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...