Pfizer

10 hours post injection - fatigue 12 hours fever - 100° Held for 48 hours Fatigue, aches, headache for 72 hours Lymph node on injection arm swollen and painful 72 hours later

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.

The child was administered the vaccine at about 11:15 a.m on 2/7/2021. She woke up about 14 hours later with vaccine side effects the family was prepared for, including headache, chills, nausea, vomiting and fatigue. This all resolved within 48 hours. Approximately one week later, the child woke up again in the night with severe chills in the middle of the night. It was a sudden onset following a week of feeling well. She had to sit in a warm/hot shower for an hour to get warm. She described it as "freezing to death." She has never experienced anything like this before.

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..

Right sided facial swelling started 24 hours post injection. No itching, pain or inflammation. No tongue, throat or lip involvement

Giant hives to face bilateral arms, chest, and trunk after injection. No SOB. VSS. Given Benedryl 50mg PO. Information given to DOH for allergist consult for 2nd dose.

Admitted to hospital on 4/10 with 2 day history of mydriasis, diplopia with blurry vision, dizziness and balance difficulty. Found to have enhancement of 6th and 3rd CNs on MRI. Patient continued to have blurry and double vision during her stay and mild gait instability. She developed mild frontal headache managed with Tylenol. Her exam was remarkable for mydriasis, mild lateral gaze limitation R>L, mild dysmetria, dizziness and unsteady gait without notable ataxia. No papilledema. Her reflexes were 2+ in her BL UE and LEs. Pediatric Neurology and ophthalmology consulted and followed patient. Eye exam remarkable for bilateral cranial nerve 6 palsy but no other element of CN3 palsy and bilateral dilated but unreactive pupils. Patient treated with IVIG 1mg/kg/day x2 days for likely miller fisher syndrome variant of Guillain-Barre.

Patient reports receiving the Pfizer Covid vaccine on Saturday 10, 2021 and the next day she began to feel an upset stomach, dizziness and swelling of the right side of the face.

lethary and altered mental status 2.5 weeks after COVID vaccine. Found to be septic (hypotension, hypothermia, suspected infection). Admitted to ICU. Required 15L vapotherm for respiratory support and several fluid boluses for blood pressure. Urine culture resulted positive for a bacterial infection. Started on antibiotics and improved. Concern for vaccine adverse event is low.

Pain and swelling in both feet and ankles, pain started evening of injection, swelling 2 days later. Still tender/swollen 4 days later. Headache/Nausea on day 2.

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.

Angioedema, PT reports history of recurrent angoedema approximately twice a week. She is being worked up. Pt came with Benadryl. Denied SOB, wheezing, hives, chest pain, n/v.

Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Lymph Node Swelling-Severe, Systemic: Vomiting-Medium, Additional Details: Patient experienceing muscle twitching in neck, head, face, and upper torso, pain behind both ears, and blurry vision

Patient developed fatigue and headache within 24 hrs of receiving 1st vaccine, over the next several days she developed periorbital edema and cervical LAD. 6 days after vaccine she developed fever and chills and was febrile to 103. She went to the ER and labs revealed pancytopenia. She was admitted on the evening of 4/20 and was observed for 36 hrs. Symptoms improved without antibiotics

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.

Soreness in the left arm with slight swelling. patient was complaining of hot flashes. Patient said only had a muffin and coffee to eat and drink all day. No aberrations Vitals- HR: 55 - RESP: 14 - BP: 129/85 Sp02: 99%

Came in for second vaccine and indicated on screening possible reaction to first vaccine. Mom stated this occurred that evening while watching TV. Patient stated she had some swelling in throat, face and some difficulty breathing that was relieved with benadryl.

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.

Developed headache, chills, hot flashes, body aches, burning eyes, nausea, and fatigue 4 hrs after vaccination. Symptoms wax and wane in severity, but have not resolved. She was seen by pediatrics and family practice by telemedicine. Treated with Tylenol and Advil. Then presented to Hospital ER 5/3/21 with worsening fatigue and weakness. ER work-up included normal/ negative CBC, d-dimer, monospot, CMP, ESR, CK, UPT, UA, RP Covid, and Influenza. Only noteworthy finding was mildly elevated CRP at 0.51. Treated with Zofran. Outpatient follow-up work-up included normal ECG, normal repeat CBC, CMP, CK, ESR, A1C. CRP 3. EBV, CMV, Parvovirus, Covid antibody, ANA, and RF pending. She briefly D/C'd Amitriptyline, so advised to resume.

Left Supraclavicular lymph node, approximately 1 cm, mobile, non tender noted by patient 5 days after vaccination

Left supraclavicular lymphadenopathy non-painful node bulging out of collar bone on the same side as vaccinated arm. Will follow up with pediatrician on Monday.

Swollen glands in her neck, no fever, pain or difficulty swallowing. She was seen by her pediatrician a week later and ENT today. The swelling has not gone down. She will follow up with the ENT in 4 weeks for observation unless it worsens and it was recommended to delay the 2nd shot.

1 cm mass; inflamed supraclavicular lymph node on left side/nodule; This is a spontaneous case received from a contactable consumer (patient's mother). A 16-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 19Mar2021 at 11:30 (at the age of 16-years-old) as a single dose on the left side for COVID-19 immunization. Medical history was none. 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 had not been diagnosed with COVID-19 prior to the vaccine. The patient did not take any concomitant medications. The patient did not have any allergies to medications, food, or other products. On 25Mar2021, the patient experienced an inflamed supraclavicular lymph node on left side (same side as vaccine administration). On 26Mar2021, the patient visited her primary care physician (PCP) as a result of the event. The physician documented a 1 cm mass. The patient was referred to another doctor for follow-up. On 07Apr2021 the patient saw another doctor who reviewed the case. The patient underwent lab tests and procedures which included a COVID-19 nasal swab on 25Mar2021 with result of negative, chest X-ray on 26Mar2021 with results of "clear" and lab work on 07Apr2021 with results of "clear." The patient did not receive any treatment for the events. The patient was told to follow-up in six weeks if the nodule was not gone. The outcome of inflamed supraclavicular node was not recovered. The outcome of 1cm mass was unknown. The patient received dose 2 of BNT162B2 on 09Apr2021 at 13:30 and was told to contact the doctor with any changes in the lymph node (smaller, larger, etc.). No follow-up attempts are possible; information about batch/lot number cannot be obtained.

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.

Patient started swelling in the left hands on Saturday May 08th and inflammation in the bowel during Monday morning May 10th. She was not able to eat and had nausea. Patient stayed at Hospital until May 13th and got many exams as endoscopy and colonoscopy and did not find any reason for such inflammation. Also, blood exams were ok. The swelling in the hands combined with inflammation on the bowel sound suspect of reaction of Pfizer vaccine as there is no event close to this date to create abnormal effects of swelling and inflammation.

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.

Immediately after the shot she had a bad headache and approximately 30 to 35 minutes later dizness, chills, and throat restriction (anaphlaxis), extreme muscle soarness( any sort of touch was extremely painful, and she couldn't move her neck, it hurt to move from side to side. Her legs began to feel extremely heavy and hard to move. These symptoms seemed to last for approx 30 minutes. Headache didn't subside until later in the day, it did lighten up.

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

Swollen Lymph Nodes, 16 hours after injection, Rest, Fluids, Benedryl 10 mg - Symptom persists Itchy Throat, 8 hours after injection, Rest, Fluids, Benedryl 10 mg - Symptom persists Low-Grade Fever, 30 hours after injection, One dose of Tylenol - Symptom persists Malaise, 8 hours after injection, Rest and Fluids - Symptom persists

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

48hrs post-vaccine began with polyarthralgia, progressed to myalgias, arthritis, weight loss, abdominal pain/diarrhea, mucosal ulceration, and dyspnea, now admitted for evaluation which is suggestive of systemic lupus erythematosus.

Knumbness and tingling in fingers and toes. Both feet knumb. Large swollen lump under armpit on same arm as injection.

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.

Vaccine administered at outside facility. Patient is a 16 yo girl, admitted on 4/19 with myocarditis, s/p IVIG (4/19) after presenting with progressive new onset chest pain. She was in usual state of health up until 2 days ago when she started developing body aches, and chest pain. Patient received her 2nd Pfizer COVID vaccine last week (4/15). No known history of COVID infection. Parents brought her to the ED yesterday after she complained of dizziness, SOB, chest pain, and had a near syncopal event. EKG showed non-specific ST abnormalities with labs showing elevated troponin, mildly elevated CRP, normal CXR, negative COVID PCR. Denies fever, GI symptoms, GU symptoms, headache, rash. Once transferred to our PICU, she was worked up for myocarditis vs MIS-C. Troponin has been trended q6 and is trending up (now 11). Of note, there have been no fevers. Patient is a 16 yo girl, s/p admission (4/19-4/23/21) with myocarditis, s/p IVIG (4/19), has now been readmitted on 5/10 with myocarditis after presenting with headache and neck pain for 2 days. Following discharge from the PICU on 4/23, patient states that symptoms have lingered (low grade fevers, feeling tired, on and off chest pain). After developing a progressive headache and neck pain, she came back to the ER for re-evaluation. Upon readmission, her troponin was elevated (2.06 on 5/10). Her CBC and CMP were reassuring. Blood culture collected on 5/11 and urine culture collected on 5/10. ID consulted for workup.

Patient developed left sided chest pain that lasted for approximately 12 hours. It then improved but she still had it with lifting heavy objects. Was seen in clinic. Went home and has follow-up with Pediatric Cardiology tomorrow.

Fever 37.5C, fatigue, headache, swollen lymph nodes, back of the neck pain, stomach ache, pale complexion. Missed school, stayed in bed at home until symptoms resolved.

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.

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

Lump under armpit; This is a spontaneous report from a contactable pharmacist from a Pfizer-sponsored program . A 16-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm on 15May2021 10:46 (Batch/Lot Number: EW0182; Expiration Date: 31Aug2021) as single dose for COVID-19 immunisation. Patient's Medical History (including any illness at time of vaccination) was none. There were no concomitant medications. No additional vaccines administered on same date of the Pfizer suspect. The patient did not receive prior Vaccinations (within 4 weeks). And had no AE(s) following prior vaccinations. Family Medical History Relevant to AE(s) was unknown. About a week after first dose (May2021) of Covid-19 vaccine administered on 15May2021, the patient developed the lump under her armpit. AE(s) did not require a visit to Emergency Room/ Physician Office. The patient wanted to know the treatment for this lump. The reporter did not know if the lump under the patient's armpit had improved, persisted, or worsened. Reporter assessed the event as non-serious. There were no Investigation assessment and no relevant tests. Outcome of the event was unknown. The reporter assessed the relatedness of drug to reaction(s)/event(s) by Global Introspection method as Related.

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 admitted with myocarditis s/p dose #2 of the Pfizer COVID-19 vaccine. At the time of the report, she is still hospitalized. From EHR note: Patient was in her usual state of health when she received her second dose of the Pfizer mRNA Covid vaccine on 6/3. She experienced mild myalgias in the day following the vaccine. However, on 6/5 she developed new severe substernal chest pain, dizziness, and dyspnea. Pain radiated to her throat. Given severity of pain, she presented to the emergency department. In the ED she was afebrile, tachycardic, and initially hypertensive. Labs demonstrated WBC 10.9 (N 49, L 27), Hb 11.7, PLT 315. ESR 25, CRP 7.61. Troponin T was mildly elevated at 0.08, consistent with mild cardiac inflammation. SARS-CoV-2 PCR and antibody testing were negative. An EKG was normal. However, an echo demonstrated low-normal LVEF (55%). Otherwise, patient denies nausea, vomiting, diarrhea, cough, runny nose, conjunctivitis, new rashes, arthralgias. Patient was admitted to the cardiology service for further monitoring. Following admission, she was started on ibuprofen. She notes that her substernal chest pain has improved somewhat since admission. Differential for patient's presentation includes infectious, post-infectious, and non-infectious causes of myocarditis. Although post-vaccination mild myocarditis seems likely, we agree with the infectious workup already undertaken, and recommend additional EBV and CMV PCR testing.

chest pain; body aches; dizziness; SOB; near syncopal event; an EKG showed non-specific ST abnormalities with labs showing elevated troponin,; mildly elevated CRP; Upon readmission, her troponin was elevated (2.06 on 5/10); myocarditis; This is a spontaneous report from a contactable nurse. A 16-year-old female patient (pregnant: No) received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), at the age of 16-year-old, via an unspecified route of administration on 15Apr2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine, unknown if any other medications the patient received within 2 weeks of vaccination. Known Allergies: NSAIDs. On 19Apr2021, the patient experienced myocarditis, chest pain, body aches, dizziness, SOB, near syncopal event, an EKG showed non-specific ST abnormalities with labs showing elevated troponin, mildly elevated CRP, with outcome of recovering. Upon readmission, her troponin was elevated (2.06 on 5/10) on 19Apr2021 with outcome of recovering. Seriousness criteria-Caused/prolonged hospitalization. The patient was hospitalized for myocarditis from 19Apr2021 to 23Apr2021. The patient was hospitalized for other events for 6 days. The adverse event result in Doctor or other healthcare professional office/clinic visit. Emergency room/department or urgent care. Clinical course as follows: patient is a 16 yo girl, s/p admission (19Apr-23Apr2021) with myocarditis, s/p IVIG (19April) after presenting with progressive new onset chest pain. She was in usual state of health up until 2 days ago when she started developing body aches, and chest pain. Patient received her 2nd Pfizer COVID vaccine last week (15April). No known history of COVID infection. Parents brought her to the ED yesterday after she complained of dizziness, SOB, chest pain, and had a near syncopal event. An EKG showed non-specific ST abnormalities with labs showing elevated troponin, mildly elevated CRP, normal CXR, negative COVID PCR. Denies fever, GI symptoms, GU symptoms, headache, rash. Once transferred to our PICU, she was worked up for myocarditis vs MIS-C. Troponin has been trended q6 and is trending up (now 11). Of note, there have been no fevers. Upon readmission, her troponin was elevated (2.06 on 10May). It was unknown prior to vaccination the patient diagnosed with COVID-19. Since the vaccination, the patient tested for COVID-19. covid test type post vaccination: Blood test. covid test name post vaccination: SARS COV2 ANTIBODIES QUALITATIVE on 19Apr2021, covid test result: Positive. covid test type post vaccination: Nasal Swab, covid test name post vaccination: Respiratory Virus Panel by PCR on 19Apr2021, covid test result: Negative. Information on the Lot/batch number has been requested.; Sender's Comments: The reported myocarditis with chest pain, body aches, dizziness, SOB, near syncopal event and the abnormal lab data were possibly related to the bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), considering temporal relationship and the inflammation features. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.

Patient vaccinated on 5/28. She reported having pleuritic chest pain and hemoptysis 3 days after that lasted about a week. Then after she developed right leg pain and swelling x 3 days. Seen at our ER 6/11- studies show DVT of the common femoral vein and other veins of the right lower extremity. Also had b/l pulmonary emboli. Started on lovenox treatment and pending thrombectomy by vascular surgeons in 2 days. (In addition she also had admitted to OCP use for a month prior to this event; no reported FH of clotting disorders)

Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Additional Details: bp was 105/78 and hr was 85

Unable to fully move left arm due to severe pain.; Supraclavicular lymphadenopathy; This is a spontaneous report from a non-contactable consumer (patient). A 16-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 22May2021 17:00 (at the age of 16-year-old) as unknown, single dose for covid-19 immunisation. Medical history was reported as none. There were no concomitant medications. There is no known allergies, no other medical history. The patient experienced unable to fully move left arm due to severe pain and supraclavicular lymphadenopathy on 31May2021 09:00. There is no other vaccine in four weeks, no other medications in two weeks. There is no covid prior vaccination. The patient did not test covid post vaccination. 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. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. AE resulted in emergency room/department or urgent care. The patient received treatment (Pain reliever) for the adverse event. The outcome of the event was not resolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Low grade fever, body aches and swollen lymph node in armpit of arm the vaccine was injected. The lymph node has been swollen for 2-3 days. She has taken Tylenol and ibuprofen to decrease the swelling

Pt developed severe abdominal pain and emesis. Pt found to have severely elevated lipase and amylase indicative of pancreatitis. Admitted to the hospital for IV hydration.

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.

Started developing paresthesias in bottom of feet 2 days after 2nd Pfizer vaccine. That progressed ascending up to legs and arms over the course of 3 weeks. She went to the hospital and was diagnosed with Gullain-Barre syndrome based on the CSF studies and MRI imaging.

18 hours after the 1st vaccine shot... healthy female while in the shower....blacked out, couldn't see, called for mother who she knew was not home, passed out, and was not coherent, felt dizzy, had a bad headache, and face was swollen, Called her doctor's office, told them about the vaccine and the incident, they said to go to the emergency room. Went to emergency room. She had a full list of tests. Was given a saline drip, hydration unit. Level V emergency code. Name vasovagal syncope, reaction to vaccine, electrolyte abnormalities, dehydration, dysthymia

weird bumps on her face and neck; weird bumps on her face and neck; This is a spontaneous report from a contactable consumer or other non hcp. A 16-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 23Jun2021 11:00 (Batch/Lot Number: EW0181) as DOSE 2, UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. Patient previously received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 02Jun2021 (Batch/Lot Number: SW0179 ) as DOSE 1, SINGLE for covid-19 immunisation. Patient took the second dose about 4 hours ago and now weird bumped appeared on her face. Caller wants to know if this is normal. At the time of this report event outcome was not recovered. No follow-up attempts are possible. No further information is expected.

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.

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.

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.

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.

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.

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

Fever of 103 F, received Tylenol, then developed tonic-clonic seizure activity for about 20 minutes (received 10mg intranasal midazolam and 0.5mg buccal clonazepam while awaiting EMS)

Lump appeared in the neck. same side as the injection Lump was visible when she woke up in the morning. lump was ~1-2cm in size The lump gradually reduced each day. Took ~1 week to resolve

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

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.

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.

Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Confusion-Mild, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: symptoms started after they had waited the 15 min in store and were well on their way home. they included: speaking overly slow or oddly, left arm tingling, chest pain/SOB, developed into shooting pain down right leg. pt laid down for nap and awoke with swollen eyelids. pt still experiencing shortness of breath and having to limit activities

Patient developed muscle pain and swelling in anterior shoulder area anterior to neck between clavicle and anterior neck , No mass but there was generalized swelling no redness

Patient had anaphylaxis with recorded trigger (Pfizer COVID vaccine). She received epinephrine onsite, and then an additional dose of 0.3mg in ED. She however, required required two more doses of 0.5mg epinephrine and racemic epi neb. She was admitted for further observation given need for multiple doses of epinephrine. At approximately 9:00 am (~18 hours post vaccine) a rapid response was called on 4/13 and patient was transferred to the PICU for further treatment. Patient also received the last dose of epinephrine 0.5mg at approximately 9:00 am (~18 hours post vaccine). Patient received famotidine 20mg IV x1 and methylprednisolone 90mg IV x2 in the PICU. Patient was discharged on 4/14 at 8:00 am from the PICU, approximately 41 hours post vaccine administration. Received a total of epinephrine x7 doses during the hospitalization.

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.

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.

At 2am 4/22 patient started to feel sick and sent a text that I didn't read until 630 as I was asleep. She had severe muscle aches, hurt to move, hurt to breathe and felt like she was having a heart attack. She felt like she might pass out and had some blurred vision. At 630am, I saw her texts and immediately brought her 2 tylenol and a large glass of water. She went back to bed. She woke up around 10:45 and was feeling decent except for a headache but no fever or anything so we went to try on some Prom dresses. At the dress shop, she collapsed and had a seizure lasting around a minute. She lost her bladder and was completely confused and incoherent. She's never had a seizure before. I scooped her up, brought her to the ER where they ran every test and scan imagineable. Full blood work up and cultures, a chest xray, a CT scan of her brain and lungs. Her temp was high 103-104 and she had full body chills and a pounding headache. Her BP kept dropping and got as low as 81/36. They threw 2 bags of IV fluids into her and admitted her to the hospital. She had also developed a heart murmur. Over the course of the night, her BP stabilized but her temp continued to spike and come back down with Tylenol/Ibuprofen. She also had IV Tordahl for the headache. Her inflammatory markers were high at 15.3 which we were told should be less than 1. They reran labs in the morning but everything can back really low which they felt was a dilution effect from all the fluids so wanted us to follow up with her primary care on Monday. On Saturday night, he lymph nodes were swollen to the size of ping pong balls but have since slowly reduced in size although still there. Her labs were better from discharge and her white blood cell count was within range and her inflammatory marker was down to 1.7. Her blood sugar was a little low. She did pass out and have seizure like response to giving blood in the doctors office, lost bladder control again, shot pupils, etc. She is still stuttering over words, has some short term memory retention and has some motor function issues which they think is a result of the initial seizure and should resolve itself over time. Her liver function tests were totally normal in the hospital but are a high now so they will be checking her out again next week.

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.

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

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

By the following morning, my daughter had a large and painful lump(s) in her armpit. We called the doctor and were told it was an adverse reaction. We were to start ibuprofen and ice, avoid any touching of the area, and monitor it for a few days. That was Monday, and it is now Friday. The lump is still there but it is slightly less painful. If it isn't better by Monday, we will see the pediatrician.

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

acute myocarditis; acute onset chest pain; admitted to the pediatric intensive care unit; about to receive IVIG. Chest pain started 5/1/20 about 2 days after her 2nd Pfizer COVID-19 vaccination

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.

Client was lightheaded post vaccine--breathing was not in distress. Client was diaphoretic and pale. Raised clients legs , propped her head up and applied ice packs to her neck. Client recovered in 10 minutes. No 911 call or meds received. Client walked out of clinic feeling "normal".

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

one week after covid #2 vaccine developed fevers, neck pain, headaches and vomiting, treated for lymphadenitis with oral antibiotics with continued fevers now x 9 days

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.

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.

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.

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 presented for second dose vaccination. Patient reported seeking medical attention for adverse effects. Patient sought medical attention due to swollen lymph nodes on neck (superficial cervical) and flu-like symptoms (fever, body aches, fatigue, nausea) following first dose vaccination. Lymph nodes prompted CT scan when checked at medical facility. Patient was not admitted as inpatient, no antibiotics were prescriber following encounter but anti-nausea medication was prescribed.

Patient received first COVID19 Pfizer vaccine on 4/18. At that time, had about 3 days of cough and chest tightness. Subsequently began having neck pain on 5/8 and received second Pfizer vaccine on 5/9. Then began having fevers (Tmax 103F), cough. Admitted to Hospital on 5/15 with respiratory failure and shock. Unclear etiology of pneumonia vs multisystem inflammatory syndrome in children (MIS-C). Did not initially respond to antibiotics so treatment for MIS-C was initiated. Now slowly improving but still hospitalized.

Tingling sensation in tongue and face. Reports swelling to left side of face with most evident swelling being to lips, cheek and eye lid. Denies any difficulty breathing or swallowing. All symptoms resolved within 24 hours, used OTC Benedryl

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.

Chest pains, difficulty breathing, outcome: diagnosed with myopericarditis and costochondritis as well as inflammation in joints. Was in the hospital for 7 days and was on IV, morphine and then switched to hydro-morph for severe pain. Was given ketorlax via Iv for inflammation as well and steroids. Has been put on steroids for 1 month, Colchicine for 3 months, naproxen for inflammation.

Multisystem Inflammatory Response to the vaccine with fever for 5 days, elevated LFT's, low Na, low platelets, elevated CPK. Patient hospitalized for 2 days.

On 5/19 she got her first Covid Vacc (Pfizer). The following day she had mild fatigue and chills, but it did not interfere with activity. Then 5/21 PM she noted a discomfort in her chest. By yesterday she had marked chills, felt burning hot, c/o a mild ST and mild nausea and abd pain. Her chest discomfort (poorly characterized in location) worsened and she was brought to ER with concerns that she had another effusion. At the hospital, she had 24 hours of fever and hypotension.

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).

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.

Fever; Joint pain; facial and tongue swelling/broken out in a rash broken out in a rash that moved to her face and lips/anaphylaxis/daughter's eye started to swell; Serum sickness; elevated CRP; Hives/an allergic reaction/lip and face swelling; This is a spontaneous report from a contactable consumer (the mother) reported for her daughter. A 17-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular, administered in left arm on 02Apr2021 10:00 (Batch/Lot Number: EN6207) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included Colitis ulcerative from 2014 and ongoing, Genetic immune deficiency, additional Information for other conditions: Caller describes it as "22q". patient was born with this but wasn't actually diagnosed until patient was 11 years old. They checked with patient's Immunologist before getting the vaccine especially with her daughter's history. Thyroid disease from 2015 to an unknown date, additional Information for other conditions: patient didn't have a thyroid- her thyroid was removed. Concomitant medications included cetirizine; famotidine; montelukast sodium (SINGULAIR); and epinephrine (EPIPEN) all taken for an unspecified indication, start and stop date were not reported; aloe vera, pramocaine hydrochloride (ATARAX ANTI ITCH LOTION) taken for itching, swelling and hives, start and stop date were not reported. The patient took first dose of Pfizer COVID vaccine on 12Mar2021 10:00 (Lot: EN6207) for COVID-19 immunization and patient had no side effects after the first dose. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations (within 4 weeks). The patient just saw her Immunologist and her Immunologist instructed her to report what is going on with patient. Caller clarifies patient's immunologist plans to call and report as well but also instructed her to call and report the side effects her daughter is experiencing. Her daughter was cleared to have the COVID vaccine. The caller explains they always check with her immunologist because of her daughter's immune issues. Her daughter received the second dose of the COVID vaccine on 02Apr2021. On the evening of 04Apr2021, her daughter broke out in hives. They didn't think it was a big deal, they thought it was just an allergic reaction. She tried Benadryl and several other things. They went and saw her daughters regular general practitioner and the doctor believed it was just a delayed skin reaction, which seems to be common with the Pfizer COVID vaccine. The doctor told her he's seen one other person with this delayed reaction. He gave her daughter a steroid injection, a Steroid Dose Pack and Pepcid. She was also placed on Benadryl as needed. About 2 weeks after this, her daughter and lip and face swelling and ended up in the Emergency Room (ER). At this ER visit, they initiated the allergic reaction protocol and it was not an anaphylactic reaction at that point. Her daughter received IV Benadryl and IV steroids, the caller is not sure what else. She confirms she has no NDC, Lot number and expiry dates for the medication her daughter received in the ER. The ER doctor contacted the Immunologist on call and the Immunologist had seen a few cases with a delayed reaction. Caller clarifies the ER doctor discussed her daughter's delayed skin reaction with the on-call Immunologist. The oncologist put her daughter on generic Zyrtec, 20mg in the morning and 20mg at night. The following week, her daughter woke her up with facial and tongue swelling. She clarifies further her daughter had fever, joint pain, and had broken out in a rash that moved to her face and lips. She immediately took her to the ER. The ER followed the whole anaphylaxis protocol and was given an EpiPen. She explains her daughter was diagnosed serum/covid sickness. This has been going on for over 6 weeks. The reaction will come and go. She was told as her daughter's body develops immunity, she is basically allergic to it. She clarifies at her ER visits, they checked her daughters liver and kidneys. It was noted her daughter had and elevated CRP, which is an inflammatory marker. The caller was told they thought her daughter had serum sickness from the vaccine which may last 4-6 weeks or it may be prolonged, so they just went with it. They told her as long as it didn't move to her lips or affect her daughters breathings, eventually it would wax and wane and go away. Her daughter started breaking out on her arms and legs and last Saturday, she woke up and her face was swelling. She clarifies her daughter's eye started to swell and her tongue. She took her straight to the ER and the ER followed the anaphylaxis protocol and injected her with an EpiPen. They contacted her Immunologist to check and make sure it wasn't anything else and consulted with the Covid Vaccine Clinic and it was found 3 other patients had this happen. No further details were provided regarding the 3 other patients. Right now, her daughter is on 4 different medications and an EpiPen. They contacted her insurance about her being placed on a biologic because not even the current medications her daughter is on is making everything going away. Caller verifies her daughter was never admitted into the hospital. When she was last seen in the ER Monday, she her daughter was monitored for 4 hours after the EpiPen was administered. The events require a visit to Emergency Room (total of three ER visits) and Physician Office. She known the last/third ER visit was Monday, 17May2021. The second ER visit was 04May2021. She believes the initial/first ER visit was probably a week or so before the second one. She clarifies she broke out in hives on 04 Apr2021 and went to the doctor on 07Apr2021 or 08Apr2021 so the ER visit was around the next week. Since her daughter had such a good response from the EpiPen the ER doctor took pictures before and after. She clarifies the name of the biologic they want to put her daughter on is Xolair, it is a monthly injection. She explains the current cocktail they have her daughter on is not working. She provides the following product information for these 4 medications and EpiPen. Relevant Tests included she knows they are testing for any other thing that it could be to rule it out. She knows they ran a CIS-tray, a complete CIQ , a Histamine release something and Tryptase. She knows they checked her CRP (inflammatory marker) because it was elevated. Every time her daughter went to the ER, they did a CBC and all of that was normal except for the CRP inflammatory marker, however her CRP was normal at the last ER visit. The outcome of events was unknown. No follow-up attempts are needed. 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.

myocarditis with ekg changes and severe chest pain requiring pediatric ICU stay. Treated with scheduled Motrin and cardiology follow up

Parent had the patient give the description: The next morning, I had sore left side/left side of neck. Later on that day, I was feeling my neck and I felt a giant lump on the left side of my neck. I thought that I had slept on it wrong. Later on, it wouldn't go away - even with massage. It was painful. It caused disturbance, I wasn't comfortable when I was sleeping. It had gotten bigger the next morning. Our doctor said that it was lymph nodes and it was a response of immune system to injection. To make sure, I'm getting an ultrasound. It has gone done but I still notice another smaller lump there still as well. (The two lumps are side by side.) For the pain and swelling, the doctor prescribed me ibuprofen. This has calmed it down. It was still a little swollen - about two weeks after. But it's going down little by little. I still feel it, but it's now very small.

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.

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.

17 y/o F with a hx of asthma and GBS presents to the ED for weakness and difficulty moving beginning on 6/7/2021. Pt got her second COVID-19 vaccination on 6/6/2021 and has had an intermittent fever since (Tmax 104 F). Pt has been taking Motrin and Tylenol; last dose was at 07:00 today. Note, pt only had a fever after the first COVID-19 vaccination. Mother reports pt's baseline includes normal range of motion. However, in 2016 pt was diagnosed with GBS and was hospitalized for temporary paralysis for 1 month. Pt was also diagnosed with mononucleosis in 2017. Mother reports pt has also had neck pain that radiates down her back, and is interacting a lot less than usual. Pt denies any confusion, but admits to a mild headache. Differential Diagnosis: Guillain-Barre Syndrome, status post vaccine, tick paralysis, thyrotoxicosis, consider meningitis and other infectious causes like UTI, URI. Patient admitted to hospital.

Lump and swelling of lymph nodes under left armpit, with tenderness. Small lump noticed the size of a marble and seems to have gotten bigger particularly after the second dose of the vaccine that was received on June 14th. still has swelling and tenderness in that area.

Large (3 cm) painful supraclavicular lymph node x 1 on the same side as vaccine sight. The patient also has headache and neck discomfort. Temp to 100.5.

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.

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)

The following day her lymph nodes under her left arm (injection side) in the armpit swelled slightly large. It was noticeable even with her arm down. The swelling took 2 days to go down. She only got a slight headache and slight ache from vaccine and no fever.

She had the vaccine on 5/16 around 10:00am. The symptoms started at 5:00pm on 5/16 exp extreme sharp chest pains with difficulty breathing. We did give her Tylenol for pain for sharp pain around 7 pm started to come back. She was taken to ER to make sure it was not related to the vaccine. At the ER she had Chest X-rays, EKG, Bloodwork and her D-Dimer test was elevated she had a CT scan done showed swollen lymph nodes on (left arm)no problems with her heart.We was told to follow up with pcp told to continue to watch her for myocarditis. She has a follow up Sonogram scheduled on 7/16 to ensure the swelling of the lymph nodes has went down.

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

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.

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.

Fatigue, enlarged left breast and lymph nodes. Dizziness, had the feeling of blacking out, headache, muscle weakness, BP was stable 58-60 when patient sitting, spikes to 100 when she stands.

FACIAL SWELLING. EYES SWELLED SHUT. TOOK DIPHENHYDRAMINE ORALLY AT 09:30PM ON 12/30/20. WENT TO SLEEP SHORTLY AFTER TAKING DIPHENHYDRAMINE AND FACIAL SWELLING WAS RESOLVED UPON AWAKENING THE FOLLOWING DAY. RESIDENT STATES SHE TESTED POSITIVE FOR COVID-19 ON 11/10/20

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

Pt presented by EMS for acute epigastric pain radiating to the back. While waiting for lab results, she was found down in her room and in post-ictal state. She was moved from an urgent care room to an ER bed and returned to near baseline when she had witnessed seizure activity and subsequently required multiple medications to break her status that lasted around 30 minutes

The next day of vaccination my lymph node was swollen. I saw a doctor the weekend after to get it evaluated to make sure it was not breast cancer related.

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.

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).

On Friday 3-19 she had a swollen lip. It went down and she had her first dose of COVID vaccine. Saturday she was well and had a fever on Sunday. Fever went away and she felt better until Tuesday when she had a high fever on Tuesday night. Wednesday she had swollen puffy eyes but they were never red in her conjunctivae. Thursday seen by Dr. Labs showed mild increase in LFTs and Cr. She had lymphocytosis and atypical lymphs consistent with a viral infection. She was negatvie for EBV and had a negative COVID swab. She does not have history of exposure to COVID a month ago. She is careful at school. They are tested frequently and no one has been sick, however one of her roommates had mono. Friday and Saturday fevers continued. Saturday repeat labs showed higher LFTs and negative CMV. ESR and CRP and ferritin are elevated. She has no rashes, cough or congestion. She is mentally clear and not light headed. She has a headache when her fever is high but otherwise is okay. No conjunctivitis, No sores in mouth or lips, and no swollen LNs.

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.

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

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.

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

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

Began to have paresthesias of L upper lip No swelling of pharynx or other signs or symptoms of anaphylaxis - no rash, nausea, vomiting, diarrhea, wheezing, dyspnea Given steroids/benadryl Swelling was stable and patient was discharged home

After the first shot on 4/4/21 i felt a little sick for a day and after 3 weeks i got a bump on my neck above my collarbone on the same side where i got my shot. After the second dose on 4/25/21 i felt very sick for about a week and the lump is still there

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.

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.

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

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

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 came in on 5/20 to receive second dose of COVID (pfizer) vaccine and her mother called on 5/21 in the morning to inform us that her daughter was having swelling in her face from the eyes down but not involving her mouth, tongue or throat. She had given her daughter ibuprofen and benadryl. I recommended she take her to the ER for further evaluation. She said she would and would contact me later to let me know how she was doing.

PT BECAME PALE AND FAINTED, FALLING FOrward OUT OF CHAIR AND HITTING HEAD ON FLOOR. SCRATHES AND BUMP Appeared on forehead. ice packs were applied to back of neck after sitting patient on floor , leaning against chair. pt sat for several minutes and felt better so she left.

Polyarthralgia significant enough to require ED evaluation for pain management (received Toradol and discharged)

Patient's mother called us on 5/28 to inform us that her daughter received the Pfizer vaccine on 5/16 and started having symptoms on 5/22: Swelling of lymph nodes, breasts, and what felt like her throat, a fever of 102F and felt like her heart was pounding. Patient's mother states that her heart is no longer pounding but is still having swelling and fever.

Patient reported swollen supraclavicular lymph node on left side. Has been swollen since first dose, remained swollen since then. RN was able to palpate it, pt reported no pain/tenderness. No other sx.

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.

One day after receiving the first dose of the SARS-CoV-2 vaccine the patient developed headache, neck pain, and fever. Her symptoms persisted for 2 more days and she then presented to the hospital where she was diagnosed with meningitis with a CSF WBC of 8. Her infectious work up of the meningitis has not revealed the cause to date.

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.

Tachycardia; Lost 14 pounds; Ulcerative colitis flare up; Throat and glands swollen; Throat and glands swollen; vomiting a lot and couldnt hold food and water down; Diarrhea; This is a spontaneous report received from a contactable consumer (reporting on herself). A 18-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0150; Expiration Date: 31Jul2021) via an unspecified route of administration in Arm Left on 07Apr2021 13:30, as 1st dose, single dose and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0171; Expiration Date: was not reported ) via an unspecified route of administration in Arm Left on 28Apr2021 12:30, as 2nd dose, single dose for COVID-19 immunization. Medical history included colitis ulcerative from 2015 and ongoing. Additional Information for Other Conditions: states was in remission for 6 years prior to her second dose of the vaccine. The patient's concomitant medications were not reported. It was reported that she had a pretty severe reaction to her second dose of BNT162B2. States she has been in the hospital for 5 days last week and has now been in the hospital for 4 days this week because of side effects from vaccine that she received on 28Apr2021 which was her second dose. She thought the side effects would go away after the first hospitalization but was readmitted. First admitted to the hospital on 01May2021 for severe reaction to the shot for 5 days then was sent home because they thought the side effects would go away but the side effects have still been heavy. She was admitted again on Friday (14May2021) to the hospital from the side effects that are continuing. States she had lost 14 pounds from the time she was home from her first visit to the hospital. Patient vomiting a lot and couldnt hold food and water down: States that right after she got the second shot a couple of hours later she vomited a lot and couldn't hold food or water down which started 28Apr2021 and that she hasn't thrown up since Friday 14May2021, but has improved. She was starting to recover from it, it was just starting to get better. The really bad diarrhea started on the 28Apr2021 and was ongoing. The doctor thinks the second dose of the vaccine caused an ulcerative colitis flare up. She noticed the tachycardia on 29Apr2021. States her resting heart rate before the vaccine was 55 on average and now her resting rate was 105-115, and when she gets up to walk around it was 140-160. States that this was what was preventing her to be able to leave the hospital now. Tachycardia was the reason for admission for the first hospitalization. she was at urgent care she was tachycardic and her throat and glands were all swollen and they thought she needed to be admitted to the hospital. Swollen glands recovered last week, either 12 or 13May2021 and was completely recovered from that. Clarifies throat and swollen glands recovered 13May2021. Her dates of admission were 01May2021- 04May2021 for tachycardia. States she was currently at hospital and was admitted 14May2021 and was still there today for tachycardia and weight loss. States the tachycardia warranted both hospital admissions but the weight loss also contributed to the second admission as well. States her current weight was 116 after losing 14 pounds. She was weighed on the 4th when discharged from her first hospital admission and she weighed 130 pounds or 59 kilograms then had a follow up appointment with her cardiologist on the 14th for tachycardia and was weighed then and was 116 pounds at that time. They then sent her to the emergency room right after that follow up appointment to be admitted. States she hasn't been weighed again during this hospital admission so she thinks her weight was the same. She coughed and said sorry something got stuck in her throat, then continued her conversation. Ulcerative Colitis flare up- states she was unsure of when it transitioned from diarrhea to this flare up of ulcerative colitis. States she has just starting getting steroids and they increased her normal medications for her condition and was starting to improve. States she has a picture of her vaccine card and the events started after her 2nd dose. They did a procedure to confirm it was flare up at around 15:00 on 17May2021, performed a sigmoidoscopy and just found her left colon and rectum were inflamed as results which was similar to the ulcerative colitis flare up. The patient underwent lab tests and procedures which included heart rate: 55, heart rate: 105-115, heart rate: 140-160 on an unspecified date, sigmoidoscopy: found her left colon and rectum were inflamed as r on 17May2021. The outcome of the ulcerative colitis flare up was recovering, for event tachycardia, diarrhea and on 29Apr2021 with outcome of not recovered , lost 14 pounds was not recovered, and for vomiting a lot and couldnt hold food and water down was unknown and for events throat and glands swollen was recovered on 13May2021.

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.

Healthy 18 yo female presented with 4 days of fever, chills, vomiting, diarrhea, headache., as well as mid-sternal chest pressure. She had lab tests as indicated below that were consistent with a diagnosis of MIS-C. She was treated with IVIG and demonstrated significant improvement in symptoms following IVIG

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.

She did experience left arm pain, headache, swollen lymph nodes, hot flashes, and feeling blah; She did experience left arm pain, headache, swollen lymph nodes, hot flashes, and feeling blah; The 18 year old daughter has experienced nausea, upset stomach (no diarrhea), and tiredness that continues.; The 18 year old daughter has experienced nausea, upset stomach (no diarrhea), and tiredness that continues.; The 18 year old daughter has experienced nausea, upset stomach (no diarrhea), and tiredness that continues.; She did experience left arm pain, headache, swollen lymph nodes, hot flashes, and feeling blah; She did experience left arm pain, headache, swollen lymph nodes, hot flashes, and feeling blah; She did experience left arm pain, headache, swollen lymph nodes, hot flashes, and feeling blah; This is a spontaneous report from a contactable consumer (Patient's Mother) via Medical information Team. The reporting mother stated that she and her two kids (son and daughter) received the first dose of the Pfizer Covid 19 Vaccine on 07June2021. Herself and her son too experienced headache, soreness in arm, and she additionally had nausea for a short period. This case is for daughter. A 18-year-old patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN0179), via an unspecified route of administration, administered in left arm on 07Jun2021 at 14:45-14:55 (Monday) (at the age of 18-years-old) as a single dose for COVID-19 immunisation. Patient has taken vaccine as everybody was getting it and was strongly suggested. Medical history included ongoing anxiety and egg allergy (reaction to egg at the age of 2 and swelled up and went through testing, she can't take a flu vaccine because it has egg in it, highly suggested to never eat an egg, she can eat cake and that has egg in it, but they do not want her to have the flu vaccine. States they have got to make sure any vaccine does not have egg in it). Patient can't take a flu vaccine because it has egg in it. Reporter stated that she panicked a bit but they told her it doesn't have egg in it, she doesn't know what the ingredients are. Patient is overweight (190- something). No familial history relevant to AEs. There was no history of previous immunization with the Pfizer vaccine considered as suspect and no additional vaccines administered on same date. Concomitant medication included vilazodone hydrochloride (VIIBRYD) taken for anxiety (started this 6-7 weeks ago), patient been on some other stuff and trying to figure that out. Sees a therapist too. Assuming Antianxiety. No prior vaccinations within 4 weeks. On 08Jun2021 (in the morning), patient had upset stomach (no diarrhea), and tiredness, left arm pain, headache. On 10Jun2021, the patient felt yucky and nauseated, lymph nodes were swollen and feels kind of blah. It was reported that the nausea has come and gone but she still complains about an upset stomach and patient has not thrown up. Those symptoms have subsided at this time. On an unspecified date, patient felt hot flashes. Patient consulted a therapist too. Patient took Advil on 08Jun2021 as a treatment as the arms were sore. Patient did not have any visit to emergency room or physician office. Reporter asked if it's normal to continue to have symptoms. The patient second dose was scheduled on 28Jun2021 and reporter asked about the chances of the same side effects with the second Pfizer Covid 19 Vaccine. The outcome of the events nausea, headache, lymph nodes were swollen, and sore left arm was recovered, while event hot flush was unknown and other events were not recovered.

A doctors office visit on 4/28. Discussed the symptoms (minimal change disease-like symptoms, possible nephrotic syndrome, possible acute kidney injury, possible blood clots).; A doctors office visit on 4/28. Discussed the symptoms (minimal change disease-like symptoms, possible nephrotic syndrome, possible acute kidney injury, possible blood clots).; A doctor's office visit on 4/28. Discussed the symptoms (minimal change disease-like symptoms, possible nephrotic syndrome, possible acute kidney injury, possible blood clots).; no facilitated urination; Severe swelling on both legs with sudden body weight increase (over 10 lbs) after about a week of second dose; Severe swelling on both legs with sudden body weight increase (over 10 lbs) after about a week of second dose; This is a spontaneous report form a contactable consumer (patient) reported for herself. A 18-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection Batch/Lot Number: EW0158) via an unspecified route of administration in arm right on 18Apr2021 as dose 2, single for covid-19 immunisation. Medical history included none history. Concomitant medications include levocetirizine (LEVOCETIRIZINE Batch/Lot number was not reported) via an unspecified route of administration from an unspecified date, at 5 mg for an unspecified indication. Historical vaccine includes bnt162b2 (Dose 1 lot number=EP7534 vaccine location=Right arm) on 26Mar2021 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 23Apr2021, the patient experienced a doctors office visit on 28Apr. Discussed the symptoms (minimal change disease-like symptoms, possible nephrotic syndrome, possible acute kidney injury, possible blood clots). Started to take 20mg furosemide for 7 days from 28Apr and 20mg prednisone for 10 days and 20mg furosemide on 04May. Even after finishing medication, there were no changes in symptoms. Continued leg swelling and no facilitated urination. There was severe swelling on both legs with sudden body weight increase (over 10 lbs) after about a week of second dose. After finishing both, the swelling in legs subsided and weight returned to normal. About 10 days later, moderate swelling in legs returned and body weight increased by about 5 lbs. The patient visited nephrologist visit on 02Jun and was prescribed 20mg prednisone, 3 tablets every other am for 20 days. Currently, patient have been taking the medicine since 03Jun. As of now 12Jun2021, the leg swelling partially decreased and the body weight decreased by 1-1.5 lbs. The clinical outcome of all the events was not resolved.

Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Nausea-Mild, Systemic: Tachycardia-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Vomiting-Mild, Additional Details: 911 was called. Evaluated and all vitals were good. Rescue felt it was a panic attack. Mom told to follow up with ER visit- rescue offered to call ambulance but mom denied. Patient left feeling better.

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.

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.

right-sided parotitis clinically, and on Ultrasound confirmation Impression: Findings suggestive of right parotitis with reactive right lymphadenopathy. No necrosis or abscess.

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.

Face had numb feeling; Face tingly feeling; Chills; Slight swollen feeling in upper cheek; 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: E130) via an unspecified route of administration in the right arm on 04Apr2021 at 13:00 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Apr2021 at 18:30 the patient experienced that her face had a numb feeling in both of her upper cheeks. She could still feel her face but had numb/tingly feeling. Developed chills and numbness when away. The patient took Advil and chills went away but face numbness returned but not as prominent and more scattered. She reported she feels mostly better this morning just slight swollen feeling in upper cheek on right side occasionally but face looks normal. Therapeutic measures were taken as a result of events and included treatment with Advil. The adverse events did not result in doctor or other healthcare professional office/clinic visit/ emergency visit. The clinical outcome of the event face had numb feeling, face tingly feeling, chills and slight swollen feeling in upper cheek was recovering at the time of report. No follow-up attempts are possible. No further information is expected.

19 y.o. female who arrived to the emergency department for 19-year-old female with history of COVID infection several months ago was receiving her COVID vaccine this morning when she developed nausea and tightness in her throat about 15 minutes after the injection. Epinephrine was administered prior to transfer to the ED. She denies any rash. She does feel slight shortness of breath. She denies headache earache sore throat or rhinorrhea cough vomiting diarrhea fever chills or abdominal pain. She has had hives and tightness in her throat from several medications in the past including Prevacid Prilosec Zantac and iodinated contrast media. No new medications. Anaphylactic type reaction and patient advised to not receive the 2nd vaccine. PMH: Diabetes mellitus Initial Vital Signs Blood Pressure 01/25/21 0902 132/85 Heart Rate 01/25/21 0902 92 Respiratory Rate 01/25/21 0902 16 Temp 01/25/21 0925 36.6 °C (97.9 °F) Temp Source 01/25/21 0925 Oral SpO2 01/25/21 0902 99 %

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.

Fever over 100 degrees; swollen lymph nodes; unable to swallow; This is a spontaneous report received from a contactable other healthcare professional (who is also the patient). A 19-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248, expiry date unknown), via an unspecified route of administration in the left arm, on 30Jan2021 07:30, at single dose, for COVID-19 immunization, at the hospital. The patient medical history was not reported. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. Concomitant medication included an unspecified birth control medication. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2 vaccine. The patient experienced "fever over 100 degrees and swollen lymph nodes causing me to be unable to swallow" on 30Jan2021 at 22:00. No treatment was received for the events. The outcome of the events was not resolved. The reporter assessed the events as non-serious.

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.

Swelling of the face and eyes, high fever, loss of appetite, rapid heart rate. The swelling of the eyes has lasted 5 days now but the face swelling went away after 3 days. I still have a high fever on and off and the rapid heart rate went away a few hours after injections

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.

at 1pm EST on 3/19/21 patient reports onset of fatigue. then around 3pm 3/19/21 she developed nasal congestion, sore throat, increased fatigue, muscle aching generalized, backache generalized mid and lower back, chills, headaches, loss of appetite, swollen neck glands. She visited the Health Clinic on 3/20/21 at 3:40pm at which time she was noted to have temp of 100.6 and heart rate of 108. General exam indicated some tender anterior nodes, nasal mucous, and fatigued appearance.

Shaking, chills, fever, severe muscle ache, headache, very painful swollen lymph node in armpit, nausea, apetite loss

Patient was receiving her first dose of the Pfizer COVID-19 vaccination and several minutes afterwards she developed dyspnea, intractable cough, nausea, sensation of her throat closing, difficulty breathing and sensation of facial swelling. In the ED, the patient was administered epinephrine 0.3 mg IM and was given albuterol inhaler, Zofran 4 mg IV, Solu-Medrol 125 mg IV, 1 L fluid bolus and milligram Pepcid IV and 50 mg of Benadryl IV. Pt received discharge instructions and stated understanding concerning medications, follow up care and when to seek emergent care. Pt PIV removed. Pt verbally acknowledged discharge instead of signing paperwork. Pt was ambulatory to discharge with all belongings and was escorted to the front of the bldg by staff.

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.

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.

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

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.

My left side of my body, arm torso and breast, feel swollen. This started early Monday morning around 8 am and has continued.

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

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

Fatigue, Nausea, dehydration, Headache (2-3 days), Vertigo (long lasting), swollen lymph nodes (long lasting) Given Meclizine, made patient numb, switched to Valium Lasting effects still stand

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.

Very swollen arm immediately after vaccine and worsened throughout the day, inflamed and painful joints, tightness in chest

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

Sore arm, sore throat, fatigue, body aches, swollen glands, headache Took Tylenol Made symptoms less severe for a little

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

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

Pt brought to ED w/concerns for allergic rxn immediately following COVID-19 vaccine at PCP office (5/19) where w/in 15 mins, experienced significant lightheadedness, dizziness & throat swelling & itch w/wheezing. In ED, developed brief episodes of syncope and was administered EpiPen, IV fluids, solu-medrol and famotidine w/improvement. After multi doses of epi IM for recurrent symptoms throughout observation, was started on epi drip. Ultimately discharged, however, returned same night with recurrent anaphylactic rxn and was again started on an epinephrine drip and claritin. Of note, pt had previously had COVID on 1/22/2021. Pt discharged w/plans to f/u w/ allergy and immunology at Hospital.

Flu like symptoms and arm soreness started the next day. Never really subsided. Transitioned to headache, stronger body aches to the point of hurting when touched. Started a fever on 5/27. Today is 6/1 and she still has intermittent fever, aches, nausea, congestion. Started on Zithormycin by doctor. Now on day 3 with no alleviation of the symptoms. Lyme, mono, covid - negative. Bloodwork all normal except for C reactive protein which was elevated at 20.

1st day of pain: Extreme Pain in Lower Extremities (Right Leg, Right abdomen, right lower back) Swelling of Right Leg 3rd day: Admitted into the hospital after visiting the ER Acute DVT in R Leg, multiple Pulmonary Embolisms 3rd-5th day in hospital: 2 Surgical Procedures to remove blood clot, on Blood thinners for a year to life

This patient received the Pfizer COVID-19 vaccine on 05/20/21, On 05/28/21 pt brought her child in for catch-up vaccines and reported this "adverse reaction". She stated that upon waking on the morning after she received the vaccine, 05/21/21, the fingers on her right hand, excluding her little finger and thumb, were swollen and "stuck in place". Pt described what sounds like "trigger finger". She took Ibuprofen and Tylenol during the day and was back to normal the next morning. Subsequently, patient stated that on the morning of her child's vaccines, 05/28/21, she experienced this issue again on only one finger. I observed no edema and the patient appeared to move all digits on both hands without difficulty.

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.

Swollen lymph nodes under left arm , Arm of injection is L arm. In addition Rib pain across chest with pain while taking a deep breath

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.

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.

My cold sores came back even though I was taking my medication for them. I might have to change to a different antiviral.

Patient reported anaphylactic type symptoms with swelling of her throat, shortness of breath, wheezing within 15-20 minutes after vaccination. Patient was taken to ER for further evaluation.

Pt noticed the 2 gland swell at left subclavicular area up few days after the first vaccine. Per pt, it had gone down but the it still there, and it has been 3 weeks already

within 24 hours of 2nd dose patient experienced intense pain in her heart. Her pain was described as intense, sharp and dull at times. She also described a sensation of her heart skipping beats or even slowing way down "stopping" a "hollow" feeling. She also felt pain that traveled across her chest to right side.

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.

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.

High fever; Chills; Shaking; Extreme muscle pain; Painful swollen lymph node in armpit; This is a spontaneous report from a non-contactable consumer, the patient. A 19-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 01Apr2021 at 08:00 (at the age of 19-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. 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 not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Apr2021 at 20:00, the patient experienced shaking, high fever, chills, extreme muscle pain and painful swollen lymph node in armpit. 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 shaking, high fever, chills, extreme muscle pain and painful swollen lymph node in armpit was not resolved at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Swollen L clavicular lymph node 3 x 2 cm; This is a spontaneous report from a contactable healthcare professional (patient). A 20-year-old female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1685; Expiration date was not reported) on 28Dec2020 (08:30) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization at the hospital. Medical history included asthma; allergies with raw fruits and vegetables; allergies with almonds; and allergies with shellfish. Concomitant medications included venlafaxine; and ethinylestradiol, norgestimate (ORTHO TRI-CYCLEN). On 03Jan2021, the patient had swollen left clavicular lymph node (3x2 cm). The adverse event resulted in doctor/healthcare professional office/clinic visit and emergency room/department or urgent care. The patient did not receive any treatment for the adverse event. The patient was not diagnosed with COVID-19 prior to vaccination. COVID test was negative on 01Jan2021. The outcome of the event, swollen left clavicular lymph node (3x2 cm), was recovering.

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.

Caller state that first vaccine 12/22 caused fever 100.0, fatigued, muscle aches, pain in arm pit on the vaccinated arm.. Caller went to doctor diagnosed with swollen lymph nodes lasting 12 days. Second Vaccine 1/12 caused high fever, headache, muscle aches and fatigue. Caller used Tylenol and went to be tested for corvid and results were negative. Caller stated that she still does have some numbness in the hand with the swollen lymph nodes. Caller completed vaers report over phone.

A day prior to getting the second vaccine (1/31/2021) my left middle toe, and right toe became very painful to walk and move when I got out of bed. They were swollen and red (2/4/2021). They are slightly less swollen now, but still are swollen and at time painful to move.

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.

Swollen L axillary lymph nodes 24 hours after receiving vaccine in L deltoid.; This is a spontaneous report from a non-contactable healthcare professional, reporting for herself. A 20-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were unknown), via an unspecified route of administration at the left deltoid on 23Jan2021 10:00 at a single dose for COVID-19 immunization. Vaccination was done in a Pharmacy/drug store. Medical history included allergies: penicillin (PCN) from an unknown date and unknown if ongoing. The patient was not pregnant. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 at the left arm on 02Jan2021 11:00 for COVID-19 immunization. The patient experienced swollen left axillary lymph nodes on 24Jan2021 07:00 (reported as 24 hours after receiving vaccine in left deltoid). No treatment was received. It was unknown if the patient had COVID prior vaccination. The patient had not had COVID tested post vaccination. There was no other vaccine in four weeks. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

swelling to the base of the neck and left side of face. Patient states she does have a little burning at the site of the swelling just above her clavicle. Patient also reports some mild swelling to the left side of the face. Patient denies any pain, redness, or swelling at the injection site. Patient states that she is taking Tylenol and Aleve to treat the discomfort and has provided minimal benefit. Patient denies any is swallowing or fever. She denies any other symptoms.

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

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.

barely able to stand; swollen lymph nodes; irregular heartbeat; severe upper back and neck pain; severe upper back and neck pain; She has barely been able to move for several weeks; dizzy; vertigo; headache; This is a spontaneous report from a contactable consumer, the patient's parent. A 20-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown ), via an unspecified route of administration on 25Jan2021 at 10:30 AM (at the age of 20-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history included allergy to eggs. Historical vaccination included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown ), via an unspecified route of administration on 04Jan2021 at 10:30 AM (at the age of 20-years-old) in the left arm for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The vaccine was administered in a hospital. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The reporter explained that the patient's adverse events "started as expected" with a headache side effect (date not specified), however two days after the vaccine, while working as an EMT the patient became very dizzy and had to stop work. She remained dizzy, like vertigo, the next day but attempted to go to work. Her co-worker could see she wasn't right and took her to the hospital. The patient spent two days in the hospital, barely able to stand, getting a head MRI with contrast, evaluated for vertigo, blood tests, and they did not find anything and gave her vertigo medicine and sent her home. She has since had shifting symptoms, swollen lymph nodes, irregular heartbeat, severe upper back and neck pain. She has barely been able to move for several weeks and has seen an ENT doctor, another emergency doctor, and her regular doctor. None have found any other cause and have tried treating her with steroids. The events were treated with Meklazine and unspecified steroids. Lab data included SARS-CoV-2 test COVID 19 testing on 28Jan2021 which was negative. The clinical outcomes of headache, dizziness, vertigo, difficulty standing, swollen glands, irregular heart rate, back pain, neck pain and unable to more for several weeks were reported as not recovered. The patient was tested for COIVD-19 after the vaccination, on 28Jan2021, and was found to be negative.

Swollen and painful lymph nodes in the left arm where the shot was received.; Swollen and painful lymph nodes in the left arm where the shot was received.; This is a spontaneous report from a contactable healthcare professional (patient). A 20-year-old female patient started received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration at the left arm on 07Jan2021 12:30 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient experienced swollen and painful lymph nodes in the left arm where the shot was received on 09Jan2021 13:00. Happened after the first dose and the second dose and have not left. The patient did not received any treatment for the events. The patient underwent lab tests and procedures which included COVID-19 test Nasal Swab: unknown results on 30Jan2021. The outcome of the events was not recovered. Information on the lot/batch number has been requested.

Fatigue, left arm swelling, left arm pain/soreness, nausea, stomach pain, headache, and severe vomiting

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.

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

Arm soreness occurred about 15 hours after injection. At about 20 hours, I experienced fatigue, dizziness, and body aches. I got stung by a bee in my upper chin near my lower lip about 3 hours after injection so I don't know what symptoms are caused by what but I also experienced a lump in my right lymphnode.

Fatigue for over two days, stiff arm for over 48 hours and a lump on neck near shoulder and lymph node swelling.

Patient reports feeling of swelling in the left hand ~25-30min after 2nd dose Pfizer covid vaccine administration. She stated this occurred with first dose and resolved when given Benadryl. I gave the patient 25mg PO Benadryl at 1550 which she states improved the swelling feeling within 10 min. She remained under my observation until 1620. Vitals remained stable and PE findings WNL. She assured me she does get drowsy side effect from Benadryl and was able to drive herself home.

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

fainted/blacked out; fainted/blacked out; Fell on floor; Tired; achey all day; Face hurt and swelling from fall; Face hurt and swelling from fall; This is a spontaneous report from a contactable consumer (patient). A 20-year-old female patient (age at vaccination: 20 years) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (brand: Pfizer, lot: EP7533) in left arm on 31Mar2021 12:15 at a single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was a Clinic. Medical history was none. Known allergies was no. Patient was not pregnant at the time of vaccination. Concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There are no other medications the patient received within 2 weeks of vaccination. Patient experienced fainted/blacked out, fell on floor, tired and achey all day (Face hurt and swelling from fall), all on 01Apr2021 06:30 AM with outcome of recovering. No treatment was received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Information on Lot/Batch number was available. Additional information has been requested.

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

small clot behind my left knee; left foot had swollen; This is a spontaneous report from a contactable consumer (patient). A 20-year-old female patient received BNT162B2 (lot number: ER2613) first dose on 20Mar2021 10:15 on left arm at single dose for COVID-19 immunisation. Medical history and concomitant medications were none. Patient is not pregnant. No other vaccine in four weeks. No Covid prior vaccination, No known allergies. She took the vaccine around 10:00am and around 6:00pm (also reported as 06:30 PM) she noticed that her left foot had swollen. She consulted with her general physician and he requested that patient did an Ultra Sound exam of her left leg. The result of the exam reported a small clot behind her left knee. Therefore, doctor suggested that she reported these events to Pfizer so an evaluation is made to identify if similar events have occurred with other patients. She was concerned if she should take the second shot on 17Apr2021. AE resulted in Doctor or other healthcare professional office/clinic visit. Patient received Eliquis 5mg (two times daily) as treatment. Patient had Nasal Swab on 01Apr2021 and tested negative. The outcome of the events was not recovered.

On 04-21-2021, my muscles started to feel fatigued and I had chills. I woke up on 04/22/2021 at 5 am throwing up. I was throwing up all morning, having diarrhea, blurred vision, extreme fatigue, dizziness, shortness of breath, and tachycardia (160.)

Patient with PMH significant for asthma, allergies to shellfish and peanuts, presents to ED for evaluation of difficulty breathing. Mother reports the patient had been wheezing for the past week, and gradually worsened. Per mother, prior to arrival patient could not breath and having increased respiratory distress. Just prior to arrival the patient became unresponsive. The patient was tachycardic, tachypneic, hypertensive and hypoxic. The patient was emergently intubated and placed on mechanical ventilation. Per the patient's mother. The patient received her first dose of COVID vaccine the day before arrival to the ED. Diagnosis: Acute Respiratory Failure; Acute Asthma Exacerbation verses Allergic Reaction.

Swelling and tenderness of entire face noted the next am. Did not respond to Benadryl. No respiratory distress.

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.

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.

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.

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.

The patient was presented to ER 4/27 with progressive swelling of R arm associated with shoulder pain. Admitted to ER 4/27-4/29 admitted by the doctor for right subclavian vein thrombus, right axillary and right brachial vein thrombus and bilateral pleural blebs largest measuring 2.1cm with small pulmonary emboli within segmental artery to the right lung base posteriorly and within the segmental artery to the left lower lobe, right sided thoracic outlet syndrome She was on Heparin drip and started on Eliquis Discharged on Eliquis She was on Xulane patches for birth control and was taken off Xulane after finding the clots Also of note she received Pfizer vaccine 1 week prior to presenting to ER

Patient had a clinical illness consistent with MIS-C after the vaccine but also had confirmed COVID infection. Hospitalized in ICU with high fever, rash, cardiomyopathy (myocarditis), renal failure requiring steroids and IVIG.

1 week post vaccination, patient developed 1 left anterior cervical lymph node edema. Patient went to the ER because she was concerned and was seen/treated there and was told this can be a side effect of the vaccination and was told to come to the place she obtained the vaccine and report it. Patient reported event to urgent care clinic on 5/5/21. Reports the lymph node edema has decreased and she is in no pain, has no concerns or issues currently.

The day after her second dose of pfizer covid shot, the patient reported that she had a swelling/knot on the left side of her neck/on shoulder. She went to urgent care and was diagnosed with a swollen lymph node. She was told to apply ice packs. She reported pain and swelling 4 days after vaccine administration.

Fever the day after receiving 2nd dose on 4/29/21. Then intense stomach pain and discomfort began 4-5 days after the 2nd dose. Facial, leg, and feet swelling began 4-5 days after vaccine was given.

Swollen lymph nodes in neck which caused migraine, this lasted a day, then swollen lymph nodes in armpit still persisting today, but has improved since yesterday.

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.

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.

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.

After receiving my first dose of the Pfizer vaccine I got arm pain, headache, armpit pain and fatigue. Eight days later I developed 2 small lymph nodes; one behind my left ear and one on the back of my head.

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.

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.

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.

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.

05/04/2021 around 8:30 AM I started feeling effects like nausea and fatigue. The typical symptoms. They lasted for about a week and a half. It lasted until about 06/14/2021 and then I noticed the lymph node protrusion on Sunday and I went to the urgent care Clinic on Monday 06/14/2021and they just said it would go away. At the Doctor they did blood pressure test and an EKG and they did EKG because I had vasovagal response after touching lymph node. There was a few nights in a row about a week after the vaccine, where I had insomnia and I couldn't fall asleep at all and had to take sleep aid. Lymph node swelling did go down and isn't inflamed anymore.

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

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.

20 Y female with h/o of cardiac transplant in 4/29/20 for HCM with history of early ACR 5/2020 treated with rATG and steroids and early CAV 1 (20% mRCA lesion) on prograf and zortress. Admitted on 7/13 with symptoms of chest pain, lower extremity swelling, chest pressure and orthopnea for rule out rejection. Found to be COVID positive on transfer. On 7/13 underwent a EmBx that revealed 1R/1A. Today, on 7/14, patient denies symptoms of chest pain. Due to COVID hospitalization, patient will be given EUA of Casirivimab and Imdevimab intravenous administration prior to discharge. Deemed stable for discharge. HX OF orthotopic heart transplant on 4/29/2020 at with hypertrophic cardiomyopathy - tacrolimus/everolimus/pred immunosuppression -- tac goal 8-10 -- everolimus goal 3-8 -- current prednisone dose 5 mg daily -- RTC in 1 month for OV -- lab work on Friday - OIP: -- CMV: D+/R+- valganciclovir -- Toxo/PCP: TMP/SMZ -- fungal: posaconazole (for 3 months after last rATG ~ 8/22/2020) -CV: on pravastatin - delayed d/t elevated transaminases - osteoporosis: zoledronic acid 5mg 5/11/2020 COVID positive --appreciate ID; Casirivimab and Imdevimab today -isolation precautions

Bodyaches , painfull joints ( more the knees), Fever(102 farenh) and chills the first day followed by swollen lymph nodes on both sides of my neck, super swollen tonsils , which were red with white patches. Then there was a sharp pain on my chest that ran down my left arm but lasted less then a minute.

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.

Swollen lymph node on left side of mouth; This is a spontaneous report from a non-contactable healthcare professional. A 21-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), intramuscular on the right arm on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient experienced swollen lymph node on left side of mouth on an unspecified date. No treatment was given for the event. The outcome of the event was recovering. No follow up attempts are possible. No further information is expected.

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.

patient got vaccine at 13:34, went thru observation period, went back to work. Returned to vaccination clinic for complaints of right hand swelling and right arm was the site of vaccination. Patient had elastic wristband on right wrist. Patient does not report loss of sensation in hand, grips equal, no shortness of breath, no swelling of tongue or difficulty swallowing. bp 127/90, hr 108, o2 sat 98%. Benadryl 25 mg liq and Pepcid 20 mg tab administered. 15:20 bp 124/88, hr 112, o2 sat 97%, patient reports that hand was less swollen. and she feels better. 16: 10 patient reorts she feels much better, cap refill < 3 secs, grips equal, decrease swelling of hand, no shortness of breath, no racing of heart, no swelling of tongue or difficulty breathing. 16:30 patient reports they feel fine and left clinic

"I had arm and armpit soreness that evening and still am experiencing some today along with lymph node swelling on the same side where the shot was administered. The night of the 9th I experienced dizziness, chills, and nausea. I woke up with a 102 fever on Sunday which continued into Monday morning. I also had a headache all day Sunday the 10th and was very fatigued."

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.

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.

chief complaint of a possible allergic reaction onset today. Patient received the first dose of the COVID vaccine. Afterward she noticed her face and neck felt mildly swollen. Her chest also became mildly red. At this time she feels a little improved but her face still feels like it is swollen. Patient was transported here by EMS

Mild swelling of face and lips; Mild swelling of face and lips; This is a spontaneous report from a contactable physician. A 21-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3249, expiry date: unknown), intramuscular in the right arm, on 15Jan2021 11:00 at a single dose for covid-19 immunization. Medical history was reported as none. The patient's concomitant medications were not reported. The patient is not pregnant. The patient was not diagnosed with covid-19 prior to vaccination and was not tested for covid-19 post vaccination. The patient had no known allergies. On 16Jan2021, the patient experienced mild swelling of face and lips. Both the events resulted in emergency room visit. Therapeutic measures were taken as a result of mild swelling of face and lips which included steroid shot, told to take ZYRTEC and PEPCID. Outcome of the events was unknown.

Experienced vomiting morning after shot along with fever of 101 and dizziness with standing, sweating and chills (1/28). Experienced Severe swelling of axillary lymph nodes (1/28-1/30). Severe swelling of supraclavicular lymph nodes ( 1/29-2/01) . Mild swelling of cervical lymph nodes (1/30-02/02). Mild swelling of submandibular lymph nodes (02/02) Lymph node swelling seemed to spread superiorly each day. Limited ability to raise arm/ sleep and pain with coughing breathing and swallowing.

Systemic: Chills-Severe, Systemic: Exhaustion-Severe, Systemic: Other- rash on tongue as ulcers, swelling of right side of face, dizziness,fatigue, sent to ER-Severe; symptoms lasted 1 day.

swollen injection site; red injection site; swollen area underneath armpit area feels like someone is pulling on a stitch type of pain; swollen area underneath armpit area feels like someone is pulling on a stitch type of pain; This is a spontaneous report from a contactable healthcare professional (patient). A 21-year-old female patient received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration in the right arm on 15Jan2021 15:45 at a single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication included ethinylestradiol, ferrous fumarate, norethisterone acetate (LARIN FE). The patient received first dose of BNT162B2 on 28Dec2020 03:15 for covid-19 immunization. On 15Jan2021 08:15, the patient experienced swollen injection site and red injection site. The patient added that swollen area underneath armpit area feels like someone is pulling on a stitch type of pain. The patient has taken Benadryl and Tylenol Friday, Saturday, and Sunday as treatment for the events. The patient is not pregnant. The patient has not tested positive for covid post vaccination. The outcome of the events was unknown. Information on the lot/batch number has been requested.

moderate swelling for 36 hours, nausea for 12 hours, fatigue for 12 hours-moderate, muscle and body aches for 12 hours -moderate, fever for 12 hours, chills for 12 hours-mild, headache and diarrhea for 12 hours-moderate

Nausea and body aches 24hours after second vaccine dose. Bruising and mild pain at vaccine site. Very swollen lymph nodes on right clavicle and Supra clavicular fossa beginning at 48 hours. Joint pain in right clavicle, shoulder, and upper hip after 72 hours.

My first dose of the vaccine was on 1/14/2021. I had a mild headache and experienced dizziness and nausea the night of receiving the vaccine. My second dose of the vaccine was 2/8/2021. I felt tired the night of receiving the vaccine and went to bed a 8pm. I woke up at 6:10am on the 9th with a severe migraine, severe nausea and dizziness. I ate a small amount and laid back down. I got out of bed at 9am and noticed both of my eyes and face were swollen and my throat was swollen. At this point I called my doctor and spoke to a nurse on the phone, she was short saying I needed to go to ER. Personally, I did not feel it was necessary at the time so I took a Benadryl and Ibuprofen. Throughout the day I continually got worse experiencing the same symptoms as the morning including sharp chest pain, restricted breathing, a low grade fever of 100.4, severe lower back pain and leg numbness. I took more ibuprofen and placed heat on my back. I took ibuprofen PM and woke up the morning of the 10th feeling better. Still have headache, lower back pain and swelling but is better than yesterday. I will notify my doctor today of the event that occurred yesterday (2/9/2021).

on the 3rd day after receiving my 2nd covid vaccine I noticed red bumps starting to form on my chest. They started to itch intently and that following Sunday I had been covered in them on my chest and back.

Progress Notes (Nurse Practitioner) ? ? Family Medicine Cosign Needed Expand AllCollapse All COVID VACCINE CLINIC 2/24/2021 Date: 02/24/2021 Subjective Patient is a 21 y.o. adult who was seen at COVID Vaccine Clinic today for patients first dose of the COVID 19 vaccination. Patient was given the Pfizer vaccination in the left deltoid muscle. During patient's 30 minute waiting period after the injection, the patient began to experience throat tightness and itching. Patient denied rash, difficulty breathing, difficulty swallowing, wheezing, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and patient was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , drooling, increased swelling, rapid progression of symptoms, respiratory distress, skin changes and tongue swelling. PMH: includes peanut allergy, carries epi-pen. She takes 75 mg of benadryl nightly to help with insomnia and seasonal allergies. ALLERGY REVIEW OF SYSTEMS: Patient complains of itching of skin Patient denies chills, malaise/fatigue, facial swelling, itching in ears, sore throat, frequent throat clearing, eyes itching, cough, chest tightness, shortness of breath, wheezing, rash, abdominal pain, muscle aches, dizziness and headaches Previous Reactions: she was brought back to bay intially for observation as she reported to pass out when she gets shots. Shortly after injection, she developed symptoms above. No vagal issues arose. Objective Vitals Vitals: 02/24/21 1048 02/24/21 1100 02/24/21 1136 BP: (!) 153/85 106/76 124/72 Pulse: (!) 101 86 81 Resp: (!) 22 16 SpO2: 99% 100% 100% Physical Exam Vitals and nursing note reviewed. Constitutional: General: Patient is not in acute distress. Appearance: Normal appearance. Patient is well-developed. Patient is obese. Patient is not diaphoretic. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Comments: Clear oral airway Eyes: General: Right eye: No discharge. Left eye: No discharge. Conjunctiva/sclera: Conjunctivae normal. Neck: Thyroid: No thyromegaly. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Skin: General: Skin is warm and dry. Capillary Refill: Capillary refill takes less than 2 seconds. Comments: Injection site without rash, erythema or swelling Neurological: General: No focal deficit present. Mental Status: Patient is alert and oriented to person, place, and time. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. Assessment/Plan Treatment included: antihistamines Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) and Anaphylaxis (dyspnea, stridor, drooling, tongue swelling) Close monitoring. Pt improving. Doing well with medication intervention. Pt has ride. Pt wheeled out to the front. Pt ambulates without difficulty. No dizziness. Instructions given on when she can take her next benadryl dose. APRN Electronically Signed 2/24/2021 11:25 AM

Day of vaccine, 4hrs post vaccine: felt drunk/high/intoxicated (touch was intensified, numbing feeling) Day 2-3: exhausted and fever of 102F, body aches, chills, nausea Day 4: started feeling better, fever went down with Tylenol Day 5 3am: woke up with chest pain (3.5-4/10), went away with Tums; 0930pm chest pain 6/10 while sitting at desk, increased to 7/10, lasting 2 hours by the time I went to the ER

I got the shot around 5:20. About 4 hours later I started to feel nauseous and ran to the bathroom and vomited. About an hour after that I had diarrhea. I went to bed, couldn?t fall asleep until 3. I woke up at 6 am sweating a lot and having body aches that were very persistent and painful in my legs. This persisted to 3/12/2021 until about 6 or 7 pm and I began to feel a lot better. That entire day I was hot and cold and had body aches. But no longer had vomiting. Then on Saturday, 3/13/2021 I woke up with a sore left armpit and neck but the armpit was way worse. I looked it up ?sore left armpit after covid vaccine? and it said swollen lymph nodes - so I?m guessing that?s what both pains were as my roommate who had the second dosage of Pfizer vaccine the week before had a protruding lymph node on her neck. They both are still in pain until today 3/15/2021.

Initially had localized redness, quarter to a half dollar sized swelling, on 3/10/2021. Patient received an iron infusion at 15:00 on 3/10/2021. Around 2:00 on 3/11/2021, patient felt a chill, her temperature was 100.4 F orally. Temperature further increased to 103 F around 13:00 on 3/12/2021. What happened as a result of the adverse event? (doctor visit, ED or urgent care visit, hospitalization, life threatening illness, disability/permanent damage, death, none of these): none of these, took OTC apap last night and this morning and just took ibuprofen after the 103 F reading. Spoke with patient's mother, who stated that the is feeling fine. The patient's temperature is currently 98.6 degrees Fahrenheit, and initially came back to normal at 02:00 today (3/13/21). The patient experienced elevated temperatures before that time (02:00), of note was at 22:00 on 3/12/21, at which time the patient had a temperature of 102 degrees Fahrenheit. A later temperature after 22:00 on 3/12/21, and before 02:00 on 3/13/21, was recorded, which was 101 degrees Fahrenheit. The patient's mother stated that the daughter may have COVID based upon speaking with her doctor, so she inquired if her daughter should be tested for the presence of antibodies against COVID-19. Patient's mother also inquired if there was a need for the second shot if it was seen that her daughter had antibodies against the virus. Advised the mother that her questions would be looked into for answers, and that she would be called back with those answers.

Progress Notes Nurse Practitioner COVID VACCINE CLINIC Subjective Patient is a 21 y.o. adult who was seen at SVH COVID Vaccine Clinic today for patient's second dose of the COVID 19 vaccination. Patient was given the Pfizer vaccination in the left deltoid muscle. During patient 15 minute waiting period after the injection, the patient began to experience rash, hives, throat tightness and dizziness. Patient denied difficulty breathing, difficulty swallowing, wheezing, hoarseness, stridor, itching, lightheadedness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and patient on was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to abdominal pain, blood pressure abnormality , chest pain, collapse, drooling, hypotension, increased swelling, rapid progression of symptoms, respiratory distress, skin changes, tongue swelling and vomiting. ALLERGY REVIEW OF SYSTEMS: Patient complains of frequent throat clearing, itching of skin and headaches CONT negative Eyes negative Respiratory negative GI negative Musculo negative Previous Reactions: Itching with first Covid shot Objective Vitals Vitals: 03/17/21 1501 03/17/21 1508 03/17/21 1523 BP: (!) 157/100 (!) 154/66 (!) 170/65 Pulse: 90 84 90 SpO2: 99% Physical Exam Constitutional: Appearance: Normal appearance. Patient is well-developed. HENT: Head: Normocephalic. Right Ear: Hearing normal. Left Ear: Hearing normal. Nose: Nose normal. Mouth/Throat: Lips: Pink. Mouth: Mucous membranes are moist. No angioedema. Pharynx: Oropharynx is clear. Uvula midline. Eyes: General: Vision grossly intact. Pupils: Pupils are equal, round, and reactive to light. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Pulmonary: Effort: Pulmonary effort is normal. Breath sounds: Normal breath sounds. Neurological: Mental Status: patient is alert. Psychiatric: Behavior: Behavior is cooperative. Pt had taken benadryl before her visit. She was given Zytec and still had some rash and hives, but the throat tightness had went away. She was given water and crackers while in the bay. Assessment/Plan Treatment included: antihistamines Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) Left at 3:42 Electronically Signed 3/17/2021 3:40 PM

Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium

I started developing local swelling on my lower left arm below my elbow, and rashes on my left eye lid. The symptoms are mild, yet itchy. No pain and no medication was taken after the symptoms developed.

Hives and itching on left arm. Mild shortness of breath but no wheezing, facial or mouth swelling and no difficulty swallowing. O2 sat 99% on room air. Given 50 mg of Benadryl, EMS called and transported to ED in stable condition

My throat / tongue swelled, difficultly breathing and swallowing (anaphylaxis). Urgent care rushed me in and gave me dexamethasone in my right arm to stop the swelling as well as Tylenol. It took about a full week to completely feel normal, mild anxiety attacks happened. But after one week felt good again.

Numbness and tingling down arm and up neck into face, face swelling, rash on face, migrane, fever, swelling and pain at injection site, fatigue, disorientation, general feeling of unwellness.

Patient received her first dose of Pfizer vaccine at 1500, she waited her required 15 minute observation time, was feeling fine and was released by the NP. Patients mother drove her back at approximately 1530 reporting difficulty breathing, throat tightness, numbness and tingling or her face and tongue swelling. RN assessed patient and administered 0.3mg of EPI and EMS was called per protocol. Patient reported some resolution after EPI was given. EMS transported patient to ER for further evaluation.

Swollen lymph nodes on same side of injection next day, slight swelling of face on left side, night sweats, chills.

I started to have hives form along essentially my whole body besides my face starting 36 hours after my initial vaccine. My legs are the most concentrated with hives. I awoke up with swelled up hands, eye lids and wrists. Today, I woke up with a swollen upper lip and swollen bottoms of my feet.

Patient seen by primary provider for redness, swelling, warmth and pain. After receiving vaccine at convenient care.

Small red irritation starting about 3 hours after injection. Increasing in size to 4 inches in diameter 48 hours post injection and is ongoing. Itchy, swollen, hard to the touch, and very painful.

Fever (low grade, sweats, lasted 24 hours on and off, treated with tylenol), chills (lasted roughly 4 hours), nausea (not severe, no medicine taken), headaches (severe and throbbing, ibuprofen), sore arm around injection site (lasted 1 day), swollen lymph node in armpit on same side as vaccine (right) (appeared night following vaccine, ongoing, armpit area is swollen and tender), bruising at injection site

Approximately 10 hours after injection (injection at 5pm on 4/21), the first symptoms came on suddenly and lasted for about 7 hours (3am-10am on 4/22). These symptoms included severe nausea, headache, weak/rapid heart rate, chills, muscle aches, and a fever of 101 degrees F. Lymph nodes in the left armpit were also swollen and painful to the touch. After 10am, the chills and fever subsided, but the headache, general muscle aches, swollen lymph nodes, and bouts of nausea persisted (these lasted the entire day). The following day (4/23), nausea and muscle aches subsided but the headache remained. The headache only came on whenever changing elevation of the head (standing up, sitting down, bending over), at which point it would be painful for a few minutes after moving. An extremely stiff, painful neck also began the same day (4/23) and persisted for approximately 2 days after injection (accompanied by the headache). Lymph nodes under the collar bone on the left side of the body also became swollen (4/23). Lymph nodes in armpit and under collarbone are still swollen 6 days after injection, although not painful.

Patient with a history of anaphylactic reaction to Advil developed a possible biphasic allergic reaction to Pfizer Covid vaccine (lot EN6208) given on 3/17. Patient initially had urticarial rash on 3/19 and it was treated with Benadryl and Solu-medrol. Patient was discharged on daily prednisone. However, patient returned on 3/21 with facial swelling, chest and throat tightness and shortness of breath. Prior to ED arrival, patient self-treated with EpiPen. At the ED, Benadryl, Pepcid, and Solu-medrol were given and continued for 2 days during hospitalization. No further respiratory distress developed, but the patient still had intermittent itching and rash. Patient was discharged on tapered prednisone, Benadryl as needed and Pepcid.

I had received mosquito bites on my leg a week before I received the first dose of the COVID vaccine. These bug bites were not itching and almost gone when I received the vaccine, however, the night after my vaccine they became very itchy. The next morning, the bites had swelled up, were very hot, itchy and unbearable to manage. They were treated with at home-remedies and over the counter itch medicine. They are almost gone again as of the 27th of April. I took various pictures when they swelled up. My partner received the Johnson and Johnson vaccine and also said his bug bites became itchy for the first time since he got the bite.

Dose#2 4/14 at 140am, at midnight that night fever 101, with large swollen lymph node on right underarm, breast pain. Then on 4/25 woke up with droopy left eye, then next day while at gym had twitching at lips, numbness check and eye swollen was seen at ER. Was not able to raise eyebrow on left side with left ear pain. With light sensitivity, states also complaints of chest pain at time of ER visit.

POST VACCINE ADMIN, PATIENT REPORTED "HOT EYES" SENSATION, STATES HAD SOME FLUSHING/SWELLING/MILD REACTION WITH FIRST DOSE PER PATIENT". FACIAL FLUSHING NOTED BILATERALLY, NO ITCHING/HIVES/SOB/WHEEZING NOTED OR REPORTED. REPORTED SOME NAUSEA AS PATIENT WAS CRYING AND ALSO MOUTH NUMBNESS, BUT RESOLVED SPONTANEOUSLY. PER ONSITE MD, BENADRYL 50MG IM GIVEN IN R DELTOID FOR INCREASING RASH/FACIAL FLUSHING/WORSENING S/S. VSS. PATIENT CALLED FRIEND TO COME DRIVE PATIENT HOME POST BENADRYL ADMIN. ONCE S/S RESOLVED, ESCORTED TO EXIT WITH FRIEND WITH NO ISSUES AT 1145. INSTRUCTED TO SEEK FURTHER MEDICAL TREATMENT/EVAL FOR WORSENING S/S. 1045 BP 133/80 HR 85 RR 22 SATS 99% RA 1105 BP 120/80 HR 75 RR 18 SATS 100% RA 1115 BP 128/87 HR 74 RR 18 SATS 100% RA 1128 SITTING BP 135/90 HR 93 RR 20 SATS 100% RA 1145 STANDING BP 138/87 HR 90 RR 18 SATS 100% RA

Lymph nodes swollen and pain; Lymph nodes swollen and pain; This is a spontaneous report from a contactable consumer. A 21-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 20Apr2021 at 14:30 (at the age of 21 years old) as a single dose for COVID-19 IMMUNIZATION. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number /expiration date: not provided), via an unspecified route of administration, on an unspecified date as a single dose for COVID-19 IMMUNIZATION. Relevant medical history included meningitis as a child. Concomitant medication were not provided. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 21Apr2021 at 09:00, the patient experienced lymph nodes swollen and pain. She complains of feeling like she did when she had spinal meningitis as a child. The patient did not receive any treatment for these events. The outcome of the events lymph nodes swollen and pain was not recovered. Since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.

Inflamed lymph node behind collarbone (between collarbone and trapezius muscle. Size of a marble that is hard and moveable. First noticed on 5/8/21, four days after first shot of the Pfizer vaccine. No noticeable symptoms, like fatigue, or pain caused by swollen lymph node yet. Swelling has not gone down as of 5/14/21.

A bubble/bump in collar bone area (near middle of the collar bone) formed underneath the skin on the ipsilateral side two days after second dose of the Pfizer vaccine. The bubble was able to move from below the collarbone to above, and vice versa, with manual manipulation and with regular movement of the upper body. I suspect that it was an inflamed supraclavicular lymph node. It hurt to touch and move. I did not see a healthcare provider for treatment. It gradually reduced in size and it took 11 days to disappear.

Patient called pharmacy about 6 hours after her vaccination, stating she was having chest pain and discomfort and shortness of breath. Pharmacist recommended patient seek emergency care to get checked out and patient agreed.

Allergic reaction/Anaphylactic shock; Hives; This is a spontaneous report from a contactable consumer. This consumer reported different events for two patients. This is 1 of 2 reports. A 21-year-old female patient (reporter's ((Name)colleague's daughter) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on 04May2021 (Batch/Lot Number: EW0171) (at the age of 21-year-old) as 2nd dose, single dose for covid-19 immunization. Medical history included allergy with garlic. The patient's concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 on an unspecified date for covid-19 immunization. The reporter stated that on 04May2021 the patient got vaccinated with the second dose of vaccine and two days later i.e., on 06May2021 she had some hives, but she never had it before, and she developed an allergic reaction and was in an emergency room having anaphylactic shock and was hospitalized for 3 time and treated with Epinephrine (treatment). She went to an allergist and they checked, they said she did not have any allergy. The outcome of the events was unknown. Information on Lot/Batch number was available. Additional information has been requested.

Patient reports feeling faint immediately following the injection with an elevated heart rate and nausea. The following day she started having episodes of vomiting, nausea, anxiety, tachycardia, pain in the sternum, shoulders and back, dizziness, weight loss, exercise intolerance, insomnia, muscle weakness, fevers, and an overall "depressed feeling".

Starting on 06/17/2021 I had chills and very intense body aches, which went away the next morning. However, when I woke up on 06/18/2021 I had decently swollen lymph nodes the size of olives on the left side of where my neck meets my trapezoid muscle. I also had physically noticeable swollen lymph nodes under my left arm. Both swollen areas are painful and tender.

swollen lymph node glands; This is a spontaneous report received from a contactable consumer, the patient. A 21years old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EN6208) via an unspecified route of administration in left arm on 18Mar2021 at 16:15 as a single dose(at the age of 21years) for COVID-19 immunisation. Medical history was not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not allergic to medications, food or other products. Prior to the vaccination, the patient was diagnosed with COVID-19 on an unknown date. Concomitant drugs include LO LOESTRIN FE from an unknown date for unspecified indication. On 20Mar2021 at 12:00, the patient experienced swollen lymph node glands under vaccination arm. The patient was not treated with any medication for the events. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. The clinical outcome of swollen lymph node glands was not recovered at the time of report. No follow-up attempts are needed. No further information is expected.

Patient described symptoms of very painful arm, tender to touch, swollen with feeling terrible and nauseous on 6/29/2021 but had been feeling this way for several days. Patient was referred to her primary doctor on 6/29/2021 from pharmacy. Patient went to doctor who diagnosis her with cellulitis and given an antibiotic on 6/29/2021.

Mild fever; Swollen lymph nodes on the left side ofmy body (the side of the injection),especially along my neck, jaw, and underarm.; Tender lymph nodes on the left side ofmy body (the side of the injection),especially along my neck, jaw, and underarm.; Neck soreness; Shoulder soreness; Upper arm soreness; This is a spontaneous report from a contactable consumer, the patient. A 21-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 30Mar2021 at 17:45 (at the age of 21-years-old) for COVID-19 immunisation. Medical history included latex allergy. The patient was allergic to macrobid (antibiotic). Concomitant medications included birth control pills (unspecified). The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 31Mar2021 at 08:00, the patient experienced mild fever, very swollen and tender lymph nodes on the left side of the body (the side of the injection) especially along the neck, jaw, and underarm, neck and shoulder soreness along with the upper arm. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic treatment was taken for the reported events. The clinical outcome of the events mild fever, very swollen and tender lymph nodes on the left side of the body (the side of the injection) especially along the neck, jaw, and underarm, neck and shoulder soreness along with the upper arm were resolving at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

lymph node in the arm pit where got my shot got sore; lymph node in the arm pit where got my shot got swollen; pain and soreness moved to my right breast; This is a spontaneous report from a contactable consumer, the patient. A 21-year-old adult female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6208), via an unspecified route of administration in the right arm on 17Mar2021 at 12:00 (at the age of 21-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history and no allergies to medications, food, or other products. Concomitant medications were not reported. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 19Mar2021 at 12:00, the patient experienced sore and swollen lymph node in the arm pit where she got her shot after days receiving the vaccine. The patient also reported that the pain and soreness moved to her right breast after the lymph node pain subsided. The patient underwent lab tests and procedures post vaccination, which included COVID-19 virus test on 22Mar2021, and the result was found to be negative. The event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events lymph node pain and lymphadenopathy was recovering and the clinical outcome of the event breast pain was unknown. No follow-up attempts are needed. No further information is expected. .

This is a spontaneous report from a contactable consumer, the patient. A 21-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 30Mar2021 at 11:15 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient did not have a history of allergies to medications, food, or other products. Concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 30Mar2021 at 11:45, the patient experienced face swelling 30 minutes after receiving vaccine, it lasted for 2 hours and it looked like fluid retention and also the patient experienced a mild fever which lasted for a couple of minutes. Adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the reported events. The clinical outcome of the events mild fever, face swelling and fluid retention was resolved on 30Mar2021. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

pain and soreness in her back and shoulder,; pain and soreness in her back and shoulder,; pain, the regular soreness; she was feeling the armpit pain; swollen arm/whole right arm and hand swollen; armpit is painful and swollen; This is a spontaneous report from a Pfizer sponsored program . A contactable consumer (patient) reported that a 21-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0183), via an unspecified route of administration in right arm on 29Jun2021 at 08:17 (at the age of 21 years old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient not had history of previous immunization with the Pfizer vaccine considered as suspect. No family medical history relevant to adverse events was provided and no relevant tests were performed. The patient did not receive additional vaccines on same date of the Pfizer suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She had initial onset of side effects on 30Jun2021 starting with pain, the regular soreness; then she was feeling the armpit pain and then slowly during the day started feeling the back pain; she is having back pain and her whole right arm and hand are swollen. She is not sure about the back pain; she can't sleep on her right arm because of having the vaccine shot and usually she sleeps on that side; so it could be that being tensed up from not sleeping on the right side could have caused the back pain. The armpit pain and swelling of right arm and hand she is not sure about. She is experiencing swollen arm, armpit is painful and swollen, pain and soreness in her back and shoulder, whole right arm and hand swollen. She asked for further information about these side effects. She specified outcome of side effects as persistent. The patient did not visit emergency room or physician office. Treatment received: Tylenol 500mg every 6 hours after the vaccine for the soreness; they told her to take it so she did and it helped the pain come down a little bit. Tylenol: Lot: SMA034, Expiry: Aug2022, UPC: Unknown, but . The outcome of events was not recovered.

The vaccination went as expected the day after with fever and chills. But the second day after the vaccine I woke up with welts on my arms and legs the grew until they encompassed my legs fully and inner arms full. It spread to my entire body in big parts. The third day is spread to everywhere it hadnt the first (chest, stomach, outer arms, feet and hands). But it swelled my hands to the point that I can't make a fist. The fourth day the welts and rash cleared up everywhere else but I woke up with it on my feet and they swelled to the point where I can't walk today. So day 3 it swelled my hands and day 4 is swelled my feet but its going away within a 24 hrs period. I am currently unable to use pens and small objects in my hands to hold due to the swelling. I am also unable to walk. The ER says to wait it out because its an allergic reaction and I intend to. But even the pharmacy said that out of their 9000 patients done i have been the only one thst has had a worse adverse effect on the second dose. Nothing occurred on the first dose, just the second. I hsvebeen taking benadryl and tylonol but they don't seem to do much ut just is taking time, but there has been no improvement on my hands or feet.

4/14/21 became confused and had cardiac arrest with seizure EMS called 1757 was taken to 2 hospitals with multiple resuscitation efforts and defibrillations declared deceased 0042 4/15/2021

pneumothorax, her right lung collapsed; cyst that was ready to burst on her lung; swelling in her right arm under the arm and in her chest area and breast; swelling in her right arm under the arm and in her chest area and breast; a heart murmur; a high resting heart rate; Back pain; lymph node swelling under her right arm pit into her chest; swelling in her lymph nodes and in her chest that were painful; swelling in her right arm under the arm and in her chest area and breast; This is a spontaneous report from a contactable consumer (patient's mother). A 21-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 09Apr2021 (lot number EW0153), at the age of 21 years, as the first single dose, for COVID-19 immunisation. Medical history was not reported. Concomitant medication included an unspecfied low estrogen birth control (she just took a birth control pill every day, probably on it since she was 16 or 17 years old). On 12Apr2021 the patient experienced back pain. On an unspecified date in 2021 the patient experienced lymph node swelling under her right arm pit into her chest. She had swelling in her lymph nodes and in her chest that were painful and she could touch them. On 16Apr2021 the patient experienced pneumothorax (on that day she went to the urgent care and they told her that her lung was about to collapse). The reporter finally got her daughter to come home from school and she took her to the emergency room on 17Apr2021. When the lung had collapsed, she felt worse and then she was in the hospital for an entire week. This event required hospitalization from 17Apr2021 to 29Apr2021. On 23Apr2021 she had a tube in her chest that was drawing the air out and they did something where they inflated her lung to see if it would stay and it wouldn't stay so they had to do surgery on 26Apr2021. When they went to do surgery they saw that on the outer part of her lung where the hole was that it wouldn't heal and they saw that it was like a cobble stone texture on the outside of the lung. The patient was in the hospital until 29Apr2021 and she was in the ICU the entire time. She went for check-ups and everything seemed to be good and her lung had healed. The caller was trying to connect dots between her family members and she had asked her daughter how she felt right after the COVID vaccine and her daughter said that she felt like "ehhh" and then on 12Apr2021 she had the back pain, then on 13Apr2021 she had air bubbles in her chest and on 15Apr2021 she was trying to walk to bars and she was out of breath. On 16Apr2021 the urgent care said they saw a cyst that was ready to burst on her lung and she was on bed rest and was given steroids. The caller thought that the swelling and the lymph nodes and having the cobble stone texture were all from irritation and then it had made a blister that popped creating the hole. On 29Jun2021 the patient experienced heart murmur and a high resting heart rate. Around 29Jun2021, the patient was feeling like her heart was moving in her chest and that it was out of synch and not right and that it was racing high and so the reporter called their family doctor who saw the patient the next day. They did an EKG that was irregular and now she had a heart murmur. She wasn't born with that and she had never had that and she didn't leave the hospital with that. She was fine until now with her having the murmur and the high resting heart rate, around 85. The caller didn't know the exact EKG irregularities because it said "normal" but they gave a copy to her and said to bring it to the cardiologist because it was not normal. The reporter didn't know the details and won't until the follow-up appointment on 16Jul2021 which was when they would have a better idea about what they were going to call this. She had the swelling in her right arm under the arm and in her chest area and breast, she was thin breasted, this was on the right side and then her right lung collapsed. The caller says that this was not a coincidence. There was no way that she would have three family members injured if it wasn't for the COVID vaccine. Her daughter should be taking an allergy medication but she won't take it. The patient did not receive the 2nd dose (when she had gotten out of the hospital after her pneumothorax that was when she was supposed to get her 2nd dose but they didn't go get it because they couldn't risk that). Back pain resolved on an unspecified date in 2021. The other events outcome was unknown. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-2021899289 same reporter/product/patient, different dose/event

Extremely swollen lymph node under left arm pit; This is a spontaneous report from a contactable consumer, the parent. A 21-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734), via an unspecified route of administration in the left arm on 03Apr2021 at 11:30 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. Medical history included methylmalonic acidemia. The patient had known allergies to eggs and latex. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included unspecified birth control pills (MANUFACTURER UNKNOWN) taken from an unknown date. The patient did not receive any other vaccination within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 03Apr2021 at 23:15, the patient experienced an extremely swollen lymph node under the left arm pit, approximately the size of a golf ball. The events did not result in a doctor or other healthcare professional office/clinic visit, and emergency room/ department or urgent care. The patient did not receive any treatment for the event experienced. The clinical outcome of the event extremely swollen lymph node under left arm pit was resolving at the time of this report. No follow-up attempts are needed. No further information is expected.

Extreme itching of entire body; Swollen face and throat; Swollen face and throat; entire body slightly puffy; hives on back; This is a spontaneous report from a contactable consumer, the patient. A 21-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 28Apr2021 at 17:30(at the age of 21-year-old) as a single dose for COVID-19 immunisation. Medical history included ADHD, depression and anxiety. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) and depression meds; both from unknown date for unknown indication. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 07Apr2021 at 17:30 (at the age of 21-years-old) as a single dose for COVID-19 immunisation and Penicillin on an unknown date for unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Apr2021 at 20:30 after 3 hours of vaccination, the patient experienced Extreme itching of entire body, Swollen face and throat, entire body slightly puffy and hives on back. Therapeutic measures were taken as a result of the reported events and included treatment herself with Ibuprofen but hadn't helped yet. The clinical outcome of the Extreme itching of entire body, Swollen face and throat, entire body slightly puffy and hives on back was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

I experienced severe arm pain for a couple of days after receiving both doses. I also experienced tingles through my right arm and right breast. At first I was feeling the tingling all over, but it's not consistent. Just yesterday, the tingling felt like rain drops hitting my skin. I have swollen lymph nodes and I am currently sick. I have been sick twice now and I hardly ever get sick. I did wake up, after a nap, the night after receiving the second dose, feeling cold and later on, I had a fever. It was 80 degrees in my house. I started to experience some chest pain. I was vaping and I stopped. The pain went away after about 3-4 days. I had to take shallow breaths for those 3-4 days because of the sharp pain I would feel. I feel skeptical that my immune system has been weakened.

Employee contacted Employee Health on 01/05/2021 after receiving COVID vaccine #1 complaining of cough, sinus headache, redness and streaking across eyelids, congestion, facial swelling that spread down her cheeks and chin area - took OTC Benadryl, fell asleep, and when she awaken, swelling to face had worsened - went to ER

On 12/30/2020 I received my 1st dose of Pfizer vaccine. Felt fine, no symptoms or side effects until 12/31/2020 I did get hives on my arm site where I received the vaccine and those hives then started to spread throughout my body. I started having hives and rashes all over for a total of 6 days . Itching, swelling on my ears, arm, wrist, hands, back etc... took Benadryl for the 6 days and it helped for the 1st 2 days of my adverse event after that the Benadryl did nothing. Me and my PCP has agreed it was a possible delayed allergic reaction to the vaccine.

The evening of receiving the vaccine she experienced itching eyes. The next morning her rt eye was swollen and she had red spots on face and forehead. Her arm was swollen and she experienced a knot at the injection site.

Swollen lymph nodes on left side in the midclavicular region. Lymph nodes are each about the size of grapes. It has been over two weeks since my vaccine and the size has not decreased. No other symptoms other than pain at the injection site for the first 2 days.

the injection site is very painful; chills; body aches; swollen lymph nodes; This is a spontaneous report from a contactable other healthcare professional (patient). A 22-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL1284, via an unspecified route of administration in Left arm from 04Jan2021 03:45 to 04Jan2021 03:45 as SINGLE DOSE COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On 05Jan2021 04:00 AM, the injection site is very painful, chills, body aches, and swollen lymph nodes (no sore throat). The outcome of the event was unknown. No treatment was received for the events.

1416 covid vaccine given IM in right deltoid 1434 patient states she isn't feeling well, nauseated, pain at injection site 4/10 on pain scale, itching to right arm. VSS 98% on RA, 86 pulse, 131/82 BP, 98.8 temp. Band-Aid removed. 1434 50mg Benadryl given lot 202906 exp 9/20/23. Sitting in chair with fan. Noted that patient was drinking a energy drink with 300mg caffeine 1/4 gone. 1445 c/o pain in right upper abdomen/lower right rib pain with breathing, "trouble breathing- hard to take deep breaths d/t this pain, a little throat pain, 1449 Dr called/updated orders Tylenol 1000mg PO now. 1456 Tylenol 1000mg given PO with water, c/o dry mouth, throat "tight", Right arm where injection given- c/o pain 8/10 on pain scale. 98.8temp, 126/83 bp, 100% saO2 on RA, states not feeling well. 1502 bilateral lower legs beefy red, capillary refill >8 seconds, pulses present states her feet are tingling. 1500 patient states she doesn't feel well and asks to go to the ER to be evaluated. 1505 99 called and ambulance dispatched 1515 ambulance arrived and assessed patient and at 1521 patient left the facility per ambulance stretcher accompanied by EMT's x2

Redness, swelling, warmth to touch, and itching at injection site. Swelling and redness are 7.5 cm x 6 cm on the left upper arm. This has been present since 01/05/2021 and has mildly increased in size since onset.

Systemic: Anaphylaxis-Severe, Systemic: Rash (other than injection site)-Medium, Systemic: chest/throat tightness-Medium

she was diagnosed with bilateral deep vein thrombosis (DVT) and pulmonary embolism (PE); she was diagnosed with bilateral deep vein thrombosis (DVT) and pulmonary embolism (PE); This is a spontaneous report from a contactable nurse (patient). A 22-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK9231), via an unspecified route of administration in left arm on 06Jan2021 13:45 at single dose for COVID-19 immunisation. Medical history included allergy to all fish, and clots. The patient was not pregnant. There were no concomitant medications. The patient previously received 1st dose of BNT162B2 (lot numer: EH9899) in left arm on 16Dec2020 13:45 for COVID-19 immunisation and experienced left sided lower back pain on 20Dec2020. No other vaccine received in four weeks. It was reported that the patient had the first covid vaccine on 16Dec2020 and on 20Dec2020 started with left sided lower back pain and then received the second on 06Jan2021 and then on 09Jan2021 11:00 her legs became blue and swollen and she was diagnosed with bilateral deep vein thrombosis (DVT) and pulmonary embolism (PE). The patient otherwise healthy and had never had covid. Other than the clots, she had no other health issues. The patient underwent lab tests and procedures which included nasal swab: negative on 09Jan2021. Events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, and life threatening illness (immediate risk of death from the event), hospitalized for 2 days (in Jan2021). Adverse event treatment: heparin drip and xarelto at home. Recovered with lasting effects on an unspecified date of Jan2020. This case was reported as serious, serious criteria was life threatening, caused/prolonged hospitalization.; Sender's Comments: The underlying risk factors/predisposing condition of thrombotic diathesis have been assessed to have played a contributory role toward the events.

Patient presented to urgent care on 1/9/2021 after receiving second COVID-19 vaccination. Patient stated that she had an enlarged tender lymph node in left axilla. Patient endorsed no familial history of cancer. Patient was told to monitor area, there was no further escalation of care.

Rash around entire neck; Swollen lymph nodes; This is a spontaneous report from a contactable nurse (patient). A 22-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) solution for injection, intramuscular on left arm on 06Jan2021 12:00 at a single dose for Covid-19 immunization. Medical history included scoliosis, sport-induced asthma, and seasonal allergies. Concomitant medications included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), ibuprofen (IBUPROFEN), and meclozine hydrochloride (BONINE). The patient experienced rash around entire neck and swollen lymph nodes, both on 09Jan2021 06:00. No treatment received. The events were reported as non-serious. Patient was not diagnosed with Covid-19 prior to vaccination. Patient has not tested for Covid-19 since the vaccination. Outcome of the event was not recovered. No follow-up activities are needed. No further information is expected.

I had the flu-like symptoms on 1/9/21 - body aches, headache, and jaw tightness. 1/10 = woke up with facial swelling, took tylenol, had 100.5 fever that night 1/11 = woke up with a HUGE face, lots of swelling - went to urgent care had a 101 fever, they sent me to GW ER (facial swelling looked similar to MUMPS - I have been vaccinated)

allergic reaction- skin rash , throat itching. patient visited the ER and was given episode and steroids but returned because symptoms were not improving. She was hospitalized on 1/11 for this reason

Fever, chills, diaphoresis, body aches, head/neck pain, lymph node swelling/tenderness in left armpit (received vaccine in L arm), numbness/tingling/pins/needles sensation throughout entire body.

Swollen lymph nodes above clavicle; Redness over those lymph nodes; Redness, pain, warmth, and swelling at injection site; Redness, pain, warmth, and swelling at injection site; Redness, pain, warmth, and swelling at injection site; Redness, pain, warmth, and swelling at injection site; This is a spontaneous report from a contactable other health professional (HCP). A 22-year-old non-pregnant female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration on her left arm on 11Jan2021 at 07:45, at a single dose for COVID-19 immunisation. Medical history included allergies to sulfa. Concomitant medications included doxycycline and vitamin D3. The patient received her first dose of BNT162B2, lot number: EL0140 on 20Dec2020 at 02:30 PM. The patient experienced swollen lymph nodes above clavicle, redness over those lymph nodes, redness, pain, warmth, and swelling at injection site on 11Jan2021 at 18:30. There was no treatment received for the adverse events. The outcome of the events was recovering.

This is a spontaneous report from a non-contactable nurse (patient). This 22-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) 1st dose on 21Dec2020 10:00 AM at left arm, and 2nd dose on 11Jan2021 07:45 AM at left arm, both at single dose via an unknown route for COVID-19 immunization. Facility type vaccine was hospital. Medical history was not provided. Patient did not have COVID prior vaccination. Concomitant drug in two weeks included polycarbophil calcium (FIBER). Patient did not have other vaccine in four weeks. No COVID tested post vaccination. Patient's left armpit had an aching pain with movement or palpation. It was also swollen. She thought her lymph nodes were swollen. Event onset date was reported as 12Jan2021 05:00 AM. This also happened with first dose and it lasted for two weeks. No treatment received. Outcome of the events was resolving. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.

Headache; Body ache; Muscle pain/muscle soreness; Feeling down; feels may be like it's a knot in the muscle; Like a lump like at the bottom of my neck; This is a spontaneous report from a contactable consumer reporting for herself (Medical Assistant). A 22-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231 and expiry date: 30Apr2021), via an unspecified route of administration on 13Jan2021 at single dose for COVID-19 immunization. Medical history was reported as none. The patient's concomitant medications were not reported. The patient stated, "I just wanted to ask about, I just received my second dose of the vaccine and I was having some adverse effects. I had headache yesterday when I got it. And body ache and muscle pain today and then I'm feeling down, and kind of like a lump like at the bottom of my neck, like to the side, on the left side, the arm that I got the (incomplete sentence). It feels may be like it's a knot in the muscle. I don't know if that is normal." The patient asked and stated, "If anybody else has had any of those symptoms? I know that the headache and the muscle pain is normal, I don't know about the like a lump or anything." The patient further stated, "It's been pretty constant headache, second day was body ache and right now just like muscle soreness." The patient stated, "I took some Tylenol, acetaminophen. And I think I had one Ibuprofen last night." The outcome of the event headache was not recovered and the outcome of the remaining events was unknown.

On and off waves of dizziness (not extreme, but noticeable) - occurred about 5 minutes after receiving the vaccine - lasted for about 10 minutes Itchy, red, puffy finger (right middle finger) - occurred about 10 minutes after receiving the vaccine - itchiness lasted about 5-10 minutes, redness lasted longer Tingly/numb face - occurred about 20 minutes after receiving the vaccine - lasted only a few minutes Slight nausea - occurred about an hour after receiving the vaccine and was more of an inconvenience than real pain, I did not vomit Fatigue - extremely tired at the end of the day Injection site pain - pain began about 2 hours after receiving the vaccine and became worse throughout the day - by about 5:00 PM I was unable to move my arm or put any amount of weight on it - pain began subsiding significantly the next morning and only feels like a bruise now (3 days after vaccine)

Chills, fever, muscle pain, joint pain, headache, general malaise, sensitive to touch- lasted for 36 hours starting late night of injection. Swollen lymph nodes starting about 24-36 hours after injection. Increased normal treatment for chronic conditions including extra saline infusion and rest

Swollen lymph nodes in left armpit. Bruising at site of injection. Bruising and swelling happened same day as dose #2. Advil taken to alleviate symptoms, but side effects still occurring on 2/5.

Tingling throughout arm and into shoulder blade on 2 occasions throughout the day. Eyes felt swollen a few hours after receiving vaccine between 1-2 pm. Symptoms went away. At around 11pm I got welts and hives all over my body but they were particularly prevalent at the vaccine site. No change in routine throughout the day nor a change in food. Largely went away by the next day around 1pm. Still experiencing slight itchiness.

The day after the vaccination I started getting a sore right TMJ. I waited a week to see if it would go away, but it didn't. I then took aleve and ibuprofen for about two days which decreased the TMJ pain and it did not return. It was then that I noticed that I had a tender swollen lymph node under the right side of my chin. I assume that the swollen lymph node was the cause of the TMJ pain.

Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Patient noted an anaphylactic response to hepatitis b as a baby. Was counseled to wait 30 minutes in pharmacy to be monitored after receiving a vaccine. Around 25 minutes later patient approached pharmacist stating felt tongue tingling. Patient drank some water stated she felt better but in next two minutes noted her throat felt obstructed. Technician called 911. Paramedics arrived within 3 minutes. No epipen was given. Paramedics and immunizing pharmacist both mentioned possible anxiety attack

From the beginning, I had extremely enlarged lymph nodes and felt fatigued. Every day my lymph nodes grew until they were the size of golf balls. On Tuesday morning at 2:30 AM, I began to have a fever and developed a mild full body rash. This severely escalated and by Wednesday, I developed full body hives and uncontrollable fevers as high as 105. Since then, I have been anti-histamines and steroids, which made my rash worse but helped the fever and lymph nodes. My hives are painful, itchy, and getting worse.

Fever; swollen lymph nodes; severe headache; body aches; This is a spontaneous report from a non-contactable consumer reported for herself. A 22-year-old female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via unknown route at the left arm on 03Feb2021 15:30 (at the age of 22-years-old) for COVID-19 immunization. The patient medical history included asthma, allergies to penicillin and peanuts. The patient was not pregnant. No COVID prior vaccination. The patient had received the first dose of vaccine on 15Jan2021 03:45 PM at the left arm. The patient experienced fever that lasted 48 hours, severe headache, body aches, and swollen lymph nodes, the events occurred on 03Feb2021 11:45 PM. The outcome of the events was recovered. The patient did not receive any treatment. Patient has not tested positive for COVID-19 since having the vaccine. No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Hives on face and back, and swollen lymph nodes happened about 90 minutes after I received the vaccine I revived the vaccine on 3/11/21 at 4:30 pm Started having a reaction on 3/11/21 at 6:00 pm

101.4 fever, chills, body aches, migraine, extreme pain in injection site, lymph node swelling in lower armpit

48 hours after vaccine administration developed facial swelling, facial rash, and dyspnea. Given epi pen x 2 and transported to hospital.

*TIME OF WRITING IS THE 7th DAY* Onset of incredible fatigue 30 minutes post-vaccination lasting 5 days Fever ranging from 99.6 to 102 which began 5 hours after vaccination and has lasted 7 days post-vaccination Nausea 5 days post-vaccination Headache 7 days post-vaccination Severe arm pain 3 days post-vaccination Eye pain 3 days post-vaccination Intense sweating 7 days post-vaccination Chills 7 days post-vaccination Labored breathing 2nd and 3rd day post-vaccination Significant face swelling 2nd day post-vaccination Decreased mental status 6 days post-vaccination All lymph nodes in neck hard and swollen 7+ days Aggravation of pre-existing sleep paralysis day of vaccination Severe throat pain in the morning, red bumps in back of throat, white pus on tonsils which has worsened and began 1 day after vaccination (antibiotics were prescribed and condition continues to worsen, no one with whom I have been in close contact with has been sick - e.g. boyfriend I kissed the day before vaccine, toddlers I babysat morning before vaccine) - followed eventually by mild cough and congestion

Swollen Lymph Node- Golf ball sized; axillary region, under left arm; Very swollen and painful; lasted for a duration of 7 days

Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild

The day after the vaccination I started to feel pain in the armpit area. When I touched the area, I felt a lump about the size of a quarter. The pain nor the size has diminished to this day.

Rash starting at 8am on 3/26/21 at her feet and ankles bilaterally, itching and painful, spread to face and elbows. Lips began to swell and become painful at 1pm on 3/26/21. Pt treated with diphenhydramine 50mg and epinephrine 0.3mg. Her rash and lip swelling improved starting 10 minutes following these medications. She was monitored for 1.5hrs and at time of discharge her rash was 80% improved and lips were no longer swollen. Pt did not have throat tightening, shortness of breath or dyspnea. She was given epinephrine for signs and symptoms of angioedema.

Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Severe, Additional Details: Patient had her own Epipen with her since she has many allergies and just had anaphylactic reaction as recently as Monday. She began to feel itchy and had redness, rash after shot during the 30 minute observation period. Epipen was self-administered and emergency services called.

On the evening of my vaccine my left arm became swollen and painful. I then became nauseous, had a high fever of 100 degrees Fahrenheit and suffered from a migraine in the front sinus cavity all night. The next morning of the 27th my symptoms persisted, now accompanied by body aches, specifically my hip flexers were very sore and I was exhausted all day. by the morning of the 28th all symptoms subsided.

I first noticed a pain in my left armpit on Sunday 04/04/2021, but I just thought I pulled a muscle or something. Then on Monday, it wasn't any better, and when I looked in the mirror I realized my lymph node was very swollen and tender. This brings me to today where the lymph node in my left armpit is still swollen. I talked to a nurse to be safe, and she told me it should go away within a week-10 days, so I'm not too concerned.

Left arm soreness initially followed by swollen left supraclavicular node and some anterolateral Chest wall swelling. initial telemedicine visit then went to urgent care 4/7.

Although I did experience extreme headaches and a sore arm within days of getting the vaccine in addition to continuing & excessive fatigue, a little over a week later I had an extreme, painful skin outbreak all over my body. I'm assuming my eczema flared up in reaction to the vaccine, but up until that day my eczema had been dormant and restricted to a mild dry patch on my arm and leg joints. Within an hour, I had red spots and red patches appear all over body, including my stomach and back, where I hadn't had an eczema outbreak in years. My neck was swollen and became extremely wrinkly in appearance, as did my elbows and anywhere else I itched. Although that night was the most abrupt and extreme part of the reaction period, it took 3 days for the flare-up to calm down, the duration of which I was incredibly itchy and experiencing some pain. I took several Benadryl tablets the next day to help calm the itchiness before bedtime.

March 5, 2021: 1st dose of Pfizer vaccine. Severe site pain. March 23, 2021: 2nd dose of Pfizer vaccine. Felt very restless and sick during night, by the next morning symptoms really sat in. March 24, 2021: Went to Urgent Care due to fever. Had COVID-19 test (negative). Very close to passing out there (put head between knees and did not). Was sent to emergency room immediately due to heart rate (high 140s-150s. Highest known was 152 BPM). ER performed following: portable chest x-ray, blood tests, urine tests, EKG. Was told results were all normal with the exception of EKG (not told anything about it, form listed as abnormal). Passed out 2x at hospital. Was given one IV rehydration solution and released that night. Symptoms below lasted for several days: Headache Aches Nausea Aggressive shakes Shortness of breath Confusion Dizziness Site pain (also developed bump under arm) Fever - 103.8 (after 2 Advil, 2 Tylenol, 3 ice packs and eating frozen grapes) Heavy sweats Racing heart Restless March 30, 2021: Still having frequent heart palpitations (they come and go but happen several times during the day. Keep having very high heart rates). Went to doctor. While there, nurse noted irregular heartbeat that sounded like it was ?skipping a beat? and heart rate was also jumping all over the place (high pace, low pace, high, etc.). It was clear something was abnormal. Doctor gave EKG approximately 20 minutes later, EKG looked normal. Was told to come back next morning for blood work and to cut out caffeine. March 31, 2021: Came in for blood work to check thyroid. April 6, 2021: Thyroid results were normal. Still having palpitations among other symptoms (see April 12 for more info) so was told to come in. Was given ?work from home? note and referred to cardiologist. April 12, 2021: Appointment at cardiologist. Still having severe palpitations, occasional dizziness/ lightheadedness, nausea, shortness of breath, exhaustion and chest pain. Heart rate was recorded this day to have gotten up to 139 BPM-- was very high majority of the day. EKG was normal (with exception of high heart rate) but 30 mins later doctor observed high heart rate and abnormal rhythm. Was told to come back in a week and one day for a heart ultrasound and heart monitoring for three days. Still no caffeine intake since 3/30/21. Previous heart rates taken at doctor's visits over the years for comparison below. Never had any prior heart problems whatsoever: 8/29/18: 70 BPM 9/17/18: 88 BPM 10/17/18: 64 BPM 10/31/18: 73 BPM 1/21/19: 78 BPM Note: At this point, I have missed over a week and a half of work, and worked from home for over a week. I'm not any better heart wise at all over the course of three weeks post vaccine.

Covid arm---redness, warmth, swelling suddenly on 4/4/21. Extended length of menstrual cycle. Menstrual cycle started day after vaccine, as scheduled, but did not end until 4/15/21. The menstrual cycle was the same amount as a normal period the entire time.

Patient received first COVID Pfizer vaccine on 3/12/2021. About 7 hours post vaccination, she developed a full body rash and facial swelling. No airway involvement. Rash started to improve in about 4 hours, at which time she went to the ER for evaluation and received benadryl. Her temp in the ED was 99.1, BP 145/98, HR 137. No other medication interventions (fluids, meds, etc) given. She reports arm soreness and itching for about 48 hours, but no other symptoms.

Around 12 hours after the shot, I took Tylenol for body aches and fever. I woke around 3:30 am to shaking and stomach pains then fell back asleep. I woke up again around 5:15 am to intense involuntary shaking. My family members wrapped me in blankets and applied pressure to my body until the shaking stopped. Within the next 40 minutes I vomited and had diarrhea. At the time also had body aches, chills, fever, and mild swelling of various areas if the body. I slept most of the morning and ate lunch around 1:30 pm. I took Tylenol again at 2:00 pm with the symptoms lessening over the next 5-6 hours. After that fever, chills, and body aches returned.

Around 3:30am on Sunday, I woke up due to feeling very cold. My teeth were chattering and regardless of the amount of layers of clothes or blankets added, I could not get warm. Later in the day I checked my temperature and it registered at 100.6 degree Fahrenheit, but I did not feel as cold as I had earlier that morning. I also had what felt like a sinus headache and my whole body felt stiff/achy. There was also some slight nausea that occurred. The nausea and slight fever went away by 11am, but the headache and body aches lasted until about 9PM Sunday night. After my nausea went away I was able to take some Aleve to help with the stiffness. At the site of injection, it is slightly raised red bump (about two inches across horizontally and vertically), and there is some slight pain in the armpit area on this side as well. The swelling of the bump was slightly bigger yesterday, but the swelling has gone down some this morning.

Immediately after vaccine, L arm was in pain, 2 days after vaccine, she begin to have a swollen neck on left side and L arm pits. She had a doctors visit on 04/15/2021, no prescription but she has been taking advil 200 2 tabs, 2x daily every 8 hrs. RN recommendation. She is no longer having any swelling or pain. She asked if she should receive the second dose, RN states yes. Her adverse reaction was mild with no respiratory issues. The benefits of her second dose outweighs the possible adverse reaction. Patient is agreeable.

On April 5th, 2021 I went to the E.D. , for shortness of breath and severe right shoulder pain. While there they got a chest x-ray, ran labs, and did a chest CT. The CT revealed that I had one blood clot in my left lung and two blood clots in my right lung, as well as slight pleural effusion in the right lower lobe. They put me on Xarelto for the next 3-6 months and monthly follow up visits with my primary care provider. I was also given Hydrocodone as need. I experienced extreme pain with breathing and sort of movement for a week and half but currently only have occasional shoulder and back pain usually at the end of the day.

Left face swelling with minimal redness; initial tightness in throat which subsided soon after initiating; BP=124/70, pulse ox=96%, HR=90

Anaphylactic reaction immediately after vaccination; This is a spontaneous report from a contactable consumer (patient). A 22-year-old non-pregnant female patient received the first dose of BNT162B2 (BNT162B2; Batch/Lot number was not reported), via an unspecified route of administration, administered in right arm on 18Mar2021 16:00 at single dose for COVID-19 immunization. The patient's medical history included asthma, known allergies to legumes, soy, egg, and tree nuts. The patient's concomitant medications were not reported. The facility type vaccine was hospital. The patient had no other vaccine in four weeks. The patient experienced anaphylactic reaction immediately after vaccination on 18Mar2021 16:00. The event resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care visit. Therapeutic measures were taken as a result of the event and included treatment with Epi pen injection. The patient had no COVID prior vaccination and has not been tested for COVID post vaccination. The outcome of the event was recovered on an unspecified date. Information about lot/batch number has been requested.

Received Moderna first dose and Pfizer for second dose. Arm swelled and red with fever. Vomiting. Vaccination arm numb. Head ache. Shortened breathe.

14 days after first shot, Pt had stinging/burning pain in her right big toe at bedtime. She thought she hurt her toe working out. As days went on, pain got so bad she went to urgent care for an x-ray. They found nothing wrong. The foot started to swell. Went to the school to see dr there. They said not broken just irritated the sesamoids under her big toe. 4-6 weeks to heal in a soft boot. The on April 16th she got her second shot. As she sat there waiting her 15 mins, she said her right foot went numb. We then went home. That night we iced her bad right foot and I noticed both feet were purple!! I looked up reactions to shots and it actually said it is a side effect. I called my doctor and he said the fact that the toes turn purple and then back to normal was ok. 9 days after the second shot she said the same pain started in her left foot. She can't walk on either foot!!! It is neuropathy from the shots!!! My doctor is scheduling tests for her.

After 1st shot: sore arm (24hrs) - limited movement in arm when in certain positions above head (still continuing) 2nd shot: sore arm, limited movement in arm when in certain positions overhead chills, body aches, fatigue, sore arm, swollen node underarm (lasted 36hr after shot) 2 weeks after 2nd: still limited mobility in arm in certain position (not to the touch, more the muscle in certain positions)(more of an discomfort rather than sharp pain)

After the 2nd dose (April 26), on April 29th at 3:00 AM I woke up because I was violently itching my right forearm and my left hand. I had a lot of bumps on my forearm that were itchy and turning red as a result of my itching. My left hand had no bumps but it was completely swollen. My face began to swell at my upper cheeks and around my jaw. The right side of my upper lip swelled up prior to the rest of my face and remained that way. It became difficult to keep my eyes open. This facial swelling lasted for three days and on the third day, my neck began to swell right along with my submandibular lymph nodes. This neck and facial swelling went down on May 2nd after I was advised by a sports medicine staff member to take ibuprofen.

Client with aches, fever starting within several hours of receiving vaccine on 5/3/2021. Those side effects resolved the next day. Within 24 hours of receiving vaccine, client with red raised area warm to touch on left arm surrounding injection site. Client also reports swollen lymph nodes in neck region. Informed client that swollen lymph nodes are listed and that there have been reports of redness at injection site and to contact PCP for any care related to side effects of vaccine.

The infection got worst, different physicians have diagnosed the patient with herpes; Felt sick; This is a spontaneous report from a contactable consumer (patient's mother). A 22-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via unspecified route of administration on 10Mar2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medication was not reported. It was reported that the patient had received the first dose of the Pfizer COVID-19 vaccine on 17Feb2021 and shortly after was diagnosed with a severe yeast infection and received treatment for this. On 10Mar2021 the patient received her second dose and the infection got worst, different physicians have diagnosed the patient with herpes. Due to this reaction the patient had to be transferred to the emergency room a couple of times. The patient felt sick and went to emergency room stated she had herpes. The outcome of the events was unknown. No follow-up attempts are Possible; information about lot/batch number cannot be obtained.

Swollen and painful lymph node at base of the neck (over the clavicle) on left side (side of injection) and tender lymph nodes on the right side of the neck; Swollen and painful lymph node at base of the neck (over the clavicle) on left side (side of injection) and tender lymph nodes on the right side of the neck; This is a spontaneous report from a contactable other HCP (patient reported herself). A 22-year-old non-pregnant female patient received second dose of BNT162B2 (COVID 19, Pfizer, Solution for injection) via an unspecified route of administration to her left arm on 25Jan2021 02.00 PM as single dose for Covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered: Hospital. The patient's medical history included anxiety and depression. No known allergies. Concomitant medications included iron supplements and desogestrel/ethinylestradiol (DESOGESTREL AND ETHINYL ESTRADIOL) (both received within 2 weeks of vaccination). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took BNT162B2 (COVID 19, Pfizer) via an unspecified route of administration to her left arm on 06Jan2021 03.00 PM as single dose for Covid-19 immunization. On 26Jan2021 07:00 PM, the patient experienced swollen and painful lymph node at base of the neck (over the clavicle) on left side (side of injection) and tender lymph nodes on the right side of the neck. The events were assessed as non-serious. The patient had been tested for COVID-19. Covid test type post vaccination, nasal swab in Oct2020 showed negative and saliva test in Nov2020 showed negative. She did not receive any treatment in response to the events. Outcome of the events was not recovered. Information on the lot/batch number has been requested.

Neuropathy; her left foot now has the same stinging, burning, pain that the right toe; swelling has decreased in the right foot; but continues in the left; her left foot now has the same stinging, burning, pain that the right toe/her left foot now has the same stinging, burning, pain that the right toe; her right foot was numb and tingling; her right foot was numb and tingling; Right foot turning purple intermittently; This is a spontaneous report from a contactable consumer. A 22-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 16Apr2021 (Batch/Lot Number: ER8731) as 2nd dose, single for covid-19 immunisation. Medical history included Hashimoto's thyroiditis, premature ovarian failure and covid-19. Concomitant medications were not reported. After the second shot the patient received in Apr2021, she was sitting for the 15 minutes after the vaccine and her right foot was numb and tingling. Her left foot was fine. At home after the vaccine the patient had her feet propped up and her toes were purple. They did not think about it being any type of side effect from the Covid Vaccine; they thought maybe her foot was wrapped too tightly. On Monday, 26Apr2021, her big toe on her left foot now has the same stinging, burning, pain that the right toe had in it when this all began. Her toes on both feet are still turning purple off and on. The doctor says that since when they are pressed the purple goes away then comes back it is okay. Both feet were swollen at one time. The swelling has decreased in the right foot; but continues in the left. It was believed that the patient was suffering from neuropathy. The patient was recovering from the event peripheral swelling. The outcome of the events was pain in extremity and skin coloring was not recovered. The outcome of other events was unknown. Information about lot/batch number has been requested.

22 year old female pt present today due to a LARGE lump on her left armpit. Patient states has always had pea like pimple under arm pit area but 2 weeks ago noticed growth and its is getting bigger, Warm to touch from scale to 0 to 10 pt states pain is a 7, worried because her breast is also tender. Patient admits took pfizer vaccine and after first dose she develop a "bump under her axilla on left side, pt went to get second vaccine 5-17-2021 and used right arm due to the bump on left and now both axilla are hurting, swollen mildly and pain in both breast. NO fever, no pus , no erythema, mostly pain as per patient.

Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Lymph Node Swelling-Medium, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.), Additional Details: Patient is experiencing extreme pain and swelling after receiving first dose of Pfizer vaccine on 5/17/21. Went to both the ER and PCP and was informed that it was administered too low and could be a potential for infection.

Had a bad fever, headache, chills and nausea the day after I got the vaccine. Then the next day, my lymph nodes on my underarms were swollen.

Painful & Swollen axillary lymph nodes on armpit side of injection site; Painful & Swollen axillary lymph nodes on armpit side of injection site; This is a spontaneous report from a non-contactable nurse reported for herself. This 22-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in left arm on 17Feb2021 13:00 (Lot Number: EL9267) as single dose (at 22 years old) for COVID-19 immunisation. Medical history included COVID-19 prior vaccination on an unknown date, known allergies: Penicillin. There were no concomitant medications. The patient experienced painful & swollen axillary lymph nodes on armpit side of injection site on 18Feb2021 with outcome of unknown. No treatment required. The patient had not been tested for COVID-19 post vaccination. No follow-up attempts are possible. No further information is expected.

Anaphylaxis; This is a spontaneous report from a contactable consumer (patient). A 22-years-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in arm left on 14May2021 11:00 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. Medical history included asthma, rocky mt spotted fever, MRSA, sepsis x2, mono (monocytes) from an unknown date. The patient's concomitant medications were none. No other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. The patient received first dose of bnt162b2 on 23Apr2021 for covid-19 immunization at 22-year-old. Prior to vaccination, the patient was not diagnosed with COVID 19. Since the vaccination, the patient has been tested for COVID 19. The patient experienced Anaphylaxis, swollen closing throat,sob, wheezing, itching, dizziness on 14May2021 11:45. The adverse event result in Emergency room/department or urgent care. Therapeutic measures were taken as a result of all the events, treatment included Epi,Prednisone,Benedryl, IV. The outcome of the events was recovering. Information about lot/batch number cannot be obtained. Additional information has been requested.; Sender's Comments: Based on the known safety profile of the drug and plausible temporal relationship, a causal association between the event of Anaphylactic reaction and suspect drug BNT162B2 cannot be excluded

Patient appears to have myocarditis/ viral pneumonia, hypoxia on 6/3/21 positive Sars-CoV-2 on viral panel in ED today.

I had a large, swollen lump on my left shoulder - which was bigger than a golf ball - that lasted 8 days. I went to Urgent Care. The doctor diagnosed it as lymphadenopathy cervical. I was told to apply a warm compress and to wait for it to clear.

Neck was chocking I feel like that I have taken a pill and it stuck in a throat; My breaths starts to close in I couldn't breathe; I have a lot of trouble in breathing; I couldn't eat; I couldn't sleep; I was very dizzy; I had a lot of vomiting; I couldn't even swallow; My neck was really getting swollen; I had fever; Chills; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: 5EW0182), via an unspecified route of administration on 03May2021 (at the age of 22-years-old) as a single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she got her shot right in, "my breaths starts to close in I couldn't breathe", "I couldn't eat", "I couldn't sleep", "I was very dizzy", "I had a lot of vomiting" and it was basically not good. Then she went to the urgent care because "I couldn't even swallow", "my neck was really getting swollen" and "neck was chocking I feel like that I have taken a pill and it stuck in a throat" and then "I had fever", chills and a lot of hard time. When paraphrased the above concern, the patient stated, and then "I have a lot of trouble in breathing". She received the second dose on 24May2021. The patient stated, the only thing that they gave her was Ibuprofen because they say, that's the only thing that they could give her. The outcome of all the events was unknown. Follow-up attempts completed. No further information expected.

Initial itchiness upon injection of vaccine; Chills within an hour of receiving the vaccine; Swelling of lymph nodes noticed one week after injection; This is a spontaneous report received from a non-contactable health care professional, the patient. A 22-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: Ep7534), via unspecified route of administration on 17Mar2021 at 13:00 (at the age of 22-year-old), as a single dose for COVID-19 immunisation. The patient medical history included depression, seasonal allergies, obesity, asthma. The patient was allergic to bananas and latex. The patient past drug history was not reported. The concomitant medication included Fluoxetine (PROZAC), FLONASE (fluticasone propionate and birth control (MANUFACTURER UNKNOWN) for an unknown indication. The patient did not have any symptoms associated with COVID-19 prior to vaccination. Since the vaccination, the patient had not tested for COVID-19. On 17Mar2021 at 13:00, the patient experienced itchiness. The patient experienced chills within an hour of receiving the vaccine. On an unknown date in Mar2021, the patient experienced swelling of lymph nodes which was noticed one week after injection. Treatment received for the adverse events was reported as no. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event itchiness, chills and swelling of lymph node were recovering at the time of this report. No follow-up attempts are possible. No further information is expected.

The first dose I experienced flu symptoms with a body ache/chills/headache that lasted for about 2-3 days. 2nd dose, next day had a fever/chills/headache/body aches, a few days later experienced shortness in my breath, numbness, and pain in both legs, extreme lower back pain and abdominal pain/cramping and the pain is still there, I have 2 swollen lymph nodes located in my groin area. I have seen the Dr a few times and had a CT scan. They discovered I have an enlarged liver/swollen spleen that they found a blood clot, the doctor has me taking aspirin for 3 months, and will need to follow up with another CT scan

Swollen lymph nodes and throat infection for one week. Extreme pain in ear and throat on left side only. Visited a Physician Assistant at Ear Nose Throat clinic and was prescribed antibiotic Cefdinir. I am halfway through the antibiotics and seeing great improvement so far.

Thyroid or throat area was pounding; Thyroid or throat area is pounding; legs swelled up so bad; Heart rate very low; circulation issues; Felt like having a stroke; Dizzy; Pitting in left leg, which was pale and had veins showing; Pitting in left leg, which was pale and had veins showing; Pitting in left leg, which was pale and had veins showing; Struggling to breathe/can't breathe; Weak; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm, on 04May2021 12:00 (Batch/Lot Number: EL9269), as dose 1, single, at age 22 years old, for COVID-19 immunization, at a pharmacy/drug store. The patient was not pregnant at the time of vaccination. Medical history included Hashimoto's disease, Ehlers-Danlos syndrome, and Raynaud's disease, all from unknown dates, not reported if ongoing or not. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. The patient received unspecified medications within 2 weeks of vaccination (unspecified concomitant medications). On 07May2021 (also reported as "around day 3 or day 4"), the patient started to get dizzy. On the same day, 07May2021, the patient felt like have a stroke because she could not make thoughts. She had pitting in left leg (also reported as "pitting in left left", pending clarification), which was pale and had veins showing, and she was struggling to breathe and was weak. On 09May2021 (also reported as "about day 5"), her heart rate was very low and she noticed circulation issues. On 11May2021 (also reported as "day 7"), her legs swelled up so bad. On 14May2021 (also reported as "day 10"), the patient's thyroid or throat area was pounding. The events resulted to emergency room and physician's office visits. Treatment for the events included turmeric and aspirin which the patient took every day, multiple times a day. Blood work on an unspecified date mostly came back normal. The patient reported the events were better in two weeks. Her physician advised her to skip the second dose. However, the patient received the second dose out of "fear of missing out" on 25May2021 12:00 (Batch/Lot Number: EW0178) in the left arm. The patient was recovering from the events. Follow-up attempts are completed. No further information is expected.

Fatigue; Headache; Swollen lymph nodes in armpit; feeling unwell; This is a spontaneous report received from a contactable consumer, the patient. A 22-years-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198), via an unspecified route of administration in the left arm on 13Mar2021 at 15:30 (at the age of 22-years-old), as a single dose for COVID-19 immunisation. Medical history included attention deficit hyperactivity disorder (ADHD) and scoliosis. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had not received any other vaccines within 4 weeks prior to COVID vaccine. Concomitant medications included lisdexamfetamine dimesylate (MANUFACTURER UNKNOWN) and etonogestrel (NEXPLANON), both taken for unknown indication from unknown date. Since the vaccination, the patient had not been tested for COVID-19. On 14Mar2021 at 12:00, the patient experienced fatigue, headache, swollen lymph nodes in armpit and was feeling unwell. The patient did not receive any treatment for the adverse events. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of events fatigue, headache, swollen lymph nodes in armpit and feeling unwell were resolved on an unknown date in Mar2021. No follow-up attempts are needed. No further information is expected

Arm pain and swelling; Arm pain and swelling; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 18Mar2021 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. It was reported that the patient had no allergies to medications, food, or other products. Concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 18Mar2021, the patient experienced arm pain and swelling. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Treatment received for the adverse events was reported as no. The clinical outcome of the events arm pain and swelling was recovered on an unknown date in Mar2021. Information about lot/batch number cannot be obtained. No further information is expected.

Developed chronic urticaria starting shortly after second dose. Demonstrates ongoing elevation of inflammatory markers and elevated d-dimer approx 2 months after 2nd dose of vaccine.

Swelling in the armpit and breast on the same side as the injection; Pain in the breast on the same side as the injection; Pain in the armpit on the same side as the injection; Body aches; Low grade fever; Fatigue; Light, red and non raised rash at the injection site; Non raised rash at the injection site; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 27Apr2021 at 13:45 (at the age of 22-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma and food allergy. Concomitant medications were not reported. The patient did not receive any medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 06Apr2021 at 14:00 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Apr2021 at 15:30, the patient experienced pain and swelling in the armpit and breast on the same side as the injection, body aches, low grade fever, fatigue, light red non raised rash at the injection site. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events which included treatment with BENADRYL. The clinical outcome of the event swelling in the armpit and breast on the same side as the injection, pain in the armpit and breast on the same side as the injection, body aches, low grade fever, fatigue and light red non raised rash at the injection site were resolving at the time of this report. No follow-up attempts are needed. No further information is expected.

experienced an auto immune reaction in the form of a flare up regarding my dermatographia.; progressively worse hives; itching; swelling at face; swelling at lips; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151), via an unspecified route of administration in the left arm on 22Apr2021 at 15:15(at the age of 22-year-old) as a single dose for COVID-19 immunisation. Medical history included sports induced asthma, depersonalization/derealization disorder and dermatographia. Concomitant medications included desvenlafaxine succinate monohydrate (PRISTIQ), topiramate (TOPAMAX), cetirizine hydrochloride (ZYRTEC) and vitamin d (MANUFACTURER UNKNOWN) from an unknown date and for an unknown indication. The patient had a history of allergy to sulfa drugs. The patient previously took 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 15:15 (at the age of 22-year-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 28Apr2021, the patient experienced an auto immune reaction in the form of a flare up regarding dermatographia, progressively worse hives, itching, and swelling in the face and lips. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events which included treatment with prednisone, ALLEGRA, BENADRYL and PEPCID. The clinical outcome of the events an auto immune reaction in the form of a flare up regarding dermatographia, progressively worse hives, itching and swelling in the face and lips was not resolved at the time of report. No follow-up attempts are needed. No further information is expected.

Fever -102; Chills; Headache; Left arm pain and swelling; Left arm pain and swelling; General body aches; Nausea; Tired; Unwell; Dizzy; This is a spontaneous report from a contactable other HCP (patient). A 23-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number E49899) (Brand: Pfizer), via an unspecified route of administration at 28Dec2020 15:45 at single dose for covid-19 immunization. Vaccine location was left arm and it was the first dose. The patient medical history and concomitant medications were not reported. No known allergies. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fever -102, chills, headache, left arm pain and swelling, general body aches, nausea, tired, unwell, dizzy at 29Dec2020 11:00 AM. It's unknown if patient received treatment for the adverse events. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was not recovered. The events were reported as non-serious.

8:05am-Patient received Covid vaccine and while being monitored c/o upper lip being numb, no other c/o voiced, no nonverbal cues noted at present time. 8:22am- Self medicated with Benadryl 25mg; tolerated without difficulty. 8:28am-Patient c/o throat tingling and verbalized having history of angio8:05am-Patient received Covid vaccine and while being monitored c/o upper lip being numb, no other c/o voiced, no nonverbal cues noted at present time. 8:22am- Self medicated with Benadryl 25mg; tolerated without difficulty. 8:28am-Patient c/o throat tingling and verbalized having history of angioedema; noted anxious, cough present, upon further evaluation noted facial swelling, top lip remains numb; patient assisted to emergency room per staff on duty; upon leaving clinic patient continued to cry for her mom; required reassurance regarding going to emergency department.edema; noted anxious, cough present, upon further evaluation noted facial swelling, top lip remains numb; patient assisted to emergency room per staff on duty; upon leaving clinic patient continued to cry for her mom; required reassurance regarding going to emergency department.

8:05am-Patient received Covid vaccine and while being monitored c/o upper lip being numb, no other c/o voiced, no nonverbal cues noted at present time. 8:22am- Self medicated with Benadryl 25mg; tolerated without difficulty. 8:28am-Patient c/o throat tingling and verbalized having history of angioedema; noted anxious, cough present, upon further evaluation noted facial swelling, top lip remains numb; patient assisted to emergency room per staff on duty; upon leaving clinic patient continued to cry for her mom; required reassurance regarding going to emergency department.

Fatigue and overall lethargic feeling/Sore throat; Dark colored urine despite pushing fluids; Frequent urination; Migraine; Swollen joints and could not move arm that received vaccine in; Swollen joints and could not move arm that received vaccine in; Stomach pains, nausea, diarrhea, swollen lymph nodes; Stomach pains, nausea, diarrhea, swollen lymph nodes; Stomach pains, nausea, diarrhea, swollen lymph nodes; Stomach pains, nausea, diarrhea, swollen lymph nodes; Chills, body aches, spiked fever of 102.; Chills, body aches, spiked fever of 102.; Chills, body aches, spiked fever of 102.; Fatigue and overall lethargic feeling; Fatigue and overall lethargic feeling; Sore throat; The initial case was missing the following minimum criteria: Invalid for no adverse effect. Upon receipt of follow-up information on (31Dec2020), this case now contains all required information to be considered valid. This is a spontaneous report from a contactable Nurse. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EH9899, Expiry Date: Mar2021), intramuscular at Deltoid Left on 29Dec2020 07:20 at single dose for COVID-19 immunization. Medical history included covid-19 from Nov2020 to an unknown date (had covid in the middle of November), surgeries from an unknown date and unknown if ongoing (She also had previous surgeries and has foreign objects in her body. Those areas were super hot. Those antibodies were like rejecting those foreign bodies because they were super hot.) There were no concomitant medications. Received call from RN calling about the Pfizer COVID vaccine. She got the vaccine on Tuesday and had a terrible reaction to it and she called a couple of different hotlines and spoke with the people who administered it. She confirmed that she did not report to Pfizer though. The people at her work that she spoke with told her to go to an Urgent care. They told her she should not get it within 90 days of having COVID. She had COVID in the middle of Nov2020. She went ahead and got it on Tuesday and had this terrible reaction. She would like to know if she should get the second dose or wait until 90 days after she had COVID and start again. There was no prescriber. She received it as part of the (hospital name withheld) front line health worker precaution. She thought that this was a normal reaction, but was told it was not. Fatigue and overall lethargic feeling happened exactly 12 hours after receiving. She works night shift and that is her base line. Pretty much everything hit after that within an hour. She was told low grade fever was normal, but not 102. She never spikes fevers, so it is medically significant. It persisted for 24 hours and is better today. She is on the 48 hour mark now. Stomach pains, nausea, diarrhea, lymph node swelling all over, including swelled armpits and groin area, Migraine, Frequent urination, were also listed as side effects. She was trying to push more fluids but her urine was dark color more than normal, despite pushing fluids. Swollen lymph nodes in her groin and armpits were concerning. Her head is lumpy. Meaning, she can feel swollen lymph nodes in back of neck area. Migraine was consistent through 24 hours and now has improved. Urine color remains dark and she will keep an eye on color. She had swollen joints, but really terrible swollen joints, and she could not move the arm that she got the vaccine in. She could not lift to above shoulder height. AE Details and time of onset: Sore Throat 12:00 on 29 Fatigue and overall lethargic feeling 20:00 Chills, body aches, spiked fever of 102: 21:00 Stomach pains, nausea, diarrhea, swollen lymph nodes- 21:00 Migraine- 21:00 Frequent Urination 23:00 Dark colored urine despite pushing fluids 23:00 Swollen joints and could not move arm that received vaccine in: 21:00. ER or physician's office required: Went to urgent care 36 hours after administration. No treatment given. She just wanted to make sure no additional infection was causing anything weird. All test were negative. Prior Vaccinations (within 4 weeks): none. Events Swollen joints and could not move arm that received vaccine in, Stomach pains, nausea, diarrhea, swollen lymph nodes, Chills, body aches, spiked fever of 102 were serious with criteria of medically significant, while the other events were non-serious. The outcome of the event Fatigue and overall lethargic feeling/Sore throat (Condition worsened) was unknown, the outcome of the events Swollen joints and could not move arm that received vaccine in, Chills, body aches, spiked fever of 102., Migraine, Dark colored urine despite pushing fluids, Frequent urination was recovering, while the outcome of the other events was not resolved.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported events due to 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.

Preauricular lymphadenopathy and tenderness initially noted on the R side. Progressive bilateral tenderness prompted symptom reporting.

Swollen lymph node in left armpit. Using ice and ibuprofen to help with over all swelling. After 5 days thought it was getting better but over night of day 5 to 6 unable to sleep due to the pain and ibuprofen not relieving anything only ice helped.

lymphadenopathy on left side of neck. It happened 5 days after first dose and has stayed swollen since first vaccine, but otherwise had no other issues. After she received her second vaccine, it has doubled or tripled in size and is painful.

The day after receiving my second dose, the lymph node in my right underarm swelled up and was painful. Now on day 4 of this reaction, it has grown bigger and the pain is intense and spread all the way down my arm and to my breasts. My arm will go numb from time to time as well. I am also feeling as if I should have a fever but I do not and feel overall not well.

After around 12 hours from getting my vaccine, I experienced strong aches, mild fever, and headaches. Treated with ibuprofen. 21 hours post vaccination was the peak of the symptoms, temperature of 101.6 with ibuprofen, strong body aches, weakness, and anorexia. Symptoms became more mild at hour 31 post vaccine. I had a swollen lymph node after the first vaccine above my left collarbone (injected on left side) and still have this, and now I have a swollen armpit that is very painful on my right side (injected on the right side).

The first day 1/07/21 I started with a pain on my throat , my throat felt really sore however I was still able to eat . The following day 1/08/21 I still had a sore throat I was able to eat , but at the end of the night I got a fever me temperature was 102.0 . I knew all these symptoms were normal but being that on 1/09/21 It was painful for me to swallow I went to immediate care where they said I still had a fever and told me I had a swollen tonsil on the left side of the mouth which is also the side I received the vaccine on. I still continued to have a fever . Saturday night I noticed I had gotten some small sores on my mouth also on the left side . On Sunday I had loose stool , but I have been eating very soft foods because of my throat . Which then I went to go see a dentist and she said they appeared to be fever blisters , those popped I have a couple on my tongue as well . As of today my throat pain feels to be getting better .I did start a oral mouth rinse also for the sores

Rash consisting of hives or small red bumps suddenly appeared on upper body (arms, chest, upper back) the morning of 12/26/20. Rash continued to spread to lower back and stomach over the next few days with the left arm being the most affected area. Facial redness and swelling occurred however breathing was never affected. Benadryl did not provide much relief. Visited an urgent care which classified it as an allergic reaction and started 5 day course of prednisone on 12/28/2020. Symptoms resolved upon completion of the prednisone. Total duration of symptoms was approximately one week. I had not used any new skin products or eaten any foods new to my diet and nothing else comes to mind as a potential contributing factor.

Folliculitis on bikini line, and in both armpits. There was a small lump in each area, with redness and swelling. Very tender lymph nodes in each area. Put Bactrim ointment on 3 times day for 5 days.

Pain to the arm which traveled to my arm pit the next day with swelling to lymph nodes on axillary region causing pain at rest and increased pain with movement. Pain is reduced today but is still present at rest

Acute Angioedema. Treated with multiple rounds of epinephrine, solumedrol, diphenhydramine, famotidine. Admitted to the ICU for continued monitoring and treatment. ICU time 42 hours.

throat felt like it was closing up; had issues swallowing; it feels like her throat will close up and open up; felt dizzy; shaky; nauseous; extremely tired; had a strong headache; It's like she is having allergy and hay fever type symptoms; It's like she is having allergy and hay fever type symptoms; The lymph nodes in her neck feel like they are swollen, it feels like she has a big lump in the middle and sides of her throat.; feels like she has a big lump in the middle and sides of her throat; This is a spontaneous report from a contactable other healthcare professional (patient). A 23-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot no: EL1283, via an unspecified route of administration on 09Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported she got the Covid vaccine on Saturday, 09Jan2021, and immediately her throat felt like it was closing up, she was instantly reacting to the vaccine. Since then, she has had issues swallowing; it feels like her throat will close up and open up. She also felt dizzy, shaky, nauseous, extremely tired, and had a strong headache. She stated that diphenhydramine (BENADRYL) helps a lot with the throat symptoms and as long as she takes it, she feels almost normal but as soon as it is out of her system, it starts again. It's like she is having allergy and hay fever type symptoms. The lymph nodes in her neck feel like they are swollen, it feels like she has a big lump in the middle and sides of her throat. She just came back from the emergency room and they gave her diphenhydramine. She wanted to know if she should she get the second vaccine. Outcome of the events was unknown.; Sender's Comments: A causal association between BNT162B2 and throat tightness cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

where patient experienced chills; skin sensitivity; joint pain in upper/lower back and fingers; sensitive/painful lymph nodes; and ran a 102.3 fever for several hours/Patient broke fever on 13Jan2021; body aches; headache; This is a spontaneous report from a non-contactable other HCP. A 23 years old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 12Jan2021 at 07:30 intramuscular at single dose for COVID-19 immunization. Relevant medical history included asthma and allergy to ibuprofen. The patient received first dose of vaccine on 24Dec2020 at 05:00 intramuscular on left arm. Concomitant medications were not reported. On 12Jan2020 at 19:30, the patient experienced chills, skin sensitivity, joint pain in upper/lower back and fingers, sensitive/painful lymph nodes in armpits/groin/neck, and fever (ran a 102.3) for several hours. Patient recovered from fever on 13Jan2021 and was recovering from other reported events. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

swollen lymph node under her arm; Pain; This is a spontaneous report from a contactable consumer (patient). A 23-years-old female patient received second dose of bnt162b2 (COVID-19 Vaccine, lot# EL1283), via an unspecified route of administration on 08Jan2021 at single dose on right arm for covid-19 immunisation. Medical history was none. There were no concomitant medications. The patient previously received first dose of COVID-19 Vaccine for COVID-19 immunisation on 18Dec2020. On 09Jan2021, she noticed she had a swollen lymph node under her arm that hadn't gone away. It had gotten more swollen and had spread. The pain had gotten more intense. The pain started as an ache then it was sharp and was now painful to touch. Both conditions were reported as worsen. The event outcome was not recovered.

Migraine afternoon of 1/25/2021. She then experienced feelings of nausea, mouth-watering, feeling overheated. While resting during the onset of these symptoms she then felt like she couldn't breath, experiencing pain in the sides of her chest. The next symptoms that occurred were angioedema to the face, she described her eyes getting so puffy she couldn't see. She also described her skin getting reddened and itching all over. She took Benadryl at home and started to feel better in about 1 hour.

Fatigue and muscle aches - day of to present Low fever (99°F) - Saturday, Tuesday, and Wednesday Pelvic/intestinal cramping that woke me up in middle of night - Monday/Tuesday Joint pain - Friday, Saturday, Sunday Swollen lymph nodes (axillary) - Sunday, Monday Swollen lymph node (right neck, under mandible) - Saturday to present, getting bigger and more painful Headache - Friday-present

Fatigue; A visibly swollen lymph node in her neck; This is a spontaneous report from a contactable healthcare professional (the patient). A 23-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: KK9231, expiration date not reported), via an unspecified route of administration (reported left arm), on 13Jan2021 at 09:45 at a single dose for COVID-19 immunization. Medical history included psoriasis from an unknown date. Concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on 23Dec2020 on her left arm (lot number: EJ1685). After receiving the second dose of the vaccine on 13Jan2021 at 20:15, the patient experienced fatigue and a visibly swollen lymph node in her neck. The patient was recovering from the events. There was no treatment given for the events.

First 2 days after vaccination, I had some injection site pain that was improving. Day 5 after vaccination, I developed lymphadenopathy on my left side with swelling into the chest area developing on day 6. Day 8 after vaccination, my injection site turned red and itchy and I began to have trouble breathing. I went to urgent care. I saw P. A. She said that it was more likely that the difficulty breathing would be due to my asthma, but she could not recommend whether or not I should receive my second dose. She proscribed 20mg of Prednisone and refilled my albuterol prescription. About 20 hours later, my breathing is still difficult and my arm still itches. We also discussed that the respiratory symptoms could be caused or exasperated by COVID-19, so I am waiting on results from a covid test.

So I received the vaccine on my left arm on January 20th and the next day I had swelling on my left arm and neck. It went away within an hour or so. However, on the 28th of January, I woke up with supraclavicular lymphadenopathy on my left side of my neck. So, I have swelling and lumps/growths above my left collar bone. My left arm is numb and tingly and I feel very sick. I am nauseous and have body aches. I went to urgent care and they believe it is a reaction to the vaccine. I was tested for mono and strep throat and do not have either. I took a rapid covid test on Wednesday the 27th and it was negative.

Noticed the day after the vaccine. Redness, swollen, feverish to touch, and itching. grew double the size by Thursday which was two days after vaccine. Was seen in urgent care on Friday four days after vaccine. was given an antibiotic and was diagnosed with cellulitis.

Injection site pain; chills; headache; body aches; nausea; swollen lymph nodes; fatigue; swollen, tender lymph nodes in the neck and armpits; This is a spontaneous report from a non-contactable other health professional. A 23-year-old female patient reported that she received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number unknown), intramuscular at single dose into the left arm on 20Jan2021 at 08:00 AM for COVID-19 immunization. The patient medical history was unknown. Concomitant drug was Sertraline and Mili tablets. Within 4 weeks prior to the COVID vaccine the patient received the vaccine TDAP on 08Jan2021 in the right arm. On 20Jan2021 at 09:00 PM the patient experienced injection site pain, chills, headache, body aches, nausea, swollen lymph nodes, fatigue. These started about 12-14 hours after getting the vaccine and worsened over the next several hours. Most symptoms resolved, but she still had swollen, tender lymph nodes in the neck and armpits as well as some mild body aches and headache (at the 48 hour mark). No treatment was received. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Itchy raised bumps on left arm the day after the vaccine and hives as well as increased itchiness throughout my body as the days progressed

swollen lymph node; lymph node was swollen and she described it as "not terrible just a constant pain."; pain and swelling at injection site; pain and swelling at injection site; This is a spontaneous report from a contactable consumer who reported for herself, a 23-year-old female patient (home health aid) who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL1283, Expiration date: 30Apr2021), intramuscular at the left arm, on 11Jan2021 at around 09:00 at the age of 23 years, at a single dose for COVID-19 immunization. There were no medical history and no concomitant medications. There were no prior vaccinations within 4 weeks. Patient reported that she experienced swelling and pain at the injection site on 11Jan2021, she didn't feel any pain until that night around 4 or 5pm. By Thursday, 14Jan2021, she woke up and felt better, she didn't have any pain or swelling. Patient reported that on 18Jan2021, on the right side of her face under her jaw she noticed her lymph node was swollen and she described it as "not terrible just a constant pain." She would like to know if this was a common side effect, and if how long should she wait before she could contact her doctor about this side effect. These were the only symptoms she experienced. The swelling has stayed the same. She did not know if the swollen lymph node could be from the COVID vaccine or not. Patient stated if the swollen lymph node was not a part of the symptoms for the COVID vaccine, she definitely needs to go see a doctor. The events were considered as non-serious by the reporter. The events did not require a visit to emergency room nor the physician office. The outcome of swollen lymph node and lymph node pain was not recovered; while pain and swelling at injection site recovered on 14Jan2021.

Swollen lymphnodes in the left collarbone area and my neck; Sore arm; This is a spontaneous report from a contactable consumer. A 23-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248 and expiration date not provided), via an unspecified route of administration in the left arm on 15Jan2021 14:00 at a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ethinylestradiol, norgestimate (SPRINTEC), and sambucus nigra (ELDERBERRY). On 16Jan2021 06:00, the patient experienced sore arm. Then on 17Jan2021 14:00 (reported as 48 hours after vaccination), the patient experienced swollen lymph nodes in the left collarbone area and on her neck on the same side as vaccination. Treatment was not provided in response to the events. The outcome of the events was recovering. The patient has not been tested for COVID-19 since vaccination.

Red swollen big bump on arm that didn't go away for 5 days; Red swollen big bump on arm that didn't go away for 5 days; This is a spontaneous report from a non-contactable healthcare professional (the patient). A 23-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EH9899), via an unspecified route of administration in the left arm on 30Dec2020 at 14:15 (at the age of 23-years-old) as a single dose for COVID-19 immunization. Medical history included the patient had COVID prior to vaccination. The patient had no known allergies. The patient was not pregnant at the time of vaccination. Concomitant medications were not reported. On 30Dec2020, the patient experienced red swollen big bump on arm that didn't go away for 5 days. The patient did not receive any treatment for the events. The clinical outcome of red swollen big bump on arm was recovered on 04Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.

Moderate generalized headache and body aches 12 hours after 2nd dose of vaccination lasting one day. Managed with Acetaminophen at home. Left axillary lymphadenopathy 36 hours afer 2nd dose, currently subsiding. No care sought

Approximately 28min after vaccine administration, pt. was noted to have red/swollen face & SOB. Pt reported hx of severe asthma. Epi pen administered by clinic RN and pt took own albuterol inhaler at 1322. 911 called. pt reported some improvement of SOB after meds, but continued w/cough and increased work of breathing. VS showed tachycardia and hypertension after epi administration. Pt reported improvements in face swelling and throat tightness after epi administration but still appeared to have labored and tachypneic breathing despite O2 sats 98-100%. Pt placed on 2L O2 via face mask to decrease work of breathing. Pt remained A&O, but developed rigors after epi administration. Paramedics and EMS arrived at approx 1328. Pt was subsequently transported to ED for further eval per EMS report.

The shot went in my arm and I immediately started feeling itchy. Before the needle was out, I knew something was wrong but almost didn?t believe how fast it happened. My throat started itching and swelling shut. I was in full blown anaphylactic shock in less than 2 minutes. I got an EpiPen shot in the parking lot and was admitted into the hospital where I continued having various reactions. A week after the shot, I?m still breaking out in hives uncontrollably.

eye pressure/pain/floaters beginning day after second vaccine dose and lasted for three days. Lymph node in under arm of injection arm swelling starting day after second vaccine those on January 20 and still swollen and tender on February 10

Shot 1: Pain and bruising at injection site Shot 2: Slight fever, shoulder muscle pains (some shooting), wrist aches, fatigue- all starting 20-24 hours post shot -swollen lymph node in armpit of the same arm as injection approximately 36 hours after injection all other symptoms receded overnight -took aleve at about 1500 the day after injection and nyquil around 19:30 the day after injection

Swelling of throat area and face. Rash on right side of throat but went away over time.; Swelling of throat area and face. Rash on right side of throat but went away over time.; Swelling of throat area and face. Rash on right side of throat but went away over time.; This is a spontaneous report from a contactable consumer (Patient) A 23-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE;lot Lot EL9262) on 28Jan2021 at 09:30 at single dose in Right arm for COVID-19 immunization. Patient was not pregnant. Medical history included High Blood pressure.No known allergy. Concomitant medication included irbesartan. On 28Jan2021 the patient experienced swelling of throat area and face and rash on right side of throat but went away over time. Events required Doctor/other healthcare professional office/clinic visit. Patient was teated with Benadryl. Final outcome of all the events was recovering.

About 1.5-2 hours post immunization the patient returned having developed a headache and a quarter sized welt that was lightly red, swollen and very tender to touch, just below her left collar bone about 4 inches from the injection site. The welt was outlined and observed and the patient was given 25mg of Benadryl. After about 20 minutes the swelling and tenderness had spread to an area approximately the diameter of a tennis ball. At this point she was refered to see a doctor at the Health Center. The nurse called to follow-up once the patient arrived as she had not seen this type of reaction after the vaccine. After discussion the physician was going to look at her. Reportedly the swelling had begun to retract and the patient apparently returned to work later that day, talking about her plans to receive the second dose.

Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Hypertension-Mild, Additional Details: Pt presented with swollen lips within 15 minutes of vaccination. Benadryl administered. 911 called and paramedics arrived to take to local ER. Patient's friend returned and said patient was being monitored at the ER for the next 6 to 7 hours.

29 minutes after being given the vaccine my tongue started itching and swelled up a bit, my mouth felt dry, my face became a bit reddened, puffy, and itchy, my throat began to swell a bit and my chest felt tight, giving me some discomfort when it came to breathing. I let the nurses who were keeping an eye on those waiting for 15/30 minutes know that I was having a reaction. I waited 1 more minute, and when my throat felt tighter and I had a bit more difficulty breathing, I took 1 Benadryl tablet, and waited 2 minutes, and when the symptoms were still worsening slowly, I took a second Benadryl tablet and after a few minutes my symptoms started to go away. I waited another 10 minutes and then went home when it seemed that my symptoms were going away. At 6:45pm on 2/21/2021 my throat and chest started feeling tight again and gave me mild breathing discomfort, so I took another Benadryl tablet, a few minutes later my face began to itchy and my mouth felt dry and my tongue felt a bit swollen, whereupon I took a second Benadryl tablet at 6:56pm, and then felt a wave of nausea. At 6:59pm, the feeling of tightness had not abated, but also hadn't worsened noticeably, and the itching feeling began to spread from my face to my ears and down my neck. At 7:04pm the tightness of my throat and chest began to increase some, and I started to feel some anxiety. At 7:11pm I inhaled two puffs from an albuterol inhaler used for treating asthma as my throat and chest were continuing to slowly get tighter. At 7:26pm I still felt itchy and my throat and chest still felt tight, but it wasn't noticeably worse. At 7:35pm, my throat began to feel tight enough to give me noticeable discomfort while breathing and for me to make a slight wheezing sound while breathing, and my tongue felt like it swelled a bit more, and my mouth still felt dry. At 7:51pm the Benadryl made me feel sleepy, but had no effect on my itchy skin or tightness of throat or chest. 8:00pm, my throat and chest felt tighter and I started having some difficulty swallowing and I felt very warm. 8:05pm, I had a lot of difficulty swallowing and had trouble breathing, so I went to the Emergency Room and was given an Epinephrine shot and sent home after an hour of observation.

Night after vaccine: extreme muscle pain 2 days later: supraclavicular and anterior cervical lymphadenopathy

Bright red rash on left arm, resolved within 12 hours with steroid anti-itch cream Sore, swollen arm, not resolved by ibuprofen or acetaminophen

24 y.o. female with no significant past medical history who was diagnosed with COVID-19 (NP PCR on 1/27/2021) with mild symptoms (3-4 days of rhinorrhea and myalgia) and complete recovery with return to work who recently completed COVID-19 vaccine series (Pfizer 1/8/2021, 2/5/2021) now presenting for hospitalization (2/26/2021) with fever, rapidly progressive hypoxia, and hyperinflammatory state including elevated ESR, CRP, ferritin, D-dimer, and troponin (20) in the setting of positive COVID-19 NP PCR (2/26/2021) and positive S.pneumoniae urine ag with clinical diagnosis of MIS-A s/p high dose methylprednisolone and IVIG.

Redness, swelling, hot to touch. Got worse from day 2 until day 4 when I went to urgent care. I was given an antibiotic and steroid. This happened with my first dose but was much more delayed.

Chills and body aches that night. Arm that vaccine was injected was sore. Armpit of the arm that was injected was sore. Developed swollen lymph node above clavicle on side of injection.

Around 1815, pt began to have numbness and tingling in left arm (arm vaccine was given), felt swelling in lymph nodes and neck, 1 or 2 small hives around left neck with some redness, then about 1820 felt "throat puffy"/swelling and slight trouble swallowing. Denies trouble breathing. Pt was conscious and stating she overall felt ok despite the above symptoms but Emergency Team called, pt was taken to ER.

pt experience allergic reaction to Pfizer covid vaccine. had facial and tongue swelling., no dyspnea. BP 110/72 98% O2 Pulse 76 and regualr. Lungs clear bilaterally and good volume. PA-C administered 2ml diphenhydramine 50mg/ml. Swelling decreased, vitals monitored by nurse until pt was well enough to leave facility. Pt picked up by her step father.

Seizure; Headache; Couldn't feel lower legs; Extreme chest pains and chills; Extreme chest pains and chills; Arm swelling; Pain; Itching; This is a spontaneous report from a contactable healthcare professional (patient). A 23-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration (left arm) on 02Mar2021, 16:15, as single dose for COVID-19 immunisation. Medical history included ongoing epilepsy, covid back in Dec2020, known allergies to flu vaccine and TB test and seizure (have history). Concomitant medications included levetiracetam (KEPPRA), lamotrigine (LAMICTAL), cenobamate (XCOPRI) and magnesium. The patient had no other vaccine in 4 weeks. On 02Mar2021 16:15, the patient experienced arm swelling, pain, itching, couldn't feel lower legs, extreme chest pains and chills. On 02Mar2021, at 17:15, the patient experienced headache an hour later. On 03Mar2021 01:00, the patient experienced seizure at the middle of the night around 01:00. The events resulted in emergency room/department or urgent care. The patient had Covid prior vaccination; and was not Covid tested post vaccination. Outcome of event seizure was not recovered; outcome of the rest of events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: The patient had underlying epilepsy. However, based on the close temporal association, a possible contributory role of bnt162b2 to the development of seizure 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.

For the past 6 days now, I've been having the following symptoms: headaches, fever, fatigue, night sweats, chills, loss of appetite, and a cough.

I received the Pfizer vaccine on Friday afternoon, and the rash presented on the face (both cheeks and forehead), chest, and both arms on Saturday morning. I also woke up with puffy cheeks, and the swelling is now gone. The facial rash is itchy, and there is tiny pustules present?however, no shortness of breath, sore throat, fever, anaphylaxis, or other severe symptoms.

I got my vaccine on 3/19 at 10am. My 6:30 pm on 3/19 my face got dark red, almost purple and started to swell. I went to and urgent care where they gave me a 50 mg shot of Benadryl. AFter about 20 minutes the reaction was getting better so they released me to go home. They told me to continue taking the Benadryl every 4-6 hours for the next 2-3 days. I did as directed for through the night and the next day. Around 6:30 pm on 3/20 I started feeling very tired, shaky, and dazed. My about 9:00 that evening I began to feel swelling in my throat/tongue. I then went to the emergency room and where they gave me another 50 mg shot of Benadryl and a 6 mg shot of Decadron. They monitored me for a couple hours and the swelling in my mouth had gone down and the rash that had also reappeared had gone down. They sent me home with a prescription for Prednisone 10mg 4 pills a day for 4 days and told me to continue the Benadryl. I took the Prednisone and Benadryl for all day 3/21 and was feeling better. When I woke up on 3/22, my chest and arms had a rash on them. I took a Benadryl around 7:30 and Prednisone around 8:30. I went to work and around 10:30 my face started getting red and swelling again. I contacted my dermatologist who did skin patch testing and got an appoint for 3/22 at 1:45. She extended the Prednisone out to 12 days and told me to switch to Zytrec during the day and I will follow up on three weeks.

Fatigue and myalgias set in about 6 hours after vaccine was administered Shortly after, tachycardia set in with pulse at 140-150 bpm resting. Fever set in at 8 pm at 103F. One OTC Benadryl brought pulse down to 130s resting. Performed Valsalva Maneuver with pulse improvement to 110s. By morning, fever was still at 103F, with headache, muscle pain, chills, fatigue, pain at injection site, and swollen lymph nodes present. Tachycardia had resolved. Within 48 hours after vaccine was administered, all side effects had resolved except fatigue and swollen lymph nodes and headache. All side effects had completely resolved 9 days after vaccine was administered.

Chills 15 hours after, sore arm, sore armpit starting 15 hours after, swollen armpit, menstrual period started early after both shots (2 days after shot administered)

Patient presented for swelling of her lips with associated burning/pain 4 days after first dose of Pfizer Covid vaccination. No strong clinical correlation of symptom onset and vaccination, however unable to completely r/o as a cause. Patient also reported onset of abdominal pain, diarrhea, and nausea after lip swelling started. Treated for angioedema vs allergic dermatitis and monitored on outpatient basis. No signs of anaphylaxis or airway compromise. No other systemic rash or signs of allergic reaction noted.

Extended tenderness in vaccination site (remains 4 days post). Swollen and tender armpit (most swollen 2 days after, went down slightly on day 4).

Patient presented to PCP's office for concern of allergic reaction. Her symptoms were diffuse hives and extremity and facial edema. Began 48 hours after 1st dose of COVID19 Pfizer vaccine. Symptoms completely resolved about 36 hours after initial onset of symptoms. Presented to office back to baseline and feeling well. Was vaccinated through Medical Center. Also did eat at restaurant the morning before pfizer vaccine dose #1. Did not seek care at an ER.

23 yo FM who received first dose of Pfizer vaccine and then was noted to have shortness of breath and complaining tongue closing sensation immediately after at Vaccine Clinic --I was called to evaluate the patient. When I arrived patient was laying down on a chair with a friend, shaking with seizure like activity but alert and oriented to person place and time. Upon my arrival she was shaking, vomited x 1 and then complained about chest pain. Vitals upon my arrival: HR 58, o2 100% RR appeared to be around 22-24 (hyperventilating) BP 88 systolic (manual)--repeated by medics upon arrival minutes later 110/72. Given throat closing sensation, vomiting, shortness of breath I advised to call 911 and ordered Epinephrine x 1 which was given by RN immediately. Pt was then placed on the grown chin up, she continued to shake throughout entire body but continued to be alert and oriented. Medics then arrived on seen, started an IV, glucose by medics 84, IVF started by medics. Pt was transported to ER via medics. Pt is not a patient, last visit 2017. Pt did state she has hx of POTS and DRESS syndrome to Lamictal. Reports taking cetirizine this AM, Zofran and Oxycodone and Baclofen (prescribed by external PCP?). Prior to transport to ER pt continued to be alert oriented, but shaking and twitching throughout her body. MD verbally communicated to patient to not receive the 2nd dose given her severe anaphylaxis like reaction to the first dose of the vaccine. Pt can be referred to allergist after ER follow up by PCP. Denied pregnancy.

Swollen lymph nodes; left arm pit lump. I mean it wasn?t a lethal side effect. But I didn?t go to the doctor?s for it, and it?s still there. So, that?s why I reported it. It?s been since the day I got the shot through now still. I just got my second vaccine today, on my right arm so I can track the left side and see if this really does correlate with the vaccine.

1.RASH AND ITCHING ON UPPER EYELIDS 12:30 PM 2. ONGOING FRONTAL HEADACHE PAIN RADIATES TO BASE OF NECK AND SKULL AT PAIN LEVEL 10+ /GREATER @ 4PM, ONGOING BODY RASH WITH ITCHING, AND REDNESS UPPER EYELIDS, FACE, CHIN, CHEEKS, LOWER FOREARM, BACK, AND ENTIRE BODY. 3. THROAT FEELING THICK AND ABNORMAL 4.FACIAL SWELLING NECK AREA UNDER CHIN, BACK OF NECK, UPPER ARMS AND LOWER ARMS, UPPER BACK ACROSS SHOULDERS, AND ENTIRE BODY TENDER TOUCH. 5. BILATERAL SWELLING OF THIGHS AND LOWER LEGS CALF AND ANKLES 6. BREATHING FELT LIKE RECOVERING FROM AN ASTHMA ATTACK 7. BLURRED VISION, VISION FELT WEAK 8. FATIGUE TREATMENT OF CARE: WENT TO URGENT CARE FACILITY LOCATED IN ON . RECEIVED IM INJECTIONS OF BENADRYL 50MG IN BUTTOCK AND SOLUMEDROL (STERIOD) INJECTION IN OPPOSITE BUTTOCKS. ON 08APRIL21: PT RECEIVED ZYRTEC PO, BENADRYL 50MG AT BEDTIME FOR ITCHING AND RASH, PREDNISOID 08APRIL202: PATIENT EXPERIENCED NAUSEA AND VOMITING AT 8PM, ON 09APRIL2021 PT C/O ZONING OUT MEMORY FOGGY AND FEELS LIKE SHE IS NOT WITH IT. 10APRIL: RASH CONTINUES TO SPREAD ON FACE, CHIN, UNDER CHIN AND NECK. FRONTAL HEADACHE CONTINUES, NECK SWOLLEN AND SHARP PAIN ON RIGHT SIDE OF NECK AND LOWER JAW. LYMPH GLAND FEELS SWOLLEN ON RIGHT SIDE OF NE``

Intense flu like symptoms and soreness at vaccination site. Fever, muscle aches, congestion, swollen lymph nodes.

23 year old female presents with right sided neck pain x 1 day, reports associated symptoms of headache, coughing, sore throat and myalgias s/p first dose of COVID19 Pfizer vaccine yesterday. Pt reports she couldn't sleep because she felt her heart was beating faster. Pt reports she received COVID19 vaccine dose in left deltoid. Pt denies fever, coughing, emesis, diarrhea, chest pain, SOB, lower extremity edema, lower extremity tenderness. No known sick contacts, no recent travel history. She reports she took Tylenol yesterday and today, with moderate relief. Pt offers no other complaints. Vitals at time revealed normaltensive T98.4F, HR of 100bpm Cardiorespiratory exam on auscultation +S1/S2, tachycardic at 100bpm on repeat, lungs CTAB There was a palpable tender anterior right cervical lymph node that was mobile and well circumscribed around 1x1cm. Pt was advised to take Tylenol and/or Motrin for neck pain, headache. She was discharged home with anticipatory guidance and ED precautions should she develop chest pain, shortness of breath, dizziness, jaw pain, and/or chest pressure, slurred speech. Pt was receptive to advice. She was contacted the following day, (today on 4/16/2021) and she reports she feels much better: palpitations and headache has resolved, and neck pain is improving.

Swelling and hardness under skin, itching, tingling feeling down whole arm, warm to the touch began around 8:00pm the following day (4/16), worsened throughout the night and into the next morning

weakness, rapid heart rate, and panic five minutes after receiving vaccine. went away on its own after a couple of minutes swelling and soreness of axillary lymph nodes five days after the vaccine, currently ongoing

swollen lymph nodes; swelling under my arm; This is a spontaneous report from a contactable consumer(patient). A 23-year-old male patient received the second dose of bnt162b2 (BNT162B2, Lot Number unknown), via an unspecified route of administration on left arm on 28Mar2021 at single dose for COVID-19 immunisation. The patient's medical history was none. Concomitant medications were not reported. Patient stated, "I have like Pfizer vaccine on Sunday my second dose and I don't know if this is the right place to ask but it says the side effects is swollen lymph nodes. Should I be concern if it goes pass like its day 4 and still have like swelling under my arm, I saw that it's a side effect I am just wondering, it's been like 4 days so (incomplete sentence)." The patient stated the onset date of the events was the day after so it was 24 hour later on 29Mar2021. No treatment was received for the events. The outcome of the events was not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Additional Details: EMS WERE CALLED. PATIENT WAS GIVEN CLARTIN 10MG AS SHE REFUSED DOSE OF BENADRYL

Arm was super sore and felt swollen. Felt numb at times. Slurred words 30 min after shot. Fatigued and exhausted causing me to sleep for hours. Felt like a hangover without the drinking. Another comparison is that it felt like the last day of being sick with the flu, just very groggy and not feeling 100 percent okay.

Hospital course: 23 yo female with no significant PMH presenting to the ED with right sided CP, worse with deep inspiration. Received 2nd covid vaccination last week- mild reaction with fever thereafter. She had w/u in the ED including an EKG with inferior and septal TWI and trop of 1.61. CTA chest was negative. She was admitted. After admit, troponin trended up (1.61--3.71--4.93). CRP 49.1, ESR 21. Echo showed apex hypokinesis so with TWI on EKG and elevated trop, cardiology elected for LHC. This was normal. Cardiac MRI showed myopericarditis. She was started on high dose ASA, colchicine and bblocker for this. Likely viral etiology (Covid, Resp 4 plex negative). Trop trended down on 4/13 (CRP still rising). Cardiology was ok with discharge. Will need 2 weeks of ASA and 3 months of colchicine. No strenuous activities for that time frame. She is getting her Masters in music/violin and did not need a return to school note. Feeling somewhat better at discharge- rated pain 6/10. Internal Medicine followup in 1 week Cardiology followup in 2 months

I (patient) developed swollen and painful lymph nodes in the underarms on both sides of my body. They began on the side of the injection but spread to include both arms. In addition, two similarly swollen and painful lumps have appeared, though I am not sure if they are lymph nodes given their locations. One is along my the line of my waistband in the front of my body, not in the traditional groin area where most charts ascribe lymph nodes to be. One is directly below my areola on my right breast. Along with these lumps, I developed a rash made up of several small, inflamed hives that range from painless, to itchy, to painful. They are concentrated along my bra line, particularly around my breasts, but are spread everywhere from below my neckline to above my ankles. These symptoms began approximately 7 days after my second dose of the Pfizer-BioNTech vaccine and are continuing at the time of this report.

At about the same time the standard soreness at the shot site from the shot began to form (in the left arm), soreness also began to form in the left armpit. Both signs of soreness began around 7pm the evening of the shot. The day after the shot was administered the soreness in the shot site began to lessen but the pain in the armpit persisted. The armpit pain, the day after the shot was administered, felt sore, almost as if I have been holding a golf ball tightly between my arm and torso for hours and a bruise had formed. That night I checked my armpit to see if there was any swelling or bruising. There was some swelling and a small lump within the tissue of the armpit the night of the day after the shot. The morning of the 23rd , two days after the shot was administered, the armpit pain persisted and the lump was bigger than the night before and the swelling remained.

24 hours after receiving vaccine, the left side of my face experienced mild swelling (it should be noted I received the injection in my left arm). I experienced heavy allergy symptoms including redness and swelling in left eye, watery eyes particularly in left eye, runny nose and pain particularly in left nostril, heaviness of breath, tiredness. I think it is of note that as of writing this, I have not received commonly reported symptoms of fever, chills and nausea in conjunction with the reported adverse symptoms.

The day following the vaccination I woke up with severe arm pain 2 inches down from the injection site. My arm had swollen about 3 inches in diameter. It was so painful that I could not roll over, I could not lift my arm, and I was in inconsolable tears. It was a deep stinging pain, as though I was repeatedly being stung by a hornet. My left hand was going numb off and on. I went to the doctor because I was incapable of lifting my arm, and the doctor identified that my lymph nodes and my left ear were swollen and enlarged. He recommended ibuprofen and ice for the lump. The second day after receiving the vaccine I had a mild headache, and my arm was only slightly swollen. The third day after receiving the vaccine my arm was still slightly swollen and sore, but the pain was manageable without pain medication. The fourth day after receiving the vaccine I woke up with a deep cough and dizzy spells lasting throughout the day.

9:00pm injection area sore, woke up at 11:00am to body aches and swelling of face along with rash on left side of the face.

I received the Pfizer second dose on May 5th and started to have an allergic reaction on May 6th at 02:32. I was not able to attend classes due to muscle pain, headache and nausea. I was having some sort of fever where I felt hot but my body was cold. I slept for the majority of the day. Around 16:35, when I woke up, I noticed a rash and that my body was feeling swollen. I took 2 Benadryl gel pills at 18:03. I felt some difficulty breathing, and itching sensation all over my body and still had a lot of tension on the left side of my jaw. I went out to eat with my boyfriend, because we had plans and he had also complained of having some cold chills from the vaccine, and he noticed that I had red marks on my hands. By May 7 10:05 I called off of work to go my doctor, because I had massive splotches of raised itchy hives all over my body. It was confirmed that I was having an allergic reaction and I received a steroid shot in my upper gluteal muscle, as well as Famotidine 20mg twice daily for 5 days and Prednisone 20mg twice daily for 5 days.

Sweeling soreness of right axillary lymph node. Started at around 10 am and lasted all day until bed.

9 am - vaccine administered .11 am - half dollar sized red bump formed ( mild discomfort). 5pm- shoulders neck and arm begin to stiffen and spasm . 10pm - full body aches and spasms.. excruciating headache behind my right eye. Lymph nodes were sore ( neck and arm pit) . 3-4 days after I kept experiencing 9/10 headaches ( behind my right eye), armpit( lymph node) pain and whole body spasms / tightness.

Day 1 (day of vaccine): weakness, shortness of breath, arm swelling, headache, fatigue, fever Day 2: face and mouth swelling, sore throat, fever Day 3: sore throat, lightheadedness, fever Day 4: no symptoms

swelling of my lymph node under my armpit on the same arm as my shot; chest started to tighten a bit; body aches; chills; fever persisted for 24 hours and surpassed 100.4; lymph node pain; headache; fatigue; This is a spontaneous report from a non-contactable consumer. A 23-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Feb2021 10:45 (Batch/Lot number was not reported) (at the age of 23) as single dose for covid-19 immunisation. Medical history was none. No known allergies. There were no concomitant medications. The patient experienced swelling of my lymph node under my armpit on the same arm as my shot on 17Feb2021 22:00, chest started to tighten a bit on 17Feb2021 22:00 with, body aches on 17Feb2021 22:00, chills on 17Feb2021 22:00, fever persisted for 24 hours and surpassed 100.4 on 17Feb2021 22:00, lymph node pain on 17Feb2021 22:00, headache on 17Feb2021 22:00, fatigue on 17Feb2021 22:00. No treatment received. No COVID prior vaccination. No COVID tested post vaccination. Most symptoms subsided after 36 hours, but lymph node pain, headache, and fatigue persisted for a bit longer. The outcome of fever was unknown, of the other events was recovered on an unknown date No follow-up attempts are possible; information about lot/batch number cannot be obtained

Swelling of hands, feet, and some of face. When I saw the pt her face had resolved but her hands and feet were slightly swollen. Her hands were swollen to the point where her rings were tight and her feet were swollen to the extent that her shoes were tight but she was able to wear them. I saw her 3 days after her vaccine

Headaches beginning Apr 21-25 Pain through right thigh Apr 24 Headache Bursts on right side of head began Apr 26- now Drowsy beginning Apr 26-now 1 sec blackout while sitting up on Apr 26 Side pain in upper right abdominal area beginning May 13 General malaise continues everyday Shooting leg pain continues through right thigh

Pt presented to ED at apx 1pm on 5/28/21 with signs of anaphylaxis. Swollen upper and lower lips, sensation of swollen throat, and facial swelling, with urticarial lesions to upper chest wall and arms. No GI symptoms. No hypotension. Received 0.3mg IM epinephrine, 50mg IV benadryl, 125mg IV solumedrol, and 20mg IV pepcid. Symptoms slowly resolved over 3-4 hours. Pt could not recall any other now inciting event or product other than vaccine she had yesterday around 4pm. No reaction to first pfizer vaccine noted.

started to have hives all over her body, extra over in chest and stomach area; It was so kind of itching this morning; Had little pain in side and they had been run for kidney; whole body ache mostly like her joints specially in her hips an her knee; she was groggy almost like entire day , sinus thing was going on; she was groggy almost like entire day , sinus thing was going on; her lymph node on her left arm was very swollen like for three days and before it finally went away; This is a spontaneous report from a contactable consumer (patient). This case is for 2nd dose. This case is split from AER# 2021552445 (BNT162B2, 1st dose). A 23-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EW0167), at the age of 23-year-old, via an unspecified route of administration, administered in Arm Left on 09May2021 at single dose for COVID-19 immunisation. Medical history included dormant asthma when she was kid. The patient received unspecified concomitant medications for birth control. The patient previously received the first dose of BNT162B2 (Lot number: EW0169), at the age of 23-year-old, via an unspecified route of administration, administered in Arm Left, on 18Apr2021 for COVID-19 immunization. The patient reported that she had been having some vaccine reaction she believed, but she went to the doctor today and they believed it to an environmental reaction but, she got the vaccine on Sunday, the evening before around 11 pm, she started to have hives all over her body, extra over in chest and stomach area and then she called registered doctor provider. They told me to take antihistamine so, took two diphenhydramine hydrochloride (BENADRYL) and the last night around 11 o' clock it came back still like around 24 hours and she took couple of more diphenhydramine hydrochloride (BENADRYL) and it was so kind of itching this morning, she took one more, but she was concern she went to the doctor, they said she reported these kind of symptoms. She had like reaction before (further clarification unknown) but this probably the most severe but she didn't believe that was an environmental was just the correlation between she getting the vaccine. Today when she went to the doctor, she had little pain in side and they had been run for kidney but like she didn't know that's the most recent one but she had other lab test in the past. She couldn't possible giving. It was reported that the diphenhydramine hydrochloride (BENADRYL) had made the hives go away but they usually like came back later in the night (further clarification unknown). The patient also received cetirizine hydrochloride (ZYRTEC) for the events. Consumer added, "they have since gone away but she had more symptoms day after when she received the vaccine. The day after woke up with whole body ache mostly like her joints specially in her hips an her knee and she was groggy almost like entire day , sinus thing was going on and her lymph node on her left arm was very swollen like for three days and before it finally went away." Event onset date was May2021. Treatment received for the events. The events resulted in Physician Office Visit. The outcome of the event hives was unknown, of the event swollen lymph nodes was recovered in May2021, of other remain events was recovering.

Went into ER with leg pain the night of 5/14. Admitted into ICU 5/15 for deep venous thrombosis in the leg and pulmonary embolisms in the lungs. Symptoms in leg started a few days prior to admittance. Was put on Heparin via shot and then IV. Clotting grew worse overnight with leg swelling, leading to an inability to walk. After increased elevation leg improved and was put on an oral dose of Eliquis. Was put on oxygen in the ICU and took portable oxygen home when discharged on 5/17. Also tested positive for strep 4/11. Was advised to file a report by my PCP.

Around 12 am after the dose of my vaccine, I got a fever, chills, body aches, headache and fatigue. I knew all of these things to be normal. My arm was sore and I also knew that was expected. I could hardly move out of bed. At 0700 this morning, on 6/4, I finally got the energy to shower. That is when I noticed my lymph node in my armpit of the same arm I received my vaccine in was swollen to about the size of a tennis ball. I had a PA that I work with recommend me to go to an urgent care to be seen because she did not believe this to be normal. I received a Toradol injection and a course of antibiotics to take in case it turned out to be infected.

I woke up 6 days after receiving the vaccine and I had some pain at my collar bone. It felt bruised and I felt something that felt like a ball rolling around. I called advice from clinic and they scheduled me a visit with Dr. for a video visit. At my visit with him, I explained what it was and I mentioned that I heard about lymph node enlargement after the vaccine. He told me that he hadn't heard anything about that, but scheduled an ultrasound for me. I scheduled an appt with my PCP and she told me that she did hear about the lymph node enlargement from the vaccine. I had the ultrasound on 03/30 and the results came back benign. Dr. called with my results and requested a follow up in 3 months.

Severe burning of skin over entire body; Hypersensitive to touch including fabric; Swollen neck and hands; Swollen neck and hands; Pain in pelvic area and anus; Pain in pelvic area and anus; Severe lower back pain accompanied with chills; Severe lower back pain accompanied with chills; Headache; Fever; Nausea; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 23-year-old non-pregnant female patient received second dose of BNT162B2 (Pfizer covid-19 vaccine, Solution for Injection, Lot number: EW0202), via an unspecified route in the right arm on 04Jun2021 at 11:00, as a single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medications included topiramate 50mg and norethrindrone 35mg (medications the patient received within 2 weeks of vaccination). Patient previously received first dose of BNT162B2 (Pfizer covid-19 vaccine, Lot number: EW0202), via on an unspecified route in the right arm on 14May2021 at 11:00, as a single dose for covid-19 immunization. Patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On 04Jun2021 at 22:00, patient experienced severe burning of skin over entire body, hypersensitive to touch including fabric, swollen neck and hands, pain in pelvic area and anus, severe lower back pain accompanied with chills, headache, fever, nausea and fatigue. Patient did not receive any treatment for the events. The clinical outcome of the events was not recovered at the time of this report. No follow-up attempts are possible. No further information is expected.

Left supraclavicular lymphadenopathy Observed 3 days post first vaccine persisting over 2 months Only lymph node observed enlarged

dizziness; Nausea; Not feeling well; Left arm pain; fever; Chills; Facial swelling; pain to neck; Muscle spasm in face (lips); This is a spontaneous report from a contactable consumer, the patient. A 23-years-old non- pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EN6207) via an unspecified route of administration in the left arm on 13Mar2021 at 14:00 (at the age of 23-years-old) as a first dose for COVID-19 immunisation. The patients medical history included diabetic, arthritis, fibromyalgia, High blood pressure, neuropathy and Gastrointestinal (GI) problems. Patient was allergic to Benadryl and certain anaesthesia. Concomitant medication taken within two weeks included ADVIL, HUMALOG, aspirin (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN), FURMIDE, gaba (MANUFACTURER UNKNOWN) all taken for unknown indications from unknown dates. 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 vaccination. The patient had not been tested for COVID-19 since the vaccination. On 13Mar2021, at 14:30 the patient developed dizziness, immediately after dizziness patient had nausea, the patient was not feeling well and had left arm pain, fever, chills, facial swelling and pain to neck and muscle spasms in face (lip). The facility where the vaccine was administered was reported to be other. No therapeutic measures were taken for these adverse events. The outcome of the events dizziness, nausea, was not feeling well, left arm pain, fever, chills, facial swelling, pain to neck and muscle spasms in face (lip) was recovering at the time of report. No follow-up attempts are needed. No further information is expected.

23 y/o with hx of hodgkins lymphoma (completed tx in 2016), anxiety, and depression and today noted L axillary lump and here for evaluation. Covid 2nd vaccine 2 days ago in L arm. PE: afeb/nontoxic, remarkable for 2x2 cm, tender, rubbery, mobile, nonfluctuant lymph node medial aspect of L axilla c/w local reaction to covid vaccination. Symptoms most consistent with known side-effect of COVID-19 vaccine of ipsilateral axillary lymphadenopathy, and is likely self-limited. Systemic infection is also possible, though less likely given time course. Unlikely recurrence of lymphoma with absence of B symptoms. Recommended Tylenol for pain. Provided reassurance and recommended following up with PCP if persists longer than 1 week.

Within the first day, my hands felt swollen and would not stop tingling. I had awful chest pain and neck numbness 24 hours after the vaccine. Two days after the vaccine, I felt fatigued, had a very rapid heart beat (130 bpm while sitting), and had hypertension (BP: 182/92). I had to go to the emergency room twice due to high blood pressure and a very rapid heart beat (both visits were on the Staurday two days after my vaccine). For 9 whole days after the vaccine, I felt fatigued, no appetite, I was not able to sleep, and I felt lots of chest paint.

A couple days after my first vaccine I noticed an enlarged lymph node near my collarbone. It got smaller over time but was still there in April, which is when I decided to get it checked by my primary care doctor.

Tachycardia; Motion sickness; Numbness of right forearm; Entire body swelling all extremities; itchy red rash: face, neck, upper chest, forearms, thighs, back eyebrows; severe frontal occipital lateral stabbing headache; sore & tender body; sore & tender body; chills; blurry vision; light sensitivity; foggy memory; swollen neck/neck was swelling; nauseated vomiting/Nausea and vomiting; nauseated vomiting/Nausea and vomiting; burning sensation; Right upper shoulder discomfort with swelling that goes into her neck; Light sensitivity; having a rash; rash is itching; scaling, and her skin is peeling; scaling, and her skin is peeling; redness; severe headache; This is a spontaneous report from a contactable Nurse (patient's mother). A 23-year-old female patient (daughter) received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: ER8737 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 07Apr2021 at 11:00 AM (age at vaccination: 23 year) as a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccine in four weeks. The patient's medical history included anemic, eczema, gastric reflex, known allergies: citrus food, latex gloves, Compazine, Augment, and headaches from concussions. Concomitant medications included Ferrous Sulfate, Diethylpropion HCL, and glucose, sodium chloride (DNS). The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. There was a product complaint to report. On 07Apr2021 12:30, the patient experienced swollen neck/neck was swelling, nauseated vomiting/nausea and vomiting, entire body swelling all extremities, itchy red rash: face, neck, upper chest, forearms, thighs, back eyebrows, severe frontal occipital lateral stabbing headache, sore, tender body and chills. On 07Apr2021, the patient experienced right upper shoulder discomfort with swelling that goes into her neck, light sensitivity, having a rash, rash is itching, her skin is peeling, redness and severe headache. On 09Apr2021, the patient experienced motion sickness and numbness of right forearm. On 12Apr2021, the patient had tachycardia and scaling. When probed to determine when the tachycardia began, the caller mentioned that the tachycardia was noted at the doctor's office. She confirmed the tachycardia began Monday, 12Apr2021. She clarified it was her second doctor's visit so if the caller gave the wrong date, they were able to find it by her records on her second doctor's visit. Caller confirmed with her daughter the tachycardia was still intermittent, it comes and goes. It seems to be that it has improved. She could consider it was medically significant because they didn't know what the root cause was. Her daughter has never experienced tachycardia before being dosed with the Pfizer vaccine. There was not treatment for tachycardia. Her daughter was still having a rash; she was breaking out intermittently. She confirmed she did not report online that her daughter was intermittently breaking out. At that time when she filed the report online, the rash just broke out. At that time, she didn't know if her daughter's rash was going to abate and then re-appear. If so, then she would have had to re-open a new event with a new date and time and rate it. She just looked at her daughter's skin, it's peeling. These were very itchy. Caller then clarified most of these events started the day of the vaccine, 07Apr2021 at 12:30 PM. She confirmed some of these events were reported online on the date of the incident and were still present. The severity of each event was on a grading scale, and right now her daughter's grading scale was 10. Online, the patient couldn't even tell how they really were feeling. The severity of each event needed to be asked. By the lack of getting all the information and the less Pfizer has, the better it looks for Pfizer. When probed for outcome, the caller confirmed the rash was still ongoing and it was medically significant because she was going to have to take her to dermatologist. She has been using hydrocortisone cream as treatment of the rash and it's not working. She did not have the NDC, LOT,EXP for the cream. She explained the skin peeling/scaling has been ongoing. Her skin breaks out in a rash and then becomes really scaly and then it peels. She clarified overall, she had a rash, but the rash was itching, had redness, scaling, and her skin was peeling. On scale of 1 to 10, the caller would rate this event as a 10. She confirmed and that it's continuous/ongoing and had not improved. Stated the rash was not to any localized area on her daughter's body, it's all over. She clarified further the rash can appear on her daughter's eyes, chin, cheeks, forearm, wrist, and leg. The severe headache was reported on the day of the vaccine as well as the rash, too. The severe headache was ongoing; caller gives it a grade 10+. She confirmed the headache was medically significant. It did prevent her daughter from driving a car, reading, or doing activities. Caller added that the headache was also disabling because it disables her daughter from functioning at her normal capacity, she's been hindered. Her normal activities she could not perform if the headache was present. The headache was described as stabbing, excruciating pain and burning sensation. When probed for the outcome of her daughter's severe headache, the caller explains it's in between persistent and worsening. On a good day, it's a grade 8.5. On a bad day, it's a grade 10+. No medical treatment for headache, she was not really allowed to do anything. She was waiting for Pfizer vaccine to wash out of her daughter's system. She explained her daughter was laying low and not introducing any more drugs to enter her body since she had a reaction. Caller again stated they were waiting for Pfizer's vaccine to wash out of her daughter's system because they feel as though something was triggering the rash that keeps appearing and the headaches were still there on a grade level of 10+. Her daughter was afraid to take medications, so they were having to do treatments like hot compresses to her daughter's head and neck, massaging her head/neck/back and turning the lights off. The Nausea and vomiting began on 07Apr2021 and was still ongoing. No treatment for nausea. Her daughter just gets still and goes to sleep. When the headaches were excruciating, it brings on nausea and vomiting. Also, she noticed motion sickness. When her daughter was riding in the car and she was experiencing a headache, she had terrible motion sickness. Caller confirmed the caller never had this motion sickness prior to the vaccine. The motion sickness was still ongoing. Her daughter was not treating the motion sickness in any way. She states maybe her daughter has taken one Zofran because it was so bad. No further details provided. The numbness of the right forearm started on 09Apr2021. She confirms the numbness is still ongoing, it comes and goes, intermittently and did not receive any treatment. On 07Apr2021, her entire neck was swelling, left and right side. The left side was better but the rightnside had intermittent swelling, there was ongoing swelling on the right side of her neck and did not receive any treatment and just rubbing of her daughter's neck. Her daughter also has right upper shoulder discomfort with swelling that goes into her neck that was ongoing. She confirmed this event to be medically significant and it has hindered her daughter's normal activity if her shoulder was swollen too bad and she was hurting. Her daughter just started physical therapy. The light sensitivity was still ongoing. If her daughter was not experiencing a headache, the light sensitivity was pretty good and treatment included dark rooms/ black out. Her daughter was following up with an allergy testing by the allergy doctor. She has to find out if there were any active ingredients in the Pfizer vaccine that triggered her daughter's reaction. Caller stated, "something in the COVID-19 vaccine triggered her daughter's body to react the way that it did". Her daughter also was following up with a dermatologist. Her primary care physician requested her daughter to be followed up with her allergy doctor and to be tested. Caller requested Pfizer's adverse team or someone to call and let the caller know how Pfizer follows up with their patients and how well Pfizer's values each patient. The patient's symptoms have not abated. The events of swelling, nausea, vomiting, tachycardia, motion sickness, hypoaesthesia, musculoskeletal discomfort, photophobia, rash, rash pruritic, skin exfoliation, erythema and headache were considered to be medically significant. The events caused the patient to visit emergency department and physician's office. The patient received IM Benadryl 50mg and IM Solumedrol steroid as treatment for the events. The outcome of tachycardia was recovering and for burning sensation it was unknown, and for all the other events, it was not recovered.; Sender's Comments: There is a reasonable possibility that the events nausea, vomiting, pruritic rash, erythema, and severe headache were related to BNT162b2 based on known drug safety profile and close temporal relationship. The association between the events swelling, tachycardia, motion sickness, hpyoaesthesia, musculoskeletal discomfort, photophobia, skin peeling, and scaly skin with BNT162b2 can not be fully excluded based on temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Abnormal/high values were in the following: WBC, Neutro, immature granulocyte, neutro absolute, immature granulocyte absolute, AST, bilirubin; Abnormal/high values were in the following: WBC, Neutro, immature granulocyte, neutro absolute, immature granulocyte absolute, AST, bilirubin; Abnormal/high values were in the following: WBC, Neutro, immature granulocyte, neutro absolute, immature granulocyte absolute, AST, bilirubin; Abnormal/high values were in the following: WBC, Neutro, immature granulocyte, neutro absolute, immature granulocyte absolute, AST, bilirubin; Abnormal/high values were in the following: WBC, Neutro, immature granulocyte, neutro absolute, immature granulocyte absolute, AST, bilirubin; Abnormal/high values were in the following: WBC, Neutro, immature granulocyte, neutro absolute, immature granulocyte absolute, AST, bilirubin; Abormal/low values were in the following: lymph, monocyte %, eosinophil %, BUN.; Abormal/low values were in the following: lymph, monocyte %, eosinophil %, BUN.; Abormal/low values were in the following: lymph, monocyte %, eosinophil %, BUN.; Abormal/low values were in the following: lymph, monocyte %, eosinophil %, BUN.; headaches; fever; fatigue; night sweats; chills; loss of appetite; cough; This is a spontaneous report from a contactable consumer. This consumer reported for herself that a 23-year-old non-pregnant female patient received first dose of BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, Batch/Lot Number: EN6206), (at the age of 23-year-old) via an unspecified route of administration in right arm on 11Mar2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. She had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. On 14Mar2021, for the past 6 days now, she had been experiencing the following symptoms: headaches, fever, fatigue, night sweats, chills, loss of appetite, and a cough. Got blood tests done on the 16Mar2021, abnormal/high values were in the following: WBC, Neutro, immature granulocyte, neutro absolute, immature granulocyte absolute, AST, bilirubin and abormal/low values were in the following: lymph, monocyte %, eosinophil %, BUN. The adverse event resulted in emergency room. There was no covid prior vaccination. On 16Mar2021, she had covid test post vaccination by nasal swab which resulted in negative. No treatment for event was provided. The outcome of the events was not recovered. Information about lot/batch number was obtained. Additional information has been requested.

minor arm pain; 7 days after the vaccine, I developed a red welt about 3inches in diameter. w; It was raised off of the skin, was a defined red circle,; caused my upper arm to swell,; as hot to the touch,; was itchy.; This is a spontaneous report from a contactable consumer, the patient. A 23-years-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727) via an unspecified route of administration in left arm on 20Mar2021 at 16:30 (at the age of 23-years-old) as single for COVID-19 immunisation. Medical history included asthma, environmental allergy to trees, molds, animals and attention deficit hyperactivity disorder. Concomitant medications included vyvanse (MANUFACTURER UNKNOWN), loratadine (MANUFACTURER UNKNOWN), breo ellipta (MANUFACTURER UNKNOWN) and birth control pill. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient experienced pain in arm after two days of vaccination and on 27Mar2021 at 12:00, red welt for about 3 inches in diameter after 7 days of vaccination, which was raised off from the skin around a defined red circle which caused the upper arm to swell, was hot to touch and itchy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The adverse events resulted in doctor or other health care professional or clinic visit. The patient did not receive any treatments for the adverse events. The clinical outcome of welts, skin red, swelling arm, hot dry skin, itchy were recovering at the time of the report. The clinical outcome of the pain in arm was recovered at the time of this report. No follow-up attempts needed. No further information expected.

swollen lymph node on left collar bone.; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER 8727) via an unspecified route of administration in the left arm on 28Mar2021 at 15:45 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had no allergies to medications, food, or other products. On 01Apr2021 at 08:00, the patient experienced swollen lymph node on her left collar bone. 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 event. The clinical outcome of the event swollen lymph node on left collar bone was not recovered at the time of report. No follow-up attempts are needed. No further information is expected.

On 12/24/2020 started developing severe headaches with dizziness. On 12/27/2020 started getting chills, muscle aches, got covid tested (negative). On 12/29/2020 face and eyes started to swell, another covid test (negative). Continuous chills, sweats. Took tylenol, motrin, and benadryl around the clock. 01/02/2020 scratchy throat, more difficult to swallow, started on prednisone.

Anaphylaxis. The COVID shot was given, no reaction then. After 7 minutes, congestion, severe cough, vomiting phlegm, feeling like throat closing started happening. Code was called, Benadryl was immediately given intramuscular in the left arm, blood pressure, pulse ox was taken, and then was taken to the Emergency Department. In the ED, I was given prednisone, one EPI, anti-nausea medication all through I.V. and many more medications given to me via I.V. that I don't sincerely remember. I was under observation for 4 hours. I was discharged after all symptoms dissipated and was given Prednisone 20 MG (3 tabs a day) to take to help my lungs. Management followed up almost immediately, everyone from the moment I had the anaphylactic reaction was quick and prepared.

Initial headache 30 min post vaccination and lasted for 1 hour. On 12/25/2020 tenderness noted in left armpit (lt injection arm). Tenderness persisted and worsened through 1/4/2021. On 1/4/2021 a lump was noted inferior lateral left neck. Ultrasound proved multiple enlarged lymph nodes in left axilla and left neck.

Patient is a 24 years old female seen today for Follow-Up (Received covid vax on 12/23, swollen, painful lymphnodes in L armpit and L side of neck) The LE is seen today on call with chief complaint of swelling of the left anterior neck. She received the Pfizer co bid 19 vaccine on 12/23 in the upper outer left on her. On the 25th she noted some discomfort in the axilla which then persisted all week. She did not have any fever or chills or malaise. She noted no redness in the axilla or in the area of the injection. She then developed visible swelling in the anterior left side of her neck and a sonogram was done which shows 6 areas of enlargement the largest one is 1.7 cm in diameter. Patient has the image on her phone and this was reviewed with her. She has no discomfort in the right axilla and no swelling elsewhere in the neck. She has no history of similar swelling.

1/7/2021- felt dizzy/nauseas about 30 minutes after injection. 1/8/2021 AM started having soreness in injection site, and some red spots on right hand. PM starting having extreme itching on dorsal sides of hands, used lotion that I normally use (sensitive skin kind) to see if it was just dryness. Red bumps still on just right hand 1/9/2021 woke up in middle of night to extreme itching and spreading red bumps on both hands. Bumps are small and fluid filled. Took Benadryl and went back to bed after washing hands. Early PM continued extreme itching and spreading bumps to wrists becoming more red and some bumps popping. Later in evening I noticed swelling starting in my hands. I have tried Benadryl cream (not difference) washing hands well (no difference) lotion (worse) hydrocortisone 1% cream (itching worse) swelling went from none to a non pitting edema. Hands hurt and swelling increasing over time more bumps showing up on hands (with no other changes to any products I have used)

Discomfort and pain associated with a soft, swollen, tender lump with no erythema located under the left ventral supraclavicular skin.

At approximately 11pm felt dizziness and coworker followed her home. When arriving home noticed facial swelling, some shortness of breath, itchy neck, "jittery", and swollen throat. Taken by boyfriend to ED at approximately 12am on 12/17/2020. Given Epipen, diphenhydramine, famotidine, and methylprednisolone. Remained in observation for a few hours and went home as all reaction had ceased.

The day after receiving my second dose of the Pfizer Covid-19 vaccine, I experienced minor side effects, including elevated temperature (99.8 F), headache, and soreness in my arm at the injection site. This lasted the whole day. The day after that, my temperature was back to normal (98.1 F), no headache, and the soreness had subsided significantly, but I am experiencing some swelling and soreness in my right armpit.

I started getting mild chills, headache and a very sore throat on Jan 18 lasting for about 3 days. I felt better after alternating with Tylenol and ibuprofen. I also noticed my lymph nodes on both sides of my neck were swollen and tender.

Chills; Fever (up to 101.8ºF ); Headache; Nausea; Fatigue; Body Aches; Swollen lymph nodes; This is a spontaneous report from a contactable nurse (patient). A 24-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283, expiry date not reported), via an unspecified route of administration in the left arm on 07Jan2021 08:00 at single dose for COVID-19 immunisation. Medical history was not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. Concomitant medications included ibuprofen (ADVIL), paracetamol (TYLENOL), calcium carbonate (TUMS), citalopram and birth control (unspecified medication). The patient previously took first dose of bnt162b2 (lot number: EJ1685, expiry date not reported), via an unspecified route of administration in the left arm on 20Dec2020 11:00 at single dose for COVID-19 immunisation. On 07Jan2021 18:30, the patient experienced chills, fever (up to 101.8ºF), headache, nausea, fatigue, body aches and swollen lymph nodes. The patient underwent lab tests and procedures which included aars-cov-2 test: negative on 08Jan2021 COVID test result=Negative. No treatment was received for the adverse events. Clinical outcome of the events recovered on an unspecified date.

Swollen/tender lymph nodes under right arm; Swollen/tender lymph nodes under right arm; Hard for movement; This is a spontaneous report from a non-contactable nurse (patient). A 24-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on the right arm, on 18Jan2021 08:00 at a single dose for COVID-19 immunization. The patient medical history was not reported. Patient was not pregnant at the time of vaccination. There were no other medications received within 2 weeks of vaccination. The patient experienced swollen/tender lymph nodes under right arm and hard for movement on 19Jan2021 08:00. Patient was recovering from the events and no treatment was received. The events were considered non-serious. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

notice pain in left ring finger/By 6pm very painful; loss of range of motion; ring finger swollen; This is a spontaneous report from a contactable nurse. A 24-year-old female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 19Jan2021 10:30 at a single dose for covid-19 immunization. Medical history included allergy to penicillin and gluten intolerance. Concomitant medication included ethinylestradiol, norgestimate (TRI-PREVIFEM). Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 31Dec2020 (first dose). It was reported that the patient received the vaccine in left arm, a few hours later began to notice pain in left ring finger. By 6pm very painful and loss of range of motion, ring finger swollen; all on 19Jan2021 13:30. No treatment was received for the events. The outcome of the events was unknown. Information on the lot/batch number has been requested.

15 minutes after booster injection, patient verbalized bilateral hand swelling and hot sensation over entire body. Skin color became red and flushed. Patient took a po 25mg Benadryl. Symptoms did not resolve. Rapid Response called and patient transported to ED for evaluation. BP 120/68. No respiratory distress or airway compromise noted.

7 days after the shot, the arm that received the shot got very itchy, irritated, and a little red. It is currently 8 days after the shot and my arm is still very itchy and feels a little swollen.

Received the vaccine on the morning of 1/13/2021 and started feeling fatigued the night of 1/13/2021. My arm the injection was given in was swollen and raised and red and warm to the touch . The swelling lasted for about 5 days and started on the eve of the injection day. The next morning, 1/14/2021, I woke up with bone pain, body aches, fatigue, and a swollen lymph node on my left lower neck. I had chills, but never ran a fever. I also suffered from headache on 1/14/2021. On 1/15/2021, I woke up and all symptoms had resolved.

I developed swelling and hives over 75% of my body and was given a shot of Epi shot because my throat closed. I developed a weakened immune system from the vaccine. I am 8 week pregnant and developed a Blighted Ovum and I am currently going through a miscarriage to date. Rather not release any info regarding the pregnancy

- 1/26/2021: headache and fatigue all day (1/27 all better), worsening around 3-6 pm, right upper arm pain, left arm pit node swelling and pain (recovered within a few days) - 1.5-2 weeks after vaccine: rashes on toe tips looks like chilblains (might be from cold? Might be from vaccine?)

Received second vaccine on 2/3/21. 25 minutes later started developing urticarial, bilateral hand swelling. Went to urgent care on 2/3/21. Diagnosed with allergic reaction.

Swollen lymph node under arm that was injected for 2 days; headache; body ache; tiredness; This is a spontaneous report from a non-contactable pharmacist (patient). A 24-years-old female patient received the secondo dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) from Lot# El0140 on left arm on 18Jan2021 14:00 at SINGLE DOSE for covid-19 immunisation . First dose details reported as follows: product=COVID 19, brand=Pfizer, lot number=El0140, administration date=28Dec2020, administration time=04:00 PM, vaccine location=Left arm, dose number=1}] Medical history included Pineapple allergy . Concomitant therapy none.There were no concomitant medications. The patient started to develop at 7:00 on 19Jan2021 Swollen lymph node under arm that was injected for 2 days, headache, body ache, tiredness that lasted for 3 days.No treatments recevied. Outcome of the events was reported as recovered in Jan2021. No follow-up attempts are possible; No further information expected .

Nausea and throwing up. Migraine. Body aches(sore arm). Fever 102.4 at peak. Swollen lymph node on same side as injection. Swollen arm.

Starting 12 hours after I got my second shot, I got chills, fever, fatigue, body aches in my joints, and I developed a swollen lymph node under my left arm. The symptoms remained in varying degrees for 84 hours. The swollen lymph node remains swollen and painful.

Face swelling and rash on the chin area. Nausea, and vomiting all within 24-48 hours of receiving the vaccine.

The patient presents today with a history of recurrent urticaria and angioedema. She received a dose of the Pfizer COVID-19 vaccine on Thursday Feb 25th (lot number EN 6206). She felt fine after her shot, but the next day felt fatigued, had chills, body aches, and left arm soreness (at the site of the injection)--she attributed her symptoms to her vaccination. Friday evening, prior to bed, she noticed the onset of several scattered hives. The next day, she noted that she had more extensive hives over her body, including her eyelids, and she said that she has been having dyspnea; she presented to the ER and was treated with steroids and antihistamines. The symptoms or urticaria returned the next day with significant angioedema of the lips, and the patient had dyspnea and nausea/abdominal discomfort, and the patient went back to the ER. With antihistamines and steroids, her symptoms improved significantly and she was sent home. Her symptoms returned today, now accompanied by throat globus as well as abdominal discomfort--she self administered an Epipen, which she said significantly helped her symptoms.

had a swollen lymph node under clavicle for a month; This is a spontaneous report from a contactable nurse (patient). A 24-year-old female patient (currently 25-years-old) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration (at the age of 24-years-old) on 06Jan2021 12:45 at 0.3 mL, single in right deltoid for COVID-19 immunization. Medical history included asthma. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899, expiry date: 31Mar2021), via an unspecified route of administration on 16Dec2020 at a single dose for COVID-19 immunization. The patient had a swollen lymph node under clavicle for a month on 09Jan2021 13:00 with outcome of not recovered. She reported, "I've had both doses of the vaccine. The last one was on 06Jan2021. I have had a swollen lymph node under clavicle for a month." She says she got the second dose 06Jan2021 and on 09Jan2021 she was at the doctor's office and he felt what he thought is a swollen lymph node like under her clavicle, it is the size of a golf ball now, it is not going away. She says the swollen lymph node is under the clavicle on her left side. The doctor didn't seem too concerned about it but it has been almost a month and it is still there she doesn't know what it is but it is still there. She confirms the second dose was 06Jan2021 and on 09Jan2021 her doctor noticed it was swollen, she didn't even notice it before he did. She thinks it has gotten worse but she also might be freaking out for no reason but she thinks it has gotten bigger. She says she has the information for the first dose but the second dose is on another card because she forgot the card when she went back for the second dose. The information for the second dose is at home and she is not at home right now. She does not see an NDC Number. She says the lot number information could be available later if needed for follow up because the card is at home. Dose: It is not on the card but she thinks it is 0.3 ml, she doesn't remember for sure. At the time she got the dose she was being treated for ring worm. Her doctor did draw a Calcium and a PTH and they were both normal. She says the doctor was not too concerned about but it has been almost a month and it still has not gone down (as reported). She has asthma which she has been dealing with kind of on and off because this winter has been so cold but other than that nothing else has happened, her vitals are normal she did not even have any temperature or anything after the vaccine. The event was assessed as non-serious. Vaccination Facility Type was hospital. The adverse event did not require a visit to the Emergency Room or Physician Office. It was noted while she was in the doctors office but she has not had to go back for it. No prior vaccinations within 4 weeks. Information on the lot/batch number has been requested.

Hx Guillain-Barré 5-10 minutes after vaccination had mottled appearance of hands and muscle stiffness of neck, no CP or SOB, given IM benadryl and sent to ED 911 for observation

Vaccination 0828 0835 reports numbness & tingling in left hand. Reports "random rashes" after 1st dose of COVID vaccine (not reported prior to vaccination). Also has history of anaphylactic reaction to mushrooms. BP 121/80, HR 68, O2 98 0845 administered diphenhydramine 25 mg. Reports relief in numbness/tingling but hand "feels" swollen. Cleared to leave at 0913 with instructions to seek care if symptoms persist or worsen.

Anaphylaxis - Throat swelled almost completely closed, wheezing, lightheadedness (nearly passed out), throat/neck and injection site were very itchy and swollen, face/eyes swelled up, turned very pale all over, heart palpitations, etc. The next day - severe, horribly painful burning sensation all throughout my body. Even clothing lightly touching my skin felt like hot razors cutting in to me. Residual swelling of the face/ arm. Migraine. For two weeks after - Very large, hard lump under my skin at the injection site. It was about the size of my hand and was very painful. After a few weeks it went away. Treatment- large amounts of benadryl. The pharmacist wanted to use an epipen and send me to the hospital, but I refused because I could still get some air in (doctor later told me that my reaction was so severe I should have gone to the hospital). I had to keep taking large amounts of benadryl for the next few days to keep the reaction down a bit.

Mild alergic reaction in face. After 30 minutes of taken the vaccine my face started to get swollen. It was not severe so I decided to take benadryl as instructed by the nurses in rhe site and stay home till it calmed down.

Initial pain, swelling and redness starting soon after injection, but mainly appearing the day after injection. 10 days after injection the swelling has gone down, but the redness has spread and formed a bullseye around the injection site.

I received the COVID vaccine on March 11, 2021. That same day arm was completely swollen, low-grade fever, chills and small headache. On March 15, 2021 I started with a top left back pain (same side as injection) where is it painful to move and difficult to breathe deeply. I'm not completely sure if this is related to the COVID vaccine but it is on the same side of the site of injection.

I had an increase protein and uric acid in my urine. I had swelling, in my face hands and feet. I was admitted to the hosptial for monitoring and I was diagnosed with mild preaclampsia. I will remain in the hosital until delivery. I am estimated to deliver twins on 03/29/2021

About an hour after receiving the vaccine I was lightheaded, nauseated and my tongue began to get itchy and swollen like the beginning of an anaphylactic reaction. I took some Benadryl and Pepcid like I would for an allergic reaction. Then I went to urgent care. While I was waiting to see the doctor at urgent care my throat began to spasm and tighten and I had trouble breathing, this was about two hours after I got my vaccine. I was given a steroid and a muscle relaxant. My throat was quite sore for a few days after, but besides that I felt much better after I was given the steroid and muscle relaxer

High fever (103F), body aches, chills, headache, tiredness, arm soreness/swelling/redness/itchiness at injection site, nausea

My whole left side felt swollen. My left ear felt clogged and ringing in it. I have had tinnitus in the left ear ever since. A constant rising in my ear.

Swollen supraclavicular lymph nodes on the left side of body, same side as injection. The lymph nodes are hard and painful to the touch. They appeared after the first shot but have grown in sensitivity after the 2nd shot. Fever, headache, fatigue and nausea are also apparent symptoms. Today I woke up with pain in my neck, like someone chopped me in the throat. It?s not a sore throat pain, but a hurts to swallow pain.

About 12 hours later I experienced extreme chills and a fever throughout the night. Full body ache and sore arm from injection. Later my lymph nodes swelled around my neck and collarbone area nearest my left arm. Extreme soreness.

3 hours following vaccine, my face started itching and swelling. My eyes swelled shut and when my lips began to itch I took a Benadryl. Eyes remained swollen for one day after. Slept for 15 hours straight

24 yo female who presents to the ED for concern for anaphylaxis after receiving her second dose of the COVID-19 vaccine. Patients presents as a rapid response after receiving Epi pen to her thigh at 11:18AM. She reports that after getting the vaccine, she was sitting in the monitoring area. At the 10 min mark she noted that she had a slight cough and some eye tearing. She went to the bathroom and noticed that her eyes were swollen and she could barely open them. Someone told her that her lip looked swollen but she did not look at it in the bathroom. She also felt some throat tightness but no wheezing. She had nausea prior to vaccine, no vomiting. She had no lightheadedness or palpitations and no itching or rash anywhere. She got an Epipen at 11:18AM. A rapid response was called and she was brought to the ED. She has no personal or family history of allergic reactions and no known allergies.

I noticed a lump under my left armpit after the second dose of the Pfizer vaccine. It's currently April 12,2021 9:21 pm. It's been almost two weeks since my second dose (March 30,2021). It's not a huge concern. It's tender and hurts a little. No treatments at the moment. I haven't contacted my doctor yet. If it hasn't gone away in another 2 weeks or so then I will contact my Doctor.

Sunday 4/11 around 2 PM - noticed minor swelling in face Sunday 4/11 9 PM - Swelling worsened. Started feeling short of breath and wheezing and coughing. Hives developed on arms, legs, and neck. Took of fexofenadine and of diphenhydramine (Benadryl). Went to sleep. Monday 4/12 7 AM - Woke up and noticed severe rash on arms and legs. Swelling on face had decreased, but still noticeable. Called and made a doctor's appointment at 10 AM. Doctor prescribed steroid injection and steroids for 9 days.

On Sunday (04/11) I woke up with pain in my left armpit, this is the arm I got the shot in. It?s still discomfort, but not intense pain and much swelling, but it definitely feels annoying when my arm is down. My injection site has also been SUPER itchy since day 3, and it?s still warm to touch. I do not have a rash or any redness. I only had redness for about 2 days after the shot

Throat and chest tightening, heating up, swelling. Difficulty breathing. Occurred initially after 5-10 min of vaccine injection. Symptoms have been reoccurring in episodes since day of injection to present day.

On the second day of receiving the vaccine the left arm started with red spots on arm and on my hands, with a little swollenness in left hand.

Received second dose of vaccine on 4/11/2021 and felt fine after. On 4/12/2021, I had a headache and felt tired which I heard is common. What's uncommon is that on 4/14/2021, I began to get hives on my stomach and I've never had a hives break-out before receiving my second vaccine dose. On 4/15/2021, I wake up with hives all over my back, butt, stomach, shoulders and arms. My daily routine hasn't changed accept for getting my second vaccine dose. On 4/16/2021, I wake up at 1am with hives all over my body in the same places as 4/15/2021 but now my face was slightly swollen especially around my under eye area. Throughout each day, the hives would go away but they would come back at night.

Anaphylaxis; Lightheaded/Dizziness; Throat Swelling; Scratchy Throat; This is a spontaneous report from a contactable consumer (patient). A 24-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP6955), via an unspecified route of administration, administered in left arm on 12Apr2021 at 09:30 (at 24-year-old, not pregnant at the time of vaccination) at single dose for COVID-19 immunisation. Medical history included known allergies: tree nuts. The patient had Covid-19 prior vaccination. The patient's concomitant medications were not reported. No other vaccine was received in four weeks. No other medications were received in two weeks. On 12Apr2021 at 10:00 AM, the patient experienced anaphylaxis; lightheaded/dizziness; scratchy throat; throat swelling. The events resulted in emergency room/department or urgent care, life threatening illness (immediate risk of death from the event). Therapeutic measures were taken as a result of the events included epinephrine and steroids to prevent swelling. The outcome of the events was recovered on an unspecified date in Apr2021. The patient did not have covid test post vaccination.

Symptoms Sunday 4/18: Red splotch on arm and small bump near injection site (warm to touch), full body muscle aches, fever, chills, headache, tiredness, lack of appetite Treatment Sunday 4/18: 1 ibeprophen + 1 Tylenol every 3-6 hours Symptoms Monday 4/19: Red splotch on arm and small bump near injection site (warm to touch), fever, slight tiredness Treatment Monday 4/19:1 ibeprophen + 1 Tylenol every 6 hours, icy-hot on arm every 3 hours, ice pack for 30 mins on/off, cortisone cream Symptoms Tuesday 4/20: Red splotch on arm and small bump near injection site (warm to touch) Treatment Tuesday 4/20: icy-hot on arm every 3 hours, ice pack for 30 mins on/off, Benadryl pill at 4pm, Benadryl cream

A week later, I had an anaphylactic reaction to a kit kat bar. I had previously ate kit kats with no issue. I had to be intubated and hospitalized. After extubation, I continued to have anaphylaxis at least once a day with no correlation to what I was eating or drinking. I also began having a severe auto immune flare up with body pains in my legs, back, and stomach immobilizing me with generalized weakness.

Starting 8am after the vaccine I was completely exhausted, body aches, and lymph nodes in neck and under arm were very swollen. That lasted about 12 hours. The lymph node under my arm in the same arm I got the vaccine in is still veery enlarged and sore 40 hours after the vaccine.

Left arm extreme sorensss; supraclavicular node swelling; bone and joint pain; bone and joint pain; fever; This is a spontaneous report received from a contactable healthcare professional (patient). A 24-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 26Mar2021 at 11:00 (at the age of 24-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included an allergy to sulfa. The patient was not pregnant at the time of vaccination. The patient had not been diagnosed with COVID-19 prior to the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Concomitant medications included spironolactone from an unknown date for an unspecified indication and drospirenone, ethinyl estradiol betadex clathrate (YAZ) from an unknown date for birth control. The patient previously received dose 1 of BNT162B2 on an unspecified date as a single dose for COVID-19 immunization. On 26Mar2021 at 22:00 the patient experienced left arm extreme soreness, supraclavicular node swelling, bone and joint pain, and fever. The patient did not receive any treatment for the events. The outcomes of left arm extreme soreness, supraclavicular node swelling, bone and joint pain, and fever were recovering. It was also reported that since the vaccine, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.

Patient reported facial swelling and throat tightness within 1 hour after vaccination. Patient treated herself with Benadryl at home. Patient advised not to receive second dose of vaccine.

Patient experienced a mild rash starting on the knuckles which spread to her elbows on 4/26. Patient went to Emergency room on 4/27 upon waking up and seeing that the rash spread to the rest of their body. The swelling/rash was painful to touch. Patient was given steroids. Exact times are unknown, but symptoms began 48 hours post vaccination per pt.

body-wide hives, chest pain,, shortness of breath, swollen hands and feet, dizziness, upset stomach, vomiting, low grade fever, fatigue, sore throat. The night after vaccine I got hives, a fever, and chills. Took Benadryl and Asprin and slept. When awoke, fever broke but all the other symptoms began and remained for the entire day. Woke up this morning, all symptoms remain aside from chest pain, though the hives are considerably worse.

Tightening; heating up; swelling of throat; swelling of throat and chest; throat closing; shortness of breath; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0153), dose 1 via an unspecified route of administration, administered in Arm Left on 10Apr2021 at 14:00 (at the age of 24-years-old) as a single dose for COVID-19 immunization. Medical history included COVID-19 diagnosis in May2020, COVID-19 test taken via nasal swab on 01May2020 was positive. The patient had never had an allergic reaction in her life and she was not allergic to anything that she knew of. There were no concomitant medications (no medications within 2 weeks prior to vaccination). The patient did not receive any other vaccine within 4 weeks prior to the COVID-19 vaccine.The patient received her first vaccine on 10Apr2021. After the shot she felt her throat closing. She experienced Tightening, heating up, swelling of throat and chest within 10 minutes of vaccine administration, also reported as at 14:15. They called the Paramedics, who gave her Benadryl injection when they picked her up from the site where she received her vaccination, which was a drug store. She was then transported to the emergency department. She was hospitalized and treated with Benadryl injection for the Tightening, heating up, swelling of throat and chest. She was monitored for 3-4 hours, and her symptoms were not worsening and she was able to leave the hospital. Ever since, this is the 9th day, everyday she had severe shortness of breath. She had no wheezing. Her chest clenches. It scared her so she had gone to the Emergency Department 2 more times for it. She had gone there 3 times in total. She had been to the Emergency Room a few times and saw doctors there. Her throat closing stopped later that evening and had come back about 4 times. Since then, she was not sure if it was just the sensation of the throat closing because it is coupled with shortness of breath. She had the sensation of throat closing about 4 times. She was short of breath every day since receiving the vaccine and up to 4 times each day. Sometimes it was worse than others. She had it while on the call (19Apr2021) and rated it 4/10. On 14Apr2021 she went to the Emergency Department in the middle of the night. She rated that episode as 9/10. Episodes of symptoms had been ongoing and reoccurring since the day of vaccine administration. She had a COVID-19 test post vaccination in Apr2021 (unknown results). The outcome of Tightening/ Chest tightness, heating up, swelling of throat and chest, throat closing and severe shortness of breath was not recovered.

itching on my neck and it was red and swollen; itching on my neck and it was red and swollen; Itchingn on my neck and it was red and swollen/ face is red and puffy, itching with rash; Face is red and puffy, itching with rash; Face is red and puffy, itching with rash; I have it (rash) underneath my stomach, right underneath injection site; This is a spontaneous report from a contactable consumer (patient). A 24-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not reported), via an unspecified route of administration on 13Apr2021 (at the age of 24-years-old) at a single dose for COVID-19 immunization. Medical history included hypertension diagnosed "for about four years". Concomitant medication included nifedipine (PROCARDIA) taken for hypertension. The patient reported that she started having issues about 30 minutes after receiving the vaccine on 13Apr2021. When she got home, she started itching on her neck and it was red and swollen. She told her nurse and was given some Benadryl. The night before report (13Apr2021), she also woke up from itching, and her face was red and puffy, itching with rash. She had the rash underneath her stomach, right underneath injection site. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.

During the post-vaccination observation, patient started to feel weak and turn pale. Our pharmacy brought patient back to the pharmacist in the immunization. She began to experience the anaphylactic reaction and a dose of Epipen 0.3mg was given to patient by the pharmacist. The pharmacist called 911 and after a few minutes patient started to feel better and and skin turned back to normal. Pharmacist continued to observed patient until paramedic team arrived.

Received her first dose Pfizer vaccine (LOT#: EW0173 EXP: 8/2021) at 1009 on 5/02/21. PHN was alerted by EMT who was told by patient that vaccinator made her anxious about the vaccine. Patient stated that vaccinator told her she was bleeding more than usual and that there was a small bump on her arm. EMT contacted patient at 1015. Patient reported swelling and hematoma at injection site. At 1025 patient reported feeling anxious and was crying. PHN assessed patient and reassured her the swelling in her arm was going down. PHN educated patient on worsening signs and symptoms at injection site and treatment of swelling. Patient verbalized understanding. PHN asked EMT to take vital signs. EMT took patients vital signs at 1033. BP: 140/111, pulse: 72, RR: 20. EMT reassessed patient at 1040. Patient stated that she was feeling a lot better and less anxious. EMT retook patients vital signs at 1042. BP: 142/108, pulse: 66, RR: 20. Patient had completed her observation time. Patient left at 1045 by herself, unassisted with a steady gait.

Swelling of the tongue, throat, and facial cheeks. I could not eat solid food for two days. Could breath just fine. Body fatigue and significant lack of energy. Sore throat, and some coughing a few days later.

Headache, nausea, swollen lymph nodes, tender/painful breasts, lump in left breast, tight chest/heart

Acute tonsillitis approximately 1-2 hours after administration, sought care at PCP?s office and was treated with prednisone over 5 days. Subsequent swelling never completely whet away and an appointment with an ENT specialist was scheduled for Tuesday, April 20th. The decision was made to remove the swollen tonsils and they were surgically removed April 23rd, 2021

Swelling of lymph nodes in right armpit (opposite side from injection site). Fatigue started the day after vaccination (18 hours after). Soreness in both sides of neck. Headache. Fever.

About 15 minutes after 1st vaccine pt felt swelling, itching of throat given Benadryl and symptoms resolved. 1330- Pt given vaccine 2nd done in first aid area. Pt lying on stretcher. 1346- Pt feeling lightheaded Allergies: Flu shot, jalapenos, rosemary, eggs Denies medical history and medications. 1345- Benadryl 25mg PO- water given 1400- Water helped, no dizziness, no complaints of itching or swelling. Pt dangled, no dizziness, standing- standing dizziness but subsided. 30 min obs- pt feel ok to go.

Persistent headache from the time of administration. Swelled ganglia in left axilla and pain in the area with limitation of movement.

patient had swelling on her neck under her ear starting day after vaccination (5/8/21). Patient states it is painful to touch, and has increased in size over the first few days but now seems to be staying at the same size. No drainage from the ear, not hot to the touch. Recommended tylenol or motrin and to follow up with doctor to get evaluated. only other symptom is a runny nose starting day after vaccination also

Bulge developed on clavicle (left) , continues to swell larger and cause pain to the left arm/shoulder/neck region. This is after BOTH shots.

injection site pain; tiredness; feeling unwell; swollen lymph nodes; sore throat; My tonsil stones have returned; my normal with this thermometer has been about 97.4, and today my temperature was 99.1; I am a little sick; cough; This is a spontaneous report from a contactable 24-year-old Other HCP reported for herself that she received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EL9264, administration time-11:30 AM, vaccine location-Left arm, dose number-1), via an unspecified route of administration on 29Jan2021 at single dose for covid-19 immunization. The patient medical history included anxiety, low vitamin D and eczema. Concomitant medications were not reported. On 30Jan2021, the patient experienced injection site pain, tiredness, feeling unwell, swollen lymph nodes, cough, sore throat, tonsil stones have returned, my normal with this thermometer has been about 97.4, and today my temperature was 99.1 and little sick. The patient laboratory details included temperature on 30Jan2021 with 99.1 (my normal with this thermometer has been about 97.4, and today my temperature was 99.1). The patient did not take the treatment for the adverse event. The outcome of the events was recovering. Follow-up attempts are completed. No further information is expected.

This is a spontaneous report from a contactable other health professional (patient). A 24-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: EL3248), via intramuscular route, administered in left arm on 10Jan2021 14:45 (at the age of 24-years) as 2nd dose, single for COVID-19 immunization. The patient previously took first dose BNT162B2 Lot Number: EJ1685 via intramuscular route, administered in arm left on 23Dec2020 10:30 as 1st dose, single for COVID-19 immunisation. Patient not pregnant at the time of vaccination. The patient medical history was not reported. The patient had allergic to augmentin. Concomitant medication(s) included Zyrtec, Vienva. The patient received the most recent COVID-19 vaccine at Hospital. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 11Jan2021, the patient experienced fever of 102, body aches, chills, lymph node swelling under left arm and headache all lasted 24 hours. The patient did not received any treatment for the events. The outcome of the events was recovered on Jan2021. The patient underwent lab tests and procedures which included body temperature: 102 on 11Jan2021. Seriousness reported as non-serious. Follow-up attempts are completed. No further information is expected.

Arm swelling (4.5 cm), erythema, warmth, and tenderness at site of injection, No treatment, Symptoms starting this morning at 8 AM

severe swelling lymph nodes; fever; chills; bodyaches; Blurred vision; feeling sick; fatigue; This is a spontaneous report from a contactable consumer (patient). A 24-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on 10May2021 (at the age of 24-years-old) at 2ND DOSE, single for COVID-19 immunization. Ongoing medical history included patient had glasses. Concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at 1ST DOSE single for COVID-19 immunization. On 11May2021 09:00, the patient started to feel really bad described as severe swelling in lymph nodes, fever, chills and body aches; and blurred vision during the day of 11May2021. The patient had glasses and had them on. Her vision would go in and out of focus during the day. She was feeling sick and fatigue in May2021 after the second dose. The doctor's nurse only said she did research for about 10 to 15 minutes and said it was recommended that the patient go to the emergency room. With blurred vision and at night, the patient could not drive herself. The patient did not call 911 because she knew the other ones were expected. The patient waited it out to see how it was. She further reported that her vision was better on 12May2021 in the morning, but her lymph nodes were still swollen and tender and still feeling sick, having body aches and fatigue. The outcome of the event blurred vision was recovering, outcome of the swelling lymph nodes, feeling sick, body aches and fatigue was not recovered; outcome of the events chills and pyrexia was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

still didn't feel good; slight fever it was 102; throwing up; anaphylactic allergies, and swell up like her throat, neck and face swelled a little bit; Cold and flu symptoms; Cold and flu symptoms; her arm was really killing her; This is a spontaneous report from a contactable consumer (patient). A 24-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 05May2021 (Lot Number: EW0167) as single dose for covid-19 immunisation. Medical history included weird blood pressure (kind of have weird blood pressure, it goes up and down pretty frequently, no treatment), endometriosis, seizure. Concomitant medications included lamotrigine (LAMOTRIGINE) taken for seizure; quetiapine. The patient had an adverse reaction to the first of the two vaccine shot and wanted to know if she can get the second. She had pretty bad cold and flu symptoms and did have anaphylactic allergies, and swell up like her throat, neck and face swelled a little bit on 06May2021. It wasn't enough to go to the emergency room. She took Benadryl and kind of monitored but she thought her doctor would have called it like a pre-anaphylactic sort of reaction. The patient was having the reactions on yesterday (06May2021), still didn't feel good today (07May2021). She started to swell up she took Benadryl and Tylenol because she had slight fever it was 102 (06May2021). So, Tylenol 400 mg (took 2 pills), took 600 mg of Ibuprofen and the Benadryl 200 (200 but not entirely sure). She tried not to take medication unless have to, the moment she started throwing up she took the Benadryl only took that once, her arm was really killing her so she did take the Ibuprofen twice yesterday (06May2021) and twice Wednesday (05May2021). The fever came back yesterday (06May2021). Tylenol, probably the same twice on Wednesday, twice on Thursday, the patient hadn't had to take any today (07May2021). The outcome of events was not recovered.

1 day after: woke up drenched in sweat, fever and chills throughout the day, headache, swollen lymph nodes on the left side of my neck (the size of a golf ball). Swollen lymph nodes lasted at least two weeks and today, two months after the shot, still slightly swollen/ not fully back to normal

Caught during Bariatric surgery. No symptoms beforehand. Oxygen levels crashed on table. Labs show increased WBC over 10-14 hr period. Pneumonia like symptoms, wasn?t confirmed by IMDrs or tests, chest X-ray showed enlarged heart (mild)

Coughing up blood, after second vaccine; Feverish, after second vaccine; Lymph nodes swollen, with bruising under arm, after second vaccine; Under arm bruised, after second vaccine; This is a spontaneous report from a contactable nurse (patient's grandmother). A 24-year-old female patient received bnt162b2 (Pfizer Covid shot), dose 2 (at the age of 24 years) via an unspecified route of administration, administered in left deltoid on 09May2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included ongoing polycystic ovaries from a couple of years ago and allergic to peanut butter from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient received the first shot of bnt162b2 one month ago (Apr2021) for COVID-19 immunization. The patient experienced coughing up blood, feverish, lymph nodes swollen, with bruising under arm/under arm bruised all on 11May2021 after second vaccine. Outcome of events was unknown. The events did not require a visit to Emergency Room or Physician Office; no treatment was given. Events coughing up blood, feverish, lymph nodes swollen were reported as serious medically significant, event under arm bruised was non-serious. Information on Lot/Batch number was requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a close temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

Starting about 3 am on 6/2/21 she had a severe headache that lasted about 24 hours. During the day on 6/2/21 she noticed a lump on the left side of her neck that is tender to touch. This was diagnosed as a swollen lymph node.

Suspected bursitis with prolonged arm pain and weakness 2 weeks after first Pfizer dose. On the day of vaccination, I had a panic attack and nearly blacked out after vaccination, something that had never happened to me after a vaccination. Once the pain started a few hours after vaccination, it significantly increased. I experienced excruciating pain in my left arm like I had never felt after any other vaccination. Complete inability to move my arm without pain; the pain persisted even with zero movement whatsoever. Within the first 12 hours the pain spread to my entire left shoulder, and within 24 hours the pain spread to my neck, and general upper left quadrant of my body to the point where inhaling deeply would cause chest pain on my left side. This extreme pain persisted for about 3-4 days. After about the 5th day, my left arm still felt different and weaker than my right arm but little pain remained. After the 7th day, pain started back up whenever I tried to use my arm in any way. The days went on and the pain and arm weakness is not passing. It is minor pains, aches, and occasional throbbing compared to those first few days after vaccination but chronic pain nonetheless. My left arm continues to feel weak and I have a concentrated area of pain directly where the vaccination site was, it's as if I could still feel exactly where the needle went through my body. My arm feels okay pain-wise upon waking most days but I am unable to do anything as simple as chopping vegetables or washing dishes without feeling pain for the rest of the day. I am unable to even wear a backpack for more than 10 minutes without my left shoulder hurting and feeling fatigued.

I got the vaccine some time in the night when i was taking a shower i noticed arm soreness. when i went to bed around 11pm from the top of my shoulder down to my finger tips it was swollen and had arm pain. I tried to go to bed and about 30 minutes later i went to get up to grab some advil. I checked in the mirror to see if there was redness and got light headed. Next thing i know i passed out. I woke up on the floor and a big pool of blood i dont know how long i was out for. I had a nose bleed and had a bruise on my head, I could leave the bath room because i was shaking so bad and couldnt use any force to get up. After 45 mins that i went to my room and called my mom who is a physican i sat on the floor for 3 or 4 hours until i could get the nose bleed to stop. I ended up then getting into bed and the shacking had stopped after 800 mg of advil. I checked my pupils for signs of cuncussion. the 1/25 i had my first appointment and we checked to see if i broke my nose. after that the next days they did see signs of concussion with sleeping 20 hours a day and blurry vision. I went back to med center to get an mri and eeg to see about the concussion because they were worried since i didnt know how long i was out for. They also sent me to a concussion specialist. I had follow up care about the concussion for a month or so. For about a week floowing the vaccine i was taking 800mg 3times a day for the tremor's and fever

armpit swelling; broke out a month later in a herpes simplex on her chest and back; This is a spontaneous report from a contactable consumer (patient's mother). A 24-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: Unknown), via an unspecified route of administration on an unspecified date as 2nd dose, single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unknown date, the patient had some armpit swelling and she broke out a month later in a herpes simplex on her chest and back. She asked if Pfizer would probably want her to call even if it shows a month out and she never had that either. Consumer stated that she declines to complete a report for her daughter stated her daughter has all the timelines of all the breakouts and she does not want to give the wrong information about when she started having symptoms. Reporter did not specify seriousness for reported events. The outcome of the events was unknown. Information on the lot/batch number has been requested

I am 30 weeks pregnant and got the covid shot and the next day i woke up with a rash all over my neck arms on the inside and on my belly and on the side of my. Belly and a rash on my vagina and swellimg and my left boob hurting and leaking

3 painful, swollen lymph nodes on left clavicle and left side of neck; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 24-years-old non pregnant female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number em9810, expiration date unspecified), via an unspecified route of administration, administered in Arm Left on 06Feb2021 11:00 as DOSE 2, SINGLE for Covid-19 immunization in hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Previously the patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number ek9231, expiration date unspecified), via an unspecified route of administration, administered in Arm Left on 15Jan2021 18:00 as DOSE 1, SINGLE for Covid-19 immunization. The patient medical history and concomitant medications were not reported. On 06Feb2021, the patient experienced 3 painful, swollen lymph nodes on left clavicle and left side of neck. Since the vaccination, the patient has not been tested for COVID-19. The patient was not treated for the events. The outcome of the event was reported as not recovered at the time of report. No follow up attempts are possible. No further information is expected.

5-6 days after second covid vaccine severe headache and swelling in roof of mouth and neck lymph node swelling that lasted one week

Sore throat; Swollen lymph nodes; injection site sore; fever; fatigue; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), via an unspecified route of administration in the left arm on 20Mar2021 at 10:15 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included WELLBUTRIN. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 20Mar2021, the patient experienced fatigue, fever, vaccination site pain, sore throat, swollen lymph nodes. The patient did not receive treatment for the reported events. The clinical outcome of the events fatigue, fever, vaccination site pain, sore throat, swollen lymph nodes was not recovered at the time of this report. Information about lot/batch number cannot be obtained. No further information is expected.

a few weeks- months my tonsils got swollen; arm swollen/ inflammation; arm swollen/ inflammation; This is a spontaneous report from a contactable Other Health Professional (patient). A 24-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EH9899), dose 1 via an unspecified route of administration on 18Dec2020 (at the age of 24-year-old) as dose 1, single for COVID-19 immunization. Medical history included ITP and blood disorder from an unknown date and unknown if ongoing. There were no concomitant medications. Patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was Workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not received any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient did not have any relevant past drug history. On 05Jan2021, patient experienced for few weeks- months tonsils got swollen, arm swollen/ inflammation. Patient stated, went to urgent care got a shot decreased my tonsils slightly, went to doctors, tried allergy meds did not work. Referred to ENT, tried strong meds did not work. Stated it was odd, I have never had issues with my tonsils. Pending if I need surgery to removed them. Due to events patient visited doctor or other healthcare professional office/clinic and emergency room/department or urgent care. Patient received medications as a treatment for the adverse events. The events were assessed as non-serious, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. The patient underwent lab tests and procedures which included flu/mono test, Covid-19 and strep: negative on 05Jan2021. Therapeutic measures were taken as a result of a few weeks- months my tonsils got swollen, arm swollen/ inflammation. The outcome of events was not recovered.; Sender's Comments: Based on the current available information and the consistency with the known safety profile of the suspect product BNT162B2, there is a reasonable possibility that event tonsillar hypertrophy were related to suspect drug based on the temporal relation between the vaccination and onset of events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Fever; Flu like symptoms; Swollen lymph nodes; Threw up; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via unspecified route of administration in left arm on 17Mar2021 at 18:00 (at the age of 24-year-old) as a single dose for COVID-19 immunisation. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via unspecified route of administration in the left arm on 24Feb2021 at 18:00 (at the age of 24-year-old) as a single dose for COVID-19 immunisation. The patient did not have any other medical history and any known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included LEXAPRO (escitalopram oxalate), metformin, YAZ (drospirenone, ethinylestradiol betadex clathrate), ZYRTEC (cetirizine hydrochloride), Vitamin b12 (cyanocobalamin), Vitamin d3 (colecalciferol), all taken for unknown indications from unknown dates. On 18Mar2021 at 05:00, 11 hours after vaccination, the patient threw up and had fever and flu like symptoms for the following 18 hours at 23:00 and also swollen lymph nodes. The patient did not receive treatment for vomiting, fever, flu like symptoms and swollen lymph nodes. 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 vomiting, fever, flu like symptoms and swollen lymph nodes was recovered on an unspecified date. Information about lot/ batch number cannot be obtained. No further information is expected. Amendment: This follow-up report is being submitted to amend previously reported information: concomitant drug updated, event onset time for events fever, flu like symptoms and swollen lymph nodes updated to 18Mar2021 23:00 and narrative updated accordingly.

Swollen lymph node; low grade fever; Severe nausea; Felt dizzy and lightheaded; Sore arm; This is a spontaneous report from a contactable health care professional, the patient. A 24-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EPT534), via an unspecified route of administration in left arm on 17Mar2021 at 15:15 (at the age of 24-year-old), as a single dose for COVID-19 immunisation. The patients medical history included GERD, 4 knees surgery (reportedly one was in last month) and spring allergies. The patient was allergic to azithromycin, chlorohexidine and tramadol. Concomitant medications included omeprazole(MANUFACTURER UNKNOWN), ibuprofen(MANUFACTURER UNKNOWN), acetaminophen(MANUFACTURER UNKNOWN) and loratadine (MANUFACTURER UNKNOWN) for unknown indications since unknown dates. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 17Mar2021 at 15:15, the patient experienced severe nausea approximately 5 minutes after receiving the vaccine, while she sat down and immediately felt she might puke, dizzy and lightheaded, which only lasted for around 5-10 minutes. On an unknown date in Mar2021, the patient experienced typical sore arm for 3 days and on 20Mar2021, reportedly on the third day the patient experienced swollen lymph node in her armpit and low-grade fever (99.5) The patient did not receive any treatment for the adverse events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events nausea and dizziness lasted for around 5-10 minutes, recovered on 17Mar2021. The clinical outcome of the event sore arm was lasted for 3 days and recovered on an unknown date in Mar2021. The clinical outcome of the events swollen lymph nodes and fever were recovered on unknown date in Mar2021. No follow-up attempts are possible. No further information is expected.

Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Tingling (specify: facial area, extemities)-Severe

Patient received her covid vaccine and about half hour later came to the pharmacy to let us know that she was experiencing some swelling on her face. She was slightly swollen under her eye on the right side of her face. The patient refused to stay for further evaluation even upon urging for her to stay. We administered 25mg of Diphenhydamine and gave her another 25mg tablet to take once she gets home. We reached out to PCP. We called the patient about 25 minytes after she left and she told us that she was doing well and would call if it worsened.

Swelling of arm; Swelling to upper arm around injection site; Stiffness of joints; Stiffness of joints especially neck; This is a spontaneous report from a contactable consumer, the patient. A 24-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 right arm on 02Apr2021 at 20:30 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history included anxiety and depression. Concomitant medications included sertraline (MANUFACTURER UNKNOWN) for unknown indication and from an unknown date. The patient previously received penicillin (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy. 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 vaccine. On 03Apr2021 at 17:00, 18 hours after the injection, the patient experienced prolonged, extensive swelling to upper arm around injection site and stiffness of joints, especially neck intensifying with swelling of arm. The adverse event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events was swelling of arm, vaccination site swelling, joint stiffness and neck stiffness and were recovering at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

HEADACHE, SWEILLING ON LEFT AXILLA AND DECREASE IN ENERGY. VISITED EMERGENCY ROOM, NO TREATMENT, PATIENT WAS ORIENTED TO MONITOR GANGLIAL SWELLING AND TO REPORT TO ER IF SIGNIFICANT CHANGES WERE NOTED LIKE INCREASE IN SIZE, INCREASE IN PAIN OR REDNESS.

Ringing in ears Sore lymph nodes Main soreness on left leg and hand on left side (only one sided pain)? Neck pain and chest soreness Fatigue/tiredness

Pt developed swollen lymph node on left side of neck on 1/3. She went to Urgent Care, and lab work is pending. Covid test was negative.

Pt developed a swollen lymph node on left side of neck. She went to urgent care and lab tests are pending. Her Covid test was negative.

Received second vaccine on 01/04/21 at 1230 and began having axillary lymph node swelling and tenderness the following morning (01/05/21) along with headache and severe fatigue. Fatigue and headache have subsided, but axillary swelling remains. Axillary tenderness beginning to subside.

Symptoms started 01/07/21 I woke up with a lump on the right side of my jaw that is closing off half of my windpipe. I also have a second lump on the back of my neck; both are tender to the touch. I had a fever of 101.3 yesterday and today it has gone between 102.6 and 103.6. I have full-body chills.

Starting in the evening on 1/6/21, night sweats and a severe headache that was not relieved with OTC meds. Signed off work on 1/7/21 due to symptoms. Fever of 100.6 that has resolved. 1/8/21 chills and sweats alternating throughout the day along with body aches and swollen lymph nodes, making it difficult to swallow.

Swollen lymph node in right arm noticed on 12/26. I saw my PCP and she said it was likely from the vaccine. Has not gone away. Also nasal congestion started from date of vaccine.

12 hours post-dose woke up with chills, fever, headache, full body aches, injection arm swollen, red, and painful

Soreness at and around the injection site on the right upper arm; Coughing; tenderness in the axillary region of the right arm; slight swelling in the axillary region of the right arm; This is a spontaneous report from a contactable healthcare professional (patient herself). A 25-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686, expiry date not reported), via an unspecified route of administration on the right arm on 31Dec2020 09:15 at single dose for COVID-19 immunization. Medical history included biliary dyskinesia from an unknown date and unknown if ongoing, and cholecystectomy (gallbladder surgically removed Nov2019), irritable bowel syndrome subtype C (diagnosed Jul2020), and COVID-19 on an unspecified date prior vaccination. Concomitant medications included polyethylene glycol [macrogol] and amitriptyline. The patient experienced soreness at and around the injection site on the right upper arm on 01Jan2021 10:00; tenderness in the axillary region of the right arm on Jan2021; slight swelling in the axillary region of the right arm on Jan2021; and coughing on 01Jan2021 10:00. No therapeutic measure was taken as a result of the events. Clinical outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.

Swollen Lymph node with tenderness to above right clavicle. I currently still have swollen lymph with no pain. Tenderness to posterior arm.

Severe lymphadenopathy (in armpits, very painful/tender), rash on left side of body (buttocks, side), nausea, extreme fatigue

Typical injection site/muscle soreness. Myalgias, chills, swollen lymph node in injected arm, ftigue/weakness, nasal congestion

tingling reaction on her arms, body/tingling in the hands and arms; swelling of the face; headaches; she had numbness in the face and tingling; weakness in the arms and legs, extremity weakness; fatigue; in the back, she had pain, soreness in the vertebrae in the middle going down; in the back, she had pain, soreness in the vertebrae in the middle going down; she hasn't been able to sleep in a few days, about probably 6 or 7 days.; a bump on her forehead with a high temperature; a bump on her forehead with a high temperature/ it is radiating heat, she feels her forehead hot from that spot; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient's father) and a non-contactable consumer (patient's mother) reported that a 25-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1284), via an unspecified route of administration at the right arm on 21Dec2020 at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. After a few days on 25Dec2020, patient started to experience reactions, like a tingling reaction on her arms, body, and also swelling of the face, and she also started to have headaches. It has been like that for a while, and patient who is a health care professional was brought to the emergency room, to check on what was going on, but she was not able to get the medication they need, it was twice that the consumer he tried to bring the patient to emergency, and she still hasn't gotten medication for the symptoms. She started having reactions, she had numbness in the face and tingling, headaches, tingling in the hands and arms, and weakness in the arms and legs, extremity weakness, she felt like fatigue and also in the back, she had pain and soreness in the vertebrae in the middle going down. She has been to emergency 3 times, the last time was yesterday, and so the one thing he needs to report to Pfizer is doctors don't seem to know what to look for, they have no idea, they are looking at other things instead of looking at vaccine side effects, the patient never had problems before the vaccine, but after she started all of these side effects, they need to be looking at what can cause with the vaccine, the first time, yesterday on (03Jan2021) they did a brain MRI because of headache, as they are concerned about nerves in the brain, but a neurologist will see her sometime this month. At this time, they are ruling out things, analyzing the MRI, she did get some medication for pain, and all that stuff since she was suffering with,headache and was sent home last night. Since they said they cannot admit her, as they are afraid she could get COVID 19 in the hospital, but they make sure she is ok, and at this point, all her knows, he hasn't talked to her since last night, and hoping she is sleeping, as she hasn't been able to sleep in a few days, about probably 6 or 7 days. The consumer was wondering, it may be necessary to call the patient directly, to talk more directly to her. The patient also did have on her forehead was a spot in the middle that was raised, kind of like a raised area, from that area, it is radiating heat, she feels her forehead hot from that spot, and they take her temperature with the new handheld touchless thermometer, and it radiates heat like 100.2 to perhaps 100.4 (Dec2020). It always raises a question at these appointments, but then they take her temperature orally and it's 98 degrees (Dec2020). It was also mentioned that the patient was experiencing tingling reaction in the arms, headache, swelling, numbness in her face, and a bump on her forehead with a high temperature. These symptoms were there until yesterday, the Emergency room gave her some medicine, but the consumer hasn't heard from her, his patient was home, they haven't talked since last night. The consumer was hoping she was able to sleep. The consumer stated that the patient was given medicine, it was give to relax her, but it is like a bandaid, not a cure. Now, the consumer stated that the patient said her symptoms were the same symptoms, headache, numbness, everything after last night, she was still with problems. The patient had the very first one, at this point, the consumer doesn't know about the second one, the way she is doing. It was given to all the people she works with, most of the people, the patient works in a hospital, she is a respiratory therapist, it was given to them as they are exposed to all that the COVID 19 in a hospital. Yesterday on 03Jan2021, brain MRI, results showed that the patient was told her that everything looks, initially, looks clear good, but a neurologist will look at the report in detail. and rule out any other conditions, she has to be followed up with by a neurologist, the appointment is pending. The patient's mother asked on behalf of her daughter if this department going to be contacting the doctor for help with resolution about to resolve the health issues, what is to be expected. She added, "What are people doing when they have these severe side effects, what is Pfizer doing for them, besides taking down information, which is helping Pfizer, what helps the patient resolve side effects from the vaccine?" The patient's father stated that it seems to them, his daughter went 3 times to Emergency, the first time they said good luck with that, second time, this and that she is ok, go home, and the third time, at least they did a brain MRI, and gave her some medicine, now this morning, she is back to where she was before she went to the ER. He asked, "Why is there not more documentation, more information provided to doctors that have take care of patients, it seems to be a small group of people with these side effects, and it is really hard, the question they have is, this suffering, why doesn't Pfizer be more active in helping people, now they are investigating that, doing research to him seems like some feedback s not necessarily directed to the patient, as they are trying to take care of themselves, but to call the doctor helping her, to know a better lead to be able to help her, his daughter has missed a lot of work, has a lot of headaches, where is the hope for this to go away? What can Pfizer do to the medical community, to help them?" Therapeutic measures were taken as a result of headaches. The outcome of the events was unknown.

Approx 1 hour after vaccination, pt. began feeling hot in her face. Face was red, noticed swelling (I was at lunch with co-worker). Assoc showed manager her face and was sent back to vaccination are. Brought to ED and given Benadryl. Initially had some itchiness in throat; resolved after Benadryl given.

Left armpit swollen and hard around lymph node developed approximately 21 hrs after vaccine administration. Hurts with movement and no movement. Took 1000mg of Tylenol at onset of symptoms and 400 mg of ibuprofen 3 hours later with no symptomatic improvement. Around the same time, severe left ear pain that is sharp and stapping developed

Dry, flaky and swollen rash on face. Left cheek, right cheek and right side bridge of nose, and under chin on left side. I noticed it on 1/12/21 and it got progressively worse by 1/14/21.

Symptoms: Woke up around 07:30 feeling off balanced, warming more than usual per EE (did not take temp) and HA. EE took temp at 09:30 (99.6) and again at 14:00 (99.9), EE did not take antipyretics. EE reports later in the day temp of 98.6. EE reports at time of call pain at injection site and mild swelling to lymph nodes under L axilla. Last day of work and shift - 1.13.21. Home remedies: Rest. Any improvement: Mild improvement. Recommendation: EE encouraged to take ibuprofen as outlined in the Medical Directive and to apply a cold compress to injection site. EE encouraged to continue to monitor her symptoms and to contact the Vaccine support line with additional questions and concerns. EE reports she called out of work yesterday and today. EE educated to manage her according to the Illness in the Workplace policy. EE verbalized back understanding and denied further questions at this time.

Headache; Chills; Swollen lymph node; exhaustion; fever; vomiting; This is a spontaneous report from a contactable consumer reported for self. This 25-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) via unspecified route of administration on 08Jan2021 09:30 AM at single dose in right arm at nursing home/senior living facility for COVID-19 immunization. The patient is not pregnant. The patient medical history included known allergies: milk products, Crohn's disease. The patient did not have COVID prior vaccination. The patient concomitant mediations included bupropion hydrochloride (WELLBUTRIN XL), hydroxyzine. The patient did not receive vaccine in four weeks. The patient experienced headache, chills, swollen lymph node, exhaustion, fever, vomiting in Jan2021. The onset date of events was reported as "01Jan2021". The events were reported as non-serious by reporter. The patient did not test COVID post vaccination. The patient did not receive treatment. The outcome of events was not resolved. Information about lot/batch number has been requested.

Headache; fever; chills; shaking; underarm swelling; arm pain; muscles pain; fatigue; lighheadness; This is a spontaneous report from a non-contactable Other Health Professional (patient). A 25-year-old female patient (not pregnant at the time of vaccineation) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL1283), via an unspecified route of administration at left arm on 07Jan2021 12:00 at single dose for COVID-19 immunization at a hospital. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization on an unspecified date at a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested for CPVOD-19 since the vaccination. On 08Jan2021 01:00, the patient experienced headache, fever, "chills/shaking", underarm swelling, arm pain, muscles pain, fatigue, and "lighheadness". The above mentioned events resulted in doctor or other healthcare professional office/clinic visit. No treatment was received for the events. The outcome of the events was recovering. The reporter considered the events as non-serious. No follow-up attempts are possible. No further information is expected.

24 hrs post vaccination, my left axillary began to hurt and was tender to touch. I noticed a lump start to form and did not go away until 5 days post vaccination.

At 4:30 am WOKE EXPERIENCING CHILLS/SWEATS, MODERATE-SEVERE PAIN AT INJECTION SITE(LEFT DELTOID), MODERATE HEADACHE. MODERAE-SEVERE BODY ACHES/SHARP PAIN IN THE BACK, LEGS. SWOLLEN FINGERS. SLEPT ON/OFF FOR 2 HRS. TEMP AT 7AM 99.5. SYMPTOMS AND FATIGUE HAVE PERSISTED THROUGH AM.

Aches, chills, loss of consious (passing out 1/13) lock jaw bilaterally, lumbar pain with swelling (unable to see spine anymore), body sweats, dizziness. Lasting 24 hours, 3 doses of benadryl

Was driving home after waiting my 15 minutes. Throat started to close up, tingling sensation throughout entire body, rush of heat, dizziness, increased heart rate. Made it back to the site (closest medical professionals near me) where my throat still felt swollen but I could breathe. Chest hurt and was still dizzy. Was given 50mg Benadryl & 20mg Pepsid. It seemed to come and go in waves but I still went to the ER. ER doc said what he saw I was experiencing was anxiety. Pharmacist who had been with me the whole time could tell that my neck and throat had been swollen but had gone down with the Benadryl. ER administered anti nausea meds and a steroid shot. Also prescribed steroids for a few days. Received the shot at 6:45, initial reaction occurred around 7:10, went to the ER around 8:45

Pfizer-BioNTech COVID-19 Vaccine EUA, - headache - chills - fever - swollen lymph nodes (sore throat)

WBCs and neutrophils and platelets elevated 3 hours later; WBCs and neutrophils and platelets elevated 3 hours later; WBCs and neutrophils and platelets elevated 3 hours later; Coat hanger neck/ shoulder pain; Coat hanger neck/ shoulder pain; flushed; felt uncomfortable; couldn't sit still; feeling clammy; saw spots; BP dropped to 60s/30s; felt like throat was closing; couldn't breathe well; hands were numb; lips were white/ blue; This is a spontaneous report from a contactable nurse (patient). A 25-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, LOT# EL1283), via an unspecified route of administration in right arm on 07Jan2021 13:30 at first single dose for COVID-19 immunization. Medical history included asthma, fibromyalgia, idiopathic hypersomnia, seasonal allergies (dust, ragweed, pollen, dander), covid-19. Concomitant medication in two weeks included duloxetine hydrochloride (CYMBALTA), modafinil, montelukast sodium (SINGULAIR), cetirizine hydrochloride (ZYRTEC), ergocalciferol (VIT D). No other vaccine in four weeks. 1-2 min after shot the patient became flushed and felt uncomfortable/ couldn't sit still, began feeling clammy, saw spots, BP dropped to 60s/30s, all other vitals stable, felt like throat was closing and couldn't breathe well, hands were numb, lips were white/ blue. No itching or hives. Resolved with trendelenburg and rest, fluids given in ED. WBCs and neutrophils and platelets elevated 3 hours later. Coat hanger neck/ shoulder pain for the next few days. Adverse event start date was 07Jan2021 01:30. Event resulted in emergency room/department or urgent care. Covid was not tested post vaccination. Outcome of the event was recovering.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the reported events cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.

Fever = 101, left side of body is weak/sore, generalized weakness, lymph nodes swollen on left side only

Enlarged lymph node above left collar bone; This is a spontaneous report from a contactable nurse (patient herself). A 25-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El3247, expiry date not reported), via an unspecified route of administration in the left arm on 13Jan2021 at single dose for COVID-19 immunisation. Medical history was not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. Concomitant medications included insulin aspart (NOVOLOG). The patient previously took first dose of bnt162b2 (lot number and expiry date not reported) on an unspecified date at single dose for COVID-19 immunisation. The patient had enlarged lymph node above left collar bone on 14Jan2021. Clinical outcome of the event was unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.

flu like symptoms, chills, hot flashes, headache, fatigue, body ache, muscle soreness, night sweats, sore/swollen throat, swollen neck lymph nodes

- fever (101 degF+) x 1.5 days - neck stiffness - chills - fatigue - lymphadenopathy - myalgia - arthralgia

Pfizer-BioNTech COVID-19 Vaccine EUA. 12 hours after vaccine experienced chills, fever, nausea, headache. 15 hours after vaccine vomited. Fever, chills and headache persisted from 12-32 hours after vaccination. Lymphadenopathy with considerable swelling and tenderness evident in ipsilateral axillary and supraclavicular lymph nodes.

swelling at injection site; swollen lymph nodes at under arm; Dizziness/Then felt like going to faint; Nausea; I became pale, diaphoretic, and tachycardia (100s).; I became pale, diaphoretic, and tachycardia (100s).; I became pale, diaphoretic, and tachycardia (100s).; Headache; Severe pain at injection site; Fatigue; Muscle weakness; For about 12 hours or so I had on and off fever and chills; For about 12 hours or so I had on and off fever and chills; This is a spontaneous report from a contactable Nurse (patient). A 25-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3249), via an unspecified route of administration on 13Jan2021 19:00 at single dose in Left arm for COVID-19 immunization. Medical history included allergies to Sulfa drugs, attention deficit hyperactivity disorder (ADHD), seasonal allergic rhinitis. Concomitant medication included ibuprofen (ADVIL), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), fluticasone propionate (FLONASE), clarithromycin (CLARITIN). Historical Vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685) on 23Dec2020 18:00 at single dose which was administered at Left Arm for COVID-19 immunization. There were no other vaccines received in four weeks. The patient did not have covid-19 prior to vaccination and covid-19 not tested post vaccination. The patient started with dizziness and nausea on 14Jan2021 12:30. Then felt like she was going to faint on 14Jan2021 12:30. The patient became pale, diaphoretic, and tachycardia (100s) on 14Jan2021 12:30. Also had a headache and severe pain at injection site as well as fatigue and muscle weakness on 14Jan2021 12:30. For about 12 hours or so the patient had on and off fever and chills as well the rest of the symptoms listed above which started from 14Jan2021 12:30. Today (40+ hours later) on 15Jan2021, the patient developed swelling at injection site and swollen lymph nodes at under arm. No treatment received for the reported events. The outcome of the events was recovered in Jan2021.

One week after my first dose I noticed that my right supraclavicular lymph node became swollen, today is 01/29/2021 and it hasn't gone away. (I got my second dose 2 weeks after the first one).

Swollen eyes (started on the morning third day post injection); lymph nodes in right armpit, mild swelling in neck region.

30 minutes after the injection she started having a headache, dizziness and fever. The next day she noticed 2 cold sores on her lips and mouth sores throughout her mouth. She was unable to eat for several days. Symptoms resolved by 1/22.

Headache, chills, body ache, lightheadedness, local swelling with COVID-19 mRNA vaccine IM into left deltoid. Patient took acetaminophen.

Mild anaphylaxis less than 5 min after injection. Symptoms onset immediately, including dizziness, rapid heart rate, tightening of the throat, making breathing/swallowing difficult, ears felt strong pressure/itch. Symptoms went away on their own, but several episodes of similar symptoms/intensity persisted throughout the evening roughly every 30min-1hour.

Supraclavicular lymph swelling after 3 days, posterior cervical chain swelling noticed after two weeks

Experienced dizziness the first week after vaccination; Axillary lymph node swelling to arm of injection; Axillary lymph node swelling to arm of injection; hands and feet tingling/numbness/Feels as if hands and feet are falling asleep often; hands and feet tingling/numbness/Feels as if hands and feet are falling asleep often; This is a spontaneous report received from a contactable nurse (who is also the patient). A 25-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, on 30Dec2020 14:00, at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2 vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. On 06Jan2021 at 14:00, first week after the vaccination, the patient experienced dizziness, axillary lymph node swelling to arm of injection 1 week until now after vaccination, and hands and feet tingling/numbness at random times of the day and feels as if hands and feet are falling asleep often. The events resulted to "doctor or other healthcare professional office/clinic visit". No treatment for the events was given. The outcome of the events was not recovered. The events were assessed as non-serious. Information on the lot/batch number has been requested.

large inflamed swollen lymph nodes under her arm / extremely swollen large lymph node under the right arm; large inflamed swollen lymph nodes under her arm / extremely swollen large lymph node under the right arm; fatigue; This is a spontaneous report from a contactable consumer reporting for a female patient (daughter). A 25-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were unknown) via an unspecified route of administration in the right arm on an unspecified date at SINGLE DOSE for covid-19 immunization. Medical history was reported as none. There were no concomitant medications. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unspecified date via unspecified route of administration in the right arm at single dose for covid-19 immunization. She received both shots (first and second dose) in the same arm. The reporter stated that patient (daughter) took her second shot (Covid-19 Vaccine by Pfizer) on unspecified date (reported as "this past Tuesday") and the next morning she woke up with a large inflamed swollen lymph nodes under her arm; upper arm but certainly it's in her armpit side. Reporter wanted to know how long the lymph nodes will just take swollen. The event was further described as extremely swollen large lymph node under the right arm. This happened on unspecified date, reported as the night patient received the vaccine (also reported as occurred the next morning). She did have additional side effects such as fatigue but no fever, no diarrhea, no upset stomach. Fatigue to the point she couldn't go to work on the day after receiving the vaccine. The fatigue passed but not the swollen lymph nodes. Patient went to see the doctor and said it could be a possible side effect of the vaccine or something else. Ultrasound was performed on unspecified date with unknown results. No treatment was received for the event (not at this time) but patient has been to physician. The outcome of the event "large inflamed swollen lymph nodes under her arm / extremely swollen large lymph node under the right arm" was not recovered. Outcome of the event fatigue was recovered on unspecified date. Information about lot/batch number has been requested.

Swollen lymph node (or unknown lump) behind the left collarbone; painful on it's own and painful to touch. Lymph node swelled up to about the size of a cherry and has stayed that size. Began at about 11 AM on 2/8 and has continued through now (~4 PM 2/9). Intense muscle aches, worse two days after the vaccine, instead of just one day after. Aching of the muscles around the eyes (the ones you would use to squint and the top of the cheeks), the scalp, neck (the base of the skull and trapezius), biceps, aching around the wrist joints, hip flexors, quadriceps, and ankle joints. Found relief with 500 mg acetaminophen throughout the day.

2 days after vaccine employee had hands swelling , blisters on both hands and hands were very puritic, has improved but lasted 10 days

fever of 102, headache, joint pains, nausea, vomiting, diarrhea, runny & congested nose, back pain by kidneys, swollen lymph nodes

Within 15 minutes my vision began to blur, I became shaky and disoriented. My heart rate increased and it felt as though my blood pressure decreased rapidly. After 30 minutes my symptoms had worsened and I was so disoriented I was not able to seek medical attention while being observed. I exited the building and once I got into my car my face (specifically under my eyes and on my cheeks) began swelling and a red burning rash appeared. By the time I got home (10 more minutes) I needed Benadryl immediately, I was not able to complete my sentences and all other symptoms had become more intense. I continued to take Benadryl every 4 hours for the next few days due to the symptoms consistently rebounding. I had one episode of throat tightness but it passed without use of my epipen. I checked my pulse and blood pressure frequently with the lowest reading being 93/60. Lethargy, shakiness, confusion, high heart rate all are still present after 5 days. The rash went away after 48 hours.

Patient developed headache, fever and extreme sweating the evening after vaccination. Also, she developed gum swelling, purple spots on the gums, sores in the mouth, and fever blisters on the lips. Symptoms worsened and patient went to the facility to get a COVID test, which was negative. Over the weekend, patient developed swollen lymph nodes/neck and also noticed a lump in the left breast (same side as vaccination). Patient was nursing 11 month old and supply diminished (never returned). Went to stat care and was diagnosed with strep throat over the weekend. About 2 weeks post-vaccinations symptoms resolved and lump in breast no longer present.

Extremely swollen lymph nodes in left axilla. Unable to press arm down against side due to the swelling. Very painful.

Chills, body aches - lasted approx. 1 day Headache, fatigue - lasted approx. 2 days Injection site swelling and Swollen lymph nodes in right armpit - lasted approx. 5 days Alternated Tylenol and Motrin to relieve head and body aches. All swelling reduced gradually without direct treatment.

I made sure to hydrate and eat well the day of the vaccine. I have had no allergic reactions to any medications/ injections in the past and I was not worried about this one. I didn't take any meds beforehand besides my normal morning modafinil. I have no fear of needles. I received the vaccine in the auditorium about 1:25pm. The RN did a fantastic job, went through all of the information, no pain at all with the injection. As I was sitting in my chair for monitoring, a few minutes in I began to feel very uncomfortable. I felt clammy/sweaty and kept shifting my weight in my seat. I didn't want to make a big deal of it at first because I worried it was all in my head. But I became more and more uncomfortable. I laid my head down on the little desk, no help. I closed my eyes, no help. About 10 minutes or so in I decided to ask if they had water available. I slowly got up and walked to the back of the room. I couldn't even get the question out of my mouth before the nurse told me to sit down. Apparently I was white as a ghost. They got a wheelchair and wheeled me to the space behind the auditorium. By then I was starting to feel like my throat was closing and I saw spots in my peripheral vision. It was kind of a blur from there. I tried to take deep breaths. I drank a few sips of water and poured some on a paper towel to wet my forehead (and spilled all over my lap because I was a little disoriented at this point). My BP was 60s/40s and then 60s/30s. A rapid response was called. They moved me to a cart flat on my back with my legs elevated. My fingers and toes were starting to go numb and my lips were apparently blue/ white. After laying for a few minutes in Trendelenburg my BP began to resolve and my breathing started to ease a bit. No further intervention was done by the rapid team. I was taken by the Rapid RN to the ED for monitoring. They eventually pushed the cart into a room and took some vitals and an EKG. They had me stand and move to a wheelchair. I felt horrible but improved from before. They had me sit in a wheelchair in the lobby for a few hours before taking me back and placing an IV and drawing labs (I believe it was 3 hours from the initial reaction). I gave a urine sample. They then put me in a wheelchair and wheeled me back into the lobby for some more time. Then, they wheeled me back to a room where they gave some lactated ringers and a PA and MD saw me. By then my BP and breathing was completely resolved. The MD said he wasn't fully convinced it was just a vasovagal episode because I haven't had issues with vaccines in the past and I was well hydrated and my HR was normal. It partly fit the picture for an allergic reaction/ severe immune response d/t the feeling of throat closing, the BP drop, and the elevated WBCs. They advised that I list the vaccine as an allergy and do not get the second dose, especially since I had COVID back in September.

Significant axillary and anterior cervical lymphadenopathy on the right side, diffuse abdominal pain/cramping

Hives on back, hands, elbow - night after vaccine and up to 4 days after Lots of itchiness all over body a few hours after vaccine Intense joint pain and swelling keeps progressing - especially in wrists, fingers, and knees

One week after receiving vaccine, this patient developed painful lumps in the left chest (side of vaccine) and left armpit. Multiple developed at different times and have increased the number since the original was discovered. Perhaps they are lymph nodes, but that has not been confirmed by a provider. They have not diminished in size or painful quality since discovery two days ago.

1st dose I had fever, body and arm pain. 2nd dose I had arm pain and swollen lymph nodes, 3 days later I lost smell and taste.

Enlarged left supraclavicular lymph node. I noticed it 8 days post-vaccine. It remained very enlarged for about 6 weeks and then began to decrease in size. It is now still enlarged but much smaller than before.

Within 1 hour of injection (10:00am), began experiencing fatigue that got increasingly worse. By 2:00pm, had slurred speech; severe fatigue; red skin on hands, face, neck; balance problems and dizziness; swollen hands. That evening through the next morning, I was experienced severe flu-like symptoms, including vertigo, extremely severe fatigue, and full-body muscle aches. My temperature was slightly elevated (98.7) from my "baseline," which is around 96.7. On Saturday, I was very tired, no appetite, still experiencing some vertigo and muscle aches. Symptoms improved overnight and by Sunday evening, I was mostly back to normal, with some lingering fatigue.

Swelling of lymph node by collar bone on left side. swelling and lumps on left breast and pain. difficult to turn neck and look left. progressively getting worse

About 30 seconds after the injection I felt a strange sharp pain right under where the injection site was. I was advised to sit near the nurses station for 30 minutes instead of 15 due to my medical history. One of the nurses came by to check on me and as we were chatting my entire left shoulder and up my neck suddenly got red and rashy. I looked down and both of my arms were rashy as well. I began to experience itching everywhere. The nurse gave me 50 mg of benedryl and monitored me for about 40 minutes. The rash went down and they had my husband come pick me up. I called my pcp and advised them or the situation. She asked to keep her informed and if anything got worse to administer the Epi-Pen and go to the ER. Once home I slept for about 5 1/2 hours and then woke up in the afternoon. I had a minor headache and my arm had started to swell, but the rash was completely gone. As of today my arm is still red and swollen under the injection site, and itches quite a lot.

About 10 minutes after the second dose, I noticed the hives and irritation come on my throat, neck and my arm. I talked to the people who were monitoring and they gave me 50 mg of Benadryl and they kept me for 45- one hour. They Benadryl took about 20-30 minutes to for having the hives and irritation go away. After that happened, I went home and I started to get body aches and feeling very fatigued; a little bit nauseous. I did have some soreness and swelling on my arm after vaccine that lasted two or three days. The fatigue and body aches lasted for one day. The hives and irritation on my throat and neck and arm didn't come back after the dose of Benadryl. I had a doctor appt on Feb 8 about the side affects of the vaccine - he told me if hives came back to take Benadryl.

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

Anaphylaxis, Urticaria Patient was transferred to the Emergency Room @ 14:14 via EMS,After 1st vaccination patient experienced tingling of the tongue. After 3 mins of observation patient began to have hives around her neck. Epi was given 14:07 lot# 9fm640. Exp apr 2021 Vital Anaphylaxis

sharp shooting pain in my right armpit (same side as injection)./my right armpit was swollen; sharp shooting pain in my right armpit (same side as injection)./my right armpit was swollen; This is a spontaneous report from a contactable other HCP. This 25-year-old female other-HCP reported that she received bnt162b2 (BNT162B2, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 04Feb2021 10:00 (Batch/Lot number was not reported) as SINGLE DOSE, dose 1 via an unspecified route of administration, administered in Arm Right on 14Jan2021 16:00 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included food allergy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. he patient reported 24 hours after getting the shot, I started having sharp shooting pain in my right armpit (same side as injection). 36 hours later, my right armpit was swollen. It has now been 4 days and my right armpit is still very swollen- have been treating with warm compress. Still have pain but has decreased. The action taken in response to the events for bnt162b2 was not applicable. The outcome of the event swelling was reported as not recovered and for other event is recovering. Information about lot/batch number has been requested.

6 days after the shot the lymphnodes in my armpit became swollen and very painful. after two days it has reduced but still has not gotten completely better.

The next morning following the vaccine injection, (4/1/21) I woke up to pain in my lymphnodes in my right armpit. I recieved the injection in my right arm. It was a dull achey pain but upon palpation became a sharp shooting pain that radiated from my armpit into my back and under my ribcage. There was also swelling and it to hurt have my right arm resting along my side. Today, on 4/2/21, I am still experiencing this pain, however, it is less severe. To treat, I have been taking 2 acetominaphen approximately every six hours. It still hurts if I am to rest my arm at my side.

I'd had Bell's Palsy (BP) twice in my life (once in 2013 and once in 2015). I have not had it since 2015 until I got vaccinated on 3/29/21 and began to develop BP symptoms on the evening of 4/6/21 (headache on right side of my head/temple, odd sensation on right side of my tongue, almost like I burned it on a hot beverage) but I didn't think anything of it. I went to sleep and then, on the morning of 4/7/21, I woke up feeling extremely fatigued, brain fogged, and weak. I didn't notice any of the BP symptoms until I went to brush my teeth and realized I had lost motor function in the right side of my mouth. I immediately made a telehealth appointment with an Urgent Care doctor in order to get an Rx of Prednisone. I began taking the Prednisone around 3pm on Wednesday, 4/7/21. I also have been taking vitamin B-12 and a Women's Multivitamin to help regenerate nerve function. However, since starting the prednisone, my symptoms have continued to develop. Symptoms currently include: right side of my face is extremely swollen; I have lost mobility on the right side of my face, the right side of my tongue still feels numb; right eye tearing non-stop; some mild ear pain in right inner ear; slight pins-and-needles sensation in my fingers on my right hand; difficulty eating and drinking; still feeling fatigued. I have recovered from BP twice before so I am not too worried about having it again. I just think the FDA needs to put out a warning to the public that there may be a correlation between the COVID-19 mRNA vaccines and Bell's Palsy recurrences. I know this is not a coincidence, and my BP relapse was a result of my body experiencing an immune reaction from the vaccine.

I received the vaccine in my left arm and noticed the pain in my left arm and armpit the day after receiving the shot. 2 days after receiving the shot, I noticed the swelling of my left lymph node in my left armpit. It was very painful to move my arm or leave my arm resting in a normal position since it would put pressure on my lymph node. I had very limited mobility on days 2,3 and 4 after the vaccine but quickly improved starting day 5 with very minimal pain. I had a video call with a doctor who recommended 800mg of ibuprofen every 8 hours & warm compress on the lymph node. In general, I had very minimal symptoms from the first vaccine except the lymph node swelling & pain. Starting day 5 post vaccine I was basically back to normal & have felt good ever since.

Swelling and redness of the arm within an hour after the vaccine. Tingling began in middle, ring, and pinky fingers within 20 minutes of injection. Numbness began within the first hour. Within two hours, I lost strength and 60% use of my left hand. The pinky and ring finger of my left hand have been either completely numb or tingling ever since my shot over one week ago. I noticed mild numbness about 3-4 days after the first dose, but assumed I had just slept funny. When my arm became red and hand became tingly after my second dose, I realized this was an effect of the vaccine and not merely a pinched nerve in my sleep.

The first dose of the Pfizer vaccine was taken on March 15th at 8:30. Within a week I started feeling weak joints, headaches followed by a sharp pain on the occipital lobe. I started my period for the second time that month, which was odd because it never happened to me before. I went to work that week, but by Friday (March 30th) I was not able to handle the pain so after work I went to the doctor and they took blood to see if there was anything going on. The result came back the following day and everything was normal. I was given medicine (muscle relaxers) for the occipital pain, but it was not enough. At that time I was not sure what was the cause of it, I thought it was a bad flu, but I didn't come to the conclusion that it was because of the vaccine, because a week had passed by, so I thought it was impossible. The doctor asked for me to take an X-Ray for the occipital pain, so I did (March 30th) and it resulted in everything being fine. She also recommended for me to get an abdominal ultrasound to see if my uterus was fine due to the second period. I currently took the second Pfizer dose in the same location, but this time around I felt all of these symptoms within 3 hours of the vaccination. I started feeling lightheaded and dazed, my joints started feeling weak, my mouth and tongue started feeling sensitive (fever blisters and sensitive to anything that is acidic, spicy, etc). I have not visited the doctor this time around because the pain is tolerable. I have noticed in increase of joint pain as the days go by.

Evening of April 1, 2021, 10:00pm- Noticed "hard lump" on top of left foot. Severe pain and tenderness on top of left foot. Friday April 2, 2021, 2:00pm - Medical visit: Family Practice, Diagnoses: Left Foot Pain, Subcutaneous Nodule Of Foot. Ultrasound ordered. Tuesday April 6, 2021, 10:30am - Ultrasound of lower left foot, Diagnoses: Thrombophlebitis Of Superficial Lower Left Extremity Tuesday April 6, 2021, 4pm - Emergency Department. Ultrasound of full left leg. Additional pain, tenderness, and swelling.

About an hour after her vaccine, patient called and said that she was nauseous, vomiting, had passed out twice, a rash from the injection site up to her throat, and her arm was swollen from the elbow up. I told her to take Benadryl and to go to the ER or to the immediate care. I followed up with her the next day and she went to the ER, she said the Benadryl helped her out significantly and that she was feeling much better that day. She was still inquiring about the second shot but, she was following up with her MD on Wednesday.

Swelling of lymph nodes and skin around shoulder area. Painful underarm and visible nodes around collar bone. Area is hot to the touch. Site looks normal.

Within 1 hour of receiving the vaccine, I had mild tongue swelling, shortness of breath, fingers swelling, intense sweating and faintness. Within 24 hours of receiving the vaccine, hives developed on my left thigh. The tongue swelling, shortness of breath and faintness happened on and off for the first day. It resolved on its own by the next day. The hives got progressively worse and peaked roughly 48 hours after getting the vaccine. They slowly faded, but are still faintly noticeable. I had general malaise for the rest of the week. I have photos showing the progression of the hives.

Swelling in left shoulder, in muscle above clavicle. Visibly swollen. Left side of neck felt stiff. Swelling went down on 4/20, but still visibly swollen and sore. Les swollen and sore on 4/21, but still noticeable. Coughed sporadically the night of 4/19, dry cough, sometimes short of breath.

At 5:15 pm, same day as shot, a migraine occurred. A bad migraine, unable to stand because it caused so much pain in my head. at 8:00PM I went to bed due to the pain. at 1:15 AM, my body was in pain. My right rib cage hurt so bad that I couldn't sleep on my right side. My legs, back, and pelvic bones were in so much pain as well. I felt as if my bones were going to break or I had severely bruised my bones. Breathing, coughing, sneezing hurt because of my rib cage hurting. My migraine had not gone away, and my lymph nodes were really swollen. Couldn't put my arms down, my neck was swollen and walking hurt because my legs were swollen. This occurred for 24 hours. Next day, migraine is gone and left a headache. Swelling is still prominent and bones still hurt.

Left armpit swelling after shot. But since January I?ve had random flare ups of pain and swelling in both armpits.

Patient reports illness started with swollen painful neck lymph nodes. On exam + painful anterior cervical lymphadenopathy. Patient states she developed dizzy spells with tunnel vision, headache and fever yesterday with max temp 102F, which has since resolved. Patient felt like she was going to faint. Patient reports she's had associated body aches and fatigue.

12 days after the vaccination (on April 24th) my left armpit got swollen and stated to ache. The pain radiates to my elbow and I can't use my arm.

Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Rash Generalized-Mild, Systemic: Chills-Severe, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Mild, Systemic: Nausea-Mild, Systemic: Shakiness-Severe, Systemic: Weakness-Mild, Additional Details: Patient recieved vaccination. 15 minutes later patient stated she wanted to stay a little longer with a feeling of uneasiness and muscle trembling/shaking and feeling cold. 27 minutes later patient stated she felt a sudden tightness in her chest and a shortness of breathing. Patient requested to get an epi-pen injection due to the difficulty in breathing. Patient had epi-pen injected into left thigh at 4:46 pm .

Very swollen lymph node above left colar bone; same side that the COVID-19 vaccine was injected. It?s been a month and it hasn?t gone down at all. The lymph node is about the size of a penny, it?s hard but moves.

The morning after (04/15/21), I woke up with soreness and slight redness. As of today (04/28/21), a red circle with the diameter of more than 1 inch, slightly tender on my left arm. Gradually increased in size over the last 2 weeks. My whole body is itchier than normal. I'm now using a body lotion daily so I have not experienced much itchiness since. I've been very fatigued & irritable. My headaches have gotten worse and I haven't had much of an appetite.

Severe arm pain for 12 hours, Tylenol for treatment, severe pain subsided after 12 hours, mild to moderate pain persists Fever for 24 hours, subsided after 24hrs Chills for 24 hours, subsided after 24hrs Lightheadedness, lasted 24 hours, subsided after 24 Swollen lymph node and sore throat, began 24 hours after vaccine and is persisting.

Lump in my neck on the left site. One is small from the first injection. The second lump is larger from the second injection and a tad sensitive and painful.

Started feeling swelling/pain in left armpit region late on the night of the 29th. Woke up and still had that pain. On the evening of the 30th (around 9 PM) noticed that the lymph node above the left clavicle had swollen up to about the size of a marble and was causing pain, both when not being touched and when being touched.

redness and swelling of injection site. is still present and currently spreads out more every day. It is painful but lessens each day. is slightly itchy. Swollen lymph nodes. Very swollen in right under arm. Painful to the touch. appeared 2 days ago (4/29/21) Tiredness that went away after 24 hours

anaphylactic reaction; This is a spontaneous report from a contactable nurse (patient). A 25-year-old female patient received the second dose of bnt162b2 (Lot Number: En6203), via an unspecified route of administration, administered in right arm on an unspecified date (at the age of 25-year-old) as single dose for COVID-19 immunization. The patient is not pregnant. Medical history included COVID prior vaccination on unspecified date. The patient had no known allergies. Concomitant medication included unspecified birth control pills. The patient previously received the first dose of bnt162b2 (Lot Number: En9581) in the right arm on 09Feb2021 at 02:00 PM (at the age of 25-year-old) as single dose for COVID-19 immunization. No other vaccine in four weeks. On 21Mar2021 at 14:00 after her second vaccine the patient had an anaphylactic reaction. It was something she had eaten before so not new to her body. It happened again on 27Apr2021. Still from things she eats normally. Both occurrences happened 30 minutes after eating and came on quickly. The event resulted in Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). Therapeutic measures were taken as a result of the event which included Benedryl, steroids, and given an epipen. The patient recovered from the event on unspecified date.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between the suspect drug and the event cannot be excluded.

Itchy throat 15min after receiving 2nd dose, notified vaccine employees and kept 15min extra, and then 24hrs after 2nd dose left neck supraclavicular lymph node swelling and tenderness. Left arm vaccine site tenderness next morning after 2nd dose as well.

Lymph nodes in her neck are severely swollen where she can barely turn her neck; Having severe lower abdominal pain; Sore throat; Headache; Overall feels horrible; Lymph nodes in her neck painful (sore); Stated that she is really tired; she could barely turn her neck; This is a spontaneous report from a contactable consumer (patient's mother). A 25-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at age of 25-year-old at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The caller stated her daughter had the vaccine on Thursday and was having bad side effects. She stated her lymph nodes in her neck were severely/extremely swollen and painful where she could barely turn her neck and her neck was sore. She was having severe lower abdominal pain that started that evening, bad first two days and had subsided. The patient was really tired. She had a sore throat, a headache, and overall feels horrible. She stated 3 days ago there were reports of hundreds of women in her age group having these same symptoms and this information was not available to them prior to the vaccine. She stated there were woman dying in Norway from thrombosis, 20 women in their reproductive years. Woman this age were getting severe reactions and there is no available information on this. She asked, how long will these symptoms last. How to make the swelling and pain go away. Stated that she was fine before the vaccine and currently she was not fine. The outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Developed Shingles (herpes zoster) approximately 8 days after second COVID-19 dose. Initially noticed one sensitive bump on upper-mid right side of body which developed into a rash within the next two days. Went to doctor and received anti-viral medication approximately 5 days after symptoms appeared. I had chickenpox as a child

Rash, swelling, itching, burning on both elbow pits? I don?t know what to call them sorry. I have a picture I can email if necessary. The rash was much worse on the arm that got the injection, lesser on the other arm. I?ve only gotten something like that one other time taking an antibiotic I was allergic to. Not as bad, is mostly gone the next morning. Still itchy, and left behind small whitehead like bumps on a few of the worse patches.

Felt like face w swollen, hot, and tired. No facial swelling noted after thirty minute observation, no rash, no SOB.

Experienced achey arm and swollen lymph nodes in the arm of injection site for over 48 hours after second shot. Also experienced fatigue. Took Tylenol and applied a heating pad to the underarm. It did not help with the pain in the underarm. Currently still experiencing slight pain (May 12), but it is less than on May 11.

Metal taste I mouth when eating or drinking, runny nose and congestion, shortness of breathe, severe fatigue, muscle and joint aches, swollen lymph nodes on armpit near site

Experienced chills and fever within first 48 hours of vaccination that subsided without need for additional treatment, but in 2-7 days after dose, still experiencing ongoing muscle weakness (leg muscles in particular sometimes feel too weak to walk), lightheadedness, fatigue, swollen lymph nodes in throat.

next day--9:00 am - chills, muscle aches 10:00 am - fever 100.5C while on Acetaminophen fever, chills, severe muscle aches, tiredness continuing all day two days following second dose--extremely swollen lymph nodes under left arm and on left side of throat (same side of body as injection site)-painful to raise arm and painful to swallow swollen lymph nodes persisted until four days following second dose

Lethargy; swollen and painful arm and armpit; swollen and painful arm and armpit; swollen and painful arm and armpit; chills; nausea; headache; muscle aches all over body; restlessness in muscles (feel like she had to flex everything); This is a spontaneous report received from a contactable consumer (patient). A 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown), via unspecified route of administration in left arm on 12Feb2021 12:30 PM (at the age of 25-year-old) as 2nd dose, single for COVID-19 immunisation. Vaccine facility type was reported as hospital. The patient's medical history included depression and anxiety, both from unspecified date. No known allergies and no COVID prior vaccination were reported. The patient's concomitant medications reported as within two weeks from vaccination included amfetamine aspartate/amfetamine sulfate/dexamfetamine saccharate/dexamfetamine sulfate (reported as generic ADDERRAL), duloxetine hydrochloride (reported as generic CYMBALTA), both from unspecified date. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not provided), via unspecified route of administration in left arm on unspecified date as 1st dose, single for COVID-19 immunisation. The patient did not receive other vaccines within 4 weeks from vaccination. On 13Feb2021 12:00 AM the patient experienced lethargy, swollen and painful arm and armpit, chills, nausea, headache, muscle aches all over body, restlessness in muscles (feel like she had to flex everything). Treatment for the events were received and reported as patient took lots of extra strength paracetamol (TYLENOL). Patient had not been tested post vaccination. The outcome of the events was not resolved. Information on the lot/batch number has been requested. Follow-up (11May2021): Follow-up attempts completed. No further information is expected.

On May 11 (ten days after second shot), I broke out in full body hives (face, arms, legs, entire abdomen). Extreme itchiness all over body - unable to sleep. Body was entirely red with raised white welts. Visited urgent care doctors, dermatologist, and allergist. Landed on a treatment plan with the allergist with a strong dose of steroids and antihistamines, which have mostly resolved the symptoms as of 5/18 (Biaxin, Medrol, Probiotic, Pepcid, Xyzal, Allegra, Benadryl). I was prescribed a Prednisone taper along with Zyrtec from Urgent Care on May 12, but my symptoms did not improve until starting the allergist's plan on 5/15.

Swollen Painful Lymph nodes in L armpit; Swollen Painful Lymph nodes in L armpit; This is a spontaneous report received from a contactable other hcp (patient). A 25-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL3247), via an unspecified route of administration, administered in left arm on 28Jan2021 (at the age of 25-year-old) as a single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included ethinylestradiol, ferrous fumarate, norethisterone acetate (JUNEL FE). The patient had allergy towards Promethazine HCL. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL3246), via an unspecified route of administration, administered in left arm on 09Jan2021 as a single dose for COVID-19 immunization. On 11Feb2021, the patient experienced swollen painful lymph nodes in L armpit. No treatment was received for the event. The patient was not diagnosed with COVID-19, prior to the vaccination. The patient had not been tested for COVID-19 since the vaccination. The outcome of the event was reported as recovering. Follow-up attempts are completed. No further information is expected.

Enlarged lower cervical node (3cm) and supraclavicular node (2.5cm) on left side. First noted 04/14/2021. Ultrasound guided biopsy of lower cervical node (FNA and core) came back benign. Performed: 05/07/2021 Both nodes less than 1 cm as of 05/12/2021

2 days after the vaccine the side effects were swelling, rash, headache, numbness in face and legs, chills after approximately 5 days had numbness in face and swelling and yesterday I had symptoms appear like shortness of breath, throat sensation, chest and stomach bloating

Two days following vaccination, on May 1 2021, the patient experienced fatigue, headache, and swollen lymph nodes in the armpits. This lasted until May 10 2021. The patient notified the pharmacist today at the time of her second dose of the side effects experience with her first dose.

lymph node swelling in armpit of injected arm; Arm soreness; headache; body exhaustion; chills; hot flashes; muscle aches; This is a spontaneous report from a contactable consumer (patient). A 25-year-old (non-pregnant) female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL3247), dose 2 via an unspecified route of administration, administered in arm left on 23Feb2021 at 08:00 as 2nd dose, single for COVID-19 immunization. The patient did not had medical history and no known allergies. The patient's concomitant medications included IUD contraceptive received in two weeks. The patient did not receive other vaccine in four weeks. The patient did not had COVID prior to vaccination and was not tested for COVID post vaccination. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL3247), dose 1 via an unspecified route of administration, administered in arm left on 04Feb2021 at 08:30 for COVID-19 immunization. On 23Feb2021, the patient experienced lymph node swelling in armpit of injected arm, arm soreness, headache, body exhaustion, chills, hot flashes and muscle aches. The patient did not receive treatment for the adverse events. The outcome of the events was recovering. Follow-up attempts completed. No further information expected.

food poisoning; swollen lymph nodes in her neck; mild nausea; fever; stomach ache; sore throat; This is a spontaneous report from a contactable consumer (patient reported herself). The report was not related to a study or programme. A 25-years-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration, in left arm, on 08Apr2021 at 3:30PM (at the age of 25-years-old), as single dose for covid-19 immunisation. The patient had no medical history, and no concomitant medications were received. No vaccinations were received by the patient within 4 weeks prior to the first administration date of the suspect vaccine. There were no adverse events following prior vaccinations. No history of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). On an unspecified date, 2 weeks after the vaccination (08Apr2021), she got food poisoning. When she had the food poisoning, she had a stomachache and fever. she was also a little bit nauseous. It was reported that as per the patient thinking the food poisoning was not due to the Covid 19 vaccine. On an unspecified date, 3 weeks after the vaccination (08Apr2021), she got swollen lymph nodes in her neck and had a fever and sore throat. On an unspecified date, at the doctor office, she had blood work and an ultrasound of her neck where her lymph nodes were swollen, and for both the results were unspecified. The patient visited physician office, where she was seen by a doctor, who prescribed Penicillin VK 500mg one tablet two times daily for the swollen lymph nodes in her neck and her sore throat. It was a pharmacy bottle. NDC/Lot/Expiry not known. The patient did not visit any emergency room. She has not felt fully recovered until now. The outcome of the events was unknown. The patient wanted to know about the timing of the second dose as it has been 6 weeks since the first dose of the Covid 19 vaccine. Information on Lot/Batch number was available. Additional information has been requested.

All of the below occurred after Pfizer shot #2 administered on 4/1/2021. Pfizer shot #1 was administered on 3/12/2021 with minimal effects lasting less than 24 hours (arm soreness, flu-like symptoms, etc.). 1) Severe worsening of costochondritis (chronic chest pain) to the point of breathing difficulty and inability to lie down. Began 4/1/2021 and became unbearable the evening of 4/7/2021, requiring an ER trip the same night (see Item 19). This pain has since continued to come and go, worse than I ever had it before the vaccine. 2) Very severe worsening of tinnitus (ringing/pulsing in ears) - lasted 1.5 months, from 4/1/2021 to around 5/15/2021. 3) Severe hormone imbalance symptoms (waves of severe nausea occurring several times daily, extremely late and painful/heavy period, swelling in ankles & feet, etc.) for ~1.5 months, from late April 2021 to around 5/15/2021. I cannot identify any other changes or life factors besides the vaccine that would have caused these issues.

After my first dose on 4/13, my left ring finger, middle finger and pinky became wrinkly looking at all times, like I had been sitting in the bath. After my second dose on 5/4, the fingers became red at all times and slowly became numb. I experienced some pain and swelling in the fingers and on the inside of my elbow before it went numb. Three weeks after my second dose, my right thumb and index finger also became swollen, wrinkly, then numb.

She had facial swelling/face is still swollen; chills; normal body aches; sweating; This is a spontaneous report from Pfizer. A contactable consumer (patient's mother) reported for a female patient (daughter). A 25-years-old female patient received an unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration Date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unknown date (age at vaccination was 25 years) as UNKNOWN, SINGLE DOSE for COVID-19 immunisation. Medical history included very allergic, anaphylactic reactions to food, eczema and other allergies. Concomitant medications were not reported. The caller was online looking for a hotline for side effects from the COVID vaccine. Her daughter had a side effect from vaccine. She had facial swelling, body aches and sweating. She was concerned about her. She wanted to know if she should get the 2nd vaccine. The consumer stated that her daughter had the Pfizer COVID 19 vaccine in (State name withheld), she was a teacher and that is why she got it at 25 years old, and she was very concerned because her daughter was very allergic, her daughter had anaphylactic reactions to food, and had eczema and other allergies and she was very reactive. The daughter got the vaccine and the only thing she got other than the normal body aches and chills was facial swelling. The facial swelling had lasted three days and her face was still swollen. Added her daughter took two Benadryl and it didn't really help. No further information provided. Caller was driving and speaking over agent and unhappy because she waited 20 minutes and was transferred from another Pfizer line. Unable to confirm details with caller as she stated her daughter already reported on the ap and she did not want to report she just wanted to be transferred to medical information. She thought she was being transferred to medical information. She wanted to speak to medical information about her daughter's facial swelling. Patient was daughter of reporter, no date of birth, no height, no weight, no ethnicity. Reporter was mother of patient; no email Primary/Prescriber: not provided Product: Pfizer COVID 19 vaccine, treatment just got it, no NDC, lot or expiration date provided as caller declined to report. The description of product complaint included consumer reported an AE for Pfizer COVID 19 vaccine and mentioned the facial swelling had lasted three days and her face was still swollen. Added her daughter took two Benadryl and it didn't really help. No further information provided. Product strength and count size dispensed was not provided. Additional lot numbers were not provided. Whether a sample of the product was available to be returned, if requested was not provided. Packaging sealed and intact was not provided. The outcome of the event facial swelling was not resolved. The outcome of the other events was unknown. Information on Lot /Batch Number has been requested. Follow-up (29Jan2021): New information received from a contactable consumer (patient's mother) reported for a patient (daughter) included: Added the patient's age, medical history, treatment medications, clinical course and description of product complaint. Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.

5/28/21 12:00 pm: queasiness, nausea, vomiting, fever, chills. Pain and soreness in left neck and left arm. Pain and soreness in left inner thigh. 5/29/21 9:00 am: fever, swelling of left side lymph nodes including ones on the face, neck, arm, armpit area. Pain and soreness in left inner thigh. More than usual pain and soreness in left neck and left arm. 5/30/21 10:00 am: Extreme swelling of left side lymph nodes. Lymph nodes in the armpit tender to touch, painful to move left arm. Neck swollen and extremely painful on the left side. Pain and soreness in left inner thigh. 5/31/21: Lymph nodes still extremely painful and swollen from left side of face, neck, and down to armpit. Pain and soreness in left inner thigh. 6/1-6/3/21: Side effects as described above continue to persist. 6/4/21: Left breast is swollen and double the size compared to right breast. Extremely tender and painful to touch. Right breast is minimally sore. Lymph nodes still tender, painful and swollen from left side of face, neck, and down to armpit. Pain and soreness in left inner thigh. 6/5-6/7/21: Left breast is still swollen and larger than usual. Extremely tender and painful to touch. Lymph nodes still remain swollen, but not as painful and tender. Left thigh pain still persists. 6/8/21 11:30pm: Lymph nodes in armpit area begin to get very painful again. Tender and painful to the touch, swelling. Painful to sleep on left side, painful to move left arm. Left breast is still swollen, larger than usual and tender. Right breast is completely normal. Left thigh pain still persists. 6/9/21 11:50am: Lymph nodes in neck are swollen and very painful again, lymph nodes in armpit area are painful and tender. Hurts to move left arm. Tightness in upper left arm area. Left breast is still swollen and sore. Left thigh pain still persists.

Swollen, painful lymph in armpit region in the same arm shot was received.; Swollen, painful lymph in armpit region in the same arm shot was received.; This is a spontaneous report from a contactable Consumer. A 25-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 09Mar2021 15:00 (Batch/Lot Number: EN6206) (at the age of 25) as single dose for covid-19 immunisation. Medical history included hypothyroidism. No known allergies. First dose was administered on 16Feb2021 15:00 right arm (lot# EL8982). Concomitant medications included levothyroxine taken for an unspecified indication, bupropion hydrochloride (WELLBUTRIN) taken for an unspecified indication, sertraline taken for an unspecified indication. The patient experienced swollen, painful lymph in armpit region in the same arm shot was received on 11Mar2021. No covid tested post vaccination. No covid prior vaccination. No treatment received. The outcome was recovering. No follow-up attempts are possible. No further information is expected.

Nausea beginning roughly five hours after injection which lasted about 6 hours - no medication taken to cease. Headache beginning roughly two hours after injection - Advil taken (two OTC tablets). The headache persisted roughly 24 hours from onset. Painful arm at site of injection began roughly 10 hours after shot and lasted about 48 hours. Swollen and painful lymph nodes under both right and left armpits started two days after injection (6/10 in the evening) and lasted until 6/13 in the evening.

Client states that as the day progressed after her vaccination, she began to swell...hands, face, legs. States "I looked like I had gained 30 lb. " She called and notified her MD and was advised to not take anymore COVID vaccine. She was not seen by a MD for evaluation. States swelling resolved by evening of 5/27/2021 and has had no more problems.

Swollen lymphnodes in left armpit, neck, shoulder, 102.4 fever for a week & continuing, soreness in eyes, vomiting, dehydration

body aches migraines frequently inflammation in chest and rib cage shortness of breathe after minimal tasks such as dishes going up and down stairs started may 13th 2021 day after vaccine symptoms are frequent present day still

Numbness in feet and hands Restlessness/Ticks/Twitches of Body Motion Sickness with slight movements/vertigo Tunneling Vertigo/Feelings of Passing Out Extreme Nausea/Lack of Appetite Flushed Face Painful sinuses Insomnia Rapid Heartbeat Heart Palpitations Random Heart Rate Spikes Shortness of Breath Nausea/Rapid Heartbeat/Weakness after a meal Super Thirsty Feeling of disassociation from body/floating swollen back of neck, tender to the touch, at base of skull. Touching causes very bad nausea Burning sinuses Tingling teeth

Patient received 2nd dose of Pfizer COVID-19 vaccine on 6/16/21. She reported having myalgia, injection site pain, and some breathlessness following the dose. The following day, she noted sharp chest pain worse when she took a deep breath. She went to bed she woke up on 6/18 with worsening sharp chest pain worse with deep breath, worse with laying back and better with sitting up: 8/10 intensity without radiation. She did feel short of breath when having the pain. Patient's ESR was elevated at 30. hs-CRP was 69. Patient was given IV morphine and Toradol for symptomatic treatment. Troponins trended up with values of 0.029, 0.070, and 0.546ng/mL. Echocardiogram was performed, which showed normal pericardium and normal LV and RV size and function. Patient was discharged with prescriptions for colchicine and ibuprofen.

itchy rash; swelling on bottom half of face and jawline; Bubbly rash; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8727), via an unspecified route of administration in the left arm on 21Mar2021 at 11:45 (at the age of 25-year-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies to medications, food, or other product. The patient did not receive any other vaccination within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included KYLEENA IUD for an unknown indication from an unknown date. On 21Mar2021 at 23:00, the patient experienced bubbly, itchy rash and swelling on bottom half of face and jawline. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown if the patient received treatment for the reported events. The clinical outcome of the events bubbly, itchy rash and swelling on bottom half of face and jawline was unknown at the time of report. No follow-up attempts are needed. No further information is expected.

Yesterday my back started having the same problems; Arms hurt; My lips and eyes were swollen; Neck swelling; My lips and eyes were swollen; I got hives and rashes all over my face, arms and chest thighs; I got hives and rashes all over my face, arms and chest thighs; chills; My muscles were hurting so much; Fever; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient herself) reported that a 25-year-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 on 08Apr2021 as single dose for COVID-19 immunization. Patient medical history included She was allergic to clams and COVID-19. Concomitant medications were not reported. Lab data included as blood work on an unspecified date results reported as allergic to clams (seafood) and COVID-19 test on an unspecified date in Jan2021 with positive results. On 23Apr2021 she got hives and rashes all over face, arms and chest thighs. On 23Apr2021 at night she went to the ER. They gave her Benadryl and steroids to see what happens. They did not prescribed anything, got one Benadryl and one steroid. They told her to just to observe. The next day she was fine. On 24Apr2021 started to get the hives again. On 27Apr2021 it was reported as patient lips and eyes were swollen and she saw her doctor and had blood work to see if she was allergic to anything. She was allergic to clams (seafood) but nothing else. In Apr 2021 she experienced chills, fever it was normal but two weeks later she got all these rashes and hives. Her doctor gave me Benadryl for 10 days and steroid for 5 days. She was scheduled on 29Apr2021 for the 2nd dose. She did not get, doctor wanted me to wait until she was done with steroids. Two days ago, her steroids were done, hives were going away it was the 28th and 29th her arms hurt. On the 29th her back started the same thing (like my hands and arms). Her muscles were hurting so much, felt like poking me with needles. On 02May2021 back started having the same problems. She was COVID positive in Jan and got better from it. Caller asked if there was seafood in the vaccine. Response was received as shellfish, fish, seafood and emailed as requested. She had a side effect after the first dose of the vaccine. It was asked as should she get the second dose and response was she should not get the Pfizer-BioNTech COVID-19 Vaccine if she had a severe allergic reaction after a previous dose of the vaccine or if she had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. We refer you to speak to your healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. She had a bad reaction on the 23Apr had a swollen lips and neck. The outcome of events (Fever and chills) was recovered on an unspecified date in Apr2021 and unknown for other events. Information about batch/lot number has been requested.

So on the Saturday after my vaccine, I was having chest pains which were like shooting pains which was pretty strange. I was driving so I pulled over and had some water then continued on. I had dinner and it continued, these shooting pains in my chest. I called the paramedics and had them evaluate me. They hooked me up to an EKG machine and they were alarmed and they recommended I go with them to the ER. I don't really know why they were that alarmed, I didn't feel that bad. The paramedic was like I have been working in cardiac care for 15 years. They wouldn't even allow me to walk down my stairs, they put me in a wheelie thing and I got in the paramedic vehicle. They said I was having premature ventricular contractions. They tested my blood levels and all that stuff and I was not having any indication of a heart attack or anything. They sent me home the next day, on 4/4/2021.

Burning with fever, shivering, 101 degree fever, lyphnodes in arm, size of small mushroom, very uncomfortable , stiff arm, lypnodes in neck swollen, stiff neck, extremely pain, painful back (feels like sunburn), couldn't eat or drink for 3 days, threw up water. Symptoms lasted for 3 days. Back pain, swollen lympnodes, stiff arm and neck still ongoing. Doctor made a house call, prescribed tylonol and ibopropin. Ongoing fatique.

Muscle aches; Low grade fever (100.1 for 24 hours); Swollen lymph nodes; Chills; headache; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN8720), via an unspecified route of administration in the left arm on 24Mar2021 at 11:30 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis and migraines. The patient did not have any 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 been tested for COVID-19. Concomitant medications included hydroxychloroquine (MANUFACTURER UNKNOWN), vitamins (MANUFACTURER UNKNOWN), ethinylestradiol; ferrous fumarate; norethisterone acetate (LO LOESTRIN FE) and escitalopram oxalate (LEXAPRO), all for unknown indications from unknown dates. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6199), via an unspecified route of administration in the left arm on 03Mar2021 at 14:30 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 24Mar2021 at 18:00, the patient experienced muscle aches, low grade fever (100.1 for 24 hours), swollen lymph nodes, chills and headache. 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 09Mar2021 and 16Mar2021 which included Covid PCR test via nasal swab and the test result was negative. The patient did not receive any treatment for the events muscle aches, low grade fever (100.1 for 24 hours), swollen lymph nodes, chills and headache. The clinical outcomes of the events muscle aches, low grade fever (100.1 for 24 hours), swollen lymph nodes, chills and headache were recovering at the time of the report. No follow-up attempts are needed. No further information is expected.

Swollen lymph node (left axillary); severe fatigue; muscle weakness; This is a spontaneous report from a contactable other health care professional, the patient. A 25-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9264), via an unspecified route of administration in the left arm on 12Feb2021 (at the age of 25-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number:EN6206), via an unspecified route of administration in the left arm on 26Mar2021(at the age of 25-years-old); as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received amoxicillin (MANUFACTURER UNKNOWN) and metoclopramide (REGLAN); both on unknown dates for unspecified indications and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had tested for COVID-19. On an unspecified date in 2021, the patient experienced swollen lymph node (left axillary), severe fatigue and muscle weakness. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient underwent lab test and procedures which included COVID test (nasal swab) on 26Mar2021 and tested negative. The clinical outcome of the events swollen lymph node, severe fatigue and muscle weakness were recovering at the time of this report. No follow-up attempts are needed. No further information is expected.

PATIENT STATED THAT ABOUT 6 HOURS AFTER VACCINE SHE BEGAN TO HAVE BUMPS WHICH THEN TURNED INTO A RASH IN THE ARMS AND THE TORSO, AS WELL AS THE LEGS. THE RASH HAS SPREAD IN THE BODY AND THERE IS SWELLING IN THE BOTH HANDS PRESENT. PATIENT STATED HER RASH IS ITCHING

25 year old otherwise healthy female who presented with chest pain 1 week after her March 4, 2021 PFizer-BioNTech COVID-19 vaccine. Chest pain was initially constant and severe, alleviated with leaning forward, worsened with lying supine. She visited her local Emergency Department 4 times and has had 1 outpatient cardiologist visit. Labs, including troponin, ESR, CRP, EKG, echo and echo stress test were negative. Naproxen and colchicine started empirically which alleviated her pain. Patient's chest pain is still persisting daily 4 months later, although no longer constant. Chest pain now lasts few minutes at a time without clear trigger. Pt is not pregnant, no history of drug allergy, no medical history of other illness.

Immediately after getting the shot within 2 minutes I started feeling very flushed and very warm. I did not have difficulty breathing so they sent me home, I took my jacket off and I had a rash from my neck, across my collar bone, across my chest and my back. My neck felt super tight so I ended up going to urgent care they did blood work and they said it must have been a swollen lymph node. They sent me to the hospital and they did an ultrasound, and it came back as nonconclusive, I also had like the more traditional symptoms, head aches, stomach ache. By the time I had the ultrasound it had already been a month. the normal symptoms went away after the week, but the tightness in my neck persisted for the whole month. They did the ultrasound and blood work and the official diagnosis was a lymphatic reaction. I was really just having difficulty swallowing and laying flat. After urgent care and had the us I followed up with my PCP and she prescribed some steroids. It took about 2 months to fully settle back down and for the inflammation to go away. Because I had trouble swallowing solid foods I lost about 20 pounds.

Nausea; A weird pain; she will be fine but if anything touches her like clothes or the couch when she sits down everything burns, it irritates her skin; her neck is stiff; Sweating; Chills; Fever; she could not eat; her lymph nodes are still swollen now and it has been over a month, they got even bigger with the second dose; her lymph nodes are still swollen now and it has been over a month, they got even bigger with the second dose; This is a spontaneous report from a contactable consumer reported for herself. This is second out of 2 reports with second dose information. A 25-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EW0196; Expiration date was not reported), via an unspecified route of administration, administered in arm left on 02Jul2021 (at the age of 25-years-old) as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Investigation assessment, additional vaccines administered on same date of the Pfizer Suspect, prior vaccinations (within 4 weeks) included none. Family medical history included neoplasm malignant (cancer) from an unknown date and unknown if ongoing. The patient previously took Prevnar 13 for pneumonia (last vaccine patient got 6 months ago, they actually told her that this vaccine might have a chance of lesser mitigated side effects but that was not the case. Patient reported that last one was. She was in another country and there you can get Prevnar 13 at any age not as like 65 or 67 like it was here. Patient did not have NDC lot expiration for the Prevnar 13 she received. Adverse events following prior vaccinations included none and was surprised because she had never had reactions). Flu vaccine (patient stated she reacts badly to the flu vaccine. Patient did not have any NDC lot expiration for the flu vaccine she received, did not get the flu vaccine in 10 years because she reacted badly and did not get the flu in 10 years) and took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EW0217), via unspecified route in left arm on 11Jun2021 (at the age of 25-years-old) for COVID-19 immunisation and experienced arm hurt a little and had swollen lymph nodes. At 03Jul2021 06:00, the patient experienced nausea, a weird pain, she will be fine but if anything touches her like clothes or the couch when she sits down everything burns, it irritates her skin, her neck is stiff, sweating, chills, fever. On the same day, the patient also experienced she could not eat, her lymph nodes are still swollen now and it has been over a month, they got even bigger with the second dose on 03Jul2021. Patient was calling about the vaccine she was told to call here and basically report her effects. She clarified it was the Pfizer COVID 19 vaccine. She does not have mailing address or email. Patient said the first vaccine was fine, her arm hurt a little. Her mother got it at the same time same place, and she was fine but the caller's hurt a little bit, but her mother felt great. And again, after the second dose her mother felt perfect, she had not had a single side effect. Caller said for herself it was different, she was fine for the first 12 hours, she got the second dose at 6:30 PM on 02Jul2021 (Friday) at 6AM on 03Jul2021 (Saturday) she was burning with fever it started and got to around 101 degrees. She was sweating, and had chills and that was everything to be expected but what really confused her was her lymph nodes, she wasn't told at the pharmacy they could swell and suddenly she felt this one under her arm and had cancer in her family so she freaked out but then they told her it could be from the vaccine but basically it cause her lymph node to swell and it felt like there is an egg it was the size of a mushroom under her skin. She was 25 years old, and her neck is stiff, it had been a week and she could barely move her neck her back and just everything hurts. it is a weird pain, she will be fine but if anything touched her like clothes or the couch when she sat down everything burns, it irritated her skin. She couldn't eat, she was nauseous she threw up water. It was awful she drank a little water and threw it right up. All the events began the next day of vaccination, 03Jul2021 at 6 AM in the morning, 12 hours after the second dose. She clarifies the swollen lymph nodes began after the first vaccine, she got the first dose on 11Jun2021 and maybe on 13Jun2021 she was in the shower and felt the lump and freaked out and began calling doctors and they said she had just got the vaccine and it could be that but she is still going to have it checked out because there was triple negative in her family and her lymph nodes are still swollen now and it has been over a month, they got even bigger with the second dose. Patient mother was worried because she was trying to get the patient to eat something, but she couldn't eat, she just didn't expect that to be a side effect, everything felt disgusting with the nausea, it was not fun. They said a very low percentage have the swollen lymph nodes, so she wanted to report. Patient did not see expiration date or NDC number on vaccine card. They just have the date when administered. And did not have any dose information, it was injection to the left arm for both first and second dose. Indication was stated as to not get COVID. Grandmother, mother, aunt, and best friend of patient were all high risk, so patient wanted to be vaccinated. Vaccination time was reported as 6:30 or 7 PM. Patient asked there if was going to be a third shot right, like a booster, because she was dreading it since getting the second shot. Caller declined to be transferred for questions about potential booster dose of the vaccine and declined to be provided with phone number to medication information. On 03Jul2021, the patient underwent lab tests and procedures which included body temperature: 101 degrees. The clinical outcome of the events was unknown.

first dose: swollen lymph node; first dose: arm hurt a little; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 25-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection, Lot number: EW0217, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 11Jun2021 (age at vaccination was 25 years) as dose 1, single for COVID-19 immunization. The patient did not have any medical history. The patient had cancer in her family. The patient's concomitant medications were not reported. The patient previously took prevenar 13 for pneumonia (last vaccine she got 6 months ago they actually they told her that this vaccine might have a chance of lesser mitigated side effects but that was not the case. She said that last one was Prevnar 13 for pneumonia) and flu vaccine (she was surprised because she has never had reactions. She said actually she reacted badly to the flu vaccine. She has not gotten the flu vaccine in 10 years because she reacts badly and she has not gotten the flu in 10 years). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No additional vaccines were administered on same date of the Pfizer Suspect. The patient said that the first vaccine was fine, her arm hurt a little. The swollen lymph nodes began after the first vaccine, she got the first dose on 11Jun2021 and maybe on 13Jun2021 she was in the shower and felt the lump and freaked out and began calling doctors and they said she had just got the vaccine and it could be that but she was still going to have it checked out because there was triple negative in her family and her lymph nodes were still swollen now and it has been over a month, they got even bigger with the second dose. They said a very low percentage have the swollen lymph nodes so she wanted to report. The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection, Lot number: EW0196, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 02Jul2021 at 18:30 or 19:00 pm (age at vaccination was 25 years) as dose 2, single for COVID-19 immunization. No relevant tests were done. She asked whether there was going to be a third shot, like a booster. She said she just asked because she was dreading it since getting the second shot. The outcome of the event first dose: arm hurt a little was resolved on an unknown date in 2021. The outcome of the event first dose: swollen lymph node was not resolved.

On Thursday, 6/24/21, PT (DOB: 12/31/1995) received her first dose of Pfizer Covid-19 vaccine (LOT #: EW0217) at 10:16 am in her left deltoid. During assessment questions, client stated she has severe allergic reaction to penicillin and experiences anaphylaxis and was to be observed for 30 minutes. At approximately 10:21 am, while in Observation Area, client stated to EMTs she was experiencing facial flushing, slight swelling from the neck to right before her eyes, numbness and tingling in her throat, neck and face. She denied SOB but stated it was "difficult to catch her breath." Client sat in anti gravity chair and was given water that she drank. Vitals offered but were not taken for client. EMT offered oral Benadryl to which the client denied and stated she had Benadryl at home. After 20 minutes client stated to EMTs that her symptoms subsided and felt ok to return home. Client was educated by EMT on signs and symptoms of adverse reactions and when to go to the ED/call MD. Client was also encouraged to sign-up on v-safe. Client left vaccination site with a steady gait at approximately 11:15 am.

Vaccine was administered at around 6:30 PM. Patient was stable during vaccination and in the 15 minute observation period afterward. Patient left the facility and returned 10 minutes later presenting with redness and swelling of the face and complaints of difficulty breathing. Patient was sat down and 0.3mg of EpiPen was administered. Symptoms rapidly improved and patient was transported to a nearby medical facility via EMS.

103.9 fever; Muscle pain; Joint pain; Swollen lymph node in armpit; Stomach pain; Swollen lymph node in armpit that issharp pain and tender; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 02Apr2021 at 12:00(at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history included polycystic ovarian syndrome. Concomitant medications included metformin (MANUFACTURER UNKNOWN) and ethinylestradiol; norgestimate (ESTARYLLA) on an unknown date for an unknown indication. The patient previously received the 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. 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 received unspecified other vaccine within four weeks prior to the vaccination. On 02Apr2021 at 22:00, the patient experienced 103.9 fever, muscle pain, joint pain, swollen lymph node in armpit that is sharp pain and tender and stomach pain. The patient did not receive any treatment for the events. Adverse events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. On 02Apr2021 at 22:00, the patient underwent lab test procedures which included body temperature and the result was 103.9 (unspecified units). The clinical outcome of the events 103.9 fever, muscle pain, joint pain, swollen lymph node in armpit that is sharp pain and tender and stomach pain was resolving at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.