Pfizer

Psychological symptom reports

Female, 16 - 25 years

Age Reported Symptoms Notes
16 2021-02-10 crying, abnormal behaviour Congestion, breathing abnormal, elevated heartrate , 02 lower then usual , tired , exhausted, fat... Read more
Congestion, breathing abnormal, elevated heartrate , 02 lower then usual , tired , exhausted, fatigue, not usual self , fussy , incosebale. Patient is a non verbal child
16 2021-03-12 feeling abnormal Patient was sitting in the observation area. Patient stated that she was feeling "off" and we helped... Read more
Patient was sitting in the observation area. Patient stated that she was feeling "off" and we helped lower her to the ground into a sitting position. She stated that she felt dizzy and we lowered her onto her back and raised her legs onto a chair. 911 was contacted. Patient remained responsive and was able to answer questions throughout. Patient stated that her shoulder felt like it was burning where she received the injection. She also stated that her face felt numb and her lips felt funny (tingling). Patient was still able to breathe and respond appropriately to all questions. Care was taken over by Ambulance service. After speaking with patients mother later in the day, it was determined patient had a vasovagal episode.
16 2021-03-25 nervousness Patient was shaky and pale during post-vaccination observation following her second Pfizer dose. Jui... Read more
Patient was shaky and pale during post-vaccination observation following her second Pfizer dose. Juice was provided to the patient. Per Mom, client has a history of "vagal" reactions following blood draws or other needle encounters. Onsite EMS evaluated client, took vital signs (below). Client's condition improved. Client was cleared by EMS to discharge home with her mother, and she left the facility of her own volition.
16 2021-03-28 irritability 20 minutes after shot. Sharp pain in arm. Daughter said it feels like the needle was left in her arm... Read more
20 minutes after shot. Sharp pain in arm. Daughter said it feels like the needle was left in her arm. Feels dizzy and out of it. 25 minutes after shot having trouble swallowing. No difficulty breathing. Very thirsty. 40 minutes after shot legs feel very heavy. Daughter was sliding them across floor instead of walking regular. She said it was like her legs forgot how to walk. She was very irritable. Two hours after shot she said she was feeling better except for sore arm. Still felt somewhat sick. Next day she said feels like she had the flu but was feeling much better except for sore arm.
16 2021-03-30 anxiety anxious & numbness to the back of the head. Medics present. Hx of anxiety & Abhb. Symptoms res... Read more
anxious & numbness to the back of the head. Medics present. Hx of anxiety & Abhb. Symptoms resolved with comfort measures. BP 114/72- HR=64
16 2021-03-31 feeling abnormal Patient complained of light headedness and throat feeling "weird." Pt was given water and 25mg Benad... Read more
Patient complained of light headedness and throat feeling "weird." Pt was given water and 25mg Benadryl and taken to observation. Patient was released to her mother and declined EMS transport.
16 2021-04-04 anxiety Anxiety Felt like fainting Dizziness Tingling and cramping in hands Weakness EMT came to Observatio... Read more
Anxiety Felt like fainting Dizziness Tingling and cramping in hands Weakness EMT came to Observation area Vitals BP #1) 173/133 Pulse 86 O2 Sat 100% #2) 95/72 Patent refused transport to hospital
16 2021-04-05 anxiety Patient had syncopal event about 5-7 minutes after vaccination. She came to within a minute or two, ... Read more
Patient had syncopal event about 5-7 minutes after vaccination. She came to within a minute or two, but was very anxious and visibly upset. She stopped shaking within another minute or two and had calmed down enough to sit up upright. She drank a few sips of water and said she was feeling better. EMS as called as a precaution and arrived in about 15 minutes. Patient's BP was normal (120/80) and blood sugar within normal range.
16 2021-04-05 feeling abnormal Patient was accompanied by mother for her Pfizer COVID-19 vaccine. After recieving her vaccine, she ... Read more
Patient was accompanied by mother for her Pfizer COVID-19 vaccine. After recieving her vaccine, she told her mother that her hands were feeling 'different.' Mother attempted to walk patient over to nurse's vaccine bay. Patient then became faint and was lowered to the ground by mom and myself. She was brought up to the chair and reclined. She states that she does not remember this occurring. Her vitals signs were taken. BP was 103/61, pulse was 61. She admits that she did not eat anything today besides a couple of chips and admits that she was very nervous prior to the vaccine. She was given some Nutella, crackers, and water. After about 10 minutes she said she felt much better and she was allowed to leave with mom. Advised to eat prior to next vaccine appointment.
16 2021-04-06 impaired work ability Feeling faint, extreme fatigue, vomiting without nausea (no warning)--foul/sour. Kept complaining th... Read more
Feeling faint, extreme fatigue, vomiting without nausea (no warning)--foul/sour. Kept complaining that she felt like she was crawling in her own skin, all through her arms and her chest, like an itch from the inside. NO HIVES. No difficulty breathing. Kept her home from school and she slept a lot. Only vomited the one time. She was fine by late afternoon and all symptoms seemed to have resolved by then.
16 2021-04-07 disorientation Asthma Attack started at 1 pm while seated and attending virtual class. She was under no distress an... Read more
Asthma Attack started at 1 pm while seated and attending virtual class. She was under no distress and was not in any way exerting herself. She described the attack as a feeling of someone sitting on her chest and began to hyperventilate. The color drained from her face and her hands felt numb. Her asthma attacks are generally exercise-induced, so this was highly unusual. She took a dose of albuterol ( 2 puffs with a spacer) and followed her asthma action plan. She laid down and slowed her breathing. 20 minutes later her facial color returned to normal. Two hours later her hands returned to normal. She was disoriented for about 5 hours.
16 2021-04-08 disorientation Patient received first dose of Pfizer covid-19 vaccine on 4/9/2021 at 1800 with her mother in attend... Read more
Patient received first dose of Pfizer covid-19 vaccine on 4/9/2021 at 1800 with her mother in attendance after consent was acquired. At 1805 patient began to feel hot and nauseous. The patient thought she was going to vomit, so she left her chair in the waiting area to head to the restroom at the back of the store. at 1807, Upon rising the patient became weak in the knees and began to collapse. The patient's mother initially supported the patient and I was called to assist the patient to the floor. The patient was very pale in appearance as she was assisted gently to the floor, avoiding any injury. EMS was called shortly after the event around 1810. The patient remained conscious however was a bit disoriented initially while lying on the floor. The patient recovered quickly, however remained nauseous and complained of feeling hot. Upon questioning the patient, she had not eaten since lunch at school at 1300. The patient was given a cold water and a sprite, of which she had a couple of drinks out of each. The patient was relocated back into a chair at 1815 as she was feeling much better. EMS arrived at 1821. EMS performed a general assessment and a blood pressure check resulting in 130/80. The patient's mother dismissed any further treatment from EMS. EMS exited the building at 1827. The patient and mother waited in the store for a while longer. Both patient and mother exited on their own, denying escort from associates at 1840.
16 2021-04-10 anxiety The patient started feeling anxious when she got out of her car to come up to the clinic. After she... Read more
The patient started feeling anxious when she got out of her car to come up to the clinic. After she received her vaccination, she started to feel anxious, felt like her heart was going fast, and sat down. We checked her blood pressure and HR which were normal.
16 2021-04-11 confusional state Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unrespo... Read more
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Medium, Systemic: Hypotension-Medium
16 2021-04-11 disorientation Within 1 minute of receiving vaccine, patient started to shake and appear to loose consciousness for... Read more
Within 1 minute of receiving vaccine, patient started to shake and appear to loose consciousness for about 30 seconds. She then came to and was disoriented for just a minute then could answer all questions asked of her (name, dob, where are you) She stated she had an intense headache, had trouble hearing but hear a buzzing sound. Mom was in the room as well, we gave her water and sat with her for about 10 minutes and she seemed weak but okay. They remained in the waiting area for another 15 minutes, she was feeling better and mom was comfortable to take her home as Mom is a Doctor.
16 2021-04-12 confusional state pt became very fatigued and has bouts of confusion. She has episodes where she doesnt know where sh... Read more
pt became very fatigued and has bouts of confusion. She has episodes where she doesnt know where she is or who she is with. She has had one episode that she didnt know who she was that lasted a few seconds. Most episodes last a couple of minutes. Her parents took her to Hospital ER i. They did an EKG and electrolytes- lab work. Test were normal. She was released to FU w/ PCP and Neurologist. She is scheduled to see a Neurologist today 4/13/2021 and is scheduled to have an EEG tomorrow on 4/14/2021. She has an appt to see her PCP on 4/14/2021.
16 2021-04-13 panic attack, anxiety, crying Patient received vaccine around 4:30pm. After 10 minutes patient reported that she was having a head... Read more
Patient received vaccine around 4:30pm. After 10 minutes patient reported that she was having a headache, felt like her breathing was a little bit heavy. Patient was brought to exam room with mother present. BP was 150s/100, O2: 99%, HR: 65, RR 20. No distress noted. Patient was slightly anxious, continued to complain about headache. Denied any blurred vision, changes in vision, nausea, vomiting. Around 4:45, patient was asked to lay down for a while to be observed further and to give her time to relax. Patient was given cold wash cloths for forehead. Patient suddenly became more increasing anxious at 4:49, complained of excruciating headache and bilateral arm pain. Oxygen remained at 100%. 911 called at 4:50pm. Paramedics arrived at 4:55pm. Paramedics checked patient's blood sugar: approximately 345. Patient reported last meal around 12:30pm. Patient was crying and continually stating that her head hurt. She was alert throughout the entire process and able to answer questions. Mother elected to have patient sent to ER for further evaluation. Followed up with family on 04/14/2021. Mother reported that patient was held at hospital for 5 hours, was given norco for headache. Diagnosed with panic attack. Mother reports that patient is doing better today.
16 2021-04-13 sensation of foreign body Approximately 10 minutes after patient was given the vaccine, she reported feeling slight lump in he... Read more
Approximately 10 minutes after patient was given the vaccine, she reported feeling slight lump in her throat. We brought her into the clinic room and sat her down. Never had trouble swallowing and did not have any swelling. Felt hot and bit sweaty and light headed. Reports has felt similar ways in past when had blood drawn. We laid her down and she immediately started feeling better. Mom and sister were with her. Refused ambulance or transfer to physician. They were all comfortable her leaving on her own, after we have observed her for over 45 minutes from vaccine.
16 2021-04-13 sensation of foreign body patient reports lump in throat, dry mouth and dizziness. Benadryl given, lump in throat sensation r... Read more
patient reports lump in throat, dry mouth and dizziness. Benadryl given, lump in throat sensation resolved.
16 2021-04-16 anxiety Anxiety; HR 88 BP 116/60; Patient stable and released from vaccination site
16 2021-04-16 crying Shortly after administration of the vaccine, patient began feeling lightheaded and nausea. Patient w... Read more
Shortly after administration of the vaccine, patient began feeling lightheaded and nausea. Patient was crying and had rapid breathing. Patient appeared to be having a anxiety attack. 911 was called. Blood pressure was taken 3 times over the course of ~5 minutes. Emergency response personnel arrived and continued to assess and monitor the patient. The patient eventually left with her father (AMA)
16 2021-04-18 mental status changes lethary and altered mental status 2.5 weeks after COVID vaccine. Found to be septic (hypotension, hy... Read more
lethary and altered mental status 2.5 weeks after COVID vaccine. Found to be septic (hypotension, hypothermia, suspected infection). Admitted to ICU. Required 15L vapotherm for respiratory support and several fluid boluses for blood pressure. Urine culture resulted positive for a bacterial infection. Started on antibiotics and improved. Concern for vaccine adverse event is low.
16 2021-04-18 nervousness Shaky feeling, dizziness, tingling in bilateral upper extremities. Dr at bedside examined and monito... Read more
Shaky feeling, dizziness, tingling in bilateral upper extremities. Dr at bedside examined and monitored for 15 mins then discharged in stable condition
16 2021-04-19 anxiety, panic attack The patient passed out completely while sitting after having her 1st covid vaccine. She was alert s... Read more
The patient passed out completely while sitting after having her 1st covid vaccine. She was alert shortly thereafter but had blurry vision and low blood pressure. She said she was very hot and was sweating somewhat. We gave her some water and gradually she started feeling better. In the meantime, we had call 911 and when they evaluated her, they felt it was somewhat of a panic attack since she did have anxiety before getting the vaccine.
16 2021-04-20 anxiety Feeling dizzy and anxious. Pt was trendelenburg, supine, then sitting. Feeling better, given goldfis... Read more
Feeling dizzy and anxious. Pt was trendelenburg, supine, then sitting. Feeling better, given goldfish crackers, and water. Back to normal. 1533: HR 86, Resp 18, BP 96/64, O2 sats 99%. 1548: HR 87, Resp 18, BP 105/73, O2 sats 100%. D/C'd to home with mother @ 1550.
16 2021-04-20 confusional state, sleep disorder All night so far: Severe headache, body aches, excessive vomiting throughout night, dizziness, almos... Read more
All night so far: Severe headache, body aches, excessive vomiting throughout night, dizziness, almost passing out, confusion, weakness
16 2021-04-21 loss of personal independence in daily activities, insomnia Time of shot: 3pm Onset of reaction: 9pm Stomach ache and headache Hour later: fever (99.5) and chil... Read more
Time of shot: 3pm Onset of reaction: 9pm Stomach ache and headache Hour later: fever (99.5) and chills Difficulty sleeping Kept her home from school today (4/22/2021)
16 2021-04-22 disorientation Low fever, chills, vomiting, disoriented, bad headache, adversion to light and sound, weakness, tire... Read more
Low fever, chills, vomiting, disoriented, bad headache, adversion to light and sound, weakness, tired
16 2021-04-22 sensation of foreign body Pt. received her second Pfizer dose at 3pm. By 11:30pm she had significant swelling on both of her e... Read more
Pt. received her second Pfizer dose at 3pm. By 11:30pm she had significant swelling on both of her eyes, mouth, and the start of red splotchy skin on arms and legs. We took her to ER. They gave her 50mg of hydroxizine and sent us home. 5min after leaving the ER at 12:30am on 4/23 she felt a golf ball sized lump in her throat and was having difficulty breathing. We brought her back to the ER. At this time they gave her an ekg, and at around 1:30am gave her an epi pin and an oral steroid. Within 5min of the oral steroid and epi pin she no longer had difficulty in breathing and the lump in her throat was gone as was the res splotches. By 5am the swelling in her face had reduced drastically to 90% normal in her left eye and 70% normal in her right eye and 70% normal in her lip. She was released from the ER at 5:45am and went home to sleep. At 11:30am on 4/23 her swelling in her face remains the same and she is complaining of a headache. She was given 50mg more of hydroxizine.
16 2021-04-23 feeling abnormal 1130 RN called. When this RN arrived patient was sitting up in a chair and was found to be pale, cla... Read more
1130 RN called. When this RN arrived patient was sitting up in a chair and was found to be pale, clammy, and non responsive verbally. Ammonia salts placed under nose and patient immediately aroused. Blood pressure at 1132 was 95/54 pulse-58, and 02 sat was 99% sitting. 1136 Blood pressure at 1136 was 76/44, pulse 66, 02 sat 99%, and Patient was still responding but somewhat dazed. Still alert and oriented. Ice pack applied. Sweatshirt removed. Patient was given water and a granola bar. Patient transferred to guerny and repeat blood pressure taken. 911 called by RN. Patient talking and awake.1138 blood pressure lying down was 113/62, pulse 67, and 02 sat was 98%. Transferred to nurse treatment room by RN RN. Patient's Mother present. 1147 Paramedics here and report given. 1158 Patient is awake and stable and transported to ER via ambulance.
16 2021-04-24 confusional state Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic:... Read more
Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild
16 2021-04-24 feeling abnormal I got the shot at around 4 in the afternoon and after sitting in the waiting area for around 15 minu... Read more
I got the shot at around 4 in the afternoon and after sitting in the waiting area for around 15 minutes I was allowed to leave. When I left I only had a slight headache, but nothing that seemed very noticeable. I felt a tad woozy but it was nothing serious so I went on with my day and went to my sports practice for an hour and a half. After I got home and had eaten, I was working and started to feel the effects. It started with an increasingly worse headache at around 9 and as the night went on it got worse and I constantly needed to lie down. My arm had started to feel sore but it was nothing much. I thought I could sleep it off but woke up feeling horrible. My stomach could not hold any food down and my headache had become really bad. I had to go to my sports game but on the car ride over (around 45 min) I got very nauseous. Throughout the course of the day my headache would get worse any time I tried to run and all I wanted to do was lie down and sleep. I was barely able to stand, let alone run and I felt sleepy all day. My arm had also gotten very sore and any contact on it made me flinch back. I was not able to eat or drink anything until about 4 in the afternoon and my stomach was not sitting right the entire time and I constantly was burping and feeling like I was going to vomit despite having only water in my stomach. After I was able to eat the stomach ache went away a bit but the headache lasted through the night and has finally started to subside two days later.
16 2021-04-25 anxiety Client reported feeling "anxious and dizzy" approx. 15 mins. after receiving vaccine. Client was led... Read more
Client reported feeling "anxious and dizzy" approx. 15 mins. after receiving vaccine. Client was led to zero-gravity chair and V/S taken. V/S @ 10:42am: BP 116/56, HR 65, RR 12. V/S @ 10:50 BP 105/58, HR 66, RR 20. V/S @ 10:57 BP 111/70, HR 60, RR 16. V/S @ 11:04am BP 108/70, HR 52, RR 16. V/S @ 11:10am BP 115/68, HR 60, RR 20. Client reported "feeling better" at 11:15am and left site unassisted and with a steady gait, accompanied by her mom. Mom reported she was driving them home.
16 2021-04-25 crying An hour after Pfizer vaccine administration, the parents of the 16 year old patient returned to the ... Read more
An hour after Pfizer vaccine administration, the parents of the 16 year old patient returned to the pharmacy and reported that their daughter was complaining of trouble breathing in the parking lot. The immunizing tech asked the parents to bring the patient back to the pharmacy. The patient returned and while crying and gasping for air, she reported that it felt as if someone was constricting her throat. She also complained of stiff fingers and feeling numbness/tingling in her upper extremities. Assuming anaphylactic reaction, one dose of epinephrine was administered. The patient said she felt slightly better after the first dose but then 2 minutes later, said her breathing was getting worse, and again described feeling her throat tightening. Five minutes later, a 2nd dose of epinephrine was administered. The patient was taken to the hospital by paramedics.
16 2021-04-25 panic attack, anxiety Patient was vaccinated and left with her mother to sit in her car for 30 minute monitoring period. ... Read more
Patient was vaccinated and left with her mother to sit in her car for 30 minute monitoring period. Patient's mother stated patient was experiencing extreme anxiety getting the vaccine and after 20 minutes was wheezing. She brought patient inside and a Pharmacist came to check on her and her mother stated that she has had a reaction to a medication in the past and just needed Benadryl. Benadryl was given to her and she took it orally. Her pulse and blood oxygen were measured with a finger pulse oximeter and were both normal. Shortly after she was panicking more and had a seizure. Her mother reported that she has frequent seizures when she has anxiety/panic episodes. Her seizures were persisting so 911 was called. Paramedics arrived shortly after and took patient to the hospital. A few hours later the patient's mother came back to us to inform us that she was released from the hospital and was feeling fine and back to normal.
16 2021-04-26 anxiety Patient experienced anxiety post vaccination, recovered and released
16 2021-05-01 confusional state Systemic: Confusion-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Mild, Systemic:... Read more
Systemic: Confusion-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Patient had fainting episode immediately after vaccine administration. She became responsive in few seconds. she said before fainting she felt tingling, rapid HR and really cold. she reports nausea and confusion right after becoming responsive. Mother denied the need for EMS said she is fine and she has had fainted once after flu shot. Her blood pressure was 100/62 and 95/82 with Heart rate of 99 and 89. She lied down for 30 minutes. she reported feeling fine before leaving.
16 2021-05-02 confusional state Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Confusion-Severe, Systemic: Dizziness / L... Read more
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe
16 2021-05-03 anxiety Patient reported feeling lightheaded status post first dose Pfizer COVID vaccine (Lot: EW0167, expir... Read more
Patient reported feeling lightheaded status post first dose Pfizer COVID vaccine (Lot: EW0167, expiration date: 08/31/2021) to medic. Medic noted that the client was CAOx4, her skin was pale, warm and slightly moist, pupils were equal, round, reactive to light and accommodating (PEARRL), respiration rate (RR) was 20. The client's sister stated the client had a history of anxiety and that "she gets this way whenever she gets a shot". Medic walked patient to the zero gravity chair. The client was given water to sip on. At 1213 baseline vitals were taken with client sitting: Blood pressure (BP): 110/82, heartrate (HR): 98, RR: 20, PEARRL. Medic reports she coached the client on her breathing to help alleviate her complaint of feeling lightheaded, mild nausea and anxiety. Client reported she felt anxious prior to her vaccination and that her last oral intake was 15 minutes prior to vaccine. Client denied headache, blurry vision and chest pain. At 1220 a second set of vitals were taken while standing: BP 108/80, HR 86, RR 16, CAOx4. Client stated her symptoms were diminishing. Client's RR slowed down to normal rate and rhythm, vital signs were trending to normal and client was negative for orthostatic pressures. Client was advised to stay for additional 30 minute observation. Client's symptoms resolved completely and she was able to ambulate away from observation site without assistance and with a steady gait.
16 2021-05-04 anxiety 16 yo female came into our injection site today 05/05/21 to receive her first pfizer vaccine. She wa... Read more
16 yo female came into our injection site today 05/05/21 to receive her first pfizer vaccine. She was accompanied by her father. Pt received vaccine IM to her left deltoid. Pt completed vaccine at 2:55pm at which she sat down for her 15 minute observation period. As soon as she sat down she called over the staff that administered the vaccine. She explained to her that she felt nausea and was breathing heavily. I then walked over to them and the attendee was very pale and breathing heavily. By that time I had RN getting attendees history from her father, She has no history of allergic reactions, not taking any medications and no current illness. She is "slightly asthmatic" but is not taking any rx. RN was helping me by putting cold pack behind attendees neck. Pt then proceeded to explain that she felt nauseas and starting dry heaving. RN then brought over trash can and attendee started to vomit. I then started to proceed and take her vitals. first set of vitals were taken at 2:58pm BP: 90/60 HR: 132 RR: 24 O2: 100%. Attendee at this point was diaphoretic, pale, breathing heavily and vomiting. We continued to monitor attendee in which she started to feel better by 3:08 pm. She was no longer pale, diaphoretic or vomitting and was breathing normally. We provided attendee with water and continued to monitor her. Now that pt was calm, I was able to ask her some questions. She stated that she had a smoothie and an avocado toast about an hour prior to vaccine. She explained to me that she does have a phobia to needles and was feeling very anxious prior to appointment. I then repeated her vitals at 3:16pm BP: 98/60 HR:89 RR: 20 O2: 99%. I had attendee stand up off chair and walk at 3:22pm. She felt fine and did not feel dizzy at all. No signs of distress noted. She was then discharged and walked out with her dad at 3:25pm.
16 2021-05-06 amnesia My 16-year-old daughter, very healthy without any health conditions, got her first dose of the Pfize... Read more
My 16-year-old daughter, very healthy without any health conditions, got her first dose of the Pfizer vaccine on Saturday evening, April 10th, at around 5pm. On Wednesday, she started complaining of shortness of breath, chest pains, which she described as a feeling of someone stubbing her heart. By Thursday, she began blacking out repeatedly throughout the day, each blackout lasting about a minute. These progressed and whenever she blacked out, she would not remember what happened. At first, she and I brushed it off as maybe lack of calcium since she rarely drinks milk. But as they intensified, I began to become more concerned. I told her I cannot leave her by herself in the house as I prepared to go pick up her young siblings from school then schedule an appointment with her doctor. On our way back home, she blacked out again, however, it was for more than a minute. Straight away, I drove to the ER close by. The doctor came back to inform me that her heartbeat was irregular and concerning based on her age. In that same moment, she began complaining of excessive pain like someone punching her heart out, and then she passed out again. Still with my two other children, the whole ordeal began to frighten them and illicit some heavy tears. Being that this ER was general admission, the doctors insisted they call in the paramedics to transport her to another ER for children. However, after being transported to the other ER, her condition began to intensify rather quickly and the pediatric doctor at the second ER informed us we would have to be transferred to Childrens intensive care unit where the cardiologists could check her heart, find the ultimate cause, and monitor her closely. In that moment, as a mother, I was speechless and extremely terrified. Seeing my daughter being transferred from ER to ER, made it even tougher on me so much that I could no longer hold myself together. Here she was in terrible pain and being moved around with no clear diagnosis and treatment. From there on, we spent a couple days in the Cardiac ICU waiting and praying with friends for answers and the best treatment she could get to ease the pain. By about the third day of being in the ICU, the cardiologists informed me, she had Acute Myocarditis. This was so shocking in a sense that both sides of the family have no history of heart issues. Secondly, she is a very healthy child.
16 2021-05-06 confusional state Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-... Read more
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Nausea-Mild, Systemic: Seizure-Mild, Additional Details: Parents were with patient. says it happens every time she gets shots or blood work. possible NES and/or hypotension. says its happened in docs office before and they're testing her for pots and her sister has non epileptic seizures. She was fine after about 15 minutes. gave her a cold packet to put on the back of her neck and just monitored her for further symptoms.
16 2021-05-07 loss of personal independence in daily activities 18 hours after administration, vasovagal syncope and low blood pressure for 11 hours after onset; pa... Read more
18 hours after administration, vasovagal syncope and low blood pressure for 11 hours after onset; patient fainted and could not sit up or stand -- blood pressure would drop; symptoms persisted for 11 hours
16 2021-05-12 feeling abnormal, incoherent The patient felt tired and describes her eyes going dark, then passed out a few minutes after vaccin... Read more
The patient felt tired and describes her eyes going dark, then passed out a few minutes after vaccination. She was vaccinated and then left the immunization room to sit down for a 15 minute waiting period. When she went to sit down, she collapsed on the floor. Her mother assisted her into a chair. She continued to be incoherent and have her eyes rolling back into her head for a few minutes. We used a cool cloth on her forehead and the back of her neck. The parents requested that we call 911. EMS arrived shortly and evaluated her. Heart rate, blood pressure, pulse ox, blood sugar and chest sounds were all within normal range. The patient stated that her arm felt heavy and "funny". She then stated that her tongue felt funny. EMS evaluated her tongue and said it looked normal. To err on the side of caution, she was taken to the hospital to determine whether or not she was having a delayed onset anaphylactic reaction. This patient has no history of seizures.
16 2021-05-12 excessive sleepiness Sore arm with rash/swelling at injection site, lasted a week. Fever and chills that evening through... Read more
Sore arm with rash/swelling at injection site, lasted a week. Fever and chills that evening through the night. Extreme fatigue, slept for 18 hours. Abnormal menstruation (spotting for 8 days prior to actual period, started 2 days after vaccine)
16 2021-05-13 anxiety, amnesia Adverse event: PT here for first dose of Pfizer COVID vaccine. PT reported feeling anxiety before va... Read more
Adverse event: PT here for first dose of Pfizer COVID vaccine. PT reported feeling anxiety before vaccination, but indicated that she was ready for her vaccination. Immediately post-vaccination, PT experienced an apparent vasovagal response, presenting with palor, slumped posture. PT's eyes were open, but PT was unresponsive and later reported no memory of events. PT became responsive within 2 minutes, but remained "shakey" and pale. RN was in attendance and provided initial assessment/response. RN also responded to PT. Aid was called at 1251 and EMTs arrived at 1253. Aid assessed PT, took vital signs (1256: BP 104/56 laying, HR 70, SPO2 98% on room air, 1303 BP 110/62 laying, HR 87, SPO2 99% RA, 1307: BP 96/58 sitting, SPO2 99%RA, 1311: BP 106/62 sitting, SPO2 99% RA). Treatment: PT was assisted to lay down on cot, water and juice were provided and consumed, cool compress were provided. Psychosocial support provided. Education to PT and mother to monitor for further s/s and to seek out urgent care if more were noted. Outcome: PT's color improved soon after laying down, PT reported "feeling better" after consuming juice and water. PT sat at edge of cot without difficulty, walked down hallway without difficulty. PT medically cleared by EMS at 1223, exited facility with mother in private vehicle.
16 2021-05-13 nervousness Right after patient received the vaccine she turned very pale and told the technician she felt light... Read more
Right after patient received the vaccine she turned very pale and told the technician she felt light headed. She remained seated in the room and closed her eyes a couple times but never appeared to lose consciousness. Her dad joined us in the room and confirmed she was really nervous before the vaccine. We kept her seated for several minutes and then she said she felt sick and vomited. After that she started to regain her color and was able to move to the waiting room. She sat there for about 5 more minutes and then felt well enough to leave with her dad.
16 2021-05-14 sleep disorder Child was complaining of pain and knot on the left side of her chest and her left shoulder and arm a... Read more
Child was complaining of pain and knot on the left side of her chest and her left shoulder and arm as well. Parent took child to the doctor on May 12, 2021 because the pain was unbearable. The doctor stated to the parent that she needs to consulted with the infections disease doctor to get his opinion on what it is and how to treat it. The infections disease doctor stated to the other doctor to treat it with antibiotics. The doctor wanted to do a follow-up with child in two to three days to see if the antibiotics is working. Childs follow-up is schedule for May 15, 2021. Child was saying that she cannot sleep on her left side because it hurts so much.
16 2021-05-15 anxiety Patient left vaccine site without waiting in observation with mother. Came back to site with report... Read more
Patient left vaccine site without waiting in observation with mother. Came back to site with reported palpitations and anxiety after going to Chik fila nearby. On arrival patient vitals 125/78 HR 85 regular O2 Sate 98% No signs of distress. Patient obviously anxious. Observed for 30 minutes and released with no treatment or transport. Released with Mother.
16 2021-05-15 confusional state Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic:... Read more
Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Systemic: Shakiness-Mild, Systemic: Weakness-Mild, Additional Details: Parademics/911 called, patient's parent refused transport to the hopsital. Patient waiting in recovery with NP and nurses, RPH to check
16 2021-05-15 nervousness Patient has a seizure history. Mother stated they have had numerous vaccines in the past without a ... Read more
Patient has a seizure history. Mother stated they have had numerous vaccines in the past without a problem though. Patient was waiting the period of time afterwards. Mother then stated she was having a reaction. Mother stated she is a nurse and said she believed the patient was having a seizure. Mother later was not sure if patient had fainted also since she was nervous about receiving the shot in the first place. After paramedics arrived, they took her glucose and was 77. Paramedics let mom then take patient home to get food.
16 2021-05-18 crying is a 16-year-old female patient admitted with tachycardia. Starting 1-1/2 weeks ago, mom notes that... Read more
is a 16-year-old female patient admitted with tachycardia. Starting 1-1/2 weeks ago, mom notes that she has had episodes where she feels her heart racing. It began 1-1/2 weeks ago with her crying and her watch that her heart rate was 208. They went to the ED, where she was given some fluids and her heart rate improved so she was sent home. She had had prior episodes of mild tachycardia up to the 140s in the past but which has always improved with fluids. Mom states that she used to have a lot of trouble maintaining her hydration and would not drink a lot of water. Since the last 1-1/2 weeks, she has been having these episodes 1-2 times a day that last about 1 to 2 minutes with a max of 5 minutes. When it comes on, she feels dizzy and lightheaded, and after the episode she feels a big rush of blood to her head. She also has some associated shortness of breath. She denies having any episodes of chest pain at all. She has never passed out, she has never felt like she was going to pass out, she has never felt like she was out of balance. She denies any nausea or vomiting during episodes. She denies any headaches during the episodes. She does have history of migraines, but has not had one in the last couple weeks. Her prior resting heart rate was in the 80s per her watch, and lately it has been in the 110s to 120s while awake in 80s while asleep. Along with the episodes, she also feels some pulsating sensation in her abdomen. She does not have any abdominal pain. Today, her heart rate was again in the 200s, but it was worse than before because it lasted about 30 minutes total. Lately they have been using an app that continuously monitors her heart rate. Since these episodes started, she has cut down on her caffeine intake and she has increased her water intake. Does not feel that this helped. She has never had syncope in the past and has never had seizures in the past. Patient was started on carvedilol which has helped control heart rate and was encouraged to drink fluids. Per primary care team, her current episode of tachycardia was not due to the vaccine.
16 2021-05-18 feeling abnormal 10 minutes after receiving vaccination, attendee had complaints of feeling "dizzy and fuzzy" and int... Read more
10 minutes after receiving vaccination, attendee had complaints of feeling "dizzy and fuzzy" and intermittently staring off into space. Parent,(mother), present at bedside and states staring off into space occasionally is a baseline behavior for attendee but 'seemed worse' at this time. Vital signs at 4:10pm: blood pressure 130/90, heart rate 124, temp 99F, respirations 22. Blood glucose 93. EMT present. At 4:20pm attendee assisted to lie down on cot. Paramedics called as attendee felt she should go to hospital. Attendee transferred to gurney at approximately 4:30pm and was looking at her phone and requesting her headphones and drink of water. Pt seemed more attentive and appeared in no acute distress. She was able to stand and move her legs to transfer to gurney. Attendee transferred to hospital via fire station vehicle at 4:40pm.
16 2021-05-19 amnesia The patient had a Vasovagal response. She had a 15 second seizure ,blood pressure dropped, was flus... Read more
The patient had a Vasovagal response. She had a 15 second seizure ,blood pressure dropped, was flush, tired and nauseated. She has no memory of the event.
16 2021-05-19 anxiety Fainted; Didn't know if it was a convulsion or a seizure; Shaking; was very anxious; This is a spont... Read more
Fainted; Didn't know if it was a convulsion or a seizure; Shaking; was very anxious; This is a spontaneous report from two contactable pharmacists. A 16-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0167, expiry date: Aug2021), via an unspecified route of administration, administered in the left deltoid, on 30Apr2021 15:30, as 1st dose, single, for COVID-19 immunisation, at a pharmacy/drug store. There were no medical history and concomitant medications. On 30Apr2021 15:30, the patient received the first dose of the COVID-19 vaccine and was very anxious. She wanted her mom to be present. On the same day, 30Apr2021 15:35, five minutes later, the patient was shaking, and she fainted. The reporter did not know if she was having a convulsion or a seizure. A few minutes later, the patient was sitting and becoming more alert. The patient was given water and one dose of Benadryl. The patient's vital signs were checked (unknown result). The reporter talked to the patient's mother and contacted the patient's pediatrician. The events resulted to emergency room and physician's office visits. Later in the evening, the reporter followed up with the mother and she confirmed that the patient was doing well and better. The mother asked the reporter if the patient should get the second dose of the COVID-19 vaccine. The outcome of the events fainted, shaking, "didn't know if it was a convulsion or a seizure" and "was very anxious" was recovering. The reporter assessed the events fainted, shaking, "didn't know if it was a convulsion or a seizure" as serious (medically significant). The reporter considered that BNT162B2 has a causal effect to the adverse events. Follow-up (18May2021: New information received from a contactable pharmacist includes: reporter information, lab data, suspect drug details (vaccination site and vaccination time), event details (onset time provided, outcome updated to recovering, causality and seriousness assessment provided). Follow up attempts are completed. No further information is expected.; Sender's Comments: Based on the available information, and on a reportedly closed temporal association, the company assessed that a reasonable possibility could not be excluded that the reported events (fainted; didn't know if it was a convulsion or a seizure) were related to the suspect product BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE). 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.
16 2021-05-21 feeling abnormal, insomnia I am her mother reporting and also an RN. She rarely complains of symptoms whenever I?ll. C/O 12 h... Read more
I am her mother reporting and also an RN. She rarely complains of symptoms whenever I?ll. C/O 12 hours post vaccination began feeling of throat closing- able to breath ok/safely but short of breath (O2 says 99% HR 60?s - WNL), feeling floaty and light- as if not on ground, body feels tingling and numb, difficulty sleeping, right pupil dilated greater than left but both pupils reacted to light appropriately with check. Pupil over dilation one side resolved by next morning. Other symptoms still continue. Other SE?s are common: HA, low grade fever 100.9, body aches. Currently 33.5 hours post vaccination at submission. Pfizer #1 on 4/30/21 Lot# EW0173 Pfizer #2 of 5/21/21. Lot# EW0187
16 2021-05-21 feeling abnormal Patient received the vaccine at 4:00p. Her mother called us over at 4:05 as Shaelynn was feeling "we... Read more
Patient received the vaccine at 4:00p. Her mother called us over at 4:05 as Shaelynn was feeling "weird". She began to itch and cough, apparently trying to throw up, felt her throat was itching and swollen. She stated she couldn't swallow and was having a hard time breathing (although she was breathing). We administered an Epi Pen 0.3mg (only one) and called 911. Patient was transported to the hospital by ambulance.
16 2021-05-22 sleep disorder Pfizer-BioNTech COVID-19 Vaccine EUA I woke up at about 4:30 AM and couldn?t fall back asleep, I kep... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA I woke up at about 4:30 AM and couldn?t fall back asleep, I kept feeling sleepy until I would get jolted back awake over and over. My joints were hurting, I had somewhat severe nausea, my head started throbbing. At about 6:40 AM my migraine started, my arm felt hot to the touch, and I got dizzy so I took some acetaminophen. At 10:00 PM I noticed the area under my left armpit was a little swollen and really sore, my throat and right tonsil was also sore and it hurt to swallow. The next day (today) I have another migraine, my throat and left armpit are still sore, and my muscles hurt. I?m getting better though.
16 2021-05-24 anxiety Faint, anxious, clammy Vital Signs: BP 85/60 HR 72 Resp 18 O2Sat 98 Skin Signs: Clammy Circulatio... Read more
Faint, anxious, clammy Vital Signs: BP 85/60 HR 72 Resp 18 O2Sat 98 Skin Signs: Clammy Circulation: Cap refill <2sec Respiratory: Breath sound clear bilaterally Initial Treatment: Brought to triage and assisted to supine, Hx of anxiety 12:43 PM Vital Signs: BP 97/61 HR 68 Resp 16 O2Sat 98 Skin Signs: Warm and dry Circulation: Cap refill <1sec Respiratory: Breath sound clear bilaterally Vital Signs: HR 79 Resp 16 O2Sat 99 Skin Signs: Warm and dry Circulation: Cap refill <1sec Respiratory: Breath sound clear bilaterally Notes: Physician advised patient to seek further medical treatment should symptoms return or worsen. Home with parent.
16 2021-05-27 feeling abnormal The patient was previously well then shortly after the first COVID vaccine she began experiencing fa... Read more
The patient was previously well then shortly after the first COVID vaccine she began experiencing fatigue slowing to her swim times ( she is an high level swimmer) and felt "Off". She presented to my office on May 6, 2021 three days after her second COVID vaccine I examined her and heard a slight hint of a wheeze and in addition to labs did a CXR which was Abnormal with evidence of a LLL consolidation and a pleural effusion. We then did a CT scan with contrast and started her on antibiotics and I called Pulmonology to get her in quickly since swimming trials were approaching and we had to do our best to get her in shape to compete. We also did a rapid COVID test which was negative at my office on May 7, 2021-- The pediatric pulmonologist repeated the CXR 5 days later and there was more fluid and she was now having more sx of cough and feeling worse so she was Admitted to the Hospital on May 11th and had a Chest tube placed and drained 950 cc of serous fluid . Pulmonology, oncology and rheumatology consulted to rule out various other causes of the pleural fluid in an otherwise healthy girl. Surgery did the procedure and followed up outpt. She was in the hospital for approximately 4 days. Proximity of sx onset to doses and other sources being essentially ruled out lead to concern for vaccine complication.
16 2021-05-28 delirium delerium; Severe myalgia; full body rash; swollen legs; facial swelling; slurred speech; stomach pai... Read more
delerium; Severe myalgia; full body rash; swollen legs; facial swelling; slurred speech; stomach pain and cramping; nausea; headache; injection for vaccine received same date; injection for vaccine received same date; injection for vaccine received same date; This is a spontaneous report from a contactable consumer (patient). A 16-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in left arm on 15Apr2021 (Lot Number: EP7533, at the age of 16-year-old) as single dose, and second dose via an unspecified route of administration, administered in right arm on 15Apr2021 (Lot Number: EW0171, at the age of 16-year-old) as single dose for covid-19 immunization. Medical history included post streptococcal reactive arthritis and bee sting allergy. The patient's concomitant medications were not reported. On 16Apr2021, the patient experienced severe myalgia, full body rash, swollen legs, facial swelling, slurred speech, delerium, stomach pain and cramping, nausea, headache. Headache and stomach pain have lasted 7 days. Rash and myalgia lasted 5 days. Delerium, facial swelling, leg swelling and slurred speech lasted 12-24 hours and were relieved by Benedryl. The treatment for the event included Ibuprofen, Acetaminophen, diphenhydramine. The injection for vaccine received same date on 15Apr2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient was not pregnant. The outcome of the events severe myalgia and full body rash was recovered on 21Apr2021, for events stomach pain and cramping and headache was recovered on 23Apr2021, for other events delirium, swollen legs, facial swelling, slurred speech, nausea was recovering.
16 2021-05-28 impaired work ability Fever 37.5C, fatigue, headache, swollen lymph nodes, back of the neck pain, stomach ache, pale compl... Read more
Fever 37.5C, fatigue, headache, swollen lymph nodes, back of the neck pain, stomach ache, pale complexion. Missed school, stayed in bed at home until symptoms resolved.
16 2021-05-30 anxiety 5/31/21 10:50a vaccine administered. Pt anxious and feel like vomiting. Pt vomited. Pt didn't eat br... Read more
5/31/21 10:50a vaccine administered. Pt anxious and feel like vomiting. Pt vomited. Pt didn't eat breakfast. Pt reported felt clamish. Pt then felt like she will move her bowel. Pt escorted to washroom and had diarrhea. 11:07a pt had a bowel movement. Pt was monitored and after drinking orange juice felt better. 11:19a Pt felt better and left with Mom and Grandmother.
16 2021-05-31 feeling abnormal, crying At 15:05 voiced complaints of feeling tired and dizzy. Crying and scared. Her mother was in attendan... Read more
At 15:05 voiced complaints of feeling tired and dizzy. Crying and scared. Her mother was in attendance. They gave her some orange juice. No tachypnea or dyspnea. Skin warm and dry. 15:10 – Attendee stated that she "felt funny". Attendee assisted to the cot and given orange juice. 15:13 - HR: 78 BP: 120/80 O2Sat%: 99. 15:16 –Water given 15:20 -No voiced complaints- skin warm and dry. Attempted to sit her up and she reported dizziness, so she laid back down. HR: 75 BP: 110/70 O2Sat%: 100 Temperature 98.7 15:25 – Sat up on cot the and dangled her legs without dizziness 15:26 – Assisted to a chair and denies feeling funny or dizzy. 15:30 - discharged to home with her parents
16 2021-05-31 sleep disorder Syncope x 3 in the early morning hours (around 3am) about 14-15 hours after vaccine. She had had hea... Read more
Syncope x 3 in the early morning hours (around 3am) about 14-15 hours after vaccine. She had had headaches that is intermittent, throbbing, phonophobia but no photophobia, from back of head to top of head and behind eyes, taking Advil or Excedrin intermittently with relief for a week prior to covid19 vaccine. Syncope, longest lapse was two minutes, her sister found her. She went to Medical Center ER at 0400, was assessed and scanned, neg CT scan of head, and was discharged home. Has felt some fatigue today due to not sleeping early the night before, has returned to school since concussion, with normal learning, and denies any exertional physical activity due to pre-existing torn ACL, torn medial meniscus L knee. After evaluation by ER, was given IV fluids, determined cause to be dehydration.
16 2021-06-01 crying, abnormal behaviour At about 3pm on 05-01-2021, my daughter started acting crazy. She does have a history of leukemia wh... Read more
At about 3pm on 05-01-2021, my daughter started acting crazy. She does have a history of leukemia which was treated 07-03-2020. She has history of neurological problems from chemotherapy. She also has down syndrome. She has headaches since the vaccine. She is non speaking, non-verbal. After her Pfizer vaccine, my daughter repeat things over and over, at night she cries, moves her hands a lot, yells when she is at school. My daughter did not have a fever, body aches after her vaccine. I feed her, bathe her and take care of her and since receiving the Pfizer vaccine she is not the same person. Before the vaccine, my daughter was sociable, respected, educated but since the vaccine she has been out of control and acting crazy. My daughter received the Pfizer vaccine at a clinic and the doctors there said that she should not get the second dose. At this time, my daughter is scheduled for an MRI appointment on 06-18-2021.
16 2021-06-01 feeling abnormal Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Chills-Mild, Systemic: Dizziness / Lighthea... Read more
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: blurry vision-Mild, Systemic: Shakiness-Mild, Systemic: Weakness-Mild, Additional Details: Patient reported leg weakness and blurred vision and dizziness/slight difficulty breathing upon getting ready to leave observation area. Said she hadn't eaten in a while and felt cold due to A/C in the store as well. BP was low and HR high, so called 911 to get her emergency help as she didn't feel like she could walk out of store safely. Felt strange and that her legs might give way. EMS arrived, vitals looked good, pt refused ambulance.
16 2021-06-02 memory impairment atient was in for 2nd covid-19 (Pfizer lot was EW0167, exp 8/31/2021): It was her and her brother r... Read more
atient was in for 2nd covid-19 (Pfizer lot was EW0167, exp 8/31/2021): It was her and her brother receiving the vaccine. Brother went first and was fine. She was second. After receiving the vaccine (~30-60sec) she appeared to lose conciseness (not sure if complete or partial) she said she didn't remember all of it, but it was more like a dream. During that she had some twitches/spams (involving circular motions with her arms and leg, leg extended and then retracted, but her head rolled back). Upon coming out/waking she appeared sensitive to light and was nauseous. Left her in the room with her mom to get an ice pack, water, paper towel. Total episode lasted less than a minute, but took about 10-15 minutes (estimate, unsure of full time spent) before she felt good enough to use a wheelchair and get in her mom's car to drive home.
16 2021-06-02 nervousness This young lady was at the school to receive her second dose of the Pfizer vaccine, she answered all... Read more
This young lady was at the school to receive her second dose of the Pfizer vaccine, she answered all the questions with a No answer, she stated she was feeling well and had minimal reaction to first vaccine. She appeared to be nervous as reported by the nurse. after recieving her second shot, as the nurse was finishing up paperwork and filling out card, the student felt like passing out, one of the other nurses that were at her side, caught her as she fainted out of chair, she was placed on the ground and EMS was called at 10:10 and Nursing Supervisor was notified at 10:15. EMS determined she had a Vasovagal Syncope. EMS attended to patient and it was unknown if she was released after observation or taken to ED for further evaluation. a field emergency record was recorded and return to the nursing supervisor at the health department.
16 2021-06-03 disturbance in attention 5/28 - swelling of right eyelid, 5/30 - swelling of left eyelid, burning eye pain, itchy, felt dizzy... Read more
5/28 - swelling of right eyelid, 5/30 - swelling of left eyelid, burning eye pain, itchy, felt dizzy, trouble focusing, fatigue
16 2021-06-06 anxiety My daughter experienced fatigue, GI issues, heart racing, anxiety, jittery (these are signs that her... Read more
My daughter experienced fatigue, GI issues, heart racing, anxiety, jittery (these are signs that her thyroid is not working). All her thyroid issues were off, her TSH value was up to 6. My daughter still has her symptoms of anxiety, GI issues and anxiety.
16 2021-06-07 confusional state Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat T... Read more
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Chills-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Severe, Systemic: Hypertension-Medium, Systemic: Shakiness-Severe, Systemic: Tachycardia-Medium, Systemic: Visual Changes/Disturbances-Severe, Systemic: Weakness-Severe, Additional Details: Patient appeared weak, pale, sweaty, shaky about 5 minutes after the first dose was given to her. She complained of visual disturbances and progressive shortness of breath. Stated her throat felt a little tight but was not experiencing and swelling of of any parts of her face. She then complained of an intense headache that was getting worse. Patient was admitted to the hospital to make sure she was ok.
16 2021-06-08 sleep disorder Patient's period started, as expected one week after her vaccine, but was much heavier than normal. ... Read more
Patient's period started, as expected one week after her vaccine, but was much heavier than normal. After that period ended, she got her period again on June 7th with incredibly heavy bleeding and painful cramping (the cramping was so bad it had her up all night June 8th). The second period is a total surprise given the she is taking her birth control regularly. Also the heavy bleeding and extreme cramping is not normal for her on her birth control.
16 2021-06-09 confusional state Mom stated that patient reported she did not feel well about 6:30 pm (the same evening). She then sa... Read more
Mom stated that patient reported she did not feel well about 6:30 pm (the same evening). She then sat down, eyes rolled back in her head, speech was slurred and finally, became unresponsive for about 10 seconds. She was sweating uncontrollably, had a temperature of 99.1 F. afterwards. After she came to, she reported that she couldn't hear, eyesight became blurry just prior to incident. Mom stated that she was a little confused. Had some bottled water and felt better. Mom states that today (6/10), she is feeling better. She did not take any medications at that time. (The vaccine clinic was held as a drive-through, with people remaining in their cars). The weather was very warm. Unknown what activities patient was engaging in the rest of the day.
16 2021-06-10 anxiety anxiety, fainting was able to drink water, was not unconscious
16 2021-06-10 confusional state, disorientation, amnesia Pt. received COVID-19 vaccine on 06/05/21 and developed a mild fever on 06/06/21, but had not had a ... Read more
Pt. received COVID-19 vaccine on 06/05/21 and developed a mild fever on 06/06/21, but had not had a fever since that day when coming to the ED on 06/10/21. On 06/07/21 while the pt. was at school pt. became dizzy and pupils dilated. Pt. was picked up from school and rested for 3 hours and she did not remember how she got home or how she got to the school nurse..Pt.in ED for similar symptoms 6/7/21 and 6/9/21 before coming again on 06/10/21 with a negative work up. Pt. has been on school zoom meetings and has been looking at pillows and thinking they are people and they were moving and talking to her. Pt. walking into walls, trouble walking and intermittent confusion and multiple episodes of conversations that she does not recall and time periods which she can not remember. Pt. was transferred to a higher level of care in another facility.
16 2021-06-12 anxiety, panic attack EVENT: 5 minutes after receiving 2nd Pfizer vaccine, patient reported she wasn't feeling good. she w... Read more
EVENT: 5 minutes after receiving 2nd Pfizer vaccine, patient reported she wasn't feeling good. she was already seated, so we had her bend forward with her head between her knees. That wasn't providing enough relief so we had her grip fingers into a fist and tense her arms. Got the patient cool water bottle to put on her neck. After approximately 2 minutes, patient was recovering and drank some water. She sat up again and her eyes started to lose focus and she said her ears were ringing. Had her put her head back down. She was too unstable to have lie down on the floor so we had her elevate her legs on another chair. Syncope symptoms resolved but patient said she was starting to have what she believed was a panic attack. Tried to have patient list 5 things she could see, hear, etc, but she was too anxious to do so. Asked patient about school/summer break and she started to relax. After 15 minutes of additional observation, patient was able to stand by herself. Guardian walked with her through the store for a few minutes before leaving.
16 2021-06-13 confusional state Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsiv... Read more
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Mild, Systemic: Nausea-Mild, Systemic: Tinnitus-Medium, Systemic: Weakness-Medium
16 2021-06-16 anxiety, insomnia Not being able to sleep well, shaking at night, anxious, not eating well 2 days after getting the va... Read more
Not being able to sleep well, shaking at night, anxious, not eating well 2 days after getting the vaccine
16 2021-06-16 feeling abnormal felt exhausted; Blood pressure low, after the seizure: 73/49 and 68/42; skin pale and sweating, afte... Read more
felt exhausted; Blood pressure low, after the seizure: 73/49 and 68/42; skin pale and sweating, after the first vaccine; skin pale and sweating, after the first vaccine; Tired and weak, with some lightheadedness, after the first vaccine; Tired and weak, with some lightheadedness, after the first vaccine; Seizure: described as staring, passing out, stiffening of arms, talking like a toddler and giddy, after the first vaccine.; Seizure: described as staring, passing out, stiffening of arms, talking like a toddler and giddy, after the first vaccine.; Seizure: described as staring, passing out, stiffening of arms, talking like a toddler and giddy, after the first vaccine.; Seizure: described as staring, passing out, stiffening of arms, talking like a toddler and giddy, after the first vaccine.; Seizure: described as staring, passing out, stiffening of arms, talking like a toddler and giddy, after the first vaccine.; felt funny; This is a spontaneous report from a contactable consumer(mother, a nursing assistant, years ago) reported for a patient(daughter). The 16-year-old female patient received bnt162b2 (BNT162B2, Pfizer vaccination, Covid vaccine) at the age of 16-year-old, dose 1 via an unspecified route of administration, administered in Arm Left on 28May2021 11:52 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. Medical history included seizure from 28May2021 to an unknown date (doctor wants to schedule an EEG, for further evaluation of the seizure ,because they did not do that test in the hospital.), ongoing Feels down at times (Consumer states the doctor originally prescribed her daughter another medication. Because all the appointments were by video, Consumer felt the doctor was not understanding her daughter's issue. Consumer states the original medication for ADHD was helping her daughter, but it made her daughter uncomfortable, as her daughter had no problems with attention, or school. Caller states then the doctor changed the medication to Zoloft. Name of previous medication was Zenzedi.). No family Medical History. Concomitant medication included sertraline hydrochloride (ZOLOFT) taken for depressed mood from 19May2021 and ongoing. Consumer states that her daughter is not depressed, but just feels down at times, and it is not severe. Consumer states the doctor had her daughter on another medication before Zoloft, that is used for ADHD. Consumer states that her daughter has not been diagnosed with ADHD, and the doctor switched the medication once her issues were further understood, as clarified in later part of report. The patient experienced seizure: described as staring, passing out, stiffening of arms, talking like a toddler and giddy, after the first vaccine on 28May2021 with outcome of recovered, felt funny on 28May2021 with outcome of recovered , blood pressure low, after the seizure: 73/49 and 68/42 on 28May2021 11:52 with outcome of recovered , skin pale and sweating, after the first vaccine on 28May2021 with outcome of recovered , skin pale and sweating, after the first vaccine on 28May2021 with outcome of recovered, tired and weak, with some lightheadedness, after the first vaccine on 28May2021 with outcome of unknown, tired and weak, with some lightheadedness, after the first vaccine on 28May2021 with outcome of unknown, felt exhausted on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included blood pressure measurement: 73/49 on 28May2021 low , blood pressure measurement: 68/42 on 28May2021 low , blood pressure measurement: normal on 28May2021, heart rate: 55 on 28May2021, heart rate: 70 on 28May2021. The clinical course was reported as follows: Consumer states she took her daughter Friday, to have her first Pfizer vaccination, later reclarified as the Covid vaccine. Consumer states her daughter had a seizure after the vaccine. Consumer states Height maybe 5'8" or 5'9". Consumer states her daughter was weighed at the hospital. Consumer states that the experience was terrifying for her, to watch her daughter have the seizure. Consumer states her husband got the vaccine, and was fine. Consumer reports that her daughter got the vaccine at 11:52 am and within 30 seconds, her daughter said she felt funny, and then rolled her eyes and passed out. Consumer states after a minute, her daughter was conscious and the staff was rushing to her aid, as the Consumer called 911. Consumer states that for the next 25 to 30 minutes, her daughter was talking like a toddler, and was pale and sweating. Consumer states that the paramedics, told her daughter that she had a seizure, as they took her to the hospital. Consumer reports her daughters blood pressure, around the time of the event. Consumer states the first blood pressure, when her daughter awakened, after the seizure about 2 minutes later was 73/49, pulse 55, and a few minutes after that it was 68/42 and her pulse was 70. Seizure: Time: 11:52 am, almost immediately after the vaccine. Outcome: caller answers as she is monitoring her daughter closely. Consumer states that during her seizure, her daughter started to stare, and then passed out. Consumer states her daughter did have some stiffening of the arms with the seizure. Blood pressure low: Consumer states he daughter's blood pressure, began to elevate, before they transported her to the emergency room. Time: 11:52 am, almost immediately after the vaccine. Outcome: Consumer answers as her daughter's blood pressure was stabilized enough by the time she was transferred to the hospital, where it normalized. Consumer reports later that her daughter's skin was pale and she was sweating, at this time. Reclarified, Consumer states that when her daughter was talking to the medical staff, she was talking like a toddler, and giddy. Consumer states she was trying to tell the staff that this is not normal for her daughter. Consumer reports her daughter feels tired and weak after all the events. Consumer states she signed up for VSafe. Time: Consumer states sometime, after the vaccine. End: Consumer answers as her daughter is not as tired and weak, as she was the first day the event happened. Caller states that the next day, her daughter relaxed all day, and the day after that, her daughter went to work and felt exhausted, but felt that she could still go to work. Consumer states that yesterday at work, her daughter said she felt weak, and lightheaded. Consumer states that after having a snack and a break, her daughter felt better and worked the rest of her shift. Outcome: Unknown. Reclarified, Caller states she does not want to assume anything, and is monitoring her daughter, and that this event may be due to another reason, as well. Consumer clarifies her daughter went to the emergency room and then was released. Vaccination Facility Type was pharmacy. No Vaccine Administered at Military Facility. No History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available).No additional Vaccines Administered on Same Date of the Pfizer Suspect. The event Seizure required a visit to Emergency Room, not Physician Office. Prior Vaccinations (within 4 weeks), list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine was none. No AE(s) following prior vaccinations. Caller reports some prior vaccinations that her daughter had without any events. Consumer states that her daughter is not going to get the second vaccination. Consumer states that she does not know the potential risk, if her daughter gets another vaccination. Information about lot/batch number has been requested.
16 2021-06-17 excessive sleepiness Dose 1 (box 11) Pain injection site, reaction to previous exposure to vaccine Dose 2 sleep excessive... Read more
Dose 1 (box 11) Pain injection site, reaction to previous exposure to vaccine Dose 2 sleep excessive, nausea, headache, feeling unwell, injection site induration, injection site pain
16 2021-06-18 disorientation 1604: 1st dose Pfizer vaccine administered 1609: Syncope episode- Client appeared limp and sliding o... Read more
1604: 1st dose Pfizer vaccine administered 1609: Syncope episode- Client appeared limp and sliding out of chair. Pallor appearance. NP and MA witnessed event and placed client on floor before she fell out of chair. Did not hit head. Feet were immediately raised. Client was vocal but disorientated. ice packs used. Client A&Ox4 within seconds. Gatorade and water offered. 1611: BP: 122/ 68 HR: 94 RR: 18. After syncope episode, mother stated that client has history of vasovagal syncope with needles. Client still laying on floor with feet raised. NP sitting on floor with client and her mother for observation. 1645-Instructed mother to follow up with pediatrician. Complexion returned to normal. Client stated that she feels fine. Mother and client left site without no further incidents.
16 2021-06-19 feeling abnormal Approximately 20 minutes after vaccine patient passed out, became pale and sweaty. She lost consciou... Read more
Approximately 20 minutes after vaccine patient passed out, became pale and sweaty. She lost consciousness briefly. I put her in a supine position on some chairs in waiting area. A technician called 911 while cool towels were applied and water was administered. She regained consciousness before EMTs arrived. She relayed while her that she disliked needles and did not eat breakfast that day.
16 2021-06-26 incoherent 18 hours after the 1st vaccine shot... healthy female while in the shower....blacked out, couldn't ... Read more
18 hours after the 1st vaccine shot... healthy female while in the shower....blacked out, couldn't see, called for mother who she knew was not home, passed out, and was not coherent, felt dizzy, had a bad headache, and face was swollen, Called her doctor's office, told them about the vaccine and the incident, they said to go to the emergency room. Went to emergency room. She had a full list of tests. Was given a saline drip, hydration unit. Level V emergency code. Name vasovagal syncope, reaction to vaccine, electrolyte abnormalities, dehydration, dysthymia
16 2021-07-04 feeling abnormal, confusional state, disturbance in attention Otherwise healthy 16 yo female developed brain fog, confusion, visual disturbances, inability to foc... Read more
Otherwise healthy 16 yo female developed brain fog, confusion, visual disturbances, inability to focus, and somnolescence approximately 2 weeks after 2nd Pfizer covid-19 vaccine. Given persistence of symptoms with no improvement, patient was taken to the ER to rule out any acute brain hemorrhage or pathology on May 31, 2021. Subsequent work-up revealed normal MRI findings, a positive ANA of 1:320, and a high positive RNP antibody. Patient was subsequently seen bu Rheumatology on June 3rd and subsequent work-up and findings were consisted with a diagnosis of Mixed Connective Tissue Disease. Patient as of today is still symptomatic and is taking Prednisone 15 mg po qd and Hydroxychloroquine 200 mg po bid and vitamin d3 supplement 50,000 u q week.
16 2021-07-10 depression No adverse effects after 1st shot. On Friday approximately 6 hours after 2nd shot at approximately ... Read more
No adverse effects after 1st shot. On Friday approximately 6 hours after 2nd shot at approximately 9pm CST, daughter started feeling depressed, body aches, lethargic. Saturday morning still not feeling well. Saturday afternoon she took about a 3 hour nap, felt 90% better. By Saturday evening, she was 100%.
16 2021-07-17 abnormal behaviour About 1 minute, or so, after her daughter received her COVID-19 Vaccine injection, her daughter pass... Read more
About 1 minute, or so, after her daughter received her COVID-19 Vaccine injection, her daughter passed out, and ended up in the ER; She said her daughter vomited twice after she passed out, and then vomited again in the Emergency Room; It was not normal for her daughter to gurgle like she was; Her daughter wet herself, clarifying her daughter involuntarily voided when she passed out.; Her daughter bit her lip really hard when she passed out; Her daughter had a really bad headache; Her daughter said she heard a nurse say as she was coming to that she was only breathing 6 breathes per minute; When her daughter received her 1st COVID-19 Vaccine, her daughter arched her back, and her daughter's arms drew in.; Her daughter may have been a little tired after getting her first COVID-19 Vaccine, but no more than normal; Her daughter said her throat was sore afterward (vomiting); This is a spontaneous report from a contactable Nurse. This Nurse (patients mother) reported for a female age 16 years old patient (reporters daughter) that patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number was EW0168), via unspecified route in right arm on 24Jun2021 13:21 as single dose for COVID-19 immunization. The patient medical history included mild asthma for a good 10 years. She did not even use an inhaler for the mild asthma, and the last time she used a rescue inhaler was in the last couple years and Dermatographia from 05Aug2020 and was ongoing she could be allergic to something, and then down the road, whether it be a few months or a few years, would not be allergic to it anymore. She had passed out from blood draws in the past, but that she would come to a few seconds afterwards. She would never get upset when she had blood draws. The patient concomitant medication included Cetirizine hydrochloride (ZYRTEC). On 24Jun2021 patient experienced for About 1 minute, or so, after she received her COVID-19 Vaccine injection, she passed out, and ended up in the Emergency Room and she vomited twice after, and then vomited again in the Emergency Room. It was not normal for her to gurgle like she was. She involuntarily voided and she bit her lip really hard when she passed out. She had a really bad headache. She heard a nurse say as she was coming to that she was only breathing 6 breathes per minute. When her daughter received her 1st COVID-19 Vaccine, she arched her back, and her daughter arms drew in. She might had been a little tired after getting her first COVID-19 Vaccine, but no more than normal and her throat was sore afterward. Patient was not given any treatment at the COVID-19 Vaccine facility but was taken by ambulance to the Emergency Room and the Emergency Room gave her daughter an Ativan 0.5mg tablet and placed an IV in her. An emergency Room ran an IV infusion of 999ml of Sodium Chloride 0.9%. On 24Jun2021 patient did an EKG, chest x-ray, urinalysis, and blood work and results of EKG, chest x-ray, urinalysis, and CBC were normal, but electrolytes were a little low. She had followed-up with her pediatrician after her Emergency Room visit. pediatrician scheduled an EEG for her daughter on 28Jul2021 because of her daughter losing her bladder control, and other things that happened when her daughter passed out. The outcome of event (sore throat, Fatigue) was unknown, event of (Passed out and bite wound) was unknown and event of (Dyskinesia, Respiratory rate decreased, Urinary incontinence and Abnormal behavior) was recovered on an unspecified date 2021 and event of (headache) was recovered on 25Jun2021.
16 2021-07-17 insomnia, anxiety full of anxiety; sleep deprived; unsure of herself; This is a spontaneous report from a contactable ... Read more
full of anxiety; sleep deprived; unsure of herself; This is a spontaneous report from a contactable consumer or other non hcp and from a Pfizer sponsored program Pfizer . A 16-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on Apr2021 as dose number unknown, single (age at vaccination 16-year-old) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced full of anxiety, sleep deprived, unsure of herself on an unspecified date. It was reported that, reporters 16-year-old daughter got the Pfizer vaccine in Apr2021 and ended up in the psyche ward for two weeks. Before the vaccine, she was a normal healthy teen. Now she is full of anxiety, sleep deprived and unsure of herself. Please look into the effects of the vaccine on teenagers and help us deal with this crisis. The clinical outcome for all events was unknown. Information on the lot/batch number has been requested.
16 2021-07-17 insomnia Severe nausea; Severe headache; Dizziness; can't sleep; This is a spontaneous report from a contacta... Read more
Severe nausea; Severe headache; Dizziness; can't sleep; This is a spontaneous report from a contactable consumer (parent reporting for daughter). A 16-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration in left arm on 23Jun2021 10:00 as dose 2, single (at the age of 16-years-old) for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was reported as Doctor office/urgent care. Patient did not receive any other vaccines within 4 weeks, prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior to vaccination. Patient has not been tested for COVID-19, since the vaccination. Patient medical history included depression and exercise asthma. Patient had no known allergies. The concomitant medications included lithium, venlafaxine hydrochloride (EFFEXOR), mirtazapine. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration in left arm as dose 1, single for COVID-19 immunization. On 23Jun2021, several hours after the vaccine she was complaining of severe nausea, headache and dizziness. She also reported she could not sleep, even after taking Advil pm. We have not yet sought treatment but may if this continues or worsens. 3 of the 4 of her kids were reporting similar symptoms although 2 are effected much more. The reported case seriousness was non-serious. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Mother was unsure if they will go to the ER or urgent care. It was unknown if any treatment was received for the events nausea, dizziness and headache. The outcome of the events was not recovered. Information about lot/batch number has been requested.
16 2021-07-21 confusional state Patient received the dose at 5:15pm. I was alerted by father at 5:25 that she was not feeling well. ... Read more
Patient received the dose at 5:15pm. I was alerted by father at 5:25 that she was not feeling well. I went to check on her and she had lost consciousness in her father's arms. I told the technician to call 911 at retrieved and epipen. I opened the epipen and checked the patient for response. She woke up and appeared very weak and confused. She responded that she could breathe. The epipen was not administered. EMS arrived and checked for vitals. Vitals were within normal range. The father decline transportation for further care. She remained sitting until 5:50 pm and she left on her own power with her family.
16 2021-07-22 nervousness Vaccine administered to left deltoid at 1836. Client was in Vaccination room with mother and brother... Read more
Vaccine administered to left deltoid at 1836. Client was in Vaccination room with mother and brother, reported to Vaccinator history of fainting and anxiety with blood draws and vaccinations. Vaccinator placed client in anti gravity chair prior to vaccination. Client stated she was nervous. Vaccinator alerted RN's that client is complaining of dizziness shortly after. RN arrived to client at 1840, client alert and oriented x4, sitting Semi-fowler's in gravity chair. Vitals at 1843: blood pressure 146/93, pulse 97, oxygen 99%. Client reported history of fainting and anxiety with prior blood draws and vaccines but reports no other medical history, no current medications and no known allergies. RN assessed for headache, nausea, and blurry vision, patient denied and reported no other symptoms. RN gave client water and client drank slowly. RN's stayed with client for the remaining observation time. Vitals at 1850: blood pressure 125/96, pulse 73, oxygen 99%. Per client Dizziness improved and feeling better, at 1852 client was positioned to upright position in gravity chair with no complaints. Vitals at 1855: Blood pressure 126/90, pulse 95, oxygen 99%. Client reported dizziness has resolved and reported no other symptoms, client was able to safely stand from chair. Per mother and client, did not want to stay the full 30 minute observation. RN educated client and mother of ER precautions and following up with medical provider. Client left facility with mother and brother at 1857 with steady gait.
16 2021-07-24 feeling abnormal Patient felt uneasy and fainted shortly after dose. Her mother caught her from falling. She remained... Read more
Patient felt uneasy and fainted shortly after dose. Her mother caught her from falling. She remained unresponsive for 1 hour. She was breathing, 911 was called. Blood pressure, breathing, pulse normal.
16 2021-07-28 crying, confusional state Per witness, patient was sitting in the waiting room post vaccination w/ Pfizer vaccine. Patient's m... Read more
Per witness, patient was sitting in the waiting room post vaccination w/ Pfizer vaccine. Patient's mother got up and walked to counter to make 2nd dose appt. Patient started leaning over in chair and fell to the floor (witness reports patient bumped head). Per witness, mother ran to patient's side. This writer heard someone call for help. This writer was in the back assisting with immunization clinic. Patient was observed lying on the floor w/ mother at her side. Patient appeared confused and was actively trying to sit upright. This writer and patient's mother explained that she had experienced a vasovagal reaction after her COVID-19 vaccine. Patient was instructed to stay in lying position while vital signs were obtained. Patient was able to verbalize name, DOB, and place. Vital signs at 1040 (BP 98/55, HR 61, O2 98% on room air). Patient was diaphoretic and pale. Patient reported eating breakfast this morning. Patient was observed crying stating "I feel like I can't breathe." This writer continued to monitor vital signs (BP 120/72, HR 77, O2 99% on room air). Staff placed several ice packs on patient. She complained of headache and told staff that her head hurt. Mother of patient requested EMS to be called. Staff called EMS. Vital signs at 1050 (BP 101/64, HR 92, O2 98% on room air). Patient reported feeling better and was able to move to sitting upright position on the floor. Patient appeared less diaphoretic and color was returning to normal. Patient was moved to wheelchair w/ assistance from staff. Patient was provided with water and crackers. EMS arrived to the facility at 1050. EMS evaluated patient, but patient declined to be transported. V/S stable. Patient reports history of passing out unrelated to vaccine administration. Staff explained that mother/patient need to inform staff w/ the 2nd dose of vasovagal hx, so patient can receive vaccine lying down. Staff provided mother w/ concussion education and explained what S/S would indicate a need to go to the ER. Patient was also encouraged to f/u with pediatrician. Patient was taken out to car via wheelchair by staff at 1100.
17 2021-03-04 feeling abnormal Patient started to feel strange within 1 minute of receiving the vaccine. Within 5 minutes of recei... Read more
Patient started to feel strange within 1 minute of receiving the vaccine. Within 5 minutes of receiving the vaccine, patient felt very faint, dizzy, nauseous, tingly, lost feeling in lower body, blurry vision, and started shaking. EMS was called at vaccination site. EMS arrived about 5 minutes later and took patient's blood pressure. First reading was 102/70, second reading a few minutes later was 108/76. By that time, patient could sit up and was alert and oriented. Patient never lost consciousness. Patient was not taken to the ER. Patient remained on-site for another 45 minutes until symptoms resolved enough that she felt it was safe to leave. Patient has not had a reaction to vaccines or other medical treatment in the past.
17 2021-03-07 anxiety Flushing, sweating, anxious, tingling in ears, nausea, blurry vision. Vitals within normal limits. P... Read more
Flushing, sweating, anxious, tingling in ears, nausea, blurry vision. Vitals within normal limits. Patient stabilized.
17 2021-03-11 impaired work ability A few hours after I had chills and a really bad body ache. I could barely move without hurting. I co... Read more
A few hours after I had chills and a really bad body ache. I could barely move without hurting. I couldn't go to work. I had a low grade fever. Tylenol helped. It was better after the second day. For the second dose the symptoms were similar. My arm is still sore.
17 2021-03-12 disorientation 5 minutes after administration of vaccine, Patient had visual white-out of vision, diminished hearin... Read more
5 minutes after administration of vaccine, Patient had visual white-out of vision, diminished hearing, disoriented, severe pallor and then vomitted.
17 2021-03-19 incoherent Patient fainted roughly 5 minutes after receiving the vaccine. She was sitting down on a chair rest... Read more
Patient fainted roughly 5 minutes after receiving the vaccine. She was sitting down on a chair resting her head on a table in the waiting room. She felt lightheaded and then fell down to the ground. Her mom was with her at the time. We made sure she was not having an allergic reaction. Patient responded seconds after she was on the floor but was not coherent. EMS was called and arrived within minutes. Patient was accessed and transported to the hospital.
17 2021-03-26 anxiety Anxious with injections, felt lightheaded, then near syncope, placed to floor by staff with recovery... Read more
Anxious with injections, felt lightheaded, then near syncope, placed to floor by staff with recovery, BP 80/50 in OBS- felt better, BP 84/54 at time of discharge and normal condition
17 2021-03-27 sleep disorder Body aches, feelings of hot cold, dizziness, temp 101, chills, mild joint pain, resulting in loss... Read more
Body aches, feelings of hot cold, dizziness, temp 101, chills, mild joint pain, resulting in loss of sleep. She drank fluids(some electrolytes), and took two Advil.
17 2021-03-28 feeling abnormal Chills, nausea, vomiting, fever, head fog, all treated just with rest
17 2021-04-01 sensation of foreign body Eyes started itching about 12 minutes after injection. Started getting very dry mouth and throat 15... Read more
Eyes started itching about 12 minutes after injection. Started getting very dry mouth and throat 15 minutes after shot. Felt lump in throat and throat tight about 17 minutes afterwards
17 2021-04-04 confusional state Pt had reaction in the waiting room. Pt became pale, diaphoretic, passed out and had brief seizure ... Read more
Pt had reaction in the waiting room. Pt became pale, diaphoretic, passed out and had brief seizure x 3-5 seconds. She suddenly became aware again with no recollection of what happened. She continued to be pale and diaphoretic and c/o confusion and blurry vision. Pulse ox 98-100, HR dropped to 40's and BP 90/60. Squad was called, they assumed care and transported pt to ER with her mother present.
17 2021-04-05 anxiety Pt reported having an uncomfortable scratchy feeling in back of throat. Pt has experienced anaphylax... Read more
Pt reported having an uncomfortable scratchy feeling in back of throat. Pt has experienced anaphylaxis in past and was anxious about experiencing it again. Pt moved away from waiting area to be evaluated by RN. RN Assessed pt. Lung sounds clear, Pt denies having difficulty breathing, O2 sat remained 98% or better for the duration. BP initially 141/89 while sitting with HR at 75. Pt laid down with feet propped on chair. Vital signs reevaluated 15 min later: O2 98%, BP 118/89, HR 77. Pt still reports itchy throat but does not have difficulty breathing. Contacted on-call physician, recommended pt be evaluated at ED or urgent care. Pt parent refused ambulance; opted to drive pt to ED for further evaluation.
17 2021-04-05 sensation of foreign body About ten minutes after injection, face and ears became flush and throat became itchy. Complained o... Read more
About ten minutes after injection, face and ears became flush and throat became itchy. Complained of mild dizziness and growing lump in her throat. Medical staff checked throat, blood pressure, O2, laid her down on cot with feet elevated. After 20 minutes of stable BP called the chief of immunology who recommended she go to Urgent Care for follow up. While waiting at Urgent Care for 30 minutes, her face, tongue, and throat became swollen, hives developed on face, and had increased difficulty in swallowing and felt short of breath. She was taken to a patient room, IV started and Epi-shot was given. Additional allergy meds were given (Benadryl and Solu-Medro). She the. Slept for the next 90 minutes. Swelling decreased and throat felt better. Monitoring for a couple hours and sent home.
17 2021-04-06 anxiety Patient passed out. tingling in finger. light headedness. chest pain related to anxiety. occurred a... Read more
Patient passed out. tingling in finger. light headedness. chest pain related to anxiety. occurred after about 15 minutes
17 2021-04-06 nervousness Patient was feeling very shaky, dizzy and nauseous 2 minutes after the shot. Patient said she felt l... Read more
Patient was feeling very shaky, dizzy and nauseous 2 minutes after the shot. Patient said she felt like she was going to pass out. We laid her on the ground and gave her water and orange juice. Patient stabilized after a couple of minutes. Paramedics came out and double checked on her, but mom said she did not need to go to hospital. Patient walked away fine. Most likely nerves that caused this incident.
17 2021-04-09 anxiety, crying dizzy, anxious and crying
17 2021-04-09 confusional state Felt dizzy, ho, confused , fell, momentary confusion
17 2021-04-11 feeling abnormal, anxiety Reportedly had some redness and blotchiness at the time but currently no signs of anaphylaxis with n... Read more
Reportedly had some redness and blotchiness at the time but currently no signs of anaphylaxis with no urticaria, no respiratory involvement, no intraoral swelling or voice changes, no GI symptoms. He is warm and well-perfused although is slightly tachycardic but appears anxious. His reported inability to move her arms and legs does not seem consistent with a neurologic etiology of this complaint and more likely consistent with anxiety/conversion reaction in the setting of a vasovagal episode. Will give zyrtec at mother and patient's request, PO challenge and reassess.
17 2021-04-11 feeling abnormal Within about 20 minutes of administration, the patient reported feeling nauseous, hot, faint, and sw... Read more
Within about 20 minutes of administration, the patient reported feeling nauseous, hot, faint, and sweaty. She stated she could "hear the lights". Her temperature was normal at 96.2 degree Fahrenheit. She stated that these same symptoms have happened before with other vaccines, Within another 20 to 25 minutes she felt better and left with her mother. I checked in 5 hours later via the phone and she was feeling better. She only reported a sore arm at that time.
17 2021-04-12 anxiety Pt anxious at the time of vaccination. Nauseated. BP 88/57, at discharge 104/62. OxSat 99%. HR 65... Read more
Pt anxious at the time of vaccination. Nauseated. BP 88/57, at discharge 104/62. OxSat 99%. HR 65, 71 @ Discharge. Blood sugar 94.
17 2021-04-13 confusional state, loss of personal independence in daily activities Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat T... Read more
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Confusion-Mild, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: symptoms started after they had waited the 15 min in store and were well on their way home. they included: speaking overly slow or oddly, left arm tingling, chest pain/SOB, developed into shooting pain down right leg. pt laid down for nap and awoke with swollen eyelids. pt still experiencing shortness of breath and having to limit activities
17 2021-04-13 confusional state Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unrespons... Read more
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Additional Details: Patient was close to vomiting, benadryl was given, patient recovered.
17 2021-04-13 insomnia Severe left arm with minimal swelling x 2 days so far. Tingling in left fingers and able to move lef... Read more
Severe left arm with minimal swelling x 2 days so far. Tingling in left fingers and able to move left arm but limited due to pain. Patient reports pain extends armpit and left side of upper back. -Symptom onset was 4/12/21 after receiving the vaccine. She was unable to sleep that night due to the pain. -Yesterday 4/13/21 symptoms persisted and went to ER where she was given a dose of oxycodone for the pain which helped her to sleep. -Today 4/14/21 symptoms continued. I spoke with her rheumatologist who recommended holding her Meloxicam and starting Ibuprofen 600 TID for a few days until symptoms resolution.
17 2021-04-14 sleep disorder On March 27, 2021 at 11:30pm started to not feel well, went to sleep woke up on and off through the ... Read more
On March 27, 2021 at 11:30pm started to not feel well, went to sleep woke up on and off through the night with chills, on march 28th felt nauseous on and off throughout the day, also had a slight fever of 101°F took tylenol and it helped
17 2021-04-15 sleep disorder Severe headache, dizziness, nausea lasting approximately 45 minutes woke from sleep on night of 4/11... Read more
Severe headache, dizziness, nausea lasting approximately 45 minutes woke from sleep on night of 4/11/21. Improved with tylenol. Milder headache/dizziness for one day following, no medication needed.
17 2021-04-16 confusional state Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Visual Changes/Disturb... Read more
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Visual Changes/Disturbances-Mild, Systemic: Vomiting-Mild, Additional Details: pt stated visual disturbance. having trouble seeing. lightheadedness, vomited once. called ems monitored pt and mom refused to go to the hospital. pt stated feeling better when she left. called at end of shift no answer laeft message
17 2021-04-19 loss of personal independence in daily activities Felt dizzy at work the next day after the second shot. Passed out and then was sitting down and I fe... Read more
Felt dizzy at work the next day after the second shot. Passed out and then was sitting down and I felt nauseous. I threw up 5 times and my arms started to get numb. I had a fever when I got home and I couldn?t move because my body hurt so badly. Migraine and dizziness has been persistent ever since and is interfering with my daily life. Been treating with tylenol which helps a little but not completely. As soon as I stand up and move I feel like I?m going to pass out.
17 2021-04-20 anxiety Per recovery RN notes: "At approximately 0841, patient stated feeling dizzy. Mother noted with patie... Read more
Per recovery RN notes: "At approximately 0841, patient stated feeling dizzy. Mother noted with patient. Patient anxious. Pt loss of consciousness for approximately 10 seconds. Rapid response called. Patient regained consciousness. Patient with emesis x1. Vital signs stable BP 109/70 HR 64. SpO2 at 99 on room air. Rapid response team arrived at scene. MD assessed patient. Per mother, patient has a history of syncope after vaccinations. Per MD, ok to go home once stable. Patient noted to leave facility at 0904, in stable condition.".
17 2021-04-21 confusional state Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Chest Tightness / Heaviness / Pain-Mild, ... Read more
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Severe, Systemic: Headache-Mild, Systemic: Hyperventilation-Medium, Systemic: Nausea-Severe, Systemic: Shakiness-Medium, Systemic: Tachycardia-Mild, Systemic: Visual Changes/Disturbances-Severe, Systemic: Weakness-Mild
17 2021-04-22 anxiety, nervousness COLD SWEATS, DIZZINESS, DROWSINESS, BP WAS TAKEN 74/44, THEN 5 MINS LATER 99/60, PT WAS LAID DOWN TO... Read more
COLD SWEATS, DIZZINESS, DROWSINESS, BP WAS TAKEN 74/44, THEN 5 MINS LATER 99/60, PT WAS LAID DOWN TO PREVENT FALLING, PT WAS NERVOUS AND ANXIOUS
17 2021-04-24 feeling abnormal Pt given vaccine and 2 minutes later she started to feel light headed and foggy. The reaction nurse ... Read more
Pt given vaccine and 2 minutes later she started to feel light headed and foggy. The reaction nurse laid her down and elevated her feet. No c/o nausea. Guardian present and watching. Pt eating w/o issues.
17 2021-04-24 sleep disorder i couldnt sleep, woke up many times with chills and a really bad headache, the whole day ive been si... Read more
i couldnt sleep, woke up many times with chills and a really bad headache, the whole day ive been sick to my stomach and my head hurt. i even threw up a lot
17 2021-04-25 anxiety Patient had flushing/sweating, dizziness, anxious, sweating. Low BP 84/46 -- > 116/75 -- > 121/82. P... Read more
Patient had flushing/sweating, dizziness, anxious, sweating. Low BP 84/46 -- > 116/75 -- > 121/82. Patient stated did not eat since 4/24/21 6PM. Patient stable, released from vaccination site.
17 2021-04-26 amnesia, confusional state, incoherent At 2am 4/22 patient started to feel sick and sent a text that I didn't read until 630 as I was aslee... Read more
At 2am 4/22 patient started to feel sick and sent a text that I didn't read until 630 as I was asleep. She had severe muscle aches, hurt to move, hurt to breathe and felt like she was having a heart attack. She felt like she might pass out and had some blurred vision. At 630am, I saw her texts and immediately brought her 2 tylenol and a large glass of water. She went back to bed. She woke up around 10:45 and was feeling decent except for a headache but no fever or anything so we went to try on some Prom dresses. At the dress shop, she collapsed and had a seizure lasting around a minute. She lost her bladder and was completely confused and incoherent. She's never had a seizure before. I scooped her up, brought her to the ER where they ran every test and scan imagineable. Full blood work up and cultures, a chest xray, a CT scan of her brain and lungs. Her temp was high 103-104 and she had full body chills and a pounding headache. Her BP kept dropping and got as low as 81/36. They threw 2 bags of IV fluids into her and admitted her to the hospital. She had also developed a heart murmur. Over the course of the night, her BP stabilized but her temp continued to spike and come back down with Tylenol/Ibuprofen. She also had IV Tordahl for the headache. Her inflammatory markers were high at 15.3 which we were told should be less than 1. They reran labs in the morning but everything can back really low which they felt was a dilution effect from all the fluids so wanted us to follow up with her primary care on Monday. On Saturday night, he lymph nodes were swollen to the size of ping pong balls but have since slowly reduced in size although still there. Her labs were better from discharge and her white blood cell count was within range and her inflammatory marker was down to 1.7. Her blood sugar was a little low. She did pass out and have seizure like response to giving blood in the doctors office, lost bladder control again, shot pupils, etc. She is still stuttering over words, has some short term memory retention and has some motor function issues which they think is a result of the initial seizure and should resolve itself over time. Her liver function tests were totally normal in the hospital but are a high now so they will be checking her out again next week.
17 2021-04-26 sleep disorder, feeling abnormal Immediately following my shot I felt brain fog and dizzy but continued with my day. The next morning... Read more
Immediately following my shot I felt brain fog and dizzy but continued with my day. The next morning I woke up with extreme nausea and a migraine. I am prone to migraines. I was hot and chilly but never read a fever. It's hard for me to sleep due to discomfort.
17 2021-04-28 confusional state, anxiety Recipient is a 17yo who presented for second dose of COVID-19 vaccine. She reported some anxiety rel... Read more
Recipient is a 17yo who presented for second dose of COVID-19 vaccine. She reported some anxiety related to receiving dose #2, and had some nausea after dose #1. She was alone as a driver of her own POV. Consent was obtained from the recipient and her custodial grandparent by phone, witnessed by doctor. She initially did well after the vaccine, but after approximately 5 minutes began to complain of feeling nauseated, lightheaded, and tingling extremities (hands and feet). She was noted to be hyperventilating, and was placed in a supine position but continued to feel some lightheadedness and difficulty breathing. Breath sounds were clear without wheezing noted, HR 70s with RRR. She was noted to have ongoing anxiety, nausea and symptoms progressed and although she remained normotensive to hypertensive (initial BP 128/74), she had repeated episodes of syncope. She was transferred to the ambulance and further vitals and EKG were obtained. She had some confusion after episodes of syncope and some seizure-like activity with syncope, with very brief episodes of LOC, with noted tachycardia with HR up to the 140s during episodes of syncope. BP ranged 129/86 to 140/84. IV access obtained and she was given NS and started on oxygen at 2 liters, but saturations remained in the 98-99% range. She was ultimately transferred to the local ER for further evaluation and management given ongoing symptoms, evaluated at hospital.
17 2021-04-29 anxiety patient felt dizzy, lightheaded, nauseous after receiving pfizer covid-19 vaccine. I checked her blo... Read more
patient felt dizzy, lightheaded, nauseous after receiving pfizer covid-19 vaccine. I checked her blood pressure, it was normal 127/96; pulse was 87. I gave patient ice pack and she said she was feeling numbness in her left arm and fingers. After 5 minutes she was feeling some chest pain and wanted me to call 911. She said she was feeling anxious and hadn't eaten all day. patient takes weekly methotrexate injections.
17 2021-04-30 emotional distress, crying After a few minutes of receiving vaccine, patient reported dizziness, light headedness, and blurry/d... Read more
After a few minutes of receiving vaccine, patient reported dizziness, light headedness, and blurry/dots in vision. She then became more upset leading to hyperventilation and crying. She then said she had tingling in her fingers, which progressed to difficulty moving her fingers/stiff fingers, and coldness and redness in tips of fingers. She then reported she was loosing sensations in her feet and legs. 911 was called. We tried to have the patient take slow deep breaths. We offered an ice pack and water up front and a heat pack for her fingers. Paramedics arrived. Her blood pressure, heart rate, oxygen saturation, glucose were within normal limits. She was given oxygen and the paramedic was able to help her slow her breathing. Her fingers went back to normal and she felt fine before leaving. She did not feel the need to go with the paramedics.
17 2021-04-30 insomnia, feeling abnormal Not sleeping well at night due to pressure feeling in her chest up; Not sleeping well at night due t... Read more
Not sleeping well at night due to pressure feeling in her chest up; Not sleeping well at night due to pressure feeling in her chest up; shivers; jaw got paralyzed; she got shaky; feeling bad/ brain fog; burning sensation in her body; She couldn't talk; slight elevated temp (99.7F max); She has been off balance this week since getting her vaccine; This is a spontaneous report from a contactable physician. A 17-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Apr2021 (batch/lot number was not reported) as a single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome, panic attacks, migraines and acne. The patient was not pregnant at the time of vaccination. It was unknown if there were other vaccines in four weeks. The patient did not have Covid prior to vaccination and was not Covid tested post vaccination. Concomitant medications in two weeks included ondansetron hydrochloride (ZOFRAN) taken for anti-nausea, start and stop date were not reported; doxycycline taken for acne, start and stop date were not reported. The patient previously took glycerol (GLYCERIN) and experienced allergies. The patient got her vaccine on 12Apr2021. Two nights after her vaccine (14Apr2021), she got shaky and feeling bad and burning sensation in her body. No fever at that time, but slight elevated temp (99.7F max) the day after the vaccine (13Apr2021). Mother gave her anti-nausea medication (ondansetron hydrochloride 2 mg) and within 5 minutes her jaw got paralyzed. She couldn't talk. It lasted about 30 min. Mother called ambulance and patient was brought to ER. ER didn't do bloodwork or any evaluation. ER didn't know what happened per mother. She has been off balance this week since getting her vaccine (Apr2021). She feels better this morning but she still feels off balance. Not sleeping well at night due to pressure feeling in her chest up and she shivers to get the feeling away per patient (unspecified date). Slept better last night as of 17Apr2021. No facial drooping. She can smile and lift her eyebrows. Patient had "brain fog" this week as well after the vaccine. The adverse events "she got shaky", "feeling bad", "burning sensation in her body", "jaw got paralyzed" and "she couldn't talk" resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care visit. There was no treatment received for the adverse events. The outcome was recovered on an unspecified date for the events "jaw got paralyzed" and "she couldn't talk"; recovering for the event "not sleeping well at night"; not recovered for the event "off balance"; and unknown for the rest of the events. Information on the lot/batch number has been requested.; Sender's Comments: Based from temporal relation of event and vaccine administration, Trismus as an event in relation to suspected drug BNT162B2 cannot be totally 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
17 2021-05-03 confusional state left-side facial drop with left mouth corner; stroke symptoms; transient mild headache; blurry visio... Read more
left-side facial drop with left mouth corner; stroke symptoms; transient mild headache; blurry vision; left side of tongue affected; slurring speech; felt confused; drowsy; This is a spontaneous report from a contactable consumer (patient). This 17-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8734), via an unspecified route of administration in the right arm at 17 years old on 30Mar2021 at single dose for COVID-19 immunization. Medical history included acquired brain injury (C-PVL) from pneumococcal strep infection, hypoxic ischemic encephalopathy, premature birth, quadriplegic dyskinetic cerebral palsy. Concomitant medications were none. The patient was not pregnant at time of vaccination. The patient previously received T-Dap vaccine at 10 years old and had prolonged migraine reaction. 12 days after, the patient developed stroke symptoms with transient mild headache, blurry vision, and left-side facial drop with left mouth corner and left side of tongue affected causing slurring speech also felt confused and drowsy which lasted for 8 hours. Events were started on 11Apr2021 at 03:30 PM. Events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient went to ER, they did stroke work-up. No evidence of stroke. The patient received treatment including CT scan, MRI, EKG, labs. The patient had no covid prior vaccination, no covid tested post vaccination. Outcome of the events was recovering.
17 2021-05-03 sleep disorder Vomitting (cant keep anything down at all),headache, body ache to the point she was crying some of t... Read more
Vomitting (cant keep anything down at all),headache, body ache to the point she was crying some of the time, diarrhea, exhausted No fever so far It started at 3:00 am and it is now 7:30 am and she is finally able to fall asleep.... hopefully she improves throughout the day (still early)
17 2021-05-04 insomnia Site: Pain at Injection Site-Mild, Systemic: Chills-Severe, Systemic: Exhaustion / Lethargy-Mild, Sy... Read more
Site: Pain at Injection Site-Mild, Systemic: Chills-Severe, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Severe, Systemic: Fever-Medium, Systemic: Headache-Severe, Systemic: Unable to Sleep-Mild, Additional Details: mom called to report adverse reaction to 2nd dose of pfizer vaccine. pt had chills on monday, fever on tuesday, wed morning child passed out in the kitchen mom heard her fall, she did call 911. child was transported via ambulance to strong ER. pt was diagnosied with syncope. pt is now home with mild headache/lethargy and recovering. mom has called pcp waiting to talk to her.
17 2021-05-05 anxiety At 1130 pt reported feeling anxious. OxSat 94%, HR 55, BP 94/58, sweaty, clammy, At1142 Spoke to fa... Read more
At 1130 pt reported feeling anxious. OxSat 94%, HR 55, BP 94/58, sweaty, clammy, At1142 Spoke to father, informed him of reaction and treatment. Parent verbalized understanding. @1157 BP 110/68, HR 65, OxSat 98%
17 2021-05-05 sleep disorder Severe headache developed on evening of vaccine. The next morning, patient developed an itchy bumpy ... Read more
Severe headache developed on evening of vaccine. The next morning, patient developed an itchy bumpy raised red rash on her Right forearm while at school. Benadryl helped a little. A worsening headache, cough and wheeze started evening 4/27/21. She took Tylenol and used her Albuterol inhaler. She slept poorly due to itch, headache, bad cough & wheezing. On 4/29/21, 4 hrs after taking Benadryl, she developed an urticarial rash on her Left forearm (right arm improved by then). A pruritic, extensive petechial Left-sided facial rash began that evening which worsened the next am and spread to right side of face. Headache comes and goes. Rash spread to upper arms 5/3/21 despite daily Claritin. Facial rash is fading
17 2021-05-06 anxiety 17 year old stated she was feeling lightheaded and anxious. Client slump to the floor. Father caug... Read more
17 year old stated she was feeling lightheaded and anxious. Client slump to the floor. Father caught client sustained no injuries. No loss of consciousness. B/P 104/62. Client laid in supine position for 10 minutes. Transfered to observation area. rechecked B/P 108/72 P102 R 20. Client stated she felt better. Patient sat in wheelchair for 30 minutes. Rechecked B/P 110/70. Client released for father to take home.
17 2021-05-06 hallucination Date and time of vaccination: (list both if they received both shots): 1st dose 4/6/2021 at 1100. 2n... Read more
Date and time of vaccination: (list both if they received both shots): 1st dose 4/6/2021 at 1100. 2nd dose 4/27/2021 at 1100. Date and time adverse event started: ~4/8/2021 (2 days post-vaccination), time unknown. Pt's mother reports that a couple hour post 1st dose vaccination, pt vomited right after. Couple days after 1st dose, pt had a breakthrough symptoms of hallucinations and delusions. Approx. a week later these symptoms gotten better and pt seems to return back to her normal self. Pt reports several hours post 2nd dose, pt vomited off and on and developed chills. In addition, pt's breakthrough symptoms appeared once again but seems worse than from the 1st dose. Today, pt is getting better but symptoms appears to lessen. ***NOTE*** Recommend pt's mom to see MD per these are not a common ADEs of the vaccine. Pt's mom advised pt have a follow up with MD on 5/4/2021. 5/5-Pfizer lot#EP7533, #ER8730. Patient no longer has symptoms, diminished on 5/3/21. No treatment was used to alleviate symptoms. Provider wrote a script for Ativan PRN yesterday but patient has not taking medication as of yet, has used non-pharmalogical coping skills to help alleviate symptoms.
17 2021-05-09 nervousness Patient received Pfizer Covid vaccine dose #1 at 4:07pm, 10 minutes later patient said that she was ... Read more
Patient received Pfizer Covid vaccine dose #1 at 4:07pm, 10 minutes later patient said that she was not feeling well. She felt her left arm was going numb, light headed, dizziness and chills. at 4:10 BP was 127/81 pulse 70. At 4:25 bp was 136/82 pulse 83. She was still feeling light headed, cold, and shaking. Pt given orange juice. At this point patient stated she has a hx of losing hearing and then a feeling of passing out. This has occurred more than one time. Pt also stated having lost feeling in both legs with no explanation as to why. 4:35pm bp 133/82 pulse 85, she was feeling cold and shaky. 4:42 pm patient stated she was getting colder and was still light headed. 4:56pm very cold, chills and dizziness. Pt was given another blanket. Both pt and father were asked if emergency services should be called. 5pm per parent;'s request were ok to give 480mg of tylenol, she was very dizzy and cold bp 132/85 pulse 89. Father approved of us calling for emergency services. Pt symptoms not improving. Emergency services arrived pt was able to get onto her feet and walk to the stretcher. Pt stated she is still very dizzy.
17 2021-05-09 panic attack Patient presented for second dose of Pfizer COVID vaccine. Per mom, patient had anxiety attack after... Read more
Patient presented for second dose of Pfizer COVID vaccine. Per mom, patient had anxiety attack after first dose last approximately 45-60 minutes. Patient transferred from vaccine clinic to private room with stretcher prior to vaccine administration. Post vaccine administration, patient exhibiting typical symptoms of panic attack per mom (seizure-like activity, unable to respond to verbal stimuli, sternal rub or fingernail pressure). EMS arrived at 0925. Patient regained consciousness after EMS arrived, back to baseline at 0940. Patient and mother declined EMS transfer to ED for further evaluation. Patient and mother informed to seek medical attention immediately for any worsening/concerning symptoms. Patient discharged via wheelchair with mother.
17 2021-05-10 sensation of foreign body Immediate sever pain at injection site, immediately followed by flushed face, racing heartbeat, ting... Read more
Immediate sever pain at injection site, immediately followed by flushed face, racing heartbeat, tingling and inching of face, watering eyes, itchy throat that felt like it was closing in, lump in throat, difficulty breathing, unable to speak. Was able to speak after a couple minutes and the other symptoms started to gradually improve at that point. Most of the above symptoms subsided within around forty minutes. The lump in the throat remained for weeks eventually coming and going.
17 2021-05-11 confusional state, feeling abnormal, memory impairment Per parent report: Friday 4-30-21. Vaccine was given at 1500, at 1730 client displayed a rash on fa... Read more
Per parent report: Friday 4-30-21. Vaccine was given at 1500, at 1730 client displayed a rash on face and chest with extreme fatigue and chills. client took Benadryl. Saturday 5-1-21. Rash gone, but extreme fatigue, crushing pain on chest and pain in arm. continued to take Benadryl. Sunday 5-2-21. Extreme fatigue. continued to take Benadryl. Monday 5-3-21. Still extremely fatigue, DC'd Benadryl. Tuesday 5-4-21. some improvement in fatigue, but experienced some brain fog. Wednesday 5-5-21. attended school where she presented to the health office with medical concerns, see quote taken from an email with the school nurse: "She missed school on Monday and Tuesday due to the reaction. On Wednesday, she presented to the health office with extreme redness to the face and chest. Emergency services was called and she was transported to the hospital. Benadryl was given in the rig to which she responded to well." parent reported that ER doctor ran many tests but did not determine cause. Tuesday 5-11-21. saw Primary Care provider. client is still having significant "brain fog". she is very confused more than half the day, not remembering things or events, and will zone out or fall asleep in inappropriate places with out realizing it.
17 2021-05-12 feeling abnormal, abnormal behaviour, crying, fear, panic reaction Approximately 5 minutes after receiving vaccine client became quiet, clenching fists, and started cr... Read more
Approximately 5 minutes after receiving vaccine client became quiet, clenching fists, and started crying. RN asked if she was okay, stated she was scared and that her arms felt weird and her chest was tight. RN asked some questions about her health history, she then offered a granola bar and water. Client drank some water, declined snack. Clients hand began to shake, RN offered to lay client on a cot but client declined. Her dad came to check on her, she broke down saying that her arms were numb and chest was tight. The 15 vaccine minute timer went off, client stood but legs were week. She sat down and then slid herself onto the floor. She at first went into a fetal position then laid out flat on the floor. Client began acting more panicked and frantic with short quick breaths and her hands appeared to be contracting some. Clinic team made the decision to call 911 and administer 0.50 mg epinephrine. Ambulance arrived quickly and client was taken to the Medical Center via ambulance.
17 2021-05-13 feeling abnormal Patient was sitting in observation for about 10 minutes and complained of feeling dizzy and fuzzy. P... Read more
Patient was sitting in observation for about 10 minutes and complained of feeling dizzy and fuzzy. Pt was pale and sweating. This RN assisted patient to wheelchair and escorted patient to EMS room. Pt was lying on the cot; ice pack was applied to Pt forehead and neck. BP 102/60, P 80. Pt refused drink and snacks when RN offered. Pt reported of feeling better after 15 minutes. Patient's mother was with Pt at all times. Pt and her mother left at 15:30 without any complications.
17 2021-05-18 anxiety 17 year old patient with no known allergies who was given 1st dose of Pfizer vaccine at 1655. At 170... Read more
17 year old patient with no known allergies who was given 1st dose of Pfizer vaccine at 1655. At 1700 during observation patient mentioned to the mother that she was not feeling well, was slumped over. The RN on observation noticed that she was apneic, whole body was rigid. Vital signs at 1701: BP 153/88, HR: 64. Oxygen saturation 99%. After 5 minutes a recheck of the vital signs: BP 115/74, HR: 64. Oxygen 97%. Patient did state that she gets anxious when she gets shots.The paramedics were called. Vital signs on arrival: 117/83, HR: 58, Oxygen saturation 100%. Blood sugar 70. After a few minutes patient stated that she was feeling a little better. Patient was able to walk to the ambulance for them to perform an EKG: Results were normal sinus bradycardia.(Patient is an athlete). Patient's mother declined further treated and signed AMA form.
17 2021-05-18 anxiety Patient felt dizzy and anxious after Pfzier dose. Patient was anxious. Had her lay flat with her leg... Read more
Patient felt dizzy and anxious after Pfzier dose. Patient was anxious. Had her lay flat with her legs elevated. BP was 116/70. Pt left home with mother OK.
17 2021-05-20 anxiety Patient experienced anxiety post vaccination, recovered and released
17 2021-05-21 anxiety Patient observed at 1647 stating she was nauseous and anxious. Patient given emesis bag and then vom... Read more
Patient observed at 1647 stating she was nauseous and anxious. Patient given emesis bag and then vomited. Assisted patient in wheelchair and taken to observation private area with guardian. Obtained a full set of vitals at 1650 as follows: O2 sat 98% RA, HR 71, RR 32, and BP 110/80. Encouraged patient to slow breathe in and out of bag. Another set of vitals obtained at 1700 as follows: O2 sat 98% RA, HR 89, RR 20, BP 110/75. Pt stated she was starting to feel better. Observed patient for another 10 minutes at 1710 vitals as follows: O2 sat 98% RA, HR 83, RR 26, BP 111/79. Assisted patient to a sitting then standing position. Patient's mom stated she thinks everything is okay..and she would monitor her at home. Explained to her to seek EMS if symptoms progress. Patient's mother Verbalized good understanding. Left site at 1718.
17 2021-05-21 sensation of foreign body Patient feeling her throat is swollen with a lump vs sat 98% HR 81 bp 131/70 patient felt better im... Read more
Patient feeling her throat is swollen with a lump vs sat 98% HR 81 bp 131/70 patient felt better immediately after IM Benadryl was OBS for 45 mins and requesting discharge home was with mother
17 2021-05-23 confusional state Patient felt light-headed and was not responding to questions. She was lowered to the ground by the ... Read more
Patient felt light-headed and was not responding to questions. She was lowered to the ground by the pharmacist and technician. She became responsive and was confused. EMS was contacted. Blood pressure measured 110/68. Patient remained on the floor until EMS arrived and took over care.
17 2021-05-23 nervousness Systemic: Chills-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Numbness (specify: facial ar... Read more
Systemic: Chills-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Weakness-Medium, Additional Details: patient was feeling cold, hot, shaky, weak, a heavy chest feeling, numbness in extremities a few minutes after her vaccine. Her pulse went from 80, 99, to 110 after 3 readings. Her BP was normal. Her brother said she just had a unspecified chest procedure. It wans't noted on her intake. She wasn't feeling after lying down for 30 minutes with legs propped up and wanted to paramedics to come. They sent her home after another 30 min. She doing well before she left.She went to school day after.
17 2021-05-23 nervousness Patient was extremely nervous prior to vaccine. Got shot, walked out of room to waiting area. about ... Read more
Patient was extremely nervous prior to vaccine. Got shot, walked out of room to waiting area. about 2-3 minutes post vaccine, realized did not feel well. Passed out. Mom said patient felt a touch rigid and twitched a couple times, then came too. Did hit head when patient fell to floor, although was not a major hit. Patient was worked up after coming to.
17 2021-05-25 anxiety Patient was feeling dizzy after getting her second Pfizer Covid shot. EMS believed patient was h... Read more
Patient was feeling dizzy after getting her second Pfizer Covid shot. EMS believed patient was having anxiety attack. Patient felt better after about 30 min and she went home with her mother.
17 2021-05-25 feeling abnormal Foggy head; Sore arm; This is a spontaneous report from a contactable consumer (reporting on herself... Read more
Foggy head; Sore arm; This is a spontaneous report from a contactable consumer (reporting on herself). A 17-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0150 and Expiration was not reported) via an unspecified route of administration in Arm Left on 08Apr2021 13:00, as 1st dose, single for COVID-19 immunization. Medical history included seasonal allergy, hypersensitivity, food, food allergy all from an unknown date and unknown if ongoing. Concomitant medication(s) included cetirizine hydrochloride (ZYRTEC ALLERGY); mometasone furoate (ASMANEX) both taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19 and did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. It was reported that after the first dose of the vaccine she had a foggy head, sore arm. The outcome of the events was recovered on an unspecified date. No follow-up attempts are needed. No further information is expected.
17 2021-05-26 confusional state Site: Pain at Injection Site-Medium, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-M... Read more
Site: Pain at Injection Site-Medium, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: BP 103/65 Pulse 62-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Mild, Systemic: Shakiness-Mild, Additional Details: EMS was called but she went home with her mother and slept the rest of the day, she had a sore arm on Tuesday but was otherwise fine per mom.
17 2021-05-26 emotional distress, feeling abnormal 1-20 minute bouts where tics appear "seizure-like," repetitive; many persistent involuntary tics inc... Read more
1-20 minute bouts where tics appear "seizure-like," repetitive; many persistent involuntary tics including coprolalia and violent motor tics; had one minor chronic tic before vaccination/many persistent involuntary tics including coprolalia and violent motor tics/Noticed increase in severity and frequency; many persistent involuntary tics including coprolalia and violent motor tics; Tics often include hitting oneself and banging head against things/violent; significant distress; persistent headache; chronic fatigue/sleepiness; lightheadedness; decrease in appetite; feeling of pressure in certain locations inside the head; intermittent earaches in both ears; persistent feeling of brain being "on fire," and "like a parasite has invaded the brain."; chronic fatigue/sleepiness; This is a spontaneous report from a contactable consumer (patient). A 17-year-old female non-pregnant patient received bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration, administered in Arm Right on 26Mar2021 as first single dose and on 16Apr2021 as second single dose (Batch/Lot number was not reported) for covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered: Other. Medical history included asthma, allergy to nuts, penicillin and ongoing chronic tic. No other vaccines within 4 weeks prior to the COVID vaccine. No covid prior vaccination. Concomitant medications included duloxetine; atomoxetine; hydroxyzine; loratadine. The patient previously took amoxicillin and experienced allergies. The patient experienced neurological symptoms included many persistent involuntary tics including coprolalia and violent motor tics. Smaller tics can be suppressed for minimal amounts of time before uncontrolled, violent/loud tics occur in rapid succession. Tics often include hitting oneself and banging head against things. The patient had one minor chronic tic before vaccination. Initial onset occurred nine days after vaccination from 04Apr2021. Noticed increase in severity and frequency approximately nine days after second dose of Pfizer vaccine. Symptoms cause significant distress. Additional symptoms included: persistent headache (from date of first vaccine to present); chronic fatigue/sleepiness; light-headedness; decrease in appetite; feeling of pressure in certain locations inside the head not related to the skull or skin; intermittent earaches in both ears; persistent feeling of brain being "on fire" and "like a parasite had invaded the brain, start date was 26Mar2021; and "1- 20 minute bouts where tics appear "seizure-like," repetitive, violent, and controlling". The patient underwent lab tests and procedures which included Spit test: negative (other) on 26Mar2021 and Apr2021, Covid test: negative on 26Mar2021 and on Apr2021. The events resulted in: Doctor or other healthcare professional office/clinic visit. No treatment received; the patient was not recovered. Information on lot/batch number has been request.
17 2021-05-27 anxiety Patient felt like she was having trouble breathing, stated it felt like someone was sitting on her c... Read more
Patient felt like she was having trouble breathing, stated it felt like someone was sitting on her chest. didn't feel like throat was closing, but felt anxious. asked patient if she would like benadryl, she stated yes. sat for 20 minutes after receiving benadryl and felt okay, felt like her trouble breathing went away.
17 2021-05-28 confusional state Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Confusion-Medium, Systemic: Dizziness... Read more
Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Weakness-Medium
17 2021-05-28 confusional state She fainted and collapsed about 18 hours after receiving the second dose (6:30 am). She was confused... Read more
She fainted and collapsed about 18 hours after receiving the second dose (6:30 am). She was confused for about an hour after she fainted. She was on ibuprofen (400 mg taken at 5:30 am). Other than weakness, headache, and fever, she has had no other adverse reactions so far besides the single fainting episode.
17 2021-05-30 anxiety Within 2-3 minutes she felt sick and dizzy, then became clammy and unresponsive. She was moved to th... Read more
Within 2-3 minutes she felt sick and dizzy, then became clammy and unresponsive. She was moved to the floor and regained consciousness within 1 minute. Was given water and a snack and felt better. She left happy and healthy, she does not like needles/vaccination - so she had anxiety from the vaccine.
17 2021-05-31 anxiety Patient was very anxious and breathing heavy. About 5 minutes after the vaccination they started to ... Read more
Patient was very anxious and breathing heavy. About 5 minutes after the vaccination they started to hyperventilate and ended up throwing up. After letting them sit and relax for 5 minutes, the patient then had to throw up again and told their mother they felt like they were going to faint. Mother and myself stood by, while patient did end up fainting. We slowly lowered them to the ground, and on the way down their body got stiff and patient had uncontrollable movements and was hardly responsive. Mother and myself finally got her safely to the floor as they came to and was responding to verbal ques and stimulation from mother. Mother went to get water and i stayed with the patient to ensure no other things happen. Patient ended up doing alright after relaxing for a few and then i walked them and mother to their car and ensured they were feeling good enough to go home. I then advised the mother to seek medical attention.
17 2021-06-01 confusional state Roughly 2 minutes after receiving her I am Pfizer vaccine, patient told mother that she was feeling ... Read more
Roughly 2 minutes after receiving her I am Pfizer vaccine, patient told mother that she was feeling slightly lightheaded. She proceeded to lose consciousness. Mother honk the horn and alerted staff to come to help. Patient was in the car on the passenger side, patient was fully sitting up. I reclined her all the way down in her passenger seat, she was slightly gasping for air, Ambulance was called for evaluation. She had loss of consciousness for approximately 30 seconds. She regained consciousness and said she was feeling confused as to what it happened. Denies any feelings of needing to vomit, Or post ictal symptoms. EMS and fire we?re on scene by then, report given to paramedics on site. Patient declined further medical treatment and Ian made with the ambulance. after this stating she was a little tired. She continue to wait for 30 minutes, she had 1 episode of emesis and felt better. At the site with no issues.
17 2021-06-01 feeling abnormal First on Saturday May 22 had sore arm, then pain that thought was possibly heartburn/indigestion, fe... Read more
First on Saturday May 22 had sore arm, then pain that thought was possibly heartburn/indigestion, fever over 100. Took acetaminophen and tried Tums. Then on Sunday May 23 chest pain that didn't feel quite like indigestion and fever over 100. Continued acetaminophen and Tums. Monday May 24 felt like heart was fast, hot flash type feeling like could faint and some light headedness/off feeling, continued chest pain. Pediatrician prescribed omeprazole to see if helped, did EKG. Checked in on Wed May 26, no change except no fever and light headedness improving. Referred to cardiology.
17 2021-06-03 feeling abnormal Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed ... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Additional Details: Patient received 1st dose of pfizer vaccine. Less than 1 minute later patients mother alerted us that the patient had lost consciousness. She was immediately laid down and gained consciousness within 10 seconds. She stated feeling lightheaded, sweaty, looked pale and felt like she was in a trance. 1st BP reading (111/67), 2nd BP reading done 15 min later (106/59 & HR 65). After 30 min of monitoring patient was able to leave.
17 2021-06-06 anxiety, nervousness patient was nervous/anxious about the shot. Sat in chair and received shot in the left deltoid with ... Read more
patient was nervous/anxious about the shot. Sat in chair and received shot in the left deltoid with no issue. Stood up to leave a minute later and told her mom that she felt dizzy and nauseous. We had her sit back down and she got a little shaky. Face seemed to loose all its color. she said everything went black and she was dizzy. she closed her eyes and laid her head back against the wall. I left the vaccine room to alert my pharmacist and as I walked out the door the patients brother said that she had started shaking like she was having a seizure and she passed out. She was seated and mom was supporting her while we called 911. patient came to within 30 seconds or so and was lethargic and dizzy still. Pharmacist too her blood pressure while waiting on emt and it was 102/52, heart rate 64. emt arrived and took over. emt was with the patient for about 10 minutes then left with her on a stretcher. emt left notes that her vitals while sitting were 93/56, heart rate 66, o2 100%. standing 80/50
17 2021-06-06 feeling abnormal After receiving the vaccine we moved to waiting area. Within minutes she told me she was not feelin... Read more
After receiving the vaccine we moved to waiting area. Within minutes she told me she was not feeling well she began sweating profusely, her skin became pale and clammy, her eyes rolled back she lost consciousness and began convulsing. She came to and said she could not hear well. She was taken to ED for observation and testing.
17 2021-06-06 excessive sleepiness Fever ranging from 99.8 to 102 for 54 hours. Fatigue (slept for 15 hours on first day); lower back ... Read more
Fever ranging from 99.8 to 102 for 54 hours. Fatigue (slept for 15 hours on first day); lower back ache, headache, muscle ache
17 2021-06-06 sleep disorder Parent had the patient give the description: The next morning, I had sore left side/left side of nec... Read more
Parent had the patient give the description: The next morning, I had sore left side/left side of neck. Later on that day, I was feeling my neck and I felt a giant lump on the left side of my neck. I thought that I had slept on it wrong. Later on, it wouldn't go away - even with massage. It was painful. It caused disturbance, I wasn't comfortable when I was sleeping. It had gotten bigger the next morning. Our doctor said that it was lymph nodes and it was a response of immune system to injection. To make sure, I'm getting an ultrasound. It has gone done but I still notice another smaller lump there still as well. (The two lumps are side by side.) For the pain and swelling, the doctor prescribed me ibuprofen. This has calmed it down. It was still a little swollen - about two weeks after. But it's going down little by little. I still feel it, but it's now very small.
17 2021-06-07 irritability Irregular Menstrual Period: short cycle (15-22 days), heavier than typical period pre-vaccine, prolo... Read more
Irregular Menstrual Period: short cycle (15-22 days), heavier than typical period pre-vaccine, prolonged period (12 days), no treatment given Extreme Fatigue: Sleeping 8-9 hours and can barely function through a typical day, irritable Frequent headaches lasting multiple days
17 2021-06-08 emotional distress, abnormal behaviour Day after vaccination, patient reports intermittent fevers (Tmax 104F), neck pain that radiates down... Read more
Day after vaccination, patient reports intermittent fevers (Tmax 104F), neck pain that radiates down her back, and is interacting a lot less than usual, The following day, she was unable to walk at all and required being carried to use the bathroom. Patient denies and fevers, cough, gi distress. She does states that she is not feeling short of breath at this time, but is having weakness in her hands as well as her legs. Additionally patient states that she has been having chest pain today that comes and goes. On neuro exam Mental status: Appears to be distressed due to photophobia. Lethargy, however easily arousable, able to have a conversation, attention intact to spelling "globe" backwards, intact to high and low frequency words. Able to name and repeat. Speech: Mild dysphonia Cranial Nerves: II: Pupils equal, round reactive III/IV/VI: EOMI. Pupils move in all four cardinal directions VII: Face symmetric when talking, however limited effort to excursion on command VIII: Responds to voice IX/X: Voice normal XI: Turns head side-to-side XII: Tongue midline Motor: Normal bulk and tone. Resistance met to passive motion of BLE RUE/LUE: shoulder abduction 4/5, elbow flexion/extension 5/5, wrist flexion/extension with give-way weakness up to 4+/5, finger flexor 4/4 RLE/LLE: On command, 0/5 -however able to support her legs in a flexed position bilaterally, with encouragement 5/5 on dorsiflexion. Able to support her weight on her legs, however does not walk slowly sits back on the bed. Sensory: Intact to light touch, proprioception intact Coordination: No obvious dysmetria on FNF testing DTR: 2+ brachioradialis, bicep, patellar, ankle b/l. Plantars mute. Absent pathological reflexes: Hoffman, cross adductor
17 2021-06-08 feeling abnormal Client Received the 2nd dose of Pfizer COVID vaccine lot #ER8735 and expiration date 07/04/21 at 1:... Read more
Client Received the 2nd dose of Pfizer COVID vaccine lot #ER8735 and expiration date 07/04/21 at 1:34pm. At 1:34pm, client reports to vaccinator that she feels dizzy. Vaccinator offer client water and client starts drinking it. PHN 1 & PHN 2 arrive client reports she "feels weird" PHN asks client to explain and client is unable to describe. Client is alert and oriented X 4 and is already seated in zero gravity chair due to reporting history of syncope. Vaccinator offered client water and client starts drinking it. Client reports no headache, no shortness of breath, no blurred vision, no chest pain, just dizziness. At 1:34PM vitals heart rate taken manually by PHN :72 and blood pressure: 128/74, unable to get oxygenation due to long acrylic nails. PHN gets report from mother that client reports with the first dose something similar happened that she experienced dizziness after vaccine. Client was kept in observation and symptoms resolved prior to client going home. Clients mother reports no medical history, no medications and no history of allergies. At 1:36PM PHN gets called away for another adverse reaction and PHN stays with client. At 1:39pm client reports dizziness is resolving but still "feels weird", PHN asks client to clarify what weird means and she says "it feels like my heart is slower." At 1:40pm client reports she is feeling sleepy, PHN attempts to call 911 and gets disconnected. At 1:41pm vitals: blood pressure: 130/82 and pulse:134. At 1:42pm PHN calls 911 again to reconnect and observes clients lips look purple, closed eyes but able to answer questions and speak in complete sentences. Ask RN to get AED as instructed by 911 dispatcher. At 1:45pm, client reports having trouble breathing and RN placed zero gravity chair to laying position and assist client with coaching her to take slow deep breaths. Fire department paramedics arrived at 1:47pm and assumed care. Client was wheeled out on a gurney at 1:50pm.
17 2021-06-13 incoherent Patient had vaccine administered at 10:11AM. Patient returned to pharmacy with parent (mom) visibly ... Read more
Patient had vaccine administered at 10:11AM. Patient returned to pharmacy with parent (mom) visibly weak and incoherent approximately 15 minutes after receiving vaccine. Patient was moved to pharmacy waiting room and blood pressure was immediately taken. Patient did not report difficulty breathing, swelling of lips, tongue or throat. Just that she was very dizzy and could not hear. Blood pressure 75/30, Heart Rate 44 bpm. with first reading. Second reading 75/30, Heart Rate 50 bpm. EMS was activated immediately and arrived approximately 5-7 minutes. Patient was provided with bottle of water and remained under pharmacist observation until EMS arrived. Patient did not lose consciousness and reported feeling better after sitting down. EMS reported her blood pressure was 80/54 and patient was taken to the hospital for fluids and further observation.
17 2021-06-13 nervousness About 10 minutes after vaccination, patient felt lightheaded, nausea and appeared to be pale. She wa... Read more
About 10 minutes after vaccination, patient felt lightheaded, nausea and appeared to be pale. She was nervous and felt scare at the time of vaccination. We found out patient didn't eat and wasn't hydrated. We provided water, orange juice and father approved for us to call paramedics. Paramedics didn't take her away. We were informed that patient had low blood pressure but did not go to the hospital. I followed up with patient and she said she was okay and she had food to eat. I informed patient to try to reach out to the family physician for follow up and discussion about the vaccine.
17 2021-06-14 feeling abnormal Systemic: Tachycardia-Mild, Additional Details: patient reported having rapid heart beat as she was ... Read more
Systemic: Tachycardia-Mild, Additional Details: patient reported having rapid heart beat as she was checking out. Had her sit, checked pulse, it was 73 but could feel full pressure of beat. She said she was feeling pouding. Had her sit another 15 min, she was feeling a little 'out of it', rechecked pulse and rhythem felt irregular. NO other symptoms. Mom was going to call PCP right away or go to Urgent Care. Did not want us to call an ambulance
17 2021-06-15 confusional state Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unrespo... Read more
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Tinnitus-Medium, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Medium
17 2021-06-16 disorientation, confusional state At around 9:25 am on Thursday, June 17th, 2021, seventeen-year-old patient walked into the vaccinati... Read more
At around 9:25 am on Thursday, June 17th, 2021, seventeen-year-old patient walked into the vaccination site. She was accompanied by two guardians, along with 14 other minors. The minors came in for their 2nd shot of Pfizer Covid-19 vaccines. Patient signed all necessary consent forms and pre-vaccination checklist requirements with guardian and entered the vaccination section at around 9:35 am. The Pfizer vaccine was administered at 9:39 am. Observation nurse reported that around 10:06 am the patient complained about having a severe headache, ?seeing stars?, feeling very dizzy, and not feeling well. Nurse assisted patient to lay down on the mat in case the patient may faint. Charge nurse obtained a pulse oximetry reading of 95% and a pulse of 96. Charge nurse checked if the patient experienced any symptoms of hives/redness, shortness of breath, or any difficulty breathing or swallowing. The patient complained to observation nurse that she was having a hard time breathing, severe headache, and chest pain. Observation nurse instructed patient to be calm and to relax. Charge nurse instructed the patient to take deep slow breaths to help increase O2 levels but the patient complained to the observation nurse that she cannot breathe through her nose. At 10:15 am charge nurse continuously monitored the patient?s B/P, pulse, and O2 level readings. The BP reading was 117/64 with a pulse of 78 and an O2 level of 100%. At approximately 10:16 am, patient started showing signs of change in LOC and lost consciousness for a few seconds. First responder paramedics from the first minor incident were still at the scene waiting for the 2nd ambulance to arrive. The first responder paramedic did a sternum rub using his knuckles with a closed fist to the center of the patient?s chest and immediately after the patient gasped for air and regained consciousness. The patient remained in a sitting position on the floor to be able to breathe easier. At approximately, 10:18 am charge nurse took another BP reading of 121/76, a pulse of 96, and O2 level of 99%. At approximately 10:20 am, patient started exhibiting a change in LOC and was very disoriented again. Observation nurse kept calling the patient?s name but did not get a response. This lasted for around 30 seconds while the patient gasped for air before becoming responsive again. At this time observation nurse observed that patient could not recall her name and did not know how she got there. At approximately 10:22 am, charge nurse took another BP reading of 165/133, a pulse of 122, and an O2 level of 96%. At around 10:24 am, the charge nurse took another BP reading of 112/78 and pulse of 112 with an O2 level of 96%. The second ambulance arrived at approximately 10:26 am and took over. The second ambulance?s first responder paramedics left with patient at approx. 10:29 am and took her to hospital for further observation.
17 2021-06-17 nervousness Patient was given the second dose of Pfizer brand Covid-19 vaccine by our immunizing tech. and said ... Read more
Patient was given the second dose of Pfizer brand Covid-19 vaccine by our immunizing tech. and said patient was ok until she stood up to leave the immunization room and that is when she immediately fainted and slumped back into the chair. Within a few seconds she regained consciousness. Mom said she had not eaten anything before coming and has fainted before when having blood drawn. (patient does have a fear of needles) We had the patient sit the immunization room for around 20 minutes. We got her some juice and a wet cloth upon moms request as she was sweating and shaky feeling. After sitting for a while she said she was feeling better and mom declined further care and we advised she follow up with her PCP
17 2021-06-20 anxiety Systemic: Body Aches Generalized-Medium, Systemic: Hyperventilation-Medium, Systemic: Joint Pain-Med... Read more
Systemic: Body Aches Generalized-Medium, Systemic: Hyperventilation-Medium, Systemic: Joint Pain-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Pt began to display symptoms related to anxiety that progressed to hyperventilation/nausea/full on body aches/ pt states she was then unable to move her arms/legs/hands due to body aches. Pt reported that her body was aching and that she was feeling nauseated. Pt's fingers were turning blue due to intense clenching. Paramedics/Ambulance called for so pt can be further evaluated.
17 2021-06-20 nervousness Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient nervous/anxiety about shot, pa... Read more
Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient nervous/anxiety about shot, patient received shot. Approximately 5 min after vaccine, during patient's 15 min, patient became lightheaded, then fainted. Patient then became responsive less than a minute after fainting. 911 was called at 6:58pm. EMT arrived, took over and patient/mother declined to hospital transportation. Patient left pharmacy on own.
17 2021-06-22 confusional state About 5 minutes after shot, pt felt extremely unwell, really hot, pale, blurry vision, confusion, a... Read more
About 5 minutes after shot, pt felt extremely unwell, really hot, pale, blurry vision, confusion, and feeling of fainting. After an ice pack , and Gatorade pt felt well enough to go home approx. 30 minutes after shot
17 2021-06-22 loss of personal independence in daily activities Within 13 hours of the second dose of the covid 19 vaccine, patient started to have tachycardia. She... Read more
Within 13 hours of the second dose of the covid 19 vaccine, patient started to have tachycardia. She got a notification from her watch that her heart rate was elevated for an extended period of time. Patient states it has gotten over 200 at times. Heart rate can increase with walking or going up stairs. Patient unable to do normal activities due to this. This does seem to be improving, but still present four weeks after the second vaccine.
17 2021-06-22 nervousness Client received the Pfizer COVID vaccine (lot #EW0187 and expiration date 7/15/21) at approximately ... Read more
Client received the Pfizer COVID vaccine (lot #EW0187 and expiration date 7/15/21) at approximately 3:30pm. Client came in for first dose Covid-19 vaccine and PHN submitted medical consult regarding concerns from mother due to client having a reaction to a vaccine at the age of 7 where she broke out in a rash and then had to go to the hospital. Mother of client reports she has no allergies and they never figured out what caused the reaction. When she was younger she had asthma and used an inhaler. Per Mother client has not needed an inhaler or had any asthma symptoms for a long time. Client reports she is just getting over a mild cold (runny nose) because her sister is a doctor and said it was not COVID and she's on antibiotics. Client states she "feels fine" today. Per Supervisor, client approved to receive first dose with 15 minute observation. Prior to arriving to the observation area client reports feeling a little nervous due to nearby emergency with another client. PHN walked client over to observation area and client reports "feeling fine." At 3:35PM EMT alerts PHN and PHN client is having reaction. PHN and PHN arrive at 3:38pm. Client reports headache 7/10, nausea and chest pressure. Client denies feeling throat closing, chest pain or shortness of breath. At 3:38 pm, pulse 75 and oxygen sat 95%. PHN calls 911 at 3:38pm. Current medications: ampicilina 500mg, guaifenesina clorfenamina metamizol 250mg. Vitals by EMT at 3:41pm: blood pressure 160/82, pulse 66, oxygen sat 98%. At 3:42pm client reports headache on temples. At 3:44 client reports headache radiating from temples to occipital area and pain level 7/10. Vitals at 3:45pm: blood pressure 140/70, pulse 66, oxygen sat: 98%. Client reports feeling a "pinching feeling in throat". PHN clarified with client if she felt swelling, closing of throat, itchiness or shortness of breath. Client denied all, stated just "pinching feeling". During assessment, mother of client reports client is allergic to nuts. At 3:47pm Fire department arrived and assumed care. Blood pressure done by paramedics at 3:50pm 165/108. Client transported to hospital via ambulance. Client left facility with paramedics at 4:01PM.
17 2021-06-23 feeling abnormal Chest pain, sinking feeling, shortness of breath,. It lasted for 1/2 a day
17 2021-06-23 feeling abnormal High fever, very achy, body aches and pains, felt lousy, didn't want to eat or drink
17 2021-06-23 memory impairment Upon walking to recovery area patient went pale and fainted. Witnessed fall, fell and hit head on th... Read more
Upon walking to recovery area patient went pale and fainted. Witnessed fall, fell and hit head on the floor. Vital signs taken: BP:110/60 HR:70 SpO2: 98% in RA. Pt initially did not recall receiving vaccine but when asked orientation questions, she answered all appropriately (A&Ox4). Within five minutes EMS on scene to assess pt. Pt could not recall last meal, BG checked and was 91. Upon sitting up pt was nauseated and dizzy. Pt transferred to ED for follow up care.
17 2021-06-25 confusional state Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at In... Read more
Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Abdominal Pain-Severe, Systemic: Confusion-Medium, Systemic: Fever-Medium
17 2021-06-27 nervousness This was the patient's second dose of the Pfizer COVID19 vaccine. The patient came with her mother. ... Read more
This was the patient's second dose of the Pfizer COVID19 vaccine. The patient came with her mother. She was slightly nervous before getting the vaccine. The vaccine was given to her; she was pleasantly surprised that it barely hurt and even said "wow that was nothing!". Her mother did mention that the patient got her first dose at a clinic where the pharmacist who gave it to her gave the vaccine very roughly and the patient and her mother were in tears after the FIRST shot at clinic so they were so thankful that it barely hurt for her SECOND dose. Then we started talked about traveling and everyone was engaged in a pleasant conversation for about 5 minutes. Then suddenly the patient almost fell to the side but thankfully the chair that the patient was in had armrests and her mother caught her. We gave the patient a bottle of Sprit soda for her to drink. The patient was still in her chair and resting against her mother and said "I'm fine" but her mother insisted that we call 911. So 911 was called while a pharmacy team member stayed in the room to help keep and eye on the patient. After 911 was called that patient didn't need to rest against her mother anymore but she looked very pale and looked like she wanted to throw up. Shortly after the fire department and EMS came and took over the situation. When EMS came they said it probably sounded like a vasovagal reaction. Afterwards they cleared the situation and the patient and mother were fine afterwards (patient regained color in her face and looked and sounded normal).
17 2021-06-28 excessive sleepiness Initially felt common side effects such as aches generally not feeling well. Then suffered extreme ... Read more
Initially felt common side effects such as aches generally not feeling well. Then suffered extreme fatigue/tiredness, sleeping 13+ hours over night and multiple hour naps. This has continued a week after the vaccine was administered
17 2021-06-30 euphoric mood Pt stated her feet felt numb and felt overall high. Doctor addressed pt and advised pt to eat crack... Read more
Pt stated her feet felt numb and felt overall high. Doctor addressed pt and advised pt to eat crackers as well as wait 15 minutes after. Pts vitals were stable.
17 2021-06-30 insomnia Fever to 101.3 and malaise night of vaccine, "bad cough" on the following day with chest pain which ... Read more
Fever to 101.3 and malaise night of vaccine, "bad cough" on the following day with chest pain which resolved over a few days, then she developed bilateral ankle swelling and pain 80 hours later with a rash and swelling spreading up to her thighs and down through her feet. hands also swelled and turned white (sounds like Raynaud's). knee pain resulting in difficulty sleeping at night. tachycardic on exam. evaluated in clinic on 6/11 and follow up on 6/15. noted loss of appetite for a week and fatigue. Myalgias made ambulation painful. instructed to use NSAIDs and elevation and she improved over the next few days
17 2021-07-02 feeling abnormal patient began on Wednesday with funny feeling face that then progressed to numbness of the right sid... Read more
patient began on Wednesday with funny feeling face that then progressed to numbness of the right side of her face. no numbness or weakness of any other extremities.
17 2021-07-03 nervousness Systemic: Fainting / Unresponsive-Mild, Systemic: Nausea-Mild, Systemic: Vomiting-Mild, Additional D... Read more
Systemic: Fainting / Unresponsive-Mild, Systemic: Nausea-Mild, Systemic: Vomiting-Mild, Additional Details: Patient fainted 5-7 minutes after receiving the vaccine. She regain consciousness within 3 minutes before the paramedic arrived. Patient felt nauseous and vomitted. Her vitals were checked and they come out normal. Patient stated she was nervous and did not drink water and only had a bagel before getting her vaccine.
17 2021-07-04 feeling abnormal, impaired work ability Ongoing low grade fever 99-101 that has not dropped. Worsened chronic fatigue, brain fog, pain, and ... Read more
Ongoing low grade fever 99-101 that has not dropped. Worsened chronic fatigue, brain fog, pain, and orthostatic intolerance that worsen with exertion. (Symptoms alleviated after the first 3 days but did not disappear and are debilitating. Not able to work/be up for more than 1-3 hours a day). Still in the process of diagnosis. Please contact the listed doctor for more information.
17 2021-07-09 feeling abnormal Severe body pain (level 7 on 1-10 chart), headache, was kinda spaced out due to pain
17 2021-07-11 loss of personal independence in daily activities, anxiety, panic attack For the 4 weeks following the first COVID vaccine dose the patient had significant loss of taste and... Read more
For the 4 weeks following the first COVID vaccine dose the patient had significant loss of taste and smell, mild nausea, mild aches and pains and increased anxiety. This resulted in an approximate 8 lbs weight loss, an acute drop in school performance & psychiatrist increased her SSRI medication dosage. She went to the doctor for blood work and a celiac disease panel, all of which were grossly normal. Unsure if she was tested for epstein-barr virus. Her escitalopram dose was increased. After the second dose of the vaccine the patient became lethargic, lost interest in things she used to enjoy, had poor tolerance for conflict and activity. She began having panic attacks, severe abdominal pains with worse nausea and intermittent vomiting. Her menstrual periods were lasting twice as long (10 days) and she was fatigued to the point of exhaustion. As the symptoms progressed the patient started having thoughts about hurting herself, definitively not suicidal, but so overwhelmed she felt the need to hurt herself.
17 2021-07-12 feeling abnormal Pt is a 17 yr/o female who presents with numbness to right side of her face that started on Thursday... Read more
Pt is a 17 yr/o female who presents with numbness to right side of her face that started on Thursday. She reports Wednesday it felt funny but no numbness or paralysis. Patient reports Thursday she went to PMD for vaccinations face still felt funny but not numb or inability to smile or raise eyebrow. Patient reports Friday and today she is unable to lift eyebrow or smile on the right side. She has not had any blurry vision, no speech abnormality, no headaches, no extremity weakness. Patient with no difficulty ambulating. She has not had any recent illness, no hx of HSV or herpes, no hx of tick bites or removal of ticks from body and no recent fevers or rash. Mom did mention that she did have the covid vaccine pfizer on 6/15. She did not have any symptoms after the vaccines and did well until Thursday. She did receive vaccinations on 7/1, hep a and menigococcal B and conjugate vaccine. She has never had any previous reactions to vaccines. She is otherwise interactive gcs 15.
17 2021-07-12 nervousness Patient stated she was nervous and received the vaccine without incidence. After receiving the vacc... Read more
Patient stated she was nervous and received the vaccine without incidence. After receiving the vaccine while sitting the patient had what appeared to be a vasovagal response. She became pail and her eyes rolled back in her head. Patient appeared to have a seizure stuck both arms straight out and was incontinent. Patients was moved to the floor where her color returned and her pulse improved. Patient was taken to hospital via ambulance.
17 2021-07-13 sensation of foreign body symptoms of lump in throat 17 mins after vaccination given. Zyrtec 10mg po given at 1303. outcome: ... Read more
symptoms of lump in throat 17 mins after vaccination given. Zyrtec 10mg po given at 1303. outcome: no improvement or worsening of symptoms - was transferred to the PEDS dept.
17 2021-07-15 anxiety The Chief Complaint is: 17 y/o F with history of PCN allergy (reports "anaphylactic shock" as a chil... Read more
The Chief Complaint is: 17 y/o F with history of PCN allergy (reports "anaphylactic shock" as a child) presents for first COVID vaccine. Discussed risk of remote PCN allergy and merits additional observation here after vaccination. Patient agreed to vaccination. During observation period the patient became tearful and stated she was feeling dizzy. This was about 15 minutes after the injection. She was taken to the treatment area for assessment. Endorsed dizziness, headache, twitching, anxiety. Denied dyspnea, itching, globus, chest pain (or pain of any type), abd pain or swelling. 17 y/o F with dizziness, anxiety but does not appear to be having a vasovagal or anaphylactic reaction. Recommend further observation - called EMS for evaluation and transport to medical facility No treatment given as BP normal, no rash or symptoms of anaphylaxis. Will file VAERS follow up but most likely cause for symptoms currently is anxiety.
17 2021-07-16 confusional state Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-M... Read more
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Tachycardia-Severe, Additional Details: pt was very complusive and her eyes rolled back. Started sweating, pulse rate going up, light headed
17 2021-07-17 feeling abnormal Fever; she was dazed/she didn't feel good; Her arm was hurting; Sleepiness; sick; This is a spontane... Read more
Fever; she was dazed/she didn't feel good; Her arm was hurting; Sleepiness; sick; This is a spontaneous report from a contactable Nurse (patient's mother). A 17-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 30Jun2021 15:30 (at the age of 17-years-old) (Batch/Lot Number: EW0172) as single dose for COVID-19 immunisation. There were no medical history and concomitant medications. The patient had been a healthy child, she had not ever had any problems. No additional vaccines administered on same date of the Pfizer suspect. The patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s). There was no AE(s) following prior vaccinations. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 09Jun2021 (at the age of 17-years-old) (Batch/Lot Number: EW0150) for COVID-19 immunisation and with the first dose she was aright. The patient was 17 years old and got the 2nd dose of the Pfizer BioNTech Covid-19 Vaccine last day (30Jun2021) and was currently experiencing sleepiness and fever. With the first dose she was aright this second one was hitting her hard. She had came down with a fever and she was pretty much been sleeping all day. On 01Jul2021, morning at 4:30 AM, the patient got her mother up telling that her arm was hurting and that she didn't feel good after that mother gave her some Tylenol. She felt her and she was pretty warm so she gave her the couple Tylenol and they would go from there and she had been asleep ever since. The patient woke up at 4:30 AM this morning (01Jul2021) and it was hitting her hard, she woke up and the caller gave her Tylenol to break the fever. She confirms the fever started 01Jul2021. The fever seemed to have broken with the Tylenol but when she checked on her she was dazed, she had been sleeping all day she has never had her sleeping like this. When asked when sleepiness began she said, they all went to bed around 10 or 10:30 last night and her daughter had been asleep ever since then, it was ongoing. She had been a healthy child, she has not ever had any problems with her being sick. Her fever had improved but the sleepiness it seems had gotten worse. They wanted to know if sleepiness and fever are included among the commonly reported side effects after the 2nd dose of the Pfizer BioNTech Covid-19 Vaccine. She wanted to know if that was a normal situation. They were referred to HCP. The AE(s) did not require a visit to: Emergency Room/Physician Office. There were no relevant tests and investigation assessment done. Outcome of the event fever was recovered on 01Jul2021, sleepiness was not recovered and other events was unknown. Follow-up actions are needed. Further information has been requested.
17 2021-07-20 feeling abnormal, nervousness pt was nervous about getting covid 19 vaccine before entering store and after vaccine she said her h... Read more
pt was nervous about getting covid 19 vaccine before entering store and after vaccine she said her heart felt like it was beating strongly and her vision was blurred she got extremely warm to touch and clamie skin she was "tingeling" felt weird
17 2021-07-21 disorientation Had a night terror; Woke up screaming and disoriented; This is a spontaneous report from a contactab... Read more
Had a night terror; Woke up screaming and disoriented; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730), via an unspecified route of administration on 31Mar2021 at 09:30 (at the age of 17-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not have any allergies to medications, food or other products. Concomitant medication included OCP (oral contraceptive pills) from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 at 23:00, the patient had a night terror. The patient woke up screaming and disoriented. The patient ran out of the room and was screaming. The patient's mom had to "wake her up" even though it looked like the patient was awake. This had never happened before. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the event night terror and woke up screaming and disoriented were resolved at the time of reporting. No follow-up attempts are needed. No further information is expected.
17 2021-07-22 loss of personal independence in daily activities Pt.initially had acute onset left arm pain with left sided chest pain worsened with deep breathing w... Read more
Pt.initially had acute onset left arm pain with left sided chest pain worsened with deep breathing with nausea and vomiting. She gave herself her stress dose hydrocortisone, but when she did not improve she presented to the ED on 4/25/2021. EKG was performed and was normal. She was discharged with ad vice to rotate tylenol and ibuprofen and to stress dose her hydrocortisone. She, however, continued to be very symptomatic and developed tachycardia and symptoms of orthostasis. Large workup was done to assess the status of her endocrine diseases and to assess for onset of new autoimmune endocrine conditions. Laboratory evaluation was normal. troponin testing was not sent. She was referred to her primary pediatrician for further evaluation. Her pediatrician did a full evaluation and could find no cause for her symptoms. Arm pain gradually resolved but palpitations, mild sinus arrhythmia with tachycardia and symptoms of orthostasis continued. She tolerated wean of her hydrocortisone poorly and required large doses and slow weaning. Symptoms were still present and bothersome on 5/17/21 but had slightly improved, although she remained unable to attend full days of school (she is an excellent student). Case was discussed with infectious disease, who recommended delaying the second COVID vaccination, so this was done. Eventual working diagnosis was marked vasomotor instability of unclear origin, likely post inflammatory, concern for triggered by COVID vaccination. cardiology referral was placed. She was seen by cardiology 7/6/2021. EKG showed sinus arrhythmia and borderline right axis deviation, unchanged from ED presentation 4/25/2021. echocardiogram revealed only previous PDA closure. Cardiology placed event monitor and noted low suspicion for myocarditis, but consideration of cardiac MRI in future if no improvement.
17 2021-07-26 anxiety Client received 2nd COVID dose @ 12:50 pm, complained of feeling anxious and "heavy head" feeling at... Read more
Client received 2nd COVID dose @ 12:50 pm, complained of feeling anxious and "heavy head" feeling at 1:00pm. Client reports history of anxiety. Denied shortness of breath or difficulty breathing, Placed in zero-gravity chair, given water to drink. Client was offered Benadryl, decined. Client denies medical issues or allergies, not taking medications. Client observed for 30 minutes, vital signs stable. Able to walk out of observation area at 1:32 pm with steady gait, aunt is present with her. Educated on when to call 911 and to follow up with primary care.
17 2021-07-27 loss of personal independence in daily activities received the 1st dose of the Pfizer covid vaccine but tested positive to covid 5 days after; Vomited... Read more
received the 1st dose of the Pfizer covid vaccine but tested positive to covid 5 days after; Vomited; got really shaky; not able to drive; bad headache; This is a spontaneous report from a contactable pharmacist. A 17-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 vaccine, formulation: solution for injection, Batch/Lot Number: EW0198), dose 1 via an unspecified route of administration, administered in Deltoid Right on 29Jun2021 (17-year-old at the time of vaccination) as dose 1, single for covid-19 immunisation. Medical history reported as none. Concomitant medication(s) included fluoxetine hydrochloride (PROZAC) 40 mg once daily taken for an unspecified indication, start and stop date were not reported. On 30Jun2021, the patient experienced Vomited, got really shaky, not able to drive and bad headache. The patient received the 1st dose of the Pfizer covid vaccine but tested positive to covid 5 days after sars-cov-2 test positive on 05Jul2021. The reporter stated her daughter received the first dose and then ended up testing COVID positive. She received her first Pfizer Vaccine and she ended up with Covid positive, 5 days later. So, my question is with her second vaccine, do they recommend any way or not, should we, because she had the first one and became infected. She also had side effects from the first vaccine. Side effects: Pharmacist stated," I know she vomited, she got really shaky, really bad headache and she was not able to drive." Laboratory test: Pharmacist stated, "No lab but she tested COVID positive e on 05Jul2021 from 'PCR' (Not spelled) COVID test. The outcome of the events were unknown. The patient underwent lab tests and procedures which included PCR sars-cov-2 test: positive on 05Jul2021. No follow-up attempts are possible. No further information is expected.
17 2021-07-27 nervousness Patient received vaccine at roughly 2:40 pm on 7/28/21. Was advised to stay at location for 15 minut... Read more
Patient received vaccine at roughly 2:40 pm on 7/28/21. Was advised to stay at location for 15 minutes prior to leaving . Patient was shopping in store and fainted . Found patient lying on floor with her mother by her side . Patient was alert but shaken . Patient said she had hit her head and scraped her leg. patient was put into a chair and given some juice and an ice pack for back of neck . After about 10 to 15 minutes patient said she felt well enough to walk and was taken home by her mother .
18 2021-01-05 feeling abnormal Time course: Received Pfizer COVID vaccine 1515. Had immediate reaction. See next page.
18 2021-01-12 anxiety Systemic: Chills-Mild, Systemic: patient reported some dizziness and tingling and anxiety. Patient h... Read more
Systemic: Chills-Mild, Systemic: patient reported some dizziness and tingling and anxiety. Patient had a pulse of 125 and temp 98.4 Called emergency services and continued observing patient till they arrived; symptoms lasted 0 days
18 2021-01-12 impaired work ability vomiting, diarrhea. called in sick to work.
18 2021-01-17 impaired work ability Patient felt dizzy and short of breath. Complained of feeling like her heart was racing and chest p... Read more
Patient felt dizzy and short of breath. Complained of feeling like her heart was racing and chest pain. Was seen in the ED and received antihistamines and was monitored. Continued to complain of symptoms 7 days after receiving the vaccine and called in to work that day as well.
18 2021-01-26 anxiety Got the vaccine about 12:30 and an hour later she said she felt she felt she was having difficulty s... Read more
Got the vaccine about 12:30 and an hour later she said she felt she felt she was having difficulty swallowing, but she does have history if anxiety but was given 1 Benadryl by nurse Elissa and observed for her for 20 min then pt. claimed to felt fine and went to, nurse instructed her to call if she had any problem.
18 2021-02-03 feeling abnormal 4 February 2021@0300-patint says she had body aches, Threw up, fever HA and SOB @ this time 1000-4 F... Read more
4 February 2021@0300-patint says she had body aches, Threw up, fever HA and SOB @ this time 1000-4 February 2021-she feels poopy/crappy I reminded her to go to the ER if she gets worse Motrin doesn't really help her feel better-she can sip some Gatorade to assist with the HA, BA & fever
18 2021-02-16 anxiety Patient felt light headed and needed to sit down, she said her tongue we itchy, paramedics were call... Read more
Patient felt light headed and needed to sit down, she said her tongue we itchy, paramedics were called, Breathing was fine, Pulse was fine, blood pressure was fine, paramedics thing patient had anxiety
18 2021-02-18 anxiety Patient received second dose of Pfizer vaccine on 2/5. Patient was anxious during administration of ... Read more
Patient received second dose of Pfizer vaccine on 2/5. Patient was anxious during administration of vaccine. Discussed how patient felt after first dose vaccine and SE experienced (sore arm only - tolerated well). After she calmed down, then administered vaccine when pt felt ready. ~10/15 min later patient reported flushing, trouble catching breath, pulsing headache & shaky. Gave 2 Benadryl, monitored BP/HR (normal), injection site (normal), no angioedema/blocking of oral cavity/throat. Patient advised to lay down and reported feeling better ~ 1 hour later.
18 2021-02-26 feeling abnormal Staff at facility informed staff that a staff member had passed out. RN from drug store found clie... Read more
Staff at facility informed staff that a staff member had passed out. RN from drug store found client sitting in a chair, awake and alert, no signs of injury. Had client lay down and elevated legs. BP at 1:50 PM is 122/86, HR is 100, regular and strong, color is good, mentation is good, no signs of injury, client state she feels "weird and tingling". Patinet monitored for over 30 minutes with multiple BP and HR checks and mentation checks. One dose of Bendaryl 25 mg given at 1:57 PM. Orthostatics completed at 2:00 PM. Both HR and BP remain WNL and client continjues to be awake and alert,. Ambulated to bathroom with RN at side. Patient declines need for EMT and went home with her boyfriend at 2:20 PM, BP at 132/88, HR at 80.
18 2021-03-20 confusional state, anxiety c/o visual disturbance - no change acuity- "bright white" everything; acting dazed & confused - tur... Read more
c/o visual disturbance - no change acuity- "bright white" everything; acting dazed & confused - turning head side to side though able to answer appropriately & follow commands; A&O x 3 (reported never doing well with "shots", anxious today as always - mask removed - car door opened- emotional support - waited 15 mins in observation X 1.5. symptoms resolved - driven home by parent.
18 2021-03-26 altered state of consciousness About two hours after getting vaccinated, Patient had her first ever migraine and the pain was so in... Read more
About two hours after getting vaccinated, Patient had her first ever migraine and the pain was so intense she passed out. Paramedics transported her to ED where she had altered consciousness for about another 4 hours.
18 2021-03-26 disorientation After getting my second shot, I felt extremely dizzy and disoriented. My vision became blurry and I ... Read more
After getting my second shot, I felt extremely dizzy and disoriented. My vision became blurry and I had trouble breathing. I also threw up several times. I felt lightheaded for a few more minutes and then I was able to stand again.
18 2021-03-31 motion sickness I was already dealing with C Diff and still am, but it caused me to become extremely motion sick in ... Read more
I was already dealing with C Diff and still am, but it caused me to become extremely motion sick in the car ride home and I had to keep pulling over to vomit. As soon as I got home my injection arm started to hurt really bad and now the morning after I can't move my arm due to the pain.
18 2021-04-01 irritability Adverse event: Hives on whole body Symptoms: itchiness and irritability Time course: at beginning of... Read more
Adverse event: Hives on whole body Symptoms: itchiness and irritability Time course: at beginning of day until treatment is taken Treatment: Benadryl Outcome: nothing life threatening
18 2021-04-05 feeling abnormal PT RECEIVED SHOT, SAT ON CHAIR FOR 5 MINUTES. PT STATES SHE DOESN'T FEEL GOOD AND SLOWLY FELL OUT OF... Read more
PT RECEIVED SHOT, SAT ON CHAIR FOR 5 MINUTES. PT STATES SHE DOESN'T FEEL GOOD AND SLOWLY FELL OUT OF HER CHAIR. I WAS ABLED TO CATCH HER IN TIME AND LAY HER DOWN ON THE GROUND. PT LOST CONSCIOUSNESS AND STOPPED BREATHING. WAS ABOUT TO PERFORM CPR BUT PT WOKE UP BY HERSELF AND ACTED NORMAL AGAIN.
18 2021-04-05 insomnia PT STATED NOT FEELING WELL AND SHE SAID SHE IS NOT ABLE TO SEE. PT FELT DIZZY AND FAINTED. SHE FELT ... Read more
PT STATED NOT FEELING WELL AND SHE SAID SHE IS NOT ABLE TO SEE. PT FELT DIZZY AND FAINTED. SHE FELT BETTER AFTER ELEVATING FEET AND WAITED 30 MIN FOR OBERVATION.
18 2021-04-06 anxiety Anxiety, headache, arm pain. Pt transported to ER. No follow up info available.
18 2021-04-07 anxiety Patient with known allergies to PEG. Had a slight reaction of hives following 1st dose. Patient cons... Read more
Patient with known allergies to PEG. Had a slight reaction of hives following 1st dose. Patient consulted with her PCP and oncologist and her oncologist was adamant that she was to receive her 2nd dose, not an option to not receive despite documented PEG allergy. After receiving 2nd dose approx 5-10 min later in monitoring area reported to EMS RN feeling dizzy, flush, and eye flutter. EMS evaluated, vitals HR 104, RR 21, BP 137/98, PulseOx 97%. RN noted patient was very anxious and this contributed to the patients symptoms. However, the patient did begin developing mild flushing and small red patches on arms, legs, trunk. Hives and flushing resolved within 30 minutes. Approx 45 minutes post reaction symptoms, patient reports feeling better, flushing resolved. Denied wanted further workup or transfer to ER and left with her mother.
18 2021-04-08 disorientation Patient was reported to have fainted in an aisle about 10 minutes after administration of the vaccin... Read more
Patient was reported to have fainted in an aisle about 10 minutes after administration of the vaccine. Upon arriving the patient was conscious but appeared to be disoriented, sitting in a chair. 911 was called and a police officer responded; patient was evaluated and EMT services were called in afterwards.
18 2021-04-08 insomnia Subacute paranoid delusions and A/V hallucinations for 1 week (since 3/29), in setting of severe ins... Read more
Subacute paranoid delusions and A/V hallucinations for 1 week (since 3/29), in setting of severe insomnia since second covid vaccine on 3/24. No personal or family psychiatric history. No substance use. Increased risk for delirium and encephalopathy in general given fragile brain. All medical workup for new-onset psychosis has been negative. Patient is being admitted to the inpatient psych unit.
18 2021-04-10 anxiety Systemic: anxiety-Mild
18 2021-04-11 amnesia Fainted and lost consciousness, came back quickly (30 seconds) but did not remember anything. Was ta... Read more
Fainted and lost consciousness, came back quickly (30 seconds) but did not remember anything. Was taken S/V, blood sugar test (DXT). All normal values
18 2021-04-15 nervousness Patient came to clinic with mother to get COVID 10 Vaccine. Patient received vaccine at 1515 and sta... Read more
Patient came to clinic with mother to get COVID 10 Vaccine. Patient received vaccine at 1515 and stated she felt nervous and asked for water and she vomited right after and was trembling. NP was notified. Patient was then escorted by nursing to another room to have her lay down. Patient was assisted to bed and VS were take BP LA Laying 122/89 HR 132 Oxygen Saturation 99% RA appeared pale. Patient awake and answering questions. BP at 1530 105/79 HR 101 Pulse Oxygenation 100% RA. VS at 1542 102/74 LA Laying HR 95 Pulse Oxygenation 99%. NP cleared patient to leave at 1545 stable vital signs patient stated she felt better no pallor noted no difficulty walking left with mother.
18 2021-04-17 sleep disorder 12 hours after receiving the second dose of Pfizer I felt fatigued and my injection site was red and... Read more
12 hours after receiving the second dose of Pfizer I felt fatigued and my injection site was red and swollen. 24 hours after the vaccine I was experiencing abdominal cramping, headache, and fatigue. 48 hours after I developed a severe full-body rash/hives/welts. It started as a small patch on my left arm and progressed to my hips, legs, arms, chest, back, and face - my whole body. The rash is extremely itchy and has caused me to bust blood vessels from scratching so hard and frequently. I began rotating Benadryl and Zyrtec, but it seemed to make it worse. I visited the ER in the middle of the night on 4/18 where I was given steroids and Benadryl IM along with Pepcid. The rash went away a few hours after, but has since then reappeared and I am currently running a low grade fever of 100.2. I am taking Prednisone 20mg 3x a day as prescribed by my doctor along with Benadryl 50mg every four hours and Pepcid twice a day. Despite these medications the rash continues to persist.
18 2021-04-18 delirium [April 10; Evening]: Headache with small pounding feeling, a slight fever. [April 11, Morning]: Slig... Read more
[April 10; Evening]: Headache with small pounding feeling, a slight fever. [April 11, Morning]: Slight pressure on injection sight, weak limbs, vomiting, fatigue. [April 11, Evening]: Unconsciousness, nausea, delirious, fever. [April12-14]: Extreme Migraines, dizziness, loss of balance while walking, unconsciousness, loss of appetite. Took Pedialyte and liquid pain reliever everyday.
18 2021-04-19 confusional state, emotional distress Pt and father moved into the waiting area with vehicle. According to dad, pt began seizing in the ca... Read more
Pt and father moved into the waiting area with vehicle. According to dad, pt began seizing in the car one minute after the vaccine administration. Dad called out to waiting area Monitor. Monitor called for help. LT and SPC appeared on scene. 1257 Pt was visibly having tonic clonic seizure. SPC administered EpiPen in Right Leg. 911 was called. Pt stopped seizing and was awake and confused. She then became AOx4. Pt visibly distressed and hyperventilating. 1259 Pt had tonic clonic movements and seizure again. Seizure last less than 15 seconds. Pt then became AOx4 again, distressed, and became nauseous. HR 56 SpO2 98% 1300 Pt vomited while sitting up. Still distressed and hyperventilating. RR 30. Post vomiting HR 116, SpO2 97%. Pt moved to stretcher and moved to shade. 1306 Firefighters arrived. HR 114 BP 141/46 SpO2 97% RR 24 AOx4 1312 Ambulance arrived. 1320 Pt left for medical center.
18 2021-04-19 feeling abnormal I did not feel any reactions to the vaccine for 4 days after I got it. However, Sunday night I got a... Read more
I did not feel any reactions to the vaccine for 4 days after I got it. However, Sunday night I got a really bad headache and my temperature was slightly higher than normal around 99. Then, all day on Monday I had a very intense fever, I was sweating all day, bad headache, and very fatigued. My fever was around 100.4 Monday afternoon around 2 PM and increased, I felt horrible. My fever peaked around 7-8 pm, it was around 102 degrees. I took 2 fever-reducing tylenol on Monday. I scheduled a rapid PCR COVID test for Tuesday morning. However, today (Tuesday. 4/20) I feel great and I do not have any side effects.
18 2021-04-19 nervousness, anxiety Event described to me by RN who administered the vaccine, the patient was nervous prior to receiving... Read more
Event described to me by RN who administered the vaccine, the patient was nervous prior to receiving vaccine and experiences anxiety regularly. After receiving vaccine, patient became increasingly anxious and began sweating. Blood pressure reportedly dropped to 90/70 at which time RN administered an epipen 0.3mg. 911 was subsequently called to further care for the patient.
18 2021-04-20 anxiety PATIENT HAD TIGHTNESS IN CHEST, BUT WAS ANXIOUS BEFORE GETTING THE VACCINE AND FORGOT HER INHALER. ... Read more
PATIENT HAD TIGHTNESS IN CHEST, BUT WAS ANXIOUS BEFORE GETTING THE VACCINE AND FORGOT HER INHALER. IT WENT AWAY AFTER 20 MINUTES.
18 2021-04-20 anxiety Within minutes of pt receiving covid vaccine, verbalized to 'not feel well' and fainted. A friend an... Read more
Within minutes of pt receiving covid vaccine, verbalized to 'not feel well' and fainted. A friend and staff members gently assisted pt to the floor. Immediate assessment of vital signs and pt taken to private area for monitoring. Pt may have had vasovagal response due to anxiety.
18 2021-04-20 feeling abnormal Patient: Female, Per RN notes: "1610 vaccinated L deltoid, Reaction time: 1611 Fainted, Chin lift an... Read more
Patient: Female, Per RN notes: "1610 vaccinated L deltoid, Reaction time: 1611 Fainted, Chin lift and head support, Patient recovered BP 82/55, HR 73 at 1614. Slight nausea. After vaccine administered, patient stated she "didn't feel good". Encouraged patient to deep breathe and wiggle toes. Noted pale in color and she lost consciousness. Noted breathing, still rapid response called. Patient awake, alert, transferred patient to gurney. Patient agreed to go/be transferred to the ER with security and ER nurse. "
18 2021-04-23 confusional state Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-M... Read more
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Medium, Systemic: Nausea-Severe, Systemic: Shakiness-Severe, Systemic: Visual Changes/Disturbances-Medium, Systemic: Vomiting-Mild
18 2021-04-23 feeling abnormal Patient is a 18-year-old, female. No known medical history. No known allergies. At 3:18 pm, the pati... Read more
Patient is a 18-year-old, female. No known medical history. No known allergies. At 3:18 pm, the patient received her first dose of Pfizer vaccine (lot number EW0179, expires on 08/2021) on left deltoid, given by RN. Patient informed RN that she has a history of fainting after vaccines. RN recommended the patient wait in the zero-gravity chair. Patient continued to be A&Ox3, walked herself over to the EMT waiting area with a steady, balanced, and sat down in zero-gravity chair. At 3:20 pm, patient checked in with EMT and stated she feels "fine". At 3:27 pm, while waiting in observation area, patient stated "I don't feel good" and went unconscious. EMT reclined patient into supine position. Patient remained unconscious for approximately 10 seconds. RN called 9-1-1 at 3:28 pm. Patient regained consciousness at 3:28 pm and stated "I need something sweet". At 3:30 pm, the patient's BP 69/44, RR 8/min, HR 63 bpm and weak, skin dry and cold to touch, lips pale and cyanotic. At 3:33 pm, the patient's BP was 87/60. Fire Department arrived on site at 3:34 pm. Patient was transferred to gurney by FD. Patient left facility at 3:34 pm .
18 2021-04-25 crying 1240pm: Mother called nurse to the car. Pt was crying and feeling shaky. BP 92/58 HR 62 RR18 sats 99... Read more
1240pm: Mother called nurse to the car. Pt was crying and feeling shaky. BP 92/58 HR 62 RR18 sats 99% T 98.4 Denies pain and SOB Emt called to the car, patient evaluate. Pt calmer and denies shakiness after 10 mins. Parent refuses emt to transfer to the hospital.
18 2021-04-27 loss of personal independence in daily activities, feeling abnormal symptom started 4/21, with pain and tightness in the left arm, progressively spreading up the arm ov... Read more
symptom started 4/21, with pain and tightness in the left arm, progressively spreading up the arm over the following 48 hours, and then to the distal right arm, and legs. The leg symptom were present when seen 5 days ago, though were not discussed as Patient wasnt sure if thats what was really starting. This is associated with a feeling of "not being able to feel muc" and "doesn't feel right", as if it "feels foreign... body says this is weird," and feels heavy. Also notes that different extremities feel different - left is worse than right. Seen 5 days ago, and noted to have been advised by hematology to stop eliquis approximately 2 weeks prior to onset of symptom after PE/Renal artery embolism 1/2021. At that visit was referred to ER, where workup for repeat clot was normal (CTA, b/l upper extremities dopplers, head/neck CT, CXR). EKG was notable for Sinus tach and nonspecific T wave abnormalities. Discharged home with close follow up. Since then the intensity of the symptom as worsened and the leg symptoms have gotten more pronounced and consistent with the upper extremities symptom. Today notes new difficulty getting dressedon because clothes were getting stuck/he couldnt pull them down. Also notes when his left arm is touched it causes burning pain that shoots up the arm. Reports headache. 2-4/day, last 30 minutes, 5/10 in severity. Worse with movement of head. Frequent nausea, no emesis. but not specifically associated with headache. No waking from sleep. Since PE, has complains of intermittent left sided squeezing chest pain, which he wonders may be due to his anxiety. Lasts a few minutes Received Pfizer COVID vaccine 3/29, hasnt received 2nd dose yet ROS: general: no fevers or weight loss. CHRONICALLY C/O FATIGUE AND TROUBLE FOCUSING. has had evaluation for executive function difficulty in the past (interdynamics), now purusing evaluation at Neurology and awaiting EEG with this. HEENT: no sore throat. + VISION CHANGES - TROUBLE FOCUSING, but not specifically blurry vision. CV: LEFT SIDED CP, NONSPECIFIC T WAVE CHANGES ON LAST EKG W/SINUS TACH. Pulm: SOB, with walking up and down stairs, since PE. not worsening. No Cough. GI: +NAUSEA, no vomitting, no abdominal pain. No current diarrhea. Neuro: + HEADACHES. + SENSORY CHANGES. + family h/o MS
18 2021-04-28 incoherent I passed out in the car.; My blood pressure was extremely low; I was pale and incoherent; I was pale... Read more
I passed out in the car.; My blood pressure was extremely low; I was pale and incoherent; I was pale and incoherent; This is a spontaneous report from a contactable consumer. An 18-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 08Apr2021 13:30 (Batch/Lot Number: ER8734) as SINGLE DOSE for covid-19 immunisation. The patient's medical history was reported as none. Pfizer shot was administered at 1:30 pm. The patient's mother decided to drive her car home. 10 minutes later the patient passed out in the car. The patient's mom called (Number) and paramedics transported her to the ER. The patient's blood pressure was extremely low, She was pale and incoherent. The patient underwent lab tests and procedures which included electrocardiogram: unknown result on an unspecified date. Therapeutic measures were taken as a result of i passed out in the car, my blood pressure was extremely low, i was pale and incoherent, i was pale and incoherent: EKG, a bag of fluids and monitoring. The outcome of the events was recovered in Apr2021. The event passed out was assessed as serious (medically significant).
18 2021-04-29 anxiety Patient, Received her first dose Pfizer vaccine (LOT#: EW0179 EXP: 8/2021) at 1347 on 4/28/21. Patie... Read more
Patient, Received her first dose Pfizer vaccine (LOT#: EW0179 EXP: 8/2021) at 1347 on 4/28/21. Patient was anxious and nervous at vaccination table. Patient was moved to the gravity chair by RN to vaccinate patient. Patient felt anxious and dizzy after vaccination. PHN recommended patient stay 30 minutes for observation. Patient agreed. EMT took patients vital signs at 1407. BP: 110/75, pulse: 85, O2: 100%. Patient was given orange juice. Patient stated that she felt much better after relaxing and sipping her orange juice. EMT reassessed patient and re-took vital signs at 1425. BP: 110/75, pulse: 75, O2: 99%. Patient stated that she was feeling much better. Patient completed observation time. Patient walked out of vaccination site unassisted and with a steady gait.
18 2021-05-03 nervousness The patient was very nervous of the vaccine and of needles & informed the certified technician of th... Read more
The patient was very nervous of the vaccine and of needles & informed the certified technician of this. She talked to her to calm her prior to administering the vaccine. Said patient was shaking during the administration. The technician informed her we would have her sit & wait for 15 minutes & when she got up she was shaking and said she was going to pass out. The technician called for assistance & told the patient to sit back down. Pharmacist came and patient did faint in the chair. We tapped her a few times and held her up in the chair for a short time until patient came to. Patient called her mom & we gave her crackers, orange juice and held ice packs on her and talked with her until her mother came.
18 2021-05-04 nervousness Patient was nervous about the vaccination. She was seated for observation then fell to the ground du... Read more
Patient was nervous about the vaccination. She was seated for observation then fell to the ground during observation. She did not lose consciousness and was asked to stay until she fully recovered.
18 2021-05-05 anxiety Patient became very pale and whole body sweating. Patient reported ears ringing and black spot in vi... Read more
Patient became very pale and whole body sweating. Patient reported ears ringing and black spot in vision. Also, said arms were tingling. lasted approximately 15 minutes
18 2021-05-05 anxiety Client explained she felt dizzy and then vomited 5 minutes after receiving vaccine. Vitals signs wer... Read more
Client explained she felt dizzy and then vomited 5 minutes after receiving vaccine. Vitals signs were: BP 110/72, 98% O2, HR 72, RR 16. Client status improved after some rest and water mouth rinse. Client explained she doesn't like needles and was feeling anxious before and after receiving the vaccine. Client educated on importance of eating a full meal and to call doctor if vomiting continues.
18 2021-05-07 emotional distress vomited; nauseous; visibly distressed; hyperventilating; began seizing/visibly having tonic clonic s... Read more
vomited; nauseous; visibly distressed; hyperventilating; began seizing/visibly having tonic clonic seizure; HR 116/ HR 114; HR 56; RR 30; BP of 141/46; This is a spontaneous report from a contactable nurse. An 18-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EW0170), intramuscular, administered in the right arm on 20Apr2021 at 12:45 as a single dose for COVID-19 immunization. Medical history included anxiety from an unknown date and unknown if ongoing. Concomitant medications included fluoxetine hydrochloride (PROZAC) taken for an unspecified indication, start and stop date were not reported. The patient did not have COVID prior to the vaccination. The patient did not receive other vaccines in four weeks. The patient had not been tested for COVID post vaccination. On 20Apr2021 at 12:45, the patient and her father moved into the waiting area with vehicle. According to the patient's dad, the patient began seizing in the car one minute after the vaccine administration. The dad called out to waiting area monitor. At 12:57 the patient was visibly having tonic clonic seizure and was administered with EpiPen in the right Leg. 911 was called. The patient stopped seizing and was awake and confused. She then became AOx4 (oriented to four spheres; time/place/person/situation). The patient visibly distressed and hyperventilating. At 12:59 the patient had tonic clonic movements and seizure again. The seizure lasted less than 15 seconds. The patient then became AOx4 again, distressed, and became nauseous. Heart rate (HR) was 56 and SpO2 was 98%. At 13:00 the patient vomited while sitting up. The patient was still distressed and hyperventilating with respiratory rate (RR) of 30. The patient's post vomiting HR was 116 and SpO2 was 97%. The patient moved to a stretcher and moved to the shade. At 13:06 firefighters arrived and the patient had an HR of 114, BP of 141/46, SpO2 of 97%, RR 24 and AOx4. At 13:12 the ambulance arrived and the patient was taken to (Place). The events resulted in a visit to the Emergency room/department or urgent care. The outcome of the events was unknown.; Sender's Comments: Based on the available information, and on close temporal association, a reasonable possibility cannot be excluded that the suspect drug BNT162B2 (Pfizer-BioNTech COVID-19 vaccine) contributed to the occurrence of the serious event Generalised tonic-clonic seizure. 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.
18 2021-05-07 feeling abnormal Had brain fog around 6 hours after injection. Felt nauseous around 11:30pm and vomited around 12:00p... Read more
Had brain fog around 6 hours after injection. Felt nauseous around 11:30pm and vomited around 12:00pm
18 2021-05-07 insomnia, feeling abnormal 8:00pm - left arm soreness 2:00am - chills, difficulty sleeping 9:00am - tiredness, body aches, feve... Read more
8:00pm - left arm soreness 2:00am - chills, difficulty sleeping 9:00am - tiredness, body aches, fever 12:00pm - felt mentally out of it 11:00pm - throat soreness
18 2021-05-08 confusional state Systemic: Confusion-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsiv... Read more
Systemic: Confusion-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Feeling of passing out, in and out of consciousness, general weakness, sweats, weakness in breathing-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Severe, Systemic: Weakness-Severe
18 2021-05-09 anxiety Shortness of breath, dizziness, faint, anxiety, headache and arm pain. Transported to ER and not abl... Read more
Shortness of breath, dizziness, faint, anxiety, headache and arm pain. Transported to ER and not able to reach patient for follow up.
18 2021-05-10 anxiety 8:26am Client complaint of dizziness and anxiety. Client evaluate by EMS onsite. BP 65/34, P 34, O... Read more
8:26am Client complaint of dizziness and anxiety. Client evaluate by EMS onsite. BP 65/34, P 34, O2Sat99%. 8:37am EMS onsite started IV on client's right arm. Client reported feeling better. 8:46am client was transported to Hospital. BP 74/30, P 69, O2Sat 98%
18 2021-05-12 feeling abnormal Woke up fatigued the next day with a headache and soreness extending to the left side of my chest an... Read more
Woke up fatigued the next day with a headache and soreness extending to the left side of my chest and back. My head feels like it's stuffed with cotton and it takes a second to process what people are saying to me.
18 2021-05-18 fear Post vaccine pt stated she started coughing, got scared. pt admin Epi-pen to right thigh per self th... Read more
Post vaccine pt stated she started coughing, got scared. pt admin Epi-pen to right thigh per self then notified medical staff of s/s. VS 1051- 120-80, 78hr. No studder, wheezing noted. BS clear BLT. HR regular. Pt requested to go to ER via ambulance 911 called by fire dept . loss- BP 120/80 hr 118Resp 24, pt transported via ambulance at in stable condition. Pt mom is aware
18 2021-05-24 feeling abnormal Tingly extremities, upset. Drank water and calmed down.
18 2021-05-25 sensation of foreign body Patient received the vaccine at 4:15 pm. 4:27 staff notified of symptom onset. 4:30 BP 110/88 ... Read more
Patient received the vaccine at 4:15 pm. 4:27 staff notified of symptom onset. 4:30 BP 110/88 P 92 Patient reports feeling lightheaded and throat feels swollen 4:35 Lightheadedness comes in waves. Last ate around 12 noon. Feels like "lump in throat" slight pain with swallowing. Denes SOB, itching or N/V 4:57 No progression of symptoms, no new onset of symptoms. educated patient and Dad on signs and symptoms of severe reaction. Left with Dad at 4:57
18 2021-05-28 anxiety Patient passed out and fell on a cardboard display box, fortunately her dad who was standing next to... Read more
Patient passed out and fell on a cardboard display box, fortunately her dad who was standing next to her picked her up immediately, and said that she had anxiety and she was ok. I spoke to the patient and when she said she was ok I had her sit down on the chair. After about 15 minutes patient and father left and confirmed that she was doing ok. Next morning patients dad called and said she was doing fine, that we might need to fill out paper work regarding the incident to submit it at patients school so she would not have to take the second dose.
18 2021-05-29 impaired work ability, sensation of foreign body, feeling abnormal, sleep disorder, loss of personal independence in daily activities within 34 hours of the 2nd dose of the Pfizer Covid shot, patient began to break out in welts/hives ... Read more
within 34 hours of the 2nd dose of the Pfizer Covid shot, patient began to break out in welts/hives behind her knees. She woke up in the middle of the night with her scalp itching and her ears hot as well as the welts behind her knees. Given Benadryl which helped a little for about 2 hours but then the hives just kept spreading and growing into huge swollen itchy patches on her body. By Friday afternoon, she had tried Benadryl and calamine lotion only to have it continue to get worse. We ended up with the Urgent care by 4pm Friday, 4-30-21. They gave her Prevacid and prescribed steroid cream. They told us if it got worse or affected breathing to go ER. We went home and kept taking the benedryl every 6 Hours and using the steroid cream. as one welt would begin to disappear, others would pop up. the steroid cream did not help in that regard. the benedrul would give about 50% relief for about 2 hours before the itching got very bad. Unable to sleep to do anything, we took patient to the pediatrician that Sat morning 5-1-21. She examined her and told her to take Claritin in the morning and Zyrtec at night to help. She was hestiant to prescribe any steroids due to unknown interaction or affects with the Covid shot. She told us to keep checking in with her and also if it got worse or spread to her face/mouth or any trouble breathing to go to the ER. We went home and tried to take an oatmeal bath. It only made things worse. By 10pm that Sat night 5-1-21, the hives had spread to patient's face and lips and were affecting her throat. Her voice got very raspy. we decided at that point to take her to the ER. They started her on steroids that night. She continued taking the steroids for 5 days after that. The steroids did help make her hives go away. However, within 2 days of finishing the steroids, patient noticed that she still did not feel 100%. That Saturday 5-8-21, She began to feel light-headed and off. She also began to feel fatigued. She came home from an errand needing to lay down and feeling dizzy. A few days after that, she began to have gas and indigestion, feeling like something caught in her throat and feeling nauseous. She also noticed that there a few nights in all of this that she would wake up shivering for no reason. The shivering would continue until she woke up in the morning. This report is being filed on 5-30-21. Since her 2nd shot and after the hives, we have been dealing with ongoing dizziness, fatigue, tiredness, lightheadedness and nausea to varying degrees. She has not been able to resume regular activates of being active or working out. WE have been back to the dr.
18 2021-05-30 confusional state Systemic: Fainting / Unresponsive-Mild, Systemic: Shakiness-Mild, Additional Details: patient said s... Read more
Systemic: Fainting / Unresponsive-Mild, Systemic: Shakiness-Mild, Additional Details: patient said she felt dizzy, and the pasted out. Her boyfriend was with her, and helped me lay her on the floor. She Shook or seized for a few seconds and then came to. She was confusion at first, but then recognized her boyfriend. She asked him to call her Mom. I talked to her Mom on the phone while she was starting to feel better. We got her some water and a fan. I had her wait an extra 30 minutes after she come to.
18 2021-06-01 abnormal dreams, anxiety The night following injection, the patient experience increased anxiety, chills, possible fever, hea... Read more
The night following injection, the patient experience increased anxiety, chills, possible fever, headache, backache, generalized muscle aches, and abnormally vivid dreams throughout the night. Monitoring of symptoms is continually being addressed by the patient's mother.
18 2021-06-01 sleep disorder Chest pain/heart palpitations with onset approximately 10 hours after second COVID-19 shot. Heavines... Read more
Chest pain/heart palpitations with onset approximately 10 hours after second COVID-19 shot. Heaviness in chest, harder to breath, tightness in throat. Blood pressure normal, but heart rate increased. No fever or other symptomology. Symptoms worse reclining and trying to rest rather than upright.
18 2021-06-03 sensation of foreign body 36h after "broke out with hives and patches all over the body with extreme itching; 36h after "broke... Read more
36h after "broke out with hives and patches all over the body with extreme itching; 36h after "broke out with hives and patches all over the body with extreme itching; her ears turned red and became very hot, the hives spread to her face and into the throat; her ears turned red and became very hot, the hives spread to her face and into the throat; gastrointestinal issues; very gassy feeling of something stuck in the throat; skaes and shivered out of blue; felt lightheaded and dizzy with extreme fatigue; felt lightheaded and dizzy with extreme fatigue; nausea; This is a spontaneous report from a contactable consumer (Patient's Mother). An 18-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation solution for injection; Lot number was not reported), via an unspecified route of administration, on an unspecified date as 2ND DOSE,SINGLE DOSE for covid-19 immunization. The patient's medical history included Hashimoto's Disease. The patient's concomitant medications were not reported. The patient previously took first dose of BNT162B2 on 31Mar2021 for covid-19 immunization and experienced severe indigestion, vomiting and did not feel well. On an unspecified date (36 hours after receiving the second dose of vaccine), the patient broke out with hives and patches all over the body with extreme itching, her ears turned red and became very hot, the hives spread to her face and into the throat. The patient was prescribed steroid creams, and she self-administered three antihistamines included Zyrtec, Claritin, & Benadryl. The hives went away. After that on an unspecified date, the patient had gastrointestinal (GI) issues, she had very gassy feeling of something stuck in the throat, and had nausea to the point of being unable to eat. Also, she shivered and shakes out of the blue, felt lightheaded and dizzy with extreme fatigue. The patient received treatment with steroid creams, and antihistamines included Zyrtec, Claritin, & Benadryl for the events 36h after "broke out with hives and patches all over the body with extreme itching and her ears turned red and became very hot, the hives spread to her face and into the throat. The caller (reporter) mentioned that she heard that the vaccine causes problems in fertility hence caller asked for information on fertility studies with regards to the vaccine in response she was explained reports on the possible side effects, mentioned no information found for non-reported AEs, and referred to health care professional (HCP) for further guidance. Further, caller asked for information on how to treat or go about with the side in response she was informed that Pfizer was unable to make treatment recommendations specific for individual patients and referred to HCP for further guidance. Again, Caller asked, "how the vaccines work" in response she was explained about vaccine mechanism and CDC information. Caller asked if there was a way to measure the spiked proteins in the body as caller wanted to know how to measure/assess immunity after vaccination in response she was being explained about CDC recommendation, and referred to HCP for further guidance. Moreover, caller asked if there were other proteins in the body/organs/cells that were similar to the spike protein that our body could possibly react to in response mentioned that no information found on body components similar to the SARS-CoV2 Spike Protein, and she was referred to HCP for discussion. Caller complained and mentioned "reporter don't think all this information is being made public, it just seems to me like the issues for the vaccine is much worse for her than as if she got COVID19. Reporter really hope that the Doctors/ CDC / Pfizer and all organizations would reconsider this, especially on the possibility on the issue on the body attacking its own self." The outcome of the event hives was considered as resolved while the outcome of all other reported events was unknown at the time of this report. Information on Batch/Lot number has been requested.
18 2021-06-08 amnesia, panic attack fell straight over on her face, hitting her chin and splitting it open; felt dizzy; cold sweating; p... Read more
fell straight over on her face, hitting her chin and splitting it open; felt dizzy; cold sweating; panic attack; significant memory loss; mild concussion; dehydration; fell straight over on her face, hitting her chin and splitting it open; insufficient food intake (had not eaten yet); felt more sick then usual; This is a spontaneous report from a contactable consumer. An 18-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8736, expiration date: not reported), via an unspecified route of administration on 14May2021 as single dose for Covid-19 immunisation (Age at Vaccination: 18years). The patient medical history was not reported. Concomitant medications included fluoxetine hydrochloride (PROZAC) 10mg/day (as medications in two weeks) taken for an unspecified indication, start and stop date were not reported. No known allergies and no other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. On 15May2021, the patient felt dizzy, had cold sweating, was scared, and thought she was having a panic attack but felt more sick than usual. On 15May2021, the patient stood up from couch, walked 15 - 20 steps and then fell straight over on her face, hitting her chin and splitting it open; she was conscious when rolled over by her parents but had significant memory loss (knew her name but not her school grade or which classes she was taking). She was taken to the hospital, computerized tomogram (CT) Scan, electrocardiogram (EKG) was normal, and no evidence of seizure were there. On 15May2021, the patient was diagnosed with mild con-cussion and got stitches on the chin as therapeutic measure for her chin splitting. Doctor suggested dehydration may had been a factor, also insufficient food intake (had not eaten yet) (start date: 15May2021). The patient stayed home from school for a week with memory improving each day and still did not remember completely a period of 48 hours starting around time of vaccination however, other symptoms had resolved. The patient had never fainted before. The treatment for rest of events was unknown. The patient underwent lab tests and procedures which included CT scan and EKG both as normal, both on 15May2021. The outcome for mild con-cussion and significant memory loss was recovering; and rest all events were resolved.
18 2021-06-09 sleep disorder That night I was feeling groggy in the head which I knew is a normal side effect. But later that nig... Read more
That night I was feeling groggy in the head which I knew is a normal side effect. But later that night I couldn?t go to sleep and began to shake all over my body. I did not have shortness of breath, or heart pains- I just couldn?t stop shaking. I tried to control my breathing to help but it did nothing. After the shaking stopped I tried to sleep again but I threw up twice and could not fall back asleep.
18 2021-06-12 mental status changes, disorientation The patient was in her usual state of health until the morning of Saturday 5/29/2021, when she woke ... Read more
The patient was in her usual state of health until the morning of Saturday 5/29/2021, when she woke up with an acute-onset right-sided headache and started screaming, followed by encephalitic presentation with urination on her mom's office desk and altered mental status. She also had right-sided facial droop. Patient was not oriented to person, place, nor time. The patient was started on acyclovir 650mg every 8 hours for 14 total days (day 1 = 5/30/2021) and had relatively rapid improvement over the course of the first 2-4 days despite negative HSV 1/2 PCR. She was continued on this treatment for the duration of her hospitalization as well as for one week as an outpatient via PICC line (final day = 6/11/2021). She has not had another episode of altered mental status since the onset of treatment and is now symptom-free with mild, transient headaches lasting a matter of seconds to minutes.
18 2021-06-13 insomnia Pain in arm, then got really tired and headache felt hot yet cold, woke up around 3 AM needing to us... Read more
Pain in arm, then got really tired and headache felt hot yet cold, woke up around 3 AM needing to use restroom. Couldn't fall back asleep then checked temperature, 100.7 Took Tylenol but didn't really help. Fever went away around 10 A.M. that morning, but I was super tired and fatigue
18 2021-06-13 panic attack Nausea, vomiting, weakness, severe panic attacks
18 2021-06-15 anxiety Patient came in for first dose and told pharmacist of her existing conditions. The pharmacist had th... Read more
Patient came in for first dose and told pharmacist of her existing conditions. The pharmacist had the patient stay for 30 minutes after the vaccine. about 20 minutes later the patient began to faint. Her mother, who was next to her, caught her in her chair and told us that this happens often when she is anxious. We immediately called 911. She was in and out for a few moments so we placed out a mat for her. When she came back to conciseness, she reported pain in her joints and acid reflux. We were able to give her fimotidine for the acid reflux.
18 2021-06-15 nervousness Patient received IM Pfizer dose in Left arm at 4:10pm and moved to the waiting area. About 5-10 min... Read more
Patient received IM Pfizer dose in Left arm at 4:10pm and moved to the waiting area. About 5-10 min later she had developed a red, slightly raised blotch area around the injection site and down her left arm. She said it did not itch, but felt warm and slight burning feeling. Patient complained of being hot and nervous, but breathing was normal no chest tightness. We had her get up and go outside (with 2 nursing staff members) to see if fresh air and no mask would help calm her. On coming back in, the rash was still present and a small patch developed on her other arm. WE gave her a cold compress and measured out 75mg of liquid diphenhydramine. She took the diphenhydramine. After about 5min, we saw the rash spread to her chest and connect the upper right and upper left arm area rashes. We then called EMS to come assess the patient. After assessment by the EMT and speaking with her PCP the patient decided not to go to the hospital for observation. Rash was still present 1 hour later when patient left. Breathing remained normal throughout the entire event and no swelling of face/tongue.
18 2021-06-16 crying crying; patient came to receive meningitis vaccine and was accidentally given a third dose of Pfizer... Read more
crying; patient came to receive meningitis vaccine and was accidentally given a third dose of Pfizer covid vaccine; patient came to receive meningitis vaccine and was accidentally given a third dose of Pfizer covid vaccine; This is spontaneous report received from contactable Pharmacist. This Pharmacist reported for 18-year-old female patient that received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0180, expiry date: Aug2021) via an unspecified route of administration on left arm on 09Jun2021, (18-year-old at the time of vaccination) 0.3ml as a single dose for COVID-19 immunization. Patient previously took first dose of covid-19 vaccine and on 13May2021 received second dose of Pfizer covid vaccine. The patient's medical history included anemic. The patient's concomitant medications were not reported. On 09Jun2021, the patient experienced patient came to receive meningitis vaccine and was accidentally given a third dose of Pfizer COVID vaccine. Caller States that the patient was only 18 years old and was now crying because she was worried about having side effects. The outcome of the events was unknown. Follow-up attempts have been completed and no further information was expected.
18 2021-06-22 feeling abnormal Myocarditis The right side of my chest began feeling sore with sharp burning pain 2-3 hours after g... Read more
Myocarditis The right side of my chest began feeling sore with sharp burning pain 2-3 hours after getting home and resting at my kitchen table. I was out of breath and would feel excruciating pain whenever I would move around. I thought I was dying or going to die because of the pain I felt and spent the next 3 days resting in bed.
18 2021-06-24 feeling abnormal She did experience left arm pain, headache, swollen lymph nodes, hot flashes, and feeling blah; She ... Read more
She did experience left arm pain, headache, swollen lymph nodes, hot flashes, and feeling blah; She did experience left arm pain, headache, swollen lymph nodes, hot flashes, and feeling blah; The 18 year old daughter has experienced nausea, upset stomach (no diarrhea), and tiredness that continues.; The 18 year old daughter has experienced nausea, upset stomach (no diarrhea), and tiredness that continues.; The 18 year old daughter has experienced nausea, upset stomach (no diarrhea), and tiredness that continues.; She did experience left arm pain, headache, swollen lymph nodes, hot flashes, and feeling blah; She did experience left arm pain, headache, swollen lymph nodes, hot flashes, and feeling blah; She did experience left arm pain, headache, swollen lymph nodes, hot flashes, and feeling blah; This is a spontaneous report from a contactable consumer (Patient's Mother) via Medical information Team. The reporting mother stated that she and her two kids (son and daughter) received the first dose of the Pfizer Covid 19 Vaccine on 07June2021. Herself and her son too experienced headache, soreness in arm, and she additionally had nausea for a short period. This case is for daughter. A 18-year-old patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN0179), via an unspecified route of administration, administered in left arm on 07Jun2021 at 14:45-14:55 (Monday) (at the age of 18-years-old) as a single dose for COVID-19 immunisation. Patient has taken vaccine as everybody was getting it and was strongly suggested. Medical history included ongoing anxiety and egg allergy (reaction to egg at the age of 2 and swelled up and went through testing, she can't take a flu vaccine because it has egg in it, highly suggested to never eat an egg, she can eat cake and that has egg in it, but they do not want her to have the flu vaccine. States they have got to make sure any vaccine does not have egg in it). Patient can't take a flu vaccine because it has egg in it. Reporter stated that she panicked a bit but they told her it doesn't have egg in it, she doesn't know what the ingredients are. Patient is overweight (190- something). No familial history relevant to AEs. There was no history of previous immunization with the Pfizer vaccine considered as suspect and no additional vaccines administered on same date. Concomitant medication included vilazodone hydrochloride (VIIBRYD) taken for anxiety (started this 6-7 weeks ago), patient been on some other stuff and trying to figure that out. Sees a therapist too. Assuming Antianxiety. No prior vaccinations within 4 weeks. On 08Jun2021 (in the morning), patient had upset stomach (no diarrhea), and tiredness, left arm pain, headache. On 10Jun2021, the patient felt yucky and nauseated, lymph nodes were swollen and feels kind of blah. It was reported that the nausea has come and gone but she still complains about an upset stomach and patient has not thrown up. Those symptoms have subsided at this time. On an unspecified date, patient felt hot flashes. Patient consulted a therapist too. Patient took Advil on 08Jun2021 as a treatment as the arms were sore. Patient did not have any visit to emergency room or physician office. Reporter asked if it's normal to continue to have symptoms. The patient second dose was scheduled on 28Jun2021 and reporter asked about the chances of the same side effects with the second Pfizer Covid 19 Vaccine. The outcome of the events nausea, headache, lymph nodes were swollen, and sore left arm was recovered, while event hot flush was unknown and other events were not recovered.
18 2021-06-25 nervousness AE: patient feeling light headed and dizzy upon vaccine administration. Patient states that she has ... Read more
AE: patient feeling light headed and dizzy upon vaccine administration. Patient states that she has not eaten anything this morning prior to the vaccine. Patient also states that she feels nervous and sweaty. Treatment: patient was placed on the Trendelenburg position as well as offered water and crackers. after few minutes, patient stated she no longer feels light-headed or dizzy. outcome: Patient was discharged to /Home.
18 2021-07-01 panic attack Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Chills-Mild, Systemic: ... Read more
Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Nausea-Mild, Systemic: Tachycardia-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Vomiting-Mild, Additional Details: 911 was called. Evaluated and all vitals were good. Rescue felt it was a panic attack. Mom told to follow up with ER visit- rescue offered to call ambulance but mom denied. Patient left feeling better.
18 2021-07-02 loss of personal independence in daily activities Pt experienced mild symptoms in the first 24-48 hours after the vaccination, including sore arm, low... Read more
Pt experienced mild symptoms in the first 24-48 hours after the vaccination, including sore arm, low grade fever, chills and fatigue. These symptoms faded within 48 hours. Approximately one day later, Laila experienced an acute onset headache (tension) which has been constant for the past two months. She describes this tension headache as a band of pressure all the way around her head that never goes away. The constant headache does not interfere with her sleep but impacts her quality of life. She also has intermittent headache pain a few times a week that is more intense but which responds to Excedrin Migraine. She has been taking Topiramate for the past 3-4 weeks to try to address the tension headache but so far it has not relieved the constant headache.
18 2021-07-06 crying Covid vaccine on the late afternoon of 7-5-21. At 11pm, general body aches turned into horrific pain... Read more
Covid vaccine on the late afternoon of 7-5-21. At 11pm, general body aches turned into horrific pain all over her body. Described as stabbing pain and electric shocks. Headache, stomachache and crying. At 10am on 7-6-21, she had chest pains and a heart rate of 170. We drove to the ER. By the time she was checked into ER, heart rate was 150 and she had a fever of 101.9 Tachycardia treated with large dose of Versed given in IV?did not work. Toroidal given for pain to reduce fever. That worked. Heart rate staying at 130 and she is in horrible pain. X-rays, lab work. Atavan given at 3:40pm which helped calm her. But heart rate stayed at 130. Inflammatory blood work was elevated. D-Dimer test was elevated. CT scan normal. At 2:30am on 7-7-21, Pt finally fell asleep. She woke up with a normal heart rate in the 80s by 7am. Critical care doctors consulted with cardiology and examined her. Pain was gone, fever gone, and heart rate was normal. They think the Covid vaccine caused her tachycardia and caused a fibromyalgia flare up with her extreme pain. Extreme pain all over body ?electric pain. Headache Stomachache Chest pains
18 2021-07-07 anxiety Patient received 1st dose of covid vaccine and instantly felt dizzy. Client's skin pale, patient ev... Read more
Patient received 1st dose of covid vaccine and instantly felt dizzy. Client's skin pale, patient eventually vomited. Patient stated they were very anxious over their 1st dose. Patient fully recovered. Symptoms no longer present.
18 2021-07-08 insomnia Mild headache at bedtime the day of vaccination.; Difficulty falling asleep; This is a spontaneous r... Read more
Mild headache at bedtime the day of vaccination.; Difficulty falling asleep; This is a spontaneous report from a contactable consumer, the parent. An 18-year-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 left arm on 25Mar2021 at 13:00 (at the age of 18-year-old) as a single dose for COVID-19 immunisation. The patient medical history included kawasaki disease at the age of six years in 2008. The patient was allergic to salicylates and milk products. Concomitant medication included ibuprofen (MANUFACTURER UNKNOWN), multivitamin (MANUFACTURER UNKNOWN) and vitamin C (MANUFACTURER UNKNOWN) all were taken for unspecified indication and from unknown date. 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 was not tested for COVID-19. On 25Mar2021 at 21:30, the patient experienced mild headache at bedtime on the day of vaccination and difficulty falling asleep. It was reported that, the patient had mild, but less, headache upon waking. The patient did not receive any treatments for the adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events mild headache at bedtime and difficulty falling asleep were recovering at the time of this report. No follow-up attempts possible. No further information expected.
18 2021-07-17 impaired work ability Neck, left arm and chest pain; Neck, left arm and chest pain; Neck, left arm and chest pain; Unable ... Read more
Neck, left arm and chest pain; Neck, left arm and chest pain; Neck, left arm and chest pain; Unable to work; discomfort; Pain; This is a spontaneous report from a contactable consumer or other non-Health care professional (patient). A 19-year-old female (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/Lot number was not reported) via an unspecified route of administration, administered in arm left on 19May2021 13:00 (age at vaccination 18-years-old) as dose 2, single for covid-19 immunisation. The patient medical history reported as none and concomitant medications were not reported. The patient had no known allergies. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/Lot number was not reported), via an unspecified route of administration, administered in arm right on 28Apr2021 13:00 as dose 1, single for covid-19 immunisation with no reaction on previous exposure to vaccine. Prior vaccination, the patient had no Covid. It was unknown if patient tested covid, post vaccination. On 24May2021 12:00, the patient experienced neck, left arm and chest pain. Patient was unable to work because of the pain and discomfort. The events resulted in doctor or other healthcare professional office/clinic visit. Events considered as serious with disability or permanent damage. The patient received treatment and doctors are still working this up for the events. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
18 2021-07-19 sleep disorder Within 2-3 minutes post vaccine, dizziness, felt like I was going to faint, weak, nauseated, loss fe... Read more
Within 2-3 minutes post vaccine, dizziness, felt like I was going to faint, weak, nauseated, loss feeling both hands, burning pain pressure back of nape of neck which spread to overall head. Sat down right away, pharmacist (? tech ; administered vaccine) were both very attentive. Stayed there 30 minutes. My grandmother who is a nurse was right there with me. I live with my grandmother; and she checked my BP at home: 120/86, Apical pulse 88 regular; rechecked today 7-20-21 and it was 98/78, Apical pulse 72. That night and next one to two days some dizziness and diff. sleeping due to pressure sides of head which is slowly improving and no more dizziness.
18 2021-07-20 feeling abnormal She was instructed to sit on a chair outside of the pharmacy for observation. A bout after 10 mi... Read more
She was instructed to sit on a chair outside of the pharmacy for observation. A bout after 10 minutes I heard someone is asking for help. I saw she was sitting on the floor and complaining about dizziness and not feeling good. We called 911. She was able to talk to them and explain her symptoms. Her mom came by too. they decided to take her . I called them about 2.00PM. and talked to her mom. She was home and doing well.
18 2021-07-21 feeling abnormal Blood rushing from head to arm of injection. Also, tingling in arm of injection. Also, feeling light... Read more
Blood rushing from head to arm of injection. Also, tingling in arm of injection. Also, feeling light headed just after injection.
18 2021-07-21 impaired work ability The first day was expected, queasy, headache, body aches, some light fever. However, at 5 in the mor... Read more
The first day was expected, queasy, headache, body aches, some light fever. However, at 5 in the morning on July 21, 2021, the second day after receiving my shot, I was not able to leave my toilet, or I was going there every ten minutes. With a trash can in front of me puking out anything I had ate the day before and earlier that morning, and having explosive diarrhea on the other end. This lasted all day to the point I couldn?t eat and was sore. The next morning still having diarrhea, but fortunately able to hold down a cracker because it went right through the other end. I had COVID-19 in February 2021, and there is nothing given for these side effects, and honestly, cannot make it away from home or the toilet to make it to the doctor. I have missed now three days of work instead of the expected 1 due to these side effects.
18 2021-07-21 nervousness Woke up at 4:00 AM with nerve pain followed by weakness in both legs. Difficulty walking: unsteady a... Read more
Woke up at 4:00 AM with nerve pain followed by weakness in both legs. Difficulty walking: unsteady and shaky. Went to the emergency room immediately, and the neurologist claimed that it was most likely nerve inflammation.
18 2021-07-25 feeling abnormal 2 hours later after vaccination, patient started feeling uncomfortable. She felt better the next da... Read more
2 hours later after vaccination, patient started feeling uncomfortable. She felt better the next day, but started having persistent symptoms on 06/30/21 with difficulty to take deep breath and felt uncomfortable in the throat as well. Patient also felt dizziness on 07/01/21 - not anymore on 07/03/21. Provider scheduled a F/U visit on 07/05/21. On 07/05/21 televisit, patient chest discomfort persistent but stable; prev episodes of shortness of breath, throat discomfort, and dizziness still recurring intermittently. Provider recommended immediate evaluation; patient declined. Provider scheduled a F/U visit on 07/06/21. On 07/12/21 televisit, chest discomfort persistent but stable. Patient was no show on 07/06/21 and self reported to ER. Patient stated that easily fatigued and needing to take deep breaths; denied palpitations, LOC, MS change, or other neuro/cardio/pulmonary symptoms. Provider referred patient to F/U with cardiologist.
19 2021-01-03 impaired work ability, insomnia Day 1: pain/swelling at injection site with redness, muscle aches, joint pain Day 2: pain/swelling a... Read more
Day 1: pain/swelling at injection site with redness, muscle aches, joint pain Day 2: pain/swelling at injection site with redness, muscle aches, joint pain, headache; worked but with considerable discomfort/strain Day 3: pain at injection site, muscle aches, joint pain, headache, chills, fatigue, feeling unwell, insomnia; unable to work Day 4: extreme muscle aches, joint pain, headache, chills, fatigue, feeling unwell, insomnia, fever, sweating, sore throat, diarrhea; unable to work; attempted to see doctor but was refused care due to "CoVid-like symptoms" Day 5: extreme muscle aches, joint pain, headache, chills, fatigue, feeling unwell, insomnia, fever, sweating, sore throat, diarrhea; unable to work Day 6: extreme muscle aches, joint pain, headache, chills, fatigue, feeling unwell, insomnia, fever, sweating, sore throat, nausea; unable to work; attempted to see care at Urgent Care but was turned away for having "CoVid-like symptoms;" went to hospital per the recommendation of MD and urgent care Day 7: mild muscle aches, fatigue, feeling unwell, insomnia, sweating, sore throat; unable to work Day 8: sore throat, mild fatigue, sweating; unable to work
19 2021-01-13 sensation of foreign body 19 year old female reaction to Covid 19 vac; she is alert and orientated; complaining of rash, diffi... Read more
19 year old female reaction to Covid 19 vac; she is alert and orientated; complaining of rash, difficulty breathing, dizzy, lump in throat, headache, nausea, cough. 1 dose of Benadryl 25 mg given at 1430. Patient states she is medical fragile and has a HX of epilepsy. EMS called at 1500 evaluation mild allergic rxn will transport to hospital for further evaluation.
19 2021-01-14 restlessness Pfizer-BioNTech COVID-19 Vaccine EUA I did not experience any symptoms until the night following th... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA I did not experience any symptoms until the night following the vaccination. Around 3:30am (01/14/2021), I was awoken by intense chills. I was restless throughout the rest of the night, having hot and cold flashes. I woke up around 8:20am and felt that I had a subjective fever. I was also experiencing intense body ache and headache. I took my temperature and it showed to be 100.6ºF. I was still experiencing chills despite also feeling hot at the same time. After an hour, my temperature was 101ºF. I took 2 naproxen sodium tablets (440mg) to relieve fever. Around 10:45am, my fever reduced but my body ache and headache stayed at the same pain level. Around 2pm, I took 2 tablets of ibuprofen (400mg). My headache stopped around 8:00pm. My body aches stopped the morning of 01/15/2021.
19 2021-01-20 loss of personal independence in daily activities Extreme muscle weakness/ache, chills and shaking. Began around 11pm on 1/19/21 and mostly cleared by... Read more
Extreme muscle weakness/ache, chills and shaking. Began around 11pm on 1/19/21 and mostly cleared by 3pm on 1/20/21. Was severe enough to prevent working, paid or otherwise.
19 2021-01-24 confusional state headaches; Confusion; Fever; muscle aches all over; This is a spontaneous report from a contactable ... Read more
headaches; Confusion; Fever; muscle aches all over; This is a spontaneous report from a contactable consumer (patient). A 19-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, LOT#: EL0140), intramuscular in upper left arm on 11Jan2021 around noon at second single dose for preventative. Medical history included ongoing attention deficit hyperactivity disorder (ADHD, diagnosed when she was 14 or 15 years old), ongoing anxiety (Diagnosed when she was 16 years old), depression. Concomitant medication included ongoing methylphenidate (has been taking for about 4 or 5 years) for ADHD, to help focus and keeps her sane, ongoing primidone (has been taking less than a year) for hand tremors, ongoing fluvoxamine maleate (taking for about 4 years) for anxiety depression. The patient previously took first dose BNT162B2 on 21Dec2020 around noon, intramuscular injection in upper left arm for preventative (Lot: EJ1685). No other prior vaccinations within 4 weeks. No AE following prior vaccinations. The patient got the second dose yesterday (reported on 12Jan2021) around noon and she was experiencing not so great side effects. The biggest thing was headaches that were pretty debilitating. She was experiencing confusion and muscle aches all over. Stated that all the side effects started around the same time around 9 pm last night. The patient reported that her fever was down a bit so she was a little bit more coherent. Fever was slightly improved at 101.5. The patient took a few medicines for ADHD or anxiety and was wondering if they could have interacted with the vaccine. The events did not require a visit to emergency room and physician office. The patient reported her headache with medication was slightly better, but consistently the same. Treatment for headache inclued Ibuprofen. Outcome of event headache and fever was recovering, of event muscle aches all over was not recovered, of event confusion was unknown.
19 2021-01-27 anxiety dizziness, headache, anxiety
19 2021-02-01 feeling abnormal Anaphylactic reaction; Throat was swollen shut, couldn't talk or breathe; Throat was swollen shut, c... Read more
Anaphylactic reaction; Throat was swollen shut, couldn't talk or breathe; Throat was swollen shut, couldn't talk or breathe; Throat was swollen shut, couldn't talk or breathe; loss of consciousness; brain fog; headache; fever; severe body aches and joint aches that make movement difficult; severe body aches and joint aches that make movement difficult; severe body aches and joint aches that make movement difficult; persistent chest pain/pressure; low blood pressure; some swollen and tender bilateral lymph nodes in my neck/trapezius/left (injection site) axillary region; fatigue; decreased appetite due to nausea; decreased appetite due to nausea; This is a spontaneous report from a contactable healthcare professional. A 19-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the left arm on 25Jan2021 08:45 at a single dose for COVID-19 immunization at a hospital. Medical history included type 1 diabetes mellitus, Celiac disease, COVID-19, and heartburn. Concomitant medication included insulin lispro (HUMALOG), spironolactone, fluvoxamine, and alprazolam (XANAX XR). The patient previously took gluten, magnesium ,and iodine and experienced allergies. On 25Jan2021 09:00, patient had an anaphylactic reaction. Throat was swollen shut, couldn't talk or breathe, loss of consciousness, brain fog, headache, fever, severe body aches and joint aches that make movement difficult, persistent chest pain/pressure, low blood pressure, and some swollen and tender bilateral lymph nodes in my neck/trapezius/left (injection site) axillary region, fatigue, and decreased appetite due to nausea. Patient had a doctor or healthcare professional visit, went to emergency room/department or urgent care, and was considered life threatening illness (immediate risk of death from the event). Events was treated with epinephrine, diphenhydramine (BENADRYL), paracetamol (TYLENOL) and had oxygen. Patient was not tested post vaccination. The patient is not pregnant. The patient has not recovered from the events.; Sender's Comments: There is a plausible time relationship between vaccine administration and onset of the events in a subject with allergic diathesis. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
19 2021-02-03 feeling abnormal non stop vomiting; headache; eyes hurt; cloudy feeling in my head; done nothing but Sleep; This is a... Read more
non stop vomiting; headache; eyes hurt; cloudy feeling in my head; done nothing but Sleep; This is a spontaneous report from a contactable consumer (reporting for herself). A non-pregnant 19-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 15Jan2021 12:00 at a 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 MRNA VACCINE) for COVID-19 immunizatio. The patient experienced non-stop vomiting, headache, eyes hurt, cloudy feeling in my head and done nothing but sleep on 15Jan2021 14:00. There was no treatment received for the events. The outcome of the events was not recovered. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
19 2021-02-04 anxiety Systemic: Other- Chest tightness and anxiety
19 2021-02-14 anxiety 1540 Pt complaint of feeling nauseous, states feels this was when anxious. Pt at POD with girlfrien... Read more
1540 Pt complaint of feeling nauseous, states feels this was when anxious. Pt at POD with girlfriend. Squad was called for girlfriend earlier after girlfriend fell to ground. States anxious watching all that happen. Denies any other symptoms. Drank Capri sun. 1551 BP 118/60, RR 18, O2Sat 99%, HR 87. States feeling much better. States ready to go home. Advised pt to seek medical care if experiencing symptoms. Pt verbalized understanding. 1553 Pt left with girlfriend at his side.
19 2021-02-22 memory impairment Bells Pals half of face, numbness, weakness, headache, fever, diarrhea, nausea, chills, body aches, ... Read more
Bells Pals half of face, numbness, weakness, headache, fever, diarrhea, nausea, chills, body aches, fatigue., tics and then a few days later had a gran mal seizure, forgetfulness
19 2021-02-28 nervousness Systemic: Dizziness / Lightheadness-Mild, Systemic: Patient was nervous due to covid vaccine. -Mild,... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Patient was nervous due to covid vaccine. -Mild, Additional Details: Emt arrived, checked patient. Patient cleared no issues.
19 2021-03-09 excessive sleepiness I was tired that night and slept until 11:00 am or 12 pm and muscle aches and body aches were notice... Read more
I was tired that night and slept until 11:00 am or 12 pm and muscle aches and body aches were noticed when I woke up. Thursday night, My heart started racing very quickly and it lasted for 30 minutes - my whole chest was hurting really bad and my heart was beating hard. I had a monitor - 207 beats per minutes. Blood pressure was normal. ER - monitored my heart. I think they gave me some medication. They gave me a heart monitor to check my heart for next 14 days. There was not another occurrence.
19 2021-03-19 sleep disorder Within 12 hours after the injection I was feeling a little dizzy and very warm. I went home and chec... Read more
Within 12 hours after the injection I was feeling a little dizzy and very warm. I went home and checked my temperature before getting into bed and saw it was 103. I had chills, pain in my arm, very hot to the touch, and could not sleep through the night with the amount of pain and discomfort I was in.
19 2021-03-23 memory impairment, confusional state Around 7-7:30 PM, I started to feel weird tingly feelings run up and down all of my limbs at the sam... Read more
Around 7-7:30 PM, I started to feel weird tingly feelings run up and down all of my limbs at the same time but it was over in about 2 minutes. Then I couldn?t stop my eyes from continuously rolling back into my head. That happened for about 4 minutes or so sometimes it would happen like 3 or 4 times in a row and sometimes it would be every 20 seconds or so. I was extremely confused and forgetful for the next 40 minutes and then I slowly began to be able to recall stuff.
19 2021-03-30 confusional state Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unrespo... Read more
Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Blue lips, white face, blurry vision-Severe, Systemic: Hypotension-Severe
19 2021-03-31 anxiety Approximately 5 minutes after vaccine administration patient reported feeling an itchy tongue and so... Read more
Approximately 5 minutes after vaccine administration patient reported feeling an itchy tongue and some swelling. I examined patients tongue and it did not appear swollen. Patient denied and shortness of breath or trouble swallowing. Patient states she had a reaction in the past to a medication that caused severe swelling of her tongue in which she now has a prescription for epi pens Vital signs were taken and were normal (BP 110/70, HR 80, O2 SAT 100%). Patient was given water and asked to sit for an additional 30 minutes. Patient reports itchy sensation had gone away and she believes it was more anxiety related.
19 2021-03-31 feeling abnormal, mental impairment Extreme Brain Fog, Lapses in time, episodes of stuttering and slurred speech, difficulty with cognit... Read more
Extreme Brain Fog, Lapses in time, episodes of stuttering and slurred speech, difficulty with cognitive thinking.
19 2021-04-05 sleep disorder Soreness at injection site which makes it painful to move arm and sleep on arm, headache, tiredness,... Read more
Soreness at injection site which makes it painful to move arm and sleep on arm, headache, tiredness, overall feeling unwell
19 2021-04-08 anxiety Vaccinated around 10 am. Patient appeared anxious and stated that she did not eat all day. After vac... Read more
Vaccinated around 10 am. Patient appeared anxious and stated that she did not eat all day. After vaccination patient felt lightheaded. Water and snacks were provided, patient was laid down on cot with legs elevated. Lightheaded ness lasted for 15 minutes. Medics on site assessed patient. Vitals stable. Patient went home with father after 30 minute observation.
19 2021-04-09 excessive sleepiness Upon resting later the day of my vaccine at home, my left arm because extremely painful and sore. Wh... Read more
Upon resting later the day of my vaccine at home, my left arm because extremely painful and sore. Which I found to be normal and expected. However, I became very exhausted suddenly and ended up falling asleep 2-3 hours before my normal bedtime. I woke up 12 hours later unable to motivate myself to get out of bed. Finally, I did and went to go take a shower. I had chills as soon as I got out of bed and had to sit down in the shower for 10 minutes out of exhaustion and had the water running extremely hot but I was still cold. My arm was still in extreme pain. Finally, I arose from the shower floor and began showering when I started to feel as if I was going to puke right away. I laid down in the shower quickly becoming dizzy, and tried to puke. I dry heaved once to no avail. Immediately after dry heaving, my ears went numb and the shower noise was barely audible. My hands went completely numb. Home alone, I knew I needed to get out of the shower before I passed out. I managed to step out of the shower before immediately falling and possibly blacking out for some seconds and fell to the floor and laid there for a minute. Finally, I was somehow able to grab a towel and struggle to my bedroom and laid there numb for about 10 minutes. This episode ended at about noon but for the rest of the day, I had to sleep on and off, it exhausted me to try and eat, I had hot flashes, more dizziness, arm pain, and nausea. I called the doctor and they said there was nothing they could do and my symptoms were normal since I had COVID-19 in December.
19 2021-04-10 anxiety, crying Hf of anxiety, crying, but not able to verbalize any physical complaints BP 162/109 HR 88, only set... Read more
Hf of anxiety, crying, but not able to verbalize any physical complaints BP 162/109 HR 88, only set of vitals emus did. Pt assured that she was ok, observed for a total of 45 min until she felt calmer, was driven home by husband once stabilized
19 2021-04-10 insomnia I had a continuous headache from about 9 pm the day of my vaccine all the way through to about 12 pm... Read more
I had a continuous headache from about 9 pm the day of my vaccine all the way through to about 12 pm the next day. It never went away even while I was sleeping. I know this because I woke up multiple times throughout the night because of it. Tylenol, an ice pack, and peppermint oil did not help it. I get migraines often and these always work for those but didn't work for the headache caused by the vaccine.
19 2021-04-11 disturbance in attention, feeling abnormal The night I got the vaccine I was studying and all of a sudden I couldn?t finish my sentence and fel... Read more
The night I got the vaccine I was studying and all of a sudden I couldn?t finish my sentence and felt like I was going to pass out. My eyes unfocused, I got slightly nauseous, I went absent, and my heart raced. I couldn?t focus the rest of the night I felt very off and strange. It was very sudden and scary. I shook for like 30 minutes after. It has been happening on and off in very short durations for four days now.
19 2021-04-12 confusional state Site: Pain at Injection Site-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Med... Read more
Site: Pain at Injection Site-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Additional Details: a few minutes after the patient took the vaacine she started getting lightheaded and she came to the pharmacy counter and passed out there. i carried the patient and sat her straight in a chair. i gave her water and orange juice. patient was confused and not aware of her surrounding and said she barely could hear. once she drank the OJ she felt better. took her vitals everything was fine. pt said she felt all good
19 2021-04-13 anxiety high blood pressure, fatigue, anxiety, chest pain
19 2021-04-13 anxiety 11:30 - 124/82, RR 22, HR 92. 11:56 - 126/82, RR 18, HR 86. Pt was vaccinated with Pfizer COVID-19 ... Read more
11:30 - 124/82, RR 22, HR 92. 11:56 - 126/82, RR 18, HR 86. Pt was vaccinated with Pfizer COVID-19 (Lot # EW0158) vaccine and went to post-vacc area. Pt told post-vacc nurses that she was feeling nauseous and anxious. Pt stated that she has Hx of anxiety and this episode felt "like my normal anxiety attack." Pt denied any chest pain, SOB, or other pain or discomfort. Pt was seated outside with post-vacc nurse and given a bottle of water because Pt stated that being outside helps her anxiety. Pt sat outside for approximately 30 minutes and then stated that she was feeling better. Pt left with her mother, who was also on-site for vaccination.
19 2021-04-13 loss of personal independence in daily activities, impaired work ability The day after I received the 2nd dose I developed a strange and extremely painful type of headache. ... Read more
The day after I received the 2nd dose I developed a strange and extremely painful type of headache. Ever since then I have that same type of headache about once a week. No over-the-counter meds, heat or ice, sleep, etc. will help subdue it. The worst of it lasts a whole day. The head then lightly lingers for 1-2 days after. This headache impedes on my ability to work and go about daily activities.
19 2021-04-17 disorientation While talking to my parents I started to say things completely opposite of the conversation we were ... Read more
While talking to my parents I started to say things completely opposite of the conversation we were having. My speech began to slur and then I passed out/fainted and was unconscious for approx 1 minute. Once I came to I was disoriented and nauseated.
19 2021-04-18 panic attack Patient slumped into chair in the observation area. I rushed to her. She was hyperventilating, but n... Read more
Patient slumped into chair in the observation area. I rushed to her. She was hyperventilating, but not wheezing or making any high pitched sound while breathing. Patient was conscious, and could answer my questions coherently. Patient was told to take off her mask so she can breath more easily. Patient kept saying "I'm sorry" and was told there's nothing to feel sorry for, and we wanted to make sure she was fine. Pulse was slightly elevated. Hands were warm and sweaty. Patient asked for a bottle of water. After drinking some water she felt better. It was likely a panic attack episode. I checked on her five minutes later. She just finished talking on the phone with a family or friend. She was a lot better at this point. She agreed that that was likely a panic attack. I advised her she should be able to receive the 2nd dose later, but should consult her PCP.
19 2021-04-19 panic attack Patient had panic attack to vaccine that resolved with observation only.
19 2021-04-20 anxiety 4/21/2021 Patientwas observed post Covid-19 immunization for 15 minutes . During the observation ... Read more
4/21/2021 Patientwas observed post Covid-19 immunization for 15 minutes . During the observation period, she experienced an adverse reaction with the following symptoms: White coat syndrome, anxiety. Assessment : Time of assessment 1110. Alert and oriented and White coat syndrome. Actions taken: Water x1 Vitals sign taken VAERS form obtained and completed by RN. VS at 110- BP 130/105, P- 95, O2- 100%, recheck at 1114- 123/97, P- 89, O2= 99% Medications administered: No medication administered. Disposition: Reports no further symptoms of adverse reaction after observation for 30 minutes. Discharged home. The Patient was provided with Vaccine Information Sheet and instruction to access the V-Safe system. Immunizations Administered Name Date Dose VIS Date Route Pfizer COVID-19 Vaccine 4/21/2021 11:07 AM 2/25/2020 Intramuscular Manufacturer: Pfizer, Inc Lot: ER8735 NDC: 59267-1000-2 Electronically signed by RN at 4/21/2021 1:24 PM
19 2021-04-20 disorientation After my second dose of the Pfizer vaccine I experienced severe headache, fatigue, disorientation, a... Read more
After my second dose of the Pfizer vaccine I experienced severe headache, fatigue, disorientation, and a runny nose. My symptoms lasted one week.
19 2021-04-20 feeling abnormal Nausea; Passed out; Felt a little dizzy; Mumbling, slurred speech; Developed a "static" feeling in h... Read more
Nausea; Passed out; Felt a little dizzy; Mumbling, slurred speech; Developed a "static" feeling in her head; Eye shutting; Weakness in her left arm and leg; This is a spontaneous report from a contactable physician. A 19-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date not reported), intramuscular on 23Mar2021 as single dose for COVID-19 immunization. Medical history included seasonal allergies from an unknown date. 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, it was unknown if the patient has been tested for COVID-19. Concomitant medication included fluoxetine 60 mg taken for an unspecified indication, and an unspecified oral contraceptive. It was reported that on 23Mar2021, the patient received Pfizer Covid vaccine and felt a little dizzy on 11:00. She also started noting mumbling, slurred speech, passed out for about 15 (unspecified) after using the bathroom, developed a "static" feeling in her head and then noted her left eye shutting and then weakness in her left arm and leg. She was taken to the Emergency Room (ER) for evaluation. Symptoms lasted about 5 hours. She fell asleep in the ER. Symptoms seemed to clear by about 8:30 PM. She had lab and head CT at the hospital which were essentially normal. She felt okay the next day, but had some nausea for a couple days starting on the 3rd day on 25Mar2021. She stated she feels fine at the time of report in the Student Health Clinic and asked whether she should receive her second Pfizer dose scheduled on 20Apr2021. The adverse events result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. No treatment was received for the adverse events. The outcome of the event nausea was recovered in Mar2021, and for other events was recovered on 23Mar2021 20:30. Information about lot/batch number was requested.; Sender's Comments: Based on the information currently available and temporal association, a possible causal relationship cannot be excluded between the suspect product BNT162B2 and the reported event Passed out. 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.
19 2021-04-20 insomnia Insomnia, malaise, soreness of entire body, nausea, vomiting (over the course of two hours), dizzine... Read more
Insomnia, malaise, soreness of entire body, nausea, vomiting (over the course of two hours), dizziness, fever, and chills
19 2021-04-21 anxiety, fear Pt got fearful and anxious. Felt dizzy. EMS called to evaluate. Pt refused transport. Sx resolve... Read more
Pt got fearful and anxious. Felt dizzy. EMS called to evaluate. Pt refused transport. Sx resolved
19 2021-04-21 impaired work ability, delirium She has been ill from day of and remains sick with no relief in that time. Developed a 102 degree fe... Read more
She has been ill from day of and remains sick with no relief in that time. Developed a 102 degree fever and delirium day of and the following day. Bones hurt, chills, joints swollen. Headache, dizziness, fatigue. The fever remained for 36 hours and she's had mild fevers off and on since. Tylenol would temporarily reduce the 102 fever before it went back up. The other symptoms have remained, predominantly bone and joint pain and stiffness, fatigue, and general feeling if being unwell. Her coloring is very pale, gray-looking. She's missed work and school due to pain and fatigue. She was completely healthy pre-vaccine.
19 2021-04-21 incoherent Pt waited 5 min out of required 15 minutes. She stated she felt fine and decided to leave. As she w... Read more
Pt waited 5 min out of required 15 minutes. She stated she felt fine and decided to leave. As she was leaving, she had dizziness and fainting spell. Her brother caught her and prevented her from hitting head. She was incoherent for 5 minutes not knowing where she was. After she regain her senses, she stated she did not eat anything the whole day. She had blood pressure of 114/84. Paramedics came, evaluated and discharged her.
19 2021-04-21 nervousness, impaired work ability 9 days ago, got Pfizer vaccine #1. Immediately after vaccine, felt nausea, lightheaded. She was sitt... Read more
9 days ago, got Pfizer vaccine #1. Immediately after vaccine, felt nausea, lightheaded. She was sitting in a chair and felt unable to sit in chair, needed support. "It was too much work to talk, knew answers, hard to speak." No LOC. BIBA to ED. Athol ED notes reviewed, found to be anemic (drew off IV), subsequently not confirmed. She has ongoing nausea (without vomiting), poor appetite (eating toast with avocado, pizza pockets), fatigue (slept 11 hours and felt tired on awakening, napping), shaky (whole body), weak (unable to break apart frozen bread loaf, but no focal weakness), high HR on ambulation (on apple watch, 170-180, even 200), vertigo (when turns head, feels tilting or rarely spinning, lasting a few seconds or minutes), gets cold very easily, throat felt and appeared to be jumping, maybe a little hard to swallow. Per mother (by text) she is "shell of her former self." Works front desk has missed work except yesterday when she was able to get through a 3 hour shift. Cognition is mostly intact. She and mom do not know what to attribute this to. She if feeling better than after she left the hospital, better for a while, some worse now but not as bad as immediately after. No CP, no cough, fever. She has felt a little SOB last week, maybe after standing or taking a few steps.
19 2021-04-21 sleep disorder Extremely painful flu-like symptoms. Body aches (most painful, writhing), headaches, hot flashes. Bo... Read more
Extremely painful flu-like symptoms. Body aches (most painful, writhing), headaches, hot flashes. Body aches began at 6:30am and woke patient (myself). With acetaminophen and ibuprofen, symptoms lessened but did not disappear.
19 2021-04-23 feeling abnormal Within 5 minutes of receiving vaccine daughter felt something was not right as we sat in 15 minute h... Read more
Within 5 minutes of receiving vaccine daughter felt something was not right as we sat in 15 minute holding period. She was holding her chest. I advised her to sit and I would get help. as I turned she was standing next to me holding her chest saying she isnt feeling right. they put her on a bed and was looking for a blood pressure cuff. they placed a pulseox on her finger which showed 100. then they placed another clip on her other finger and it showed her heart rate increasing to 138 from 93 in seconds. her face was red her neck was red and she said her heart was racing. they finally found a BP cuff and her blood pressure was 148/94 which they said this was normal. it was not. they they told us to seek medical attention. She continued to complain about chest pain and racing and her face and next continued to be red. the nurse then gave her 50ml of benadryl with no relief. She was taking out by wheelchair to a waiting ambulance then to the Hospital Emergency Room. They treated her with a Steroid and IV. She was released after about 3 hours. we came home and 2 hours later went back to the same Emergency room for the same chest pain and racing at which point she now had a rash on chest and neck. this time they gave her medicine to slow down her heart which made her feel better. she was then released. Since then she continues to have heart papatations and rashes, and a heard time swallowing with a continue feeling something is stuck in her throat.
19 2021-04-26 feeling abnormal approximately 10 minutes after receiving her first COVID vaccine, the pt developed dizziness, palpit... Read more
approximately 10 minutes after receiving her first COVID vaccine, the pt developed dizziness, palpitations and feeling "out of it". heart rate regular at106 bpm, bp 131/69. the pt drank 8 oz of , her vitals were monitored every 5 minutes. she developed tremors to bilateral upper extremities, chills, and chest pressure substernally that was worse with deep inspiration the pt has a history of anxiety however she states that the symptoms were not her "typical anxiety. the pt was feeing worse and ER was recommended, the pt accepted and 911 activated. bp was 134/66, hear rate 96, pulse ox 99%, resp rate 20
19 2021-04-26 panic attack PATIENT REPORTED FEELING WARM, NAUSEATED, VOMITTING, LIGHT HEADED AND DIAPHOTRETIC. PATIENT STED SHE... Read more
PATIENT REPORTED FEELING WARM, NAUSEATED, VOMITTING, LIGHT HEADED AND DIAPHOTRETIC. PATIENT STED SHE TOOK ZOLOF THIS MORNING AS HE HAS PANIC ATTACKS. PATIENT REPORTED TO FEEL BETTER AFTER VOMITTING AND KNEW THAT THE VOMITTING WAS DUE TO PANIC ATTACK AS THIS IS THE SYMPTOM THAT MANIFEST DURING THE EPISODE OF PANIC ATTACK. O PATIENT WAS INSTRUCTE TO WAIT OUT 15 MINUTES AND NOTIFY OBSERVER IF SYMPTOMS OCCUR OR WORSEN
19 2021-04-27 anxiety FELT LIGHTHEADED AND C/O NAUSEA POST VACCINE. REPORTS FEAR/ANXIETY WITH NEEDLES. IMPROVED UPON ARRIV... Read more
FELT LIGHTHEADED AND C/O NAUSEA POST VACCINE. REPORTS FEAR/ANXIETY WITH NEEDLES. IMPROVED UPON ARRIVING TO OBS, AMBULATED WITHOUT DIFFICULTY. GIVEN WATER AND SNACK PRIOR TO ARRIVING TO OBS, FELT BETTER. ORTHOSTATIC VSS. FELT SIMILAR S/S ALONG WITH FEELING HOT AND "WORKED UP" PTA. ONCE S/S RESOLVED, ESCORTED TO EXIT WITH NO FURTHER ISSUES AT 1545. 1528 INITIAL/LYING BP 143/82 HR 88 RR 18 SATS 100% RA 1532 SITTING BP 97/79 HR 99 RR 20 SATS 100% 1535 REPEAT SITTING BP 137/70 HR 91 RR 20 SATS 98% RA 1537 STANDING BP 115/77 HR 88 RR 20 SATS 99% RA
19 2021-04-27 irritability Client has cerebral palsy and received vaccine during a visit. Client is non-verbal. Saturday evenin... Read more
Client has cerebral palsy and received vaccine during a visit. Client is non-verbal. Saturday evening (4/17/21), Mom noticed rash on daughters legs (groin). She stated it looked flushed red. On Sunday she noticed her face was flushed as well. She gave Tylenol on Sunday at 3:50 pm. Mom has been putting hydrocortisone cream on her face for the past week and states the rash is mostly resolved. Mom states Saturday and Sunday she was very irritable and "moody." She states as of today, 4/28/21 she is not irritable any longer and the redness from her face has mostly resolved.
19 2021-04-28 feeling abnormal At 7:40 pm on 04/27 I received my second Pfizer COVID19 shot. I felt okay for the rest of the night ... Read more
At 7:40 pm on 04/27 I received my second Pfizer COVID19 shot. I felt okay for the rest of the night and went to bed around 2am that night. The next day, I woke up around 10:30am and was sore until about 12pm when I began to feel completely awful. I was tired and no pain reliever helped with the muscle aches in my shoulders and back. I felt like my chest was being weighed down and it felt like a horrible chore to even breathe. About 24 hours after the shot, under my jaws began to hurt terribly and ice didn't do much to help it. I finally fell asleep on 04/28 around 2am and woke up on 04/29 without any pain.
19 2021-04-30 anxiety Patient began to feel light headed about 5 minutes afterward. She came up to the counter to tell us... Read more
Patient began to feel light headed about 5 minutes afterward. She came up to the counter to tell us and by the time we got to her with a chair she fainted into the technicians arms. We sat her down and she was only unconscious for about 3 seconds. We called 911. She asked for some water and we also gave her some OJ. By the time the paramedics got here she was pretty much back to normal and said she knew it was because she was anxious. She signed a refusal for the paramedics and sat for a few more minutes before she said she felt fine to leave.
19 2021-04-30 excessive sleepiness her first dose was invalid because it had not been properly stored; her first dose was invalid becau... Read more
her first dose was invalid because it had not been properly stored; her first dose was invalid because it had not been properly stored; she slept for 12 hours after the vaccine; arm hurt; This is a spontaneous report from a contactable consumer (patient). A 19-year-old female patient received bnt162b2, dose 1 via an unspecified route of administration on 19Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received a call saying that her first dose was invalid because it had not been properly stored, there was a quality assurance measure that was done and the cold chain temperure had been broken. She believes she got some immunity from the first vaccine though because her arm hurt and she slept for 12 hours after the vaccine. The outcome of the event was unknown. No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
19 2021-05-03 feeling abnormal woke up with symptoms of headache, chills, feeling like she was hit by a truck.
19 2021-05-03 nervousness 5/4/2021 Pt was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screen... Read more
5/4/2021 Pt was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening . During the observation period, she experienced an adverse reaction with the following symptoms: very nervous, complains of itching to face and lips Assessment : Time of assessment 1445. Alert and oriented and redness and visible stratching to face and lips. Actions taken: Vitals sign taken VAERS form obtained and completed by RN. VS- BP- 155/83, O2- 100 % at 1445, recheck at 1455- BP- 135/90, O2- 99%, drinking water, 1510- BP- 133/91, P- 72, O2- 100 %, 1522- BP-144/101, 1549- BP- 138/88/ P- 71, O2- 100 % Medications administered: Loratadine (Claritin) 10 mg by mouth. Time: 1505. Administered by RN. Diphenhydramine (Benadryl) 25 mg capsule, by mouth. Time: 1522. Administered by RN. Diphenhydramine (Benadryl) 12.5 ml (25 mg) by mouth. Time: 1445 and 1455. Administered by RN. Famotidine 20 mg 1 Po x 1 at 1518 by RN Disposition: Reports no further symptoms of adverse reaction after observation for 60 minutes. Discharged home. Instructed to call 911 for trouble breathing, rapid heart rate, dizziness, swelling of tongue or throat. Immunizations Administered Name Date Dose VIS Date Route Pfizer COVID-19 Vaccine 5/4/2021 2:35 PM 0.3 mL 2/25/2020 Intramuscular Manufacturer: Pfizer, Inc Lot: EW0167 NDC: 59267-1000-2 Electronically signed by RN at 5/4/2021 4:40 PM Immunization on 5/4/2021 Detailed Report Note shared with patient
19 2021-05-05 anxiety After receiving my first vaccine on 4/13/21, I had a small asthma attack after about 20 minutes that... Read more
After receiving my first vaccine on 4/13/21, I had a small asthma attack after about 20 minutes that went away quickly. After my second dose, I started feeling out of control of my muscles almost immediately. I also noticed the injection site was bleeding more than the first shot. 30 minutes later, the shaking became extensive and uncontrollable. I returned to clinic and the paramedics told me I was having an anxiety attack. The shaking continued on and at about 4:00pm I felt that my throat was puffing up. I went to the hospital and they put me on a variety of medications (Benadryl, Pepcid, and methylprednisolone). I felt better soon after. The next morning I have a sore throat, feel feverish and have a headache.
19 2021-05-05 memory impairment Patient received the [1st] COVID vaccine (Pfizer Lot # ER8732). RN 1 reported to RN 2 that client ha... Read more
Patient received the [1st] COVID vaccine (Pfizer Lot # ER8732). RN 1 reported to RN 2 that client had a reaction within the 4 hours following administration of first dose. RN 2 responded. Client report experiencing fatigue, dizziness and that the "floor looked funny" approximately 5 minutes after vaccination. Client reports she was offered EMS and client denies. Today she admits to some shortness of breath that lasted about 1 minute and that she does not fully recall what the EMTs and Nurses were telling her. RN 2 consulted with medical team who determined that this client is not eligible for Pfizer as 2nd dose. Medical team determined client can be offered Janssen as 2nd Dose. RN 2 reported to client that her name and phone number would be sent to our scheduling team for her second dose Janssen. Client verbalized understanding. Client denied additional concerns.
19 2021-05-06 anxiety, disorientation Patient expressed anxiety and a headache before vaccination, but was able to ambulate to the waiting... Read more
Patient expressed anxiety and a headache before vaccination, but was able to ambulate to the waiting area. After about 5-10 minutes, she slumped in her chair, then fell to the floor. She seemed to hit her head on the concrete floor. She was unresponsive at first, but had pulse and clear airway. Staff turned her on her side and protected. Her eyes were fluttering and rolling back. Within 3 minutes, she was able to respond to questions with her name, though she was disoriented. EMS was called at that time. She stated she had not eaten anything today, so she was given small sips of apple juice. After 5 more minutes, she was more oriented and responding to commands. EMS arrived and assisted her to a seated position. She was transported by EMS to hospital.
19 2021-05-06 confusional state Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Confusion-Medium, Syst... Read more
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium
19 2021-05-06 insomnia, disorientation Night after vaccine (4/30/2021 to 5/1/2021): had trouble sleeping despite being tired (atypical for ... Read more
Night after vaccine (4/30/2021 to 5/1/2021): had trouble sleeping despite being tired (atypical for me), felt overly warm (atypical for me) 5/1/2021, 8am: woke up feeling disoriented, fell back asleep 5/1/2021, 11:30am: woke up and could not fall back asleep, even though I still felt tired. Felt very overheated, had migraine headache, felt sore in hips, knees, and neck. Treated migraine with 2 tablets of 220mg naproxen sodium. Fell back asleep around 12:15pm and slept till 2:30pm. Felt better when I woke up. 5/1/2021, 6:00pm: headache returned, felt drowsy. Napped for approximately 1hr 45min. Woke up and headache was still bothersome. Took 2 more tablets of 220mg naproxen sodium. Headache faded. 5/2/2021: mild headache and soreness persisted on and off until the evening.
19 2021-05-07 anxiety, panic attack Dizzy Lightheaded Brain zaps Fast heart rate/pain Increased anxiety and panic attacks
19 2021-05-10 insomnia Dizziness, fatigue, muscle spasms, chills, chest pain, vomiting, insomnia
19 2021-05-10 panic attack, anxiety Patient experienced significant anxiety and panic attacks lasting several days
19 2021-05-12 crying 1:15 Patient left the building after 15 minute wait ,went to eat. Felt chest and throat tightness... Read more
1:15 Patient left the building after 15 minute wait ,went to eat. Felt chest and throat tightness and burning. Came back to COVID vaccine clinic. Also reported a headache. PSO2 100 %Pulse 72 b/p 128/82, crying ,face red. Skin pink warm and dry. Respirations even and unlabored. Informed her that her vital signs are stable , she can be taken to ER. Wanted to wait and be monitored here. 1:25 PSO2 99% pulse70 calming down called mother to talk. 1:37 PSO2 97% pulse 78 reports chest and throat tightness 1:42 Still reports throat and chest tightness. B/P 132/84 Pulse 76 PSO2 98 does not want to go the ER wants to go home. Informed to go to ER for any shortness of breath or further problems.
19 2021-05-19 anxiety 30 minutes after vaccine administration patient alerted paramedic in observation room that her arm w... Read more
30 minutes after vaccine administration patient alerted paramedic in observation room that her arm was feeling tingly and worried that due to her history she was starting to have an allergic reaction. Patient self-administered oral benadryl, waited an additional 15 minutes. Patient declined need for epi-pen and adament that she did not need to be transported to emergency room. Patient left facility stating if condition got worse she would take herself to the closest emergency room and/or call 911. Contacted patient for follow-up within 5-10 minutes after leaving building. At which time she stated that she was feeling fine and thought her seasonal allergies were exacerbating symptoms, as she stated she is very allergic to pollen. In addition, patient stated she was feeling very anxious while in observation room, however feels better once exited building. Instructed patient on signs/symptoms of worsening reaction, what to look for, and when to administer epi-pen and seek additional help. Patient verbalized understanding and stated she feels fine at this time and thinks she will be okay.
19 2021-05-19 nervousness pt passed out 5 minutes after the shot was given. Then the pt started to shake a little for about 10... Read more
pt passed out 5 minutes after the shot was given. Then the pt started to shake a little for about 10 -15 seconds. When pt came back to she vomitted. Pt felt better about 5 minutes after event.
19 2021-05-19 sleep disorder Dizziness and fatigue in head developed and lasted for two weeks after the shot that was administere... Read more
Dizziness and fatigue in head developed and lasted for two weeks after the shot that was administered on April 25th.. About 5 days after the shot in the evening, I experienced hot, shooting pain in left leg that felt like a band around my thigh but would sometimes shoot down into my calf and feet. My feet would feel tingly and sore. I experienced shooting pain on and off again in my left and right arms as well as my right leg, but the pain in my left thigh stayed for over a week. The feeling in my legs made it difficult to sleep. Two weeks after the shot on Wednesday May 12th at 11am, the dizziness and fatigue made me lightheaded and I could not keep my eyes open. My head got really hot and my vision blurred and I could feel my heart beating in my head loudly and all over my body. I tried to walk to my thermometer to take my temperature but struggled to hold things in my hands or walk properly. My sister called my mother who took me to the Emergency Room around 11:50. The doctors took urine and blood samples, X-rayed my chest and did an EKG but could not figure out what was wrong with me and discharged me at 3pm.
19 2021-05-24 loss of personal independence in daily activities i woke up on 5/4 with extreme vertigo. i wasn?t able to go to class that day. symptoms lasted the en... Read more
i woke up on 5/4 with extreme vertigo. i wasn?t able to go to class that day. symptoms lasted the entire day but got better as the day went on and were gone by 5/5
19 2021-05-26 amnesia Headache; Episode of stiffness, going pale; Episode of stiffness, going pale; 15 seconds of memory l... Read more
Headache; Episode of stiffness, going pale; Episode of stiffness, going pale; 15 seconds of memory loss; This is a spontaneous report from a non-contactable female other HCP reported for herself. A 19-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via intramuscular route of administration on 19May2021 16:45 (at the age of 19-year-old) as single dose for COVID-19 immunization. Medical history was none, and no allergies were reported. Concomitant medication included sarecycline(SARECYCLINE) contraceptive pill via oral route of administration. On 20May2021 11:00 AM, the patient experienced headache, episode of stiffness, going pale, 15 seconds of memory loss. Adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment medications for events. It was unknown whether the patient received any other vaccines within 4 weeks prior to the COVID vaccine, diagnosed with COVID-19 prior to vaccination and has been tested for COVID-19 since the vaccination. The events were reported as non-serious. Outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained
19 2021-05-26 anxiety Patient reported anxiety and light headed. Vitals stable. Laid patient down with legs elevated. cold... Read more
Patient reported anxiety and light headed. Vitals stable. Laid patient down with legs elevated. cold water offered. patient was fine 15 minutes later.
19 2021-05-27 agitation, confusional state Pt had a mild headache prior to vaccine. Developed a worse headache 2 days later that worsened to th... Read more
Pt had a mild headache prior to vaccine. Developed a worse headache 2 days later that worsened to the point she was brought by EMS to the hospital on 5/14/21. She was admitted overnight with an aseptic meningitis with severe headache, confusion and agitation. She has subsequently improved and only has mild fatigue at this time/
19 2021-05-31 anxiety Administered Pfizer COVID vaccine, 1 minute post administration, while in Observation, patient exper... Read more
Administered Pfizer COVID vaccine, 1 minute post administration, while in Observation, patient experienced lightheadedness/"heat" sensation. VS: 130/88, O2 sat 100% RA, P 88. Ice pack applied, patient reported less anxiety and feeling better. Released to home in care of parents.
19 2021-06-01 feeling abnormal Client received the 1st COVID vaccine (Pfizer Lot #EW0187 and 06/28/2021) at 1848. At 1859, Office A... Read more
Client received the 1st COVID vaccine (Pfizer Lot #EW0187 and 06/28/2021) at 1848. At 1859, Office Assistant was walking past the client when she noticed that the client appeared unwell. Assistant asked the client if she was feeling ok, the client responded, ?I feel dizzy.? Assistant alerted PHN that the client was feeling dizzy. PHN responded. The client appeared drowsy but was oriented to person and place. The client?s eyelids were open halfway, and the client was mumbling answers to the questions. The client stated, ?I feel dizzy and hot under my skin.? Vital signs were taken by EMT at 1901 (Heart rate 92, Oxygen 99%, blood pressure 112/P?client was wearing a long-sleeved shirt). Client?s skin was warm and dry. At 1902 client appeared more alert, and PHN gave the client juice to drink, which she accepted and drank. Client stated that she has a history of vasal vagal reactions to needles and was anxious about receiving today?s vaccine. EMT and PHN transitioned client to zero gravity chair at 1904 and gave client chips and a granola bar to eat. The client accepted the snacks and started to eat them. At 1905 client stated, ?my head feels weird like I want to lay back.? PHN advised client to lay her head back onto the gravity chair head rest. Client laid her head back for less than 30 seconds than continued to eat. PHN offered the client Benadryl and she refused. Client stated that the last time that she ate was around 1100 or 1200. Client was wearing a beanie and long sleeves, we asked the client if she can remove her hat and outer layer, however, she refused. The client had a flat affect and was soft spoken. Vital signs taken at 1915 (oxygen 98%, heart rate 94, blood pressure 138/84). Client denied any shortness of breath. At 1919, client stated, ?I feel like I?m going to throw up.? The zero-gravity chair was positioned into a seating position and the client was given an emesis bag. Client did not vomit, and she sat with the emesis bag until 1923 and then stated that the feeling was gone. Client has a history of sickle cell anemia and stated that she receives blood transfusions every 2-3 weeks but had not received a transfusion in 8 weeks. Client is currently prescribed Metformin but has not taken the medication because ?she does not trust it.? Client stated that she was prescribed Lexapro 1 month ago and took her first dose the day before the vaccine but did not take it the day of the vaccine. She stated that she has anxiety but denied any other medical conditions. She is allergic to Toradol. Vital signs taken at 1924 (oxygen 98%, heart rate 91, blood pressure 146/102). At 1925 she sated ?my head hurts, it?s a sharp pain.? PHN called EMS at 1926. EMS arrived at 1928 and assumed care. EMS medic stated that her blood glucose levels were at 82 and advised her that they wanted to take her to the emergency room to be examined. The client refused transport to the hospital and stated, ?I don?t want to go to the hospital, it?s so expensive.? Client continued to refuse transport and stated that she will have her boyfriend take her to the hospital. Client?s boyfriend entered the building and client signed an AMA at 1953. PHN provided education to client and boyfriend on life threatening symptoms and to call EMS if any symptoms appear on their way to the hospital. PHN also advised client to follow up with her primary care provider and to follow up with an allergist before receiving her second vaccine. Client left the facility AMA at 1954 with her boyfriend, unassisted and with a steady gait. Client and her boyfriend stated that they would go to the hospital.
19 2021-06-02 anxiety Patient had anxiety and nausea. Did vomit 1X. Patient was given water and crackers. 25 min later ... Read more
Patient had anxiety and nausea. Did vomit 1X. Patient was given water and crackers. 25 min later feel better
19 2021-06-05 anxiety Systemic: Flushed / Sweating-Mild, Additional Details: patient said she was prone to passing out fro... Read more
Systemic: Flushed / Sweating-Mild, Additional Details: patient said she was prone to passing out from anxiety of getting vaccines and within 3 minutes of receiving vaccine patient said she felt like she was going to pass out and did seem to black out for a few seconds. 911 was called but patient refused treatment and was fully recovered before leaving EMT recommended patient take antiaxiety medication before receiving another vaccine
19 2021-06-07 feeling abnormal patient started it thing really bad and it will not stop; This is a spontaneous report received from... Read more
patient started it thing really bad and it will not stop; This is a spontaneous report received from a contactable consumer (patient) reported that 19-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), first dose (lot number: Ew0151) and second dose (lot number: Er8731) both via an unspecified route of administration in right arm on unknown date in 2021 (at the age of 19 years) as a single dose for COVID-19 immunisation. The patient medical history was not reported. Patient was not pregnant at time of vaccination. Concomitant medications included fluoxetine. Patient has taken birth control medications in two weeks and has not taken any other medications in four weeks. Patient previously took lactose and had allergies. It was reported that on 22May2021, the patient started it thing really bad and it will not stop and this event resulted in Doctor or other healthcare professional office/clinic visit. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination the patient has not been tested for COVID-19, has not received any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the event was not recovered. No follow-up attempts are possible. No further information is expected.
19 2021-06-09 confusional state, nervousness As soon as patient exited the vaccination room and sat in the waiting room chair she started to feel... Read more
As soon as patient exited the vaccination room and sat in the waiting room chair she started to feel lightheaded and slumped over and fainted. She lost consciousness for less than a minute. She lost color in her skin and was confused when she woke up. Her mother and brother were with her and called for help. The pharmacist and a technician also went out to assist. Patient was seated in the chair and assisted the whole time not to fall out or get up and walk after waking back up. She was given a cold compress and water. Her blood pressure was taken and was WNL. We asked them to stay in the pharmacy an additional 15-30 minutes after to watch over her. Her mother and brother were able to stay with her in the waiting room. After resting for an additional 20 minutes patient was able to walk out on her own and color returned to her body. Her mother felt comfortable taking her home at this point. Patient is very nervous about shots and had little to eat today.
19 2021-06-09 feeling abnormal My daughter was fine on the first day. She woke up the next day with a weird headache that her scal... Read more
My daughter was fine on the first day. She woke up the next day with a weird headache that her scalp hurt. She went into work and started to feel poorly throughout the day. When she came home, she went to bed at 4:30 pm as she had aches & pains, continued headache, felt nauseous, tired, and noticed her left leg where she had surgery previously was bothering her with pins and needles. I told her to go to bed and she would be fine the next day. On 5/26, her leg was giving her increased problems where she could not flex her foot, nerve pain in her leg along with numbness, and she still had the headache. I told her to call her primary care physician and the nurse had her go the the ER. They ran no tests, but consulted with neuro on call and surgeon who performed surgery on her leg two years ago. She was instructed to follow-up with a neuro and start PT. We got her into a PT. The next day she continued to have same issues, but her leg pain increased. She followed up via phone twice to primary where the nurse told her to go back to the ER. She had blood work, ultra sound and x-ray. She saw neurologist on 6/2 and is scheduled for follow-up with an EMG on 6/14. She has seen physical therapist 6x since 5/26 and still has numbness, nerve pain, etc. The form from neuro office said left foot drop and parathesia. She has had headaches this week including a migraine on 6/8.
19 2021-06-10 nervousness, anxiety PATIENT RECEIVED UNDILUTED PFIZER COVID DOSE. DAY AFTER RECEIVING DOSE, SHE STARTED TO FEEL HOT AND... Read more
PATIENT RECEIVED UNDILUTED PFIZER COVID DOSE. DAY AFTER RECEIVING DOSE, SHE STARTED TO FEEL HOT AND COLD AT THE SAME TIME AND ANXIOUS AND SHAKEY. FEVER IN WAVES, THEN CHILLS, AND ACHES. FELT VERY TIRED.
19 2021-06-12 anxiety patient was given pfizer 1st dose vaccine at 3:35pm and at 4:40pm reported feeling hot/nausea/neck p... Read more
patient was given pfizer 1st dose vaccine at 3:35pm and at 4:40pm reported feeling hot/nausea/neck pain (stiffness). BP 102/76 HR 81. Re took at 5:04 BP 96/62 HR 86. patient did report occasional anxiety but not with vaccines. called EMT at her request.
19 2021-06-12 feeling abnormal Late night on the 12th after feeling bad due to an elevated temperature, I noticed my forehead was s... Read more
Late night on the 12th after feeling bad due to an elevated temperature, I noticed my forehead was sore like it was bruised. When I looked in a mirror, I noticed a red splotch on my forehead that felt slightly raised like it was swollen. Sunday morning I checked and it was mostly gone. It?s now a very pale red almost normal skin color and less sore but still is to touch.
19 2021-06-21 loss of personal independence in daily activities So I had some on and off chest pain for the week after I got the vaccine, I didn't think it was beca... Read more
So I had some on and off chest pain for the week after I got the vaccine, I didn't think it was because of the vaccine initially. It started to get consistent and then 2 weeks after the vaccine it became very intense pain to where I could not carry anything or sit or stand comfortably. About three weeks after my vaccine I was able to get in with a PCD and she did not attribute it to the vaccine, she put me on 600MG of Motrin every 8 hours and that managed the pain pretty well. She wanted me to take the meds for a week but the pain continued so I am now still taking the medicine. I saw my own PCD a week later and she ran a lot of tests, still no definitive answers.
19 2021-06-29 depression Severe arm pain at injection site, sudden onset dizziness about 2 hrs after injection; the next morn... Read more
Severe arm pain at injection site, sudden onset dizziness about 2 hrs after injection; the next morning, fatigue, aches & pains, extreme nausea, dizziness, passing out upon standing up (lost consciousness twice, resulting in a fall and mild head injury). For several days afterward experienced unexplained depression, not sure if it was related.
19 2021-06-29 feeling abnormal, confusional state, irritability, memory impairment Dizziness; Hungry; Tingling lips; Shakiness/ trembling; Fast heartbeat; Easily irritated; Confusion;... Read more
Dizziness; Hungry; Tingling lips; Shakiness/ trembling; Fast heartbeat; Easily irritated; Confusion; Slurred speech; Muscle weakness; Memory issues; Foggy brain; Exhaustion; This is a spontaneous report received from a contactable consumer, the patient. A 19-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206) via unspecified route of administration in left arm on 20Mar2021 at 12:00 as a single dose for COVID-19 immunisation. The patients medical history included type 1 diabetes, celiac disease, asthma, vasovagal syncope, chiari malformation and major depressive disorder. The patient was allergic with naproxen, nonsteroidal anti-inflammatory drugs (NSAIDs), avocado and almonds. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior vaccination. Concomitant medications included Humalog, Cymbalta and Remeron. On 21Mar2021 at 18:00, the patient experienced dizziness, hungry, tingling lips, shakiness, trembling, fast heartbeat, easily irritated, foggy brain, confusion, slurred speech, muscle weakness, memory issues and exhaustion. After vaccination on 21Mar2021, the patient underwent lab test for COVID-19 (nasal swab test; RT-PCR for SARS-CoV-2) and the result was pending. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for these events. The clinical outcome of the events dizziness, hungry, tingling lips, shakiness, trembling, fast heartbeat, easily irritated, foggy brain, confusion, slurred speech, muscle weakness, memory issues and exhaustion was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
19 2021-07-07 hallucination, confusional state Fever with confusion/hallucinations
19 2021-07-07 sensation of foreign body patient received vaccine, was walking store after shot was feeling dizzy and came back to pharmacy. ... Read more
patient received vaccine, was walking store after shot was feeling dizzy and came back to pharmacy. Sat down and gave her water, was still feeling dizzy with lump in throat. Had her lay down in vaccination room and called 911. paramedics came and took vitals still feeling lump in throat so they took her to hospital for observation
19 2021-07-08 confusional state Systemic: Confusion-Mild, Systemic: Fainting / Unresponsive-Severe, Systemic: Seizure-Mild
19 2021-07-13 anxiety, sleep disorder 1. My period, which I got on April 20th (18 days after dose 2), resulted in extreme and debilitating... Read more
1. My period, which I got on April 20th (18 days after dose 2), resulted in extreme and debilitating cramps, which are lasting to this day. They're so bad I can't get out of bed for the first two days of my period - then I have infrequent occasional pangs of pain on day 3, and I'm okay days 4 and 5. I have never had cramps during my cycle before April 2021. 2. On April 16th, I was driving my car and I noticed that when I had my foot on the the brake, it was shaking uncontrollably in almost every position I put my leg in. The frequency of this leg tremor during driving became more frequent, and I started noticing heightened anxiety, trouble focusing, weight loss of 7 pounds thus far (my weight has not fluctuated more then 3 pounds in the last 4 years so this was a surprise to me), lightened period, increased heat intolerance, heart palpitations that keep me awake at night and tachychardia, muscle weakness, and fatigue. I had a really stressful semester in school so I chalked these symptoms up to anxiety. Then, in the first week of June, I went to the gynecologist to get the cramps situation checked out. She told me she wanted me to check out my thyroid for the rest of the symptoms. When my blood test came back, my Thyroid Stimulating Hormone (TSH) result came back as 0.03 (lowest acceptable range is 0.4). My primary care provider ran T3 and T4 tests, which came back as 15 and 5, respectively - which are both quite elevated for their range. So, I went to an endocrinologist at my primary care provider's referral, who ran more tests. This time, they found TSH to be 0.006 (got lower), T3 and T4 were elevated, very slightly lower than they were before. My endocrinologist then ran a test for Thyroglobulin antibody, which came back as 53.3, when the highest reference value was 0.9. Thus, my endocrinologist determined hyperthyroidism, but wanted to figure out the what I had so she sent me for a thyroid uptake scan. In the scan, they found my thyroid to be working at 51%, when the highest value after 24 hours of receiving the radioactive iodine was 33%, and my endocrinologist determined that I had Graves' Disease, an autoimmune hyperthyroid disease. I am now on Methimazole and Propranolol for Graves' Disease. I don't know if the vaccine caused my horrendously painful cramps and the onset of the autoimmune disease, but I just wanted the CDC to know! I am curious to know if there is a correlation. Please let me know if you have any questions.
19 2021-07-17 crying PT USUALLY HAS A SWOLLEN ARM AT THE INJECTION SITE WHEN SHE DOES GET INJECTIONS. AND HER MOM SAID SH... Read more
PT USUALLY HAS A SWOLLEN ARM AT THE INJECTION SITE WHEN SHE DOES GET INJECTIONS. AND HER MOM SAID SHE GETS ANXIETY KINDA FEELING WHEN SHE GETS INJECTIONS BC OF THAT. WAS TOLD AFTER THE SHOT THAT INFO. PT INITIALLY EXPERIENCED , WHILE CRYING VERY LITTLE SHORTNESS OF BREATH. BUT WHEN SHE PUT HER MASKED DOWN, SHE FELT A LOT BETTER. SHE THEN FELT A LITTLE DIZZY THEN AFTER PUTTING HER AGAINST THE WALL AND RAISING HER LEGS , FELT BETTER AND DIZZINESS WAS GOING AWAY. AFTER 5 MINUTES, SHE FELT SLIGHT CHEST TIGHTNESS. KEPT MONITORING HER. CALLED THE AMBULANCE.. THEY CAME AFTER 1O MINUTES..
19 2021-07-20 feeling abnormal Soon after the shot she didn't feel "right" and her arm was very sore to the point where she didn't ... Read more
Soon after the shot she didn't feel "right" and her arm was very sore to the point where she didn't want to move it. The next morning she woke up with a stuffy nose and head and lethargy. Her symptoms progressed to fever, chills and body aches by the afternoon. She didn't feel well enough to eat through the evening and at midnight she became nauseas and had stomach cramps. She was then simultaneously vomiting and having diarrhea with moderate-to-severe stomach cramping for approximately an hour. After, the chills were even worse and the nausea continued. The second day after the vaccine she continued to have an upset stomach and lethargy. The lethargy and slightly upset stomach continued into the third day after being vaccinated. I cannot report further because this is the third day.
19 2021-07-26 nervousness Nervousness, c/o feeling hot, sleepy. EMT on site-client assessed. No sob, BP 90/50, r 18, P 70, O... Read more
Nervousness, c/o feeling hot, sleepy. EMT on site-client assessed. No sob, BP 90/50, r 18, P 70, O2Sat 99, BP 80/50. Client observed for additional 15 minutes. Denies further c/o previous or any symptoms. BP retaken by EMT 110/70, P 70, R 12. Client and client's mother instructed to follow up or seek medical assistance for any further symptoms or change.
19 2021-07-27 impaired work ability Client reported development of shortness of breath, chills, fever, and nasal congestion 2 days afte... Read more
Client reported development of shortness of breath, chills, fever, and nasal congestion 2 days after the 1st COVID vaccine Pfizer. The client stated the symptoms lasted one week. The has a history of asthma and is prescribed Albuterol. The client stated she used her Albuterol inhaler, which helped with the shortness of breath. The client presented to the emergency department for evaluation in order to return to work. The client states she was prescribed Tylenol in the emergency department. The client also received a negative COVID test while in the emergency department. The client has a history of allergies to cats which is controlled with Loratadine.
19 2021-07-27 sensation of foreign body At 40 minutes post vaccination the patient experienced lightheadedness, nausea, and shaking. at ... Read more
At 40 minutes post vaccination the patient experienced lightheadedness, nausea, and shaking. at 60 minutes the patient experienced a slight lump in her throat which did not progress. The patient was taken to the emergency room for observation.
19 2021-07-28 amnesia After receiving a 1st dose of Pfizer vaccine, patient fell to the ground within a minute. A pharmaci... Read more
After receiving a 1st dose of Pfizer vaccine, patient fell to the ground within a minute. A pharmacist rushed back to check her heart rate and consciousness. She was quickly alert and breathing normal. She did not recall what happened. Her face was still pale and she felt dizzy. 911 was called. After 5 minutes, she had new seizure episode last for 10 seconds then stopped. 911 came and checked her blood pressure, heart rate and oxygen level. They were all normal. Patient was advised to see doctor for follow up. Her mother took her to seek medical care.
20 2021-01-08 crying, panic attack 10/30-tested + for COVID; recovered @ home suffers from chronic anxiety after 10 mins after vac, pat... Read more
10/30-tested + for COVID; recovered @ home suffers from chronic anxiety after 10 mins after vac, patient thought throat was Scratchy & closing. leading to crying/hysteria/panic attack. Once attended to, all calm. 20% of who presents with throat itchy & swelling that occurred shortly after her vaccination. Pt thinks it could be a panic attack. PE - unremarkable. Plan - home with monitoring.
20 2021-01-13 anxiety, impaired work ability EE reports, started to be nauseous overnight, 1/12 into 1/13. 1/13 10 am, chest heaviness, SOB, an... Read more
EE reports, started to be nauseous overnight, 1/12 into 1/13. 1/13 10 am, chest heaviness, SOB, anxiety, unable to function at work 1/13/2021, to Urgent Care, prescribed zofran for nausea. Was asked to contact her PCP regarding her HR 130, EE was on buprion and abruptly stopped taking it for 2 weeks without PCP recommendation, "I thought I didn't need it anymore". EE reported to OHN on 1/13, she restarted the med and took her first dose on 1/12 and her second one on 1/13. Covid results negative
20 2021-01-17 impaired work ability I felt feverish and had joint and body aches the day following my vaccine. I was also nauseous, had ... Read more
I felt feverish and had joint and body aches the day following my vaccine. I was also nauseous, had a headache, and felt fatigued. Today, 01/18/2021 I had a migraine so bad I vomited twice. I had to go home from work because I was so sick.
20 2021-01-18 restlessness Body aches, Headache, Fatigue, Nausea, Restless Took Tylenol
20 2021-02-03 motion sickness 0300: woke up with widespread body pain/joint pain (7 out of 10), nausea (lasted about 20 hours) Tre... Read more
0300: woke up with widespread body pain/joint pain (7 out of 10), nausea (lasted about 20 hours) Treatment: took Advil and Tylenol according to manufacturers directions as continuously as possible, took 1 dose anti-nausea/motion sickness at 18:30 Symptom-free starting 02/04/2021 at 0915
20 2021-02-03 sensation of foreign body 0925 AMThroat light swelling, feels something back of throat, dysphagia, dyspnea. Recent sinus infec... Read more
0925 AMThroat light swelling, feels something back of throat, dysphagia, dyspnea. Recent sinus infection, 0928 Benadryl po Last meal 1200am,Vital signs stable 0939am Feels better, still feels a lump in throat. 0955 Vital signs stable D/C
20 2021-02-07 anxiety Client developed chest tightness and pain after vaccination. Vital signs normal, and lungs clear to... Read more
Client developed chest tightness and pain after vaccination. Vital signs normal, and lungs clear to auscultation. No other local or systemic allergic type signs or symptoms noted. Client appeared anxious and admitted to same. Responding well to reassurance. She normally takes hydroxyzine PRN for anxiety, and we offered diphenhydramine which she accepted (50mg po x 1). Feeling improved prior to discharge, this is NOT suspected to be a severe adverse reaction to the vaccine (suspect panic/anxiety).
20 2021-02-08 feeling abnormal mental fogginess; headache; body ache; 99.5 temp; swollen lymph nodes; sore jaw (from lymph nodes); ... Read more
mental fogginess; headache; body ache; 99.5 temp; swollen lymph nodes; sore jaw (from lymph nodes); swollen lymph nodes; sore jaw (from lymph nodes); swollen injection site; severe tiredness; muscle pain; muscle stiffness (neck and upper extremities); This is a spontaneous report from a contactable consumer (patient herself). A 20-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL8982, expiration date was unknown), via an unspecified route of administration on the left arm on 25Jan2021 at 13:45 at a single dose for COVID-19 immunization. The vaccination facility type was reported as the hospital. Relevant medical history included asthma and glucose intolerance; both from an unknown date and unknown if ongoing. The patient had no known allergies. Concomitant medications included metformin and etonogestrel (NEXPLANON) for birth control. The patient was not pregnant at the time of vaccination. The patient had no other vaccine in 4 weeks. The patient had no COVID-19 prior vaccination. On 25Jan2021 at 15:30, the patient experienced mental fogginess, headache, body ache, 99.5 temperature (temp), swollen lymph nodes; sore jaw (from lymph nodes), swollen injection site, severe tiredness, muscle pain, and muscle stiffness. The patient did not receive any treatment for the adverse events (AE). The patient was not tested for COVID-19 post vaccination (pending clarification). The patient was not recovered from all the events.
20 2021-02-09 impaired work ability fever. called in sick to work.
20 2021-02-10 anxiety After two minutes post vaccination patient reported feeling extremely anxious, hyperventilating. Ad... Read more
After two minutes post vaccination patient reported feeling extremely anxious, hyperventilating. Advised to lay in recliner, given fluids and monitored for an extended period. Vitals 110/82, 76 HR. After 60 minutes observation patients symptoms resolved and cleared to leave.
20 2021-02-15 anxiety Immediately after injection, patient began to feel hot, nauseated, and anxious. She vomited x3. Up... Read more
Immediately after injection, patient began to feel hot, nauseated, and anxious. She vomited x3. Upon arriving to the observation room, patient reports that all symptoms have resolved. Monitored for an additional 15 min with no complications. Pt ambulatory to private transportation.
20 2021-03-05 sensation of foreign body Patient stated after vaccination that she has difficulty swallowing, "lump in throat," chest tightne... Read more
Patient stated after vaccination that she has difficulty swallowing, "lump in throat," chest tightness, and dizziness. Vitals stable. MD at bedside. An RN gave Benadryl 50mg IM. Patient no longer having chest tightness or feeling of lump in throat.
20 2021-03-18 disorientation Delayed vasovagal response with possible seizure. 911 called and arrived minutes later. Pt was sit... Read more
Delayed vasovagal response with possible seizure. 911 called and arrived minutes later. Pt was sitting in chair and was lowered to the floor when she slumped and started to have a seizure. As soon as she was on the floor she snapped awake. She was disoriented for a moment but was aware. After a few minutes she sat back down in chair and her blood pressure was taken. it was 139/81 with HR of about 79. The fire department came in at this point. Eventually, the fire dept released her as she was with her mother.
20 2021-03-19 anxiety Part one: Within one minute of injection, I was extremely dizzy and had to force myself to breathe. ... Read more
Part one: Within one minute of injection, I was extremely dizzy and had to force myself to breathe. My hearing became muffled and I couldn't hear. I was hot and cold, pouring sweat. My tongue was numb and my mouth became dry. Part two: As the dizziness began to subside, the second phase of the reaction started. I had nausea. I felt EXTREME abdominal/uterine cramping, which was the worst part. The cramps came in waves (Ex: cramp for a minute, subside for 10 sec, repeat). I thought I was going have an uncontrollable bowel movement as a result, but thankfully did not. The cramps lasted about thirty minutes. The dizziness became mild during this phase but was still there. I was in excruciating pain and debated calling an ambulance. This pain felt worse than when I broke two bones. During the entire reaction I felt extreme anxiety and impending doom (I did not feel this way prior to receiving the vaccine). For the rest of the day I felt tired and extremely anxious (impending doom).
20 2021-03-22 insomnia Body pain from legs to arms to shoulders and neck, Nausea beginning two days after vaccination. Feve... Read more
Body pain from legs to arms to shoulders and neck, Nausea beginning two days after vaccination. Fever starting three days after vaccination reaching 102. Profusely sweating combined with inability to sleep. Painful headaches with persistent sinus pressure.
20 2021-03-22 loss of personal independence in daily activities My period was so much heavier than normal and so much more painful. I was unable to go to school or ... Read more
My period was so much heavier than normal and so much more painful. I was unable to go to school or do any work. This is NOT how I usually experience my period. Many people I've spoken to have said that after receiving the Pfizer shot, their period was heavier and earlier than normal. This information should have been included in the warnings, as this seems to be an EXTREMELY common side effect to people who mensurate. Please start including female-specific health outcomes in your research.
20 2021-03-25 anxiety At approx. 1238, pt reported feeling lightheaded to vaccinator. Pt was assisted into anti-gravity ch... Read more
At approx. 1238, pt reported feeling lightheaded to vaccinator. Pt was assisted into anti-gravity chair. Pt appeared anxious and reported hx of lightheadedness and fuzzy vision after prior vaccinations. Pt stated "I'm not good with needles". Pt given water and emesis bag. Pt denied needing to vomit. Vital signs assessed at approx. 1240. BP 140/80 mmHg, PR 88 BPM, SpO2 99% RA. Patient advised to wait for 30 mins for further observation. At approx. 1310, vitals reassessed. BP 154/94 mmHg, PR 72 bpm, SpO2 98% RA. Pt advised to sign up with CDC V-safe. Pt left facility at approx. 1314 with steady gait and unlabored breathing..
20 2021-03-26 anxiety blurry vision, anxiousness
20 2021-03-26 feeling abnormal Approx 10 minutes after vaccination, patient in waiting area noted L arm tingling, head feeling "fu... Read more
Approx 10 minutes after vaccination, patient in waiting area noted L arm tingling, head feeling "fuzzy" and blurriness to vision L eye only
20 2021-03-28 nervousness Patient was feeling nervous after receiving vaccine. Patient said she didnot want EMS, just needed t... Read more
Patient was feeling nervous after receiving vaccine. Patient said she didnot want EMS, just needed to sit down. Patient blood pressure is dangerously low and might need some fluids. patient refused and said she was fine. Patient signed refusal form and walked away.
20 2021-04-01 feeling abnormal, anxiety Patient received 1st dose of Pfizer COVID vaccine. Upon administration, patient reported she felt as... Read more
Patient received 1st dose of Pfizer COVID vaccine. Upon administration, patient reported she felt as though she was having an anxiety attack. She then fainted and started falling forward in her chair. The pharmacist and technician caught the patient as she fell forward and as they were leaning her back in the chair she began seizing in their arms for approximately 5-10 seconds (no more than 20-30 seconds). At this point, the patient spoke and stated that was weird and said she felt lethargic. Another technician was on the phone with 911 at this time. We gave her a bottle of water and kept the patient seated in the immunization room until EMS arrived. She was complaining of being very hot and lethargic. EMS arrived and checked her vitals and recommended the patient go with them to the hospital due to B/P and pulse being very low (exact vitals were not communicated to us). She agreed to go to the hospital and we will be following up with the patient tomorrow.
20 2021-04-07 hallucination Immediately after the vaccine was injected, I felt like I got slugged in the arm. I also had a momen... Read more
Immediately after the vaccine was injected, I felt like I got slugged in the arm. I also had a momentary hot flash. Then, I went to go sit in the waiting area, and I continued to get warmer and warmer. After 5 minutes, I went up to the front desk, and told them I didn?t feel well and that I felt like I was overheating. They put me in a wheelchair, and I immediately passed out and hallucinated for a minute or two. I felt incredibly weak, and I had sweat completely through my shirt. A paramedic came and put me in a stretcher in a cornered off area of the clinic. After 30 minutes or so, I started feeling better, but I got several spirts of cold flashes. All of my vitals came back normal.
20 2021-04-08 disturbance in attention, memory impairment memory and attention problems
20 2021-04-09 feeling abnormal moderate vertigo (Feeling of spinning, loss of balance, dizziness, lightheadedness, nausea, feeling ... Read more
moderate vertigo (Feeling of spinning, loss of balance, dizziness, lightheadedness, nausea, feeling of floating, feeling of the floor tilting), coldness and slight discoloration of hands and feet
20 2021-04-12 nervousness, feeling abnormal received her first dose of Pfizer vaccine of the series. On her way to the observation area she beg... Read more
received her first dose of Pfizer vaccine of the series. On her way to the observation area she began feeling weak, lightheaded, nauseas and dizzy. This was about 5 minutes post vaccination. She made it to an observation chair and an RN was notified She was given an ice pack and water. VItals were initially read at BP 69/42, SPO2 99%, and HR between 90 and 100. BP was then taken manually and was 98/62. Despite SPO2 level steady of >95% , patient state she was having trouble breathing and speaking. She also stated that her throat felt sore. She also felt "shaky" and was visibly shaking. She continued to appear and feel worse. Her mother was with her and agreed with the move to call an ambulance and she was transported to the ER.
20 2021-04-13 confusional state Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-... Read more
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Hypotension-Mild, Systemic: Shakiness-Mild, Systemic: Tachycardia-Mild, Additional Details: Patient refused Benadryl, was monitored for 30 minutes. Patient felt dizzy and faint, we monitored, gave water, an ice pack. Patient's symptoms resolved after 30 minutes.
20 2021-04-13 nervousness Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Severe, Syste... Read more
Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Severe, Systemic: Shakiness-Mild, Additional Details: Pt stated that she was nervous that she would \"pass out from vaccine\", recommended she stay 30 min instead of 15 min for monitoring. Has hx of anxiety d/o & panic attacks (3x/month). Stated she felt dizzy after getting vaccine and she contributed it to that. Gave 12oz OJ, 1 protein pack (nuts & chocolate berries) and water. Only had ramen noodle soup today & was dehydrated. Checked in after 30 minutes, felt fine and was back to normal.
20 2021-04-14 panic reaction panic reaction to vaccine that resolved with observation.
20 2021-04-14 sleep disorder Before I went to bed at around 11:30pm the day of my shot (4/13), I took one extra strength tylenol ... Read more
Before I went to bed at around 11:30pm the day of my shot (4/13), I took one extra strength tylenol as prevention. I woke up around 2:40am 4/14 trembling as if I was having a seizure (it did not feel like chills) and extreme aches. I took my temperature and was at 100.8. I took another extra strength tylenol and tried to calm down. At around 3:30 the trembling stopped and I was finally able to relax a bit. I fell back asleep around 5am and woke up at 9:00am with more extreme aches and pain. I switched to ibuprofen (400mg) and that worked way better. My fever was at 101.8 when I woke up. Around mid morning and afternoon I was feeling fine just a bit achy and fatigued and my fever broke to 99. I took a nap around 2pm and woke up feeling bad again with a fever of 100.6. I took another 400mg of ibuprofen and that got me through my class and the evening feeling okay. Before bed, I was feeling achy and fatigued yet again. I took 200mg of ibuprofen and went to bed just fine. I woke up at 4:30am 4/15 for my clinical feeling back to normal. I have been fine ever since.
20 2021-04-15 anxiety heart palpitations, anxiety.
20 2021-04-15 restlessness My right arm was sore almost immediately after being vaccinated, but it wasn?t bad. Then later at ni... Read more
My right arm was sore almost immediately after being vaccinated, but it wasn?t bad. Then later at night when I was trying to get to sleep I was horribly restless, shaking, and feverish. I had to bundle up in blankets because I was so cold. My whole body ached terribly, and I had a headache. It lasted a few hours and I couldn?t get to sleep. At one point I felt extremely nauseous and ran to the bathroom, barely holding back vomit, but then it went away and never came back. The day after that (April 15th) I was extremely fatigued and still had body aches and a headache. I took my temperature at 5 am on April 15th and it was 99.4°. I mostly just slept a lot and didn?t have much of an appetite. My arm was still a little sore during this whole time. As I?m writing this at 5 am on April 16th, I still have a headache.
20 2021-04-16 insomnia After I was administered the vaccine at the University, after spending a few minutes I began to feel... Read more
After I was administered the vaccine at the University, after spending a few minutes I began to feel a sensation in my throat as if it were swelling, scratching and when I swallowed I did not feel it. Every time the minutes passed I felt it more. After the 15 minutes passed, I notified him and a paramedic gave me all the vital signs which had an elevated blood pressure and an elevated pulse. They took me to the ambulance where I was under supervision. I continued with the sensation of throat and dizziness. I took the medicine that the doctor had prescribed: benadryl and prednisone in case of having an allergic reaction. I continued with the symptoms and my mother was watching me in case of having difficulty breathing and when I got home I got a little nauseous. Present tiredness and pain in the area that disappeared on Sunday. From Sunday until today I have presented insomnia since it is difficult for me to sleep and I manage to sleep a few hours.
20 2021-04-16 sleep disorder Within the first 20 minutes her arm was heavy. By 9:30 pm extreme arm soreness, chills, swollen and ... Read more
Within the first 20 minutes her arm was heavy. By 9:30 pm extreme arm soreness, chills, swollen and burning throat. That night intense fatigue but couldn?t sleep because of nausea and vomiting. By morning a cough developed, sneezing and clogged and mucus dripping from nose. By 1:00 pm 4/17/2021 fever of 99.9. By 3:20 pm it is 101 degrees with a headache, body aches and straining eyes.
20 2021-04-17 anxiety, feeling abnormal Vaccine- Related Anxiety; experience shaky, feeling like she "was seeing stars but not passing out; ... Read more
Vaccine- Related Anxiety; experience shaky, feeling like she "was seeing stars but not passing out; Lightheaded; experience shaky, feeling like she "was seeing stars but not passing out; This is a spontaneous report from a non-contactable other hcp. A 20-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 19Mar2021 (Batch/Lot Number: EN6207) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The reporter stated that during her 15 minute waiting period after the injection, the patient began to experience shaky, Feeling like she "was seeing stars but not passing out". Lightheaded on 19Mar2021. She denied rash, hives, welts, difficulty Breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, dizziness, facial Swelling, lip swelling and tongue swelling. Treatment included: water and snacks. The report considered as a non serious. Differential Diagnosis: Vaccine- Related Anxiety (include misc mental health) and Red flag symptoms. The outcome of the events experience shaky, feeling like she "was seeing stars but not passing out and Lightheaded was reported as recovered on 19Mar2021 and other event was reported as unknown. No follow-up attempts are needed. No further information is expected.
20 2021-04-18 loss of personal independence in daily activities Full body aches starting the day after i received the vaccine. The next day the body soreness was se... Read more
Full body aches starting the day after i received the vaccine. The next day the body soreness was severe enough to where it was painful to clench my fist or walk even a small distance. I also experienced nausea, loss of appetite, migraines and light sensitivity, and was unable to do normal tasks around the house for about 3-4 days. The full body soreness was the most debilitating symptom and certain aresa like elbows, knees, wrists and hips were painful to the touch. I think my joints were most affected. The soreness and pain can be compared to a flu but it was more intense than anything i have experienced before.
20 2021-04-19 confusional state Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unrespo... Read more
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Additional Details: Patient was fainted and was unresponsive. EMS was called. Father stated this was a known issue. It was more of a phobia.
20 2021-04-19 nervousness Shaky sensation, mostly in legs
20 2021-04-20 anxiety Patient fainted and hit her head on floor of gym. All vital signs are normal. She has anxiety and be... Read more
Patient fainted and hit her head on floor of gym. All vital signs are normal. She has anxiety and bee allergies. Patient fainted for 30 seconds
20 2021-04-21 hallucination, amnesia, abnormal behaviour started having hallucinations and delusions, thought someone was after her, thought someone broke in... Read more
started having hallucinations and delusions, thought someone was after her, thought someone broke into the house, seeing relatives who have passed, paranoia, refers to herself as her given name not legal name, refers to an awakening, quit her job, accused coworker of harassing her, talking loudly-normally very quiet and reserved started April 13, 2021. Symptoms escalated from 4/13 until she was involved in high speed chase on April 16, 2021, has no recollection of being involved in high speed chase.
20 2021-04-21 panic attack, suicidal thoughts During the second vaccination I was on my period. After 3 hours of getting the vaccine I started ha... Read more
During the second vaccination I was on my period. After 3 hours of getting the vaccine I started having large emotional spells. It made me start to have suicidal thoughts, a panic attack every other hour and overall get overwhelmed very quickly. The suicidal thoughts specifically started 6 hours after the vaccine and lasted through the whole night and day after receiving the vaccine. Thankfully I was able to reach out to other people in my support system, but I was not expecting to feel that way and get those thoughts and feelings right after receiving the shot. I think that there should be more research done with females who are on their periods when getting the shot because I cannot be the only one who was affected by that factor.
20 2021-04-24 disorientation patient received first dose of Pfizer covid 19 vaccine, after 5 minutes her friend yelled to us that... Read more
patient received first dose of Pfizer covid 19 vaccine, after 5 minutes her friend yelled to us that she wasn't doing well. We went out and shook her to see if she would come to, after a minute she came to and asked where she was. we called 911 and emts arrived to check her out and took her out of the store.
20 2021-04-25 anxiety Had Chest pains (thought lungs) went to urgent care, urgent care sent to Medical Center. Had Pulse o... Read more
Had Chest pains (thought lungs) went to urgent care, urgent care sent to Medical Center. Had Pulse of 168 thought drugs but too screen was all need. Told them had Covid shot 3 days before, said anxiety ended up admitting to hospital with tachycardia. Elevated D dimmer and WBC. They said I had anxiety, heart rate didn't go down after anxiety drugs x2. Ran lots of tests and sent home the rolling day with no answers and a pulse still around 100. Release from hospital at 5 pm last vitals were taken at 12pm with pulse of 96.
20 2021-04-26 anxiety Patient had dizziness, anxious (didn't have breakfast). Given juice, water, crackers. Dizziness reso... Read more
Patient had dizziness, anxious (didn't have breakfast). Given juice, water, crackers. Dizziness resolved, patient stable, released from vaccination site.
20 2021-04-26 sensation of foreign body 20 YO FEMALE WITH HX OF ANXIETY WHICH MANIFESTS WITH INCREASE HR P/W CHEST STIFFNESS, INCREASE HR, L... Read more
20 YO FEMALE WITH HX OF ANXIETY WHICH MANIFESTS WITH INCREASE HR P/W CHEST STIFFNESS, INCREASE HR, LUMP ON THE THROAT 2 MINS AFTER RECEIVING 1ST DOSE OF COVID VACCINE. HER LAST ANXIETY ATTACK WITH SIMILAR SYMPTOMS OCCURRED APPROX 1 YR AGO WHICH LASTED FOR HOURS AFTER FALLING ASLEEP. SYMPTOMS WERE SELF LIMITING WITHOUT MEDS. PT FELT IMPROVEMENTS UPON ARRIVING TO OBS 1 AREA. NO LONGER HAVING CHEST TIGHTNESS OR LUMP ON THE THROAT HOWEVER STILL WITH INCREASE HR. DENIES CHEST PAIN, SOB, DIZZINESS, SYNCOPE, RASH, HA, WEAKNESS, LIGHTHEADNESS, OR VERTIGO. VITALS: 1430 LAYING 143/83; 109; 98% 1437 1223/80, 97, 100%, RR 15 1504 SITTING 121/83; 103; 98% 1518 STANDING 124/84; 102; 99% HEART- RRR; NO MURMUR; LUNGS- CTA; NO WHEEZING; CN2-12 INTACT; 5/5 MOTOR BUE AND BLE; PT ABLE TO STAND AND AMBULATE WITHOUT ASSISTANCE. FEELS MUCH BETTER BUT CAN STILL FEEL INCREASE HR; PT AND MOM DID NOT WANT TO GO TO THE ED/URGENT CARE; STATES SHE FEELS BETTER AND ANTICPATES TO IMPROVE MORE AT HOME WIHT FURTHER REST. PT WAS ADVISED TO GO TO ED IF SYMPTOMS PERSISTS AT HOME OR WORSENS. ADVISED TO ALSO CALL PCP IMMEDIATELY FOR THEIR GUIDANCE. PT WALKED WITH HER MOM AND YOUNGER SISTER TO THE CAR WITH NO CONCERNS RELEASED TIME 1520
20 2021-04-27 disturbance in attention Left arm rash within minutes of receiving vaccine. Then resolved. Headache, dizziness, difficulty c... Read more
Left arm rash within minutes of receiving vaccine. Then resolved. Headache, dizziness, difficulty concentrating, difficulty focusing vision, right ear pain-intermittent. Shortness of breath-improved with albuterol inhaler. History of asthma.
20 2021-04-27 feeling abnormal she felt like she was being stung by wasps at the COVID-19 Vaccine injection site; injection site pa... Read more
she felt like she was being stung by wasps at the COVID-19 Vaccine injection site; injection site pain/ bad injection site pain; extremely swollen left axillary lymph nodes; numbness and tingling in her left elbow and left wrist, as well.; numbness and tingling in her left elbow and left wrist, as well.; fatigue; persistent diarrhea; weakness; headache; chills; muscle aches; injection site pain was a burning sensation; it inhibited her left arm movement; left axillary lymph nodes painful; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 20-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248) via unspecified route of administration in left upper arm on 18jan2021 09:20 at single dose for covid-19 immunization. Medical history includes recurring history of croup since she was young with her last croup diagnosis during Christmas of 2018. Concomitant medication reported as COLECALCIFEROL (NATURE MADE VITAMIN D3 2000iu, UPC Number: 3160403183, Lot Number: 2404901 and Expiration Date: Oct2023) continued taking both the first and second Covid-19 vaccine dose. After second vaccine she only took 2 ibuprofen 200mg tablets on first day. The patient historical vaccines included: flu vaccine in mid-Nov2020 and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EK5730, Expiration Date: Unknown) via intramuscular route of administration in left upper arm on 28Dec2020 09:20 at single dose for covid-19 immunization. The patient had Injection site pain, Flu-like symptoms (clarified as flu minus vomiting), Headache, GI symptoms, Weakness, Fever, Muscle fatigue and leg shakiness with the first dose. There were no other vaccines administered within four weeks. On 18Jan2021 she experienced more interesting side effects. She had injection site pain the afternoon of 18Jan2021 by 20:00 that night (18Jan2021), she had laid down in bed, and she felt like she was being stung by wasps at the COVID-19 Vaccine injection site. The injection site pain was not bad but the pain was constant and by the second day the injection site pain had faded. The bad injection site pain clarifying the injection site pain was a burning sensation. She said if she puts her hand on the vaccine injection site now, she can still feel a burning sensation. She said there is not swelling or redness at the vaccine injection site. She said she developed extremely swollen left axillary lymph nodes after her second COVID-19 Vaccine dose. She said the left axillary lymph node swelling was so extreme it inhibited her left arm movement. She said she developed numbness and tingling in her left elbow and left wrist as well. She said the left axillary lymph node swelling has gone down, so the swollen lymph nodes are not impeding her left arm movement now. She said the left axillary lymph node remains swollen enough that her bra hits the swollen lymph node, making the left axillary lymph nodes painful. She said the numbness and tingling in her left elbow and left wrist is less frequent, but not gone. She said her side effects after the second COVID-19 Vaccine didn't improve for probably 4-5 days after they developed. She said the left axillary lymph node swelling has improved marginally, and the vaccine injection site burning sensation is less, but the left elbow and left wrist numbness and tingling is persistent. On 23Jan2021 or 24Jan2021 she developed fatigue, persistent diarrhea, weakness, headache, and very mild chills and muscle aches. She said she had no fever. Her symptoms lasted 2 days and then completely resolved on Jan2021. She said her left elbow and left wrist numbness and tingling is persisting. She said the vaccine injection site still hurts (burning sensation), and her left axillary lymph nodes are still swollen. She said the burning sensation at the vaccine injection site has her concerned. She feels an increase in the burning sensation if she touches the vaccine injection site. The clinical outcome of the event vaccination site pain, swollen lymph node, numbness, tingling, Limb discomfort reported was recovering, outcome of the event burning sensation was not recovered, outcome of event Feeling abnormal and Lymph node pain was unknown and for other events it was recovered on Jan2021. Follow-up attempts are completed. No further information is expected.
20 2021-04-28 excessive sleepiness Headache, chills, fever; took Ibeuprofen throughout day and night of vaccine; slept most of the day
20 2021-05-01 insomnia Nausea, feeling like fainting, insomnia, fatigue, joint aches
20 2021-05-02 disturbance in attention, insomnia About 13 hours post-injection I developed a low-grade fever, chills, body aches, loss of appetite, e... Read more
About 13 hours post-injection I developed a low-grade fever, chills, body aches, loss of appetite, exhaustion, difficulty concentrating, and difficulty sleeping. These have remained for two days.
20 2021-05-04 anxiety Pt received 2nd dose of pfizer vaccine. Pt stated feeling lightheaded and anxious. Pt stated he was ... Read more
Pt received 2nd dose of pfizer vaccine. Pt stated feeling lightheaded and anxious. Pt stated he was feeling nervous and anxious before getting the shot and has a history of panic attacks in the past that last a few minutes than he's back feeling normal. Pt was then laid on the floor with legs elevated by the reaction nurse. He then was sent to Med Ops 2 where we assessed him. Vital signs were done all WNL. Pt also given water and crackers. Pt stated was feeling better. He soon after left with mother waiting outside in the car.
20 2021-05-04 insomnia I woke up with a fever and extreme thirst. I had a hard time sleeping, but at some point during the ... Read more
I woke up with a fever and extreme thirst. I had a hard time sleeping, but at some point during the night my fever broke. When I woke up (~5 hours later) I felt significantly better, though I was experiencing a headache, eye pain, and fatigue. I got up and then went back to sleep after eating something, and when I woke up I felt completely fine.
20 2021-05-04 insomnia Sneezing, constant runny nose, achy bones/joints, sore throat, headache, fatigue, insomnia, discomfo... Read more
Sneezing, constant runny nose, achy bones/joints, sore throat, headache, fatigue, insomnia, discomfort/nausea; lasted 24 hours, with only a few lasting effects the next day but nothing severe. Tylenol/general antihistamines, rest, and hydration helped to relieve symptoms
20 2021-05-05 confusional state Patient received her vaccine and almost immediately blacked out for 10-15 seconds. Patient regained ... Read more
Patient received her vaccine and almost immediately blacked out for 10-15 seconds. Patient regained consciousness and was initially unaware of surrounding. We supported the patient and she remained upright in her seat. She was given orange juice and instructed to relax and take deep breaths. After a few minutes she felt better and moved to the observation area. After 15 more minutes the patient was back to herself and left the clinic with her significant other.
20 2021-05-05 impaired work ability Dizziness and nausea. Dizziness subsided after 30 minutes but nausea continued and she had to go hom... Read more
Dizziness and nausea. Dizziness subsided after 30 minutes but nausea continued and she had to go home, couldn't finish her work shift.
20 2021-05-07 insomnia 103 fever, congestion, nausea, headache, chills, muscle pain, insomnia
20 2021-05-07 nervousness Started to feel lightheaded an then got laid on the floor. Was given water and pretzels to eat. I as... Read more
Started to feel lightheaded an then got laid on the floor. Was given water and pretzels to eat. I asked the patient how she is doing and she stated that she is still shaky. I handed her the pretzels to finish eating and she drank some water. I asked the patient if she ate anything today and she stated that she did not. I asked how she was feeling after eating some more pretzels and she stated that it is helping but she is still shaky. I took the patient vitals at 10:25 am heart rate is 66, 02 100 and BP 105/71, again at 10:30 am heart rate 73, o2 100 and BP 101/69. I asked the patient how she was feeling. She stated that she was feeling better so i had her sit up the rest of the way and then stand up and then i made sure that she was not dizzy or light headed. The patient stated that she was back to her normal self. I released the patient home with mom and other sister at 10:35 am.
20 2021-05-12 panic reaction Immediately after receiving vaccine, patient began to panic. Patient stated she has a fear of needle... Read more
Immediately after receiving vaccine, patient began to panic. Patient stated she has a fear of needles. Patient given gatorade water and encouraged to do deep breathing relaxation techniques.
20 2021-05-14 depressed mood fever; Body aches; Not feeling well; She had been feeling ok all week, has not felt bad, just felt a... Read more
fever; Body aches; Not feeling well; She had been feeling ok all week, has not felt bad, just felt a little rundown; Sore left arm where injection site was; This is a spontaneous report from a contactable consumer (daughter). A 20-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: EL9269; Expiration Date: 03May2021), dose 1 via an unspecified route of administration, administered in Arm Left on 07Feb2021 at 10:30 (at the age of 20-year-old) as 1st dose, single for COVID-19 immunization. The Patient's Medical History was not reported. Family medical history of the patient was not reported. Concomitant medications were reported as none. The Patient has received prior vaccinations (within 4 weeks), prior to the COVID vaccine reported as none. Additionally, vaccines administered on same date with the Pfizer vaccine considered as suspect was reported as None. Consumer stated that her daughter received the first dose of the pfizer covid 19 vaccine while at school on 07Feb2021. The patient woke up around at 08:00, 15Feb2021 with fever, body aches and not feeling well. She had been feeling ok all week, had not felt bad, just felt a little rundown since around 08Feb2021; but she was a college student so that was not shocking. She had sore left arm where injection site was with onset around 08Feb2021. Consumer wanted to know if those were common to get side effects from the Pfizer COVID-19 Vaccine this long after vaccine or could she (patient) had COVID-19, should they had her tested for COVID-19. Consumer stated, they kind of anticipated side effects immediately following the vaccine; but unsure about side effects that was long after she was administered the Pfizer COVID-19 Vaccine. On 15Feb2021 at 08:00, the patient experienced fever, body aches, not feeling well; on 08Feb2021, felt a little rundown and sore left arm where injection site was. The patient did not require any visit in emergency room or physician office for events. The reporter classified the patient was not hospitalized. The patient underwent lab tests and procedures which included body temperature: 101 Fahrenheit on 15Feb2021 and Saliva tested for COVID-19: negative on Feb2021, Negative for COVID-19 at school every other day. The outcome of the event 'Sore left arm where injection site was' resolved on unspecified date of Feb2021, event 'Felt a little rundown' was with unknown outcome and all other events was not recovered. Follow-up (15Feb2021): This is a follow-up spontaneous report from a contactable consumer. event information and patient information was added. Follow-up (12May2021): Follow-up attempts completed. No further information expected.
20 2021-05-15 anxiety client complained of dizziness and anxiety after receiving 1st Pfizer Covid. Client informed EMT she... Read more
client complained of dizziness and anxiety after receiving 1st Pfizer Covid. Client informed EMT she needed to step out due to anxiety. EMT accompanied client to patio. Vitals at 1614: blood pressure 110/70, pulse 120, oxygen 98%. Per client history of anxiety and had been anxious the last few days due to vaccine appointment. No current medication, no allergies. Vitals at 1631: pulse 114, oxygen 98%. Client stated feeling calmer at 1642. Vitals at 1644: pulse 113, oxygen 98%. Client completed 30 min observation. Friend with client, would drive home. RN gave ER precautions. Client left facility at 1643 with steady gait.
20 2021-05-17 anxiety Patient described feelings of anxiety and dizziness about 15 minutes post injection. RN had patient... Read more
Patient described feelings of anxiety and dizziness about 15 minutes post injection. RN had patient lie down on cot for several minutes and perform deep breathing exercises. After about 30 minutes of rest, laying flat, and deep breathing, patient stated she felt much better and was able to walk to her car and she can drive home. VS 1230: p102 pox100% bp140/90 r30 temp97.8 1240: p102 pox99% bp140/80 r24 temp97.7 1245: p93 pox97% bp130/70 r20 temp98
20 2021-05-23 anxiety felt very hot and faint, feeling of passing out, very anxious, happened after first dose as well. ta... Read more
felt very hot and faint, feeling of passing out, very anxious, happened after first dose as well. talked to patient and calmed her down
20 2021-05-25 feeling abnormal Dizziness, brain fog, lightheadedness, and fatigue.
20 2021-05-25 feeling abnormal sharp pain; felt like it was stretched tight or stiff muscle; felt like it was stretched tight or st... Read more
sharp pain; felt like it was stretched tight or stiff muscle; felt like it was stretched tight or stiff muscle; usual arm pain at injection site; Headache; Chills; Fatigue; This is a spontaneous report received from a Pfizer sponsored program. A contactable consumer (Patient) reported that a 20-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/ Lot number and expiration date: Not reported) via intramuscular route of administration in left arm on 23Apr2021 15:25 at single dose for covid-19 immunisation. Medical history included diagnosed allergies, compromised immune status, respiratory illness, chromosomal abnormalities, endocrine abnormalities, genetic / (including diabetes) and obesity. The patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (Solution for injection, Batch/Lot: ED8734) intramuscular (at the age of 20 years) in left arm on 02Apr2021 at 16:30 for covid-19 immunisation and experienced Pain at left arm injection site. The patient experienced the "usual arm pain at injection site which started on 24APR2021 and went away a few days later. On 07MAY2021 having a new pain, that has been persisting since then, it is a sharp pain. On 24Apr2021, the patient experienced headache at 04:00, chills and fatigue at 01:00 or 02:00, Pain in left arm at injection site at 04:00. The patient later stated pain starting at 04:00 pretty similar to normal pain after injection of second dose which was dull and sore and hurt to lift arm. It was the same as the first shot. It cleared up within 3 days. The patient did not notice anything else. Friday, 07May2021, the patient noticed that left arm felt like it was stretched tight or stiff muscle. If patient lifted her arm up in a certain way, very sharp pain near injection site. That has persisted. It did totally go away and restarted as a different type of pain 2 weeks after. After received second vaccine and pain in the injection site. Had sharp sensation near injection site when raising arm. The outcome of usual arm pain at injection site was recovered on 07May2021; sharp pain, headache, chills and fatigue was recovering and felt like it was stretched tight or stiff muscle was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
20 2021-05-27 confusional state About 5 min after giving the vaccine, patient complained of not feeling well. Symptoms included hea... Read more
About 5 min after giving the vaccine, patient complained of not feeling well. Symptoms included headache, loss of sensation in arms, light headedness. Patient appeared pale, and confused. Attempted to have patient stand up and walk to counsel room opposite where she was sat. After standing, she immediately sat down, and fainted while she was seated. Pharmacist supported her head, and her boyfriend/significant other prevented her from falling off the chair. Patient was momentarily unresponsive for about 3 seconds. During this time her eyes remained open. Once patient regained consciousness, walked her to counsel room and had her lie down on her back with her legs elevated on a chair. Blood pressure was within normal limits. Patient was feeling better in about 10 minutes, and continued to monitor for another 5. Gave water to sip on, and no additional adverse effects noted.
20 2021-05-27 sleep disorder Was awoken early ~ 16 hours after shot with severe nausea, back pain, hot and and cold chills. Initi... Read more
Was awoken early ~ 16 hours after shot with severe nausea, back pain, hot and and cold chills. Initially also only able to breathe shallowly, (has since resolved). Unusual sensation in bladder/ genital area. Repeated urge to urinate but unable to, also felt painfully swollen/ engorged in genital area, but no actual redness or swelling. Symptoms are still ongoing at about the same level 48 hours after the shot. Still disinterested in food and feels dehydrated despite trying to ingest fluids.
20 2021-06-01 loss of personal independence in daily activities, insomnia For the first week I could not lift my arm enough to even put my hair in a pony tail. I was up every... Read more
For the first week I could not lift my arm enough to even put my hair in a pony tail. I was up every hour of the night. I?m a college athlete who normally works out find, but due to the shot even now (2 1/2 weeks later) I cannot lift any weight with my left arm. I?ve taken Tylenol almost every day since the shot. The first week my arm throbbed all night long. It?s not as bad now as the first week, but I still cannot lift with my left arm and wake up with a very fatigue arm.
20 2021-06-01 nervousness Systemic: Fainting / Unresponsive-Mild, Systemic: Shakiness-Mild, Additional Details: Patient appear... Read more
Systemic: Fainting / Unresponsive-Mild, Systemic: Shakiness-Mild, Additional Details: Patient appeared to have short (<1min) seizure approximately 5 minutes after having COVID vaccine administered. She woke up, eventually alert and oriented. EMS was called and responded to call. She refused ER visit stating she was feeling fine, just a little shook up.
20 2021-06-02 insomnia She was shaking really bad at 1:00 in the morning; Her daughter felt like she couldn't move; She di... Read more
She was shaking really bad at 1:00 in the morning; Her daughter felt like she couldn't move; She didn't sleep very much; She started not feeling well/ She really didn't feel good; Chills; Hands were very cold/ hands were freezing and finger nails purple; Fingernails were purple; Body aches; Heart was racing very fast./Her heart was beating really fast.; Low grade temperature of 103.2 F/ temperature was 101.5 F/ Fever; Arm sore and lumpy under arm pit/ It really felt lumpy under her arm pit.; Sore arms/she couldn't touch her arm pit because it hurt so much; She said her lymph nodes under her right arm seem like they are feeling better- before, she couldn't even put her arm down because they hurt so bad; She felt so sweaty; This is a spontaneous report from a contactable consumer (Patient mother). A 20-years-old female patient (daughter) received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: ER8733, Expiry date: Jul2021) via an unspecified route of administration in right upper arm on 20May2021 13:30 as SINGLE DOSE for covid-19 immunization. Medical history and concomitant medication was not reported. Patient historical vaccination was Flu vaccine on an unknown date in Sep2020 for immunization and first dose of BNT162B2 lot Number ER8733, Expiry Date: Jul2021 on 29Apr2021 at right upper arm for COVID-19 immunization and patient experienced little sore arm but it was no big deal. On 20May2021 patient experienced sore arms, had chills, her hands were very cold and her fingernails were purple. For a 3 hour period she had low grade temperature of 103.2F. Her heart was racing very fast. The mother gave her Tylenol in 15ml liquid form at 04:00 am and the temperature went down to 2 degrees. Her heart was still racing very fast at 5am. 3 hours later at 08:00 am her temperature was 101.5 F more Tylenol was given but her heart was still racing fast. Later that day it settled down. Her temperature went down to maybe a hundred and heart rate was slowly settling down. The mother said that it was really scary. They had call the doctor on Friday and talked with the nurse two times and the nurse said that they never heard anyone experienced a fever that high with the vaccine. She is asking if this was normal and if anyone has experienced this before. She is asking if ever there would be a third or booster dose, can her daughter take it after experiencing side effects after the second dose. She went back this past Thursday 20May2021 around 1:30pm for the second dose and she felt fine. About 10 hours later that night, she started not feeling well. She had gotten her second dose 3 days before and had a low grade fever, body aches, chills and didn't feel well for 24 to 48 hours. She started not feeling well and started getting chills. She was shaking really bad at 1:00 in the morning. She really didn't feel good. She took her temperature and it was 100.5. Her hands were freezing and her finger nails were purple. Her hands were cold and she was getting a fever. She guesses that can happen. Lasted a little longer from 1:00 until about 3:30 in the morning. Caller was up with her the entire night. Her fever went up to 103.2. Her heart was beating really fast. Caller was getting really scared and was thinking about taking her to the emergency room. She thought this was really weird. She gave her Tylenol trying to hold off. She was trying not to give her too much because there are dozens of interactions. She needed to give her something. Within an hour, it brought her fever down about 2 degrees and was then around 101.5. Her heart rate was still pretty fast. Was still a bit concerned but was glad her fever went down. Other than that, she seemed fine. Her daughter was drinking a lot of water to keep hydrated and was peeing a lot because she was drinking so much water. She seemed okay after that but her heart was still beating faster. Her daughter got up, she didn't sleep very much, and got up around 8:00 am, about 4 hours after taking the Tylenol. She didn't have a high fever but it was still around 101. She gave her more Tylenol and her heart was still beating fast. Reporter did not time it to see how fast it was. She could just tell that it was beating fast, like she was doing aerobics or something. Her daughter got the shot in her right arm. It really felt lumpy under her arm pit. Caller had read that some people get that, their lymph nodes get inflamed. Consumer only gave those 2 doses of Tylenol, her daughters fever got better. Her heart rate went back to normal and she seems fine now. She said her lymph nodes under her right arm seem like they are feeling better- before, she couldn't even put her arm down because they hurt so bad. She does seem to have improved; This was last Thursday and this is Tuesday. She did call the doctors office and talked to the nurse who said she hadn't heard of a fever that high. Said that sometimes when people get a fever, their heart rate can increase and that it is not unheard of. She didn't think that she had to be seen because she was improving. It bothered her the next few days. She heard on TV that kids were getting heart inflammation. Heart beating really fast: Reporter felt her wrist and felt her heart beating really fast. Lasted a little longer, until about 3:30 in the morning. Her daughters heart was beating so fast, it felt as if she were exercising but, she was sitting still. Her daughter seems fine now and caller has been checking her every day. Arm sore and lumpy under arm pit: This happened the next morning, Friday. Her daughter felt like she couldn't move and wanted to take a shower. She felt so sweaty and she couldn't touch her arm pit because it hurt so much. Reporter had read that some peoples lymph nodes get inflamed. It seemed better as the day went on. Treatment: Had only 2 doses of Tylenol. Her daughter doesn't swallow pills, so she had given her Children's strength Tylenol that is for children ages 2-11. She had only given her 15ml, which for her wasn't a lot. It says it's for up to 80 pound kids. Gave her 15ml at 04:00 am and it did bring it down 2 degrees. She gave her the same dose at 8:00 am. It wasn't even an adult strength dose. Fever: Her daughter's fever went away. She went back to bed, she had only slept from 05:00 am to possibly 08:00am, and didn't even sleep well then. After the second dose of Tylenol, her daughter went back to bed. Later in the afternoon, when her daughter got up, it seemed like she had a fever but a low grade fever, probably around 100. She hasn't seen it go back up. It seemed like it had settled down. Caller has been checking every day. Chills: Occurred after the second dose, maybe about 10 hours after on 20May2021. Called the CDC yesterday but was not able to talk to a person. She left some messages with the vaccine adverse something but no one ever called her back. Tests: She hasn't had any blood work done recently. She had her yearly check up last September. Adverse Event: Fever, body aches, chills, shaking really bad about 1:00am. had called the doctor's office and talked to the nurse twice. Was told that if she had swelling in throat to go to the ER. Prior Vaccinations (within 4 weeks): No, her last vaccine was the flu vaccine last September. Outcome of the events sore arms, Chills, Hands were very cold/ hands were freezing and fingernails purple, Fingernails were purple, Body aches and She started not feeling well/ She really didn't feel good, Her daughter felt like she couldn't move, She was shaking really bad at 1:00 in the morning, she didn't sleep very much, Arm sore and lumpy under arm pit/ It really felt lumpy under her arm pit. and She felt so sweaty was unknown and Heart was racing very fast./Her heart was beating really fast and fever was recovered on an unknown date, She said her lymph nodes under her right arm seem like they are feeling better- before, she couldn't even put her arm down because they hurt so bad was recovering. Information on Lot/Batch number was available. Additional information has been requested.
20 2021-06-02 sleep disorder I had a sore arm the first day after the shot. Two days after I woke up from my sleep with very bad ... Read more
I had a sore arm the first day after the shot. Two days after I woke up from my sleep with very bad chills and a 102 fever at 11:30 pm. After two hours, the chills stopped but my fever was still at 102. I went back to sleep at 3:00 am and woke up without a fever but still felt very tired and groggy for the next two days. Also, am not sure if it is related, but I am usually very regular on my menstrual cycle, but was 20 days late after getting the first vaccine. I know this because I track my menstrual cycle. Also, when my period did finally come, it was the most painful period that I have had in a while. The cramping was very painful and I bled very heavily. Although, I got my second shot on the 27th of May and had no symptoms. I also, to my knowledge, did not have covid prior to getting either shot.
20 2021-06-07 feeling abnormal Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generali... Read more
Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Hypertension-Medium, Systemic: Hyperventilation-Medium, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Shakiness-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic: Visual Changes/Disturbances-Severe, Systemic: Weakness-Medium, Additional Details: Patient was given the vaccination and she moved from the immunizing chair to the waiting area. While in the waiting area, the patient passed out briefly (less than 15 seconds), revived and was complaining of blurred vision and that her brain felt "funky." She then broke out in full body hives and was administered 2x25mg benadryl tablets orally. 911 was called. Patient then began complaining that her face and body felt numb and tingly all over. Paramedics arrived and took patient to the hospital.
20 2021-06-07 feeling abnormal stomach hurting; started not feeling good; nauseated; headache; coughing; sneezing; cold-like sympto... Read more
stomach hurting; started not feeling good; nauseated; headache; coughing; sneezing; cold-like symptoms/cold; nose got itchy/eyes got itchy; difficulty breathing/having trouble breathing; feels weak/has no energy; She experienced chills about three hours after the vaccine.; abdominal pain; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A 20-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EW0191; Expiration Date: Sep2021), via an unspecified route of administration, in Left arm on 22May2021 at 11:30 (at the age of 20-years) as single dose for covid-19 immunization. Medical history included ongoing acid reflux in the stomach; was diagnosed about one or two years ago. The patient did not receive any vaccinations within 4 weeks prior to the administration of suspect vaccine. The patient's concomitant medications included ongoing Tri-lo-sprintec (started taking it to regulate her cycle as she had an irregular period; she started this birth control 2 or 3 years ago). On 22May2021, the patient waited 15 minutes after the shot and felt fine, but later on that day (a couple of hours after) she got chills (about three hours after the vaccine). She stated she had normal side effects and did not think anything of it. On Sunday (23May2021), she had difficulty breathing (trouble breathing) and felt weak (feeling very weak and has no energy). She voiced it's hard for her to wear a mask. When she had to put a mask on it really felt like she could not breathe, and the air feels stuffy especially if she wears a mask; every couple of seconds she had to wear the mask under her nose because she could not breathe. Caller stated that she did not have this problem before receiving the COVID vaccine. On Monday (24May2021), she felt like she was coming down with a cold. Caller stated that she thought that might be her trouble breathing was from her cold-like symptoms, but she does not think it was, because she was not experiencing any cold-like symptoms on Sunday and was only having trouble breathing. She experienced coughing, sneezing, itching eyes/nose, chills, and headache. On Wednesday (26May2021), she started feeling nauseated (got very nauseous), not feeling good, she was getting a headache and had caught a cold. Caller stated she did not know if it was from vaccine shot but her eyes got itchy, her nose got itchy, and she kept sneezing and coughing. Yesterday (26May2021), the chills went away, she has not had any chills today, but she does not know if she will have any from this point on. She believed that she has recovered with lasting effects. Caller stated that not feeling well was ongoing and persisting, but then stated that she feels it was worsening. Yesterday, she just felt nauseous, today she woke up with her stomach hurting very badly and abdominal pain; her weakness has continued. Yesterday she took pantoprazole for the abdominal pain and Tylenol for the pain and headache. She stated that she had a slight headache that is now coming and going, clarifies that it is persisting. Caller thought the reason that her stomach is hurting was because of her stomach acid problem. She deals with a strict diet that she must follow for things she was not supposed to have. Since she had the COVID shot, she believes it was affecting the acid problems in her stomach. Caller clarified that she was calling to see what she should do, if she should go see a doctor or if this is normal. The outcome of events Dyspnoea, Asthenia, Sneezing, Headache, stomach hurting, Itchy was not resolved. The outcome of events of Nausea, started not feeling good, Cold like symptoms was resolving. The outcome of events chills was resolved with sequel on 26May2021, and Cough resolved with sequel on 25May2021. The outcome of Abdominal pain was unknown. Information on Lot/Batch number was available. Additional information has been requested.
20 2021-06-07 sleep disorder, nervousness has been really shaky; has a headache; hasn't felt good; when she went to sleep she woke up 2 hours ... Read more
has been really shaky; has a headache; hasn't felt good; when she went to sleep she woke up 2 hours later; couldn't move her arm; cold chills; she believes she was running a fever last night because she was burning up but she couldn't find a thermometer though so she is not sure; she believes she was running a fever last night because she was burning up but she couldn't find a thermometer though so she is not sure; sharp pain throughout her arm; This is a spontaneous report from a contactable consumer (patient). A 20-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: UNKNOWN), via an unspecified route on 27May2021 (at the age of 20-years) as 1st dose, single dose in the left arm for covid-19 immunisation. The patient medical history and concomitant medications were not reported. patient side effects are that she has been really shaky, she has a headache, she hasn't felt good since yesterday, 27May2021, and she went to sleep yesterday, 27May2021, and woke up 2 hours later and couldn't move her arm at all and every time she did move it, it was shooting sharp pain throughout her arm, she has cold chills and she believes she was running a fever last night because she was burning up but she couldn't find a thermometer though so she is not sure. Clarified vaccine to the Pfizer COVID vaccine 1st dose. Reporter seriousness was Unspecified. She says they are all continuing to today except for she doesn't have the fever anymore and her arm is not shooting pain. But she does still have headache and cold chills every now and then and she's shaky. The outcome of the events Sleep disorder; Joint range of motion decreased; Fever; Burning sensation, Pain in arm was recovered in 2021. and rest of the events was not recovered. Information on the lot/batch number has been requested
20 2021-06-10 anxiety My heart beats weird, i feel like i?m having a constant anxiety attack, i can?t eat much. my jaw hur... Read more
My heart beats weird, i feel like i?m having a constant anxiety attack, i can?t eat much. my jaw hurts sometimes, same with ears i feel like i have an ear infection
20 2021-06-14 impaired work ability, insomnia About a week after the first dose, she went to sleep. She woke up to a burning sensation in her left... Read more
About a week after the first dose, she went to sleep. She woke up to a burning sensation in her left arm in the forearm. It was more painful towards the wrist, but went up to the elbow. She could not go back to sleep. Woke up boyfriend to take her to urgent care. They drew blood, gave her pregnancy test. Gave her an inflammatory (Toradol). Gave her a prescription to take at home. Then sent her home. She had to miss 2 days of work. After 24 Hours pain dissolved and has not returned.
20 2021-06-16 sleep disorder, feeling abnormal Feels like her heart is going to stop, chest tender and heavy, sharp pains in chest, can't sleep.
20 2021-06-17 insomnia Same day as the shot she was having chest pains, hard time sleeping
20 2021-06-17 sleep disorder She read in the Fact sheet that this could be a severe allergic reaction; shivering; temp was up; pa... Read more
She read in the Fact sheet that this could be a severe allergic reaction; shivering; temp was up; pale; dizzy; elevated heart rate; weakness; muscle ache pains; Woke up in the middle of the night; This is a spontaneous report from a contactable consumer. This 20-year-old female consumer (patient). A 20-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), dose 1 via an unspecified route of administration on 08Jun2021 (at the age of 20-yearsr-old) as 1st dose, single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date on Jun2021, the patient experienced woke up in the middle of the night with shivering, temp was up, was pale, dizzy, elevated heart rate, weakness, muscle ache pains trying to calm down, but trying to get to relax from shaking/shivering. She read in the Fact sheet that this could be a sever allergic reaction and was wondering if she should received the second dose of the vaccine. As noted in the Fact Sheet for Recipients, should not get the Pfizer-BioNTech COVID-19 Vaccine if the patient had a severe allergic reaction after a previous dose of the vaccine or if had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. We refer you to speak to your healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Your healthcare provider knows your health situation and has access to information that can better help inform this decision. The outcome of the events were unknown. Information regarding Lot/Batch number has been requested
20 2021-06-21 confusional state It started with a numbing feeling in my left arm and somewhat of cramping in that same wrist. About ... Read more
It started with a numbing feeling in my left arm and somewhat of cramping in that same wrist. About 2 minutes later, I felt extremely dizzy and lightheaded. My boyfriend realized that I stopped responding to him and my eyes rolled back. I ended up passing out, falling to the floor, and having convulsions for about 45 seconds before waking up extremely confused.
20 2021-06-22 anxiety Pt presented with complaint of mild nausea. Pt denied CP, SOB. Full assessment performed and V/S obt... Read more
Pt presented with complaint of mild nausea. Pt denied CP, SOB. Full assessment performed and V/S obtained. Pt denied any significant PMH. Pt denied the possibility of pregnancy. Pt stated that she felt as though it may have been an anxiety reaction. Pt did not vomit while with Observation Staff. Pt rested in observation area x10 mins. At conclusion of time, pt noted relief of symptoms. Pt stated that she did not want to go to the hospital. Pt informed of risks of refusing, up to and including death. Pt accepted risks and stated she would follow-up with his PCP. Pt signed AMA and released without incident. Pt transported home by mother who accompanied her to appointment
20 2021-06-22 disorientation Client's mother came to office stating that client reported that she was feeling disoriented, as if ... Read more
Client's mother came to office stating that client reported that she was feeling disoriented, as if her heart rate was slow, light headed. Instructed that they needed to call primary provider who referred them to paramedics. Paramedics monitored. Conclusion that it was not an allergic reaction, but a "bad reaction". Client feeling better today.
20 2021-06-23 insomnia 05/04/2021 around 8:30 AM I started feeling effects like nausea and fatigue. The typical symptoms. T... Read more
05/04/2021 around 8:30 AM I started feeling effects like nausea and fatigue. The typical symptoms. They lasted for about a week and a half. It lasted until about 06/14/2021 and then I noticed the lymph node protrusion on Sunday and I went to the urgent care Clinic on Monday 06/14/2021and they just said it would go away. At the Doctor they did blood pressure test and an EKG and they did EKG because I had vasovagal response after touching lymph node. There was a few nights in a row about a week after the vaccine, where I had insomnia and I couldn't fall asleep at all and had to take sleep aid. Lymph node swelling did go down and isn't inflamed anymore.
20 2021-06-24 anxiety Syncope while sitting in chair post vaccination. HR 70. Verbally responsive to questions. Anxious... Read more
Syncope while sitting in chair post vaccination. HR 70. Verbally responsive to questions. Anxious.
20 2021-06-29 crying Site: Pain at Injection Site-Severe, Systemic: enitre arm pain to the point of TEARS and unable to u... Read more
Site: Pain at Injection Site-Severe, Systemic: enitre arm pain to the point of TEARS and unable to use arm day 2-Severe, Systemic: Headache-Severe, Additional Details: Day of Vax = Arm pain in upper arm..but NEXT DAY = entire Arm pain / unable to move it arm at all with Severe Migraine (" I get headaches but never migraines") ...pain level enough to make me cry.
20 2021-06-30 feeling abnormal 2nd dose Pfizer shot administered at 9:37am. Pt was noticed to be really out of it near the front o... Read more
2nd dose Pfizer shot administered at 9:37am. Pt was noticed to be really out of it near the front of the store. No previous history of allergic reactions and no issues with 1st dose. Patient said head was hurting bad and throat felt weird. Her eyes were rolling back in her head and she was in and out of responsiveness. Ice pack was given at 10:07am, EMS was called, at 10:10am bp 129/101 pulse 89, ems arrived on scene at 10:15am and took patient to the hospital.
20 2021-07-09 anxiety, confusional state Woke up with a loud heartbeat and severe chest pain, especially when breathing in - shortness of bre... Read more
Woke up with a loud heartbeat and severe chest pain, especially when breathing in - shortness of breath, dizzy/confused, anxious. Went to the emergency room and was given an ECG which was abnormal, tested positive in blood test for blood clot but was negative on a CAT scan. Doctor stated it was minor myocarditis, was perscribed ibuprofen and percocet and sent home
20 2021-07-13 anxiety, feeling abnormal Patient reported after receiving vaccine that she felt tingly. Mom noticed faint red rash to her an... Read more
Patient reported after receiving vaccine that she felt tingly. Mom noticed faint red rash to her anterior neck. Patient reported that she felt "weird." No angioedema, SOB, wheezing or stridor noted. Patient had taken benadryl prior to arrival due to history of developing a rash 3 days after her previous Pfizer dose. Patient admits that she is very anxious. Due to rash, we administered solu-medrol 125mg IM and pepcid 40mg PO. VS were BP 144/90 HR 120 RR 24 Spo2. Patient very anxious appearing. Approx 10 minutes after receiving meds, patient reporting feeling slightly better. Rash appears fainter. No SOB, angioedema, stridor. Patient in no distress. Continued to monitor patient for at least 30 more minutes. Patient reports feeling much better. Symptoms continuing to improve. Prior to arrival, rash noted to be gone. No further development of symptoms. BP 133/83. HR 106. RR 18 Spo2 100%. Patient has been eating goldfish and drinking water. Reports that she feels much better. Mom feels comfortable continuing to monitor at home. If there is any concern for needing a booster dose, would advise allergy consult.
20 2021-07-17 feeling abnormal Swollen lip; Brain fog; Headache; Arm pain; This is a spontaneous report from a non-contactable cons... Read more
Swollen lip; Brain fog; Headache; Arm pain; This is a spontaneous report from a non-contactable consumer, the patient. A 20-years-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 20-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was unknown if the patient was diagnosed with COVID-19 . Since the vaccination, the patient had not been tested for COVID-19. On an unknown date the patient experienced headache, swollen lip, brain fog and arm pain. 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 headache, swollen lip, brain fog and arm pain were unknown at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
20 2021-07-17 nervousness feeling like she "was seeing stars but not passing out" Lightheaded; the patient began to experience... Read more
feeling like she "was seeing stars but not passing out" Lightheaded; the patient began to experience shaky; This is a spontaneous report from a non contactable other healthcare professional. A 20-year-old female patient received first dose of BNT162b2 (COVID-19 MRNA VACCINE BIONTECH; lot number: EN6207) via an unspecified route of administration on 19Mar2021 (at the age of 20-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication details were not provided. On 19Mar2021, during her 15 minutes waiting period after the injection, the patient began to experience shaky, feeling like she was seeing stars but not passing out - Lightheaded. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, dizziness, facial swelling, lip swelling and tongue swelling. It was reported that the treatment included: water and snacks and follow up response to treatment was excellent. The patient was discharged and was stable to go home and follow up with PCP (primary care physician). The clinical outcome of the events feeling shaky and light headedness was unknown. No follow-up attempts are possible. No further information is expected. Amendment: This follow-up report is being submitted to amend previously reported information: Protect Confidentiality in reporter tab was unticked. Patient name updated since First Name and Last Name should be captured separately.
20 2021-07-19 amnesia, feeling abnormal, disturbance in attention, mental impairment On both my first and second shot I got really bad brain fog. I went to the ER after my first shot on... Read more
On both my first and second shot I got really bad brain fog. I went to the ER after my first shot on June 29, 2021 but they told me it was a psychological thing and that I was freaking myself out and that it was not vaccine related but I knew the at wasn?t the case. After my first shot the pressure in my head remained for about a week and the brain fog and vision/auditory issues only occurred on the first day mainly. On my second shot today (07/20/2021) it occurred again and so I know it?s vaccine related, not psychological. On both shots it was an immediate reaction. As soon as the person began to inject the vaccine into me I would feel immediate pressure in my head (on the first shot it felt like the vaccine literally traveled to my fingertips in my left arm and up into my head, it was very strange). Then about 2-5 minutes after I got the vaccine on both occasions my vision became filled with floaters and my coherency decreased. The first vaccine was the worst as the floaters stayed longer and my vision would go in and out of bluriness more. On the second shot the floaters were very obvious for the first hour and then slowly decreased over time but it is currently 6 hours after my shot right now and I still see a couple. On my second shot my vision did blur but not as bad. Both times I felt tremendous pressure in my head and I couldn?t think straight or focus. My speech was very slow and the ordering of my words were inaccurate. My texting was bad because I couldn?t spell and the structure of my sentences was incorrect. I have issues putting words together to say what I want to say and I can?t concentrate. Both times I have stared at a wall in fixation for hours which is not normal. It?s not so much as a headache, just a lot of pressure and I?ve never experienced it with anything else in my life. After my second dose I was also extremely exhausted but could not sleep because of the pressure in my head. My memory is also affected as I cannot remember things very well. It takes me about 30 seconds to understand what someone says because I just can?t think. I feel like my cognitive processes are faulty. It?s like a very intense brain fog that affects my vision and on the first vaccine also affected my hearing as stuff sounded muffled.
20 2021-07-20 confusional state Systemic: Confusion-Severe, Systemic: Headache-Severe, Systemic: Nausea-Severe, Systemic: Numbness (... Read more
Systemic: Confusion-Severe, Systemic: Headache-Severe, Systemic: Nausea-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic: Visual Changes/Disturbances-Severe, Systemic: Weakness-Severe, Additional Details: pt developed severe headache within minutes of vaccine felt like eyes were bulging out of head. She had tingling/numbness in arms then couldn't move arms. Her mental cognition declined and she was unable to speak. Patient had fluid coming out of her nostrils and eyes. Transported to ER by ambulance.
20 2021-07-21 panic attack Patient received a COVID vaccine. A couple minutes after administration. Patient stated that she was... Read more
Patient received a COVID vaccine. A couple minutes after administration. Patient stated that she was feeling faint and dizzy. Patient mentioned that she was having blurred vision. Pharmacist provided a cool compress to the patient's head, neck, and wrists. Patient was also provided water. Patient's blood pressure was taken several times which read extremely low (90s/ 50s). Patient mentioned that her hands were going numb and stiff. EMS was called for patient for assessment. Patient was observed by EMS in which it was concluded that patient experienced what appeared to be a panic / anxiety attack. Patient believed that the vaccine was giving the patient covid. Once the EMS told her otherwise, patient was able to calm down. After about 25-30 minutes after the vaccine, patient felt better and left with her mother.
20 2021-07-22 sleep disorder A couple of hours after getting the second dose (yesterday), I was had weird abdominal cramping, eve... Read more
A couple of hours after getting the second dose (yesterday), I was had weird abdominal cramping, even though I hadn't eaten anything weird. This cramping slowly increased in discomfort and pain throughout the rest of the evening and into the night. Despite taking one caffeine 200mg pill (Equate Stay Awake), I was even more tired and feeling lightheaded. I didn't have diarrhea but I frequently went to the bathroom (unusual for me). I had really bad chills all throughout the night. I kept waking up in pain and vomited quite harshly. I felt like I had a fever. I took my temperature a total of three times after the worst of my symptoms had pasted. Once I was able to sit up without feeling too dizzy. I was extremely nauseous (this morning). I took my temperature. The first one at around 11 am said 98.4 (I'm usually at 95.4 on a normal day). And I took it again (twice) at around 2 pm: the first one was 99.1 and the second was 99.2.
20 2021-07-27 feeling abnormal she has been in bed all week; feel under the weather,had a little upchuck; had a little upchuck; she... Read more
she has been in bed all week; feel under the weather,had a little upchuck; had a little upchuck; she started throwing up; pooping experienced at the same time that was very, like a lot, it was excessive, coming out in a rush, a lot coming out; her stomach feels queasy all the time/ stomach pains and upset stomach; her stomach feels queasy all the time/ stomach pains and upset stomach; chills; body aching; This is a spontaneous report from a contactable consumer (Patient). A 20-years-old female Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EW0158, Expiration date: 31Jul2021), via an unspecified route of administration, in Arm left, on 07Apr2021 at 08:10 (at the age of 20-years-old), as a single dose for COVID-19 immunization. The patient medical history included diagnosed allergies as Allergies to foods like pomegranates and latex from 2016 and ongoing, Medication allergies including Aleve, Advil and Motrin. Does not have specific products but any medication of those sort products taken recently or in the past still have allergic reactions, compromised immune status, respiratory illness, genetic / chromosomal abnormalities and obesity. The patient need to take strictly Tylenol only. Family medical history relevant to AE included patients dad had Diabetes, caller thinks it was Type II Diabetes, he also had prostate cancer. They have a lot of other cancers and Diabetes in the family including her grandparents, aunts and uncles. Her grandpa had lung cancer and grandmother had pancreatic cancer. The concomitant medications included Vitamin D (Verified unit of measurement as milligrams with caller, documented as provided. Started about 1 month ago, almost done now) from Mar2021 and ongoing taken as going through depression towards end of 2020, so started as result of blood test results. There was no Investigation Assessment. There was no other vaccinations within four weeks prior to the first administration date of the suspect vaccine. She never had a vaccination other than this first dose of Pfizer-BIONTECH Covid-19 Vaccine. No allergies to vaccines to her awareness. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was reported as none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was reported as none. This consumer called regarding her first dose of Pfizer-BIONTECH COVID-19 Vaccine on 07Apr2021. She knows that there are a series of side effects you can get from the Pfizer-BIONTECH COVID-19 Vaccine. She reported onset of side effects starting 13Apr2021 that are ongoing. Starting 13Apr2021 she started to feel under the weather, had a little upchuck; she started throwing up and pooping experienced at the same time that was very, like a lot, it was excessive, coming out in a rush, a lot coming out. Since those events she was not able to keep anything down or eat, her stomach feels queasy all the time, having chills and body aching. She knows she could be signs from the Pfizer-BIONTECH Covid-19 Vaccine but knowing this was first dose and second dose was going to be rougher. The patients temperature last night was 98 degrees Fahrenheit and this morning was 97.7 degrees Fahrenheit so she had no fever. Just having stomach pains and upset stomach. She called to ask if these side effects are normal, or if there was any recommendation on if or when she should go see a healthcare provider or go to the hospital for these side effects. She was talked with her roommate about if the events kept persisting or got worse going to the healthcare provider's or hospital but she wanted to talk to Pfizer about this to see their information or recommendations. The patients second dose was scheduled to be administered at the end of the month. There was no relevant Tests performed. The patient underwent lab tests and procedures which included body temperature with result of 98- and 97.7-degrees Fahrenheit on an unknown date. The patient was not hospitalized. Adverse events does not require a visit to Emergency Room or Physician Office. Outcome of the events was reported as unknown. Reporter seriousness for Side effects was reported as Unspecified. No follow-up attempts are needed. No further information is expected.
20 2021-07-29 insomnia Temperature at 99.2 F at noon today; Moderate to severe diarrhea beginning the morning after injecti... Read more
Temperature at 99.2 F at noon today; Moderate to severe diarrhea beginning the morning after injection.; Pain in the upper left arm around the injection site. Wosened over night.; Pain when using arm.; Light nausea; Unable to sleep on the left side because of this.; This is a spontaneous report from a non-contactable consumer, the patient. A 20-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 06Apr2021 at 12:00 (at the age of 20-years-old) as a single dose for COVID-19 immunisation. Medical history included migraines, IBS, ADHD and depression. Concomitant medications included methylphenidate 54 (MANUFACTURER UNKNOWN) and fluoxetine 50 (MANUFACTURER UNKNOWN); both from unknown dates for unknown indications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Apr2021 at 13:00, the patient experienced pain in the upper left arm around the injection site, worsening with pressure beyond the expected level for an injection that worsened over night, pain when using arm, unable to sleep on the left side because of pain and light nausea. On 07Apr2021, the patient experienced moderate to severe diarrhea beginning the morning after injection. Despite having IBS, it was not accompanied with the intense cramps that an IBS episode usually would have. On 07Apr2021 at noon, the body temperature was reported as 99.2 F (Fahrenheit). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events moderate to severe diarrhea, pain in the upper left arm around the injection site, pain when using arm, unable to sleep on the left side because of pain, light nausea and temperature at 99.2 F was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.
21 2021-01-03 impaired work ability On Sunday, December 27, I had the injection. I was fine. Monday the 28th, I was in pain in my arm. D... Read more
On Sunday, December 27, I had the injection. I was fine. Monday the 28th, I was in pain in my arm. December 29 to currently ( January 4 2021) I am sick. I believe I got it from the vaccine. I have been out of work for two weeks. I will not go get the other vaccine. I thought I was protecting myself but find out I am not. I am currently laying in bed sick as a dog. I have shortness of breath, cough, sneezing,sore throat, and bodyaches. I am in severe pain
21 2021-01-06 impaired work ability Pt received Pfizer-COVID vaccine (under EUA) yesterday 16 Dec 2020 at approx 1700. She did not have... Read more
Pt received Pfizer-COVID vaccine (under EUA) yesterday 16 Dec 2020 at approx 1700. She did not have any immediate problems after vaccination. . She woke up today feeling achy and feverish, and measured her oral temp at 1000 as 101.4 at home. She drank fluids, but took no meds -- repeat oral temp at 1200 was 99.0. . Other sxms include sore arm at vaccination site with min redness but no swelling. . She additionally reports nasal congestion and sore throat that began 1 day prior to vaccination, that she attributed to her seasonal allergies. No meds for allergies. No cough or SOB. No headache or neuro sxms. No GI sxms. . She was concerned about fever and went to drive-thru COVID testing at approx 1300... results due back in 24h. She has no known COVID contacts. . She works in sterile processing at NMCSD with no direct patient contact usually; She is on night shift now. - Fever and achy symptoms, as above, in previously healthy hospital worker, with onset approx 18h after receipt of COVID-Pfizer vaccine, dose #1. With questionable URI-like sxms one day prior to vaccination, COVID testing was very reasonable -- and results are pending now. If COVID test negative, this most likely represents mild-moderate systemic reaction to vaccine. Advised no work this evening, rest at home, increase clear fluids, and take Motrin 400mg q4-6h as needed for subjective fever or achiness -- use/precautions reviewed. Will follow-up tomorrow with this team by phone. If vaccine reaction, expect sxms to lessen rapidly and resolve over next 1-2 days. Indications for urgent care -- including marked worsening of sxms or new sxms -- reviewed. She also has number for 24/7 Immunization Support. Will file VAERS, since work missed for sxms. Will encourage enrollment in VSAFE as well. Advised that, if mild-moderate systemic reaction determined most likely source of sxms, dose #2 of COVID-Pfizer vaccine will still generally be recommended. Pt expresses understanding and appreciation of all issues.
21 2021-01-07 crying, anxiety tested positive for Covid test; tested positive for Covid test; difficulty breathing; chills; fluctu... Read more
tested positive for Covid test; tested positive for Covid test; difficulty breathing; chills; fluctuating fever; nausea; weakness; weakness/extreme fatigue; loss of taste and smell; loss of taste and smell; muscle pain; cough; sore throat; nasal drip; dizziness; fast heartbeat; injection site pain; anxiety; crying; This is a spontaneous report from a contactable healthcare professional. This 21-year-old female patient reported for herself that she received BNT162B2 1st dose on 31Dec2020 10:00 AM intramuscular at left arm for COVID-19 immunisation. Medical history included known allergies: Penicillin and Covid-19. Concomitant therapy included BC as reported. The patient experienced difficulty breathing, chills, fluctuating fever, nausea, dizziness, weakness, fast heartbeat, tiredness, loss of taste and smell, muscle pain, injection site pain, anxiety, cough, sore throat, nasal drip, crying, extreme fatigue, Etc on 31Dec2020 at 06:00 PM. The events resulted in doctor or other healthcare professional office/clinic visit, emergency. The patient was hospitalized for 1 day and received treatment included blood thinner rivaroxaban (XARELTO) and had 2 weeks quarantine. The patient had Covid prior to vaccination and tested positive for Covid test post vaccination on 01Jan2021. The outcome of the events was not resolved. Information on Lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the suspected LOE, SARS-CoV-2 test positive and the other reported events due to temporal relationship. Of note, it is reported that the patient had history of COVID 19 infection prior to the vaccination. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
21 2021-01-07 loss of personal independence in daily activities, excessive sleepiness Pfizer 1st dose- Not even five minutes after receiving the vaccine I started sweating, dizziness, he... Read more
Pfizer 1st dose- Not even five minutes after receiving the vaccine I started sweating, dizziness, headache, nausea and getting hives on both arms. They made my crew take me to the ER. When they took my vitals my O2 was 88% and they put me on 4lpm, HR was upper 110s and my BP was 160s/100s... The next day I couldn?t walk, keep my eyes open, had a headache, my whole body was aching and sore. I ended up sleeping for over 20 hours that day, couldn?t eat my husband had to actually help me walk to the shower and bathe me because I kept almost passing out.
21 2021-01-08 disturbance in attention Severe body aches and fatigue, chills, tachycardia, chest pain and tightness, headache, stomachache,... Read more
Severe body aches and fatigue, chills, tachycardia, chest pain and tightness, headache, stomachache, gastrointestinal issues, nausea, inability to focus, fever
21 2021-01-12 disturbance in attention Spiked a fever of 101.1, aches, muscle fatigue, general fatigue, nausea, abdominal pain, joint pain,... Read more
Spiked a fever of 101.1, aches, muscle fatigue, general fatigue, nausea, abdominal pain, joint pain, loss of concentration, chills, dizziness. Symptoms came on very suddenly
21 2021-01-14 impaired work ability 1/13/21: received second dose of COVID-19 vaccine. One hour later experienced sensation of arm numbn... Read more
1/13/21: received second dose of COVID-19 vaccine. One hour later experienced sensation of arm numbness, resolved within hours. Later in evening experienced a sensation of burning in entire right arm. 1/14/21: woke at 2 a.m. with sensations of shortness of breath. At 5:30am developed muscle spasms in form of twitches in right arm and diffuse muscle discomfort. Additionally describes chest pain in substernal location with radiation to right rib cage. Chest pain reproduced and accentuated by direct pressure. Developed fever of 99.9 degrees and was turned away when going to work. Returned home and recorded temperature slightly above 100 degrees. 1/14/21: experienced continued muscle discomfort and right arm twitches. Remains short of breath but seems to be improving. 1/15/21: continued complaints of chest pain radiating from middle of chest to right side, continued shortness of breath, and whole body pain.
21 2021-01-17 anxiety anxious, c/o a tightness of throat, and itching. She took oral loratadine followed by oral Benadryl... Read more
anxious, c/o a tightness of throat, and itching. She took oral loratadine followed by oral Benadryl. She verbalized improvement in symptoms but requested assistance to go the Emergency department.
21 2021-01-18 impaired work ability chills, fever, body aches, fatigue. called in sick to work.
21 2021-01-19 insomnia Fever greater than 100°F, extreme chills, cold extremities, muscle aches, hard breathing, and diffi... Read more
Fever greater than 100°F, extreme chills, cold extremities, muscle aches, hard breathing, and difficulty sleeping. I took 2 tablets of Acetaminophen 650mg when started to fever around 10pm, drank lots of warm uncaffeinated tea, and slept on a heated bed. Slight fever of about 99°F and muscle ache the day after, took another 2 tablets of 650mg acetaminophen at 10am.
21 2021-01-20 anxiety Upon arrival to observation room, just after vaccination, patient c/o decreased vision, feeling hot ... Read more
Upon arrival to observation room, just after vaccination, patient c/o decreased vision, feeling hot and as though she was going to pass out. Pt. appeared anxious stated she did not like needles. Removed face mask to take slow deep breaths, sipped water. BP 81/51, pulse 84, pulse ox 98%, skin mildly diaphoretic. Did not lose consciousness, answered questions appropriately. Continued to drink water and take slow deep breaths, felt better after 4-5 minutes. Felt well enough to walk to the first aid room for additional observation (30 minutes). Sitting in the first aid room she continued to drink water (16 oz) and ate several crackers; symptoms continued to improve and patient she felt much better, ready to leave the clinic. Patient was calm, conversant, BP improved to 97/57, skin was warm and dry, pulse 74-78 and pulse ox 100%.
21 2021-01-22 disturbance in attention, feeling abnormal Dizziness, unable to focus, foggy brain, left arm pain, weakness. Nurse monitored me for about an ho... Read more
Dizziness, unable to focus, foggy brain, left arm pain, weakness. Nurse monitored me for about an hour, vitals taken frequently, slayed my down, given water and juice, Benadryl. After side effects only worsening, nurse sent me to the ED where they checked me out and watched me for several hours and I was discharged me at 10pm. it is now over 24 hours after the vaccine and I feel 60% better.
21 2021-01-26 irritability Neck pain almost immediately after injection. Headache followed about 4 hours later. Continued to g... Read more
Neck pain almost immediately after injection. Headache followed about 4 hours later. Continued to get worse. Very irritable and tired around 3 hours after injection. Advil did not help headache, only sleep did. Feeling much better now (~21 hrs post injection.)
21 2021-01-28 disorientation Employee states that later that eveningwhen she got home she began having some lightheadedness and d... Read more
Employee states that later that eveningwhen she got home she began having some lightheadedness and describes feeling loopy. She described seeing stars at times and then her vision would go black. A friend came over to stay with her and did say that at one point she became unresponsive for about 45 sec to 1 minute. The second day she still had the lightheadedness and felt loopy. On the 3rd day she felt completely fine.
21 2021-01-29 insomnia Nausea, insomnia, abdominal pain, fatigue/exhaustion, fever, chills, overheating, dry eyes, muscle a... Read more
Nausea, insomnia, abdominal pain, fatigue/exhaustion, fever, chills, overheating, dry eyes, muscle aches and joint pain (more/different than usual related to health condition)
21 2021-02-01 sleep disorder Experienced vomiting morning after shot along with fever of 101 and dizziness with standing, sweatin... Read more
Experienced vomiting morning after shot along with fever of 101 and dizziness with standing, sweating and chills (1/28). Experienced Severe swelling of axillary lymph nodes (1/28-1/30). Severe swelling of supraclavicular lymph nodes ( 1/29-2/01) . Mild swelling of cervical lymph nodes (1/30-02/02). Mild swelling of submandibular lymph nodes (02/02) Lymph node swelling seemed to spread superiorly each day. Limited ability to raise arm/ sleep and pain with coughing breathing and swallowing.
21 2021-02-03 crying Sore muscles, chills, freezing cold, hard time walking, headache, light headed, nauseous, pins and n... Read more
Sore muscles, chills, freezing cold, hard time walking, headache, light headed, nauseous, pins and needles feeling in legs, sore in injection site, bruising in injection site, pain that caused crying
21 2021-02-03 sleep disorder After receiving the second dosage of my COVID vaccine at 2 PM on 02/03/21, I only had left arm pain ... Read more
After receiving the second dosage of my COVID vaccine at 2 PM on 02/03/21, I only had left arm pain near the site of the injection. However, I went to sleep and at 2 AM on 02/04/20, I started having fever, a severe HA, and myalgia that hindered my sleep. I took 500 mg Tylenol at 6 AM and went back to sleep. When I woke up at 8:30 AM, I went to use the restroom and felt dizzy with hot flashes. Immediately afterwards, I noticed that I had fainted and my mother helped me to my bed. After drinking soup and juice and having a bowel movement, I felt normal and alerted my PCP.
21 2021-02-10 impaired work ability Woke up next day at 5:00am very nauseous. Threw up at 6:45 am and had to call off work. Felt chills ... Read more
Woke up next day at 5:00am very nauseous. Threw up at 6:45 am and had to call off work. Felt chills and fatigue and weakness the whole day. Felt fine the next day. No symptoms in second dose.
21 2021-02-12 impaired work ability Staff member received her 2nd dose on Mon 2/8 at 8am. She woke up on Tues 2/9 with a pounding headac... Read more
Staff member received her 2nd dose on Mon 2/8 at 8am. She woke up on Tues 2/9 with a pounding headache / migraine that would not go away. She went to her MD office on Wed 2/10. As of Thurs 2/11, the migraine still persisted. Her MD has decided to keep her out of work until Mon 2/15. She does not have a history of migraines.
21 2021-02-13 feeling abnormal Intense brain fog, dizziness, and nausea. Dizziness lasted about 5hrs. Brain fog began to fade after... Read more
Intense brain fog, dizziness, and nausea. Dizziness lasted about 5hrs. Brain fog began to fade after 20hrs. Nausea persisted for about 30hrs.
21 2021-02-16 feeling abnormal After injection, she was instructed to stay for observation. Upon checking on her, patient stated h... Read more
After injection, she was instructed to stay for observation. Upon checking on her, patient stated her heart was racing and she felt weak. She was instructed to remain for 30 more minutes of observation. Checked patient post 30 mins. and attempted to have ambulate. She stated she still felt "woozy". Conversation was had with another RN. Pulse was checked and 104. Pupils were dilated and her speech was delayed. We felt she should go to ED to be checked and she agreed. Patient was taken by W/C to ED
21 2021-02-19 feeling abnormal The morning after my second dose of Pfizer?s Covid-19 vaccine, I woke up feeling freezing (at 9:00 a... Read more
The morning after my second dose of Pfizer?s Covid-19 vaccine, I woke up feeling freezing (at 9:00 am) and suspected I had a fever. After waking up again later (around 12:30 pm), I took my temperature and found that I have a fever of 101°F. I still have a fever and chills (2:50 pm). I have not taken any medication to treat the fever yet and plan to just take it easy. If I begin to feel worse, I might take an ibuprofen. After getting the vaccine, my left shoulder was sore, and is still sore, but it?s my understanding that this is normal, and just as my arm was sore with the first vaccine, it may be 2 days before my arm feels better. I am not concerned about the soreness of my arm.
21 2021-02-22 feeling abnormal 21 yo female return from 2nd dose , c/o SOB , Flushed, foggy brain. 1608 BP- 128/88, SPO2- 98, P-87... Read more
21 yo female return from 2nd dose , c/o SOB , Flushed, foggy brain. 1608 BP- 128/88, SPO2- 98, P-87, R-18 Administered 50 mg Benadryl, pt began to feel increased dizziness, lowered patient to the floor and administered 6L of O2. doctor assessed patient, patient Alert and Oriented X3 lowered O2 level to 2L, Sat patient up in chair @1623 BP-146/98, SpO2-98, P-83, R-20. Pt sated she felt better and was released to aunt @ 1627.
21 2021-02-25 euphoric mood, feeling drunk Day of vaccine, 4hrs post vaccine: felt drunk/high/intoxicated (touch was intensified, numbing feeli... Read more
Day of vaccine, 4hrs post vaccine: felt drunk/high/intoxicated (touch was intensified, numbing feeling) Day 2-3: exhausted and fever of 102F, body aches, chills, nausea Day 4: started feeling better, fever went down with Tylenol Day 5 3am: woke up with chest pain (3.5-4/10), went away with Tums; 0930pm chest pain 6/10 while sitting at desk, increased to 7/10, lasting 2 hours by the time I went to the ER
21 2021-03-03 nervousness blacked out for a moment, shaky before blacking out. Evaluated by EMS-Cleared
21 2021-03-03 restlessness Severe body aches, fever, chills, restlessness
21 2021-03-05 anxiety pt felt lightheaded and vomited and anxious bp 100/69 p 72 SA02 99 r-18 lungs clear pt laid down 30... Read more
pt felt lightheaded and vomited and anxious bp 100/69 p 72 SA02 99 r-18 lungs clear pt laid down 30 minutes, felt better, and released to mother to go home
21 2021-03-07 feeling abnormal The next day after the vaccine the injection site got a big round red circle around the injection si... Read more
The next day after the vaccine the injection site got a big round red circle around the injection side which began to get black and blue under the skin which lasted about a week. I felt bad and was vomiting and super tired for about 3 or 4 days.
21 2021-03-14 disturbance in attention, insomnia hard to fall asleep; felt like she was going to pass out/vasovagal reaction; heartbeat was high; Fat... Read more
hard to fall asleep; felt like she was going to pass out/vasovagal reaction; heartbeat was high; Fatigue; Woozy/Dizzy; hard to concentrate; feeling hot; he also felt as though was on the verge of a headache but never got one/she felt like the blood was rushing to her head; This is a spontaneous report from a contactable consumer (patient). A 21-year-old female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL3249), via an unspecified route of administration on 16Jan2021 09:00 at SINGLE DOSE for covid-19 immunisation. The patient medical history was none. No prior vaccinations within 4 weeks. No family history relevant to adverse events. Patient has no concomitant medications. On 16Jan2021 09:20, 20 minutes after vaccination, the patient felt like she was going to pass out reported as vasovagal reaction, and experienced heart beat was high, fatigue, woozy/dizzy, hard to concentrate, feeling hot, and felt as though she was on the verge of a headache but never got one/she felt like the blood was rushing to her head. On 16Jan2021 10:00, 1 hour after vaccination, the patient experienced had to fall asleep. On the day she got the shot she sat for a full hour with the nurse to be monitored. Then she went home. The events lasted from 09:20 until 18:00 on that day. 13 days after vaccination on 29Jan2021, 12:00 and ongoing until reporting time, the symptoms recurred about the same when they started. The patient was wondering if this could be a side effect 2 weeks after getting the shot or if she should look elsewhere on what could be causing these events. She is supposed to get the second dose on Friday and was wondering about getting the second dose after her experience. Patient wanted to know it is safer for her to have the 2nd dose. No physician office visit and emergency room visit. No prior vaccinations within 4 weeks. Outcome of the events was recovered on 16Jan2021 18:00.
21 2021-03-17 anxiety Immediately, I had increased heart rate - 194 - I fainted to the ground. I became nauseous, sick an... Read more
Immediately, I had increased heart rate - 194 - I fainted to the ground. I became nauseous, sick and had seizure like episode and then I had tingling sensation in my face and limbs. They gave me shot epi-pen - two doses. I was pretty much paralyzed for hands and legs. I was brought to hospital and they treated me there for about a week and I had muscle weakness. I gained feeling back in my hands but not in my feet. I was at Haywood for a week. Outpatient therapy and a visiting nurse for three weeks. B12; Iron; Gabapentin and that was for anxiety through it all. Test results came up as neuropathy on left side of my body. I have pins and needles pain now. I did gain my walking back. I take Gabapentin for neuropathy pain. I went to hospital - went one day and I didn't get anything back from them. I now use handicap parking for disability.
21 2021-03-17 sleep disorder Had really bad neck pain following shot. Was awoken in middle of the night with ?brain on fire? feel... Read more
Had really bad neck pain following shot. Was awoken in middle of the night with ?brain on fire? feeling that lasted about 10 minutes and then went away.
21 2021-03-18 anxiety Progress Notes Nurse Practitioner COVID VACCINE CLINIC Subjective Patient is a 21 y.o. adult who... Read more
Progress Notes Nurse Practitioner COVID VACCINE CLINIC Subjective Patient is a 21 y.o. adult who was seen at SVH COVID Vaccine Clinic today for patient's second dose of the COVID 19 vaccination. Patient was given the Pfizer vaccination in the left deltoid muscle. During patient 15 minute waiting period after the injection, the patient began to experience rash, hives, throat tightness and dizziness. Patient denied difficulty breathing, difficulty swallowing, wheezing, hoarseness, stridor, itching, lightheadedness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and patient on was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to abdominal pain, blood pressure abnormality , chest pain, collapse, drooling, hypotension, increased swelling, rapid progression of symptoms, respiratory distress, skin changes, tongue swelling and vomiting. ALLERGY REVIEW OF SYSTEMS: Patient complains of frequent throat clearing, itching of skin and headaches CONT negative Eyes negative Respiratory negative GI negative Musculo negative Previous Reactions: Itching with first Covid shot Objective Vitals Vitals: 03/17/21 1501 03/17/21 1508 03/17/21 1523 BP: (!) 157/100 (!) 154/66 (!) 170/65 Pulse: 90 84 90 SpO2: 99% Physical Exam Constitutional: Appearance: Normal appearance. Patient is well-developed. HENT: Head: Normocephalic. Right Ear: Hearing normal. Left Ear: Hearing normal. Nose: Nose normal. Mouth/Throat: Lips: Pink. Mouth: Mucous membranes are moist. No angioedema. Pharynx: Oropharynx is clear. Uvula midline. Eyes: General: Vision grossly intact. Pupils: Pupils are equal, round, and reactive to light. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Pulmonary: Effort: Pulmonary effort is normal. Breath sounds: Normal breath sounds. Neurological: Mental Status: patient is alert. Psychiatric: Behavior: Behavior is cooperative. Pt had taken benadryl before her visit. She was given Zytec and still had some rash and hives, but the throat tightness had went away. She was given water and crackers while in the bay. Assessment/Plan Treatment included: antihistamines Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) Left at 3:42 Electronically Signed 3/17/2021 3:40 PM
21 2021-03-19 panic attack I received my shot at 11:47 and started to lose sensation in my hands in the waiting area. After abo... Read more
I received my shot at 11:47 and started to lose sensation in my hands in the waiting area. After about 25 minutes I felt dizzy and was about to stand up but my muscles started shaking. My heart rate was checked and found to be 140. This lasted for about another 30 minutes. My heart rate went down and I was taken to a private area and checked out by EMS they gave me water and concluded it was some sort of panic attack. However, these are the same symptoms I have whenever I am allergic to a medication, NSAIDS, dicyclomine, etc. It always starts with ascending numbness from my fingers to the rest of my body. Then I start to shake and my heart rate goes way up. Usually I start to cough then vomit and my airway closes. Thankfully this time we were able to slow the process and I never experienced some of the last symptoms.
21 2021-03-20 sleep disorder On March 7, 2021 my daughter experienced extreme tiredness. I called 911 and paramedics said it may... Read more
On March 7, 2021 my daughter experienced extreme tiredness. I called 911 and paramedics said it may be the effects of vaccine. I was concerned because this symptom came on 2 weeks later. On 3/6/21, I took her to urgent care because I didn't feel comfortable with her extreme tiredness. I was told the same thing. On 2/23/2021, the day that she was supposed to get the second vaccine, she awoke at 12 midnight and was having a full blown psychotic episode. She was make loud noises, hitting the wall, etc. I then took her to the emergency room. My major concern was because my daughter has Down syndrome, a seizure disorder and had heart surgery at three months old (atrio ventricular canal defect).
21 2021-03-21 anxiety wheezing, SOB, anxiety, vomiting
21 2021-03-21 sensation of foreign body Throat Swelling/lump
21 2021-03-24 anxiety, feeling abnormal Patient fell from chair hitting head on ground after passing out. She responded to questions with ap... Read more
Patient fell from chair hitting head on ground after passing out. She responded to questions with appropriate answers within 45 seconds. She reported feeling dizzy and thought it was related to anxiety then woke up on the floor. Patient remained on the floor while being assessed by EMS then moved to a sitting position then to a chair when safe. Patient remained in chair for 10 minutes before leaving the vaccine site.
21 2021-03-24 impaired work ability Nausea at least daily from day 1. Vomiting 5 times from 12am until 7am on the 23rd. Got treatment pr... Read more
Nausea at least daily from day 1. Vomiting 5 times from 12am until 7am on the 23rd. Got treatment prescribed ondansetron 8mg and lordataine 10mg started taking on the 24th. Symptoms almost fully aliveated by the 25th. Still residual nausea and unable to work.
21 2021-03-24 motion sickness motion sickness; Pain in injection spot; dizziness; headache; nausea; fatigue; weakness; This is a s... Read more
motion sickness; Pain in injection spot; dizziness; headache; nausea; fatigue; weakness; This is a spontaneous report from a contactable consumer, the patient. A 21-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: unknown), via an unspecified route of administration in the right arm on 22Feb2021 at 08:30 (at the age of 21-years-old) as a single dose for COVID-19 immunization. Medical history included penicillin allergy and COVID-19 (prior to vaccination), both as of unspecified dates. Concomitant medications included sertraline hydrochloride (ZOLOFT) and bupropion. The patient did not receive any other vaccines within 4 weeks of the vaccination. On 22Feb2021 at 15:45, the patient experienced pain in the injection spot, dizziness, motion sickness, headache, nausea, fatigue and weakness. The patient was not treated for the events. Since the vaccination, the patient had no been tested for COVID-19. The clinical outcome of pain in the injection spot, dizziness, motion sickness, headache, nausea, fatigue and weakness was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
21 2021-03-24 sleep disorder about 12 hours post injections I woke up feeling very nauseous, I had chills, body aches, and a head... Read more
about 12 hours post injections I woke up feeling very nauseous, I had chills, body aches, and a headache. About an hour after that I vomited and experience diarrhea. Returning to bed I had trouble sleeping due to the chills and headache bordering on migraine. Once I did fall asleep I would wake up dripping in sweat and needing to go to the bathroom for more diarrhea. This continued for several hours and several trips to the bathroom. The whole day after my vaccine I was unable to eat food, even the smell made me want to throw up. I was cold and nauseous all day.
21 2021-03-29 confusional state Pt came back to pharmacy stating she did not feel good and had ringing in her ears. She was took to... Read more
Pt came back to pharmacy stating she did not feel good and had ringing in her ears. She was took to the immunization room where she was unable to sit in a chair and was helped to to lie down. She had blank look on her face for a couple of seconds and then started looking around slightly confused then started talking again. She laid there for about 5 minutes and started to feel better so she sat on the chair for about 5 minutes before EMT's arrived as a precaution. After getting check out she left on her own accord. She stated while talking that when she gave blood in the past this has happened.
21 2021-03-30 anxiety Post Covid vaccine while in observation area patient complained of heart beating fast, some difficul... Read more
Post Covid vaccine while in observation area patient complained of heart beating fast, some difficulty breathing, feeling anxious. Skin was warm and clammy, vital signs taken, O2 sat 100% and she developed hives on her upper chest and neck area. Benadryl 12.5 mg given x 2 , 5 minutes apart. EMS was called and patient transported to Hospital for further evaluation.
21 2021-03-30 feeling abnormal Our daughter began having bone pain around 9 p.m. She threw up approx 11 p.m. Through the night, she... Read more
Our daughter began having bone pain around 9 p.m. She threw up approx 11 p.m. Through the night, she began to develop a fever 101.9. Around 5 p.m she said something was wrong over and over. We got ready to go to ER. She wanted to go to bathroom and throw up. When she did, she had a grand mal seizure. My husband had to begin CPR. Fire Rescue team arrived and transported to ER. She was treated and released. Follow up with cardiologist, primary care, and neurologist.
21 2021-03-31 abnormal behaviour, feeling drunk I started out having normal, expected lethargy, but it quickly got worse to the point where I was dr... Read more
I started out having normal, expected lethargy, but it quickly got worse to the point where I was drooling slightly, my breathing slowed down for about half an hour (4:30-5pm), my speech was slurred and slowed, and my mood and behavior were somewhat erratic for about an hour (4:30-5:30pm). A friend I talked to on the phone while these symptoms were ongoing described me as sounding ?kinda drunk.?
21 2021-03-31 insomnia On Friday after 7 hours of receiving vaccine I was nauseous, had chills, my arm at the injection sit... Read more
On Friday after 7 hours of receiving vaccine I was nauseous, had chills, my arm at the injection site was very sore and I couldn?t sleep for about 24 hours. My symptoms were gone within 24 hours of receiving vaccine. However my symptoms came back on Wednesday at 4pm (5 days after receiving vaccine). My arm was all of the sudden sore again and hot to touch. I had chills, couldn?t sleep through the night, and was nauseous for another 24 hours.
21 2021-04-01 disorientation Patient became dizzy and disoriented aprox 3 minutes after shot. ems help refused pt fully recovered... Read more
Patient became dizzy and disoriented aprox 3 minutes after shot. ems help refused pt fully recovered after 30 minutes
21 2021-04-01 panic attack 4:49PM 'FEELS JITTERY - HAVING A PANIC ATTACK'. A/O, PINK, W/D, RESP WITH EASE. BP 115/77, HR 10,5 ... Read more
4:49PM 'FEELS JITTERY - HAVING A PANIC ATTACK'. A/O, PINK, W/D, RESP WITH EASE. BP 115/77, HR 10,5 R20, 02 SAT 99%. 5PM 'FEELS BETTER'. AMBULATORY TO EXIT - GAIT BRISK AND STEADY. NO ACUTE DISTRESS. HR 90.
21 2021-04-02 confusional state Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsiv... Read more
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Patient fainted shortly after injection. She recovered quickly, but felt confused, sweaty, and tingling in her arms after. She felt better after about 15 minutes, but we had to stay to observe for 30minutes after. She was feeling better by the time she left the store.
21 2021-04-02 depressed mood Felt down that day and until the 13th i got diagnosed with bacterial bronchitis.
21 2021-04-04 anxiety My throat / tongue swelled, difficultly breathing and swallowing (anaphylaxis). Urgent care rushed ... Read more
My throat / tongue swelled, difficultly breathing and swallowing (anaphylaxis). Urgent care rushed me in and gave me dexamethasone in my right arm to stop the swelling as well as Tylenol. It took about a full week to completely feel normal, mild anxiety attacks happened. But after one week felt good again.
21 2021-04-04 nervousness Approximately 10 minutes after vaccine administration the patient told her mother she was dizzy whil... Read more
Approximately 10 minutes after vaccine administration the patient told her mother she was dizzy while sitting in a chair outside the pharmacy. I, the pharmacist, ran to the scene and the patient was regaining consciousness as I approached. Her skin was red, and she was disoriented for a moment before asking what had happened. Her mother state she began shaking, and her head slumped as she fainted momentarily. EMS arrived and determined the patient was well enough for her mother to drive her home. The patient reported nervousness, and stated before vaccination that she had dizziness and fainting with Guardisil, but that it did not occur until 3 hours after administration while she was at home.
21 2021-04-05 anxiety After vaccination, felt tightness in throat, similar to GERD, and then had an anxiety reaction. Skin... Read more
After vaccination, felt tightness in throat, similar to GERD, and then had an anxiety reaction. Skin appeared flushed. BP elevated and pulse was regular, 120 beats. O2 saturation= 98%. With relaxation techniques pulse and BP came down, but skin remained flushed. Benadryl 50mg IM given in left deltoid by APRN. At 5:30 pm, pulse was 85. Parents were contacted and arrived to clinic to drive the patient home. Advised to come accompanied by parent for dose #2.
21 2021-04-05 confusional state Patient felt weak, lightheaded, confused, tongue tingling, doubled over herself. Called 911 and took... Read more
Patient felt weak, lightheaded, confused, tongue tingling, doubled over herself. Called 911 and took BP 118/57, Pulse 56, Temp 79,9. When paramedics arrived, her BP was much lower and they took her to the ER to administer fluids and further observation.
21 2021-04-07 anxiety Pt became anxious, sweaty and dizzy. Developed tunnel vision and loss of consciousness. Staff with p... Read more
Pt became anxious, sweaty and dizzy. Developed tunnel vision and loss of consciousness. Staff with pt at time of syncopal episode and assisted pt to floor. Pt regain consciousness within 1 minute. Pt placed on stretcher and arrived to med obs at 1558. Vitals obtained. At this time pt states she is feeling normal. At 1611 c/o dizziness and nausea. BP rechecked and notably dropped. Pt placed in the trendelenburg position. BP increased. Nausea and dizziness resolved. Snacks and water given. Pt left facility 1712, friend driving. Vitals as follows; 1600 BP 107/74 HR 85 RR 22 spo2 98% 1611 BP 97/68 HR 78 RR 20 spo2 100% 1625 BP 109/76 HR RR 18 spo2 99% 1705 BP 95/66 (standing, asymptomatic)
21 2021-04-07 crying Patient was sitting with her mother and family member when she slumped down. They noticed when the p... Read more
Patient was sitting with her mother and family member when she slumped down. They noticed when the patient slumped down and was immediately at the patients side. Paramedics were also called to patient side. Mother states that patient with history of Seizures (3-4 times a week). Mother describes that patient puts her head down and bends forward in a sitting position with her Seizure activity. Patient was immediately placed on stretcher and frequent vitals taken. Patient vitals stable throughout visit. Patient Seizure like activity lasted for 5-6 mins then became post itcal and crying. At that time it was determined that patient be transported to the nearest ER for further evaluation. Patients pediatrician called and notified of patient condition and plan for transport. office agrees for patient to be transported to the nearest ER. Fire rescue on site at 1220 pm and patient transported to ER by 12:23pm. Mother followed with her paramour in separate vehicle.
21 2021-04-07 loss of personal independence in daily activities severe Weakness, and body fatigue limiting ability to conduct normal activities of daily living .ad... Read more
severe Weakness, and body fatigue limiting ability to conduct normal activities of daily living .additionally tachycardia and hypotension
21 2021-04-09 anxiety Patient stated feeling blurred vision, throat tightness, anxiety, shortness of breath, patient appea... Read more
Patient stated feeling blurred vision, throat tightness, anxiety, shortness of breath, patient appeared pale Patient provided water and seen by medical team Patients blood pressure was 86/59 and heart rate 97, patient provided with water Patient advised to be seen in hospital, patient refused medical transport and signed AMA form Patient agreed to go to hospital , driven by boyfriend
21 2021-04-09 disorientation Numbness and tingling down arm and up neck into face, face swelling, rash on face, migrane, fever, s... Read more
Numbness and tingling down arm and up neck into face, face swelling, rash on face, migrane, fever, swelling and pain at injection site, fatigue, disorientation, general feeling of unwellness.
21 2021-04-11 restlessness, insomnia Fatigue and body ache, restlessness, difficulty falling asleep, woke up with headache
21 2021-04-12 anxiety Patient in clinic to receive first dose of COVID-19 Vaccine. Per vaccinator patient oriented/alert, ... Read more
Patient in clinic to receive first dose of COVID-19 Vaccine. Per vaccinator patient oriented/alert, behaving and talking normally prior to vaccine administration. Pfizer dose administeredd in left deltoid, patient completed 30 minute observation period due to her medical history and previous allergic reactions (swelling after pain medication at dentist, anaphylaxis with carbonated drink and tuna). Per patient's report: was getting in to her vehicle ready to leave and vision in right eye became blurry, came back to clinic. Patient reports this is not the first time the blurred vision has occurred, reports blurry vision to right eye occurs anytime she is stressed or tired and typically lasts about 20 minutes.
21 2021-04-12 sensation of foreign body, anxiety, nervousness A few minutes after injection patient complained of feeling dizzy and shaky, she thought it might be... Read more
A few minutes after injection patient complained of feeling dizzy and shaky, she thought it might be from anxiety. About 10 minutes after injection nursing staff asked that I check on patient. She was alert oriented, trying to be calm but was anxious. No rash or swelling to upper chest/face noted. Nurses report she was pale but never diaphoretic. Patient denies trouble breathing, she was eupneic and breath sounds clear to auscultation, no coughing. Heart rate 110. Patient c/o lump in her throat. Given Epinephrine 1:1000, 0.3 ml SQ R upper arm. After about 5 minutes patient reports lump in throat has subsided. She was tremoring, heart rate 110-120. About 8 minutes later she was given Benadryl 25 mg PO from marked pill bottle in her purse. About 12 minutes after 1st epinephrine dose she stated the lump in throat feeling was coming back. Gave another dose of Epinephrine 0.3 ml and called EMS. When EMS arrived about 10 minutes later patient said no lump in throat. it just felt dry. O2 sat 99$ Heart rate 130, BP 130/60. Transported to ER. Called patient next day to check on her. Reports in ER given IV steroids, sent home on PO steroids and an epinephrine pen. Told not to get second dose of vaccine. Patient states hasn't had any problems since. Never had a rash or swelling or trouble breathing.
21 2021-04-13 anxiety anxious, shaking 5 min after vaccine. BP 118/79, O2: 99%, HR:135. Pt. assessed by MD and EMT, observ... Read more
anxious, shaking 5 min after vaccine. BP 118/79, O2: 99%, HR:135. Pt. assessed by MD and EMT, observed for 35 minutes and sent home. No meds required.
21 2021-04-14 excessive sleepiness After the first course of Pfizer's vaccine, in three hours, I had a severe headache, sore arm, and w... Read more
After the first course of Pfizer's vaccine, in three hours, I had a severe headache, sore arm, and was rather tired. I went to sleep for the rest of the day. 24 hours from the time of the injection, I still had a headache, so I went back to sleep. Eventually, at 48 hours after the injection, the headache, muscle soreness, and fatigue no longer lingered.
21 2021-04-15 anxiety @ 1317 c/o anxiety, encouraged to drinking water, eat gyms. VS 122/p, OxSat 100%, HR 98, RR 12. Pt... Read more
@ 1317 c/o anxiety, encouraged to drinking water, eat gyms. VS 122/p, OxSat 100%, HR 98, RR 12. Pt reports not eating today and fear of medical situation. Called leader, F/U information offered and accepted. PT feeling better and discharged thereafter.
21 2021-04-16 anxiety, nervousness C/O anxious & nervous. "did not want to be touch" "I'm with my older sister & will go home with the... Read more
C/O anxious & nervous. "did not want to be touch" "I'm with my older sister & will go home with them.
21 2021-04-17 anxiety Patient received the first dose of Pfizer BioNTech Covid 19 Vaccine (LOT# EW0162, exp. 7/2021) at 1... Read more
Patient received the first dose of Pfizer BioNTech Covid 19 Vaccine (LOT# EW0162, exp. 7/2021) at 1327. At 1335, patient reported needing to vomit to EMT. MT gave patient emesis bag. Patient vomited in emesis bag and immediately stated she vomited due to anxiety. Patient reported stated she felt completely fine after vomiting. Patient refused assessment and treatment. EMT gave patient water and and an extra emesis bag. Patient advised to wait for further observation. Patient waited for 10 minutes. At 1445, patient stated she wanted to leave. At approximately 1446, patient was accompanied by her mother and left facility with unlabored breathing and steady gait.
21 2021-04-19 anxiety Pt. develop reaction to 1st dose of covid-19 vaccine. Symptoms described as having nausea and tired... Read more
Pt. develop reaction to 1st dose of covid-19 vaccine. Symptoms described as having nausea and tiredness. Pt. works outside in park, verbalizes having plenty of fluids and meals eaten prior to vaccination. Pt. currently of medications: Anxiety, buspirone and lexipro. Pt. verbalizes feeling better, no hospital care provided. V/S 182/91, 103 P, 99 O2.
21 2021-04-19 feeling abnormal Approximately half an hour after receiving the vaccination, the patient (me) became extremely dizzy ... Read more
Approximately half an hour after receiving the vaccination, the patient (me) became extremely dizzy while standing still and lost her balance. She nearly fell into a display case at the pharmacy location, and experienced extreme brain fog and balance issues following the vaccination and up until this day.
21 2021-04-20 loss of personal independence in daily activities New onset verbal and motor tics 24 hrs after vaccine. Query Tourettes - does meet diagnostic criter... Read more
New onset verbal and motor tics 24 hrs after vaccine. Query Tourettes - does meet diagnostic criteria - but had very very subtle symptoms prior to vaccine (noticble to patient but not to mother or provider). Post-vaccine with significant vocalizations, involuntary motor tics both very disruptive to daily life. Seeing specialists (neurology, psychiatry) now for treatment.
21 2021-04-25 anxiety patient reported tightened airway, lightheaded BP 129/79 99%, reports she has anxiety attacks, emot... Read more
patient reported tightened airway, lightheaded BP 129/79 99%, reports she has anxiety attacks, emotional reassurance given. Tolerating H2O At 1322 patient reports feeling much better 114/83 78.
21 2021-04-25 feeling abnormal Patient had dizziness, pain (left shoulder, injection site). Felt lightheaded + foggy, alert & orien... Read more
Patient had dizziness, pain (left shoulder, injection site). Felt lightheaded + foggy, alert & oriented. Placed in Trendelenberg position with good effect. Provided orange juice. Patient dizziness/lightheadedness resolved, stable, released from vaccination site.
21 2021-04-26 disorientation Patient received her vaccine around 1:10 pm and was waiting in our lobby for the recommended 15 minu... Read more
Patient received her vaccine around 1:10 pm and was waiting in our lobby for the recommended 15 minutes. After 10 minutes, her body began to seize/shake for about 10-15 seconds and then she went completely limp in the chair she was seated in. I removed her mask to help with her breathing and lifted her head slightly. She began to seize/ shake again and then woke up. Patient was disoriented and reported of head pain, feeling hot and rapid heart rate. We called 911 and EMT arrived a few minutes later, checked her vitals, which all came out normal, and spoke with the patient for a few minutes. Patient refused to go to the hospital and wanted to wait for her mother to arrive. She has no history of seizures and only takes Zyrtec OTC. The patient's mother arrived and spoke with the EMT personnel and I spoke with her as well. I recommended that the patient does not receive the second dose until she has been checked by a doctor and has been given approval to receive it. The patient recovered after about 20-30 min since the event and went home with her mother.
21 2021-04-30 feeling abnormal, disturbance in attention extremely strong menstrual cramping and bleeding; extremely strong menstrual cramping and bleeding; ... Read more
extremely strong menstrual cramping and bleeding; extremely strong menstrual cramping and bleeding; Throbbing pains in the side of head; Extremely cloudy in the head; Attention span is limited; Migraines longer than 4 days; This is a spontaneous report from a contactable consumer (patient). A 21-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine via an unspecified route of administration, administered in left arm on 06Apr2021 at 08:15 AM, at 21 years of age, (Batch/Lot Number: EW0150) as single dose for COVID-19 immunization. The patient had no relevant medical history. She was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. The patient was not pregnant. Concomitant medication included etonogestrel (NEXPLANON) 68 mg taken for an unspecified indication since an unknown date. On 07Apr2021 at 14:30 the patient experienced extremely strong menstrual cramping and bleeding, throbbing pains in the side of head, extremely cloudy in the head, attention span was limited and migraines longer than 4 days. The patient didn't receive any treatment. At the time of the report the reported events had not resolved yet.
21 2021-05-02 sensation of foreign body After waiting for 15 minutes after the vaccination, the patient and her mother returned to the pharm... Read more
After waiting for 15 minutes after the vaccination, the patient and her mother returned to the pharmacy. The patient had a heavy feeling in her chest and it felt like a lump in her throat. She was not having trouble breathing. I had her sit down next to her mother to monitor further. After about 5 more minutes, she felt like her symptoms were getting worse. She stated that she was feeling cold and shivering. I had her lay on the floor. I had my technician call 911. I stayed next to her to monitor. I had her also sit up to drink some water. She complained of her jaw starting to hurt and her head was throbbing. The paramedics arrived shortly after.
21 2021-05-03 disturbance in attention, memory impairment Prolong fatigue, generalized body aches, lack of focus-memory lag/comprehension-, lack of appetite, ... Read more
Prolong fatigue, generalized body aches, lack of focus-memory lag/comprehension-, lack of appetite, and sore throat. Received second dose of vaccine 7 day ago and symptoms still persist. Symptoms gradually improved with the exception of fatigue/body aches, decrease focus/appetite. Prescribed Ibuprofen or Tylenol as needed for pain, and take a few days off to rest and hydrate. If no relief in symptoms, instruct pt to f/u with Health Department/new establish PCP for further direction/management/treatment. Pt denied any SOB, chest pain, chest tightness, swelling, rash, or trouble swallowing.
21 2021-05-05 crying POST VACCINE ADMIN, PATIENT REPORTED "HOT EYES" SENSATION, STATES HAD SOME FLUSHING/SWELLING/MILD RE... Read more
POST VACCINE ADMIN, PATIENT REPORTED "HOT EYES" SENSATION, STATES HAD SOME FLUSHING/SWELLING/MILD REACTION WITH FIRST DOSE PER PATIENT". FACIAL FLUSHING NOTED BILATERALLY, NO ITCHING/HIVES/SOB/WHEEZING NOTED OR REPORTED. REPORTED SOME NAUSEA AS PATIENT WAS CRYING AND ALSO MOUTH NUMBNESS, BUT RESOLVED SPONTANEOUSLY. PER ONSITE MD, BENADRYL 50MG IM GIVEN IN R DELTOID FOR INCREASING RASH/FACIAL FLUSHING/WORSENING S/S. VSS. PATIENT CALLED FRIEND TO COME DRIVE PATIENT HOME POST BENADRYL ADMIN. ONCE S/S RESOLVED, ESCORTED TO EXIT WITH FRIEND WITH NO ISSUES AT 1145. INSTRUCTED TO SEEK FURTHER MEDICAL TREATMENT/EVAL FOR WORSENING S/S. 1045 BP 133/80 HR 85 RR 22 SATS 99% RA 1105 BP 120/80 HR 75 RR 18 SATS 100% RA 1115 BP 128/87 HR 74 RR 18 SATS 100% RA 1128 SITTING BP 135/90 HR 93 RR 20 SATS 100% RA 1145 STANDING BP 138/87 HR 90 RR 18 SATS 100% RA
21 2021-05-05 disturbance in attention After the second does that night I had a really bad headache and felt like I was getting sick. It wa... Read more
After the second does that night I had a really bad headache and felt like I was getting sick. It was hard to focus on doing work and bright lights and loud noises made the headache worse. The next morning, I felt very fatigued and got very tired after even walking short distances. The headache was much lessened but still present. Advil was taken for the headache that night and the next day and helped a bit. Just rest was the most effective. My arm was sore for a couple days after each dose and went away over time. Period was late, as it was due in-between the doses but did not arrive until the day after the second dose (This could have been stress related but is very abnormal)
21 2021-05-05 nervousness Immediately following and for two weeks after I experiences mild to moderate dizziness. Over time th... Read more
Immediately following and for two weeks after I experiences mild to moderate dizziness. Over time they became less frequent and now, on week three, I'm fine. However this has made me. Nervous about the second shot. I did not see any warnings of long term dizziness which is apparently not that uncommon.. This should be listed on the warnings for the vaccine. If this occurs again after my second dose I will file another report.
21 2021-05-09 feeling abnormal Started getting chills at around 8 pm, about 10 hours after receiving the shot. By 11 pm, I had a fe... Read more
Started getting chills at around 8 pm, about 10 hours after receiving the shot. By 11 pm, I had a fever, which lasted until around 2 am. The next morning I had some body aches and my head was a bit cloudy.
21 2021-05-10 nervousness PFIZER BIONTECH COVID-19 VACCINE EUA. ADMINISTERED VACCINE TO PATIENT AND SHE WENT TO THE OBSERVATIO... Read more
PFIZER BIONTECH COVID-19 VACCINE EUA. ADMINISTERED VACCINE TO PATIENT AND SHE WENT TO THE OBSERVATION AREA. AFTER APPROXIMATELY 10 MINUTES THE PATIENT CAME BACK INTO THE VACCINATION AREA AND SAT. SHE WAS FEELING NAUSEOUS AND THOUGHT SHE MIGHT VOMIT. PATIENT COMPLAINED OF BEING SHAKY AND CLAMMY AND COLD. PATIENT'S BP AND PULSE WAS NORMAL. PATIENT RETURNED TO NORMAL AFTER 20 MIN.
21 2021-05-10 sleep disorder Night of: Arm sore, Shakes, Fatigue, Muscle aches Took Tylenol, went to bed early. Had trouble slee... Read more
Night of: Arm sore, Shakes, Fatigue, Muscle aches Took Tylenol, went to bed early. Had trouble sleeping/bad sleep. Day after: Arm sore, Armpit sore, Fatigue, Muscle aches, Fever, Hot flashes, Headache (back of head-weird to move around too much) Took Tylenol, drank water, rested in bed. Third day: Arm sore, Armpit sore, Headache (back of head-weird to move around too much) Fourth day (Today): Armpit sore, Headache (back of head-weird to move around too much), Some sort of inconsistent sharp nerve pain on upper back, neck, behind/ in front of ear, temples Did some minor neck stretches and massaging of area. Helped a little.
21 2021-05-11 insomnia A few hours after my shot I started to feel dizzy and nauseous. I threw up about 3 hours after I got... Read more
A few hours after my shot I started to feel dizzy and nauseous. I threw up about 3 hours after I got it and had a fever. I went home where I had chills, nausea, vomiting, dizziness, headache, and pain all over my body for most of the day. I took 2 ibuprofen. Both of my arms broke out in hives/rashes and were extremely itchy. At bedtime I was so cold with the chills that I had uncontrollable shaking and shivering even though I was completely bundled up. I took 2 more ibuprofen (6 hours had passed since I took the last 2). I could not sleep because my body was in so much pain and I couldn't eat or drink because, if I even took a sip of water, I would throw it up. I was getting up to vomit all night long. Eventually I could keep food down but I still couldn't sleep because my body was in so much pain. I took 2 ibuprofen (again, 6 more hours had passed) and I did fall asleep. The next morning I woke up and took 2 ibuprofen as I was in so much pain all over my body that I couldn't get up and out of bed. I stuck to the BRAT diet because my stomach was still upset and I didn't want to vomit again. After that I slowly started feeling better. I am not at 100% yet but huge improvement.
21 2021-05-13 feeling abnormal, agitation, depression, irritability Neuropathy; Feel crazy; Irritable; Depression; Feel extremely agitated and unstable; This is a spont... Read more
Neuropathy; Feel crazy; Irritable; Depression; Feel extremely agitated and unstable; This is a spontaneous report from a contactable consumer (patient). A 21-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on the left arm on 23Apr2021 (10:00) as a single dose, with route of administration unspecified, for COVID-19 immunization. Medical history included type 1 diabetes; peripheral neuropathy; autonomic neuropathy; and clinical depression. The patient was not pregnant at the time of vaccination. Concomitant medications included propranolol, gabapentin, metformin and duloxetine hydrochloride (CYMBALTA). On 23Apr2021 (18:00), the patient had neuropathy; had felt crazy; was irritable; had depression; and had felt extremely agitated and unstable. The outcome of the events was not recovered. The patient had no COVID-19 prior to vaccination, and had not been tested post-vaccination. Information on lot/batch number was available. Additional information has been requested.
21 2021-05-14 panic attack The patient stated that she had not received a vaccine in several years but that the last time she d... Read more
The patient stated that she had not received a vaccine in several years but that the last time she did, she blacked out for maybe 30 seconds and felt dizzy. She states she thinks it was because she did not eat that day and stood up too quickly because she felt ok after. I notified (pharmacist) to be on stand by in case any incidence occurred and we had smelling salts and epipen on hand. I had the patient sit in the vaccine chair afterwards and about 3 minutes later, she started screaming to the top of her lungs that she felt like she was going to die. She screamed that she couldn't breathe and that her chest and head were "killing her". She kept screaming to remove the vaccine out of her arm (the liquid). Her eyes were starting to roll, but I knew she was breathing because she was screaming to not let her die. Her mother was with her and was very nervous and wanted emergency services, so We called 911. I took the girls hands and asked her to look me in the eyes and follow my deep breaths, because I began to think it was more of a panic attack. She followed by breaths and regained some composure but was sweating profusely, so I began fanning her. After a while of talking her through taking deep breaths and assuring her she was breathing and we had emergency services on the way, she began to calm down. EMS showed up about 15-20 minutes later and she declined to go with them. I stayed with the patient the entire time. She did not faint. I believe she just had a panic attack from working herself up about the vaccine. She was a little scared since she had fainted with the last vaccine.
21 2021-05-14 sleep disorder Started feeling achey 10 hours after shot. Warm and sweaty all Night 1. Couldn?t fall asleep due to ... Read more
Started feeling achey 10 hours after shot. Warm and sweaty all Night 1. Couldn?t fall asleep due to full-body pain. At around 5:30 am, 16 hours after shot, almost fainted and vomited three times. Extreme full-body pain and fatigue for the entire next day. By Day 3, only a little achey and tired. Some digestive issues (upset stomach, very frequent small bowel movements) remained until Day 9.
21 2021-05-15 excessive sleepiness I was super tired and warn out shortly after the first shot, sleeping for most of the next two days ... Read more
I was super tired and warn out shortly after the first shot, sleeping for most of the next two days with lot of arm pain, dizziness, and nausea. Than in the early morning on 04/19/2021 I became absolutely horribly ill with severer vomiting and the inability to keep anything down, sipping water made me vomit immediately. I had horrendous heart burn but the vomiting was so bad I couldn't even finish chewing a tum before it came up. I had body aches, chills, was over heating, and had lots of horrible pain from heart burn and vomiting. I couldn't keep fluids down end till 3:30 in the afternoon, I wasn't able to eat anything end till the next day.
21 2021-05-16 sensation of foreign body Developed sensation of "lump" in throat. No rash, itching, chest tightness or shortness of breath. ... Read more
Developed sensation of "lump" in throat. No rash, itching, chest tightness or shortness of breath. BP 100/67, P 90 and O2 Sat 98%. Symptom resolved after 20 minutes.
21 2021-05-17 delirium Feeling delirious, lasted 24 hours Sleep helped
21 2021-05-18 anxiety Pt anxious with first dose of vaccine. Pt rt Lightheadedness and dizziness while still in her 15min ... Read more
Pt anxious with first dose of vaccine. Pt rt Lightheadedness and dizziness while still in her 15min observation time. Pt transition onto a stryker with initial vs as BP 115/64, HR 77, RR 20-24. Pt was emotional, 2nd vs at 1035 BP 12/, HR , RR 18-20. Pt was talking to staff and became unresponsive for 5sec. ER Rapid response call for assistance. 3rd vs 122/78, HR 80 Map 89. Pt transported to ED. From ED Note: Patient symptoms improved and discharged from ED with counseling and return parameters. Patient evaluated by behavorial health for anxiety with outpatient follow up referral.
21 2021-05-19 anxiety Systemic: anxiety-Medium, Systemic: Hyperventilation-Mild
21 2021-05-19 sleep disorder Sharp knife piercing pain in left ear. Extremely painful tinnitus. Ringing in ear kept me up all n... Read more
Sharp knife piercing pain in left ear. Extremely painful tinnitus. Ringing in ear kept me up all night. Fever, muscle pain and chills.
21 2021-05-20 feeling abnormal 4 days after first shot, she called me complaining of bad back pain. She was going to her family doc... Read more
4 days after first shot, she called me complaining of bad back pain. She was going to her family doctor the next day for her 21 yr old well visit and was going to get it checked out then. She had a complete physical and was cleared even her lungs were clear and she was good. Tuesday night April 13th at 10pm, she told me she had "air bubbles" in her chest. I said you mean indigestion, take tums I said. She said not mom, actual air bubbles and they are popping in my chest. I said you just got your physical, you are fine. They Thursday night April 15th she started having difficulty breathing and was out of breath. She went to urgent care on April 16th because she felt awful and they saw in an X-ray that she had a "cyst" in her upper right part of her lung and her lung was about to collapse. Sent her home on bed rest with a stereos and 2 inhalers. We got her Friday night from college because the pain in her back and now her chest was worse. Took her to ER and she had a collared lung and pneuomothroax. She was admitted to the hospital and they tried to see if the lung would heal itself. It did not. They had to do surgery to repair the hole. When they were in there they saw a cobblestone texture where the hole was an they removed that texture and repaired the hole. She has never had a lung issue. Ever. She is also the 3rd person in my family to have had an adverse reaction to the shot. 6 of us vaccinated and 3 with injuries.
21 2021-05-22 depression, insomnia, mental status changes Fatigue, chills, headache, heart palpitations, stomach pain, bruising, insomnia, change in mental st... Read more
Fatigue, chills, headache, heart palpitations, stomach pain, bruising, insomnia, change in mental status (depression), nerve pain in hands/feet
21 2021-05-22 insomnia I got the second dose at ~1:10 and I started getting a small rash on my arms, neck, and face at 11:... Read more
I got the second dose at ~1:10 and I started getting a small rash on my arms, neck, and face at 11:00 that night. I could not sleep that night because I was shivering so much. I felt regular fever symptoms the day after like many people but even though those symptoms disappeared by the end of the day my rash got worse. I got the shot on my right arm because I am left handed but the rash is the most severe on my left arm. The rashes go all along from the back of my hand to above my elbows and are mostly crowded around the underside of my arm. I have had this rash for over a week now and it is still painfully itchy and sensitive. Only recently the swelling and itchiness around my left eye got better but my arms are still the same and look as if its still slowly spreading.
21 2021-05-24 anxiety This is a 21 year old female who reported to the emergency department on 5/17/21 at 0917 with compla... Read more
This is a 21 year old female who reported to the emergency department on 5/17/21 at 0917 with complaints of intermittent chest pain since the previous Tuesday (5/11/21). She described it as light in pressure, pain 4/10, in the right upper chest/right breast area. The patient believed her chronic anxiety may be playing a role since she has recently started a new job that involves public speaking and she had stopped her paxil due to adverse effects. No pleuritic pain described, no pain on exertion described. Differential diagnosis included low risk for ACS, PE given oral contraceptives, anxiety. Given no evidence of abnormality in labs/work-up, the patient was discharged home with instructions to follow-up with PCP for any ongoing symptoms/anxiety.
21 2021-05-31 anxiety Patient received the 2nd COVID vaccine (Pfizer, Lot #: EW0185 and expiration date: 08/31/2021) on th... Read more
Patient received the 2nd COVID vaccine (Pfizer, Lot #: EW0185 and expiration date: 08/31/2021) on the left arm at 0918. Patient hailed medics attention and complained of "nausea, seeing purple, and lightheadedness" at 0921. Patient was conscious, alert, and oriented x4. Patient's skins were normal for ethnicity, moisture and temperature. Pupils were equal, accommodating, and reactive to light. Patient appeared anxious and was coached by medic on her breathing. Signs and symptoms began about 2 minutes status post vaccine, but patient claimed no previous reaction with 1st dose. Patient denied any pertinent medical history, allergies, or medications. At 0923 patient was still conscious, alert, and oriented x4 and pupils were still equal, accommodating, and reactive to light. Patient then complained of "seeing everything in purple color," then stated she "could not see anything at all." Medic held up 5 fingers and patient advised she could not see them. Patient began to look pale and skins felt moist and warm. Patient was able to walk with assistance to anti- gravity chair. Nurse then responded to Medic with patient. Baseline vital signs were taken by Medic at 0926, while patient was sitting: blood pressure: 98/60, heart rate: 60, respiratory rate: 16. Patient stated that she runs cross country and that these vital signs were of normal range for her. Patient was given water to sip on. Color and moisture of skins were slowly pinking/drying up. Patient initially experienced nausea and lightheadedness but denied chest pain, shortness of breath, headache, dizziness, or blurry vision. Nurse informed the patient's mother, who was waiting outside, of the situation and brought the mother inside to the patient. At 0935, patient was able to stand her own, with a steady stance. A second set of vitals were taken: blood pressure: 100/64, heart rate: 60, respiratory rate: 14. Patient was negative for orthostatic pressures. Patient stated that symptoms had resolved and that she "felt better, just tired." Patient remained in the observation area for an additional 15 minutes. Patient was conscious, alert, and oriented x4 and skins were normal for ethnicity, moisture, and temperature at 0949. Patient able to walk on her own accord with a steady gait. Mother was driving personal vehicle. Mother and patient were educated on when to contact their primary care physician with any other concerns and when to call 911 if symptoms warrant or when go to ED.
21 2021-06-01 feeling abnormal Felt "spacey" Patient was given water and was observed, symptoms resolved Discharged to home
21 2021-06-06 panic attack Fainting. Pt did not feel well. Felt like she was having a panic attack (chest tightness, arm tingl... Read more
Fainting. Pt did not feel well. Felt like she was having a panic attack (chest tightness, arm tingling, dizzy). Happened over the course of 10 minutes.
21 2021-06-07 anxiety Anxiety
21 2021-06-09 disturbance in attention, sleep disorder Severe pain starting at location of shot, spreading through entire arm over course of 30 minutes, th... Read more
Severe pain starting at location of shot, spreading through entire arm over course of 30 minutes, then through rest of body over the next 30 minutes. Severe period like cramps on right side of abdomen, naseua, severe eye pain in left eye, trouble focusing, head pain, trouble sleeping, dizziness, all lasting until 1 pm next day after several hours of sleep.
21 2021-06-13 insomnia, depression, anxiety Patient reports feeling faint immediately following the injection with an elevated heart rate and na... Read more
Patient reports feeling faint immediately following the injection with an elevated heart rate and nausea. The following day she started having episodes of vomiting, nausea, anxiety, tachycardia, pain in the sternum, shoulders and back, dizziness, weight loss, exercise intolerance, insomnia, muscle weakness, fevers, and an overall "depressed feeling".
21 2021-06-22 disturbance in attention, anxiety Sat down to wait for 15 minutes like they usually ask after a new vaccine, thought I felt fine then ... Read more
Sat down to wait for 15 minutes like they usually ask after a new vaccine, thought I felt fine then next thing I know the pharmacist is waking me up telling me I went unconscious and I?m puking. I don?t remember where I am or what happened while this was happening, then my whole body goes numb and my vision goes extremely blurry and my chest is tight, then apparently I pass out again because I have EMTs waking me up after. My bp dropped extremely low, my chest and throat was tight, it was hard to breathe, my tongue felt weird, I was anxious, could hardly see for a while and it was hard to hear. I was so out of it for a while it was hard to talk. EMTs took me to the hospital. Was released that evening, but had continuing dizziness, body numbness, chest pain etc for several days before it got better. (Doctor at ER said he couldn?t fully say if it was an allergic reaction because it?s so new he didn?t have that information, but the paperwork I have from the Walgreens RX lists Several of the events I experienced as allergic reactions)
21 2021-06-25 loss of personal independence in daily activities not feeling well; viral meningitis; fatty liver; pre-diabetes; weak; pale; couldn't get up; runny no... Read more
not feeling well; viral meningitis; fatty liver; pre-diabetes; weak; pale; couldn't get up; runny nose; congestion; ear infection; Illness; Headache, like someone is poking her head repeatedly, after first vaccine; This is a spontaneous report from a contactable consumer. A 21-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0179), via an unspecified route of administration, administered in right arm on 28Apr2021(at the age of 21-year-old) as single dose for covid-19 immunization. Medical history included ongoing viral meningitis (as her older sister had Viral Meningitis), diabetic, Covid-19 from Oct2020 to Dec2020, ongoing food allergies and medication allergies. Concomitant medications included caffeine/codeine phosphate/paracetamol (TYLENOL WITH CODEIN #3) for an unspecified indication from 18May2021 to 20May2021; paracetamol (TYLENOL EXTRA STRENGTH) for headache from 14May2021 to 17May2021. No additional vaccines administered on same date of the Pfizer suspect. On 08May2021 19:00 the patient experienced headache, like someone is poking her head repeatedly, after first vaccine. On 09May2021 the patient experienced ear infection. On 17May2021 the patient experienced weak, pale, couldn't get up, runny nose, congestion. The patient missed second dose, scheduled for 21May2021. On 22May2021 the patient experienced viral meningitis, fatty liver, pre-diabetes and illness. On an unspecified date the patient experienced not feeling well. The patient was hospitalized for events from 18May2021 to 31May2021 except headache and illness. The patient underwent lab tests and procedures which included lumbar puncture: viral meningitis on 19May2021. Therapeutic measures were taken as a result of ear infection. The outcome of events not feeling well, viral meningitis, fatty liver, pre-diabetic and illness was unknown while the outcome of rest all event was recovering. No follow-up attempts are possible. No further information is expected.
21 2021-06-27 anxiety Client approached EMT station complaining that her "blood pressure felt high." Client was alert an... Read more
Client approached EMT station complaining that her "blood pressure felt high." Client was alert and tracking and appeared mildly anxious. Client had a chief complaint of anxiety. Client stated that she was reluctant to receive her second dose of Pfizer and stated that now she felt anxious after waiting several minutes in the observation area. Client stated that she experienced vomiting and other mild side effects after her first COVID vaccine dose but was approved for her second Pfizer COVID vaccine dose by medical team. Client denied allergies or medical history. Assessment revealed no swelling, discoloration, hives, shortness of breath or other signs of anaphylaxis. Client stated that she felt lightheaded and denied having breakfast this morning. Airway, breathing and circulation were intact. Vital signs 1155-BP 128/98 heart rate 68 respirations 18, 02 sat-100% room air. Client was alert and oriented to person, place, time and event. Client agreed to stay an additional 30 minutes and was provided with water while she waited. Client refused any food. Client's vitals were reassessed 15 minutes later. 1210- BP 120/82 HR 79 Resp. 18 and O2 sat 98% on room air. Client refused to stay her remaining 15 minutes and stated that she felt "better? and that she wanted to "go home and eat." She refused to stay for the remainder of the 30mins. Client departed vaccination site with a steady gait.
21 2021-07-02 confusional state Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsiv... Read more
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: Patient's mother was with her at time of vaccine administration. A few minutes later she stated her daughter was not feeling well. Patient was confused, stated she was unable to see at that time &dizzy. Then the patient lost conciousness and was unresponsive. 911 was called and epinephrine was administered due to concern for anaphylaxis. Patient regained consciousness and was responsive to questions. EMTs &police arrived, evaluated her & recommened she go to ER. Mom was going to take her to ER
21 2021-07-08 confusional state Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Abdominal Pain-Mild, Systemic: Confusion-Mi... Read more
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Abdominal Pain-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Additional Details: CALLED EMS TO ATTEND TO PATIENT
21 2021-07-08 feeling abnormal Patient was administered 2nd dose of Pfizer COVID-19 vaccine, 0.3mL, IM. Instructed to wait in lobby... Read more
Patient was administered 2nd dose of Pfizer COVID-19 vaccine, 0.3mL, IM. Instructed to wait in lobby for 15 minutes. Approximately 10 minutes after vaccine administration, patient stated that they felt dizzy, stuffy, had throat pain, and had an itchy throat. Immunization nurse notified and responded. Vitals taken at 0955 BP 95/62 supine position, pulse 76, O2 sat 98%, temp 98.7 F. Declared medical emergency via overhead announcement at 0956. Doctor lead team upon response. No epinephrine or dyphenhydramine administered. vitals reassessed at 1002, BP 109/78. Patient was moved to treatment room for further observation. Doctor said patient was stable and scheduled for release of her own accord at approximately 1100, given Sick in Quarters status, and with a follow-up telephone consult scheduled for tomorrow, 07/10/2021.
21 2021-07-17 confusional state I had 8 hangovers at once; complete loss of appetite; constant body aches and pain; intrusive brain ... Read more
I had 8 hangovers at once; complete loss of appetite; constant body aches and pain; intrusive brain fog; Any time I would sit down it would take at least 10 minutes to have the physical energy to stand up again.; This is a spontaneous report received from a non-contactable consumer, the patient. A 21-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration on 26Mar2021 at 14:00 (at the age of 21-years-old), as a single dose for COVID-19 immunisation. Medical history included bipolar disorder. The patient had known allergies to artificial sweeteners, fish and tree nuts. The concomitant medication included lamotrigine (MANUFACTURER UNKNOWN) for unknown indication on an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 27Mar2021 at 08:00, the patient experienced feeling like she had 8 hangovers at once after waking up and had experienced complete loss of appetite for full day, constant body aches and pain, and intrusive brain fog. It was also reported that at any time the patient would sit down, it would take at least 10 minutes to have the physical energy to stand up again. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events hangover, appetite lost, general body pain, mental confusion and loss of energy was resolving at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
21 2021-07-19 anxiety, nervousness Upon injecting, patient said, she immediately felt like her arm was warm, radiating down her arm, up... Read more
Upon injecting, patient said, she immediately felt like her arm was warm, radiating down her arm, up to her neck. Patient said she had a sore throat prior to the shot, and she felt her throat was warm, and her face was warm. Patient said, her arm felt numb and heavy but not tingly. Pharmacist called EMS. Her vitals were normal, but her BP was slightly high because patient was experiencing anxiety. Patient said she normally suffers from anxiety. Patient's mom said, she was nervous from the morning. EMS said, it's likely a mixture of anxiety and not feeling well combined.
21 2021-07-19 confusional state 4/14/21 became confused and had cardiac arrest with seizure EMS called 1757 was taken to 2 hospitals... Read more
4/14/21 became confused and had cardiac arrest with seizure EMS called 1757 was taken to 2 hospitals with multiple resuscitation efforts and defibrillations declared deceased 0042 4/15/2021
21 2021-07-19 loss of personal independence in daily activities The vaccination went as expected the day after with fever and chills. But the second day after the v... Read more
The vaccination went as expected the day after with fever and chills. But the second day after the vaccine I woke up with welts on my arms and legs the grew until they encompassed my legs fully and inner arms full. It spread to my entire body in big parts. The third day is spread to everywhere it hadnt the first (chest, stomach, outer arms, feet and hands). But it swelled my hands to the point that I can't make a fist. The fourth day the welts and rash cleared up everywhere else but I woke up with it on my feet and they swelled to the point where I can't walk today. So day 3 it swelled my hands and day 4 is swelled my feet but its going away within a 24 hrs period. I am currently unable to use pens and small objects in my hands to hold due to the swelling. I am also unable to walk. The ER says to wait it out because its an allergic reaction and I intend to. But even the pharmacy said that out of their 9000 patients done i have been the only one thst has had a worse adverse effect on the second dose. Nothing occurred on the first dose, just the second. I hsvebeen taking benadryl and tylonol but they don't seem to do much ut just is taking time, but there has been no improvement on my hands or feet.
21 2021-07-22 anxiety Systemic: Hyperventilation-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, System... Read more
Systemic: Hyperventilation-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Weakness-Mild, Additional Details: Patient asked about possible side effects from vaccine. They were discussed with her. She asked about why she needed to stay15 minutes after vaccination which was stated to assess for possible allergic reaction. Pt reported she had severe panic attacks in the past and that she was then concerned about allergic reaction. She stated she had numbness at her hand which went away after 30 minutes. she was assessed for 30 minutes. Her anxiety deminished and she wanted to leave.
21 2021-07-27 feeling abnormal Eyes won't stop twitching spastically all day from the moment of waking until sleeping. Eyes twitch ... Read more
Eyes won't stop twitching spastically all day from the moment of waking until sleeping. Eyes twitch at least 1000 times a day. Right eye twitches more than left.; Cognitive disconnect after first and second doses for a week; Brain fog; emotional disassociation.; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age (adult) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number was EW 0177) dose 1 via an unspecified route of administration, administered in arm right on an unspecified date (at the age of 21-year-old) as dose 1, single and dose 2 via an unspecified route of administration, administered in arm right on an unspecified date (Batch/Lot Number: EW 0172; at the age of 21-year-old) as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications (other medications within 2 weeks of vaccination) included docosahexaenoic acid, eicosapentaenoic acid, tocopherol (OMEGA 3); ascorbic acid (VITAMIN C); vitamin D3; curcuma longa (TURMERIC); all concomitant medications taken for an unspecified indication, start and stop date were not reported. Patient received the most recent dose of vaccination at pharmacy or drug store facility. 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 an unspecified date, the patient's eyes would not stop twitching spastically all day from the moment of waking until sleeping. Eyes twitch at least 1000 times a day. Right eye twitched more than left. Cognitive disconnect after first and second doses for a week. Brain fog and emotional disassociation. The events immediately followed both vaccines but the eye twitching started more profusely after the second dose. No hospitalization prolongation was reported. No treatment received for events. The outcome of the events was not resolved. No follow-up attempts are possible. No further information is expected.
21 2021-07-27 excessive sleepiness Double vision and couldn't focus; Slept for over 30 hours; Bad arm pain; This is a spontaneous repor... Read more
Double vision and couldn't focus; Slept for over 30 hours; Bad arm pain; This is a spontaneous report from a contactable consumer, the patient. A 21-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6208 6/21) via an unspecified route of administration in the left arm on 13Mar2021 at 15:00 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. Medical history included bipolar 2, obsessive-compulsive disorder (OCD), anxiety, depression, sensory processing disorder and insomnia. The patient had no allergies to medications, food, or other products. Concomitant medications included doxepin (MANUFACTURER UNKNOWN), venlafaxine hydrochloride (EFFEXOR), gabapentin (MANUFACTURER UNKNOWN), eszopiclone (LUNESTA) started on an unknown date and was taking for close to an year with no issues for sleep, omeprazole (MANUFACTURER UNKNOWN) and patient had been on unspecified sleep medication for 7 years. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 14Mar2021, the patient had some bad arm pain. Starting on 15Mar2021 at 04:00 and also on 16Mar2021, the patient slept for over 30 hours and those were her days off. On 16Mar2021, when she did manage to stay awake for 6 hours she had double vision and could not focus. She had to take off on 17Mar2021 as well. The patient stated it was real worrying thing. On 30Mar2021, the patient slept for 18 straight hours, woke up showered and still felt asleep again after only being awake for 3 hours. No one seemed to have any information and the patient was pretty sure when she would go to sleep on the day of report at night, she would sleep for 20 hours again as that was her day off. The patient had never slept for more than 12 hours before. The patient stated that she had been on sleep medication for 7 years and eszopiclone cannot be blamed as she had no issues with it. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the reported events. The clinical outcome of the events bad pain in arm, slept for over 30 hours and double vision/couldn't focus were not resolved. No follow-up attempts are needed. No further information is expected.
21 2021-07-28 anxiety Patient received the shot, 10 minutes later her mother came to the pharmacy window saying her daught... Read more
Patient received the shot, 10 minutes later her mother came to the pharmacy window saying her daughter couldn't breathe. I went to speak to patient and patient said she "couldn't breathe" then lost consciousness shortly thereafter. I injected her with an epipen in her left hip. She regained consciousness about 90 seconds later. Her lips were blue, she was pale, her pulse was strong, and heartbeat rapid. She expressed a phobia of shots before the shot and her mother said she has high anxiety about shots. Was taken away via ambulance.
22 2021-01-07 feeling abnormal chills and not feeling very good; chills and not feeling very good; rapid COVID test positive; rapid... Read more
chills and not feeling very good; chills and not feeling very good; rapid COVID test positive; rapid COVID test positive; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is the first of two reports. This case is serious, the other one is non-serious. A 22-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EH9899) intramuscular at left deltoid on 22Dec2020 19:00 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. No other vaccines given at the same time. The patient received a flu shot back between 27th or 28th Nov2020 in her left deltoid. Caller reported getting the COVID vaccine on the 22Dec2020 and feeling fine before that. On the 28Dec2020 she started feeling chills and not feeling very good and that hasn't gone away. The patient went and got a rapid COVID test and it came back positive, not sure if it was because of the vaccine having antigens in it or she came into contact with it or if she just weakened immune system from the shot. The patient wanted to know if that was true. Then stated she and her mom got the COVID vaccine and her mom received it on the 23Dec. On the 29Dec her whole family started to get sick and experiencing the same things she experienced. The patient was not feeling well at the time of the call. The outcome of the events was not recovered.; Sender's Comments: Linked Report(s) : 2021001266 same reporter/ drug, different patient/event
22 2021-01-10 impaired work ability fever, chills, nausea. called in sick to work.
22 2021-01-12 impaired work ability Within one hour of getting first dose of vaccine PT sts she experienced a headache and sore throat, ... Read more
Within one hour of getting first dose of vaccine PT sts she experienced a headache and sore throat, a few hours later, vomiting and diarrhea began. On 20DEC20 PT sts headache and vomiting continued iwht diarrhea persisting intermittently over next 48 hrs. Pt went home from work 20DEC20 and was able to resume regular duties the next day with intermittent diarrhea.
22 2021-01-12 impaired work ability Within one hour of getting first dose of vaccine PT sts she experienced a headache and sore throat, ... Read more
Within one hour of getting first dose of vaccine PT sts she experienced a headache and sore throat, a few hours later, vomiting, and diarrhea began. on 20DEC20 PT sts headache continued and vomiting began. Diarrhea and vomiting continued intermittently over following 48 hrs. Pt went home 20DEC20 from work and was able to resume regular duties the next day with intermittent diarrhea.
22 2021-01-13 feeling abnormal Customer rec'd first dose of COVID-19 vaccine approximately 18:07 and transferred to post vaccine ob... Read more
Customer rec'd first dose of COVID-19 vaccine approximately 18:07 and transferred to post vaccine observation. At 18:20 customer reports feeling nauseated with rapid onset occipital headache radiating into eyes at 7/10. She reports feeling "sweaty" and is flushed in appearance. Customer moved to ante room, closer to emergency supplies. Customer denies feeling SOB, difficulty breathing or tongue/throat swelling. O2 sat monitor not reading to due nail polish. BP 160/105, HR 88 (RRR) R 20 (unlabored). Lungs CTA. History of hypertension when pregnant but does not take medications at this time. History of kidney stones and "stuff." Customer accepts BENADRYL 50mg PO at 18:28. Customer monitored at site. Customer downplays symptoms and is a difficult historian. Does not wish to lay down. States "I'll be fine" and wishes to drive home to lay down. Customer given snack and water. Reports ongoing nausea with blurry eyes. Continues to rub her neck and shrug her shoulders up and appears quite uncomfortable. She reports history of significant nausea post flu shot which resolved within a couple of hours. Denies history of migraines. Denies known allergies and has never been given epinephrine. She denies taking any medications prior to receiving this vaccine. Reports heaviness in eyes and photophobia. TYLENOL 1000mg PO given at 19:00. Customer again begins flushing, feeling nauseated and diaphoretic. Admits to her symptoms worsening. She reports feeling like she wants to pass out and throw up. Continues to deny respiratory symptoms. BP 135/78, HR 86, RR 18. Denies decrease in headache "feels like I can't even hold my head up. It hurts so bad." She becomes tearful and is agreeable to transfer to ED for further work up and evaluation. Customer gives verbal consent to share medical information with mother, who is given ED phone number for follow up. Customer escorted via wheelchair by RN staff member. Handoff report given to, ED physician. Customer is aware that this information will be shared with her PCP Team for follow up. Recommend consult prior to next vaccine appointment to discuss post vaccine course and discuss risks/benefits and/or pre-treatments prior to next vaccine.
22 2021-01-13 sleep disorder At first I felt slightly light headed which lasted about 2 hours. At around 7 PM that night, the arm... Read more
At first I felt slightly light headed which lasted about 2 hours. At around 7 PM that night, the arm pain started. I had a very bad nights sleep due to this arm pain. I would rate this 8/10. The next day, I had significantly less arm pain, about 4/10. I felt light headed the whole day. After 36 hours, all of my side effects were gone.
22 2021-01-14 feeling abnormal Shortly after receiving vaccine started feeling foggy. upper lip began to tingle, felt numb, and st... Read more
Shortly after receiving vaccine started feeling foggy. upper lip began to tingle, felt numb, and starting swelling. Started having palpitation and having shortness of breath.
22 2021-01-14 impaired work ability became nauseated about 24 hours after vaccine. She threw up around 1pm 1/14 then was sent home from ... Read more
became nauseated about 24 hours after vaccine. She threw up around 1pm 1/14 then was sent home from work. She continued to have bad nausea and vomiting through out the night and into the morning of 1/15. She was again sent home from work.
22 2021-01-15 sleep disorder Currently ongoing, starting approx. 12 hours after second dose: Nausea, severe chills, severe arthra... Read more
Currently ongoing, starting approx. 12 hours after second dose: Nausea, severe chills, severe arthralgia, severe myalgia, low fever (100.0 F). Currently ongoing, starting approx. 24 hours after second dose: What is listed above, fever (101.1 F), and diarrhea. I can keep water down and some food. Ibuprofen helps mute the symptoms but does not mask them well enough for comfort. Losing sleep and drying to stay hydrated.
22 2021-01-18 anxiety Approximately 5 minutes after receiving vaccine, patient felt anxious, face felt hot, felt like she ... Read more
Approximately 5 minutes after receiving vaccine, patient felt anxious, face felt hot, felt like she "couldn't sit still". BP 148/78 HR=66 O2=100% at 12:30pm. BP 118/72 HR=71 O2=100% at 12:42pm. Patient clinically stable. Patient released from clinic at 12:45pm.
22 2021-01-19 anxiety At last observation check for patient so about 2:45pm, 15min after receiving her dose 2 COVID19 vacc... Read more
At last observation check for patient so about 2:45pm, 15min after receiving her dose 2 COVID19 vaccine she complained of feeling lightheaded. The observer recommended additional monitoring and contacted their lead. At this time ARNP arrived to further evaluate. Pulse ox obtained: 99% and HR 110's trending down as patient took some sips of water and reported feeling better. Vitals @ 3:00pm: SaO2: 97%, HR 99. Vitals @ 3:02pm: Sa02:99%, HR 86. Vitals @ 3:04: SaO2: 99%, HR 86. At 3:09 while patient being observed 1:1, she began to c/o itching on her hands, she was scratching them and her chest. Noted exanthem like reaction to tops of hands and chest. Assessed this could be early signs of allergic reaction, post-observation monitor lead (ARNP) initiated internal response. Activating site supervisor, site safety officer and scribe to the scene. Observation lead discussed clinical picture to patient and obtained consent to administer epi pen x1 @ 3:14pm. Epi 0.3mg administered IM to left thigh. At the time of administration 911 was notified. Vitals obtained: SaO2: 99%. HR: 99, BP: 138/78. Epi was tolerated well & itching improved. At 3:20pm BLS ambulance arrived. Patient was evaluated and briefed on what is anticipated when someone receives an EpiPen. Notified that medics were in route as that is the EMS protocol when Epi is administered. Upon arrival of medics patient was feeling anxious but symptoms improving. She declined EMS transport, signing their AMA paperwork. Patient accompanied by boyfriend who drove. Our immunization clinic involved many licensed providers, because we had an ER physician who was willing to pop over and evaluate her
22 2021-01-25 impaired work ability Called out of work over weekend
22 2021-01-26 anxiety Patient developed red blotches anterior base of neck, throat feeling tight. Patient shared has anxie... Read more
Patient developed red blotches anterior base of neck, throat feeling tight. Patient shared has anxiety with receiving vaccines, similar symptoms have happened in the past.
22 2021-01-27 depressed mood Headache; Body ache; Muscle pain/muscle soreness; Feeling down; feels may be like it's a knot in the... Read more
Headache; Body ache; Muscle pain/muscle soreness; Feeling down; feels may be like it's a knot in the muscle; Like a lump like at the bottom of my neck; This is a spontaneous report from a contactable consumer reporting for herself (Medical Assistant). A 22-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231 and expiry date: 30Apr2021), via an unspecified route of administration on 13Jan2021 at single dose for COVID-19 immunization. Medical history was reported as none. The patient's concomitant medications were not reported. The patient stated, "I just wanted to ask about, I just received my second dose of the vaccine and I was having some adverse effects. I had headache yesterday when I got it. And body ache and muscle pain today and then I'm feeling down, and kind of like a lump like at the bottom of my neck, like to the side, on the left side, the arm that I got the (incomplete sentence). It feels may be like it's a knot in the muscle. I don't know if that is normal." The patient asked and stated, "If anybody else has had any of those symptoms? I know that the headache and the muscle pain is normal, I don't know about the like a lump or anything." The patient further stated, "It's been pretty constant headache, second day was body ache and right now just like muscle soreness." The patient stated, "I took some Tylenol, acetaminophen. And I think I had one Ibuprofen last night." The outcome of the event headache was not recovered and the outcome of the remaining events was unknown.
22 2021-01-28 anxiety Flushing, anxious feeling. Reported feeling flushed after 15 minutes. Felt like having a panic att... Read more
Flushing, anxious feeling. Reported feeling flushed after 15 minutes. Felt like having a panic attack. Reports history of such. BP 125/92, HR 115, RR 25 RA100%. Provided water and rested. VS 122/88 HR 91. Symptoms resolved after an additional 30 minutes of monitoring.
22 2021-01-30 feeling abnormal, anxiety - Needed inhaler each night since - Jan. 25th night was worst yet, took over an hour for inhaler... Read more
- Needed inhaler each night since - Jan. 25th night was worst yet, took over an hour for inhaler to kick in. Tried steam and heating pad, little improvement - Jan. 26th Took ProAir inhaler at 2pm before shift - Little improvement - Pain still in chest - Called my primary Dr. at 4:30 - Prescribed prednisone and Advair - Thinks vaccine caused inflammatory response - Took prednisone at 8pm - Took Advair around 11 - Took ProAir inhaler around midnight - Heart racing (HR130) - SOB, pain when breathing - Localized to sternum, on either side as if something was grabbing my lungs and squeezing - Feel like lightning coursing thru my veins - Shaky I ended the up in the ER Jan. 26th. * I took prednisone at 8pm * I took Advair at 11pm * I was still having trouble breathing and my last hit of my ProAir had completely worn off * I took my ProAir around midnight * Over the course of the next two hours I was SOB, tachy (HR 130s), hot and cold flashes, pain while breathing, couldn?t catch my breath * My friends took me to the ER around 2am * At the hospital they did a 12 Lead EKG, blood work, labs, 2 chest X-rays, and a COVID-test * They gave me 0.5 mg lorazepam IV * All of my blood work and labs came back normal. * X-rays came back clear * EKG came back fine * Negative COVID test * I took a nap after the lorazepam hit and woke up feeling much better * ER doc thinks my ProAir exacerbated some anxiety because my lungs were clear and no wheezing * Discharged me with a script for lorazepam PRN x10 and instructions to follow up with my primary is back at home. * Doc said I could continue the prednisone and Advair * Woke up today and yesterday feeling better, still some pain when breathing and exhausted. Pain is mostly at top of my lungs, going across my chest. Deep breathing sometimes helps but there?s also pain upon inhalation. * Took the next doses of Advair and my Dexedrine (ADHD meds). Nothing weird yet just drained. They switched my Ventolin inhaler to ProAir, I have been taking it about five times a week so I can workout. When I was on Ventolin I didn?t have any of the side effects I have with ProAir.
22 2021-01-31 anxiety Patient is a registered nurse at facility. She reported having slight itchy lips and scratchy throa... Read more
Patient is a registered nurse at facility. She reported having slight itchy lips and scratchy throat after 1st dose. Patient very much wanted full protection that 2nd dose offers in order to be safe and keep family members safe. We discussed the possibility of an increased reaction, but she wanted to go ahead and felt the benefits outweighed the risk. I considered the fact that she is a health care professional, was fully informed and that we were at a skilled nursing facility and were prepared in case she had any reaction. About 10 minutes after vaccination she seemed to be coughing and felt like her throat was maybe swelling. She seemed to be breathing ok, but I asked her to take a Benadryl, which she did. Within 5-10 minutes after that she began shaking and seemed very pale. She said her symptoms were getting worse. I told her I was going to administer an epi-pen dose. 911 was called, I administered the epipen, we had heart rate monitor and pulse ox monitor on patient and she was stable, but scared. EMT's arrived and transported patient to ER. She was later released with Benadryl.
22 2021-02-01 impaired work ability Woke up 1/29 with body aches, chills, and fever over 102 until 10 pm. Called out sick for 1/30 due t... Read more
Woke up 1/29 with body aches, chills, and fever over 102 until 10 pm. Called out sick for 1/30 due to symptoms. 1/30 symptoms improved but lethargy continued for the remainder of the day
22 2021-02-02 feeling abnormal, sleep disorder About 5 mins after the shot I received on Sunday, I got a cooling effect in my chest and began to fe... Read more
About 5 mins after the shot I received on Sunday, I got a cooling effect in my chest and began to feel a bit off with an elevated HR of 132. I raised my hand to talk to a nurse and she said I was probably just nervous, got me a water, and said to continue to monitor symptoms. Then, after 15 minutes were up with no other symptoms I left the facility where I got the vaccine. The rest of the day I began to get a burning and cooling effect all around my sternum. It persisted through the day despite Tylenol 500 mg and worsened at night, keeping me up along with a slight fever and chills. The next morning I awoke with slightly lowered symptoms but the sternum pain would flare up on and off through the day and again was worse at night on Monday. So, I took a Benadryl and a 500 mg Tylenol and slept great. I woke up Tuesday feeling great with no fever and minimal chills and no sternal pain. I thought since I hit the 48 hour mark everything was going fine and I was recovering. I ran some errands and even went to the gym to do a mild workout. Then at about 6pm all the symptoms of the sternal pain flared up and was just as bad as Monday night. I took another 500mg Tylenol and 1 Benadryl again and they did not seem to work or help nearly as much as the night before. I woke up this morning with some pain in my sternum again and did not sleep much last night due to the pain as well. I have not taken any further medications at this time and I am also experiencing the worst fatigue I have so far today.
22 2021-02-04 sleep disorder Received the second dose of the shot at 4pm on Tuesday. Woke up at 2am the next morning with severe ... Read more
Received the second dose of the shot at 4pm on Tuesday. Woke up at 2am the next morning with severe chills and fever. Tossed and turn unable to sleep because of body aches. The next day (Wednesday) I suffered from low grade fever, headache, body ache, chills, hot flashes, and slight nausea. By the next day,(Thursday) I still had slight fever and headache and sore arm. The next day (today- the third day) I've continued with fatigue and headache but much less severe.
22 2021-02-07 anxiety 0944 Patient experienced nausea and vomiting after vaccine; vitals BP- 132/88, P-123, O2 saturation-... Read more
0944 Patient experienced nausea and vomiting after vaccine; vitals BP- 132/88, P-123, O2 saturation-97%. Patient has history of same in the past post vaccine. No other symptoms; no SOB, no diaphoresis. Patient feels anxious with tingling in hands. Patient was given water and is feeling better. She does not want any further medical intervention. Patient is advised to call 911 if further medical need arises. Patient has girlfriend in the car to drive her home. 0954- vitals- BP- 110/78, P-98, O2 saturation- 98%. Patient?s anxiety decreased, hand tingling is gone. No more nausea and vomitting and feels back to normal. Released home after monitoring.
22 2021-02-09 excessive sleepiness I woke up at 2:00 am and was experiencing nausea, fever, and chills. I was up from 2:00-4:00 am, and... Read more
I woke up at 2:00 am and was experiencing nausea, fever, and chills. I was up from 2:00-4:00 am, and then went to sleep until 12 pm 1/24/2021. I slept for most of the day and then around 7:00 pm on 1/24/2021 I felt better and my fever, and chills were gone. The nausea lasted from 2-4 am, and then stopped, and the fever and chills stopped sometime throughout the day from 12-3 pm on 1/24. I took one NyQuil and did not go to a doctors office or hospital.
22 2021-02-11 insomnia Beginning at 2:15 pm I experienced injection site soreness. At 10 pm I experienced a mild headache a... Read more
Beginning at 2:15 pm I experienced injection site soreness. At 10 pm I experienced a mild headache and muscle aches. Between the hours of 12-1 am I experienced chills, vomiting, and muscle aches. At 2 am I experienced insomnia, a fever of 102, continued muscle aches, and my oxygen saturation was between 92-95%. At 2:25 am I took 1000 mg of Tylenol to reduce the fever and muscle ache discomfort.
22 2021-02-12 sensation of foreign body I received my second dose of the COVID vaccine around 12:30 pm. At around 4:00 pm, I noticed that my... Read more
I received my second dose of the COVID vaccine around 12:30 pm. At around 4:00 pm, I noticed that my lips were slightly swollen. I went and bought liquid Benadryl. At around 5:45 pm, I took 20ml of the liquid Benadryl. I proceeded to sleep the rest of the night. I woke up around 8:20 am the next morning and noticed that my lips were significantly more swollen. I took 20ml more of the liquid Benadryl and noticed that my tongue was a little swollen as well. At around 9:40 am, I took 20ml more of liquid Benadryl. I noticed no change in my swelling and my throat started to feel like there was a lump. At around 10:20 am, I drove to the emergency room. The doctor noticed swelling in my lips and some in my tongue and throat. I was given cimetidine and methylprednisolone through an IV, which reduced the swelling. I was discharged 2 hours later after the swelling went down and was given 2 prescriptions to take the next 4 days, which were prednisone 20mg (three tablets once a day) and famotidine 20mg (twice a day). There is some swelling in my lips in the morning (for the last two days) until I take the steroids, then it reduces the swelling. The overall cost of the emergency room visit was $1669.17.
22 2021-02-13 insomnia 8 hours after the second vaccine dose, I suddenly experienced body aches, chills, and a fever. This ... Read more
8 hours after the second vaccine dose, I suddenly experienced body aches, chills, and a fever. This lasted throughout the night (lasted 24 hours after vaccine administration). I had a lot of trouble sleeping due to the pain and temperature fluctuations (I would wake up hot and sweating, then an hour later cold and shivering, multiple times throughout the night). I treated the symptoms with Acetaminophen 500mg throughout the evening and the day after. The day after (24 hours later), I was fatigued and had stomach pains, with not much of an appetite.
22 2021-02-16 feeling abnormal Foggy headed, feeling of pressure in ears, flu feeling, pain in left deltoid
22 2021-02-16 mental impairment, amnesia I can not think or remember things my arms go to sleep i cant feel hot and cold i cant drive and i g... Read more
I can not think or remember things my arms go to sleep i cant feel hot and cold i cant drive and i get very winded
22 2021-02-20 confusional state Fever of 102 and dehydration contributed to a syncope collapse early the morning after vaccination (... Read more
Fever of 102 and dehydration contributed to a syncope collapse early the morning after vaccination (7:15 AM 02/20/21). Just before collapsing, I experienced nausea, dizziness, confusion, weakness, and seeing all black in my field of vision. Emergency Room doctors say it was very likely related to an adverse reaction to the second Pfizer Covid vaccination. Treatment included Tylenol and Ibuprofen, rest, and fluids.
22 2021-02-22 sensation of foreign body At 3:30pm after receiving vaccine patient began to notice itching of both arms and anterior of neck.... Read more
At 3:30pm after receiving vaccine patient began to notice itching of both arms and anterior of neck. Said she felt like she had something in had a lump in throat. She was given Benadryl 25mg tablet, orally and a ice pack placed on injection site due to complaint of pain in arm. BP was 118/80, pulse 80, respirations 16. She was alert, skin was pink, warm to touch and dry. 10 minutes later hives started to subside, BP was 116/72, pulse 68, respirations 16, skin was warm, pink and dry. 4:15pm left clinic site being driven by mother - no itching, no lump i throat, redness resolved.
22 2021-02-24 feeling abnormal 2/1/2021 Vaccinated C/o "foggy" after vaccine, but otherwise felt well 2/7/2021 felt tired 2/8/2021... Read more
2/1/2021 Vaccinated C/o "foggy" after vaccine, but otherwise felt well 2/7/2021 felt tired 2/8/2021 vomited 2/11/2021 vomited several times during night and went to the Emergency Dept. 2/11 had emergency appendectomy
22 2021-03-02 feeling abnormal had chills about 18 hours after; felt cloudy in the head; This is a spontaneous report from a contac... Read more
had chills about 18 hours after; felt cloudy in the head; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female patient received second dose of bnt162b2 (BNT162B2, lot number: EL3247) , via an unspecified route of administration at arm left on 09Feb2021 15:00 at SINGLE DOSE for COVID-19 immunisation. Medical history included inflammatory bowel disease (IBS) from an unknown date. Not Pregnant at the time of vaccination. No allergies to medications, food, or other products.Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included plecanatide (TRULANCE) received within 2 weeks of vaccination. The patient historical vaccine included first dose of bnt162b2 (lot number=EL3247) on 19Jan2021 03:00 PM, at left arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No symptoms after the first dose. After the second dose, had chills about 18 hours after and felt cloudy in the head, but was able to go to work and function. Adverse event start date was 10Feb2021 06:30 AM. No treatment received for the adverse event. Event was reported as non-serious. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on an unspecified date.
22 2021-03-05 anxiety Chest tightness, anxiety. BP 119/66 (pulse 81), 100% O2 sat. Given water and graham crackers.
22 2021-03-07 feeling abnormal I received the vaccine at 4:30 PM and later that night, I had a headache and I felt very out of it. ... Read more
I received the vaccine at 4:30 PM and later that night, I had a headache and I felt very out of it. By the end of the day; however, I was feeling better. The next day, I woke up around 5 AM and my muscles were all tensing very strongly and I could not stop shaking. This went on for about 30 minutes, and then I stopped shaking and tensing so much, though my muscles still felt a bit tense. I can't really eat in the morning, so I drank two glasses of water over the course of a few hours and took 2 acetaminophen. I stayed in bed until around 10 AM. Then, I took a shower, but while taking it, I felt very lightheaded and my vision had some black spots, and I had to sit down several times. After I got out, I tried to eat something, but then I felt really nauseous and had acid reflux for at least 30 minutes. Afterwards, I drank a bit of water and went back to bed. My muscles started tensing and shaking again, though not quite as intensely as when I first woke up. I felt very cold, so I turned up the heat and put on warm clothes. I fell asleep for about 20 minutes around 12, and when I woke up I felt a little less nauseous and headache-y. I stayed in bed for an hour, and I ate some pudding over the course of an hour or two, but I thinking about eating much else made me feel nauseous. I fell asleep around 5:30 and woke up again around 7:30. I felt better after waking up, but still had a bit of a headache and my muscles were slightly tense. On Sunday and Monday (today) I felt about the same, physically tired but otherwise mostly ok.
22 2021-03-14 nervousness patient was nervous about the injection but still got it. she said she was okay but sat down to mak... Read more
patient was nervous about the injection but still got it. she said she was okay but sat down to make sure, then fell off her chair and fainted. patient woke up shortly after and paramedics evaluated her for concussion
22 2021-03-15 amnesia Dizziness/lapse in memory on two separate occasions. First occasion while driving, abruptly stopped ... Read more
Dizziness/lapse in memory on two separate occasions. First occasion while driving, abruptly stopped speaking in middle of sentence and forgot roughly 5 minutes of drive home from work (pt is an RN). Second occasion while in shower, lapse in memory lasted roughly 1-2 minutes.
22 2021-03-16 anxiety Patient stated she felt as though her breathing was changing. Not sure if it was anxiety or a reacti... Read more
Patient stated she felt as though her breathing was changing. Not sure if it was anxiety or a reaction. Assessed by myself, lungs clear, no throat swelling. Taken back for observation, while in observation, stated throat felt tight. Examined throat, no swelling noted, had physician also check and agreed. pox 98% r-18 120/84 and remained stable throughout obs. Patient stated she felt better, ambulated without difficulty. d/c after 30 minutes.
22 2021-03-16 panic attack Pt reported to the vaccination area stating that she had a history of fainting after medical procedu... Read more
Pt reported to the vaccination area stating that she had a history of fainting after medical procedures, including vaccination. Was with her mom, in case she had an issue. Vaccination without incident. Kept pt at the vaccination area to observe. About three minutes after receiving the vaccination, pt started to shake. Was conversing. Stated she was warm, so got her a cold bottle of water. Stated she was dizzy so helped her to the floor to lay down. She had contractions of her hands, which she stated that they were numb. She recovered from the dizziness, but then had a panic attack. Her BP was normal, but her heart rate became elevated. Had her lay down until she felt better, helping to slow her breathing. After about 40 minutes,p t felt good enough to sit in the recovery area. Ensured she had water and some food to help prevent a blood sugar drop.
22 2021-03-17 disturbance in attention, sleep disorder fainting; Fatigue; dizziness/sleep disturbance (wake up with hot, dizzy, nauseous every few hours); ... Read more
fainting; Fatigue; dizziness/sleep disturbance (wake up with hot, dizzy, nauseous every few hours); nausea/sleep disturbance (wake up with hot, dizzy, nauseous every few hours); hot flashes/sleep disturbance (wake up with hot, dizzy, nauseous every few hours); chills; loss of appetite; unable to focus; sleep disturbance (wake up with hot, dizzy, nauseous every few hours); This is a spontaneous report from a contactable consumer (patient). A 22-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, LOT#EL9269), via an unspecified route of administration in left arm from 02Feb2021 14:00 at first single dose for Covid vaccine. Medical history included known allergies: Oak trees, kiwi. Concomitant medication in two weeks included hydroxyzine hydrochloride (ATARAX), sertraline hydrochloride (ZOLOFT). No other vaccine was received in four weeks. The patient experienced fatigue, dizziness, nausea, hot flashes, chills, fainting, loss of appetite, unable to focus, sleep disturbance (wake up with hot, dizzy, nauseous every few hours). Adverse event start date: 03Feb2021 02:00 AM. AEs resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No treatment was received for the events. No covid prior vaccination. Covid was tested post vaccination: nasal swab on 05Feb2021: negative. Symptoms lasting 6 days and counting. Outcome of the events was not recovered.
22 2021-03-18 sensation of foreign body, anxiety At time of the shot nurse noticed an immediate bump at the injection site. Patient then started to h... Read more
At time of the shot nurse noticed an immediate bump at the injection site. Patient then started to have rash down arm. Ice was applied. Benadryl 25 mg was given. At the time no throat issues. Patient drinking water without difficulties. Rash progressed to neck area. Patient then complained of lump in throat. Additional 25mg Benadryl given. Patient also very anxious and says gets hives and feel lump in throat with that. Patients rash started to improve and lump resolved. Rash almost resolved by time of leaving. Patient felt much better and refused hospital transport.
22 2021-03-20 mental impairment *TIME OF WRITING IS THE 7th DAY* Onset of incredible fatigue 30 minutes post-vaccination lasting 5 d... Read more
*TIME OF WRITING IS THE 7th DAY* Onset of incredible fatigue 30 minutes post-vaccination lasting 5 days Fever ranging from 99.6 to 102 which began 5 hours after vaccination and has lasted 7 days post-vaccination Nausea 5 days post-vaccination Headache 7 days post-vaccination Severe arm pain 3 days post-vaccination Eye pain 3 days post-vaccination Intense sweating 7 days post-vaccination Chills 7 days post-vaccination Labored breathing 2nd and 3rd day post-vaccination Significant face swelling 2nd day post-vaccination Decreased mental status 6 days post-vaccination All lymph nodes in neck hard and swollen 7+ days Aggravation of pre-existing sleep paralysis day of vaccination Severe throat pain in the morning, red bumps in back of throat, white pus on tonsils which has worsened and began 1 day after vaccination (antibiotics were prescribed and condition continues to worsen, no one with whom I have been in close contact with has been sick - e.g. boyfriend I kissed the day before vaccine, toddlers I babysat morning before vaccine) - followed eventually by mild cough and congestion
22 2021-03-21 anxiety a 22 y.o. female who received the Pfizer-BioNtech Covid-19 Vaccine, mRNA, BNT162b2 (PF) 30 mcg/0.3 m... Read more
a 22 y.o. female who received the Pfizer-BioNtech Covid-19 Vaccine, mRNA, BNT162b2 (PF) 30 mcg/0.3 mL IM Susp, Lot ER2613 on 3/22/2021. The patient experienced the following reaction(s) during the immediate of observation: 9:32am Patient c/o non-radiating mid "chest discomfort 2/10." Denies difficulty breathing. Patient was treated/managed as follows: 9:33am VS BP 110/60, HR 77, RR 18, 98% on room air. Patient reports symptoms may be anxiety induced. 9:44am VS BP 105/70, HR 74, RR 18, 98% on room air. Patient reports symptoms subsiding. Discomfort improved to 1/10. Patient given educational material regarding vaccine and advised to continue to self-monitor per the CDC guidance. Education provided on worsening symptoms and to seek medical attention and call 911. Patient and patient mother states understanding. 9:48am Patient escorted to car with mother and nurse.
22 2021-03-21 impaired work ability I got the usual cold-like symptoms the next day. I took a nap and woke up and felt pretty much fine ... Read more
I got the usual cold-like symptoms the next day. I took a nap and woke up and felt pretty much fine after that. After the 1st, I started getting waves of dizziness. I would lay on ground and I couldn't get up. After a couple of days, I could do stuff but would get random waves of dizziness and would have to sit down until it went away. My doctor told me to take Allegra and I just kind of lived with it. It didn't help with symptoms. It started affecting my work because I'm a CNA and I couldn't be having dizzy spells at work. I went to ER - on January 10th. They sent me to Hasboro because they were to busy at ER. The nurse said I had Vertigo - and they discharged me with Meclizine while I was in ER and it didn't help. I called me doctor a couple of days after. She told me to combine the Allegro with the Meclizine and that didn't help with either. I called my doctor back and she said that there is nothing else I can do because my bloodwork came back normal. I'm not currently taking anything and I'm still getting random dizzy spells. I have returned to work and so I just have to take breaks at work when it happens. I got the second vaccine on the 19th of January.
22 2021-03-23 confusional state Client felt lightheaded when asked how she was feeling. She was immediately advised to put her vehic... Read more
Client felt lightheaded when asked how she was feeling. She was immediately advised to put her vehicle in park. Client started seizing and nurse was called over. Her eyes were rolling and her muscles were tightening up. ALS called over. Client regained consciousness but was confused. Fire Dpt. and ambulance was called as well. PT moved to stretcher. While being moved, car seat was noted to be wet. ALS took PT to ambulance, patient transported to local hospital.
22 2021-03-23 nervousness The Pt is a 22 year old female who had a syncopal episode following her 2nd Pfizer vaccination to th... Read more
The Pt is a 22 year old female who had a syncopal episode following her 2nd Pfizer vaccination to the left deltoid. She states that she was "feeling nervous" before the vaccination and did not eat before her vaccine. Following administration, she felt an onset of dizziness while walking away from the vaccination tent. The Pt immediately returned to the tent, told a clinician that she was feeling unwell, and was helped into a chair where she had LOC of about 3 seconds. No head trauma. Upon evaluation, the Pt endorses lightheadedness but denies diplopia, nausea, vomiting, or diaphoresis. Pt also denies any swelling of the face/lips/eye, difficulty swallowing, tightness of the throat, or itching of the skin.
22 2021-03-24 feeling abnormal Patient presented to clinic 6 days post covid vaccine feeling "off". Routine labs drawn 3/12/2021 ... Read more
Patient presented to clinic 6 days post covid vaccine feeling "off". Routine labs drawn 3/12/2021 Treatment plan is to continue serial LFTs weekly to twice monthly. Hold off on second vaccine until LFTs normalized. Once within normal range second dose vaccine will be administered and will check her LFTs 1 week post vaccine. Multiple consults to internal medicine physicians assisted in case. Today patient is feeling "better"
22 2021-03-25 anxiety 3-24-21 3PM PT STATES SHE 'FEELS JITTERY WITH HEDACHE'. NO SOB/DYSPNEA, NO PAIN, NO DIFFICULTY SWA... Read more
3-24-21 3PM PT STATES SHE 'FEELS JITTERY WITH HEDACHE'. NO SOB/DYSPNEA, NO PAIN, NO DIFFICULTY SWALLOWING. A/O, PINK, W/D, RESP WITH EASE. PT STATE SHE' WAS ANXIOUS ABOUT GETTING THE SHOT'. REASSURANCE GIVEN. NO ACUTE OR OBVIOUS DISTRESS NOTED. 3:15PM PT STATES SHE 'FEELS BETTER' AMBULATORY TO EXIT WITH FRIEND TO DRIVE HER HOME. GAIT BRISK AND STEADY. 3-25-21 8AM TC: STATES SHE 'FEELS FINE NOW'.
22 2021-03-25 panic attack, confusional state Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemi... Read more
Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: panic attack-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium, Systemic: Tingling (specify: facial area, extemities)-Severe
22 2021-03-26 feeling abnormal ABOUT 5 MINUTES POST VACCINE, PATIENT REPORTED FEELING "ZONED OUT", DESCRIBES "LIGHT HEADED, HOT, N... Read more
ABOUT 5 MINUTES POST VACCINE, PATIENT REPORTED FEELING "ZONED OUT", DESCRIBES "LIGHT HEADED, HOT, NAUSEATED. SHE THEN HAD SYNCOPAL EVENT FOR 5-10 SECONDS WAS CAUGHT BY PA WHO WAS AT HER SIDE. IMMEDIATELY RESPONSIVE, ALERT AND ORIENTED AFTER. BROUGHT TO TRIAGE 1 BY WHEELCHAIR WITH PA AT HER SIDE AND ASSISTED TO GUERNEY. SYMPTOMS SLOWLY ABATED, PALLOR IMPROVED. BP 104/50 THEN 101/49 P 68, SPO2 96% ROOM AIR, BLOOD GLUCOSE 99. RELEASED VIA WHEELCHAIR AFTER SITTING AND STANDING AT 5:23. EMT AND NP PASSED HER AND TRANSPORTATION ATTENDANT AT 5:27 AND PATIENT WAS RETURNED TO TRIAGE ARE DUE TO NAUSEA. PHYSICIAN AGAIN EVALUATED AND ORDERED ZOFRAN. WHICH WAS ADMINISTERED AT 5:30.
22 2021-04-01 euphoric mood I stayed for 30 mins because after my first shot my arm ended up VERY swollen and I had a rash. So I... Read more
I stayed for 30 mins because after my first shot my arm ended up VERY swollen and I had a rash. So I was okay after the 30 minutes but when I started driving I felt like I was high on strong drugs. Like as if I?d taken an extremely strong marajuana edible and it just hit me. I had to pull over because my eyes wouldn?t stay open, my whole body was feeling very heavy and I was extremely tired and out of it. I didn?t have another way to get home (I had traveled about an hour) so I just kept driving and taking 15 min rests along the way. When I got home I fell asleep as soon as I sat down and slept for about four hours. I feel better now that I?m awake, still light headed but not near as bad.
22 2021-04-04 anxiety Complained of tingling in hands/face. Dizziness when standing. VS pt was verbal with with history of... Read more
Complained of tingling in hands/face. Dizziness when standing. VS pt was verbal with with history of P.O.T.S. Awake and alert x3, no s/s of SOB/resp distress. At 1308: BP 104/76, HR 90, SPO2 90%. At 1317: BP 102/62, HR 85, SPO2 98%, pt complained of tingling/nausea/ ears tingling, awake and alert x 3, c/o throat closing/ tightness. Benadryl was given about 50 mg At 1330: O2 sat 100%, pulse 110, BP 113/72. She stated her throat was closing and she was starting to have difficulties breathing. She mentioned that when she has anxiety she never had tingling and she has no history of allergies
22 2021-04-05 impaired work ability, loss of personal independence in daily activities I received the first dose of the Pfizer vaccine at 9:15 AM on March 9, 2021. I then returned to wor... Read more
I received the first dose of the Pfizer vaccine at 9:15 AM on March 9, 2021. I then returned to work. At about 4:30 PM on that same day, I started feeling dizzy. I felt like I was going to faint at work. Every time I would stand up, I would feel like I was going to pass out. I had someone drive me home because I felt that I was too dizzy to drive. I arrived home at 6:00 PM and began to vomit profusely. I threw up all night and had the chills. In the morning, I felt better but still had a dizzy feeling. The dizziness and vomiting completely subsided by March 11, 2021. On March 12, 2021, I noticed that I had floating black spots in my left eye accompanied by a painful migraine. I have never had eye floaters or migraines previous to this vaccine. My migraine lasted for 5 days straight and I had to be off work to go to the emergency room because I started to loose vision in my left eye. They were unsure of the cause because I did not have any pre-existing health conditions. The migraine finally subsided after the 7th day. I have had eye floaters every since I got the vaccine. I?ve been to an eye doctor and my primary and they all have told me that it could be from this vaccine because I have never had the problem until I received it.
22 2021-04-08 feeling abnormal, disturbance in attention 4 days after the vaccine I started feeling very out of it, couldn't concentrate, very fatigued. Thes... Read more
4 days after the vaccine I started feeling very out of it, couldn't concentrate, very fatigued. These effects are still going.
22 2021-04-08 sleep disorder Started as a my arm being sore I could not fall asleep then my muscles started to get sore and a fev... Read more
Started as a my arm being sore I could not fall asleep then my muscles started to get sore and a fever with chills happened right after and it wouldn?t let me sleep.
22 2021-04-09 anxiety Throwing up from anxiety post vaccine
22 2021-04-12 anxiety, depression Severe mood swings causing intense anxiety attack and depression. Also developed painful ovarian cys... Read more
Severe mood swings causing intense anxiety attack and depression. Also developed painful ovarian cysts immediately after receiving the second dose
22 2021-04-12 feeling abnormal, delirium delirium; aches; chills; headache; fever; sore muscle in vaccine location; head congestion; earaches... Read more
delirium; aches; chills; headache; fever; sore muscle in vaccine location; head congestion; earaches; brain fog; This is a spontaneous report from a non-contactable consumer reporting for herself A 22-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ER8730) on 22Mar2021 at 10:00 am at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history included known allergy to sulfa. The patient received first dose of vaccine on 05Mar2021 (Lot #:EN6199) at 12:00 pm, on Left arm. Concomitant medications included ethinylestradiol, norgestimate (TRI FEMYNOR) and minocycline. On 22Mar2021 at 19:00 the patient experienced aches, chills, headache, fever, sore muscle in vaccine location, head congestion, earaches, brain fog and delirium. The patient recovered from the events on an unspecified date. No follow-up attempts are possible. No further information is expected.
22 2021-04-12 restlessness, confusional state, impaired work ability March 5, 2021: 1st dose of Pfizer vaccine. Severe site pain. March 23, 2021: 2nd dose of Pfizer vac... Read more
March 5, 2021: 1st dose of Pfizer vaccine. Severe site pain. March 23, 2021: 2nd dose of Pfizer vaccine. Felt very restless and sick during night, by the next morning symptoms really sat in. March 24, 2021: Went to Urgent Care due to fever. Had COVID-19 test (negative). Very close to passing out there (put head between knees and did not). Was sent to emergency room immediately due to heart rate (high 140s-150s. Highest known was 152 BPM). ER performed following: portable chest x-ray, blood tests, urine tests, EKG. Was told results were all normal with the exception of EKG (not told anything about it, form listed as abnormal). Passed out 2x at hospital. Was given one IV rehydration solution and released that night. Symptoms below lasted for several days: Headache Aches Nausea Aggressive shakes Shortness of breath Confusion Dizziness Site pain (also developed bump under arm) Fever - 103.8 (after 2 Advil, 2 Tylenol, 3 ice packs and eating frozen grapes) Heavy sweats Racing heart Restless March 30, 2021: Still having frequent heart palpitations (they come and go but happen several times during the day. Keep having very high heart rates). Went to doctor. While there, nurse noted irregular heartbeat that sounded like it was ?skipping a beat? and heart rate was also jumping all over the place (high pace, low pace, high, etc.). It was clear something was abnormal. Doctor gave EKG approximately 20 minutes later, EKG looked normal. Was told to come back next morning for blood work and to cut out caffeine. March 31, 2021: Came in for blood work to check thyroid. April 6, 2021: Thyroid results were normal. Still having palpitations among other symptoms (see April 12 for more info) so was told to come in. Was given ?work from home? note and referred to cardiologist. April 12, 2021: Appointment at cardiologist. Still having severe palpitations, occasional dizziness/ lightheadedness, nausea, shortness of breath, exhaustion and chest pain. Heart rate was recorded this day to have gotten up to 139 BPM-- was very high majority of the day. EKG was normal (with exception of high heart rate) but 30 mins later doctor observed high heart rate and abnormal rhythm. Was told to come back in a week and one day for a heart ultrasound and heart monitoring for three days. Still no caffeine intake since 3/30/21. Previous heart rates taken at doctor's visits over the years for comparison below. Never had any prior heart problems whatsoever: 8/29/18: 70 BPM 9/17/18: 88 BPM 10/17/18: 64 BPM 10/31/18: 73 BPM 1/21/19: 78 BPM Note: At this point, I have missed over a week and a half of work, and worked from home for over a week. I'm not any better heart wise at all over the course of three weeks post vaccine.
22 2021-04-13 confusional state Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Det... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: pt was dizzy and light headed after vaccine and lost conciousness for a couple of seconds. she was sweaty and a little confused for a couple of seconds. she ate and drank something after and was feeling better and we phoned 911 to check her out. she was released and doing much better.
22 2021-04-13 hallucination Hallucinating, lightheadedness, sore body
22 2021-04-18 feeling abnormal Dizzy, feeling cold, headache-intense per patient, foggy head. slight temp.
22 2021-04-19 emotional distress About 10 minutes after vaccine, I was going out to give another vaccine and saw pt in distress. Got ... Read more
About 10 minutes after vaccine, I was going out to give another vaccine and saw pt in distress. Got her in vaccination room and got 2 Benadryl from Emergency Bag down her - pt was able to talk but her wheezing was getting progressively worse so we called her emergency person (because she wanted to take herself to ER) to take her and let them know what was happening then I called 911 because even I could tell it was getting worse (Pt was reluctant to take an EpiPen - wanted to wait til it was worse) Dispatch highly recommended EpiPen and since I felt it was getting worse also I gave an EpiPen from Emergency Bag as well. Within 5 minutes pt was clearly doing better. Kept her in room just to stave off gawkers since we had 5 other shots waiting in waiting room - took ambulance about 15 minutes to arrive ... but that gave pt mom time to get to the store and accompany pt to ER with ambulance.
22 2021-04-20 sleep disorder Around 12 hours after the shot, I took Tylenol for body aches and fever. I woke around 3:30 am to sh... Read more
Around 12 hours after the shot, I took Tylenol for body aches and fever. I woke around 3:30 am to shaking and stomach pains then fell back asleep. I woke up again around 5:15 am to intense involuntary shaking. My family members wrapped me in blankets and applied pressure to my body until the shaking stopped. Within the next 40 minutes I vomited and had diarrhea. At the time also had body aches, chills, fever, and mild swelling of various areas if the body. I slept most of the morning and ate lunch around 1:30 pm. I took Tylenol again at 2:00 pm with the symptoms lessening over the next 5-6 hours. After that fever, chills, and body aches returned.
22 2021-04-22 anxiety At 10:30 both of my legs and arms were tingling. Legs were worse than arms. In the morning, the feel... Read more
At 10:30 both of my legs and arms were tingling. Legs were worse than arms. In the morning, the feeling was still there and it worried me so I went to Urgent Care, but they just told me to monitor my symptoms and make sure that I don't start to feel weak. It persisted through the day. The next morning I woke up and it was mostly just on my right side in the leg, feet, hands and arms. Around 9:00 AM the right side of my face began to go tingling-- felt like I had Novacane injection. No pain. Because of my anxiety, throughout the day I got nauseous and warm, but never had a fever or anything like that. Been drinking lots of fluids.
22 2021-04-22 panic attack About five to ten minutes after I received my first shot, I started to feel like my throat was closi... Read more
About five to ten minutes after I received my first shot, I started to feel like my throat was closing a little. I knew it wasn?t an allergic reaction because I could still speak, but I also became very dizzy and sweaty. I stood up to go see the nurse and she took my blood pressure and it was slightly higher than normal and my heart rate was extremely elevated. I sat down on a stretcher and felt incredibly light headed and gained a metallic taste in my mouth. I also felt very nauseous and started experiencing chest pains. It felt like a panic attack but more severe and more sudden. My throat felt very tight but I could still talk, and my cheeks felt like they were on fire. My face was bright red. They gave me some water and monitored me some more and encouraged me to go to the hospital, but my symptoms subsided after about 35 minutes. After that I just felt tired and didn?t have any more symptoms.
22 2021-04-24 insomnia Roughly 12 hours after the vaccine, side effects began. Started with worsened insomnia, chills, naus... Read more
Roughly 12 hours after the vaccine, side effects began. Started with worsened insomnia, chills, nausea, and the usual vaccine site soreness. Has grown within roughly 8 hours to include these symptoms: fatigue, dizziness, soreness, excessive thirst, headache.
22 2021-04-26 anxiety Pt exhibited signs of anxiety prior to vaccination. 1 minute post-vaccination, pt stated that she w... Read more
Pt exhibited signs of anxiety prior to vaccination. 1 minute post-vaccination, pt stated that she would like some water. Pt reported feeling dizzy and warm. 3 minutes post-vaccination, patient verbalized throat feeling "rough". Vital signs taken; abnormal values as follows: HR 102, BP 152/90. SPO2 normal at 99% on RA. No pain or swelling. This nurse called rapid response and patient was taken to Emergency Department.
22 2021-04-26 feeling abnormal, confusional state Symptoms started five days after vaccine. Symptoms gradually lessened and I am now on week 4, I was ... Read more
Symptoms started five days after vaccine. Symptoms gradually lessened and I am now on week 4, I was bed ridden through week 3. Symptoms included my body feeling strange, visual disturbances, migraine aura (no previous history of migraines), chest pains, hot breath, temperature changes, faint feeling, fatigue, head pains all around head, pain in spinal chord, pain and numbness on entire body (mostly head), confusion, heat around nape of neck, ringing in ears, nausea, weight loss, strange breathing (not soreness)
22 2021-04-27 anxiety, confusional state I got the first dose of the Pfizer Covid-19 vaccine at the Medical University. Approximately 10 minu... Read more
I got the first dose of the Pfizer Covid-19 vaccine at the Medical University. Approximately 10 minutes after administration, an allergic reaction began while I was driving alone in my car. Most notably my blood pressure dropped suddenly, causing me to almost pass out. I stopped driving and my symptoms worsened. Symptoms included shaking, sweating, nausea, confusion, rapid heart rate, red blotchy face, slightly labored breathing, itching and slight swelling of my tongue and lips, anxiety. I could still breathe, so I did not seek treatment, but sat in the parking lot of a medical building for at least an hour for symptoms to subside. Symptoms were acute for about 45 minutes and gradually decreased over four hours. The rest of the day and the next day I felt extremely weak. The following six weeks I continued to have swollen, dry, painful lips every single day and a very itchy rash on my hands and wrists. Occasionally I would wake up with swelling around my eyes. I also had an unusual reaction after eating a salad where my lips swelled even more and became numb, along with an itchy mouth. These long lasting symptoms did not go away until I got a steroid cream from a dermatologist, who denied that my reactions were from the vaccine after talking to me for only five minutes. I just believe that there are many more cases of reactions to the vaccines that have not been reported.
22 2021-04-29 anxiety Patient received the 1st COVID vaccine (Pfizer, Lot #: EW0173, and expiration date: 08/2021) at 2:55... Read more
Patient received the 1st COVID vaccine (Pfizer, Lot #: EW0173, and expiration date: 08/2021) at 2:55 PM. Patient received the vaccine while sitting in the zero gravity chair, due to a history of feeling lightheaded and passing out with needles. After a few minutes in the zero gravity chair, patient expressed that she was feeling good and wanted to sit in the observation area next to her boyfriend. She got up and walked to another chair without assistance and with a steady gait. EMT made contact with the patient at 3:12 PM, while she was sitting in the observation area. Patient was conscious, alert, and oriented to person, place, time, and situation but complained of "lightheadedness." EMT grabbed a wheelchair and patient was then transferred to wheelchair, without assistance. At 3:15 PM, baseline vital signs were taken, while patient was sitting: blood pressure: 136/82, heart rate: 108, respiratory rate: 18. Skin was cold, dry, and normal for ethnicity. Patient claimed to have anxiety and explained that fainting and lightheadedness was "common" for her after receiving a shot. Patient denied taking any medications or having any allergies. A second set of vital signs were taken at 3:20 PM: blood pressure: 136/86, heart rate: 108, respiratory rate: 18. Skin was moist, warm, and normal for ethnicity. Patient was negative for orthostatic pressures. EMT advised patient to stay an additional 30 minutes for further observation. Around 3:50 PM, patient was asked how she was feeling and she stated "good." EMT educated the client on what to do if additional signs and symptoms developed and when to contact her provider. EMT also explained the use of V- safe to the patient. Patient then left the vaccination site, unassisted and with a steady gait.
22 2021-04-29 poor quality sleep Onset of headache 7-8 hours after injection Restless light sleep the night following injection (pot... Read more
Onset of headache 7-8 hours after injection Restless light sleep the night following injection (potentially caused by fever) Fever of 100.3 noted upon waking the following morning Inability to sleep and generalized muscle aches over the course day following injection Fever of 100.7 noted 24 hours after injection 650mg Tylenol taken 26 hours after injection--All symptoms (headache, fever, muscle aches, inability to sleep) cleared within one hour of taking Tylenol Intercostal muscle soreness with no apparent cause localized to upper left side 48 hours following injection-- cleared within 24 hours
22 2021-04-30 restlessness feeling antsy/cannot relax even though she was tired; can not relax even though she was tired/tiredn... Read more
feeling antsy/cannot relax even though she was tired; can not relax even though she was tired/tiredness; muscle and joint pain; muscle and joint pain; headache was worse/headache very much so; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on 21Apr2021 (at the time of 22-year-old) at single dose for COVID-19 immunization. The patient medical history included chronic migraines. Concomitant medications were not reported. The patient previously took acetylsalicylic acid/caffeine/paracetamol (EXCEDRIN) for chronic migraines. On an unspecified date it was reported that patient had the first dose of the Pfizer covid 19 vaccine yesterday, 21Apr2021. She has underlying health issues. She was feeling antsy which only started today. it was not like her heart was racing or beating really hard, just she cannot relax even though she was tired. She has chronic migraines and took Excedrin earlier. It was also reported that maybe the ingredients of the vaccine do not coincide with the caffeine in the Excedrin. She has muscle and joint pain bad today, but her arm was fine. Tiredness and headache very much so. The headache was worse today. She took fiorinal with codeine for the bad headache because the RPh (registered pharmacist) said it was ok. she read side effects and asked the agent if agent was saying that feeling antsy is not a side effect of the vaccine. The outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
22 2021-05-01 confusional state Sore throat, headache, nausea/vomiting, muscle aches and pains, drowsiness, confusion
22 2021-05-01 sleep disorder Cold Shivers around 15 hours after my second dose. I had a sweatshirt, sweatpants and 4 thick blanke... Read more
Cold Shivers around 15 hours after my second dose. I had a sweatshirt, sweatpants and 4 thick blankets on while trying to sleep and I was still shaking because I was so cold.
22 2021-05-03 impaired work ability DOS: 5/4/21 Patient received vaccine 4/27/21 administered by , APRN. Patient reports that she woke u... Read more
DOS: 5/4/21 Patient received vaccine 4/27/21 administered by , APRN. Patient reports that she woke up on 4/30/21 with fever (tmax 101.1), headache, and dry cough. Over the course of 5/1/21-5/3/21 she developed significant hoarseness with her voice. She denied sore throat, described more as "itchy". She has not had a confirmed Covid-19 case in the past. At DOS she expressed that she felt greatly improved compared with 4/30/21 but work sent her home and requested she get evaluated for illness.
22 2021-05-03 panic attack Patient got her first shot 03/25/21 and the next morning she had some shortness of breath, chest tig... Read more
Patient got her first shot 03/25/21 and the next morning she had some shortness of breath, chest tightness and headaches. It got much wore the next day. She also experienced some dizziness and pre-syncope. EMS was dispatched but did not transport her. Her O2 sat, blood pressure, pulse and temperature were all normal. She then went to a walk in clinic later that day and they told her she had a panic attack. She was still having the shortness of breath and chest tightness. She used her Pro-air and it helped somewhat.
22 2021-05-04 feeling abnormal platelets have also dropped down; Hgb has been dropping from 11.9 on 06Mar2021 down to 8.3 on 11Mar2... Read more
platelets have also dropped down; Hgb has been dropping from 11.9 on 06Mar2021 down to 8.3 on 11Mar2021; LDH was 2019; Alk phos was 137 mild elevated; felt poorly; AST 206 on 09Mar2021 down to 118 on 11Mar2021; red/bloody urine; red/bloody urine; migraine; Fever; nausea; diarrhea; very heavy period; Coombs negative hemolytic anemia; Hgb urine was 3+; presumed UTI; This is a spontaneous report from a contactable physician. A 22-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), second dose intramuscular, administered in the left arm on 04Mar2021 11:30 (lot number: EN6205) as single dose (at the age of 22-years-old) for COVID-19 immunisation. Medical history included rhinitis allergic. The patient has no known allergies. Concomitant medications included ibuprofen; cefuroxime; clarithromycin (MACROBID [CLARITHROMYCIN]); ethinylestradiol, ferrous fumarate, norethisterone acetate (JUNEL FE); spironolactone; acetaminophen; origanum minutiflorum oil (OREGANO OIL); tretinoin; ondansetron (ZOFRAN [ONDANSETRON]) and "Olly probiotic/prebiotic"; all taken for an unspecified indication, start and stop date were not reported. The patient received the first dose of BNT162B2, intramuscular on the left arm on 11Feb2021 11:45 (lot number: EL9267) for COVID-19 immunisation at the age of 22-years-old. The patient did not have other vaccine in four weeks. The events started on 04Mar2021 at 11:45. Within minutes of second dose of vaccine, the patient had urination of dark brown urine. This turned to dark red/bloody urine. She felt migraine, fever, nausea, diarrhea. She started having a very heavy period which was not normal for her. She was treated twice for presumed UTI but cultures were negative. UA had no RBCs, but Hgb urine was 3+. Her Hgb has been dropping from 11.9 on 06Mar2021 down to 8.3 on 11Mar2021 and it appeared she has a Coombs negative hemolytic anemia (haptoglobin undetectable). Her platelets have also dropped down to 59 on 11Mar2021 from 80 on 06Mar2021. WBC/diff are normal. LDH was 2019 on 10Mar2021 and improved to 1728 on 11Mar2021. Blood smear had no schistocytes, but ADAMTS13 was pending (unknown results). Her creatinine remains normal and electrolytes were largely normal. She had max AST 206 on 09Mar2021 down to 118 on 11Mar2021. Alk phos was 137 mild elevated on 09Mar2021 and was now normal. Her symptoms were slowly improving but she still felt poorly. Several other tests were pending, and they were checking daily labs. The adverse events resulted in a clinic visit and a visit to the emergency room. The patient received unspecified antibiotics twice for presumed UTI, ER visit gave fluids, Tylenol and Zofran ODT. The patient had no covid prior to vaccination. The patient was not covid tested post vaccination. The patient has not recovered from the events.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events coombs negative haemolytic anaemia and aspartate aminotransferase increased and the suspect drug 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.
22 2021-05-04 nervousness Patient fainted and vomited approximately 5 minutes after receiving her shot. Patient was extremely ... Read more
Patient fainted and vomited approximately 5 minutes after receiving her shot. Patient was extremely nervous prior to receiving her vaccine.
22 2021-05-05 anxiety, feeling abnormal I woke up the night after the shot with difficulty keeping my breath even and feeling weak which led... Read more
I woke up the night after the shot with difficulty keeping my breath even and feeling weak which led to pretty high anxiety. This went away after a few hours
22 2021-05-09 feeling abnormal April 25th (within 24 hours of vaccine) I felt the typical fever, severe chills, fatigue, etc that I... Read more
April 25th (within 24 hours of vaccine) I felt the typical fever, severe chills, fatigue, etc that I'd often reported. No soreness. This was gone by the end of the day. April 26th I began feeling some light-headedness and feeling faint. My heart was fluttering every time I stood up, my vision went blurry, and I was very unstable (had to hold something to keep from falling). This feeling was bad enough to cause me to become uncoordinated and fall down the stairs while home alone. That evening I went to the ER where they verified that I was "stable" and checked for bigger issues, and sent me home without treatment. These symptoms continued for the next week. Improving a little each day. It is now May 10th and I am still experiencing some light headedness and clumsiness. Still needing to rebalance myself on something if I stand up quickly. At some point over this time, I've started making mistakes in my words and sentences. Just odd things like omitting words from phrases or confusing "up" with "over" etc. I did not notice this at first, but my co-workers did. Before the vaccine, this is not something I ever did. Correlation? Causation? Regardless, I'm still a little unwell and a little worried. But the ER seemed unconcerned, so I've been continuing about my life.
22 2021-05-10 feeling abnormal Sick as a dog since; Hot and cold; Feeling weak; Achy; Nauseous but cant throw up; Arm hurts; she go... Read more
Sick as a dog since; Hot and cold; Feeling weak; Achy; Nauseous but cant throw up; Arm hurts; she got in the right arm and now it hurts; she was dying; This is a spontaneous report received from a contactable consumer (patient's mother). The reporter reported for her twin daughters. This is one of the 2 cases. A 22-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in arm right on 20Apr2021 3 pm (Batch/Lot number was either EW0150 or EW01S0, caller not sure, there was not an expiration date, NDC number, or dosing information on the vaccine card) as single dose in the right arm at the age of 22-year-old for COVID-19 immunisation. Medical history included her thyroid surgically removed on 17Sep2020 and taking medications for it (they thought it was cancerous but it turns out it was not), postural orthostatic tachycardia syndrome from Mar2021 and ongoing. No family medical history relevant to events. The patient's concomitant medications were none. The patient received the 1st dose of bnt162b2 (BNT162B2, lot number ER2613) in left arm on 30Mar2021 11 am. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of BNT162B2. No prior vaccinations (within 4 weeks). No events occurred following prior vaccinations. On 20Apr2021 since vaccination the patient experienced sick as a dog since, hot and cold, feeling weak, achy, nauseous but can not throw up, arm hurts, she got in the right arm and now it hurts, events were described by the patient as she was dying. No event required a visit to Emergency Room or physician office. No relevant tests performed. The outcome of events was not recovered, events were still ongoing. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
22 2021-05-14 anxiety Felt dizzy, nauseous. vomited multiple times, claimed of stomach cramps and stomach pains due to anx... Read more
Felt dizzy, nauseous. vomited multiple times, claimed of stomach cramps and stomach pains due to anxiety
22 2021-05-16 sleep disorder Injection site soreness, cold cloth, hurt to move arm or touch, about 36 hours. Whole body aches, w... Read more
Injection site soreness, cold cloth, hurt to move arm or touch, about 36 hours. Whole body aches, warm bath/ heating pad, aches that felt like flu and made it hard to sleep, from 9 hours after injection to 30 hours after. Tingling skin, warm bath, body tingles when touched or moved, from 11 hours after injection to 36 hours after. Nausea and/or decreased appetite, eat small light foods like crackers and applesauce, had Waves of nausea and then decreased appetite after nausea wore off, from 6 hours after injection to 32 hours after.
22 2021-05-18 disorientation severe menstrual cramps, fever, disorientation, hot flashes
22 2021-05-19 anxiety Pt reported chest pain (mid chest, mild pressure) few minutes post vaccination & suspects it is rela... Read more
Pt reported chest pain (mid chest, mild pressure) few minutes post vaccination & suspects it is related to anxiety. Denies SOB/dizziness/difficulty breathing. AOx4; BP 124/68; HR 65. Pt reported improvement upon laying down & drinking water. Pressure pain improve, ambulated w/out difficulty. Instructed to call 911 if CP worsens or if difficulty breathing. Pt will follow, released from vaccination site in stable condition
22 2021-05-27 confusional state Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Letharg... Read more
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Mild, Systemic: Weakness-Mild
22 2021-05-31 feeling abnormal Patient reports abnormal chest pain, weird "poking" feeling in heart, and abnormal thigh pain after ... Read more
Patient reports abnormal chest pain, weird "poking" feeling in heart, and abnormal thigh pain after receiving vaccine. She is still feeling a bit of chest pain but the worst was Monday following the vaccine administration. She has not gone to the ER but was advised to go if she experience any severe pain or difficulty breathing, and was also advised to reach out to her doctor prior to next dose.
22 2021-05-31 loss of personal independence in daily activities, mental impairment Day 1: Mild headache and fatigue starting around 2pm and progressing throughout the night. Day 2: Wo... Read more
Day 1: Mild headache and fatigue starting around 2pm and progressing throughout the night. Day 2: Woke up with severe fatigue but was able to get up and eat/get ready for my day, having hot flashes that began right when I woke my bed was soaked, and woozy feeling even laying down. Day 3: Unable to get out of bed completely relying on my partner to assist me with basic tasks such as getting water. Was still getting hot flashes with mild headache/woozy feeling and muscle cramps. Day 4(today 6/1)- Still unable to get out of bed getting to toilet is very hard, still experiencing muscle cramps and hot flashes. Cannot think straight. Contacted doctor, said if progressively continues to get worse go to ER.
22 2021-06-01 memory impairment Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient received first dose of vaccine... Read more
Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient received first dose of vaccine with her mother. Prior to administration, patient mentioned she was anxious receiving shots having a history of fainting. Immediately after administration, patient stated that she was relieved. About 2 minutes later, patient's mother called for the pharmacist for help claiming patient was having convulsions and was unconscious. Paramedics were called. Patient regained consciousness after 20 secs with nausea & no recollection of loss of consciousness.
22 2021-06-03 nervousness Patient started feeling tingling and tightness at the throat, with some tachycardia approximately 20... Read more
Patient started feeling tingling and tightness at the throat, with some tachycardia approximately 20 minutes into the vaccination (Admin: 13:43). Due to area of concern and weight, patient was administered (2) tablets of diphenhydramine 25 mg [Geri-Dryl Allergy Relief by Geri-Care] at 13:07 from our travel clinic's emergency kit. Patient reports that they had tachycardia and nervousness prior to the vaccine by 10 minutes. After further inquiry, patient had a recent asthma attack 3-days ago that was also newly diagnosed then. Patient did not have a rescue inhaler but has a prescription on hand. After, 45 minutes of watchful waiting and 32 fl. oz. of water during observation, patient was "feeling fine" and able to converse normally (with laughter), no lightheadedness or further throat sensations.
22 2021-06-05 agitation, amnesia The patient stood up to signal something was wrong, and she immediately sat back down. As I went ove... Read more
The patient stood up to signal something was wrong, and she immediately sat back down. As I went over to her, she was leaning over out of her chair at which time she fainted, and I had her lieing on the groung. she woke up 5-10 seconds later and didn't know what had happeneded and was upset. We moved to the immunization room and elevated her legs while applying ice packs to the back of her neck. She drank water and ate an apple. Within 45 minute she was feeling a lot better.
22 2021-06-05 anxiety Systemic: Dizziness / Lightheadness-Medium, Systemic: Fever-Medium, Systemic: Flushed / Sweating-Sev... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fever-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe, Systemic: Nausea-Medium, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: after shot at 2:10pm complained of sweating, asked if "Am i going to dye" very anxious, nausea, lightheaded. had pt elevate legs and took bp1: at 2:15pm 96/55 pulse 68, bpt2: 21pm 117/80 pulse 93, complained of tingleness in lower extremities, 3rd bp: at 2:29pm 120/80 pulse 88, had pt leave with friend at 2:34pm advised not to drive
22 2021-06-06 nervousness Systemic: Body Aches Generalized-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed /... Read more
Systemic: Body Aches Generalized-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: patient has a history of getting nervous with vaccines and needles. said she has passed out in the past. this was her first shot and was very nervous said she felt dizzy after shot and wanted to lay down, breathing fine no trouble breathing. had some tingling in her hands and cramping so 911 was called. she was checked out and completely fine after, refused transport to hopstial. mother drove her home. she is feeling fine now
22 2021-06-12 anxiety Patient suffered a vasovagal syncope without losing consciousness, pt suffers from anxiety and did n... Read more
Patient suffered a vasovagal syncope without losing consciousness, pt suffers from anxiety and did not eat, only in the morning
22 2021-06-12 insomnia Abdominal cramps, headache, fatigue, minor body aches, minor chest aches during sleep, trouble sleep... Read more
Abdominal cramps, headache, fatigue, minor body aches, minor chest aches during sleep, trouble sleeping.
22 2021-06-14 sensation of foreign body Patient stated that she felt a "lump and tightness" after 15 minutes of injection in her throat afte... Read more
Patient stated that she felt a "lump and tightness" after 15 minutes of injection in her throat after receiving her first Pfizer covid vaccine. Vital signs taken o2 97%, HR 102, temp 98.4 orally, BP 126/88. Patient seen by PA who stated no swelling in mouth seen, vitals normal. Patient waited an additional 15 minutes. Patient felt better when she left clinic.
22 2021-07-01 excessive sleepiness doctor told her that it was an adverse reaction to the vaccine and not to get the second dose; She's... Read more
doctor told her that it was an adverse reaction to the vaccine and not to get the second dose; She's been sleeping for days so she is not feeling well; She's been sleeping for days so she is not feeling well; Broke out in hives and hives went around her mouth; Throat was getting swollen; This is a spontaneous report from a contactable consumer (parent). A 22-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported; Expiration Date: Aug2021, patient was 22-year-old at the time of vaccination), via an unspecified route of administration in Arm Left on 15Jun2021 at 08:00 as single dose for covid-19 immunisation. No medical history was reported. Concomitant medication(s) included spironolactone and birth control (unspecified). Reported that caller was not sure about lot number, it just says EW, it could be 0 or it could be an O, it just says EW it might be 0, its just say EW0178 or O187, I am not sure. It was reported that caller reported on behalf of patient and stated that caller and her daughter got a vaccine on Tuesday morning and Tuesday afternoon, she broke out in hives and I had to take her to the emergency room and get her shot of epinephrine (Treatment) and they put her prednisone (Treatment) on because her hives were around to her mouth and throat was getting swollen and their doctor told her that it was an adverse reaction to the vaccine and not to get the second dose and they told us to call an report it. she's been sleeping for days so she is not feeling well. Patient was about about 5 (feet) 7 (inches) and about 200 (pounds) and she will be 23 on Saturday. Patient not received prior Vaccination within four weeks. On 15Jun2021, the patient experienced broke out in hives and hives went around her mouth, throat was getting swollen, on an unspecified date, She won't be getting her second dose, she's been sleeping for days so she is not feeling well. Reporter seriousness for Broke out in hives and hives went around her mouth, Throat was getting swollen, she's been sleeping for days so she is not feeling well was unspecified. Patient visit emergency room after the Broke out in hives and hives went around her mouth, Throat was getting swollen. Reported that the hives went away, and they have not come back, she just went all off. Reported that doctor said that we should call because she has definitely a serious reaction so, she won't be getting her second dose, but I will. Patient received treatment for event (broke out in hives and hives went around her mouth and throat was getting swollen). The outcome of event (broke out in hives and hives went around her mouth) was recovered on an unspecified date in 2021 and the outcome of events (Throat was getting swollen, she's been sleeping for days so she is not feeling well) was unknown. Information about lot/batch number has been requested.
22 2021-07-02 sleep disorder around 1.5 weeks after 2nd vaccine dosage, I began experiencing severe, debilitating pain in my arm/... Read more
around 1.5 weeks after 2nd vaccine dosage, I began experiencing severe, debilitating pain in my arm/shoulder. With no prior injury, sickness, history, accident, or physical activity, I had no idea where the pain was coming from. I've never broken a bone, I'm healthy, and I hadn't done any strenuous activity in the past year. The pain continued and worsened to the point I was unable to use my arm, sleep laying down, and act without pain medication. Almost 2 weeks and no pain subsiding, I went into a walk in ortho clinic where they found abnormal x rays of my arm/shoulder. My humorous bone was in the wrong place because the muscles were weighing down & there was no fracture/anything wrong with the bone. After a visit to an orthopedist, I was treated for **parsonage turner syndrome** and put on steroids. Currently scheduled for physical therapy and still only have limited use of my arm.
22 2021-07-06 insomnia Neck was chocking I feel like that I have taken a pill and it stuck in a throat; My breaths starts t... Read more
Neck was chocking I feel like that I have taken a pill and it stuck in a throat; My breaths starts to close in I couldn't breathe; I have a lot of trouble in breathing; I couldn't eat; I couldn't sleep; I was very dizzy; I had a lot of vomiting; I couldn't even swallow; My neck was really getting swollen; I had fever; Chills; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: 5EW0182), via an unspecified route of administration on 03May2021 (at the age of 22-years-old) as a single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she got her shot right in, "my breaths starts to close in I couldn't breathe", "I couldn't eat", "I couldn't sleep", "I was very dizzy", "I had a lot of vomiting" and it was basically not good. Then she went to the urgent care because "I couldn't even swallow", "my neck was really getting swollen" and "neck was chocking I feel like that I have taken a pill and it stuck in a throat" and then "I had fever", chills and a lot of hard time. When paraphrased the above concern, the patient stated, and then "I have a lot of trouble in breathing". She received the second dose on 24May2021. The patient stated, the only thing that they gave her was Ibuprofen because they say, that's the only thing that they could give her. The outcome of all the events was unknown. Follow-up attempts completed. No further information expected.
22 2021-07-08 anxiety flutter and AFIB; anxiety; threw up; her heart was racing; This is a spontaneous report from a conta... Read more
flutter and AFIB; anxiety; threw up; her heart was racing; This is a spontaneous report from a contactable consumer (patient mother) reported patient (reporter daughter). A 22-year-old female patient received first dose of BNT162B2 (Pfizer covid-19 vaccine, Solution for Injection, Lot Number: EN6205, Expiration date: Unknown), via an unspecified route in the right arm on 07Apr2021 (age at vaccination: 22-year-old) as a single dose for covid-19 immunization. Medical history included extreme immune system and seizures that only lasted about 2 years when she was a baby. The patient concomitant medications were not reported. Patient had issues when she was born, she was 3 weeks post term, she was adopted and when all the kids would get sick, she would always get the sickest. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unknown date, few days later she felt something and thought it was anxiety, 2 weeks after vaccination from 15May2021, she woke herself up threw up and saying that her heart was racing around 8:30 in the morning, so she went and got their finger monitor, and her heart rate was out of control, so they took her to the emergency room. They tried to get her heart rate down with medications and sent us to an electro physicist, and the rest is history. Patient has been an athlete her whole life, has been in great shape with no heart problems. She was taken to the ER and they captured flutter on the EKG and AFIB issues. Later she was hospitalized and ended up having cardiac surgery about a week ago at 13:00 (16Jun2021 to 17Jun2021). Caller states that her daughter was doing really well, they had to do an ablation. Caller states they saw the cardiologist today, her daughter may have bouts of palpitations, but has had nothing since 3 days after the surgery. Caller wanted to know if AFIB has been reported as a reaction. She received her second shot of BNT162B2 (Pfizer covid-19 vaccine, Solution for Injection, Lot Number: EN6199) in the right arm on 28Apr2021. They said she will recover completely, but it will take about 3 months. She will have to be followed by a cardiologist. The patient underwent lab test and procedure on 15May2021 which included flutter on the EKG. The clinical outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
22 2021-07-09 confusional state, panic reaction Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unrespo... Read more
Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Weakness-Severe, Additional Details: PT received vaccine and then felt light headed and began to panic. She was being assisted by pharmacist and shift supervisor when she stood up to attempt to walk into the vaccination booth to calm down. She passed out, flew forward hitting her forhead on the corner of the wall, she was momentarily unconcious and she had a cut on her forehead and was bleeding. Shift supervisor called 911 while pharmacist tended to her until emts arrived.Her parents were contacted and she was taken to er
22 2021-07-12 feeling abnormal, confusional state Sudden vertigo, confusion, and drowsiness. Pain in left arm and tingling in arms when dizzy. Usually... Read more
Sudden vertigo, confusion, and drowsiness. Pain in left arm and tingling in arms when dizzy. Usually after eating. Almost constant head fog. Slight nausea from dizziness.
22 2021-07-13 sleep disorder Since July 4th I have felt as though I can't breathe, exercise is difficult and I haven't been sleep... Read more
Since July 4th I have felt as though I can't breathe, exercise is difficult and I haven't been sleeping because it's harder to breathe when I lay down. I have chest tightness and pain.
22 2021-07-14 feeling abnormal After the 20 minute mark, I felt very nauseated and threw up as well. I got some food and snacks and... Read more
After the 20 minute mark, I felt very nauseated and threw up as well. I got some food and snacks and I was in observation for an hour. I could not drive so I waited for a ride. I slept until 4PM and 1AM and went back to sleep until 9AM the next morning. I felt very weak and nauseated and threw up acid even though I had an empty stomach. I had a headache and fever and slept more. 3 more days passed and I was still feeling awful. 46 hours later, I saw the doctor in my clinic until I got back to normal which they prescribed me Tylenol, 650mg.
22 2021-07-15 feeling abnormal, disorientation Immediately upon administration of covid19 vaccination, patient became flushed (face and arms), dizz... Read more
Immediately upon administration of covid19 vaccination, patient became flushed (face and arms), dizzy and nauseous. Patient also reported vision changes (seeing spots) Flushing resolved in about 5 minutes and nausea/dizziness in about 10-15 minutes while patient was monitored by pharmacy staff. Patient reported heavy breathing at this time believed due to anxiety but was continued to be monitored by staff. After about 20 minutes patient was able to stand briefly and moved to another chair to relax and to continue monitoring. At this time most symptoms had resolved but patient still reported feeling uneasy and a little disoriented. Water was provided and pharmacy staff continued to sit with patient until patient felt that she had calmed down and reported no further adverse conditions. After sitting for another 10 minutes patient stood on her own, was stable and felt comfortable returning to work.
22 2021-07-17 feeling abnormal, insomnia left leg is struggling again with circulation; cant sleep; heart hurts; viens hurt so bad; Feels lik... Read more
left leg is struggling again with circulation; cant sleep; heart hurts; viens hurt so bad; Feels like choking on blood/ Feels like it skips a beat once every 30 minutes; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in Arm Left on 25May2021 12:00 PM (Lot Number: EW0178) (at age of 22-year-old, not pregnant at time of vaccination) as single dose for covid-19 immunisation. Medical history included Hashimotos, Elhers Danlos, Raynaud's. The patient received Other medications within 2 weeks of vaccination. The patient previously took first dose of BNT162B2 on 04May2021 12:00 PM (lot number: EL9269) (at age of 22-year-old) administered in Arm Left for covid-19 immunisation and experienced dizzy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient took dose 2 anyway out of FOMO, first 3 days great. In May2021, start to notice the left leg was struggling again with circulation. Viens hurt so bad that she could not make it more than a mile into her daily hike. Taking tons of antioxidants, even more tumeric. Day 7 wind up in ER because her heart hurts and she could not sleep. Feels like it skips a beat once every 30 minutes. Sent home. Day 11 ER again. Feels like choking on blood. No treatment received for AE. The adverse event result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Prior to vaccination, was the patient did not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Event outcome was recovering.
22 2021-07-17 loss of personal independence in daily activities I have been having trouble breathing since I had the vaccine done. I get really bad chest pains just... Read more
I have been having trouble breathing since I had the vaccine done. I get really bad chest pains just from laying down and it is a daily struggle to do everyday things like walking because I get short of breath really easily after I had the vaccine done. It has been 3 and a half months now and I am still struggling trying to recover. My treatment right now is that my pulmonologist put me on Symbicort to see if it could give me a little bit of relief and I am still being seen by the cardiologist as well, and I am also using my rescue inhaler Albuterol HFA more often than before. I am taking Singulair and I was also put on a heart monitor for 2 days to check my heart rhythm to see if that has anything to do with the chest pains I have been feeling
22 2021-07-20 confusional state, amnesia Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unrespo... Read more
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: temporary loss of vision-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Visual Changes/Disturbances-Severe, Systemic: Weakness-Medium, Additional Details: pt was given vaccine and approximately 5minutes or less later patient fell out of chair and onto floor. patient was pale,unresponsive for less than 30 seconds and clammy to touch. her lips were blue. 911 was called. came to almost immediately and did not remember what happened. vision went black but came back after a few minutes. tested her blood sugar is was 114. pulse was rapid. anbulance arrived pt walked out on her own power. refused treatment from emts and refused to go to er.
22 2021-07-25 anxiety Around 2-3 weeks after receiving the vaccine, I was sitting and noticed my heart was racing really f... Read more
Around 2-3 weeks after receiving the vaccine, I was sitting and noticed my heart was racing really fast. The next morning it did not stop. On 5/1, I went to a doctor who said I was having an anxiety attack and was sent home. On 5/2, I was having palpations around 145/150. I went to the ER and they took my blood, and did a chest X ray. I checked in with my primary care who said I might have PAP. I went to a cardiologist who did a stress test and a 2 week and 24hr Holter monitor. No conclusive results were found so they did a tilt table test with no conclusive results. An echo of my heart was also conducted. I also get fatigued easily, headaches, dizziness, and heat flashes. I was prescribed propranolol which I did poorly on so I was put on cardanol which seems to be helping.
22 2021-07-26 poor quality sleep PATIENT DID NOT FEEL ADVERSE EVENTS UNTIL AFTER SHE LEFT OUR FACILITY AND HAD BEEN HOME AT ONSET. AD... Read more
PATIENT DID NOT FEEL ADVERSE EVENTS UNTIL AFTER SHE LEFT OUR FACILITY AND HAD BEEN HOME AT ONSET. ADVERSE EVENTS INCLUDED FAINTING (WITH A FALL), LOW BLOOD PRESSURE (80s/60s; MEASURED AT HOME), AND BLUE COLORATION OF LIPS. PATIENT RECOVERED FROM FAINTING AND HAD DINNER. SHE SLEPT POORLY OVERNIGHT AND VOMITTED UPON WAKING UP THIS MORNING. SHE IS FEELING MUCH BETTER TODAY AND BLUE COLORATION OF LIPS IS COMPLETELY GONE. HOWEVER SHE CONTINUES TO BE HYPOTENSIVE.
22 2021-07-27 feeling abnormal Headache; Fatigue; Fogginess; This is a spontaneous report from a non-contactable consumer, the pati... Read more
Headache; Fatigue; Fogginess; This is a spontaneous report from a non-contactable consumer, the patient. A 22-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 05Apr2021 at 16:30 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included cetirizine hydrochloride (ZYRTEC) and women's daily multivitamin (MANUFACTURER UNKNOWN); both taken for unknown indication from an unknown date. 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 05Apr2021 at 17:15, the patient experienced headache, fatigue and fogginess. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events headache, fatigue and fogginess was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.
22 2021-07-27 loss of personal independence in daily activities Severe full body muscle aches resulting in loss of work; severe full body muscle aches resulting in ... Read more
Severe full body muscle aches resulting in loss of work; severe full body muscle aches resulting in loss of work and difficulty getting out of bed; Continued period, and approximately 1 week after the shot; Heavy bleeding; Very heavy bleeding and severe cramps; Nausea; Fatigue; Severe arm soreness at shot location; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old, non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route in right arm on 20Apr2021 at 15:15 hours (at the age of 22-year-old) as single dose for COVID-19 immunisation. The medical history of the patient included blood clots (continued use of blood thinners), depression and a birth control user at the time of this report. The patient received rivaroxaban (XARELTO) 10 mg, norethisterone (NORETHINDRONE), citalopram (MANUFACTURER UNKNOWN) and vitamin D (MANUFACTURER UNKNOWN) on an unknown date within 2 weeks prior to the COVID-19 vaccine for an unknown indication. Previously, the patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route in left arm on 30Mar2021 at 15:15 hours as single dose for COVID immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccination within 4 weeks prior to the COVID vaccine. Post the vaccination, the patient was not tested for COVID-19. On 21Apr2021, on the day following the vaccine shot, the patient experienced severe arm soreness at shot location, nausea, fatigue, and severe full body muscle aches resulting in loss of work and difficulty getting out of bed. Pain was still serious after taking acetaminophen but was eased after taking Percocet. The patient was on period at the time of the COVID vaccine and it should have ended a few days after receiving it. However, it continued for approximately one week after the shot, it intensified to several days of very heavy bleeding and severe cramps. For comparison, she did not have cramps that bad since beginning birth control three years ago, and the cramps usually never last longer than 24 hours. The flow was also greatly increased, around twice as heavy as her usual heavy days. These increased cramps and bleeding lasted around four days. Therapeutic measures were taken as a result of the events and included treatment with acetaminophen and Percocet. The clinical outcome for the events severe arm soreness at shot location, nausea, fatigue, severe full body muscle aches resulting in loss of work and difficulty getting out of bed was recovering and for the events of continued period, for approximately one week after the shot, heavy bleeding and severe cramps was recovered on an unknown date in 2021. No follow-up attempts are possible; information about lot number cannot be obtained.
22 2021-07-27 restlessness Chills; Nausea; Vomiting; Heavy chest; Restlessness; Ache; This is a spontaneous report from a conta... Read more
Chills; Nausea; Vomiting; Heavy chest; Restlessness; Ache; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 01May2021 at 11:30 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history included PCOS (polycystic ovarian syndrome), vulvodynia and COVID-19. Concomitant medications included paracetamol (TYLENOL), ibuprofen (MOTRIN), loratadine (MANUFACTURER UNKNOWN) and diphenhydramine hydrochloride (BENADRYL); for unknown indications and from an unknown date. Past drug history included any protein pump inhibitor, latex, cinnamon, coconut and berberine (MANUFACTURER UNKNOWN). Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 01May2021, the patient experienced chills, nausea, vomiting, heavy chest, restlessness and ache. The clinical outcomes of the events chills, nausea, vomiting, heavy chest, restlessness and ache were not recovered at the time of reporting. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
23 2021-01-03 sensation of foreign body tightness in throat and lump in throat/had a tightness and lump in her throat; tightness in throat a... Read more
tightness in throat and lump in throat/had a tightness and lump in her throat; tightness in throat and lump in throat/had a tightness and lump in her throat; allergic reaction like rash, tightness in throat, and lump in throat; allergic reaction like rash/red rash on her chest and rash was on her arms too; cheeks were flushed; This is a spontaneous report from a contactable nurse (patient). This nurse reported similar events for 3 patients. This is the first of 3 reports. A 23-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EK9231, intramuscular in the right deltoid, first dose on 27Dec2020 14:15 at a single dose for covid-19 prevention. Medical history included ongoing asthma and reactive airway which she was diagnosed when she was like 5 years old (2002). Concomitant medication included albuterol [salbutamol] for asthma which started when she was 8 years old or so. The patient wanted to know if she can receive the second dose of covid vaccine after experiencing symptoms of allergic reaction like rash, tightness in throat, and lump in throat. She wanted to know the ingredients and specific proteins in the covid vaccine. The patient received the COVID Vaccine and she developed a reaction. On 27Dec2020, she had a red rash on her chest, and her cheeks were flushed, and the rash was on her arms too, and she had a tightness and lump in her throat, it was not painful to swallow but she could feel the pressure with swallowing. She stated that she did not experience shortness of breath, but regardless, she was seen in the ER and she was given IV SOLUMEDROL, and BENADRYL, and she was watched for 5 or 6 hours and then she was sent home with an Epi Pen, around the clock Benadryl, and prednisone. She asked the ER doctors if they thought it was okay for her to receive the second dose of the product, and they told her to contact employee health for that question. She mentioned that she contacted that employee health and was told to contact her primary care provide which she did. Her primary care doctor instructed the caller to call Pfizer and gather some more information regarding ingredients, as the she may have had the reaction to a particular protein filler. She was also wondering if this is a known reaction to the product. She received the vaccine on 27Dec2020 at 2:15 PM. She reported that the red rash on her chest and arms, and her cheeks being flushed, resolved yesterday after receiving IV BENADRYL. Had a tightness and lump in her throat which was still ongoing, and it was kind of off and on and when the she takes Benadryl it goes away. She reported that this one is medically significant because even though she did not have shortness of breath, it could have affected her airway. She confirmed that she received no other vaccines on the same day as the COVID vaccine. The outcome of the events 'had a tightness and lump in her throat', allergic reaction was not recovered (a s reported); while recovered on 27Dec2020 for allergic reaction like rash/red rash on her chest and rash was on her arms too and cheeks were flushed.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the events throat tightness, sensation of foreign body, allergy to vaccine, rash erythematous and flushing cannot be excluded. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2020517134 different patient, same drug and same event;US-PFIZER INC-2020517133 different patient, same drug and same event.
23 2021-01-05 anxiety 8:05am-Patient received Covid vaccine and while being monitored c/o upper lip being numb, no other c... Read more
8:05am-Patient received Covid vaccine and while being monitored c/o upper lip being numb, no other c/o voiced, no nonverbal cues noted at present time. 8:22am- Self medicated with Benadryl 25mg; tolerated without difficulty. 8:28am-Patient c/o throat tingling and verbalized having history of angioedema; noted anxious, cough present, upon further evaluation noted facial swelling, top lip remains numb; patient assisted to emergency room per staff on duty; upon leaving clinic patient continued to cry for her mom; required reassurance regarding going to emergency department.
23 2021-01-05 anxiety 8:05am-Patient received Covid vaccine and while being monitored c/o upper lip being numb, no other c... Read more
8:05am-Patient received Covid vaccine and while being monitored c/o upper lip being numb, no other c/o voiced, no nonverbal cues noted at present time. 8:22am- Self medicated with Benadryl 25mg; tolerated without difficulty. 8:28am-Patient c/o throat tingling and verbalized having history of angio8:05am-Patient received Covid vaccine and while being monitored c/o upper lip being numb, no other c/o voiced, no nonverbal cues noted at present time. 8:22am- Self medicated with Benadryl 25mg; tolerated without difficulty. 8:28am-Patient c/o throat tingling and verbalized having history of angioedema; noted anxious, cough present, upon further evaluation noted facial swelling, top lip remains numb; patient assisted to emergency room per staff on duty; upon leaving clinic patient continued to cry for her mom; required reassurance regarding going to emergency department.edema; noted anxious, cough present, upon further evaluation noted facial swelling, top lip remains numb; patient assisted to emergency room per staff on duty; upon leaving clinic patient continued to cry for her mom; required reassurance regarding going to emergency department.
23 2021-01-06 feeling abnormal At around 1 pm on 1/5/2021, my right face started feeling weird. There was a tightness/tingling sens... Read more
At around 1 pm on 1/5/2021, my right face started feeling weird. There was a tightness/tingling sensation starting below the right eye down to my whole cheek. This reaction was present until the following day, 1/6/21 and seemed to resolve on the morning of 1/7/21
23 2021-01-07 anxiety Sore arm where vaccination was administered; Intermittent nausea; Increased heart rate; anxiety; Tir... Read more
Sore arm where vaccination was administered; Intermittent nausea; Increased heart rate; anxiety; Tiredness; This is a spontaneous report from a contactable nurse (Patient). A 23-year-old female patient received the first dose of bnt162b2 (PFIZER COVID 19 VACCINE, lot number: EH9899, Batch/lot number: EK5730 as reported), via an unspecified route of administration at Right arm on 16Dec2020 17:00 at a single dose for COVID-19 immunization. Medical history included General Anxiety Disorder, depression, and COVID-19. The patient had no known allergies. Concomitant medication included escitalopram oxalate (LEXAPRO), levonorgestrel (NORTREL[LEVONORGESTREL]). The patient experienced sore arm where vaccination was administered, intermittent nausea for 3 days, increased heart rate and anxiety for 1.5 days, and tiredness; all on 16Dec2020. There was no treatment for the adverse events. The patient did not test positive for COVID post vaccination. The event Nausea recovered in 19Dec2020, while patient recovered from the other events in Dec2020. The vaccine was administered at the hospital. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The events were considered as non-serious.
23 2021-01-09 sleep disorder Swollen lymph node in left armpit. Using ice and ibuprofen to help with over all swelling. After 5 d... Read more
Swollen lymph node in left armpit. Using ice and ibuprofen to help with over all swelling. After 5 days thought it was getting better but over night of day 5 to 6 unable to sleep due to the pain and ibuprofen not relieving anything only ice helped.
23 2021-01-10 feeling abnormal Patient alerted clinic worker that she wasn't feeling well. Reported scratchy throat, not feeling he... Read more
Patient alerted clinic worker that she wasn't feeling well. Reported scratchy throat, not feeling herself, and potential tongue swelling. Called 911 at 1357. Arrived at 1402. Patient left with EMS at 1410. Patient talking and alert upon departure with EMS.
23 2021-01-10 excessive sleepiness Received at about 0800. I work night shift, went after work, went to sleep when I got home. Woke up ... Read more
Received at about 0800. I work night shift, went after work, went to sleep when I got home. Woke up at about 5 pm very tired, weak, with chills; painful arm. By the next day my arm was swollen and painful around the injection site and stayed that way for about 3 days. Chills primarily first 48 hours. Weakness, fatigue - sleeping a lot, feeling exhausted walking upstairs/short distances, things felt heavier than usual - lasted about 3-4 days
23 2021-01-11 impaired work ability I got the shot at 6:36 pm, I was fine until 11:45pm when I got shaky and got the chills but 4am I h... Read more
I got the shot at 6:36 pm, I was fine until 11:45pm when I got shaky and got the chills but 4am I had the hot sweats and but 7am I felt super weak and the weakness got worse as the day went on, I had to leave work because walking down the hallway felt like running a mile
23 2021-01-11 sleep disorder had chills, fever and nausea with vomiting in middle of the night so badly it woke me up from my sle... Read more
had chills, fever and nausea with vomiting in middle of the night so badly it woke me up from my sleep.
23 2021-01-13 anxiety after 10', felt short of breath and anxious. Transferred to ED: sx resolved after arrival/. No int... Read more
after 10', felt short of breath and anxious. Transferred to ED: sx resolved after arrival/. No intervention - Observation for 4 hrs
23 2021-01-13 impaired work ability The day after my injection on 1/13/2021 I started getting body aches and a headaches. I also had a f... Read more
The day after my injection on 1/13/2021 I started getting body aches and a headaches. I also had a fever of 100. I called off of work that night . The next morning I woke up and felt normal and called they told me to fill this form out since it was a reaction and I was free to return to work.
23 2021-01-13 sensation of foreign body flushed; hives; tongue felt "thick"; the lump in my throat feels bigger; This is a spontaneous repor... Read more
flushed; hives; tongue felt "thick"; the lump in my throat feels bigger; This is a spontaneous report received from a contactable pharmacist. A 23-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EL0142), via an unspecified route of administration in the left arm on 22Dec2020 (at the age of 23-years-old) as a single dose for COVID-19 immunization. The patient's medical history included: allergies to medications, food, or other products (unspecified). It was unknown if the patient was pregnant at the time of vaccination. The patient's concomitant medications were not reported. It was unknown if the patient received any other vaccine within 4 weeks prior to the vaccine. On 22Dec2020, approximately 8 minutes after vaccine administration, the patient began feeling flushed. She reported to the observation area, and the registered nurse noted hives on her left neck (22Dec2020). The patient was brought back for closer monitoring. The doctor evaluated the patient. Vital signs were monitored every 5 minutes (22Dec2020). The patient was given 50 mg diphenhydramine (BENADRYL) orally. Some improvement was noted in hives; however, the patient began to state her tongue felt "thick" and "the lump in my throat feels bigger" (both on 22Dec2020). Per doctor, 0.3 mg epinephrine (MANUFACTURER UNKNOWN) given intramuscularly with rapid improvement in hives. The patient reported feeling some improvement as well. The patient was taken to the emergency department for ongoing observation. The patient was released from emergency department after observation. The clinical outcome of flushed, hives, tongue felt "thick", and "the lump in my throat feels bigger" was recovered on an unspecified date.; Sender's Comments: Based on the compatible time association, the events flushing, urticaria, tong disorder, sensation of foreign body are possibly related to suspect BNT162B2 administration. 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.
23 2021-01-13 sleep disorder Several hours after vaccine, I started developing fatigue, chills, a low grade fever, and inability ... Read more
Several hours after vaccine, I started developing fatigue, chills, a low grade fever, and inability to sleep due to severity of chills. I also experienced headaches, arm soreness and dizziness. The next day my left arm hurt more than the night before, and I had a fever off and on from 8am to 12pm. No additional symptoms after 5pm the next day 12/31/2020.
23 2021-01-14 sleep disorder woke up in the middle of the night with a fever of 100.2 degrees F and muscle soreness took Tylenol ... Read more
woke up in the middle of the night with a fever of 100.2 degrees F and muscle soreness took Tylenol 500mg at 5am then at 8am fever and muscle sorenessbeginning to come back around 5pm
23 2021-01-15 sensation of foreign body About 15-20 minutes post vaccination the patient hands became itchy. She was given a 50mg dose of di... Read more
About 15-20 minutes post vaccination the patient hands became itchy. She was given a 50mg dose of diphenhydramine and advised to sit and rest. The staff checked on her every 5-10 minutes for changes, the reaction to her hands was unchanged and she began to feel a lump in her throat. There no visible swelling of her lips and she denied an swelling of her tongue. The patient declined epinephrine administration or emergency support. She was advised to have a family member pick her up to bring her to immediate care. She left the pharmacy about 7:10pm and by 8:20pm she reported back that she received immediate care and was given a steroid dose pack and feeling well.
23 2021-01-17 feeling abnormal 515 PM - PT COMPLAINED OF DIZZINESS, FEELS OUR OF IT. DENIES OTHER S/S HR 64, 99% 124/80 WATER GIV... Read more
515 PM - PT COMPLAINED OF DIZZINESS, FEELS OUR OF IT. DENIES OTHER S/S HR 64, 99% 124/80 WATER GIVEN CRACKERS. 524 PM DIZZINESS STILL BP 124/80 534 PM DIZZINESS STILL NO OTHER S/S 535 PM DIZZINESS STILL THERE IF I LOOK DOWN. MORE CRACKERS AND WATER GIVEN 545 PM DIZZINESS SL IMPROVED, GAVE TEAM MEMBER BOX LUNCH 610 PM FEELING BETTER DIZZINESS GONE FELT OKAY TO LEAVE MOM WAS COMING TO TAKE PT HOME NO OTHER S/S
23 2021-01-18 anxiety Approximately 15 minutes after the vaccination the patient reported dizziness and possible rash on h... Read more
Approximately 15 minutes after the vaccination the patient reported dizziness and possible rash on her upper chest. It was difficult to assess if the rash was truly a rash or it was simply skin lesions that were already present (patient claimed she did not know). It did not resemble a maculopapular rash. It marginally resembled minor hives/urticaria. Patient did not report any localized symptoms at injection site. Patient was informed to remain seated and that her vitals would be taken and she would be further observed. Then about 10 minutes after this (25 minutes after vaccination), patient reported difficulty breathing. Facial redness was noted at this point and patient's breathing sounded difficult. Emergency medical services were called and EpiPen was administered at this point. Patient began to tremble and pace of breathing increased. Emergency medical technicians arrived, took vitals / EKG, and assessed the patient. EMT assessment did not reveal urticaria. EMT instructed patient to control her breathing. The EMTs believe that it may not have been a true reaction but rather the patient may have been suffering from an anxiety attack. Patient was then taken to local ER for further evaluation.
23 2021-01-18 mental status changes The patient presented to the Emergency Department for evaluation after receiving her second Pfizer v... Read more
The patient presented to the Emergency Department for evaluation after receiving her second Pfizer vaccine for COVID-19. She reports that after the first vaccine she became tachycardic and lightheaded with symptoms resolving. About 30 minutes after receiving the 2nd dose of the vaccine she started to notice difficulty forming words, difficulty walking and feeling generally tired. Two hours after vaccine, patient arrived to Emergency Department with chief complaints of altered mental status altered sensorium and difficulty ambulating. Had difficulty word finding, speaking, ambulating altered sensation in her hands and feet.
23 2021-01-19 feeling abnormal I experienced extreme chills, body aches, nausea and headache. The severity resolved in 48 hours b... Read more
I experienced extreme chills, body aches, nausea and headache. The severity resolved in 48 hours but throughout the week I still felt "off". My headache persisted for 7 days though. I treated it with Excedrin migraine and Ibuprofen.
23 2021-01-20 loss of personal independence in daily activities About 1:00 am woke up with chills, bad headache, fever - got up to 99.8 - fatigue - took med_Tylenol... Read more
About 1:00 am woke up with chills, bad headache, fever - got up to 99.8 - fatigue - took med_Tylenol - and all day the next day these symptoms continued and I had to stay in bed and not do anything. The day after that it resolved.
23 2021-01-20 nervousness After sitting about 15 minutes, felt a bit dizzy. States had minimal breakfast; had water, oj, crack... Read more
After sitting about 15 minutes, felt a bit dizzy. States had minimal breakfast; had water, oj, crackers. Pulse device on arm showed HR 145; refused BP initially. Feeling better after po intake; still reports "shaky". Agreeable to VS: BP 122/80; HR 100. Continued sitting for 10-15 minutes and drinking water. Feels comfortable leaving; works in hospital and escorted to floor. Will be eating snack once back at work.
23 2021-01-24 sensation of foreign body, nervousness throat felt like it was closing up; had issues swallowing; it feels like her throat will close up an... Read more
throat felt like it was closing up; had issues swallowing; it feels like her throat will close up and open up; felt dizzy; shaky; nauseous; extremely tired; had a strong headache; It's like she is having allergy and hay fever type symptoms; It's like she is having allergy and hay fever type symptoms; The lymph nodes in her neck feel like they are swollen, it feels like she has a big lump in the middle and sides of her throat.; feels like she has a big lump in the middle and sides of her throat; This is a spontaneous report from a contactable other healthcare professional (patient). A 23-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot no: EL1283, via an unspecified route of administration on 09Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported she got the Covid vaccine on Saturday, 09Jan2021, and immediately her throat felt like it was closing up, she was instantly reacting to the vaccine. Since then, she has had issues swallowing; it feels like her throat will close up and open up. She also felt dizzy, shaky, nauseous, extremely tired, and had a strong headache. She stated that diphenhydramine (BENADRYL) helps a lot with the throat symptoms and as long as she takes it, she feels almost normal but as soon as it is out of her system, it starts again. It's like she is having allergy and hay fever type symptoms. The lymph nodes in her neck feel like they are swollen, it feels like she has a big lump in the middle and sides of her throat. She just came back from the emergency room and they gave her diphenhydramine. She wanted to know if she should she get the second vaccine. Outcome of the events was unknown.; Sender's Comments: A causal association between BNT162B2 and throat tightness cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
23 2021-01-25 crying 01/23 sat left arm soreness and left axillary intensified pain/ was so uncomfortable/feel like cr... Read more
01/23 sat left arm soreness and left axillary intensified pain/ was so uncomfortable/feel like crying for intensified pain on Sunday and had no pain relief after Tylenol 1000mg and Children's Motrin 15ml
23 2021-01-25 feeling abnormal She reported feeling lightheaded and foggy. Patient reports being a cancer survior and having a simi... Read more
She reported feeling lightheaded and foggy. Patient reports being a cancer survior and having a similar reaction to a past flu vaccination. She was able to ambulate to the recliner and denies other symptoms such as shortness of breath, rash, or diaphoresis. BP 96/70 mmHg, HR 64 bpm, SPO2 99% After 30 minutes in the recliner she states she is feeling much better and denies any current symptoms. BP 100/70mmHg, HR 71bpm, SPO2 99%.
23 2021-01-26 feeling abnormal I started yesterday about 8 p.m. with an upset stomach, diarrhea and nausea, this morning about 7 a.... Read more
I started yesterday about 8 p.m. with an upset stomach, diarrhea and nausea, this morning about 7 a.m. I started getting hot and cold flashes, lightheaded, dizzy, extreme head ache and I just felt not myself.
23 2021-01-26 sleep disorder Fatigue and muscle aches - day of to present Low fever (99°F) - Saturday, Tuesday, and Wednesday ... Read more
Fatigue and muscle aches - day of to present Low fever (99°F) - Saturday, Tuesday, and Wednesday Pelvic/intestinal cramping that woke me up in middle of night - Monday/Tuesday Joint pain - Friday, Saturday, Sunday Swollen lymph nodes (axillary) - Sunday, Monday Swollen lymph node (right neck, under mandible) - Saturday to present, getting bigger and more painful Headache - Friday-present
23 2021-01-27 impaired work ability Patient states she received 2nd dose Pfizer Covid 19 vaccine lot #EL3302 on 1/11/2021. Patient repor... Read more
Patient states she received 2nd dose Pfizer Covid 19 vaccine lot #EL3302 on 1/11/2021. Patient reports 7/10 body aches, fever 38.2, nausea and dizziness that prevented patient from standing without being steadied by someone else. Patient reports dizziness and nausea lasted two days. Body aches improved after one day. Fever present only on the second day. Patient had to miss work on 1/12/21 & 1/13/21 due to symptoms. Patient was tested for Covid and reports Covid swab was negative. Patient denies any side effects following the 1st Pfizer vaccine. Patient denies any ongoing symptoms or concerns today. VAERS. D/c from EHS.
23 2021-01-27 sleep disorder The evening after I got the first dose I experienced painful muscle aches starting in my legs and pr... Read more
The evening after I got the first dose I experienced painful muscle aches starting in my legs and progressing to the rest of my body, around 7pm. My left shoulder was a little achy, but no different than any other shot. About 30 minutes later I felt chills and felt really cold. I went to bed and tried to sleep. I woke up several times in pain. I did not take any pain meds. At 1am I went to the bathroom and felt nauseous and lightheaded. My vision got blurry and it felt like I was going to pass out, so I grabbed the towel rack and closed my eyes. I must have blacked out for a second and lowered myself down to the floor. I came to, and I was sitting on the ground, sweating a lot. I stayed on the floor for at least 10 minutes cooling down. (I had dressed warmly and turned on my heater after the chills started). I heard ringing in my ears while I was sitting on the floor. It went away after 5 minutes. I got up and went back to bed. I woke up at 9am and felt a lot better. Some minimal soreness. No more chills.
23 2021-01-28 sleep disorder In the night, I had constant shivers and could not get any sleep. I woke up with a tension headache ... Read more
In the night, I had constant shivers and could not get any sleep. I woke up with a tension headache and slight cough. I also felt very tired as if I had just starved for 5 days. I was also nauseous.
23 2021-01-31 impaired work ability Night following vaccine (1/25): Arm soreness Morning following (1/26; 7:00am): Fever 101.1, chills, ... Read more
Night following vaccine (1/25): Arm soreness Morning following (1/26; 7:00am): Fever 101.1, chills, sweats, arm soreness Throughout day (1/26): Fever up to 102, chills, sweats, fatigue, no appetite, arm soreness and extreme headache. Could not complete anything that required any type of focus such as watch TV/go on phone, the light increased headache. Slept on and off all day. Evening (1/26; 4:30pm): Took Excedrin for headache, was told by other coworkers not to medicate until 24 hours after at least, so did not take anything up to this point just in case. Slept another 2 hours, woke up extremely sweaty, fever had broken to 99.1, and headache was gone.
23 2021-01-31 impaired work ability 1/25: Evening after vaccine: arm soreness 1/26: Morning after vaccine at 7:00am: Fever of 101.1, chi... Read more
1/25: Evening after vaccine: arm soreness 1/26: Morning after vaccine at 7:00am: Fever of 101.1, chills, sweats, arm soreness 1/26: Throughout day: Fever up to 102, chills, sweats, arm soreness, no appetite, body aches, fatigue, and extreme headache. Could not do anything that required focus such as watch TV/go on phone. Light increased headache. Slept on and off all day. 1/26: Evening: Took Excedrin at 4:30pm. Waited 24 hours post vaccine to take any medication as I was told by various people at my hospital. Slept another 2 hours, woke up extremely sweaty, fever broke and down to 99.1, and headache mostly gone.
23 2021-02-02 impaired work ability I received my vaccine at 3:30pm on 1/30 feeling no symptoms. When waking up the next morning, I had ... Read more
I received my vaccine at 3:30pm on 1/30 feeling no symptoms. When waking up the next morning, I had felt a slight fever, chills, nausea, continuous fatigue, and headaches throughout the day. Once I woke up the next day, 2/1, my fever and chills had completely gone away, however I was still feeling fatigue, headaches, and nausea and have not stopped feeling these symptoms since. My fatigue most notably has been present enough to where I?ve needed to call out of work. Eating meals also does but subside the fatigue by a substantial amount.
23 2021-02-03 confusional state, disorientation Time: 6 pm; Feb 4 1. Patient HR: 120. BP 131/109 2. Patient complains of neck tightening - My team ... Read more
Time: 6 pm; Feb 4 1. Patient HR: 120. BP 131/109 2. Patient complains of neck tightening - My team immediately lowered from sitting position to lying down with legs bended. Patient feels very unease, confused, disoriented Patient complained of flickering eyes and yellow lights (was staring at overhead ceiling lights yellowish in color) Patient complained of hot chest after 10 minutes
23 2021-02-03 impaired work ability Headache pain scale of 1-10, it was a 7. Tylenol did not relieve pain. Had to leave work early. With... Read more
Headache pain scale of 1-10, it was a 7. Tylenol did not relieve pain. Had to leave work early. With rest, it got better the next day. Estimated gestation that day, 1/13/2021, was 27 weeks and 6 days. Estimated date of delivery will be 04/08/2021. No expected complications with fetus.
23 2021-02-04 feeling abnormal, impaired work ability, confusional state After the vaccine was given, Patient stated her heart became racing. Pulse taken at the time listed... Read more
After the vaccine was given, Patient stated her heart became racing. Pulse taken at the time listed it as 180. Patient also said she felt like she could not talk as if the words would not come out. She felt like she could not feel her arms and legs and felt numbness in her chest. Dizziness also occurred. Vision became blurry. That night after being released from the hospital she still had trouble walking . To this day she suffers from intense brain fog. She says she has so much to say but it wont come out. She still is having trouble walking, her gait is very unsteady. She finds herself unable to work like before and suffers from confusion.
23 2021-02-05 confusional state, feeling abnormal Severe brain cloudiness, confusion and body aches
23 2021-02-08 feeling abnormal Immediately after the shot I was very tired. The next morning I woke up about 6am, I felt out of sor... Read more
Immediately after the shot I was very tired. The next morning I woke up about 6am, I felt out of sorts. I got very light headed and dizzy. I had a headache and noticed I had a 101.2 fever so I took Tylenol. I also had body aches. All day I was very weak. Later in the day about 4pm I became nauseous and threw up. Symptoms carried over into the next day. I am tired with a bad headache and nauseous.
23 2021-02-08 sleep disorder Nausea prior to going to bed awakened by tachycardia, found to be sinus tachycardia in ED, respondin... Read more
Nausea prior to going to bed awakened by tachycardia, found to be sinus tachycardia in ED, responding to IV fluids No fever, headache, rash or hypotension
23 2021-02-09 insomnia Woke up day after with a slight pain in chest. As day progressed pain became much worse and when t... Read more
Woke up day after with a slight pain in chest. As day progressed pain became much worse and when tried to lay down to sleep could not. Breathing in caused pain as well. She went to ER and was diagnosed with Acute Pericarditis. Was in ER for 4 hours and sent home on oral Ibuprofen 600 mg.
23 2021-02-09 sleep disorder The night after I was vaccinated I experienced knee and ankle pain as well as soreness at the vaccin... Read more
The night after I was vaccinated I experienced knee and ankle pain as well as soreness at the vaccination site (left arm/shoulder). I experienced this throughout the night and this made sleeping difficult. The next morning, I took 2 500-mg tablets of acetaminophen. This relieved my pain for several hours. At about 1 pm, I became very fatigued. I slept the whole afternoon, ate dinner, took 2 more 500-mg tablets of acetaminophen, and slept for 11 hours. The next day, I felt good and have not had any symptoms since
23 2021-02-10 anxiety ABOUT 15MIN AFTER VACCINE PATIENT C/O FEELING FLUSHED, ANXIOUS,SHAKING AND OVERALL NOT FEELING WELL.
23 2021-02-10 crying On 2/10/2021, two days after my 2nd dose, I started experiencing mild abdominal pain at around 10am.... Read more
On 2/10/2021, two days after my 2nd dose, I started experiencing mild abdominal pain at around 10am. I knew it was a side effect from the vaccine for I had been experiencing severe chills, fever, muscle and joint pain, fatigue, headache, diarrhea, and nausea the day before (2/9/2021) and those symptoms except for the fever had subsided on the 10th. I had been unable to eat all day on the 10th due to the pain but it was manageable. At 2pm the abdominal pain got worse. At 4:30pm the pain became unmanageable and I could not walk erect without severe pain. I was crying and bend over trying to walk. I had a family member drive me to the ER and arrived at around 4:40pm. Lying down with my knees up seemed to help the pain a bit but was exacerbated when lying flat or ambulating. I was given Pepcid, zofran, and toradol all IV push at 8pm and the pain subsided within 15 minutes. Today I still have mild abdominal pain but I would rate it at a 1/10.
23 2021-02-12 nervousness MR came to work as normal at 9am. Reported feeling achy and a sore arm at injection site. Within 30... Read more
MR came to work as normal at 9am. Reported feeling achy and a sore arm at injection site. Within 30 minutes began vomiting several times over the 15 minutes. Symptoms progressed to feeling light headed and shaky. MR tried to eat something to see if this would help. Continued to become more nauseous, weak and lightheaded. Reported "face felt like it was vibrating" around 10:30 am. Was too weak to stand but was fully communicating. Symptoms began to improve around 11:40am. MR picked up by family member. Does not plan to seek medical treatment. No fever. No trouble breathing. No signs of allergic reaction.
23 2021-02-16 sleep disorder A few hours after receiving my second dose of the COVID vaccine, I was extremely fatigued. I lay do... Read more
A few hours after receiving my second dose of the COVID vaccine, I was extremely fatigued. I lay down for a short nap and woke up 4 hours later still feeling groggy. 12 hours after the dose, I began feeling very ill? I can?t describe it better than that it was like being hit by a car. Every muscle and joint in my body hurt. My temperature spiked to 100, and kept going up. In half an hour it went from 101* F to 101.5* F. I was exhausted, but could only sleep intermittently all night because I was in so much pain. I was also very nauseous and very thirsty? the only thing I wanted was Gatorade, which I drank 8 bottles of in 12 hours. It was difficult to walk up and down stairs. The whole-body pain faded after 36 hours. The pain in my left arm and the fatigue lingered longer, lasting for 72 hours after vaccination.
23 2021-02-18 crying 20 hours after the first dose of the Pfizer vaccine I developed right flank pain that felt like a ki... Read more
20 hours after the first dose of the Pfizer vaccine I developed right flank pain that felt like a kidney stone. The pain was mild at first but got quite severe within an hour to the point where I was on the floor crying. My boyfriend talked me into going to the ER, and I felt very nauseated in the elevator and the car. At the Hospital?s ER I received pain medication (Toradol and an opiod I can?t remember the name of), and a CT scan to determine if I had a kidney stone. No stone was seen on CT. After discussing the events with Dr., we determined that the Pfizer vaccine was the most likely, yet still quite unlikely, cause of my symptoms. I was sent home with some pain (Norco) and nausea (Zofran) medications and was told to follow up if the lain didn?t resolve over the next few days. My pain slowly faded and was gone by the next morning. Later that day (Jan. 16, 2021) I noticed I felt like I had a sunburn starting just superior to my right iliac crest and descending anteriorly about 20 cm, but my skin had no visible abnormalities. A few days later on Jan. 21 I noticed the area was slightly red. I took a photo and sent it to my mother, who is a PCP, asking what I should do and she instructed me to try applying topical Hydrocortisone. I did so 2-3 times per day as needed and the redness resolved within a few days. The sunburn sensation faded slowly but lasted until about a week ago (Feb. 12). Yesterday (Feb. 17) I noticed that my skin in that area is slightly numb. I can feel pressure and temperature, but I am unable to tell the difference between a touch and a light scratch. Sensation outside the affected area is normal.
23 2021-02-24 impaired work ability, insomnia I received the COVID-19 vaccine yesterday, Monday December 21, at 0700. Last evening I was up all ni... Read more
I received the COVID-19 vaccine yesterday, Monday December 21, at 0700. Last evening I was up all night with fairly severe symptoms, including a severe migraine unrelieved by pain medication, nausea and vomiting, muscle and joint pain, and a low grade fever. I felt unsafe to return to work today and called out due to my fever.
23 2021-02-24 impaired work ability Felt dizzy and nauseous immediately after shot, during the next day I had a severe headache and expe... Read more
Felt dizzy and nauseous immediately after shot, during the next day I had a severe headache and experienced dizziness so severely that I thought I might pass out and went home early from work.
23 2021-02-28 memory impairment, feeling abnormal Within the first 10 minutes of receiving the vaccine I felt extremely lightheaded, eyes were blurry ... Read more
Within the first 10 minutes of receiving the vaccine I felt extremely lightheaded, eyes were blurry for 5-10 minutes, and extreme sweating all over my body. These symptoms subsided after 25 minutes. I then became on and off light headed through the remainder of the day. The day after receiving the vaccine I felt a lot of brain fog, forgetfulness, and fatigue. The night of day two I had a sudden onset of nausea and headache which only lasted 20 minutes. During this time I was massaging the injection site because it was sore.
23 2021-03-01 disturbance in attention I had chills, low-grade fever, fatigue for over 24 hours. I was uncomfortable and struggling to focu... Read more
I had chills, low-grade fever, fatigue for over 24 hours. I was uncomfortable and struggling to focus for 36 hours.
23 2021-03-02 feeling abnormal headache/ lingering headache; nausea; spells of dizziness/feeling extremely dizzy; feel like I am fl... Read more
headache/ lingering headache; nausea; spells of dizziness/feeling extremely dizzy; feel like I am floating; fever of 101.1; chills; body aches; extreme fatigue; This is a spontaneous report from a contactable other health care professional (patient). A 23-years-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot EM9810, intramuscular on 12Feb2021 14:15 (at the age of 23-years-old) as a SINGLE DOSE for covid-19 immunisation. The patient's medical history was not reported. Concomitant medications were none. Historical vaccine information included BNT162B2 (Pfizer BioNtech), lot unknown False, administration date 22Jan2021 01:45 AM, dose number 1 for COVID-19 immunization (at 23 years old). 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, patient has not been tested for COVID-19. Patient did not have allergies to medications, food, or other products. The most recent COVID-19 vaccine was administered in a hospital. The patient reported she was on day 5 post second vaccine and am still experiencing a lingering headache, nausea and spells of dizziness. These ease up some with acetaminophen (TYLENOL), but do not fully go away nor has she noticed any improvement in her symptoms. The headache started approximately 11 hours after her vaccination 13Feb2021 01:15. The following day unspecified date Feb2021, she had fever of 101.1, chills, body aches, extreme fatigue, and a worsening headache. This headache has continued and is still present, coming and going in severity. She had spells where she feels like she was floating on unspecified date in Feb2021 and feeling extremely dizzy while also being nauseated. She has not seen any reports of these symptoms lasting this long after vaccination. "The adverse events started on 17Feb2021 at 12:00 PM". The patient underwent lab tests and procedures which included body temperature: 101.1 (fever) on 17Feb2021. No treatment was received for feel like I am floating, fever of 101.1, chills, body aches and extreme fatigue. Outcome of the events was recovering.
23 2021-03-04 anxiety Incident began 9:22am. Patient reports he was anxious. RN observed patient was diaphoretic and dire... Read more
Incident began 9:22am. Patient reports he was anxious. RN observed patient was diaphoretic and directed to treatment area. VS: BP 118/86, HR 62 O2 98 on room air, and RR 20. Patient alert and verbal. Lungs sounds clear, Heart sounds within normal limits. Patient reports no past medical history, no known allergies, and states he has not eaten breakfast. Patient reports feeling better. Vital signs rechecked 9:32am BP 112/82, HR 70, RR 20, O2 sat 97% on room air. Patient observed for additional 15 minutes. Patient verbalized feeling better and feels ok. Education on adverse effects and signs and symptoms provided by RN. Patient states understanding. Patient escorted to car at 9:45am with RN.
23 2021-03-10 anxiety Flushing/sweating, anxiety. BPs 150/98 (pulse 118), 141/85 (pulse 98). O2 sats 97%, 98%. Rested and ... Read more
Flushing/sweating, anxiety. BPs 150/98 (pulse 118), 141/85 (pulse 98). O2 sats 97%, 98%. Rested and drank water.
23 2021-03-13 confusional state ?Pfizer-BioNTech COVID-19 Vaccine Began shortly after injection. Fatigue, confusion (minor), Inject... Read more
?Pfizer-BioNTech COVID-19 Vaccine Began shortly after injection. Fatigue, confusion (minor), Injection site pain (moderate to severe, mild with tylenol, ice, and heat), increased cardiac PVCs.
23 2021-03-13 feeling abnormal, sleep disorder I got chills on and off through the day starting at noon. At 10 pm in a matter of a second I went fr... Read more
I got chills on and off through the day starting at noon. At 10 pm in a matter of a second I went from wide awake to barely able to keep my eyes open and feeling like I got hit by a truck. I felt like I could not get in enough air when breathing. I would breath in and I felt like my lungs would feel the way you feel when you stretch the day or 2 after working out super intensely
23 2021-03-14 nervousness, feeling abnormal At approx. 0855, pt reported feeling "lightheaded, nervousness, and I feel hot internally"; RN obser... Read more
At approx. 0855, pt reported feeling "lightheaded, nervousness, and I feel hot internally"; RN observed pt's bilat hand/legs shaking, pt eating/drinking water and pt appears pale; pt denies dyspnea, difficulty swallowing; pt alert and oriented x 4. Vitals taken and pt remained in observation with RN. At approx. 0905 RN obtained 2nd vitals; vitals WNL. RN observed pt to no longer have hand/leg shaking and skin color is back to pt's normal. Pt denies all other symptoms. At approx. 0915, pt states "I feel fine to go now." Pt then stays in observation and takes a phone call and continues to eat/drink. At approx. 0923 Pt reports to RN "My chest feels tight, like a stabbing pain." Pt denies dyspnea, anxiety, difficultly swallowing. ER team was paged to assist. RN obtained 3rd set of vitals. At approx. 0933 Pt reports worsening symptoms: stabbing in chest but non-radiating, lightheaded, memory fog, severe headache, hands/legs shaking uncontrollably; Pt is alert and oriented x 3 and is again, pale. At approx. 0936 ER team arrived and spoke with pt; ER did not assess/treat pt but did speak with pt. Pt denied further assessment, refused to be evaluated in ED and declined to allow this RN to contact her emergency contacts at approx. 0940. ER Team left scene at approx. 0943 and at that time pt reports she will drive herself home. At approx. 0947, pt left CENTER
23 2021-03-15 anxiety 23 yo F with h/o POTS who was feeling fine until about 25 minutes after the vaccine at which time sh... Read more
23 yo F with h/o POTS who was feeling fine until about 25 minutes after the vaccine at which time she developed shortness of breath, chest tightness, flushing sensation, lightheadedness with sense of impending doom and abdominal cramping. Reported she felt similar to when her POTS flares up, but that only occurs with standing which she hadn't done. HR 126 and BP 174/93 and repeat was 132 and 152/113. Oropharynx appeared normal but she appeared pale and very weak, and slumped over in the seat of the car. 911 called and EpiPen and IM Benadryl given with some improvement of symptoms. BP continued to be hypertensive and HR tachycardic. O2 sats remained stable at 99%. With her overall symptoms, concern for anaphylaxis, although her symptoms were likely multifactorial - POTS, anxiety.
23 2021-03-19 loss of personal independence in daily activities The first day I got my vaccine, I felt fine, but my arm with the injection sight was very sore and ... Read more
The first day I got my vaccine, I felt fine, but my arm with the injection sight was very sore and body slightly achy. The second day I woke up and my arm was sore, but other than that I felt normal. Around 4pm on the second day, my back started to hurt where the break break in my spine is. It was just a normal amount of pain at first, but within an hour there was throbbing pain in my lower back, spreading into my legs. This is where I normally feel my chronic pain, but I had a spinal injection a little over 6 months ago and doesn't usually stop working until about a year. It is the normal pain I experience in the normal places, but the pain is worse and out of no where. That is not usually how the pain comes on when the spinal block wears off. It is much more gradual. It could be a coincidence, but the pain is not the way I have ever experienced the pain. My back hurts too much to do things I need to do to function, which only happens to me when I have done something with a lot of physical activity that puts tension on my back like jumping, dancing, roller coasters. Before I started experiencing this pain, it was just a normal day for me where I didn't exert my back any more than normal, which is very little.
23 2021-03-22 feeling abnormal, anxiety Progress Notes APRN (Nurse Practitioner) ? ? Family Medicine Cosigned by: MD at 3/23/2021 1:26 PM ... Read more
Progress Notes APRN (Nurse Practitioner) ? ? Family Medicine Cosigned by: MD at 3/23/2021 1:26 PM Expand AllCollapse All COVID VACCINE CLINIC 3/19/2021 Date: 3/19/2021 MRN: 8812976 Subjective Patient is a 23 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience anxiety. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality and rapid progression of symptoms. PMH: not significant. ALLERGY REVIEW OF SYSTEMS: Patient denies chills, fever, malaise/fatigue, facial swelling, sore throat, frequent throat clearing, eyes watering, eyes itching, cough, chest tightness, shortness of breath, wheezing, rash, hives, itching of skin, vomiting, abdominal pain, muscle aches, joint pain, dizziness and headaches Previous Reactions: none Objective Vitals Vitals: 03/19/21 1355 03/19/21 1413 BP: 95/62 92/63 Pulse: 99 SpO2: 100% Physical Exam Constitutional: General: She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is not diaphoretic. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Eyes: Extraocular Movements: Extraocular movements intact. Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Gait: Gait normal. Psychiatric: Mood and Affect: Mood is anxious. Affect is flat. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. 1415: attempt to stand patient up after she finished eating and drinking. She reports her legs feel weird and felt weak. + dizziness/lightheadedness when standing. Pt sat back down and laid back in recliner, blanket given. Monitor at this time. 1422: pt bp rechecked with new bp cuff. Still in the 90's systolic. Pt feels okay. Pt sat up in recliner. Plan to recheck bp. 1428: pt bp rechecked, still in the 90's systolic. Pt feels tired. No other new symptoms reported. Pt given another snack. 1440: pt reports feeling a little better. Repeat bp still in the 90s systolic. Pt able to stand up w/o dizziness. She was ambulated around the bay w/o assistance. States she feels as well as she did when she first got here. Assessment/Plan Treatment included: water, snacks and blanket Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) and Systemic reaction (hypoglycemia, hypotension, generalized rash) Decreased bp (questionable if this is her baseline), and anxiety. Pt w/o known hx of what her bp normally runs. Monitored in bay. Improved with water, snack and time. Pt able to leave w carrying her instrument w/o issues and feels well. Walked out accompanied by RN. APRN Electronically Signed 3/19/2021 2:03 PM
23 2021-03-23 hallucination Headache; Fatigue; depersonalization; feeling of mild hallucination/dream-like; Moderate allergic re... Read more
Headache; Fatigue; depersonalization; feeling of mild hallucination/dream-like; Moderate allergic reaction: face and body itching; Moderate allergic reaction: face and body itching; difficulty swallowing; extremely dizzy and spinning sensation; extremely dizzy and spinning sensation; This is a spontaneous report from a contactable other healthcare professional (patient) reported for herself. A 23-year-old female patient (Not Pregnant at the time of vaccination) received first dose of bnt162b2 (Batch/Lot Number: Unknown), via an unspecified route of administration in left arm on 06Mar2021 14:45 as single dose for covid-19 immunization. Medical history included anemia, migraines, asthma, seasonal/pet allergies, polycystic ovaries (PCOS), allergies: Itchiness with prior pain medication all from an unknown date and unknown if ongoing. Concomitant medications included montelukast; cetirizine hydrochloride (ZYRTEC). The patient experienced feeling of mild hallucination/dream-like, moderate allergic reaction: face and body itching, difficulty swallowing, extremely dizzy and spinning sensation, fatigue, depersonalization all on 06Mar2021 14:45, headache on 08Mar2021. The events were reported as non-serious. Therapeutic measures were taken as a result of moderate allergic reaction: face and body itching. The outcome of events was not resolved. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The adverse event result in doctor or other healthcare professional office/clinic visit. diphenhydramine hydrochloride (BENADRYL) and steroid on site for allergic reaction. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. Information about batch/lot number has been requested.; Sender's Comments: Based on the available information, the known safety profile and the temporal association of bnt162b2 administration to the events, a possible contribution of the drug to the 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 appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
23 2021-03-24 confusional state Fever, body aches, chills, vomiting, chest pressure, headache, upset stomach, mental confusion. It w... Read more
Fever, body aches, chills, vomiting, chest pressure, headache, upset stomach, mental confusion. It was fine for the most part in a day and a half. The headache and chest pain lingered for two days.
23 2021-03-24 sensation of foreign body Patient experienced chills, numbness of lips, itching around haw area, elevated heartrate 103 bpm, a... Read more
Patient experienced chills, numbness of lips, itching around haw area, elevated heartrate 103 bpm, and lump in throat. Blood pressure slightly elevated at 121/90. Oxygen levels and breathing remained normal. Administered 25mg diphenhydramine orally. No improvement after 15 minutes. EMS called. EMS evaluated patient and took her to the hospital.
23 2021-03-27 anxiety After receiving vaccine at 3 pm I started to have anxiety and my heart rate went up. This was presum... Read more
After receiving vaccine at 3 pm I started to have anxiety and my heart rate went up. This was presumably because I also have a needle phobia but I did almost faint and had to have on site EMT asses condition and observe for 30 minutes. At 4 pm one hour after injection face felt itchy and irritated and noticed hives on neck and jawline. Immediately administered benadryl 50 mg which made the hives subside.
23 2021-03-28 feeling abnormal, anxiety Progress Notes (Nurse Practitioner) Cosigned by: MD at 3/23/2021 1:26 PM, Expand All Collapse All. ... Read more
Progress Notes (Nurse Practitioner) Cosigned by: MD at 3/23/2021 1:26 PM, Expand All Collapse All. COVID VACCINE CLINIC , 3/19/2021, Patient: Date: 3/19/2021, Patient 23 yr. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience anxiety. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality and rapid progression of symptoms. PMH: not significant. ALLERGY REVIEW OF SYSTEMS: Patient denies chills, fever, malaise/fatigue, facial swelling, sore throat, frequent throat clearing, eyes watering, eyes itching, cough, chest tightness, shortness of breath, wheezing, rash, hives, itching of skin, vomiting, abdominal pain, muscle aches, joint pain, dizziness and headaches, Previous Reactions: none Objective, Vitals Vitals:03/19/21 1355 03/19/21 1413, BP: 95/62, 92/63, Pulse 99, SpO2:,100%. Physical Exam Constitutional: General: She is not in acute distress, Appearance: Normal appearance. She is well-developed. She is not diaphoretic. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Eyes: Extraocular Movements: Extraocular movements intact. Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Gait: Gait normal. Psychiatric: Mood and Affect: Mood is anxious. Affect is flat. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. 1415: attempt to stand patient up after she finished eating and drinking. She reports her legs feel weird and felt weak.+ dizziness/lightheadedness when standing. Pt sat back down and laid back in recliner, blanket given. Monitor at this time. 1422: pt bp rechecked with new bp cuff. Still in the 90's systolic. Pt feels okay. Pt sat up in recliner. Plan to recheck bp 1428: pt bp rechecked, still in the 90's systolic. Pt feels tired. No other new symptoms reported. Pt given another snack. 1440: pt reports feeling a little better. Repeat bp still in the 90s systolic. Pt able to stand up w/o dizziness. She was ambulated around the bay w/o assistance. States she feels as well as she did when she first got here. Assessment/Plan Treatment included: water, snacks and blanket, Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc. mental health) and Systemic reaction (hypoglycemia, hypotension, generalized rash) Decreased bp (questionable if this is her baseline), and anxiety. Pt w/o known Hx of what her bp normally runs. Monitored in bay. Improved with water, snack and time. Pt able to leave w carrying her instrument w/o issues and feels well. Walked out accompanied by RN.
23 2021-04-01 anxiety Vital Signs: BP 102/60 HR 86 Resp 20 O2sat 99 Skin Signs: Warm and dry, cool and dry initially Resp... Read more
Vital Signs: BP 102/60 HR 86 Resp 20 O2sat 99 Skin Signs: Warm and dry, cool and dry initially Respiratory: Breath sound clear bilaterally Initial treatment: Pillow under head until she was awake and talking. 04:15 PM Vital Signs: BP 108/60 HR 96 O2sat 99 Skin Signs: Warm and dry Respiratory: Breath sound clear bilaterally Drinking H2O 4:30 PM Vital Signs: BP 104/58 HR 108 Resp 16 O2sat 99 Skin Signs: Warm and dry Respiratory: Breath sound clear bilaterally Follow up treatment: Recommended and assisted patient with calling for a ride home. Continued to feel alert and less anxious. 4:50 PM AOx3. Denies N/V. Denies dizziness. BP 104/62 HR 90 Resp 18 O2sat 99 Left with friend
23 2021-04-01 anxiety syncopal episode post vaccination. pt lowered to ground by spouse. hx anxiety with blood draws and v... Read more
syncopal episode post vaccination. pt lowered to ground by spouse. hx anxiety with blood draws and vaccines. did not eat today. nauseated. brought to observation, monitored, sent home
23 2021-04-04 anxiety Patient stated in VARS form that she "might" pass out after receiving shot. She said that she has an... Read more
Patient stated in VARS form that she "might" pass out after receiving shot. She said that she has anxiety when receiving vaccination shots. Patient received vaccine and about one minute later the patient passed out and fell forward. I was able to catch her and lower to the ground safely. I called for pharmacist on duty to assist in the care of the patient. Less than a minute after the patient passed out she was awake and alert. The patient was asked multiple times if she needed to go to the hospital and asked if she was okay to drive home. She insisted that she faints frequently from vaccines and denied any further care. She stayed in the waiting area while being checked on several times. The patient left after she said she was "100% good." She thanked us for taking care of her and apologized for what happened.
23 2021-04-07 loss of personal independence in daily activities The second the person gave me the shot my index finger went numb, stiff and my range of motion decre... Read more
The second the person gave me the shot my index finger went numb, stiff and my range of motion decreased. Within less than 24 hours day my whole hand and lower arm were stiff, numb, painful, and tingling. I also have overall weakness and doing basic tasks like writing essays for school has become painful and difficult. My hand is stiff and looks like a claw. While it has gotten a little better after taking medications that my doctor prescribed my fingers are still weak stiff, numb, tingling, and painful. The vaccine was administered too far up and too far to the left which has most likely caused nerve damage. There is also a small bruise at the injection site and the injection is still visible 5+ days later. This could have been prevented through better training of health officials working at state-run vaccine sites. I hope this hasn't caused lasting damage.
23 2021-04-08 anxiety Anxiety, tachycardia, chest tightness, nausea
23 2021-04-08 anxiety patient reported nausea to staff, lead RN was called. Diaphoresis was immediately noted patient was... Read more
patient reported nausea to staff, lead RN was called. Diaphoresis was immediately noted patient was tachypneic and anxious, denied throat swelling reported "heavy chest" has a couple "tics" tremors reported this to be someone normal. HR elevated to 130, ems called with patients permission. 2 minutes later patient lost consciousness and epi was administered. EMS updated. Patient brought to hospital via EMS
23 2021-04-08 feeling abnormal Injection site pain, joint pain (shoulder, elbow), brain fog, headache, muscle aches, fatigue
23 2021-04-09 feeling abnormal 1.RASH AND ITCHING ON UPPER EYELIDS 12:30 PM 2. ONGOING FRONTAL HEADACHE PAIN RADIATES TO BASE OF NE... Read more
1.RASH AND ITCHING ON UPPER EYELIDS 12:30 PM 2. ONGOING FRONTAL HEADACHE PAIN RADIATES TO BASE OF NECK AND SKULL AT PAIN LEVEL 10+ /GREATER @ 4PM, ONGOING BODY RASH WITH ITCHING, AND REDNESS UPPER EYELIDS, FACE, CHIN, CHEEKS, LOWER FOREARM, BACK, AND ENTIRE BODY. 3. THROAT FEELING THICK AND ABNORMAL 4.FACIAL SWELLING NECK AREA UNDER CHIN, BACK OF NECK, UPPER ARMS AND LOWER ARMS, UPPER BACK ACROSS SHOULDERS, AND ENTIRE BODY TENDER TOUCH. 5. BILATERAL SWELLING OF THIGHS AND LOWER LEGS CALF AND ANKLES 6. BREATHING FELT LIKE RECOVERING FROM AN ASTHMA ATTACK 7. BLURRED VISION, VISION FELT WEAK 8. FATIGUE TREATMENT OF CARE: WENT TO URGENT CARE FACILITY LOCATED IN ON . RECEIVED IM INJECTIONS OF BENADRYL 50MG IN BUTTOCK AND SOLUMEDROL (STERIOD) INJECTION IN OPPOSITE BUTTOCKS. ON 08APRIL21: PT RECEIVED ZYRTEC PO, BENADRYL 50MG AT BEDTIME FOR ITCHING AND RASH, PREDNISOID 08APRIL202: PATIENT EXPERIENCED NAUSEA AND VOMITING AT 8PM, ON 09APRIL2021 PT C/O ZONING OUT MEMORY FOGGY AND FEELS LIKE SHE IS NOT WITH IT. 10APRIL: RASH CONTINUES TO SPREAD ON FACE, CHIN, UNDER CHIN AND NECK. FRONTAL HEADACHE CONTINUES, NECK SWOLLEN AND SHARP PAIN ON RIGHT SIDE OF NECK AND LOWER JAW. LYMPH GLAND FEELS SWOLLEN ON RIGHT SIDE OF NE``
23 2021-04-11 anxiety Patient starting feeling anxious as she came to the observation area. Hyperventalating and diaphoret... Read more
Patient starting feeling anxious as she came to the observation area. Hyperventalating and diaphoretic, pale
23 2021-04-11 feeling abnormal Feeling like I was going to pass out at work with continued vertigo like feeling and fluttering in c... Read more
Feeling like I was going to pass out at work with continued vertigo like feeling and fluttering in chest. Went to ER and received labs and EkG with nothing outstanding. Dizziness continued for a total of 3 hours on 4/9. 4/10 I felt a brain fog and vertigo feeling for most of the day. 4/11 I felt better. 4/12 I had another episode of feeling like I was going to pass out along with brain fog. I went to urgent care and got more labs drawn.
23 2021-04-12 confusional state Systemic: Confusion-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Weakness-Mild
23 2021-04-13 delirium Severe chills, shaking, fever, faintness, nausea, pounding heart, delirium, fatigue, body ache, swea... Read more
Severe chills, shaking, fever, faintness, nausea, pounding heart, delirium, fatigue, body ache, sweating
23 2021-04-17 feeling abnormal Arm was super sore and felt swollen. Felt numb at times. Slurred words 30 min after shot. Fatigued a... Read more
Arm was super sore and felt swollen. Felt numb at times. Slurred words 30 min after shot. Fatigued and exhausted causing me to sleep for hours. Felt like a hangover without the drinking. Another comparison is that it felt like the last day of being sick with the flu, just very groggy and not feeling 100 percent okay.
23 2021-04-17 panic reaction weakness, rapid heart rate, and panic five minutes after receiving vaccine. went away on its own aft... Read more
weakness, rapid heart rate, and panic five minutes after receiving vaccine. went away on its own after a couple of minutes swelling and soreness of axillary lymph nodes five days after the vaccine, currently ongoing
23 2021-04-18 loss of personal independence in daily activities developed Meniere's disease; It's severe and affecting my daily life; pregnant at the time of vaccin... Read more
developed Meniere's disease; It's severe and affecting my daily life; pregnant at the time of vaccination; This is a spontaneous report from a contactable consumer (patient). A 23-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6206), via an unspecified route of administration into left arm on 05Mar2021 17:30 as single dose for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications include prenatal vitamins (unspecified). Patient was reportedly pregnant at the time of vaccination 05Mar2021 17:30 and was due to deliver on 29Jul2021. The last menstrual period was 23Oct2020. On 12Mar2021, patient developed meniere's disease which was reportedly severe and affecting her daily life. The patient was reportedly hospitalized on an unspecified date for 1 day. It was also reported that the patient was given a prescription for physical therapy as treatment. Outcome of events was not recovered.
23 2021-04-19 nervousness Itching bilateral feet on the bottom started 25 min after receiving vaccine, she got vaccine at 12 P... Read more
Itching bilateral feet on the bottom started 25 min after receiving vaccine, she got vaccine at 12 PM. . Took Allegra at 12:45 PM and not sure if it helped. The feet were not painful or discolored. And the itching was mild. Itch is intermittent. Also noticed tickle in back of throat 30 min after vaccine, and she felt nervous at that time. This tickle in the throat lasted 15 min , and it was gone before she took Allegra .Has noticed intermittent back itching too.
23 2021-04-20 anxiety Patient sliding down in chair, became weak and slumped in chair, appears pale and sweaty. Vitals wer... Read more
Patient sliding down in chair, became weak and slumped in chair, appears pale and sweaty. Vitals were all within normal limits. Patient was offered juice but she declined due to feeling nauseous. 10 minutes later patient was given orange juice and was advised to drink it slowly. Patient states that the fainting feeling comes in waves. After finishing the juice, color came back to her face but still complained of mild dizziness, and denies nausea. Patient appears anxious and fingers are shaking. After some time, patient began to feel better and states her dizziness improved significantly. She was able to walk around and her dizziness did not return. 20 minutes later, all her symptoms subsided; fingers were no longer shaky, and she was no longer pale and sweaty.
23 2021-04-20 anxiety Patient felt lightheaded immediately after dose. She moved to a waiting area under observation. she ... Read more
Patient felt lightheaded immediately after dose. She moved to a waiting area under observation. she reported feeling hot, and anxious. She was provided cool cloths for her head, a water bottle, juice and a nutrigrain bar. She sat upright for about 6 minutes, then reclined with her head and feet at the same level. She reported continued anxiety and feeling hot. No rashes or skin involvement was observed. After 10 minutes supine, she sat up on her own. She reported feeling better, but elected to stay under observation. At 12:24pm she stood up and reported feeling well enough to leave the clinic.
23 2021-04-20 excessive sleepiness Woke up exactly 12 hours after my second dose at 3am with a high fever, vomiting, and visual halluci... Read more
Woke up exactly 12 hours after my second dose at 3am with a high fever, vomiting, and visual hallucinations probably due to the fever. It felt like things were moving in slow motion, frame by frame, when I woke up at 3am. Was light headed, couldn't stand, chills and shaking. I vomited from 3-4 am and then again at 8am when I woke up, with my visual disturbances limited to the 3-4am hours. I took Advil and was able to go back to sleep for most of the day, sleeping from around 9am to 1pm. Nausea, fever, and vomiting have all have cleared. Now I just have a headache and muscle aches, especially near the injection site. Almost 24 hrs after my vaccine now and I feel drastically better than I did overnight.
23 2021-04-22 anxiety Shortly after receiving the vaccine, complaints headache, and sharp mid back pain, and epigastric b... Read more
Shortly after receiving the vaccine, complaints headache, and sharp mid back pain, and epigastric burning. Anxious about getting shot. Blood pressure 128/70, HR 90, Sat 89-91%. Complaints of dizziness when standing up. Oxygen 2 liters started and pulse ox at 92%. First response team notified. Transported to ER via wheelchair. First response team given report on patient by this lead.
23 2021-04-23 anxiety 23 year old female s/p syncope after 2nd Pfizer Covid19 vaccinaton to her left deltoid. Pt was sitt... Read more
23 year old female s/p syncope after 2nd Pfizer Covid19 vaccinaton to her left deltoid. Pt was sitting outside and notified the nurse of being dizzy and thirsty. While ambulating inside had a syncope episode of about three seconds and immediately awakening very anxious. She does not remember the episode. Post VS 114/72 100 28 and 100% O2 sat on RA while in the supine position. 1307 f/u VS 100% RA with heart rate of 84 bpm. C/O of dizziness and placed back into supine position with legs elevated on car . Then placed on 10 lpm non rebreather VS at 1318 106/67 84 24 Now sitting up with NAD , reported no symptoms. Eating Cheetos and drinking a bottle of water. Also placed on RA At 1324 placed in seat, denies any symptoms at this time. VS 98% RA 96/62 85 24 At 1331 89/63 85 24 Denies any symptoms, ambulated to the bathroom without help Patient reported systolic blood pressure in the 100s. No complaints after ambulating 1137 pm 91/60 85 20 Patient reported feeling fine and requesting to go home. Advised to f/u with PCP. DCd home with steady gait MAEW, NAD a+ox3 Ate all of the cheetos and drank all of the bottle of water 16.9 ounces Reported no medical history Denies taking any medications Denies any allergies Occurred at center HCP notified of occurrence
23 2021-04-24 sleep disorder Severe arm pain 2 days following the vaccine dose #1. Seven days later arm pain started to come back... Read more
Severe arm pain 2 days following the vaccine dose #1. Seven days later arm pain started to come back. Unable to sleep due to amount of pain. Subsided after about 12 hours and went from severe to mild.
23 2021-04-26 loss of personal independence in daily activities, disturbance in attention I'm having an extremely painful menstrual period that is new and unusual for me. The pain is impedin... Read more
I'm having an extremely painful menstrual period that is new and unusual for me. The pain is impeding my normal daily activities to the point that I am not able to function as I normally would. I also have increased fatigue and impaired focus. It literally hurts for me to stand up. This is my 1st period after my 2nd dose. I had no issues of this nature after my 1st dose.
23 2021-04-26 panic attack i?ve had several panic attacks, which i have never experienced before
23 2021-04-27 anxiety NAUSEA AND ANXIETY POST VACCINATION ? FELT BETTER AFTER AND BOTTLE OF WATER.
23 2021-04-27 crying about 5-10 minutes after receiving vaccine (patient's first dose) patient started to slouch/slide in... Read more
about 5-10 minutes after receiving vaccine (patient's first dose) patient started to slouch/slide in her seat. She never lost consciousness but was non-verbal, only moaning, shivering and crying. EMS was immediately contacted and arrived to the scene. Her blood glucose was checked by EMS and was 52. She was given fluids via IV and recovered shortly after.
23 2021-04-29 insomnia Soreness around injection site, difficulty sleeping the following night, fatigue the next day and di... Read more
Soreness around injection site, difficulty sleeping the following night, fatigue the next day and difficulty sleeping during the day despite fatigue
23 2021-04-30 abnormal dreams Fever (Night of 4/27) - fever peaked at 100.4 Nausea (Night of 4/27, day 4/28) Headache (4.28-4.30)... Read more
Fever (Night of 4/27) - fever peaked at 100.4 Nausea (Night of 4/27, day 4/28) Headache (4.28-4.30) Rash (4.28- ongoing/spreading) - rash on arms/stomach, back, and legs - itchy Vivid fever dream
23 2021-05-01 crying The day following the vaccination I woke up with severe arm pain 2 inches down from the injection si... Read more
The day following the vaccination I woke up with severe arm pain 2 inches down from the injection site. My arm had swollen about 3 inches in diameter. It was so painful that I could not roll over, I could not lift my arm, and I was in inconsolable tears. It was a deep stinging pain, as though I was repeatedly being stung by a hornet. My left hand was going numb off and on. I went to the doctor because I was incapable of lifting my arm, and the doctor identified that my lymph nodes and my left ear were swollen and enlarged. He recommended ibuprofen and ice for the lump. The second day after receiving the vaccine I had a mild headache, and my arm was only slightly swollen. The third day after receiving the vaccine my arm was still slightly swollen and sore, but the pain was manageable without pain medication. The fourth day after receiving the vaccine I woke up with a deep cough and dizzy spells lasting throughout the day.
23 2021-05-03 disorientation Extreme fatigue Dizziness Muscle aches Fever Pain at vaccination site Muscle soreness in right arm b... Read more
Extreme fatigue Dizziness Muscle aches Fever Pain at vaccination site Muscle soreness in right arm began within 39 minutes of shot administration. Pain worsened throughout the day, and by evening it was difficult to move it around because of the pain. This level lasted 30hrs and is reduced to initial soreness on day 3. Dizziness began around 10pm, everything seemed disoriented. Extreme exhaustion occured about 11pm and patient slept for 18 hours. With brief episodes of coherence lasting no more than 5 minutes. Dizziness was still present when conscious. Fever occured in the middle of that night at 100.2. Fever was gone by 5pm. Dizziness had subsided also by 5pm. Muscle pain in full body persisted until 1am on may 4.
23 2021-05-03 insomnia Constant heart palpitations (day and night), feeling cold and dizzy, insomnia
23 2021-05-03 sleep disorder Site: Pain at Injection Site-Severe, Systemic: Abdominal Pain-Mild, Systemic: Body Aches Generalized... Read more
Site: Pain at Injection Site-Severe, Systemic: Abdominal Pain-Mild, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Diarrhea-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Severe, Systemic: throat felt dry and scratchy -Severe, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Joint Pain-Severe, Systemic: Nausea-Severe, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Unable to Sleep-Severe, Systemic: Weakness-Severe, Additional Details: pt received 2nd dose on 5/2/21 at pharmacy (did not get first dose here). pt had severe pain in right arm, numbness and tingling in hand, severe pain from wrist to upper shoulder to neck. pt had weakness as well and couldnt move arm. pt did see her pcp today. he diagnosied her with brachial neuritis which he states is a direct adverse reaction from vaccine. he did confirm not an administration error.
23 2021-05-05 anxiety General anxiety , nausea, light headed , no syncopal episode
23 2021-05-05 disturbance in attention I have been noticeably more tired since getting my first dose of this shot almost a month ago. It i... Read more
I have been noticeably more tired since getting my first dose of this shot almost a month ago. It is affecting my ability to concentrate.
23 2021-05-05 excessive sleepiness Extreme fever (103) Tuesday morning, horrible aches and chills, migraine. Didn't eat for 24 hours (7... Read more
Extreme fever (103) Tuesday morning, horrible aches and chills, migraine. Didn't eat for 24 hours (7 pm Monday to around 7 pm Tuesday). Slept 18+ hours Tuesday (normally 6-7 hours a night). Nausea all morning. Bruising (size of an orange) at injection site), as well as swelling (normally doesn't happen when I get vaccinated). Very sore joints and muscles (hard to stand, rotate, or walk) from late Monday night (11 pm) to Wednesday morning (8 am).
23 2021-05-06 impaired work ability I received the Pfizer second dose on May 5th and started to have an allergic reaction on May 6th at ... Read more
I received the Pfizer second dose on May 5th and started to have an allergic reaction on May 6th at 02:32. I was not able to attend classes due to muscle pain, headache and nausea. I was having some sort of fever where I felt hot but my body was cold. I slept for the majority of the day. Around 16:35, when I woke up, I noticed a rash and that my body was feeling swollen. I took 2 Benadryl gel pills at 18:03. I felt some difficulty breathing, and itching sensation all over my body and still had a lot of tension on the left side of my jaw. I went out to eat with my boyfriend, because we had plans and he had also complained of having some cold chills from the vaccine, and he noticed that I had red marks on my hands. By May 7 10:05 I called off of work to go my doctor, because I had massive splotches of raised itchy hives all over my body. It was confirmed that I was having an allergic reaction and I received a steroid shot in my upper gluteal muscle, as well as Famotidine 20mg twice daily for 5 days and Prednisone 20mg twice daily for 5 days.
23 2021-05-09 anxiety From ED note: Briefly, this is a 23-year-old female with past medical history of not allergies, ast... Read more
From ED note: Briefly, this is a 23-year-old female with past medical history of not allergies, asthma who presents for evaluation of shortness of breath, nausea and chest discomfort following Covid vaccine 30 minutes prior to presentation. Patient received her first dose of Pfizer Covid vaccine this morning, was observed and ultimately started to drive home with mother when she developed shortness of breath, nausea and chest discomfort. These have been progressive. She reports she is not taking her Flovent. No vomiting, no rash, no weakness, headache or dizziness. Remainder of history per note above. Vital signs as noted above (tachycardia, tachypneic). On physical exam, the patient is anxious appearing, hyperventilating; HEENT exam with MMM, clear conjunctivae, normal TMs & clear oropharynx without uvular swelling or edema; neck is supple; cardiovascular exam is stable with regular rhythm, mild tachycardia, no murmurs; pulmonary exam is clear to auscultation bilaterally, good aeration, no wheezes; abdomen is soft, non-tender & non-distended; neurologic exam nonfocal, moves all four extremities, 5/5 strength in upper and lower extremities, carpal spasm of bilateral hands (L>R). My impression is that this patient is having a panic attack given her rapid onset of hyperventilation, chest discomfort, and bilateral carpal spasms. Carpal spasms improved with controlled breathing. Considered anaphylaxis given patient's history, but absolutely no wheezing, rash or significant GI symptoms; no hypoxia; no hypotension. Epi-pen at bedside, but not given. Considered asthma, but no wheezing - patient is not wheezing and has good aeration on exam, she is requesting albuterol, which I think will help with her anxiety surrounding this - 2 puffs given. No evidence of persistent tachycardia to suggest PE (no OCPS). Initial ECG with sinus arrhythmia, one PVC, slightly prolonged QTc 477 - will check repeat. Patient briefly on NRB for comfort - slowly able to be weaned off and during observation in ED, symptoms improving but not completely resolved. Repeat ECG w/ NSR, slightly prolonged QTc 460. Given persistence of symptoms, patient given epi-pen and had almost complete resolution of symptoms within 10 minutes. We will plan to observe for 4 hours post-epi administration. Recommended discussion of second COVID vaccine with primary care provider but may have to avoid given this could have represented a serious allergic reaction. Recommend follow-up with PCP/cardiology for repeat EKG. Admit to Ed Observation Status Diagnosis: Allergic reaction Goals of observation: (1) Ensure continued improvement of symptoms, (2) Improved HR Interventions: (1) CRM, (2) Close monitoring, (3) Frequent exams 5/7/2021 15:00 23-year-old female received COVID-19 vaccine today and after which developed shortness of breath. Initially felt this was anxiety however symptoms persisted. Treated with albuterol as well as epinephrine and observed. Developed shortness of breath and complaints of chest pain after approximately 3 hours of observation. Repeat EKG obtained and is normal. Labs were obtained which demonstrated normal CBC. Normal D-dimer. Normal electrolytes but an elevated TSH (known hyperthyroidism). Treated with cetirizine and steroids with improvement of her symptoms. Discharged with PCP follow-up in 2 days.
23 2021-05-09 mental impairment Times are approximates. Patient reports to have started experiencing an increase in symptoms of par... Read more
Times are approximates. Patient reports to have started experiencing an increase in symptoms of paranoia and thought disorganization in the days immediately following her first injection of the Pfizer COVID19 vaccine. Patient was medically evaluated by myself via teleHEALTH 16 days later and found to be increasingly paranoid, with somatic preoccupations, increased thought and speech disorganization that may require additional antipsychotic medication. This mental status examination represents a significant worsening compared to the patient's baseline.
23 2021-05-10 disorientation, feeling abnormal Weeks 1 . Extreme dizziness and headaches. Week 2.- Brain fog, disorientation, double vision, heada... Read more
Weeks 1 . Extreme dizziness and headaches. Week 2.- Brain fog, disorientation, double vision, headaches, depersonalization, dizziness, heart palpitations. Week 3-Brain fog, painful nerve pain in feet, legs, arms, hands. Hand/eye tremors. Double vision, headaches. Week 4-Brain, persistent nerve pain, leg weakness, hand weakness, disorientation , double vision, headaches , depersonalization, persistent tremors.
23 2021-05-10 suicidal thoughts, depression, disturbance in attention, irritability adverse events: day of vaccine: headaches and lightheaded, chills and severe aches and sweats. day a... Read more
adverse events: day of vaccine: headaches and lightheaded, chills and severe aches and sweats. day after: severe sweats and chills and severe body pain EVERYWHERE. tylenol only lasted for 2 hours. fever. VOMITING every 15 minutes for 10 HOURS and my vomit was BLACK and tasted like blood. every day since then: inability to eat, severe loss of appetite, stomach pains, headaches moderate to severe, severe lightheadedness and inability to concentrate, irritability and severe depression and suicidal thoughts
23 2021-05-11 feeling abnormal Floating sensation, tingling down L arm, lightheaded 1439- 118/63 103HR 99%RA 24RR 1445- 98/64 79HR ... Read more
Floating sensation, tingling down L arm, lightheaded 1439- 118/63 103HR 99%RA 24RR 1445- 98/64 79HR 100%RA 100.8F tingling down R arm and fingers 1454- 97/59 78HR 98%RA 97.3F improvement of symptoms, no floating, light headedness minor tingling DC 1506
23 2021-05-12 anxiety 1100 After receiving first dose Pifzer vaccine and was standing at desk making appointment, 2 minute... Read more
1100 After receiving first dose Pifzer vaccine and was standing at desk making appointment, 2 minutes after actual vaccination felt overwhelming nausea feeling, dizziness, and actual vision blacked out. Within seconds, opened eyes and said, where am I? BP 116/78 P88 R20 Pulse ox 99%. Color initially pale. Registration person states she did not hit her head as she sat to floor on own prior to passing out. 1107 States has history of passing out with any type of procedures. She passed out 2/2018 with Nexaplanon implant for birthcontrol insertion. She also passed out in spring 2019 in grocery store. 1110. Sat up in chair. BP 124/88 P84 R18 Pulse ox 98%. States feeling much better. Skin warm and dry. Color now pink. States feeling better but anxious and shakiness of arms. Benadryl 25 mg po given for anxiety and shakiness. 1130 BP 120/81 P84 R 18 Pulse ox 99%.. 1145 Still recumbent on cot, states symptoms relieved. Has been drinking fluids and ate crackers. BP 123/71 P84 R 18 Pulse ox 99%. Sat up in high fowlers to check orthostatic BP. 123/71 P84 R18 Pulse ox 99% No further complaints at this time. 1215 Left facility. Denies any further complaints. Encouraged to follow up with PCP and advise of recent events.
23 2021-05-14 anxiety, panic attack increase in anxiety to the point of panic attack occurring; Anxiety; Intense abdominal cramping/Abdo... Read more
increase in anxiety to the point of panic attack occurring; Anxiety; Intense abdominal cramping/Abdominal burning/cramps were at an 8 on the pain scale during the worst periods; Abdominal burning/Abdominal burning/cramps were at an 8 on the pain scale during the worst periods; vomiting since the day after the vaccine; Chills; body shakes; periods of chest tightness; shortness of breath; unable to keep food or fluid down; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 23-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at Left arm on 25Apr2021 15:15 at first dose, single for COVID-19 immunization in Pharmacy or Drug Store. Medical history included Major depressive disorder, General anxiety disorder and Known allergies to Z-Pak. concomitant medication was none (the patient was not received any medication within 2 weeks of vaccination). Patient was not Pregnant at Time of Vaccination. the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported on 26Apr2021 16:45, patient experienced intense abdominal cramping and vomiting since the day after the vaccine. Chills, body shakes, and periods of chest tightness and shortness of breath. patient was unable to keep food or fluid down until she received a prescription for Ondansetron from her doctor. Abdominal burning/cramps were at an 8 on the pain scale during the worst periods. Also an increase in anxiety to the point of panic attack occurring on 28Apr2021. the adverse event result in Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. treatment received for the adverse event included Ondansetron and Proair inhaler. Outcome of the events was recovering. Information on Lot/Batch number was available. Additional information has been requested.
23 2021-05-17 disturbance in attention, confusional state 3 days of severe fatigue, dizzy w/ change of position, feeling of her head spinning when getting out... Read more
3 days of severe fatigue, dizzy w/ change of position, feeling of her head spinning when getting out of bed or up from a chair & sometimes when sitting. "feeling confused, trouble concentrating, very tired". Hands feeling cold, not tingling.
23 2021-05-18 nightmare Extremely sore muscles 6 inches from injection site, severe fatigue, vivid nightmares the following ... Read more
Extremely sore muscles 6 inches from injection site, severe fatigue, vivid nightmares the following night.; Extremely sore muscles 6 inches from injection site, severe fatigue, vivid nightmares the following night.; Extremely sore muscles 6 inches from injection site, severe fatigue, vivid nightmares the following night.; This is a spontaneous report received from a contactable consumer. A 23-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration on 08May2021 as single dose in left arm for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history included severe ovarian cysts, PTSD, food allergy and past drug event was bactrim. Concomitant medications included benadryl, ibuprofen, naproxen, acetaminophen. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. After vaccination the patient experienced extremely sore muscles 6 inches from injection site, severe fatigue, vivid nightmares the following night on 08May2021. The outcome of events was recovering. No follow-up attempts are needed. No further information is expected.
23 2021-05-19 loss of personal independence in daily activities Approx. 11 hours after injection I developed a low grade fever accompanied by extreme headaches and ... Read more
Approx. 11 hours after injection I developed a low grade fever accompanied by extreme headaches and full body aches. Pain impacts daily life activity.
23 2021-05-23 nervousness PATIENT PRESENTED TO THE VACCINATION EVENT WITH NAUSESA AND VOMITTING AND A CERTGAIN DEGREE OF NERVO... Read more
PATIENT PRESENTED TO THE VACCINATION EVENT WITH NAUSESA AND VOMITTING AND A CERTGAIN DEGREE OF NERVOUSNESS. AFTER RECEIVING THE VACCINE, SHE WAS DIRECTED TO THE WAIT AREA FOR OBSERVATION. FIFTEEN MINUTES LATER I WAS CALLED TO THE WAIT AREA WHERE THE PATIENT COMPLAINED OF MORE NAUSEA. SHE SAT FOR THE ENTIRE TIME AND WENT WITH FAMILY MEMBERS TO GET SOMETHING TO EAT. I INSTRUCTED THE PATIENT TO CONSUME A SPRITE TO HELP SETTLE HER STOMACH AND TO EAT A LIGHT SNACK. AFTERWARDS, THE PATIENT AND HER FAMILY LEFT THE PREMISES.
23 2021-05-26 anxiety Anxiety/mental related; Lightheaded; Sore arm; This is a spontaneous report from a contactable consu... Read more
Anxiety/mental related; Lightheaded; Sore arm; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP 6955), via an unspecified route of administration in the left arm on 16Mar2021 at 02:30 PM (at the age of 23 years), as a single first dose for COVID-19 immunisation. The patient was allergic to Penicillin, Sulfa drugs, Cefalexin, walnuts and pecans. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included Zoloft (Sertraline) and Estarylla (Ethinyl Estradiol and Norgestimate). The patient did not receive any other vaccines within 4 weeks prior to vaccination. On 16Mar2021 at 02:45 PM (directly following the vaccination), the patient experienced light headedness, and she thought it was mostly anxiety/mental related and not vaccine related as she was nervous; fully recovered after 10 minutes or deep breaths and drinking Gatorade. Four hours later, she experienced sore arm. Therapeutic measures taken for the adverse events was unknown. The clinical outcome of events lightheaded, anxiety/mental related, nervous were fully recovered, and sore arm was not recovered at the time of reporting. No follow-up attempts are needed. No further information is expected.
23 2021-06-01 confusional state Systemic: Chills-Mild, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Syste... Read more
Systemic: Chills-Mild, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Shakiness-Mild, Systemic: Weakness-Medium, Additional Details: EMT and paramedics came
23 2021-06-03 sleep disorder ?Pfizer-BioNTech Covid 19 Vaccine EUA? The night of getting the first shot I barely slept because I ... Read more
?Pfizer-BioNTech Covid 19 Vaccine EUA? The night of getting the first shot I barely slept because I had chills all night long & my entire body was so sore it hurt to lay in any position. In the morning, I still had extreme muscle pain all over. I was extremely light headed & dizzy, I had a throbbing headache so I took 2 aleve pills. I was getting super nauseous and almost passed out while trying to get to my bathroom just in time to throw up only water. Just before throwing up my vision went fuzzy, my ears were ringing, I was dripping sweat, it was getting hard to breathe, & my hands were shaking. After taking a cold shower, laying down, & drinking some water I feel a bit better but not 100% normal.
23 2021-06-06 anxiety, nervousness, suicidal thoughts, crying, depression 4/30 - Five minutes after the vaccine, I passed out. I felt uncontrollably shaky and my vision went ... Read more
4/30 - Five minutes after the vaccine, I passed out. I felt uncontrollably shaky and my vision went white. I was not anxious prior to getting the vaccine and felt terror afterwards. 5/1 - I developed severe depression and suicidal ideation. I reported to those around me that I did not feel safe. I am not diagnosed with depression and did not experience depression prior to the vaccine. I felt suicidal, completely hopeless, anxious, and was uncontrollably bursting into tears without an identifiable trigger. 5/2 - I developed shooting pain in my legs and arms. It felt like a pulsating, stabbing pain that throbbed. It was unlike any pain I had experienced ever before. 5/3 - I developed a metallic taste in my mouth that could not be washed away with water or food. It was extremely noticeable. 5/4 - My period came a week early. I have been on birth control for seven years and have never experienced any changes in my menstrual cycle. I made no other lifestyle or health changes other than the vaccine. The period was extremely heavy, full of clots, and was painful. It lasted longer than usual, until about 5/9. 5/16 - I developed another period only a week after the first period. This period was equally as heavy and long-lasting. It remained until about 5/21. Following the vaccine, I began suffering from heart palpitations, leg cramps, and random pains. I did not experience these prior to the vaccine. I cannot identify the date these symptoms began, but it was within the first week of taking the vaccine.
23 2021-06-08 amnesia Global amnesia 24 hrs after the vaccination; This is a spontaneous report from a contactable consume... Read more
Global amnesia 24 hrs after the vaccination; This is a spontaneous report from a contactable consumer or other non HCP (patient herself). A 23-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 09Mar2021 (at the age of 23-years-old) as unknown, single dose for covid-19 immunisation. The patient medical history included colitis ulcerative. The patient had covid-19 prior vaccination. The patient had no known allergies. The patient's concomitant medications were not reported. On 10Mar2021, at 07:00 pm, 24 hours after the vaccination the patient experienced global amnesia. The patient was tested for covid post vaccination. The nasal swab was collected, and polymerase chain reaction (PCR) test was done which resulted as negative. The patient did not receive treatment for the event. The outcome of the event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
23 2021-06-08 loss of personal independence in daily activities Severe menstruation cramps/pain to the point of tears, inability to hold a conversation, or get out ... Read more
Severe menstruation cramps/pain to the point of tears, inability to hold a conversation, or get out of bed. Symptoms began roughly 3.5 hours after second dose and are still continuing in waves nearly 8 hours later. I have had my menstrual cycle for nearly 15 years and have never experienced anything like this. Recently I had a well-women?s check-up/PAP and results were normal, so no reason to suspect any health issues that may suddenly cause this. I have tried applying heat, taking a magnesium supplement, and massaging my stomach to no avail.
23 2021-06-09 confusional state Fatigue; confusion; injection site pain (moderate to severe, mild when treated with tylenol, ice, an... Read more
Fatigue; confusion; injection site pain (moderate to severe, mild when treated with tylenol, ice, and heat); increased cardiac PVCs; Upper abdominal cramping; This is a spontaneous report from a contactable consumer (patient). A 23-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EN6202) via an unspecified route of administration, administered in left arm on 13Mar2021 at 16:00 (at 23 years old) as single dose for COVID-19 immunization. There were no other vaccinations within 4 weeks prior to the first dose of BNT162B2. Medical history included Ehlers-Danlos Syndrome-Hypermobility type, fibromyalgia, and severe obesity; all from unspecified date. Known allergies: kiwi, penicillins, and sulfa. The patient previously took cefdinir (OMNICEF), esomeprazole sodium (NEXIUM), and levaquin on unspecified date and experienced allergies. Concomitant medications included sertraline hydrochloride (ZOLOFT), lamotrigine (LAMICTAL), dexlansoprazole (DEXILANT), tethinylestradiol/norethisterone (BALZIVA), norethisterone (CAMILA), and "zerte" (as reported); all from unspecified date for unspecified indication. The patient did not have COVID prior vaccination. The patient was not tested for COVID post vaccination. The patient experienced fatigue, confusion, injection site pain (moderate to severe, mild when treated with tylenol, ice, and heat), increased cardiac PVCs, and upper abdominal cramping; all non-serious on 13Mar2021 at 17:00. No treatment received for the other events. Outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.
23 2021-06-22 crying Pt had a negative response to the Pfizer injection. This was her 2nd dose. When doing the Covid inje... Read more
Pt had a negative response to the Pfizer injection. This was her 2nd dose. When doing the Covid injection screening in her chart, she did mention that she had some itchiness and a rash after the first injection. I had FNP assess her and clear her to have the injection. Pt was cleared and vaccination was given. Pt stated she didnt even feel the injection and looked well. I told her to wait the allotted 15 mins and left the door open. I told her that if she felt anything coming on, to say something, as we had staff in ear shot. Pt understood. By the time I was finished giving the next 2 injections to the next 2 Pt's on the schedule, 2 staff members were holding and supporting Pt because she was not able to hold herself up. Pt was no responsive in the physical sense but when I asked her if she was scared, she started to cry. Which indicated to us that she could hear us and understood. BS was low at 79. Juice was given. She was able to take small sips when strongly encouraged. BP was 148/78 at one point but eventually leveled out. Pulse was around 120 but then lowered. We had tried to cool her down with a cool pack, as she was sweating. Temp was normal at 98.2 degrees. AED was obtained and 911 was called. I told Pt that I had called her emergency contact/Husband of what had happened and to meet her at Hospital. Her husband didnt sounds distressed on the phone. Pt was taken by ambulance with all of her belongings. the Supervisor was informed of the situation and agreed to call Pt on Monday to do a wellness phone check.
23 2021-06-22 insomnia Tingling in hands, shaking, inability to sleep, chest paint, numbness in throat, high blood pressure... Read more
Tingling in hands, shaking, inability to sleep, chest paint, numbness in throat, high blood pressure, fast beating heart.
23 2021-06-23 sensation of foreign body Started with nausea, quickly become vomiting, then headache and exhaustion. This cycle repeated ever... Read more
Started with nausea, quickly become vomiting, then headache and exhaustion. This cycle repeated every 20 minutes or so for approximately 3 hours until eventually each cycle would have more time in between each one and I rested for longer each time. I did not fully go to sleep until shortly after 2 am. I was also supposed to get my period a week or so after I got the vaccine and it never happened. It is now 6/24/21 and I have still not had a period since receiving the 2nd dose of the pfizer vaccine. According to my cycle pattern, I should get my next period next week, but have yet to have any PMS symptoms that I usually get. If I don't get in by the end of June, I will be consulting medical help.
23 2021-06-27 loss of personal independence in daily activities Severe, full-body muscle pain beginning the morning following my second vaccination. This was temper... Read more
Severe, full-body muscle pain beginning the morning following my second vaccination. This was tempered only a little with 600mg of ibuprofen, but the aches worsened around 3pm, a full 24 hours after my shot. On Saturday morning I was unable to leave the bed due to how painful it was to move. My legs hurt the worst, I couldn't lift, bend, or walk on my legs in the morning. I also had severe pain in my lower back, my hands, wrists, and forearms. I forced myself to walk through tears and agony which eventually helped "loosen" my legs. Throughout the day the mobility in my legs came back and the pain eased slightly. I continued to need to either support myself or rest often. On Sunday the same symptoms as described above came back with a vengeance. I didn't have to even move to be in agony all of the time. Forcing myself to break through the stiffness and pain seemed to help awaken and revive my muscles slightly. Ibuprofen didn't help much, I was taking a maximum of 800mg doses about three times a day. Monday is the first day the pain is not unbearable, though it is extremely painful and difficult to move. I struggle to go up or down stairs, I struggle to get up from a sitting position, I struggle to put my pants on, and I struggle to walk. If I stand for too long of a duration my legs shake and I feel like I might collapse.
23 2021-06-28 sleep disorder PATIENT DEVELOPED SMALL RASHES THROUGHOUT THE BODY, SLIGHT DIFFICULTY BREATHING AT BEDTIME AND COULD... Read more
PATIENT DEVELOPED SMALL RASHES THROUGHOUT THE BODY, SLIGHT DIFFICULTY BREATHING AT BEDTIME AND COULDNT SLEEP ON BACK, HAD TO SLEEP SIDEWAYS.
23 2021-06-29 irritability This is a spontaneous report received from a contactable consumer, the patient. A 23-year-old non pr... Read more
This is a spontaneous report received from a contactable consumer, the patient. A 23-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: ER 2613) via an unspecified route of administration on the left arm on 19Mar2021 at 02:00 PM (at the age of 23-year-old) as single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Medical history and concomitant medication were not reported. On 21Mar2021 at 20:00, the patient experienced rash, irritating and red spot. No therapeutic measures were taken as result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of rash, irritating and red spots were unknown at the time of this report. No follow-up attempts are possible. No further information is expected.
23 2021-06-30 sleep disorder, insomnia Within the first day, my hands felt swollen and would not stop tingling. I had awful chest pain and ... Read more
Within the first day, my hands felt swollen and would not stop tingling. I had awful chest pain and neck numbness 24 hours after the vaccine. Two days after the vaccine, I felt fatigued, had a very rapid heart beat (130 bpm while sitting), and had hypertension (BP: 182/92). I had to go to the emergency room twice due to high blood pressure and a very rapid heart beat (both visits were on the Staurday two days after my vaccine). For 9 whole days after the vaccine, I felt fatigued, no appetite, I was not able to sleep, and I felt lots of chest paint.
23 2021-07-02 memory impairment, motion sickness Tachycardia; Motion sickness; Numbness of right forearm; Entire body swelling all extremities; itchy... Read more
Tachycardia; Motion sickness; Numbness of right forearm; Entire body swelling all extremities; itchy red rash: face, neck, upper chest, forearms, thighs, back eyebrows; severe frontal occipital lateral stabbing headache; sore & tender body; sore & tender body; chills; blurry vision; light sensitivity; foggy memory; swollen neck/neck was swelling; nauseated vomiting/Nausea and vomiting; nauseated vomiting/Nausea and vomiting; burning sensation; Right upper shoulder discomfort with swelling that goes into her neck; Light sensitivity; having a rash; rash is itching; scaling, and her skin is peeling; scaling, and her skin is peeling; redness; severe headache; This is a spontaneous report from a contactable Nurse (patient's mother). A 23-year-old female patient (daughter) received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: ER8737 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 07Apr2021 at 11:00 AM (age at vaccination: 23 year) as a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccine in four weeks. The patient's medical history included anemic, eczema, gastric reflex, known allergies: citrus food, latex gloves, Compazine, Augment, and headaches from concussions. Concomitant medications included Ferrous Sulfate, Diethylpropion HCL, and glucose, sodium chloride (DNS). The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. There was a product complaint to report. On 07Apr2021 12:30, the patient experienced swollen neck/neck was swelling, nauseated vomiting/nausea and vomiting, entire body swelling all extremities, itchy red rash: face, neck, upper chest, forearms, thighs, back eyebrows, severe frontal occipital lateral stabbing headache, sore, tender body and chills. On 07Apr2021, the patient experienced right upper shoulder discomfort with swelling that goes into her neck, light sensitivity, having a rash, rash is itching, her skin is peeling, redness and severe headache. On 09Apr2021, the patient experienced motion sickness and numbness of right forearm. On 12Apr2021, the patient had tachycardia and scaling. When probed to determine when the tachycardia began, the caller mentioned that the tachycardia was noted at the doctor's office. She confirmed the tachycardia began Monday, 12Apr2021. She clarified it was her second doctor's visit so if the caller gave the wrong date, they were able to find it by her records on her second doctor's visit. Caller confirmed with her daughter the tachycardia was still intermittent, it comes and goes. It seems to be that it has improved. She could consider it was medically significant because they didn't know what the root cause was. Her daughter has never experienced tachycardia before being dosed with the Pfizer vaccine. There was not treatment for tachycardia. Her daughter was still having a rash; she was breaking out intermittently. She confirmed she did not report online that her daughter was intermittently breaking out. At that time when she filed the report online, the rash just broke out. At that time, she didn't know if her daughter's rash was going to abate and then re-appear. If so, then she would have had to re-open a new event with a new date and time and rate it. She just looked at her daughter's skin, it's peeling. These were very itchy. Caller then clarified most of these events started the day of the vaccine, 07Apr2021 at 12:30 PM. She confirmed some of these events were reported online on the date of the incident and were still present. The severity of each event was on a grading scale, and right now her daughter's grading scale was 10. Online, the patient couldn't even tell how they really were feeling. The severity of each event needed to be asked. By the lack of getting all the information and the less Pfizer has, the better it looks for Pfizer. When probed for outcome, the caller confirmed the rash was still ongoing and it was medically significant because she was going to have to take her to dermatologist. She has been using hydrocortisone cream as treatment of the rash and it's not working. She did not have the NDC, LOT,EXP for the cream. She explained the skin peeling/scaling has been ongoing. Her skin breaks out in a rash and then becomes really scaly and then it peels. She clarified overall, she had a rash, but the rash was itching, had redness, scaling, and her skin was peeling. On scale of 1 to 10, the caller would rate this event as a 10. She confirmed and that it's continuous/ongoing and had not improved. Stated the rash was not to any localized area on her daughter's body, it's all over. She clarified further the rash can appear on her daughter's eyes, chin, cheeks, forearm, wrist, and leg. The severe headache was reported on the day of the vaccine as well as the rash, too. The severe headache was ongoing; caller gives it a grade 10+. She confirmed the headache was medically significant. It did prevent her daughter from driving a car, reading, or doing activities. Caller added that the headache was also disabling because it disables her daughter from functioning at her normal capacity, she's been hindered. Her normal activities she could not perform if the headache was present. The headache was described as stabbing, excruciating pain and burning sensation. When probed for the outcome of her daughter's severe headache, the caller explains it's in between persistent and worsening. On a good day, it's a grade 8.5. On a bad day, it's a grade 10+. No medical treatment for headache, she was not really allowed to do anything. She was waiting for Pfizer vaccine to wash out of her daughter's system. She explained her daughter was laying low and not introducing any more drugs to enter her body since she had a reaction. Caller again stated they were waiting for Pfizer's vaccine to wash out of her daughter's system because they feel as though something was triggering the rash that keeps appearing and the headaches were still there on a grade level of 10+. Her daughter was afraid to take medications, so they were having to do treatments like hot compresses to her daughter's head and neck, massaging her head/neck/back and turning the lights off. The Nausea and vomiting began on 07Apr2021 and was still ongoing. No treatment for nausea. Her daughter just gets still and goes to sleep. When the headaches were excruciating, it brings on nausea and vomiting. Also, she noticed motion sickness. When her daughter was riding in the car and she was experiencing a headache, she had terrible motion sickness. Caller confirmed the caller never had this motion sickness prior to the vaccine. The motion sickness was still ongoing. Her daughter was not treating the motion sickness in any way. She states maybe her daughter has taken one Zofran because it was so bad. No further details provided. The numbness of the right forearm started on 09Apr2021. She confirms the numbness is still ongoing, it comes and goes, intermittently and did not receive any treatment. On 07Apr2021, her entire neck was swelling, left and right side. The left side was better but the rightnside had intermittent swelling, there was ongoing swelling on the right side of her neck and did not receive any treatment and just rubbing of her daughter's neck. Her daughter also has right upper shoulder discomfort with swelling that goes into her neck that was ongoing. She confirmed this event to be medically significant and it has hindered her daughter's normal activity if her shoulder was swollen too bad and she was hurting. Her daughter just started physical therapy. The light sensitivity was still ongoing. If her daughter was not experiencing a headache, the light sensitivity was pretty good and treatment included dark rooms/ black out. Her daughter was following up with an allergy testing by the allergy doctor. She has to find out if there were any active ingredients in the Pfizer vaccine that triggered her daughter's reaction. Caller stated, "something in the COVID-19 vaccine triggered her daughter's body to react the way that it did". Her daughter also was following up with a dermatologist. Her primary care physician requested her daughter to be followed up with her allergy doctor and to be tested. Caller requested Pfizer's adverse team or someone to call and let the caller know how Pfizer follows up with their patients and how well Pfizer's values each patient. The patient's symptoms have not abated. The events of swelling, nausea, vomiting, tachycardia, motion sickness, hypoaesthesia, musculoskeletal discomfort, photophobia, rash, rash pruritic, skin exfoliation, erythema and headache were considered to be medically significant. The events caused the patient to visit emergency department and physician's office. The patient received IM Benadryl 50mg and IM Solumedrol steroid as treatment for the events. The outcome of tachycardia was recovering and for burning sensation it was unknown, and for all the other events, it was not recovered.; Sender's Comments: There is a reasonable possibility that the events nausea, vomiting, pruritic rash, erythema, and severe headache were related to BNT162b2 based on known drug safety profile and close temporal relationship. The association between the events swelling, tachycardia, motion sickness, hpyoaesthesia, musculoskeletal discomfort, photophobia, skin peeling, and scaly skin with BNT162b2 can not be fully excluded based on temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
23 2021-07-04 disorientation Flashes (feeling like muscle tensing but muscles aren?t actually tensed, disorientation, pressure on... Read more
Flashes (feeling like muscle tensing but muscles aren?t actually tensed, disorientation, pressure on brain) immediately after both Pfizer doses. Heart palpitations 2 weeks after 2nd dose - diagnosed as iron deficiency. Started taking multivitamin/mineral pills with iron and had horrible reaction (felt like it was hard to breath, extreme fatigue and couldn?t even sit up, extreme nausea) went to ER and blood/ekg/chest X-ray all normal. Let go and during the night had blood rushing, neck swelling, flicking lights when eyes closed. Tried 2 different iron pills, same reaction. Went to Er again and all tests negative. Trying to supplement iron through food (week 4-now). In beginning, week 4 - not getting enough iron from food and constantly feeling short of breath and blood rushing (felt like a lot of blood was being pumped at a time even though pulse was normal). Found iron fortified cereal and it helped shortness of breath, but re-triggered flashes. Flashes getting worse in intensity, length, and frequency. Exertion also shortness of breath and not oxygenating properly walking fat and doing anything more exertional.
23 2021-07-11 feeling abnormal Brain fog; Dizziness; migraine headache with visual aura (stars); tingling that started at the base ... Read more
Brain fog; Dizziness; migraine headache with visual aura (stars); tingling that started at the base of my neck and spread over my entire head that lasted about 7 hours (sensory aura); felt fatigue; tension; suspicion of a possible MCAS reaction; This is a spontaneous report from a contactable other health care professional (patient). A 23-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: Unknown) via an unspecified route of administration, in the right arm on 20Feb2021 at 18:30 (at the age of 23-years-old) as dose 1, single for covid-19 immunisation. Medical history included celiac disease, MCAS (mast cell activation syndrome), CKD (chronic kidney disease), MTHFR (methylenetetrahydrofolate reductase deficiency), HLA-B27+, Morton's Neuroma, migraines, pancreatic insufficiency. Known allergies reported zofran, tanalbit, gluten, wheat, dairy, pineapple, lobster, crab, potatoes, egg plant allergies. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination the patient had been tested for COVID-19. Concomitant medications were not reported. Patient received other medications in two weeks. The patient did not receive any vaccines within four weeks prior to the vaccination. On 20Feb2021 at 18:45 (about 5-10 minutes after receiving the vaccine), the patient experienced migraine headache with visual aura (stars) and tingling that started at the base of her neck and spread over her entire head that lasted about 7 hours (sensory aura). She felt fatigue and tension. She took 25mg diphenhydramine an hour before, stayed at the administration site for about an hour, and took another 25mg about 1.5 hours after on suspicion of a possible MCAS reaction. Day 2 side effects involved brain fog, dizziness, and migraines. Events seriousness criteria reported as non-serious. The patient did not receive any treatment for the event. The patient underwent lab tests and procedures which included negative sars-cov-2 test (PCR, nasal swab), on 23Mar2021. Adverse events resulted in doctor or other healthcare professional office/clinic visit. Outcome of event suspicion of a possible MCAS reaction unknown and for all other events was recovered in 2021. Information about lot/batch number has been requested.; Sender's Comments: based on the reported information ,a causal relationship between the events and suspected drug 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
23 2021-07-27 feeling abnormal Really lethargic and fatigued; Tested positive for the Covid virus; Tested positive for the Covid vi... Read more
Really lethargic and fatigued; Tested positive for the Covid virus; Tested positive for the Covid virus; Can't taste or smell; Can't taste or smell; Horrible stomach ache; Diarrhea; Exhausted/really lethargic and fatigued; Felt ill, run down and not herself; Voice was gone and was very cracky; Did not feel good; Throat sore and vocal cords hurting; Throat sore and vocal cords hurting; Freezing cold and had the chills; Freezing cold and had the chills; Woke up in a puddle of sweat and hair was soaking wet and dripping; Nose really runny and super congested; Nose really runny and super congested; Deep cough/a little cough; Feels nauseas; Her energy was very low; She thought she caught the flu and was not thinking that it was Covid; freezing and shaking; She didn't have an appetite the first couple of days; She felt horrible in her chest and it was hard to breathe; Chest sore and felt like pressure on her chest; Chest sore and felt like pressure on her chest; This is a spontaneous report from a Pfizer sponsored program by a contactable consumer (patient). This 24-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration Arm Left on 25Feb2021 14:00 at age of 23 year-old (Lot: EL9267) as DOSE 1, SINGLE, Arm Left on 19Mar2021 11:00 at age of 23 year-old at DOSE 2, SINGLE (Lot # EN6208) for covid-19 immunisation. Medical history included none. Concomitant Products included ongoing lisdexamfetamine mesilate (VYVANSE) Has been taking since grade 10 at Believes it is 40mg, once daily for Attention deficit hyperactivity disorder. No prior vaccinations within 4 weeks.On 09Jul2021, she tested positive for Covid-19. States that she does not know the exact strain that it was. She is trying to get genome sequencing done so that they can find out. She has one but, she is (withheld) and has a PCP back home. She hasn't given them any info about her having Covid yet. She hasn't called her physician. She saw someone in the clinic. She hasn't told them yet, so she wants to call them first. In the clinic, they assumed it was as sinus infection and the prescribed her with Amoxicillin. She was taking it last week when she didn't know that she had it yet. She is still taking it right now. They gave her nasal spray and she did that for 2 days completely and it is clear now. She had every possible symptom she can think of. On Tuesday, 06Jul2021, she woke up with a horrible stomach ache and diarrhea. When she got to campus, she was more exhausted on 06Jul2021 and just felt ill and run down, not herself on 06Jul2021. Her voice was so gone. She did not feel good on 06Jul2021. She felt like that is probably because she took the vaccine while she was sick. She had all this work to do, so she went through it. She took her Vyvanse medication instead of resting and it almost masked the symptoms but, she felt ok for an hour, then all of a sudden she had to go to bed because she felt so sick. She just thought it was food she had eaten because of her birthday. She had eaten cake and a whole lot of junk food. She usually eats really healthy. She went to clinic that morning to see patients. She also had no voice and it was very crackly/ Voice was gone and was very cracky on 06Jul2021. Her throat didn't hurt, it was just very sore and her vocal chords were hurting on 06Jul2021. It hurt to talk. Those were the only 2 symptoms she had the first day. She felt ill, fatigued and her body started to hurt and she felt really tired. She came home and didn't feel like she usually did. She just felt really sick. She could taste and smell, it was all still there. She is still getting the runs though out the day. She was with family and 2 friends and did not pass anything on to them. They are all vaccinated. That night, she was exhausted and went to bed early, then she was freezing cold, had the chills but didn't take her temperature in Jul2021. She took Nyquil and Dayquil. She woke up again at night and was freezing and shaking and Woke up in a puddle of sweat and hair was soaking wet and dripping in Jul2021. She felt horrible. She thought she caught the flu and was not thinking that it was Covid in Jul2021. That day, she kind of tried to get though school and do work online. She was feeling really crummy. All of those symptoms, she had the next couple of days. Then her Nose really runny and super congested in Jul2021. her throat didn't really hurt but she had a kind of deep cough in Jul2021. This was the last night before she saw the doctor. She had tried going for testing the day before but the lines were 3 hours. She booked a test and a doctor's appointment for the next day because she thought she caught the cold or flu. One night, she woke up again and it was the same, with chills and sweat but, her chest was really sore. It felt like pressure on her chest in Jul2021. It felt not normal, like it was maybe a variant. She was super contagious and vaccines may not be fully effective against them. She felt horrible in her chest and it was hard to breathe in Jul2021. When going up and down the stairs, she would get really tired and was out of breath. She tested at the Drive through. It was a nasal swab in each nostril. That night, 08Jul2021, when she had dinner, she couldn't taste anything or smell anything on 08Jul2021. She thought, it must be Covid. The next day, she went to the clinic and saw a Nurse Practitioner. She made her put her head down to see if there was pressure in the sinuses. She tested her breathing and her lungs, everything was clear. She didn't really think it was Covid. She put her on amoxicillin and has been taking that ever since. She tested positive (09Jul2021) was when she was starting to feel better but really, she was still tired and exhausted. Her energy was very low in Jul2021. She was only really sick for 3 full days. On Saturday, she was really lethargic on 10Jul2021 and fatigued. She knew she was getting better, just not 100 percent. When she knew that it was Covid, if it wasn't for the vaccine, she didn't think she would be able to tough it out. She still can't taste or smell at the moment. She is in self isolation. She feels completely normal. If she hadn't gotten the Covid test, she would have never thought that it was Covid. She feels 90% right now. She is back to studying. Horrible stomach ache and Diarrhea: Did not last very long, would say, like 30 minutes and then it passed. Still has diarrhea every morning but it may because of the amoxicillin. Lethargy and fatigue and all of the other symptoms: They were all on 6Jul2021, 7Jul2021 and 8Jul2021. On 9Jul2021, she started to get better. Treatment included Before Friday, when she saw the Nurse practitioner on 9Jul2021, she started taking the Flonase. She only did it a couple of times. It was fluticasone propionate, Flonase nasal spray and Sodium chloride nasal spray, 1 spray in each nostril. She only did it 3 times since she got it. Her nose was really runny through out the time and super congested. The only thing is that her stomach feels a little nauseous and has a little cough. Her cough has gotten way better, so much better. The nausea/ Feels nauseas didn't happen that often in Jul2021. She didn't have an appetite the first couple of days in Jul2021. Just today, she is a little nauseated but, it may not be Covid. No Emergency Room and Physician Office. She went to the clinic. She barely had any symptoms from the second dose. She looks like she has Covid and it is not good. Was tested prior to getting the vaccine and was negative. Outcome of the event Tested positive for the Covid virus, Nose really runny and super congested, Nose really runny and super congested was unknown. Outcome of the event hard to breathe, Exhausted/really lethargic and fatigued, Felt ill, run down and not herself, Voice was gone and was very cracky, Did not feel good, Throat sore and vocal cords hurting, Freezing cold and had the chills, Woke up in a puddle of sweat and hair was soaking wet and dripping, Deep cough/a little cough, Really lethargic and fatigued, Chest sore and felt like pressure on her chest, Feels nauseas, Her energy was very low, She thought she caught the flu and was not thinking that it was Covid, freezing and shaking, She didn't have an appetite the first couple of days was recovering. Outcome of the event Horrible stomach ache was recovered in Jul2021. Outcome of the event Diarrhea, Can't taste or smell was not recovered. (Parent) Evaluation Comment: Pfizer withheld reviewed this complaint and agrees with the site assignment, investigation decision, classification, sub-classification, and priority. The reported lot number is valid and an investigation will be performed. QA Review & Rationale: The complaint and its classification have been reviewed. No immediate containment actionis required. The complaint, its priority, and its classification have been reviewed and determined to be appropriate. A full investigation will be performed. This is a complaint for lack of effect of lot EN6208 of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE. The initial scope of this investigation is limited to the reported finished goods lot EN6208 pending review of lot genealogy. The investigation will include a review of the returned complaint sample (if received) and reserve samples, if necessary. Conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE lot EN6208 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot EN6208, fill lot EN5338, and the formulated drug product lot EN5329. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. The complaint for an adverse event requested by safety with the use of the PFIZER-BIONTECH COVID-19 VACCINE lot EL1283 was investigated. The investigation included reviewing the manufacturing and packaging batch records, retained reference samples, deviation investigations and an analysis of the complaint history for the reported lot and product type. The final scope was expanded to the reported finished goods lot EL1283, fill lot EL1281, and the bulk formulated drug product lot EL1279. A complaint sample or photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. The complaint was not confirmed. Follow-up attempts are completed. No further information is expected.
24 2021-01-04 excessive sleepiness Pfizer-BioNTech COVID-19 Vaccine EUA Low grade fever of 99.4, chills, tiredness, injection site pai... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Low grade fever of 99.4, chills, tiredness, injection site pain (couldn?t raise my arm for almost 24 hours), and feeling unwell. Most of my symptoms started over 24 hours after receiving the vaccine. I took Tylenol and Motrin to help with the pain and fever and used warm compresses to my neck and injection site. I also slept a lot. I just started feeling normal again after 2.5 days.
24 2021-01-04 sleep disorder Woke up at about 3:30am feeling warm. Checked my temperature and it was 101.4. Also experienced join... Read more
Woke up at about 3:30am feeling warm. Checked my temperature and it was 101.4. Also experienced joint aches and a headache.
24 2021-01-05 feeling abnormal 2-3 hours after vaccination developed a "weird feeling" or brain fogginess. At 1545 she developed bo... Read more
2-3 hours after vaccination developed a "weird feeling" or brain fogginess. At 1545 she developed body aches, chills, dizziness, and chest tightness prior to falling asleep on her couch. She woke up drenched in sweat and took some Emergen-c. Overnight she developed a headache which woke her up and she took Excedrin. This AM se continues to have body aches, dizziness, and a slight headache, but denies feeling any disorientation now.
24 2021-01-07 nervousness Pfizer-BioNTech COVID-19 Vaccine Patient was administered vaccine at 0951. Patient reports not feel... Read more
Pfizer-BioNTech COVID-19 Vaccine Patient was administered vaccine at 0951. Patient reports not feeling well. Got a rush of feeling very warm and shaky. Upon assessment patient is pale, diaphoretic and has a rapid bounding pulse. Moved patient to exam room where we assisted her to lay down. Hooked her up to vitals machine for a set of vitals. HR-140-150, BP 146/88, O2 100%, R-24. Upon patient laying down she started to complain of her throat feeling hot and tingly. She began to develop a blotchy rash first noted above BP cuff on right arm, but quickly spread up neck and down trunk. Assessed mouth and throat, no swelling of tongue or lips noted. Patient still c/o feeling hot and tingly on neck and all the way down to her legs. Blotchy rash had subsided. HR dropping to 80-90 and BP came down to 124/82. O2 remained 100% throughout. Patient transferred to emergency department.
24 2021-01-07 sensation of foreign body On 01Jan2021 my jaw was also getting sore; feel what felt like a lump in her left armpit. Physically... Read more
On 01Jan2021 my jaw was also getting sore; feel what felt like a lump in her left armpit. Physically there wasn't any lump but it felt swollen and as if there was a big lump; left arm was tender to the touch/left arm get sore; major body pain/ minor aches and body sores; major headache; pain, especially in my lower back and knees; body chills; but my body pain was solely in my arm and my knees; By night time, my left arm was tender to the touch and I could not raise it very high; This is a spontaneous report from a non-contactable other health professional (patient). A 24-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1284), via an unspecified route of administration in left arm on 30Dec2020 12:15 at single dose for COVID-19 immunization. There were no medical history or concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no known allergies. Immediately after receiving the vaccine on 30Dec2020, the patient did not have any side effects. It wasn't until 14 hours later that the patient started to feel the effects. the patient woke up at 2 am with major body pain. the patient had a major headache and pain, especially in her lower back and knees. In addition to the pain, the patient also had body chills. The next morning the patient felt better but with minor aches and body sores. However, around 7 pm on 31Dec2020, the patient started to feel her left arm get sore. By night time, her left arm was tender to the touch and the patient could not raise it very high. the patient started getting headaches again but her body pain was solely in her arm and her knees. 01Jan2021 her jaw was also getting sore. In addition, the patient started to feel what felt like a lump in her left armpit. Physically there wasn't any lump but it felt swollen and as if there was a big lump. The feeling persisted until 03Jan2020 then it eventually went away. The outcome of felt like a lump in her left armpit was recovered on 03Jan2020 while for other events was recovered on unknown date. No treatment was received for events. No follow-up attempts are possible. No further information is expected.
24 2021-01-10 excessive sleepiness, feeling abnormal Moderate - Severe Fatigue, sleeping 12-14 hours a night/day and still waking up feeling horrible. B... Read more
Moderate - Severe Fatigue, sleeping 12-14 hours a night/day and still waking up feeling horrible. Body aches. Staying in touch with employee health to determine when next steps need to be taken.
24 2021-01-11 insomnia Chills, body aches, insomnia, and headache, starting at 5pm the day of the vaccine. Still having res... Read more
Chills, body aches, insomnia, and headache, starting at 5pm the day of the vaccine. Still having residual headache today. Very sever symptoms left me in bed for the remainder of the day.
24 2021-01-14 feeling abnormal About 1 hr after vaccination, started to feel nauseous and bad headache, increased over 3 hr, felt "... Read more
About 1 hr after vaccination, started to feel nauseous and bad headache, increased over 3 hr, felt "brain fuzzy" after 1 hr.; About 1 hr after vaccination, started to feel nauseous and bad headache, increased over 3 hr, felt "brain fuzzy" after 1 hr.; About 1 hr after vaccination, started to feel nauseous and bad headache, increased over 3 hr, felt "brain fuzzy" after 1 hr.; This is a spontaneous report from a contactable consumer. A 24-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK4176; expiry date: unknown) via an unspecified route of administration (left arm), on 08Jan2021 at 12:30, at a single dose, for COVID-19 immunization. Relevant medical history included atopic dermatitis, allergy to latex, nitrile, nickel, mint, mango, eggplant, tomatoes, coconut, some specific blue pigments. Concomitant medications included dupilumab (DUPIXENT), fluoxetine (FLUOXETINE), ibuprofen (IBUPROFEN), and vitamin D3). The patient previously received dexamethasone and experienced allergies. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) in the left arm, on 18Dec2020 at 12:00, for COVID-19 immunization. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On 21Dec2020, the patient showed a negative nasal swab. On 08Jan2021, at 13:30, about 1 hour after vaccination, patient started to feel nauseous, experienced bad headache which increased over 3 hours, and felt "brain fuzzy" after 1 hour. Three hours after onset, patient took Tylenol 1000 mg and Dramamine as treatment for the events. Outcome of the events was recovering. The patient underwent PCR test post vaccination with an unknown result.
24 2021-01-14 feeling abnormal Sore body & bones; Sore body & bones; Headache; Dizziness/Light headed; Nauseous; Vomiting; Fever; N... Read more
Sore body & bones; Sore body & bones; Headache; Dizziness/Light headed; Nauseous; Vomiting; Fever; Night sweats; Chills; Goosebumps from being so cold; Goosebumps from being so cold; Feeling like I'm in a dream/Foggy; This is a spontaneous report from a contactable consumer (patient). A 24-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: El1284), via an unspecified route of administration at Left arm on 06Jan2021 08:30 AM at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Workplace clinic. Medical history included covid-19, Known allergies: Latex. There were no concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 06Jan2021 at time of 03:30 PM, the patient experienced Sore body & bones, headache, dizziness, nauseous, vomiting, fever, night sweats, chills, light headed, goosebumps from being so cold, feeling dizzy, feeling like i'm in a dream, foggy. No treatment received for the events. Prior to vaccination, the patient was diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovering.
24 2021-01-15 impaired work ability Extreme dizziness when standing up and flu like symptoms that prevented me from going into work.
24 2021-01-17 impaired work ability I got the second dose to the Pfizer vaccine on 1/12/2021at 11 AM. I felt throughout the day and was ... Read more
I got the second dose to the Pfizer vaccine on 1/12/2021at 11 AM. I felt throughout the day and was able to finish my shift. Later that night, I had very strong rigors, chills, severe headache and felt feverish. I took some Tyenol and felt a little better. I woke up at 5 AM to go to work, and my body was so fatigued and tired I couldn't move. My hands were shaking badly, and my whole body hurt. My joints hurt, my muscles, ect. I called out of work, as I work in the Micro lab doing COVID-19 PCR testing, I couldn't pipet correctly if I was shaking. I do not have any pre-existing conditions, and I have no allergies. I have never experienced an adverse reaction to a vaccine.
24 2021-01-18 poor quality sleep I received the vaccine on 01/15/2021 at 8:20am and around 6:00pm that night I started feeling fatigu... Read more
I received the vaccine on 01/15/2021 at 8:20am and around 6:00pm that night I started feeling fatigued and weak. I woke up at 1:00am on 01/16/2021 with vomiting, nausea, fever of 102.3, severe body aches, and chills. I was able to take 400mg ibuprofen and my fever subsided for about 4 hours. Those symptoms continued on for the whole day of 01/16/2021. on 01/17/2021 I was still very weak with body aches which came and went throughout the day. Around 6:00pm on 01/17/2021 i started feeling normal again.
24 2021-01-19 nervousness Got COVID vaccine dose #1 around 0740-0745, waited the 15 minutes then was driving home from hospita... Read more
Got COVID vaccine dose #1 around 0740-0745, waited the 15 minutes then was driving home from hospital, throat felt a radiating warmth from the inside, hard to swallow, heart was racing, felt light headed and shakey. Pulled over and called EMS at exactly 0816. Symptoms subsided after 20 minutes. EMS took vitals but did not get transported to hospital.
24 2021-01-20 anxiety 4:28pm vaccinated 4:47pm c/o lightheadedness, weakness; patient placed in semi-reclining chair; brie... Read more
4:28pm vaccinated 4:47pm c/o lightheadedness, weakness; patient placed in semi-reclining chair; brief medical h/o revealed the following: Stated that she has severe allergies to shellfish, nuts, carries epipen; takes Benadryl every night, 50mg for excema; BP 145/88, HRT 87, states breathing fine; denies tightness in chest or difficulty breathing; states she believes it may be due to anxiety, had anxiety prior to being vaccinated. Sips of water tolerated well; patient appears pale, hands shaking. As requested by patient, fiance came up to comfort her 4:56pm patient states she feels lightheaded; given cool cloth for forehead; BP 132/88, HRT 94. States that she ate full lunch, felt nauseous at 2:30pm, believes it was due to anxiety about getting the vaccine 5:01pm BP 142/73; states her mouth feels like it is tingling; given 25mg benadryl liquid by mouth, tolerated well. 5:10pm BP 136/79, HRT 87 Patient requested to use rest room; was wheeled to bathroom with assist to toilet, tolerated well; 5:24pm BP 132/85, HRT 73 5:47pm feels better, BP 131/83, 72 HRT Discharged ambulating, with fiance accompanying and parents outside waiting to drive her home; patient will stay at parents' house tonight.
24 2021-01-21 nervousness Individual received the vaccine and was initially stable. Approximately 10 minutes after receiving t... Read more
Individual received the vaccine and was initially stable. Approximately 10 minutes after receiving the vaccine, she reported increasing dizziness and became extremely pale with BP 73/44. She became nauseated and vomited. She also reported numbness in the right arm and hand. A doctor was onsite to evaluate. She eventually recived epinephrine 1 amp. She had improving symptoms and remained very pale and shaky. Her BP improved to 94/66, HR 88, and O2 sats 100%.
24 2021-01-24 feeling abnormal Describe the adverse event(s), treatment, and outcome(s), if any: (symptoms, signs, time course, etc... Read more
Describe the adverse event(s), treatment, and outcome(s), if any: (symptoms, signs, time course, etc.) This is a spontaneous report from a Pfizer-sponsored program. A contactable nurse (patient) reported that a 24-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection, lot number: EH9899, expiration date: 31Mar2021) on the left deltoid intramuscularly on 22Dec2020 08:24 at a single dose (30mcg/0.3mL) for COVID-19 immunization. The patient had no medical history. There were no concomitant medications. The patient reported she took the first Pfizer Covid-19 shot and is scheduled to take the second one today 12Jan2021. She had nausea and diarrhea and wanted to know if it's okay to go take the second vaccine, Pfizer Covid-19. The nausea and vomiting started on 11Jan2021 and she also had a headache, but the headache has resolved on 12Jan2021. She felt like crap. Nausea and diarrhea were reported as worsened. No other vaccines given at that time with the first dose. No vaccines 4 weeks prior. Received this vaccine at her workplace and they were very efficient and very quick. Did have a flu shot 30Oct2020. Provides flu shot Lot number of 33BN3 and expiry of 30Jun2021, left deltoid. Never had any problems with previous vaccines. No relevant tests done. No known allergies. Outcome of the event headache was resolved on 12Jan2021; nausea aggravated, and diarrhea aggravated were not recovered and unknown for the other events.
24 2021-01-25 insomnia Soreness of the arm 2 hours after injection. The night of the injection I had chills, muscle and joi... Read more
Soreness of the arm 2 hours after injection. The night of the injection I had chills, muscle and joint pain the point I could not sleep and a severe headache and tiredness.
24 2021-01-25 panic attack Patient comment immediately after receiving vaccine that her arm hurt, within mins of sitting in obs... Read more
Patient comment immediately after receiving vaccine that her arm hurt, within mins of sitting in observation area she commented that her arm was numb down to her fingertips, the pharmacist administered Benadryl, very shortly after the patient stated she was having difficulty breathing, the pharmacist administered an epi-pen, shortly after she was brought to a room in the facility for observation, Before leaving the clinic, the facility stated that they believe she had a panic attack due to her history, We have reached out for confirmation but the patient has not returned our call.
24 2021-01-25 panic attack Patient commented immediately after she received the injection that it was painful, within minutes o... Read more
Patient commented immediately after she received the injection that it was painful, within minutes of having a seat in the observation area she commented that her left arm was numb down to her fingertips, within mins the pharmacist administered Tylenol, patient commented she was having issues breathing, at 12:07pm the pharmacist administered an epi pen. After, she was brought to a room at the facility for observation. Before we left, the center informed us that they believe she had a panic attack due to her history, we have contacted the patient for confirmation of final outcome but are awaiting a call back.
24 2021-01-27 anxiety, nervousness Rapid heart rate; Feeling shaky and anxious; Feeling shaky and anxious; This is a spontaneous report... Read more
Rapid heart rate; Feeling shaky and anxious; Feeling shaky and anxious; This is a spontaneous report from a contactable nurse (patient). A 24-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number:EL0142, expiration date unknown) , via an unspecified route of administration in the left arm on 14Jan2021 at 09:15 AM at a single dose for COVID-19 immunization. Medical history included COVID-19 on unknown date prior to vaccination, patient had no known allergies. Patient is not pregnant. Concomitant medications included over the counter (OTC) vitamins. The patient had not received other vaccines in four weeks. On 14Jan2021, the patient experienced rapid heart rate noted in the 150s approximately five minutes after receiving first dose lasting only a few minutes and was feeling shaky and anxious. There was no treatment received for the adverse events. The patient was not tested for COVID post vaccination. The outcome of the event rapid heart rate was recovered on 14Jan2021 while the rest of events was unknown.
24 2021-01-27 feeling abnormal 2:40pm Patient reported feeling "weird" after seeing blood after receiving Pfizer vaccine. Patient's... Read more
2:40pm Patient reported feeling "weird" after seeing blood after receiving Pfizer vaccine. Patient's pulse was elevated and felt her "heart racing" and "nausea". Vitals taken every 5 minutes. Patient given 25mg of Diphenhydramine by mouth. Patient was alert and oriented.
24 2021-01-31 impaired work ability I woke up the morning after receiving the second dose of the Covid-19 vaccine with a severe headache... Read more
I woke up the morning after receiving the second dose of the Covid-19 vaccine with a severe headache, nausea, vomiting, fever of 101.3, body aches, fatigue, and a sore throat. I took Tylenol twice that day and felt a small amount of relief. I woke up the following day, 2 days after the vaccine, still feeling nauseous, had a headache, temperature 100.4, fatigue, and body aches. I woke up in the middle of the night drenched in sweat. 3 days following the vaccine I am still having nausea with vomiting, body aches, and fatigue, my temperature day 3 is 100.1. I had to call into work because of my symptoms and the screening tool used to get into work flagged me.
24 2021-02-01 sleep disorder At around 7PM 01/29/2021, I was at the store to get groceries when walking around the store became d... Read more
At around 7PM 01/29/2021, I was at the store to get groceries when walking around the store became difficult due to being out of breathe. When I got home the body aches got worse and I started getting severe chills and could not stop shaking. That night was difficult to sleep because of the pain I was in. When I woke up the next day, 01/30/2021, I was dizzy, severe fatigue, had severe migraines, I could not breathe when standing up and moving around, my heart was racing, and it felt like I had a sun burn all over my body. I called the nursing coordinator for that day and asked what to do and she said to go to the ER. When I arrived at the ER, they said I had 100 degree temp., I was tacky. They gave me medicine for the pain and the doctor said I was having a adverse reaction to the vaccine but by the next day I would feel better. I went home and slept after the ER all day and night and by Sunday 01/31/2021, I was feeling better after excedrine and advil
24 2021-02-05 anxiety Approximately 10 minutes after receiving vaccination I was called to the observation area where pati... Read more
Approximately 10 minutes after receiving vaccination I was called to the observation area where patient was complaining of difficulty swallowing and tightness in the chest. She denied itching, wheezing or difficulty breathing, lightheadedness, nausea, swelling of lips or face or mouth. Also denied history of anxiety. Patient was mildly anxious, not in distress, verbalizing well. No visible urticaria or oral abnormalities, no angioedema. lungs clear heart RR&R. She c/o worsening sense of difficulty swallowing and tightness in chest and was given an EpiPen dose of .3ml IM. She improved thereafter regarding subjective symptoms but became "jittery." paramedics arrived and evaluated her, asked her to stand up (from reclining) and she did well. Approximately 30-40 minutes later she was picked up by family members and asked to follow up with ER, paramedics or PMD as needed. i advised that I did not see a reason to not get the 2nd dose of vaccine . I gave her my name and contact information.
24 2021-02-07 disturbance in attention Symptom onset within 10 hours after vaccination: Swelling >5cm at injection site, significant pain a... Read more
Symptom onset within 10 hours after vaccination: Swelling >5cm at injection site, significant pain and throbbing in extending down the arm of the injection site, swelling extending down to the forearm. Syncope and loss of consciousness occurred with trauma to the forehead and nose causing nose bleed. Unable to determine how long patient lost consciousness. When patient woke up, she was laying in a pool of blood from nose bleed and patient described shaking/rigors that were only relieved by taking Ibuprofen 800mg Q8H for 6 days. Denies fever. Due to syncope and head trauma, patient suffered concussion with symptoms of HA, blurry vision, difficulty concentrating, and fatigue.
24 2021-02-07 restlessness, insomnia sore arm; cannot sleep at all; chills; body aches; a bit of a hard time breathing; restless; feeling... Read more
sore arm; cannot sleep at all; chills; body aches; a bit of a hard time breathing; restless; feeling warm/heat; nauseous; This is a spontaneous report from a contactable consumer. A 24-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at right arm, via an unspecified route of administration on 21Jan2021 10:00 at single dose for covid-19 immunisation. Medical history included depression. The patient had no covid prior vaccination and no known allergies. Historical Vaccine included first dose of bnt162b2 taken on 01Jan2021 (Vaccine location: Left arm) for covid-19 immunisation and the patient experienced sore arm. Concomitant medication included bupropion hydrochloride (WELLBUTRIN), and birth control for awhile. The first dose the patient just had a sore arm, the second dose which she took yesterday 21Jan2021 around 10:00 caused a much more sore arm than the first dose she felt this after 2-3 hours of 2nd dose of vaccine, tonight she cannot sleep at all Jan. From 21Jan2021 to 22Jan2021 she keep waking up every 2 hours with chills body aches very sore arm a bit of a hard time breathing feeling very restless and not able to sleep, feeling warm/heat as well and a bit nauseous. The adverse events started on 21Jan2021 13:00. The patient received no treatment for the adverse events. The patient had no covid tested post vaccination. The outcome of events was not recovered. Information on the lot/batch number has been requested.
24 2021-02-09 feeling abnormal, excessive sleepiness I started to get a headache then became more fatigued throughout the evening. I went to bed around 9... Read more
I started to get a headache then became more fatigued throughout the evening. I went to bed around 9 pm and had some chills and mild body aches so I took some Tylenol. I woke up around 12pm with sore muscles and cramps/aches in my back, hips, legs, and neck. I also had a mild fever of 100.7 and was nauseous. I took some Zofran for nausea. I had chills and was flushed and sweating. That next day I felt like I had been hit by a truck, I was very fatigued, had little to no appetite, and had a pounding headache. I slept the entire day 1/25. The following day 1/26 I felt better but still groggy, I slept the majority of the day before heading off to work.
24 2021-02-09 impaired work ability chills, fatigue, headache. called in sick to work.
24 2021-02-13 sleep disorder Diarrhea and Cramping : I felt fine on Friday I was doing well. My arm was sore but over the course ... Read more
Diarrhea and Cramping : I felt fine on Friday I was doing well. My arm was sore but over the course of Saturday it started to go away. The one thing that I have been clocking is diarrhea. I would have a cramping cramping feeling in my stomach on my left side it would feel like it?s coming from my uterus. I had first thought it was because I was in a sitting position and the 90° angle wasn?t great for my body and so I thought I just had to leave straight because even as I?m talking this right now like I feel a little bit of cramping sitting in a 90° angle. But the diarrhea is still ongoing it?s been waking me up at five almost 6 AM and I woken up at least three times in the middle of the night going into Sunday. I was actually fine during the whole entire day of Saturday because I was able to like be on a long meeting call but after that was done my body just needed to expel things. I did eat a tiny bit while I was in a meeting I ate cake chocolate, A bunch of sweets. Also after I?ve woken up right now at 6 AM I drink some water and the water felt like it was sitting in the top of my stomach and I have to slowly very very slowly go down not in my esophagus in my throat in my stomach like it bloated me and as I was walking around it slowly went away I am trying to drink a lot of water because I?m conscious that I?m having diarrhea. Is the diarrhea an an allergic reaction? Is the diarrhea a reaction to an active ingredient in the vaccine? (polyethylene glycol)
24 2021-02-14 feeling abnormal sever body aches, chills (no fever), extreme fatigue, malaise, brain fog
24 2021-02-14 insomnia Difficulty sleeping night of vaccination and mild nausea Saturday (next day): Fever (max 100.8), chi... Read more
Difficulty sleeping night of vaccination and mild nausea Saturday (next day): Fever (max 100.8), chills, headache, and body aches that started to resolve late Saturday night; fatigue and lack of appetite Sunday & Monday: Fatigue and brain fog
24 2021-02-16 anxiety Pt was in observation room when she stated to me that she felt dizzy and like her heart was "beating... Read more
Pt was in observation room when she stated to me that she felt dizzy and like her heart was "beating fast." She stated it was approx 5-10 minutes after her vaccine was administered. I explained that I would like to extend her observation time to 30 minutes, and perhaps longer if she didn't feel better then. I offered her water and food. She declined water and asked for "a snack." I re-evaluated her approximately every 5 minutes over the next half hour.
24 2021-02-16 loss of personal independence in daily activities From 3:00pm on 1/8 to the morning of 1/12, experienced high fevers, severe body aches, chills, fatig... Read more
From 3:00pm on 1/8 to the morning of 1/12, experienced high fevers, severe body aches, chills, fatigue, night sweats, and headache. My heart rate was consistently in the 110s-120s and my blood pressure was in the 100s/40s. My highest temperature was 103.5. My fiancé is a nurse who took care of me at home. I alternated Tylenol and ibuprofen for the aches and fever. I slept the majority of each day and was unable to perform my activities of daily life or exercise. I lost my appetite for about 1 week. I had no sense of taste in Sunday, which slowly returned over the next week. I was concerned about the loss of taste so I scheduled a COVID-19 swab which came back negative on 1/11.
24 2021-02-16 sleep disorder Deep Pain through your my entire arm, under my arm pit and into my rib on the left side Not sore to ... Read more
Deep Pain through your my entire arm, under my arm pit and into my rib on the left side Not sore to the touch The pain is bad enough to wake me up every two hours
24 2021-02-21 anxiety I experienced a full-body tingling/vibrating feeling. This includes my face/head. I also experienced... Read more
I experienced a full-body tingling/vibrating feeling. This includes my face/head. I also experienced vomiting and diarrhea, and extreme anxiety.
24 2021-02-25 anxiety, confusional state, disorientation, hallucination hallucination; severe confusion; dizziness/light headedness; disorientation; fatigue; tachycardia; a... Read more
hallucination; severe confusion; dizziness/light headedness; disorientation; fatigue; tachycardia; anxiety; full body weakness; full body muscle aches; chills; headache; This is a spontaneous report from a contactable healthcare professional (patient). A 24-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL3247), intramuscular in left arm on 22Jan2021 at a single dose for COVID-19 immunisation. Medical history included generalised anxiety and allergies: Sulfa sensitive. Patient was not pregnant at the time of vaccination. Prior to vaccination, the patient has not been diagnosed with COVID-19. The patient's concomitant medications were not reported. On 22Jan2021, 45-60 minutes after vaccination, patient experienced hallucination, severe confusion, dizziness/light headedness, disorientation, fatigue, tachycardia, anxiety, full body weakness, then on 22Jan2021, 8 hours after, patient had full body muscle aches, headache, chills, fatigue, confusion, hallucination, anxiety, tachycardia, 16 hours after, experienced confusion, full body muscle aches, headache, chills, fatigue, confusion, hallucination, tachycardia, anxiety, then 48 hours after, had confusion, full body muscle aches (TYLENOL helped), headache, fatigue, confusion, hallucination, tachycardia, anxiety, then 1 week after vaccination, patient was experiencing confusion, anxiety, and hallucinations throughout the entire week. Patient was unsure if she ever had a fever, as she did not check her temperature. The events were reported as non-serious. The patient underwent lab tests and procedures which included COVID saliva test: negative on 27Jan2021 and negative on 10Feb2021. Therapeutic measures were taken as a result of full body muscle aches. No treatment was received for the other adverse events. The outcome of the events was recovered with sequelae.; Sender's Comments: Based on the limited information currently available, a possible contributory role of the suspect drug in the reported event hallucination cannot be completely excluded given the known suspect drug profile and/or implied temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regul atory Authorities, Ethics Committees and Investigators, as appropriate.
24 2021-02-28 sensation of foreign body The patient presents today with a history of recurrent urticaria and angioedema. She received a dos... Read more
The patient presents today with a history of recurrent urticaria and angioedema. She received a dose of the Pfizer COVID-19 vaccine on Thursday Feb 25th (lot number EN 6206). She felt fine after her shot, but the next day felt fatigued, had chills, body aches, and left arm soreness (at the site of the injection)--she attributed her symptoms to her vaccination. Friday evening, prior to bed, she noticed the onset of several scattered hives. The next day, she noted that she had more extensive hives over her body, including her eyelids, and she said that she has been having dyspnea; she presented to the ER and was treated with steroids and antihistamines. The symptoms or urticaria returned the next day with significant angioedema of the lips, and the patient had dyspnea and nausea/abdominal discomfort, and the patient went back to the ER. With antihistamines and steroids, her symptoms improved significantly and she was sent home. Her symptoms returned today, now accompanied by throat globus as well as abdominal discomfort--she self administered an Epipen, which she said significantly helped her symptoms.
24 2021-03-01 sleep disorder 2/28- 1am: chills, muscle ache, stiff joints - hard to sleep 7am-5pm: headache, nausea, fever, musc... Read more
2/28- 1am: chills, muscle ache, stiff joints - hard to sleep 7am-5pm: headache, nausea, fever, muscle aches, stiff joints (neck and back), chills 6pm-9pm: only nausea went away (Went to bed) 2/29 (all day) Woke up with a really stiff neck/upper body, shortness of breath and chest pain while breathing, exhausted, headache. Shortness of breath getting better throughout the day, headache didn?t leave. Still exhausted
24 2021-03-02 insomnia Saturday at 1:00am, I was feeling extremely nauseous, shivering, and achey. I had trouble sleeping a... Read more
Saturday at 1:00am, I was feeling extremely nauseous, shivering, and achey. I had trouble sleeping and finally at 7:00am got up. I was nauseous, achey, fatigued, and shivering all morning. I had a temperature of 99.4 degrees. Between 11am-1pm on Saturday 02/27, I vomited three times. I had a horrible headache, stomach ache, and felt achey, cold, and weak all day. On Sunday, 02/28, my fever resided, and I did not vomit but still had stomach aches and slight nausea. I had eaten nothing out of the ordinary on Friday (made pizza at home like I do every Friday), and there were no other abnormalities during the day.
24 2021-03-02 sleep disorder, feeling abnormal, feeling drunk Pfizer given on Friday evening 6.30pm waited for 12 mins as requested before leaving. Felt fine and ... Read more
Pfizer given on Friday evening 6.30pm waited for 12 mins as requested before leaving. Felt fine and well. Early saturday morning 1am woke up with acheing bruise sensation at injection site. Woken up twice during the night Saturday (1am-6am) feeling cold and covered in sweat. Saturday morning around 10am, bruised feeling and tender at the back of the injected arm. Sore to touch that area and also sore to touch injection site. Saturday Evening around 6pm pins and needles tingling sensation in both feet and also sharp stabbing pain on and off in left calf muscle. Saturday night waking from sleep sweaty and disoriented. Sunday morning 10am light foggy feeling headache. Taken paracetamol with no change. Same symptoms continued on and off but were manageable at home. Monday evening dizziness during the day time and fstigue. Feeling of being drunk, everything in slow motion. Chest tightness began monday evening 8pm aprox (like my asthma symptoms) tickle in throat but no cough. Woken up feeling cold but sweating. Tuesday morning mild headache again front of head. Chest tightness persisting but taken usual asthma medications. Tuesday evening 6pm Palpitations began. More of a hiding feeling than heart racing. Stronger than I have ever felt before and more frequent (6-8 times in 30 mins) Felt light headed again, hands and feet freezing cold and blue colour, body trembling, called NHS 111 advised A&E. Had blood tests, ECG and BP monitoring. ECG normal at the time but heart shows working harder than it should. Still waiting on blood results Weds (3/3/21)
24 2021-03-02 sleep disorder I received Covid about 7 days after i got the vaccine. After the vaccine i felt very sluggish and ju... Read more
I received Covid about 7 days after i got the vaccine. After the vaccine i felt very sluggish and just did not want to do anything. I also felt like my sleep pattern got all messed up, I was not able to sleep.
24 2021-03-03 confusional state sudden feelings of nausea; dizziness; rapid heart rate; sweating; tingly sensation in extremities; s... Read more
sudden feelings of nausea; dizziness; rapid heart rate; sweating; tingly sensation in extremities; sudden fatigue; confusion; Chest tightness and pressure; This is a spontaneous report from a contactable healthcare professional (patient herself). A 24-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: EN9581) on 13Feb2021 12:30 PM, via unknown route of administration, at the age of 24-year-old at single dose in Left arm for COVID-19 immunization. The patient medical history includes known allergies: Penicillin, Sulfur meds. The patient concomitant drug includes desvenlafaxine succinate (PRISTIQ). 10 mins after shot (as reported), the patient experienced sudden feelings of nausea, dizziness, rapid heart rate, sweating, tingly sensation in extremities, sudden fatigue, confusion. Chest tightness and pressure lasting 4 days. All the events reported started at 13Feb2021 12:45 PM, resulted in: [Emergency room/department or urgent care, Prolongation of existing hospitalization (vaccine received during existing hospitalization)]. Treatment was reported as no. No COVID prior vaccination. No COVID tested post vaccination. The event outcome of 'Chest tightness and pressure' was recovered on 17Feb2021 and the rest of event was recovered in Feb2021.; Sender's Comments: Based on the temporal relationship, the reasonable possibility of an association between reported events and suspect product BNT162B2 cannot be ruled out. 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.
24 2021-03-05 feeling abnormal Mental fogginess for about 12 hours
24 2021-03-09 mental impairment, feeling drunk 10min after getting her first dose of Pfizer, patient started experiencing dizziness. No shortness o... Read more
10min after getting her first dose of Pfizer, patient started experiencing dizziness. No shortness of breath, no numbness/tingling. Stated she 'felt like she was drunk and that she couldn't read the paper in front of me." BP 132/86, P88, O2 on room air 99%. Patient was escorted to Emergency Room where she was evaluated by provider.
24 2021-03-12 nervousness Patient felt light headed and stated felt like fainting. She stated she was nervous about getting s... Read more
Patient felt light headed and stated felt like fainting. She stated she was nervous about getting shots. Monitored patient blood pressure 125/75 pulse 76 and five minutes later 123/81 pulse 80. Patient waited 15 minutes after vaccination and stated was fine and did not want further intervention then left with family.
24 2021-03-13 anxiety Diaphoretic, anxious. Evaluated by EMS-Cleared
24 2021-03-14 feeling abnormal Sudden tingling and numbness in hands, I couldn't move my fingers for 2 minutes. My whole body start... Read more
Sudden tingling and numbness in hands, I couldn't move my fingers for 2 minutes. My whole body started pouring sweat. My head got foggy and my vision got blurry and for a second. I vomited once and felt nauseous the rest of the night, and also felt like I had a migraine the rest of the night as well.
24 2021-03-15 sleep disorder Left deltoid pain began at about 2:30 pm, approximately 3 hours after vaccine was administered in th... Read more
Left deltoid pain began at about 2:30 pm, approximately 3 hours after vaccine was administered in that arm. Pain progressed throughout the next few hours but was moderate. Around 11:30 pm the pain became more severe, to the point where any deltoid movement caused extreme pain. I used an ice pack to try to alleviate the pain but it only provided mild relief. When changing my shirt around this time I touched the area lightly and saw it was slightly swollen with fluid around the site of vaccination. Continued using ice because I had not eaten recently and did not want to take ibuprofen on an empty stomach and cause heartburn. I was unable to sleep on my left side and woke up around 4:30 am in severe pain, put ice on it again and fell back asleep. I had a low grade fever of about 99.4 F at this time and some chills. On 3/16 I woke up around 9:30 am and pain was still fairly moderate-severe and swelling was present but less than the night before. Around 10:00 am I ate breakfast and took ibuprofen, and the pain and swelling have been more moderate since.
24 2021-03-16 anxiety Patient complained of feeling anxious and light headed.
24 2021-03-19 feeling abnormal Minor allergic reaction. Mouth lips and tounge tingling and feeling weird similar to nut allergy re... Read more
Minor allergic reaction. Mouth lips and tounge tingling and feeling weird similar to nut allergy reactions. Bumps on lips. Started about 20minutes after and went away after an hour and came and went though the rest of the day.
24 2021-03-22 anxiety, nervousness Patient reported feeling dizzy and briefly loss consciousness after walking over to the first aid ar... Read more
Patient reported feeling dizzy and briefly loss consciousness after walking over to the first aid area. Patient was clammy, sweating. Vital signs were obtained at 3:17pm blood pressure 87/73, pulse 52, temp 96.8, respiration 17. Pt denied any medical history. Pt reported while donating blood had a similar reaction. EMS called and arrived at 3 :30pm. Pt stated she felt shaky, anxious, and lightheaded. FSBS 131. Pt reported feeling cold. EMS left the facility at 3:40pm. Pt declined EMS services, vital signs were rechecked at 3:20pm 134/69, 52, 17, 97.0, denied any pain. client stayed with nurses for 30 extra minutes and reported feeling better, no longer feeling light-headed, reported feeling weak. Pt was advised to call someone to pick her up as she drove herself. Pt declined stating that she lives an hour away and will be ok to drive herself home.
24 2021-03-22 feeling abnormal Lightheaded, fuzzy. BP low 90/50.
24 2021-03-24 poor quality sleep At 11:00pm on 03/23/2021 I started to feel sore from my shoulders to my knees. I also have a headach... Read more
At 11:00pm on 03/23/2021 I started to feel sore from my shoulders to my knees. I also have a headache that is not relieved with ibuprofen or Tylenol. The sore muscles make it hard to walk. I did not develop a low grade fever, but I did have a few hot flashes. I?m more fatigued than normal and haven?t been sleeping well at night since the last dose of the vaccine.
24 2021-03-28 feeling abnormal The next day I started feeling extreme fatigue. Other symptoms I?ve had are chest pain, congestion, ... Read more
The next day I started feeling extreme fatigue. Other symptoms I?ve had are chest pain, congestion, a slight cough, and brain fog. I have mucus buildup as well.
24 2021-03-29 feeling abnormal headache - not bad enough to need pain medication with my activity set for that day, but with a diff... Read more
headache - not bad enough to need pain medication with my activity set for that day, but with a different activity set I would have taken an OTC pain reliever - headache lasted throughout the first evening and got worse the next day. After about 36 hours it had resolved itself. strange feeling that I can best describe as "trippy" - lasted from about two hours after the vaccine until I went to bed that night - The cheese I ate with dinner tasted abnormally strong, I kept feeling like everything around me was moving even though it wasn't (felt like the floor / walls were moving - similar to when I'm super tired and / or severely jet lagged), and somehow colors seemed a little off. When I woke up the next morning this "trippy" feeling was gone.
24 2021-03-31 altered state of consciousness Pt received vaccine and was waiting in a chair for the required 15 minutes with her dad. after 10 mi... Read more
Pt received vaccine and was waiting in a chair for the required 15 minutes with her dad. after 10 minutes, she told her dad she was feeling dizzy and wanted a water. He left to get water. Another RPH saw pt. falling over in her chair. Patient's eye were open and tears were coming down but she could not speak. Her eyes began to close and she kept trying to pass out. We took pts mask off and fanned her and kept talking to her. After about 3 minutes, she was able to focus her eyes and could say her name. After about 3 more minutes, she was able to count to 10 backwards. Her dad returned. She drank water and was feeling much better after about 20 more minutes.
24 2021-03-31 insomnia Abnormal vaginal bleeding & cramps 48 hours after vaccine. Intense headaches. Insomnia.
24 2021-04-01 feeling abnormal patient with difficulty breathing and difficulty swallowing. she presented to ED once, no distress b... Read more
patient with difficulty breathing and difficulty swallowing. she presented to ED once, no distress but still feeling abnormal sensation. she was given steroids and potassium for low potassium and felt better. she returned a few hours later after she went to sleep and woke up with difficulty breathing and dysphagia again. this time her potassium and the rest of her blood work normalized, imaging was unimpressive and she was admitted for overnight observation. she was given benadryl, steroids and fluids the second time around.
24 2021-04-01 panic attack Panic attack after 15 minutes of the injection. Than more panic attacks the next day (4/2)
24 2021-04-02 feeling abnormal I started to feel out of it around 10pm the same day, and developed a fever. I felt dizzy and hot/co... Read more
I started to feel out of it around 10pm the same day, and developed a fever. I felt dizzy and hot/cold. The next day I had bad nausea, stomach pain, and diarrhea. I wasn?t able to keep food in my stomach, and kept having to use the bathroom. I was very tired and went to sleep around 4pm. I woke up about 30 mins later and had a fever of 103. I was shaky and out of it. I had diarrhea throughout the night, and still do today. I still feel shaky, but the fever has come down though I think it?s a low grade one still.
24 2021-04-05 anxiety Tight chest, anxiety. Vitals wnl - given water.
24 2021-04-05 feeling abnormal, depression Stomach cramping, severe dizziness, brain fog, depression, paranoia, general mood changes, joint sti... Read more
Stomach cramping, severe dizziness, brain fog, depression, paranoia, general mood changes, joint stiffness
24 2021-04-06 confusional state Systemic: Confusion-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Visual Changes/Distu... Read more
Systemic: Confusion-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Visual Changes/Disturbances-Medium, Additional Details: Pt arrived to recieve Pfizer vaccine. Pt reported that they experience fainting with vaccines and blood draws. Vaccine given. Mother of pt present. Pt passed out and was not responding to name. Pt regained clear vision and was able to respond normally within 5 minutes. Pt stayed and left with mother after 30 minutes.
24 2021-04-07 feeling abnormal Nausea - 12 hours Headache - 12 hours Body Aches - 12 hours Brain fog - 12 hours Fever (101 degrees ... Read more
Nausea - 12 hours Headache - 12 hours Body Aches - 12 hours Brain fog - 12 hours Fever (101 degrees F) - 12 hours, mitigated by Tylenol every 6 hours Sore Arm at site of injection - 12 hours
24 2021-04-08 crying PT WEEPING 10 MINUTES AFTER SHOT. CALLED 911 AT HER REQUEST. NO SYMPTOMS OF ANAPHYLAXIS. PT STATES S... Read more
PT WEEPING 10 MINUTES AFTER SHOT. CALLED 911 AT HER REQUEST. NO SYMPTOMS OF ANAPHYLAXIS. PT STATES SHE FELT COLD AND HANDS FELT STRANGE AS WELL AS MIDSECTION
24 2021-04-09 anxiety CC/tightness & SOB post Vax. Hx of asthma & Anxiety BP 130/70, HR 90, 19 02 99% RA Lungs clear BUL/... Read more
CC/tightness & SOB post Vax. Hx of asthma & Anxiety BP 130/70, HR 90, 19 02 99% RA Lungs clear BUL/BLL MD @ bedside Pt states she feels better.
24 2021-04-09 hallucination Uncontrollable chills lasting about 5 hours, hallucinations during that time, headache, joint pain, ... Read more
Uncontrollable chills lasting about 5 hours, hallucinations during that time, headache, joint pain, skin sensitivity/pain, fatigue, nasal congestion. All but the chills and hallucinations are ongoing as of almost 30 hours after being vaccinated.
24 2021-04-09 excessive sleepiness, feeling abnormal 7 AM (about 21 hours after I received the second dose) I woke up having the most intense nausea I h... Read more
7 AM (about 21 hours after I received the second dose) I woke up having the most intense nausea I have ever experienced. I went to my kitchen to get water and passed out, dropping the glass I was in the process of getting from the cabinet, and I crashed. I felt so horrible I just tried to get back to my bed at that point without getting water. I passed out again trying to get back to my bed, bruising my right knee and my ribs. One the most horrible feelings I have experienced. I stayed on the floor for a bit recovering the second spell. My sister heard the commotion and quickly brought me water and Tylenol. My head felt full of pressure that I couldn?t get rid of by holding my nose and blowing. Eventually that went away. I stayed in bed for the rest of the day drinking water and Gatorade. I felt like I had an intense flu for the remainder of the day with chills and fever. The following day I needed more sleep but felt better. Now today, Saturday I feel better, but I still feel shocked at how intense my body?s reaction was to the second dose.
24 2021-04-10 anxiety, nervousness, panic attack 445 PM - STARTED FEELING NAUSEA, HOT FLASH, NERVOUS, POSSIBLY DIZZY.. PATIENT SAID IT WAS PROBABLY ... Read more
445 PM - STARTED FEELING NAUSEA, HOT FLASH, NERVOUS, POSSIBLY DIZZY.. PATIENT SAID IT WAS PROBABLY A PANIC ATTACK/ANXIETY. PUT WET PAPER TOWEL ON BACK OF NECK AND WRISTS. ADVISED PATIENT TO LAY DOWN WITH FEET ELEVATED BUT SHE DID NOT WANT TO; SHE SAID SHE WAS FEELING BETTER. SHE SAID HER THROUGHT WAS NOT BOTHERING HER. HER BLOOD PRESSURE WAS 124/80 AND REGULAR HEART RATE. AT 520 PM PATIENT SAID SHE FELT FINE, BLOOD PRESSURE WAS 134/68, REGULAR HEART RATE. SHE SAID SHE WAS JUST A LITTLE NERVOUS ABOUT WHAT HAPPENED. OFFERED TO CALL 911 TO HAVE HER CHECKED OUT, PATIENT REFUSED. SUGGESTED FOR PATIENT TO CALL SOMEONE FOR A RIDE HOME, PATIENT REFUSED. 542PM - CHECKED IN WITH PATIENT. SHE IS STILL SHOPPING IN STORE AND SHE FEELS PERFECTLY FINE FEELS COMFORTABLE TO HEAD HOME.
24 2021-04-12 anxiety Site: Itching at Injection Site-Mild, Systemic: Fainting / Unresponsive-Severe, Systemic: patient ha... Read more
Site: Itching at Injection Site-Mild, Systemic: Fainting / Unresponsive-Severe, Systemic: patient has severe anxiety -Mild, Systemic: Shakiness-Mild, Additional Details: patient suffers from severe anxiety. Patient reported it has happened before with other vaccinations
24 2021-04-12 feeling abnormal Syncope while waiting in the waiting period for the 15 minutes. I felt weird and nauseous and starte... Read more
Syncope while waiting in the waiting period for the 15 minutes. I felt weird and nauseous and started having tunnel vision.
24 2021-04-14 abnormal dreams Very vivid, outlandish dreams
24 2021-04-14 anxiety Extreme shortness of breath rapide pulse; warm and sweaty; oxygen saturation = 100%; anxious
24 2021-04-14 crying Minimal pain around injection site within 15 minutes of receiving injection. Minimal pain until arou... Read more
Minimal pain around injection site within 15 minutes of receiving injection. Minimal pain until around 3 am, woke up with severe muscle pain that continued to worsen into the next day- 4/14/2021. I could barely move my arm, the pain had me in tears a few times. Accompanied by inflammation surrounding injection site. Used a cold pack on the area within the first 24 hours, it did not help nor did ibuprofen, naproxen sodium, or acetaminophen. Used a heating pad on low on the area to help with muscle stiffness, it helped minimally. Today, 4/15, the pain and inflammation is improved greatly but hives developed along with a very mild temperature. Symptoms improving overall
24 2021-04-14 disturbance in attention 24 year old female who has completed a 90 minutes-minute observation period with the following signs... Read more
24 year old female who has completed a 90 minutes-minute observation period with the following signs and symptoms of an adverse reaction: other - nausea, vomiting, dizziness, hot flashes, weakness 20 minutes after Pfizer-BioNTech COVID-19 vaccine # 1 in series administered. Action(s) taken: Vital sign at 1135 blood pressure ; 157/84, heart rate: 89, respiration ; 16, Spo2: 100% Repeat Vital sign at 11:47: blood pressure ; 146/95, heart rate: 96, respiration ; 16, Spo2: 100% Vital sign at 12:03: blood pressure ; 134/84, heart rate: 107, respiration ; 16, Spo2: 100 % Vital sign at 1215: blood pressure ; 142/87, heart rate: 97, respiration ; 18, Spo2: 100 % 1147: I called to the Urgent Care, spoke with Dr., recommended benadryl 25 mg po and continue monitor patient in the covid vaccination clinic. If patient symptoms do not improved to transfer patient to the urgent care or to the Emergency Room. - 1150: emesis x 1 no blood on emesis noted - 1205: benadryl 25 mg po given, patient was able to tolerated well. - Patient denies chest pain ,shortness of breath, diarrhea, abdominal pain, difficulty swallow, headache, or vision changes - Patient was able to tolerated small sip of water. - Patient continue complains of dizziness, nausea, and unable to focus. Patient was transfer to ER in no acute distress , report given to triage nurse Patient advised to discuss second dose considerations with a clinician
24 2021-04-15 disorientation, anxiety Syncope the evening of 4/12, witnessed by family. Woke up sweaty, chills and disoriented. Within 30 ... Read more
Syncope the evening of 4/12, witnessed by family. Woke up sweaty, chills and disoriented. Within 30 minutes overall felt much better. Residual symptoms the following day - chest tightness, anxious, fatigue.
24 2021-04-15 feeling abnormal Injection site soreness starting about 4 hours after injection (around 6:00pm) and lasting through t... Read more
Injection site soreness starting about 4 hours after injection (around 6:00pm) and lasting through the end of the following day. Body aches, soreness, and head fogginess starting at the beginning of the following day (4/15/2021) and lasting the entire day. Tylenol was taken multiple times for soreness and did slightly reduce soreness for a few hours.
24 2021-04-16 anxiety The patient received the Pfizer vaccine, given by HCP. After the vaccine, the patient felt a little ... Read more
The patient received the Pfizer vaccine, given by HCP. After the vaccine, the patient felt a little anxious with increased heart rate so she asked HCP for a bottle of water. HCP went to get the water and informed the pharmacist on duty. Both pharmacist and HCP came back to the patient. She got the bottle and was about to open the bottle, but closed her eyes and started shaking like having a seizure and passed out. She came back right after passing out but didn't know what happened. She then started shaking again for a few seconds but didn't pass out. Everything happened so quickly when she remained sitting on the chair. We called 911 and paramedics came. She mentioned that the seizure happened to her before, maybe once or twice a year. When paramedics came, they checked her blood pressure and it was ok. We asked her and she wanted to come to the hospital to check out to make sure that she is ok.
24 2021-04-18 anxiety Post vaccination pt. reports dizziness, lightheadedness, and feeling anxious. Pt. transferred to med... Read more
Post vaccination pt. reports dizziness, lightheadedness, and feeling anxious. Pt. transferred to med obs via stretcher accompanied by grandmother. Vital signs obtained and monitored, administered snack and water., pt. reports immediately feeling better after lying down and snack. Pt. escorted back to exit accompanied by grandmother at 1335. vital signs as follows, 1320 LYING BP 130/76 HR 89 RESP 17 02 93% 1324 SITTING BP 117/75 HR 79 RESP 17 O2 SATS 95% 1330 STANDING BP 132/74 HR 86 RESP 17 O2 SATS 95%
24 2021-04-19 sleep disorder 4/4: Woke up Easter Sunday with the following symptoms: sweats, chills, uncontrollable shaking, fati... Read more
4/4: Woke up Easter Sunday with the following symptoms: sweats, chills, uncontrollable shaking, fatigue, dizziness, nausea, and shortness of breath. Went to Urgent Care, but it was closed for the holiday, so instead went to ER. See Item 19 for details. I was discharged within an hour because there was nothing seriously wrong with me, doctor wrote it off as a stomach bug and ordered me to rest and hydrate. 4/4 - 4/10: Virtually every day for this week went the exact same. I would wake up between 6-7am, feel nauseous, weak, no appetite, and shaking. Walking around my apartment would leave me utterly exhausted. I would nap from 9am-12pm, then again from 2-4pm. Ate very little, drank water and sports drinks when awake. Breathing was still shaky. Occasional diarrhea. 4/10: Although slightly less ill than the previous 6 days, I still felt weak, shaky, and exhausted. I went back to Urgent Care this time, and the doctor examined me. She noted my left ear was very inflamed and suspected an ear infection. She prescribed me a week of amoxycilin and told me to rest and eat bland foods. 4/12: After 2 days on the antibiotics, some of my symptoms cleared. I was no longer shaking or having shortness of breath, and although still tired, I did not sleep for half the day as I had the previous week. My appetite was not fully there yet, and in the mornings of this week I would wake up feeling nauseous for about 2 hours. On this day 4/12 my period also started, which is unusual. It was not due to start until around April 17th. My period is very regular and light due to being on birth control, so I consider this abnormal. The flow was also very heavy. 4/17: Heavy flow of my period slows significantly and is now just a slight pink/brown color. I only need a liner to contain it. This is also my last day of antibiotics, so I buy a probiotic supplement in the hopes that it will help settle my gut. 4/17-present (4/20): The morning nausea and lack of appetite are still present despite being off the antibiotics. Occasional discomfort in abdomen/chest. Unexplained muscle soreness in hips, legs, back, and chest. My bowel movement schedule has also completely changed. Normally I do not experience a bowel movement until late morning, after 10am. But for the past 2 weeks I have been woken up around 5:30am with a sudden urge. At the beginning of my illness it was diarrhea but now it has transitioned to slightly more solid feces. It is not really diarrhea anymore.
24 2021-04-19 sleep disorder Received 2nd vaccine at 1:30pm on a Sunday afternoon. Woke up in the early hours of Monday not feeli... Read more
Received 2nd vaccine at 1:30pm on a Sunday afternoon. Woke up in the early hours of Monday not feeling great, didn't sleep well. Woke up at 8am for work with extreme chills, aches and pains. Tried to get up to get water, was so nauseous and lightheaded, I felt like I was going to pass out. Could barely stand up straight. Walked back to room and collapsed onto bed. Dry heaved into a trash can for a few minutes, feeling like I was about to throw up. Did not throw up. Took 2 Tylenol layed in bed, unable to move as I was extremely dizzy, nauseous and generally unwell. Fever of 99.?? (I forget). Fell asleep and woke up 2 hours later feeling better. Tylenol wore off around 5pm. Extreme chills and body aches came back. Fever of 100.4. Did not want to eat but had a few pieces of bread. Went to bed like normal that night. Felt almost back to normal the next day, still a little nausea with low energy but no fevers.
24 2021-04-20 nervousness Patient denied symptoms during 15-minute required observation period. When she got up from chair to... Read more
Patient denied symptoms during 15-minute required observation period. When she got up from chair to pick up vaccination card, endorsed near-syncope and bilateral lower extremity weakness like "she felt she was walking in sand." Denies visual symptoms, oral swelling, dyspnea, pruritis, nausea. Patient sat back down and was attended to. She was noticeably nervous (hand/leg shaking). SpO2 99%, HR 62. Patient endorses history of anxiety that is treated with beta blocker. Patient felt back to her baseline after approximately 15 additional minutes of rest and sipping on water. Trial of ambulation at that time with complete resolution of symptoms. She was cleared to return to work with return precautions.
24 2021-04-21 incoherent Patient collapsed while walking/running in the pharmacy waiting area. Patient was incoherent for se... Read more
Patient collapsed while walking/running in the pharmacy waiting area. Patient was incoherent for several minutes. Asked if she would like ambulance called, in which she replied yes. Ambulance was called. They assessed the patient and left her at the pharmacy to recover.
24 2021-04-22 feeling abnormal Systemic: Dizziness / Lightheadness-Mild, Additional Details: felt weird and dizzy, RN gave her wate... Read more
Systemic: Dizziness / Lightheadness-Mild, Additional Details: felt weird and dizzy, RN gave her water and juice, HR 89, O2 99%, BP 120/92. Advised to have ride home vs driving. Pt called for ride home, lives with roommate.
24 2021-04-24 feeling abnormal fatigue, brain fog, dizziness, body aches, pain at injection site, no appetite, feeling hot
24 2021-04-26 sleep disorder, anxiety - 24 hours after felt typical, fatigue, achs, and nausea - 4 days after my second dose I got severe ... Read more
- 24 hours after felt typical, fatigue, achs, and nausea - 4 days after my second dose I got severe upper back pain for two weeks (no prior history of back pain ever) - 10 days after my second dose I began to have severe acid reflux after anything and everything I ate. These symptoms have lasted for over seven weeks and are so bad to the point I cannot eat or sleep and have sought out emergency medical attention. In this same time period, I got what my doctors believe is Eosinophilic Esophagitis where my throat is now chronically inflamed, making it difficult to swallow. I am also experiencing extreme fatigue, anxiety, and mood swings when I never had a history of this. I have tried taking several medications and PPI's with no success as well as trying every type of diet and lifestyle change possible with no success. I have not recovered from this and expect it will be some time before I do.
24 2021-04-27 disorientation This incident occurred at a mass vaccination clinic. After the individual received her 2nd COVID-19... Read more
This incident occurred at a mass vaccination clinic. After the individual received her 2nd COVID-19 vaccine, she walked over to the monitoring area and sat down. After a few minutes she became dizzy and disoriented, and then fainted. She woke up face down on the floor surrounded by a RN, EMT, and Paramedic. Baseline of vitals obtained, registering a low BP. Patient was monitored until VS were all WNL. After patient was considered in stable condition, she was asked to walk a lap around the indoor venue to ensure she was well enough to leave. She did so without issue and stated she felt "back to normal" and was ready to leave. Patient was released at 15:07.
24 2021-04-28 impaired work ability Injection site started feeling sore after about four hours. The following day, my arm hurt much wors... Read more
Injection site started feeling sore after about four hours. The following day, my arm hurt much worse and the rest of my body began to ache throughout the morning. I developed a fever at 99.5°. Took Advil which helped a lot. Advil started to wear off at about 1:30. At that time, I became nauseous and a little dizzy. I ended up going home early from work because of it. That night, I had such intense pain around my midsection I could barely move and deep breaths such as a yawn hurt way more.
24 2021-04-28 sensation of foreign body POST VACCINE, C/O PULSATING LUMP IN THROAT, NUMNESS IN VACCINATED ARM, PAIN IN THROAT 2/10 WITH TIGH... Read more
POST VACCINE, C/O PULSATING LUMP IN THROAT, NUMNESS IN VACCINATED ARM, PAIN IN THROAT 2/10 WITH TIGHTNESS FOLLOWING AFTER, AS WELL AS PRESSURE IN EAR. BILATERAL LS CLEAR, TOLERATING COLD WATER, STARTED TO IMPROVE. SIG OTHER COMING TO DRIVE PATIENT HOME, AND BROUGH HOME MEDS INCLUSING FLONASE, PATIENT USED AND STATED FELT MUCH BETTER. VSS THROUGHOUT. ESCORTED TO EXIT WITH NO ISSUES ONCE S/S IMPROVED, INSTRUCTED TO SEEK FURTHER EVAL/TREATMENT IF S/S RETURN/WOSREN. EXITED 1600. 1503 BP 119/81 HR 67 RR 20 SATS 99% RA 1515 BP 124/81 HR 94 RR 18 SATS 100% RA 1545 STANDING BP 118/84 HR 80 RR 20 SATS 100% RA
24 2021-04-29 anxiety Shakes, chills, hot flashes, extreme soreness throughout entire body, headaches,fever, muscle pain, ... Read more
Shakes, chills, hot flashes, extreme soreness throughout entire body, headaches,fever, muscle pain, lightheaded ness, increased anxiety,
24 2021-04-30 impaired work ability Second dose seemed to be placed higher than the first. Pain started roughly four hours later and I c... Read more
Second dose seemed to be placed higher than the first. Pain started roughly four hours later and I could not move my arm for 5 days at all without being in excruciating pain. I started stretching arm out and most of pain went away but I still cannot go to work and function normally without being in major pain, 9 days later.
24 2021-05-01 crying, sleep disorder, feeling abnormal Woke up at 2am crying from whole body being in pain. Could not stop shivering even when covered in 4... Read more
Woke up at 2am crying from whole body being in pain. Could not stop shivering even when covered in 4 blankets but also sweating. Managed to sleep for a few hours before waking up with the worst headache- it felt like someone had wrapped something around my head and was squeezing. Moving made it worse. Could barely stand and head was foggy.
24 2021-05-02 anxiety, crying Received her first dose Pfizer vaccine (LOT#: EW0173 EXP: 8/2021) at 1009 on 5/02/21. PHN was alerte... Read more
Received her first dose Pfizer vaccine (LOT#: EW0173 EXP: 8/2021) at 1009 on 5/02/21. PHN was alerted by EMT who was told by patient that vaccinator made her anxious about the vaccine. Patient stated that vaccinator told her she was bleeding more than usual and that there was a small bump on her arm. EMT contacted patient at 1015. Patient reported swelling and hematoma at injection site. At 1025 patient reported feeling anxious and was crying. PHN assessed patient and reassured her the swelling in her arm was going down. PHN educated patient on worsening signs and symptoms at injection site and treatment of swelling. Patient verbalized understanding. PHN asked EMT to take vital signs. EMT took patients vital signs at 1033. BP: 140/111, pulse: 72, RR: 20. EMT reassessed patient at 1040. Patient stated that she was feeling a lot better and less anxious. EMT retook patients vital signs at 1042. BP: 142/108, pulse: 66, RR: 20. Patient had completed her observation time. Patient left at 1045 by herself, unassisted with a steady gait.
24 2021-05-07 delirium, memory impairment Delirium; mumbling unintelligbly; shaking uncontrollably; not recognizing family members; This is a ... Read more
Delirium; mumbling unintelligbly; shaking uncontrollably; not recognizing family members; This is a spontaneous report from a non-contactable healthcare professional, the patient. A 24-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient did not receive other vaccine in four weeks. The patient did have COVID prior vaccination and the patient did not test for COVID post vaccination. On an unspecified date, the patient experienced delirium at night of given dose in the morning. The patient was not feverish, but she was mumbling unintelligibly, shaking uncontrollably and not recognizing family members. The patient received ibuprofen and acetaminophen as the treatment for the events. the outcome of events, delirium, mumbling unintelligibly, shaking uncontrollably and not recognizing family members was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on chronological connection to the vaccine a causal relationship between event delirium and BNT162b2 (PFIZER-BIONTECH COVID-19 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.
24 2021-05-07 excessive sleepiness Tremendous headache; sore arm; exhaustion. My arm was sore somewhat from when the moment I got my va... Read more
Tremendous headache; sore arm; exhaustion. My arm was sore somewhat from when the moment I got my vaccine. My headache started around 5:30-6:30 pm but was terrible from 6:40 pm for almost exactly 24 hours to the minute. I was so tired I laid around all day and slept from 8:30pm until 3:50am, when I woke up in a lot of pain and aches in my head. I?d also sweated through my pjs and sheets. Once I got back to sleep at around 5:30am, I slept until around 9:00am. I still felt very tired and had a very bad headache until around 4pm I took some Ibuprofen which helped with the aches somewhat. Then at around 6:40pm I had a moment where all the sudden I could open my eyes more & could handle light (I?d shut all windows and turned off all lights when my headache began). Storms were coming in so I started to feel a sinus headache which I think was coming from that, so I took Sudafed and Ibuprofen at around 8:30pm.
24 2021-05-07 excessive sleepiness About 12-13 hours after receiving the second dose, I began getting a bad headache, which let to naus... Read more
About 12-13 hours after receiving the second dose, I began getting a bad headache, which let to nausea and chills. I am usually hot in the middle of the night, but I couldn't get warm. I woke up the next morning feeling like I had been hit by a bus. My entire body was sore, my head still pounded and was nausea. That continued for the rest of the day. I was extremely tired but had to work. Could barely eat. Was hot and cold at the same time. After work slept for 11 hours, woke up and ate, then slept for 2 more hours. Continued to be fatigued for the next 5 days, making it hard to work.
24 2021-05-09 insomnia Extreme pain in shoulder that has lasted 3 weeks. Inability to move shoulder or function properly. I... Read more
Extreme pain in shoulder that has lasted 3 weeks. Inability to move shoulder or function properly. Inability to sleep because of deep throbbing sensation.
24 2021-05-10 anxiety DOB: 11/06/1994. Received her second dose Pfizer vaccine (LOT#: EW0179 EXP: 8/2021) at 1426 on 5/10... Read more
DOB: 11/06/1994. Received her second dose Pfizer vaccine (LOT#: EW0179 EXP: 8/2021) at 1426 on 5/10/21. Patient alerted one of the ancillary at site and stated that she was not feeling well. Ancillary staff alerted EMT Cand EMT. EMT's sat patient down on zero gravity chair. Patient stated that she felt a burning sensation in her chest and her throat about 10 minutes after the vaccine. PHN arrived on scene and offered patient water and asked EMT to take patients vital signs. EMT took vital signs at 1500. BP: 130/82, HR: 83, RR: 22, O2: 100%. Patient stated that she has a history of anxiety and does not take medications for her diagnosis. Patient was ANOX4, skin warm, normal. Patient stated that breathing slowly, drinking water and talking are her coping mechanisms for her anxiety. PHN asked patient to stay an extra 30 minutes for observation. EMT reassessed patient and re-took vital signs at 1515. BP: 116/65, HR: 62, RR: 20, O2: 100%. Patient stated that she no longer had any burning sensation but still felt anxious. EMT reassessed patient and re-took vital signs at 1530. BP: 111/61, HR: 75, RR: 20, O2: 100%. Patient stated that she no longer felt any burning sensation but still felt anxious. Patient had completed observation time but asked to stay a little longer. Patient stayed 8 minutes extra. EMT reassessed patient. Patient stated she was feeling better and no longer felt anxious. Patient was educated on worsening signs and symptoms of side effects of the vaccine and when to seek help from EMS. Patient verbalized understanding of education. Patient left vaccination site at 1538 unassisted with a steady gait.
24 2021-05-11 insomnia chills; sore arm; nausea; acid reflux causing extreme damage to the esophagus; cannot eat or sleep; ... Read more
chills; sore arm; nausea; acid reflux causing extreme damage to the esophagus; cannot eat or sleep; cannot eat or sleep; rapid weight loss; Eosinophilic Esophagitis; cripeling upper back pain; This is a spontaneous report from a contactable consumer (patient). A 24-year-old female patient (non-pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL1283), via an unspecified route of administration on 01Mar2021 as 2nd dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL1283) on 08Feb2021 for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications was received within 2 weeks of vaccination. On 15Mar2021, the patient experienced chills, sore arm, nausea, acid reflux causing extreme damage to the esophagus, cannot eat or sleep, rapid weight loss, eosinophilic esophagitis, cripeling upper back pain. Therapeutic measures were taken as a result of the events and included PPI's, diet and lifestyle changes. The events resulted in doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events chills, sore arm, and nausea was unknown; and the outcome of the other events was unknown. Events were serious due to disability (as reported). Information on lot/batch number was available. Additional information has been requested.
24 2021-05-12 disorientation Patient complained of feeling disoriented and sick to her stomach. Pain worsens if patient moves aro... Read more
Patient complained of feeling disoriented and sick to her stomach. Pain worsens if patient moves around. Patient has received water from vaccinator. Patient recovered and was released at 2:45 pm. At 2:26pm, the heart rate was at 79 bpm and the blood pressure was at 143/85. The oxygen saturation and respirations were normal. At 2:36pm, the heart rate was at 72 bpm and the blood pressure was at 135/84. The oxygen saturation and respirations were normal. At 2:43pm, patient had normal respirations and oxygen saturation. Heart rate was at 77 bpm and blood pressure was at 126/72.
24 2021-05-12 panic attack, anxiety Severe Panic Attacks and Anxiety, high blood pressure, high heart rate, red welts on forearms and ch... Read more
Severe Panic Attacks and Anxiety, high blood pressure, high heart rate, red welts on forearms and chest. Anxiety still persistent after 6 weeks
24 2021-05-14 anxiety On Friday, May 14th, 2021 client received her first dose of Pfizer COVID vaccine to left deltoid (LO... Read more
On Friday, May 14th, 2021 client received her first dose of Pfizer COVID vaccine to left deltoid (LOT # EW0182, EXP 5/15/21) at approximately 11:04 AM. Pt verbalized the only medication she is on is hormonal birth control, and has a history of a Penicillin allergy, no further allergies or conditions indicated. After receiving the vaccine, the client told RN that she has a history of anxiety and syncopy after blood draws. Pt sat at the vaccine station and stated she was feeling very weak and anxious. Co-lead RN and Lead RN noticed pt across the room and went to assess around 11:10. Upon observation, pt looked pale in color and had cool, clammy skin. While at vaccine station, pt had small emesis x2 at 11:12 am. At 11:10 am vitals were taken by EMT : BP: 126/89, HR: 99, O2: 100%. Client was escorted to the zero-gravity chair and was given a bottle of water and Gatorade. Upon assessment by EMTs client's last meal was cereal at 09:00 am. At 11:35 am vitals were taken: BP: 88/74, Hr: 77, RR: 16, O2 sat: 99%, with a strong radial pulse. Immediately after, Co-Lead RN offered pt chips as pt had no further episodes of emesis. Pt sat in zero-gravity chair eating chips and vitals were taken again at 11:55 am, BP: 88/78, HR: 79, RR: 20, and O2: 98%. At that time pt stated that she was ?feeling much better?. At 12:05 pm, final vitals were taken, BP: 95/65, HR: 74, RR: 20, O2: 98%. Patient was alert and oriented x4 during entire interaction. No further interventions indicated. Pt was educated by Co-Lead RN and Lead RN on signs and symptoms of adverse reactions and when to go to the ED/call MD. Pt was able to ambulate with her brother-in-law to her car unassisted with a steady gait at approximately 12:07 pm.
24 2021-05-14 insomnia 9pm started to get really tired...9:30pm began to feel nauseous and get the chills so went to bed. C... Read more
9pm started to get really tired...9:30pm began to feel nauseous and get the chills so went to bed. Couldn?t sleep because of chills but fell asleep around 11:30pm. Woke up around 2:20am because my fever broke. I went downstairs to get water and realized I was starting to get a headache similar to the one I had when I was diagnosed with Covid. Woke up at 10am with a pounding headache and couldn?t get out of bed. Wound up taking ibuprofen around 10:30am and felt so much better the rest of the day. No symptoms since.
24 2021-05-15 delirium Patient 3 minutes after receiving the Pfizer first dose vaccine was manifesting symptoms of dizzines... Read more
Patient 3 minutes after receiving the Pfizer first dose vaccine was manifesting symptoms of dizziness, nausea, delirious and out of focus as verbalized. EMT came and took vital signs (BP 124/80& Pulse 85) and attended right away. Patient has history of anxiety for 10 years and was anticipating this to happen. Patient was alert and coherent during assessment and verbalized that she was fine and wanting to go home. Second and Final VS (BP-120/78 & Pulse-80) were taken before leaving.
24 2021-05-18 anxiety Fever; breathing poorly; chills; anxiety; vomiting every 30 min for hours and can't hold any food or... Read more
Fever; breathing poorly; chills; anxiety; vomiting every 30 min for hours and can't hold any food or liquid down; soreness of her arm at the injection site; throat was closing; This is a spontaneous report from a contactable consumer (parent). A 24-year-old female patient received BNT162B2 (COMIRNATY, Formulation: Solution for Injection, Lot Number: EL9262), via an unspecified route of administration, on an unspecified date at 08:30 (at the age of 24-year-old) as 2nd dose, single, in left arm for COVID-19 immunization. The patient's medical history included allergic to penicillin when she was little. Concomitant medications were not reported. the patient previously received first dose of BNT162B2 (Lot Number: EL3246), via an unspecified route of administration, on 05Jan2021, as single dose in the left upper arm for COVID-19 immunization, and experienced breathing issues ever since the first vaccine. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within two weeks of vaccination. There was no illness at time of vaccination. On an unspecified date after second dose, the patient experienced fever, breathing poorly, vomiting every 30 min for hours and can't hold any food or liquid down, so she was just vomiting bile. Patient had chills and fever. Patient could not eat or hold anything down. Breathing was really laboured. Right after receiving vaccine, patient felt like her throat was closing and doctor watched her for an hour. On an unspecified date, at 01:00 in the morning, patient felt like she can't breathe and felt like anxiety. Patient experienced soreness of her arm at the injection site, but this was to be expected. patient followed basic treatment methods, by staying hydrated, applying Vapor rub on chest and under nose, which helped her, and did not use Acetaminophen and hydration drink which she had. The clinical outcome of the events soreness of her arm at the injection site and throat was closing was unknown. The clinical outcome of all other events was not recovered. Follow-up attempts are completed. No further information is expected.
24 2021-05-23 anxiety Within 20 minutes I felt like I couldn?t breathe my whole body went numb and I felt like I was gonna... Read more
Within 20 minutes I felt like I couldn?t breathe my whole body went numb and I felt like I was gonna pass out. I had chills, cough, nausea, body aches, loss of appetite , shortness of breath , accelerated heart, and chest pain. Since the day of the vaccine I have been struggling with my physical and mental health. I?ve been in and out of hospitals, doctors, specialist.
24 2021-05-24 feeling abnormal up all night with diarrhea; dry heaving; headache,splitting headache; chills; sick; felt tired,fatig... Read more
up all night with diarrhea; dry heaving; headache,splitting headache; chills; sick; felt tired,fatigue; brain fog; nausea; This is a spontaneous report from a contactable consumer (patient). A 24-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EM9809), via an unspecified route of administration, in Arm Right on 10Feb2021 at 12:00 (at 24 years) at single dose for covid-19 immunisation. Medical history included seasonal allergy. Patient previously took Levaquin and had allergy. The patient previously took the first dose of the vaccine on 15Jan2021 at 10:00 am (at 24 years; lot EL9261) administered in right arm for covid-19 immunisation with no adverse event.Concomitant medications included probiotics, cetirizine hydrochloride (ZYRTEC), ergocalciferol (VIT D) and birth control pills (unspecified). Patient received second dose of the vaccine on 10Feb2021 and she felt tired and sick on 11Feb2021 and on 12Feb2021. On 13Feb2021 night patient was up all night with diarrhea, dry heaving, chills and headache. On 14Feb2021 she was in bed all day. Every day since then (Feb2021) she had a horrible splitting headache, nausea, brain fog, fatigue and chills. She had not had a fever. Her doctor tested her for covid via Nasal swab on 17Feb2021 and she was negative. On 17Feb2021 she also ran comprehensive metabolic panel and other labs and they were normal. Her symptoms point towards an extreme and long reaction to the covid vaccine. Events required doctor or other healthcare professional office/clinic visit. Treatment included Prescription nausea medication. The final outcome of all the events was recovering.
24 2021-06-02 amnesia, feeling abnormal, sleep disorder So at around 9pm the evening of my shot, I started feeling feverish so I went to the other room to g... Read more
So at around 9pm the evening of my shot, I started feeling feverish so I went to the other room to get my temperature and while I was waiting for my temperature to be recorded, I started to feel lightheaded and I called out for help. I woke up on the floor, I woke up to my roommate and boyfriend standing over me. They were on the phone with 9-1-1. I was out for about a minute and unresponsive. According to them, my arm was flailing and seizure-ish. I went to the ER, I was taken by EMS services. They gave me fluids and ran bloodwork and monitored me. They sent me home, I did have another episode of what I think was an episode of memory loss/passed out. I just remembered waking up in a room alone. I was at the ER for about 4-5 hours. They gave me IV fluids and I don't remember what else, some sort of supplement. It was magnesium oxide they gave me. When I left the ER I was really exhausted, and feverish and gross and I was pretty sick for the remaining two days. I didn't sleep well that night, I had a fever the following day and into the second day upon returning home as well.
24 2021-06-03 disturbance in attention soreness and pain on injection site; fatigue; muscle aches; unable to focus; This is a spontaneous r... Read more
soreness and pain on injection site; fatigue; muscle aches; unable to focus; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EB6202), via an unspecified route of administration in the right arm on 17Mar2021 at 11:30 (at the age of 24-years-old), as single dose for COVID-19 immunisation. Medical history included decreased blood sugar, vitamin D deficiency, ovarian cyst and was diagnosed with COVID-19 virus prior to vaccination. The patient was allergic to bananas (fruit allergy). Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. On 17Mar2021, the patient experienced soreness and pain on injection site, fatigue, muscle aches and was unable to focus. No therapeutic measures were taken for the reported events. The clinical outcome of the soreness and pain on injection site, fatigue, muscle aches and unable to focus were not recovered/ongoing. No follow-up attempts are possible. No further information is expected.
24 2021-06-03 loss of personal independence in daily activities, panic attack Suspected bursitis with prolonged arm pain and weakness 2 weeks after first Pfizer dose. On the day ... Read more
Suspected bursitis with prolonged arm pain and weakness 2 weeks after first Pfizer dose. On the day of vaccination, I had a panic attack and nearly blacked out after vaccination, something that had never happened to me after a vaccination. Once the pain started a few hours after vaccination, it significantly increased. I experienced excruciating pain in my left arm like I had never felt after any other vaccination. Complete inability to move my arm without pain; the pain persisted even with zero movement whatsoever. Within the first 12 hours the pain spread to my entire left shoulder, and within 24 hours the pain spread to my neck, and general upper left quadrant of my body to the point where inhaling deeply would cause chest pain on my left side. This extreme pain persisted for about 3-4 days. After about the 5th day, my left arm still felt different and weaker than my right arm but little pain remained. After the 7th day, pain started back up whenever I tried to use my arm in any way. The days went on and the pain and arm weakness is not passing. It is minor pains, aches, and occasional throbbing compared to those first few days after vaccination but chronic pain nonetheless. My left arm continues to feel weak and I have a concentrated area of pain directly where the vaccination site was, it's as if I could still feel exactly where the needle went through my body. My arm feels okay pain-wise upon waking most days but I am unable to do anything as simple as chopping vegetables or washing dishes without feeling pain for the rest of the day. I am unable to even wear a backpack for more than 10 minutes without my left shoulder hurting and feeling fatigued.
24 2021-06-06 anxiety Patient states feeling anxiety. Patient states she felt nausea. No vomit and rapid heart rate. HR... Read more
Patient states feeling anxiety. Patient states she felt nausea. No vomit and rapid heart rate. HR 88, RR 22. 6:25pm Patient left accompanied by aunt. was walking c/1 steady gait with vitals within normal limits. Patient recommended to seek medical attention if any other adverse reactions arise.
24 2021-06-07 confusional state Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsiv... Read more
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Weakness-Mild, Additional Details: Patient fainted shortly after recieving the first dose of the Pfizer COVID19 vaccine. Her brother was able to catch her before she hit the floor and regained consciousness 10 seconds after fainting. She felt flushed, sweaty and dizzy. She was seen by EMTs who arrived on site and pronounced her fine. Patient refused to go to the hospital to get checked out. Patient remained in the pharmacy until she was able to successfully walk around the store anf felt fine before leaving.
24 2021-06-10 confusional state Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Letha... Read more
Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Severe, Systemic: symptoms consistent with serotonin syndrome, likely unrelated to vaccine after discussion with caregiver-Medium, Systemic: Headache-Medium, Systemic: Tachycardia-Medium, Systemic: Tingling (specify: facial area, extemities)-Severe, Additional Details: Pt on multiple sertonergic agents and additionally admitted to taking st john's wort, which was never discussed with psych or pharmacy. Pt never had trouble breathing and was released with husband and 2 caregivers with instructions to call MD immediately and report to ER. Not likely related to vaccination, however reporting just in case. symptom onset was almost immediately after vaccination.
24 2021-06-13 sleep disorder 01/27/2021- That afternoon, I started to feel feverish, temp was lightly elevated, I waited to treat... Read more
01/27/2021- That afternoon, I started to feel feverish, temp was lightly elevated, I waited to treat the fever to see if it would raise or if it was nothing. Around 10pm it had raised to 101 and I developed body aches and chills, muscle aches and back pain, joint pain, fatigued, loss of appetite, it caused sleep issues, I started taking Tylenol and then rotated with ibuprofen , which brought temp to 100 but not back to normal, next day I finally fella sleep and slept for about 12 hours, when I woke my peak temp was 102.3, this would have been while the Tylenol and ibuprofen was no longer active in my system. I had a mild sore throat, slight post nasal drainage. A day or two after I saw the Dr. and was examined. No relief from Bromfed.
24 2021-06-18 insomnia Immense back pain; vomiting; Nausea; super fatigued; Migraine; not sleeping or sleeping over 20 hour... Read more
Immense back pain; vomiting; Nausea; super fatigued; Migraine; not sleeping or sleeping over 20 hours.This has been happening for 5 days; This is a spontaneous report from a contactable other healthcare professional, the patient. A 24-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID 19 mRNA VACCINE; lot number:en6206) via an unspecified route of administration in left arm, on 12Mar2021 at 16:45 (at the age of 24-year-old),as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Concomitant medication included citalopram (CELEXA) for unknown indication from unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced Immense back pain, vomiting, nausea, fatigue, migraine and difficulty sleeping on 14Mar2021 at 00:00. The patient did not receive any treatment for the reported events. The clinical outcome of Immense back pain, vomiting, nausea, fatigue, migraine and difficulty sleeping was not recovered. No follow-up attempts are needed. No further information is expected.
24 2021-06-21 feeling abnormal Fever, elevated heart rate 30+ point above normal. Stomach pains and stomach cramps. Fatigue. Back a... Read more
Fever, elevated heart rate 30+ point above normal. Stomach pains and stomach cramps. Fatigue. Back aches. Overall bad feeling. Rare chest pain.
24 2021-06-22 sleep disorder Some injection site pain, felt okay until 04:00am 06/23. Woke with a screaming migraine (head, eyeba... Read more
Some injection site pain, felt okay until 04:00am 06/23. Woke with a screaming migraine (head, eyeballs, neck) with an extreme sensitivity to light, sound, or movement; joint swelling, chills, fever, muscles aches and spasms, dizziness, weakness in the muscles, nausea, and an inability to ingest sustenance. Lastly, a very large feeling of unwellness.
24 2021-06-23 memory impairment, confusional state 12 days after my 2nd covid vaccine I had my 1st seizure. I've never has any seizures before and sinc... Read more
12 days after my 2nd covid vaccine I had my 1st seizure. I've never has any seizures before and since then I've had seizures nearly every day. My symptoms during my 1st seizure were; couldn't understand words, couldn't remember my wife's name, convulsions, and migraine.
24 2021-06-23 sleep disorder woke up from sleep with tightness in chest about 3:00 am April 26th, couldn't take deep breath and c... Read more
woke up from sleep with tightness in chest about 3:00 am April 26th, couldn't take deep breath and could hardly breath, left arm started going numb when i got to the ER at 4 am. Felt like my heart was going to beat out of my chest. couldn't lay down. had a sharp pain in the left side of my chest. This lasted almost the whole day Monday the 26th, would get a little better then woke up again on the 27th with the same pain. My pain was at about an 8.5/10. I would take tylenol and ibuprofen to control the pain. After about 5 days the pain had gone completely away.
24 2021-06-24 anxiety After the first dose had a headache, after second dose started having heart palpitations. Anxiety ha... Read more
After the first dose had a headache, after second dose started having heart palpitations. Anxiety has gotten worse.
24 2021-06-24 excessive sleepiness Constant fatigue and hypersomnia. Blood tests normal, waiting to see sleep specialist.
24 2021-06-24 sleep disorder The day after my vaccination i had a bad cheat pain, i thought it was gas. The next day after noon i... Read more
The day after my vaccination i had a bad cheat pain, i thought it was gas. The next day after noon i started to get rapid and hard heartbeats that were a little annoying. I thought those were only momentary, but they lasted all night. And since then, every day i have that same symptom that makes me t up at nights because of the loud heart beat
24 2021-06-30 crying The patient told that she fainted after she got the first dose of pfizer vaccine. she cautioned us t... Read more
The patient told that she fainted after she got the first dose of pfizer vaccine. she cautioned us that it may happen again. the patient dad is with her. After 5 minutes getting the vaccine she felt dizzy and she started crying and we called 911 and before the paramedics came the patient recovered and refused to go to the hospital.
24 2021-07-01 amnesia I have short term memory loss and gastrointestinal issues. I also have extreme back pain.
24 2021-07-08 feeling abnormal Head fogginess; tiredness; feeling unwell; Nausea; light vomiting; This is a spontaneous report from... Read more
Head fogginess; tiredness; feeling unwell; Nausea; light vomiting; This is a spontaneous report from a non-contactable consumer, the patient. A 24-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ERB727), via unspecified route of administration, at left arm on 25Mar2021 at 9:00 (at the age of 24-year-old) as a single dose for COVID-19 immunisation. The patient medical history included anxiety, depression, asthma. Concomitant therapy included venlafaxine hydrochloride (EFFEXOR), doxycycline (MANUFACTURER UNKNOWN), cetirizine hydrochloride (ZYRTEC) for unknown indication. The patient was not allergic to medications, foods or other products. 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 25Mar2021 at 11:00 (within 2 hours of vaccine), the patient experienced head fogginess, tiredness and feeling unwell whereas, she experienced nausea and vomiting later on (as reported). No therapeutic measures were taken for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcomes of the events head fogginess, tiredness, feeling unwell, nausea and vomiting were resolved on unknown date in Mar2021. No follow-up attempts are needed. No further information expected.
24 2021-07-10 anxiety Heartbeat raising like tachycardia; going up 115 and then dropped down to 65; Average heartbeat is a... Read more
Heartbeat raising like tachycardia; going up 115 and then dropped down to 65; Average heartbeat is around 65-70 but still feels like heart is racing; It felt some pain in my ribs every time; I do have medicine allergy; heightened anxiety; This is a spontaneous report from a contactable consumer(patient) reported that. A 24-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, dose 1 via an unspecified route of administration on 11May2021 (age at vaccination was 24-year-old) (Lot Number: EW0173 Expiry date was UNKNOWN) as a SINGLE DOSE for covid-19 immunisation. Medical history included asthma and Anaphylaxis to some food allergies from an unknown date and unknown if ongoing. Concomitant medication included albuterol sulfate 90 mcg (Inhaler about 1-2 puffs as needed) (ALBUTEROL SULFATE) taken for asthma, start and stop date were not reported; loratadine (took every 12 hours rather than 24 hours, but do not know the dosage) (CLARITINE) taken for an unspecified indication, start and stop date were not reported. On an unknown date patient stated that few days after vaccination probably on thursday started feeling like her heartbeat was raising a little bit, but she didn't really think it was that much figured it was maybe because she worked out that morning or maybe she had much coffee or something. she didn't do anything in last couple of days and her heartbeat has been going up and down doing actually nothing, it was 115 and then dropped to 65. It feels almost like tachycardia. Average heartbeat was around 65-70 but it still feels like heart was racing even though she was taking oxygen puff and it says normal. On Friday her heart rate going up every time. she was breathing in the right side of her chest and it was about for 30 minutes. It felt like there was some pain almost in her ribs every time she takes a deep breath to relax herself, the patient had medicine allergy. She mentioned that her heart would start racing out of nowhere, which had then caused her heightened anxiety. While sitting down, her pulse would go up to 115 then drop to 50- 60. She already went to a doctor and they were not sure, so she was referred to a cardiologist. She mentioned that it was almost like sinus tachycardia. No treatment received for the events. The patient underwent lab tests and procedures which included heart rate 115, going up 115 and then dropped down to 65, heart rate 65, going up 115 and then dropped down to 65, heart rate 65-70, average heartbeat was around 65-70. The outcome of the events was unknown. Information on the lot/batch number has been requested.
24 2021-07-14 sleep disorder I woke up shortly after falling asleep feeling as though someone had punched me in the chest as hard... Read more
I woke up shortly after falling asleep feeling as though someone had punched me in the chest as hard as they could. I was unable to draw in a breath or breathe at all. I shook my boyfriend awake and he could see I was passing out. My head began to fall back as I passed out from lack of oxygen. After this I was weak and was short of breath. An ambulance was called. I also ended up going to the ER. Throughout weeks after I had other heart episodes and tests. It was believed to be possible heart arrhythmias. I had a heart monitor for about two and a half weeks for testing. We have still not found answers and I still have episodes where my heart will randomly take off and race uncontrollably and I will get faint. I deal with chest pain on a regular basis. I have no history of heart issues and previously was always told I had a healthy heart. My current medications I have been on for some time and have never caused me issues. Ever since I received my second vaccination my heart hasn?t been the same.
24 2021-07-16 crying, sleep disorder Left arm extremely sore (interfered with sleep, feels like a significant shoulder/arm injury). Extre... Read more
Left arm extremely sore (interfered with sleep, feels like a significant shoulder/arm injury). Extreme headache. General muscle soreness and joint aches and pains. Significant nausea. Pain going down left leg. Fever/chills. Curled up on couch sobbing from pain.
24 2021-07-18 disorientation, loss of personal independence in daily activities 05/08/2021 (about 12 days after 2nd vaccine): Started feeling a little dizzy. Short bursts of dizzin... Read more
05/08/2021 (about 12 days after 2nd vaccine): Started feeling a little dizzy. Short bursts of dizziness lasting no longer than 20-30 seconds occurring about 1-3 times a day at most. Did nothing about it because it was extremely manageable. From 5/08-06/18: Dizziness continues in small time frames throughout this period of time. Doesn't get better but also does not get worse. 06/18/2021: Dizziness worsens slightly and finding it hard for eyes to focus at work. Did nothing about it because it was manageable at the time. 06/22/2021: Dizziness has become unmanageable. Eyes won't focus, room is spinning, feel slightly nauseous, feel like I'm going to pass out, can't do my work properly. Go to walk in clinic right after work. Taking a ride share because I am so dizzy I am nervous to drive. Find that I have an impacted ear-clean it out and go back home. 06/23/2021: Go back in to work. Think I'm feeling better. Almost pass out at work, dizziness is worse than before. Leave work early and spend the rest of the week working from home. 06/24/2021: Dizziness does not improve. Barely able to get work done. Dizziness progresses into a headache and feel nauseous all the time. Go to walk in clinic again and get referred to an ENT. 06/26/2021: Do some digging on the internet and find antihistamines provide some relief for vertigo. Take 1 10mg dose of Zyrtec and feel some relief about 2 hours later. 06/28/-7/02: Return to work for the week because Zyrtec has provided enough relief that it is relatively easy to get work done. Manage to get things done enough. 06/30/2021: Go to ENT. Do hearing tests, etc. and Dr. says ears are not the cause and everything looks good. Get referred to a neurologist. 07/02/2021: Pass out. Feel so dizzy I can't figure out which way is up or down. 07/06-07/09: Continue to work out of the office. Feeling same as previous week. Zyrtec still providing some relief. 07/09/2021: Pass out again. Super dizzy again. 07/12-07/15: Work out of the office again. Zyrtec starts to feel like it is not providing relief anymore. 07/15/2021: Leave work early and work from home the rest of the week. Go to pharmacy and buy Claritin, Allegra, and generic brand Claritin 07/16/2021: Take Allegra and think it provides relief. It works well enough. 07/17-07/19: Allegra is no longer working and back to square 1. Pushing through symptoms and trying to manage at work. No clue what is causing symptoms. 07/17/2021: Take Allegra
24 2021-07-19 anxiety, impaired work ability February 2021 I received my 2nd dose of Pfizer. A day later I experienced flu like symptoms which we... Read more
February 2021 I received my 2nd dose of Pfizer. A day later I experienced flu like symptoms which went away within 3 days. About a week later I experienced dizziness and nausea. I did not have an appetite and could not eat well for about 3 weeks. I got an upper endoscopy which found mild acid irritation to my stomach (gastritis) and I was placed on medication. I then proceeded to get a gastric stomach emptying test, HIDA scan for constant nausea. I went to PT for dizziness. This is now July and I have been to an ENT doctor, received CT scan for dizziness checking my sinuses. Went to a neurologist for an MRI for headaches and dizziness. Everything came back fine but I am now to the point I can barley work and it is July. I have gone to acupuncture as well but nothing is working. On Friday I ate gummy bears and my heart rate went to 160, chest tightness, tongue itchy and shaking. The hospital did not find anything and reported this as an anxiety attack. I ate gummy bears again on Sunday and the same thing happened. I am wondering if the shot trigger this and how can I get help? I was fine before this and I am looking for answers. I am not blaming the shot, I would just like feedback on how to help. Thank you.
24 2021-07-19 feeling abnormal, confusional state, thinking abnormal Confusion; Trouble with walking straight; Vertigo; Feeling tired; Chills and fever; Cas in like brai... Read more
Confusion; Trouble with walking straight; Vertigo; Feeling tired; Chills and fever; Cas in like brain fog, where I can't think clearly and I was having a bit of confusion; I still had dizziness for a week.; Chills; I can't think clearly; This is a spontaneous report received from a contactable consumer or other non-health care professional (Patient). A 24-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: EW0173), 1 via an unspecified route of administration, administered in Arm Left on 30Jun2021 (at the age of 24-years-old) as dose 1, single for covid-19 immunisation. Medical history included asthma. The patient's concomitant medications included, fluticasone propionate (FLOVENT), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at for an unspecified indication and it was like a steroid inhaler like I Quit taking after I got vaccine because I had feeling maybe that was why I was getting those such effects. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On unknown date, she experienced confusion and trouble with walking straight and vertigo that lasted for 1 week. It was the first dose and I had got the shot I started feeling tired which was expected, I started having fever, chills and then I started feeling like a brain fog and I got a little bit of confusion and I began to dizzy and so, like I supposed it does not need to be in order but so I started out and felt tired which was expected and I started to get chills and fever, again kind of expected that, then I started to get, I was in like brain fog, where I can't think clearly and I had a bit of few visions and then I was having a lot of trouble in walking straight for 3 hour. That continued for few hours and then I still had dizziness for a week and now I feel fine, that was my experienced. The reason for transfer would be that the caller had very severe case of side effects after her first dose of COVID Vaccine 10 days ago and she was also trying to get the information as much as possible regarding what side effects are to be expecting from her second dose which was going to be soon. Consumer stated, I just want to make sure I did not had a reaction that I was not supposed to had and now like it was okay. I know you can not give medical advice probably but I just want to make sure it was safe for me to get second dose. Consumer was informed about the role of Pfizer drug Safety and also informed that Pfizer Medical Information was the right department answer the question consumer have regarding the vaccine and offered the number. Consumer stated, I experienced with first shot of Pfizer (Covid-19 Vaccine) and if it was different from anybody else got, I want to know that I am safe to get the second shot and I do not if someone had side effect like that or something. Patient received vaccination facility in: Consumer stated, It was like, made like a building inside of our shopping centre specifically for getting vaccinated but it was through the hospital. So, it was a walk-in clinic type of thing. Patient received treatment as Tylenol for fever, but other than that I think I just took some vitamins like zinc, vitamin C and vitamin D3. I did not get like any other treatment. The outcome of the events dizziness, vertigo, difficulty in walking, confusion was reported as recovered on unknown date and while for other event was unknown. No follow-up attempts are possible. No further information is expected.
24 2021-07-19 excessive sleepiness chills; low grade fever; extremely exhausted; slept most of the day; This is a spontaneous report fr... Read more
chills; low grade fever; extremely exhausted; slept most of the day; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the left arm on 24Mar2021 at 09:15 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history included inflamed kidney (right side). Concomitant medications included ethinylestradiol (+) norgestimate (ORTHO TRI-CYCLEN LO), vitamin D NOS (MANUFACTURER UNKNOWN) and sertraline (MANUFACTURER UNKNOWN) for an unknown indication and from an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the right arm on 03Mar2021 at 09:15 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID vaccine. On 25Mar2021, the patient woke up at 02:00 with chills which then felt like it turned into a low-grade fever. The chills went away in the early morning, but then the patient was extremely exhausted and slept most of the day. The patient reported that she felt better the following day. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of the events chills, low grade fever, extremely exhausted and slept most of the day were recovered on an unknown date in Mar2021. No follow-up attempts are needed. No further information is expected.
24 2021-07-19 insomnia Inability to sleep; Body aches; Skin uncomfortable to touch,; 4 days with a fever; the first two wit... Read more
Inability to sleep; Body aches; Skin uncomfortable to touch,; 4 days with a fever; the first two with a fever between 103-104,; Injection site red and swollen to the circumference of a golf ball.; Injection site red and swollen to the circumference of a golf ball.; Severe body chills; On the 4th day after, my left ear(the same side I got the injection on) feels clogged up; This is a spontaneous report from a contactable consumer (patient). A 24-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 01Jul2021 11:30 (at the age of 24-years-old) as dose number unknown, single for covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. The patient past Medical history included irritable bowel syndrome (IBS-C) from an unknown date and unknown if ongoing, vertigo from an unknown date and unknown if ongoing, chronic migraine from an unknown date and unknown if ongoing, known allergies for latex from an unknown date and unknown if ongoing. Concomitant medication(s) included cyanocobalamin (B12) supplement taken for an unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. On 01Jul2021, the patient experienced injection site red and swollen to the circumference of a golf ball, 4 days with a fever; the first two with a fever between 103-104, inability to sleep, severe body chills, body aches, skin uncomfortable to touch, on the 4th day after, on unspecified date in Jul2021, her left ear (the same side she got the injection on) feels clogged up like there's water in it. Adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included Body temperature: 103-104 on 01Jul2021. The patient was treated with pain relievers for fever and unspecified treatment for rest all other. The outcome for events was not recovered. Device date was 04Jul2021. Information on the lot/batch number has been requested.
24 2021-07-20 feeling abnormal, insomnia Difficulty breathing, consistently lightheaded, fogginess, inability to sleep and extreme difficulty... Read more
Difficulty breathing, consistently lightheaded, fogginess, inability to sleep and extreme difficulty waking in morning, severe shooting pain in right arm at sight of injection still months later, chest pain, eye pressure
24 2021-07-21 feeling abnormal SUNDAY 06/27/2021: HEADACHES AND LETHARGY (ALL DAY) MONDAY 06/28/2021: HEADACHES (MORNING), LETHARGY... Read more
SUNDAY 06/27/2021: HEADACHES AND LETHARGY (ALL DAY) MONDAY 06/28/2021: HEADACHES (MORNING), LETHARGY AND MENTAL FOGGINESS (ALL DAY) TUESDAY 06/29/2021: LETHARGY AND MENTAL FOGGINESS (ALL DAY)
24 2021-07-22 motion sickness lightheaded and dizzy; Severe motion sickness; loss of appetite; sore arm; This is a spontaneous rep... Read more
lightheaded and dizzy; Severe motion sickness; loss of appetite; sore arm; This is a spontaneous report received from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 22Mar2021 at 13:00 (at the age of 24-year-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient was allergic to sulfa (sulfonamide allergy). Concomitant medications included ethinylestradiol and norethisterone acetate (JUNEL), desvenlafaxine succinate monohydrate (PRISTIQ) and buspirone hydrochloride (BUSPAR). The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 22Mar2021, the patient experienced sore arm. On 23Mar2021 at 12:00, the patient was very lightheaded and dizzy and also experienced severe motion sickness and loss of appetite. Next day after that, the patient felt fine and ok. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit. The patient did not receive any treatment for the reported events. The clinical outcome of the events sore arm, lightheaded, severe motion sickness and loss of appetite was resolved on an unknown date in Mar2021. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
24 2021-07-24 sleep disorder Vaccine Tuesday PM, woke up around 1am Wednesday morning with intense body aches and was not able to... Read more
Vaccine Tuesday PM, woke up around 1am Wednesday morning with intense body aches and was not able to get comfortable. Hot and Cold flashes. Spot where vaccine administered was severely tender. Fell back asleep and woke up almost normal. Thursday morning woke up and had the feeling as if I had gotten water up my nose swimming and the feeling it gives you in the back of your throat. Headache. Friday - same feeling but worse headache, also little bit of runny/stuffy nose. Saturday - runny/stuffy nose. Headache. Congested. Sunday(today) - Same thing.
24 2021-07-27 anxiety Patient became light headed and started to have a anxiety attack shortly after receiving the vaccina... Read more
Patient became light headed and started to have a anxiety attack shortly after receiving the vaccination.
24 2021-07-27 confusional state Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unrespo... Read more
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension-Medium
24 2021-07-28 insomnia Terrible mensuration cramps began in June, didn't think anything of it, went away. In July terrible ... Read more
Terrible mensuration cramps began in June, didn't think anything of it, went away. In July terrible shooting pains in left hip/uterine area, assumed it was mensuration related until I couldn't walk because the pain moved down my legs and I couldn't sleep. Really bad bloating, fatigue, cervix extremely painful to touch during exam. Diagnosed with Pelvic Inflammatory Disease and a Yeast infection.
25 2021-01-03 sleep disorder, confusional state Around midnight I woke up and was extremely confused, felt like I had pretty bad cold, had some hiv... Read more
Around midnight I woke up and was extremely confused, felt like I had pretty bad cold, had some hives and started having some shortness of breath, that it kept waking me up. I also got nauseous. Almost threw up but did not. Took Benadryl and felt better. Had fever 100F in the morning, felt very fatigued next day. Went to work and the symptoms came back and they were intensified. I could barely walk. Took Benadryl and they decided to wheel me to the ER. I was unable to talk, I did not make sense. They gave me Benadryl and made me wait in the ER. I had tachycardia my pulse was fine. My BP was jumping around. I never had problems with that. At the ER they told me to take Benadryl and Pepcid for the next 3 days. My fever went down while I was at the ER. The next morning I checked it again and no more fever and I was feeling a lot better. I also had a slight headache, not bad. I called my PCP and they do not think it might be a good idea to receive the 2nd dose.
25 2021-01-05 altered state of consciousness she got tunnel vision; almost passed out; Blood pressure dropped to 70/50; heart rate went up to 140... Read more
she got tunnel vision; almost passed out; Blood pressure dropped to 70/50; heart rate went up to 140; whole body got cold and tingly; whole body got cold and tingly; This is a spontaneous report from a contactable pharmacist (patient) reported for herself. A 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer Biotech; lot number: EL0142) via an unspecified route of administration at left arm on 30Dec2020 at 12:45 PM at a single dose (dose number: 1) for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was workplace clinic. Medical history included premature ventricular contractions (PVCs). No known allergies (no allergies to medications, food, or other products). The patient was not pregnant. No other vaccine in four weeks and no other medications in two weeks. The patient experienced adverse events included blood pressure dropped to 70/50, heart rate went up to 140, whole body got cold and tingly and she got tunnel vision and almost passed out. The events all started on 30Dec2020 at 12:45 PM. The events were reported as non-serious. No treatment received for events. The outcome of events was resolving. Prior to vaccination, the patient was not diagnosed with COVID-19, and since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the close temporal relationship, the association between the event tunnel vision with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
25 2021-01-05 anxiety Shortly after receiving the Covid vaccine EE states she has a dry throat, water given, the stated, "... Read more
Shortly after receiving the Covid vaccine EE states she has a dry throat, water given, the stated, "It feels like it did when I had my allergic reaction to Gain detergent. Seriously feels like I have cotton balls in my throat and it seems to be getting worse. Rapid response team notified, observed, monitored and reassured EE BP 156/74 HR 89 O2 sat 99%, BP 141/70 HR 81, O2 sat 99% EE was allowed to go home after close obs for greater than 30 min EE states she felt anxious and just wanted to go home, her mom was picking her up and bringing Benadryl with her
25 2021-01-06 feeling abnormal Patient receive the Pfizer COVID Vaccine earlier in the day. She called the Clinic line at 1500 and... Read more
Patient receive the Pfizer COVID Vaccine earlier in the day. She called the Clinic line at 1500 and spoke with a nurse. She said she went to sleep and awoke with numbness in her right hand with pain. She complained of pain radiating from her biceps to her elbow. She states she has a headache along with lower back pain. She states she has nausea, vomiting, and that she feels really bad. She is able to move her right hand but states " it hurts". Reported to physician and patient instructed to call Emergency Services.
25 2021-01-07 feeling abnormal severe arm pain, dizziness (spins) anytime I woke in the middle of the night starting at 12am on 01/... Read more
severe arm pain, dizziness (spins) anytime I woke in the middle of the night starting at 12am on 01/01/2020, when trying to get out of bed at 0800 on 01/01/2020 I continued to have severe dizziness to the point I couldn't walk, vomitting, in ability to keep anything down by mouth, muscle pain, severe arm pain in arm vaccine was given. At 2pm I was still having moderate dizziness, nausea, and began to have a headache. For a week I continued to have mild dizziness, headache, extreme fatigue, brain fog, and swollen lymph node pain in the armpit of the arm I received the vaccine in (right side). I continue to have mild brain fog and headache.
25 2021-01-08 insomnia Immediately after vaccine I had a bad headache which was cleared up with Ibuprofen. Then 12 Hours af... Read more
Immediately after vaccine I had a bad headache which was cleared up with Ibuprofen. Then 12 Hours after vaccine my arm became VERY sore, took my ibuprofen and alternated with Acetaminophen. Then my face became very flushed (I used ice packs) and I got a mild sore throat. That night I had difficulty sleeping. I kept waking up with terrible body aches. About 24 hours after the vaccine I just had fatigue, mild fever, and chills. I slept on and off throughout the day and then started to feel better. But at about 32 hours post vaccine I started to feel worse. My headache and sore arm came back and I became very light headed and dizzy.
25 2021-01-09 sleep disorder Almost exactly 12 hours after receiving the second dose of COVID vaccine, I woke up from sleep curle... Read more
Almost exactly 12 hours after receiving the second dose of COVID vaccine, I woke up from sleep curled into a ball, covered in sweat, absolutely freezing, teeth chattering, and all my muscles were shaking violently. I tried to roll over in bed and all of my muscles locked up and I began to convulse even stronger. This made me feel extremely nauseous and then I began to vomit. I know I had a high fever but I was unable to keep down any medications as I kept vomiting. I felt ill like this for the next 24 hours, with a 100.1 fever even after rounds of ibuprofen and tylenol, and severe muscle soreness and achiness, and headache. I also have intermittent nausea and will occasionally vomit bile. I finally woke up on 1/10/2020 and don?t have a fever, but my body feels very beat up and sore.
25 2021-01-10 impaired work ability called in sick to work. not feeling well.
25 2021-01-11 insomnia tingling reaction on her arms, body/tingling in the hands and arms; swelling of the face; headaches;... Read more
tingling reaction on her arms, body/tingling in the hands and arms; swelling of the face; headaches; she had numbness in the face and tingling; weakness in the arms and legs, extremity weakness; fatigue; in the back, she had pain, soreness in the vertebrae in the middle going down; in the back, she had pain, soreness in the vertebrae in the middle going down; she hasn't been able to sleep in a few days, about probably 6 or 7 days.; a bump on her forehead with a high temperature; a bump on her forehead with a high temperature/ it is radiating heat, she feels her forehead hot from that spot; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient's father) and a non-contactable consumer (patient's mother) reported that a 25-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1284), via an unspecified route of administration at the right arm on 21Dec2020 at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. After a few days on 25Dec2020, patient started to experience reactions, like a tingling reaction on her arms, body, and also swelling of the face, and she also started to have headaches. It has been like that for a while, and patient who is a health care professional was brought to the emergency room, to check on what was going on, but she was not able to get the medication they need, it was twice that the consumer he tried to bring the patient to emergency, and she still hasn't gotten medication for the symptoms. She started having reactions, she had numbness in the face and tingling, headaches, tingling in the hands and arms, and weakness in the arms and legs, extremity weakness, she felt like fatigue and also in the back, she had pain and soreness in the vertebrae in the middle going down. She has been to emergency 3 times, the last time was yesterday, and so the one thing he needs to report to Pfizer is doctors don't seem to know what to look for, they have no idea, they are looking at other things instead of looking at vaccine side effects, the patient never had problems before the vaccine, but after she started all of these side effects, they need to be looking at what can cause with the vaccine, the first time, yesterday on (03Jan2021) they did a brain MRI because of headache, as they are concerned about nerves in the brain, but a neurologist will see her sometime this month. At this time, they are ruling out things, analyzing the MRI, she did get some medication for pain, and all that stuff since she was suffering with,headache and was sent home last night. Since they said they cannot admit her, as they are afraid she could get COVID 19 in the hospital, but they make sure she is ok, and at this point, all her knows, he hasn't talked to her since last night, and hoping she is sleeping, as she hasn't been able to sleep in a few days, about probably 6 or 7 days. The consumer was wondering, it may be necessary to call the patient directly, to talk more directly to her. The patient also did have on her forehead was a spot in the middle that was raised, kind of like a raised area, from that area, it is radiating heat, she feels her forehead hot from that spot, and they take her temperature with the new handheld touchless thermometer, and it radiates heat like 100.2 to perhaps 100.4 (Dec2020). It always raises a question at these appointments, but then they take her temperature orally and it's 98 degrees (Dec2020). It was also mentioned that the patient was experiencing tingling reaction in the arms, headache, swelling, numbness in her face, and a bump on her forehead with a high temperature. These symptoms were there until yesterday, the Emergency room gave her some medicine, but the consumer hasn't heard from her, his patient was home, they haven't talked since last night. The consumer was hoping she was able to sleep. The consumer stated that the patient was given medicine, it was give to relax her, but it is like a bandaid, not a cure. Now, the consumer stated that the patient said her symptoms were the same symptoms, headache, numbness, everything after last night, she was still with problems. The patient had the very first one, at this point, the consumer doesn't know about the second one, the way she is doing. It was given to all the people she works with, most of the people, the patient works in a hospital, she is a respiratory therapist, it was given to them as they are exposed to all that the COVID 19 in a hospital. Yesterday on 03Jan2021, brain MRI, results showed that the patient was told her that everything looks, initially, looks clear good, but a neurologist will look at the report in detail. and rule out any other conditions, she has to be followed up with by a neurologist, the appointment is pending. The patient's mother asked on behalf of her daughter if this department going to be contacting the doctor for help with resolution about to resolve the health issues, what is to be expected. She added, "What are people doing when they have these severe side effects, what is Pfizer doing for them, besides taking down information, which is helping Pfizer, what helps the patient resolve side effects from the vaccine?" The patient's father stated that it seems to them, his daughter went 3 times to Emergency, the first time they said good luck with that, second time, this and that she is ok, go home, and the third time, at least they did a brain MRI, and gave her some medicine, now this morning, she is back to where she was before she went to the ER. He asked, "Why is there not more documentation, more information provided to doctors that have take care of patients, it seems to be a small group of people with these side effects, and it is really hard, the question they have is, this suffering, why doesn't Pfizer be more active in helping people, now they are investigating that, doing research to him seems like some feedback s not necessarily directed to the patient, as they are trying to take care of themselves, but to call the doctor helping her, to know a better lead to be able to help her, his daughter has missed a lot of work, has a lot of headaches, where is the hope for this to go away? What can Pfizer do to the medical community, to help them?" Therapeutic measures were taken as a result of headaches. The outcome of the events was unknown.
25 2021-01-11 sleep disorder Headache, Body aches, Chills/trouble regulating body temperature, nauseous. Unsure how long it laste... Read more
Headache, Body aches, Chills/trouble regulating body temperature, nauseous. Unsure how long it lasted because it was in the middle of the night. I was able to fall back to sleep and felt okay the next morning. I am still feeling a little nauseous and I am very tired because I didn't sleep well as a result of the symptoms but I felt fine enough to go to work.
25 2021-01-12 amnesia Patient stated Pain in left hand finger tips, swelling in left wrist, body shaking, teeth chatterin... Read more
Patient stated Pain in left hand finger tips, swelling in left wrist, body shaking, teeth chattering and Patient states she was forgetting were she was. Patient stated Shortness of breath./ Treatment: Gave Oxygen, and sat with her and calmed her down and she felt good to leave one hour later. Pt currently is feeling good and no symptoms currently as of today.
25 2021-01-12 impaired work ability body aches, chills, fever. called in sick to work.
25 2021-01-12 sensation of foreign body Pfizer-BioNTech COVID-19 Vaccine Patient received her COVID vaccine .. During the observation perio... Read more
Pfizer-BioNTech COVID-19 Vaccine Patient received her COVID vaccine .. During the observation period, the patient reported feeling a lump in her throat, clammy hands, lightheadedness, and tingling of her lips and face. Patient was taken back to an exam room. Orange juice provided, patient laid down. Each time patient would sit up, she would feel jittery and lightheaded. After having the patient stay in the patient exam room for 45 minutes with clinical staff monitoring her status, the patient did not report any improvement in symptoms, therefore, she was transported to the ED
25 2021-01-14 impaired work ability Symptoms: Woke up around 07:30 feeling off balanced, warming more than usual per EE (did not take te... Read more
Symptoms: Woke up around 07:30 feeling off balanced, warming more than usual per EE (did not take temp) and HA. EE took temp at 09:30 (99.6) and again at 14:00 (99.9), EE did not take antipyretics. EE reports later in the day temp of 98.6. EE reports at time of call pain at injection site and mild swelling to lymph nodes under L axilla. Last day of work and shift - 1.13.21. Home remedies: Rest. Any improvement: Mild improvement. Recommendation: EE encouraged to take ibuprofen as outlined in the Medical Directive and to apply a cold compress to injection site. EE encouraged to continue to monitor her symptoms and to contact the Vaccine support line with additional questions and concerns. EE reports she called out of work yesterday and today. EE educated to manage her according to the Illness in the Workplace policy. EE verbalized back understanding and denied further questions at this time.
25 2021-01-17 impaired work ability I received my 2nd vaccination on Monday 01/11/21 at 1200 pm in the hospital. on Tuesday 01/12/21 at ... Read more
I received my 2nd vaccination on Monday 01/11/21 at 1200 pm in the hospital. on Tuesday 01/12/21 at 0300 I woke up with sever rigors chills and a temperature of 100.4. throughout the rest of that 24 hour period I had severe exhaustion, pain in my upper extremities and weakness in my lower extremities with poor appetite throughout the day. Again on 01/13/21 around 0200, I woke with fever of 101.0. at that time I had to call out of work for my 7 am shift. by Wednesday 01/13 at 1300 my fever had broken, body aches decreased and appetite improved.
25 2021-01-17 memory impairment, feeling abnormal It feels like I have mono without the sore throat. My head hurts, my joints hurt, I?m tired, and the... Read more
It feels like I have mono without the sore throat. My head hurts, my joints hurt, I?m tired, and the worst of all of them is brain fog. I?ve had brain fog to a point where i forgot which trashcan was mine at the curb.
25 2021-01-18 amnesia transient ischemic attack I was working and felt unusually exhausted, lost vision in my right eye f... Read more
transient ischemic attack I was working and felt unusually exhausted, lost vision in my right eye for over an hour, and called my boyfriend to tell him I wasn't feeling well and that I would try to make it through my work shift. I then called him back 4 minutes later and failed to form words, and also could not type words. I felt like I was going to faint and have no recollection of 10 minutes during that time. I had to leave work to go to the emergency room. I had a massive headache for 3 days following my TIA.
25 2021-01-18 feeling abnormal allergy; Short of breath; Tachycardia/my heartrate was like 140 - 150; Blood pressure was like 165 o... Read more
allergy; Short of breath; Tachycardia/my heartrate was like 140 - 150; Blood pressure was like 165 over 114/my blood pressure just like skyrocketed; Upset stomach; Tired; Started to feel not very good/not feeling like wonderful/overall sickness; Muscle ache; This is a spontaneous report from a contactable consumer (patient). A 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL014 (can't really tell), via an unspecified route of administration on 31Dec2020 at single dose for COVID-19 immunization. Medical history included allergy and heartburn. Concomitant medication included omeprazole for heartburn, cetirizine hydrochloride (off-brand for Zyrtec) as allergy medicine and a birth control medicine. Consumer stated, she just was calling this number because she didn't necessarily know if she had an adverse reaction or a symptom. She just wanted to report it and see if maybe you had any insight if this has happened to anybody else. Consumer further stated, she had an adverse reaction where she had to go to the emergency room. So, she didn't know if it was from the Vaccine or not because her reaction was very delayed. She got her vaccine on 31Dec2020, New Year's Eve and then starting on Monday after the vaccine on 04Jan2021. She started to feel not very good, it was mostly just like overall sickness, just as muscle aches, tired, having upset stomach so that was after 4 days. Patient had allergy from an unspecified date. And then on 07Jan2021, a week after she got the vaccine, she had signs of tachycardia and her blood pressure just like skyrocketed, her blood pressure was like 165 over a 114 and her heartrate was like 140 - 150. And she worked in healthcare, which was why she was one of the first ones to get the vaccine and she went to the ER and got worked up and they couldn't find, nothing was abnormal with her labs or blood work. She even had a chest X-ray and they couldn't find anything and they just gave her fluids and sent her home. And she was home now and still not feeling like wonderful, she felt better though but she just wanted to report that and see if there was any correlation. She didn't really know because it was so delayed, a week later. So she just wanted to report it. Consumer further stated, she forget to tell one thing, she was also short of breath on 07Jan2021. So that was why they had sent her to ER because of Tachycardia, shortness of breath and her blood pressure was really high. They didn't give her any medicine they just gave two big bags of fluid and then they discharged her. Consumer stated, she was scheduled to have her second one, she thought it was 14Jan2021. She wanted to know if she should get the second one. Consumer stated, when she went into the ER she had a lot of lab work. She didn't even know what all they did but a lot like, blood panels, she checked everything was there, that was on Thursday, last week, 07Jan2021. Consumer stated no treatment was received for the events. Outcome of the events was unknown.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
25 2021-01-18 sensation of foreign body approximately 5 min after receiving the vaccine, felt flushed and a swelling sensation in the throat... Read more
approximately 5 min after receiving the vaccine, felt flushed and a swelling sensation in the throat. Felt like a globes sensation without itching or hives. Nurses at vaccine site checked vitals multiple times. BP at start of symptoms 152/106, HR 140, O2 sat 99%. EMS was called but I did not feel symptoms were worsening, my lungs were clear without wheezing or stridor. I made the decision to not have EMS transport me to the ER. Symptoms improved so I decided to not go to the ER. Symptoms returned moderately for which I took 25 mg tab of Benadryl. As time progressed, symptoms waxed and waned, about 4 hours after the vaccine the globus sensation in the throat has improved, but there is a globs sensation in the lower esophagus, almost GERD-like in nature.
25 2021-01-18 sensation of foreign body 1357 client complained of a lump in her throat feeling; sensation of having trouble swallowing; feel... Read more
1357 client complained of a lump in her throat feeling; sensation of having trouble swallowing; feels hot at back of neck 1358 BP 152/106 P 140 R 12 SpO2 99% LOC A&O x 3; Skin cool, pink and dry; Resps unlabored and lungs clear-no wheeze or stridor; heart regular and pulse strong 1405 BP 142/88 P 116 R 12 SpO2 99% Resps continue unlabored; sensation of lump in throat continues; EMS notified 1410 BP 136/84 P 108 R 12 SpO2 99% Resps unlabored; sensation still present; pulse has an irregularity; EMS arrived; Handoff given to EMS crew; client dispositioned to local ED at Hospital
25 2021-01-19 confusional state 101.8 fever, chills, aches, confusion, body pain, headache, fatigue
25 2021-01-21 anxiety Was driving home after waiting my 15 minutes. Throat started to close up, tingling sensation through... Read more
Was driving home after waiting my 15 minutes. Throat started to close up, tingling sensation throughout entire body, rush of heat, dizziness, increased heart rate. Made it back to the site (closest medical professionals near me) where my throat still felt swollen but I could breathe. Chest hurt and was still dizzy. Was given 50mg Benadryl & 20mg Pepsid. It seemed to come and go in waves but I still went to the ER. ER doc said what he saw I was experiencing was anxiety. Pharmacist who had been with me the whole time could tell that my neck and throat had been swollen but had gone down with the Benadryl. ER administered anti nausea meds and a steroid shot. Also prescribed steroids for a few days. Received the shot at 6:45, initial reaction occurred around 7:10, went to the ER around 8:45
25 2021-01-21 feeling abnormal PT stated she felt funny. Began assessment. PT lost pulse, began CPR. PT regained pulse, was transfe... Read more
PT stated she felt funny. Began assessment. PT lost pulse, began CPR. PT regained pulse, was transferred via EMS to hospital
25 2021-01-21 impaired work ability 1/20/2021: Around 20:00, I started to feel a little achy. Checked my temperature, it was 99 degrees ... Read more
1/20/2021: Around 20:00, I started to feel a little achy. Checked my temperature, it was 99 degrees F. 1/21/2021: Around midnight, I woke up in a cold sweat, shaking. My entire body hurt and I had a headache. I checked temp again. It was at 102 degrees. I went back to sleep. I woke up again around 2:00, temp was 103. I took 1000 mg of Tylenol and drank water. Around 4:00, I checked temp again. I was back down to 101. I called into work. I kept sleeping all day and took 1000 mg of Tylenol every four hours. Symptoms slowly subsided throughout the day. By 22:00, I was down to 98.8 degrees before bed. 1/22/2021: I woke up at 4:00 and checked temp. It was still at 98.0. I go to work. My hands are tingling and I am hot with no increased temperature. It is now 9:00 and my hands are still tingling.
25 2021-01-21 impaired work ability fever 101, body aches, chills, profuse sweating headache, abdominal cramping call sick 1/19 and 1/2... Read more
fever 101, body aches, chills, profuse sweating headache, abdominal cramping call sick 1/19 and 1/20
25 2021-01-21 impaired work ability On 12/20/2020 I got my first dose Pfizer: only symptoms slight headache and sore arm. On 1/20/2021 ... Read more
On 12/20/2020 I got my first dose Pfizer: only symptoms slight headache and sore arm. On 1/20/2021 I received my 2nd dose. First day, I only had a sore arm. On 1/21/2021 @800am my food was not tasting appetizing. Around 930am I started to feel nauseous, fatigue, headache. @1000am I started to feel really hot. I took my temp around 1020am and it was 100.2. I was immediately sent home from work. I continue to have the same symptoms the rest of the evening and slight body aches. @530pm I started to feel chills and felt like I was freezing. @8pm I started to feel better, only symptoms I had at that time was headache. @930pm-1200am I started to feel very hot and began to sweat. On 1/22/2021 only symptoms I currently have is a headache.
25 2021-01-21 insomnia, feeling abnormal Achiness especially in back and knees, pain like nerve pain in fingers, nausea, loss of appetite, fa... Read more
Achiness especially in back and knees, pain like nerve pain in fingers, nausea, loss of appetite, fatigue, brain fog, diarrhea, low grade fever up to 101.4, trouble sleeping overnight after getting the vaccine the evening before. The symptoms lasted all day on 01/20/2021, the day after I got the vaccine, all better the following day on 01/21/2021.
25 2021-01-22 anxiety Five minutes after vaccine, I started having trouble breathing. Thought it was anxiety attack but I ... Read more
Five minutes after vaccine, I started having trouble breathing. Thought it was anxiety attack but I didn't feel anxious. I felt light headed and I don't get that with my panic attacks; At 15 minutes, my heart was beating really fast. They checked my vitals - pulse and BP was elevated. Pulse is over 130 and normally when I have an anxiety attack it doesn't go above 110. Went to the ER . The breathing felt better after thirty min after being in ER and Blood pressure 1-2 hours later went down. No treatment. After about two weeks I saw my primary care doctor for check up.
25 2021-01-23 crying came on 1/23/2021 to vaccinate at Facility. She vaccinated patient. This patient was very apprehensi... Read more
came on 1/23/2021 to vaccinate at Facility. She vaccinated patient. This patient was very apprehensive about receiving the Pfizer vaccine. She held her hand to calm down. gave her the vaccination and 5 mins later the patient said she has a headache, was upset, and started crying. She covered her eyes with her hands and started to shake. She also went to her bed and was rolling in it. The facility called 911 and they came within 5 mins. They did confirm that the patient wasn't having a seizure. Patient was calmed down but still went with the paramedics to be checked out. When I followed up with the facility, they said it was an anxiety event and the patient is back at the facility doing well. Let me know if you have any additional questions.
25 2021-01-24 restlessness WBCs and neutrophils and platelets elevated 3 hours later; WBCs and neutrophils and platelets elevat... Read more
WBCs and neutrophils and platelets elevated 3 hours later; WBCs and neutrophils and platelets elevated 3 hours later; WBCs and neutrophils and platelets elevated 3 hours later; Coat hanger neck/ shoulder pain; Coat hanger neck/ shoulder pain; flushed; felt uncomfortable; couldn't sit still; feeling clammy; saw spots; BP dropped to 60s/30s; felt like throat was closing; couldn't breathe well; hands were numb; lips were white/ blue; This is a spontaneous report from a contactable nurse (patient). A 25-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, LOT# EL1283), via an unspecified route of administration in right arm on 07Jan2021 13:30 at first single dose for COVID-19 immunization. Medical history included asthma, fibromyalgia, idiopathic hypersomnia, seasonal allergies (dust, ragweed, pollen, dander), covid-19. Concomitant medication in two weeks included duloxetine hydrochloride (CYMBALTA), modafinil, montelukast sodium (SINGULAIR), cetirizine hydrochloride (ZYRTEC), ergocalciferol (VIT D). No other vaccine in four weeks. 1-2 min after shot the patient became flushed and felt uncomfortable/ couldn't sit still, began feeling clammy, saw spots, BP dropped to 60s/30s, all other vitals stable, felt like throat was closing and couldn't breathe well, hands were numb, lips were white/ blue. No itching or hives. Resolved with trendelenburg and rest, fluids given in ED. WBCs and neutrophils and platelets elevated 3 hours later. Coat hanger neck/ shoulder pain for the next few days. Adverse event start date was 07Jan2021 01:30. Event resulted in emergency room/department or urgent care. Covid was not tested post vaccination. Outcome of the event was recovering.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the reported events cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
25 2021-01-25 anxiety Complained of pressure in chest, was anxious prior to vaccination. VS 154/100, HR 138. Asked to remo... Read more
Complained of pressure in chest, was anxious prior to vaccination. VS 154/100, HR 138. Asked to remove mask and took slow deep breaths, no improvement. 141/100 HR 103, complained of tongue feeling thick, speech impacted. Transfer to ED via stretcher
25 2021-01-26 insomnia Extreme fatigue (2.5 weeks, would sleep 9-16 hours per day) Insomnia (2 weeks, difficulty sleeping w... Read more
Extreme fatigue (2.5 weeks, would sleep 9-16 hours per day) Insomnia (2 weeks, difficulty sleeping when lying down to sleep at night until 2-3:30 AM) Painful injection site (5 days) Bruising at injection site (3 weeks)
25 2021-01-26 sleep disorder broke out in hives all over her body; didn't sleep for 2 nights because she was so uncomfortable; di... Read more
broke out in hives all over her body; didn't sleep for 2 nights because she was so uncomfortable; didn't sleep for 2 nights because she was so uncomfortable; areas on her legs and ankles that are reddened; This is a spontaneous report from a contactable nurse (patient). A 25-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EJ1685), via an unspecified route of administration in the left deltoid, on 29Dec2020 at 18:40 (at the age of 25-years-old) as a single dose for COVID-19 immunization. The patient had no medical history or concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced broke out in hives all over her body on 03Jan2021, which was reported as medically significant. The patient also didn't sleep for 2 nights because she was so uncomfortable and areas on her legs and ankles that are reddened on 03Jan2021. The clinical course was reported as follows: The patient received her first dose of the vaccine on 29Dec2020 and said 5 days later she broke out in hives. The patient stated her hives began on the evening of 03Jan2021. She clarified she had hives all over her body and didn't sleep for 2 nights because she was so uncomfortable. She said she still had areas on her legs and ankles that were reddened. She said the reddened areas on her legs and ankles are not fully raised or itchy, like she had experienced with the hives on the rest of her body. The patient went to an urgent care on 06Jan2021. She saw a dermatologist for the hives on 07Jan2021, who suspected that since she did not have any prior history of hives, her hives are from the COVID-19 vaccine. She said the dermatologist told her there is no way to truly test if the vaccine caused her hives. The patient received an intramuscular unspecified steroid shot at the dermatologist and was prescribed methylprednisolone (MANUFACTURED BY: PAR PHARMACEUTICAL; Lot number: 1129091; Expiration date: Dec2021) 4 mg tablets in a taper dose pack. She also stated that she took the following over-the-counter medications: diphenhydramine hydrochloride (reported as: generic BENADRYL; MANUFACTURER UNKNOWN; Lot number: 0MR0456; Expiration date: Sep2022) 25 mg tablet, taken as needed; cetirizine hydrochloride (ZYRTEC; Lot number: 1652346; Expiration Date: Dec2021) 10 mg tablet, taken as one tablet up to four times a day; and hydrocortisone (MANUFACTURER UNKNOWN) cream. Therapeutic measures were taken as a result of all of the events as aforementioned. The clinical outcome of broke out in hives all over her body and didn't sleep for 2 nights because she was so uncomfortable was recovering and of areas on her legs and ankles that are reddened was not recovered.; Sender's Comments: Based on temporal association, a possible contributory role of suspect BNT162B2 cannot be excluded for reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
25 2021-01-27 anxiety Patient alerted staff of tingling in throat at approximately 2:10 PM. Staff alerted nurses. I respo... Read more
Patient alerted staff of tingling in throat at approximately 2:10 PM. Staff alerted nurses. I responded, ushered patient to a room to sit down. Vitals taken, assessed symptoms. Tingling in tonsil area down throat and towards ears, choking sensation, apprehension, anxiety noted. Called district clinical nursing director. Instructed me to administer EPI pen. Epi pen 0.3 mg administered to left thigh while another nurse called 911 at approximately 2:14 PM. Vital signs taken every 5 minutes. Patient began feeling better within minutes of receiving epi pen. EMS arrived at 2:30. Patient refused transport to hospital. Patient stated her husband, who was present, would drive her to the hospital. Refusal documentation signed, and incident report filled out. Patient encouraged to follow up with PCP as well.
25 2021-01-27 confusional state Thigh and groin paresthesia, cognitive confusion, and intense arthralgia from 1/27/21 2:00 am to 12... Read more
Thigh and groin paresthesia, cognitive confusion, and intense arthralgia from 1/27/21 2:00 am to 12:00 pm.
25 2021-01-28 anxiety I have felt minor chills; muscle aches; headaches; general unwell/unease; general unwell/unease; min... Read more
I have felt minor chills; muscle aches; headaches; general unwell/unease; general unwell/unease; minor sore throat; coughing; This is a spontaneous report from a contactable healthcare professional (patient). A 25-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on left arm on 05Jan2021 07:45 at single dose for COVID-19 immunization. Facility type vaccine was in workplace clinic. No other vaccine in four weeks. Medical history included chronic right sided tightness/discomfort. The patient was not pregnant at the time of vaccination. The patient had no known allergies. Concomitant medications included (other medications in 2 weeks) included Magnesium, Iodine, dexpanthenol;nicotinamide;pyridoxine hydrochloride;riboflavin;thiamine hydrochloride (VITEX) and colecalciferol (VITAMIN D). On the 5th of Jan2021 at around 16:00, the patient experienced a minor sore throat and some coughing. From the 11th of Jan2021 through the present day I have felt minor chills, muscle aches, headaches, and general unwell/unease. There was no treatment for the events. No COVID prior vaccination. The patient was tested for COVID post vaccination, tests included COVID-19 Rapid Antigen Test (COVID test type post vaccination=Nasal Swab) and COVID-19 IgG/IgM Antibody Test (COVID test type post vaccination=Blood test) both done on 07Jan2021 and both with negative results. The outcome of the events was recovering. Information on the lot/batch number has been requested.
25 2021-02-01 impaired work ability nausea; diarrhea; fatigue; loss of taste and smell; loss of taste and smell; stomach upset; tested p... Read more
nausea; diarrhea; fatigue; loss of taste and smell; loss of taste and smell; stomach upset; tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report from a contactable consumer (patient). A 25-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 31Dec2020 at single dose at left arm for covid-19 prophylaxis. There were no medical history and concomitant medications. Patient said that she got the first dose on 31Dec2020. She stated that she got Covid 2 weeks later. She said that she positive test on 12Jan2021. She stated that she was still having mild symptoms of Covid. She said that because of that, she was not cleared to go back to work yet. She stated that she was not having fever or shortness of breath. Patient clarified that her covid-19 symptoms were stomach upset, nausea, diarrhea, loss of taste and smell, and fatigue. She was supposed to get the second dose on 19Jan2021. Outcome of all events was recovering. Information about Batch/Lot number has been requested.
25 2021-02-03 excessive sleepiness Woke up 1:30 AM with rigors for 2 hours; woke up in puddle of sweat; felt hungover; malaise; slept m... Read more
Woke up 1:30 AM with rigors for 2 hours; woke up in puddle of sweat; felt hungover; malaise; slept most of the day; sore arm; This is a spontaneous report from a contactable consumer. A 25-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK 9231), via an unspecified route of administration on 14Jan2021 at a single dose on Left arm for COVID-19 immunization. Medical history included none. No concomitant medications were received. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, "lot unknown=False"), via an unspecified route of administration on an unspecified date for COVID-19 immunization. The patient woke up 1:30 AM on 14Jan2021 with rigors for 2 hours; after that fell back asleep and woke up in puddle of sweat. In AM felt "hungover"; malaise, slept most of the day and woke up around 5:30 PM; was almost back to normal except sore arm. No treatment received for the event. The outcome of the event sore arm was not recovered while the rest of the events was recovered on 14Jan2021. The events were considered as non-serious. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was Hospital. No other vaccines received within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
25 2021-02-04 insomnia 1st dose - moderate site injection pain lasting ~2 days, mild fatigue, mild headache 2nd dose - majo... Read more
1st dose - moderate site injection pain lasting ~2 days, mild fatigue, mild headache 2nd dose - major site injection pain lasting ~3 days, moderate fatigue, moderate headache, mod Body/joint aches, low grade fever, insomnia
25 2021-02-07 feeling abnormal dizziness; increased heart rate; increased blood pressure; flushed; weakness; shakiness; lethargy; c... Read more
dizziness; increased heart rate; increased blood pressure; flushed; weakness; shakiness; lethargy; chilled; in particular hands were very cold; pale color; slurred speech; mental fog; This is a spontaneous report from a non-contactable other healthcare professional (patient). A 25-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number=EL3249), via an unspecified route of administration at site of right arm on 20Jan2021 09:30 at single dose for COVID-19 immunization. Medical history reported as none. Concomitant medication included vitamin D3 and iron (SLOW RELEASE IRON) and daily multivitamin. Within minutes of receiving the dose on 20Jan2021 at 09:45 AM, dizziness, increased heart rate, increased blood pressure, flushed, weakness, and shakiness. About an hour after receiving the dose on 20Jan2021, lethargy, chilled, in particular hands were very cold, pale color, mental fog, and slurred speech. The patient did not receive any treatment from events. The outcome of events was recovered in Jan2021. No follow-up attempts are possible. No further information is expected.; Sender's Comments: The reported temporary mental fog/mental impairment was likely related to first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), due to temporal relationship and clinical course of the events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
25 2021-02-08 impaired work ability Dizzy, nausea, chills, body aches on 1/29. Gradual left lower leg pain and rash starting 1/30. Had t... Read more
Dizzy, nausea, chills, body aches on 1/29. Gradual left lower leg pain and rash starting 1/30. Had to go to urgent care on 2/1/21 and missed work for 2 days.
25 2021-02-08 loss of personal independence in daily activities, impaired work ability I am a third-year medical student. Since receiving the second dose of the COVID vaccine (Pfizer) on ... Read more
I am a third-year medical student. Since receiving the second dose of the COVID vaccine (Pfizer) on Tuesday 2/2, I have had persistent and worsening muscle spasms of the torso. I presented to the Emergency room on 2/6 due to worsening symptoms and was admitted until 2/7. The neurology team evaluated my condition was not able to make a firm diagnosis. They believe the vaccine has caused a dystonic reaction. I was given benadryl 25mg to continue for one week q6 hours prn. However, benadryl has provided minimal relief. They also strongly recommended that I be seen by a movement disorder specialist at hospital ASAP. However, due to the fact that I have insurance I am not covered for care from hospital. My insurance said they will review the referral which will take another 5-7 business days from today 2/9. As a medical student, I have had to miss one week of clinic rotations and will continue to miss vital medical training as well as my board exam this Friday due to my worsening symptoms. It has created such a negative impact on my life including pausing my medical training, and physically being incapable of driving or performing many of my basic daily activities. I live alone and near hospital. I am urgently requesting if there is anyway CDC can help me, a medical student who has put in her all to fight the pandemic alongside you. I am extremely concerned about my symptoms and the panic that it has created for my family and friends. I hope that a rapid response can help me and my loved ones find some answers during these challenging times.
25 2021-02-09 confusional state, disorientation, nervousness Within 15 minutes my vision began to blur, I became shaky and disoriented. My heart rate increased a... Read more
Within 15 minutes my vision began to blur, I became shaky and disoriented. My heart rate increased and it felt as though my blood pressure decreased rapidly. After 30 minutes my symptoms had worsened and I was so disoriented I was not able to seek medical attention while being observed. I exited the building and once I got into my car my face (specifically under my eyes and on my cheeks) began swelling and a red burning rash appeared. By the time I got home (10 more minutes) I needed Benadryl immediately, I was not able to complete my sentences and all other symptoms had become more intense. I continued to take Benadryl every 4 hours for the next few days due to the symptoms consistently rebounding. I had one episode of throat tightness but it passed without use of my epipen. I checked my pulse and blood pressure frequently with the lowest reading being 93/60. Lethargy, shakiness, confusion, high heart rate all are still present after 5 days. The rash went away after 48 hours.
25 2021-02-09 impaired work ability vomiting, diarrhea, fatigue, headache. called in sick to work.
25 2021-02-11 crying At 7:00am the morning after receiving my second dose of the vaccine, I arose from bed and went to th... Read more
At 7:00am the morning after receiving my second dose of the vaccine, I arose from bed and went to the bathroom to brush my teeth. At the sink, I immediately started feeling extremely dizzy and lightheaded and felt like I was going to throw up. I was also extremely clammy and started sweating. I tried to make my way to the kitchen to get a glass of water and blacked out and the next thing I remember is waking up on the floor of my apartment hallway covered in sweat and screaming and crying. I called my primary care physician's office and spoke with a triage nurse who advised me to go to the ER for examination due to my loss of consciousness and lingering feelings of dizziness, nauseous, and body aches.
25 2021-02-13 feeling abnormal Vaccinated at 12:31 pm on 2/13. No side effects during the day except for the injection site being a... Read more
Vaccinated at 12:31 pm on 2/13. No side effects during the day except for the injection site being a little sore when any pressure was applied. At around 6:00 am on 2/14, I woke up with some brain fog and my skin being incredibly sensitive to touch and textures. Even just the sheets or blankets touching me was painful. After sleeping for a couple more hours the sensitivity has decreased but is still significant. The sensitivity is all over, not restricted to one area.
25 2021-02-14 confusional state, disorientation Sudden LOC, possible seizure (rigidity) for 5 sec, no post-ictal state, but some disorientation. 99 ... Read more
Sudden LOC, possible seizure (rigidity) for 5 sec, no post-ictal state, but some disorientation. 99 on RA,118/76, 99-103 HR, tachypnea to 26. Assessed by EMS, pt refused transport- paramedic got AMA signed. Vasovagal response, Confusion, Disorientation, Loss of consciousness
25 2021-02-16 anxiety C/O flushing , scratchy and dry throat , anxious elevated BP : 157/114 elevated HR : 111 ... Read more
C/O flushing , scratchy and dry throat , anxious elevated BP : 157/114 elevated HR : 111 improved after approx. 10 minutes, HR: 89 BP : 148/84 DECLINED taken to ER.
25 2021-02-21 feeling abnormal Patient received vaccine, then proceeded to the monitoring station in the clinic. Upon arrival to th... Read more
Patient received vaccine, then proceeded to the monitoring station in the clinic. Upon arrival to the Monitoring station, client stated she felt light-headed and appeared dazed. Client escorted to recliner chair to recover. BP 120/78 while seated with legs reclined. Gatorade was given, which the client drank with good effect. After 20 minutes, the client sat up (no longer reclining) and tolerated the position change well. After an additional 5 minutes, the client stood up and felt she had recovered.
25 2021-02-21 loss of personal independence in daily activities Left hand, specifically thumb, has numbness and tingling; Left hand, specifically thumb, has numbnes... Read more
Left hand, specifically thumb, has numbness and tingling; Left hand, specifically thumb, has numbness and tingling; Unable to perform daily activities with this hand after vaccination.; muscle weakness in right thigh.; This is a spontaneous report from a contactable Other HCP (patient). A 25-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Intramuscular in right arm on 06Feb2021 07:45 at single dose for COVID-19 immunization. Medical history was none. Concomitant medication included isotretinoin (ACCUTANE). The patient previously received first dose of BNT162B2 on unknown date 11:15 on right arm. The patient had no covid prior vaccination. The patient had no covid tested post vaccination. The patient had no Known allergies. On 06Feb2021 14:00, the patient had Left hand, specifically thumb, has numbness and tingling. Unable to perform daily activities with this hand after vaccination. Also muscle weakness in right thigh. It was unknown if treatment was received for the events. The events resulted in Disability or permanent damage. The outcome of all events was not resolved. Information about lot/batch number has been requested.; Sender's Comments: A contribution from BNT162B2 to reported events cannot be fully excluded based on the temporal relationship and lack of alternate explanation at this time. Case will be reassessed if additional information is received The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
25 2021-02-23 panic attack, altered state of consciousness Psychosis, altered sense of reality, fear of attack, distrust of partner, lasting about 4 hours.
25 2021-03-04 restlessness, disorientation, feeling abnormal I made sure to hydrate and eat well the day of the vaccine. I have had no allergic reactions to any ... Read more
I made sure to hydrate and eat well the day of the vaccine. I have had no allergic reactions to any medications/ injections in the past and I was not worried about this one. I didn't take any meds beforehand besides my normal morning modafinil. I have no fear of needles. I received the vaccine in the auditorium about 1:25pm. The RN did a fantastic job, went through all of the information, no pain at all with the injection. As I was sitting in my chair for monitoring, a few minutes in I began to feel very uncomfortable. I felt clammy/sweaty and kept shifting my weight in my seat. I didn't want to make a big deal of it at first because I worried it was all in my head. But I became more and more uncomfortable. I laid my head down on the little desk, no help. I closed my eyes, no help. About 10 minutes or so in I decided to ask if they had water available. I slowly got up and walked to the back of the room. I couldn't even get the question out of my mouth before the nurse told me to sit down. Apparently I was white as a ghost. They got a wheelchair and wheeled me to the space behind the auditorium. By then I was starting to feel like my throat was closing and I saw spots in my peripheral vision. It was kind of a blur from there. I tried to take deep breaths. I drank a few sips of water and poured some on a paper towel to wet my forehead (and spilled all over my lap because I was a little disoriented at this point). My BP was 60s/40s and then 60s/30s. A rapid response was called. They moved me to a cart flat on my back with my legs elevated. My fingers and toes were starting to go numb and my lips were apparently blue/ white. After laying for a few minutes in Trendelenburg my BP began to resolve and my breathing started to ease a bit. No further intervention was done by the rapid team. I was taken by the Rapid RN to the ED for monitoring. They eventually pushed the cart into a room and took some vitals and an EKG. They had me stand and move to a wheelchair. I felt horrible but improved from before. They had me sit in a wheelchair in the lobby for a few hours before taking me back and placing an IV and drawing labs (I believe it was 3 hours from the initial reaction). I gave a urine sample. They then put me in a wheelchair and wheeled me back into the lobby for some more time. Then, they wheeled me back to a room where they gave some lactated ringers and a PA and MD saw me. By then my BP and breathing was completely resolved. The MD said he wasn't fully convinced it was just a vasovagal episode because I haven't had issues with vaccines in the past and I was well hydrated and my HR was normal. It partly fit the picture for an allergic reaction/ severe immune response d/t the feeling of throat closing, the BP drop, and the elevated WBCs. They advised that I list the vaccine as an allergy and do not get the second dose, especially since I had COVID back in September.
25 2021-03-06 sleep disorder ~8 hours after injection: achy, shaky, chills ~hour 9-12 after injection: splitting headache - slept... Read more
~8 hours after injection: achy, shaky, chills ~hour 9-12 after injection: splitting headache - slept and woke every hour ~hours 25-27 after injection: throbbing headache, lightheaded, overheating, minor vomiting, Increased heart rate
25 2021-03-08 feeling abnormal 1/14 vaccination @ 12 By 1:30 I was experiencing light headedness, brain fog. I went to leave work e... Read more
1/14 vaccination @ 12 By 1:30 I was experiencing light headedness, brain fog. I went to leave work early and experienced a near syncopal episode. Co workers took vitals. O2 was fine, BP was low. Monitored at work for a couple hours and then helped home. *anemic **heaviest day of period ***was informed by vaccine administer that these factors would not be a barrier to getting the vaccine.
25 2021-03-09 impaired work ability My heart rate elevated to 120bpm; This side effect was unexpected, uncomfortable; This side effect w... Read more
My heart rate elevated to 120bpm; This side effect was unexpected, uncomfortable; This side effect was unexpected, uncomfortable and resulted in me being unable to work for the rest of the day.; This 25- year-old female patient contactable consumer (reported for herself) received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE lot EL3247), via an unspecified route of administration, on 03Feb2021 at 1:00 PM (at the age of 25-years-old) as a single dose for COVID-19 immunization, in left arm. She has had no other vaccines in the past 4 weeks. Patient has not taken any medications in the past 2 weeks. The patient has no relevant medical history and is not taking any concomitant medications. The patient is not pregnant. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 03-FEB-2021 13:05, she reported: my heart rate elevated to 120bpm approximately 5 minutes after receiving the Pfizer COVID19 vaccine. This side effect was unexpected, uncomfortable and resulted in me being unable to work for the rest of the day. This side effect lasted approximately 36 hours. Patient did not receive any treatment. The outcome of the events heart rate elevated and unable to work the rest of the day was recovered. It was reported that since the vaccination, the patient had not been tested for COVID-19.
25 2021-03-10 anxiety C/o anxiety prior to administration. Approx 15 minutes after administration individual developed inc... Read more
C/o anxiety prior to administration. Approx 15 minutes after administration individual developed increased anxiety, headache, dizziness, tachycardia, shakiness, and sweatiness. VS: 95/51 HR 63. Evaluated and monitored, provided PO fluids, improvement noted. No transport.
25 2021-03-11 suicidal thoughts, depression Extreme fatigue, Depression, Suicidal thoughts. Persisted over the course of 3-4 days with the worst... Read more
Extreme fatigue, Depression, Suicidal thoughts. Persisted over the course of 3-4 days with the worst day being 2 after the vaccination.
25 2021-03-13 insomnia Sleeplessness, chills, morning throat and sinus soreness and fatigue
25 2021-03-17 loss of personal independence in daily activities Patient states she received her COVID-19 vaccine on Friday, March 5, 2021. Reports she noticed "it w... Read more
Patient states she received her COVID-19 vaccine on Friday, March 5, 2021. Reports she noticed "it was high up on her shoulder". Reports asymptomatic at time of vaccination and when leaving facility. Reports later in the evening her "whole arm was sore and stiffened and she wasn't able to move it without a great deal of pain". Also describes lost range of motion. Rated pain at a 7-8/10 at that time. Reports she was not able to "get ready or dressed in the morning". Reports "roughest" Friday night through Saturday. States she did not do much on Saturday. Patient stated she used ibuprofen every 4 hours and iced injection site for 15 minutes without effectiveness.
25 2021-03-18 sleep disorder After 12 hours of getting the shot, I woke myself and my partner up from shaking so bad. I took some... Read more
After 12 hours of getting the shot, I woke myself and my partner up from shaking so bad. I took some Benadryl to call the Nausea but I vomited everything in my stomach up by 1AM. I cannot sleep because of the fever (100.5 F) and I cannot eat anything without being sick
25 2021-03-19 sensation of foreign body AT APPROXIMATELY 15:33 PATIENT THINKS HER THROAT IS SCRATCHY. NO APPARENT DISTRESS IS PRESENT. AT 15... Read more
AT APPROXIMATELY 15:33 PATIENT THINKS HER THROAT IS SCRATCHY. NO APPARENT DISTRESS IS PRESENT. AT 15:35 PATIENT FEELS LIKE A LUMP WHEN SWALLOWING. REPORT CALLED TO MEDICAL CONTROL AT 15:45. AT 15:57 NOW PATIENT STATES THROAT IS TIGHTENING. PATIENT DECLINED MED CONTROL AND DROVE HERSELF TO EMERGENCY DEPT ESCORTED BY MEDIC.
25 2021-03-24 impaired work ability Patient called at around 10 AM on 3/25/2021 and explained that she had developed a rash that morning... Read more
Patient called at around 10 AM on 3/25/2021 and explained that she had developed a rash that morning. It started in her scalp, moved to her face, and then onto her throat. She was at work at this time. I advised her to take a 25 mg Benadryl (which may cause drowsiness). Based on her size (145 lbs) employee did not recommend she take a 50 mg Benadryl. Patient did not know if she had a fever or not. She reported NO fever at that time. Employee called her back at 6:30 PM to check on her. She said she had to leave work around 2 pm; she was feeling bad, achey. She said she took some ibuprofen as she was feeling achey and feverish. she didn't feel the need to go to the doctor or urgent care at this time.
25 2021-03-28 feeling abnormal Terrible ?off? taste in mouth for the last two days
25 2021-03-28 feeling abnormal Fogginess, headache, sore arm, stiff neck on left side, very fatigue
25 2021-03-29 anxiety Patient experienced dry throat, felt anxious and dizzy. EMS was called and a banana and benadryl wer... Read more
Patient experienced dry throat, felt anxious and dizzy. EMS was called and a banana and benadryl were administered by the clinical team.
25 2021-03-29 feeling abnormal Pt States "Feels funny". Nausea. No SOB; Pulse strong and regular. Oriented x 3 Color normal. ... Read more
Pt States "Feels funny". Nausea. No SOB; Pulse strong and regular. Oriented x 3 Color normal. @ 1615 states feels better. Instructed to f/u with PCP if needed.
25 2021-03-29 insomnia I got like really sick last night; I couldn't sleep; My body was really hot, I think I had a fever; ... Read more
I got like really sick last night; I couldn't sleep; My body was really hot, I think I had a fever; Chills; Leg cramps; Body aches; Arm is really sore; This is a spontaneous report from a contactable consumer.A 25-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown), via an unspecified route of administration in the left arm on 17Feb2021 as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported.The patient previously received first single dose of bnt162b2 on 28Jan2021 for Covid-19 immunization. The patient stated she just want to report that she got the vaccine yesterday (confirmed as 17Feb2021) and on 17Feb2021 she got like really really sick last night, she couldn't sleep, her body was really, really hot and then she also had chills with it. So, she think she had a fever but she just didn't have the thermometer to check exactly what it was. And she had really bad leg cramps and body aches and she just felt really sick, she couldn't sleep, her arm is really sore and she just wanted to report it because she know as an employee that is our responsibility to report it. She stated she took Tylenol and Advil last night .She took 1 Advil last night and 1 Tylenol this morning. The outcome of the events were recovering. Information about lot/batch number has been requested.
25 2021-03-30 disorientation, delirium Delirium; Fainting episode with convulsions; Fever with Chills; Nausea; Dizziness and disoriented; D... Read more
Delirium; Fainting episode with convulsions; Fever with Chills; Nausea; Dizziness and disoriented; Dizziness and disoriented; This is a spontaneous report from a contactable consumer (patient). A 25-year-old female patient (not pregnant) received first dose of bnt162b2 (Batch/Lot Number: EN6207), via an unspecified route of administration, administered in left arm on 18Mar2021 08:30 as single dose for covid-19 immunization. Medical history included cystitis interstitial from an unknown date and unknown if ongoing. Concomitant medications included ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE) taken for an unspecified indication, start and stop date were not reported. The patient experienced delirium, fainting episode with convulsions, fever with chills, nausea, dizziness and disoriented on 18Mar2021 09:00. No other vaccine in four weeks. The adverse event was not resulted in a visit to doctor or other healthcare professional office/clinic or Emergency room/department or urgent care. No treatment received. The outcome of events was resolving. No Covid prior vaccination. No Covid tested post vaccination. Not Known allergies.
25 2021-03-30 restlessness high fever; chest tightness; Vicious vomiting; left eye swelling; restlessness; body aches; headache... Read more
high fever; chest tightness; Vicious vomiting; left eye swelling; restlessness; body aches; headache; difficulty breathing; difficulty speaking; shortness of breath; This is a spontaneous report from a contactable consumer (patient). This 25-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EN7206) at the age of 25 years, via an unspecified route of administration at single dose in the left arm on 07Mar2021 10:00 AM for COVID-19 immunisation. Medical history included asthma. Concomitant medications included salbutamol (ALBUTEROL HFA), lansoprazole (PREVACID), both taken for an unspecified indication. Previously the patient received the first dose of BNT162B2 (Lot Number: EL9266) at the age of 25 years on 13Feb2021 10:00 AM in the left arm for COVID-19 immunisation. On 07Mar2021 23:00, the patient experienced high fever, chest tightness, vicious vomiting, left eye swelling, restlessness, body aches, headache, difficulty breathing, difficulty speaking, shortness of breath. No treatment required. The events required a visit to the physician's office. The outcome of the events was not recovered. The vaccine was administered at a Clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination.
25 2021-03-31 anxiety light headed, anxious, pt. advised to hydrate BP 86/48, O2 98%, P=80. Had a snack. States that s... Read more
light headed, anxious, pt. advised to hydrate BP 86/48, O2 98%, P=80. Had a snack. States that she feels better and wants to go home. Accompanied by husband.
25 2021-03-31 panic attack, feeling abnormal, anxiety Sudden onset of intrusive thoughts like constant blinking. Extreme anxiety, panic attacks and brain ... Read more
Sudden onset of intrusive thoughts like constant blinking. Extreme anxiety, panic attacks and brain fog lasting weeks. Originally went to ER for one day ruled out physical symptoms got an mri and blood work completed, went to primary care doctor after and was told it would go away in a couple days but continued for weeks right before getting second vaccine I started seeing a psychiatrist to work on brain fog/ anxiety.
25 2021-04-01 confusional state 12 hours after receiving my 2nd dose of the Pfizer COVID-19 vaccine, I experienced the following: Se... Read more
12 hours after receiving my 2nd dose of the Pfizer COVID-19 vaccine, I experienced the following: Severe body aches Fever (100.4 average throughout the day, highest was 101.7) Chills No appetite Nausea Diarrhea Severe fatigue Severe joint pain Muscle Weakness Sore Throat Racing heart Confusion Sore arm from injection site These symptoms lasted the entire day of April 1, 2021. My symptoms on April 2, 2021 are not as severe and I do not have a fever.
25 2021-04-07 impaired work ability I started becoming dizzy 10 to 15 minutes after I received the first dose of the vaccine. I remained... Read more
I started becoming dizzy 10 to 15 minutes after I received the first dose of the vaccine. I remained dizzy for the next 4 days feeling like I was on a boat. By the 6th day it was even worse. It has lasted over 3 weeks now and is ongoing. I have been trying the epley maneuver as I was instructed to do so by my doctor and take my allergy medication (Flonase) to potentially decrease inflammation as well as take tylenol. I will be going to see an ENT specialist next week to try to get some relief. It has been horrible and I haven't been able to work full time for the last 2 weeks.
25 2021-04-08 anxiety C/o sharp pain in left side of head that migrated down her arm & across her chest. She was shaking a... Read more
C/o sharp pain in left side of head that migrated down her arm & across her chest. She was shaking all over & felt "warm all of a sudden" she was Extremely anxious. Code Green called when H2O & trying to calm her down didn't work. paramedics arrived to assess.
25 2021-04-08 feeling abnormal, loss of personal independence in daily activities I'd had Bell's Palsy (BP) twice in my life (once in 2013 and once in 2015). I have not had it since ... Read more
I'd had Bell's Palsy (BP) twice in my life (once in 2013 and once in 2015). I have not had it since 2015 until I got vaccinated on 3/29/21 and began to develop BP symptoms on the evening of 4/6/21 (headache on right side of my head/temple, odd sensation on right side of my tongue, almost like I burned it on a hot beverage) but I didn't think anything of it. I went to sleep and then, on the morning of 4/7/21, I woke up feeling extremely fatigued, brain fogged, and weak. I didn't notice any of the BP symptoms until I went to brush my teeth and realized I had lost motor function in the right side of my mouth. I immediately made a telehealth appointment with an Urgent Care doctor in order to get an Rx of Prednisone. I began taking the Prednisone around 3pm on Wednesday, 4/7/21. I also have been taking vitamin B-12 and a Women's Multivitamin to help regenerate nerve function. However, since starting the prednisone, my symptoms have continued to develop. Symptoms currently include: right side of my face is extremely swollen; I have lost mobility on the right side of my face, the right side of my tongue still feels numb; right eye tearing non-stop; some mild ear pain in right inner ear; slight pins-and-needles sensation in my fingers on my right hand; difficulty eating and drinking; still feeling fatigued. I have recovered from BP twice before so I am not too worried about having it again. I just think the FDA needs to put out a warning to the public that there may be a correlation between the COVID-19 mRNA vaccines and Bell's Palsy recurrences. I know this is not a coincidence, and my BP relapse was a result of my body experiencing an immune reaction from the vaccine.
25 2021-04-11 disorientation Patient fainted while sitting in the waiting area about 5 minutes after receiving her first dose of ... Read more
Patient fainted while sitting in the waiting area about 5 minutes after receiving her first dose of the Pfizer COVID Vaccine. Patient was unconscious briefly, but woke up after less than a minute a little disoriented. She was sweating and felt very hot, except for her hands that were cold. We gave her water and an ice pack to cool her down and waited with her until paramedics came to treat her. She seemed alert and that the issue had mostly resolved as she left with paramedics approximately 15 minutes later, but it is unknown what happened after she left with them.
25 2021-04-13 feeling abnormal 10 minutes after the injection I felt my blood pressure rise up. When I got home it was 134/94, mac... Read more
10 minutes after the injection I felt my blood pressure rise up. When I got home it was 134/94, machine told me I had mild hypertension. When I measured a few hours later it was at 137/90. It remained like that until the evening when it lowered back down to 120/87. Later that evening, I had a fever and took Tylenol to help. My headache got worse in the evening as well. Arm was sore. This morning (day after my 1st dose) my BP was at 108/79, fever creeped up as the day went on, body aches, arm was hurting more, headache continued, pressure on chest made it a bit hard to breathe, dizziness, some nausea, brain fog.
25 2021-04-14 feeling abnormal The first dose of the Pfizer vaccine was taken on March 15th at 8:30. Within a week I started feelin... Read more
The first dose of the Pfizer vaccine was taken on March 15th at 8:30. Within a week I started feeling weak joints, headaches followed by a sharp pain on the occipital lobe. I started my period for the second time that month, which was odd because it never happened to me before. I went to work that week, but by Friday (March 30th) I was not able to handle the pain so after work I went to the doctor and they took blood to see if there was anything going on. The result came back the following day and everything was normal. I was given medicine (muscle relaxers) for the occipital pain, but it was not enough. At that time I was not sure what was the cause of it, I thought it was a bad flu, but I didn't come to the conclusion that it was because of the vaccine, because a week had passed by, so I thought it was impossible. The doctor asked for me to take an X-Ray for the occipital pain, so I did (March 30th) and it resulted in everything being fine. She also recommended for me to get an abdominal ultrasound to see if my uterus was fine due to the second period. I currently took the second Pfizer dose in the same location, but this time around I felt all of these symptoms within 3 hours of the vaccination. I started feeling lightheaded and dazed, my joints started feeling weak, my mouth and tongue started feeling sensitive (fever blisters and sensitive to anything that is acidic, spicy, etc). I have not visited the doctor this time around because the pain is tolerable. I have noticed in increase of joint pain as the days go by.
25 2021-04-14 sleep disorder Sore Arm within 5 hours causing me to wake up in night Body aches and fever after 16 hours I did hav... Read more
Sore Arm within 5 hours causing me to wake up in night Body aches and fever after 16 hours I did have covid previously
25 2021-04-16 restlessness I started getting heart palpitations that night that haven't stopped. I couldn't sleep and all day t... Read more
I started getting heart palpitations that night that haven't stopped. I couldn't sleep and all day the next day I have having chest pain, heart palpitations, and physical feeling of panic although mentally I was fine. it felt like I kept having adrenaline rushes
25 2021-04-17 anxiety 2 MINUTES POST VACCINATION PT BECAME SWEATY, ANXIOUS, DIZZY AND DEVELOPED TUNNEL VISION. PT TRANSPOR... Read more
2 MINUTES POST VACCINATION PT BECAME SWEATY, ANXIOUS, DIZZY AND DEVELOPED TUNNEL VISION. PT TRANSPORTED TO OBS VIA WC. VSS. HUSBAND AT BEDSIDE. PT SLOWLY TRANSITIONED FROM LYING, TO SITTING AND THEN STANDING. ALL SYMPTOMS RESOLVED. PT RELEASED AT 1700. PT AND HUSBAND ESCORTED TO EXIT WITH NO FURTHER ISSUES. VITALS AS FOLLOWS: 1643 BP 138/85 HR 68 RR 20 SPO2 99 1649 BP 138/87 HR 77 RR 20 SPO2 100 1656 SITTING BP 133/88 HR 78 SPO2 98 1659 STANDING BP 130/66 HR 100 SPO2 98
25 2021-04-19 anxiety 1:40P COMPLAINED OF RAPID HT RATE, SWEATING AND ANXIETYSHE WAS DIAPHORETIC, HYPERVENT, AND SLIGHTLY ... Read more
1:40P COMPLAINED OF RAPID HT RATE, SWEATING AND ANXIETYSHE WAS DIAPHORETIC, HYPERVENT, AND SLIGHTLY HYPER- TENSIVE. 133/83 HR 97 O2 98%. PLACED ON STRETCHER, GIVEN H2O STATED THIS HAPPENED TO A LESSER DEGREE WITH FIRST VACCINE. IT HAS BEEN 21/2 MTHS SINCE FIRST DOSE ASHE WAS ANXIOUS ABOUT RECEIVING SECOND DOSE. 2P 122/87 HR 88 O2 100%. COLD CLOTH TO HEAD , SEMI FOWLERS POSITITO FACILITATE BREATHING. 2:05 FEELING BETTER. DANGLED WITHOUT DIFF. AMBULATED TO BR WITH SUPERVISION. FELT BETTER AFTER AMBULATING. 2:15 121/74 HR 87 02 100% SKIN WARM AND DRY. DENIES UNTOWARD EFFECTS. DISCHARGED
25 2021-04-20 depression, impaired work ability Extreme change in menstrual cycle. I got cramps the same day as the vaccine, more than a week early,... Read more
Extreme change in menstrual cycle. I got cramps the same day as the vaccine, more than a week early, which has never happened before in my life. I have already had my period for over 9 days, and it is not done yet, which is already much longer than normal. Stronger cramps and stronger flow. It also started differently than normal, with light bleeding for days at the beginning. I also felt much stronger depression than I have ever felt in my life before. It was overwhelming. I was about to change my birth control method before I put the two together because the pain, flow, and depression were so bad it was unbearable. I was unable to work. I did not report these symptoms on my follow-up survey that I received every day for a week after because I did not know it was connected to the vaccine. I feel so relieved to understand what is going on.
25 2021-04-22 sleep disorder At 5:15 pm, same day as shot, a migraine occurred. A bad migraine, unable to stand because it caused... Read more
At 5:15 pm, same day as shot, a migraine occurred. A bad migraine, unable to stand because it caused so much pain in my head. at 8:00PM I went to bed due to the pain. at 1:15 AM, my body was in pain. My right rib cage hurt so bad that I couldn't sleep on my right side. My legs, back, and pelvic bones were in so much pain as well. I felt as if my bones were going to break or I had severely bruised my bones. Breathing, coughing, sneezing hurt because of my rib cage hurting. My migraine had not gone away, and my lymph nodes were really swollen. Couldn't put my arms down, my neck was swollen and walking hurt because my legs were swollen. This occurred for 24 hours. Next day, migraine is gone and left a headache. Swelling is still prominent and bones still hurt.
25 2021-04-23 anxiety Patient received a second dose of Pfizer vaccine at 3 pm today 04/23/2021 at our store. After notici... Read more
Patient received a second dose of Pfizer vaccine at 3 pm today 04/23/2021 at our store. After noticing some blood coming from the injection site patient became very worried and said she felt lightheaded. She was offered a chair to sit on but within 5 minutes of sitting down she said she was not feeling any better. While I was talking to her she seemed to have a mild seizure-like episode which lasted less than a minute. After she became alert she said her thumbs were cramping up and asked us to call 911 for her. Paramedics took her to the hospital.
25 2021-04-23 confusional state, anxiety EMS came upon patient in observation after receiving second dose of vaccine. Patient was having an ... Read more
EMS came upon patient in observation after receiving second dose of vaccine. Patient was having an anxiety attack and stated she was going to have a seizure. Patient slid down in chair and began having a full body seizure. Patient was lowered to the ground by EMS. Patient was kept safe on the floor in right lateral recumbent position. Patient's seizure lasted approximately 2 minutes. Patient was lifted to a stretcher. Was alert to voice but was confused about where she was and what happened. Placed on O2, 4L nasal cannulla. Patient felt nauseous and cold. Was transported to local hospital.
25 2021-04-23 sensation of foreign body I have trouble swallowing solid food. Specifically, after chewing the solid foods finely (i.e. eggs,... Read more
I have trouble swallowing solid food. Specifically, after chewing the solid foods finely (i.e. eggs, spam, meat, edamame), the throat will not swallow. It just feels like the throat forgets how to swallow, which should have been a natural response normally that does not require conscious thinking. If I forcefully swallow it, it feels like the food did not go down well and some pieces were stuck in the trachea and I want to spit out mucous. When I spit out, there were nothing strange, mainly just saliva. I had no issue swallowing liquid or soft foods (i.e. yogurt and steamed egg). I do not feel pain or swollen on throat but do sometimes feel there was something at the back of the throat. But again when I spit out mucous there was nothing abnormal. I went to the Purdue student health center and they did not find any abnormal in the throat, only seemed a little red but nothing abnormal.
25 2021-04-25 anxiety Patient reported experience shortness of breath and some anxiety after receiving second dose of vacc... Read more
Patient reported experience shortness of breath and some anxiety after receiving second dose of vaccine. She was received in the observation room and made comfortable. She was encouraged to take in slow deep breath and relax to help with the anxiety and shortness of breath. Serial vital signs were collected on the patient. Patient verbalized relief from her symptoms. She was discharged at 5:18pm in stable condition
25 2021-04-25 confusional state, anxiety Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: A... Read more
Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Rash Generalized-Mild, Systemic: Chills-Severe, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Mild, Systemic: Nausea-Mild, Systemic: Shakiness-Severe, Systemic: Weakness-Mild, Additional Details: Patient recieved vaccination. 15 minutes later patient stated she wanted to stay a little longer with a feeling of uneasiness and muscle trembling/shaking and feeling cold. 27 minutes later patient stated she felt a sudden tightness in her chest and a shortness of breathing. Patient requested to get an epi-pen injection due to the difficulty in breathing. Patient had epi-pen injected into left thigh at 4:46 pm .
25 2021-04-26 disorientation, confusional state, amnesia Migraine, fatigue, memory loss, confusion, disorientation starting 1-2 days after and persisting day... Read more
Migraine, fatigue, memory loss, confusion, disorientation starting 1-2 days after and persisting day 4.
25 2021-04-26 feeling abnormal First 4 days sore arm near the injection site. On day 5, I woke up with extreme fatigue, muscle ache... Read more
First 4 days sore arm near the injection site. On day 5, I woke up with extreme fatigue, muscle aches and seeming weakness, headache, dizziness, nausea, brain fog, and feeling feverish. Some symptoms have continued today - fatigue and muscle aches and weakness.
25 2021-04-27 irritability The morning after (04/15/21), I woke up with soreness and slight redness. As of today (04/28/21), a ... Read more
The morning after (04/15/21), I woke up with soreness and slight redness. As of today (04/28/21), a red circle with the diameter of more than 1 inch, slightly tender on my left arm. Gradually increased in size over the last 2 weeks. My whole body is itchier than normal. I'm now using a body lotion daily so I have not experienced much itchiness since. I've been very fatigued & irritable. My headaches have gotten worse and I haven't had much of an appetite.
25 2021-05-02 feeling abnormal 14 hours after the vaccine was received, I woke up so uncomfortable, no matter how I moved I couldn?... Read more
14 hours after the vaccine was received, I woke up so uncomfortable, no matter how I moved I couldn?t get comfortable. It was the kind of uncomfortable where I swear I could feel it in my bones. Laid in bed until 8:30 when baby boy woke up, promptly threw up, got so nauseated and dizzy that I could not move from the bathroom floor, and had to ask grandma to bring me my medicines. The mix of ibuprofen, migraine medication, and anti-nausea all combined made me feel no symptoms for several hours until they wore off and I lost all ability to stand. My legs just felt so weak. And now I?m finally starting to feel a little better, and it?s been 2.5 days now. Boy, those side effects are no joke. Still worth it though so I don?t bring a deadly virus home to my baby boy ?????
25 2021-05-03 anxiety After she was vaccinated she said " I need to lay down " I need water" "I get anxious " she stared ... Read more
After she was vaccinated she said " I need to lay down " I need water" "I get anxious " she stared look pale. she ask to let her lay down on the floor we assisted her to the floor and called rapid response. I put some alcohol behind her ears and brought a wheel chair. she was able to get on the chair we took vitals @2:52 BP 113/76, P 73, O2 95 she said "This happens all the time when I get shots" . Response team arrived and saw that vitals were good and offered her to go to the ER to get checked out and she refused. I took her vitals again @3:05 125/65, P 70, O2 97. Took her to the hallway she wait 30min and she looks and said she was ok and insisted " this happen all the time i get a vaccine." I then walked her to the parking lot.
25 2021-05-04 feeling abnormal Lymph nodes in her neck are severely swollen where she can barely turn her neck; Having severe lower... Read more
Lymph nodes in her neck are severely swollen where she can barely turn her neck; Having severe lower abdominal pain; Sore throat; Headache; Overall feels horrible; Lymph nodes in her neck painful (sore); Stated that she is really tired; she could barely turn her neck; This is a spontaneous report from a contactable consumer (patient's mother). A 25-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at age of 25-year-old at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The caller stated her daughter had the vaccine on Thursday and was having bad side effects. She stated her lymph nodes in her neck were severely/extremely swollen and painful where she could barely turn her neck and her neck was sore. She was having severe lower abdominal pain that started that evening, bad first two days and had subsided. The patient was really tired. She had a sore throat, a headache, and overall feels horrible. She stated 3 days ago there were reports of hundreds of women in her age group having these same symptoms and this information was not available to them prior to the vaccine. She stated there were woman dying in Norway from thrombosis, 20 women in their reproductive years. Woman this age were getting severe reactions and there is no available information on this. She asked, how long will these symptoms last. How to make the swelling and pain go away. Stated that she was fine before the vaccine and currently she was not fine. The outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
25 2021-05-04 loss of personal independence in daily activities I had joint and muscle pain throughout my body, dizziness and weakness three days after my vaccine a... Read more
I had joint and muscle pain throughout my body, dizziness and weakness three days after my vaccine after giving blood that Saturday at 11 am. The pain was throughout my body so much that I couldn't do my normal functions. I also developed stomach pain a day after I gave whole blood. These symptoms lasted 5 days, after which I still had some muscle pains and weakness but not that I couldn't continue on in my normal activities. The muscle pain and weakness symptoms lasted another week before I felt more normal, although, the stomach pain went away after about 5 days. After my second dose on April 7th, 2021 with Pfizer lot number ER8727 in my left arm, I was tired and had a little bit of muscle pain right away but these symptoms only lasted 24 hours after my shot at 9am that Wednesday I received that dose.
25 2021-05-05 feeling abnormal Arm soreness that was mild went away after the shot. Then the "weird" or uncomfortable soreness th... Read more
Arm soreness that was mild went away after the shot. Then the "weird" or uncomfortable soreness that feels to her like cold nerve pain or just super mild discomfort did not go away completely and has still not gone away so far 5 days after the vaccine.. Patient also leg discomfort (super mild but also not totally normal) for 1-2 days after the vaccine. She is not sure if the neck moderate pain that radiates to the back is associated and it started on Tuesday or 4-5 days after the vaccine. Like a cold numbness is how she would describe it.
25 2021-05-05 loss of personal independence in daily activities Started to experience vertigo a day after injection. Currently on day 5 of symptoms. Can not operate... Read more
Started to experience vertigo a day after injection. Currently on day 5 of symptoms. Can not operate vehicle and is causing vomiting. Can not preform daily tasks.
25 2021-05-06 anxiety PATIENT HAD AN ANXIETY MOMENT FOLLOWING VACCINE. VITALS WERE TAKEN, EVERYTHING WAS WITHIN NORMAL RAN... Read more
PATIENT HAD AN ANXIETY MOMENT FOLLOWING VACCINE. VITALS WERE TAKEN, EVERYTHING WAS WITHIN NORMAL RANGE EXCEPT HEART RATE WHICH WAS 107. PATIENT WAS INSTRUCTED TO BREATHE. PATIENT REQUESTED TO GO TO THE HOSPITAL. WE ASKED IF SHE WOULD LIKE TO GO PRIVATE AUTO BUT DECLINED. PATIENT WAS ALSO ASKED IF A FAMILY MEMBER WANTED TO COME PICK HER UP, SHE SAID SHE WANTED TO GO VIA AMR. PATIENT WAS TRANSPORTED TO HOSPITAL FOR FUTHER EVAULUATION.
25 2021-05-06 impaired work ability FULL BODY RASH - red and purple, painful, VERY itchy, now looks bruised symptoms started sunday 5/2... Read more
FULL BODY RASH - red and purple, painful, VERY itchy, now looks bruised symptoms started sunday 5/2/2021 and still continuing and ongoing as of 5/7/2021
25 2021-05-06 motion sickness, feeling abnormal, euphoric mood I woke up with severe vertigo & nausea on Sunday, May 2nd. Continued to experience severe vertigo un... Read more
I woke up with severe vertigo & nausea on Sunday, May 2nd. Continued to experience severe vertigo until Wednesday, May 5th. I had trouble walking, moving my head & eyes to the side or vertically, and couldn't tolerate bright lights or loud sounds. Vertigo symptoms mainly subsided on Wednesday evening, but I have been experiencing other symptoms since then. I have felt very "off" as if I'm floating, or high on drugs (I have not taken any medication for this). I've experienced a headache and felt lightheaded, and dizzy if I make certain head movements. I have never experienced anything like this before. I've had vertigo once before this, but it only lasted several hours and I did not experience any other symptoms. I also experienced slight vertigo (only a couple of seconds) as the first symptom of COVID when I had it in March 2020.
25 2021-05-09 excessive sleepiness The first COVID-19 shot put me into a sort of zombie like coma for some reason I was a little bit ti... Read more
The first COVID-19 shot put me into a sort of zombie like coma for some reason I was a little bit tired and slightly dizzy and my arm hurt the day of the shot but I thought nothing of it at the time then went to bed and passed out into the deepest sleep and got woken up by my concerned mother 18 hours later who was freaked out that she had gone to work and come back again and I was still sleeping so she forced me to stay awake for the next 3 hours during which all I wanted to do was go back to sleep again immediately and I was not terribly alert and remember nothing of those 3 hours other than begging her to let me go back to sleep again because i was just SO TIRED but according to her she apparently dragged me to IHOP for my grandmothers birthday dinner and I made very bare minimum mumbling small talk conversation only if you prompted me to respond two or three times and kept nodding off leaning against the side of my booth seat partner and having to be shaken awake again she finally let me go back to bed again at 9 that night and I slept for another 15 hours and woke up more alert but with the feeling that I had a moderate but semi functional case of sleep deprivation like I had just pulled an all nighter working on a school project or something so thinking i was feeling better I went grocery shopping and by the time I got to the end of my list I was starting to feel more fatigued and I remember driving to the store but not driving back and only random bits and pieces of putting the groceries away and then thinking that i was unbearably hot and being concerned that I had a fever so i went to the bathroom and checked my temperature which was 98.6 then stood in front of the AC vent thinking I should take a cold shower and the very next second i am startling awake to a super loud song on my MP3 player that i don't remember turning on and curled up in the foidal position on the couch and the contence of my pockets are all over the living room floor for some unknown reason and i have lost nearly two hours worth of time but feel much better and only a normal amount of tired then went to bed that night at 10 and slept for 12 hours then woke up by myself totally normal fully rested fully functioning awake and alert and with no more memory or lost time or fatigue or sleep issues ever since that point and when I went in to get my second stage of the COVID-19 shot today (about an hour ago from the time I am currently typing this report and FYI as of this moment so far I feel fine luckily) and told the pharmacist about my zombie coma experience and asking if that was going to happen again she told me that she didn't know and also that it was apparently an abnormal reaction to the shot to try to sleep it off like that and she told me that I should report it here on the website so here I am reporting it now...
25 2021-05-10 feeling abnormal 1st shot only experienced an expected amount of soreness around the injection site. 2nd dose: experi... Read more
1st shot only experienced an expected amount of soreness around the injection site. 2nd dose: experienced mild flu symptoms (body aches, fatigue, headache, lack of appetite) the day after the shot and the symptoms only lasted 24 hours with just some slight soreness leftover the next day. That same week on Friday I woke up with an intense migraine that came in and out even after taking Midol. This migraine started shooting pain from the top of my head, down through my neck, into my arms, and all the way down my back. These were sharp sudden pains that I would feel. I started to have muscle spasms in my face and felt a bit nauseous/didn?t have an appetite. I felt very foggy, like I was just floating around but also that my body weighed 1000lbs. I?ve been experiencing these symptoms for 4 days now. I?m mostly still struggling with headaches, some fatigue, and muscle aches. I?ll get these aches randomly throughout my body. Sometimes it feels a bit flu like, the same as it felt on the day after I had got my 2nd dose. I don?t know if these symptoms are related to the vaccine or not.
25 2021-05-12 anxiety Patient reported symptomatic heart palpitations after receiving the 2nd dose of the Pfizer SARS-CoV... Read more
Patient reported symptomatic heart palpitations after receiving the 2nd dose of the Pfizer SARS-CoV2 mRNA vaccine on 5/11/2021 at 1pm which lasted a few hours. She then presented to her urgent care clinic around 3pm and was transferred to the Hospital ED. She was found to be in sinus tachycardia to HR 140s-150s. Work-up as described below was largely unrevealing. Plan for TTE on this hospital admission. Overall believe that severe anxiety is a the driving factor behind her sinus tachycardia, and that the SARS-CoV2 vaccination was just coincidental in time course.
25 2021-05-17 insomnia On May 11 (ten days after second shot), I broke out in full body hives (face, arms, legs, entire abd... Read more
On May 11 (ten days after second shot), I broke out in full body hives (face, arms, legs, entire abdomen). Extreme itchiness all over body - unable to sleep. Body was entirely red with raised white welts. Visited urgent care doctors, dermatologist, and allergist. Landed on a treatment plan with the allergist with a strong dose of steroids and antihistamines, which have mostly resolved the symptoms as of 5/18 (Biaxin, Medrol, Probiotic, Pepcid, Xyzal, Allegra, Benadryl). I was prescribed a Prednisone taper along with Zyrtec from Urgent Care on May 12, but my symptoms did not improve until starting the allergist's plan on 5/15.
25 2021-05-17 restlessness Lethargy; swollen and painful arm and armpit; swollen and painful arm and armpit; swollen and painfu... Read more
Lethargy; swollen and painful arm and armpit; swollen and painful arm and armpit; swollen and painful arm and armpit; chills; nausea; headache; muscle aches all over body; restlessness in muscles (feel like she had to flex everything); This is a spontaneous report received from a contactable consumer (patient). A 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown), via unspecified route of administration in left arm on 12Feb2021 12:30 PM (at the age of 25-year-old) as 2nd dose, single for COVID-19 immunisation. Vaccine facility type was reported as hospital. The patient's medical history included depression and anxiety, both from unspecified date. No known allergies and no COVID prior vaccination were reported. The patient's concomitant medications reported as within two weeks from vaccination included amfetamine aspartate/amfetamine sulfate/dexamfetamine saccharate/dexamfetamine sulfate (reported as generic ADDERRAL), duloxetine hydrochloride (reported as generic CYMBALTA), both from unspecified date. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not provided), via unspecified route of administration in left arm on unspecified date as 1st dose, single for COVID-19 immunisation. The patient did not receive other vaccines within 4 weeks from vaccination. On 13Feb2021 12:00 AM the patient experienced lethargy, swollen and painful arm and armpit, chills, nausea, headache, muscle aches all over body, restlessness in muscles (feel like she had to flex everything). Treatment for the events were received and reported as patient took lots of extra strength paracetamol (TYLENOL). Patient had not been tested post vaccination. The outcome of the events was not resolved. Information on the lot/batch number has been requested. Follow-up (11May2021): Follow-up attempts completed. No further information is expected.
25 2021-05-19 confusional state Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flus... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Tinnitus-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: spoke with patient after recovery: patient states she started to feel light headed after vaccination. patient was seated when she fell over and fainted. patients was brought to lying position and legs raised. after awakening, patient felt, confused, had tinnitus, flushing, and very warm. was given water and fanned to cool down. patient states that she never has passed out before. after 15-20 minutes patient fully recovered and left with no further issues.
25 2021-05-19 disorientation, confusional state Anaphylaxis: extreme fatigue, chest tightness/ pain, shortness of breath, cough, skin redness/ rash ... Read more
Anaphylaxis: extreme fatigue, chest tightness/ pain, shortness of breath, cough, skin redness/ rash on both arms and face, itchiness, confusion/disorientation 45 minutes post injection
25 2021-05-20 anxiety, insomnia Vaccine given approximately 4pm, Friday April 30th. Insomnia (cannot sleep at all during the night)... Read more
Vaccine given approximately 4pm, Friday April 30th. Insomnia (cannot sleep at all during the night). Approximately 5am, begin to feel aches and malaise. Approximately 6am, aware of faster heartbeat and anxiety. Begin to feel dizzy and sit up in bed. Nausea begins. 6:10am vomit. Feel better after vomiting though achey, weak, shakey. Further dizzy spells throughout the next 6-8 hours, every time I get out of bed, but no further vomiting. At 10:55am, blood pressure is 86/58 with pulse at 94. Headache throughout the day. Abnormal fatigue lasts approximately 72 hours. Left arm is, of course, very sore at site of injection for approximately 36 hours. Treatment: rest and hydration (Gatorade & water). Ice at injection site for sore arm. Outcome: full recovery within 72 hours.
25 2021-05-24 impaired work ability After receiving my second dose, I was seen by my primary doctor for suspected Celiac disease (which ... Read more
After receiving my second dose, I was seen by my primary doctor for suspected Celiac disease (which came back positive). I had a strange medical episodes during the bloodwork (April 15th) that they originally assumed was anxiety. Symptoms were shortness of breath, lightheadedness, and loss of feeling in extremities. I?m a first responder and did not feel this was anxiety, but didn?t argue and forgot about it until it happened again. I had my second episode on April 20th, and debated going to the ER for it. A third episode on April 23rd did put me in the ER. I proceeded to have more episodes on almost a daily basis after that and started monitoring blood pressure, pulse, blood sugar, and food intake at home (some of my bloodwork levels were off due to the celiac). I purchased a heart rate monitor, a blood glucose meter, and a smartwatch to monitor some of my symptoms. Both devices (monitor and watch) would later flag me as having a suspicious heart rhythm (heart monitor could be for fast/slow rhythm or for arrhythmia, smartwatch flagged me as Afib twice). I could not recreate these results when my husband wore the devices. Episodes could be as brief as 45 mins or last more than 12 hours. I have a high pain tolerance and illness tolerance, and had to leave work several times due to my symptoms (extremely abnormal for me). After several more appointments with my primary doc and another visit to the ER (where they did another EKG, an X-ray, and more bloodwork), things were still coming back inconclusive. After about April 28th, I started having significant chest pain with my episodes. The ER checked me for possible clotting related to the heart issues and my birth control pills. My arrhythmia could not be captured on their devices. My doctor has since diagnosed it as suspected myocarditis (pending more testing). We?ve ruled out all possible things related to my Celiac diagnosis, and can?t seem to find a cause for this. I had a few things I brought to her attention that may be the cause (pinched nerve at chiropractors, covid vaccine) and she says it may be the vaccine, and said I should report it to you.
25 2021-05-28 sleep disorder body aches; I had fever; severe chills; diarrhea; nausea; headache; hung over; stiff neck; it preven... Read more
body aches; I had fever; severe chills; diarrhea; nausea; headache; hung over; stiff neck; it prevented me from sleeping; This is a spontaneous report from a contactable consumer. A 25-year-old non-pregnant female received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot Number/batch number: 59267100001, expiration date: unknown), via intramuscular route of administration in the left arm on 27Jan2021 at 09:00 (at the age of 25-year-old) as 2nd dose, single dose for COVID-19 immunization. Medical history included asthma. Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included escitalopram, IUD. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot Number/batch number: 59267100001, expiration date: unknown), via intramuscular route of administration in the left arm on 06Jan2021 at 02:00 as a single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unspecified date in Jan2021, about 18 hours after the 2nd dose (1 AM), the patient experienced fever, severe chills, diarrhea, nausea, headache, body aches, and I was prevented from sleeping then it lasted about four hours before she got back to sleep. She woke up with a headache, stiff neck and generally felt "hung over" the next day. Advil was relieving at this point. The outcome of all the events was recovered. Follow-up attempts are completed. No further information is expected.
25 2021-06-01 feeling abnormal Chills; muscle aches; joint aches; vomiting; headache; fatigue; brain fog; This is a spontaneous rep... Read more
Chills; muscle aches; joint aches; vomiting; headache; fatigue; brain fog; This is a spontaneous report from a contactable consumer(patient). A 25-years-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: EW0176) via an unspecified route of administration, administered in Arm Left on 28Apr2021 (at the age of 25-year-old) as single for covid-19 immunisation. The patient medical history was not reported. The patient received Birth control pill within 2 weeks of vaccination. The Patient did not receive any other vaccines within 4 weeks Prior to vaccination. The patient was not diagnosed with COVID-19 Prior to vaccination. Since the vaccination, patient was not tested for COVID-19. On 21May2021 at 23:00 the patient experienced chills, muscle aches, joint aches, vomiting, headache, fatigue and brain fog. The patient did not receive any treatment for the events. On an unspecified date, the outcome of the events was resolving.
25 2021-06-03 mental impairment, feeling abnormal Feels out of it Mentally; chills; lack of energy/Zero Energy; loss of appetite; nausea; feeling supe... Read more
Feels out of it Mentally; chills; lack of energy/Zero Energy; loss of appetite; nausea; feeling super crappy/Not feeling 100%; This is a spontaneous report from a contactable consumer (patient, self-reported). A 25-years-old female patient received bnt162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; Lot Number: EW0177, Expiration date: Unknown), dose 2 via an unspecified route of administration in the left arm, on 15May2021 in afternoon at 15:00-16:00 (age at the time 25-year-old) last Saturday, as single dose for her autoimmune disease (COVID-10 immunization). The patient's medical history included colitis ulcerative from 2012 and ongoing and has auto immune diseases. The patient previously received bnt162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; Lot Number: ER8736, Expiration date: Unknown), dose 1 via an unspecified route of administration in the left arm, on 24Apr2021 (age at the time 25-year-old), as single dose for COVID-10 immunization. No additional vaccines administered on same date of the Pfizer suspect. Concomitant medications included azathioprine and balsalazide was anti-inflammatory taken for colitis ulcerative from 2012, the patient takes a bunch of other medications, but these are the only two, she felt these concomitant medications could be related to her adverse events and she takes valsalide. The patient reported she took high dose of immunosuppressants. No prior vaccination within 4weeks. On 16May2021 (Sunday morning) at 07:00-08:00, the patient started having chills, still feels mentally out of it, lack of energy/Zero energy, nausea, loss of appetite, feeling super crappy, not feeling 100% and everything CDC has on the list. She enquired that how long will her side effects last, and any connection to the immunosuppressants. On 24May2021, today, the patient still feels out of it mentally, had zero energy, and she tried going into work and can't do what she needs to do. The patient stated that it took her up until Friday to stop having chills and to stop feeling super crappy. The patient doesn't know if there was any information about how long it will take to fully recover, and she was worried, and her boss was worried about her too. The patient did not visit emergency room. The patient enquired her physician last week and her boss wants her to go see a doctor or someone, so she probably will be going to some form of Urgent Care today. Therapeutic measures were taken with Tylenol. The patient underwent lab tests and procedures which were not included. The clinical outcome of the events loss of appetite, and asthenia was not recovered, chills was recovered on 21May2021, all other events was recovering. Additional information has been requested.
25 2021-06-05 irritability Fever, fatigue, body aches, irritability, jolting pain in arm given the shot
25 2021-06-08 loss of personal independence in daily activities Patient had persist migraines that have made it so the patient has been unable to do her daily work... Read more
Patient had persist migraines that have made it so the patient has been unable to do her daily work and activities.
25 2021-06-10 insomnia headache/Headache, excruciating, which caused trouble sleeping; Feeling weak, after second vaccine; ... Read more
headache/Headache, excruciating, which caused trouble sleeping; Feeling weak, after second vaccine; not feeling well; Vomiting/ sensation of vomiting; coughing; headache/Headache, excruciating, which caused trouble sleeping; This is a spontaneous report received from a contactable consumer (patient). A 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EW0186), via an unspecified route of administration in left arm on 21May2021 at 14:50 (age at vaccination 25 year) as second dose, single dose for COVID-19 immunisation. The patient had received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EW0167), via an unspecified route of administration into left arm on 30Apr2021 at 14:50 (Age at vaccination: 25 year) as a single dose for COVID-19 immunisation. Patient did not had any Medical History. No Family Medical History Relevant to AE. No additional vaccines were administered on same date of the Pfizer vaccine. Patient previously took tylenol. No prior Vaccinations within four weeks to the first administration date of the suspect vaccine. Concomitant medication was not reported. Patient Stated she had some vomiting after second vaccine. Vomiting, occurred on two separate occasions, after second vaccine. She stated that she reacted strongly, for about 24 hours, and had vomiting, and a headache and she had trouble sleeping. She stated she got through that and felt fine, in the days that followed. She stated that last night, about two weeks after her second vaccine, she had similar events of headache and vomiting, that mimicked those initial symptoms. Patient was concerned that maybe she had food poisoning. She stated vomiting returned yesterday (03Jun2021) along with a headache. Described also as sensation of vomiting, coughing on 04Jun2021. On 04Jun2021 01:00 am, she experienced headache, excruciating, which caused trouble sleeping, she woke up and felt weak after second vaccine. Caller states that she had the sensation of vomiting, similar to coughing, and this was identical to the first experience, but milder. She then thought that it was not food poisoning. Caller stated she was healthy, and that is why these reactions were concerning to her. She reported that compared to other people, she felt her effects a little stronger. She later reclarified, from earlier in report, that after the second vaccine, she initially did not have a headache until later. She stated she had vomiting initially after the second vaccine that was stronger last time. She stated the vomiting lasted the first time for about 23 hours. She stated the vomiting that occurred, again, the second time at 3 am on an unspecified date in 2021, was milder. She stated she still felt a little weak, which could be from the vomiting, and she was still not feeling well, and taking it easy and not working today. She stated she did not take anything and a couple of hours went by and she took some Tylenol for headache. Caller stated the Tylenol, did not help her headache. She stated she had taken Tylenol before and it had been effective. Regarding feeling weak, patient stated when she woke up this morning at 7:18 am, she felt better now than earlier today. The outcome of the event "headache/Headache, excruciating, which caused trouble sleeping" with PT 'Insomnia' was recovered on 04Jun2021; Feeling weak, after second vaccine was recovering; Event Vomiting/ sensation of vomiting, "headache/Headache, excruciating, which caused trouble sleeping" with PT 'Headache' was not recovered; coughing and not feeling well was unknown.
25 2021-06-15 impaired work ability Started feeling lightheaded, fatigued, dizzy, nauseous about one week after 2nd dose. Heart rate rap... Read more
Started feeling lightheaded, fatigued, dizzy, nauseous about one week after 2nd dose. Heart rate rapidly spikes (up to 163 bpm) for minor tasks such as getting the mail, taking out the trash, vacuuming, etc. Worsened rapidly for another week and could not get off the couch for several days. Has improved some but energy is still at 75% 2 months later and have been unable to work since April. Seen several doctors for blood tests and cardiologists for EKG, Holter monitor, and echocardiogram.
25 2021-06-16 confusional state, disorientation Systemic: Chills-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Sys... Read more
Systemic: Chills-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Medium, Additional Details: patient lost consciousness within few minutes post injection; came to soon after but was disoriented asking for help, saying her kids are calling after her; she appeared very pale; rph helped her to the floor; she rested for about 10 minutes; an attempt to sit up was unsuccessful at that point as nausea, dizziness, visual changes came right back; at that point technician called 911; paramedics assessed the pt -bp & hr were normal. however, 40 mins post-injection pt still had all above symptoms
25 2021-06-16 feeling abnormal, nervousness According to the patient, she was in observation and started to feel "funny". Her throat started to ... Read more
According to the patient, she was in observation and started to feel "funny". Her throat started to feel closed and her arms felt tingly. She was assessed by the physician observer and put on a stretcher with her legs elevated. Vitals report BP 140/80, HR 112, and 02 sat of 99%. Patient was provided with water and cool cloth for her head. At 3:50pm, HR 83, O2 sat 99% still lying on the stretcher with legs elevated. At 4pm patient was assisted to sit up, but felt dizzy and was repositioned lying down. At 4:10pm vitals BP 142/82, HR 84, patient at this time refused to go to the emergency department. At 4:20pm patient was reported to feel "a little shaky but better" and sat in an upright position drinking water and eating a snack. Patient was monitored while standing and released after an extended observation and patient reporting that she was "feeling better".
25 2021-06-20 insomnia, motion sickness, feeling abnormal, restlessness Numbness in feet and hands Restlessness/Ticks/Twitches of Body Motion Sickness with slight movements... Read more
Numbness in feet and hands Restlessness/Ticks/Twitches of Body Motion Sickness with slight movements/vertigo Tunneling Vertigo/Feelings of Passing Out Extreme Nausea/Lack of Appetite Flushed Face Painful sinuses Insomnia Rapid Heartbeat Heart Palpitations Random Heart Rate Spikes Shortness of Breath Nausea/Rapid Heartbeat/Weakness after a meal Super Thirsty Feeling of disassociation from body/floating swollen back of neck, tender to the touch, at base of skull. Touching causes very bad nausea Burning sinuses Tingling teeth
25 2021-06-21 incoherent Pt came out from receiving vaccine and once she left the room started falling to the floor. She was ... Read more
Pt came out from receiving vaccine and once she left the room started falling to the floor. She was incoherent for a few seconds. She quickly came through. Pt says she felt tingling in her hands, arms, and legs. Throat felt a little scratchy. Gave her some water and got some frozen water bottle because her skin was clammy. It took her about 20 minutes to come back to normal. Paramedics were called but by the time they arrived she felt better. Patient refused the paramedic ride. She stayed and extra 30 minutes to call down. She says the tingling in legs was gone but the arm and hand she receivied the vaccine in were still a little tingly. Informed pt that if she felt and worse or anything out of the ordinary to go to ER.
25 2021-06-22 loss of personal independence in daily activities, sleep disorder Received my second shot on Friday 4/30/21 at 12:15pm, had chills and body aches that night and felt ... Read more
Received my second shot on Friday 4/30/21 at 12:15pm, had chills and body aches that night and felt fatigue through to Sunday morning 5/2/21. On Sunday morning when I woke up my vagina felt sore, later in the day the pain intensified and was extremely painful Sunday night, barely slept because of constant burning and itching feeling. There was also a brownish discharge leaking out. Monday morning I made an appointment with my gynecologist, and a nurse practitioner did an exam showed me the genital ulcers and told me it was most likely herpes. They swabbed one of the ulcers and gave me a prescription for Valacyclovir for 10 days. I also took a blood test for HSV1/HSV2 IGG and IGM the next day. For the first 5 days the pain was horrible, worst pain I've ever felt, couldn't walk, stand, sit or sleep. I got my period Wednesday morning which made it even worse. On Friday morning 5/7/21 I got a call from the nurse practitioner and she said the swab and blood test came back negative, I went back the same day so the doctor could look. They still thought it was herpes and told me to take another blood test in a month. I did not have a prior diagnosis of herpes and showed no symptoms before. My partner of the past 1.5 years got tested for herpes and was also negative. After a month I went took another blood test and it came back negative again for HSV-1 and HSV-2. The only thing different in my medical history is that I got the vaccine and 36-48 hours later I had herpes symptoms. These symptoms lasted for 2.5 weeks until I started to no longer feel any pain.
25 2021-06-23 irritability Due to my IUD, have not had a period in 2 years (PMS symptoms are minimal too). On 4/25, I woke up w... Read more
Due to my IUD, have not had a period in 2 years (PMS symptoms are minimal too). On 4/25, I woke up with horrible cramping and nausea. I was irritable, in pain, and needed to use feminine products for the first time in years. Since this vaccine, I have had spotting and cramping randomly. This did not happen pre-vaccine. No treatment known (other than removal) that is preferable. Slowly this is going back to normal but still having random days of spotting. Filing a report in case there is a reaction found between hormones (birth control) and vaccine ingredients.
25 2021-06-26 insomnia 6/24 5pm: arm pain upon injection 6pm: abdomin and lower back pain Late at night time unknown: full ... Read more
6/24 5pm: arm pain upon injection 6pm: abdomin and lower back pain Late at night time unknown: full body aches, nausea (with throw up), vertigo upon standing, difficulty sleeping, ringing in both ears that lasted a couple minutes, persistent arm pain 6/25 6:30 am nausea with throw up provoked upon smelling food (specifically Kashi raisin no sugar added wheat cereal) did not attempt eating, severe headache, persistent arm pain, hot flash sttong enough to cause hair to drip with sweat, drank small glasses each of water and berry 100% juice 8am-12:30 at work primarily sitting: noticable shivering, color alternated between flushed-deathly pallor-green (reported to self by coworkers 5 RNs/1 LPN/1 MA), severe headache persisted, arm pain persisted, nausea without throwing up, emotional, back pain, no hunger 12:30: napped for 30 min in car backseat with sunshades up and windows cracked. 1pm: reduced headache and nausea, ate .5 peanut butter sandwich and cheezit crackers with water, other sympotoms continued Rest of 6/25: mild headache, moderate arm pain, back pain, slight nausea 6/26: slight headache and sporatic leg weakness throughout the day. No medications/herbal remedies were ever taken.
25 2021-06-28 agitation, feeling abnormal Pt.'s mother states 06/17/2021 4:00pm, really agitated hitting herself, pulling skin off of arm. ER ... Read more
Pt.'s mother states 06/17/2021 4:00pm, really agitated hitting herself, pulling skin off of arm. ER visit (stitches). communicated everything burns, she felt dirty. 06/29/2021 regular Physician appt. Still experiencing symptoms.
25 2021-06-28 fear, sleep disorder Second vaccine dose was on Monday, Friday night started with severe tremors, cold chills, severe hea... Read more
Second vaccine dose was on Monday, Friday night started with severe tremors, cold chills, severe heart palpitations, extreme rapid heat beat, heart pounding. Very scary, couldn't sleep. After 24 hours it hadn't gone away so I sought medical treatment at an emergency room. They did tests and said everything as normal. They sent me home with an antihistamine to take as anxiety medicine. Heart palpitations lessened but extreme symptoms persisted for 3 more days. It has been 10 days since my hospital visit and symptoms have mostly gone away. Terrible experience.
25 2021-07-05 sleep disorder Extra and extremely strong heart beating, makes me hard to sleep and feel tired during the day.
25 2021-07-09 feeling abnormal, panic attack Late and heavy menstruation. (I have never been late before) Brain fog Night time panic attacks Fati... Read more
Late and heavy menstruation. (I have never been late before) Brain fog Night time panic attacks Fatigue
25 2021-07-12 crying Burning pains everywhere that come and go at random, sometimes lasts days. Neurological. First day o... Read more
Burning pains everywhere that come and go at random, sometimes lasts days. Neurological. First day of "adverse event" was July 3rd, but the night before I had thrown up but felt fine. On July 3rd, had first time bad Acid Reflux, took OTC Prilosec which helped over the course of a few days. Someone suggested trying Claritin for the random burning, but it does not help. Strong back pain. Random bouts of nausea (trying not to throw up to avoid Acid Reflux again). Difficulty eating and drinking as a result of symptoms. Sleeping a lot more than usual. Weak in general. A few days ago started to feel better, still kept diet specific to avoiding Acid Reflux. Overnight, horrible burning in limbs and random parts of body came back. Slept and napped for about 18 hours yesterday as burning was ongoing. Can sleep through pain. Pain is instant upon waking up. Sometimes (like right now as I write this) burning is tolerable, sometimes it is unbearable and crying hurts too. Muscle spasms and twitching occasionally, sometimes in frequent in a session. Primary doctor agrees that all of these symptoms are from the vaccine.
25 2021-07-13 disturbance in attention Had bad flu like symptoms - chills, muscle aches, joint aches, nauseous, fatigue, difficulty concent... Read more
Had bad flu like symptoms - chills, muscle aches, joint aches, nauseous, fatigue, difficulty concentrating Took ibuprofen Most symptoms subsided after 24 hours but still having some muscle and joint aches
25 2021-07-17 insomnia couldn't lift her arm; couldn't sleep on that side, and had trouble with everyday things; It kind of... Read more
couldn't lift her arm; couldn't sleep on that side, and had trouble with everyday things; It kind of goes like a numb thing; talking in her sleep and pointing at things; Sore throat; Nauseous; Nosebleeds; Pain at injection site; Fatigue/ very heavy fatigue; Not feeling well; It was definitely worse in the first 7 to 10 days/ It has lightened up; Headache; Muscle between her shoulder has been very tight since she had the vaccine on the left side; she fell asleep/she doesn't take naps and yesterday and today she took a 3 hour nap.; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer (patient) reported that a 25-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EWO172, Expiry date: unknown, at the age of 25-year-old), dose 1 via an unspecified route of administration, administered in Arm Left on 08Jun2021 10:30 or so as dose 1, single for covid-19 immunisation. Medical history included asthma from an unspecified date and ongoing (She has had it her entire life), insomnia from an unspecified date and ongoing (She was diagnosed in high school), Borderline anemia from an unspecified date in May2021 and ongoing (It began in the beginning of May), diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity, Cholesterol (Her grandpa had high cholesterol. Concomitant medication included fluoxetine at 20 mg from 20May2021 and ongoing and ascorbic acid, folic acid, iron, lysine hydrochloride, nicotinic acid, pyridoxine hydrochloride, riboflavin, thiamine, zinc sulfate (MULTIVITAMIN IRON) pill from an unspecified date and ongoing (every other day) for Borderline anemia. She had taken it for a couple weeks back in May and was eating foods to try and boost her iron and with the iron pill was overdosing. The patient experienced pain at the injection site and was feeling fatigue on 08Jun2021. She wanted to hold on getting the second dose because she is not feeling well. She has been doing better than she has been over the past week. Pain at injection site was really bad the first and continued throughout the rest of the week. It was her second week, and she couldn't lift her arm, sleep on that side, and had trouble with everyday things. That is when she started to get concerned and annoyed. She put ice on it last night and over the past week has been trying Dayquil and Nyqui. She took Daytime Cold and Flu Multi Symptom Relief, lot: 9LKO654, expiration date: Apr2021. The lot has either an O or 0. She doesn't know where the Nyquil. She doesn't remember when she took them. In the first week she tried to make use of the medications she had. When she tries to do exercises, she still gets pain. Her arm wanted to go to sleep like it did not want her to use it. It has lightened up. It was definitely worse in the first 7 to 10 days. She can move her arm now. When she touches her arm it does hurt, but the pain kind of gets less throughout the day. It kind of goes like a numb thing and wants to go to sleep. On 15Jun2021 or 16Jun2021 she thought she was good to go, and the next day she was nauseous on 08Jun2021, her arm was hurting, she had a headache on an unspecified date, and she had a sore throat. She thought she was doing better, but normally she doesn't take naps and yesterday and today she took a 3-hour nap. In the middle of something she will fall asleep. The first week she was watching a movie with her siblings and they said she fell asleep in the middle of it but was talking in her sleep and pointing at things. It is a very heavy fatigue. Sore throat would be the first thing she noticed when she woke up in the morning. It was definitely the morning after she had the vaccine, and for the first week it was every day she woke up with a sore throat and later had a nose-bleed. She chalked it up to being dehydrated and drank coconut water. Another symptom she noticed only for the first week that started on 08Jun2021 was nosebleeds. That does not commonly happen. She tries to stay hydrated and drink water. It was the first 7 to 10 days where she had a nosebleed al-most every day. She has a pain that causes headaches where the muscle between her shoulder has been very tight since she had the vaccine on the left side. She tries to put ice on it, and it does cause a headache every now and then. She tries to take cold showers and an ice pack to relax the muscle. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. Prior Vaccinations within 4 weeks was none. The outcome of events Pain at injection site, It was definitely worse in the first 7 to 10 days and nauseous was Recovering and for Fatigue, Headache was Not recovered and for rest of the events it was unknown.
25 2021-07-18 crying Fatigue, severe chest pain that's causing me to cry.
25 2021-07-18 loss of personal independence in daily activities So the evening before, my friends and I had a gathering, the next AM, I was having a lot cramping ri... Read more
So the evening before, my friends and I had a gathering, the next AM, I was having a lot cramping right lower quadrant, and feel my abdomen pressing on it worse. I was hoping it would go away. I was feeling nausea, I laid in bad and didn't go to work that day. I didn't get better after a few days. Normal bowel movements. I thought I among have an appendicitis.
25 2021-07-20 insomnia Exhaustion; Extreme insomnia; This is a spontaneous report from a contactable consumer, the patient.... Read more
Exhaustion; Extreme insomnia; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8733) via an unspecified route of administration in the left arm on 29Mar2021 at 12:45 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome, post-traumatic stress disorder and IgA deficient. Patient had allergies to cephalosporin (MANUFACTURER UNKNOWN) class of antibiotics. Concomitant medications included vilazodone hydrochloride (VIIBRYD), topiramate (TOPAMAX), cetirizine hydrochloride (ZYRTEC), vitamin D6 (MANUFACTURER UNKNOWN), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate and dexamfetamine sulfate (ADDERALL). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient had not received any other vaccine within four weeks prior to the vaccination. On 29Mar2021 at 22:00, the patient experienced exhaustion. And on an unknown date in Mar2021, the patient experienced extreme insomnia. It was reported as day 1- the patient experienced exhaustion and days following-extreme insomnia. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measure was taken as a result of the events. The clinical outcome of the events exhaustion and extreme insomnia was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.
25 2021-07-21 anxiety Pt was fine receiving the vaccine. Right afterward, she started feeling faint, and she broke out in ... Read more
Pt was fine receiving the vaccine. Right afterward, she started feeling faint, and she broke out in a sweat. We called 911, and layed her down on the ground, so she wouldn't fall. We gave her water and an ice pack. The paramedics came here and checked her vitals. All was fine. She fully recovered and was able to go home. Pt's faintness was due to anxiety after receiving the vaccine.
25 2021-07-23 anxiety But it felt like I was dying,I thought I was having a heart attack; panic disorder; my left arm star... Read more
But it felt like I was dying,I thought I was having a heart attack; panic disorder; my left arm starting getting a sensation of pins and needles; My bp and heart rate were so elevated for a month; I could feel my left chest muscle tensing up; dizziness/light headed ness; fatigue; My heart then started to palpitate; My bp and heart rate were so elevated for a month.; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 25-year-old female (Non-pregnant) consumer received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Er8736, Expiry Date: Unknown), via an unspecified route of administration, administered in right arm on 24May2021 at 14:00 (at the age of 25-years-old) as dose 2, single for covid-19 immunization at Pharmacy or Drug Store. Medical history included PCOS, depression, insulin resistance, asthma, allergies all from unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included which patient received within 2 weeks of vaccination included Prenatal vitamins, Tylenol. No known allergies reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Er8731, Expiry Date: Unknown), via an unspecified route of administration, administered in right arm on 03May2021 at 15:00 (at the age of 25-years-old) as dose 1, single for covid-19 immunization and experienced with some chills and fatigue for the first 24 hours. The patient was not diagnosed with COVID-19, prior to vaccination and has not been tested for COVID, since the vaccination. After second vaccine, she had no side effects until exactly 6 days after her second dose. On 30May2021 at 9:30 PM, patient experienced as her left arm started getting a sensation of pins and needles. Her heart then started to palpitate and she could feel her left chest muscle tensing up. She thought that she was having a heart attack, so her husband rushed her to the ER. While in the waiting room, she calmed down and realized it wasn't life threading. She also was experiencing extreme dizziness, light headedness, and fatigue. She never had dealt with this before until her vaccine. But it felt like she was dying. Her BP and heart rate were so elevated for a month. She went to her primary and was diagnosed with panic disorder. She went home and it happened again for an hour and she took magnesium and went to sleep. It happened about every other day for three weeks after that. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Therapeutic measures were taken for the events caused which included Zoloft, hydroxyzine, and Xanax and was terrified to ever stop because that was the scariest month of her life. Seriousness as reported as No. On 30May2021, patient underwent lab test which included Blood pressure measurement and heart results increased. The outcome of all events was recovered with sequel/ Recovered with lasting effects. Follow-Up (15Jul2021): Follow-up attempts are completed. No further information is expected.
25 2021-07-23 confusional state Severe muscle aches, headache, severe arm pain, fever, sweating, hot flashes, fever, severe fatigue,... Read more
Severe muscle aches, headache, severe arm pain, fever, sweating, hot flashes, fever, severe fatigue, confusion
25 2021-07-27 excessive sleepiness has terrible pressure on her spine.; inflammation of spine; Difficulty breathing, no throat closing;... Read more
has terrible pressure on her spine.; inflammation of spine; Difficulty breathing, no throat closing; Coughing; Kidney pain; Tiredness; Muscle pain; Headache; injection site really, really sore; slept most of time; This is a spontaneous report from a contactable consumer. This consumer (patient friend) reported for a 25-year-old female patient that: A 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EW0177 and Expiry date was not reported), dose 1 via an unspecified route of administration in arm right on 19May2021 17:30 (age at vaccination was 25-year-old) as single dose for covid-19 immunisation. Medical history included attention deficit hyperactivity disorder from an unknown date and unknown if ongoing. concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for attention deficit hyperactivity disorder/ for mental health, 30mg, 1 tablet by mouth twice daily, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior or the same day and no problems with the vaccines in past. On 19May2021, it was reported on behalf of his friend, who got the first Pfizer BionTech vaccine yesterday and since then has been having most of the symptoms read about but had one that was not heard of. Has had terrible pressure on the lower spine, it feels like she got an epidural. Clarifies most symptoms patient experienced as inflammation of the spine, difficulty breathing, but no throat closing, more coughing, kidney pain, tiredness, muscle pains, headache, and the inject site was really really sore. When she first got it she was kind of tired and slept most of the time afterwards and this morning the spine pressure/inflammation started getting worse and worse as time goes by. Everything has gotten worsened. The patient did not visit Emergency Room and Physician Office. The outcome of the events was not recovered. Follow up needed, further information has been requested.
25 2021-07-27 insomnia EXTREME insomnia/COULD NOT SLEEP. I was waking up every 30 minutes. All night.; was absolutely exhau... Read more
EXTREME insomnia/COULD NOT SLEEP. I was waking up every 30 minutes. All night.; was absolutely exhausted; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 04Apr2021 at 15:45 (at the age of 25-years-old), as a single dose for COVID-19 immunisation. The patient's medical history was reported as several. The patient received several unspecified concomitant medications for unspecified indications on unknown dates. The patient had many unspecified allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 04Apr2021 at 22:30, the worst side effect the patient experienced was extreme insomnia. The patient was absolutely exhausted, took all of her medicines, including muscle relaxers and high dose gabapentin and could not sleep. The patient was waking up every 30 minutes, all night. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken for the reported events and included all the patient's medicines, including muscle relaxers and high dose gabapentin. The clinical outcome of the events extreme insomnia and absolutely exhausted was recovering at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
25 2021-07-28 feeling abnormal Mental fog; Acid reflux; Chest pain; Diaphoretic; Exhaustion; Muscle pain; Joint pain; Fever; Chills... Read more
Mental fog; Acid reflux; Chest pain; Diaphoretic; Exhaustion; Muscle pain; Joint pain; Fever; Chills; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0172) via an unspecified route of administration in the left arm on 01May2021 at 08:45 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not receive any other medications within two weeks of vaccination. The patient previously took Keflex and had received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0162) via an unspecified route of administration in the left arm on 10Apr2021 at 09:00 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02May2021 at 11:00, the patient had experienced mental fog, exhaustion, muscle pain, joint pain, fever, chills, diaphoretic, nausea, acid reflux and chest pain. The clinical outcome of the events mental fog, exhaustion, muscle pain, joint pain, fever, chills, diaphoretic, nausea, acid reflux and chest pain was resolving at the time of this report. No follow-up attempts are needed. No further information is expected.
25 2021-07-28 impaired work ability, feeling abnormal Patient came in after having two tonic-clonic seizures at work. Had been vomiting, having diarrhea, ... Read more
Patient came in after having two tonic-clonic seizures at work. Had been vomiting, having diarrhea, and feeling off. Vision was blurry on the way to work. BG was less than 20. Had seizure in 2019. So far Ativan has been ordered PRN for seizures and neurology to see pt for full workup.