Pfizer

Cardiovascular symptom reports

Female, 60 - 75 years

Age Reported Symptoms Notes
60 2020-12-31 hypertension I received the COVID-19 Vaccination in 12-29-2020. As time went on, I felt a little flushed , Ligh... Read more
I received the COVID-19 Vaccination in 12-29-2020. As time went on, I felt a little flushed , Lightheaded , some dizziness that night. Forced the water intake. 12-30-2020, went to work, as the day went on the rash on my face and neck into upper chest increased and Hypertension. I went to the ER Dept at Hospital. IV Fluids and IV Benadryl and oral Prednisone and Prednisone to be taken at home. Face and neck rash goes away and comes back as of Jan 1 2021.
60 2021-01-01 chest pain Within 5 minutes of the vaccine, patient had wheezing, shortness of breath and chest pain. patient g... Read more
Within 5 minutes of the vaccine, patient had wheezing, shortness of breath and chest pain. patient given epi x 4, decadron, fluids with some improvement and then hospitalized. IN the hospital, patient continued to have chest pain and satting well but with protracted course and is still in the hospital.
60 2021-01-04 pallor Employee received the vaccine around 1130. She was monitored for a least 30 minutes due to her hist... Read more
Employee received the vaccine around 1130. She was monitored for a least 30 minutes due to her history of CA and Immunosupressed state. She went back to her office post monitoring. Around 1535, one of her employees called reporting that she didn't look good and was acting weird - pale; stumbling; slurred speech. The coworker brought employee to the immunization clinic in private vehicle. Dr. along with the CNE and another RN went to the vehicle to asses. It was noted that employee did have slurred/slow speech; droopiness to face. She reported that she started to not feel well while in her office. V/S: B/P 141/102; pulse 108; O2 sat 96% on RA; skin pale. She stated that she felt "loopy". Employees husband was called and her co-worker was instructed to take the employee to the ER where her husband would meet them. At 1540, employee was taken to ER for evaluation.
60 2021-01-04 palpitations Palpitations; Weakness; sore throat; Burning sensation and the soreness in tongue; Burning sensation... Read more
Palpitations; Weakness; sore throat; Burning sensation and the soreness in tongue; Burning sensation and the soreness in tongue; vomiting severely 5 times; could not eat and breathe; could not eat and breathe; abdomen was upset; cramps and pain; cramps and pain; diarrhea; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received the receive bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EK5730), via an unspecified route of administration on 21Dec2020 at 60-years-old at a single dose for COVID-19 immunization. Medical history included high cholesterol from an unknown date and unknown if ongoing. Concomitant medications included rosuvastatin calcium (CRESTOR) taken for high cholesterol from an unspecified date to an unspecified date. The patient experienced the following events and outcomes: palpitations (non-serious) on 22Dec2020 with outcome of unknown , weakness (non-serious) on 22Dec2020 with outcome of unknown, sore throat (non-serious) on 22Dec2020 with outcome of unknown, burning sensation and the soreness in tongue (non-serious) on 22Dec2020 with outcome of unknown, vomiting severely 5 times (non-serious) in Dec2020 with outcome of unknown, could not eat and breathe (non-serious) in Dec2020 with outcome of unknown, abdomen was upset (non-serious) in Dec2020 with outcome of unknown, cramps and pain (non-serious) in Dec2020 with outcome of unknown, diarrhea (non-serious) in Dec2020 with outcome of unknown. The nurse stated she received the COVID vaccine on 21Dec2020. The nurse stated she did not have any adverse reaction immediately on the first day but on the second day, after 24 hours, she started to have "little bit palpitations that too for a short period of time and a little bit weakness for a short period of time and sore throat. It is not just soring or swelling but it is burning sensation and, on my tongue, also I feel the same thing, burning sensation and the soreness. That was for a small period of time but on my tongue, it is still there, and my throat is still there and last night I experienced vomiting severely 5 times. After the vomiting, I could not eat and breathe." Then, the nurse slept about 3-5 hours, and woke up and her abdomen was upset. The nurse had cramps and pain and when she went to the bathroom and she had huge diarrhea, 2 times."
60 2021-01-05 blood pressure increased dizzy; fever; elevated blood pressure; flushed feeling day of vaccine. The next day she continued to... Read more
dizzy; fever; elevated blood pressure; flushed feeling day of vaccine. The next day she continued to feel flushed; This is a spontaneous report from a contactable pharmacist. This pharmacist reported for a 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular route on 29Dec2020 15:00 at single dose for COVID-19 immunization. Medical history included COVID-19, hypertension and depression. Concomitant medications included vitamins received within 2 weeks of vaccination. The patient previously took duloxetine and experienced allergies. Facility that the most recent COVID-19 vaccine was administered in Workplace clinic. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 29Dec2020, the patient was dizzy, had fever, elevated blood pressure, and flushed feeling day of vaccine. The next day she continued to feel flushed that moved through her face and down her neck. It felt like she was on fire. The adverse events resulted in the following: Emergency room/department or urgent care. Outcome of the event feel flushed was recovered on 30Dec2020, outcome of other events was recovered in Dec2020. Treatment received for the adverse events included IV fluids, prednisone, diphenhydramine hydrochloride (BENADRYL). Events were reported as non-serious. Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the events dizzy, fever, elevated blood pressure and flushed feeing 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.
60 2021-01-05 heart rate increased INJECTION SITE REDNESS, NAUSEA, FEELING UNWELL, HEADACHE, FAST HEART BEAT, SLIGHT ITCHING, DIZZINES... Read more
INJECTION SITE REDNESS, NAUSEA, FEELING UNWELL, HEADACHE, FAST HEART BEAT, SLIGHT ITCHING, DIZZINESS, TIREDNESS, MUSCLE PAIN, CHILLS ALL BY 13:30PM AND LASTED FROM 1.04.21 AND CURRENTLY ON 1.06.21 STILL TIRED, DIZZY, HEADACHE, CHILLS AND ITCHY BUT IS BETTER THAN ON 1.04.21.
60 2021-01-05 hypertension hypertension, dizziness - occurred ~15 minutes after her first dose; first BP was 166/81, second dos... Read more
hypertension, dizziness - occurred ~15 minutes after her first dose; first BP was 166/81, second dose was 158/84; Taken to ED; outcome unknown
60 2021-01-06 heart rate increased Received 2nd dose at 10:30 am at Hospital. I went to work as usual at 1:45 pm though 10:00 pm. wit... Read more
Received 2nd dose at 10:30 am at Hospital. I went to work as usual at 1:45 pm though 10:00 pm. without any issues. Came home, had 2 glasses of wine, as usual, at 1:00 a.m. feeling body aches and headache continued sleeping, woke up at 9:00 a.m. with dry heaves with phlegm with small streaks of blood, rapid heart rate, fatigue with body aches, pain in location of injection, occasional headache, loss of appetite. The body aches, fatigue continued the following day, appetite returned slightly. Thankful these were my scheduled days off from work. Third day after injection body aches dissipating able to go out of the house to do errands.
60 2021-01-06 fast heart rate 1/6/21 - 3pm. Experiencing chills, headache, heart rate at 103/min sitting. - 10:06... Read more
1/6/21 - 3pm. Experiencing chills, headache, heart rate at 103/min sitting. - 10:06 pm, chills, headache, fever 99.6 - 10:38 pm, chills headache, fever 100.1 - 11:05pm, chills headache, fever 101.5 -
60 2021-01-07 blood glucose increased Facial flushing, different sensation to head and ears, anxiety, unable to think. Pt. evaluated by MD... Read more
Facial flushing, different sensation to head and ears, anxiety, unable to think. Pt. evaluated by MD, Benadryl 50mg IM administered with 1 hour in clinic observation. Pt. with improved breathing and relaxation, vitals stable.
60 2021-01-07 chest pain Chest pain Abdominal pain Fever, severe chills, diaphoresis Seizure like activity for two night
60 2021-01-07 hypertension, heart rate increased When got shot my heart rate went up right away. Felt faint. Doctor took blood pressure and was ver... Read more
When got shot my heart rate went up right away. Felt faint. Doctor took blood pressure and was very high. Had me lay down and took blood pressure several more times until it went back down to normal. Took about 20 minutes.
60 2021-01-10 chest pain She experienced head ache, neck pain, sinus pain, weakness, aches, very short of breath on exertion ... Read more
She experienced head ache, neck pain, sinus pain, weakness, aches, very short of breath on exertion and when wearing a mask. Aching in left arm, in chest and in right arm pit. Very dry eyes and bloodshot. Sweating and very warm. Temperature 1-11-21 96.2°F
60 2021-01-10 chest pain Muscle and joint weakness with chest muscle pain x 5 days hurts all over and worse when gets up and ... Read more
Muscle and joint weakness with chest muscle pain x 5 days hurts all over and worse when gets up and moves. Diarrhea started 1-5-2021. No fever 97.7. Off work for 4 days. Using heating pad and inhalers. Has appointment with provider 1-5-2021 and 1-7-2021. Test for COVID on 1-7-2021 and negative Symptoms resolved 1-9-2021 and returned to work on 1-11-2021
60 2021-01-10 transient ischaemic attack Pfizer-BioNTech COVID-19 Vaccine EUA: Soon after receiving vaccination patient became tired and expe... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: Soon after receiving vaccination patient became tired and experienced a headache. The next day at 2:15pm the patient reported a temperature of 99.0 degrees Fahrenheit, not being as tired, but starting at 9:30 am that morning experiencing "tongue being tied" and having difficulty communicating described as "know what they want to say but it... doesn't come out" that lasted three hours. The patient denied problems walking or being confused. The patient was immediately referred to the emergency department for evaluation. Upon arrival to the emergency department patient had clear speech speaking in complete sentences and ambulating independently with a steady gait. Physical and neurological exams both normal: no aphasia and no focal neurological deficits, normal strength and sensation throughout. Initial vital signs within normal ranges except blood pressure 149/88 mmHg. Patient remained asymptomatic and stable throughout emergency department stay. Repeat vital signs were within normal ranges and patient was discharged to home with a diagnosis of transient ischemic attack. On follow-up visit with primary care physician four days after vaccination patient reports feeling much better and no new symptoms reported.
60 2021-01-11 heart rate increased, blood pressure increased Discomfort in throat caused coughing which then led to Bronchospasm. Patient used own Albuterol Inh... Read more
Discomfort in throat caused coughing which then led to Bronchospasm. Patient used own Albuterol Inhaler for 3-4 inhalations. Given Epinephrine, Benadryl, Solu-Medrol IM injections administered. 2L O2 via NC applied. Elevated BP and HR noted. Patient transported to ER. Duo-Neb nebulizer treatment provided. Bronchospasm and Wheezing subsided after approximately 45 minutes. Patient discharged hone with Prednisone and EPI pen prescriptions.
60 2021-01-11 heart rate irregular, chest discomfort, cardiac arrhythmia Dizzy Clammy Heavy legs Frequent PVC on monitor Irregular heartbeats Headache Tightness in throat an... Read more
Dizzy Clammy Heavy legs Frequent PVC on monitor Irregular heartbeats Headache Tightness in throat and chest
60 2021-01-12 oxygen saturation decreased, chest discomfort, heart rate increased Approximately 5 minutes after receiving vaccine, patient started feeling chest tightness and increas... Read more
Approximately 5 minutes after receiving vaccine, patient started feeling chest tightness and increased heart rate and decreased oxygen. She was give 75 mg of Benadryl, and it did not help. 1 Epipen was administered and symptoms improved, but they began to return and a second epipen was administered approximately 30 minutes after the first epipen. EMS was already on site at that point and patient was taken in ambulance to hospital.
60 2021-01-13 palpitations Employee states she felt dizzy, lightheaded, palpitations and like her blood pressure was elevated.... Read more
Employee states she felt dizzy, lightheaded, palpitations and like her blood pressure was elevated. Vitals signs WNL, monitored for 60 minutes.
60 2021-01-13 fainting Systemic: Fainting-Medium; symptoms lasted 0 days
60 2021-01-14 chest pain 1/13/21 had pain in R arm and employee woke up 1/14 with cramping, chest pain and feeling of heavine... Read more
1/13/21 had pain in R arm and employee woke up 1/14 with cramping, chest pain and feeling of heaviness from belly button down to the legs. Advised to go to the EC for evaluation. Update 1/15: Seen in ED and had EKG with inverted T wave. Still has heaviness in legs. Will get a referral to cardiology after speaking with PCP.
60 2021-01-14 nosebleed None stop Nose bleed in right nostril
60 2021-01-14 palpitations reported "weird" sensation in her body and "like a pulsing in my chest". 1337 - Patient reports wea... Read more
reported "weird" sensation in her body and "like a pulsing in my chest". 1337 - Patient reports weakness,
60 2021-01-16 pallor, fast heart rate, chest discomfort Initial symtom of warm flush (head to toe), followed by added symtoms over course of next 5-10 min: ... Read more
Initial symtom of warm flush (head to toe), followed by added symtoms over course of next 5-10 min: light headed, dizziness, pale, tachycardia, scratchy throat, heaviness in chest, tightness in throat, spike in blood pressure (initial 144/88, 168/96, 152/87, 146/84-final). Monitored symptoms 45 min to one hour. Temp 97.3. Symtoms lasted approx one hour, then began improving, with exception of light headedness and general malaise and fatigue for 4 hrs. Additional event at approx 10 hours post vaccine: excruciating upper arm pain (left shoulder to elbow), felt "down to the bone". Unable to move arm and very painful to touch. Took 600 mg ibuprofen. Severe pain lasted approximately 3-4 hours (unable to sleep). Then became moderate soreness at injection site x 8 hrs. Mild soreness x 12 hrs, no pain 36 hrs after vaccine. Continued fatigue and malaise for 3-4 days after vaccine.
60 2021-01-17 chest pain patient states that she had a reaction with the first vaccine but not until after she left the clini... Read more
patient states that she had a reaction with the first vaccine but not until after she left the clinic here. She states she had tingling in her lips and throat, she states she has already taken Benadryl 25mg prior to coming here today. Within 10 minutes of receiving vaccine she began with tingling of throat and lips, feeling woozy and ears itching. After speaking with healthcare worker the patient was given Benadryl 25mg IM. A medical alert was then called due to patient c/o chest pain. She was taken to the ER as a precaution.
60 2021-01-17 lightheadedness limping one side of foot; wanted to pass out; numbness to right side of face; every muscle in her bo... Read more
limping one side of foot; wanted to pass out; numbness to right side of face; every muscle in her body hurts; stomach is cramping; This is a spontaneous report from a contactable consumer. A 60-years-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0140) , via an unspecified route of administration on 04Jan2021 at the first single dose at Arm Left for covid-19 immunisation . Medical history reported as none. There were no concomitant medications. The patient experienced wanted to pass out, numbness to right side of face, every muscle in her body hurts, stomach is cramping on 08Jan2021, limping one side of foot on 11Jan2021. The outcome of event wanted to pass out was unknown; outcome of event numbness to right side of face, stomach is cramping, limping one side of foot was not recovered; outcome of event every muscle in her body hurts was recovering;
60 2021-01-18 palpitations, heart rate increased Systemic: Fever-Medium, Systemic: rapid heartbeat-Medium
60 2021-01-19 heart rate increased Dizziness, Nausea, clammy, shaky, trouble swallowing, throat closing, pulse racing . Treated at WS ... Read more
Dizziness, Nausea, clammy, shaky, trouble swallowing, throat closing, pulse racing . Treated at WS GSH ED Was given Benadryl, Prednisone and Pepcid orally Was discharged after 4 hours
60 2021-01-19 heart rate increased Within 5 minutes of getting injected, felt heat over entire body, from top of head to toes, heart ra... Read more
Within 5 minutes of getting injected, felt heat over entire body, from top of head to toes, heart rate increased. Nurses came over and took VS. BP 180/100, P128, Throat scratchy and hard to swallow. Monitored continuously and had epinephrine ready but didn't inject as about 10 minutes later symptoms started to subside. Stayed in hospital for longer period (unsure of exact time) and then went home. Over the next 2 days, felt listless, weak and no appetite.
60 2021-01-20 pallor, chest discomfort Received vaccine at 1:10pm. At 1:30pm, while in observation lot,patient complained of chest pressur... Read more
Received vaccine at 1:10pm. At 1:30pm, while in observation lot,patient complained of chest pressure 8/10 and appeared ashen and diaphoretic. Paramedics from the vaccine facility immediately responded to the patient. Patient stated these were the same symptoms she has had in the past when she has an allergic reaction, and stated she has reactions to 10 different "things". Patient carried an epi pen but stated she usually went to the ER and was treated there. On-site paramedics gave 0.5 mg IM to Left deltoid. Patient stated chest pressure went down to a 3/10, and she felt better. Ambulance arrived and patient was transported to Hospital.
60 2021-01-20 palpitations Heart palpatations, fatigue, light hededness
60 2021-01-20 lightheadedness, atrial fibrillation, heart rate abnormal Episode of atrial fibrillation documented by my husband, a physician. He could not find a pulse aft... Read more
Episode of atrial fibrillation documented by my husband, a physician. He could not find a pulse after I had 2 near syncopal episodes. He listened to my chest and heard the abnormal rhythm . By the time I arrived at the ER, I had converted into normal sinus rhythm. We are both physicians. I am currently being evaluated by my PCP.
60 2021-01-21 pallor Patient had stated she felt well. 1-2 minutes later she c/o feeling woozy and was uncertain if her r... Read more
Patient had stated she felt well. 1-2 minutes later she c/o feeling woozy and was uncertain if her right hand was pale. + tingling. Brought to be evaluated by EMT.
60 2021-01-21 fainting, hypotension Extreme fatigue day of and following week of vaccine. On 1/20/21 had episode of brain fog or complet... Read more
Extreme fatigue day of and following week of vaccine. On 1/20/21 had episode of brain fog or complete lapse in memory of event I talked to a person just the day before. (Never happened before) Today, 1/22/21 I was sitting at my desk talking to another person and fainted for no reason. (Never happened before). I came to and after short while felt better.. Left work to rest at home. Have not seen a doctor yet but worried about 2nd vaccine dose. The syncope episode concerns me.
60 2021-01-24 blood pressure increased Swollen lip within minutes of 2nd Covid 19 vaccination. Blood pressure elevated at 206/110, heart r... Read more
Swollen lip within minutes of 2nd Covid 19 vaccination. Blood pressure elevated at 206/110, heart rate 97, pulse 97.8. Gave patient 50mg of oral diphenhydramine and monitored vitals and symptoms post dose for approximately 1 hour and 45 minutes. 1/2 hour post vaccination dose BP=180/100. At 1 hour post injection BP was returning to patients normal BP 164.98, pulse 81, Lip swelling is reducing. Also took patients blood sugar to check 1 hour post vaccination , it was 120.
60 2021-01-24 heart rate increased, oxygen saturation decreased, chest discomfort Temperature 101.7; Back pain/pain in her back; Right upper jaw pain that felt like sinus; Heart rate... Read more
Temperature 101.7; Back pain/pain in her back; Right upper jaw pain that felt like sinus; Heart rate 130's; Oxygen Saturation dropping; Headache/head felt like it would explode; Ringing in the ears; Thighs are burning; calf pain/Calves were sore in back; Calves were sore in back and felt like DVT; Chest pressure; she sound like a hypochondriac; flu like symptoms; can barely walk; Nausea; Shivering; weak; felt miserable; dry hives; This is a spontaneous report from a contactable Nurse reporting for herself. A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Batch/lot number: EL1283, Expiry Date: 30Nov2021, intramuscularly into right deltoid on 11Jan2021 07:15 at single dose at the hospital for Precaution as frontline healthcare worker. Medical history included Wolff-Parkinson-White (WPW) syndrome from 2000, heart surgery in the past on unknown date, had surgery that was in 2000. Years of chest pain and PVC after that; allergic to Sulfa with hives: One time she mixed it up with a medication of her sons and took it by mistake and did not realize it and she did not have any reaction, she has not had in years. It was an injection and she doesn't have the name, lot or expiration. Family medical history included Mother was diabetic and sister was prediabetic and was 61. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (Lot E49899) on 18Dec2020 at 10:30 am injected in Right Deltoid for COVID-19 immunisation and experienced shivering; same body aches, she took TYLENOL; had major headache all night long, all over her head; It was a pressure headache; Someone gave her MOTRIN and within 3 hours she was totally fine. The patient stated she received the Pfizer COVID vaccine second dose on 11Jan2021 and has had problems since then. She has been miserable, took paracetamol (TYLENOL), headache, have ringing the ears, head was exploding, back aches, calf pain, temperature at 8 am 101.7 and 101.7 at 10:40 on 12Jan2021, feeling very weak, nausea, dry hives, Right upper jaw pain that felt like sinus, all in Jan2021. Her heart rate was in the 130's at 3:30-4:00 on 12Jan2021 and now down to 115-108. Her Oxygen saturation has been 91-95 %. She just had a miserable night (Jan2021). She had this pressure in her chest. Her heart rate was 130 and O2 was 93%. Her O2 saturation last night (on 11Jan2021) was 91-94%, mostly about 93%. Chest Pressure began around 3am on 12Jan2021. She called healthcare provider and was waiting to get advice from them if she needs an EKG. She was still having a little bit of mild pressure. She noticed that her oxygenation was 93% when this was happening. It went up to 95% for a second last night. Her heart rate was now between 112-115. When she walked, it went to 125-130. It started around 3:30-4:00 this morning (on 12Jan2021) and was mildly improved. she was feeling the chest pressure back pain had lesson, but had pain in the upper jaw, flu like symptoms on 12Jan2021. she said she could not get out of the bed right. She did have a heart surgery in the past, her legs were burring, and week. she said after the first dose she did had a reaction but took MOTRIN and went to work the next day. The patient wanted to know about the heart rate being high and ringing in the ears. She wanted to know if it was supposed to drop your saturation and increase your heart rate. Is she just behaving like the norm or should her O2 be much higher. Her first shot was not as bad as this reaction. There was no prescriber. The temperature just began now as she just took it. Oxygen Saturation dropping began when she woke up in middle of night around 3:30- 4:00. She used her pulse oximeter and noticed it then. It was associated with her ears ringing and her head felt like it would explode at 3:30 on 12Jan2021. She felt better with headache but still had it. She was so weak on 12Jan2021, she did not want to go anywhere. Her oxygenation had worsened to 93% on average. She had a headache last time but did not have ringing in her ears. She woke up about 3:30 with it. The headache now was all over head from front to back and comes and goes. Last time she went to work after receiving the first one and today (on 12Jan2021), there was no way she could go to work. She took TYLENOL when she got home because she was shivering and took more at 3:30 because she felt miserable because of her chest. She took 1 gram. Her headache did not go away. She got to sleep after she took the TYLENOL. Her back and jaw was bothering her. It felt like the flu. She had upper jaw pain and pain in her back. She didn't have a good back and just aches. After the first one, it took 10 hours for the shivering to start. This time it was very similar. The shivering started about 10 hours later, at 9pm on 11Jan2021. Back pain starting at 05:00 on 12Jan2021 was stated as being sharp on right side scapula and feel like the flu. It is to the right of spinal vertebrae. She thought she would go to bed and lie down. She has had back pain before. The jaw pain started around 05:00 on 12Jan2021. She felt it in her cheek. It was a little bit better. Nausea started at 11:00 pm on 11Jan2021 and got worse at 03:30 when she got up to go to the bathroom around midnight. She felt like she could vomit and felt better, but she couldn't. Her thighs were burning at 03:30 on 12Jan2020. It was persistent weak and burning. She can barely walk. The areas that have hurt like when you get the flu, she was having now in the same places, so she thought it was from the shot. Calves were sore in back and felt like a DVT (Deep vein thrombosis), started at 03:30 of 12Jan2021 and was still sore. She said she sound like a hypochondriac. It was in back of calf towards knee. She did not think it was a blood clot. It was feeling better. It was still sore but nothing like it was at 03:30. It is just an odd pain. She did not want to leave the house and surprised that her oxygen saturation was low. She just wanted to go back to sleep for a bit. Oxygen Saturation dropping was reported as worsened. The outcome of events Chest pressure, Heart rate 130's, Headache/head felt like it would explode, Right upper jaw pain that felt like sinus, calf pain/Calves were sore in back and Calves were sore in back and felt like DVT was recovering. The outcome of events Oxygen Saturation dropping, Ringing in the ears, Shivering, Back pain/pain in her back, Nausea, and Thighs are burning was not recovered. The outcome of events Temperature 101.7, she sound like a hypochondriac, dry hives, flu like symptoms, weak, felt miserable and can barely walk was unknown. The reporter considered events Heart rate 130's, Temperature 101.7, Oxygen Saturation dropping, Right upper jaw pain that felt like sinus and Thighs are burning were related to BNT162B2. The reporter considered events Chest pressure, Heart rate 130's, Temperature 101.7, Oxygen Saturation dropping, Headache, Ringing in ears, Shivering, Back pain, Nausea, Thighs are burning, Right upper jaw pain that felt like sinus and Calves were sore in back and felt like DVT as serious due to Medically significant.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
60 2021-01-24 low blood pressure Awoke in the early morning hours of 1/23/21 with severe vertigo, almost fell over twice while walkin... Read more
Awoke in the early morning hours of 1/23/21 with severe vertigo, almost fell over twice while walking to the bathroom. Vertigo caused severe nausea and vomiting, with inability to drink or eat for 36 hours. I became dehydrated. Went to the ED and was admitted overnight for vertigo, orthostatic hypotension, dehydration.
60 2021-01-24 palpitations, hypertension I had a rash on my face, started with itchy nose and eyes. The hives spread to the neck. I told the ... Read more
I had a rash on my face, started with itchy nose and eyes. The hives spread to the neck. I told the male nurse that was present and he said that had Epinephrine, I had benadryl and he said that I could take one. Half an hour later my rash got worse and I took 20 mg prednisone that I had for my asthma. During the next two days I have had palpitations, fatigue and tiredness. Today my blood pressure was high and I have never had it like that before.
60 2021-01-25 chest discomfort, hypertension Pfizer-BioNTech COVID- 19 Vaccine EUA Symptoms included exacerbated blood pressure of 200/90, chest... Read more
Pfizer-BioNTech COVID- 19 Vaccine EUA Symptoms included exacerbated blood pressure of 200/90, chest tightness, itching throat, and headache,
60 2021-01-25 chest pain Left arm very painful, pain in my neck left side goes into my chest and back of head left side, dizz... Read more
Left arm very painful, pain in my neck left side goes into my chest and back of head left side, dizziness, and horrible fatigue. Feeling out of it.
60 2021-01-25 chest pain Fever 103.5, shaking chills, headache, pain in chest on inspiration
60 2021-01-25 chest pain Bumpy red rashes in arms and legs; Shortness of breath; Mild chest pain; Severe dizziness; Congestio... Read more
Bumpy red rashes in arms and legs; Shortness of breath; Mild chest pain; Severe dizziness; Congestion; This is a spontaneous report from a contactable healthcare professional (patient). A 60-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown, vaccine location: right arm), intramuscular on 04Jan2021 13:00 at a single dose for COVID-19 immunization. Medical history included hypertension/high blood pressure controlled, GERD/acid reflux, fast heart rate, and prediabetic. Concomitant medications included losartan, metoprolol, gemfibrozil (LOPID), aspirin [acetylsalicylic acid], atorvastatin, vitamin D3, zinc, magnesium, ascorbic acid (VIT C), vitamin B complex (VIT B COMPLEX), alpha-d-galactosidase (BEANO), angelica keiskei leaf, sambucus nigra extract (SAMBUCOL), and unspecified stress supplement. The patient is not pregnant. The patient received a flu shot administered on the right arm on 28Oct2020 and pneumo vacc administered on the left arm on 28Oct2020. The patient received no other vaccine in four weeks. The patient had no COVID-19 prior to vaccination. The patient was tested for COVID-19 post vaccination (test type: nasal swab, test name: COVID PCR) on 22Dec2020 with result negative. On 04Jan2021 13:15, the patient experienced bumpy red rashes in arms and legs, shortness of breath, mild chest pain, severe dizziness, and congestion. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Outcome of the events was recovering. Information about lot/batch number has been requested.
60 2021-01-25 hypertension, blood pressure decreased, fainting The patient experienced syncope within 30 minutes after receiving the covid-19 vaccine. At 2:30pm, s... Read more
The patient experienced syncope within 30 minutes after receiving the covid-19 vaccine. At 2:30pm, she felt dizziness, her head was spinning, weakness of the arms, and slurred speech. Her FS was at 108 (Normal), BP 195/105 (Extremely high), Pulse 91, O2 saturation was at 100%. At 2:48PM, her BP lowered to 167/92. At this time, she can smile, she can put her hands up, she can kick her feet and she can opened/closed her eyes. Due to her high BP, Doctor requested that the should go to the ER via the ambulance.
60 2021-01-25 fainting Syncope,dizziness, head spinning,weakness of arms slurred speech BP 195/105 PULSE 91 Repeat BP 167/... Read more
Syncope,dizziness, head spinning,weakness of arms slurred speech BP 195/105 PULSE 91 Repeat BP 167/92
60 2021-01-26 chest discomfort, heart rate irregular, chest pain Fatigue but only in evening. Able to work. Irregular heart beat (not normal intermittent PVC) that c... Read more
Fatigue but only in evening. Able to work. Irregular heart beat (not normal intermittent PVC) that caused chest discomfort. Nothing concerning, just more curious. With second vaccine, developed chills within one hour and went to bed. Upon awakening, had headache, nausea, chills, kidney area pain, chest discomfort from irregular heart beat. This resolved for about 18 hours, then started again and lasted for 1 week. Chest pain became sharp at times spreading to arm with mild shortness of breath. Having had a full heart workup last year, did not pursue tests. wanted to see if would pass on it's own. After one week, only have occasional chest discomfort. Arrhythmia has returned to baseline occasional PVC. No further chills, headache, nausea or other pains.
60 2021-01-26 chest pain allergy like symptoms/allergy; nose running; congested and blockage in her nose; shortness of breath... Read more
allergy like symptoms/allergy; nose running; congested and blockage in her nose; shortness of breath; couldn't sleep during the night; burning sensation in her chest; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported), via an unspecified route of administration on the upper left arm on 12Jan2021 16:00 at single dose for COVID-19 immunization. Medical history was not reported. There were no concomitant medications. The patient reported that she took it yesterday and an hour into it she started having a burning sensation in her chest. What happen next, around 8pm, she started having allergy like symptoms that lasted throughout the night. She was experiencing nose running, congested and blockage in her nose, and shortness of breath. She couldn't sleep during the night until this morning. She had to breathe through her mouth because she couldn't' breathe through her mouth. For treatment, she took Mucinex tablets for allergy. She couldn't sleep during the night until this morning. She had to breathe through her mouth because she couldn't' breathe through her mouth. This was the first dose, her second dose is due on 02Feb2020 and she wants to know if she can skip it. Before she got it she contacted her primary care due to having allergies before the vaccine and asked if she should take; she was told to hold on but then she went ahead and took it. Within the first 30 minutes she was ok but in an hour is when she had the burning sensation in her chest. The burning sensation lasted about an hour. The dose was administered around 4pm on 12Jan2021.The caller reports that the Mucinex and she has breathing treatment, nebulizer treatments for her lungs, that she did and these things helped. Early this morning she felt she can now close her mouth and breathe normally. It was administered in the upper left arm. She did not require a visit to the doctor or ER. The patient has had no reactions to vaccines in the past nor were any administered on the day of or within the prior 4 weeks. Therapeutic measures were taken as a result of allergy like symptoms, congested and blockage in her nose and shortness of breath which included Mucinex. The patient recovered from burning sensation in her chest on 12Jan2021, from allergy like symptoms/allergy and shortness of breath on 13Jan2021 while the outcome of the other events was unknown. Information on the lot/batch number has been requested.
60 2021-01-26 blood clot First vaccine small bruise at her left knee and extreme pain in her neck, shoulder and left arm and ... Read more
First vaccine small bruise at her left knee and extreme pain in her neck, shoulder and left arm and missed work. Second vaccine she has 4 bruises and clots on her inner leg from ankle to thigh. So painful she can't sleep and she is having a hard time walking. Her left shoulder is limited due to extreme pain. She sought care from her physician and he is sending her for scans that the facility is requiring a deposit.
60 2021-01-28 chest discomfort After my vaccine, started coughing so bad. I had a Covid test which was negative and they gave me an... Read more
After my vaccine, started coughing so bad. I had a Covid test which was negative and they gave me antibiotics. They also gave me an inhaler for my wheezing. I also felt a tightness sensation in my chest and lungs from all the coughing.
60 2021-01-28 chest discomfort nasal congestion. chest congestion. chest discomfort. Has been persistent to today 1/29/21.
60 2021-01-30 chest discomfort Wheezing, shortness of breath, felt like someone was sitting on my chest. Was given a burst of 40mg ... Read more
Wheezing, shortness of breath, felt like someone was sitting on my chest. Was given a burst of 40mg of Prednisone for 3 days and Nebulizer treatments 4 x a day. The Prednisone and nebulizer treatments helped.
60 2021-01-31 nosebleed nose bleed/kind of "blew like a quarter size of blood clot"; congestion in her throat; headache; tir... Read more
nose bleed/kind of "blew like a quarter size of blood clot"; congestion in her throat; headache; tired, very tired and just wanted to sleep; nausea, some nausea; feeling unwell; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL0140 and expiry date unknown) via unspecified route of administration on 14Jan2021 at single dose for Covid-19 immunization on her job (nursing home). Medical history included blood pressure high. Concomitant medications vitamins. The patient took that COVID-19 vaccine shot yesterday (later clarified the date as 14Jan2021) on her job. The patient informed that she was okay the first day, but yesterday (15Jan2021) last night she had some new problems and she wanted to talk about and see it's a clinical sign. The patient informed that it was headache, tired, very tired and just wanted to sleep. The patient had no swelling/no swelling in arm, nausea, some nausea and even she has been just feeling unwell. The patient informed that today (16Jan2021) this morning, she was having nosebleed until the last time she felt like congestion in her throat and she kind of "blew like a quarter size of blood clot". The patient blew her nose and it bled a while, but then a quarter size blood clot come out and since then it wasn't bleeding, her nose was not bleeding. The patient did not receive treatment due to the events. The patient underwent lab tests and procedures which included COVID testing; swab the nose: negative on 13th or maybe 14th (Jan2021). The outcome of the events headache, tired, very tired and just wanted to sleep, nausea, some nausea, feeling unwell, nose bleed/kind of "blew like a quarter size of blood clot", congestion in her throat was unknown.
60 2021-02-01 palpitations pt stated about 2 hours after receiving her covid vax that her heart was racing, beating harder than... Read more
pt stated about 2 hours after receiving her covid vax that her heart was racing, beating harder than normal but subsided after about 2 hours. She was about to go to the ER but waited a little longer since she thought she was just having anxiety issues and did not have to go. She will contact her PCP today to let them know and discuss getting the second dose.
60 2021-02-03 atrial fibrillation Episode of atrial fibrillation; This is a spontaneous report from a contactable physician (patient).... Read more
Episode of atrial fibrillation; This is a spontaneous report from a contactable physician (patient). A 60-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK4176), via an unspecified route of administration at Left arm on 13Jan2021 09:15 at SINGLE DOSE for COVID-19 immunization. The patient was not pregnant. Medical history included scoliosis and depression. Concomitant medications in two weeks included duloxetine hydrochloride (CYMBALTA), estradiol/norethisterone acetate (COMBIPATCH). Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number, EH9899) received on 20Dec2020 05:00 PM at left arm for COVID-19 immunization. The patient previously took codeine and experienced drug allergies. The patient experienced episode of atrial fibrillation on 17Jan2021 at 05:45 AM. No treatment received, no COVID prior vaccination. The outcome of the event was unknown.; Sender's Comments: Based on a compatible temporal relationship, causality between event episode of atrial fibrillation and BNT162B2 vaccine 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.
60 2021-02-03 chest discomfort, palpitations minor local injection site pain , SOB, palpitation, chest tightness. 1/14 sx started and she reporte... Read more
minor local injection site pain , SOB, palpitation, chest tightness. 1/14 sx started and she reported to job 1/15. She had hard time to ambulate wearing a facemask. 1/17 sx fully resolved.
60 2021-02-03 heart rate increased Rigors that lasted about 10 minutes at around 45 mins to 1 hour post vaccine. Elevated heart rate.
60 2021-02-04 platelet count decreased, low blood platelet count admitted to hospital with platelet count of 8,000; petechiae; This is a spontaneous report from a co... Read more
admitted to hospital with platelet count of 8,000; petechiae; This is a spontaneous report from a contactable physician. A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL0140) via Intramuscular on 18Jan2021 into left arm at a single dose for covid-19 immunization. Medical history included hypothyroidism and neomycin allergies. The patient did not get covid prior vaccination. Concomitant medications included calcium, levothyroxine sodium (SYNTHROID), trazodone, tocopherol (VIT E) and no other vaccine in four weeks. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL9261) via Intramuscular on 28Dec2020 into left arm at a single dose for covid-19 immunization. 24 hours after injection she developed petechiae and was admitted to hospital with platelet count of 8,000 on 20Jan2021 22:00, the patient has ITP with baseline platelet count of 60,000. All events lead to hospitalization for 5 days (PENDING CLARIFICATION) and received IgG and oral Dexamethas as treatment. On 20Jan2021, the patient did Sars Co V 2 RNA test via Nasal Swab and result negative. The outcome of the events was recovering.; Sender's Comments: Based on a close chronological association, a causal relationship between events petechiae and thrombocytopenia and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) cannot be excluded. The case will be reevaluated 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.
60 2021-02-06 heart rate increased Swelling of face & throat; rapid heart beat Hospital I received, a steroid shot & Hydroxyzine pill a... Read more
Swelling of face & throat; rapid heart beat Hospital I received, a steroid shot & Hydroxyzine pill and Rex?s + contact regular doc 3 Rx-1) 40 mg Prednisone for 4 days 2) Hydroxyzine 25mg as needed 3) Epi pen RETURNED TO ER 2/5/21 same symptoms after taking prednisone; told to take Hydroxyzine even though I have no rash & rare itchiness. ON GOING SYMPTOMS; UNRESOLVED
60 2021-02-06 heart rate increased High heart rate. Vomiting, extreme fatigue. My body feels like is vibrating on the inside & shaking ... Read more
High heart rate. Vomiting, extreme fatigue. My body feels like is vibrating on the inside & shaking on the outside. Headache & extreme stomach pain. Which all of this has made it to where I'm unable to work.
60 2021-02-07 chest pain, fainting, chest discomfort 12/22 Vaccination 4 hours later, chest pain. Felt heavy. Got extremely sleepy. I tried to lay down,... Read more
12/22 Vaccination 4 hours later, chest pain. Felt heavy. Got extremely sleepy. I tried to lay down, episode of syncope. Chest discomfort. ER for observation
60 2021-02-08 pallor The symptoms began 10 minutes after administration of the vaccine. The symptoms were: anxiety and g... Read more
The symptoms began 10 minutes after administration of the vaccine. The symptoms were: anxiety and globus sensation pale and tremulous. Nurse noted that she had a 4mm hive above her lip. The treatment of the reaction was: o Epinephrine: x1 Transferred to ED
60 2021-02-08 low platelet count Thrombocytopenia. Bone marrow biopsy on 2/1/2021 showed severe peripheral pancytopenia and acellular... Read more
Thrombocytopenia. Bone marrow biopsy on 2/1/2021 showed severe peripheral pancytopenia and acellular marrow space, consistent with aplastic anemia. Patient has received dexamethasone, platelets, and PRBC. Unknown outcome patient has been discharged from the hospital.
60 2021-02-09 fast heart rate Pt reported tachycardia post receiving vaccination. Pt reported PMHX of anxiety. Symptoms response... Read more
Pt reported tachycardia post receiving vaccination. Pt reported PMHX of anxiety. Symptoms response within 5 minutes. No Treatment or Transport.
60 2021-02-10 blood pressure increased pt reported mild dull headache and warm head.given water and saltines with improvement. BP slightl... Read more
pt reported mild dull headache and warm head.given water and saltines with improvement. BP slightly elevated. Pt admitted to stress. Monitored for additional 30 min. Pt felt ok to go.
60 2021-02-10 chest discomfort Tightness in chest, throat swelling, tongue tingling. Lasted about 45 minutes. Did NOT use epipen. W... Read more
Tightness in chest, throat swelling, tongue tingling. Lasted about 45 minutes. Did NOT use epipen. Went to ER on site, received saline IV, was thoroughly checked and monitored, stayed 2 hours.
60 2021-02-14 chest discomfort 2MIN AFTER DOSE DIZZY, VERY CONFUSED, SLIGHT CHEST PRESSURE, 30 MIN LATER SLIGHT SWELLING OVER EYE... Read more
2MIN AFTER DOSE DIZZY, VERY CONFUSED, SLIGHT CHEST PRESSURE, 30 MIN LATER SLIGHT SWELLING OVER EYELIDS, 1 HR LATER STILL VERY CONFUSED IN A FOG. VERY CONGESTED , SNEEZING, ITCHY EYES, STUFFY EARS, VERY CONFUSED. STRANGE FEELING INSIDE MY BODY - TINGLING . FEELING OUT OF BODY .... NOT MY SELF ...ITCHING. VERY CONFUESED AND VERY DIZZY FOR ABOUT 4 HR... SEVERED HEADACHES. NAUSAUES. 6 HRS LATER SWOLLEN FACE RIGFHT SIDE.
60 2021-02-14 heart rate increased, chest pain, chest discomfort Sore arm at injection site. Itchy throat and itchy body. Extreme Fatigue. Heavy and fast heartbea... Read more
Sore arm at injection site. Itchy throat and itchy body. Extreme Fatigue. Heavy and fast heartbeat with severe pressure and chest pain. Ongoing muscle and joint pain that moves from location to location. Redness on chest and facial - cheeks.
60 2021-02-14 heart rate increased, hypotension shortness of breath, heart rate high, dizziness, low blood pressure, dry mouth, feeling faint, weakn... Read more
shortness of breath, heart rate high, dizziness, low blood pressure, dry mouth, feeling faint, weakness, fatigue all over, numbness in feet and hands, two -three weeks of morning anxiety, difficult to operate a car, two tp three weeks stiffness in joints, and headache.
60 2021-02-14 palpitations About 30 hours after vaccine I had bumps on my shoulder blade on left side where I received the vacc... Read more
About 30 hours after vaccine I had bumps on my shoulder blade on left side where I received the vaccine - a rash that itched. It lasted about 4 or 5 hours - I put Calamine lotion on it and that soothed it. I also experienced a little itching of eyes and a slight itching in mouth. About 9:30 pm I had a rapid heartbeat for about 30 or 40 minutes. The itching sensation continued off and on the next day but bumps weren't visible any longer. The itchy eyes continued off and on for the next day as well.
60 2021-02-15 palpitations Right after the vaccine I felt a little funny. Within 10 minutes of receiving the vaccine I started ... Read more
Right after the vaccine I felt a little funny. Within 10 minutes of receiving the vaccine I started coughing, lost my voice, Itchy eyelids, my chest was pounding, and overall just did not feel right. EMS Took my blood pressure and it was 255, then they waited a smidge and decided to give me an injection of Benadryl, within 10 minutes of the Benadryl my blood pressure went down to 225, and I overall felt a little bit better. My eyelids were still swollen and itchy and I didn?t have a voice, they took my blood pressure again and it went down to 218. They stayed with me. I was starting to feel a little bit better. My blood pressure went down to 180 and there?s no wheezing in my chest. They let me leave shortly after that. I still do not have a voice. My eyelids are still swollen slightly and very itchy and my lips tingle.
60 2021-02-15 lightheadedness, heart rate increased 12/19/2020 130 vaccination. When got up to leave, near syncope episode. Monitored for 15+ more minu... Read more
12/19/2020 130 vaccination. When got up to leave, near syncope episode. Monitored for 15+ more minutes. Left after. Later that evening, I felt like I was on 'speed'. Chills, HA, couldn't sleep. HR was increased. I wasn't able to eat; no appetite. Symptoms lasted for several days. Don't think I ran a fever. I was very dizzy, double vision, extreme fatigue. Did what i could with work online. *HX of aura migraines and happened during this episode. Within that week, saw NP.
60 2021-02-17 lightheadedness lightheaded to the point of nearly passing out; nausea; general feeling of being unwell; lightheaded... Read more
lightheaded to the point of nearly passing out; nausea; general feeling of being unwell; lightheaded to the point of nearly passing out; cold sweat; loss of appetite; pain in upper shoulder/back area; pain in upper shoulder/back area; This is a spontaneous report from a contactable consumer (patient). A 60-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL-9265), via an unspecified route of administration on 29Jan2021 12:30 in left arm, at single dose for covid-19 immunization. Medical history included chronic low BP, hypothyroidism, HRT, nasal allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included estradiol, levothyroxine sodium (SYNTHROID), multivitamin NOS (MULTIVITAMIN). The patient previously took amoxicillin; clavulanic acid (AUGMENTIN) and known allergies: Augmentin, being treated for nasal allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced nausea, general feeling of being unwell, lightheaded to the point of nearly passing out; cold sweat, loss of appetite, pain in upper shoulder/back area, on 01Feb2021 06:30. No treatment was received. The outcome of the events was recovering. Since the vaccination, the patient had not been tested for COVID-19.
60 2021-02-17 lightheadedness This is a spontaneous report from a contactable nurse reported for herself. A 60-year-old female pat... Read more
This is a spontaneous report from a contactable nurse reported for herself. A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE;lot EL3247) intramuscular in right arm on 01Feb2021 at 11:30 am (at 60 years) at single dose for covid-19 immunisation . Medical history included hypertension (HTN) , hypergammaglobulinaemia benign monoclonal (MGUS) , mononucleosis (recent mononucleosis one year before). Patient was not pregnant. Concomitant medication included venlafaxine hydrochloride (EFFEXOR), hydrochlorothiazide/ losartan potassium (HYZAAR), amfepramone hydrochloride (TENUATE). The patient previously took IV dramamine, tetanus and ceclor and experienced allergy. Previously, on 18Jan2021 at 10:30 am (at 60 years) she took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE;lot EL3248) intramuscular in right arm for covid-19 immunisation. Patient took the 1st dose of the vaccine on 18Jan2021 and 2nd dose on 01Feb2021 (inappropriate schedule of vaccine administered). Events were described as follows: next day, on 02Feb2021 at 06:00 temperature of 100.6, arthralgias and myalgias, dizziness. Second day (Feb2021), temp lower but still around 99.8 (normal for her 97.2), vasovagal, dizziness, arthralgias and myalgias. Events were non serious. Patient (a nurse) treated herself with dramamine for the dizziness, Nyquil and Advil. The final outcome of pyrexia, vasovagal, dizziness, arthralgias and myalgias was recovering.
60 2021-02-17 superficial blood clot Pt with superficial thrombophlebitis and possible Tibial DVT
60 2021-02-21 palpitations During 30 minute observation after 1st dose of covid vaccine patient began experiencing palpitations... Read more
During 30 minute observation after 1st dose of covid vaccine patient began experiencing palpitations/dizziness with BP of 157/99, requested transfer to ED for further evaluation. Began experiencing scratchy sensation to throat, difficulty swallowing with hoarseness of voice 5 minutes after vaccination. Received epinephrine 0.5mg IM once, protonix 40mg IV once, and solu-medrol 125mg IVPB once in ED. Patient was observed in ER for 3 hours and reported having EpiPen and Benadryl at home, was discharged with Prednisone 20mg, 2 tablets daily for 3 days.
60 2021-02-22 chest pain, troponin increased presented 1/27 to ED with rigors, dyspnea chest pain and R ear pain post COVID vaccine, thought to i... Read more
presented 1/27 to ED with rigors, dyspnea chest pain and R ear pain post COVID vaccine, thought to initially be systemic SEs from the vaccine but found to have re-collapse of the BI on chest CT with probable post obstructive pneumonia. still admitted as of 2/23/2021
60 2021-02-22 pallor Round rash the size of a 50 cents coin. Itchy and red. The area turns white when I lift my arm.
60 2021-02-22 palpitations Within a few seconds of receiving vaccine I experienced rapid heart beat/palpitations. This lasted f... Read more
Within a few seconds of receiving vaccine I experienced rapid heart beat/palpitations. This lasted for about 15 minutes then subsided.
60 2021-02-24 chest pain 10 min. After shot developed rash to chest, torso. On 4th day developed SOB, chest pain and fatigue.
60 2021-02-25 chest pain, blood glucose increased, cardiac arrhythmia, palpitations Sunday after administration, pt stated she started to feel her hear racing when going to bed, woke... Read more
Sunday after administration, pt stated she started to feel her hear racing when going to bed, woke up with her heart racing in the am. Pt stated to experience tingling and burning in her feet that later traveled to her hands. Pt has a history of PVCs but noted an increase in the PVC frequency. Chest pain that was intermittent but lasted for 4-5 days. Continues to experience twitches and tingling feet to this day.
60 2021-02-25 hypertension About 15 minutes after vaccination, patient reported symptoms of lightheadedness and feeling flushed... Read more
About 15 minutes after vaccination, patient reported symptoms of lightheadedness and feeling flushed. BP was high but otherwise vital signs within normal limits. Symptoms resolved.
60 2021-02-26 chest discomfort Patient reported dizziness and blurred vision initially. Vital signs checked, BP 174/73, HR 87, SpO2... Read more
Patient reported dizziness and blurred vision initially. Vital signs checked, BP 174/73, HR 87, SpO2 97% on intial check. She also reported a right frontal headache 5/10. Moved to cot to lie down, VS re-checked. Dizziness did not resolve with lying down. BP remained elevated as well. Once lying down, patient also reported "heaviness" in chest. A nurse remained with patient throughout entire incident and VS assessed frequently. After about 45 minutes, patient still reported HA, dizziness. Patient reported chest heaviness had resolved, but BP and dizziness did not resolve. Discussed calling EMS with patient, she agreed to allow us to call EMS. She was transported to local hospital by EMS at approximately 11:30am.
60 2021-02-28 blood glucose increased started to feel dizzy after getting the first dose of the COVID-19 Vaccine today; just checked her b... Read more
started to feel dizzy after getting the first dose of the COVID-19 Vaccine today; just checked her blood sugar, and her blood sugar was high at 146.; This is a spontaneous report from a contactable consumer (patient's daughter). A 60-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: Unknown), via an unspecified route of administration in the right arm on 28Jan2021at 09:30 (at the age of 60-years-old) as a SINGLE DOSE for covid-19 immunisation . Medical history included breast cancer female from 17Feb2019 (taking medicine for the breast cancer for 2 years), Cardiac disorder from an unknown date (problems with her heart about 2 weeks ago, and had to have her heart examined), and Prediabetes Concomitant medication(s) include takes medication for breast cancer and prediabetes. No other vaccines were given within 4 weeks No Additional Vaccines were administered on Same Date of the Pfizer Suspect. On 28Jan2021, The patient experienced started to feel dizzy after getting the first dose of the COVID-19 Vaccine today and just checked her blood sugar, and her blood sugar was high at 146. No Physician office visit and No Emergency room visit required due to the events. Reporter stated her mother is feeling better now. Patient checked her blood pressure and it was 127/72. The patient underwent lab tests and procedures which included blood glucose: High 146 on 28Jan2021; blood pressure measurement: 127/72 on 28Jan2021, cardiac stress test: unknown results on an unknown date, heart resistance test: unknown result on an unknown date. Caller asked what Pfizer recommends for the dizziness. The clinical outcome of the event dizzy was recovering which blood glucose high was unknown Information on the lot number has been requested.
60 2021-02-28 fainting Fainting Extreme muscle aches
60 2021-03-01 blood glucose increased Being a diabetic, my blood sugar was in the 300's, and even after changing my insulin pump because I... Read more
Being a diabetic, my blood sugar was in the 300's, and even after changing my insulin pump because I believed there may have been an issue with delivery, my blood sugar continued to rise. I did not eat anything until about 6 PM when my blood sugar began to lower. At that time, I tried to eat some chicken soup, but after a few mouthfuls, my throat began to constrict and my tongue and the inside of my mouth began to itch. This continued every time I began to try to eat something and I still could feel what felt like some constriction in the back of my throat the next day (Monday).
60 2021-03-01 blood glucose increased Left upper abdominal pain after receiving COVID vaccine radiating to left jaw rapid response, had pa... Read more
Left upper abdominal pain after receiving COVID vaccine radiating to left jaw rapid response, had patient remove mask and reported facial drooping. Transferred to ED for acute, painless, unilateral facial paralysis with no forehead sparing most likely secondary to Bell?s Palsy. Patient was monitored and discharged with prescriptions for valacyclovir 1000mg tid and prednisone 50mg qday x 7 days
60 2021-03-01 chest discomfort 5 Min after vaccine, pt. reported sharp poking sensation in left chest; heart palpitations. History ... Read more
5 Min after vaccine, pt. reported sharp poking sensation in left chest; heart palpitations. History of heart palpitations.
60 2021-03-01 heart rate increased SHORTNESS OF BREATH 1.29.21 TO CURRENT AND HAS NOT STOPPED, EXTREMLY TIRED FOR 7 DAY, FAST HEART BEA... Read more
SHORTNESS OF BREATH 1.29.21 TO CURRENT AND HAS NOT STOPPED, EXTREMLY TIRED FOR 7 DAY, FAST HEART BEAT. DIZZINESS FOR APPROX 4 DAYS, HEADACHE FOR APPROX 4 DAYS
60 2021-03-01 inflammation of the heart muscle, heart attack Heart attack; Myocarditis; Chills; didn't check her temperature but is sure she had one/She didn't c... Read more
Heart attack; Myocarditis; Chills; didn't check her temperature but is sure she had one/She didn't check her temperature but she is sure she had a fever; was soaking wet when she woke up like her fever had broken and then she was fine/She woke up and was very sweaty; achy right side; Headache; This is a spontaneous report from a contactable consumer who reported for herself, a 60-year-old female patient who received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3246), via an unspecified route of administration in the right arm, on 06Jan2021 at 18:00 at the age of 60 years, at a single dose for Covid Prevention/COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously received the first dose of Covid-19 vaccine (Manufacturer: Pfizer, with Lot Number: EK5730) in the right arm, on 18Dec2020 at the age of 60 years for COVID-19 immunization. The patient reported that 13 days after the last dose of the vaccine, on 19Jan2021, she had a heart attack. She has no heart issues whatsoever. She had diagnostic testing such as a cardiac catherization, echocardiogram, both on 19Jan2021; and a heart MRI with contrast on 20Jan2021. The test results indicated that she had myocarditis caused by a virus. The cardiac catherization and echocardiogram also revealed heart attack because of myocarditis. She did not have any other issues with her heart. The patient asked if they would they let her know if anything comes up as far as information. The patient has recovered with lasting effects. She would be on medication for the next 3 years supposedly. The heart attack was caused by myocarditis which was caused by a virus. There were no other issues with her heart, arteries or anything. These events required a visit to the emergency room. She first went to a hospital in the city and was transferred via ambulance to another hospital in another city on the same day. Patient was hospitalized for the heart attack and myocarditis from 19Jan2021 to 22Jan2021. She had a lot of other symptoms the next day after receiving the vaccine on 07Jan2021. She also experienced chills. She didn't take her temperature but is sure she had one. She was achy on her whole right side and she had a headache. She started having chills at 1:30 PM (13:30) while at an eye doctors appointment. She laid down and was soaking wet when she woke up like her fever had broken and then she was fine. She didn't check her temperature but she is sure she had a fever. She woke up and was very sweaty. The outcome of the events heart attack and myocarditis was recovered with sequelae on Jan2021. The outcome of the remaining events was recovered on 07Jan2021.
60 2021-03-02 blood pressure increased Elevated blood pressure, headache (2 days), fever, EXTREME chills/shaking, congestion, loss of appet... Read more
Elevated blood pressure, headache (2 days), fever, EXTREME chills/shaking, congestion, loss of appetite, fatigue, could not lift arm.
60 2021-03-02 blood pressure increased Patient felt like she needed to cough, dry throat. Iniital BP 151/83. Final BP 137/88 (pulse 71). Gi... Read more
Patient felt like she needed to cough, dry throat. Iniital BP 151/83. Final BP 137/88 (pulse 71). Given water.
60 2021-03-02 cerebrovascular accident stroke occurred five days after receiving vaccine. I was hospitalized overnight in General Hospital... Read more
stroke occurred five days after receiving vaccine. I was hospitalized overnight in General Hospital. Have had two MRI's.
60 2021-03-04 chest discomfort Sore throat, and chest feels heavy. Hurts to swallow. No treatment. I am currently monitoring my is... Read more
Sore throat, and chest feels heavy. Hurts to swallow. No treatment. I am currently monitoring my issue. If symptoms worsen I will go to ER
60 2021-03-04 chest discomfort Pt in 30 min waiting area. At 10:36 am reported tongue feeling funny. Upon assessment tongue was t... Read more
Pt in 30 min waiting area. At 10:36 am reported tongue feeling funny. Upon assessment tongue was thick , interfering with speech. BP: 186/93, Heart Rate : 66, Oxygen Saturation 99%, Temperature 97.6 F. Epinephrine 0.3 mL administered on left thigh at 10:42 am and 911 called. Pt reported inability to swallow and chest tightening at 10:51 am. Ambulance arrived.
60 2021-03-04 loss of consciousness Pt was observed to drop her phone on the floor. When it was picked up & RN attempted to hand it to ... Read more
Pt was observed to drop her phone on the floor. When it was picked up & RN attempted to hand it to her, she appeared to be sleeping. She did wake after physical stimulus but was lethargic, confused & stated she "felt dizzy"
60 2021-03-04 fainting COVID Vaccine Adverse Event Documentation After vaccination with COVID Vaccine Dose #1, patient dev... Read more
COVID Vaccine Adverse Event Documentation After vaccination with COVID Vaccine Dose #1, patient developed evidence of Immediate (within 4 hours of dose) adverse reaction starting 3/5/2021 2:02 PM. Signs/Symptoms: Dry Mouth, Flushing, Lightheadedness, Nausea/Vomiting and Other (see comments) Reaction Comments: Skin blotchiness, dizziness, shaky, responsive but limp Treatment Administered: Cold Compress and Sips of Water Treatment Comments: Crackers, put in supine position Disposition: Home Disposition Comments: Next vaccine should be supine when receiving it. Additional Documentation: Pt became faint immediately after vaccine, warm, shaky and went limp I her chair but was responsive. BP: (!) 150/94 Pulse: 75 Supervising Provider Notified of Reaction: MD
60 2021-03-04 fast heart rate First CPVOD Pfizer on 1/22/2021, 2nd COVID Pfizer on 2/19/2021 Developed episodes of tachycardia sta... Read more
First CPVOD Pfizer on 1/22/2021, 2nd COVID Pfizer on 2/19/2021 Developed episodes of tachycardia starting 2/12/21. Seen by me (MD) 2/15. BW showed low TSH, otherwise NL. Labs repeated and TSH undetectible with high Total T3 and NL Free T$. TSH stimulating AB very high, suggesting new Graves disease/Hyperthyroidism. We have a NORMAL TSH on file from March 2020
60 2021-03-07 blood glucose increased Since the week after the first Pfizer vaccine, I began struggling with symptoms of diabetes. I exper... Read more
Since the week after the first Pfizer vaccine, I began struggling with symptoms of diabetes. I experienced extreme thirst, frequent urination and I lost 17 pounds in the 3 weeks following the first dose. I never associated it with the vaccine, initially, because I never heard of any side effects like increased glucose, and my dad and sister have type 2 diabetes, so I was altering my diet, but the symptoms did not subside. I proceeded to get the second vaccine and that?s when I knew something was seriously wrong. That afternoon my blood sugar was 528, my vision was blurred, and I experienced a strange feeling in my heart. I was diagnosed by my GP with diabetes, and put on medication (Metformin and Glipizide). I proceeded to see an endocrinologist, I was put on insulin and after additional blood tests was diagnosed with Latent Autoimmune Diabetes , and Premature Atrial Complexes.
60 2021-03-07 chest discomfort Throat tight, tongue feels numb, chest pressure. Evaluated by EMS- Transported to Emergency room/dep... Read more
Throat tight, tongue feels numb, chest pressure. Evaluated by EMS- Transported to Emergency room/department or urgent care.
60 2021-03-07 chest discomfort On the day of the shot, by Noon I could feel the vaccine moving into my throat and my face. My thr... Read more
On the day of the shot, by Noon I could feel the vaccine moving into my throat and my face. My throat and left cheek started to swell and turn slightly red. I took more Benadryl and called my allergist in the afternoon. They told me I needed to get to the hospital for treatment. At the hospital, they gave me steriods, benadryl and Pepcid in an IV. After allowing this to work, they sent me home with a steriod prescription for 60Mg for the next 5 days. They asked me to follow up with my allergist if I had other issues , they also told me that I would not be able to get the 2nd dose of the vaccine. Over the next several days, I continued to have issues with this redness that had grown over my entire face. I looked like I was totally sunburned. I did not feel well, the redness was very hot, and I struggled with some breathing. I made an appointment on Monday morning with my allergist, and they adjusted my allergy medicine and gave me more asteroids for 5 more days. They advised me to use my nebulizer treatments as needed to remove the heaviness in my chest. This redness and swelling has moved around my body, almost as if I can see where the vaccine is at in my body. It went from my head to my chest/back and right arm. Down to my abdomen, and then down below my knees. In the morning, it is usually in my face and then it moves around during the day. I can feel this fluid moving around in my body because the redness brings swelling/fluid. This last saturday 3/6/2021 was horrible, it was in my right ear and right foot. It was very painful and made me very dizzy. I struggled to walk. Then on Sunday morning, I felt fine all day. Today Monday, it feels like it is in my right foot again, but I feel like It is getting better.
60 2021-03-07 heart rate increased, chest discomfort I received the shot at 4:30 pm. About an hour after receiving the shot, I felt a little dizzy, and ... Read more
I received the shot at 4:30 pm. About an hour after receiving the shot, I felt a little dizzy, and my heart started beating faster. My body felt weird. I had a small headache and was very tired and laid down. I fell asleep pretty quickly. I woke up around 2:30 am the following morning, with a greater headache. I took tylenol for the headache. I took another dose of tylenol 4 hours later. I had loose stools, fatigue and my lungs felt heavy (cough) for approx 12 hours. Most symptoms resolved by the following day. A little fatigue and heaviness remains.
60 2021-03-07 heart rate increased Extreme soreness in Left upper arm; chills; headache; tiredness; feeling like I had the flu; extreme... Read more
Extreme soreness in Left upper arm; chills; headache; tiredness; feeling like I had the flu; extreme weakness; rapid heartrate; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248), via an unspecified route of administration in the left arm on 29Jan2021 14:00 at a single dose for COVID-19 immunization. The patient's medical history included penicillin allergy, coronary artery disease (CAD), hypertension (HTN), pulmonary hypertension, sick sinus syndrome, hypothyroidism, hyperlipidemia, osteoporosis, chronic kidney disease (CKD), and diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medications included alprazolam (XANAX), venlafaxine hydrochloride (EFFEXOR), quetiapine fumarate (SEROQUEL), sertraline hydrochloride (ZOLOFT), isosorbide mononitrate (IMDUR), and metoprolol. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Jan2021 02:15, the patient experienced extreme soreness in left upper arm, chills, headache, tiredness, feeling like she had the flu, extreme weakness, and rapid heartrate. No treatment was received for the adverse events. Outcome of the events was recovering. The events were considered non-serious.
60 2021-03-07 palpitations Lip tingling, palpitation, flushing and wheezing/slight SOB within 15-30 mins and sensation that she... Read more
Lip tingling, palpitation, flushing and wheezing/slight SOB within 15-30 mins and sensation that she was unable to swallow while driving home. Used rescue inhaler when she reached home for relief. Symptoms now resolved. H/O asthma
60 2021-03-07 fainting Fever greater than 104° for 24 hours. Syncope for 24 hours following that.
60 2021-03-08 chest discomfort, palpitations, chest pain difficulty breathing, chest tightness, pain palpitation (chest). Evaluated by EMS-Cleared
60 2021-03-08 heart rate increased, chest discomfort throat tightness, elevated HR, difficulty swallowing, chest pressure. Evaluated by EMS-Cleared
60 2021-03-08 hypertension High Blood Pressure now am on medication and I have never had High blood pressure nor have I been on... Read more
High Blood Pressure now am on medication and I have never had High blood pressure nor have I been on BP medication. I have been taking medication for 2 weeks and my BP has maintained high
60 2021-03-08 fainting Syncope, difficulty focusing- Evaluated by EMS-Transported to Emergency room/department or urgent ca... Read more
Syncope, difficulty focusing- Evaluated by EMS-Transported to Emergency room/department or urgent care.
60 2021-03-09 chest discomfort, blood glucose increased acute chest tightness, chest pressure, SOB, severe cough, tachypneic, throat closing feeling hoarse ... Read more
acute chest tightness, chest pressure, SOB, severe cough, tachypneic, throat closing feeling hoarse voice, presyncope but epipen administered on site of vaccination location to avert syncope or cardiovascular collapse promptly. Symtoms occurred within 10 minutes of vaccine administration . Vaccine given 12:18 pm or 12:25 pm and symptoms within 10 minutes since in ER 12:30 pm but had received epipen en route before ER arrival since medical building was next to ER
60 2021-03-09 palpitations within a couple of minutes after receiving the shot, I felt a sudden flash of warmth throughout my b... Read more
within a couple of minutes after receiving the shot, I felt a sudden flash of warmth throughout my body. Then my heart started racing. This lasted about a minute. I just sat there since I wasn't sure if this was normal. I started to feel like my heart was going back to normal so I just sat there for the specified 15 minutes. After I left and was driving home, I stated to feel a shortness of breath and difficulty getting air. I also felt like a hard to swallow. I was about 1 mile from venue so this happened with 30 minutes of receiving the shot. This only lasted what seemed like a short time and then I started to feel like I could get my breath. By the time I returned home I was breathing ok but my lips were a little tingly. I felt fine by 5:00 pm.
60 2021-03-10 palpitations heart racing, anxious. Evaluated by EMS-Cleared
60 2021-03-11 chest discomfort 1538 Patient received vaccine and felt neck swelling and chest tightness.
60 2021-03-14 palpitations, chest pain Fever, nausea, whole body aches, pain in arm, armpit, back, chest, dizziness, palpitations, headache... Read more
Fever, nausea, whole body aches, pain in arm, armpit, back, chest, dizziness, palpitations, headache.
60 2021-03-15 blood pressure decreased Approximately 5 minutes post injection my blood pressure plummeted and I began to feel faint. I also... Read more
Approximately 5 minutes post injection my blood pressure plummeted and I began to feel faint. I also started shaking uncontrollably particularly hands and arms. Vaccine administrator was immediately notified and they summoned the closest EMT. Emergency Services took my BO and pulse oximeter. A few minutes after the start of the symptoms. They explained that since my HR was at 84, BP was 110/68 and oxygen saturation was at 98% and I wasn't having difficulty breathing that I was not having an allergic reaction to the vaccine but a parasympathetic response instead. They sat with me until the shaking stopped approximately 15minutes later.
60 2021-03-15 blood pressure increased experienced chills and body pain on the 3rd day after receiving the 2nd dose vaccine . chills and bo... Read more
experienced chills and body pain on the 3rd day after receiving the 2nd dose vaccine . chills and body pain lasted for 2 days . on the fifth day felt like black curtain in front of my eyes and felt dizzy. checked my blood pressure was 170/90. Blood pressure went up to 200/100 . went to the hospital emergency and was admitted for observation overnight. CT, MRI , blood work done. BP controlled with medication Nefidefine 60mg. discharge home next day. was still having very light headedness and BP will shoot up to 190/90. physician had to change the medications couple of time. felt very exhausted . could not go to work almost 3 weeks because of the symptoms like lightheadedness. lasted at least 4 weeks to get back to work normal. never experienced this before. I was taking Olmasartan 5mg for blood pressure and my Bp always stated 130/80s
60 2021-03-15 chest discomfort Within the first 30 min of receiving first COVID vaccine pt report feeling dizzy and nauseated. Pt t... Read more
Within the first 30 min of receiving first COVID vaccine pt report feeling dizzy and nauseated. Pt taken to vaccine clinic observation area to be closely monitored. Pt placed on gurney and given water to drink. VS stable. Pt report headache 5/10, feeling sensitive to light, and nauseated. While in observation area pt reports feeling what she describes as "feeling weird wavey sensation over entire body, warm head, and cool body." Pt offered but declined to go to ED. explained risks and benefits to pt. Pt states that she drove herself to vaccine clinic. Pt advised that it it would be unsafe to drive herself home and advised to to contact husband for ride home. Pt called her husband to pick her up. After several min pt states stated that she was "feeling a little better" and "headache was also a little better" 3/5 on pain scale but still feeling dizzy and chest feeling a little tight. " Pt states having a history of Asthma. Pt again offered to be treated in ED and accepted. Pt transported to ED by gurney accompanied by three RN's.
60 2021-03-16 blood glucose increased, heart rate irregular High blood sugar Irregular heart beat
60 2021-03-16 blood pressure increased, fainting Hot Flash with Sweats, Followed by fainting, Non-responsive, Elevated blood pressure
60 2021-03-16 chest discomfort A few days after the vaccine on that Wednesday I began having pain in the upper shoulder and back ar... Read more
A few days after the vaccine on that Wednesday I began having pain in the upper shoulder and back area which persisted to a heaviness in my chest going into Thursday. Thursday night I woke up in the middle of the night to the feeling of not being able to breathe. I laid awake for a while but dosed back off and it happened again a little later. It felt as if someone was sitting on my chest which prompted me to go to the ER the next day. Various test were done and I was admitted in the hospital for further observation. After admission I developed a massive headache which lasted from that Friday afternoon until that Sunday. I was released on that Sat and the symptoms seemed to be getting better and by that Sunday evening all symptoms had subsided.
60 2021-03-16 nosebleed After 2nd dose vaccine on 2/14/21 of Pfizer, got a very bloody nose beginning 2 days later and conti... Read more
After 2nd dose vaccine on 2/14/21 of Pfizer, got a very bloody nose beginning 2 days later and continuing 3 days later. Nose blood dried up but was very irritated for a total of 5 days
60 2021-03-17 cardiac arrest This is a 60 year old female was brought into emergency department as cardiac arrest. Patient was s... Read more
This is a 60 year old female was brought into emergency department as cardiac arrest. Patient was seen at care now urgent care with the complain of epigastric pain associated with nausea vomiting and intermittent diarrhea. Patient received her initial COVID vaccine 2 days ago. History is obtained from urgent care chart. As per notes patient started nausea vomiting 6 hours post COVID vaccine administration. Patient was seen in urgent care for epigastric pain and nausea vomiting. Patient was found unresponsive at 0902 by tech. No carotid pulses palpated. CPR was started. Patient was brought into the emergency department with Lucas on. Patient was given 5 epinephrine prior to arrival. CPR was in progress. Patient was asystole. Resuscitation was continued in the ED. Patient was intubated in the ED by physician assistant 5 epinephrine 2 bicarb and 1 calcium chloride was given in the ED. Cardiac Ultrasound didn't show any cardiac activity. Asystole on the monitor. No corneal reflex people are fixed and dilated. Patient was pronounced at 1007 am
60 2021-03-17 heart rate irregular, blood pressure increased Irregular heart beat that lasted about 14 hours....elevated blood pressure that reached 181/108...to... Read more
Irregular heart beat that lasted about 14 hours....elevated blood pressure that reached 181/108...took my Amlodipine when I got home and then the blood pressure fell to 110/74...after a couple hours the pressure returned to normal 123/75. Did not go to hospital..kept thinking it would go away and after many hours it did.
60 2021-03-17 hypertension, heart rate increased I already alerted you to the rash and itching. I got a headache starting about 30 minutes after the ... Read more
I already alerted you to the rash and itching. I got a headache starting about 30 minutes after the shot. I started having what looked like bruising all along the veins in my arms and hands. Still have that. I went to the doctor and also found that I had high blood pressure and an elevated heart rate. BP 140/90 and Heart rate 85. My normal heart rate is between 55-60 and my usual blood pressure is 108/70. The doctor gave me a steroid shot. This morning, my blood pressure and heart rate were still high and I still had a headache. Then the headache stopped and I took my blood pressure and it was down to around my usual 108/70 and the heart rate was 60. So hopefully I'm starting to recover from this shot.
60 2021-03-17 loss of consciousness The day after her vaccine patient went to the bathroom and passed out. EMS came, but she started to ... Read more
The day after her vaccine patient went to the bathroom and passed out. EMS came, but she started to feel better and did not go to the hospital.
60 2021-03-18 arrhythmia Dizzy; Nausea; Vomit; Pain on all body; Frequent fall; Severe fatigue; Strange feeling; Abdominal pa... Read more
Dizzy; Nausea; Vomit; Pain on all body; Frequent fall; Severe fatigue; Strange feeling; Abdominal pain on and off; Arrhythmia; This is a spontaneous report from a contactable physician. A 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular, administered in left arm on 11Feb2021 09:00 (batch/lot number was not reported) as single dose for COVID-19 immunisation. Medical history included (G60.9) PN - Peripheral neuropathy (SCT42658009), (M79.2) A Neuralgia (SCT16269008), (R55) Syncope (SCT271594007), (I10) HTN - Hypertension (SCT38341003), (R00.0) Tachycardia (SCT3424008), (E16.2) Hypoglycemia (SCT302866003), (R55) Vasovagal symptom (SCT248229009), (M25.50) Joint pain (SCT57676002), (F41.9) Anxiety (SCT48694002), (K21.9) Acid reflux (SCT235595009), and (M06.4) Polyarthritis (SCT416956002); all were current or ongoing. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 on 12Jan2021 for COVID-19 immunization (product: COVID 19, brand: Pfizer, administration time: 09:00 AM, route: intramuscular, vaccine location: left arm). On 11Feb2021 11:00, the patient experienced dizzy, nausea, vomit, pain on all body, frequent fall, severe fatigue, strange feeling, abdominal pain on and off, and arrhythmia. The AEs resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. There were no treatments given for the events. The patient was not diagnosed with COVID-19 prior vaccination. The patient has not been tested for COVID post vaccination. The patient has no known allergies. No other vaccines received within four weeks prior to COVID vaccine. The events were reported as serious and disabling. The patient has not recovered from all the events. Information on the lot/batch number has been requested.; Sender's Comments: Drug causality for suspect drug in the onset of the reported events cannot be excluded assuming a plausible temporal association and considering the known safety profile of the product. The impact of this report on the benefit/risk profile of the Pfizer drug 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.
60 2021-03-18 blood pressure increased Client c/o light headed feeling immediately after receiving vaccine. Client denies any other sympto... Read more
Client c/o light headed feeling immediately after receiving vaccine. Client denies any other symptoms. Client seen and assessed by EMT and assessments are: BP 173/78, HR 94, O2 96%, Client verbalized a decrease in symptom and cleared to go home by EMT. Client advised to seek medical attention if symptoms worsened and she verbalized understanding.
60 2021-03-18 heart rate increased Fast resting heart rate (>100 bpm), chills, difficulty/pain taking deep breath, dizziness
60 2021-03-18 palpitations Heart palpitations, anxiety,(felt this prior to today). 126/84, 87, 6, 99%, BGL 176
60 2021-03-19 chest pain, loss of consciousness 3 days after 2nd dose of Pfizer vaccine I started getting itching, rashes and hives all over. Went t... Read more
3 days after 2nd dose of Pfizer vaccine I started getting itching, rashes and hives all over. Went to bed about 10:30. Got up about 4:30 am to use bathroom, felt lightheaded and blacked out and apparently hit my head on something. Realized ears were closing up and had soreness in chest that made deep breath's difficult. Called 911 and nursing line and decided to go to Emergency Dept. Did CT scan for bumps on head and IV and gave me epinephrine and Pepcid. Was discharged with prescription for Epi Pen, Zyrtec, and Pepcid. Still have rash and hives but not as extensive, comes and goes.
60 2021-03-19 fainting Pt was admitted 6 weeks post second covid vaccination with c/o sudden onset of generalized abdominal... Read more
Pt was admitted 6 weeks post second covid vaccination with c/o sudden onset of generalized abdominal pain, nausea, vomiting and diarrhea resulting in 2 syncopal episodes. CBC showed leukocytosis with neutrophilia which resolved. She was treated with IV fluids and antiemetics and was discharged on 3/19/2021
60 2021-03-20 blood glucose increased COVID Vaccine clinic. Per chart review, pt received COVID vaccine at 1426. At approximately 1505 p... Read more
COVID Vaccine clinic. Per chart review, pt received COVID vaccine at 1426. At approximately 1505 pt c/o nausea and ran outside. Pt awake, alert, respirations easy and unlabored, no distress noted. No vomiting occurred. Pt stated history of throat swelling and facial swelling/rash after PCN. 1510: Pt stated nausea resolved. Pt Diabetic and had not eaten lunch. Juice and crackers given, pt tolerated well with no difficulty. Respirations remain easy and unlabored, no distress. 1517: Pt clearing throat, c/o throat swelling, able to manage oral secretions, speaking in complete sentences. Pt to triage area via wheelchair by RN. BP 171/80 | Pulse 77 | Resp 17 | LMP 02/01/2013 (LMP Unknown) | SpO2 98% 1523: Pt awake, alert, c/o difficulty breathing. RN called for assistance, attempted to located on site MDs. 1526: No MDs on site, 911 called. BP 184/84 | Pulse 82 | Resp 20 | LMP 02/01/2013 (LMP Unknown) | SpO2 100% 1528: RN called ED MD, Dr., verbal order received for Epinephrine 0.3 mg subcutaneous one time now. 1530: Epinephrine given per MD order. 1532: EMS crew on scene, Sac City 7, assessing patient, full report given by RN. During transfer of care, pt started shaking, full body, eyes closed, assisted to supine position on gurney by EMS crew, no injuries occurred, very short duration- pt aroused. Pt and her personal belongings to ED by EMS crew.
60 2021-03-21 nosebleed 3-22-21 11AM TC: PT STATES ON '3-19-21 7PM SHE HAD SWELLING OF HER TONGUE AND RT SIDE OF FACE AND NE... Read more
3-22-21 11AM TC: PT STATES ON '3-19-21 7PM SHE HAD SWELLING OF HER TONGUE AND RT SIDE OF FACE AND NECK; SHE CALLED HER PCP WHO HAD HER SUE HER EPI PEN - THE SWELLING RESOLVED. ON 3-20-21 SHE ALSO HAD A EARACHE, HEADACHE AND BLOODY NOSE. HAS TAKEN TYLENOL.'
60 2021-03-21 heart rate increased, chest discomfort, palpitations 8.5 hours after vaccine injection, I suddenly began experiencing fatigue and extreme joint and muscl... Read more
8.5 hours after vaccine injection, I suddenly began experiencing fatigue and extreme joint and muscle soreness. Initially I noticed my knees hurting with radiating pain up into my thighs. My head hurt, particularly at the back of my skull, near my neck. My neck muscles were sore, as were BOTH shoulders - my right shoulder (injection site) was only slightly sorer than my left shoulder. I called a 24/7 nurse associated with insurance company to ask if ibuprofen or tylenol were acceptable treatments for my symptoms. She told me I could take either and alternate if I felt I needed to maximize relief. I noticed the joins in my toes and fingers were hurting. It was frightening to experience tightness in my chest and back muscles. I never felt like my lungs were compromised, there was just a heaviness as the muscles seemed constricted. I felt a slight rise in my heart rate and experienced a few palpitations mostly because I kept pondering how much worse my symptoms could get. I was a little cold, so I decided to go to bed after drinking extra water (also a suggestion from the nurse). I slept for a few hours 10:00 PM - 4:00 AM then got up and called an advise nurse to report that my joint and muscle pain were not subsiding. She encouraged water and more painkiller. As the day wore on, I felt less achy and more shaky/jittery. My thinking was somewhat unclear - I felt a little dizzy, out of balance, off-kilter and brain "foggy." As I write this 36 hours after my injection, my symptoms are subsiding. Where I felt a little chilled during our cool and rainy afternoon, I now feel a wave of heat sort of traveling through my body. It isn't a fever - just an odd sensation that something is still going on.
60 2021-03-22 chest discomfort, hypertension At about 3:55PM my left arm, where injectiion was administered began tingling from upper arm to fing... Read more
At about 3:55PM my left arm, where injectiion was administered began tingling from upper arm to fingers. Pain to the back of my neck, a flush of warmth to my upper body and difficulty breathing. Felt like a truck ran over my chest. I was weak, dizzy and nauseous as well. The tingling sensation also affected both my legs. The RN took to their infirmary area and began taking my vitals. Vitals seems normal, Blood Pressure and Pulse were high. I am asthmatic but did not bring my inhaler with me. Because of my difficulty breathing, they decided to inject me with Benadryl which is all they had. After about twenty minutes, my breathing started to calm down and blood pressure began coming down as well.
60 2021-03-22 chest discomfort Shortness of breath, dizziness, chest pressure, started about 5 minutes after administration of vacc... Read more
Shortness of breath, dizziness, chest pressure, started about 5 minutes after administration of vaccine.
60 2021-03-22 chest pain I could actually feel the vaccine entering my blood stream above and below injection area. I had sh... Read more
I could actually feel the vaccine entering my blood stream above and below injection area. I had sharp pain on right upper side of my chest that came and went for several hours along with dizziness. Arm hurt so bad later that night from my elbow to my neck it woke me up and I took aspirin until pain died down some.
60 2021-03-23 blood pressure increased developed life threatening high blood pressure; This is a spontaneous report from a contactable nurs... Read more
developed life threatening high blood pressure; This is a spontaneous report from a contactable nurse (patient). A 60-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection; Lot Number: EN6199), via an unspecified route of administration in the left arm on 03Mar2021 at 10:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had not received any other vaccine within 4 weeks prior to the vaccine. On 04Mar2021 at 02:30, the patient developed life threatening high blood pressure. Adverse event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient did not receive any treatment for the event. The outcome of events was not recovered.; Sender's Comments: Based on the strong temporal relation in the case report, a causal relationship between adverse event Blood pressure increased and suspect product BNT162B2 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.
60 2021-03-23 chest pain, chest discomfort patient states she is having chest tightness and pain around 10 minutes after vaccination. BP 160s/1... Read more
patient states she is having chest tightness and pain around 10 minutes after vaccination. BP 160s/110s. Clinic provider notified. Transferred to ED at patient request.
60 2021-03-23 chest pain Felt abnormal and went to bed. Woke up at 9:35am with 101.7 temperature and called into work to advi... Read more
Felt abnormal and went to bed. Woke up at 9:35am with 101.7 temperature and called into work to advise I will not be coming in. I went back to bed no food no medicine, Most information I read and was aware is that it would be better with sleep. Only to wake up at 8:30pm with a 102.7 had 500 mg acetaminophen went back to bed. Woke up Thursday morning at 9:45am fever free. Friday afternoon I noticed swelling on my left neck area. Just inside my left clavicle. I made a Dr appointment for Monday and Dr. found several Lymph nodes swollen as well as under my left arm pit area. Due to some chest pain she sent me for a chest x-ray.
60 2021-03-23 heart rate increased Patient presented to emergency department at Hospital 30 minutes after receiving vaccine, complainin... Read more
Patient presented to emergency department at Hospital 30 minutes after receiving vaccine, complaining of tingling in tongue/lips. Patient was evaluated and given diphenhydramine and famotidine. Symptoms were improved and patient was discharged. Patient returned to emergency department approximately 4 hours later with general weakness/lightheadedness, rapid heartbeat, feeling of throat closing. Solu-medrol and IV fluids were administered. Patient felt much better and was discharged with a prescription for oral prednisone. **Note, this information was reported from patient's primary care office. An event have already been reported to VAERS for this patient by Hospital**
60 2021-03-23 heart rate irregular I was submitting my events daily on website and two days it tells me my session has expired and won'... Read more
I was submitting my events daily on website and two days it tells me my session has expired and won't let me report anything. On Sunday night, March 21st, I started with very painful joint and muscle aches with fatigue. The next morning I felt terrible and could barely function, I had a bought with diarrhea that lasted almost the entire day and had no energy. I developed a large lump on my left clavicle area that seemed to be filled with fluid. My knees I had replaced are still very painful today ( 7 days post vaccine). I phoned my Dr. yesterday and they told me to take 1000mg of Tylenol 3 times a day. I am doing this now for the second day with some relief. I feel this is very unusual to feel this way 7 days after the vaccine. On day 1-2 the only symptoms were a sore arm from the vaccine. Saturday was actually a good day with no symptoms, the other symptoms started on Sunday. I feel like my heartbeat is irregular also but my BP is good. I would like to be able to to report daily on v-safe like I was the first few days.
60 2021-03-23 palpitations As per ER report from medical center, pt first reported tingling in tongue and lips 30 min post vacc... Read more
As per ER report from medical center, pt first reported tingling in tongue and lips 30 min post vaccine admin. Was discharged from ER, but returned later for general weakness/lightheaded, heart racing, felt throat was closing.
60 2021-03-24 fainting Day 1 muscle stiffness lower back and slight fever, tired. Day 2 bone, muscle pain moved to right hi... Read more
Day 1 muscle stiffness lower back and slight fever, tired. Day 2 bone, muscle pain moved to right hip, sore to touch, tired. Day 3 bone, muscle pain moved upper back, tired. Took aspirin. Day 4 bone, muscle pain more extreme, tired. Took aspirin. Day 5 extreme pain in hip and ribs, sore to touch hard to breath, fainted, tired. Took tylenol. Pain went away
60 2021-03-25 loss of consciousness, hypertension things went black; my blood pressure was alarmed was over 200 checked other arm same called there te... Read more
things went black; my blood pressure was alarmed was over 200 checked other arm same called there team ER member to triage still B/P high; severe dizziness; severe headache nausea; weakness; severe headache nausea; This is a spontaneous report from a contactable other healthcare professional (patient). An 60-year-old non-pregnant female patient received bnt162b2 (COVID 19, brand: Pfizer, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 07Feb2021 11:00 (Batch/Lot Number: EL9264) as SINGLE DOSE for covid-19 immunisation. Medical history included Stent in LAD (Left anterior descending coronary artery). Concomitant medications included losartan potassium, lorazepam (ATIVAN), acetylsalicylic acid (BABY ASPIRIN) and furosemide. It was reported that, within 15-20 minutes went to stand up severe dizziness and things went black started to get severe on 07Feb2021 at 11:15 AM. On 07Feb2021 at 11:15 AM, Headache, nausea Nurse Practitioner that gave shot took her blood pressure was alarmed was over 200 checked other arm same called there team ER member to triage still B/P high and she could not stand up due to weakness dizziness apparently they called Paremedic/EMT advised in her best interest to be seen in Emergency department. they did not how ever ask if she belonged to a ambulance company which she do so know she have a bill of about 1,500 with ambulance company. was in the ED for about 4 hours till blood pressure can down. was given medication for nauseas, felt like she was hit by a truck. Patient had Cardiac montering/medication. No covid prior to vaccination. No covid tested post vaccination. Outcome of events was recovered on an unspecified date in 2021. No follow-up attempts are possible. No further information is expected.; Sender's Comments: The events assessed as possibly related to the suspect drug BNT162B2______ based on strong temporal association, but consider also possible contributory effects from patient's medical history and/or concomitant medications. 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.
60 2021-03-25 pallor The VR has a history of vagal response to immunizations and blood. The VR had the vaccine without i... Read more
The VR has a history of vagal response to immunizations and blood. The VR had the vaccine without incident and went to the observation area. The VR was then sitting with his wife when he "was thinking of the vaccine" and he became unresponsive. I was called to the site. The VR was pale, cool, and diaphoretic. The VR became responsive and was assisted to the cot where he laid flat. The VR's wife states that this is typical behavior and response for him. An ambulance was called by the paramedics that were on scene in the observation area. The VR refused transport. The VR was given water and candy and was able to ambulate without difficulty. VR remained in the observation area for 40 minutes and then discharg
60 2021-03-26 blood pressure decreased, blood pressure increased My blood pressure shot up the first night. It came down for a while Wed and Fri, but shot back up to... Read more
My blood pressure shot up the first night. It came down for a while Wed and Fri, but shot back up to 181/102 Sat. I take Clonidine when it goes over 160. I have had several this week. My pulse has stayed in the 60s and 70s. My oxygen saturation has been above 95.
60 2021-03-26 chest discomfort 100? Fever, total body aches, nausea, inflammation, some shortness of breath, chest tightening, fati... Read more
100? Fever, total body aches, nausea, inflammation, some shortness of breath, chest tightening, fatigue, headache.
60 2021-03-27 fainting Site: Pain at Injection Site-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness... Read more
Site: Pain at Injection Site-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: vomiting-Severe, Systemic: Nausea-Severe, Systemic: Shakiness-Medium, Systemic: Vomiting-Severe, Systemic: Weakness-Severe
60 2021-03-28 blood pressure increased, chest discomfort, heart rate increased Heart rate increase Blood Pressure increase Chills Fever Headache Body Ache Tight Chest Lethargy W... Read more
Heart rate increase Blood Pressure increase Chills Fever Headache Body Ache Tight Chest Lethargy Weakness
60 2021-03-28 chest discomfort Chest pressure difficulty breathing
60 2021-03-28 palpitations About 29 hours after, when I went to bed, I noticed my heart was racing. My Fitbit registered 155 bp... Read more
About 29 hours after, when I went to bed, I noticed my heart was racing. My Fitbit registered 155 bpm, normal is around 90. I used my husband?s Apple Watch to do an EKG and it was inconclusive due to rapid pulse. It would go down to 107 and then back up. The highest was 176. I was not lightheaded or feeling sick. I googled this and found it was a thing. I read about a teen who got myocarditis from the Pfizer vaccine and was in ICU. Since that is inflammation, I decided to take a Tylenol and went to sleep. When I got up on the morning I felt fine, pulse was normal. I have not had any more symptoms except this. It was a bit scary.
60 2021-03-28 palpitations BP 153/89, HR 84,O2 100%, 12 lead normal. Anxiety, weakness, palpitations. Exit time 11:22 am.
60 2021-03-30 blood pressure increased pt. reported hx of anxiety and forgot to take medication. BP 152/84. HR-WNL. pt. now wants her BP ... Read more
pt. reported hx of anxiety and forgot to take medication. BP 152/84. HR-WNL. pt. now wants her BP checked. No interventions other than reassurance. pt. verbalized understanding to call 911 for any assistance after leaving clinic.
60 2021-03-30 blood pressure increased 07:50 Client noiticed metalic taste in her mouth, tingling of her tongue and lower lip. 07:58 ... Read more
07:50 Client noiticed metalic taste in her mouth, tingling of her tongue and lower lip. 07:58 154/82 98%pso2 heart rate 81 said thought she should mention it once tingling of her tongue started. No signs of distress. 08:09 tingling gone just feels a sensation on her tongue does not want to be seen in ER or continued to be monitored. States she feels safe to go. Informed to seek medical attention for further problems. Also informed to notify her MD of the event so he can advise for 2nd covid vaccine. 140/82 pso298% heart rate 77. No signs of distress.
60 2021-03-30 chest pain, chest discomfort COMPLAIN OF CHEST BURNING, TIGHTNESS AFTER 5 MINS POST VACCINE. REFUSED TRANSPORT AFTER WATER AND DE... Read more
COMPLAIN OF CHEST BURNING, TIGHTNESS AFTER 5 MINS POST VACCINE. REFUSED TRANSPORT AFTER WATER AND DEEP BREATHING.OBSERVED FOR 45 MINUTES. 154/88, 67,98% 128/86, 69,99%
60 2021-03-30 chest pain After leaving facility, lips were tingling and tongue felt swelling. Little chest pain. Got home ... Read more
After leaving facility, lips were tingling and tongue felt swelling. Little chest pain. Got home and took 2 Benadryl. Symptoms stopped in about 20 min.
60 2021-03-30 hypertension, chest pain Important to share: I had a strong case of Covid in March, 2020. No hospitalization and no need to g... Read more
Important to share: I had a strong case of Covid in March, 2020. No hospitalization and no need to go to hospital but I was very sick for three weeks. Oddly, after Covid I had odd heart pains and erratic high blood pressure. I saw a cardiologist and my heart was fine but it lasted on and off for months. I've been very well for months now. 1) The day after the shot, I felt tired and had a headache, which is expected and no big deal. The evening after the shot I experienced a lot of pain around my heart area. It was very similar to what I experienced post-Covid but more painful. It hurt enough that I went to the ER at Hospital in because of the chest pain. EKG, chest x-ray, and all blood tests were normal. 2) The next day, I fell asleep on a hammock in my backyard. I was wearing jeans and a sweater so the sun wasn't directly on me but I noticed later that the outside of my R leg and the inside of my L leg were covered in a red, lacey-looking rash. Oddly, my arms and torso had no rash. I called my Internist (Dr.) who asked me to email photos. She said it looked like an allergic reaction to the vaccine and advised me to submit info on this site and to take a benedryl. The rash was definitely where the warm sun hit me.
60 2021-03-30 hypertension, heart rate increased, palpitations High blood pressure 160/109 ten minutes after shot. Still elevated at 154/94 on recheck 5 minutes l... Read more
High blood pressure 160/109 ten minutes after shot. Still elevated at 154/94 on recheck 5 minutes later. Patient reports a "pounding" heart. HR was also elevated. Patient reports this happened last time as well.
60 2021-03-30 hypertension pt. c/o of headache on her back side. BP 154/73: P=100; pt. states feeling better. Hx- HTN
60 2021-03-30 low blood platelet count, platelet count decreased After developing blood blisters in my mouth and a rash on my feet & legs, I phone the Advice Nurse ... Read more
After developing blood blisters in my mouth and a rash on my feet & legs, I phone the Advice Nurse and had a phone consult with Dr. I had a blood test the following morning and recieved a call the next morning at 5:40 a.m. directing me to my local Emergency Department as my platelets measured only 16. I checked in 3/30/21 and following a new blood test showing my platelet count was down to 2, a Gastroenterologist diagnosed me with severe ITP. I then was treated with prednisoone, plasma transfusion and IGG (i think) infusion. An additional blood test showed my platelet count rose to 50. A CT scan showed no abnormalities.
60 2021-03-30 palpitations Within 5 minutes, patient began to have blurry vision, chest pounding, and trouble breathing. Epinep... Read more
Within 5 minutes, patient began to have blurry vision, chest pounding, and trouble breathing. Epinephrine (patient thinks 2 doses) and Benadryl administered in the field. Patient brought to hospital by ambulance where she received IV SoluMedrol, Pepcid, Benadryl, and fluids scheduled throughout hospitalization. Patient improved and was discharged the following day (3/27/21).
60 2021-03-30 lightheadedness dizziness, near syncope
60 2021-03-30 fainting fainted; This is a spontaneous report from a contactable consumer (patient) reported that a 60-year-... Read more
fainted; This is a spontaneous report from a contactable consumer (patient) reported that a 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Mar2021 11:30 as a single dose (at the age of 60-years-old) for covid-19 immunisation. The patient medical history was reported as none. The patient was not pregnant at the time of vaccination. Concomitant medications included glipizide and lisinopril both were taken for an unspecified indication, start and stop date were not reported. On 13Mar2021 14:30, the patient fainted and was rushed to the hospital and admitted with outcome of recovered on Mar2021. The reported event resulted in emergency room/department or urgent care, and hospitalization for 1 day on an unspecified date. The patient received treatment for the reported event as Catscan (as reported). The patient underwent lab tests and procedures which included sars-cov-2 test (nasal swab): negative on 13Mar2021. Information on Lot/batch number has been requested.
60 2021-03-30 fast heart rate pt. c/o of tingle on her lip & back of her throat a little redness on nose & cheeks. no shortness ... Read more
pt. c/o of tingle on her lip & back of her throat a little redness on nose & cheeks. no shortness of breath. lungs all clear & vitals BP=142/88; P=82; O2=95%. Hx= tachycardia
60 2021-04-01 chest discomfort, fainting, hypotension Site: Pain at Injection Site-Mild, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Ch... Read more
Site: Pain at Injection Site-Mild, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Fever-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Hypotension-Mild, Systemic: Shakiness-Mild, Additional Details: Patient reported vitals from ER BP=107/70, Liver tests were off due to dehydrated per ER , had fever ,sweats then chills and Headache followed by fatigue for a few days. Patient did notify her PCP
60 2021-04-01 chest discomfort Patient is a 60-year-old female with a past medical history of of restrictive lung disease, Poland s... Read more
Patient is a 60-year-old female with a past medical history of of restrictive lung disease, Poland syndrome right side of the chest, 50% lung capacity at birth s/p multiple surgeries, left breast cancer in 2018 s/p lumpectomy/chemo/radiation, neuropathy presented to the ED with complaints of chest tightness and shortness of breath which started yesterday morning. She reports that she uses oxygen 3 L nasal cannula as needed at bedtime, her O2 sat was 93%, yesterday she was using the oxygen. She received her second dose of Covid vaccine yesterday, the symptoms worsened after that. She received DuoNeb, magnesium sulfate 2 g, Solu-Medrol 125 mg from ED. ED provider planned her discharge, patient states she has to come back after calling EMS since she is hard to breathe. Patient wants to currently she is resting in bed without any distress, O2 sat 96% on room air at the monitor. Her second EKG showed ventricular bigeminy. Troponin 0.012, 0.012. 2 D echo done on 4/29/2019 shows EF 58%, mild concentric LVH. Her BP was high while at ED, states usually normal.
60 2021-04-01 heart rate increased Rapid heartbeat in short bursts for 5-30 seconds at a time. Got worse toward evening. Clocked at 140... Read more
Rapid heartbeat in short bursts for 5-30 seconds at a time. Got worse toward evening. Clocked at 140 beats per minute when it went long enough I could measure it. Same thing the next day.
60 2021-04-01 hypertension 30 minutes after receiving COVID 19 vaccine, patient began to experience blurry/double vision, hyper... Read more
30 minutes after receiving COVID 19 vaccine, patient began to experience blurry/double vision, hypertension and a tingling sensation to her tongue and lips.
60 2021-04-01 palpitations Asthma and heart palpitations
60 2021-04-01 fainting Vaccine administered 07:15, patient reported syncope approx 11:00. Patient was reclined on floor fo... Read more
Vaccine administered 07:15, patient reported syncope approx 11:00. Patient was reclined on floor for 20-30 minutes until episode passed.
60 2021-04-01 fainting syncope about 3 minutes after dose administered. Patient was in reclined chair and recovered quickl... Read more
syncope about 3 minutes after dose administered. Patient was in reclined chair and recovered quickly. Paramedics were called and they assessed her in the store. Patient declined further treatment, walked out of the store on her own, and a relative drove her home.
60 2021-04-02 hypertension, fast heart rate, palpitations Tachycardia, hypertensive episode within 2 minutes. Diarrhea, flushing, and palpitations about an ho... Read more
Tachycardia, hypertensive episode within 2 minutes. Diarrhea, flushing, and palpitations about an hour later, and later that afternoon. Diarrhea, dizziness, fatigue, and palpitations the afternoon of 4/2/2021.
60 2021-04-03 atrial fibrillation, arrhythmia 12-48 hrs post vaccine: nausea, fever, headache, muscle aches, malaise; took tylenol; 48-96 hrs post... Read more
12-48 hrs post vaccine: nausea, fever, headache, muscle aches, malaise; took tylenol; 48-96 hrs post: malaise; 5th-10th day post: coronary vasospasms, malaise, arrhythmia; took nitroglycerin patches, nitro bid paste; 11th day: met with rheumatologist, started medrol dose pack, improved spasms for a short time, 13th day: afib symptoms and Apple Watch reading noted by patient; 15th day spasms began again and increased symptoms of afib: saw doctor in office for EKG showing afib; met with cardiologist ordered increase in diltiazem and second medrol dose pack; first 48 hrs on second dose pack improved spasms, by 3rd day spasms significantly increased and constant afib w headache, dizziness, malaise. Visited ER, admitted. cardio version. Reduced dilitiazem, reduced ramipril, increased isosorbide. Continued symptoms with waxing and waning of spasms and atrial fibrillation . Although this is a pre-existing chronic condition, Afib without relief is not normal. Spasms without resolution not normal nor have I experienced an episode of this duration ever.
60 2021-04-03 atrial fibrillation, palpitations Pt reports onset on nausea and palpitations approximately 10 hours after receiving first dose of vac... Read more
Pt reports onset on nausea and palpitations approximately 10 hours after receiving first dose of vaccine. Pt reports Emergency room visit, where she states she was diagnosed with atrial fibrillation. Pt reports she underwent 3 days of hospitalization, converting spontaneously without treatment to normal sinus rhythm.
60 2021-04-03 loss of consciousness Fainted morning after 2nd Pfizer shot and needed 8 staples for gash on back of my head. Second day a... Read more
Fainted morning after 2nd Pfizer shot and needed 8 staples for gash on back of my head. Second day after shot I woke up with 102 fever and general malice.
60 2021-04-04 chest pain Woke up at 2 AM with severe chest pain, no dyspnea, but she felt like she was going to die. Chills, ... Read more
Woke up at 2 AM with severe chest pain, no dyspnea, but she felt like she was going to die. Chills, back pain (from the front of the chest to the back), slight nausea. Sore arm the next day, chest continued to hurt over the next 24 hours, developing lower right groin pain ~ 32 hours after injection onset. Diaphoretic 36-48 hours afterwards, severe abdominal pain when waking up in the morning . 53 hours s/p injection, pt now feeling queasy.
60 2021-04-04 loss of consciousness Pt got a pfizer COVID vaccine on Saturday 3/27 States that she was out in the sun over an hour to ge... Read more
Pt got a pfizer COVID vaccine on Saturday 3/27 States that she was out in the sun over an hour to get a vaccine and then waited another 40 mins inside a warm building before she got her vaccine States that she had nothing to drink and barely anything to eat and prior to her appt she had been doing yard work States that about 10 mins after she got her vaccine she blacked out, clinic staff noted seizure like activity which resolved prior to EMS arrival. States that this is not the first time she was outside in the sun without water and she passed out before States that the vaccine site thought that this was a reaction to her getting the vaccine but she thinks it was due to her being in the sun for over an hour waiting to get the vaccine States that she has never had any reaction to any vaccines before States that the vaccine site informed her to call her PCP to inform them of what happened States that once she got a few sips of water she felt normal again. Was refereed to PCP who felt most likely related to orthostasis and clearred patient to receive dose # 2.
60 2021-04-04 palpitations Started feeling unusual burning in right arm ( opposite from vaccine side), from wrist to elbow then... Read more
Started feeling unusual burning in right arm ( opposite from vaccine side), from wrist to elbow then elbow to shoulder. Attributed it to tennis elbow from strenuous hitting, then got raised welts like hives following evening on right shoulder. Rash appeared and I started to suspect shingles. ( have never had before) saw doctor on 3/30/2021 and got shingles diagnosis. I believe it is due to the vaccine and have spoken to multiple medical professionals that believe there is a connection. I have had racing heartbeat, numbness on right side of face, severe pain in right ear.
60 2021-04-05 chest discomfort Became nauseated has itchy throat and chest tightness with in 5 mins of receiving the vaccine
60 2021-04-05 heart rate irregular rapid Heart Beat
60 2021-04-05 fainting, loss of consciousness Pfizer-BioNTech COVID- 19 Vaccine EUA: Vaccine recipient is known to have syncopal events after rece... Read more
Pfizer-BioNTech COVID- 19 Vaccine EUA: Vaccine recipient is known to have syncopal events after receiving needles and she did not notify the team. She was sitting in observation when she had a syncopal event and experienced a loss of consciousness for a second. By the time the medic got over to her she was AAOx3 and denied any help from the medic. No further intervention.
60 2021-04-06 blood pressure increased, heart rate increased Patient reports of feeling flush. She reports she feels she has a rash on her hands. Reports of shor... Read more
Patient reports of feeling flush. She reports she feels she has a rash on her hands. Reports of shortness of breath, Blood pressure elevated and elevated Heart rate. Duration: 30+ minutes.
60 2021-04-06 heart rate increased rapid heartbeat; she has been having insomnia ever since she went to the hospital; This is a spontan... Read more
rapid heartbeat; she has been having insomnia ever since she went to the hospital; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 60-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN6199), via an unspecified route of administration administered in the right arm in a hospital facility on 10Mar2021 at 12:30 PM (at the age of 60-year-old) as SINGLE DOSE for COVID-19 immunisation. The patient had no prior vaccinations within 4 weeks and had no additional vaccination administered on same date of the Pfizer suspect. The patient had no medical history (including any illness at time of vaccination. The patient had no family history. Ongoing concomitant medications included amlodipine besylate from 2019, vitamin D3 taken for general health, calcium taken for bone density, and fish oil taken for heart health. On 12Mar2021, the patient experienced rapid heartbeat. The patient continues to have rapid heartbeat "on and off." The patient asked if it was considered a severe allergic reaction. The patient added that she went to the ER and was admitted to the hospital on 12Mar2021 and discharged on 14Mar2021 due to rapid heartbeat. While hospitalized they did an electrocardiogram (EKG); and Echocardiogram and a computerized tomogram (CT) of the heart and chest and all showed no heart disease and no pulmonary embolism. Adds whenever she gets up and does some slight activity, her heart goes for about 30 seconds. Sometimes it goes from 70 to 115 and then goes back. also added that she was going to see her primary care doctor on 29Mar2021 about it. She was scheduled to get the next dose but she was asking if she should get the next dose. She also added that she has been having insomnia on 12Mar2021 ever since she went to the hospital and it was still happening because she was so anxious about this. The events did require emergency room visit but did not required physician office visit. Therapeutic measures were taken as a result of rapid heartbeat which includes amlodipine and metoprolol. The patient had not yet recovered from rapid heartbeat and insomnia.
60 2021-04-06 hypertension, loss of consciousness IMMEDIATELY AFTER VACCINATION I HAD DIZZINESS, VOMITING, MENTAL BLACKOUT, HIGH BLOOD PRESSURE, TOTAL... Read more
IMMEDIATELY AFTER VACCINATION I HAD DIZZINESS, VOMITING, MENTAL BLACKOUT, HIGH BLOOD PRESSURE, TOTAL FATIGUE, HEADACHE. THAT WAS SEEN BY PARAMEDICS
60 2021-04-07 chest pain shortness of breath, chest pain, altered mental status, weakness, hallucinations, admit to hospital ... Read more
shortness of breath, chest pain, altered mental status, weakness, hallucinations, admit to hospital and discharged on 4/2
60 2021-04-07 heart rate abnormal Within an hour I experienced a rapid heartbeat; This is a spontaneous report from a contactable cons... Read more
Within an hour I experienced a rapid heartbeat; This is a spontaneous report from a contactable consumer, the patient. A 60-years-old non-pregnant female patient received first dose of bnt162b2 (Solution for injection, Lot Number: EM9810), via an unspecified route of administration in left arm on 06Feb2021 11:15 as single dose for covid-19 immunisation. Medical history included covid-19 from beginning of Nov2020. There were no concomitant medications. On 06Feb2021 12:15, the patient experienced within an hour I experienced a rapid heartbeat. The patient did not receive any treatment for the events. The clinical outcome of the within an hour I experienced a rapid heartbeat was recovering. No follow-up attempts are possible.
60 2021-04-08 chest pain, fast heart rate, chest discomfort Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Sys... Read more
Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium
60 2021-04-08 heart rate increased, blood pressure increased ~12 hours after vaccination, began experiencing chills, lower back pain, bilateral side/abdominal cr... Read more
~12 hours after vaccination, began experiencing chills, lower back pain, bilateral side/abdominal cramping (gas-like), and rapid heart rate with elevated blood pressure (normal 120s/80 but up to 146/84), was advised to come to EC for evaluation but patient declined
60 2021-04-08 pallor, loss of consciousness The patient received her second Pfizer vaccine at 1401 pm, was monitored in the observation area for... Read more
The patient received her second Pfizer vaccine at 1401 pm, was monitored in the observation area for 15 minutes per pre-vaccination screening, and was discharged to home at 1421 pm without incidence with her spouse who was discharged at 1435 pm. At approximately 1445, the spouse states that the patient lost consciousness in the vehicle and that he panicked and brought her back to the clinic site because he couldn't remember where the hospital was. The patient was found to be sitting in the clinic alert and oriented, pale, diaphoretic, and nauseated. Vital signs were checked at 1457 with B/P of 124/71, O2 sat 99%, HR 80, and blood glucose of 149. After being monitored for 15 minutes in her vehicle, the patient stated she was feeling better and was escorted to the restroom via wheelchair. The patient stated that she felt like she could go home but was advised to call 911 immediately if symptoms returned or she started having any other reactions. The patient and spouse both verbalized understanding and agreement.
60 2021-04-09 chest discomfort tightness in chest; Headache; dizziness; shortness of breath; nausea; itching; severe pain in both k... Read more
tightness in chest; Headache; dizziness; shortness of breath; nausea; itching; severe pain in both knees; numbness in both thighs; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 21Mar2021 14:30 (Batch/Lot number was not reported) at the age of 60 years old, as single dose for covid-19 immunization. Medical history included sleep apnea, history of breast cancer left side lumpectomy, chemotherapy, radiation, asthma, osteoarthritis, vestibular disorder, allergies to unspecified medications and food, and GERD (gastrooesophageal reflux disease). The patient was not diagnosed with COVID prior to vaccination. Concomitant medications included lisinopril (LISINOPRIL); hydrochlorothiazide; hydroxyzine; and meloxicam (MELOX); all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 21Mar2021 03:00, the patient experienced tightness in chest, headache, dizziness, shortness of breath, nausea, itching, severe pain in both knees, and numbness in both thighs. The events resulted in: doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The events were treated with Benadryl, solution medrol pf, sodium chloride. The patient has not recovered from the events. The patient has not been tested for COVID post vaccination. The events were reported as non-serious. Information on the lot/batch number has been requested.
60 2021-04-09 chest pain, chest discomfort pt c/o tingling hands and arms, chest pain 6/10 described as tightness and pressure; pt self medicat... Read more
pt c/o tingling hands and arms, chest pain 6/10 described as tightness and pressure; pt self medicated with Nitrogycerin SL 1 tab 0.6mg; advised by on site physician to go to the hospital, pt did not want to and sign AMA
60 2021-04-09 loss of consciousness Went to bed and woke up at 4 am to pee. Afterwards I blacked out and work up on the bathroom floor; ... Read more
Went to bed and woke up at 4 am to pee. Afterwards I blacked out and work up on the bathroom floor; Anaphylaxis; chest hurt to breathe; Itching in my arms and chest in the evening.; rash; This is a spontaneous report from a contactable healthcare professional (patient). A 60-years-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Left arm on 15Mar2021 at 17:00 (Batch/Lot Number: EP8534) as SINGLE DOSE for covid-19 immunisation. Medical history included Only occasional migraines. Never anything like this and known allergies: Some grasses. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included probiotics (PROBIOTICS) taken for an unspecified indication, start and stop date were not reported; betaine hydrochloride, bromelains, cellulase, pancreatin, papain (DIGESTIVE ENZYMES) taken for an unspecified indication, start and stop date were not reported. On 18Mar2021, at 8pm, the patient reported that "3 days after 2nd shot I started itching in my arms and chest in the evening. Went to bed and woke up at 4 am to pee. Afterwards I blacked out and work up on the bathroom floor. My rash was worse and spreading and chest hurt to breathe and I had bumps on head so we called # and nurse and my husband drove me to (Name). They gave me an IV and epinephrine shot and Pepcid and did CT scan of head and blood work. Diagnosed Anaphylaxis. They sent me home a couple hours later with prescription for Epi pens Zyrtec and Famotidine. Over the course of Friday my rash/hives got worse and spread over my body and my lips /mouth started to swell. I called the nurse who suggested I come back in and they checked by throat to ensure it wasn't closing up and gave me ibuprofen and Benadryl and sent me home. Rash/hives worse and spread all over body and face when I woke up Saturday morning (today). Plan to see specialist Sunday or Monday." The outcome of the events was not recovered. The patient was not tested for COVID-19 after vaccination.
60 2021-04-10 chest discomfort approximately 12 hours after vaccination 4/10 woke up with severe muscle aches, arms, shins, ankles ... Read more
approximately 12 hours after vaccination 4/10 woke up with severe muscle aches, arms, shins, ankles and headache. Also felt nauseous. In morning had very slight fever and sore throat. Overnight on 4/10 woke up with extreme tightening feeling in center of chest Today 4/11 have rash on arm where I received vaccination in an area that covers an oval about 5 x 8". Took Ibuprofen in am for pain then tylenol for slight fever and pain. have marked rash to see if it spreads.
60 2021-04-10 hypertension itching to face and facial flushing. hypertensive 151/108,78, 16,99% RA. After some time the patient... Read more
itching to face and facial flushing. hypertensive 151/108,78, 16,99% RA. After some time the patient Blood pressure improved 146/92. refused transport
60 2021-04-10 fainting, loss of consciousness Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Seizure-Mediu... Read more
Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Seizure-Medium, Additional Details: Thirty minutes after shot, patient passed out and urinated on herself. Plus, had what she discribed as a seizure.
60 2021-04-11 chest discomfort 9 minutes after vaccination patient developed chest discomfort with burning sensation and anxiety. B... Read more
9 minutes after vaccination patient developed chest discomfort with burning sensation and anxiety. BP 151/86 HR 75 RR14 Sat 98% 0.9 % NSS to keep vein open Benadryl 50 mg IV one dose stat
60 2021-04-11 loss of consciousness 18 hours after receiving shot, experienced extreme sweating, chills, diarrhea, dizziness, passed out... Read more
18 hours after receiving shot, experienced extreme sweating, chills, diarrhea, dizziness, passed out in my husbands arms. Husband shook me awake, applied cold compresses, and took two Ibuprofen tablets. Chills and sweating continued for several hours. The following day I was very weak and had a head ache. Next day was better.
60 2021-04-11 fainting Bleeding at injection site. Seven minutes after being seated for observation, I fainted and vomited... Read more
Bleeding at injection site. Seven minutes after being seated for observation, I fainted and vomited while I was out for 5 minutes. An ambulance was called and took vitals for the 20 minutes after I awoke and vitals were all good, so I declined going to the hospital.
60 2021-04-12 atrial fibrillation 4 hours after shot I was in Atrial Fibrillation I waited until Friday hoping they would go away
60 2021-04-12 chest pain Very bad sometimes extreme pain in my left breast area that radiates into my chest area. Hurts to... Read more
Very bad sometimes extreme pain in my left breast area that radiates into my chest area. Hurts to touch my left breast area and the pain is a shooting pain that is constant and feels like a stabbing pain. Hurts to move my left arm. I've been taking 3 Advil at a time and the pain subsides for a couple of hours but comes back. It doesn't matter if I'm sitting up or lying down the pain is always there. I sometimes feel like I've had the wind knocked out of me when the pain radiates to the front of my chest area. There is no longer any pain at the injection site.
60 2021-04-12 pulmonary embolism Two weeks after 1st Pfizer shot I began to have very heavy breathing while on a daily walk that cont... Read more
Two weeks after 1st Pfizer shot I began to have very heavy breathing while on a daily walk that continued with any exertion. It continued for several days. I called PCP and was seen. Chest Xray & bloodwork was done. Was called to go to E.R. for CT scan of lungs. Pulmonary Embolisims were seen and a blood thinner was given. Heart monitored for previous Afib (ablation performed 5 yrs ago). CT scan w/dye was done of abdomen, Right leg ultrasound with compare L, MRI w/contrast done of abdomen/pelvis. No reason has been found for cause of several blood clots in both lungs - sub arteries. Am being followed up by Vascular Doctors in 2 weeks.
60 2021-04-13 blood pressure increased I felt fine following vaccination so kept appointment to donate blood 3 days later. I've donated man... Read more
I felt fine following vaccination so kept appointment to donate blood 3 days later. I've donated many, many times in past without any side effects. It was uneventful. The following AM, I felt exhausted, dizzy, had mild headache, thirsty, and had minimal nausea. And when I tried to do my daily walk of 3 miles, I was SOB on hills so I stopped. I had no F/C, cough, CP, palpitations or resp symptoms at rest. I pushed fluids and rested. I held my BP meds thinking I was a bit dehydrated and maybe my BP was low. After 4 days of no improvement, I went to see my internist. Exam, ECG and CBC, Chem 7 were all normal. BP was mildly elevated so I restarted my meds. These symptoms slowly resolved over next several days and now I feel back to normal. So I don't know if these were delayed side effects to COVID vaccine or due to the blood donation. I'm a bit worried about receiving the #2 vaccine.
60 2021-04-13 chest pain Patient having chest pain and jaw numbness and difficulty breathing
60 2021-04-13 palpitations, heart rate increased, chest discomfort 04/07/21 at 1205 Pt. sitting in Vaccination monitoring area post first dose Pfizer vaccine (lot ER87... Read more
04/07/21 at 1205 Pt. sitting in Vaccination monitoring area post first dose Pfizer vaccine (lot ER8733); noted to be tearful with hand over chest. Voiced "feels like heat is beating fast all of a sudden". 1207 Pt. moved to monitoring cot into semi - reclined position. 1208 BP 140/82, HR 103, O2 sat 99%, R 20. Skin slightly clammy with no skin redness / rash or throat / tongue edema. 1208 EMS called to site. Pt denies medical hx or any allergies. 1213 Pt. voiced "HR starting to feel better, only notes some lightheadedness / spacey feeling; P 91 / Sat 98%. 1215 BP 132/78, P 65, R 18, Sat 98% - Voiced "thinks everything is okay now; notes only dull ache at right arm injection site. Pt. also called husband to site at time. 1217 EMS arrives and pt. assessed. 1226 EMS provided pt. education on self monitoring & hospital f/u. Pt. declines transport to hospital; will monitor self at home with assist of husband: sitting on side of cot. 1228 EMS departed scene and pt. husband now present; P - 61 and O2 98%. 1229 Pt. and husband voiced readiness to leave. Educated to let pt. PCP know about events post vaccination. Pt. voiced understanding and will just monitor self at home. Both ambulated to from site together
60 2021-04-14 pulmonary embolism Pt developed symptoms of a pulmonary embolism (4/3/21) 10 days after 1st vaccine (3/24/21) Presented... Read more
Pt developed symptoms of a pulmonary embolism (4/3/21) 10 days after 1st vaccine (3/24/21) Presented to hospital 4/12 with progressive symptoms. Diagnosed and started on blood thinners with tpa administration for severe right heart strain followed by discharge home.
60 2021-04-15 heart rate irregular, hypertension, heart rate increased ueststarted to develop high heart rate and hypertension....150/100 initially. started hypertensive ... Read more
ueststarted to develop high heart rate and hypertension....150/100 initially. started hypertensive therapy. after second shot on April 8, (Thursday), BP went to 155/108. had an irregular heart rate...and constrictive feeling around my neck. thyroid lab studies were abnormal. my
60 2021-04-16 chest pain 4 days following the injection I had chest pain similar to the reaction after Dupixent injection.
60 2021-04-16 palpitations Pt felt her heart racing and a flushed feeling over her body. After a few minutes, symptoms resolved... Read more
Pt felt her heart racing and a flushed feeling over her body. After a few minutes, symptoms resolved without any intervention.
60 2021-04-16 superficial blood clot experienced extreme pain on my inner thigh on my left leg; It was hot to the touch, very red and swo... Read more
experienced extreme pain on my inner thigh on my left leg; It was hot to the touch, very red and swollen; It was hot to the touch, very red and swollen; It was hot to the touch, very red and swollen; difficulties to sleep and walk; difficulties to sleep and walk; Superficial Thrombophlebitis; This is a spontaneous report from a contactable consumer (patient). A 61 year old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EL9263, expiry date not reported), at the age of 60 years old, via an unspecified route of administration, administered in left arm on 02Feb2021 09:00 at a single dose for covid-19 immunisation. The patient then received the second dose of covid-19 immunisation on 23Feb2021 08:00 AM (lot EN6200), via an unspecified route of administration, administered in the left arm. Medical history included rheumatoid arthritis and multiple sclerosis, both from an unknown date and unknown if ongoing. The patient was not pregnant at the time of vaccination and the events. The patient no covid prior to vaccination. The patient's concomitant medications were not reported. The patient was not tested for covid post vaccination. Soon after COVID-19 vaccination, on 21Feb2021, patient experienced extreme pain on inner thigh on left leg. It was hot to the touch, very red and swollen causing difficulties to sleep and walk. Patient then saw a vascular doctor for the pain on 16Mar2021 and was advised that patient have superficial thrombophlebitis (since 21Feb2021) and was prescribed to take Xarelto 15 mg for two weeks. Therapeutic measures were taken as a result of the events reported which included Xarelto 15 mg and had a venous ultrasound of area on an unknown date (unknown results). The events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events reported was recovering.
60 2021-04-17 nosebleed I'm 60 years old and have never had a nosebleed in my life. I had a severe nosebleed two weeks after... Read more
I'm 60 years old and have never had a nosebleed in my life. I had a severe nosebleed two weeks after first vaccine and two weeks after second vaccine. I was able to stop the bleed myself at home with pressure and ice.
60 2021-04-18 blood pressure increased, chest discomfort 2 days after shot I felt unable to get deep breaths, slight pressure in chest and feeling of shortne... Read more
2 days after shot I felt unable to get deep breaths, slight pressure in chest and feeling of shortness of breath. 3rd day cough developed, and continued for 6 days, now is improved but still slight cough and not quite normal
60 2021-04-18 deep vein blood clot Deep Vein Thrombosis right leg, superficial femoral vein to popliteal vein and distal
60 2021-04-18 hypotension, fainting Patient had syncopal episode falling from seated position in chair 10 minutes after vaccination. Pt ... Read more
Patient had syncopal episode falling from seated position in chair 10 minutes after vaccination. Pt had low BP and was transported to the hospital
60 2021-04-18 fainting Patient had syncopal episode 10 minutes after being vaccinated and fell off the chair from a seated ... Read more
Patient had syncopal episode 10 minutes after being vaccinated and fell off the chair from a seated position. Blood pressure was low and patient was transported to the hospital for evaluation.
60 2021-04-19 chest discomfort, oxygen saturation decreased Received the shot about 1:30. Everything was fine. By evening, the arm was sore and left armpit hu... Read more
Received the shot about 1:30. Everything was fine. By evening, the arm was sore and left armpit hurt. Went to bed about 10. Woke up about 1:30/2:00 with left arm hurt a lot. Took Advil and went back to bed. Woke up at 4 am to get ready for work and felt awful. Noticed was out of breath on short horizontal walk from bedroom to bathroom, chest tight, acting like an asthma attack. Took a puff of albuterol inhaler and went back to sleep. Got up just before 7, still sore to breath. Grabbed oximeter (being asthmatic, I have one) and noticed )s level down to 94/95 when normally it reads 98/99 on this one. Called allergist to cancel allergy shot scheduled for that morning. Took another puff of albuterol. (Waiting to see if need nebulizer.) Breathing becoming easier and reading now about 97/98 with pulse lower, more normal. Lungs a bit touchy this time of year anyway. And I have had allergic reactions in the past take place as an asthma attack. (For instance, if I eat a small quantity of something with yellow dye 5 in it, I will notice that my breathing is more difficult.)
60 2021-04-19 fainting, haemoglobin decreased, very slow heart rate, hypotension, troponin increased Pfizer-BioNTech COVID-19 Vaccine EUA: patient presents to emergency department (ED) bradycardic and ... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: patient presents to emergency department (ED) bradycardic and hypotensive three days after vaccination and immediately following a syncopal episode. Found to have high grade AV block while on metoprolol and verapamil. Patient admitted and symptoms improved with glucagon administration and medication dose adjustments. Discharged to home medically stable.
60 2021-04-20 atrial fibrillation vaccine 4/16 and afib 4/18 resulting in hospitalization
60 2021-04-20 blood glucose increased DIZZINESS, ATAXIA, WEAKNESS FOR 1 WEEK, THEN DEVELOPED HYPERGLYCEMIA AND DEHYDRATION AND ACUTE DELIR... Read more
DIZZINESS, ATAXIA, WEAKNESS FOR 1 WEEK, THEN DEVELOPED HYPERGLYCEMIA AND DEHYDRATION AND ACUTE DELIRIUM AND HYPERTENSIVE EMERGENCY REQUIRING ICU HOSPITALIZATION
60 2021-04-20 fainting, blood clot, pallor I fainted; blood clots; light headed; I lost all color and my skin was wet and clammy; I lost all co... Read more
I fainted; blood clots; light headed; I lost all color and my skin was wet and clammy; I lost all color and my skin was wet and clammy; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EN6199, via an unspecified route of administration, administered in right arm on 04Mar2021 15:00 as single dose for Covid-19 immunisation. Medical history included known allergies to Atovaquone/proguanil. Concomitant medications were not reported. On 04Mar2021, approximately 10 minutes post vaccine, the patient fainted in the waiting area. She was told by a witness that she fainted two times. EMTs administered an IV and did a simple EKG. The patient lost all color and her skin was wet and clammy. EMTs were concerned about her heart and transported her to the ER where she had a full EKG and lab work for D-Dimer to consider blood clots. The patient has remained lightheaded for weeks after the vaccine. The outcome of the events was recovered with sequelae.
60 2021-04-21 heart rate increased Rapid heart rate that started 3 days after vaccination On April 20 rapid heart rate around 5pm and ... Read more
Rapid heart rate that started 3 days after vaccination On April 20 rapid heart rate around 5pm and was 103 the it fluctuates between that and 110/114. Stayed elevated constant and called the clinic to report and appointment. Was seen by a dr and immediately transferred to ER. Test done for heart attack and blood clot. Negative. It slowly came down and was released with instructions if persist to contact provider and heart monitor might be option. O4/22 and still hovering around 95.
60 2021-04-21 palpitations Severe migraine, heart palpitations and nausea lasting 24 hours
60 2021-04-22 chest discomfort post vaccine pt was noted to have a light rash on upper extremities, c/o of tightness in chest. Pt o... Read more
post vaccine pt was noted to have a light rash on upper extremities, c/o of tightness in chest. Pt offered Benadryl and refused as pt had a full schedule planned today. Pt expressed that she was feeling well enough to leave on her own. Pt was released at 10:47 am vital as follows: 1032 BP 136/89 HR 94 RR 20 SpO2 97% 1040 BP 137/91 HR 92 RR 20 SpO2 98% 1045 BP 138/90 HR 83 RR 18 SpO2 99%
60 2021-04-22 chest pain, heart rate increased, blood pressure increased Have had rapid heartbeat, little shortness of breath, blood pressure has been elevated. More severe ... Read more
Have had rapid heartbeat, little shortness of breath, blood pressure has been elevated. More severe than normal heartburn, little burning in chest and gallbladder pain. not sleeping well because of it
60 2021-04-23 loss of consciousness Pt became dizzy, diaphoretic and felt like passing out approx 10 minutes after receiving the vaccine... Read more
Pt became dizzy, diaphoretic and felt like passing out approx 10 minutes after receiving the vaccine. Upon arrival to med obs area, pt was alert. BP 97/68, HR 76, O2 95%. Pt rested on gurney and felt better shortly after having water and crackers. recheck BP 109/72, O2 94%. Pt stayed in observation until 1300, with last check of BP 112/67, HR 76 and O2 97% while standing. Pt felt comfortable being released. She was discharged with her daughter in her own wheelchair.
60 2021-04-24 cerebrovascular accident Stroke - Cerebellar hemorrhage. Had to have brain surgery to relieve the pressure and a drain placed... Read more
Stroke - Cerebellar hemorrhage. Had to have brain surgery to relieve the pressure and a drain placed. She has a history of low blood pressure, never high. They did an angiogram that came back normal and an MRI as well. They have been unable to find a cause of the stroke at this time. She was in ICU for four days then Neuro PCU for about 4 days and now she is in inpatient rehab. She is currently learning to walk and has weakness on her whole left side. Vision issues. And motor control issues of the left arm. The stroke came on very sudden and she felt fine before her sudden ?worst migraine ever?. Luckily my brother was with her and took her to get help straight away before she became unconscious.
60 2021-04-24 chest pain intermittent chest pain; This is a spontaneous report from a contactable consumer (patient). A 60-ye... Read more
intermittent chest pain; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) via an unspecified route of administration on an unspecified date in 2021 (60-year-old at time of vaccination), at single dose, for COVID-19 immunization. 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, batch/lot number and expiration date unknown) via an unspecified route of administration on an unspecified date (unknown age at time of vaccination), at single dose, for COVID-19 immunization. Patient reports that she received second dose of vaccine on the day of reporting and has started to experience intermittent chest pain. Patient would like to know what she should do about the chest pain. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
60 2021-04-24 heart rate increased Fever; Fast heart rate; Shortness of breath; This is a spontaneous report from a contactable consume... Read more
Fever; Fast heart rate; Shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received the second dose of bnt162b2, via an unspecified route of administration, administered in Left arm on 05Apr2021 17:00 (Lot Number: EW0150) as single dose for covid-19 immunisation. Medical history included ongoing cholesterol high (States it doesn't require to take medication, it's under control. Diagnosed in 2016-2017). The patient's concomitant medications were not reported. The patient received the first dose of bnt162b2, via an unspecified route of administration on unspecified date (Lot Number: EN6204) as single dose for covid-19 immunisation and the patient sprained her ankle and it is a little swollen, not so much. The patient experienced fast heart rate, shortness of breath on 06Apr2021; fever on 06Apr2021 10:00. Her symptoms started with a fast heart rate and a little shortness of breath. She went to the doctor and had an echocardiogram which was negative for any heart problems. She adds that she had the vaccine on Monday, on Tuesday she had fever. Her fever started in the morning at 10:00 and had it the whole day until 2200-2300 that same night. Her fever reached 100.6 degrees Fahrenheit. She did not treat the fever in any way. Her fast heart rate started on Tuesday, which come and goes. She did not treat her symptoms in any way after the second dose. The doctor had told her it would be better if she doesn't take anything. The events fast heart rate, shortness of breath required a visit to physician office. The outcome of the event Fast heart rate was recovered on 08Apr2021, fever was recovered on 06Apr2021 23:00, Shortness of breath was recovering. No follow-up attempts are needed. No further information is expected.
60 2021-04-24 fainting Had 2nd Pfizer vaccine at 11:00 a.m. on April 2, 2012. On morning of April 3, 2021 woke up around 7:... Read more
Had 2nd Pfizer vaccine at 11:00 a.m. on April 2, 2012. On morning of April 3, 2021 woke up around 7:15 a.m. and walked to kitchen to get Tylenol and fainted. Received 8 staples at Emergency Room. Had a fever for 5 days between 100.4 and 102
60 2021-04-24 blood clot Blood Clot; This is a spontaneous report from a contactable nurse. A 60-year-old female patient (no... Read more
Blood Clot; This is a spontaneous report from a contactable nurse. A 60-year-old female patient (no pregnant) received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6208), intramuscular at the age 60-year-old at arm right on 11Mar2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200), intramuscular at the 60-year-old at right arm on 19Feb2021 for COVID-19 immunisation and experienced pneumonia. There was no other vaccine in four weeks. Facility type vaccine was reported as public health clinic/administration facility. The patient experienced blood clot on Mar2021 after 2nd. The patient was hospitalized for event for 5 days. Adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness. The patient received the treatment for event. The outcome of event was unknown.; Sender's Comments: Based on information available, a possible contribution role of the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of event clot blood cannot be completely excluded. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021422806 same patient/product, different dose and event
60 2021-04-25 blood pressure increased, hypertension 60 y/o female, with past medical history HTN, anxiety, high cholesterol, and artery stenosis seen to... Read more
60 y/o female, with past medical history HTN, anxiety, high cholesterol, and artery stenosis seen today for report of feeling lightheaded, hot flashes, tremors and the feeling of something cold running through her legs going to her stomach about 5 minutes post vaccination. Patient also reports that she took her medications this morning. (amlodipine 5 mg, HCTZ 12.5 mg, Atorvastatin 40 mg, metoprolol ER 100 mg, and escitalopram 10 mg. Patient states that this is her second dose in the series. NP and Paramedics at patient side. Patient is hypertensive despite taking all blood pressure medications. B/P 184/88, HR 78, 99% RA, 19 Resp, bs 108). Bottle of water provided to patient and her legs were elevated on a chair. Repeat BP obtained. Patient BP decreased to 187/82. Patient blood pressure is still elevating 152/76 and still complains of coldness feeling that moves to her abdomen. Patient advise to go the hospital. Patient and her husband agree to go the hospital. Patient transferred to the hospital accompanied by her husband.
60 2021-04-26 chest pain Body aches, skin feels like its burning but no fever, psoriasis flared up on my legs and it had been... Read more
Body aches, skin feels like its burning but no fever, psoriasis flared up on my legs and it had been cleared up, frequent chest pains.
60 2021-04-26 lightheadedness This is a spontaneous report from a contactable consumer who reported for herself, a 60-year-old fem... Read more
This is a spontaneous report from a contactable consumer who reported for herself, a 60-year-old female patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Ew0158), via an unspecified route of administration, administered in right arm on 08Apr2021 at 16:00 (at the age of 60 years old) at a single dose for COVID-19 immunization. Medical history included overactive immune system, valley fever, Lyme disease, and known allergies to penicillin and morphine. The patient was not pregnant at the time of vaccination. Patient had no COVID prior to vaccination and was not COVID tested post vaccination. Concomitant medications included supplements. Patient had no other vaccines in four weeks. On 09Apr2021, patient experienced very sore arm and vertigo. Then 24 hours later, on 10Apr2021, a feeling of dizziness/severe dizziness and nausea that comes and goes - which has been going on for days. It felt like patient was about to pass out. The patient was not able to stand, she can't stand up. Her body suddenly got hot then followed by feeling chills, but no fever. She was feeling so odd and severe brain fog. The patient was feeling so ill. She tried to call Pfizer because she wanted to know how long this will be going on. She didn't know whether to take the second dose. She felt so sick she couldn't drive or work. The events resulted in doctor or other healthcare professional office/clinic visit. Unspecified treatment was received for the events vertigo, dizziness, nausea, "Not able to stand/can't stand up" and "feeling so ill/feel so sick". The outcome of the events was not recovered.
60 2021-04-26 fainting, loss of consciousness This is a spontaneous report from a contactable consumer. A 60-year-old female patient received bnt1... Read more
This is a spontaneous report from a contactable consumer. A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 27Mar2021 12:30 (at the age of 60-years-old) (Batch/Lot Number: ER-8730) as SINGLE DOSE for covid-19 immunization. Medical history included Hypothyroid, High Blood Pressure. Concomitant medications included levothyroxine sodium (SYNTHROID); losartan potassium (LOSARTIN); amlodipine; hydrochlorothiazide; all taken for unspecified indications, start and stop dates were not reported. On 27Mar2021 13:30, the patient experienced Bleeding at the site, fainting and vomiting while passed out for 5 minutes. The patient believes the injection was too high and she hit a vein. It was further reported that the patient is not a squeamish person and have never had reactions to any shots or blood draws in the past. The event fainting and passed out was assessed as serious (medically significant). Therapeutic measures were taken as a result of bleeding at the site. The patient did not receive treatment for the events fainting, passed out, and vomiting. The outcome of the events was recovered.
60 2021-04-26 fast heart rate Tachycardia within 5 minutes of injection. Elevated HR for about 3 days; This is a spontaneous repo... Read more
Tachycardia within 5 minutes of injection. Elevated HR for about 3 days; This is a spontaneous report from a contactable consumer (Patient herself). A 60-year-old non-pregnant female patient received first dose BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6201, Expiration date: Unknown) via an unspecified route of administration in the left arm on 09Feb2021 12:15 as SINGLE DOSE for covid-19 immunisation. The patient's medical history included genital herpes and gastro oesophageal reflux disease from an unknown date and unknown if ongoing. The patient previously took morphine and flagyl and experienced drug hypersensitivity. The patients concomitant medications were not reported. On 09Feb2021 12:30 she experienced tachycardia within 5 minutes of injection and she had elevated heart rate for about 3 days on. She also had other medications in two weeks. She had no other vaccine in four weeks. The patient underwent lab tests and procedures which included heart rate: elevated. The outcome of event was recovered with sequele.
60 2021-04-27 cerebrovascular accident thought she was having a stroke; severe cramp in her left leg below the knee to her toes and it is e... Read more
thought she was having a stroke; severe cramp in her left leg below the knee to her toes and it is extremely painful; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration in the right arm on 09Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included ongoing blood pressure high diagnosed about 7-8 years ago. The patient's concomitant medications were not reported. The patient got her first dose of the Pfizer Covid vaccine on 09Apr2021. On Saturday, 10Apr2021, she got this severe cramp in her left leg below the knee to her toes and it is extremely painful and thought she was having stroke. She stated that she was treating with a warm cloth and was going to go to the emergency room; rubbing down in case there is a blood clot. She wanted to know if this could be from the vaccine. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
60 2021-04-27 deep vein blood clot DVT Right Leg; This is a spontaneous report from a contactable other healthcare professional (patien... Read more
DVT Right Leg; This is a spontaneous report from a contactable other healthcare professional (patient). A 60-year-old female patient received second dose bnt162b2 (BNT162B2), via an unspecified route of administration, administered in right arm on 04Feb2021 08:30 (Lot Number: EL1283), at the age of 60-years at vaccination, as SINGLE DOSE for covid-19 immunisation. Medical history included osteoarthritis, asthma, fibromyalgia. Historical vaccine includes first dose of BNT162B2, Lot number: EL1283, on 14Jan2021 08:45 AM in left arm at the age of 60-years. The patient is not pregnant at the time of vaccination. The patient did not have COVID-19 prior vaccination. Concomitant medications included etodolac (LODINE); montelukast; amitriptyline; acetylsalicylic acid (BREOPRIN), all were taken for unspecified indication, start and stop date were not reported. The patient previously took Vioxx and experienced allergies. The patient experienced DVT on right leg on 21Feb2021 with outcome of recovered. The event required physician office visit. The patient has not been tested for COVID-19 post vaccination. Therapeutic measures were taken as a result of DVT in right leg which includes Eliquis.
60 2021-04-27 hypertension Received Vaccine on 12/19/20 around 5pm. next day Sunday on 5/20/20 in the evening had, nausea, a... Read more
Received Vaccine on 12/19/20 around 5pm. next day Sunday on 5/20/20 in the evening had, nausea, abdominal pain, headache, fatigue symptoms worsened to include chills and fever went to Emergency room 12/21/20 evening, had high Blood pressure and fever. had labs done, bedside ultrasound, and Abdominal CT. was diagnosed with Acute Appendicitis. I just learned that Appendicitis was one of the serious adverse side effects of the Pfizer Vaccine.
60 2021-04-27 heart attack heart attack; This is a spontaneous report from a contactable consumer (patient herself). This 60-y... Read more
heart attack; This is a spontaneous report from a contactable consumer (patient herself). This 60-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route of administration in the right arm, on 06Mar2021 at 15:30 (Lot number EN6203) as single dose and the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route of administration in the left arm, on 27Mar2021 at 15:30 (Lot number EP7534) as single dose, for COVID-19 immunisation. Relevant medical history included allergy to nickel and latex). Past drug history included allergy to penicillin. Relevant concomitant medications included ezetimibe, chondroitin sulfate, glucosamine, biotin and vitamin (unspecified). No other vaccine was received in four weeks. The patient had a mild heart attack approximately two weeks after her first dose of the vaccine (untreated) in Mar2021 and a major heart attack 2 weeks to the day after her second dose (11Apr2021, at 02:00). The patient visited the emergency room and she was hospitalized for 5 days. The event was also considered serious as life-threatening. Therapeutic measures taken as result of the event includes angioplasty. The patient was recovering from the event.
60 2021-04-28 haemoglobin decreased, platelet count decreased, low platelet count 50 year old female had 1st Covid Pfizer vaccine on 3/18/21 and second dose on 4/14/21. Developed muc... Read more
50 year old female had 1st Covid Pfizer vaccine on 3/18/21 and second dose on 4/14/21. Developed mucosal bleed in tongue and lips. Went to the ER on 4/25/21 and found to have WBC 8.1, Hb 10.2, Plt 10K. Peripheral smear showed thrombocytopenia, no platelet aggregates. WBCs were normal. RBCs showed mild normochromic, normocytic anemia. Patient was started on Prednisone 60mg x 3 days. PLT increased to 75K on 4/27/21 and patient was discharged on 4/27. She was seen in the outpatient clinic on 4/29/21, on Prednisone 50mg . Her Prednisone taper is planned at 50mg x 3d, 40mg x 3d, 30mg x 3 days, 20mg x 4 days, 10mg qd then office visit scheduled again to monitor response. Bleeding spot from the tongue, and lips resolved.
60 2021-04-28 palpitations Driving home my eyes were sensitive to light and I couldn't see, very sensitive, and soon as I got h... Read more
Driving home my eyes were sensitive to light and I couldn't see, very sensitive, and soon as I got home I experience flashes of light, then string of lights going off and on, by Thursday, the string of lights were wider and were everywhere. There were flashes of light like being on the red carpet and you can t see because of the flash of lights. I also had heart palpitations. Now I have blurry eye vision and my eyes are puffy and feels like something is inside my eye.
60 2021-04-28 blood clot, pulmonary embolism, chest pain multiple pulmonary embolisms/Pulmonary embolism and subsegmental pulmonary embolus; felt sluggish di... Read more
multiple pulmonary embolisms/Pulmonary embolism and subsegmental pulmonary embolus; felt sluggish directly; feeling discomfort in my lungs; pain in my lung/chest area; pain in my lung/chest area/right-sided chest pain under the rib; difficult and extremely painful to breathe/significant shortness of breath/shortness of breath due to extreme pain; blood clots; This is a spontaneous report from a contactable consumer (patient) and physician. A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EP7534 and expiration date not provided), via an unspecified route of administration, administered in Arm Left second dose on 07Apr2021 17:00 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient was not pregnant at time of vaccination. The patient's concomitant medications included cetirizine, diphenhydramine, and phenylephrine. The patient historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6203), right arm first dose on 10Mar2021 for COVID-19 Immunization. On 07Apr2021 21:30, the patient felt sluggish directly after receiving the second dose. The patient began feeling discomfort in my lungs about 5 hours after the dose. The pain in my lung/chest area grew worse throughout the night to the point where it was difficult and extremely painful to breathe. The patient went to urgent care in the morning, and they ran an EKG, urine analysis, and chest X-ray: all with unknown results. They were concerned it could be something worse along with potential pneumonia, so they sent me to the emergency room. In the emergency room, I received a CT scan where they found multiple pulmonary embolisms (1 large one in my right and multiple in my left lung). The patient stated that she had just had my yearly physical the previous week (Apr2021), with no signs of any health issues. With that, the doctors believed my condition to be related to my 2nd dose, so I was admitted to the hospital. I had to stayed for 2 nights. I am now on blood thinners, other meds (pain medications), and require oxygen during sleep (O2 levels drop too low). I have been referred to lung and hematology specialists. Also, reported that patient experiencing significant shortness of breath and right-sided chest pain under the rib. This persisted for some time until she presented to the emergency department found to have segmental and subsegmental pulmonary embolus. Additionally, the patient experienced blood clots, chest pain, and shortness of breath due to extreme pain. Hypercoagulable work-up pending. The patient underwent lab tests and procedures which included COVID-19 virus test (nasal swab) with result of negative. The outcome of the events was recovering.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events occurred in a plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified.
60 2021-04-29 cardiac arrest Cardiac Arrest at 1:30 pm on 4/30/2021. . Arrest was witnessed by family and Emergency Medical Pe... Read more
Cardiac Arrest at 1:30 pm on 4/30/2021. . Arrest was witnessed by family and Emergency Medical Personnel. Cardiopulmonary Resuscitation was initiated. Pt was very anxious when EMS arrived.
60 2021-04-29 brain sinus blood clot Cerebral venous sinus thrombosis Patient received vaccine in March (exact date is unknown but around... Read more
Cerebral venous sinus thrombosis Patient received vaccine in March (exact date is unknown but around March 8-12 per husband); in mid-April patient started reporting intermittent low intensity headaches. On April 23, patient had severe headache and vomiting, went to urgent care and was thought to have sinusitis and started on antibiotics and discharged home. On April 24th, patient became more drowsy with worsening headache and unresponsive. On April 25, she was taken to outside hospital and was noted to have abnormal brain MRI. She was transferred to our facility on April 26 after clinical worsening. Imaging revealed venous sinus thrombosis in deep cerebral veins and patient was intubated due to worsening mentation. Imaging also revealed a venous stroke with hemorrhage in her left thalamus and diffuse brain edema. Treatment includes extraventricular drain placement, anticoagulation (heparin), hypertonic saline to manage brain edema. We also did extensive workup but no history of hormone therapy, contraceptive pills, underlying cancers. Tumor markers are negative. Hypercoagulable panel and rheumatologic panel are negative. Body imaging did reveal multiple uterine fibroids but no other cancer. Patient remains in the ICU, on the ventilator, heavily sedated for management of refractory intracranial hypertension.
60 2021-04-29 excessive bleeding significant blood in urine for 3 days after vaccine. seems to be clearing up by 4th day
60 2021-04-30 chest pain Chest pain/dizziness/throat swelling/weakness. 0.3 autoinjector EpiPen and 50mg IM Benadryl given wh... Read more
Chest pain/dizziness/throat swelling/weakness. 0.3 autoinjector EpiPen and 50mg IM Benadryl given while patient was observed for acute life-threatening changes. EMS came and took the patient in a distressed but stable condition to the nearest ER.
60 2021-04-30 chest pain my chest started hurting; I couldn't breathe; This is a spontaneous report from a contactable health... Read more
my chest started hurting; I couldn't breathe; This is a spontaneous report from a contactable healthcare professional (reported for herself). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Dec2020 16:00 (lot number: not reported) as single dose for COVID-19 immunisation. Medical history included mild asthma. The patient is not pregnant. Concomitant medications included lisinopril; fexofenadine hydrochloride (ALLEGRA); and estradiol. The patient previously took morphine, tramadol, and nickel and all had known allergies. The patient experienced her chest started hurting and she couldn't breathe the next day (29Dec2020). She slept for 2 days. Symptoms progressed and got worse and she had been to the emergency room (ER) five times. She also had many Doctor (Dr) appointments and symptoms had not improved. The events assessed as serious with disability and hospitalization of one day. Treatment received for these events included dexamethasone, duo neb, lorazepam, and hydromorphone. No COVID prior to vaccination and COVID tested post vaccine (unspecified date): unknown results. No other vaccines received in four weeks. The outcome of the events was not recovered. Information on about lot /batch number has been requested.; Sender's Comments: Drug causality for suspect drug in the onset of the reported events cannot be excluded assuming a plausible temporal association and considering the known safety profile of the product. The impact of this report on the benefit/risk profile of the Pfizer drug 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.
60 2021-04-30 deep vein blood clot, fibrin d dimer increased, oxygen saturation decreased, fainting DVT blood clot; ankle was still swollen and uncomfortable; ankle was still swollen and uncomfortable... Read more
DVT blood clot; ankle was still swollen and uncomfortable; ankle was still swollen and uncomfortable/discomfort; nights were the worst for the pain; pulse ox was low; d-dimer was very high; fainted; Fracture of ankle/two fractures on her ankle; severely nauseous; Vomiting; Diarrhea; deathly sick; This is a spontaneous report from a contactable consumer, reporting for herself. A 60-year-old female patient received the first dose of the bnt162b2 (BNT162B2; Lot Number: ER8727), via an unspecified route of administration in the left arm on 26Mar2021 at 14:00 at a single dose for covid-19 immunisation. Medical history included osteoporosis at least 10 years, terrible nausea, mild case of covid from Nov2020 to an unknown date. There were no concomitant medications. The patient previously took alendronate from 2008 to an unknown date and experienced very sick, nausea, diarrhoea and zoledronic acid (RECLAST) from Dec2017 and experienced nausea and vomiting. On 27Mar2021 at 2:00, the patient experienced deathly sick, fainted, fracture of ankle/two fractures on her ankle, severely nauseous, vomiting, and diarrhea. On an unknown date, the patient experienced dvt blood clot, ankle was still swollen and uncomfortable/discomfort, the nights are the worst for the pain, pulse ox was low, and d-dimer was very high. The event, deathly sick, was life-threatening. The clinical course was as follows: the patient had the first dose of the vaccine on 26Mar2021 at 14:00 in the afternoon in her left arm. Twelve hours after the first dose, later in the night about 02:00 AM she woke up deathly sick; and severely nauseous. She remembered she was going to the bathroom then she must have fainted because they were taking her to the hospital. She went to the ER and they found she had a fractured ankle. She was not admitted to the hospital. She was in the ER from about 03:00 AM to noon the next day. There must have been something in there; she knew there must be something in the vaccine because of her reaction. Adds a few years ago, something like this happened before. She had osteoporosis and had similar reactions with other products she had tried for osteoporosis; she had terrible nausea. The other products she tried included: in 2008 she took alendronate, it made her very sick but not as severe as this time, she never fainted. She had nausea and diarrhea. Then in Dec2017 she had zoledronic acid. She went for an infusion at the hospital then went shopping, and was fine until the early morning, when she woke up with nausea and vomiting. In the ambulance, they gave her ondasetron (ZOFRAN) for the nausea so the vomiting stopped. With regard to her ankle, first they thought it was a DVT blood clot. They did the xray and saw actually two fractures on her ankle but she does not need surgery. She saw the orthopedic doctor the other day and he said her ankle was healing but she still will have no weight bearing for 6 weeks and she was in a boot. Adds her ankle was still swollen and uncomfortable. She hated to take medications and they gave her oxy but she didn't want to take it. She was taking ibuprofen but that messed up her stomach. The nights are the worst for the pain and discomfort. Doctor at the hospital and primary care agreed she should not have the second dose. She did have mild case of COVID in Nov2020 and they are hoping she had antibodies from the infection and the first dose. Her primary care doctor was reviewing the blood work she had done at the hospital and told her they were surprised the hospital didn't admit her for observation because her pulse ox was low and there was another test that she was questioning because the d-dimer was very high. They did a chest x ray with unknown results. The doctor was questioning why they didn't do something else to rule out a blood clot. Therapeutic measures were taken as a result of the events, deathly sick, DVT blood clot, fainted, fracture of ankle/two fractures on her ankle, severely nauseous, vomiting, diarrhea, ankle was still swollen and uncomfortable/discomfort, nights were the worst for the pain, pulse ox was low, and d-dimer was very high. The clinical outcome of the events, deathly sick, fainted, severely nauseous, vomiting, diarrhea, was recovered on 27Mar2021. The clinical outcome of the events, DVT blood clot and nights were the worst for the pain, pulse ox was low, and d-dimer was very high, was unknown. The clinical outcome of the event, fracture of ankle/two fractures on her ankle, was recovering. The clinical outcome of the event, ankle was still swollen and uncomfortable/discomfort, was not recovered. No follow-up attempts are needed. No further information is expected.
60 2021-04-30 nosebleed anaphylactic reaction; anti kell antibodies in her blood; nausea; her left and her right hips, both,... Read more
anaphylactic reaction; anti kell antibodies in her blood; nausea; her left and her right hips, both, had severe pain/her right knee joint is in severe pain; she could barely walk and she couldn't bend at all; really weak; had leg aches; she couldn't stay awake/she couldn't sleep again; diarrhea; severe pain at the back of her neck with a headache; severe pain at the back of her neck with a headache; had extreme fatigue; lightheadedness; upper back pain; bloody nose; she couldn't see out of her left eye for about 2 hours; she couldn't breathe; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8731), via an unspecified route of administration, administered in Arm Right on 08Apr2021 10:41 as SINGLE DOSE for covid-19 immunisation (Age at vaccination: 60 years). Medical history included ongoing chronic obstructive pulmonary disease, ongoing chronic kidney disease and Positive ANA. The patient's concomitant medications were not reported. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8727) on 18Mar2021 for covid-19 immunisation and experienced First dose: a little bit of soreness and swelling all on the site. The patient stated that during her second dose last Thursday on 08Apr2021, she had an anaphylactic reaction and she couldn't breathe and long story short she had to go to the emergency room and she was given all kinds of epi shots and treatment and stuff and eventually she had to be kept in the ICU unit. She is not sure why she had such a severe reaction. She wanted to report that since then she has kept track every day on how she has been and she actually thought yesterday was the first day that she had felt better. She had extreme fatigue, lightheadedness, upper back pain and even a bloody nose on 10Apr2021 and also she couldn't see out of her left eye for about 2 hours. Then on 11Apr2021, she had severe pain at the back of her neck with a headache that lasted about 20 minutes and she couldn't move her neck. She had diarrhea and the only temperature she had was on 12Apr2021, it was only 99.5 degrees Fahrenheit, which isn't bad, but she had really bad diarrhea on 12Apr2021 and she took Imodium. She had a headache and slight breathing difficulties and things like that. On 13Apr2021 she had a headache, was really weak, had leg aches, fatigue that was really bad and she couldn't stay awake and her temperature that day was 98.7 degrees Fahrenheit which is normal. Then yesterday, 15Apr2021, she thought she was over all the things and that she was feeling better from the fatigue, nausea (occurred on an unspecified date), lightheadedness but she couldn't sleep again. She didn't sleep since Wednesday morning until last night finally and she only slept for an hour since Wednesday morning. She woke up on 15Apr2021 and had no symptoms except her left and her right hips, both, had severe pain and she could barely walk and she couldn't bend at all. All she could do it take Tylenol and she used a heating pad and the pain was excruciating. She went to bed last night and she did sleep for maybe a total of 2 hours and when she woke up this morning her left hip seemed to be a little better but her right hip is still in severe pain and now her right knee joint is in severe pain too. Other than that, she has no other symptoms just the joint pain. She didn't know it would go on for this long, it has been over a week now and she just wanted to let us know about this. The patient was hospitalized for the event anaphylactic reaction from 08Apr2021 to 08Apr2021. The patient underwent lab tests and procedures which included Blood typing: anti kell antibodies (doctor randomly decided to do a blood typing and they found anti kell antibodies in her blood) on an unspecified date, temperature: 99.5 degrees fahrenheit on 12Apr2021, temperature: 98.7 degrees fahrenheit on 13Apr2021. Therapeutic measures were taken as a result of anaphylactic reaction, dyspnoea, diarrhea and arthralgia. Outcome of the event anaphylactic reaction was recovered with sequelae on 09Apr2021 while outcome of the events nausea, dyspnea, arthralgia, sleep disorder and movement disorder was unknown. Outcome of the event vision impairment was recovered on 10Apr2021 while outcome of the event neck pain was recovered on 11Apr2021. Outcome of the remaining events was recovered on 15Apr2021.
60 2021-05-01 inflammation of the heart muscle Heart & BP Event: Angiogram - to rule out heart attack - heart looks good and no blockages; Echocard... Read more
Heart & BP Event: Angiogram - to rule out heart attack - heart looks good and no blockages; Echocardiogram - showed small area in left ventricle thinning/bulging; MRI of heart - findings were consistent of acute myocarditis. I am on 2 additional BP medications and 1 heart medication. I was in the hospital for 5 days.
60 2021-05-02 loss of consciousness Patient was working in the traffic area of the parking lot. The patient was exiting the area after t... Read more
Patient was working in the traffic area of the parking lot. The patient was exiting the area after the 15 min observation period. She reported no symptoms or complications prior to leaving the area and no usual behavior was noted at this time. Patient was accompanied by her husband and son. Near the parking lot the patient was witnessed losing consciousness and falling to the ground. Patient immediately assisted the patient and also called for assistance. I was notified immediately and myself, the paramedics on sight, and NP responded to the patient incident. The patient was diaphoretic and had abnormal vital signs that were repeated multiple times. The set I obtained were 117 heart rate, 99% oxygen on room air, 167/94, 225/112, both taken lying down. Patient complained of severe headache, blurry vision, tinnitus, and dizziness over the past 2 days prior to days. Patient reports having only one medical condition, psoriasis, and takes a cream for it, but also reports she has not seen a doctor in "many years". No stroke symptoms were observed.
60 2021-05-02 pulmonary embolism 4/9/21 Pt had URI symptoms. She was seen at a Minute Clinic. Tested negative for Sars-Co-V-2 4/12 Ha... Read more
4/9/21 Pt had URI symptoms. She was seen at a Minute Clinic. Tested negative for Sars-Co-V-2 4/12 Had continued symptoms. Test positive for SARS-CoV-2 4/15 Treated with mAB 4/17 Presented to ED w/nausea and decreased appetite. Vitals stable. No hypoxemia. +electrolyte imbalance K+ was 2.9. Given IFV and K repletion and discharged to home 4/19 Started on Zpack and Decadron as outpt 4/21 Returned to ED with increasing SOB and reported home pulse ox 75-82% w/ exertion. In ED, sats in low 90's. Tachypnea with RR24-28. CTA + for PNA and new PE Discharge summary : Pulmonary embolus Likely secondary to COVID-19 infection; HRT possibly contributing Chest CTA showed a small subsegmental pulmonary embolus in the left lower lobe. Flattening of the interventricular septum possibly indicating acute right heart strain Lovenox 1 mg/kg twice daily in the hospital and transitioned to Eliquis at discharge Patient currently on estrogen placement therapy-discontinued Covid-19 Virus Infection Date of onset of symptoms: 4/9/2021 Symptoms present on admission: Productive cough, dyspnea Date of covid positive test: 4/12/2021 Vaccination status: First dose given on 3/31/2021 Special isolation anticipated end date: 4/22/2021 if symptomatically improving Imaging: Chest CTA with interval worsening of diffuse interstitial infiltrates Oxygen requirements on admission: Room air Current oxygen requirements: Room air Medical therapy: Continue oral Decadron 6 mg daily Consultants following: None Inflammatory markers: LDH 306, ferritin 507, CRP 54.3 and D-dimer 2.07 Disharged on codeine cough syrup and Tessalon for persistent cough
60 2021-05-03 chest discomfort swollen node, extreme pain in my left armpit, some pressure in my chest as a result of the pain in a... Read more
swollen node, extreme pain in my left armpit, some pressure in my chest as a result of the pain in armpit area
60 2021-05-03 chest pain Patient received 2nd dose of Pfizer Vaccine. Patient reported to Vaccinator that she had experienced... Read more
Patient received 2nd dose of Pfizer Vaccine. Patient reported to Vaccinator that she had experienced sudden onset of nausea and vomiting and chest tightness post 1st dose and was taken by EMS to Hospital after 1st dose. Per patient she was given clearance by her PCP to receive 2nd dose of Pfizer Vaccine. Within 5 minutes of receiving dose, patient with sudden nausea, sharp headache, and complaining of chest pain. EMS called, and patient transported to ER. Vital Signs Stable: 124/71, HR 80, 100% on Room Air upon transfer.
60 2021-05-03 palpitations Pt arrived to med obs #1 via wheelchair with ODI c/o dizziness, lightheadedness, and diaphoresis. Pt... Read more
Pt arrived to med obs #1 via wheelchair with ODI c/o dizziness, lightheadedness, and diaphoresis. Pt has holter monitor in place, placed yesterday (5/3/21) by pt cardiologist for ongoing s/s of palpitations and dizziness per her report. Pt also c/o tingling to bilateral hands and abdomen, and "strange sensation" in throat. Denies difficulty swallowing, soreness, or tightness of throat. Pt cannot elaborate further on the way her throat feels. Pt accepted water, declined snack. Pt began c/o worsening dizziness, placed in trendelenburg position with relief. Orthostatic VS obtained. Pt reports her BP tends to run low at baseline. VSS. Pt declined wheelchair to exit, escorted by staff with pt son to exit. VS are as follows: 1640: BP 128/55, HR 81, RR 12, O2 sat 96% on RA 1650: BP 117/60, HR 74, RR 14, O2 sat 96% on RA 1655 (lying): BP 110/55, HR 72, RR 16, O2 sat 95% on RA 1657 (sitting): BP 119/62, HR 83, RR 16, O2 sat 97% on RA 1659 (standing): BP 115/55, HR 77, RR 16, O2 sat 97% on RA
60 2021-05-03 fainting, loss of consciousness Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic... Read more
Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: syncope-Mild, Additional Details: Patient reported throat tightness and difficulty breathing. immediately after patient lost consciousness. patient was repositioned and one injection of epinephrine was given. paramedics came within 10 minutes and carted her off to hospital.
60 2021-05-04 hypertension blood pressure (BP) went over 269/149, it made my blood pressure go up.; left side of middle back ha... Read more
blood pressure (BP) went over 269/149, it made my blood pressure go up.; left side of middle back had some excruciating pain; Nauseous; I had a major body ache; it started hurting the minute she put it in my arm/Excruciating pain; pain in the neck down the arm; I had a major body ache; it started hurting the minute she put it in my arm/Excruciating pain; pain in the neck down the arm; I had a major body ache; it started hurting the minute she put it in my arm/Excruciating pain; pain in the neck down the arm; I got a mark on my arm, my arm started swelling; This is a spontaneous report from a contactable consumer reporting for herself. A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EW0164/expiration date: 30Jun2021), via an unspecified route of administration, on 16Mar2021 (at the age of 60 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EN6208/expiration date: not provided), via an unspecified route of administration, on 16Mar2021 (at the age of 60 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION and experienced a headache. Relevant ongoing medical history included Diabetes Type II from about 5 years ago in 2016, fibromyalgia diagnosed about 6 years ago in 2015, and high blood pressure. Concomitant medication included gabapentin from an unspecified date at 600mg 3x/day for fibromyalgia, empagliflozin (JARDIANCE) from an unspecified date at 10mg 1x/day for Diabetes Type II, clonidine from an unspecified date at 30 mg, 2x/day for high blood pressure and labetalol from an unspecified date at 200 mg, 2x/day for high blood pressure. On an unspecified date in Mar2021, the patient experienced her blood pressure (BP) went over 269/149, it made my blood pressure go up, which required hospitalization overnight. Also on an unspecified date in Mar2021, the patient experienced a mark on her arm, and her arm started swelling. On 16Mar2021, the patient experienced major body ache, described as it started hurting the minute she put it in her arm, excruciating pain and pain in the neck down the arm, and she was nauseous. She described that she couldn't get out of the bed because of so much body pain. On 21Mar2021, the patient experienced her left side of middle back had some excruciating pain. The clinical course was as follows: I had a major body ache with the second vaccine. I did not have any problem except the headache with the first one but I took second one on this past Friday, I got very nauseous, it started hurting the minute she put it in my arm, which is on the left side. I got a mark on my arm, my arm started swelling. Saturday morning I couldn't get out of the bed because of so much body pain, Sunday my left side my middle back I had some excruciating pain I rushed to the doctor to the ER, my BP went over 269/149 and they had to give me pain medicine and BP medicine to reduce the blood pressure. I made it to the doctor and I'm getting medicine for the pain. I woke up in the morning there's pain in the neck down the arm and it's aching, the side I got the shot, the side is hurting, excruciating pain in my arm. I had to go to the ER straight to my doctor's office, they wouldn't let me drive or anything straight to the ER where they administered 2 doses of pain medicine and 3 doses of blood pressure, the pain was so intensive it made my blood pressure go up, the doctor said all of this was coming from the vaccine." Relevant lab data on an unspecified date in Mar2019 included blood pressure 269/149. The patient received treatment for the events blood pressure high, body pain, neck pain, pain in arm, and back pain. The outcome of the events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021446955 same reporter/patient/drug, different event in separate dose
60 2021-05-04 blood clot 1/7/2021 vaccination 1/8/2021 bruise/pain R lower leg, hard warm to touch. Painful and sore. Progre... Read more
1/7/2021 vaccination 1/8/2021 bruise/pain R lower leg, hard warm to touch. Painful and sore. Progressively got worse; red, bluer. 1/10 or 1/11 ER . Ultra sound on leg. 10cm clot. Put me on aspirin, warm compresses. Had to increase aspirin up to 2x day. It eventually cleared. Referred to surgeon. Found some other veins their inspecting further. *have not had any more clots
60 2021-05-05 chest discomfort, chest pain 1557: Pt went up to nursing staff ~15 minutes after vaccine administration, to report tongue and thr... Read more
1557: Pt went up to nursing staff ~15 minutes after vaccine administration, to report tongue and throat itching. VS assessed: BP 169/101, HR 109, O2 99%. Pt then c/o chest pain and discomfort, was seen gripping chest for relief. Code MET called 1602: Code MET team transported pt to ER for higher level of care Pt received diphenhydramine PO and methylprednisolone IV in the ED
60 2021-05-06 chest pain c/o CP within 10 minutes of admin then a headache. CP resolved after 10 minutes. Given Tylenol of HA... Read more
c/o CP within 10 minutes of admin then a headache. CP resolved after 10 minutes. Given Tylenol of HA. Refused transport to ER. D/C'ed home.
60 2021-05-09 haemoglobin decreased, pulmonary embolism, deep vein blood clot patient with unprovoked large left lower extremity DVT and bilateral PE with moderate/high clot burd... Read more
patient with unprovoked large left lower extremity DVT and bilateral PE with moderate/high clot burden. Platelet count was normal. Hemoglobin was still low at 9 but improving with iron supplementation over the last month. She does not have a previous history of blood clot or family history of blood clot or hypercoagulable state.
60 2021-05-09 haemoglobin decreased April 1, dark urine April 2, Fatigue, injection site pain dark urine April 3, Extreme fatigue, dark ... Read more
April 1, dark urine April 2, Fatigue, injection site pain dark urine April 3, Extreme fatigue, dark urine Jaundice went to urgent care, they advised i go to ER as they felt i needed an abdominal scan to see why i had so much bilirubin in my urine. Went to Hospital. CBC showed my hemoglobin was 5.9. Went down to 4.9 before first transfusionhad CT SCan and sonogram.. Was admitted and disagnosed with hemolytic Anemia brought on by Covid Vaccine. had 5 blood transfusions over the course of my 8 day hospital stay. As of 5/06/21 My hemogloblin is 10.3 and has been at this level for past three weeks, I am currently under the care of a hemotologist
60 2021-05-10 chest pain light headed/dizzy; shortness of breath; chest pain; headache; her arm bothered her for couple of da... Read more
light headed/dizzy; shortness of breath; chest pain; headache; her arm bothered her for couple of days; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 60-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 22Apr2021 (Lot Number: EW0172, Expiry date: Unknown) as single dose for COVID-19 immunisation. Medical history included stroke from an unknown date and unknown if ongoing, Cancer; Variant Cancer with Vitamin D from an unknown date and unknown if ongoing, thoracic aortic aneurysm from an unknown date and unknown if ongoing, heart Surgery from an unknown date and unknown if ongoing, seizures from an unknown date and unknown if ongoing, anaemia from an unknown date and unknown if ongoing, problem with my stomach from an unknown date and unknown if ongoing, lost my gall bladder from an unknown date and unknown if ongoing, reflux from an unknown date and unknown if ongoing, thyroid cancer from an unknown date and unknown if ongoing. The patient previously took cipro 1a pharma and experienced hypersensitivity before, it stopped her heart, demerol and experienced hypersensitivity, it made her throat close up and Pneumonia vaccine in the past, made her swell up all over her body. Patient had Gastric Bypass before heart surgery. Patient can only take Acetaminophen. Patient cannot take anything with Naproxen in it. So, patient do not know if that matters with this vaccine or not. So, just thought and will let you know. Patient cannot take pain killers because patient raise her grandson. Concomitant medication(s) included topiramate (TOPAMAX) 100 mg taken for seizure, start and stop date were not reported; atenolol (ATENOLOL) 100 mg taken for an unspecified indication, start and stop date were not reported; calcium carbonate, colecalciferol (CALCIUM WITH VITAMIN D 3) taken for osteopenia, start and stop date were not reported; cyanocobalamin (B-12) taken for anaemia every 2 months, start and stop date were not reported; benzethonium chloride, ethanol (PENTAL COL) 20 mg 3 times a day for Problem with my stomach, start and stop date were not reported; pepsin (PEPSIN) 20 mg taken for an unspecified indication, start and stop date were not reported; fluorometholone (FLUROMET) do take 1 or 2 Over the Counter pills. I take Fluromet if that is needed when I have migraine, that's not everyday and 2 more over the counter taken for migraine, start and stop date were not reported; diphenhydramine hydrochloride, paracetamol (LEGATRIN PM) taken for restless legs, start and stop date were not reported; rivaroxaban (XARELTO) for Antithrombin 3 blood clotting disorder, start and stop date were not reported; pamabrom, paracetamol (BACKAID) taken for an unspecified indication, start and stop date were not reported; levothyroxine sodium (SYNTHROID) taken for thyroid disorder, start and stop date were not reported; hctz (HCTZ) 12.5 mg taken for heart, start and stop date were not reported; ascorbic acid, betacarotene, biotin, calcium, chlorine, chromium, copper, cyanocobalamin, dl-alpha tocopheryl acetate, folic acid, iodine, magnesium, manganese, molybdenum, nickel, nicotinamide, pantothenic acid, phosphorus, phytomenadione, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, silicon, thiamine, vanadium, vitamin d nos, xantofyl, zinc (CENTRUM SILVER +50) taken for an unspecified indication, start and stop date were not reported; duloxetine hydrochloride (CYMBALTA) 60 mg twice a day taken for an unspecified indication, start and stop date were not reported. On an unspecified date, the patient experienced lightheaded/dizzy, shortness of breath, chest pain, headache and her arm bothered her for couple of days. She states the paramedics made her stay for about 30 minutes to monitor her. Consumer stated, she was going to check with her Cardiologist and if he says that's okay patient was going to take the other shot. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.
60 2021-05-10 chest pain Chest pain and couldn't hardly breathe and hard to get up off the bed; Chest pain and couldn't hardl... Read more
Chest pain and couldn't hardly breathe and hard to get up off the bed; Chest pain and couldn't hardly breathe and hard to get up off the bed; Sweats; Hot and Cold; Chills; Sweats; Hot and Cold; Chills; Sweats; Hot and Cold; Chills; Body Aches where can't walk; Body Aches where can't walk; Fatigue; Nauseated and Can't Eat; Vomiting Dry Heaves; Nauseated and Can't Eat; Vomiting Dry Heaves; Nauseated and Can't Eat; Vomiting Dry Heaves; Nauseated and Can't Eat; Vomiting Dry Heaves; Dehydrated and Dry Mouth and Mucous; Dehydrated and Dry Mouth and Mucous; Dehydrated and Dry Mouth and Mucous; Fever 102F; Weak and Can't Hardly Walk; Diarrhea; Blurred Vision in Both Eyes; Right Arm Pain; Headache; Lightheadedness; flu bug, virus in her body; This is a spontaneous report received from a contactable consumer (patient). A 60 years old female patient received the first dose of bnt162b2 (Pfizer COVID 19 vaccine) via unspecified route of administration in right arm on 09Apr2021 09:10 AM at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were reported as no. No history of all previous immunization with the Pfizer vaccine considered as suspect ad no additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations within 4 weeks. No family medical history. The patient experienced diarrhea on 18Apr2021, blurred vision in both eyes on 18Apr2021, sweats; hot and cold; chills on 19Apr2021, body aches where can't walk on 19Apr2021, really bad fatigue on 19Apr2021, nauseated and can't eat; vomiting dry heaves on 19Apr2021, dehydrated and dry mouth and mucous on 19Apr2021, fever on 19Apr2021, weak and can't hardly walk on 19Apr2021, chest pain and couldn't hardly breathe and hard to get up off the bed from 20Apr2021 to 20Apr2021, right arm pain from 09Apr2021 to 12Apr2021, headache from 09Apr2021, lightheadedness comes and goes from 09Apr2021. Right after the shot her headache started and the soreness in the arm. The patient stated she didn't know how to ride out her headaches, they were so severe like bricks in her brain. For diarrhea, the patient stated it is like water and she is going to the bathroom right now. For Nausea, the patient stated if she eats or drinks anything she is throwing up, further clarifies that nothing comes up but dry heaves. For fever, the patient stated her temperature was 102F 19Apr2021 night, 100F 20Apr2021 morning, and it is 101F at the reporting time. The patient stated she had a cold rag on her forehead. For weakness, she has to use a cane to get up and move around because of the weakness. The patient received none treatment. The events did not require a visit to Emergency Room or Physician Office. The PCP stated he is treating it like flu bug and said she just has to ride it out. The patient stated she was supposed to go back for her second shot 28Apr2021, but she is hesitant because she can't take care of her children because she is sick. The patient stated she didn't know if she was going to take the second vaccine and didn't know what to do for her side effects. The patient asked, with these symptoms, if recommended she get the second shot, because it is like a virus in her body. The outcome of the events sweats; hot and cold; chills was resolving. The outcome of the event chest pain and couldn't hardly breathe and hard to get up off the bed, right arm pain was resolved. The outcome of the other events was not recovered. Diarrhea, blurred vision in both eyes worsened. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
60 2021-05-10 hypotension After 15 minutes, lightheaded as ready to leave. Is DM, BS 126 before came; ate lunch; takes 75U. BP... Read more
After 15 minutes, lightheaded as ready to leave. Is DM, BS 126 before came; ate lunch; takes 75U. BP 100/60--bit low for her; pulse 80, pulse ox 98. No hives, itching, trouble breathing. Monitoring, gave water, juice, cracker. BP 118/60. Still lightheaded plus nausea. Rapid response; agreed to be monitored in ED; went by cart.
60 2021-05-10 palpitations, arrhythmia, pulmonary embolism Same-day reactions -within 5 minutes: hives in face and neck - a few more minutes later: swollen li... Read more
Same-day reactions -within 5 minutes: hives in face and neck - a few more minutes later: swollen lips (had to take Benadryl and 20 mg of prednisone that I was carrying because the hospital only had the epipen) - within 24 hours: shortness of breath, palpitations - couple of days later: admitted to the ER with pneumonia and PVC arrhythmia
60 2021-05-11 fainting Patient had syncope when rising from sitting position. Hx of fainting/anxiety, needs to be supine f... Read more
Patient had syncope when rising from sitting position. Hx of fainting/anxiety, needs to be supine for blood draws. BP not measured because no large cuff available. HR 108; O2 sat 98%; RR 18. Patient was stable, AO x3 with no dizziness and discharged stable from vaccination site
60 2021-05-13 hypertension Client reports she began to experience muscle twitching to vaccinated arm about 20 minutes after vac... Read more
Client reports she began to experience muscle twitching to vaccinated arm about 20 minutes after vaccination. Client reports she told the EMT during her observation. Client was guided to private observation room and evaluated by EMTs. Client reports upon assessment EMTs found that she had a blood pressure of 190s systolically. Client cannot recall exact blood pressure. Client denied any other symptoms at this time other than muscle twitching. Client was taken to the Emergency Room where she was evaluated. Client reports her blood pressure went down on its own without the need of medications. Client denies history of hypertension.
60 2021-05-14 oxygen saturation decreased She starts having headaches; Flu like symptoms; Fever; Chill/Chills; Pain in her lungs; oxygen drops... Read more
She starts having headaches; Flu like symptoms; Fever; Chill/Chills; Pain in her lungs; oxygen drops when she walks she has to get back on oxygen; This is a spontaneous report from a Contactable Consume (patient) reported. A 60-year-old non-pregnant female received first dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number: EN6201), via unspecified route on 13Feb2021 (patient was 60-year-old at the time of vaccination) at a first single dose for COVID-19 immunisation. The patient's medical history included patient She does had COPD which was ongoing She has had it for years she doesn't know how long. patient stated she had asthma and they said it turned into COPD. She had been off oxygen for 3 months, but her oxygen has been dropping whenever she gets up, it gets low and she doesn't like that part. She says if it gets too low, she starts having headaches, she says that happened with the headaches when she was in the hospital last July with double pneumonia, she confirms that was happening last July before the vaccine not right now. "Patient stated, she had double pneumonia related to Covid back in Jul2020 and was in the ICU for almost a month and had double pneumonia. The patient's concomitant medications were not reported. On an unspecified date, after the first dose of the Pfizer Covid-19 vaccine the patient experienced fever, chill, pain in lungs, and oxygen dropping when she walks. reporter wanted to know if that was associated with receiving the first Covid-19 vaccine on 13Feb2021. Patient was Referred to HCP for treatment of symptoms and to discuss receiving second dose of vaccine. She had the shot Saturday 13Feb then Sunday, yesterday at about 9:00 that morning, she said her shot was after 3 pm Saturday but about 9:00 Sunday she had flu like symptoms. This was her first dose not the second one complication anyone have to go through on the shot. She clarified with complications reported, have these been associated with the first dose. Her oxygen drops when she walks she had to get back on oxygen. She had COPD. She says she had asthma and they said the asthmas changed into COPD. She had the Pfizer COVID-19 vaccine. She had the shot Saturday 13Feb2021 then Sunday, yesterday at about 9:00 that morning, she says her shot was after 15:00 Saturday but about 9:00 Sunday she had flu like symptoms. She felt fever, chills, pain in her lungs. She does have COPD and she COVID 19 back in July last year and had double pneumonia. She says the shot has affected her lungs her oxygen drops when she walks, she had to get back on oxygen. She had been off oxygen for 3 months, but her oxygen has been dropping whenever she gets up, it gets low and she doesn't like that part. She said if it gets too low she starts having headaches, she said that happened with the headaches when she was in the hospital last July with double pneumonia, she confirms that was happening last July before the vaccine not right now. The patient also wants to know how long it will last, fever is done but she is still having the problems with her lungs and her oxygen and she would like to know how long that had supposed to last. She said she also wants to know how long will it last. Her fever is done but she is still having the problems with her lungs and her oxygen and she would like to know how long is that supposed to last. This is her first dose not the second one complication anyone have to go through on the shot. She clarifies she means had with complications reported, had these been associated with the first dose. The case classified as non-serious. The outcome of the events were unknown. Follow-up (12May2021): Follow-up attempts completed. No further information expected.
60 2021-05-18 atrial fibrillation, ischaemic stroke Patient tested positive for COVID on April 12th after having received both COVID-19 vaccines - pfize... Read more
Patient tested positive for COVID on April 12th after having received both COVID-19 vaccines - pfizer. Patient has known COVID19 exposure from her son and was COVID19 positive in April. The patient had a positive asymptomatic COVID-19 test. Patient was tested prior to planned colonoscopy. The patient completed 10 days of quarantine until April 22. Patient presented to hospital (sister hospital) on May 2nd after 1 week of fevers and productive cough. At MSQ patient received cefepime/vancomycin/doxycycline for CAP. She initially improved, but on 5/5 she had recurrent fever with rapid decline, her respiratory status requiring 2L of NC to HFNC to NRB. CXR with B/L opacifications. CTA chest was negative for PE, but patient with diffuse groundglass and consolidative opacities. Also had TTE that showed LVEF 71% and grade 1 diastolic dysfunction. She was evaluated by MSQ Infectious Diseases physician and was started on bactrim for PCP prophylaxis and resumed on broad spectrum antibiotics. She was also evaluated by rheum in sitting of her SLE and patient was started on prednisone 40 mg q8h methylprednisolone for potential SLE flare. Continued on cefepime and vancomycin. Patient was transferred to Hospital due to worsening respiratory status and tested positive for COVID-19 at MSH on 5/9. Admitted to the MICU, patient received a loading dose and one 100 mg dose of remdesivir - stopped due to elevated liver enzymes. On 5/16 extensive new ischemic/hemorrhagic strokes throughout intracranial vascular distribution, DIC d/t COVID vs AF and intubated for mental status changes. Patient's clinical picture worsening - requiring pressors. Chest x-ray with diffuse ground glass opacities, ARDs and pulmonary edema. Patient remains in critical condition in MICU as of 5/19.
60 2021-05-18 heart rate increased Twelve days after 1st covid vaccine dose profuse sweating and increased heart rate 148. Two days lat... Read more
Twelve days after 1st covid vaccine dose profuse sweating and increased heart rate 148. Two days later no energy or appetite and decreased exercise intolerance
60 2021-05-18 loss of consciousness I have been sick; couldn't eat anything down; lost consciousness; Trigeminal neuralgia attack; Trige... Read more
I have been sick; couldn't eat anything down; lost consciousness; Trigeminal neuralgia attack; Trigeminal neuralgia attack; massive vertigo attack; eye was so swollen; This is a spontaneous report from a contactable consumer (patient). This 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 09Apr2021 (at the age of 60-year-old) (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Relevant medical history included trigeminal neuralgia, head injury, pulmonary problems, severe migraine and tumor in lymph node. Concomitant medications were not reported. On 09Apr2021, the patient lost consciousness; in Apr2021, she experienced trigeminal neuralgia attack, massive vertigo attack and eye was so swollen; on an unspecified date she experienced also sickness and couldn't eat anything down. The patient specified that right after she got the injection, they make you to sit there for 15 minutes to see. She lost consciousness, it was like they gave her a shot before you go on for surgery and the doctor had come over, they had to wake her up. She didn't know what happened, so that was the first thing and the doctor said that's out of all the 1000's of people they vaccinated she was the first one that passed out right after the injection. So, she thought may be that should be noted somewhere and she didn't get a headache that she has a condition called Trigeminal neuralgia which was extremely painful and it's like only 3% of the population get it and it's usually caused after major head injury, was the very next day her shot was on the Friday and then Saturday the pain was terrific and she had the trigeminal pain for a week, took a week to go away and then right after that the next week she had a massive vertigo attack. And she really didn't know all these things or side effects from her head injury. But her conditions are pretty rare, you only get them if you've got massive concussions and fractured skull and stuff like that which happened a long time ago. So she didn't know if the shot had anything to do with it. She has pulmonary problems so she was getting it no matter what because she can't go anywhere hery Pulmonologist won't let her leave the house unless she has to go to a doctor or an emergency room. And she did go to the emergency room because her pain medication wasn't working at all (Unspecified medication). She used to have migraine but after the head injury the migraine went away which she was very happy because she had severe migraine. What she didn't know was this Trigeminal neuralgia the nerve pain. The consumer further specified that she was so happy with the vaccine and she mean she doesn't care what the normal side effects are, she didn't have any other side effects her arm never hurts, she never had any fatigue or headache but she didn't know it was odd, the very morning she woke up Saturday she was in excruciating pain, its nerve pain that went down to the jaw, right under her eye and over the forehead and it's the most extremely painful thing that people get. She takes medication (Unspecified medication) daily to try to control it but sometime the pain is really really bad. She had been sick for the 3 weeks, she did not think anything had to do with the vaccine except the trigeminal. But it could have caused a massive vertigo attack which lasted 8 or 9 days. Today was the first day she was eating food in a week because she couldn't eat anything down. The patient was on a lot of steroids, she was reducing but she was still very plump so she thinks it's about 270 pounds right now. At the time of the report, the outcome of the events was unknown. The information on the batch number has been requested.
60 2021-05-19 atrial fibrillation Atrial fibrillation started, one hour after vaccine. Rushed to ER, Electrical Cardioversion given E... Read more
Atrial fibrillation started, one hour after vaccine. Rushed to ER, Electrical Cardioversion given Experienced Vertigo, 18 hours after vaccine.
60 2021-05-19 chest pain Pt also had received covid vaccine at~934am. Hx of HTN and DM (nonadherent to BP meds). then around ... Read more
Pt also had received covid vaccine at~934am. Hx of HTN and DM (nonadherent to BP meds). then around 9:57am, pt c/o be Vomiting, Diaphoresis, HA, Chest pain 3/10. Pt was offered by staff to call ED but pt decline. Pt will go to ED with family member for further evaluation. During ED visit, it was found by provider that patient has been out of her blood pressure medications for over a year. Pt was prescribed amlodipine and recommended for pt to follow-up with PCP at discharge
60 2021-05-19 heart rate increased, blood pressure increased, chest pain BP 169/101; HR 109; tongue and throat itching; tongue and throat itching; chest pain; discomfort; Th... Read more
BP 169/101; HR 109; tongue and throat itching; tongue and throat itching; chest pain; discomfort; This is a spontaneous report from a non-contactable pharmacist. A 60-years-old non-pregnant female patient received bnt162b2 (BNT162B2), at the age of 60 years-old, dose 2 intramuscular, administered in Arm Left on 14Apr2021 (Batch/Lot Number: ER8733) as a single dose for covid-19 immunisation. And dose 1 Lot number: ER8727Administration route: Intramuscular, Administration Date: 24Mar2021, Vaccine location: Left arm. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Vaccination was given in a hospital. on 14Apr2021, at 1557: Pt went up to nursing staff 15minutes after vaccine administration to report tongue and throat itching. VS assessed: BP 169/101, HR 109, O2 99%. Pt then c/o chest pain and discomfort, was seen gripping chest for relief. Code MET called 1602: Code MET team transported pt to ER for higher level of care. Pt received diphenhydramine 50 mg PO and methylprednisolone 125 mg IV in the ED as well as cardioversion (as reported). Prior to vaccination, the patient was not diagnosed with COVID-19, nor was tested after vaccination. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.
60 2021-05-20 chest discomfort Client c/o tightness in chest, dry mouth and shortness of breath 20 min. after vaccination. Care in... Read more
Client c/o tightness in chest, dry mouth and shortness of breath 20 min. after vaccination. Care initiated by onsite EMS. Client placed on stretcher. O2 applied. EMS transported client to ambulance for transport to hospital. Client's son and niece declined transport. EMS monitored client in the ambulance for 10-15 min. Client stated that she felt "okay". Declined transport to hospital. Client signed papers provided by Fire Rescue. Client exited ambulance, ambulating with assist by son and niece. Stated that she was "okay". Encouraged client to follow up with Emergency Services and PCP as needed. Verbalized understanding. Driven off site by son.
60 2021-05-20 chest pain First vaccine on April 5th, 24 hours later I had painful blisters in my chest Second vaccine on Apr... Read more
First vaccine on April 5th, 24 hours later I had painful blisters in my chest Second vaccine on April 26. Had no immediate symptoms but on May 13 I started having pain in my gums, then severe canker sores all over my mouth. Could not eat, sleep or talk. I thought it was mouth infections and went to see my dentist but I was told they were canker sores. He thought it was unusual to have that many especially when I had not diet change, eat home cooked meals, with normal stress level. He asked about the vaccine. Later I googled on the internet and found out other Pfizer patients had same reaction.
60 2021-05-20 deep vein blood clot, pulmonary embolism bilateral pulmonary embolus; left leg DVT diagnosed on May 17, 2021
60 2021-05-20 heart attack Inferior RCA MI on 05/19/2021
60 2021-05-21 loss of consciousness, hypertension I had dizziness, I was so dizzy I thought I was going to pass out and that was like at the top of th... Read more
I had dizziness, I was so dizzy I thought I was going to pass out and that was like at the top of the steps when you getting to walk down the stairs; Severe allergic reaction; I had dizziness, I was so dizzy I thought I was going to pass out and that was like at the top of the steps when you getting to walk down the stairs; My body was red and I had blotches bumps all over me my back under my right breast; My body was red and I had blotches bumps all over me my back under my right breast; My entire body was inflamed; Started getting hives on my back, under my right breast, both arms and both legs and thighs and I started getting bump. I broke out in hives in sleep in middle of night; I woke up out of my sleep in the middle of the night like the wee hours of the morning itching; I had like difficulty breathing; I had severe headache and I had it like all week; severe headache; My pressure went up like 140 over 100; high blood pressure; This is spontaneous report from a contactable consumer (Patient herself). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EW0172), via an unknown route route on 04May2021, as a single dose, for COVID-19 immunization. Patient's medical history included seasonal allergy (using an inhaler), Asthma and Diabetes. The patient's concomitant medications included insulin. On the same day of vaccination on 04May2021, at the first hour, the patient had a severe allergic reaction. The patient also experienced severe headache and I had it like all week and her pressure went up like 140 over 100 and then like the next day you know I had like difficulty breathing. On the third day, The patient also had a severe allergic reaction. The patient stated that her entire body was inflamed and then she started getting hives on her back, under the right breast, both arms and both legs and thighs. The patient also experienced bumps. The patient further stated that she had dizziness and was going to pass out when she had to walk down the stairs. The patient also stated that she broke out in to hives in her sleep in the middle of the night. The patient had itching at the wee hours in the morning. The patient stated that she went and looked in the mirror and her body was red and I had blotches bumps all over her back under my right breast. The patient wanted to know whether she can take the second shot. The patient asked whether the vaccine was going to affect her and if so, she cannot take it. Patient was supposed to take the second shot on 26May2021. The patient did not had any physician visit for the events. The patient used Benadryl as treatment medication for the events. The patient asked whether the vaccine was going to affect her and if so, she cannot take it. Patient was supposed to take the second shot on 26May2021. The outcome of the events was unknown. Information about batch/lot number was available. Further information was expected.
60 2021-05-21 inflammation of the heart muscle Please check with her doctors. I know she mentioned Myocarditis. She was vaccinated I am correct, o... Read more
Please check with her doctors. I know she mentioned Myocarditis. She was vaccinated I am correct, on March 8 and April 6, 2021
60 2021-05-23 palpitations 36 hours after receiving the vaccination, I felt heart palpitations. The severity increased and last... Read more
36 hours after receiving the vaccination, I felt heart palpitations. The severity increased and lasted over two hours. I monitored my oxygen levels which were in the high 90s. 63 hours after receiving the vaccination, I woke with a severe headache. This lasted ten hours.
60 2021-05-23 transient ischaemic attack, palpitations naseaa, headaCHE, VOMITiNG, HEart paLPATIATIONS, BLURRY VISION, TIA
60 2021-05-24 platelet count decreased, fibrin d dimer increased, haemoglobin decreased Pfizer-BioNTech COVID-19 Vaccine EUA: one day after vaccination patient presented to hospital with f... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: one day after vaccination patient presented to hospital with fever and chills starting on day of vaccination. During oncology clinic visit two days prior to vaccination patient was jaundiced and fatigued. Patient admitted to hospital, diagnosed with autoimmune hemolytic anemia, received transfusions, steroids, folic acid, and iron. Fever and chills resolved, patient improved, and patient discharged medically stable.
60 2021-05-25 ischemic chest pain An hour after vaccination, it hurt around my heart and for 3 days there was pain in my collar bone o... Read more
An hour after vaccination, it hurt around my heart and for 3 days there was pain in my collar bone on the left side, a lot of heart burn or air bubbles in my chest also, and now I'm scared to get the 2nd dose and I've not felt right since.
60 2021-05-25 chest pain, chest discomfort incredible chest pressure; shortness of breath; anxiety; chest started hurting; pain across her brea... Read more
incredible chest pressure; shortness of breath; anxiety; chest started hurting; pain across her breasts; concentration levels are off; but being that sick makes her so weary.; She goes to the bathroom 12 times a night to urinate; body aches; feet hurt/top of her feet hurt really super bad/legs hurt; pressing under her arm and she had pain really bad there; pain went around her back /whole back started hurting; This is a spontaneous report from a contactable consumer (patient). This 60-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration administered in right arm on 27Apr2021 (Batch/Lot Number: ER8731) as single dose for COVID-19 immunisation. Medical history included ongoing congestive heart failure, diabetes, high cholesterol and high blood pressure. Concomitant medication(s) included aripiprazole (ABILIFY) taken for an unspecified indication, start and stop date were not reported; atorvastatin calcium (ATORVASTATIN CALCIUM) taken for an unspecified indication, start and stop date were not reported, noted as on of the 2 new heart medication; and another unspecified heart medication. No other vaccine within 4 weeks. The patient received the first dose of the COVID-19 vaccine on 27Apr2021, then 2 days later on 29Apr2021 she developed side effects of body aches and couldn't get comfortable sitting, laying down, or standing, and her feet hurt, the top of her feet hurt really super bad and her legs hurt. She stated she was feeling "fair to partly cloudy" and "this is just beyond anything". She stated she literally didn't want to exist anymore the pain was that horrible, that when she was experiencing adverse effects she couldn't get comfortable in any way, nowhere to go, nothing to do, no warm bath, no hot warm or cool compresses, it was just her whole body. She said there was nothing that would help and she just didn't know if she could do that again. She only had relief through paracetamol (TYLENOL) and she took so much that she felt her liver was in jeopardy. She stated it was a really bad experience. The patient was also having incredible chest pressure and shortness of breath, onset date unspecified. She had a diagnosis of heart failure/a history of congestive heart failure, with the body aches she was having, she thought she was going into heart failure. She did call an ambulance twice (maybe 29Apr2021 then 01May2021; she didn't remember exactly which days) and the emergency medical technicians (EMT) took an EKG each time. The first time she called the ambulance the EMT's offered to take her to the hospital. Her EKG did look abnormal but it could have been attributed to her history of heart related issues or anxiety. The second time her chest started hurting it was hard to distinguish between pain and pressure. There was definitely pressure. There was also pain across her breasts (onset date unspecified) and underneath her arm (on 29Apr2021; initially she was pressing under her arm and she had pain really bad there), she was questioning her lymph nodes. Then the pain went around her back and then her whole back started hurting and her whole body was hurting, onset date 29Apr2021. She had never experienced anything like this before, as stated. She also reported that her concentration levels were off (onset date unspecified). She couldn't listen to music or do anything like that. She spoke with her doctor but being that sick made her so weary (onset date unspecified). The patient reported she didn't know if her symptoms were because of the COVID-19 vaccine or because of her new heart medication, but she said it's stupid to think her symptoms could be caused from her new pills. Her doctor wanted blood work on 27Apr2021 primarily because of all the medical diseases she had. She's guessing maybe blood work would give her an indication of why the vaccine made her feel the way it did. She went on 05May2021 to get bloodwork. She went to the bathroom 12 times a night to urinate (onset date unspecified) and she asked her doctor to put her on Lasix so she could just get the urine out. The doctor told her that her heart and her lungs sound good. The patient asked if she should still get the second dose of the vaccine as she was worried that the symptoms could be worse after the second dose. She was supposed to return for her second COVID-19 vaccine on 14May2021, but she was not going (though she knew she needed to get the second dose), she did not want to get it. The events body aches, feet hurting/legs hurting, pain underneath her arm, back pain, were ongoing but lessened in severity. As of the time of reporting, she had started to feel better, these events (body aches, feet hurting/legs hurting, pain underneath her arm, back pain) were resolving. The outcome of the other events was unknown.
60 2021-05-25 fast heart rate, blood pressure increased Tongue swelling, facial numbness, rash to both arms, tachycardia, headache, eye pain, elevated b/p 2... Read more
Tongue swelling, facial numbness, rash to both arms, tachycardia, headache, eye pain, elevated b/p 210/103, dizziness, and shaky. Epinephrine given with relief of swelling within 20 min. Two hours later reports vomiting and diarrhea.
60 2021-05-26 chest pain chest pain, shortness of breath, fatigue, malaise, headache that occurred the evening after vaccine ... Read more
chest pain, shortness of breath, fatigue, malaise, headache that occurred the evening after vaccine was given
60 2021-05-26 inflammation of the heart muscle, fluid around the heart, chest pain Myopericarditis, chest pain, pericardial effusion, pleural effusion
60 2021-05-26 pallor It was swollen up pretty big/My arm swelled up. It almost looked like I had a big muscle; Feeling re... Read more
It was swollen up pretty big/My arm swelled up. It almost looked like I had a big muscle; Feeling really sick; Her arm was hurting/Sore arm; I did have COVID, the virus; Slight headache; Weak; I don't even feel that well right now with the first shot; So I think this was an allergic reaction to the medicine because its not real clear; She was pale and dizzy/kind of dizzy; She was pale and dizzy; Nauseated; She's tired/I just feel tired; I just feel like I am dragging; This is a spontaneous report from a contactable consumer. A 60-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EW0176) dose 1 via an unspecified route of administration in the left arm on 04May2021 (at the age 60 years old), as single dose for COVID-19 immunization. The patient's medical history included patient had a pulled tendon for which she was wearing a boot, hypothyroidism for which the patient was taking Synthyroid since 1991, COVID-19 in Dec2020 and was sick from Dec2020 to Jan2021, it took patient a month to get over it. The patient's concomitant medication included Diclofenac Sodium delayed release tablets 75mg, two times a day for 2 pulled tendons in her foot. On 05May2021, patient's arm was hurting/Sore arm. On 06May2021, arm swelled up, it was swollen up pretty big, it almost looked like patient had a big muscle, feeling really sick. On an unspecified date in May2021, patient did have COVID, the virus, patient was pale and dizzy/kind of dizzy, felt nauseated, tired/ just feel tired like patient was dragging, slight headache, weak, patient didn't even feel that well right now with the first shot and patient thought that this was an allergic reaction to the medicine because it was not real clear. Patient was started on Diclofenac Sodium 75mg two tabs daily- started on Tuesday, the same day she got her Pfizer Vaccine. On an unspecified date, patient had ultrasound of the leg to check for clots, but she did not have any. The patient reported that her arm was still really sore, and she was not as nauseous and pale as she was last night but then was tired and slept all night. She just felt tired. The patient did not receive any treatment for the adverse events. Patient wanted to know if this could be a reaction between the medication (Diclofenac Sodium) and the vaccine and also wanted to know if she was allergic to something in the vaccine and how many days side effects might last, patient did not know anyone who got sick after the first dose. Patient was scheduled for the second dose of the vaccine on 26may2021. Outcome of the pale and nauseated was recovering, patient's arm was hurting/sore arm, arm swelled up, it was swollen up pretty big, it almost looked like patient had a big muscle not recovered was not recovered while for the other events was unknown. Patient reported that her 83-years-old mother got Moderna and her arm was a little sore after the first dose and nothing after the second shot. No follow-up attempts are needed. No further information is expected.
60 2021-05-26 inflammation of the pericardium, fluid around the heart Patient received COVID-19 vaccine on 4/3/21 subsequently admitted from 4/10-21-4/12/21 for acute per... Read more
Patient received COVID-19 vaccine on 4/3/21 subsequently admitted from 4/10-21-4/12/21 for acute pericarditis.
60 2021-05-26 dilation of blood vessels bulging veins in wrists and hands; experiencing side effects with her veins looking like they are bu... Read more
bulging veins in wrists and hands; experiencing side effects with her veins looking like they are bulging in her legs, feet and ankles at first and they are now spreading to her hands.; Neck pain; Caller states the Vitamin E supplement that she takes can have a blood thinner property so she is not sure if that could have caused her reaction; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 17May2021 (Batch/Lot Number: EW0183; Expiration Date: 31Aug2021) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included hypersensitivity and arthritis. Concomitant medication(s) included D-flame, Vitamin E, daily dose. The patient she has been experiencing side effects last night with her veins looking like they are bulging in her legs, feet and ankles at first and they are now spreading to her hands on 17May2021 22:00 and this morning the veins in her wrists and hands are bulging as well on 18May2021. She takes a daily supplement something like a multivitamin and she would like to know if the ingredients in the supplement could have caused an interaction with the vaccine? She states the Vitamin E supplement that she takes can have a blood thinner property so she is not sure if that could have caused her reaction. Ingredients of the supplement include holy basil 250 mg, turmeric 100 mg, ginger 100 mg, green tea 100 mg, baikal skullcap 50 mg, bromelain extract 100 mg, resveratrol 10 mg, berberine 5 mg and boswellia 100 mg. States the dosages provided are for two capsules and she only take one so it would be half. She said she really had bad neck pain last night on 17May2021. It was severe but went away after dinner. It was last evening, and she noticed it around 10:00pm. Took Tylenol before bed. She had nuclear stress test result unknown on 05May2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of event for bulging veins in wrists and hands was not resolved and for rest of the events it was unknown. Follow up needed, further information has been requested.
60 2021-05-27 blood pressure increased Patient is a 60-year-old, female. Alert, oriented X4, clear speech, able to answer to questions. Pat... Read more
Patient is a 60-year-old, female. Alert, oriented X4, clear speech, able to answer to questions. Patient has history of smoking and elevated blood pressure. No history of allergies. At 11:14 am, the patient received her second dose of Pfizer (lot number EW0187, expires on 08/2021) on left deltoid. Patient walked with a steady, balanced gait to EMT observation area. At 11:30 am, patient notified EMT that she was experiencing numbness in left fingers. EMT assisted patient to anti-gravity chair. Patient states she has not eaten. Patient was given a granola bar and water bottle. Patient remained A&Ox4 and talking to EMT. Lead RN was notified of reaction. RN requested vitals Q5 minutes for 30 minutes. At 11:33 am: BP of 137/91, HR 88. At 11:35 am, patient states numbness is ?improving?. At 11:40 am: BP of 132/99, HR 77, SPO2 99%. At 11:44 am, patient states numbness in fingers is ?almost gone?. Patient denies any additional adverse symptoms, such as dizziness, lightheadedness, and shortness of breath. At 11:50 am, patient sat up with a BP of 152/94, HR 80, SPO2 99%. Patient states she is "feeling better" and requested to leave facility. Patient was A&Ox4 with no reports of dizziness and lightheadedness. Lead RN provided patient with education concerning when to call 9-1-1, including worsening of symptoms and trouble breathing. Patient was instructed to follow up with PCP. At 11:52 am, patient stood up from chair, denied lightheadedness and dizziness. Patient walked to car with steady, balanced gait. Patient's husband drove patient home.
60 2021-05-27 heart rate increased Released from ER after receiving 2nd Pfizer vaccine. 1 mile down the road, I could no longer drive. ... Read more
Released from ER after receiving 2nd Pfizer vaccine. 1 mile down the road, I could no longer drive. I had to pull over on the highway. I had a tingling in my face, immediately followed by a combination of severe headache, hard to breath, rapid heartbeat and feeling like I was going to pass out. I wasn't able to even dial my phone. A construction worker on the side of the highway called for the ambulance and I was transported back to the ER.
60 2021-05-28 heart rate increased aching all over; her arm hurt very bad where she got shot, right arm, "her arm was killing her; shoo... Read more
aching all over; her arm hurt very bad where she got shot, right arm, "her arm was killing her; shooting from her arm up to her neck; chills; feeling really unwell; heart started beating a little bit fast; shortness of breath; tiredness; headache; muscle pain; joint pain really bad; really weak; Back Pain; Throat Hurting; injection site pain; This is a spontaneous report from a contactable consumer (patient). This 60-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533), via an unspecified route of administration in the right arm on 12May2021 08:30 (at the age of 60-year-old) as single dose for COVID-19 immunization. Medical history included allergic to dye (last time she had black dye, her head was itching and burning like fire and her head is still red and her hair is falling out by handfuls), back injury ongoing since 2004, and ongoing diabetes mellitus that started 14.5 years ago. The patient was tested negative on the COVID Nasal swab on 08Nov2020. The patient was hospitalized for 7 days for COVID-19 from 07Feb2021 or 08Feb2021 when she had "diarrhea coming out both ends", and when she had come home, she had on/off head spinning for 2 weeks and in a month her head stopped spinning. She waited 90 days before getting the vaccine. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not enrolled in a clinical study or a program. Concomitant medications included naproxen (NAPROSYN E) taken as needed for back pain. On 12May2021, the patient experienced injection site pain. On 13May2021, she started experiencing aching all over for about 8 hours and has been hurting all morning from 08:00, "her arm hurt very bad where she got shot, right arm", "her arm was killing her; shooting from her arm up to her neck", tiredness, couldn't hardly walk legs were hurting started today worse, headache, muscle pain, really bad joint pain, chills, feeling really unwell, really weak, heart started beating a little bit fast and shortness of breath. she has no swollen lymph nodes. She stated her back wasn't hurting yesterday and now today (13May2021) she has back pain so much so that she can't hardly get out of bed. She also stated throat hurting. She reported that the persistent/significant aching all over for about 8 hours & "her arm hurt very bad where she got shot, right arm" were serious due to disability/incapacity. If it keeps up like this, she doesn't know if she will take the second one. She is scheduled for her second one on 02Jun2021. Later, she stated, "I was aching about 8 hours. After that I think I had took a Tylenol" but she can't be sure. The clinical outcome of the event "aching all over" was resolved after 8 hours on 13May2021 around 16:00. The clinical outcomes of the events chills and heart started beating a little bit fast were resolving, the events injection site pain, "her arm hurt very bad where she got shot, right arm", "her arm was killing her; shooting from her arm up to her neck", tiredness, headache, muscle pain, joint pain really bad, really weak, throat hurting were not resolved, while the events feeling really unwell, shortness of breath and back pain were unknown. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.
60 2021-05-28 hypertension 60 y/o female with past medical history of HTN who presents with leg left numbness post vaccination.... Read more
60 y/o female with past medical history of HTN who presents with leg left numbness post vaccination. Patient states that this is her second vaccine in the two-dose series. Patient states that she had fever, weakness and right arm difficulty moving 8 days post vaccination, lasting 4 days. Patient states that she received the first vaccination to the left arm and experienced the symptom of difficulty moving post vaccination to the right arm. Patient states that she received todays vaccination to the left arm. NP and Paramedics at patient side. Patient was able to stand and sit in wheelchair without difficulty. Patient was able to ambulate from wheelchair to cot without difficulty. Within in 2-3 mins patient states that numbness to left leg improved. NP questioning if numbness was due to the way that patient was sitting post vaccination. Patient able to move all digits of her left foot, normal color and temp of left lower extremity. No swelling visualized. Patient initial vitals with hypertension noted, 170/77 BP R arm, 80 HR, 98% RA, 12 Resp. Patient monitored for blood pressure normalization. Patient BP decreased to 151/79, which is described as normal for patient. Patient able to ambulate without difficulty and states that she feels better and ready to go home. Patient discharged in stable condition with numbness resolved. Patient aware that if symptoms worsen or persist, to seek further medical care.
60 2021-05-31 palpitations, heart rate increased feeling tired; mild heart increase; mild heart palpitations; chills; feeling bad; low-grade fever of... Read more
feeling tired; mild heart increase; mild heart palpitations; chills; feeling bad; low-grade fever of 100; This is a spontaneous report from a contactable other healthcare professional (patient). A 60-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, #lot: EL9264) via an unspecified route of administration, administered in Arm Right on 02Feb2021 08:45 (at the age of 60-years-old) as single dose for covid-19 immunisation. The patient's medical history includes history of colon cancer, anaemia, hypertension and asthma and drug hypersensitivity. The patient previously known allergies includes: Sulfa, EES, Augmentin, oxycodone, vancomycin, duramorph. The patient's concomitant medications included budesonide, formoterol fumarate, glycopyrronium bromide (BREZTRI AEROSPHERE), hctz, meloxicam and zolpidem tartrate (AMBIEN). It was reported that on 02Feb2021, at 08: 45 AM initially within five minutes after the vaccine, the patient felt mild heart palpitations with mild heart increase. She monitored on her (company name) watch heart rate, ECG and oxygenation level. This resolved within 15 minutes. During the day following she started having chills just generalized feeling bad. Had a low-grade fever of 100 last evening. This morning feeling tired on 03Feb2021. The outcome of the events was recovering. Therapeutic measures were not taken by the patient for resolving of the events. Follow-up attempts are completed. No further information is expected.
60 2021-06-02 heart rate increased The caller's heart was really fast and heart pressure went up; has been experiencing runny nose, has... Read more
The caller's heart was really fast and heart pressure went up; has been experiencing runny nose, has the flu; has been experiencing runny nose, has the flu; Only pain on arm for two or three days; got a panic; got a panic; The caller's heart was really fast and heart pressure went up; This is a spontaneous report from a contactable consumer (Patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EW0182) via an unspecified route of administration in right arm on 10May2021 at 11:30 (age at vaccination 60-year-old) at single dose for covid-19 immunisation. Medical history included tachycardia from 12Apr2021 and ongoing, transient global amnesia from 25Mar2021 and ongoing, anxiety from 25Mar2021 to an unknown date, panic reaction from 25Mar2021 to an unknown date, amnesia from 25Mar2021 to an unknown date. Concomitant medication included cannabidiol (CANNABIDIOL) taken as needed for amnesia from 28Mar2021. The patient is not taking the CBD oil right now, only takes when needed. Has not taken in two weeks, was not she should take it. Suspended for four or five days before first dose. Really does not need it. No other vaccine in four weeks. On 26May2021, patient experienced runny nose, on 25May2021 patient experienced flu like symptoms, on 10May2021 patient got a panic after receiving the first dose Pfizer Covid Vaccine on, the caller got a panic and had to stay at the vaccine facility for half an hour. The patient's heart was fast and heart pressure went up. The patient stayed at the vaccine facility like thirty minutes after receiving the first dose Pfizer Covid Vaccine. The patient stated this went away. The patient knew every time she has anxiety her heart goes up, it is something that happens. The patient let the persons know at the vaccination facility it is not the Pfizer Covid Vaccine, because the patient has that problem right now. Patient's heart was fast and heart pressure went on, on 11May2021 patient experienced pain on arm for two or more days. Patient also experienced cardiac discomfort. The patient stated that the side effects were only pain on arm for two or three days and this began on 11May2021, the day after receiving the first dose Pfizer Covid Vaccine. The patient is experiencing a runny nose right now had the flu but doesn't have any high temperature. The patient states she does not speak English that well HCP: the caller does not wish to provide name, address, telephone number or email. The physician stated she doesn't have a primary care physician yet. The patient was experiencing a runny nose right now began on 26May2021 and is persisting. Had the flu but doesn't have any high temperature: The patient states this began on 25May2021 is ongoing and is improving a little bit. The patient states she is taking CBD oil because she had an issue back on 25Mar2021 of amnesia. The patient has tachycardia and has issues with anxiety and panic. The patient stated after receiving the first dose Pfizer Covid Vaccine on 10May2021, the caller got a panic and had to stay that the vaccine facility for half an hour. The caller's heart was really fast and heart pressure went up. The caller stayed at the vaccine facility like thirty minutes after receiving the first dose Pfizer Covid Vaccine. The caller states this went away. The caller knows every time she has anxiety her heart goes up, it is something that happens. The patient let the persons know at the vaccination facility it is not the Pfizer Covid Vaccine, because the caller has that problem right now. The caller states this went away in thirty minutes. Anxiety and panic not diagnosed, she can just feel it. This started after problem of amnesia the caller had on 25Mar2021. Transient Global Amnesia, had a problem of amnesia on 25Mar021. The patient is not taking the CBD oil right now, only takes when needed. Hasn't taken in two week, wasn't she should take it. Suspended for four or five days before first dose. Really doesn't need it. The patient received the first dose Pfizer Covid Vaccine on 10May2021 and is scheduled for the second dose on 31May2021. The patient has a runny nose right now and had the flu. The caller is asking if they should get a Covid test prior to receiving the second dose Pfizer Covid Vaccine. Only pain on arm for two or three days The patient states the side effects were only pain on arm for two or three days began on 11May2021, the day after receiving the first dose Pfizer Covid Vaccine. She has recovered from the arm and everything. The patient mentioned she was scheduled to receive the second dose Pfizer Covid Vaccine next Monday, 31May2021. Patient did not undergo lab tests and procedures. The outcome of event was recovered in 2021. Information on Lot/Batch number was available. Additional information has been requested.
60 2021-06-02 palpitations shot entry is the size of an apple; heart palpitations; diarrhea; blisters in her mouth on her cheek... Read more
shot entry is the size of an apple; heart palpitations; diarrhea; blisters in her mouth on her cheeks and roof of her mouth on her tongue, the back of her throat and lips; Because of the blisters she had a hard time breathing and couldn't can't eat; had a fever of 102°F; weak; tooth throbbing; body aches; food tasted like crap for anything that she could get into there; Because of the blisters she had a hard time breathing and couldn't can't eat; Her injection arm was "swollen so bad" from her neck to her fingertips. She couldn't lift up her arm because of the swelling; injection arm was "swollen so bad" from her neck to her fingertips; vomiting; lightheaded, dizziness; Migraine headache/migraine; her arms swollen down to her fingertips which she could not sleep on her left side; could not get out of bed; This is a spontaneous report from a contactable consumer (patient). A 60-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 18May2021 (Batch/Lot Number: EWO182) as single dose for COVID-19 immunisation. Medical history included allergic reaction to back yard tree and had sniffles and watery eyes prior to shot. There were no concomitant medications. The patient received her first Pfizer Covid vaccine dose on 18May2021. That evening she began to experience side effects. Her injection arm was "swollen so bad" from her neck to her fingertips. She couldn't lift up her arm because of the swelling. She had Migraine headache and vomiting. At 5 AM the following day 19May2021, she was vomiting, had diarrhea, a migraine, and then developed blisters in her mouth. Because of the blisters she had a hard time breathing and couldn't can't eat, had a fever of 102 degree F, was feeling weak, had to crawl to bathroom. She reported that 24May2021, was the first day that she felt ok. It was reported that her arms swollen down to her fingertips which she could not sleep on her left side, blisters in her mouth on her cheeks and roof of her mouth on her tongue, the back of her throat and lips, stated that she could not go to her dentist appointment the following day because of blisters and her tooth was throbbing on 19May2021. Stated that she had migraine headaches with vomiting, diarrhea, heart palpitations, weak, 102 fever, food tasted like crap for anything that she could get into there. The patient is supposed to go on 08Jun2021 for her second shot and was told that the second is worst than the first. Stated that she refused second shot. Stated that she could not get out of bed. Stated that she has a 7 and 8 year old to take care of by herself. Stated that the shot entry is the size of an apple on 24May2021. Clarified that she had the shot in her left arm. Caller stated that she had the Covid shot 18May2021 and she still does feel well today. Clarified that the blisters all started at the same time. Stated that she has had no heart palpitations since 5am this morning (24May2021). Stated that her fever is 99.9 Caller keeps rambling on; unable to clarify details with each event. Stated that the migraine is now a headache. She wants to know what would happen if she doesn't get the second dose of the vaccine. The patient received no treatment. Outcome of the events could not sleep on her left side, could not get out of bed was unknown; peripheral swelling was recovered with sequelae on 23May2021, vomiting was recovered with sequelae on 24May2021; Heart palpitations was recovered on 24May2021; Fever, migraine, couldn't lift up her arm, hard time breathing was recovering; all other events was not recovered. Follow up attempts needed. Further information is expected
60 2021-06-03 chest discomfort Shortly after 1st covid vax pt reported fullness at top of head and chest. No SOB. No itching, SOB. ... Read more
Shortly after 1st covid vax pt reported fullness at top of head and chest. No SOB. No itching, SOB. OP clear Lungs clear RRR Sx resolved shortly after. Pt advised discussing the incident and 2nd vaccination with PCP.
60 2021-06-03 heart rate increased soreness on her arm/ sore arm; felt very cold; weird sensation which she can't fully explain. It was... Read more
soreness on her arm/ sore arm; felt very cold; weird sensation which she can't fully explain. It was like electrical impulses all over her body started appearing and like her blood is running inside all over her body; heart rate went a little fast, recorded at 110-112; could not sleep; This is a spontaneous report from a contactable Nurse. A 60-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration on 01Mar2021 (Batch/Lot Number: EN6205; Expiration Date: Jun2021) as 1st dose, single dose for covid-19 immunisation. Medical history included covid-19 from 27Nov2020 to an unknown date and aggressive fever. The patient's concomitant medications were not reported. The patient previously took albuterol, tylenol and mucinex for covid-19. The patient reported that she was fine after 1st dose of the Pfizer vaccine but experienced some soreness on her arm and took tylenol. When she got home, she felt very cold but did not have a fever and had a normal temperature. As she was laying down, she felt a weird sensation which she can't fully explain. It was like electrical impulses all over her body started appearing and like her blood is running inside all over her body. Her heart rate went a little fast, recorded at 110-112 while her normal is 100-110. She could not sleep because of this. She woke up today and mentioned that her symptoms are lessening, not as intense as they were last night, and there is a little improvement. She took Tylenol for her symptoms and did not go to work. She received the vaccine amidst having a previous COVID Diagnosis last thanksgiving, 27Nov2020 and stated that she may still have antibodies from her infection and that the vaccine might be interacting with it. She knew that the Pfizer vaccine was not tested in people with previous COVID Diagnosis and just followed the CDC's recommendation to get vaccinated after 90 days after the infection and inquired for information, Pfizer may have on these topics and if she should receive the 2nd dose on 22Mar2021. She had covid around thanksgiving being about 3 months ago, so she waited the 90 days to get the vaccine. She reported that since she was a covid patient, she was thinking is it because she had antibodies. She was checked 2 weeks in Feb2021 and she was positive for antibodies and wanted to know the relationship between antibodies and the vaccine. Therapeutic measures were taken as a result of soreness on her arm/ sore arm. The patient underwent lab tests and procedures which included heart rate: 110-112, heart rate went a little fast, recorded at 110-112 while her normal is 100-110, sars-cov-2 antibody test: positive on Feb2021. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
60 2021-06-03 loss of consciousness I was unresponsive, he could not wake me up; Had pain in my neck on the same site of the shot; Had p... Read more
I was unresponsive, he could not wake me up; Had pain in my neck on the same site of the shot; Had pain in my neck on the same site of the shot.; Nerve pain; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), first dose via an unspecified route of administration, administered in left deltoid (left arm) on 17May2021 (at the age of 60-year-old, Batch/Lot Number: EW0177) as a single dose for Covid-19 immunization. Medical history included the patient had a child arrhythmia; she believed it was from 1996 but it pretty much controlled and prior to vaccine. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. This report was not related to a study or programme. The patient stated that she had a concern because she took the first COVID vaccine on the 17May2021 and she was due to get the second one on the 07Jun2021 however she had some concern today. The patient stated that she had some changed episode of reactions on 17May2021, she started having pain, after she took the first one, on the same day, she had pain in her neck on the same site of the shot and had some effect of pain, a nerve pain and it had devastated to the back of her neck where she had her thick neck and she had to use warm pack on the back of my neck. It would be about 4'O clock in the morning which would be on the 18May2021 her husband was observing her because he is a nurse and he could not wake her up, he tried everything possible to wake her up and he attempted to perform cardiopulmonary resuscitation (CPR) on her, so she was concerned about putting herself again such an event taken place. The patient went to the emergency room. They took her to the emergency room however she got her name administered in 'first a clinic' and he was able to stabilize her. The patient went to the emergency room and when she got there it was like a concerning so when she got there, she was not seen by the doctor because she was feeling little better but the context person, and they did concern that some of the episode she had, she saw the effect after COVID vaccine, she was concerned because she was due for the second vaccine and this was the first episode which she had, and she was concerned whether not should, she take the second shot, she went on her and she reported. The patient could not get this anyone, all she got was the worst. They took her to late but whatever she never got a chance to speak with anyone in her life, you know she do consult with her doctor has followed her so she was concerned now that she would have a second shot, she did not know if she could really take it. When concern confirmed the patient stated that she did have adverse reactions to the Covid-19 shot. The outcome of the events was recovering. Information on Lot/Batch number was available. Additional information has been requested.
60 2021-06-03 palpitations, fast heart rate, chest discomfort Four days after initial vaccine she developed chest tightness and palpitations which occurred interm... Read more
Four days after initial vaccine she developed chest tightness and palpitations which occurred intermittently and then gradually faded. Again four days after the second shot she developed palpitations. This time she was undergoing heart monitoring which revealed several episodes of symptomatic SVT. These have gradually reduced over time but not completely resolved. She had no previous cardiac history.
60 2021-06-06 chest pain, chest discomfort 2nd dose: Stinging a few minutes after shot, I felt really woozy, and then started shaking all over... Read more
2nd dose: Stinging a few minutes after shot, I felt really woozy, and then started shaking all over having a hard time processing and talking. Went home the next day (Wed) fever, chills, headache, 24 hours better, returned to work on Thursday, day (2). Day (3), Friday, I noticed a red rash at the site of the injection earlier in the day, but no symptoms, just a little tender. Friday evening I noticed a little SOB, a little burning sensation under my skin on both forearms, and a couple times felt a little dizzy, but I didn't think much about it. Day (4) Saturday morning, I went to spin class, I felt a little off, halfway through spin class I noticed I was struggling with some breathing, thought it was because I was wearing mask, but pushed through. Ran a couple of errands afterwards and then noticed the SOB was continuing, my skin started burning again under forearms and now my legs with tingling into my feet. At this point I decided I probably needed to go home. On my way home my chest started to hurt in the very center of my chest, and slowly felt like some pressure, with squeezing sensation. Then starting at the center of my chest I could almost feel what felt like a numbness creepy from my chest to my throat. I went to the ER. My legs felt really wobbly and had a difficult time walking, and was feeling dizzy. They ran a variety of blood work and tests. They noted my D-dimers were elevated and (4) lymph nodes enlarged. They ran an additional series of test and released me at 10pm with follow-up to cardiologist. I am still experiencing SOB, not as bad, and the burning sensations under my skin.
60 2021-06-09 body temperature decreased After 18 hours of 2nd dose. Symptoms: cold, temperature degrees from 37.8 C to 39.9 C. 6/8 around 1... Read more
After 18 hours of 2nd dose. Symptoms: cold, temperature degrees from 37.8 C to 39.9 C. 6/8 around 12:00AM, I had headaches, muscle pain, shortness of breath, cough, muscle pain, weakness, dizzy. Sleeping until 1:00pm on 6/9. The body temperature was down to 37.8C?but still dizzy and no energy at all. I feel better today, and body temperature has down to 37.4, and the shortness of breath is getting better, but not as normal, and had cough sometimes, but not too bad.
60 2021-06-09 superficial blood clot Superficial thrombophlebitis of the forearm distal to injection site. Persistent nausea and vomitin... Read more
Superficial thrombophlebitis of the forearm distal to injection site. Persistent nausea and vomiting following injection
60 2021-06-10 cardiac arrhythmia, heart rate decreased Erratic blood pressure. Decreased heart rate. Weakness. Fatigue, increase in PVC?s. I am an athlete ... Read more
Erratic blood pressure. Decreased heart rate. Weakness. Fatigue, increase in PVC?s. I am an athlete and was simply unable to workout due to response. I did workout the two days after the vaccine and perhaps I shouldn?t have done that. The following week I was exhausted and ended up I?m emergency room with dropping pulse rate and erratic blood pressure, swelling in my face and ankles.
60 2021-06-12 chest pain patient received Pfizer covid vaccine on 5/12/21. pt called and spoke to rph about having chest pain... Read more
patient received Pfizer covid vaccine on 5/12/21. pt called and spoke to rph about having chest pain and SOB. she was advised to seek medical help. pt went to urgent care according to pt she had an abnormal EKG and was referred to her pcp and cardiologist. In addition to the chest pain and SOB, she also reported having a blistering rash on her back She finally able to see her pcp and her cardiologist. Per pt, EKG is back to normal . She is only complaining about the blister scabs on her back
60 2021-06-12 hypertension May 1, 2021 ? Received 1st Covid19 shot around 3:00PM at a Pharmacy. No concerning reaction. May 2,... Read more
May 1, 2021 ? Received 1st Covid19 shot around 3:00PM at a Pharmacy. No concerning reaction. May 2, 2021 ? Arm a little sore at site of shot. Not a problem. Later afternoon some posterior leg muscle pain. Not severe. May 3, 2021 ? Bowels are hardened and a little difficult to push out. In the afternoon definite pain in various places in the large posterior muscles of both legs. In the evening abdominal cramping. A little tired feeling. May 4, 2021 ? Bowels hardened. Abdominal cramping. Deep specific areas of pain in both my posterior leg muscles including: calves, hamstrings, gluteals ? felt like someone sucker punched me up and down the backs of my legs. Right thigh is going numb while I work. Forearms and hands are going much more numb. Extreme fatigue by afternoon, to the point I had to sleep for a while. Diarrhea by early evening. May 5, 2021 ? Hardened bowels. Pain in legs is less severe but still there plus pains in inner thigh. Slight headache (I very rarely get headaches), extreme fatigue by afternoon, Debilitating, I had to take a nap. Thigh continues to go numb off and on while I work. My forearms and hands are tingling and going numb at times. May 6, 2021 ? I am noticing mild headache comes and goes, am experiencing ringing in head like I had with past concussion. Extreme fatigue by afternoon and have to lie down. My bowels are less hardened but still not regular. Still have deep pains in legs muscles but not as severe. Joints are achy: wrists, elbows, hips, knees. May 7, 2021 ? Same as day before. Also realize my blood pressure is running high. May 8, 2021 ? One Week Since Shot. Have noticed I am not able to focus in on specific things as well as normal. The fatigue is debilitating at times. It is affecting my daily chores. I have definitely gained weight, joints continue to be achy and stiff. Less headaches and leg pains are much less. No more abdominal cramping. Bowels are still a little hard. May 8, 9, 10, 11, 12 ? Still more tired than usual but not as debilitating. Bowels are better. My joints and muscles are still sore but not as bad. I am noticing swelling in my arms and legs and face ? feels like I am retaining fluid. I have occasional periods where I am not mentally focused/ forgetting things/ not as observant. Ringing in head happens from time to time. Blood pressure is higher than normal. May 13, 14, 15, 16, 17, 18 ? No more leg muscle pains but continue to have fluid retention. My joints are more sore than normal. Thigh and forearms are no longer going numb. Still more tired than normal but no longer need naps. Mental clarity is better but still feel ?off.? May 19, 20, 21 ? Exhausted. Completely exhausted. Legs and arms and face swollen. Bowels are hardened again. I feel like I have regressed. No deep muscle pain. Joints are stiff again. Mentally out of it. Not able to intently focus. Blood Pressure is up again. May 22, 23, 24 ? Body edema continues. On Sunday the 23rd my face literally swelled up! I took a benedryl and did lymph drainage massage on myself. It eventually went down after several hours. Never experienced difficulty breathing, my parotid glands did not seem to be swollen. May 25 to June 13 - Some days I feel okay, other days I am having swelling in legs, arms / seems like I am still retaining fluid, still more tired than I was before the Covid shot/ still have times a don't focus in as well as normal / joints are stiff at times from swelling and right thigh goes numb off and on when standing.
60 2021-06-13 inflammation of the pericardium Patient developed life-challenging pericarditis approximately 7 days following vaccination #2 (given... Read more
Patient developed life-challenging pericarditis approximately 7 days following vaccination #2 (given on May 1, 2021) causing fever, DOE and prompting emergent hospitalization followed by surgery for a pericardial window. The patient continued to have fever after the pericardial window and has been treated for possible flare of her arteritis with increased prednisone and increased CellCept. Prior to vaccination she had been in remission for at least 24 months on prednisone 1 mg per day and CellCept 500 mg twice per day.
60 2021-06-16 arrhythmia, palpitations Starting on the day of the vaccine, nothing significant. The next day, I started having palpitation... Read more
Starting on the day of the vaccine, nothing significant. The next day, I started having palpitations and arrythmias. I waited a day or 2 to see if it would go away and it did not go away and made an appt to see her. The doctor wanted to try a natural inflammatory supplement called Curcuim and Oscillococcinum. It did not help. I went to see an acupunturist and it help tremendously and reduced my arrythmias by 50% by the 2nd session. I did a total of 5 sessions. I went back to the doctor and was put on Hawthorne Supreme (another herbal supplement). It seems to be helping a little. I do not feel comfortable getting the 2nd vaccine dose.
60 2021-06-16 blood glucose increased 61 y/o with past medical history of Diabetes who presents with shortness of breath, nervousness and ... Read more
61 y/o with past medical history of Diabetes who presents with shortness of breath, nervousness and possibly elevated glucose. Patient states that she did not take any of her prescribed medications this am or check her glucose. Patient states that she had Cuban coffee, café con leche and pastelitos (Cuban pastries) prior to arrival. Patient states that this is the first dose in the two-dose series (Pfizer). Patient states that she received the vaccination to the left arm. Patient denies previous reaction to vaccinations in the past. Patient denies sore throat, difficulty swallowing, chest pain or rash. NP and Paramedics at patient side. Patient vitals within normal limits (156/81, 127/85, 132/79, 146/82, 133/85 BP, O2 Sats 96-99% RA, 86-98 HR). Patient glucose markedly elevated (202). Patient placed on 2 L O2 by nasal cannula. Within 5 mins of observation patient states that she is feeling better. Patient states that prescribed medication is on her person. NP instructed patient to take prescribed Metformin. Patient states was nervous to get the vaccination and didn?t want to take medications. Patient states also didn?t want to check sugar in case it was high. Glucose rechecked 25 mins post medication administration. Patient glucose decreased to 194. Advise patient needs to seek further medical evaluation/Fire Rescue. Patient denies need for transport and states that she wants to go home. Patient signed Against Medical Advice form. Patient walked off site with husband at side.
60 2021-06-16 blood glucose increased After second shot, could not get her blood sugars below 400; headache; had a stomach virus; sleepy; ... Read more
After second shot, could not get her blood sugars below 400; headache; had a stomach virus; sleepy; This is a spontaneous report from a contactable consumer or other non hcp. A 60-years-old female patient received BNT162B2 (BNT162B2, PFIZER-BIOECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 19Apr2021 09:30 (age at vaccination: 60-year-old) as second dose, single for covid-19 immunization. Medical history included ongoing type 2 Diabetes (she had it for about 6 years) and high blood pressure from Apr2021 and ongoing, ongoing depression (she had it since she was a teenager), kidney removed from 06Jul2020 to an unknown date, ongoing blood cholesterol, and ongoing bad allergies. Historical vaccine included BNT162B2 on 29Mar2021 (at the age of 60 years, Dose: 1, Time: 09:30, anatomical location: left arm) for covid-19 immunization. Concomitant medication included montelukast sodium (SINGULAIR); pravastatin; venlafaxine hydrochloride (EFFEXOR) at 150 mg taken for depression, start and stop date were not reported; losartan potassium (COZAAR) at 100 mg taken for high blood pressure from Mar2021 to an unspecified stop date. it was reported that After the second shot, she was feeling wonderful, but since then she can not get her sugars below 400. On 14Jun2021 morning she drank. She had breakfast like she was supposed to. She drank tea. She put 1/4 cup sugar per gallon in the tea. Her blood sugar was 311. she stated that she had seen the diabetic doctor regularly. She talked to lots of friends who are diabetic and other people who couldn't get their sugars down, she contacted friends and on looked on social media and they were having the same problem. she stated that she felt like a guinea pig. she went to the doctor after about 2 days. She did not know the dated. She told the doctor that she was dying. The doctor told her that her body was responding to the vaccine. She was sent home. She was told to drink plenty of liquids and rest. she stated that she did not have any treatment for her high sugars. She was watching what she ate. She added that she thought she had a stomach virus. She drank tea. She got sleepy. She had a headache. Her blood sugar was 311 this morning. she stated that her blood sugars were over 300 about 2 weeks after getting the second shot. She complained to her doctor and her diabetes doctor about the sugars. They wanted to put her on medications she could not take. This had never done this before. She cannot get her blood sugars down. It happened since she took the vaccine. She said her friends cannot get blood sugars below 300. The patient underwent lab tests and procedures which included blood sugar: 311 on 14Jun2021. The outcome for the event After second shot, could not get her blood sugars below 400 was reported as not resolved and for remaining events was unknown. Information about batch/Lot number has been requested.
60 2021-06-16 heart attack Seven hours after the vaccine I began vomiting, followed by diarrhea and indigestion that lasted for... Read more
Seven hours after the vaccine I began vomiting, followed by diarrhea and indigestion that lasted for two days May 28th and 29th 2021.
60 2021-06-18 chest discomfort, chest pain Within 1 hour had tightness in her chest, wheezing and her throat started to tighten up; Within 1 ho... Read more
Within 1 hour had tightness in her chest, wheezing and her throat started to tighten up; Within 1 hour had tightness in her chest, wheezing and her throat started to tighten up; Pain in the right side of her leg and in her stomach; Caller stated she has been vomiting mainly from the draining that is choking her.; Throat tightened up and glands swell; Barely able to breath, shortness of breath; Pain in right side, below her breast; Within 1 hour had tightness in her chest, wheezing and her throat started to tighten up; She was so sick; Caller stated she has been vomiting mainly from the draining that is choking her.; Headaches; Pain in the right side of her leg and in her stomach; Burning in her chest and throat/ pain was in the right side of the chest; Burning in her chest and throat/ throat has been like its on fire; This is a spontaneous report from a contactable consumer (patient). A 60-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 02Jun2021 (Batch/Lot Number: EW0177) as 1ST DOSE, SINGLE for covid-19 immunisation. Time the Vaccination Was Given: Between 12:00 and 1:00pm. Medical history included when she was a child, she had bronchial asthma. Has not had any problems in years. Prior Vaccinations (within 4 weeks): No, has been years. Has not even had the flu shot in 3 years. The patient's concomitant medications were not reported. Caller stated she had the first dose of the Pfizer covid 19 vaccine and stated she is having a reaction. Caller stated it feels like she has covid. Caller stated she got the vaccine 3 days ago and within 1 hour had tightness in her chest, wheezing and her throat started to tighten up. All she could do was wheeze. Her throat started tightening up and her glands started swelling. Caller stated she then had draining down the back of her throat. Caller reported burning in her chest and throat. Caller reported pain in the right side of her leg on 02Jun2021 and in her stomach. Caller stated she has been vomiting on 02Jun2021 mainly from the draining that is choking her. Caller stated she is still draining but not vomiting. Caller reported she is having headaches. Caller was concerned about what she should do, go to her doctor or go to the ER. Caller wanted to know how long the symptoms should last. Caller stated she is 52 hours out from the vaccine, Throat tightened up and glands swell, Barely able to breath, shortness of breath, pain on 02Jun2021. She was so sick. She was barely able to breathe within an hour and has been in pain. It is now a struggle, with shortness of breath. Her throat has been like its on fire, and lungs filled with a huge amount of drainage in the back of her throat. Is having right leg pain and pain in her stomach. It is not severe pain, but there is some pain there, is having a lot of burning sensation with the drainage. It now feels like she has Covid now. She read in the paperwork that this could not cause Covid. She was perfectly fine when she had the vaccine. She has no allergies. Does not know what to do. It has been 48 hours. She was perfectly fine until an hour later. She contacted the pharmacy and they didn't do anything. She then contacted this number to report this. Her biggest concern was the severe drainage. There were globs of drainage down the back of her throat. Her chest tightened prior to that and she was wheezing. She has not had bronchial asthma since she was a child. Has had no flus, or nothing. Had the pain after the burning in her chest, the pain was in the right side of the chest. Pain in right side of leg: Hasn't stopped completely. Still has pain in the right leg and in the chest. It is barely any better. It is probably because it is in one spot in the calf on her right leg. The pain in the right side, below her breast. The pain seems to be in the right side. Pain in stomach: Seems to be both sides. Has gotten better some, in the stomach. Vomiting: Was vomiting from all the drainage, it was choking her. It started within 2 hours. She is still experiencing the drainage, but not the vomiting. Has also been experiencing headaches. Shortness of breath: Was the same time as the tightness in the chest. It was within an hour after she left. They kept her there 15 minutes and she was fine when she left. Within the hour, she could barely breathe. She didn't know if she should go to the emergency room or if it would get better in a few days. The shortness of breath and wheezing is not worse, but is constant and really hard. Her breathing is really labored. She is not having pain, other than the tightness and wheezing, which she can hear. It is like she had asthma for years, or pneumonia. Outcome of events Wheezing, Chest burning, Throat burning sensation, headache, and Shortness of breath, pain of was not recovered, of Pain in leg, Stomach pain was recovering, of Vomiting was recovered in Jun2021, of others was unknown.
60 2021-06-20 oxygen saturation decreased Patient was 7 months post successful double lung transplant. Able to perform all ADL's and exercise... Read more
Patient was 7 months post successful double lung transplant. Able to perform all ADL's and exercise on room air with no need for supplimental oxygen. Three days following vaccination, patient noticed oxygen saturation begain dropping from baseline of 98-99% to 90-91%. Sats continued to drop. By day five, oxygen was 88%. Pt phoned lung transplant coordinator, who advised pt to see family doctor on Monday. Pt saw pcp on Monday, who ordered at CT scan. CT scan on Tuesday. PCP called and told patient he thought she had PNE. Pt went to scheduled appt with transplant center on Thursday, May 6th, and was admitted to hosptial. Pt was told it wasn't "exactly Pneumonia" and that her body was rejecting her lungs. Received care at hospital for three weeks, requiring oxygen for the first time since transplant. Discharged home on home O2 and continues to need oxygen at 4L to maintains sats above 90%.
60 2021-06-21 palpitations, heart flutter I had pulsing/fluttering around my heart. Arm pain. Lymph pain. Severe vomiting and diarrhea.
60 2021-06-22 chest pain I had no effects after first shot except pain in arm. After second dose I had randomly occurring st... Read more
I had no effects after first shot except pain in arm. After second dose I had randomly occurring stabbing pains in my chest over my heart for 2 to 3 days. After the stabbing pains left, I then had more frequent, but also randomly occurring, dull pain in the same area. This pain lasted about 6 weeks but grew less frequent and less painful over time until it dissipated completely. I immediately researched the reason for the pain and decided it was indeed a side effect of the vaccine and odds were good it would not kill me. I am a very healthy, fit woman with no health issues or weight problems.
60 2021-06-23 palpitations shortness of breath heart racing lasted for 36 hours
60 2021-06-24 heart attack, fast heart rate Within 5 weeks of receiving the second dose of Pfizer Covid vaccine, (on April 3, 2021) the patient ... Read more
Within 5 weeks of receiving the second dose of Pfizer Covid vaccine, (on April 3, 2021) the patient developed unprovoked SVT to 200 beats per min & then within 24 hrs had an acute Non-ST segment MI, with accompanying chordae tendineae rupture of her Mitral Valve. Required emergent Cardio conversions and Mitral Valve replacement.
60 2021-06-26 hypertension I have had high blood pressure but the ringing of the ears are thd worse . I also have gearing loss.
60 2021-06-27 inflammation of the pericardium One month after my second dose I felt aching in my shoulders and neck area. The symptoms were simila... Read more
One month after my second dose I felt aching in my shoulders and neck area. The symptoms were similar to those I had when I had a minor heart attack in 2015. I went to the emergency room and after many test it was determined I had pericarditis.
60 2021-06-28 chest discomfort Day of First shot: headache, sore arm, extreme exhaustion, feeling that some virus or illness was c... Read more
Day of First shot: headache, sore arm, extreme exhaustion, feeling that some virus or illness was coming on, intermittent chills. 36 hours after first shot: sore arm, headache, stomach ache (upper and lower), cramping, swollen gland on front of neck (just one gland). Had all of these symptoms on my second shot too, but not as bad. I did not have a swollen throat/neck gland, BUT had shortness of breath/asthma reaction on my second shot, and chest & sinus congestion. The intermittent asthma/shortness of breath, (haven't had in a long time), was without wheezing. I used my albuterol rescue inhalor and it seems to help me get through these boughts. The asthma came on at about 29-36 hrs and has lasted 6 days so far.
60 2021-06-29 heart failure I experienced heart failure and my ankles swelled.
60 2021-06-29 hypertension 4 Days after 2nd injection I woke up having pulsing in my ears, I was very lightheaded and nauseous ... Read more
4 Days after 2nd injection I woke up having pulsing in my ears, I was very lightheaded and nauseous as if I was having motion sickness at 11 a.m. I checked my blood pressure and it was extremely high, Over the course of 15 minutes, I got a pain in my shoulders, and could barely walk. I check my blood pressure again it was 180/120. My stomach was upset and I had to crawl to the bathroom, too dizzy to walk. I checked my blood pressure again and it was 178/130. My head was pounding and I was losing my ability to walk. I was taken to the Emergency Room, I wasn't sure if this was a stroke or Heart attack, or neuro problem. I was admitted for two nights and released on January 19, 2021. I still had extremely high blood pressure and motion sickness. The hospital did several tests and ruled out a heart attack and stroke. As of today, I am still undergoing treatment for high blood pressure. I had no issue with this before the vacine
60 2021-06-29 palpitations Pt was on 15 min observation following injection. After approximately 10 min pt began to complain of... Read more
Pt was on 15 min observation following injection. After approximately 10 min pt began to complain of feeling like her heart was racing, dry mouth and feeling "Jittery", dizzy and weak
60 2021-06-30 chest pain I went into the hospital with chest pains on the left side of my body (developed a rash that wrapped... Read more
I went into the hospital with chest pains on the left side of my body (developed a rash that wrapped around on side of my body and I went to the ER where the Doctor saw red marks all over my body (developed shingles a month after taking the vaccine) and was placed on antivirals for 7-days days by the PA in my doctor's office. I have never had Shingles before. The pain was very severe and it didn't go away until a month later. I was referred to a Cardiologist to perform a stress test to ensure my heart was ok.
60 2021-06-30 nosebleed I have had four nose bleed.; This is a spontaneous report from a contactable consumer (patient). A 6... Read more
I have had four nose bleed.; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route on an unspecified date (Lot Number: ER8736) as a single dose at the age of 60-year-old for covid-19 immunisation. Medical history included blood pressure from an unknown date and unknown if ongoing. Concomitant medications included losartan taken for blood pressure, start and stop date were not reported; estradiol taken for an unspecified indication, start and stop date were not reported. The patient was on different medication along with blood pressure medication. The patient takes the first dose two weeks before and have had four nose bleed. The patient never had any nose bleed since before the vaccination. The patient wanted to know if the nosebleed would be part of the symptom and should she got the second one. The outcome of the event was unknown.
60 2021-07-01 hypertension, fibrin d dimer increased, palpitations Sick with had fever; flu-like symptoms; She felt like she was having neuro symptoms in her head, lik... Read more
Sick with had fever; flu-like symptoms; She felt like she was having neuro symptoms in her head, like she was having a stroke; Palpitations; Blood pressure high; Tingling in her feet, fingers, face, arms, legs, and head; She reports having extreme anxiety; D-dimer is still high; She says her feet have gone numb; Waking up in the morning feeling like the petal was to the metal, feeling everything is revved up. She couldn't control that; Abdominal pain; Fogginess in the head; fever; Shaking; Chills; This is a spontaneous report from a contactable consumer or other non health care professional. A 60-years-old female patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection, Lot Number: EM9809, Expiration date: Unknown), dose 2 via an unspecified route of administration, in Left Arm on 20Feb2021 (at the age of 60 years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history included high blood pressure Diagnosed 20 something maybe 30 years ago, underactive thyroid Diagnosed 20 something maybe 30 years ago, autoimmune thyroid disorder. Patient previously received first dose of bnt162b2 (Solution for injection, Lot number EL3248, Expiration date: Unknown) via an unspecified route of administration, in Left Arm on 30Jan2021 (at the age of 60 years-old) as 1 ST DOSE, SINGLE for Covid-19 immunisation. The patient concomitant medications included Atenolol years ago, she doesn't know taken for hypertension, Levothyroxine taken 20 years ago, a long time ago for thyroid disorder. The patient experienced abdominal pain on 01Mar2021. Patient had, palpitations, blood pressure high , tingling in her feet, fingers, face, arms, legs, and head, she reports having extreme anxiety, d-dimer is still high, she says her feet have gone numb, waking up in the morning feeling like the petal was to the metal, feeling everything is revved up. she couldn't control that, She flu-like symptoms, she felt like she was having neuro symptoms in her head, like she was having a stroke in Apr2021. she was sick with had fever on an unspecified date. she had fever, shaking, chills, had fogginess in the head in 2021. She stated she was at the emergency room 3 times since receiving the vaccine. The reason she went to the emergency room was she felt like her blood pressure was very high, and it was extremely high, they had to bring it down with a beta blocker. She was on blood pressure medication prior to this but her blood pressure was under control, it then became un-controlled. She had to start seeing a Cardiologist. she has become an extremely anxious person. She states that due to SOB and pulse ox and all, he did CAT scan to determine if she had pulmonary embolism. She did not. She states her D-dimer is still high so he changed blood pressure meds, increasing and manipulating them. Now she feels her blood pressure is under control. The cardiologist has manipulated her medications, increased them, and that has brought her blood pressure under control. She is seeing a neurologist. She states she was perfectly fine until she took the vaccine. She hopes that will show some things on the status of her nerves. She does not know where all of this came from as she was perfectly fine before the vaccine. Waking up in the morning feeling like the petal was to the metal, feeling everything is revved up. She couldn't control that; that went on for awhile. She tried different antidepressants which didn't work. She tried 2 antidepressants and that didn't help, it made it worse. Since she has gotten off these she feels a little bit better now. she was calling were for the cardiology, neurology, and anxiety issues. still has to work and her feet and legs are not the best. She reported that going to the ER on 17Apr2021, and she also thinks she went on the 25th and 29th. She reports they put her on gabapentin, a nerve drug and it is helping her nerve problem. states she does not have results of the tests other than she does not have a blood clot in her lung. After the first dose she had total and complete brain fog for an entire day, also she had a sore arm. Patient was working with the elderly in nursing home type of environment. The patient underwent lab tests and procedures which included computerised tomogram results unknown, fibrin d dimer was high, magnetic resonance imaging showed mri of brain it was ok. She has a nerve conduction test on 12Jul2021. The Outcome of event abdominal pain was recovered on an unspecified date in 2021. Outcome for the events palpitations, blood pressure high, She reports having extreme anxiety, Waking up in the morning feeling like the petal was to the metal, feeling everything is revved up. She couldn't control that, fever, Shaking, Chills, flu-like symptoms, She felt like she was having neuro symptoms in her head, like she was having a stroke was recovering. Outcome for the other events tingling in her feet, fingers, face, arms, legs, and head, She says her feet have gone numb, fogginess in the head was not recovered. The outcome of D-dimer is still high, Sick with had fever was unknown. Information on Lot/Batch number was available. Additional information has been requested. No Follow-up attempts completed. No further information is expected.
60 2021-07-01 hypotension, low platelet count Possible anaphylactic shock, acute kidney injury, shock liver, hypotension, rash, thrombocytopenia. ... Read more
Possible anaphylactic shock, acute kidney injury, shock liver, hypotension, rash, thrombocytopenia. Full body rash, abdominal pain, vomiting, diarrhea, RLE pain, fever, dizziness, body aches, headache. Sx onset 06/26/2021 after receiving COVID vaccine #2 the same day. Pt went to medical facility on 06/30/2021 and was sent to ED. Pt admitted to ICU 06/30 - 07/02. Transferred to general medical floor on 07/02/2021.
60 2021-07-02 fast heart rate SVT; This is a spontaneous report from a contactable physician. A 60-years-old female patient receiv... Read more
SVT; This is a spontaneous report from a contactable physician. A 60-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), (At the age of 60-years) dose 1 via an unspecified route of administration, administered in Arm Right on 15Mar2021 15:00 as DOSE 1, SINGLE, dose 2 via an unspecified route of administration, administered in Arm Right on 05Apr2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included supraventricular tachycardia and History of svt. S/p ablation Onset date: 20-year Hx of sporadic episodes Pertinent details: Hx of 2 ablations- last one Nov2020. Patient was not Pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. Patient did not diagnose with COVID Prior to vaccination. Patient did not test for COVID-19 Since the vaccination. No Allergies ware reported. The patient concomitant medications were not reported. The patient experienced supraventricular tachycardia on 25Mar2021. Patient was visited Emergency room for event. Treatment received for the adverse event: Adenosine. It was reported that patient received Treatment: B blocker for 2nd dose. Seriousness Criteria: Important medical event. The outcome of event was recovered on 2021. Follow-up attempts are completed; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of supraventricular tachycardia. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
60 2021-07-05 chest discomfort Woke up three days after the vaccination with sever fatigue, shortness of breath, and a severe heada... Read more
Woke up three days after the vaccination with sever fatigue, shortness of breath, and a severe headache. Fiance rushed me to the ER because I couldn't catch my breath. All tests came back negative/normal. CT scan didn't show any pulmonary embolism which they thought I had. They released me. The symptoms have continued and have gotten worse. I now have tightening around the heart and lungs along with headaches on a daily basis. When I get those "attacks" it can drop me to my knees. Am currently looking to follow up with a cardiologist.
60 2021-07-06 blood glucose increased On oxygen had major congestion for 3 weeks has subsided; Since the vaccine it will not go down under... Read more
On oxygen had major congestion for 3 weeks has subsided; Since the vaccine it will not go down under 250 stays there to 300 with same insulin requirements; This is a spontaneous report from a contactable consumer (patient reported for herself). A 60-year-old non-pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in arm left on 10May2021 11:00 AM (At the age of 60-year-old) as dose 1, single for COVID-19 immunization. Medical history included oxygen insulin COPD (chronic obstructive pulmonary disease). The patient had known allergies to Amoxicillan. Concomitant medications included Insulin, metformin, furosemide, lisinopril and atorvastatin all taken for an unspecified indication, start and stop date were not reported. The patient previously took amoxicillin and experienced drug hypersensitivity. 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. On 11May2021 at 07:00 AM, the patient experienced on oxygen had major congestion and Insulin dependent sugars not going down under 250 stays there to 300. The clinical course of the events as follows: on oxygen had major congestion for 3 weeks has subsided. Insulin dependent sugars level was between 110 and 130. Since the vaccine it would not go down under 250 stayed there to 300 with same insulin requirements. The patient visited the physician office for the events. On 18May2021, COVID test post vaccination: Nasal Swab was Negative. The events were not resulted into the seriousness criteria of death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating and Congenital anomaly/birth defect. The outcome of the event on oxygen had major congestion was resolving and the outcome of other event was not resolved at the time of this report. Information about lot/batch number has been requested.
60 2021-07-06 ejection fraction decreased My EF went from 45 to 30. Two months after vaccination.
60 2021-07-06 heart rate increased, palpitations, blood pressure increased AFTER RECEIVING MY FIRST DOSE I WENT TO WAIT IN THE WAITING ROOM AND BEGAN HAVING A RACING HEARTBEAT... Read more
AFTER RECEIVING MY FIRST DOSE I WENT TO WAIT IN THE WAITING ROOM AND BEGAN HAVING A RACING HEARTBEAT ABOUT 10 MINUTES AFTER THE SHOT. I BEGAN TO FEEL DIZZY, MY HEART WAS RACING, MY PULSE SHOT UP FROM 64 TO 154 PER MY WATCH AND MY MOUTH GOT DRY. I ASKED FOR A NURSE AND THEY ESCORTED ME BACK TO A ROOM. I WAS FEELING LIKE I WAS GOING TO PASS OUT SO THEY LOWERED ME ON THE THE TABLE. THEY CHECKED MY PULSE AND 02. MY MOUTH WAS DRY AND MY LEGS AND HANDS WERE TINGLING. MY HEART WAS POUNDING AND I FELT SICK TO MY STOMACH. THEY CHECKED MY BP WHICH IS USUALLY LOW AND IT WAS REALLY HIGH. I WAS FEELING WEAK AND UNABLE TO STAND SO THEY TOLD ME THEY WERE TRANSPORTING ME TO THE ER. I WAS SHAKING, FREEZING, MY MUSCLES WERE CRAMPING IN MY ARMS AND LEGS. MY HEART CONTINUED TO RACE, I WAS DIZZY AND REALLY WEAK. I HAVE CONTINUED TO HAVE A RACING HEART BEAT AT RANDOM TIMES DURING THE DAY, STILL FEEL DIZZY AND FATIGUED. MY HEART ALSO POUNDS AT RANDOM TIMES DURING THE DAY. I AM NOT FEELING WELL.
60 2021-07-06 palpitations Worst part so far is inability to sleep, feels like heart racing since at least 07/06/2021 around n... Read more
Worst part so far is inability to sleep, feels like heart racing since at least 07/06/2021 around noon or 1:00; many many feelings like heart flip flops during same period - these things are continuing. injection site still hot, red and swollen and painful. Had fever 100.4 to 101.6 for twelve hours, head and body aches, joint pain - the fever and aches and pain started subsiding today. - the fever, aches and pains I understand are fairly common. Really had not expected the feeling that my heart is racing and flip flopping or the inability to sleep - may have got two hours last night - so that is why I am reporting. Not planning to seek medical care unless it continues another night or two.
60 2021-07-06 pulmonary embolism, deep vein blood clot She developed a right DVT and bilateral pulmonary embolisms
60 2021-07-07 loss of consciousness, chest pain BPPV VERTIGO, NO TREATMENT, BUT MANEUVERS. IN GOOD HEALTH UNTIL I TOOK VACCINE. Last shot 4/24/2021... Read more
BPPV VERTIGO, NO TREATMENT, BUT MANEUVERS. IN GOOD HEALTH UNTIL I TOOK VACCINE. Last shot 4/24/2021 - BPPV VERTIGO - 5/11/2021
60 2021-07-08 chest discomfort Swelling in glands/lymph nodes; earache (right ear); burning and tightness in chest; burning and tig... Read more
Swelling in glands/lymph nodes; earache (right ear); burning and tightness in chest; burning and tightness in chest; Aches; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 60- years-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ep6955) via unspecified route of administration in the left arm on 15Mar2021 at 15:15 (at the age of 60-years old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced swelling in n glands/lymph nodes, earache (right ear), burning and tightness in chest, aches and fatigue on 19Mar2021. The patient underwent lab tests and procedure which included COVID test (Nasal swab) on an unknown date and tested negative. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive treatment for the reported events. The clinical outcome of events swelling in n glands/lymph nodes, earache (right ear), burning and tightness in chest, aches and fatigue was not resolved. No follow-up attempts are needed. No further information expected.
60 2021-07-08 nosebleed Patient reported several itchy wheals/hives that started on the writs of the arm the vaccination was... Read more
Patient reported several itchy wheals/hives that started on the writs of the arm the vaccination was given in, and some on the opposite arm. They were limited, not widespread. These began the day following vaccination. Roughly 12 hours post-vaccination she stated she had a severe headache that woke her up. This headache continued 7 days, peaking on day 3. She almost went in for treatment, but did not end up doing so. She also reported swollen, tender lymph nodes in axilla on side of vaccination, as well as a blood nose.
60 2021-07-08 palpitations, nosebleed Itching, bloody nose, palpitations, headaches for the week following, one severe, nausea
60 2021-07-09 chest discomfort The patient received her first dose of the Pfizer Covid-19 vaccine in her home. About 15 seconds aft... Read more
The patient received her first dose of the Pfizer Covid-19 vaccine in her home. About 15 seconds after administration the patient subjectively stated, "I can't breath", and "my throat and chest feel tight". I objectively evaluated the patient who appeared unchanged from baseline. The daughter and caretaker were present during the event, and the daughter stated that "she always say's that". However, the patient replied, "she is lying, I don't always say that, I can't breath!". Due to the patient's subjective complaint of shortness of breath EMS was called and arrived within 10 minutes. During that 10 minutes the patient remained stable. No hives, no wheezing, no eye tearing or nasal discharge. No facial, tongue, or throat swelling observed. Patient continued to speak in full sentences and did not have any labored breething. Epinephrine was not adminstered during this time due to the lack of objective signs of anphylaxis. EMS arrived and performed an evaluation; vital signs were stable; however, the patient continued to state that she "couldn't breath". No medications were administered by EMS on-scene at the patient's house. The patient was taken to the hospital for observation and possible treatment. Symptoms most likely due to a panic attack but anaphylaxis could not be ruled out and the patient was trasferrred to a higher level of care.
60 2021-07-11 heart rate increased No treatment was sought, I immediately had elevated heart rate at rest and upon exertion for the fol... Read more
No treatment was sought, I immediately had elevated heart rate at rest and upon exertion for the following 2 1/2 weeks. The most troublesome adverse event was the extreme short-term memory loss. It is beginning to rectify itself now hopefully.
60 2021-07-12 chest pain, troponin increased I woke up around 2:30 in the morning of the 18th and I was having pain that went across my shoulders... Read more
I woke up around 2:30 in the morning of the 18th and I was having pain that went across my shoulders. In half an hour, it was going down both arms, up my neck and in my jaw. I started having chest pains. I went to the ER and they sent me to another hospital where they gave me blood thinners. They think something affected my heart or I had a blood clot. I was discharged two days later and was given an MRI of my heart. They determined that the lining of my heart was swollen. I am now on blood pressure meds and cholesterol meds and am not allowed to spike my heart rate for the next 3-6 months. The doctors believe it was caused by the vaccine.
60 2021-07-12 chest pain Burning , kneedle pain in left hand, chest pain, paralysis, not able to move or talk for hours, was ... Read more
Burning , kneedle pain in left hand, chest pain, paralysis, not able to move or talk for hours, was taken to ER, was kept at the hospital overnight, released next day. Follow up with cardiologist & Neurologist, EKG test, Nuclear cardio test, angiogram of the heart , medication.
60 2021-07-12 palpitations Heart started feeling like it was racing on Friday night and has not stopped since.; This is a spont... Read more
Heart started feeling like it was racing on Friday night and has not stopped since.; This is a spontaneous report from a contactable consumer, the patient. A 60-years-old non-pregnant female patient received a first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204), via an unspecified route of administration in right arm on 23Mar2021 at 11:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. The medical history and concomitant medications were reported as no. The patient was not aware if she had any allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not been diagnosed with COVID-19 prior to the vaccination. The patient had not been tested for COVID-19 since the vaccination. On 26Mar2021, at 21:00, the patient had experienced heart racing. The patient reported that she had the vaccine on Tuesday and her heart started feeling like it was racing on Friday night and had not stopped since. No treatment was received for the adverse event. 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 heart racing was not recovered at the time of report. No follow-up attempts are needed; No further information is expected.
60 2021-07-12 palpitations hives on my knees; light sensitivity; concentration difficult throughout experience; felt very dizzy... Read more
hives on my knees; light sensitivity; concentration difficult throughout experience; felt very dizzy; Knees swollen; neck discomfort; headache; area swollen from nose to chin; sore injection site,; fatigue; foggy during day; felt my heart beating hard within 5 minutes of vaccine; my lips were numb; I felt a little trouble swallowing.; Had chills; had swelling around lips/mouth; This is a spontaneous report received from a contactable consumer, the patient. A 60-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no : ER8727) via an unspecified route of administration in the left arm on 24Mar2021 at 11:300 (at the age of 60-year-old), as a single dose for COVID-19 immunisation. The patient had no Medical history. Concomitant medications included with supplements. The patient previously received Sulpha Drugs on an unknown date for unspecified indication and experienced a sulfonamide allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 24Mar2021 at 11:00, the experienced heart beating hard within 5 minutes of vaccine and her lips were numb and she felt a little trouble swallowing, and had chills, and had swelling around lips/mouth. On 25Mar2021, the Patient experienced area swollen from nose to chin and Had headache, sore injection site, fatigue, foggy during day. On 26Mar2021, the patient experienced Fatigue and neck discomfort. On 27Mar2021, the patient experienced very dizzy, Knees swollen and Could not sleep on injection site. On 28Mar2021, the experienced hives on her knees, Light sensitivity and concentration difficult throughout experience. The patient underwent lab tests and procedures, which included Blood pressure on unknown date and resulted normal. The patient called clinic for instructions and receive Benadryl for lips numbness, heart beating hard, trouble swallowing and chills. Patient had called doctor and awaited to call back. The clinical outcome of felt heart beating hard, numb lips, trouble swallowing, chills, area swollen from nose to chin, headache, fatigue, foggy during day, neck discomfort, dizzy, swollen knees, hives on knees, light sensitivity and concentration difficult was not recovered and of the vaccination site pain was recovered on 26mar2021. No follow-up attempts are possible. No further information is expected.
60 2021-07-13 heart rate increased, palpitations I began having a high heart rate and I felt my heart beating out of my chest. Heart rate was up to 1... Read more
I began having a high heart rate and I felt my heart beating out of my chest. Heart rate was up to 115. I felt pretty weird. I went to cardiologist and had all the cardiac tests done: wore a heart monitor for 48 hours, echocardiogram, several EKG's, and a stress test. All the tests came back normal. But I still didn't feel good. Cardiologist put me on Bystolic and it helps.
60 2021-07-13 blood clot, dilation of blood vessels Sore Right Arm and swollen vein ; ultrasound confirmed a blood clot in Right Arm. Trip to ER 6/30/2... Read more
Sore Right Arm and swollen vein ; ultrasound confirmed a blood clot in Right Arm. Trip to ER 6/30/21; put on blood thinner. No history of blood clots.. self or family. 2nd vaccine shot was 6/22/21 LOT EW0217
60 2021-07-15 loss of consciousness passing out 3 days after vax, missing days, 2 days in hospital, passed out in car wreck, disorientat... Read more
passing out 3 days after vax, missing days, 2 days in hospital, passed out in car wreck, disorientated, fell down stairs, passed out eating, passed out in bathtub face first, nearly drown.
60 2021-07-15 pulmonary embolism, deep vein blood clot Bi-Lateral Pulmonary Embolisms, Left Leg Deep Vein Thrombosis Noticed Symptoms on 5/28/2021 Hospita... Read more
Bi-Lateral Pulmonary Embolisms, Left Leg Deep Vein Thrombosis Noticed Symptoms on 5/28/2021 Hospitalized on 6/2/2021
60 2021-07-17 blood pressure decreased Client reported nausea, tingling in her left hand, and slight dizziness at 6:45ish. Vitals obtained ... Read more
Client reported nausea, tingling in her left hand, and slight dizziness at 6:45ish. Vitals obtained at 6:53PM PM were as follows: BP 120/78, HR 71, O2 96%. The client reported a history of nausea when she is nervous. Client was provided an emesis bag. Vitals obtained at 6:58PM were as follows: BP 120/68, HR 65, and O2 98%. The client reported a history of hypotension. The client stated she has to be sure to stay adequately hydrated or she notices a decrease in her blood pressure. Current medications include Avapena. The client denied any s/s of anaphylaxis. At 6:55PM the client reported a headache. The client did eat today. At 7:02PM RN provided the client a cotton ball with peppermint oil on it to smell.. The client stated her headache was very light at 7:05PM. The client left at 07:10PM.
60 2021-07-17 blood pressure increased, heart rate increased Dizzy; wretched; blood pressure was got high; fast heart rate beating; I was very sick; This is a sp... Read more
Dizzy; wretched; blood pressure was got high; fast heart rate beating; I was very sick; This is a spontaneous report from a contactable consumer (patient herself). A 60-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number was not reported) via an unspecified route of administration, administered in Arm Left on 14Mar2021 as single dose for COVID-19 immunization. Medical history included blood cholesterol abnormal and blood pressure abnormal from an unknown date and unknown if ongoing. Concomitant medication included potassium (POTASSIUM) taken for an unspecified indication. It was reported that, she got one Pfizer shot and she was due for the next one in the morning at 11:25. The first shot that had gotten, she went to the emergency room; on 23Mar2021 she was wind up, dizzy, wretched and blood pressure was got high. It was one she thought like 184 over like a 160 or 170 and she had fast heart rate beating and it. She was in the emergency room with elevated blood pressure; she had fast heartbeat and pressure was very high. She was very sick and was afraid to take that second shot of vaccine. Therapeutic measures were taken as a result of blood pressure was got high as she was taking Metoprolol tartrate pills for it. The patient underwent lab tests and procedures which included blood pressure measurement which was elevated and heart rate which was fast on an unspecified date. The outcome of all events was recovered on an unspecified date in 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
60 2021-07-17 blood pressure increased, hypertension, atrial fibrillation This is a spontaneous report from a contactable consumer or other non hcp (patient). A 60-year-old f... Read more
This is a spontaneous report from a contactable consumer or other non hcp (patient). A 60-year-old female patient received BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: ER8729, Expiration Date: UNKNOWN), via an unspecified route of administration, in left arm, on 19Apr2021 (at the age of 60-years-old) as dose 2, single for COVID-19 immunisation. The medical history of the patient included atrial fibrillation from Jun2020 and ongoing patient stated she was diagnosed after the heart surgery, heart surgery on 20May2020 patient stated she had a new Tricuspid valve placed and she was in the hospital for two weeks during the surgery and she was still having some problems from the heart surgery, ongoing BP elevation patient stated about two weeks ago, her heart doctor kept her on a blood pressure medication, and she cannot provide the name, stroke on 27Feb2020 and ongoing, had hole in heart from birth and unknown if ongoing. The concomitant medications of the patient included apixaban (ELIQUIS) taken as blood thinners from Jun2020 and ongoing and metoprolol (METOPROLOL) taken for heart issues from Jun2020 and ongoing. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: ER2613, Expiration Date: UNKNOWN), via an unspecified route of administration, in left arm, on 26Mar2021, as single dose for COVID-19 immunisation and she also received flu shot on an unspecified date in Oct2020 (at the age of 59-years-old) and reported arm sore. There was no investigation assessment. There were no additional vaccines administered on same date of the Pfizer suspect. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. The family medical history relevant to AE(s) was not provided. The relevant tests were reported as none. AEs prior vaccination was reported as arm sore. On 04May2021, the patient reported she's had severe arm pain on the arm with the injection (left). She stated she is still having the pain. it's like someone punched you in the arm with their fist, the pain was running my blood pressure so i had to go to the hospital/blood pressure elevated, 212/109 and atrial fibrillation on an unspecified date. The patient reported that her arm hurt so bad, pain, cannot put her arm behind her back, after second vaccine, it had been over 2 months since her arm hurting her, and she went to the emergency room and her blood pressure went way up and she had some heart issues and had atrial fibrillation two to 3 weeks after the second shot, and it lasted one day. She asked how long the pain will last and was anyone else reporting arm pain for this period of time. The patient was hospitalized as a result of events from 06May2021 to an unknown date. The patient visited emergency room. The patient underwent lab tests and procedures which included Blood Pressure elevated: 212/109 on 06May2021. Therapeutic measures were taken as a result of events that included, she took Tylenol. She reported that she was given medication in the hospital, cannot provide the name and the medication did help to bring her blood pressure down and she also did get a shot of a steroid states the steroid did help to relieve some of the arm pain. The outcome of the events having the pain. it's like someone punched you in the arm with their fist and the pain was running my blood pressure so i had to go to the hospital/blood pressure elevated, 212/109 was reported as unknown and the patient recovered from atrial fibrillation on an unspecified date in 2021. Follow-up attempts are completed. No further information is expected. ; Sender's Comments: A causal association between BNT162B2 and the reported events atrial fibrillation, blood pressure increased and pain in arm cannot be completely excluded based on information provided. However, patient's underlying medical conditions atrial fibrillation, septal defect, heart surgery, hypertension and advanced age were confounders. 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.
60 2021-07-17 cardiac failure congestive Congestive heart failure; shortness of breath; This is a spontaneous report received from a contacta... Read more
Congestive heart failure; shortness of breath; This is a spontaneous report received from a contactable consumer (patient sister). A 60-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was Unknown), via an unspecified route of administration, administered in Arm Right on 10Mar2021 11:00 (at the age of 60-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included atrial fibrillation, heart disease. The patient's concomitant medications were not reported. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 10Mar2021, the patient experienced shortness of breath, time of onset: (24-hour clock) was unsure but possibly after the first dose. On an unspecified date congestive heart failure. Patient called regarding the Pfizer COVID 19 vaccine mentioned while providing family history, her sister had the COVID 19 vaccination and also had shortness of breath. Added her sister got her vaccination in Mar2021 but she doesn't have her card with her. She also had shortness of breath and was still having it. She do not put two and two and together until her sister had it. This was a clone report is created to document the sister's experience. Patient added the shortness of breath that started in Mar2021. States she had previously been off work for a year with AFib but she was doing really well; she had started walking around the block and everything. Then she had the first dose of the Pfizer COVID 19 vaccine on 10Mar2021 at 1100AM in the right arm; and the second dose 30Mar2021 she thought at 1100am in the right arm. Reports she is unsure of exactly when she noticed the shortness of breath. She went from the car to the store and she was short of breath so she went to the emergency room to get it checked but everything was good. Mentions she was also diagnosed with congestive heart failure about a month ago. After she went to the emergency room she just went back and forth to her doctors. The lung doctor said she was okay; and the heart doctor, too. She kept going to the doctor because it do not dawn on her that the shortness of breath might be related to the vaccination until her sister got her vaccination and had the shortness of breath. Now she believed she noticed the shortness of breath after the first dose. Mentions she has the emergency room records and her vaccination card at home to verify her information. Adds she was talking to a guy at the bus station and he had shortness of breath too. She could go get the test results when she gets the information and had blood, EKG, and chest x-ray; they said was it was good. Mentioned she was still pressing the issue about her breathing but they couldn't detect it. History of all previous immunization with the Pfizer vaccine considered as suspect. Additional vaccines administered on same date of the Pfizer suspect was none. No vaccine administered at Facility. The patient underwent lab tests and procedures which included blood test, chest x-ray, EKG: was good on an unspecified date. Events resulted in emergency room visit and physician office visit. The clinical outcome of events shortness of breath was not recovered and congestive heart failure was unknown. Information about batch/Lot number has been requested.
60 2021-07-17 cardiac failure congestive This is a spontaneous report from a contactable consumer (patient's sister) or other HCP. This is 1s... Read more
This is a spontaneous report from a contactable consumer (patient's sister) or other HCP. This is 1st of 2 reports.A 60-years-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number and expiry date was not reported) via an unspecified route of administration at Arm Right on 10Mar2021 at 11:00 (at the age of 60-years-old) as Dose 1, single for COVID-19 immunization. The patient's medical history included atrial fibrillation, cardiac disorder from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. No other products were used.On an unspecified date the patient experienced congestive heart failure and shortness of breath on an unknown date in Mar2021. The patient underwent lab tests and procedures which included blood test: good on, chest x-ray: good on, electrocardiogram: good on. Outcome of the event was cardiac failure congestive was unknown, shortness of breath was not recovered on unspecified date. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
60 2021-07-17 cardiac failure congestive Congestive heart failure; This is a spontaneous report received from a contactable consumer (Patient... Read more
Congestive heart failure; This is a spontaneous report received from a contactable consumer (Patient). A 60-years-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: Unknown), via an unspecified route of administration, administered in Arm Right on 30Mar2021 11:00 (at the age of 60-years-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included atrial fibrillation, cardiac disorder from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (Lot: unknown) on 10Mar2020 at 11:00 PM in the right arm for COVID-19 immunisation and experienced shortness of breath. The patient experienced congestive heart failure on Jun2021. The events assessed as serious (medically significant). Call was from two sisters, a 57 year old female and a 60 year old female. One received her Pfizer Covid-19 vaccine on 22Jun2021 and started experiencing shortness of breath and dyspnea. The other sister received the Pfizer Covid-19 vaccine on 10Mar2021 and starting experiencing shortness of breath as well but attributed to her history of atrial fibrillation initially. Both are wondering if anyone else was having these complaints and if there are any recommendations for the complaints. Patient mentioned while providing family history, her sister had the COVID 19 vaccination and also had shortness of breath. Adds her sister got her vaccination in Mar2021 but she does not had her card with her. She also had shortness of breath and was still having it. She did not put two and two and together until her sister had it. This was a clone report was created to document the sister's experience. Patient adds the shortness of breath that started in Mar2021. States she had previously been off work for a year with A-Fib but she was doing really well, she had started walking around the block and everything. Reports she was unsure of exactly when she noticed the shortness of breath. She went from the car to the store and she was short of breath so she went to the emergency room to get it checked but everything was good. Mentions she was also diagnosed with congestive heart failure about a month ago. After she went to the emergency room she just went back and forth to her doctors. The lung doctor said she was okay and the heart doctor, too. She kept going to the doctor because it did not dawn on her that the shortness of breath might be related to the vaccination until her sister got her vaccination and had the shortness of breath. Now she believes she noticed the shortness of breath after the first dose. Mentions she has the emergency room records and her vaccination card at home to verify her information. Adds she was talking to a guy at the bus station and he had shortness of breath too. She does not know this person and declined to report regarding the guy at the bus station. Patient visited Emergency Room, but not admitted. Patient visited physician Office. The patient underwent lab tests and procedures which included blood test: good, chest x-ray: good, electrocardiogram: good on More information available (Y/N): No. The outcome of the events was reported as unknown. Information on the Batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021829874 same reporter/drug/event, different patient
60 2021-07-17 blood clot in the brain, cerebrovascular accident, transient ischaemic attack Gota a transient scheme stroke on April 8th,2021 when a blood clots went to my right side brain. I ... Read more
Gota a transient scheme stroke on April 8th,2021 when a blood clots went to my right side brain. I was shown by an MRI , when I was admitted to the ER. I Was hospitalized for 3 days and all the hospital test and future cardio and neurological tests not shoed any reasonable causes for developing the blood clothes and a stroke , as the Lipid test as well showed that my cholesterol, blood pressure ,weight and sugar level were in normal ranges. Given that Y have a family history of cardiovascular conditions I maintain councioly my good health condition,the only different in my health was getting my second dose of the Pfizer vaccine on March 19,2020 three weeks before I developed the schema stroke.
60 2021-07-17 nosebleed Nose bleed right nostril; This is a spontaneous report received from a contactable consumer, the pat... Read more
Nose bleed right nostril; This is a spontaneous report received from a contactable consumer, the patient. A 60-year-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8730) via an unspecified route administration in the left arm on 28Mar2021 at 16:00 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. The patient had as medical history of atrial fibrillation and allergies with penicillin, bee stings and mosquito bites. The patient received diltiazem (MANUFACTURER UNKNOWN) 120mg for day, melatonin (MANUFACTURER UNKNOWN) 10mg for day and cetirizine hydrochloride (ZYRTEC) within 2 weeks of vaccination. The patient had received erythromycin (MANUFACTURER UNKNOWN), tetracycline and cipro (MANUFACTURER UNKNOWN) in the past and experienced drug allergy. The patient had not received other vaccines within 4 weeks prior to vaccination. Prior to vaccination, the patient had not been diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 29Mar2021 at 15:45, the patient experienced with nose bleed right nostril, it was mild flow that she was able to stop by pinching her nose and she has not had a true nose bleed before. The adverse events did not result in doctor or other healthcare professional office/clinic visit. The patient did not receive treatment for the reported event. The clinical outcome of the event was recovered at the time of report. No follow-up attempts are needed. No further information is expected
60 2021-07-19 chest pain Patient fully vaccinated with Pfizer COVID vaccine. Patient experienced COVID symptoms including: h... Read more
Patient fully vaccinated with Pfizer COVID vaccine. Patient experienced COVID symptoms including: headache, sore throat, chills, body aches, chest pain, shortness of breath, cough, nausea, congestion, runny nose, change in taste started on 7/11/21. Patient initially tested COVID negative via antigen test on 7/12/21. Patient then tested COVID positive via PCR swab on 7/18/21. Patient had to be seen at urgent care for chest pain, shortness of breath, cough, and severe headache on 7/18/21 prompting 2nd COVID test.
60 2021-07-20 cardiac arrest Pain in upper abdomen, sudden cardiac arrest on 5/3/21
60 2021-07-22 ejection fraction decreased I started feeling bad about mid May, May 15 2021. I was feeling very out of sorts. I had started cou... Read more
I started feeling bad about mid May, May 15 2021. I was feeling very out of sorts. I had started coughing, some of the coughing was to the point where I could not breath. I went to the DR and they put me on antibiotics. May 18th 2021, that was when I went to the DR. Then on June 1st 2021 I went to the DR as well and I think that is when they put me on Z-Pack. I continued to cough and get very exhausted regardless of the medication. Then July comes along - through the rest of June I could not even walk without getting winded and panting for my own breath. So then on July 6th 2021 I just couldn't go anymore and decided to go to the ER, at the Hospital and I was admitted. They did tests and I was in the hospital until July 8th 2021. My heart is apparently not pumping as it is supposed to. I thought maybe I had bronchitis because of the coughing but apparently not. The DRs say I have Cardiomyopathy, never having heart problems before I was really taken aback by this news. I was sent home with a life vest for my heart now that is scary too. The DRs tell me I am not allowed to do much of anything, basically sit around. I see an electrophysiologist and I see a heart DR. I saw my PCD on the 19th of July 2021 as well. I will see the electrophysiologist on August 10th 2021 as well. Oh I was also put on four new medications: Entresto 2x daily, Carvedilol 2x daily, Atorvastatin 1x daily, Spironolactone 1x daily. I was also taken off of Vyvanse and now I just kind of play the waiting game.
60 2021-07-22 hypertension Hypertension after second vaccine noted. B4 vaccine avg at home bp 115/70, after vaccine noted as h... Read more
Hypertension after second vaccine noted. B4 vaccine avg at home bp 115/70, after vaccine noted as high as 180/90. Avg after vaccine 150/90. Had to go to cardiologist and received medication bystolic 5mg. Gastrointestinal issues: after second dose severe bloating, no bowel movements, could not eat solid food for over 10 days. My primary physician ordered ct scan with contrast. Outcome no blockages or masses. Still bloating but am moving bowels.
60 2021-07-23 deep vein blood clot, inflammation of the pericardium Initial problem 2/8/21 pericarditis. Hospitalized 2 days. Started on colchicine, metoprolol and ros... Read more
Initial problem 2/8/21 pericarditis. Hospitalized 2 days. Started on colchicine, metoprolol and rosuvastatin, pain medications. EC 4/12/21 for DVT; Admit 4/16/21 for worsening DVT in right leg.
60 2021-07-27 ischemic chest pain, chest pain angina on june 25 followed by chest pain, on and off, for a month (ongoing).
60 2021-07-27 loss of consciousness pneumonia; loss of consciousness; difficulty in breathing; feeling weak; diarrhea; Arm fracture; Fal... Read more
pneumonia; loss of consciousness; difficulty in breathing; feeling weak; diarrhea; Arm fracture; Fall; This is a solicited report received from a contactable consumer (patient) based on the information received by Pfizer. (MFR Control No. # 21K-163-3955081-00). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular on 26Apr2021 (Batch/Lot Number: ER8730) as single dose for covid-19 immunisation; adalimumab (HUMIRA 40MG/0.4ML, Solution for injection in pre-filled pen), subcutaneous from 03Apr2020 (Batch/Lot number was not reported) to Mar2021, at Citrate Free (40 mg,1 in 2 wk), subcutaneous from Mar2021 (Batch/Lot number was not reported) and ongoing, at 40 mg for Ulcerative Colitis. Medical history included tobacco user: one pack of cigrette per day (Started 1978), abstains from alcohol. Concomitant medications included tizanidine; carvedilol (COREG); pregabalin; atorvastatin calcium (LIPITOR) taken for an unspecified indication, start and stop date were not reported; apixaban (ELIQUIS). The patient previously took hydrocodone. The patient experienced loss of consciousness on May2021 with outcome of recovered on May2021, pneumonia on 05May2021 with outcome of recovered in 2021, feeling weak on 27Apr2021 with outcome of unknown, difficulty in breathing on 27Apr2021 with outcome of unknown, diarrhea on Mar2021 with outcome of recovered in 2021, arm fracture on 27Feb2021 with outcome of recovering, fall on 27Feb2021 with outcome of recovering. Clinical course: In 2021, the patient experienced chest tube had been drained and removed. On 27Feb2021, the patient experienced broken right arm in two different places and fell. In Mar2021, the patient experienced diarrhea. in May2021, the patient experienced loss of consciousness. on 05May 2021, the patient experienced pneumonia. in May 2021, the loss of consciousness resolved. in 2021, the pneumonia and diarrhea resolved. Covid-19 vaccine was also considered suspect. the patient shared that she fell in 27Feb2021 and broke her right arm so she went to the emergency room. Her x-ray revealed that she broke her arm in two different places. she was then asked to meet with an orthopedic surgeon and was scheduled for an out-patient procedure to repair her broken arm with pins and plates on the second week of Mar2021. she was sent home and was given hydrocodone for pain. she also added that the physician placed her humira on hold two weeks prior and after the procedure. because of humira was placed on hold, she experienced diarrhea for a week until it resolved. she received her first dose of her covid-19 vaccine in 26Apr2021. she noticed that she started feeling weak and had difficulty in breathing the next morning. she was rushed to the hospital in 05May2021 because her weakness and difficulty of breathing worsened. a series of unrecalled tests had been performed including chest x-ray which showed that she had pneumonia. she was then admitted and was hooked up to a machine because she had difficulty in breathing. she added that she could not recall any other treatments or diagnostic tests that was done to her because she was unconscious for three weeks and was monitored in the intensive care unit. she added that her chest tube had been drained and removed the day she got released in the hospital. she was sent home in 25May2021. alternative etiology of pneumonia, weakness, loss of consciousness, difficulty breathing were reported as covid-19 vaccine.it was unknown if patient was enrolled in a covid-19 vaccine trial. The action taken in response to the events for bnt162b2 was not applicable, for adalimumab was unknown. Causality for humira 40mg/0.4ml(adalimumab)-the reporter's causality for the event(s) of loss of consciousness, broken right arm in two different places, pneumonia, fell and diarrhea with humira 40mg/0.4ml(adalimumab) was no reasonable possibility. the reporter's causality for the event(s) of chest tube had been drained and removed was not provided. Programs opinion is that there is no reasonable possibility that the events of loss of consciousness, broken right arm in two different places, chest tube had been drained and removed, pneumonia, fell and diarrhea are related to humira 40mg/0.4ml(adalimumab). COVID-19 VACCINE (COVID-19 VACCINE)(Injection) (COVID-19 VACCINE), Causality: Loss of consciousness-Causality as per reporter (Drug/Vaccine): Probable; Arm fracture-Causality as per reporter (Drug/Vaccine): Not Related; Pneumonia-Causality as per reporter (Drug/Vaccine): Probable; Fall-Causality as per reporter (Drug/Vaccine): Not Related; Diarrhea-Causality as per reporter (Drug/Vaccine): Not Related. The reporter's assessment of the causal relationship of the events (feeling weak, difficulty in breathing) with the suspect products was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the plausible temporal relation, the association between the events of loss of consciousness, pneumonia, asthenia and dyspnoea and the suspect product of BNT162B2 cannot be completely ruled out. The confounding factor for the event of pneumonia is the co-suspect drug Humira Due to implausible temporal association, the events of diarrhoea, arm fracture and fall are assessed as unrelated to BNT162B2 The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
60 2021-07-28 blood pressure increased Patient to clinic 07/29/21 to receive first dose Pfizer vaccine. Later c/o tingling of tongue and he... Read more
Patient to clinic 07/29/21 to receive first dose Pfizer vaccine. Later c/o tingling of tongue and headache. No c/o swelling or indication of anaphylaxis. Airway unobstructed. No apparent swelling of tongue. Vital signs: BP 186/98 HR 99 RR 20 Temp 99 O2 s sat 98%. Onsite paramedic offered ibuprofen for headache, patient received 400mg of ibuprofen at 5:09 P.M.. Patient advised to seek emergency care due to elevated BP. Patient refused.
60 2021-07-28 heart rate increased Numbness on face; Fast heartrate; Fatigue; Headache; This is a spontaneous report from a contactable... Read more
Numbness on face; Fast heartrate; Fatigue; Headache; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208), via an unspecified route of administration in the right arm on 15Mar2021 at 16:00 (at the age of 60-year-old), as a single dose for COVID-19 immunisation. Medical history included migraine, allergies and the patient had a history of several foods allergy and environmental allergy. Concomitant medications included cetirizine hydrochloride (ZYRTEC) on unknown date for an unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Mar2021 at 16:00, the patient experienced numbness on face, headache, fast heartrate and fatigue about 45 minutes after the first dose. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken for the events. The clinical outcomes of the events numbness on face, headache, fast heartrate and fatigue were resolved on an unknown date in 2021. No follow-up attempts are needed. No further information is expected.
60 2021-07-28 hypotension 2nd dose was EW0162, 4/15/2021;~3 wk after first dose had episode of epigastric pain, malaise, light... Read more
2nd dose was EW0162, 4/15/2021;~3 wk after first dose had episode of epigastric pain, malaise, light headedness for ~3 hrs. Got 2nd dose ~4 days later. Then 5/14, had ER visit for above epigastric pain, malaise, lightheadedness then 5/22-5/25; had ER visit after similar episode but also developed whole body hives, low blood pressure event, suspected to be mastocytosis, however bone marrow biopsy later suggested against this. 5/31 similar episode started, required epi at home and led to another 3 day hospitalization.
60 2021-07-29 blood glucose increased very sore arm; soreness spread to my whole body/My pain right at the moment is at a 7; Erythromelalg... Read more
very sore arm; soreness spread to my whole body/My pain right at the moment is at a 7; Erythromelalgia/Since the shot, this rare condition has not stopped flaring; Erythromelalgia/Since the shot, this rare condition has not stopped flaring; My blood sugar has stayed over 250 with a top number on the evening of the last shot of 419; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 28Apr2021 18:30 (Batch/Lot Number: EW0171) (at the age of 60 years old) as single dose for covid-19 immunisation. Medical history included diabetes, hypertension (HBP), ongoing erythromelalgia, overweight. Patient was not pregnant at the time of vaccination. Patient did not have Covid prior to vaccination. No known allergies. The first dose was administered on an unknown date for covid-19 immunisation where patient felt nothing. Concomitant medication included oxycodone taken for erythromelalgia, start and stop date were not reported. After the second dose, on 28Apr2021, her blood sugar has stayed over 250 with a top number on the evening of the last shot of 419. On 29Apr2021 01:00, she developed a very sore arm, unlike the first shot where she felt nothing, her soreness spread to her whole body. Patient would be in more pain than the level 5 she was at but she took Oxycodone 10.05-325 for a rare condition called erythromelalgia. Since the shot, this rare condition has not stopped flaring. Her pain right at the moment was at a 7 (29Apr2021). Therapeutic measures were taken as a result of all the events. Increased insulin. Patient was not tested for Covid after vaccination. Outcome of the events was not recovered.
61 2021-01-03 lightheadedness, heart rate increased, chest discomfort, blood pressure increased About 5 minutes after injection: fast growing wave of internal burning sensation throughout body, ... Read more
About 5 minutes after injection: fast growing wave of internal burning sensation throughout body, feeling that I would pass out, lightheafdedness, increased heart rate and blood pressure, mild difficulty with speech/thought/concentration, freezing hands, wabbly/shaky., chest tightness, very slight throat soft tissue sensation
61 2021-01-04 heart rate increased Received COVID vaccine, severe headache started 5 minutes after the administration. Jittery, nauseat... Read more
Received COVID vaccine, severe headache started 5 minutes after the administration. Jittery, nauseated. Continued to have worsening symptoms. Nausea/Vomiting, muscle twitching, severe headache, increased heart rate went to ED on 1/5 at 0100.
61 2021-01-05 chest discomfort, chest pain dizzyness within minutes. was told by nurse onsite this was not an adverse reaction. the paperwork ... Read more
dizzyness within minutes. was told by nurse onsite this was not an adverse reaction. the paperwork they gave stated otherwise. after about 30-40 mins the dizzyness subsided. no treatment. chest pain. not sure if heart or lungs. was not due to eating as symptom was steadily getting worse across 3 days whether I ate or not. was difficult to eat due to the pain. didnt matter if was sitting, standing or laying down. felt like saran wrap around my heart...sqeezing it...with pain. pain stayed centered in chest. behind sternum. still there, but tonight does seem a little better. was not intermittetent but was more pain sometimes and less pain sometimes. longterm outcomes unkn.
61 2021-01-05 coughing up blood, cardiac arrest coughing up blood, significant hemoptysis -- > cardiac arrest. started day after vaccine but likely ... Read more
coughing up blood, significant hemoptysis -- > cardiac arrest. started day after vaccine but likely related to ongoing progression of lung cancer
61 2021-01-06 blood pressure increased, heart rate increased Mild difficulty with thought/speech/concentration; strong wave of burning sensation growing inside t... Read more
Mild difficulty with thought/speech/concentration; strong wave of burning sensation growing inside the body; Lightheadedness; Blood pressure went up; Heart rate went up; Hands freezing; Mild difficulty with thought/speech/concentration; Mild difficulty with thought/speech/concentration; Weakness; Mildly shaky; Anxiety; Feeling that may pass out; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 61-year-old female patient received 1 dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686) via unspecified route on left arm single dose for COVID-19 immunization on 02Jan2021, 02:30 PM, at 61-year-old. Medical history: allergies to sulfa, paclitaxel (TAXOL); breast cancer in 2003 and 2007. Prior to vaccination, the patient did not be diagnosed with COVID-19. Concomitant medication in two weeks included: escitalopram oxalate (LEXAPRO, strength: 10m); omeprazole; multivitamin; ibuprofen. About 5 minutes after the vaccine (02Jan2021, 02:35 PM), the patient had a strong wave of burning sensation growing inside the body, lightheadedness, blood pressure went up, heart rate went up, hands freezing, mild difficulty with thought/speech/concentration, weakness, mildly shaky, anxiety, feeling that may pass out. Emergency room/department or urgent care visited. Treatment received for the adverse event included: heart rate H20 and BP monitor, water, observation. Since the vaccination, the patient did not have been tested for COVID-19. Action taken for BNT162B2 was not applicable. Outcome of the events was resolving. It was reported as non-serious per the reporter.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Mental impairment cannot be totally excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
61 2021-01-06 chest discomfort Within several minutes after receiving the vaccine she began experiencing chest tightness. She was g... Read more
Within several minutes after receiving the vaccine she began experiencing chest tightness. She was given oxygen and benedryl but the chest tightness worsened and EMS was called. She was transported to the ED.
61 2021-01-07 blood glucose increased patient reports fasting high blood sugar >200 12+ hours after vaccination - she is diabetic on oral ... Read more
patient reports fasting high blood sugar >200 12+ hours after vaccination - she is diabetic on oral metformin and has never had elevated blood sugar >140 with fasting; controlled HgA1C at 6.1%; felt dizzy, nauseated, HA and sweaty as if she may pass out - never passed out
61 2021-01-07 blood glucose increased Average increase in blood sugar levels by 50 to 80 points, that haven't returned to prior levels yet... Read more
Average increase in blood sugar levels by 50 to 80 points, that haven't returned to prior levels yet. Also achiness, and tiredness.; Average increase in blood sugar levels by 50 to 80 points, that haven't returned to prior levels yet. Also achiness, and tiredness.; Average increase in blood sugar levels by 50 to 80 points, that haven't returned to prior levels yet. Also achiness, and tiredness.; This is a spontaneous report from a contactable nurse (patient). A 61-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730) solution for injection via an unspecified route of administration on left arm on 22Dec2020 02:30 at a single dose for Covid-19 immunization. Medical history included CREST Syndrome, type 2 diabetes, osteoarthritis, allergies to Sulfa and Dermabond tape. The patient previously took acetylsalicylic acid (ASPIRIN) and experienced allergy. The patient took other medications in the last two weeks. On 26Dec2020, the patient experienced average increase in blood sugar levels by 50 to 80 points, that haven't returned to prior levels yet. Also, she experienced achiness, and tiredness on 26Dec2020. No treatment received for the events. The patient was not diagnosed with Covid-19 and has not been tested prior to vaccination. Outcome of the events was unknown. No follow-up activities are needed. No further information is expected.
61 2021-01-07 fast heart rate, chest discomfort Tachycardia (HR in the 110s), substernal chest pressure, dizziness 15 min post vax Observation and f... Read more
Tachycardia (HR in the 110s), substernal chest pressure, dizziness 15 min post vax Observation and fluids Sxs resolved after 30 mins of close monitoring NKA
61 2021-01-08 blood pressure increased fatigue- employee just wanted to lay down, runny eyes, runny nose, elevated BP and @ 101 Narrative:
61 2021-01-08 heart rate increased First dose given 12/18/20 with expected muscle stiffness soreness later that evening and the next da... Read more
First dose given 12/18/20 with expected muscle stiffness soreness later that evening and the next day. Dose two given on 01/07/21 with onset of shaking chills on 01/08/21 at 2:00am, ensuing fever max 101.7 degrees Fahrenheit, at 4:00 am noticed redness of eyes, face flushed with burning feeling, headache, dizziness, blood pressure of 184/96 and heart rate of 153. This required medical evaluation and treatment with IV fluids and Toradol for resulting headache. Patient also self administered 1000mg oral Tylenol prior to ER evaluation.
61 2021-01-08 heart rate increased About 5 minutes after receiving vaccine: suddenly- Felt hot all over; feeling of anxiety; and left d... Read more
About 5 minutes after receiving vaccine: suddenly- Felt hot all over; feeling of anxiety; and left deltoid muscle felt completely numb; palms slightly flushed, felt as if heart rate slightly elevated, but not tachycardia. No rash, no hives, no difficulty breathing. Acute episode lasted about 20-30 minutes, then just felt a little off for 1.5 hours more, then back to normal. For next 34-48 hours-mild fatigue.
61 2021-01-10 chest pain Lymph node swelling under left arm and aching down left arm and side of chest. Lymph node painful to... Read more
Lymph node swelling under left arm and aching down left arm and side of chest. Lymph node painful to touch.
61 2021-01-10 heart rate increased Elevated heart rate to 120, fever, shortness of breath, headache
61 2021-01-10 hypertension I had diarrhea, numbness in my face, high blood pressure. 9 days of symptoms. The symptoms started a... Read more
I had diarrhea, numbness in my face, high blood pressure. 9 days of symptoms. The symptoms started a few days after.
61 2021-01-11 hypertension Myalgia, HYPERtension, rash/wheal at injection site; then severe body aches Narrative:
61 2021-01-12 chest discomfort Was premedicated with Medrol, Singulair and Zyrtec 20 minutes after vaccine developed paresthesias o... Read more
Was premedicated with Medrol, Singulair and Zyrtec 20 minutes after vaccine developed paresthesias of both sides of lower face, lips and face swelling. This resolved in @ 20 minutes. Next day developed excessive fatigue with difficulty talking and a heavy sensation in the chaste with an event of fullness sensation of the right soft palate and tongue.. This became worse on the second day for which needed treatment with Medrol pack and antihistamins.
61 2021-01-12 chest pain Nausea, chest pain, difficulty breathing following first dose of Pfizer COVID-19 vaccine 0.3 mL IM i... Read more
Nausea, chest pain, difficulty breathing following first dose of Pfizer COVID-19 vaccine 0.3 mL IM in right deltoid. Went to outside ED and placed on BiPAP. Given diphenhydramine, epinephrine, and steroid (unknown doses). Prescribed outpatient epinephrine in case of flare of reaction once stabilized.
61 2021-01-12 nosebleed Three moderate nosebleeds
61 2021-01-13 low blood pressure At time of shot, maybe 3 mins after, rush of hotness through entire body and severe nausea. Passed a... Read more
At time of shot, maybe 3 mins after, rush of hotness through entire body and severe nausea. Passed after about 4 mins then occurred a second time lasting for about 5 mins. Rested for about 45 mins before I felt well enough to drive. All better after about 2 hours.Next day, tired, sweaty, nauseous, lightheaded when standing.
61 2021-01-13 fainting, chest discomfort Systemic: Anaphylaxis-Severe, Systemic: Fainting, Systemic: Pharmacist submitting: unable to determi... Read more
Systemic: Anaphylaxis-Severe, Systemic: Fainting, Systemic: Pharmacist submitting: unable to determine if anaphalaxis or panic attack, patient experienced facial weakness, chest tightening, tremmors, inability to breathe, and fainting within 10 min of administ
61 2021-01-14 loss of consciousness Increased fatigue with dizziness. On the 3rd day at around 2130 I walked into my home and woke up on... Read more
Increased fatigue with dizziness. On the 3rd day at around 2130 I walked into my home and woke up on the floor. EMS was called and I was sent to the emergency room. Bruising to my left eye with a short LOC.
61 2021-01-14 fainting As stated I fainted about 3 hours after injection. I thought it was because I had worked all night. ... Read more
As stated I fainted about 3 hours after injection. I thought it was because I had worked all night. I fell forward and sustained bruising to my right cheek and temple. I will be reporting another report regarding the second dose with adverse reaction that is the same but required EMS and Emergency Room visit. Approximately 3 hours after injection I was getting ready for bed (as I work nights). I was talking with my daughter and I stood up and remember waking up on the floor. Bruising to the right cheek and temple. I did not seek medical attention and went to bed. I had no further episode but remained dizzy for several days.
61 2021-01-15 fast heart rate immediate metallic taste in mouth accompanied by tachycardia to 120 (usu pulse is 65) followed by ... Read more
immediate metallic taste in mouth accompanied by tachycardia to 120 (usu pulse is 65) followed by unusual feeling in mouth, not itchy, but tingly-type sensation. lasted about 1 1/2 hours, same reaction happened with both first and second doses, the second time was a little more intense and longer lasting.
61 2021-01-16 cardio-respiratory arrest Ventricular fibrillation- Code blue
61 2021-01-18 blood pressure decreased 1. SOB 2. Flushed 3. Tremble 4. Decrease in blood pressure EpiPen was administered. Attending physi... Read more
1. SOB 2. Flushed 3. Tremble 4. Decrease in blood pressure EpiPen was administered. Attending physician was contacted and advised to send to ER for follow-up and monitoring.
61 2021-01-18 heart rate abnormal Pfizer-biotech COVID-19 Vaccine EAU Expected extreme sleepiness, could only stay awake for 20 minute... Read more
Pfizer-biotech COVID-19 Vaccine EAU Expected extreme sleepiness, could only stay awake for 20 minutes at a time for next 24 hours. O2 saturation went down as low as 91 but mostly was at 93, heart rate 112 on Jan 13, along with a 100.1 oral temp. I did not Check on Jan 12. Morning of Jan 14: 99 oral temp and 95 O2 saturation. By evening temp and O2 were back to normal: 98° and 98%. Jan 17 I experienced some wheezing. I did have COVID with pneumonia Sept 2020.
61 2021-01-19 chest discomfort Dose 2 given at 1208 on 1/20/2021. At 1232 pt noticed flushing in the arms b/l, persistent pins and ... Read more
Dose 2 given at 1208 on 1/20/2021. At 1232 pt noticed flushing in the arms b/l, persistent pins and needles in arms, hands, and feet b/l, with "slight tingle" in lips. Unusual taste in mouth (that happened after 1st dose as well). Small wave of nausea. Sensation of heat in chest. At 1301 on 1/20/2021, 50 mg of IM Benadryl administered to RD (Lot # 080010, Exp 8/20/2022) by NP. At 1320, arms were less flushed, however b/l pins and needles persistent in both arms and feet, with "tingling" still in lips. Pt will wait until symptoms improve further to d/c to home. NP checking in continuously.
61 2021-01-19 chest discomfort Second, dose 1/16/21 Pfizer LOT: EL3248 Saturday 11:30 am ? Side Effects started about 1.5 - 2 hours... Read more
Second, dose 1/16/21 Pfizer LOT: EL3248 Saturday 11:30 am ? Side Effects started about 1.5 - 2 hours after injection (I took 2 Tylenol and took a 3 hour nap) o Tired o Left Eye twitch o Blurred double vision o Headache o Nauseous ? Side Effects started about 5 - 6 hours after injection (I took 2 Tylenol a Benadryl and used my Ventolin inhalator) o Tired o Watering eyes o Sore tongue o Headache o Nauseous o Heavy feeling in chest ? Side Effects started some time during the night after injection o Muscle cramping in both legs and opposite arm of injection site o Low fever 100.3 Sunday side Effects (I took 2 Tylenol and took a 3-4 hour nap) o Tired o Left Eye twitch o Watering eyes o Sore tongue o Excessive thirst o Swollen neck glands o Nauseous (only after eating) o Muscle cramping in both calves o Blurry vision in the evening o Runny nose Monday side Effects (Went to work) o Tired o Left eye lid twitch o Swollen neck glands o Nauseous o Runny nose o Achy body o Diarrhea Tuesday side Effects (Went to work) o Left eyelid twitch o Swollen neck glands o Runny nose o Sore throat o Diarrhea BLOODY Wednesday side Effects (went to work) o Swollen neck glands o Runny nose o Sore throat Note: I have several Allergies that require me to take an allergy pill every day. I also use an inhaler as needed. My symptoms were not any worse than when I have a bad allergic reaction, I have received shots of Epinephrine for my allergies and did not feel one was necessary.
61 2021-01-19 chest discomfort Due to hx of allergic reactions, pt was told to wait for 30 minutes in observation prior to vaccinat... Read more
Due to hx of allergic reactions, pt was told to wait for 30 minutes in observation prior to vaccination. At 1208 on 1/20/2021 pt received 2nd dose of COVID Pfizer vaccine. Immediately after vaccination, pt experienced unusual taste in mouth, flushing, and feeling of heat in chest. At 1232, pt noticed flushing on arms and feelings of heat and pins and needles in both arms, hands, chest, both feet, and back. Sensation was persistent, so at 1301, 50 mg of IM Benadryl administered to RD by NP. By 1320 flushing on arms and chest subsided, feeling of pins and needles persisted but was not as severe as initial reaction. By 1345 flushing on arms returned, pins and needles sensation worsened again in all locations noted prior, spread to scalp, and tingling sensation occurred on lips. Pt communicated with Dr advised to stay under observation, but transfer to ED not medically necessary. At 1415, pt was advised to go home with supervision of partner and monitor symptoms from there.
61 2021-01-19 heart rate increased I had an immediate reaction to the covid vaccine within 30 seconds after the injection. I felt a wa... Read more
I had an immediate reaction to the covid vaccine within 30 seconds after the injection. I felt a warm sensation after the vaccine in my deltoid muscle then felt it go up both my ears, around my head. I then felt the same warm sensation in my abdomen, followed by buzzing of my entire body with light headedness. I could breath, I could talk, but I had an urgency for others around me to know that I wasn?t feeling well and something was not right. I asked my colleagues if someone could take me to the ER for monitoring. They immediately put me in a recliner and elevated my legs. This did not relieve my symptoms and asked to go to the ER. I got to the ER and laid on the stretcher with continued increased buzzing sensation especially in my finger tips and arms. My vital signs were 148/88 and HR 88 (elevated from my normal of 100-120/60-70, HR 60s). The buzzing turned into a sensation in my arms that rumbled erratically. I thought something bad was about to happen and that my blood cells would burst. Then I also felt icy cold in my arms and my gut. Next what happened were teeth chattering shivers. All these symptoms occurred in a matter of minutes. They started an IV, drew blood, gave me Benadryl and ran IV fluids. My vitals did not reflect what I felt inside, but as symptoms let up, my VS returned to normal. As quickly as the symptoms started, they eventually calmed down and I was able to leave the ER in 1.5 hours to go home. I was very scared. The ER doctor thought I had a hyperimmune response to the vaccine.
61 2021-01-19 heart rate increased Rapid heart Rate that began about 12 hours after the injection. Heart rate of 123 all night and wen... Read more
Rapid heart Rate that began about 12 hours after the injection. Heart rate of 123 all night and went to ER next morning after calling Nurse on Call system. I was admitted and the Dr ordered bag after bag of fluids to and kept me in the unit overnight for observation. Did may hear tests (EKG, ECHO STRESS,CTA chest) and results all came back good. I was released on 1/19/21 at 2pm and my hear rate is back to normal (82 bpm).
61 2021-01-19 fast heart rate After getting this vaccine I start feeling dizzy, headache, fatigue, tachycardia and body aches
61 2021-01-20 hypertension High Blood Pressure - 211/101 (initial reading) - stayed high for five or six days. Headache becaus... Read more
High Blood Pressure - 211/101 (initial reading) - stayed high for five or six days. Headache because your blood pressure was so high. Dr visit (Telemed) and they increased the dosage one of my medications - the Quantitine (from 0.1 mg pill to one and half pills now and the Hydrochlorizide (to twice a day), That resolved it.
61 2021-01-20 palpitations Felt that my heart was racing , I also felt light headed. I was sent to the ER to be monitored for 4... Read more
Felt that my heart was racing , I also felt light headed. I was sent to the ER to be monitored for 4 hours.. they checked my vital and sent me home after everything was clear .
61 2021-01-21 chest pain STarted having nausea around 10am on 1/21/21, then at noon started having chest pain and a migraine.... Read more
STarted having nausea around 10am on 1/21/21, then at noon started having chest pain and a migraine. Went home early from work. As of 1/22/21 0830, still has chest pain but not as intense and it radiates to left shoulder and towards back (advised employee to have this evaluated)
61 2021-01-21 heart rate increased, palpitations Palpitations with elevated heart rate and some chills.
61 2021-01-23 hypertension, heart rate increased 10:58 Reported increased HR HR 77-80, BP 138/90, Reported High HR and High BP. Water provided. 11:1... Read more
10:58 Reported increased HR HR 77-80, BP 138/90, Reported High HR and High BP. Water provided. 11:15 HR 77, BP 132/80, Reports feels better and this is a normal feeling for her. Encouraged to notify PCP
61 2021-01-24 nosebleed Nose bleed never ever do i get nose bleeds 19 hours after vaccine very odd This was my second vaccin... Read more
Nose bleed never ever do i get nose bleeds 19 hours after vaccine very odd This was my second vaccine nothing happened with the first one
61 2021-01-24 fainting Chills. Fever. Nausea. Vomiting. Fainted
61 2021-01-24 fast heart rate, fainting, pulse abnormal, hypertension Malaise, High Blood pressure, fainting, tachycardia, thready pulse, facial drooping, chest discomfor... Read more
Malaise, High Blood pressure, fainting, tachycardia, thready pulse, facial drooping, chest discomfort, disoriented, feeling a sense of impending doom.
61 2021-01-27 blood pressure increased 10 -15 minutes after shot: Swelling of tongue; drainage from nose and back of throat;gourde voice; t... Read more
10 -15 minutes after shot: Swelling of tongue; drainage from nose and back of throat;gourde voice; trouble swallowing : elevated blood pressure Told nurse 25 minutes later.given benedryl injection Things improved and an hour later tongue began to swell again and blood press increased Paramedics called and they transported me to the ER where I was given an Epi injection and steroids. Monitored for three hours and sent home with prescription for steroids: epi pen; and zyrtec Still experiencing fatigue , headache and lots of drainage off and on
61 2021-01-27 cardiac arrest Client was being treated with antibiotics by her PCP for diverticulitis flare up. It had not been r... Read more
Client was being treated with antibiotics by her PCP for diverticulitis flare up. It had not been resolved on the date of her death which occurred 01/27/21, She was found unresponsive by staff, 911 contacted, and paramedics pronounced her deceased at 7:48 AM. After consultation with PCP manner of death was noted as cardiac arrest. PCP was to sign off on death certificate.
61 2021-01-27 heart rate increased Increased HR, Weakness, Throat Irritation, Diaphoresis. Patient was asked to sit in observation for... Read more
Increased HR, Weakness, Throat Irritation, Diaphoresis. Patient was asked to sit in observation for 30 min. Hx of allergies. Very anxious, anxiety causing increased HR and Sweating. throat itching/tightness. Legs elevated, 50 mg of Benadryl given.
61 2021-01-29 lightheadedness, pallor, hypertension, fast heart rate alost fainted- very pale, then tachycardia, high blood pressure, diarrhea. This reoccurred i waves ... Read more
alost fainted- very pale, then tachycardia, high blood pressure, diarrhea. This reoccurred i waves over the next week. Also fatique,, muscle and joint pain. for 6 days also had sever headace, numbness in face and lips, spasm of left eyebrow. Mised wek of work, ended up in Emergency room. Had negative covid test. sent home. Was fatiques and dizzy and brain fog for next three weeks. Took a month to feel rigtht.
61 2021-01-30 chest discomfort Bad headache Tight chest Shortness of breath Chills
61 2021-01-31 chest discomfort Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Other- CHEST TIGHTNESS,TROUBLE BREATHI... Read more
Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Other- CHEST TIGHTNESS,TROUBLE BREATHING-Medium
61 2021-01-31 chest pain Received second dose of Pfizer COVID vaccine on 1/17/2021 at about 10:30 am. Started having soreness... Read more
Received second dose of Pfizer COVID vaccine on 1/17/2021 at about 10:30 am. Started having soreness in arm, headache, and fever of 99.4 at about 2:30am on 1/18/2021. Side effects persisted all day on 1/18/2021 but relieved with acetaminophen 325mg every 6 hours. All side effects resolved by morning of 1/19/2021. Around 4:30pm on 1/19/21 started having pain in left axilla which was due to swollen lymph node. The pain and swelling progressed over the evening and pain radiated to chest, throughout left arm, and shoulder. All of these side effects continued all day on 1/20/21 but started getting better around 6pm. All side effects resolved by morning of 1/21/2021.
61 2021-02-03 blood pressure increased 61-year-old female presents the ED for evaluation of lightheadedness. Patient reports shortly after... Read more
61-year-old female presents the ED for evaluation of lightheadedness. Patient reports shortly after receiving first dose of Covid vaccine, began to feel lightheadedness 15 minutes later. Patient reports that she started off with a right-sided headache, and when she went to stand up took 2-3 steps forward and fell lightheaded, and and sat back in her chair. Denies loss of consciousness, chest pain, shortness of breath. Denies alleviating or exacerbating factors. Patient reports that they taken her blood pressure after symptoms, was found to be elevated, 200/100 systolic. Patient denies previous history of blood pressure medications. Denies previous reactions to vaccines
61 2021-02-04 chest discomfort, cerebrovascular accident Pfizer-BioNTech COVID-19 Vaccine EUA Approximately 3 mins after vaccination, pt reports nausea, diz... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Approximately 3 mins after vaccination, pt reports nausea, dizziness, chest pressure, and profound weakness. Brought to Emergency Department by crisis RN where she remains achy with weakness, fatigue and had no energy. Pt reports "feeling tired" and "my speech is slower". On exam, slight R facial droop noted, tongue noted to be leaning towards the right, pronator drift noted in R arm. Code Brain activated with real time audio video interaction. MRI completed with normal results. Symptoms resolved. Stroke team ok with discharge to home with f/u with PCP.
61 2021-02-04 hypertension feeling tired but also edgy; edgy/ nervous; anxious; unable to focus; headaches; blood pressure was ... Read more
feeling tired but also edgy; edgy/ nervous; anxious; unable to focus; headaches; blood pressure was much higher than normal; This is a spontaneous report from a contactable nurse (patient). A 61-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL1284) via an unspecified route of administration on the left arm on 11Jan2021 10:30 at a single dose for COVID-19 immunization. Medical history included hypothyroidism and back pain. Concomitant medication included levothyroxine sodium (SYNTHROID), ibuprofen and ergocalciferol (VIT D). The patient previously received 1st dose of BNT162B2 on 20Dec2020 for COVID-19 immunization (left arm, lot number: EH9899). After receiving second dose on 11Jan2021 the patient was feeling tired but also edgy, nervous, anxious, unable to focus, some headaches. Discovered 18Jan2021 that blood pressure was much higher than normal and associated with the way I was feeling. Had to go to primary care to have medication prescribed. The events resulted to a doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events. Patient was not pregnant. No known allergies. The facility where the vaccine was administered was in a workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has been tested for COVID-19 (Nasal swab), on 13Jan2021 and 16Jan2021 both test results were negative. Outcome of the events was not recovered.
61 2021-02-04 loss of consciousness I experienced muscle aches the spread across my entire back starting at about 8 PM on 2/4/21. At 2:3... Read more
I experienced muscle aches the spread across my entire back starting at about 8 PM on 2/4/21. At 2:30 AM on 2/5/21, I passed out three times after rising from the toilet, resulting in a split lip. I was covered with sweat the third time I "came to" and soon got the chills.
61 2021-02-06 chest pain Patient began to have chest pains, SOB, feeling flushed and tingling down both arms. EMS began with... Read more
Patient began to have chest pains, SOB, feeling flushed and tingling down both arms. EMS began with heart monitor on patient. EKG WNL B./P 140/97, HR 57 o2 Sat 100 %Ambulance transported patient to Hospital.
61 2021-02-07 blood pressure increased Elevated blood pressure
61 2021-02-07 fast heart rate Patient stated she felt tachycardic post vaccination [BP 176/95 mm/Hg & HR 78] enhanced observation ... Read more
Patient stated she felt tachycardic post vaccination [BP 176/95 mm/Hg & HR 78] enhanced observation vitals improved slightly [173/94 mm/Hg & 74 BPM.] Patient stated she felt better,
61 2021-02-08 chest discomfort From charting for point of care services before EMS transport: Chief Complaint: Immunization Visi... Read more
From charting for point of care services before EMS transport: Chief Complaint: Immunization Visit: Client received Pfizer Vaccine at 11:30am. At 11:32 am client reports "throat feels a little funny" and Chest tightness. No difficulty breathing reported. Lung sounds clear bilaterally per RN at 11:38am. Pt reports that her throat still feels funny after administration of benadryl by RN. Epi was administered at 11:40am by RN. EMS arrived at 11:42am. Client has is now complaining of jaw pain. Reports shoulder pain ( residual from recent accident). Vital signs obtained by RN Her husband was present when EMS arrived and will follow client to the hospital.
61 2021-02-08 hypertension, heart rate increased Rapid heart beat, high blood pressure, sinuses blocked, and anxiety.
61 2021-02-08 palpitations Initially after injection I felt as if a rapid heart beat (but 60 minute pulse count was no more tha... Read more
Initially after injection I felt as if a rapid heart beat (but 60 minute pulse count was no more than 80 and was regular). Discomfort in arm began, progressed to inflammation and difficulty in movement of arm especially to lift arm. Used Tylenol or Motrin PRN for relief as well as heating pad intermittently. After 1/23 injection discomfort seemed to lessen but on 2/9 (4 days before second injection due) discomfort still persists. Due to persistence of symptoms seen in Urgent Care diagnosis Adhesive Capsulitis of right shoulder and acute pain of right shoulder. Treatment, Physical Therapy and Ibuprofen. Unable to use steroids due to diabetes. Follow up scheduled 2 weeks 2/16/2021.
61 2021-02-11 blood pressure increased, palpitations pt stated about 10 minutes after rcvg vax she started feeling funny, warm and her heart was racing. ... Read more
pt stated about 10 minutes after rcvg vax she started feeling funny, warm and her heart was racing. She was checked out by the attending nurse at the vaccine facility. Her pulse was 120 and BP was 189/89. Pt drank a bottle of water while her pulse came down. About 5 minutes later her heart was racing again and BP back up. She was monitored for additional 15 minutes. During this time she had another episode with the same symptoms so she was rushed to the ER. Her heart rate was 110 and blood pressure still 189/? She was monitored for about an hour and 20 minutes. Pt was released from ER about and 1 1/2 ago and has not had another episode so far. She was told to FU w/ PCP in 2-3 days.
61 2021-02-11 blood pressure increased AT 3:41PM PATIENT TONGUE FEELS "OFF", HAS HAD FEELING FOR 10 MINUTES BEFORE REPORTING. PATIENT REPOR... Read more
AT 3:41PM PATIENT TONGUE FEELS "OFF", HAS HAD FEELING FOR 10 MINUTES BEFORE REPORTING. PATIENT REPORTS FEELING SMALL AMOUNT OF DRAINAGE IN THROAT. ADMINISTERED 50MG OF DYPHENHYDRAMINE, IM, RO AT 3:43PM. PATIENT MONITERED VITALS EVERY 5 MINUTES. AFTER MEDICATION PATIENT REPORTS FEELING DIZZY AND "LOOPY" AT 5:17PM PATIENT COMPLAINS OF TONGUE SWELLING AND BLOOD PRESSURE ELEVATED. EMS CALLED, ARRIVED AT 5:34PM, PT TRANSPORTED TO NORTHSIDE HOSPITAL. FOLLOW UP CALL, NEXT DAY PATIENT STATES SHE WAS GIVEN STEROIDS IN THE ER AND PRESCRIBED AN EPI PEN FOR FUTURE USE.
61 2021-02-11 palpitations Left arm pain at injection site x 3 weeks, nausea, heart palpitations x 1 1/2 weeks
61 2021-02-12 heart rate increased Patient reports feeling unwell after injection. She felt like "throat was swollen." Also reports h... Read more
Patient reports feeling unwell after injection. She felt like "throat was swollen." Also reports having nausea/vomiting, fatigue and headache that persisted until 2/9/2021 (approximately 2-3 days after injection). She did not eat Saturday and Sunday (day of the injection and day after injection). She was finally feeling able to eat on 2/9/2021. She also reported sensation of heart going "fast" up to 93 on Sunday (2/7/2021). She denies any fevers or diarrhea. She also developed soreness in left arm at area of injection site, but did not have any redness at injection site.
61 2021-02-14 fast heart rate, ischemic chest pain Began to have identical symptoms as pericarditis (tachycardia, constant heart pain) 3 days after vac... Read more
Began to have identical symptoms as pericarditis (tachycardia, constant heart pain) 3 days after vaccine. Lasted 3 weeks with around the clock prescription strength ibuprofen. History of viral pericarditis with pericardial effusion which took 1 1/2 years to resolve with cardiologist management. Will not be taking second dose of vaccine.
61 2021-02-16 chest discomfort, heart rate abnormal Patient was administered vaccine at 11:00 AM in the left deltoid muscle IM. Patient reported feeling... Read more
Patient was administered vaccine at 11:00 AM in the left deltoid muscle IM. Patient reported feeling chest tightness, heaviness as if someone was sitting on her chest, pressure on her chest, and found it a little hard to breath at 11:10 am. Patient had a history of congestive heart failure and suffers from anxiety, but wasn't sure if the chest pain was due to her past medical history or the vaccine. At 11:17 am the chest pain remained the same. At 11:30 she was still feeling chest pressure and her right arm was feeling weak. At 11:30 Heart rate was 56, Blood Pressure was 138/72, and respiratory rate was 12. EMS was called at 11:35. Patient was taken to the hospital once EMS arrived.
61 2021-02-16 troponin increased, oxygen saturation decreased, cerebral haemorrhage 61 yo F with history of bilateral lung transplant 6/23/17 presented to ED on 2/4/21 with chief compl... Read more
61 yo F with history of bilateral lung transplant 6/23/17 presented to ED on 2/4/21 with chief complaint of worsening shortness of breath, nausea and diarrhea for past week since receiving since receiving COVID-19 vaccine (Pfizer) on 1/28/21. Upon arrival to triage she was obviously dyspneic with significantly low oxygen saturations. O2 sats on arrival were 65%, improved to mid 90's with O2 6 liters per NC. Admitting diagnosis: hypoxic respiratory failure post COVID vaccine. Lab work shows an elevation of the BUN and creatinine at 31 and 1.71 which is slightly higher than her usual baseline levels. BNP is elevated at 2 448 with a mildly elevated troponin. Procalcitonin is also elevated. Patient's white blood cell count is 11.07. Full viral panel including COVID-19 is not detected. All blood cultures and respiratory cultures were negative. Patient chest x-ray shows numerous bilateral patchy opacities which is significantly different from her previous chest x-ray here. Empiric rejection treatment initiated including high dose methylprednisolone, plasmapheresis, IVIG, Thymoglobulin. She continued to decline and ultimately required intubation, proning and paralyzing on 2/8/2021 and then VV ECMO cannulation on 2/13/2021. EGD done 2/14/2021 as unable to pass the TEE probe during cannulation prior day (unable to complete due to abnormal anatomy). Acute pupil exam change in the early am hours of 2/15/2021 prompted urgent head CT which revealed catastrophic brain bleed. Brainstem reflexes were lost soon after. Despite placing an EVD emergently at bedside, brain stem reflexes were not recovered. GOL engaged and patient not an organ donation candidate. Therefore discussion with sister at bedside resulted in decision for cessation of life support. Patient expired shortly after support withdrawn and pronounced dead on 2/15/2021 at 11:11 AM.
61 2021-02-18 chest discomfort Around 2am on 1/8/2021 I woke up having chills, nauseas, fever, dizzy felt like I was going to faint... Read more
Around 2am on 1/8/2021 I woke up having chills, nauseas, fever, dizzy felt like I was going to faint, foggy head, very fatigue, shaky weak legs & body aches. The chills, body aches, fevers & dizziness were under 48hrs. The other symptoms lasted till 2 days before I got my second dose. Tight Chest going on but I think it might of been anxiety. Phone consult with doctor and prescribe some steroids.
61 2021-02-19 loss of consciousness, blood pressure decreased Patient presented for COVID vaccination today, first dose. Prior to receiving dose, she mentioned to... Read more
Patient presented for COVID vaccination today, first dose. Prior to receiving dose, she mentioned to RN that she has a history of vasovagal syncope following her shingles vaccine. She routinely has flu vaccines without any adverse reaction. RN requested I standby and observe while patient receives vaccine. Within minutes of receiving vaccine, patient endorses prodromal symptoms lightheadedness, hot flashes, then lost consciousness while seated in the chair. After approximately 1 minute, the patient did regain consciousness. She was given orange juice and crackers and felt well enough to ambulate to a chair in the observation area. Vital signs were WNL and she was monitored closely in the observing area. She continued to complain of "queasiness" often stating that she just feels that she would like to go lay down and nap in her car. Rechecked her blood pressure which dropped to 94/64, patient states she usually runs low but systolic within the low 100's. She was taken to a private hallway where she laid down on a stretcher. Blood sugar checked reading 121. She was given more water but she was uninterested in any more food, as she questions if the orange juice and the crackers were the cause of the queasiness. Blood pressure was rechecked and she was again WNL. Given her persistent fatigue and "queasiness", team lead contacted ED charge nurse to discuss case. The recommendation was to have the patient further evaluated. Discussed with team lead, and it was agreed upon that this was best course of action given her persistent symptoms. EMS was called. Per EMS report, patient's blood pressure did rise which patient attributed to excitement/anxiety surrounding the situation. Patient ultimately declined EMS transfer to ED. Her husband arrived to drive her home. Discussed the importance of monitoring symptoms for the next 48 hours. If she has any worsening "queasiness", weakness, fatigue, nausea/vominting, throat swelling, wheezing, dyspnea then she is to call 911 immediately. Patient verbalizes understanding and is agreeable to emergency services should any of these problems occur.
61 2021-02-23 palpitations, chest discomfort Pt states experiencing heart palpitations and chest pressure.
61 2021-02-25 cerebral haemorrhage, oxygen saturation decreased, troponin increased [COVID-19 mRNA vaccine (Pfizer-BioNtech] treatment under Emergency Use Authorization (EUA)
61 2021-02-26 chest discomfort Lips tingling, throat feels thicker, chest pressure, numbness in fingers. Evaluated by EMS-cleared
61 2021-02-26 heart rate increased, hypertension, palpitations Palpitations lightheaded nauseous Developed high blood pressure Elevated heart rate Blood Tests D... Read more
Palpitations lightheaded nauseous Developed high blood pressure Elevated heart rate Blood Tests Dextrose
61 2021-02-28 heart rate increased Localized rash; High fever; Nausea; Vomiting; Dizziness; Rapid heart rate; it was after the shot, if... Read more
Localized rash; High fever; Nausea; Vomiting; Dizziness; Rapid heart rate; it was after the shot, if she pressed where the injection was it is still a little sore; She called in sick last week; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686 and expiration date not provided), via an unspecified route of administration in the right arm on 19Jan2021 13:30 at a single dose for COVID-19 vaccination. Medical history included Blood pressure high diagnosed a couple years ago. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284) for COVID-19 immunization on 29Dec2020 and unspecified flu shot last fall, she thinks in Sep or Oct2020, but she has never had problems with those. Concomitant medications included unspecified medications. The patient called and said she had reaction to the Pfizer COVID-19 vaccine 12 hours after her second dose and wanted to report it. She said also this past weekend, on Sunday, on 24Jan2021, she started to develop a localized rash that has like a border to it. She added that she got her second dose of the COVID-19 vaccine on 19Jan2021 at about 01:30 PM in her right arm. She said that she woke up the next morning, 20Jan2021 at 03:00 AM with a high fever, nausea, vomiting, dizziness, and rapid heart rate. She said that the high fever that started the temperature she took was 103 initially, she says she took paracetamol (TYLENOL) and it came down to 101, and the next day it was probably 100 most of the day, then it broke that evening. She said the Tylenol, the dose was the extra strength, unknown if it was 500 mg, they were capsules. She says she normally doesn't keep it around, the in-house nurse suggested it so she went and got a sample thing and took a couple doses, she doesn't have it with her as she is at work and is not at home. She said that the nausea and vomiting subsided after the first day or second day, she had the on and off fever and slept most of the day both days. She said that she doesn't have a fever now. She said that she doesn't have her exact heart rate from when she was having the rapid heart rate, she just felt it in her chest. She added that the only reason she said anything was because she called in sick last week on an unspecified date in Jan2021. She said that the rash started developing after that and it is now probably the size of a 16 oz or 60 oz cup, unable to clarify number with caller, she said that it is definitely big but it doesn't bother her, though she is concerned it is there. She clarified that it is a couple inches in diameter and kind of looks like the state of (State Name), on her injection arm which was her right arm. She said her arm is not sore now, it was after the shot on an unspecified date in Jan2021, if she pressed where the injection was it is still a little sore. She said that the hospital said to report it. She said she also has a concern if she should she get another shot if they decide this is needed for more than two vaccinations. She said that she knows they are still gathering information at this point, so she thought she should better turn in, hopefully there will be solution later on. The outcome of the events localized rash, dizziness, heart rate increased and sickness was unknown. The outcome of the events fever, nausea and vomiting was recovered on an unspecified date in Jan2021 while the outcome of the event vaccination site pain is recovering.
61 2021-03-01 loss of consciousness, fainting Patient had a syncope episode aprox. 30 minutes after administration. She passed out while in observ... Read more
Patient had a syncope episode aprox. 30 minutes after administration. She passed out while in observation. Paramedics on scene responded and gathered information. She passed out again and at that point she was put on the stretcher and brought to a nearby hospital.
61 2021-03-02 chest discomfort Pt received vaccine and was being monitored following receipt. After ~30 minutes, developed right si... Read more
Pt received vaccine and was being monitored following receipt. After ~30 minutes, developed right sided chest pressure with shortness of breath. Used her inhaler, which helped with shortness of breath. EMS was called and patient was transported to the ED where she also endorsed a headache. EKG showed some ST depression with T-wave inversion that was not present in 2008. Patient was monitored for a few hours - had 2 negative troponins and repeat EKG and was discharged home.
61 2021-03-02 heart rate increased, hypertension Increased heart rate following second dose; they took her blood pressure which was 193; she feels a ... Read more
Increased heart rate following second dose; they took her blood pressure which was 193; she feels a little lightheaded still; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on the left arm shoulder (as reported) on 29Jan2021 at single dose for COVID-19 immunization. Medical history included high blood pressure from 2017 and ongoing, open heart surgery in Aug2017 (for 2 holes in the heart), complete heart valve replacement in Oct2017 and ongoing, "pacemaker" from Oct2017 and ongoing. Concomitant medication included metoprolol for thyroid condition, amlodipine for high blood pressure, clarithromycin (CLARITIN [CLARITHROMYCIN]) for allergies; all from 2017 and ongoing. Patient previously took first dose of BNT16B2 on an unspecified date for COVID-19 immunization and experienced heart rate increased. She was brought to the emergency room and they gave her an intravenous medication for cardioversion where they stopped her heart and restarted it to get the rhythm back to normal. Family medical history included mother and sister died from lung cancer; father died of pancreatic cancer. Heart rate increased following second dose of Pfizer-BioNTech COVID-19 vaccine administered on 29Jan2021; onset of event was in the afternoon on 30Jan2021 while at work. Her heart kind of jumped, skipped a beat and then just took off; she could feel her body twerking. Her heart rate went up to 193 beats per minute. She went to the nurses station at work, they took her blood pressure which was 193-verified this as same number of bpm of heart rate-documented as provided. That nurse told her she should go to the hospital, so patient just left work and walked to the hospital which was a block away from work. She did not feel lightheaded, sick, or pain, just heart racing. She was again seen in the emergency room in response to this event, but was not admitted to the hospital. She was again given an intravenous medication for cardioversion where they stopped her heart and restarted it to get the rhythm back to normal. She does not know the name of the intravenous medication for cardioversion that she was administered. The only thing still ongoing related to this event was that she feels a little lightheaded still. Relevant Tests: All were good. They tested her kidneys, heart did an X-ray, EKG; tested her liver and thyroid and they said everything came back good; They said her heart rhythm was fast, and irregular, but something else was normal-she does not remember what that was. She had no further details or results for testing/investigations to provide at this time. Outcome of increased heart rate was recovered while outcome of the remaining events was unknown. Information on the batch number has been requested.
61 2021-03-02 heart rate increased As soon as injection I got a horrible taste in my mouth then wi seconds my heart rate increased then... Read more
As soon as injection I got a horrible taste in my mouth then wi seconds my heart rate increased then some shortness of breath, that lasted less then a minute approx 5 minutes later a bad headache started then I felt extremely tired the headache lasted about 5 minutes the tired about 15. Nothing was needed everything got better on its own.
61 2021-03-03 fast heart rate Patient had moderate reaction to COVID-19 first dose vaccination. Tachycardia, lightheadedness, chil... Read more
Patient had moderate reaction to COVID-19 first dose vaccination. Tachycardia, lightheadedness, chills, throat discomfort. Patient had improvement with water, O2 and juice. Patient left in wheelchair after 90 minutes of observation with resolution of tachycardia and throat discomfort.. States she had similar reactions to influenza vaccine in past, but did not last that long. We discussed ER evaluation at which patient elected to go home as she had driver and wanted to go home. Patient instructed Benadryl, rest and fluids day of event. 911/ER if worsening symptoms. Patient in agreement to plan.
61 2021-03-04 nosebleed, blood clot still have sore muscles in my shoulders; still feeling bad with all the above symtoms; 23Jan2021 wen... Read more
still have sore muscles in my shoulders; still feeling bad with all the above symtoms; 23Jan2021 went to get covid test but due to blood in my nose received antibody test which was neg; bad headache; winded; vomited; diaherra; coughing/cough; large clots gushed from my rt nostril went to er stopped bleeding after 2 hrs; large clots gushed from my rt nostril went to er stopped bleeding after 2 hrs; This is a spontaneous report from a contactable other hcp (patient). A 61-year-old female patient received their first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1283, expiry date not reported), via an unspecified route of administration on the left arm on 20Jan2021 18:45 at single dose for COVID-19 immunization. Medical history included diabetes mellitus and high BP from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine, losartan potassium and sodium fluoride (CREST CAVITY PROTECTION). The patient previously took septra and experienced allergies. The patient reported that on 21Jan2021, they woke up and brushed their teeth then at 6:40am blood with large clots gushed from their right (rt) nostril. The patient went to ER and stopped bleeding after 2 hrs. On 22Jan2021, the patient woke up with bad headache, winded, vomited, diaherra (as reported), coughing. On 23Jan2021, they went to get covid test but due to blood in their nose, they received antibody test which was negative. On 24Jan2021, the patient was still feeling bad with all the above symptoms. Then on 25Jan2021, they went to ENT doctor who cauterized their nose and stated that since antibody was negative to take the maderna vaccine since they have no antibody in their system, the Pfizer vaccine did not work. From 26Jan2021 to 13Feb2021, the patient felt same started feeling better 14Feb2021 but still have sore muscles in their shoulders and cough. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative on 23Jan2021. The action taken in response to the event(s) for bnt162b2 was not applicable. Therapeutic measures were taken as a result of epistaxis and clot blood which include the doctor cauterized their nose. The patient recovered with sequel from the events.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the epistaxis and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including CBC and coagulation panel, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
61 2021-03-05 chest discomfort Immediately after I got the shot, My nose started running and. Lips felt big and tingling. ( MD d... Read more
Immediately after I got the shot, My nose started running and. Lips felt big and tingling. ( MD did not see visible swelling). And roof of mouth was numb, throat felt like it was closing up, Started getting hoarse, chest tightening. MD gave me 25mg Benadryl and after 30 minutes starting relaxing, Coughing up phlegm. My left arm was very sore and swollen like a lemon... Today. My lip feels kind of burning (like pre herpes outbreak). and roof of my my mouth is still numb. I noticed that I lost sense of taste completely!
61 2021-03-06 atrial fibrillation I am having ongoing Atrial Fibrillation
61 2021-03-06 palpitations Heart Palpitations, refused to be seen by EMS. Cleared by medics
61 2021-03-06 fast heart rate On day 2, I developed confusion and could not focus making it impossible for me to complete my work ... Read more
On day 2, I developed confusion and could not focus making it impossible for me to complete my work at my job. The confusion made driving dangerous. By Friday, I went to my PCP and they noticed that my blood pressure was only 90/58 and they were concerned so she told me that she was calling my cardiologist who said to reduce the dose of my Diltiazem from 180 mg daily to 120 mg daily. She also said to take a few days off of taking the Diltiazem. I have also had a serious increase in Tachycardia. That evening I went to the ED because I was so weak and couldn't breath well. I am also retaining a lot of fluid. The lab work indicated an elevated Pro-B-Natriuretic Peptide level of 227. I am still not well and each doctor I have spoken to said they believe it is due to the vaccine. I do not know if I should take the second dose.
61 2021-03-07 chest discomfort 110/68 97% pulse83 Left arm injection. Client reports heaviness in right arm pressure in her chest ... Read more
110/68 97% pulse83 Left arm injection. Client reports heaviness in right arm pressure in her chest almost immediate 10:10 108/68- pulse 96 pso2 97% right arm heaviness- chest pressure resolved. Client declined ER visit and requested to leave, spouse present will drive client home.
61 2021-03-08 nosebleed Woke up at 1 am to use restroom and noticed dripping from the nose and noticed it was blood. I have... Read more
Woke up at 1 am to use restroom and noticed dripping from the nose and noticed it was blood. I have never had a bloody nose where it actually was running from the nose.
61 2021-03-08 heart rate increased Rapid heartbeat, flushing, tingling of whole body like an adrenaline rush, felt like my blood was on... Read more
Rapid heartbeat, flushing, tingling of whole body like an adrenaline rush, felt like my blood was on fire. Hoarse voice and constant clearing of throat due to production of phlegm in throat. Tingling lips and tongue. This continued all day until I took 10 mg of prednisone. Within 3 hours, all symptoms were gone. Slept well all night. The next day (Wednesday) I felt fine. Slept fine Wednesday night. Thursday morning, all of the above symptoms returned. I took 5 mg prednisone, which didn?t alleviate symptoms so I took an additional 5 mg. I also took 2 Benadryl. Symptoms went away. Slept well Thursday night. Friday morning they returned. I had a doctor?s appointment scheduled (new patient visit) which I canceled as the office told me to go to the ER at the hospital where I got my shot. By the time I got to the ER, my symptoms had subsided. The ER doctor gave me 60 mg of prednisone, 1 famotidine, Benadryl.
61 2021-03-08 hypotension Tongue swelled and then went numb - like novacaine had been shot into it, throat swelling by 6 PM, t... Read more
Tongue swelled and then went numb - like novacaine had been shot into it, throat swelling by 6 PM, took a big swig of Benadryl, went to Fire station, transported by ambulance to ER, blood pressure got way too low on ambulance ride, difficulty breathing/taking air in, IV applied - hospital by 6:30 PM, breathing still difficult, blood pressure better until it dropped again, IV given and monitored. Stable and discharged around midnight. Friday - Tuesday - very tired, heavy arms and legs, sore throat and tongue, limited to soft, bland. foods.
61 2021-03-10 chest discomfort, blood pressure increased Dizziness at 5 to ten minutes of injection , elevated blood pressure. Dizziness was improving after ... Read more
Dizziness at 5 to ten minutes of injection , elevated blood pressure. Dizziness was improving after 30 minutes so I was allowed to leave the vaccination facility shortness of Breath started 35 o 40 minutes after injection. When I was was walking out to my car My daughter was in area and picked me up and she had Benadryl Took 2 Benadryl Shortness of breath started to improve after An hour of Benadryl. Hoarse voice improved some but continued to improve after second dose of Benadryl. Now on March 11 I still have a slight hoarse voice but so much better. I?ve been taking Benadryl every 4 to 6 hours regularly per my Dr I don?t have shortness of breath anymore but my chest does feel a little tight
61 2021-03-11 nosebleed Monday 3/08/21 after work, I was very tired and achy. I went to bed and slept 10 hours. When I eat I... Read more
Monday 3/08/21 after work, I was very tired and achy. I went to bed and slept 10 hours. When I eat I had diarrhea. On Tuesday, no appetite. Ate very little - crackers, and some chicken noodle soup. I had headache and chills on Tuesday evening, Wednesday and Thursday. I didn't feel well at all. Lightheaded Thursday morning, another diarrhea after a small breakfast. Called my doctor, suggested a covid test. Had a rapid covid test. It was negative. Teleconference call with my doctor on Thursday at 3pm. Nose bleed Friday morning 11:00am.
61 2021-03-11 hypotension, fainting Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unrespo... Read more
Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Medium
61 2021-03-12 chest pain Pt c/o tingling in throat progressing to difficulty swallowing and mid sternal CP. Pt given 180 mg ... Read more
Pt c/o tingling in throat progressing to difficulty swallowing and mid sternal CP. Pt given 180 mg allegra and with in 5 minutes was feeling better. VS stable. Released to home with instructions. BP: 125/71, P=100z, Pox=97% 1215 BP=129/73, P=103, Pox=97% 1225 BP=121/66, P=82, Pox= 99%
61 2021-03-14 cerebrovascular accident I had a stroke; This is a spontaneous report from a non-contactable Nurse. A 61-years-old female pat... Read more
I had a stroke; This is a spontaneous report from a non-contactable Nurse. A 61-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:EL3302), via an unspecified route of administration in left arm on 02Feb2021 at single dose for Covid-19 immunisation in hospital. Medical history included hypothyroid. Patient is not pregnant. Concomitant medication included levothyroxine, trazodone, famotidine (PEPCID), cyanocobalamin (VITAMIN B 12). The patient previously took codeine and experienced drug hypersensitivity. Historical vaccination included BNT162B2(lot number:EL3248) on 12Jan2021, in left arm, first dose. No other vaccine in four weeks. No Covid prior vaccination. The patient stated I don't know if it was a result of the Covid shot. But I don't have any comorbidities and I had a stroke on to four which was two days after the shot on 04Feb2021 09:30 with outcome of recovering (as reported). AE result in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, hospitalization (2 days), disability or permanent damage. The patient underwent lab tests and procedures which included Nasal Swab, Covid test result: negative. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Despite insufficient clinical information provided, by close temporal relationship and absence of factors which may provide an alternative cause, the company deems there is a reasonable possibility that the reported stroke is related to the suspect drug Comirnaty. The impacts 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.
61 2021-03-14 hypotension, blood pressure increased, chest discomfort Constriction of throat followed by heaviness in chest, followed by a headache. Had distress but was ... Read more
Constriction of throat followed by heaviness in chest, followed by a headache. Had distress but was afraid to say something. hands tingling fingers both hands. NOT hyperventilating. Oriented but sluggish to respond to questions. initially elevated bp then hypotensive. after leaving vaccine clinic throat felt like a golf ball and went to ER to seek treatment. DX- allergic reaction and given IV Benadryl, Pepcid and solumedrol.
61 2021-03-14 fast heart rate Tacycardia and shortness of breath, followed by chills. Duration of 10 minutes until resolved. Subs... Read more
Tacycardia and shortness of breath, followed by chills. Duration of 10 minutes until resolved. Subsequent abdominal pain with mild diarrhea and then extreme fatigue for 5 hours. Similar to a food allergy reaction
61 2021-03-15 arrhythmia She also experienced shortness of breath/out of breath; heart out of sync; new heart rhythm abnormal... Read more
She also experienced shortness of breath/out of breath; heart out of sync; new heart rhythm abnormality; she has heart rhythm problem (premature atrial contraction); feeling exhausted; This is a spontaneous report from a contactable Nurse (patient). A 61 -year-old female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL3249), via an unspecified route of administration on 19Jan2021 (at the age of 61 -years-old), single dose for COVID-19 immunization. Medical history included covid infection over a year ago. The patient had no concomitant medicines were not reported. The patient She had flare ups when she took Hep b vaccine before and did not get the 2 remaining doses because of the reaction. She has had so many vaccines over the years and had her flu shot every year. Patient had the 1st dose of the PFIZER-BIONTECH COVID-19 VACCINE last 19Jan2021. Consulted the doctor 01Feb and told she has heart rhythm problem (premature atrial contraction). She also experienced shortness of breath. Not sure if it is vaccine related or due to her age. She will have the 2nd dose on 09Feb2021. Stated that she was feeling exhausted (29Jan2021) and out of breath. Stated that the doctor told her that her heart rhythm out of sync. Stated that in Dec she had her heart checked and it was okay. Stated that her other Covid is due to be given 09Feb. Does not know if the vaccine is contributing to her heart rate's bivalvular rhythm. Stated that she had Covid infection over a year ago. Stated that she is worried that the vaccine caused an abnormal rhythm to her heart. Stated that she has a new heart rhythm abnormality. Stated that she had all of her lab work done on 11Jan2021 and it was okay. Stated that on 27Jan-28Jan that she tried to pick up a watermelon and was short of breath for no reason. Stated that it happened a couple of times. Stated with her rhythm being out of sync that it feels like her heart is failing. The outcome of the event dyspnea was recovered, heart disorder and fatigue was not recovered, other events was unknown.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported arrhythmia 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.
61 2021-03-15 chest pain, blood glucose increased nausea; chills; diarrhea; bad chest pain could barely breathe; bad chest pain could barely breathe; ... Read more
nausea; chills; diarrhea; bad chest pain could barely breathe; bad chest pain could barely breathe; left arm where the injection was given was very painful from the injection site to her wrist and; left arm where the injection was given was very painful from the injection site to her wrist and; can barely lift her arm over her head; increase in her blood sugar; arm pain; This is a spontaneous report from a contactable consumer (patient herself). A 61-year-old female patient, not pregnant, received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9265), via an unspecified route of administration in the left arm, on 02Feb2021 14:30, at a single dose, for covid-19 immunization. Medical history included diabetes, high blood pressure, and sciatica. Concomitant medications included insulin glargine (LANTUS); metformin; hydrochlorothiazide; candesartan; glipizide (GLIPIZIDE XL) and; colecalciferol (VITAMIN D [COLECALCIFEROL]) - all taken for unspecified indications with start and stop dates not reported. The patient previously received sitagliptin (JANUVIA) and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. The patient did not have Covid prior vaccination. The patient received the vaccine in a public health clinic/veterans administration facility. The patient received the Pfizer vaccine dose 1 on 02Feb2021. The patient experienced nausea, chills, diarrhea and bad chest pain could barely breathe - these have passed. Her left arm where the injection was given was very painful from the injection site to her wrist and she has been alternating ice pack/heat pad and taking Tylenol 650 mg for the pain. She can barely lift her arm over her head. She also noticed an increase in her blood sugar and her blood was really dark - she stated this was unusual. She asked if there was anything she can do or take that might decrease her arm pain. All the adverse events happened on Feb2021 and resulted in doctor or other healthcare professional office/clinic visit. It was reported that the patient had not recovered from all the adverse events at the time of the report. No treatment was received for all the adverse events, except for "left arm where the injection was given was very painful from the injection site to her wrist" (alternating ice pack/heat pad and taking Tylenol 650 mg for the pain). The patient has not been Covid-tested post vaccination.
61 2021-03-15 increased heart rate, palpitations, fibrin d dimer increased 61 yo female admitted with palpitations and flushing since getting the Covid 19 Vaccine on 3/8.. She... Read more
61 yo female admitted with palpitations and flushing since getting the Covid 19 Vaccine on 3/8.. She was prescribed metoprolol and a short course of steroids by her pcp for symptomatic relief which patient took 1 dose of metoprolol and did not start steroids. She came to the ED due to her symptoms, Her main concern was why did she react to the Vaccine., and wanted answers.
61 2021-03-15 blood clot I am retired handicap-MS. I was doing light housework. I started getting pain in right lung, over... Read more
I am retired handicap-MS. I was doing light housework. I started getting pain in right lung, over course of 2 hours pain became very severe. Only in right lung. Felt like blood clot or pulmonary embolism (which I had 15 yrs ago). Went to hospital, check X-ray no clot/embolisms. Blood work showed no clotting factor. Was admitted 4 days. We treated possibility of MS reaction (solu-methyl) as well as heparin in event of unknown clotting issue. Here?s why this is strange: If this was MS flare/relapse, I would have muscle lockup, drop foot, sight issues, sever balance issues ...(i always have sight issues).. with this even it was only severe lung pain. Did not appear to be MS driven issue. Being educated ?high analytic person, in reflection, My ms is very territorial, it fights anesthesia, colds/flus/covid when my husband had it. My MS gets cranky when my immune system is attacked. I suspect the second covid injection was doing its thing, dna modification, and I had some lung inflammation and my MS compounded the reaction with crippling issue. I was in hospital 4 days, IV fluids, heparin, and steriod IV. Within first 36 hours the extreme lung pain disappeared and I got better. I do have cats scan, mri, X-rays from stay. Cat scan clear, X-ray, normal, mri-classic ms history. Was this Ms event? I?m not sold as I didn?t have other normal MS flare symptoms. Was this injection aggreviated? Perhaps... I?m sharing this because I think tracking auto immune disease people is important data gathering. Feel free to call if more dialogue is necessary
61 2021-03-16 fast heart rate, hypertension [Vaccinated at another site] -- 24 hrs after first COVID dose, she had several days of dyspnea, trem... Read more
[Vaccinated at another site] -- 24 hrs after first COVID dose, she had several days of dyspnea, tremors, headache, tachycardia, and hypertension, all without fever.
61 2021-03-16 fast heart rate Nausea, tachycardia, dizziness
61 2021-03-17 chest discomfort Pt described later after she got home a "warm sensation in her chest and felt like she swallowed a g... Read more
Pt described later after she got home a "warm sensation in her chest and felt like she swallowed a golf ball". Felt similar to GERD she had in the past but she has not had anything other than the shot to trigger this reaction
61 2021-03-17 palpitations 3/17 Headache -- heart racing -- contact doctor's office and took some meds
61 2021-03-18 blood pressure increased Patient called Health Department on 3/16/21 at 10:37 am and reported that approximately 40 minutes b... Read more
Patient called Health Department on 3/16/21 at 10:37 am and reported that approximately 40 minutes before call she became extremely dizzy. She has no history of dizziness and no history of health problems. Reports she does take Fosamax on Saturday and normally feels some nausea with that. She did take the Fosamax on 3/13/21. She questioned if this was a normal reaction and said it was severe enough that she did not feel she could walk to the office on the college campus. I recommended she call her doctor and if she continued to feel severe dizziness go to Emergency Room. I called her back at 4:54 pm on 3/16/21 and she reported she did go to the Emergency Room and they did a CT Scan and also some other tests but she could not remember everything. She said her blood pressure was elevated while in the Emergency Room. Was discharged and has a follow up appointment with her normal provider. Client called on 3/18/21 at 4:46 pm and said the dizziness continued and she was started on a steroid and meclizine by her provider.
61 2021-03-18 chest discomfort, chest pain Narrative: 61 yo female with PMH Gastroparesis, carotid atherosclerosis, cervicalgia, angina, depre... Read more
Narrative: 61 yo female with PMH Gastroparesis, carotid atherosclerosis, cervicalgia, angina, depression, hypothyroid, and IBS. reported having chest pain 1 week after his covid19 vaccine on 2/22/201. Pt said pain/tightness radiated down his left arm. Per patient, he went to his cardiologist on the day of his chest pain and was told that it was "significantly different from his last EKG". Pt was not seen at facility so there is no official record. Pt also reported fatigue/chills evening of the first vaccine x 3 days. This ADR was reported on 3/15/2021 when patient came back for her second covid19 vaccine dose.
61 2021-03-18 chest pain, chest discomfort At about exactly 12 hours after receiving the vaccine. I was sitting in my living room watching TV a... Read more
At about exactly 12 hours after receiving the vaccine. I was sitting in my living room watching TV and a sudden severe pain shot through my chest and followed by tightness and difficulty breathing. It was immediately accompanied by a pain between the shoulder blades, cold sweat, nausea, then neck pain and faintness along with the uncontrollable need to move my bowels which was in diarrhea form and continued 3 times within 20 minutes with the other symptoms. After about 5 minutes of receiving the onset of the initial shocking pain, the intensity of the chest pain left but the tightness remained and faded but would return and then subside again every 10 minutes. I went to the emergency room at 11:20pm discharged at 2:50am on 3/19/21.
61 2021-03-18 chest pain Patient felt gassy with chest pain. History of GERD. Burping a lot during the sensation. Some reprod... Read more
Patient felt gassy with chest pain. History of GERD. Burping a lot during the sensation. Some reproducible L sided chest pain likely radiating from the vaccine site.
61 2021-03-18 hypertension 1. Started Mar 8: Swollen lymph nodes on the right side behind the ear and at the root of sculp. ... Read more
1. Started Mar 8: Swollen lymph nodes on the right side behind the ear and at the root of sculp. Painful, in 4 days started fading away, in 6 days no pain , in 9 days completely gone. 2. started Mar 9: High Blood pressure - 167/97; was taken Amlodipine ( 2*2.5 mg); in 4 days it stabilized. 3. started Mar 14: Fever, treated with Tylenol taking every 6-8 hours. on Mar 19 temp is normal. 4. on Mar 18 Dr. took blood and urine tests. No sings of any abnormality. Came to conclusion - should be vaccine side-effect, report to.
61 2021-03-19 chest discomfort Pt c/o Right chest tightness, and phlegm in her throat, coughing. Her VS (BP/HR, SBP @ 140-170'a) VS... Read more
Pt c/o Right chest tightness, and phlegm in her throat, coughing. Her VS (BP/HR, SBP @ 140-170'a) VS stable all throughout, sat 100% the whole time. Called Dr., ordered to give Benadryl 25 mg po and Albuterol 2 puffs inhaler. Her symptoms got better, but continued. Called 911 since she's still coughing and continue to have the 'phleghm' like symptoms in her throat.' 911 assessed her and pt refused to go to ER for further treatment, she signed the paper. Sent her home with her husband, and instructed her to call 911 if her symptoms get worst.
61 2021-03-19 chest pain I developed burning across my chest and felt as though I swallowed a golf ball. The burning occurre... Read more
I developed burning across my chest and felt as though I swallowed a golf ball. The burning occurred approximately 30 minutes after injection and the feeling in my throat occurred approximately 1.5 hours later. I called the pharmacy that administered the injection and they advised me to call my physician. Since I had not yet had my first visit with a new primary care physician, I opted to go to the local emergency room later the same evening.
61 2021-03-19 nosebleed I woke up at 2:30am morning of March 19, 2021 with fever, chills, severe headache, throbbing arm pai... Read more
I woke up at 2:30am morning of March 19, 2021 with fever, chills, severe headache, throbbing arm pain in left arm from shoulder to elbow (injection was in left arm), and nausea. Got up to try to get Tylenol tablets, but returned to bed because I was unsteady on my feet & didn't feel like I should try to go downstairs to get the Tylenol or a thermometer to take my temperature. But my husband said I was warm to touch when he brought me extra blankets to help mitigate persistent chills I was having t/o the night. Symptoms continued until morning of March 20, 2021 and gradually lessened by evening. Stayed in bed all of March 19th and took Tylenol 650mg every 6 hours to lessen bad headache. Ate a few saltine crackers to lessen nausea symptoms & drank ice water. Had a small nosebleed evening of Mar 19th that resolved with pressure to the bridge of my nose. Today (Mar 20th), I have residual light headache that goes away with Tylenol, but no fever, chills, nosebleeds or arm pain.
61 2021-03-20 nosebleed 1. Cold chills in store, had to use restroom and urinate immediately. 2. Cold chills at home, starte... Read more
1. Cold chills in store, had to use restroom and urinate immediately. 2. Cold chills at home, started to shiver, jaw rattling, immediately had hot tea and wrapped in blanket. 3. Nosebleed, very unusual for me, 7 am. 4. Nosebleed, severe tinnitus, nausea, had to get out of bed and get to restroom, immediate bowel movement, severe dizziness vertigo getting back to bed. Slight tinnitus day after while writing report. Still have low nausea. 5. Sore arm for 4-5 days.
61 2021-03-21 chest pain, chest discomfort Chest pain/pressure, treated with Aspirin 324 mg PO with no change.
61 2021-03-21 chest pain The Covid Pfizer vaccine was injected into my left arm muscle. On March 3, Wednesday, the day of vac... Read more
The Covid Pfizer vaccine was injected into my left arm muscle. On March 3, Wednesday, the day of vaccine, immediately after injection, I felt numbness/tingling in lips, upper & lower & inside left of head/brain area, and also brief very sharp pains in my upper body randomly throughout my arms and chest. Intermittent sharp pain in center of chest.- scale 2/10 After the first 15 min, I sat outside the tent, and noticed a numbness in my left leg and foot and sharp pain in my left big toe - (03/21/21 left big toenail showed a light discoloration). Symptoms subsided within an hour, yet a residual minor numbness in my lips, continued, and intermittent sharp pain in center of chest. 2/10 On March 7, Sunday following the vaccine, at 11:00 am I felt definite numbness on the left side of my face. I touched it to determine if I could detect a sensation with my fingers, and I felt the numbness as I touched my face as well. My right side of my face was normal. Residual numbness to left face/head intermittently. including today more noticeable March 22, 2021.
61 2021-03-21 pallor Patient received vaccine then sat in the observation area. I was called over when she looked pale an... Read more
Patient received vaccine then sat in the observation area. I was called over when she looked pale and felt dizzy a few minutes after receiving the vaccine. We took her vitals and her O2 was 98%, HR 61, and BP 92/67. Her normal BP is in the 110s. No history of syncopal episodes or diabetes. Patient then became unresponsive to questions and stared off into the distance for about 10 seconds. She never lost consciousness. She proceeded to gurgle up vomit and I called 911. She became responsive again and able to converse normally, but still felt dizzy. We wheeled her to the front, and EMS arrived. She agreed to go to the hospital due to the concern for her unresponsive episode, inability to walk on her own, and living by herself.
61 2021-03-22 chest discomfort After waiting 20 minutes, noted some back pain, tightness; on oxygen at home; cannister almost emp... Read more
After waiting 20 minutes, noted some back pain, tightness; on oxygen at home; cannister almost empty. VSS ; uncertain after called about whether to be evaluated/go home; refused ED at that time. Decided if could get in car comfortably would go home, if not, to ED for evaluation. More chest tightness as tried to get in car, decided to go to ED for evaluation; again called.
61 2021-03-23 chest discomfort SOB Narrative: Pt reported itching and SOB at 1247. BP 134/88 HR 71 SAT 99% RA. RRT called at 1253, ... Read more
SOB Narrative: Pt reported itching and SOB at 1247. BP 134/88 HR 71 SAT 99% RA. RRT called at 1253, cetirizine 10mg PO AT 1253, epi-pen administered at1253, diphenhydramine 50mg IM at 1257. Pt was then transported to ED. While in ED, given nebs and 125mg solumedrol. Intermittent chest tightness, given albuterol inhaler with good response. Patient was discharged with prednisone 40mg x5 days, cetirizine 10mg x5 days, famotidine 20mg x5 days, albuterol inhaler upon resolution of wheezing.
61 2021-03-23 chest discomfort About 50 minutes after the vaccine was given, my tongue began to swell and I experienced tightness i... Read more
About 50 minutes after the vaccine was given, my tongue began to swell and I experienced tightness in my throat and chest and shortness of breath. (This was occurring while I was driving myself home from the vaccination site.) I administered my Epipen. And I then drove myself to the Emergency Room, which is near my home. At the ER, I was injected with cortisone, Benadryl, and Pepcid, and had my heart and blood pressure monitored for about 3 hours and then I was released, with a prescription for 50MG Prednisone (1q/day) and 10MG Pepcid (2q/day) x 5 days (for both scripts). I finished the prescriptions, but am still feeling some discomfort in my throat and some dizziness.
61 2021-03-23 heart rate increased Got hot, felt nauseated, fast heart rate and a little light headed and dizzy I also did not eat bef... Read more
Got hot, felt nauseated, fast heart rate and a little light headed and dizzy I also did not eat before i got the shot they seem to think my sugar dropped as soon as i had something to eat and drink i was fine
61 2021-03-23 heart rate increased PT RECEIVED THE COVID VACCINATION AND STARTED C/O RAPID HEART BEAT; VACCINE CLINIC OBSERVED PT AND T... Read more
PT RECEIVED THE COVID VACCINATION AND STARTED C/O RAPID HEART BEAT; VACCINE CLINIC OBSERVED PT AND THEN TRANSPORTED HER TO THE ED FOR MONITORING. PT WAS GIVEN IVF AND PLACED ON CARDIAC MONITOR.
61 2021-03-23 hypotension BP dropped to 70/40; seizures; She did fall into a cabinet; bruised up; inflamed; back was on fire; ... Read more
BP dropped to 70/40; seizures; She did fall into a cabinet; bruised up; inflamed; back was on fire; if she moves her head quickly, she can feel like she will have a headache, hangover; could not walk; Trouble walking; Funny taste in mouth; Pain/ felt achy; tingling sensation from head to her to spine/ hands tingling/ it was also in her abdomen area and in her leg; Back pain; Could hardly move; could not stand up; autoimmune response; delayed allergic reaction; tweaky muscle/ pulled a muscle in her back; pain at the top of her head down to her hip; pain at the top of her head down to her hip; having trouble holding her urine; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID19 VACCINE, Solution for injection, lot number: EL9266), via an unspecified route of administration in the left arm, on 05Mar2021 1:45 PM at a single dose for COVID-19 immunization. The patient did not receive any vaccines within 4 weeks prior to receiving the BNT162B2. Medical history included allergic reaction, autoimmune disease, brain barrier fever, epilepsy, encephalitis and meningitis. She had epilepsy as a child. She gets epilepsy when she gets sick. The last 4 times she got sick she had a seizure. The last seizure was 1 year ago (in 2020). She may have had COVID, but she got really sick and had a seizure. She is not sure if it was COVID or not. If it was the flu, she does not want that again. She had ataxia and ended up in hospital two times but did not stay. Prior to this, she did not go to hospital for 30 years. She was unable to walk, her gait was real bad. The neurological disorder messed her up for a while. Concomitant medications were not reported. It was reported that the patient received the PFIZER-BIONTECH COVID19 VACCINE first dose and experienced autoimmune response. After the vaccine, she had pain and tingling sensation from head to her to spine (05Mar2021), BP dropped to 70/40 (06Mar2021), seizures (06Mar2021), and delayed allergic reaction (Mar2021). She wanted to know if she should take the second dose or not. She also wanted to know if that would be considered the anaphylactic reaction. It was also reported that the patient experienced funny taste in mouth, back pain, hands tingling on 05Mar2021. The patient further explained that when she got the shot, she had a funny taste in her mouth. It started immediately after she got the vaccine and it lasted 30 minutes. She mentioned this to the people at the facility, but they said she was crazy and no one else has mentioned this. She thought they would be interested, but they did not care. About 20 minutes later she had a tingly sensation. It was in the back of her head that developed into a stingy, painful, heat, funny type feeling. It was all the way down to her back. She later further explained the back of her head was tingling (05Mar2021). Like were the cerebellum is to spine. This sensation is still there, but better. After she felt this feeling her back then started hurting. She bent over and her back went out. She felt achy. She already had what she called a tweaky muscle (05Mar2021). She had pulled a muscle in her back, but it was nothing that had caused a problem. After getting the COVID vaccine it triggered an immune response in her body. She started to have pain at the top of her head down to her hip (05Mar2021). She bent over and she could not stand up (05Mar2021). Her husband had to help her put her pants on and sit down due to this. She started to have horrible back pain (05Mar2021). She could hardly move (05Mar2021). She was having trouble walking (05Mar2021). She was having trouble holding her urine (05Mar2021). On Saturday evening (06Mar2021), her blood pressure started dropping and she later had a seizure. After the seizure occurred it seems like everything got better and she did not have any trouble since. It was very scary. She mentioned she was in the bathroom and there was a tub full of water. She had a hard time already getting to the bathroom. She was in a lot of pain. The amount of pain she had she thinks affected her blood pressure. She had pain in the back, middle of her back. It started at her head, back of head, down her spine, came down to her back and hips. She was hurting a lot and having a terribly hard time getting around. She could hardly walk. She was going to the bathroom because she felt like she had to go. Her husband was helping her sit on the toilet. When she stood up it was like her blood pressure dropped, she almost went headfirst in the tub full of water, but her husband caught her, laid her down, and had a seizure. This was a very unnerving feeling. The seizure did not last more than a minute, maybe two at the very most. The seizure occurred probably around 6PM or 7PM. It did not last long at all. She woke up on the floor. She had been sitting and she thought she had fallen off the toilet. However, her husband had to remind her that a few things happened in between. She almost fell in the bathtub and she has glass doors. She mentioned she felt as clarified and confirmed sped up. She did fall into a cabinet and is bruised up from that seizure (06Mar2021). She is sore from the pain from that. Still inflamed (06Mar2021) possibly due to the seizure. Like she has ruminants of what occurred to back of head, cerebellum. Before she had the seizure, her blood pressure had started dropping. It started dropping in the evening around 5PM or 5:30PM. Mentioned she is a little confused about the time onset because she was hurting so much and bad all day. She does not take any pain medication. She has an autoimmune disease and it is difficult for her to take medications. On top of that, if she wanted to take an Aspirin she was told she should not take one. She was informed she was trying to promote an auto-immune response to the vaccine. As the day ran on, she was in a lot of pain. She had been in pain since Friday and was trying to deal with that. The patient further stated her blood pressure is back, no illness. After the seizure her blood pressure went back to normal and at this time it is perfectly fine. The back pain she experienced went from the brain down to her backbone. The pain is gone. It started to go away after the seizure and by Sunday 07Mar2021 it was totally gone. At first it was like she could not walk (05Mar2021). It was like she/her back was on fire (05Mar2021). The patient also mentioned if she moves her head quickly, she can feel like she will have a headache, hangover. She feels it in her back. She feels like she is near recovery, and this is a feeling she does not thing will stay. She further went on to say her hip where she fell is a different story. However, this is associated to a fall and not a vaccine. She was having this problem when she had the vaccine, but the vaccine caused it to be more and extra aggravating. She later added, when she first got home along with head tingling her hands were tingling as well. When her brain and hands were going through this tingling sensation, she started to notice the back trouble and it was also in her abdomen area and in her legs causing trouble walking (05Mar2021). The events did not require a visit to the emergency room or physician office. Outcome of the events trouble walking, could not walk, tingling sensation and hangover was recovering. Outcome of BP dropped to 70/40 was recovered on Mar2021. Outcome of seizures recovered on 06Mar2021. Outcome of funny taste in mouth was recovered on 05Mar2021. Outcome of back pain was recovered on 07Mar2021. Outcome of bruised up was not recovered. Outcome of the remaining events was unknown. The patient provided an unrelated causality between the vaccine and event fall. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the current available information, the event Fall is most likely related to an intercurrent or underlying condition which is not related to the suspected drug.
61 2021-03-23 fainting Fainting, fever, chills, nausea. Had repeated fainting spells the morning after the day I was vacci... Read more
Fainting, fever, chills, nausea. Had repeated fainting spells the morning after the day I was vaccinated. Felt better the next day, still had slight fever. By Wednesday (third day after vaccine day), felt fine. The reason I am reporting this is the fainting episodes. I do not see that online as a listed common side effect of the vaccine.
61 2021-03-24 chest discomfort Diabetes; unable to concentrate; arm is killing her; hands are swelled up; constipated; nausea; tigh... Read more
Diabetes; unable to concentrate; arm is killing her; hands are swelled up; constipated; nausea; tightening of chest every so often; acid reflux; hot flashes; sweating; stomach aches; upper abdominal pain radiating to back; severe fatigue; Dizzy/dizziness; stomach feels odd; Headaches; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot Number: EN6198), via an unspecified route of administration, administered in upper left arm on 25Feb2021 9:00 (at the age of 61-year-old) as single dose for virus (COVID-19 immunisation). Medical history included chronic pain, pancreatitis, allergic to medications, old injury in her right arm, menopause and an ongoing mass in parotid lobe discovered in 2019 with CT scan. MRI performed in Mar2020 and CT scan in Oct2020. She stated that they are just watching it because it has not changed. Well defined borders are present, caller stated that doctor was unconcerned. Her mother had heart disease. Ongoing concomitant medications included ibuprofen for chronic pain and gabapentin from 2019 for chronic pain. The patient also took unspecified medication for pancreatitis. She has taken all kinds of stuff after pancreatitis but they do not work. The patient got deadly ill from the flu shot. Unsure of onset age, vaccine/brand name, or vaccination date. She stated that it was before 2003, possibly in the late 1990's or early 2000's. The patient had no history of all previous immunization with the Pfizer vaccine and no additional vaccines administered on same date of the Pfizer suspect. On unspecified date the patient experienced diabetes; on 25Feb2021, the patient experienced dizzy, stomach feels odd, hot flashes, severe fatigue, sweating, stomach aches, acid reflux, upper abdominal pain radiating to back; on 26Feb2021 she experienced tightening of chest every so often; and in Feb2021, she had headache. It was further reported as follows: The patient stated that she took the Pfizer shot, clarified that she received the Covid-19 vaccine, on 25Feb2021, not quite 2 weeks ago. She stated that she had a little bit of a reaction after receiving the vaccination while there, so they were monitoring her. She has been experiencing hot flashes, sweating, and stomach aches for 2 days. She cannot get rid of hot flashes and that she has not had a hot flash in 2 years. She states that she has been down for 2 days with fatigue, that it's really bad. She is inquiring if the side effects that she is experiencing are common side effects and if it is ok to get 2nd shot. Her second vaccine is scheduled for 17Mar2021. She stated that she wanted to take the time to make a report as she is allergic to medications. While inquiring about dates of vaccines and side effects, she stated that she was experiencing tightening of chest every so often. She stated that she only had a few days of stomach pain and she has not stopped eating. She is unable to concentrate (unspecified date) and she has been experiencing headaches, experiencing them twice in 2 weeks. She also reported that she has been having upper abdominal pain radiating to her back. This concerns her, every time she gets it, it scares her. She had pancreatitis when she was 36. It is a nightmare thought. Does this sound like maybe she is possibly starting Diabetes? She reported that this shot has triggered everything. She has an old injury in her right arm. Her arm is killing her, her hands are swelled up, she has acid reflux again, she felt terrible. She stated that the dizziness not as strong as it was at the beginning. The fatigue it comes and goes and that she has spurts where she is energetic. She stated that it's more on than off. She is no longer having stomach aches. She compared the pain to pains of constipation. She also stated that she was constipated after receiving the vaccine on unspecified date. She had nausea at the beginning. The tightening of chest happened off and on, the last day that she experienced tightening of chest was on Sunday. For acid reflux, she is taking Zegerid as treatment, 20mg 20 mg capsules by mouth once daily as needed. She started this on 02Mar2021. She experienced upper abdominal pain yesterday and some this morning, but it was mostly in her back this morning. Her Sweating is off and on. She experienced headache just a couple of times but that she has not had one in a while. She stated that they lasted only an hour or two, and that she does not usually get headaches. She suggested that these may be due to sinuses and weather change. She has been taking Ibuprofen twice a day as treatment. But she normally takes Ibuprofen for chronic pain. Supposed to be 3 times a day but she does not want to take that much. She stated that all of this could also be stress related and that this could also be menopause. The patient recovered from stomach aches on 02Mar2021. The outcome of the events dizzy, sweating, tightening of chest every so often, upper abdominal pain radiating to back, headache was recovering; the outcome of stomach feels odd, hot flashes, severe fatigue, acid reflux was not recovered. The outcome of the remaining events was unknown.
61 2021-03-24 chest pain Huge bruise with a knot. Warm to touchArm pain to the point I couldn?t lay on it. Side effect symp... Read more
Huge bruise with a knot. Warm to touchArm pain to the point I couldn?t lay on it. Side effect symptoms started 3 days after injection on 03/24/2021. Headache, chills, fatigue, atypical chest pain.
61 2021-03-24 chest pain Patient came in received second dose Pfizer vaccine at 3:00pm and reported she had burning sensation... Read more
Patient came in received second dose Pfizer vaccine at 3:00pm and reported she had burning sensation in top of mouth, throat, chest area at 15:03. Patient stated this reaction had also occured after first dose and lasted 3 days. Patient vitals were 99% O2, pulse 82, BP 122/82, Resp. 18 at time of reaction. Patient has no s/s of shortness of breath, n/v, dizziness, swelling, hives. Patient was given 25mg of PO diphenhydramine and monitored for 30minutes. No increase in symptoms. Patient left with symptoms starting to resolved. Patient educated by provider on site to take famotidine and continue diphenhydramine PO as needed every 4-6 hours. If s/s increase to report to the emergency department.
61 2021-03-24 heart rate decreased, hypotension Low BP 74/40, low heart rate- 40, sweating, dizzy, gave ice pack on back of neck and under arms, too... Read more
Low BP 74/40, low heart rate- 40, sweating, dizzy, gave ice pack on back of neck and under arms, took vitals after 10 min again HR 53- BP 82/43, RR 16 96% drank water, 14:55 not dizzy, sitting up, BP 133/82, no sweating, HR 50, RR 16, 99%, 15:00 took to car gave water for way home
61 2021-03-24 heart rate increased On 3/22/21 I experienced several bouts of diarrhea coupled with clammyness/sweating/heart rate of 10... Read more
On 3/22/21 I experienced several bouts of diarrhea coupled with clammyness/sweating/heart rate of 102. On 3/22/21 and continue to have swelling in my left armpit (Lymph node area), spasms in my left shoulder blade and surrounding soft tissue adjacent to my left armpit and neck area. I have experienced soreness in that arm/shoulder but not at the injection site - overall bicep and clavicle area. I have been able to alleviate symptoms to a degree by taking a tylenol once or twice a day but the pain is limiting some of my daily activities to a degree.
61 2021-03-25 blood pressure increased Patient expressed anxiety. Had same symptoms with flue vaccine in 10/2020. Left arm injection site... Read more
Patient expressed anxiety. Had same symptoms with flue vaccine in 10/2020. Left arm injection site no redness, warmth. Patient expressed both parents recently passed away and expressed increased anxiety. Pt walked to the car, steady and stable. Pt will take tylenol as prescribed, rest, and hydrate. Recommend pt to follow-up with PCP on Monday for anxiety and elevated BPs. Pt denied HTN. Vitals: At 13:25, 160/82. 1 minute after 99 At 13:45, 160/82, 98HR, 99% spo2.
61 2021-03-25 blood pressure increased Lip Tingling and Minor Swelling started approximately 5 min after shot Tongue Tingling and Minor Sw... Read more
Lip Tingling and Minor Swelling started approximately 5 min after shot Tongue Tingling and Minor Swelling started approximately 5 min after shot Blood Pressure increase to over 200/100 - taken approx 10 min after shot and then 15 min after shot, at approx 25 min after shot was down to approximately 160/90
61 2021-03-25 chest pain Between 10 and 15 minutes after receiving the vaccine, I felt like someone had thumped me in the che... Read more
Between 10 and 15 minutes after receiving the vaccine, I felt like someone had thumped me in the chest over my left breast. I tried to breathe deeply, and I started to feel light headed. I didn't tell anyone, I was let go after 15 minutes. I sat in my car about 5 minutes and then decided I was worse. I was weak and shaky and light headed, my top lip was fuzzy feeling. I didn't feel like there was a blockage in my airway but I felt like I was having trouble getting my rib cage to expand so I could breathe. I went back in and was sat down, I was evaluated. Paramedics were called, by time they came I was lightheaded and I was foggy brained. I couldn't respond easily. My BP was 165/99 and my heart rate was 98. my O2 was fine but by that time I felt like I had to work hard to get a deep breath. I was feeling worse quickly. I was taken to the ER in a wheelchair. I was put in a bed and hooked me up to monitors. I was left alone for a while. When the dr came in he checked me out and listen to my lungs. I had a hard time getting my lungs to expand. Doctor ordered a blood sugar test and it was below 100. Chest x-ray, EKG and blood work. He told me later that everything was normal. I was there for 2 hours before I felt like I could go home. I didn't receive any medication. I was able to breathe easier by time I left the hospital. I was thinking more clearly as well. The next day I was still feeling shaky and weak. I went to my PCP on friday and I was feeling normal by then.
61 2021-03-25 deep vein blood clot 3 days after completing vaccine series, pt develop right leg pain and swelling, which progressed lat... Read more
3 days after completing vaccine series, pt develop right leg pain and swelling, which progressed later on to shortness of breath after a week.
61 2021-03-25 fainting syncope, n/v
61 2021-03-25 fast heart rate Pasting clinicians note below: Patient is 61 year old female with hx of anaphylaxis presenting for C... Read more
Pasting clinicians note below: Patient is 61 year old female with hx of anaphylaxis presenting for Covid-19 vaccine, Dose #1. She developed itching in there throat within 30 minute waiting period. She was taken to Rapid Response Room. Symptoms progressed from itchy throat, to congestion in throat/upper chest, clearing her throat, watery eyes. Then dry cough. No nausea, no vomiting, no light headed feeling. No facial swelling No hives. OBJECTIVE: Vitals - 154/97, 105, 100%RA Neck - Supraclavicular mild retractions, end inspiratory stridor CV: tachy, regular, no murmur pulm - diminished breathe sounds throughout, no wheezing. Speaking full sentences. Assessment/ Plan: Anaphylaxis to Covid-19 Vaccine: - emergency responders - epi 0.3 mg IM administered to L mid outer thigh at 9:35 am by me - epi 0.3 mg IM administered to R mid outer thigh at 9:41 am because symptoms not subsiding by me -benadryl 50 mg IM x 1 L deltoid by RN 9:45 am - Itching in throat subsided but still retracting and clearing throat so albuterol 3 puffs given at 9:50 am Vitals stable entire time (see midas report) EMS arrived to transport to local hospital.
61 2021-03-26 hypertension, heart flutter PATIENT STATES FEELS LIGHTHEADED AND HEART FLUTTERING. VITALS ARE BP 185/90, HR 103, RESP 20 AND O2 ... Read more
PATIENT STATES FEELS LIGHTHEADED AND HEART FLUTTERING. VITALS ARE BP 185/90, HR 103, RESP 20 AND O2 SAT 0F100%. MONITOR STRIP DONE WITHA HR OF 112 AND REGULAR. PATIENT MONITORED ANOTHER 15 MINS WITH HR OF 90 AND REGULAR. PATIENT ISTRUCTED TO GOTO EMERGENCY CLINIC IF SYMPTOMS RETURN.
61 2021-03-26 fainting Pfizer COVID-19 Vaccine EUA Patient presents 3/23/21 for medical monitoring of syncopal episode s/p... Read more
Pfizer COVID-19 Vaccine EUA Patient presents 3/23/21 for medical monitoring of syncopal episode s/p COVID - 19 vaccine # 2. Lowered to the floor by vaccine staff. Patient reports symptoms of weakness, other wise states she ""feels fine"". Two additional syncopal episodes witnessed by myself when patient attempts to change position. Past medical history is significant for mild persistent allergic asthma, pre-diabetes, OSA, obesity and BPPV. Patient reports history of same reaction s/p previous vaccine. At a approximately 0837 patient was noted to have a worsening rash present to her face. EpiPen administered via left lateral thigh at 0838. EMS called to transport patient the ED for further evaluation. Treatment administered: epipen (lot 0FM406, exp 02/22) left lateral thigh at 0838. Upon arrival to the ED, patient's temperature is 98.8° F, heart rate 92-103, respiratory rate 30, saturating 99% on room air with blood pressure 164/91. The patient's laboratory studies were largely unremarkable. While in the ED, the nurse was getting ready to get the patient up to the commode when the patient started to ""not feel right again."" She asked her to administer the medications for allergic reaction and reports wall the 2nd medication was being infused, she felt paralyzed and unable to talk, although she was able to hear everything and was aware, she was unable to move or speak for a short amount of time. CT head with completed at this time and showed no acute intracranial findings. Chest x-ray unremarkable. EKG showed normal sinus rhythm with sinus arrhythmia, heart rate 80 and prolonged QT at 470. The patient was administered Solu-Medrol 125 mg IV, Pepcid 20 mg IV, Benadryl 50 mg IV, normal saline 1 L IV. Pt was admitted to hospital for observation. The patient was seen on the unit laying in bed with her husband at the bedside. She reports that she is feeling slightly better and hungry and has never felt at paralyzed/unable to speak feeling before and is very nervous about this. She was wondering if she had a seizure, although she reports feeling aware the entire time and did not lose bowel or bladder function. We discussed that that is not typical for a seizure, but even if we did an EEG at this time, it would not be able to tell us what occurred in the past. We discussed continue the Benadryl, Pepcid, and IV steroids for today and likely decreasing them tomorrow. We discussed the workup of syncopal episodes as well. The patient and her husband were agreeable to this plan. Patient was discharged from the hospital on 03/24/2021 in a stable medical condition. Patient was instructed to follow-up with her PCP in 1 week.
61 2021-03-27 chest pain, palpitations at 3am I woke up with a racing heart rate and mild burning in my belly. I couldnt go back to sleep. ... Read more
at 3am I woke up with a racing heart rate and mild burning in my belly. I couldnt go back to sleep. The next day the burning in the belly got worse. My stomach became bloated and I was having shortness of breath walking short distances. The racing heart and chest pain ebbed and flowed. I made a video appointment with my PCP group on Thursday and they prescribed omeprazole and asked me to come in for physical exam the next day. When I went in the symptoms persisted, they did blood work, did a chest x-ray and sent me over to the emergency room. At the ER they did an EKG, more blood tests and recommended I have a abdominal CT on an outpatient basis. They couldnt say my symptoms were a result of the Pfizer shot but they could not rule it out that it was related to the shot.
61 2021-03-27 heart rate increased, palpitations, blood pressure fluctuation 3/11-3/12/21 - heart palpitations, start of flu symptoms 3/13-3/18/21 - heart palpitations and high ... Read more
3/11-3/12/21 - heart palpitations, start of flu symptoms 3/13-3/18/21 - heart palpitations and high heart rate, blood pressure high and low, chills, weak, diarrhea, nausea, headache 3/19-3/23/21 - heart issues better, still had flu symptoms Propanolol and Alprazolam for heart palpitations. ER visit 3/16 - recv IV's, all labs normal. PCP visit 3/23.
61 2021-03-27 hypertension Extreme High Blood Pressure: 171-112, pain and swelling on the injection site.
61 2021-03-28 chest pain Pt c/o chest pain 20 min after vaccine. Pain in middle of chest, dull quality. Asked pt if she wante... Read more
Pt c/o chest pain 20 min after vaccine. Pain in middle of chest, dull quality. Asked pt if she wanted to be seen by ED, and she agreed. Pt wanted to walk, so staff assisted patient to ED. After arrival ro ED, pt stated chest pain resolved. pt was checked in to be further evaluated. Pfizer dose #1. Lot EN6198 Exp 6/30/21.
61 2021-03-29 chest discomfort Hit with heaviness limbs; whelps all over body arms legs stomach back groin; pain in joints; felt li... Read more
Hit with heaviness limbs; whelps all over body arms legs stomach back groin; pain in joints; felt like fire ants; chills; no energy; tightness in chest; This is a spontaneous report from a consumer reported for herself. An 61-year-old female non- pregnant is unknown female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6198), via an unspecified route of administration on Left arm on 02Feb2021 17:45 at single dose for covid-19 immunisation. Medical history included COVID-19, Congested Heart disease, and Penicillin allergy. The patient's concomitant medications were not reported. The patient experienced Hit with heaviness limbs pain in joints whelps all over body arms legs stomach back groin felt like fire ants chills no energy tightness in chest on 22Feb2021. Received Inhalers for breathing and steroids. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient diagnosed with COVID-19; Since the vaccination, the patient not been tested for COVID-19. The seriousness was reported as non-serious. The outcome of the events was "Recovering".
61 2021-03-29 hypertension, heart rate increased, oxygen saturation decreased High BP (178/78), Low Oxygen, Increased Pulse, Heart burn, Left side facial numbness, "hot feeling"
61 2021-03-29 hypertension, palpitations A short time after having received the vaccine, patient complained of lightheadedness, palpitations ... Read more
A short time after having received the vaccine, patient complained of lightheadedness, palpitations and was noted to have sustained high BP readings. Transported to ER via personal vehicle, refused transport. On follow up, patient reports having been started on new med for BP but otherwise recovered.
61 2021-03-29 loss of consciousness 2nd day: Soreness of injection site 3rd day: Soreness of injection site with swelling at site 4t... Read more
2nd day: Soreness of injection site 3rd day: Soreness of injection site with swelling at site 4th day: Soreness with sensitivity to touch throughout the upper part of the arm 5th day: Severe pain throughout the arm. Numbness in my fingers. light headiness, passed out for a few second. light tremors.
61 2021-03-29 fainting Date and time adverse event started: 3/26/21, 0800 Adverse events experienced and are they still occ... Read more
Date and time adverse event started: 3/26/21, 0800 Adverse events experienced and are they still occurring now: syncope, headache 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): Recommended Tylenol or ibuprofen for headache and to stay hydrated as well as continuing to rest. In addition, if symptoms worsen, advised to see primary provider.
61 2021-03-30 chest pain violent heavying, sweating for 2 hours; pain in chest; diarrhea; chills; sore; This is a spontaneous... Read more
violent heavying, sweating for 2 hours; pain in chest; diarrhea; chills; sore; This is a spontaneous report from a contactable consumer (patient) reported that a 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 06Mar2021 14:00 as a single dose (at the age of 61-years-old) for covid-19 immunisation. The patient had known allergies to flu shot, contrast dye, aspirin and codeine. She had a major reaction to flu shot so was scared to have this. She took Pepcid and Zyrtec 3 days prior and 1 week following. The patient was not pregnant at the time of vaccination. The patient had no COVID prior vaccination. There were no other vaccine in four weeks. There were other medications in two weeks. The patient received the first shot, day 1 and 2 was fine. On day 3 (09Mar2021 11:00), diarrhea started, day 4 (10Mar2021) - violent heavying, sweating for 2 hours then pain in chest. The patient thought she was having a heart attack. After many test it was not her heart, then more test that would not cause these issues. The physician determined it was the vaccine. On Mar2021, she still feel chills and very sore. The patient was scared to get her second dose. It was unknown if the patient received treatment for the reported events. The reported events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient was not tested post vaccination. The outcome of the events was unknown. Information on the lot/ batch number has been requested.
61 2021-03-31 chest pain, chest discomfort Severe pain in center chest. Felt as if my chest/breastbone was being hit repeatedly with a ball ha... Read more
Severe pain in center chest. Felt as if my chest/breastbone was being hit repeatedly with a ball hammer. 10 days after vaccine I had 4 episodes of extreme tightness/pain in chest & right side of lower abdomen. Walking dog when I experienced episode #2. Did not think I would able able to walk home 1 block away. Got on knees and vomited (in neighbors yard!). Got home tried to vomit again (nothing came up) So sever I almost went to ER but episodes dissipated. Experiences 2 more episodes on 3/24. Experienced 1 more episode during night of 3/24. Went to DR. on 3/25 early AM. Have not had any additional episodes!!
61 2021-03-31 hypertension Within 15-minutes of their second vaccination, the patient reported shortness of breath and that the... Read more
Within 15-minutes of their second vaccination, the patient reported shortness of breath and that their throat was closing. EMS evaluated the patient on-site. Patient was slightly hypertensive (144/78). EKG demonstrated Pacer rhythm, rate 60bpm, no ST elevation. The patient was placed on 4LPM O2 via nasal cannula. EMS administered 50mg IV Benadryl, 125mg IV Methylprednisolone/Solu-Medrol, and .5L IV Saline en-route. In the ED, the patient reported shortness of breath, difficulty breathing, tongue swelling, and throat swelling. EMS stated that they did not administer epinephrine. The patient was in stable condition without angioedema or signs of respiratory distress. The patient was discharged with a diagnosis of Allergic Reaction and prescribed a 4-day course of 40mg Prednisone BID.
61 2021-03-31 loss of consciousness Woke up very dizzy, light headed, felt like diarrhea, hot, sweaty, passed out approximately 4 tim... Read more
Woke up very dizzy, light headed, felt like diarrhea, hot, sweaty, passed out approximately 4 times, had a harder time breathing, than normal being on oxygen. Stayed in bed for approximately 27 hours, just couldnt function well. Didnt contact Dr. About it, had family stay with me for couple days. I know it was from the vaccine.
61 2021-03-31 fainting PATIENT FAINTED IMMEDIATLEY AFTER RECEIVING THE VACCCINE. WAS MONITORED AND BLOOD SUGAR CHECKED BEC... Read more
PATIENT FAINTED IMMEDIATLEY AFTER RECEIVING THE VACCCINE. WAS MONITORED AND BLOOD SUGAR CHECKED BECUASE SHE REPORTED NOT EATING THAT DAY
61 2021-04-01 blood pressure increased bad taste, burning sensation on arm, BP slightly elevated. Evaluated by EMS-Refusal to transport
61 2021-04-01 chest pain, palpitations pt states her arm felt like it was on fire as the vaccine was being administered. She became very di... Read more
pt states her arm felt like it was on fire as the vaccine was being administered. She became very dizzy and had a headache. On 3/16/21 her arm was sore at the injection site. Her throat hurt and when she swallowed she would have a sharp pain right between her eyes. Her left arm became very painful and every time she tried to move it would cause pain in her chest. She had diarrhea, sweating and had 101 fever. On 3/17/21 she had to have someone help her our of bed on this day. She felt like she was going to pass out. She had this feeling on at least 3 occasions. Pt had pain when opening her eyes, trouble breathing and having heart palpitations. She called her cardiologist with her symptoms and was told it was related to taking the vax. She had a televisit w/ PCP and she was sent to have a Covid test which was negative. She was told to drink plenty of fluids and rest. By 3/20/221 pt started feeling better at this time.
61 2021-04-01 chest pain A few days after the vaccine I woke up with shape pin pricking pain in the center of my chest. I la... Read more
A few days after the vaccine I woke up with shape pin pricking pain in the center of my chest. I laid back down for a while and the symptoms dimished. Throughout the day they came and went but by the end of the day they left completely. That Wed the same feeling came back and was off and on until that Friday causing me to reach out to my physician. At 5pm that Friday I had an EKG performed which was good. And by that Sat all symptoms had subsided. I was also extremely tired during this time but that dimished as well when the symptoms subsided.
61 2021-04-01 heart rate increased Face swelled almost double in size. Severe headache very fast heart rate nausea diarrhea about 3-4 ... Read more
Face swelled almost double in size. Severe headache very fast heart rate nausea diarrhea about 3-4 minutes after leaving the vaccine site. Symptoms begin to decrease then stop within 5 minutes. Face remained somewhat swollen for about an hour. Headache remained for about 6 hours then arm hurt for about 6 hours. Diarrhea remained for 24 hours
61 2021-04-01 fainting 11 hours after?intense shivering shuddering 22 hours after, awoke to?shivering, sweating, dizziness,... Read more
11 hours after?intense shivering shuddering 22 hours after, awoke to?shivering, sweating, dizziness, lightheadedness, inability to get out of bed, dry heaves 23 hours after?attempted to get out of bed, fell/collapsed/fainted sustained many bruises
61 2021-04-01 fainting Left arm started to hurt minutes after the injection, radiating down toward elbow and my arm started... Read more
Left arm started to hurt minutes after the injection, radiating down toward elbow and my arm started to go numb, especially the pinkie and ring finger. Difficult to hold my phone while waiting, I dropped it, then started to get dizzy. Called a volunteer over, who summoned another lady. They told me they were going to move me to another area, and attempted to help me there, but I fainted about 3 steps out. When they were lying me down on the floor, I came to and was oriented at that point. BP was somewhat low initially, but increased as I lay there, and oxygen levels increased from 94 to 99 before I left facility.
61 2021-04-02 blood pressure increased Complaining of headache, nausea. BPs 124/76 (pulse 109), 153/97 (pulse 101). O2 sat 99%. Taken to th... Read more
Complaining of headache, nausea. BPs 124/76 (pulse 109), 153/97 (pulse 101). O2 sat 99%. Taken to the ED.
61 2021-04-02 chest pain Pt reports severe left arm pain. Pt also reports left sided chest pain and difficulty getting a ful... Read more
Pt reports severe left arm pain. Pt also reports left sided chest pain and difficulty getting a full breath.
61 2021-04-03 chest discomfort ears plugged and ringing; ears plugged and ringing; tongue sore; chills; muscle aches; weakness; joi... Read more
ears plugged and ringing; ears plugged and ringing; tongue sore; chills; muscle aches; weakness; joint stiffness; nausea; sharp pains in stomach and breasts; sharp pains in stomach and breasts; tightness in chest; fatigue; dizziness; impaired mental clarity; 102 fever/99 degree fever; This is a spontaneous report from a contactable consumer (patient). A 61-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in the left arm on 15Mar2021 at 18:00 (06:00 PM) (Batch/Lot Number: EN6208) at the age of 61-years-old as single dose for COVID-19 immunization; administered to the patient in public health clinic/administration facility. The patient had no other vaccine in four weeks. The patient had no COVID prior to vaccination. The patient's medical history included known allergies (unspecified). The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 in the left arm on 22Feb2021 at 07:30 PM (lot number: EL9266) at the age of 61-years-old for COVID-19 immunization. The patient experienced 102 fever the night of 16Mar2021 (also reported as 16Mar2021 at 06:00 AM) with chills, muscle aches and weakness, joint stiffness, nausea, sharp pains in stomach and breasts, tightness in chest, fatigue, dizziness, and impaired mental clarity. On 17Mar2021, the patient experienced ears plugged and ringing, weakness, tongue sore, and impaired mental clarity. The patient had 99 degree fever during the nights of 17Mar2021 and 18Mar2021 thus far. The patient did not receive treatment for the events. The patient has not been tested for COVID post vaccination. The outcome of the events was recovered with sequelae (reported as recovered with lasting effects).
61 2021-04-03 chest pain Dull ache in left side of chest near breastbone.Unable to sleep. Began 9:30pm. Emergency room visit ... Read more
Dull ache in left side of chest near breastbone.Unable to sleep. Began 9:30pm. Emergency room visit 2pm next day.
61 2021-04-04 chest discomfort Approximately 10 minutes after administration, patient stated her chest felt heavy and she was feeli... Read more
Approximately 10 minutes after administration, patient stated her chest felt heavy and she was feeling sweaty/hot. Approximately 5 minutes later, patient went into a absence seizure for roughly 5 minutes.
61 2021-04-04 chest pain c/o chest pain and shortness of breath 10 minutes after vaccine administered
61 2021-04-04 chest pain Chest pains, migraine, difficulty breathing with mask on, out of breath easily,low grade temp, chill... Read more
Chest pains, migraine, difficulty breathing with mask on, out of breath easily,low grade temp, chills and body aches, runny nose ear pain Started with chest pains 4am 3/26 and lasted about 2 1/2 days
61 2021-04-04 hypertension, heart rate increased 2 days after vaccine elevated heart rate and elevated blood pressure.By March 25 head to toe all ove... Read more
2 days after vaccine elevated heart rate and elevated blood pressure.By March 25 head to toe all over constant itch.I am trying different antihistamines at this time.
61 2021-04-05 chest discomfort Pt brought to EMS room due to cough and chest tightness, FNP @ bedside zyrtec 10mg by mouth given @ ... Read more
Pt brought to EMS room due to cough and chest tightness, FNP @ bedside zyrtec 10mg by mouth given @ 955, repeat dose @ 1015am. BP: 148/58, pulse 85, pulse ox 99% @ 1020, verbal orders for benadryl 50mg by mouth given, patient dischared to care of son in no distress, she reported chest tightness had improved and cough had dissipated.
61 2021-04-05 hypotension, pallor 5 MINUTES AFTER RECEIVING COVID VACCINE PATIENT REPORTED EXTREME DIZZINESS, AND A FEELING OF FULLNES... Read more
5 MINUTES AFTER RECEIVING COVID VACCINE PATIENT REPORTED EXTREME DIZZINESS, AND A FEELING OF FULLNESS IN HER LEGS. SHE LOOKED PALE AND HER SKIN WAS CLAMY. GAVE HER SOME WATER AND 1 GLUCOSE TABLET (4GRAM CARBOHYDRATE). TOOK HER BLOOD PRESSURE AS WAS LOW AT 76/51, RECHECK 86/62, RECHECK, 86/58. ATTEMPTED TO CALL 911 BUT PATIENT REFUSED AND WANTED HER DAUGHTER TO COME GET HER. AT 3:54 PM SHE REPORTED THAT THE DIZZINESS WAS GETTING BETTER AND BLOOD PRESSUER RECHECK WAS 98/68. AT 4:01 HER BLOOD PRESSURE WAS 117/71 HR 73 THEN EVENTUALLY CAME BACK UP TO 128/80 AT 4:08PM. PATIENT LEFT AT 4:17PM. WILL FOLLOW UP WITH A PHONE CALL TODAY.
61 2021-04-06 atrial fibrillation AFib; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 61-year-old... Read more
AFib; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration in right arm, on 15Mar2021 at 14:00 (02:00 PM), at a single dose, for COVID-19 immunization. The patient had no medical history and concomitant medications. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. One week after the vaccine on 22Mar2021 at 09:00 AM, the patient had an atrial fibrillation (Afib) event. On 22Mar2021, the patient went to the emergency room (ER) or department or urgent care and ran tests including electrocardiogram (EKG), chest X-ray, and blood work which were all normal. Now, the patient had to go to a cardiologist for further understanding of the reason for AFib event. No treatment was given for the event. The patient has not been tested for COVID-19 post-vaccination. The patient was recovering from the event. Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
61 2021-04-06 hypertension 440, Pt arrives in observation, approx 5 min after receiving vaccine, observed sitting in chair comf... Read more
440, Pt arrives in observation, approx 5 min after receiving vaccine, observed sitting in chair comfortably, no apparent distress, no cough observed at this time, skin appears dry, appropriate skin color, no s/s increased respiratory effort, Smiling playing games on phone, denies any discomfort at this time. 500- Observed pt with intermittent dry cough Pt describes as "just a little tickle", lips pink (mask removed temporaily), talking without difficulty. Denies distress, Offered water, no obvious increased respiratory effort. Pt agrees to continued observation, Offered water, appears to be swallowing without difficulty. 5:05 pt reports "harder to talk without cough" observed increase in frequency of dry cough, pt reports that she wants to continue to be observed, does not want benadryl at this time. Pt agrees to plan that includes, if she feels worse, she will be offered benadryl, she agrees, that if she does receive benadry, she will not attempt to drive herself home.She reports that benadryl "makes me drowsy"She agrees to call family to have them come pick her up. Lead RN at pt;s side. 510- increased frequency in coughing, pt reports that "it's harder to talk without coughing, itchiness in throat increasing" she denies shortness of breath, but reports that she is concerned that she will become short of breath, therefore agrees to 50mg benadryl IM (r deltoid), still awaiting family arrival. Pt reports, "feel hot" No observed increase in respiratory Moved to bench couch(prior to recivng benadryl, , EMT present , vitals taken, bp 148/92,pulse=83, pulse ox 96-98%, pt reports that this BP reading is "higher than usual for me", denies pain except for pain at vaccine injection site, 5:20. No obvious change of status noted, skin remains pink, +cap refill, lungs cta no wheeze herd per EMT. 5:24- pt reports that she is "getting a little drowsy, but feeling better". Cough appears to be less frequent.Pt appears more relaxed, talking without effort, respirations appear to be without effort, relaxed.Conitues to agree not to drive herself home, awaiting her daughter to come get her and drive her home, Encouraged pt to have daughter come up to floor, did discuss with pt, although she is feeling better at this time, if she feels worse, once she is driven home by daughter, she will seek emergent care immediately. Pulse ox 98%, appears to be in no distress. Only occasional cough noted. 5:28, pt reports that she sees her daughter on floor and walks (with normal gait),towards a couple, went to offer to escort pt to car, but she walked away from couple, and left floor without coming back to observation. 5:30, pt observed (from 3rd floor window), talking to another adult woman presumptively her daughter, 5:35, pt observed (from 3rd floor window getting into a different car, by herself, sitting in drivers seat and drives off by herself, driving the car.
61 2021-04-06 hypotension, blood pressure increased, hypertension shortly after: dizziness, nauseated, rise in blood pressure, tingly lips/ mouth they sent me to Emer... Read more
shortly after: dizziness, nauseated, rise in blood pressure, tingly lips/ mouth they sent me to Emergency Room but I did not get seen thinking it would pass nest couple days blood pressure mildly high and then extremely low, dizziness, nausea with vomiting (vomiting started 3 days) and then i stoped eating 6 days later started Zofran to combat the nausea; blood pressure less variable
61 2021-04-06 palpitations 45 minutes after shot lips tingled and puffed up, roof of mouth became sore , a bit swollen and irri... Read more
45 minutes after shot lips tingled and puffed up, roof of mouth became sore , a bit swollen and irritated ,periodic heart palpitations. I took liquid benedryl and after 15-20 minutes symptoms subsided, so I did not use my EPI Pen.
61 2021-04-07 hypertension Irregular heart rhythm, fever of 100.8, chills, headache, high blood pressure 145/94, frequent urina... Read more
Irregular heart rhythm, fever of 100.8, chills, headache, high blood pressure 145/94, frequent urination, body aches
61 2021-04-07 palpitations, chest discomfort After vaccine given, patient complained of discomfort to throat. Patient felt like heart racing and... Read more
After vaccine given, patient complained of discomfort to throat. Patient felt like heart racing and slight chest heaviness.. O2 sat within normal limits. Taken to ED. HR 122, BP 141/66, O2 sat 98%. Symptoms resolved on own.
61 2021-04-08 heart rate increased Fever >101, muscle aches, joint pain, swollen lymph nodes, INCREASED HEART RATE performing normal ta... Read more
Fever >101, muscle aches, joint pain, swollen lymph nodes, INCREASED HEART RATE performing normal tasks
61 2021-04-08 palpitations racing heartbeat, breathlessness, coughing, nausea
61 2021-04-09 blood pressure increased, chest pain Patient said she woke up the next day and her arm hurt very bad and it was hurting even in her chest... Read more
Patient said she woke up the next day and her arm hurt very bad and it was hurting even in her chest. It got worse throughout the day. She noted that her blood pressure was high as well. She tested it and it was over 180 sbp. She called me on the evening of 4/9/21 to let me know the chest and arm pain was getting worse. She told me her current systolic blood pressure was over 160 and she normally does not have elevated blood pressure. I advised her to go to the ER. She called the next day to let me know at the ER she found out that she had fluid around her lungs. They told her this was from her immune system's response from the vaccine.
61 2021-04-10 atrial fibrillation AFib one week after injection
61 2021-04-10 nosebleed mild headache, itchy nose, runny eye, sneezing- nose bleed the next morning headache, sneezing was o... Read more
mild headache, itchy nose, runny eye, sneezing- nose bleed the next morning headache, sneezing was over by morning
61 2021-04-10 ischaemic stroke, blood pressure increased, cerebrovascular accident I experienced a slight headache sore arm and elevated blood pressure after the shot. My blood press... Read more
I experienced a slight headache sore arm and elevated blood pressure after the shot. My blood pressure is usually very well controlled. On Monday the 29th, at about 3:30 pm, I started to slur my words. At first we blamed it on the Novocaiine earlier in the day, but I had been talking fine after it and had had it many, many times before and it was worn off. We called my doctor's office after my right arm and leg became very heavy and awkward. They told me to go to the nearest hospital. When I got there, I presented ass a full stroke. I was very hard to understand and my mouth drooped and I had very little use of my right arm and leg. They ran tests, but could not give me the medication because I was already on Eliquis. They thought they saw a small clot very high up. I was hospitalized over the next four days and improved my speech dramatically after a bad headache on March 30. The doctors go back and forth to whether it was a Acute Ischemic Stroke, which is what my paperwork says and a complex migraine. I do not experience migraines or anything like this ever before. I did not have a real headache on the 29th. Since my symptoms, right arm and leg difficulties are still here, my Doctor believes it was a stroke. I have an appointment with a Neurologist and I have to have another MRI. I am going to Physical Therapy. My Doctor told me to fill this out, she thinks it may be from the vaccine.
61 2021-04-10 pallor Upon receiving 1st dose, pt ambulated to observation area w/ unsteady gait. Pt sat down in observati... Read more
Upon receiving 1st dose, pt ambulated to observation area w/ unsteady gait. Pt sat down in observation area w/ noticeable labored breathing, inspiratory stridor, cough, dyspnea. Pt was pale and diaphoretic. Pt was offered vitals check by medical staff, pt refused, stating she recently had an AMI and this was normal for her. Pt stated she carried EpiPen due to latex and iodine allergies, and "if this was an allergic reaction," she "would have known by now." Pt was told to notify medical staff of symptom changes. Throughout her 15 minute wait, pt produced violent coughing and could be seen with noticeable SOB. Pt stood up and ambulated with unsteady gait for approximately 5 ft, where she stopped and was assisted into w/c. Pt was wheeled out to vehicle, where she was asked to stay for another 15 minutes given her symptoms, pt refused. Pt was offered vitals check, pt refused, stating she is "just a minute away from home" and if she would place herself "on low oxygen" upon arrival. Pt drove off, returning approximately two minutes later. Pt c/o throat swelling, SOB, w/ inspiratory stridor, hoarse voice, and violent cough. EMS was called at this time. EMS transported to local hospital.
61 2021-04-10 palpitations, heart rate increased Mild head ache and lightheaded ness started within a few minutes. Fast heartbeat followed. After my ... Read more
Mild head ache and lightheaded ness started within a few minutes. Fast heartbeat followed. After my 15 minute wait time before leaving, I told them my experience. They took my blood pressure which was 175 over something. They let me leave when it was down to 144 over something. Within a few minutes after we left I experienced a severe hot flash, my air cutoff, and I felt weak/faint. I experiencedy airways close, then open again. Nothing like I have experienced before with an asthma attack. This was different. My husband pulled over and I was able to call 911. My heart was racing. The paramedics asked me about the rash on my chest which I new nothing about until he mentioned it. Said my face was flushed? And
61 2021-04-10 palpitations Main adverse effect is heart palpitations, that I experienced 3 days after the first vaccine. This l... Read more
Main adverse effect is heart palpitations, that I experienced 3 days after the first vaccine. This lasted for 2 weeks. After second vaccine I experienced even stronger heart palpitations started on the day 3 after, and still continues now, which is over 3 weeks after the second dose of vaccine.
61 2021-04-11 chest discomfort Received vaccine on 04/07/2021 at 07:47 AM; Presented at ED on 4/08/2021 at 8:29 am and received pre... Read more
Received vaccine on 04/07/2021 at 07:47 AM; Presented at ED on 4/08/2021 at 8:29 am and received prednisone 60 mg and diphenhydramine HCl 50 mg: chest tightness and throat swelling that began yesterday afternoon. She explains that she has h/o anaphylaxis to flu vaccine. She got the first dose of Covid19 vaccine yesterday, she did premedicate with benadryl. She was monitored on site for an hour and felt some left neck pain and jolt of pain down left arm, but it resolved and she went home. Shortly after, she began feeling like she was having asthma attack, wheezing, chest pressure and throat swelling. She used inhaler and took benadryl. Last dose of benadryl at midnight, took Zyrtec D at 7am this morning, last nebulizer and symbicort at 6:30am. She states she still feels chest tightness and throat swelling. She feels like her tongue was very swollen but improved after benadryl. States her voice is different. Feels a little harder to swallow but she is able to drink fluids. She took pantoprazole this morning. States this does not feel like her usual asthma. Rates chest tightness a 4/10 on pain scale, states it feels like something is sitting on chest or squeezing chest. States it does feel a little better in anterior chest now, but she feels it on lateral lower chest still. Denies h/o cardiac issues. Denies h/o MI. No jaw or arm pain at this time. Discharged from ED at 9:27 am and reported to ED at 10:03am on 4/08/2021. Received famotidine 20 mg and discharged home at 1206pm on 4/08/2021 with prednisone, Pepcid, EpiPen
61 2021-04-11 heart rate increased, blood pressure increased, chest discomfort Patient received her second Pfizer covid vaccine on Tuesday 4/6/21. She said she had been doing yard... Read more
Patient received her second Pfizer covid vaccine on Tuesday 4/6/21. She said she had been doing yard work before she came to get her vaccine. After she received her vaccine she felt fine. On Tuesday night she started to feel some itchiness. She said the itchiness got worse over the next two days. She talked to her husband and he advised her to take Benadryl so she took two Benadryl. On Wednesday she had some soreness at her injection site. Very early Thursday morning she noticed a golf ball sized knot in her armpit. She said it was sore and if she rubbed it, it felt like it was pushing into her breast. She said it felt like pressure going all the way to her breast bone and along her esophagus. She ended up calling EMS and her blood pressure was up to 181/107 and had a high heart rate. She said she never had any hives but did have some throat, tongue, and lip swelling and said that her throat felt raw. The EMS gave her 2 nitroglycerin tablets and 5 aspirin. She spent Friday and Saturday in the hospital. She said the hospital did all kinds of cardiac tests on her and everything can back clear besides a leaky heart valve. She said she is feeling much better now and that the hospital was not sure if it was a reaction to the vaccine, something else, or a combination of things that caused it.
61 2021-04-12 cardiac arrest Witnessed cardiac arrest with death as the outcome
61 2021-04-13 cerebral haemorrhage, nosebleed, platelet count decreased, blood clot 4/9/21-30 minutes to 1 hour after receiving 2nd dose of vaccine patient had bloody nose, clots, with... Read more
4/9/21-30 minutes to 1 hour after receiving 2nd dose of vaccine patient had bloody nose, clots, with bleeding sores on tongue and side of mouth. Began to have bruises on arms, feet and legs. Blood in urine and bruises on back. Presented to emergency department on 4/11/21. CT brain revealed a right sided posterior temporal hemorrhage. Patient was emergently treated with platelets, DDAVP, factor VII, Decadron, IVIG. 4/12/21, patient denies headache, changes in vision, double vision, change in sensation, including burning, pinprick, numbness, no focal or motor weakness. No change in bowel or bladder control. No sensory changes. Patient states she is now back to her normal state of health, save for the bruising described.
61 2021-04-13 skin turning blue, blood glucose increased Within 1 hour severe side effects: body aches, cough (dry like asthma) , fatigue, dizziness, chills... Read more
Within 1 hour severe side effects: body aches, cough (dry like asthma) , fatigue, dizziness, chills, nausea, could not sleep, Swelling, warmth, burning swellinge first dose size of 1/2 orange. No fever. Second not as severe as the first. Body aches, muscle pain, dizziness, chills, nausea, painful injection site not as much swelling,No fever. Blood Sugar spikes: 1/31/2021 280, 2/1/21 2112/27/21 319, 2/28/21 418. 9 days after second vaccine. Purple swelling of both feet. cellulitis rt foot pain worse in lt than rt .PCP to ER (soles, top lower legs black): susp tibial artery occlusion lt . Heparin. Farxiga, Ultram, baby aspirin, procardia, metformin.Possible Reynauds.Still pain discoloration and swelling.
61 2021-04-13 palpitations, loss of consciousness Passed out. Heart palipatations & vomiting lasted 7 hours,
61 2021-04-14 chest discomfort Patient had prior allergic reaction to tetanus shot in 2007. Also given diagnosis of mast-cell disor... Read more
Patient had prior allergic reaction to tetanus shot in 2007. Also given diagnosis of mast-cell disorder, she pre-medicated with Benadryl 25mg, then received the vaccine. After about 15 minutes, she started to feel itchy and transient chest tightness. No rash noticed pulse-ox 98-100%, Heart rate 75 and BP 123/80. She was given 25mg more of Benadryl and observed for another 20 minutes. She said her symptoms has completely resolved and she went home with her husband after being given strict instructions to return.
61 2021-04-14 chest pain, chest discomfort At approx. 9:22 AM on 4/2/21, I began having problems swallowing my saliva and felt my throat begin ... Read more
At approx. 9:22 AM on 4/2/21, I began having problems swallowing my saliva and felt my throat begin to close. I also began having problems breathing, began coughing and choking, chest pain, and dizziness. The nursing staff at Hospital immediately got a wheelchair and rushed me next door to the ER. The nurses had called ahead so that the ER doctors were ready to assist me. I was given Epinephrine, steroids, nubilizer treatments, Bendryl, IV fluids and oxygen. After some time I began feeling a little better but then the reaction restarted and treatments had to be re-administered several times. It was quite frightening. I also had a severe headache and tightness of the chest . The ER doctor believed that I should be admitted which was done on 4/2/21 and was kept thru 4/4/21.
61 2021-04-14 haemoglobin decreased ! day after the second dose patient developed sore throat, mouth sores, body aches and swollen joint... Read more
! day after the second dose patient developed sore throat, mouth sores, body aches and swollen joints. She initially had a fever that resolved.
61 2021-04-14 hypertension Metallic taste 2 min later. High blood pressure 5 min later. Swollen lymph mode on collarbone 10 da... Read more
Metallic taste 2 min later. High blood pressure 5 min later. Swollen lymph mode on collarbone 10 days later.
61 2021-04-14 palpitations dizzy, weak, stomach pain, loose bowel movements, confusion, heart palpitations
61 2021-04-14 fainting Within 15 minutes of vaccination, patient became diaphoretic. Shortly after, had syncopal episode a... Read more
Within 15 minutes of vaccination, patient became diaphoretic. Shortly after, had syncopal episode and was taken to urgent care for EKG evaluation. No abnormal findings, and patient was discharged in alert, stable condition.
61 2021-04-15 blood pressure increased, fainting Patient received first Pfizer Covid-19 immunization on 4/12/2021. The shot was administered at 11:01... Read more
Patient received first Pfizer Covid-19 immunization on 4/12/2021. The shot was administered at 11:01 am into the left upper deltoid. Approximately 3 minutes later patient complained of faintness and experienced syncope. Patient was able to lie on the ground without assistance and her legs were elevated. Emergency services were placed on standby, and a first responder from the fire department was on hand. Patient was responsive and alert, citing tingling in her left arm and an irritated, scratchy throat. Diaphoresis, but no signs of dyspnea or acute anaphylaxis. Blood pressure elevated. Supine position with elevated legs maintained for about 30 minutes. Patient declined EMT evaluation and was able to leave without assistance.
61 2021-04-15 blood pressure increased after receiving vaccine started to get anxious due to environmental factors was feeling faint and wa... Read more
after receiving vaccine started to get anxious due to environmental factors was feeling faint and wanted to lay down assisted to stretcher placed in trendelenburg snacks and water and juice provided bp elevated sat up bp cont to be elevated pt states having anxious thoughts about covid vaccine expressed to nurse bp elevated pt agrees to lay down and rest for a few minutes and close eyes deep breathing exercises enc to pt. per pt stress relieved after a few minutes and feeling better and requesting to leave, escorted to exit ambulated without difficutly, spouse awaiting in car and driving pt home. pt left at 1053 vs as noted VS 1015 bp 144/89 hr 72 rr 18 o2 95, 1020 bp 157/91 hr 80 rr 18 o2 98 1025 bp 177/107 hr 81 rr 18 o2 100 1035 bp 162/83, 1041 bp 137/87 1045 bp 155/84 1051 148/89
61 2021-04-16 heart rate increased Loss of breath. Very hard to breathe; Vision degrade; Heart rate increase over 100 BPM; This is a sp... Read more
Loss of breath. Very hard to breathe; Vision degrade; Heart rate increase over 100 BPM; This is a spontaneous report from a contactable consumer, the patient. This 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 12Mar2021 12:30 (at the age of 61-year-old) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not have any allergies to medications, food, or other products. The patient did not receive any other vaccines within 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. The patient had not had symptoms associated with COVID-19 and was not enrolled in the clinical trial. On 13Mar2021 00:45, the patient experienced heart rate increased over 100 BPM, vision degraded, loss of breath and very hard to breath. As a result of the events, a visit was made to the doctor or other healthcare professional office/clinic with the patient's heart rate, blood pressure and oxygen (level) were checked. As of 14Mar2021, the clinical outcomes of the heart rate increased over 100 BPM, vision degraded, loss of breath and very hard to breath were resolved on an unspecified date in Mar2021. The expiration date of the lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.
61 2021-04-16 fainting Fainted around 3:00 am on 4/17/2021. Fortunately, I was able to catch my fall by holding on to thing... Read more
Fainted around 3:00 am on 4/17/2021. Fortunately, I was able to catch my fall by holding on to things, so no major injury.
61 2021-04-17 heart flutter, heart rate increased My heart flutters; heart spasms; uncalm coming into my dreams viciously, morbidly gross; super water... Read more
My heart flutters; heart spasms; uncalm coming into my dreams viciously, morbidly gross; super watery bowel movement then went into clay like and drier consistency but still dark (I never had stool this dark).; I was dry/ I needed water; room seemed like it was so much further away, my stairs the spindles were larger in size, it was if I was high on something/feeling of peace, calm/high feeling; I was whistling in my breathing/ I had a loud whistle; feeling my eyes and hearing were sharp/ my eyes were changed eventually; had my eyes dilated; felt I like I was getting hemorrhoids/I woke up feeling like I had too much sugar; black stool; constipation; Chills; wanted to vomit; I got shaky; scares; There's a feeling of hardness in my lower abdomen and heart area (Belch); There's a feeling of hardness in my lower abdomen and heart area (Belch); reversed my beta blockers (it keeps it in the 50s) it went to 79; My energy was so much more.; The next day I gained 3.2 pounds then the next day lost 3 pounds; My injection site for the first 2 weeks,I had an itch/ extreme itch; injection site for the first 2 week/there's pain there on touch (no throbbing pain); My tooth broke; movement under my skin/shingles feeling; My skin is extremely dry; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. It was reported that the patient vision wasn't as good. She also had glasses to read (eyeglass wearer and ongoing) and behind her eyes they were dry one (left) mostly. Concomitant medications included unspecified beta blockers. On 11Mar2021, she got chills on the same day. Right as she got the shot, she wanted to vomit also and got shaky. On 12Mar2021, she woke up with whistling in her breathing for a few minutes then it was done. At the same moment, her eyes were changed eventually. She had mucus in my eyes as her vision wasn't as good and behind her eyes, they were dry one eye (left). So, watching TV wasn't as good and became bothersome. She later noticed, the black in here eye was taken up most of her eye (as if her eyes were dilated). Her eyes and hearing were sharp also now sharp as she was reading better (without my read glasses) and had to turn down the volume in her TV. She also felt like she was getting hemorrhoids for a few days but then it went away. She also had black stool, then constipation (harder stool) eventually went the day right after the shot (12Mar2021). Then around 5pm, she had feeling like she had too much sugar and was dry which she needed water. Once she sat down, her living room door seemed like it was so much further away, stairs the spindles were larger in size, it was if she was high on something. It was different nothing but this injection. She was also experiencing a feeling of peace and calm. As if nothing was wrong, no stress (stressing about something) she couldn't even think of- everything was gone, a calming effect. It was high feeling. The next day (13Mar2021), she had a super watery bowel movement then went into clay like and drier consistency but still dark (she never had stool this dark). In Mar2021, she also stated that there was a movement under her skin like a pre-herpes or a pre-shingles. She mentioned that she knew herpes and the movement under her skin was shingles feeling. Her skin was also extremely dry. On 17Mar2021 (a week after the injection), she woke up to my heart spasm. It was beating real fast (beating like right under her skin), no pain and heart attack but more than a heart flutter. She didn't know whether it was going to beat or stop. She also woke up with a loud whistle (louder than before) out of a dream. She stated that during the day she doesn't get the stressed, but in her dream, it was magnified and woke up in a violent vicious fury. She had 3 nights of this (uncalm coming into my dreams viciously, morbidly gross) started on 14Mar2021. The heart spasms come as a few seconds and goes away but that's happened twice which it scares her. She also stated that there was feeling of hardness in her lower abdomen and heart area (belch) in Mar2021. The injection almost reversed her beta blockers (which keep it in the 50s) it went to 79 (same as it was before she started taking beta blockers) but her blood pressure was normal 121/something (that was a good thing). She also mentioned that her energy was so much more while other people woke up early, cleaning up -would get sleepy and a little tired. But this (injection) gave her energy. Her injection site for the first 2 weeks also had an itch, that would come up (not constant) almost like a yeast infection which had an extreme itch. There's pain was there on touch (no throbbing pain) it took over a week before it was gone. She also mentioned that the chills were off and on for 4 days. The vaccine also did something to her weight as she was expecting to lose weight, but she didn't. One day, she gained 3.2 pounds then the next day lost 3 pounds. Her tooth also broke (but no pain in her tooth) even she had a sensation of her teeth being weak which she could feel it. Her tooth broke eating a tortilla chip and that's weird. She wanted to know if other people had called in with the symptoms that she had experienced. The patient recovered from breath sounds abnormal and constipation on 12Mar2021; cardiospasm, chills and vaccination site pain in Mar2021 while the remaining events were unknown. No follow-up attempts are possible. Information on the lot/batch number cannot be obtained.
61 2021-04-17 chest discomfort Chills, coughing, headache, muscle aches, fatigue, tightness in chest, skin tenderness.
61 2021-04-17 chest pain Developed chest pain, fever, chills, dyspnea, and diarrhea beginning a most immediately after the va... Read more
Developed chest pain, fever, chills, dyspnea, and diarrhea beginning a most immediately after the vaccination
61 2021-04-17 palpitations headache 1st 24 hours. very tired into the next 48, then 4 days later violent vomiting, Diarrhea, sh... Read more
headache 1st 24 hours. very tired into the next 48, then 4 days later violent vomiting, Diarrhea, shaking badly with chills, fever of 102, heart racing, shortness of breath, horrible horrible migrain; headache 1st 24 hours. very tired into the next 48, then 4 days later violent vomiting, Diarrhea, shaking badly with chills, fever of 102, heart racing, shortness of breath, horrible horrible migrain; headache 1st 24 hours. very tired into the next 48, then 4 days later violent vomiting, Diarrhea, shaking badly with chills, fever of 102, heart racing, shortness of breath, horrible horrible migrain; headache 1st 24 hours. very tired into the next 48, then 4 days later violent vomiting, Diarrhea, shaking badly with chills, fever of 102, heart racing, shortness of breath, horrible horrible migrain; fever of 102; headache 1st 24 hours. very tired into the next 48, then 4 days later violent vomiting, Diarrhea, shaking badly with chills, fever of 102, heart racing, shortness of breath, horrible horrible migrain; headache 1st 24 hours. very tired into the next 48, then 4 days later violent vomiting, Diarrhea, shaking badly with chills, fever of 102, heart racing, shortness of breath, horrible horrible migrain; headache 1st 24 hours. very tired into the next 48, then 4 days later violent vomiting, Diarrhea, shaking badly with chills, fever of 102, heart racing, shortness of breath, horrible horrible migrain; headache 1st 24 hours. very tired into the next 48, then 4 days later violent vomiting, Diarrhea, shaking badly with chills, fever of 102, heart racing, shortness of breath, horrible horrible migrain; very tired and exhausted; This is a spontaneous report received from contactable consumer. A 61-years-old female patient had taken BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EP6955), via an unspecified route of administration at the right arm on 23Mar2021 18:00 at single dose for COVID-19 immunization. The patient's medical history included thyroid disorder, severe asthma, osteoporosis, heart disease (previous heart attack). The patient had allergies to penicillin, zpac, sulfa drugs, symbicort, hydrocodone, kiwi, shellfish. Concomitant medications included amlodipine besilate, simvastatin, levothyroxine sodium, fluticasone furoate. The patient had headache 1st 24 hours and very tired into the next 48 (on 23Mar2021), then 4 days later (on 27Mar2021) violent vomiting, diarrhoea, shaking badly with chills, fever of 102, heart racing, shortness of breath, horrible migraine (not prone to migraines), was sick for about 36 hours and have been exhausted every since. It was reported that patient was homebound for the most part and no one in my house was sick but me. The patient was not diagnosed with covid prior vaccination not tested since vaccination. Outcome of events was reported as recovered with sequel. No follow-up attempts are needed. No further information is expected.
61 2021-04-17 fainting Extreme weakness & Fatique Dizziness Fainting Death 04/09/2021
61 2021-04-17 fainting dizziness; headache; fever; stomach cramps; migraine; no appetite; dry cough; fainting; stomachache;... Read more
dizziness; headache; fever; stomach cramps; migraine; no appetite; dry cough; fainting; stomachache; This is a spontaneous report received from a contactable consumer (patient). A non-pregnant 61-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 61 years old, administered in arm left on 23Mar2021 19:15 (Lot Number: EN6207) at single dose for covid-19 immunisation. Medical history included ongoing rheumatoid arthritis, arthrosis, osteoporosis, due to arthritis the patient couldn't eat pork because her joints get swollen. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included etanercept (ENBREL); methotrexate sodium (METHOTREXAAT). The patient experienced fainting, stomachache, stomach cramps, migraine, no appetite, dry cough on 24Mar2021 15:30, dizziness, headache, fever on 25Mar2021. The patient stopped using Enbrel and taking Methotrexate a few days prior Pfizer's vaccine. Next day on 24Mar2021, the patient had stomachache, 3rd day (25Mar2021) started with dizziness, headache and fever. Symptoms kept going after 10 days. 5 days later the patient went to the hospital and was prescribed something for stomach cramps and migraine. But the fever continued. 3 days later doctor prescribed an antibiotic since she didn't know the reason of the fever. During the course of the fever the patient had been taking Tylenol on daily basis. Fever came and went and the patient had no appetite and keep with fainting. Doctor ordered lung rx but the patient couldn't do it. 10 days later the patient had dry cough (event onset date was also reported as 24Mar2021, 15:30). The same symptoms remained. The patient did not receive treatment for all events (except fever). Events resulted in Emergency room/department or urgent care and Doctor or other healthcare professional office/clinic visit. The outcome of the all events was reported as not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
61 2021-04-18 cerebrovascular accident having a stroke; I began to experience numbness on my entire left side, left arm; hand weakness, lef... Read more
having a stroke; I began to experience numbness on my entire left side, left arm; hand weakness, left leg weakness; trouble walking/stumbling; speech problems; slurred speech; fatigue; injection site pain; nausea; pain in my left hip; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ER8727), via an unspecified route of administration, administered in left arm on 29Mar2021 16:30 at single dose for COVID-19 immunisation. The patient's medical history included chronic fatigue syndrome, fibromyalgia, sulfa allergy. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered was Pharmacy/drug store. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient experienced immediate fatigue, injection site pain, nausea, along with pain in her left hip the day after her first Covid vaccine on 30Mar2021 05:00 (Tuesday). The injection site pain resolved after a few days, but she continued to be exhausted and nauseous all week. On 02Apr2021 (Friday), she began to experience numbness on my entire left side, left arm and hand weakness, left leg weakness, trouble walking, speech problems, having to really think about her words (her daughter-in-law was typing this as she could not), slurred speech, stumbling. Her family was concerned she was having a stroke on 02Apr2021 05:00, but have no drooping in her face. She was so scared that she will not be getting her second vaccine. She have not gone to a doctor, as she do not have insurance. The symptoms were continuing. No treatment was received for the adverse events. The outcome of the event 'injection site pain' was recovered; the events fatigue and nausea was not recovered; and unknown for the rest of the events. Events were reported as non-serious. Information on lot/batch number was available. Additional information has been requested.
61 2021-04-18 fibrin d dimer increased, hypertension, chest pain, fluid around the heart Severe left chest back and shoulder pain lasting more than 2 days; Severe left chest back and should... Read more
Severe left chest back and shoulder pain lasting more than 2 days; Severe left chest back and shoulder pain lasting more than 2 days; Severe left chest back and shoulder pain lasting more than 2 days; high BP; fluid around heart; elevated D DIM; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (brand: Pfizer BioNTech, lot: EN6199) in left arm on 06Apr2021 06:30 PM at a single dose for COVID-19 immunization. Facility type vaccine was Pharmacy or Drug Store. Medical history was not reported. Patient was not pregnant (AS REPORTED) at the time of vaccination. Concomitant medications were unspecified. No other vaccine in four weeks. Other medications in two weeks was yes. Patient used to receive Wellbutrin and experienced allergies. Historical vaccine included the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: ER8733) in left arm on 17Mar2021 05:00 PM at a single dose for COVID-19 immunization. Patient experienced severe left chest back and shoulder pain lasting more than 2 days accompanied by high blood pressure (BP), fluid around heart and elevated D DIM on 07Apr2021 05:30 AM. Adverse events (AE) resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). The outcome of the events was recovering. AE treatment: Ultrasound, CT Scan, morphine. If COVID prior vaccination was no. If COVID tested post vaccination was no.
61 2021-04-18 heart rate abnormal anaphylaxis/anaphylactic condition; abnormal heart problems; vocal cord dyskinesia; SOB; extremely r... Read more
anaphylaxis/anaphylactic condition; abnormal heart problems; vocal cord dyskinesia; SOB; extremely red all over body; Abnormal liver enzymes; Hr became Brady with widening if qtinterval; leg cramps; neuro s/s migraine severe; throat closed; Weight gain 15+ lbs on body non pitting edema; non pitting edema; extreme leg pain; breathing problems; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of bnt162b2 via an unspecified route of administration in right arm on 27Mar2021 16:45 (Lot Number: er8733, expiration date was unknown) as single dose for covid-19 immunisation. Medical history included asthma, brain disorder, arthritis, vertigo. Patient had known allergies. It was unknown if patient had COVID prior vaccination. She was not pregnant at the time of vaccination. Patient did not have other vaccine in four weeks. She used other medications in two weeks. The patient experienced anaphylaxis within 5 minutes went home extreme leg pain. Her throat closed and she had short of breath (SOB). She had extremely red all over body. She went back to emergency department (ED). Electrocardiogram (EKG), X-ray and blood work were done. She had c/o leg cramps. Her weight gain more than 15 lbs on body with non-pitting edema. She received treatment for events. She had abnormal liver enzymes, abnormal heart problems and breathing problems. Anaphylactic condition was to step down was on bipap epi (Epinephrine injection) Benadryl 50 mg every 4 hours and intravenous steroids along with fluids. Renal replacement therapy (RRT) called the next day. Patient didn't remember exact cause. Neuro s/s migraine severe Ajovy taken Uberlvy and not else remembered (as reported). Heart issues maintained and pulmonary showed improvement. Ear, nose, and throat (ENT) consult with scope done showing vocal cord dyskinesia. Heart rate became brady with widening if qt interval. She transferred to telemetry 2 d and echo done. Monitor patient for low heart rate 24 hours. Patient released from hospital on 06Apr2021 evening. At home patient continue to have organs change every 24- 36 hours keeping video monitoring and pictures. All events occurred on 27Mar2021 16:45 and resulted doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization/Prolongation of existing hospitalization (vaccine received during existing hospitalization), Life threatening illness (immediate risk of death from the event). The duration of hospitalization was 6 days. Patient tested COVID-19 via nasal swab on 01Apr2021 with negative result. Benadryl 50 mg she had around the clock, steroids and epi used as treatment. The outcome of all events was not recovered. No follow up attempts are possible. No further information is expected.
61 2021-04-18 fast heart rate tachycardia (avg. 125 bpm); dry mouth; low sodium; low potassium; excruciating headache with light a... Read more
tachycardia (avg. 125 bpm); dry mouth; low sodium; low potassium; excruciating headache with light and sound sensitivity/head pounding; light and sound sensitivity; light and sound sensitivity; nausea; lightheadedness; My arm was sore; Felt absolutely terrible; This is a spontaneous report from a contactable consumer (patient). A 61-year-old non-pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8734), via an unspecified route of administration, administered in left arm on 01Apr2021 13:30 (1:30 pm) as single dose for COVID-19 immunization in a clinic. Medical history included autoimmune hypothyroidism, gastrooesophageal reflux disease and don't tolerate NSAIDs but not allergic all from an unknown date. Concomitant medications included levothyroxine; esomeprazole magnesium (NEXIUM); cetirizine hydrochloride (ZYRTEC ALLERGY); gabapentin; and estradiol (ESTROGEL) all taken for an unspecified indication, start and stop date were not reported. The patient previously took erythromicin and experienced drug intolerance but not allergic on an unspecified date. The patient previously received the first dose of bnt162b2 (lot number: EN6204) on 11Mar2021 1:30 pm administered in left arm for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested since the vaccination. On 01Apr2021, it was reported that the patient experienced tachycardia (avg. 125 bpm), dry mouth, low sodium, low potassium, excruciating headache/head pounding, light and sound sensitivity, nausea, lightheadedness, arm was sore, and felt absolutely terrible. The patient was hospitalized for tachycardia (avg. 125 bpm) for 1 day. The events required physician office and emergency room visit. the patient was treated with IV saline, IV anti-nausea, and IV morphine. The patient underwent lab tests and procedures which included blood potassium: low, blood sodium: low, and heart rate: 125 bpm - tachycardia all on 01Apr2021. The outcome of the events was recovered.
61 2021-04-19 chest discomfort, heart rate irregular, ischemic chest pain DAY ONE April 15, 2021. On Thursday April 15th at 10:00 a.m. I received the first dose of the Covid... Read more
DAY ONE April 15, 2021. On Thursday April 15th at 10:00 a.m. I received the first dose of the Covid 19 vaccine. They gave me the shot in my left arm. Within about 5 seconds, I started feeling nauseated and light headed like I was going to pass out. I asked to just sit there for awhile because I did not feel stable to stand up and go to the waiting area. I stayed seated for about 1-2 more minutes then the paramedics took me to the Medical area in a wheelchair. The paramedics checked my vitals. My blood pressure was 135 over ?? I don't remember. I told the medic my BP is normally 98/58. She said my BP was elevated. My pulse was in the high 80's. My temperature was 98.6 and my oxygen was 100. I started getting pain and pressure going up the back of my neck, into my head, eyes and ears. It was very painful and throbbing pressure. I felt dizzy and really high. It felt like I was floating on the top of the ceiling and the people were off in a distance. I was really woozy. I then got diarrhea. The nausea continued but I did not throw up. At times my thinking was spacey, so I talked to the paramedic to help me stay grounded. I narrated what was happening in my body. They did a glucose finger prick test because of my spaceyness, but it was normal. It was like my whole system was freaking out. I was there and then not there, feeling like I was floating. These symptoms continued for about 90 minutes and getting worse. The paramedics offered me to go to the hospital, but I thought eventually I would be fine. I did not want to go to the hospital and have a huge medical bill. At around 90 minutes, I started having pain in my heart left side, under my left breast on my left shoulder. The paramedics did an EKG and did not find anything but some irregular heartbeats. The heart beats felt like BA BOOM, then my heart would do a cartwheel. BA BOOM and another cartwheel. At this time, my husband arrived and took me to the hospital emergency room because the pain in my heart was getting worse. I stayed in the hospital emergency room until around 5:00pm on April 15th. They did another EKG and some lab work and did not find anything but low thyroid. I continued to feel drunk, nauseated, pain pressure and throbbing in my head neck, ears and eyes, diarrhea, and like I was High and going to pass out. The chest pain in my heart was off and on. It felt like muscle cramping in my heart, under my left breast and the left shoulder. I also got a pain in my left groin area, then behind my left knee. It was a sharp and throbbing pain for about an hour in each location, but eventually went away. While in the Emergency room, they tried to give me Ativan. I asked what it was for and they said Anxiety. I said I wasn't anxious; I was just having a reaction to my first Covid 19 vaccine. I said I did not want it because my body was already struggling to handle the Covid 19 vaccine. They said the doctor prescribed it. I said I had not seen a doctor, and they said it is protocol. The nurse then came in and wanted to give me a shot for nausea and I said no, I don't want any more chemicals in my body, it is really having a hard time already with the Covid vaccine. I went home, was wiped out, still feeling drunk/woozy/high, also nauseated, diarrhea, very dizzy, had a hard time walking. The pain, throbbing in my head, neck, ears and eyes was still there. By this time, I could not find clear thoughts, and could not make sense of things. I was very agitated and at the same time exhausted and only wanted to sleep. DAY TWO April 16, 2021 I woke up with a smashing head ache, neck ache, back ache and general feeling like Crap. The nausea and diarrhea were still there and had woken me in the middle of the night. I felt like a truck had hit me. I stayed in bed all day and tried to eat and drink as much as I could. I drank a lot of water that day. I felt horrible, but was able to stand without feeling like I was going to fall over. Had trouble finding clear thoughts at times. Still felt out of it and had chest pain off and on. Also had the BA BOOM heart beats and cartwheels in my heart. DAY THREE April 17, 2021 Very similar to day two. I felt weak, nauseated, diarrhea, pain all over, jittery, not able to have clear thoughts at times. It felt like my body was still on RED ALERT!!! I also had very shallow breathing on day 2, 3, 4 and 5. It tired me and I panted just getting up to go to the restroom. I am able to eat fine and keep food down. BA BOOM hear beats and cartwheels in my heart have lessened. DAY FOUR April 18, 2021 I felt a little better and made the mistake of thinking I was getting over the reactions and did too much. Shortness of breath. DAY FIVE April 19, 2021 I feel horrible again, Nausea is really strong as well as the diarrhea. I am feverish, sweaty and shaky. Shortness of Breath. Tight in my chest. I just took my temperature and it is normal, although I am hot, sweaty, feel feverish and shaky. I am exhausted. The headache is still here as well as the pains in my neck, ears and eyes. The aches in my body are still here. I have no energy. A wave of emotions is also here and I am weepy and crying. This is no fun. I am able to eat food OK and drink lots of water to counteract the diarrhea. DAY SIX April 20, 2021 Shortness of breath, very tight in my chest, having to take Benadryl and use my rescue inhaler to keep my breathing open. Feverish, chills, shakey, hot. Temperature 97.0 Blood pressure 90/66 Pulse 70. I feel like crap, just wiped out.
61 2021-04-19 heart rate increased Six days after my 2nd vaccine I had an anaphylaxis reaction. Out of the blue while I was driving my... Read more
Six days after my 2nd vaccine I had an anaphylaxis reaction. Out of the blue while I was driving my face started to burn like acid was rubbed on it. It got really hot and turned very bright red. Then my lips began to feel like they had been sunburned badly. Then my forearms both started burning and also turned bright red. I was very anxious. Had two bouts of diarrhea. All this occurred within about a 20 minute time-frame. I chewed up 4 children's Benadryl (50mg) and the redness, burning and anxiousness subsided mostly. My heart rat was still over 100 bpm even after 6 hours. (Usually my HR is 68-70 bpm). I slept for 12 hours and the next day seemed fine. This has occurred two more times since that first time. The 2nd reaction being 5 days after that first one and the 3rd reaction being 5 days after that. Same reaction, same treatment and same outcome.
61 2021-04-19 fast heart rate, fast heart rate Pfizer-BioNTech COVID-19 Vaccine EUA: two days after vaccination patient presents to emergency depar... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: two days after vaccination patient presents to emergency department (ED) tachycardic (heart rate 180s) found to be in SVT and hypokalemic. Blood pressure normal and denies chest pain. Vagal manuvers did not resolve SVT. Administered adenosine with resolution of SVT. Administered oral potassium replacment and discharged to home stable.
61 2021-04-19 fainting Patient suffered a syncopal episode and confusion while under observation following her booster vacc... Read more
Patient suffered a syncopal episode and confusion while under observation following her booster vaccination. Patient has a history of diabetic related emergencies but this syncope/confusion resolved itself while under the care of on site paramedics. Patient was transported to a hospital of her choosing.
61 2021-04-20 blood pressure decreased, heart rate increased severe allergic reaction to the vaccine; sore arm; neck pain; getting lots of saliva; tongue started... Read more
severe allergic reaction to the vaccine; sore arm; neck pain; getting lots of saliva; tongue started swelling; rapid breathing, couldn't control her breathing; heart rate it got faster; started getting confused; shaky; wheezing; swelling of her throat; blood pressure dropped; This is a spontaneous report form a contactable consumer reporting for herself. A 61 years old female consumer received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; NDC number 59267-1000-01) on 29Mar2921 at 14:15, in left upper arm, for COVID-19 immunisation. No other vaccines were given on the same date or within 4 weeks. Medical history included allergic to hamsters (she found out that this one had the Chinese Hamster Ovary cells and she knew she had problems with those things), allergic to prednisone (crazy rash, itching), allergic to a lot of different things, sinus infection. Family history included allergy (the whole family had allergies). Concomitant medications included unspecified antibiotics for sinus infection (but it had cleared up by then) and unspecified allergy shots (but not a vaccine). The patient just wanted to report that she had a severe allergic reaction to the vaccine on 29Mar2021. Symptoms began minutes after getting vaccine. The patient experienced getting lots of saliva started with a couple of minutes of getting the shot, tongue started swelling, rapid breathing, couldn't control her breathing, heart rate it got faster, started getting confused, shaky, wheezing, swelling of her throat, blood pressure dropped, all on 29Mar2021. On 30Mar2021 the patient experienced sore arm and neck pain but she thought that was more of a vaccination saying it was working. Clinical course of the events included the following information: the patient had to stay for a while since she had allergies normally. She started getting lots of saliva and she thought that was her body saying, she did something, not a big deal. Around 15 minutes, she was at a grocery store, she started walking around, her tongue started swelling, rapid breathing, she couldn't control her breathing and heart rate, it got faster. She started getting confused, shaky, it wasn't too good. She made her way back to the place where the injections were done, they were trying to get her to use her epinephrine (EPIPEN). She took a diphenidramine (BENADRYL) while walking around looking for her husband and then took another and was wheezing. She thought BENADRYL would have helped. She should have taken her EPIPEN looking back, she thought BENADRYL would help. They heard wheezing, they contacted the other pharmacist, who contacted EMS then they came and took her to the emergency room on 29Mar2021 in the afternoon. When she was wheeled in, the doctor met her in the hall and he said they could give her a steroid shot. The patient stated she was allergic to prednisone, she got a crazy rash, itching, it's not just prednisone, it's an allergy. She got the shot at 14:15 and she was at the hospital by 15:00. The patient thought she was there for 5 hours and then she was sent home. Her blood pressure dropped. The only one she saw was 114/39 but her husband saw it went even lower than that. At the emergency room, they had the automatic thing strapped on so they watched her until it started going back up again. The vaccine shot was probably the easiest shot she had ever had. She had never had any problems. She did not research it very well in the beginning because she thought they should be good. The patient was told to not get the second vaccine. The events also required physician office visit. Allergic reaction symptoms resolved on 29Mar2021 but the swelling of her throat and heart rate lasted about four days, until 02Apr2021. Neck pain resolved on 01Apr2021. Sore arm resolved on 03Apr2021 or 04Apr2021. Blood pressure dropping resolved on an unspecified date in 2021. Information on the lot/batch number has been requested.
61 2021-04-20 chest discomfort, chest pain At 11:27 AM, Pt states that within approximately 10 minutes of receiving Pfizer vaccine pt c/o tingl... Read more
At 11:27 AM, Pt states that within approximately 10 minutes of receiving Pfizer vaccine pt c/o tingling ?to roof of her mouth?. She notified RN of symptoms and nurse asked her to open her mouth and observed that tongue was WNL without swelling, speech clear, no respiratory distress. Discussed with Pharmacist and instructed pt to wait another 15 min and to sit close to nurse for observation. RN also asked pt to notify her of any worsening of symptoms and also to not leave site without evaluation of nurse. At 11:42 AM pt stated symptoms were worsening and c/o think tongue, numbness, tingling of lips. Denies any SOB or difficulty breathing. Lungs clear to auscultation posteriorly all lobes.B/P 180/110, Left arm, Pulse ? 100. Pt also c/o blurred vision, numbness across forehead, chest pain and pressure, dizziness and increased tiredness, denies headache and anxiousness. At 11:46 AM 12.5mg liquid Benadryl given p.o. and after consulting with Pharmacist, another 12.5mg Benadryl given at 11:51AM and pt taken to ED via wheelchair. Pt verbalized consent.
61 2021-04-21 blood pressure increased Severe HA (8/10), BP increase to 177/89, 182/90 (no hx of hypertension), HR remained in the high 90?... Read more
Severe HA (8/10), BP increase to 177/89, 182/90 (no hx of hypertension), HR remained in the high 90?s, pulse ox 98%, minimal diaphoresis, c/o numbing to face, when asked to smile, states she cannot. Patient sent to ED for evaluation.
61 2021-04-21 chest discomfort, ischemic chest pai