Caller wants to know what can do with hives that have formed all over her daughter body including her face. The following information was provided from the attached document: In general, local side effects; the ones you get on the arm where you got the shot (such as injection site redness and injection site swelling) were mostly mild-to-moderate in severity and resolved within 1 to 2 days. Side effects that you may experience throughout the rest of your body; (systemic side effects) including fever and chills were observed with the first 1 to 2 days after vaccination and resolved shortly thereafter. Swollen lymph nodes (lymphadenopathy), which generally resolved within 10 days, is likely to have resulted from a robust vaccine-elicited immune response. Caller wants to know that if her daughter gets a booster shot will she have the same reaction or worse? The following information was provided to the caller: The need for a booster dose of Pfizer-BioNTech COVID-19 vaccine based on duration of protection or impact of variant strains has not yet been determined. On 25Feb, Pfizer and BioNTech announced they initiated an evaluation of the safety and immunogenicity of a potential third dose of the Pfizer-BioNTech COVID-19 vaccine (BNT162b2) to understand the effect of a booster on immunity against COVID-19 caused by the currently circulating and potential newly emerging variants. It is important to have a vaccine technology that allows us to both provide boosting doses if needed and to address potential changes in the virus itself if a new variant emerges that the vaccine does not protect against. While we have not seen any evidence that the circulating variants result in a loss of protection provided by our vaccine in our laboratory studies, we are taking multiple steps to be ready in case a strain becomes resistant to the vaccine. The administration of more than a 2-dose series of Pfizer BioNTech COVID-19 Vaccine is not approved. Pfizer is unable to make any recommendations regarding administration of a booster dose of Pfizer-BioNTech COVID-19 Vaccine; Pfizer does not suggest or recommend the use of the vaccine in any manner other than as described in the authorized information. The patient PA stated cortisone would be contraindicated with the effects of the vaccine. The caller is worried and watching the patient for her breathing in case she needs to go to the emergency room. The caller feels the rash is from the vaccine. If the patient needs another booster in the future, the caller is worried that the reaction will be worse. On 13Jun2021, the patient experienced fever and rash on 15Jun2021. It was reported that The patient had the fever the same day and day after, that Sunday and Monday. Tuesday and today, the patient has a rash all over her body- arms, face, big hives on back and legs. When the patient woke up today, the rash was on the patient's face. The patient went to an urgent care center today and was told to keep taking Benadryl and if the rash is not gone in 48 hours then to come back in, but the caller was concerned that the patient didn't get cortisone or benadryl shot. The patient has been taking Benadryl every 4 hours and it has not helped with the rash. Benadryl- lot, NDC, and expiration unknown. The rash is worse today than yesterday. The PA said giving the patient cortisone would be contraindicated with the effects of the vaccine. The caller is worried and watching the patient for her breathing in case she needs to go to the emergency room. The caller feels the rash is from the vaccine. The caller was told to report this event. It was reported there was a product complaint. The patient Therapeutic measures were taken with cortisone and Benadryl every 4 hours as a result of hives that have formed all over her body including her face, fever, rash. The outcome of event fever was recovered on 14Jun2021, for event hives that have formed all over her body including her face outcome was unknown and for event rash outcome was not recovered

Patient had immunization at 5:40pm on left arm. Patient returned back at 6:40pm showing she had a bleeding (stopped at the time)and swelling at injection site. She complained that she did not have reaction on first dose. RPH cleaned up the blood on injection site and applied another bandage for for her, then informed the patient that she still can have reaction to second dose even she did not have reaction to first dose. Her swelling was localized at the injection site. She was advised to watch for any potential allergic reaction like rash, SOB or unusual swelling (anaphylaxis), call MD or 911 if severe allergic reaction occurred. Meanwhile she may use ice pack and ibuprofen to bring down the swelling.

itching all over and breaking out into hives. Arms, legs, back, neck, face; itching all over and breaking out into hives. Arms, legs, back, neck, face; This is a spontaneous report from a contactable consumer (patient). A 20-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 03Apr2021 11:00 (at the age of 20-year-old) (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient had no medical history and no concomitant medications. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive other medications within 2 weeks of vaccination. On 03Apr2021, 23:00, about 12 hours after the shot, the patient started itching all over and breaking out into hives in her arms, legs, back, neck, and face. She applied diphenhydramine (BENADRYL) cream which helped somewhat. By the morning, it was gone. When she went to get the 2nd vaccine, they wouldn't give it to her because of the reaction she had and said that the 2nd could give a worse reaction. She stated that she will play soccer in college and was required to get a full vaccine prior to returning to school in August, so she needs to know what she can/should do. Prior to vaccination, the patient was not diagnosed with COVID-19 and Since the vaccination, the patient had not been tested for COVID-19. Outcome of events was recovered in Apr2021. Information about batch/Lot number has been requested.

Pt. reports feelings of warmth/flushed, itching in face. No reports of difficulty breathing, no acute distress noted. Skin appears normal for ethnicity, however patients mother reports "her face is red". Patient was due to exit the clinic @ 1145, however kept and monitored until 1205. No difficulty breathing, no worsening of complaints, however reports continued facial itching. Patient and family advised to follow up with PCP and seek emergency treatment if symptoms continue/worsen.

The day of the shot (7/3) my left arm hurt and was sore. The next day (7/4) the left side of my body was sore. This continued until about 7/6, at the beginning of the day my arm was lightly sore, while my leg was still averagely sore. As I used and walked on my leg, by the end of the day, my leg was very sore, sorer than in the morning. The pain felt like a shot down the side of my leg. The worst pain was in my ankle and foot area. As each day passes, the sore pain seems to be getting worse. I contacted my doctor and talked to her yesterday (7/12) and she recommended some medicine that may help but advised that I report the events to you.

Patient reported after receiving vaccine that she felt tingly. Mom noticed faint red rash to her anterior neck. Patient reported that she felt "weird." No angioedema, SOB, wheezing or stridor noted. Patient had taken benadryl prior to arrival due to history of developing a rash 3 days after her previous Pfizer dose. Patient admits that she is very anxious. Due to rash, we administered solu-medrol 125mg IM and pepcid 40mg PO. VS were BP 144/90 HR 120 RR 24 Spo2. Patient very anxious appearing. Approx 10 minutes after receiving meds, patient reporting feeling slightly better. Rash appears fainter. No SOB, angioedema, stridor. Patient in no distress. Continued to monitor patient for at least 30 more minutes. Patient reports feeling much better. Symptoms continuing to improve. Prior to arrival, rash noted to be gone. No further development of symptoms. BP 133/83. HR 106. RR 18 Spo2 100%. Patient has been eating goldfish and drinking water. Reports that she feels much better. Mom feels comfortable continuing to monitor at home. If there is any concern for needing a booster dose, would advise allergy consult.

body/joint pain.; Roughly 24 hours after injection, dark bruising and a line of several yellow blisters grew vertically around injection site. Blisters continued to get bigger, filled with blood, and began to itch.; a line of several yellow blisters grew vertically around injection site. Blisters continued to get bigger, filled with blood, and began to itch; Blisters continued to get bigger, filled with blood,; Blisters continued to get bigger, filled with blood, and began to itch.; Some sites began to drain.; experienced fever; experienced fever, fatigue, and body/joint pain.; experienced fever, fatigue, and body/joint pain.; This is a spontaneous report from a contactable consumer (patient). A 20-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EW0181), second dose via an unspecified route of administration on left arm on 18Jun2021, 16:00 at single dose for covid-19 immunisation. Patient medical history included allergies to Penicillin, Reglan, Iodine, Sulfa, Gastroparesis, PCOS, Insulin resistance. Concomitant medications included medroxyprogesterone acetate (DEPO-PROVERA) on 03Jun2021 on Left arm, levothyroxine sodium (TIROSINT) 150mcg, topiramate (TOPAMAX) 100mg, Metformin 500mg. She received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was EW0173) via an unspecified route of administration on left arm on 26May2021, 16:00 at single dose for covid-19 immunisation. She was not pregnant at time of vaccination. Prior to vaccination patient was diagnosed with Covid 19. Since the vaccination patient was not tested for Covid 19. Patient reported roughly 24 hours after injection, dark bruising and a line of several yellow blisters grew vertically around injection site. Blisters continued to get bigger, filled with blood, and began to itch. Some sites began to drain. Also experienced fever, fatigue, and body/joint pain on 19Jun2021. Treatment received for the adverse event was prescribed Pepcid, Allegra & hydrocortisone cream. Averse events resulted in Emergency room/department or urgent care. The outcome of Events was recovering. Information on Lot/Batch number was available. Additional information has been requested.

Fairly severe lymph node swelling in armpit area of left arm (injection site); Hours after second dose causing significant pain/discomfort, persisting for multiple days; Hours after second dose causingsignificant pain/discomfort; This is a spontaneous report from a contactable consumer, the patient. A 20-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202), via an unspecified route of administration in the left arm on 10Mar2021 at 17:45 (at the age of 20-years-old) and a second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8730), via an unspecified route of administration in the left arm on 31Mar2021 at 14:45 (at the age of 20-years-old), each as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient had no known allergies to medications, food or other products. Concomitant medications included birth control pill for an unknown indication from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On an unspecified date in Mar2021, 2 weeks after dose 1, the patient experienced lymph node swelling in armpit area of left arm (injection site) with less severity which caused significant pain/discomfort. On 01Apr2021 at 01:00, the patient experienced the same reaction after the second dose which was fairly severe and persisted for multiple days. The patient did not receive any treatment for the reported events. The events result in a visit to the doctors or other healthcare professional office/clinic visit. The clinical outcome of the lymph node swelling in armpit, significant pain/discomfort was recovering. No follow-up attempts are needed. No further information is expected.

Temperature at 99.2 F at noon today; Moderate to severe diarrhea beginning the morning after injection.; Pain in the upper left arm around the injection site. Wosened over night.; Pain when using arm.; Light nausea; Unable to sleep on the left side because of this.; This is a spontaneous report from a non-contactable consumer, the patient. A 20-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 06Apr2021 at 12:00 (at the age of 20-years-old) as a single dose for COVID-19 immunisation. Medical history included migraines, IBS, ADHD and depression. Concomitant medications included methylphenidate 54 (MANUFACTURER UNKNOWN) and fluoxetine 50 (MANUFACTURER UNKNOWN); both from unknown dates for unknown indications. 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 pain in the upper left arm around the injection site, worsening with pressure beyond the expected level for an injection that worsened over night, pain when using arm, unable to sleep on the left side because of pain and light nausea. On 07Apr2021, the patient experienced moderate to severe diarrhea beginning the morning after injection. Despite having IBS, it was not accompanied with the intense cramps that an IBS episode usually would have. On 07Apr2021 at noon, the body temperature was reported as 99.2 F (Fahrenheit). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events moderate to severe diarrhea, pain in the upper left arm around the injection site, pain when using arm, unable to sleep on the left side because of pain, light nausea and temperature at 99.2 F was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.

nauseous; weak; no appetite; numbness on the skin of my arms and legs; I was post Ictal for 2+ hours; seizures/having 2 non epileptic seizures; dizzy and lightheaded; This is a spontaneous report from a contactable nurse (patient). A 21-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE. Batch/lot number: EK5730), intramuscularly on 28Dec2020 07:45 AM at right arm, at single dose for covid-19 immunization. Medical history was none. There were no concomitant medications. The patient was not pregnant at the time of vaccination. The patient received vaccine around 7:45 AM. Within 2 minutes she felt extremely dizzy and lightheaded on 28Dec2020. She sat down and drank some Gatorade and took deep breaths. The feelings persisted 5 minutes later. She then woke up after having 2 non epileptic seizures while still in 15m waiting period, (This included posturing and color change) a rapid response was called and she was taken to the ER. She was post Ictal for 2+ hours. Dizzy and nauseous, weak and no appetite for the rest of the day. She had no history of epilepsy. She also have numbness on the skin of my arms and legs within 24 hours of the vaccine. Onset date of all events (except dizzy and lightheaded) was reported as 28Dec2020 08:00AM. Treatment fluids, Zofran was received for all events. All event resulted in emergency room. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the events was recovered with sequel.; Sender's Comments: A possible contributory effect of suspect BNT162BW on reported seizures 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.

Patient was administered the first dose of the Pfizer vaccine 0.5mg IM Rt Deltoid this AM in the Covid-19 Vaccine Clinic.Patient waited 12 min went to change her clothes and come back to the clinic with complaints of hives and feeling warm. Patient had raised red welts on right upper arm. Patient has a history of Anaphylaxis reaction with a Meal Ready to Eat (MRE) in the past, other allergies to grapefruit seed extract with reaction of edema. Pt has no c/o of SOB or Chest pain, no other swelling at this time. Dr. notified, 0.3mg Epinephrine 1mg/mL (1:1000) given IM Left Deltoid, 25mg Benadryl IM given Rt Deltoid per MD verbal order and anaphylactic protocol. Pt transferred by wheelchair to the ER for further evaluation. Report given to ER RN.

Arm soreness at injection site, body aches, headaches. All occurred approximately 12:00pm the day after the injection and lasted 8 hours.

Pt received Pfizer-COVID vaccine (under EUA) yesterday 16 Dec 2020 at approx 1700. She did not have any immediate problems after vaccination. . She woke up today feeling achy and feverish, and measured her oral temp at 1000 as 101.4 at home. She drank fluids, but took no meds -- repeat oral temp at 1200 was 99.0. . Other sxms include sore arm at vaccination site with min redness but no swelling. . She additionally reports nasal congestion and sore throat that began 1 day prior to vaccination, that she attributed to her seasonal allergies. No meds for allergies. No cough or SOB. No headache or neuro sxms. No GI sxms. . She was concerned about fever and went to drive-thru COVID testing at approx 1300... results due back in 24h. She has no known COVID contacts. . She works in sterile processing at NMCSD with no direct patient contact usually; She is on night shift now. - Fever and achy symptoms, as above, in previously healthy hospital worker, with onset approx 18h after receipt of COVID-Pfizer vaccine, dose #1. With questionable URI-like sxms one day prior to vaccination, COVID testing was very reasonable -- and results are pending now. If COVID test negative, this most likely represents mild-moderate systemic reaction to vaccine. Advised no work this evening, rest at home, increase clear fluids, and take Motrin 400mg q4-6h as needed for subjective fever or achiness -- use/precautions reviewed. Will follow-up tomorrow with this team by phone. If vaccine reaction, expect sxms to lessen rapidly and resolve over next 1-2 days. Indications for urgent care -- including marked worsening of sxms or new sxms -- reviewed. She also has number for 24/7 Immunization Support. Will file VAERS, since work missed for sxms. Will encourage enrollment in VSAFE as well. Advised that, if mild-moderate systemic reaction determined most likely source of sxms, dose #2 of COVID-Pfizer vaccine will still generally be recommended. Pt expresses understanding and appreciation of all issues.

tested positive for Covid test; tested positive for Covid test; difficulty breathing; chills; fluctuating fever; nausea; weakness; weakness/extreme fatigue; loss of taste and smell; loss of taste and smell; muscle pain; cough; sore throat; nasal drip; dizziness; fast heartbeat; injection site pain; anxiety; crying; This is a spontaneous report from a contactable healthcare professional. This 21-year-old female patient reported for herself that she received BNT162B2 1st dose on 31Dec2020 10:00 AM intramuscular at left arm for COVID-19 immunisation. Medical history included known allergies: Penicillin and Covid-19. Concomitant therapy included BC as reported. The patient experienced difficulty breathing, chills, fluctuating fever, nausea, dizziness, weakness, fast heartbeat, tiredness, loss of taste and smell, muscle pain, injection site pain, anxiety, cough, sore throat, nasal drip, crying, extreme fatigue, Etc on 31Dec2020 at 06:00 PM. The events resulted in doctor or other healthcare professional office/clinic visit, emergency. The patient was hospitalized for 1 day and received treatment included blood thinner rivaroxaban (XARELTO) and had 2 weeks quarantine. The patient had Covid prior to vaccination and tested positive for Covid test post vaccination on 01Jan2021. The outcome of the events was not resolved. Information on Lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the suspected LOE, SARS-CoV-2 test positive and the other reported events due to temporal relationship. Of note, it is reported that the patient had history of COVID 19 infection prior to the vaccination. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, 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.

Pfizer 1st dose- Not even five minutes after receiving the vaccine I started sweating, dizziness, headache, nausea and getting hives on both arms. They made my crew take me to the ER. When they took my vitals my O2 was 88% and they put me on 4lpm, HR was upper 110s and my BP was 160s/100s... The next day I couldn?t walk, keep my eyes open, had a headache, my whole body was aching and sore. I ended up sleeping for over 20 hours that day, couldn?t eat my husband had to actually help me walk to the shower and bathe me because I kept almost passing out.

lost all motion and feeling in her right arm/no feeling in right arm or hand/no feeling in her fingers; developed a horrible rash; problems breathing; flu-like symptoms; fever; body aches; vomiting; diarrhea; still really painful at injection site; chills; This is a spontaneous report from a contactable nurse (patient herself). A 21-year-old female patient (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EJ1686/PF2), via an unspecified route of administration in right arm on 02Jan2021 13:15 at single dose for COVID-19 immunization. The patient's medical history were not reported. Allergies to medications, food, or other products was none. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Not any other medications the patient received within 2 weeks of vaccination. Facility type vaccine was workplace clinic. Caller reported to have taken the vaccine last Saturday (02Jan2021 13:15) and 2 hours (02Jan2021 15:15) after had experienced vomiting and then an hour later (02Jan2021 14:15) 3 times with diarrhea. She also experienced flu-like symptoms which included fever, body aches, problems breathing and chills later that evening. On Sunday morning (03Jan2021), patient woke up with no feeling in right arm or hand. She lost all motion and feeling in her right arm and developed a horrible rash. The rash and other symptoms have been resolved but she still has no feeling in her fingers as of the moment. Doctor on call said to rest and take paracetamol (TYLENOL) every 4 to 6 hours. Patient had feeling in arm started to come back but still really painful at injection site and still had no feeling in fingers or thumb. The patient underwent lab tests and procedures which included nasal Swab: pending results on 04Jan2021. Events result in doctor or other healthcare professional office/clinic visit. All events were reported as non-serious. Outcome of lost all motion and feeling in her right arm/no feeling in right arm or hand/no feeling in her fingers, painful at injection site was not recovered and outcome of other events were recovered in Jan2021.

Soreness at location of injection, during both vaccines on 12/22 and 01/11. Rash located on both arms, chest and back, rash occurred 01/10 and is ongoing as of 1/13/21. Swelling of face, hands, arms and ankles. Ongoing. Doctor advised these may be delayed reactions from the initial dose on 12/22.

Pfizer Vaccine. 1st dose. Rash to chest area and slight difficulty swallowing; rash "hot" but not itchy; scratchy throat; occurred 2 min post dose; Diphenhydramine 50 mg IV, methylprednisolone 125 mg IV, NS 1000 mL; Discharged on medrol dose pack; approximate vaccine and adr time.

The injection site was red, raised, warm to the touch.; The injection site was red, raised, warm to the touch.; The injection site was red, raised, warm to the touch.; This is a spontaneous report from a contactable healthcare professional reporting for herself. A 21-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EK9231/expiration date: not provided), via intramuscular route of administration, on 04Jan2021 01:00 PM (at the age of 21 years old) as a single dose in the left arm for COVID-19 vaccination. Relevant medical history included heart murmur. The patient has an allergy to sulfa. Prior to the vaccination, the patient was diagnosed with COVID-19 on an unspecified date. Concomitant medication included atenolol, spironolactone, and alprazolam (XANAX). The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 05Jan2021 at 12:00 AM, the patient experienced the injection site was red, raised, warm to the touch. The patient did not receive any treatment for these events. The outcome of the events the injection site was red, raised, warm to the touch was recovering. Since the vaccination, the patient had not been tested for COVID-19.

Had previous non- anaphylactic reaction with 1st dose of Pfizer vaccine. Consulted her physician and was encouraged to get the 2nd dose. Within 5 minutes of 2nd dose vaccination, patient experienced numbness and tingling in the face. Vital signs within normal linits, but worsening paresthesias. Sent to ED. O2 sat in ED 99%. No shortness of breath. Noted with scattered hives to torso. Given Benadryl and famotidine and improved.

Headache; body aches; joint pain; chills; fever; general malaise; dental pain; soreness at injection site; pain; Loose stools; Stomach upset; Dose Number:1/ Date of start of drug: 21Dec2020/ Dose Number:2/ Date of start of drug: 07Jan2021; Dose Number:1/ Date of start of drug: 21Dec2020/ Dose Number:2/ Date of start of drug: 07Jan2021; This is a spontaneous report from a contactable Other healthcare professional (patient). A 21-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number=EL0140), via an unspecified route of administration on left arm at 09:45 AM on 07Jan2021 at single dose for COVID-19 immunization. Medical history reported as none. Concomitant medication included ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE) and Women's Daily Multivitamin, Hair Vits. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number=EL0140), on right arm at 11:30 AM on 21Dec2020 for COVID-19 immunization and experienced only mild discomfort. The patient experienced headache, body aches, joint pain, chills, fever, general malaise, dental pain, pain and soreness at injection site, loose stools, and stomach upset at 21:30 on 07Jan2021. The events were reported as non-serious. The patient did not receive any treatment for events. The outcome of events was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the had not patient been tested for COVID-19.

Anaphylactic reaction- started shortly after. Rapid response called about 7:45. Blood pressure elevated, heart rate elevated, oxygen 90, itching face/chest with a rash.

Rash on lower legs similar to that seen with Thrombocytopenia.; Rash on lower legs similar to that seen with Thrombocytopenia.; This is a spontaneous report from a contactable Other HCP (patient). A 21-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number= EJ1686), via an unspecified route of administration at Left arm on 05Jan2021 10:00 AM at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. The patient's medical history and concomitant medications were unknown. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced rash on lower legs similar to that seen with thrombocytopenia on 09Jan2021 at time of 12:00 PM. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was not recovered.; Sender's Comments: A possible contributory effect of suspect drug on reported thrombocytopenia 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.

On 1/16/21 at approximately 8PM started to experience left axilla discomfort. Initially she thought she may have a muscle strain. On 1/17/21 reports she continued to have left axilla pain and the pain was worse. On 1/18 & 1/19 she continued to experience pain in the left axilla and now in the left arm. The injection site was normal. On 1/20 the pain continued (able to work) and now she had redness and swelling at the injection site. The perimeter of the injection site had plum size redness with some mild to moderate swelling and warm to touch. I instructed to call her PCP that she may be experiencing a localized rxn., to the COVID vaccine. has no other sx. notified her PCP and has a 3pm, scheduled ZOOM call today.

1st covid shot. 12 hours after, developed pain at injection site and muscle pain all over body. 24 hours after, developed severe headache and fatigue

Symptoms: Severe chills in the middle of the night approx. 16 hours after vaccination. Aches and feelings of general malaise accompanied by mild fever at the 24 hour mark. Fatigue lasting at least to the 36 hour mark. Moderate injection site pain for about 24 hours. Symptoms of malaise generally resolved with 400mg of Advil, fatigue continuing.