Pfizer

Started vomiting 2hrs after vaccination. Went to ER who initially obtained CBC with stable Hgb and sent home with Zofran. Patient continued to have bloody emesis so presented back to ER where they did CXR which was normal, gave IVF bolus, zofran, repeat CBC with Hgb 12.4 and transferred to another hospital for higher level of care. At the hospital, Initially made NPO and placed on IV fluids in preparation for possible endoscopy. Repeat labs showed stable hemoglobin compared to outside hospital. GI consulted and determined that hematemesis was most likely due to Mallory Weiss tear. Recommended carafate before meals, chloraseptic spray as needed for sore throat, continuing IV Protonix and IV zofran as needed, and gradually advancing her diet. On HD#3, she had another episode of hematemesis after eating solids. Overnight, tolerated liquids and solids without any further episodes of emesis. Tolerated transition from IV to PO meds and maintained hydration off of IV fluids. Due to symptom improvement, GI did not recommend endoscopy at this time and recommended that she be discharged on 1 week course of carafate, 2 month course of omperazole, and zofran as needed with plans for GI follow-up in 1-2 months. Had another episode of hematemesis at home after discharge. Went back to hospital and admitted again. The patient underwent upper endoscopy which showed no source of upper GI bleed. ENT was consulted and performed a nasopharyngolaryngoscopy which was negative for an ENT source of bleeding. She remained stable without an identifiable source of bleeding. Mom was comfortable with her being discharged home with close follow up by PCP. Pt seen on 6/7/21 at pediatrician's office for ER F/U. Pt reported she was still vomiting, 2x so far that day. The day before vomited 4x during the day and continued until the night. No more bright red blood in vomit. Describes vomit as blue and pink colors now. Pt does take a light green tablet that is her levothyroxine. Threw up the blue colored vomit immediately after taking this medication. Instructed to take zofran when feeling nauseous. Seen again by pediatrician on 6/10/21- Currently, per mom pt is still vomiting. Last time she vomited was last night. Pt is taking omeprazole. Pt vomited 5-6x yesterday. Decreased appetite, but has been eating some crackers and rice. Complaining of stomach pain after eating and vomiting. Pt used zofran once and it helped a little. Pt denies self induced vomiting. Pt has ben observed by family when vomiting and they do not report any self induced vomiting. Pt denies trying to lose weight. Pt never vomits up food, always liquid. Vomit is different colors, can be pink or blue. No more red color in vomit, only pink. Pt drinks water and gatorade. Pt denies feeling any burning before vomit, but feels burning sensation after vomiting. Pt has been having BMs, not regularly and hard. Taking one capful of miralax at night. Instructed for next five days, instructed to take zofran pill 1hr before dinner. F/U with GI. Seen again by pediatrician on 6/15/21- Per mom and pt she is still vomiting about 5-6 times a day. Pt went to GI yesterday, given lansoprazole 30mg qd and told to continue zofran.. Pt is now able to eat all her meals, takes zofran 1hr before dinner. Pt has vomited 1hr after dinner and has only vomited liquids. Hematemesis has resolved. Still has some blue colored vomit, most likely from levothyroxine medication she takes daily. Stopped taking Miralax 3 days ago. Pt had a soft BM earlier this morning. Pt states she has occasional stomach pains after vomiting, takes a while to calm down but then resolves. Described as lower abdominal. Pt has nausea before vomiting, after vomiting takes 15-30mins for nausea to resolve. Pt states she had a headache with a heavy sensation when vomiting. No headaches at night, but does vomit 3-4x overnight. LMP: 2wks ago. Recommended to go to ophthalmologist to r/o papilledema. WIll contact hospital to get results of any bloodwork done inpatient (reviewed - only CBC done inpt).. F/U in 1wk. Ordered MRI brain w/contrast. CMP. lipase, amylase, celiac disease panel. All results pending.

After the second dose she had immediate pain at the injection site and over the next 24 hours she developed: A fever of 101.4 severe abdominal pain and chest pain that made her feel like her heart was being pulled out painful electric shocks down her neck and spine that made her walk hunched over numbness and swelling in the arm she got the shot pain in her fingers and toes that turned white and were ice cold to the touch Over the next 2.5 months her abdominal, muscle and nerve pain became unbearable plus she developed new symptoms: Fatigue gastroparesis, nausea and vomiting Eventually she couldn?t even swallow food or liquids without immediately spitting it up. An itchy rash on her arms peeling skin on her feet Her menstrual cycle lasted a month with large clumps of blood She had unexplained painful cysts vision problems headaches erratic blood pressure and heart rate memory loss, mixing up words and brain fog Dizziness, fainting and then nonepileptic seizures that we suspect were from lyrica verbal and motor tics loss of feeling from the waist down, muscle weakness, abnormal gait and eventually she wasn?t able to walk at all urinary retention From the day she got her 2nd dose to today we took her to the ER nine (9) times and she was admitted to the hospital a total of 3 times totalling 2 months. The last time she was admitted to the hospital she could not walk, was unable to feel or move below her waist, threw up anything she tried to eat or drink, had tachycardia and her blood sugar was at 47. Once she got an NG tube and was stable they transferred her to Inpatient Rehabilitation and she was just discharged on June 1st. Today she is able to walk with a walker and take care of herself but she still has little to no feeling below her waist. She still has an NG tube for nutrition and continues to have GI and urinary retention problems.

6/12 - patient developed fever and cervical lymphadenopathy. Worsened gradually with difficulty swallowing. 6/16 - presented to ED. Patient also reported rash in right lower extremity that is pruritic, 2 episodes of non-bloody non-bilious emesis daily since Saturday, intermittent chest pain and dyspnea, myalgias, diarrhea, generalized abdominal pain, and neck pain. Concern for infectious mononucleosis with lymphadenitis. Prescribed Augmentin and discharged home. 6/17 - returned to ED due to worsening rash (no longer pruritic) and diarrhea. Continued fever and neck pain. Hypotensive requiring 3L bolus and norepi. Large volume diarrhea. Mild AKI that resolved with fluid resuscitation. Treated broadly with antibiotics for toxic shock syndrome but rash was not consistent and cultures were negative, so eventually narrowed to ampicillin-sulbactam. Neck pain and swelling improved, but fever persisted through 6/19. Transferred to the floor on 6/20 and gradually improved without further intervention. Antibiotics were continued to target possible tonsillitis/lymphadenitis, but course did not seem to be truly responding to these antibiotics. CRP continued to increase despite antibiotics. Patient's presentation seemed most consistent with MIS-C; she also met criteria for incomplete KD with fever, rash, cervical lymphadenopathy and lab abnormalities, but this was felt less likely and she was not treated with IVIG or any other anti-inflammatories. Patient eventually improved and was discharged home 6/24.

Fever onset day after second vaccine dose, associated with gross hematuria, proteinuria and rhabdomyolysis (metabolic crisis due to Very long chain acyl carnitine dehydrogenase deficiency VLCAD). Admitted to the Hospital on 6/12 with hypertension and elevated creatinine. Renal biopsy c/w IgA nephropathy. She was discharged on 6/23 on prednisone 60 mg daily with plan for slow taper. Acute kidney injury, proteinuria, rhabdomyolysis and hypertension improved at discharge. She had 2 additional admissions for elevated CK on 6/29 and 7/6. CK improved with IV hydration and glucose, and both admissions were <48 hours. Of note, patient had transient episode of gross hematuria in 1/21. Creatinine normal, BP normal. Proteinuria and hematuria resolved spontaneously on repeat testing of urine 3 weeks later. Also of note, patient had multiple episodes of rhabdomyolysis as young child due to VLCAD, with most recent episode in 2016. Trigger was viral illness or fasting. Previous episodes had higher max CK >20,000, no prior history of acute kidney injury during these episodes.

patient presented with vaginal pain and dysuria within one week of receiving second Covid vaccine dose. Vaginal ulcerations (Lipschutz ulcers) noted on exam. Required treatment with topical lidocaine and steroid due to pain.

Lipschultz Ulcer in vaginal area. Extremely painful to urniate. Extreme pain and buring. Treated with Clobetasol ointment & Lidocane jelly for pain. 10 days to heal.

Patient received second dose of Pfizer vaccine on 6/10/21. 12 hours after administration she developed fever (Tmax 103F), chills, myalgia. On 6/13/2021, she developed vaginal mucositis prompting hospital admission for evaluation and pain management. She was originally discharged with supportive care (Tylenol/ Motrin for pain) and if needed triamcinolone 0.1% cream. Per chart check, she was seen by PCP six days later and had not yet started triamcinolone cream and still in pain. PCP prescribed topical clobetasol, and oral prednisone 20mg BID for 5 days based on dermatology recommendations for treatment of Lipshutz ulcers.

She woke up in pain around 6am thinking maybe she had scratched her Labia major. She went back to bed. Throughout the day the pain and discomfort grew. Around 5pm she told me that she was hurting a lot and she needed help. I examined her and it looked like a bruise about the size of a dime but long. I asked if she fell or hurt herself, no. I called the pediatrician and informed them and they suggested seeing them the following day. Took her to the ER later that night due to significant pain. They thought she might have yeast infection or herpes. Gave her some antibiotics and sent her home her pain level was a 7 and she now looked like she chemical burn. The next day I took her to pediatrician. She felt like it could be herpes or something else. Prescribed different meds and sent us home. Nothing for pain. The antibiotics worked a little, but by Monday everything was horrible. She was covered in sores from the labia major to her vulva. Took her to ER where they felt like it was herpes. She was asked about her sexual experience or being molested. They immediately admitted her to the hospital where we stayed for 4 days. With antibiotics, steroids and pain meds. She saw her Gynecologist Tuesday morning where she determined PT was suffering from aphthous ulcers, a side effect that she was aware of from the covid19 vaccine.

Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Shakiness-Severe, Systemic: Visual Changes/Disturbances-Severe, Additional Details: Vaccination was administered, within 10 min patient became unresponsive and appeared to lose conciousness. upon immediate assessment no signs of anaphylaxis were present, 911 was called. pt felt very warm to the touch and lost control of bladder. mother mentioned pt had passed out 7/14 at home but no prior history of any events. no reaction to any previous vaccines. paramedics arrived and took over pt was released under care of mother with suspision of dehydration

Generalized rash, weakness, swollen lymph nodes, general malaise, fever, chills, one episode of diarrhea and vomiting and headache.

Patient temporarily lost consciousness twice becoming incontinent after the second episode. Patient complained of lightheadedness, dry mouth and was pale throughout. EMT arrived and administered an IV ultimately transporting the patient to the hospital as they remained weak and unable to maintain balance.

Pt. sitting with mother and sister in observation area. Mother signed for assistance. Pt reported feeling hot and having blurred vision. Able to state name throughout event. Pupils dilated, skin hot. Pt instructed to remove mask and breath deeply, cool pack applied to back of neck. After several minutes patient reported vision retuning to normal. Patient incontinent during episode. Pt transferred to private room. Water, peanuts, and fruit snacks provided. Sister very tearful and anxious. Water and snacks provided. Family remained 30 minutes. Verbalized feeling okay, reported slight headache. Mother made appointment for patient to see pcp today, family left clinic.

3 days of severe abdominal and pelvic pain that was debilitating. Patient was hardly able to walk - she had extreme pain with urination and defecation. She also had headache, fatigue, arm pain, fever and rash - hives, with pruritus of scalp.

Patient is a 15 yo female with a history of anxiety, recent ankle sprain, and no other known medical history who presents to ED today after she developed persistent shaking movements after her COVID 19 vaccination today. Medical work up has been thorough and has resulted negatively, including blood work, UDS, CT Head. She has remained slightly tachycardic, though she has also been moving continuously for several hours. Her physical exam is notable for several indicators of psychogenic origin, including demonstrating variability in tremor frequency (head, legs and arms vacillating it variable rates over time), distractability from motor tasks (head or arms stop shaking when asked to focus on moving her legs, for example). Her speech has also been affected, but this is also variable and she is at times using only 1 word sentences and other times responding more completely. Certainly she may have suffered a psychological stress today as she is fearful of needles and has a history of vasovagal response and her mother notes recent overwhelm with school performance, though this is not unusual for her. If medical work up continues to be negative, it may be reasonable to conclude she is suffering a conversion disorder "FINAL DIAGNOSIS: Conversion reaction after a Covid 19 vaccine. Patient To be transferred via ground ambulance."

Fever the following morning. Then, 38 hours after shot: abdominal cramping, rapid heart beat, dizziness while laying in bed. Then, upon standing, passing out with loss of bowels and bladder and a tonic response.

PT LOST CONSCIOUSNESS 5 MINUTES AFTER VACCINE, SLOW HEART RATE, CLAMMY SKIN, NAUSEA, UNCONTROLLED BLADDER RELEASE. PT REGAINED CONSCIOUSNESS AFTER 30 SECONDS AND AMBULANCE WAS CALLED. BP NORMAL AND PT RECOVERED AFTER ABOUT 20MINUTES AND WAS ABLE TO WALK ON HER OWN.

Painful vaginal ulcerations (Lipschutz ulcers) which began 2 days after second Covid vaccine. Had fever and fatigue 24 hours after receiving vaccine which resolved then developed vaginal ulcerations. Ulcerations very painful. Presented with pain and dysuria. Was treated with Ibuprofen and topical lidocaine

severe aches and pains in muscles and joints; severe aches and pains in muscles and joints; it hurt to pee; in tears from the pain; throwing up; This is a spontaneous report from a contactable consumer (patient). A 15-year-old non pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0168, Expiration date: Unknown), via an unspecified route of administration, administered in right arm on 25Jun2021 at 10:00 (at the age of 15-year-old) as a single dose for covid-19 immunisation at Center. The patient had no medical history and no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included Colecalciferol (VITAMIN D), birth control and anti-depressant medications received within 2 weeks of vaccination. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8736, Expiration date: Unknown), via an unspecified route of administration, administered in right arm on 04Jun2021 at 10:00 (at the age of 15-year-old) as a single dose for covid-19 immunisation. The patient was fine at first from the day of vaccination, on 30Jun2021 at 07:00, (after 5 days of vaccination) she started having severe aches and pains in muscles and joints. No one could touch her. She thought it was the vaccine and then she mentioned that it hurt to pee. Patient was taken to urgent care to rule out UTI infections, which they did and then referred her to the E.R (emergency room) because no one could touch her. She was in tears from the pain, and she was also throwing up. Patient received pain medications through an IV (intravenous) and anti-nausea medication as a treatment. The events resulted in emergency room/department or urgent care. The reporter assessed the events as non serious. The outcome of the events was not recovered. Follow up needed, further information has been requested.