Pfizer

Nervous system symptom reports

Male, 16 - 25 years

Age Reported Symptoms Notes
16 2021-01-13 pain in extremity, hot flush Vaccination occurred on 1/12 at 13:00. A few hours after the vaccination, I experienced muscle pain ... Read more
Vaccination occurred on 1/12 at 13:00. A few hours after the vaccination, I experienced muscle pain in the vaccinated arm. 1/13: I had trouble sleeping; left arm was in immense pain. 07:00: experiencing arm soreness, muscle pain, nausea, hot flashes; temperature = 99.5 08:20: experiencing arm soreness, muscle pain, hot flashes, chills, sensitivity to light; temperature = 100.6. Took 650mg acetaminophen. 09:00: experiencing arm soreness, muscle pain, sensitivity to light; temperature = 100.8 10:30: experiencing arm soreness, muscle pain; temperature = 99.2 11:15: experiencing arm soreness, muscle pain; temperature = 99.0 12:20: experiencing arm soreness, muscle pain; temperature = 98.0 Extremely fatigued; took nap (13:00-17:00) 17:00: experiencing arm soreness, muscle pain, headache; temperature = 99.3 18:00: experiencing arm soreness, muscle pain, headache; temperature = 99.2. Took 650mg acetaminophen. 19:00: experiencing arm soreness, muscle pain, headache; temperature = 100.8 20:00: experiencing arm soreness, muscle pain; temperature = 98.3 21:00: experiencing arm soreness, muscle pain; temperature = 100.6 21:30: experiencing arm soreness, muscle pain; temperature = 99.2 22:20: experiencing arm soreness, muscle pain; temperature = 100.1. Took 400mg Ibuprofen. 1/14: 07:00: woke up experiencing pain at the injection site, neck pain, headache. These events continued throughout the day. No temperature over 99.5. 18:30: Took 650mg acetaminophen for headache.
16 2021-01-27 feeling hot Patient received COVID vaccine at 1317 today. At monitor station c/o feeling lightheaded. At 1323 pa... Read more
Patient received COVID vaccine at 1317 today. At monitor station c/o feeling lightheaded. At 1323 patient assessed to be sweaty, pale and c/o feeling hot. Yawning and looking faint. Patient seen by provider.. At 1330 patient transferred by wheel chair to an exam room to lie down. Vitals obtained. Patient began to feel better and feelings of lightheadedness began to resolve. Lungs CTA, no signs of allergic symptoms, color to skin returned At 1340 patient wanted to sit up. Orthostatic vital signs obtained. Patient had no complaints of dizziness. Patient was discharged at 1355, ambulatory, alert, NAD.
16 2021-02-24 discomfort 05:02PM MOM STATES PT 'FEELS NAUSEA AND HEADACHE'. (PT HAS DIFFICULTY DESCRIBING HOW HE FEELS). PT ... Read more
05:02PM MOM STATES PT 'FEELS NAUSEA AND HEADACHE'. (PT HAS DIFFICULTY DESCRIBING HOW HE FEELS). PT ALERT, PINK,W/D, RESP REG WITH EASE. 05:06PM COOL CLOTH PLACED ON BACK OF NECK, TUMS GIVEN PO, LIQUID BENADRYL 25MG GIVEN PO. 05:20PM 'FEELS A LITTLE BETTER, LESS NAUSEA.' NOW HAS RT CLAVICLE PAIN. ALERT, PINK, W/D, RESP WITH EASE. 05:30PM STILL C/O HEADACHE, NAUSEA AND RT CLAVICLE PAIN. 05:55PM TO EXIT PER W/C TO BE DRIVEN HOME PER MOM. NO ACUTE DISTRESS NOTED. ALERT, PINK, W/D, RESP WITH EASE. 2-25-21 10AM TC- MOM STATES SHE GAVE PT LIQUID TYLENOL LAST NIGHT FOR DISCOMFORT. STATES HE DOES FEEL BETTER TODAY BUT STILL HAS HEADACHE AND RT CLAVICLE PAIN- NO NAUSEA. SHE STATES SHE DID KEEP HIM HOME FROM SCHOOL TODAY. HE HAS HIS REG APPT WITH HIS PCP ON 3-1-21 AND WILL ASK ABOUT HIM GETTING DOSE #2.
16 2021-02-26 unresponsive to stimuli Systemic: Fainting/Unresponsive-Medium. Additional Details: Patient fainted about 5 minutes after re... Read more
Systemic: Fainting/Unresponsive-Medium. Additional Details: Patient fainted about 5 minutes after receiving 2nd dose of vaccine. Pt hit his head on a table on way down. EMS called. PT was alert and oriented, but was taken to the hospital for evaluation by ambulance.
16 2021-03-10 muscle twitching, involuntary muscle movements Summary: Syncopal espisodes x 2 16 yo patient received his Covid-19 vaccine and as he was going to... Read more
Summary: Syncopal espisodes x 2 16 yo patient received his Covid-19 vaccine and as he was going to sit down in observation, he leaned on his mom and passed out. His mother gently lowered him to the ground (@ 1804). Patient's mother stated he just passed out and that this was his first injection ever in his life. Patient was immediately assessed by multiple nurses. Patient did not fall or hit his head or injure any part of his body. Patient took less than 60 seconds to respond to verbal commands and comprehend what had happened. Patient's legs were immediately raised and vital signs were obtained. He was diaphoretic and pale but both were dissapating. Patient denied difficulty breathing, pain, discomfort. Patient was moved to a reclined chair. Patient and family at side (mother and father) agreed to be monitored. At 1828, Patient complained of feeling "a star" on the left side of his chest. Patient was unable to describe this further. I asked if he was feeling anxious and he said yes. I instructed patient to take several deep breaths in through his nose and out through his mouth. After doing this 3 times, patient stated he did not feel anything funny in his chest anymore. At 1835, while still seated in a reclined chair, patient passed out again. He was pale and diaphoretic. A few team members saw him jerk/twitch and it was questionable if he was having a seizure. The jerking did not last but a few seconds. 911 was called @ 1826. Patient was transferred to a wheelchair and put in the ambulance @ 1841. Vitals were obtained throughout and charted. Pulse ox saturation levels were not below 96%. Immediately after the patient passed out the second time, his pulse was measured at 38 bpm and his lips displayed slight cyanosis. His pulse quickly rose to 52 bpm, within less than 10 seconds. One minute later his pulse was up to 68 bpm.
16 2021-03-10 tingling 0930 red, puffy, tingling hands 0945 cough 0948 benadryl 50 mg administered by medic. pt hx of anaph... Read more
0930 red, puffy, tingling hands 0945 cough 0948 benadryl 50 mg administered by medic. pt hx of anaphylaxic reactions to nuts. mom stated she did not have pt's epi pen with her. pt stated these same symptoms happen with anaphylaxis prior. mom/pt wanted transport via ambulance vs POV for peace of mind in case any symptoms worsened. to ED.
16 2021-03-18 seizure seizure like symptoms; Dizziness; lethargy; fatigue; This is a spontaneous report from a contactable... Read more
seizure like symptoms; Dizziness; lethargy; fatigue; This is a spontaneous report from a contactable pharmacist. A 16-year-old male patient received first dose of intramuscular BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Mar2021 at 12:00 at single dose in left arm for COVID-19 immunisation at the age of 16-year-old. Lot number was EN6205. Medical history and concomitant medications were unknown. On 02Mar2021 at 12:00, the patient experienced Dizziness, seizure like symptoms, lethargy, fatigue. It was unknown if the patient was treated due to the events. The patient recovered from the events in Mar2021. It was unknown if the patient had COVID prior vaccination; it was unknown if the patient was tested for COVID post vaccination.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Seizure cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
16 2021-03-20 seizure Patient received vaccine and went to sit down in front of pharmacy. He then immediately started feel... Read more
Patient received vaccine and went to sit down in front of pharmacy. He then immediately started feeling lightheaded, his eyes rolled into the back of this head and he had a couple of convulsion. He did not lose consciousness and was immediately aware. He was pale, lips were blue tinged, pulse was 60, sweating and blood pressure was 98/50. Paramedics were called but he had recovered by the time they got there. They said he had a fainting episode due to the vaccination and did not have a seizure. The patient had not eaten anything the whole day and he felt that contributed. Followed up with patient's parent and he is feeling just fine now.
16 2021-03-23 seizure On day 9 after the first dose, He Had an unprovoked seizure for the first time ever. He never had s... Read more
On day 9 after the first dose, He Had an unprovoked seizure for the first time ever. He never had seizures his entire life. We took him to the emergency room , all tests were normal (including CT scan). Subsequently, he had his first-ever EEG that came back normal as well.
16 2021-03-24 flushing Flushing, macular rash/warm. BP 127/74 (pulse 91), O2 sat 95%. Erythematous rash on chest, lungs cle... Read more
Flushing, macular rash/warm. BP 127/74 (pulse 91), O2 sat 95%. Erythematous rash on chest, lungs clear. Given Benadryl 25 mg PO.
16 2021-03-24 unresponsive to stimuli Systemic: Confusion-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient and hi... Read more
Systemic: Confusion-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient and his mother presented about 30 minutes after receiveing vaccine stating he passed out in the car for about 15 seconds and fell on his way back into the store. He lied down for a while and said he was fine. Mother said do not call an ambulance, she would take him to the emergency department.
16 2021-03-25 pain in extremity Sore arm on 3/20/2021. No other symptoms/signs. Presented for routine heart transplant follow up v... Read more
Sore arm on 3/20/2021. No other symptoms/signs. Presented for routine heart transplant follow up visit 3/22/2021 and was found to have new decreased cardiac function by echo, new 1st degree heart block by ECG, and new gallop. Patient taken to cath lab 3/22/2021 for biopsy and hemodynamic assessment, but he had V fib arrest with anesthesia induction. After initiation of CPR, patient was placed on ECMO. Biopsy shows ACR 2R (moderate cellular rejection) and pAMR 2 (moderate antibody-mediated rejection). Labs show new donor specific, complement-fixing Antibody against the cardiac allograft. Patient is in ICU being treated for acute rejection.
16 2021-03-29 seizure, flushing Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flus... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Seizure-Medium
16 2021-03-30 hot flush Since 11 PM the day I recieved the shot, I have experienced extreme thirst and dryness of the throat... Read more
Since 11 PM the day I recieved the shot, I have experienced extreme thirst and dryness of the throat. I believe this is a side effect from the vaccine since my diabetes is controlled and is in normal range. I also have experienced hot flashes followed by extreme chills
16 2021-03-31 pain in extremity Within 5 to 6 mins, patient noticed arm pain in the OPPOSITE arm. Injection was given in right arm, ... Read more
Within 5 to 6 mins, patient noticed arm pain in the OPPOSITE arm. Injection was given in right arm, he stated there was some "pain" in the left arm.
16 2021-03-31 throat numbness Pt states he felt some numbness and a lump in his throat following the vaccination. He arrives to t... Read more
Pt states he felt some numbness and a lump in his throat following the vaccination. He arrives to the observation area with his mom, patient did not attend school today because he was having a migraine. arrives 1400 to observation BP 128/69 HR 83 oxygen sat 97% room air 1405 pt feels that he can breathe easier 1415 he still feels like he has a small lump in his throat bp 126/62 hr 90 oxygen sat 97% room air 1420 patient stateshe feels like he is back to normal mom feels comfortable taking him home 1425 patient left observation via wheelchair and his mom with symptoms relieved
16 2021-04-04 weakness Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Medium, Systemic: Weakness-Medium, Addi... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Medium, Systemic: Weakness-Medium, Additional Details: Patient felt like he was going to pass out, said he has never had a reaction to needles or shots. EMS evaluated the patient and determined he could go home.
16 2021-04-04 feeling hot patient reported feeling hot and dizzy 5 minutes after injection and collapsed to the floor next to ... Read more
patient reported feeling hot and dizzy 5 minutes after injection and collapsed to the floor next to his mother. Denies loss of conscience or injury. Patient was transported via gurney to EMS room for observation by physician, patient reports he had not ate anything this morning, apple juice and granola bar given to patient with no issues. Mother reports that this has happened in the past. Patient denies chest pain shortness of breath nausea, discharged into mothers care in no distress @ 9:55am.
16 2021-04-04 tremor Patient received 1st dose of vaccine. Minutes after, while in the observation area, pt appears to h... Read more
Patient received 1st dose of vaccine. Minutes after, while in the observation area, pt appears to have had a vasovagal reaction with a brief loss of consciousness, pt fell to the floor, had very brief shaking activity followed by immediate arousal by patient as medical provider has seen in other vasovagal incidences. Pt was alert and oriented upon arousal and pale. EMS was called by a store patron. Upon EMS arrival, Patients blood sugar was taken and found to be 55, pt does not have a history of diabetes. Pt stated he had had a waffle that morning for breakfast and had not eaten since the morning (time of event is estimated around 11am). Vital signs within normal limits. Patient stated he felt like he was having an anxiety attack prior to event. Parents decided to take patient to the hospital for further testing. Mother stated patient was discharged from the hospital that day and tests were normal.
16 2021-04-05 cold sweat, tremor, weakness, pain in extremity Patient was nervous upon receipt of vaccine. It was an unscheduled (expiring) dose. Per parent, he... Read more
Patient was nervous upon receipt of vaccine. It was an unscheduled (expiring) dose. Per parent, he had fallen asleep outside vaccine room and they had to wake him up to get vaccine. I gave immunization and asked him to stay for 15 minutes afterwards. His Mom ran to consult window to notify staff patient was passing out. I was sanitizing vaccine room so I immediately ran to him and his Dad and I caught him as he was slumping over. He was shaking really hard, weak, and clammy. He was coherent b/c I asked him his name but did not have clear recollection of timing of vaccine. He was very pale in color. His Mom grabbed him a Gatorade and he seemed very thirsty as he was drinking. He mentioned he felt dizzy and that both arms were hurting and the arm I gave vaccine in felt like he had sweat dripping off it. (I felt his arm and it did not). I grabbed an instant cold pack and placed on his neck to help cool him off. His color returned over the 30 minutes. I asked parents if they wanted me to call ambulance but they wanted to wait and see how he responded. He looked at his iPhone data and his heart rate had spiked. Unclear if right before vaccine or right after but I believe he mentioned it went up to 120 when Mom said his normal resting heart rate was 60. He ate some gold fish and seemed to perk up and have a few funny conversations showing his personality. I explained to him very important to let parents know if he experienced any other side effects after leaving. He was able to stand up and walk out of RX with parents.
16 2021-04-06 feeling hot About 10 minutes after receiving vaccine patient got hot/sweaty and vomitted. Drank sips of water a... Read more
About 10 minutes after receiving vaccine patient got hot/sweaty and vomitted. Drank sips of water and sat for another half hour and was fine
16 2021-04-06 tingling About 5 minutes after shot he said arm is tingling then fell off chair and hit the floor. He passed ... Read more
About 5 minutes after shot he said arm is tingling then fell off chair and hit the floor. He passed out for a couple of minutes and then opened eyes and said my throat is closing up. The EMS gave Benadryl and used the Epi Pen. He was transported by ambulance to the hospital.
16 2021-04-06 seizure This patient has a history of epilepsy. He received the vaccine approximately 1pm. This is a minor w... Read more
This patient has a history of epilepsy. He received the vaccine approximately 1pm. This is a minor who was here with his father. At approximately 1:10pm we were alerted that he started to seize. 911 was called. The father had him on the floor. He came out of the seizure prior to EMS arriving. Once they arrived, the parent declined ambulance transportation to the hospital and said he would call his physician.
16 2021-04-07 weakness Systemic: Dizziness / Lightheadness-Medium, Systemic: Weakness-Medium, Additional Details: PT PALE A... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Weakness-Medium, Additional Details: PT PALE AND WEAK
16 2021-04-07 seizure Approximately 5 minutes after receiving his first shot he passed out and seizured for approximately ... Read more
Approximately 5 minutes after receiving his first shot he passed out and seizured for approximately 15 seconds. Fire and EMT called and stabilized him then taken to hospital for tests.
16 2021-04-08 weakness, feeling hot Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Medium, Additional Details: Patient was felling hot and had anxiety before getting the shot. He said he had breakfast at 7am and recieved the shot around 11:30 am.
16 2021-04-08 involuntary muscle movements 11:15 Patient fell out of chair and hit his head on the gym floor, he lost conscientiousness, after ... Read more
11:15 Patient fell out of chair and hit his head on the gym floor, he lost conscientiousness, after he work up, he stated " I have a headache." Blood pressure elevated, sweating, kicking, confused initially but quickly able provide his name, birthdate, and current location. B/P 147/85 HR: 100 Oxygen Sat: 100% 11:20 am B/P 153/78 HR: 99 Oxygen Sat: 99% 11:40 Patient states " I'm not feeling alright but I think I'm going", patient was talking on the phone to his dad, unable to complete his sentence and began to fall out of his chair, patient eye's began to twitch, legs kicking, but patient was able to state his name. Patient was sent to the Emergency Room via ambulance. Father of the child will meet them at the hospital for further evaluation.
16 2021-04-09 flushing dizzy, flushed
16 2021-04-09 unresponsive to stimuli Systemic: Fainting / Unresponsive-Mild, Additional Details: pt fainted but regained his consiousness... Read more
Systemic: Fainting / Unresponsive-Mild, Additional Details: pt fainted but regained his consiousness shortly after, he was observed for 1 hour after the incident, I called the parent on 4/9/21 and father said that he is doing well and back to normal
16 2021-04-11 unresponsive to stimuli, feeling hot Patient felt warmth in his arm and became faint. He had his eyes open and remained sitting, but beca... Read more
Patient felt warmth in his arm and became faint. He had his eyes open and remained sitting, but became pale and not responding appropriately. He was reclined with his feet up, cold cloth and returned to normal rather quickly. His vitals were withing normal limits, drank water, was observed x 30 minutes. His mother, who was present the entire episode, stated he has had a sililar reaction to a previous routine vaccine. Instructed to contact Primary Care MD to discuss further immunizations. Patient walked out with his mother feeling fine.
16 2021-04-12 pain in extremity Urticaria of trunk and extremities developed ~48 hours after vaccination. Relatively mild with only... Read more
Urticaria of trunk and extremities developed ~48 hours after vaccination. Relatively mild with only intermittent pruritis. Pain and swelling of feet. Still present as of visit on 4/12/21. No other symptoms.
16 2021-04-12 tingling Mother reported to nurse son wasn't feeling good. Client had put head down on table. When nurse g... Read more
Mother reported to nurse son wasn't feeling good. Client had put head down on table. When nurse got to him he was pale with thready pulse. Lowered client to floor with feet elevated and ice pack placed on back of neck. Client stated throat "hurt." Blood pressure was 80/52. Client remained alert and oriented. EMS was called. Client then complained of hands and legs tingling as well as his bottom teeth. Encouraged client to take breaths. EMS arrived at 4:17pm. Blood pressure 100/68. EMS took over care at that time. 4:40pm Client feeling better. Wasn't transported to hospital for follow up. Client walked out with the assistance of mother.
16 2021-04-13 migraine, tremor Shaking violently when awoken, migraine, nausea, difficulty walking straight and fever
16 2021-04-13 seizure Within a few seconds of receiving vaccine, patient had a seizure last approx 10 sec. Code blue call... Read more
Within a few seconds of receiving vaccine, patient had a seizure last approx 10 sec. Code blue called, transferred to ED for evaluation. Stable and discharged home following event. Mom later reported previous hx of seizure following vaccination.
16 2021-04-13 seizure had a seizure shortly after receiving his first dose of Pfizer Covid 19 vaccine. After EMS arrived ... Read more
had a seizure shortly after receiving his first dose of Pfizer Covid 19 vaccine. After EMS arrived they performed a fingerstick to check blood sugar and he had another seizure.
16 2021-04-15 feeling hot Patient felt dizzy, hot and light headed immediately following vaccination. He lied on the floor for... Read more
Patient felt dizzy, hot and light headed immediately following vaccination. He lied on the floor for about 5 minutes and had some water. He sat up since he was feeling better. He then became nauseated and lied back down. After another 5 minutes he was feeling better. He slowly went from lying to standing to walking. He sat outside for another 5 minutes and felt back to normal.
16 2021-04-15 tingling was in school on 4/15 and he said that his hands and fingers got "tingley" and then he woke up on th... Read more
was in school on 4/15 and he said that his hands and fingers got "tingley" and then he woke up on the floor.
16 2021-04-15 tremor, nerve pain Severe arm tremor from elbow down to hand; significant nerve pain and muscle weakness. This tremor ... Read more
Severe arm tremor from elbow down to hand; significant nerve pain and muscle weakness. This tremor was severe Monday, Tuesday. Still experiencing muscle weakness and nerve pain 6 days post shot only in right arm that vaccine was injected into.
16 2021-04-16 flushing Syncope, Flushing/sweating Pt felt light headed, assisted to ground by RN. Placed in wheelchair an... Read more
Syncope, Flushing/sweating Pt felt light headed, assisted to ground by RN. Placed in wheelchair and moved to med bay. VSS on arrival. Pt eating and drinking w/ no issues. Feeling normal. Ovbserved patient to stand. Stron/steady gait. BP 130/85, HR 93, RR 22 -- > 130/80, 81, 18. Patient stable and released from vaccination site. Grass allergy
16 2021-04-16 seizure pt was getting his first covid vaccine with his mom. pt was vaccinated first then mom was vaccinated... Read more
pt was getting his first covid vaccine with his mom. pt was vaccinated first then mom was vaccinated. After mom was vaccinated I had my bad to the patient and his mom throwing away supplies, Pt passed out and was not responsive to mom or to myself the pharmacist. I thought the patient needed an EpiPen and went to get the EpiPen out of the pharmacy and while my back was turned mom stated that the patient convulsed a few times. By the time I returned with the EpiPen pt was not convulsing and had passed out and started to recover and become responsive. Pt was pale but was aware of his name, birthday, date, and current president. A tech called EMS. Pt was talking when EMS arrived and color had started to return to normal. pt was able to walk out to the ambalance to be checked out. Mom stated she wanted to take pt to ER for more evaluation.
16 2021-04-17 unresponsive to stimuli, flushing Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushe... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Medium, Additional Details: After getting the vaccine, patient was feeling lightheaded while he was sitting down. He tripped over the chair and fell over when he tried to get up too quickly. Patient fainted briefly as we were trying to get him to a chair and was pale initially. 911 was called. After he was given water and the paramedics arrived patient got better. paramedics tested vitals and everything was in normal range. patient reported being nervous about getting the vaccine. paramedics left after collecting info
16 2021-04-18 discomfort Fever, chills, headache and swallen axillary lymphnodes. Pain and redness in left axillary area lim... Read more
Fever, chills, headache and swallen axillary lymphnodes. Pain and redness in left axillary area limited left arm and shoulder range of motion. Tylenol and warm compress was used to provide comfort. Today a call is going out to the Dr. to provide any further instruction as today is day 3 and there is still quite a bit of axillary discomfort.
16 2021-04-18 flushing Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild
16 2021-04-18 flushing Flushing, sweating, dizziness. BPs 104/55 (pulse 68), 102/60 (pulse 64), O2 sat 100%. Water, juice, ... Read more
Flushing, sweating, dizziness. BPs 104/55 (pulse 68), 102/60 (pulse 64), O2 sat 100%. Water, juice, and crackers given.
16 2021-04-19 unresponsive to stimuli Patient had a syncopal/near syncopal episode shortly after vaccine given, becoming very lightheaded/... Read more
Patient had a syncopal/near syncopal episode shortly after vaccine given, becoming very lightheaded/dizzy. Had a very short period of unresponsiveness, approximately 5 seconds. He does report having a similar situation after flu vaccine in the past. He was placed in supine position, cool compress applied to forehead. After several minutes was able to consume water and lollipop. He was made to remain in the treatment area for 30 minutes post vaccination, at which time he recovered without any further treatment and was able to leave with his mother, ambulating steadily without assistance.
16 2021-04-20 cold sweat Patient appeared pale, light headacheness, near fainting, tunnel vision, skin cold and clammy within... Read more
Patient appeared pale, light headacheness, near fainting, tunnel vision, skin cold and clammy within 10 minutes of 2nd Pfizer injection. Patient rested on gurney and felt better. 1st BP taken at 10:45 BP 85/47, HR 56. 2nd BP taken at 10:55 BP 95/57, HR 61. Patient left the facility 30 minutes after his vaccination with stable condition.
16 2021-04-20 seizure like phenomena, muscle twitching Customer 30 seconds -1 minute after administration of the vaccine became unresponsive, and had facia... Read more
Customer 30 seconds -1 minute after administration of the vaccine became unresponsive, and had facial twitching and overall body clenched down for 15 seconds--seizure like. Customer woke and assisted customer to ground, he reported lightheadedness, customer was pale. Customer was fasting. Customer reports within 5 minutes on the floor that he felt better. Assisted customer into sitting position and observed for 20 more minutes. customer reports being 100% at time of departure. Customer with his father.
16 2021-04-20 seizure like phenomena Seizure like activity and racing heart immediately after administration, BP 75/35 and HR 48
16 2021-04-21 flushing Syncope, flushing/dizziness, sweating, BP 92/50 (pulse 77). F/u pulse 116/56, O2 sat 99%.
16 2021-04-22 weakness Patient is a 16 year old male alert and oriented x4 accompanied by his mother who complained of weak... Read more
Patient is a 16 year old male alert and oriented x4 accompanied by his mother who complained of weakness immediately upon administration of vaccine. The patient and patients mother stated that this same type of event has occurred in the past with previous vaccinations. Patient was seated on a cot a vital signs stable. Patient stated the he immediately felt better and no longer had any complaints. No chest pain, shortness of breath, weakness, dizziness, signs of stroke or allergic reaction. The offer was made to call paramedics for further evaluation and transport but patient and mother politely refused. Patient and mother were advised of all risks and consequences and advised to seek medical treatment if any symptoms return. Patient left with his mother via private vehicle.
16 2021-04-22 feeling hot, cold sweat, numbness About 5 minutes after the vaccination by our pharmacy student, the patient reported that he wasn't f... Read more
About 5 minutes after the vaccination by our pharmacy student, the patient reported that he wasn't feeling well. He said he was hot and dizzy. His hands were clammy. He said he felt like his body was numb. We had him remove his mask and got him some water. He never actually lost consciousness. Eventually we had him lay down and put his feet up. His father was contacted and came to pick him up. We spoke to his mom later and she said he was feeling much better.
16 2021-04-22 grand mal seizure Physician assistant at Patient's pediatrician office call pharmacy and informed us that patient had ... Read more
Physician assistant at Patient's pediatrician office call pharmacy and informed us that patient had a grand mal seizure after yesterday's vaccine and was being sent to the ER at Hospital.
16 2021-04-22 grand mal seizure Patient received vaccine around 745 am on 4/22/21. He did not have any side effects or concerns unt... Read more
Patient received vaccine around 745 am on 4/22/21. He did not have any side effects or concerns until 4/23/21 at approximately 9:30 am when he had what Mom describes as a grand mal seizure while at school. Patient was reportedly sitting in his chair at school. He stretched his arms above his head then fell onto the floor with full body convulsions for just under 1 minute. Patient vomited about 20 minutes later. Our office was informed by mother around 10:30 am. Patient at home and sleeping. Advised Mom to take patient to local ED for further evaluation and monitoring.
16 2021-04-23 cold sweat, unresponsive to stimuli Patient started to feel dizzy for about one minute. His father states that patient was sitting up on... Read more
Patient started to feel dizzy for about one minute. His father states that patient was sitting up on a chair and he started to fall backward, so his father caught him and lowered him to the ground. He did not hit his head. He was not responsive for approximately 10 seconds, per the father. Clinical monitors arrived and patient was alert and oriented to name, place, date/time. He was slightly pale and clammy but he denied any dizziness, chest pain, palpitations, shortness of breath, headache, changes in his vision/hearing, or nausea. He was laying on his back on the ground with his legs elevated on a chair and he started to feel better, and his blood pressure and oxygen saturation were stable with mild bradycardia per the vital signs obtained by one RN. He said he was feeling better and he was smiling and joking with staff. He slowly started to sit up and sipped bottled water. Stated that he had not eaten since 11am, and he agreed to a snack. I left to get him a snack, and RN said that he started to "zone out" and he lost consciousness again for approximately 20 seconds. When I came back, he was sitting up, conscious, and had spit up saliva and water onto his shirt. His breathing was steady. He again stated that he was feeling better very quickly, again in good spirits, but his father and I agreed that it would be best to call 911 to transport him to the ER just to be safe. He did not hit his head. He denied dizziness, chest pain, palpitations, shortness of breath, nausea, changes in vision, and headache. He was alert and oriented to name, place, and time. EMS was requested and they arrived, took his vitals, and he was transported to the Emergency Dept for futher care. He and his father were confident that he would recover quickly as he had a history of syncopal episodes related to vaccines in the past.
16 2021-04-23 feeling hot, unresponsive to stimuli, seizure PATIENT PASSED OUT AND EXPERIENCED CONVULSIONS APPROXIMATELY 1-2 MINUTES POST VACCINATION. HE WAS UN... Read more
PATIENT PASSED OUT AND EXPERIENCED CONVULSIONS APPROXIMATELY 1-2 MINUTES POST VACCINATION. HE WAS UNRESPONSIVE FOR 5 - 10 SECONDS AND THEN BECAME ALERT COMPLAINING OF "FEELING HOT" AND HAD TROUBLE BREATHING. EMS WAS CALLED AND PATIENT WAS TRANSPORTED TO LOCAL HOSPITAL.
16 2021-04-23 seizure Patient began to seize less than 5 minutes after receiving vaccine. the seizure lasted less than 1 m... Read more
Patient began to seize less than 5 minutes after receiving vaccine. the seizure lasted less than 1 minute. registered nurse on site laid patient down and supported head and neck. EMS was called and patient was taken to hospital
16 2021-04-24 weakness, pain in extremity Leg and knee pain and weakness. Myalgia unable to run or walk
16 2021-04-24 weakness Fever, congestion, loss of energy 2 days
16 2021-04-24 flushing Flushing/sweating, nausea, vitals wnl.
16 2021-04-24 tremor Immediately after receiving the Pfizer COVID19 vaccine, patient began feeling sick, dizzy, lighthead... Read more
Immediately after receiving the Pfizer COVID19 vaccine, patient began feeling sick, dizzy, lightheaded. Patient was shaking and went unconscious for a few seconds. Patient regained consciousness but was able to sit and drink water until paramedics arrived. Administering pharmacist suspects it was a seizure but that was not verified. Patient left with paramedics.
16 2021-04-25 tremor Mother called Rn to the car. Pt is feeling shivery and shaky. BP 109/61 HR 90 RR 18 sats 99% Temp 98... Read more
Mother called Rn to the car. Pt is feeling shivery and shaky. BP 109/61 HR 90 RR 18 sats 99% Temp 98.1. Denies pain. Emt to carside to evaluate. Patient evaluated. Parent refused for pt to be transported to hospital.
16 2021-04-26 weakness, pain in extremity Symptoms started on Saturday night after receiving vaccine Thursday afternoon (60 hours after vaccin... Read more
Symptoms started on Saturday night after receiving vaccine Thursday afternoon (60 hours after vaccine?). Symptoms included loss of taste and smell, nausea, sore throat, chest congestion, coughing, chills/sweating, pain in limbs. Chest congestion, sore throat, chills were all helped with Dayquil and Tylenol. Chest congestion and cough improved by Monday morning, still slight on Tuesday morning. Taste and smell were recovered on Monday evening (5pm, dinner) after approximately 36 hours At time of submitting this report (Tuesday morning), still experiencing chills, limb pain, very slight cough and very slight nausea (weak and dehydrated). Consultation with nurse practitioner at primary care suggested filing this report.
16 2021-04-26 pain in extremity headache, all over body ache, tiredness, sore arm, inability to sleep
16 2021-04-26 seizure Pt had a seizure roughly 5 min after receiving the vaccine
16 2021-04-26 tremor After reporting symptoms of dizziness, Patient was monitored by RN at vaccination site. While monito... Read more
After reporting symptoms of dizziness, Patient was monitored by RN at vaccination site. While monitoring, RN noticed patient exhibiting muscle tremors throughout his body that he reported not being able to control. Reaction intensified with patient advising that the was having sharp right sided chest pains that he rated on a pain scale of 0 to 10 as being an 8. In addition he stated that the felt as though his throat felt as though it was closing off. EMS were notified and while en route, RN continued to monitor patient. Patient remained able to speak with RN, pulse remained 70s bpm and respirations within normal range of 14 to 20. Patient did not display any symptoms of having trouble breathing. EMS arrived to evaluate patient; administered oxygen therapy and ran a 12-lead echocardiogram. Patient's parents opted to take patient local hospital to be evaluated, but declined to do so via the ambulance and transported patient via private vehicle.
16 2021-04-27 numbness Numbness, dizziness, blurred vision
16 2021-04-27 tremor Immediately after the injection, patient was lightheaded, had tremors, felt like he was gonna pass o... Read more
Immediately after the injection, patient was lightheaded, had tremors, felt like he was gonna pass out, had a hard time breathing and couldnt swallow.
16 2021-04-28 cold sweat palpitations, clammy, fatigued x 1 hr
16 2021-04-29 weakness Systemic: Dizziness / Lightheadness-Severe, Systemic: Weakness-Mild
16 2021-04-29 unresponsive to stimuli, flushing Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flus... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Severe, Additional Details: Patient passed out and lost conciousness. EMS called. Patient was breathing. O2Sat >95%. EMS arrived after patient regained conciousness. Patient refused transport to hospital.
16 2021-04-29 unresponsive to stimuli Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: pt fainted after injection but was fine after laying down for roughly 15 min. gave h2o and waited 30 min before ok to drive home. consulted parents... will drive son to next appt.
16 2021-04-30 weakness, tingling, inability to speak Difficulty awakening; tingling to hands; difficulty standing up; difficulty with mobility; unable to... Read more
Difficulty awakening; tingling to hands; difficulty standing up; difficulty with mobility; unable to answer questions; hyperglycemic; incoherent; vomiting; weakness; dizziness; increased white blood cells; increased lactate value; Concomitant medication included an unspecified vaccine given on 08Apr2021; Concomitant medication included an unspecified vaccine given on 08Apr2021; This is a spontaneous report from a contactable consumer (patient). A 16-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, on 08Apr2021 13:45, as single dose, for COVID-19 immunization, at a hospital. Medical history included asplenic, diabetes, Ehlers-Danlos syndrome (EDS), and autism. The patient did not have COVID-19 prior to vaccination. The patient previously took gabapentin and lactose and experienced allergies. Concomitant medications included an unspecified vaccine (reported as "other vaccine") given on 08Jan2021; and other unspecified medications. On 08Apr2021 at 22:00, the patient experienced difficulty awakening, tingling to hands, difficulty standing up, difficulty with mobility, unable to answer questions, hyperglycemic, incoherent, vomiting, weakness, dizziness, increased white blood cells, and increased lactate value. These events resulted to physician's office and emergency room visits; and hospitalization for one day (unspecified date). Treatment for the events included IV fluid and IV antibiotics. The patient had COVID nasal swab on 09Apr2021 and tested negative. The patient recovered from the events on an unspecified date. Information on batch/lot number was requested.
16 2021-04-30 migraine Triggered migranes the following 5 days.
16 2021-04-30 seizure About an hour later he was disoriented; headache; seizure; fever was over 103/temperature spiked so ... Read more
About an hour later he was disoriented; headache; seizure; fever was over 103/temperature spiked so quickly; This is a spontaneous report from a contactable consumer. A 16-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in right arm on 16Apr2021 13:00 (Batch/Lot number was not reported) (at the age of 16-years-old) as a single dose for COVID-19 immunisation. Medical history included mental illness and autism from unspecified dates and unknown if ongoing. There were no concomitant medications. Patient previously took the first dose of BNT162B2, administered in right arm on Mar2021 (Lot number was unknown), at the age of 16 years old, for COVID-19 immunisation. There were no other vaccines in four weeks. Several hours after receiving the second dose of Pfizer Covid vaccine on 16Apr2021 20:00, the individual developed a headache and took ibuprofen (ADVIL) and water. About an hour later, he was disoriented and the parent (who was a nurse practitioner) asked him questions and he was having a hard time answering. Patient's fever was over 103 in the ambulance. He was tested for everything at the hospital and all was negative. It was determined to be an adverse reaction to the vaccine and what likely happened is his temperature spiked so quickly that he had a seizure. The events resulted in emergency room/department or urgent care. Treatment for other adverse events was unknown. There was no COVID prior vaccination and patient was not COVID tested post vaccination. The outcome of the events was recovering. Information about lot/batch has been requested.
16 2021-04-30 tremor his hands just started shaking really bad; This is a spontaneous report from a contactable consumer ... Read more
his hands just started shaking really bad; This is a spontaneous report from a contactable consumer (Parent) . A 16-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot# EW0151), via an unspecified route of administration on 10Apr2021 (at the age of 16-years) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Apr2021 (one week after vaccination), patient hands just started shaking really bad. Patient experienced it again during an exam making it hard for him to write. Reported parent asked if this was normal and a common side effect or something she should be concerned about. The outcome of the event was unknown. No follow-up attempts are needed. No further information is expected.
16 2021-04-30 tremor After waiting in the waiting area for about 10 minutes the PT said he felt light headed and passed o... Read more
After waiting in the waiting area for about 10 minutes the PT said he felt light headed and passed out falling to the floor. Mom was at his side and stated that he went to 'dead weight' and then she lowered him to the floor as best as she could. Mom said that she started 'shaking' and then stopped after about 15 seconds. After PT was stood up he felt like he was going to vomit but he did not. PT was extremely diaphoretic.
16 2021-05-01 tremor Patient came into the immunization room for his shot along with his mom. He did state he hated needl... Read more
Patient came into the immunization room for his shot along with his mom. He did state he hated needles, but was in good spirits. He got the shot, I filled out his card, and directed him and his mom to sit in the waiting area for 15 mins in case of dizziness or a reaction. They were walking out of the room to the waiting area and he almost immediately fainted. He fell and possibly hit his head on the chair/ floor when he went down. (This was maybe 2 mins post-injection). He almost looked like he was going to have a seizure (arms were tensed up, his eyes were not focused, was starting to shake) but then he suddenly came-to. He seemed to be pretty coherent after he woke back up but 911 was called since he was bleeding
16 2021-05-02 weakness Patient felt weak and got really sweaty (cold sweat) , then he vomited for a few minutes and felt be... Read more
Patient felt weak and got really sweaty (cold sweat) , then he vomited for a few minutes and felt better. The sick feeling came on within 2 minutes of the administration and he felt better after vomiting
16 2021-05-02 burning sensation Pt in for covid vaccine. Immediately after pts dose pt stated he began to feel like his arm was on f... Read more
Pt in for covid vaccine. Immediately after pts dose pt stated he began to feel like his arm was on fire. Pt stated his ears were ringing and he became diaphoretic. Pt aslo states he feels like he loss vision for about 30 seconds. Pt had small amount of emesis as well. Vitals 110/67 hr 70 rr 20 temp 97.8 oxygen 98%. After about 5 minutes pt stated he felt so much better. Pt monitored for 30 minutes by nurse vitals q5 min. Last vitals 120/72 hr 72 respiratory rate 18 oxygen 98% t 97.8. Pt left facility accompanied by family. Educated to follow up with PCP.
16 2021-05-02 pain in extremity Fever, left arm soreness, head ache and tiredness
16 2021-05-02 pain in extremity The patient received the second dose of the Covid vaccine on 4/30/21, on 5/2/21 at 0230 the patient ... Read more
The patient received the second dose of the Covid vaccine on 4/30/21, on 5/2/21 at 0230 the patient reported an episode of palpitations, chest pain, and left arm pain that was relieved after 1 hour. On 5/3/21 at 0230 the patient reported a second episode of palpitations, chest pain, and left arm pain that was not relieved, pt presented to the Clinic, to ED at 0340 on 5/3/21, the patient had an EKG and lab work done. Troponin I lab level was 4.52, which is over 100 times the normal limit. Pediatric cardiology was consulted and the patient was sent to Hospital via life flight.
16 2021-05-03 weakness Our son vomited for 6 hours and ran a moderate fever after 2nd dose. He also was lethargic, weak, a... Read more
Our son vomited for 6 hours and ran a moderate fever after 2nd dose. He also was lethargic, weak, and had bad body aches and chills.
16 2021-05-03 seizure, unresponsive to stimuli Patient was given dose #1 at a vaccine community clinic on Friday. There were no reports of him bein... Read more
Patient was given dose #1 at a vaccine community clinic on Friday. There were no reports of him being ill. Parents were present at the time of the vaccine. He went to school on Monday and had a seizure and was transported to hospital. He was placed on life support and was unresponsive. He began improving and was taken of life support on Wednesday and was discharged after a few days.
16 2021-05-04 feeling hot Felt hot, really tired, and headache the morning after the vaccine. Symptoms began when he woke up-... Read more
Felt hot, really tired, and headache the morning after the vaccine. Symptoms began when he woke up- he woke up about 30 minutes earlier than normal saying he did not feel well. Stayed home from school to rest. Felt better a few hours later, but did take Tylenol to help (only needed one dose). He felt better by evening and eturned to school the next day.
16 2021-05-05 numbness, tingling Dizziness, tingling/numbness of bilateral hands, pale. Vitals wnl. Water given.
16 2021-05-05 seizure like phenomena, slurring 5 Minutes post vaccination, pt experienced seizure like symptoms. Speech was slurred and patient wen... Read more
5 Minutes post vaccination, pt experienced seizure like symptoms. Speech was slurred and patient went into a fetal position and was flailing his arms. He returned to the chair and we placed him on the floor while waiting for 911. The paramedics check him out and with advice from the mother he was not taken to the hospital. He was escorted to his parents car and driven home.
16 2021-05-06 pain in extremity Itching, hives and pain around injection site. Pain in injected muscle. Pain in shoulder joint. Heat... Read more
Itching, hives and pain around injection site. Pain in injected muscle. Pain in shoulder joint. Heat and redness around injection area. Finally, nausea and arm pain. Nausea may be unrelated to vaccination.
16 2021-05-06 tingling, feeling hot Patient got dizzy, vision was blurry, body felt tingly and hot. Patient felt like he was going to fa... Read more
Patient got dizzy, vision was blurry, body felt tingly and hot. Patient felt like he was going to faint. His face/lips turned a gray color. We called emergency number. Patient did not have anaphylaxis. Symptoms started within a few minutes of the dose.
16 2021-05-06 tingling Numbness and tingling in right arm and right leg with mild tingle in right cheek. Headache respondin... Read more
Numbness and tingling in right arm and right leg with mild tingle in right cheek. Headache responding to Tylenol, mild soreness at injection site. No weakness or gait changes. Symptoms almost completely resolved at 20 hours.
16 2021-05-07 weakness, pain in extremity Too trashed to train for his sport/described as too weak to train; Swelling; Loss of taste and smell... Read more
Too trashed to train for his sport/described as too weak to train; Swelling; Loss of taste and smell to some extent; Brain fog; Swollen glands; Loss of taste and smell to some extent; Leg pain; Joint pain; passed out/hit the floor, put a big bump on his head; passed out/hit the floor, put a big bump on his head; Redness; Chills; Fever; Too sick to get out of bed; Shortness of breath; Headache; Muscle pain; Tiredness/Fatigue; Pain in the arm; 2 inch diameter raised circle at injection site; could not barely remember his name; tried to study but just wasn't there, head on desk. Still has difficulty focusing; This is a spontaneous report from a contactable consumer (patient's father). A 16-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: ER2613 and expiry: Jul2021), via an unspecified route of administration in right arm on 31Mar2021 14:30 (at the age of 16-year-old) as single dose for covid-19 immunisation. Vaccination was taken because he was going back to school. The vaccine was not administered at a military facility. No additional vaccines administered on same date of BNT162B2 and no prior vaccinations (within 4 weeks). The patient received first dose of bnt162b2 (Lot: EN6199, Expiry: Jun2021) on 10Mar2021 at 13:30 in right arm (at the age of 16-years-old) as single dose for covid-19 immunisation and experienced loss of taste and smell and joint pain, all events started in Mar2021. Medical history included mild allergy to Birch pollen (which everybody has, but nothing else/patient tested for allergies, and had no significant allergies, they thought he might be because he spilled a sugared soda behind his bookcase in his room and there was mold growing so they thought he might be allergic to mold, so they tested for allergies and he has no allergy to mold) and ongoing vitamin supplementation. Family Medical History included Sarcoidosis with mother. Concomitant medications included vitamin d3 for vitamin supplementation from 2020 (about a year ago) and ongoing; ascorbic acid, rosa canina fruit (VITAMIN C) for vitamin supplementation from an unspecified date (several years ago) and ongoing and an unspecified ongoing multivitamin from an unspecified date (several years ago) at 1 taken daily for vitamin supplementation. On 31Mar2021, the patient experienced pain in the arm at 17:30, tiredness at 20:30, shortness of breath, headache at 22:30 and muscle pain at 22:30. On 01Apr2021, the patient experienced fever at 00:30, chills at 01:30, redness at 02:30, leg pain at 08:30, fatigue (ongoing) at 02:30, joint pain at 08:30, too sick to get out of bed and passed out and hit the floor, put a big bump on his head at 05:30 (about 15 hours after second dose, patient was at the kitchen table with his head between his knees trying to breathe, passed out, hit the floor and put a big bump on his head). On 02Apr2021, the patient experienced brain fog at 14:30, swelling at 14:30, swollen glands at 02:30, loss of taste and smell to some extent at 14:30 and too sick to get out of bed. On day 2 (02Apr2021) and was still about pushing 100 degrees Fahrenheit and on 21Apr2021 (after 21 days) sometimes over sometimes less. On the following Monday (05Apr2021), he struggled back to school after 5 days, but came home early. He has just been trashed, too trashed to train for his sport, further described as too weak to train, he hadn't trained for 3 weeks. He still has a fever. His local doctor did not have any suggestions other than he should take acetaminophen and ibuprofen alternately to get rid of the headache and fever. In 2021, the patient experienced 2-inch diameter raised circle at injection site and disappeared after 10 days and there was a time he could not barely remember his name, tried to study but just wasn't there, head on desk. Still has difficulty focusing and doing his calculus. It was reported that the time to recover from any exertion seems to be longer by a lot. On 01Apr2021, body temperature reached 103 degrees Fahrenheit. The patient tried to do a few things like a week ago just because he couldn't stand to be in the house anymore he took a bike out for about 15 minutes and was just trashed from that experience and took 3 days to recover. The events did not require emergency room visit nor physician's office neither hospitalized. The outcome was recovered from loss of consciousness, head injury on 01Apr2021; from illness on 02Apr2021; from headache on 04Apr2021; from chills on 06Apr2021; from pain in arm and fatigue on 07Apr2021; from erythema on 11Apr2021; from ageusia and anosmia on 14Apr2021; from lymphadenopathy on 16Apr2021; from arthralgia on 17Apr2021; from myalgia on 18Apr2021; from leg pain on 21Apr2021; from vaccination site swelling in 2021; then recovered with sequel from dyspnoea on 05Apr2021 and from swelling on 07Apr2021; then recovering from pyrexia, feeling abnormal; then not recovered from asthenia and unknown for the remaining events.
16 2021-05-07 weakness Child woke up at 3 am with severe nausea. Within minutes he complained about not being able to breat... Read more
Child woke up at 3 am with severe nausea. Within minutes he complained about not being able to breathe. His lips turned blue and he was about to pass out. As I was able to keep him awake, I am not sure whether he would have had a febrile seizure (it very much looked like it) or just fainted. The fever spike was too fast, and his body couldn't handle it. His extreme nausea persisted for four hours (but he didn't vomit). He was completely debilitated. Fever spiked to 103 but stabilized at 102 for the following 24 hrs.
16 2021-05-07 difficulty speaking, seizure seizure; passed out; light headed; fell out of chair and hit floor; making a gurgling/growling sound... Read more
seizure; passed out; light headed; fell out of chair and hit floor; making a gurgling/growling sound; his right arm was contracted and tight; his right arm was contracted and tight; This is a spontaneous report from a contactable consumer, the parent. A 16-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: ER8736), via an unspecified route of administration in the left arm on 23Apr2021 at 09:30 (at the age of 16-years-old) as a single dose for COVID-19 immunization. Medical history included Ehlers-Danlos syndrome. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior to the vaccination. Concomitant medications were none. The patient did not receive any other vaccinations within 4 weeks of the vaccine. On 23Apr2021 at 09:45 (reported as 13 minutes after the vaccine), the patient said he was lightheaded and then fell out of the chair and hit the floor. He started making a gurgling/growling sound. After the nurses flipped him over, they noted that his right arm was contracted and tight. They were unable to determine if he had passed out or had a seizure. He had no seizure history. He regained consciousness after about 45 seconds to a minute. The patient was not treated for the events. Since the vaccination, the patient was not tested for COVID-19. The clinical outcome of passed out was resolved on 23Apr2021, while of seizure, lightheaded, fell out of chair and hit floor, making a gurgling/growling sound, his right arm was contracted and tight was resolving.
16 2021-05-07 tremor, pain in extremity Woke up shaking, low fever, sore arm and nausea.
16 2021-05-08 pain in extremity Day 1: arm soreness Day 2: headache, fatigue, body aches Day 3: fever of 102, fatigue, headache
16 2021-05-08 tingling, numbness Dizziness, tingling/numbness of bilateral hands, pale. Vitals wnl. Water given.
16 2021-05-08 seizure, unresponsive to stimuli Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Seiz... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Seizure-Medium
16 2021-05-09 feeling hot Pt reports feeling very hot and dizzy. Pt appears very anxious. BP 89/54, HR 73-- > 1min later BP ... Read more
Pt reports feeling very hot and dizzy. Pt appears very anxious. BP 89/54, HR 73-- > 1min later BP 122/99 -- > BP 105/56, HR 81 prior to D/C. Pt given ice pack, observed x15min. Patient stable and released from vaccination site.
16 2021-05-09 muscle twitching, seizure, involuntary muscle movements Mom contacted our clinic today reporting that patient received the COVID vaccine at the Pharmacy. Mo... Read more
Mom contacted our clinic today reporting that patient received the COVID vaccine at the Pharmacy. Mom reports about 2-3 minutes after the vaccine was given, patient 'had a seizure'. Mom reports loss of consciousness, twitching/jerking, pale skin, nausea. These s/s lasted less than 1 minute. They were at the pharmacy when the episode occurred. When he was alert and awake after the episode, he was acting normal and continues to act normal.
16 2021-05-09 pain in extremity Patient received his 2nd Pfizer COVID vaccine on Tuesday 4/27/2021; he had low grade fever (100.3 de... Read more
Patient received his 2nd Pfizer COVID vaccine on Tuesday 4/27/2021; he had low grade fever (100.3 deg F) on Wed 4/28/2021. On Thursday 4/29/2021, he developed "heartburn", and on Friday 4/30/2021 he developed chest pain that radiated to his jaw and left arm. He presented to Hospital on late 4/30/2021 or early 5/1/2021 for evaluation; initial labs showed a CRP of 1.23, POC troponin of 6.56 ng/mL (03:18 on 5/1) and lab level of 17.6 ng/mL (03:05 on 5/1) that increased to 24 ng/mL later in the morning on 5/1. COVID-19 PCR was negative. He was transferred to another Hospital mid-day on 5/1/2021 due to concerns for myocarditis/myopericarditis. He was started on NSAIDs. His troponin level improved, had decreased to 9.69 ng/mL on 5/2/2021; at that point as his chest pain had improved and labs were improving, parents requested that he be discharged from the hospital. He had 2 echocardiograms at PCH which reportedly showed normal biventricular systolic function. He had an echo at the hospital on 5/2/2021 which showed normal biventricular systolic function, no pericardial effusion, and normal valves. As an outpatient, he had repeat troponin-I levels: 2.49 ng/mL on 5/3; 0.31 ng/mL on 5/5; the troponin level was reportedly normal on 5/10/2021 per his primary cardiologist
16 2021-05-10 cold sweat Patient was given first dose and was in waiting area for observation. About ten minutes after his s... Read more
Patient was given first dose and was in waiting area for observation. About ten minutes after his shot our vaccine coordinator alerted me that he was having a reaction. When I went out to the patient his eyes were open but he was staring blankly. His father was shaking him and waving his hand in front of his face and asking him if he was okay and the patient was not responding. I also tried to get the patient to respond and he did not. Since the patient was not responsive to any questions we called 911. While waiting on the paramedics to arrive the patient came around and started to answer some simple questions. He was clammy and sweating and he threw up one time. When the paramedics arrived they took over. They checked all the patients vital signs and were with him for about 15 or 20 minutes assessing him. The patient walked out of the store on his own and was not taken by ambulance. I called the patient around 3:10pm to check on him and I spoke with him and he said he was doing fine.
16 2021-05-11 inability to speak Pt. felt dizzy immediately after vaccine. Sweating profusely and was not able to speak. Vitals: HR ... Read more
Pt. felt dizzy immediately after vaccine. Sweating profusely and was not able to speak. Vitals: HR 78, BP/105, O2 98 and EKG heart seemed to have prolonged QT but EMT used pump to stimulate heart. Pt. transferred to hospital.
16 2021-05-11 pain in extremity presented to outside ED with complaints of new onset chest pain that radiated to the back and down h... Read more
presented to outside ED with complaints of new onset chest pain that radiated to the back and down his arms with concurrent nausea. Patient was sitting in the living room around 2030-2045 when he developed midsternal and epigastric region pain. Pain radiated to his upper middle back and down both left and right arms. There were no notable exacerbating or relieving factors. Pain was a 4-7 in severity. He was also nauseated. He was given tums by his mother without significant change in symptoms. After 45 minutes they decided to go to the ER. At ER labs were notable for elevated troponin (2-- >15-- >9). EKG with J-point elevation. Non-contrast CT chest/abd/pelvis was unremarkable. He was given ASA 325 and famotidine in the ED. Pain eventually subsided around 2345. He was transferred to another hospital for further evaluation of troponinemia.
16 2021-05-12 weakness Extreme fatigue/tiredness Fever Upset stomach Headache Couldn?t concentrate Weak Chills Was extre... Read more
Extreme fatigue/tiredness Fever Upset stomach Headache Couldn?t concentrate Weak Chills Was extremely tired with the first dose also, for three days
16 2021-05-12 flushing Swelling of the fingers, face, and lips. Flush red and warm to touch on hands and arms.
16 2021-05-12 pain in extremity Started with sore arm and headache, progressed to high fever (101). Next day had sores on mouth, whi... Read more
Started with sore arm and headache, progressed to high fever (101). Next day had sores on mouth, which spread all over lips and started sore throat. Fever did not go away without medication. Medication would alleviate it but it continued for 6 days, reaching 102.4. Pediatrician tested for strep and for COVID, both were negative. Sore throat persisted after fevers subsided. Had to finally be prescribed magic mouthwash. Doctor said sores on lips were herpes so prescribed viral medications. My son never has a sore throat and has never had a herpes sore until after the shot.
16 2021-05-12 tingling Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)
16 2021-05-12 seizure like phenomena, unresponsive to stimuli, muscle spasms, tremor Patient is a 16-year-old male patient admitted with seizure like activity. One day prior to admissi... Read more
Patient is a 16-year-old male patient admitted with seizure like activity. One day prior to admission patient received his second COVID vaccine, Pfizer brand. On the day of admission Patient woke at 0200 with pain in the left side of the chest, mid-axillary per patient's description it was cramp-like pain and he was able to go back to sleep. At 0500 he got up to use the restroom and went into the kitchen. He told his mom he didn't feel well and fell forward making a gurgling sound, arms rigid, was unresponsive, and this lasted 1.5minutes according to mom. Mom called EMS and when he awoke he stated he was nauseous. After EMS arrived it was 2-3 minutes and he did not feel well again, he stood up and head fell back, eyes open, he was shaking, and making a gurgling noise again, this episode lasted 30 seconds. Upon awaking he was disorientated for a few minutes then back to baseline, he was nauseous again and very tired. He came to the ED where EKG (pending), CBC (normal), PT/PTT/INR (slight elevation), CMP (normal), TSH (normal), Ethanol (None), Troponin (normal), Head CT (normal), and chest xray (normal) were done. He received a NS bolus was given. He was admitted to the pediatric hospitalist for further evaluation and management. This is where he had a 24hour Video EEG with normal EEG he was discharged home.
16 2021-05-14 feeling hot Within minutes of receiving the vaccine, the father says patient became slumped down in his chair, w... Read more
Within minutes of receiving the vaccine, the father says patient became slumped down in his chair, was drowsy, and he thought his son had passed out. Patient had become very pale in color, and his father says he was sweaty/warm to the touch. He was conscious, but wasn't very alert.
16 2021-05-14 flushing, unresponsive to stimuli Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flus... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium
16 2021-05-14 seizure, pain in extremity pt received the shot and immediately felt according to him, intense pain in arm and began to loose s... Read more
pt received the shot and immediately felt according to him, intense pain in arm and began to loose sight. Patient then seized and went limp. We put the patient flat on the ground to protect from a fall injury and his seizing stopped. His color was very ashy and he was not responding properly to questions we asked. In about 2 minutes, he became more coherent and began talking and responding to our questions. Paramedics were immediately called and they arrived 30 minutes later after 3 phone calls to follow up. Father was with patient.
16 2021-05-15 cold sweat, tingling faint, pale color, cold sweat, vomiting, nausea, tingling in fingers. EMS was called to the pharmacy... Read more
faint, pale color, cold sweat, vomiting, nausea, tingling in fingers. EMS was called to the pharmacy lobby. After patient drank some water and juice, he felt better. EMS treated on the scene for suspected panic attack. (Patient saw blood running down arm post injection). Patient and parent left the pharmacy after about 45 minutes from time of injection feeling and looking much better.
16 2021-05-15 feeling hot WAVE OF NAUSEOUSNESS AND WARMTH, "FEVERISH", UPSET STOMACH.
16 2021-05-15 seizure Patient was given Pfizer Vaccine on 5/16/21 at 11:00-11:10am. I read through the patient medical hi... Read more
Patient was given Pfizer Vaccine on 5/16/21 at 11:00-11:10am. I read through the patient medical history through the handheld and noticed there was "yes" on seizure history. I ask the mother what happened and she told me it was from the first incident with the Pfizer vaccine. At the time of the first incident the mother stated that patient fainted and convulsed upon regaining consciousness. Patient has had no history of seizures prior to then or had any big injuries that could trigger it. Patient's mother states physicians think it's triggered by anxiety and not a true seizure, so MRI or tests was not needed. Doctor recommended patient to come back if it happens again. With the information provided I used professional judgement and was on high alert with the patient. After administrating the vaccine to the patient, I monitored patient's vitals carefully. Patient was stable and I walked with him to his seat near the wall and left him with his family. About a few minutes later the mother told me to come to her aid. Patient had a 1 time continuous seizure for about 30 seconds-1minute. After regaining consciousness the patient said he did not remember getting the vaccine. Patient's mother was very concerned and under control and did not overreact to the situation. Also, I promptly relayed to (pharmacist) to call 911 and he called a member of management. While pharmacist was on the phone with 911 the patient regained consciousness. I monitored patient's vitals while I waited for a member of store management. Store management took a little bit longer to respond (5-10 minutes) but arrived to document the whole incident. About 30 minutes after the incident patient's vitals were stable and the ambulance was not needed and the family took him to the hospital to get monitored. Patient rode the electric wheelchair was escorted out by store management to the car.
16 2021-05-15 unresponsive to stimuli Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient seemed to have a faiting spell a... Read more
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient seemed to have a faiting spell about 10 minutes after vaccine was given, patient came too and felt "sick to his stomach", patient stated he felt okay, but once paramedics came, mom wanted him to go to with them to the hospital.
16 2021-05-17 feeling hot While sitting in the observation area, patient was sitting in chair then fell forward and hit the ri... Read more
While sitting in the observation area, patient was sitting in chair then fell forward and hit the right side of his head on the floor. Patient was turned onto his side. BP 100/58 P68 SpO2 99% on room air. Pt did not lose consciousness. Alert and oriented x3. Patient stated before he fell onto the ground, he felt "warm and zoned out." EMS activated. BP 130/90 P72 SpO2 99% room air. water given. Sister who is legal guardian stated to cancel EMS and she would take patient to the hospital. Left facility at 1:23pm. No s/sx of distress noted.
16 2021-05-17 flushing Systemic: Allergic: Rash Generalized-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Ton... Read more
Systemic: Allergic: Rash Generalized-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild
16 2021-05-17 tremor Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: F... Read more
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Shakiness-Mild, Additional Details: 911 was called for vitals after patient passed out. Paramedics stated that patient experienced syncope when standing up. also has history of anxiety.
16 2021-05-18 numbness Around 1:30 am my son complained of his eye feeling swollen and tight. his right eye was completely... Read more
Around 1:30 am my son complained of his eye feeling swollen and tight. his right eye was completely swollen and closed. I gave him Benadryl and ibuprofen and water and he went back to bed. Woke up 12 hrs later with a less swollen but still swelled eye and blurred vision. Complained the left side of his face felt numb. Was extremely groggy and tired.
16 2021-05-18 pain in extremity back was hurting; acute chest pain; elevated white blood count; acute pericarditis; Arm pain; This i... Read more
back was hurting; acute chest pain; elevated white blood count; acute pericarditis; Arm pain; This is a spontaneous report from a contactable other health professional (parent). A 16-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 intramuscular, administered in Arm Left on 29Apr2021 15:30 at the age of 16 years old (Lot Number: E000167) as 2nd dose, single for covid-19 immunisation. The patient had no medical history, no known allergies. Concomitant medications received within 2 weeks of vaccination included vitamins nos (MULTIVITAMIN [VITAMINS NOS]), acetaminophen. The patient previously received the first dose of bnt162b2 (lot number: EN6208) intramuscular in Arm left on 07Apr2021 13:00 at the age of 16 years old for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was Other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Arm pain the first few days after receiving vaccine (2021). Then last night (02May2021), at 03:00 he came to his parent's room and said his back was hurting. His parent gave him one Advil. He tried to go back to sleep but came back an hour later saying it felt like his heart was being squeezed. The doctor on call recommended they go to the ER. At the ER, they performed 2 EKGs, bloodwork, chest X-ray and an echocardiogram on 02May2021. His diagnosis upon discharge: acute chest pain and acute pericarditis on 02May2021. His bloodwork showed an elevated white blood count on 02May2021. They were to follow up with the pediatric cardiologist later this week. This events happened three days after his receiving his 2nd Covid vaccine shot. The adverse events result in Emergency room department or urgent care. Treatment received for the adverse events included Two EKGs, bloodwork, chest X-ray and echocardiogram. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was recovering.; Sender's Comments: The causal relationship between BNT162B2 and the events cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
16 2021-05-18 tingling c/o feet and toes tingling 15 minutes after vaccine. States tingling had happen before but cannot r... Read more
c/o feet and toes tingling 15 minutes after vaccine. States tingling had happen before but cannot remember when or what he was doing. P66 strong & regular BP126/88. EMS evaluated student. Student went to nurse office to wait for his mother to take him home.
16 2021-05-19 weakness Immediately after vaccination patient became nauseous, diaphoretic, weak, pale and then brief ?LOC ... Read more
Immediately after vaccination patient became nauseous, diaphoretic, weak, pale and then brief ?LOC HR66 Pulse Ox 98 BP 1 78/58 BP 2 100/70
16 2021-05-19 numbness, cold sweat Immediately after injection Patient began to faint and clench his arms. His head tilted back and eye... Read more
Immediately after injection Patient began to faint and clench his arms. His head tilted back and eyes were glazed over. Lips became pale and face was pale. He was clammy to the touch on the back of his neck. His blood sugar at the time of injection was 113. He had not eaten breakfast yet. This lasted about a minute or so. He was finally able to say that he felt ok, but asked what happened. This happened a second time about 4minutes after the first time. But didn't seem to last as long. I gave him some juice and saw that his blood sugar was dropping to 85. Then a few minutes later his blood sugar was at 62. He continued to drink the juice and had 3 4carb glucose tablets. He started to feel better about 15 minutes later. He states that he felt numbness in his hands and feet initially. All feelings returned and color to his face and lips. His blood sugar began to rise again and he was feeling better. No hives or rash was noted on his body and the injection site was normal.
16 2021-05-19 tremor PATIENT WAS EXTREMELY NERVOUS, STATED DOES NOT LIKE NEEDLES. WITHIN 2 MINUTES FELT CHEST TIGHTNESS,... Read more
PATIENT WAS EXTREMELY NERVOUS, STATED DOES NOT LIKE NEEDLES. WITHIN 2 MINUTES FELT CHEST TIGHTNESS, LIGHTHEADEDNESS, STARTED SHAKING AND EYES ROLLED UP BEFORE PASSING OUT. COME TO WITHIN A FEW SECONDS BUT WAS NOT COHERENT. COULDN'T ANSWER BASIC QUESTIONS AND LOOKED AS IF WAS GOINT TO PASS OUT AGAIN. COULD NOT STAND, TALK ETC. HE WAS LIKE THIS FOR 10 MINUTES OR SO. CALLED 911 THEY STATED TO LAY PATEINT CAREFULLY ON THE FLOOR TO RECOVER BLOOD FLOW UNTIL THEY COULD GET THERE. PATEINT STARTED COMING BACK AROUND WITHIN THE NEXT 5 MINUTES. MOTHER REFUSED LEAVING IN AMBULANCE BELIEVED SON WOULD BE FINE.
16 2021-05-20 flushing, weakness Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotensi... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Weakness-Medium, Additional Details: Patient started to get lightheaded while sitting in a chair during his post vaccine observation time. He was hypotensive and had lost the color in his face. His mother and I were able to get him over to a bench to lay down, where he also drank a bottle of water. After roughtly 45 minutes he felt strong enough again to walk around and leave.
16 2021-05-20 tingling upset stomach, chills, tingles, vomiting, unable to even drink water bc i puke it up, light head, 10... Read more
upset stomach, chills, tingles, vomiting, unable to even drink water bc i puke it up, light head, 100.4 fever
16 2021-05-21 pain in extremity have ST elevated with elevated troponins in the 1000s, concerning myocardial infarction vs myoperica... Read more
have ST elevated with elevated troponins in the 1000s, concerning myocardial infarction vs myopericarditis; have ST elevated with elevated troponins in the 1000s, concerning myocardial infarction vs myopericarditis; have ST elevated with elevated troponins in the 1000s, concerning myocardial infarction vs myopericarditis; 36 hours of left chest pain radiates to left arm; have ST elevated with elevated troponins in the 1000s, concerning myocardial infarction vs myopericarditis; 36 hours of left chest pain radiates to left arm; This is a spontaneous report from a contactable Physician. A 16-year-old male patient received bnt162b2 (BNT162B2), dose 2 intramuscular, administered in arm left on 12May2021 10:15 (Batch/Lot Number: EW0167) as single dose at the age of 16-year-old for COVID-19 immunisation, administered ad hospital. Medical history included acne with no medications. The patient's concomitant medications were not reported. patient received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in arm left on 21Apr202110:15 (Batch/Lot Number: ER8735) as single dose at the age of 16-year-old for COVID-19 immunisation. No past drug history. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced ST elevated with elevated troponins in the 1000s, concerning myocardial infarction vs myopericarditis, 36 hours of left chest pain radiates to left arm on 13May2021. The course of events was as follows: Previously healthy 16 year old male complaining of 36 hours of left chest pain radiates to left arm. Had Pfizer vaccine dose #2 about one day prior to chest pain onset. Found to have ST elevated with elevated troponins in the 1000s, concerning myocardial infarction vs myopericarditis. Admitted to the Pediatric ICU for further management on 15May2021 7:00AM. The patient was hospitalized for the events, considered life threatening. Since the vaccination, the patient has been tested for COVID-19: Sars-cov-2 test: negative on 15May2021 Nasal Swab. Therapeutic measures were taken as a result of events, treatment in process. The outcome of events was unknown.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of reported events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
16 2021-05-21 tremor, seizure Not sure if seizure; body muscles started shaking; Pain in lower spine on back; Pain in lower spine ... Read more
Not sure if seizure; body muscles started shaking; Pain in lower spine on back; Pain in lower spine on back; This is a spontaneous report from a contactable consumer (patient). A 16-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration (at the age of 16-years-old), administered in Arm Right on 07May2021 13:00 (Batch/Lot Number: Unknown) as 2nd dose, single for COVID-19 immunization. Medical history included type 1 diabetic, allergies to severe peanut, "tree but", shellfish. Concomitant medication included insulin lispro (HUMALOG) taken for an unspecified indication, start and stop date were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration (at the age of 16-years-old), administered in right arm on 16Apr2021 13:00 (Batch/Lot Number: Unknown) as 1st dose, single for COVID-19 immunization. The patient experienced Pain in lower spine on back and body muscles started shaking uncontrollably, not sure if seizure on 08May2021 02:00. No treatment received for the events. The outcome of the events was recovered. The event seizure was considered as serious (medically significant). Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Information about lot/batch number is requested.
16 2021-05-22 cold sweat 10 minutes after vaccined. pt felt dizziness, feeling lightheaded, cold skin and sweating. mom had ... Read more
10 minutes after vaccined. pt felt dizziness, feeling lightheaded, cold skin and sweating. mom had pt lied on floor and elevate the legs. after symptoms subsided and was checked by paramedic. pt left without any help.
16 2021-05-23 unresponsive to stimuli ONE MINUTE AFTER ADMINISTERING PAITENT HIS FIRST DOSE OF PFIZER COVID-19 VACCINE, THE PATIENT FELL T... Read more
ONE MINUTE AFTER ADMINISTERING PAITENT HIS FIRST DOSE OF PFIZER COVID-19 VACCINE, THE PATIENT FELL TO THE FLOOR. PATIENT REPORTS , " HE FELL ASLEEP", BUT CLAIMED HE WAS OKAY. THE PATIENT WAS ESCORTED TO THE WAITING AREA AND INSTRUCTED TO WAIT FOR 15-30 MINUTES FOR OBSERVATION. SOON AFTER SITTING IN THE WAITING AREA,THE PHARMACIST WHO ADMINISTERED THE VACCINE REPORTS THE PATIENT PASSED OUT FOR THE SECOND TIME. PER PHARMACIST REPORT, THE PATIENT WAS UNRESPONSIVE AND SEEMED NOT TO BE BREATHING. EPINEPHRINE 0.3MG DOSE WAS GIVEN INTRAMUSCULARLY AND EMERGENCY WAS CALLED AT 11:56AM. THE PATIENT REVIVED AND REPORTED HE "FELT FINE". EMERGENCY HEALTHCARE AND AMBULANCE ARRIVED AT 12:06PM AND TOOK OVER CARE OF THE PATIENT.
16 2021-05-24 numbness, pain in extremity, tingling One week after 2nd dose, developed extreme fatigue, numbness and weakness in both legs, aching/pain ... Read more
One week after 2nd dose, developed extreme fatigue, numbness and weakness in both legs, aching/pain in legs, loss of feeling in feet and occasional pins and needles feeling in feet. Some numbness/tingling in hands as well. Difficulty walking, just needs to sit. Difficulty raising arms. Complaints of legs and arms feeling very heavy. Shortness of breath.
16 2021-05-24 tingling Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)
16 2021-05-25 feeling hot Previously healthy 16 year old male presenting to hospital as a transfer for chest pain and elevated... Read more
Previously healthy 16 year old male presenting to hospital as a transfer for chest pain and elevated Troponin levels concerning for myocarditis. Patient has otherwise been healthy. Two days ago he received his second dose of COVID vaccination. He initially felt fine, but later that day had some body aches. The next day he felt feverish off and on and had dull left upper sternal border chest pain intermittently. Today, he reports sharp 7/10 mid sternal chest pain, lightheadedness, sweating, chills, and intermittent non-productive cough. He presented to original hospital for evaluation. The patient admits to tactile warmth since Sunday with no documented temperatures. He recently received his second dose of Pfizer just before onset of these symptoms. He reports difficulty sleeping since Sunday, but no shortness of breath, rashes, syncope, nausea, or vomiting. He has not had any other recent illness, fevers, or known COVID-19 exposures. He denies any history of prior cardiac disease and there is no known family history of cardiac disease, arrhythmias, or sudden death in the child or adolescent period. He denies illicit or recreational drug use. In the ED, he was well appearing with pain now 1 out of 10. POC troponin was 16.8 ng/mL. He had labs pertinent for ESR 10, CRP 3.0, BNP 24. RP2 PCR was negative. UDS was negative except for opiates (s/p morphine). IV was placed and patient was started on IV fluids. EKG was obtained and showed questionable left atrial enlargement per ED read. Cardiology was consulted and performed Echocardiogram in the ED at bedside and was within normal limits. Cardiology resident team contacted for admission. Past Medical History: No major medical diagnoses Past Surgical History: Orchiopexy, T&A Family History: No cardiac family history Social History: Lives at home with mother. Has two healthy siblings not living at home Immunizations: Up to date Medications: None Allergies: NKDA Etiology of likely myocarditis remains unclear at this time. In his age group, this would most likely represent a viral myocarditis. He would likely benefit from cardiac MRI during this admission for further evaluation of myocarditis. His EKG findings with his age group are unlikely to be secondary to myocardial infarct. No arrhythmias or heart block noted on EKG at time of admission or telemetry in ED. There is no family history of autoimmune disease or cardiac disease to suggest an autoimmune component or genetic etiology.
16 2021-05-25 seizure Patient had the vaccine and then he fainted after the needled removed. He passed out and then he had... Read more
Patient had the vaccine and then he fainted after the needled removed. He passed out and then he had seizure after. He brought to the Emergency room and was released.
16 2021-05-25 unresponsive to stimuli Patient received the Pfizer COVID vaccine at 1745. Patient states he didn't feel right but stood up ... Read more
Patient received the Pfizer COVID vaccine at 1745. Patient states he didn't feel right but stood up to go to the observation area and lost consciousness causing him to fall backwards to the floor where he was witnessed hitting his head on the gym floor. Patient was unresponsive for approximately one minute and was then alert and oriented but c/o dizziness. VS at 1756 BP 137/63 HR 85 and O2 Sat 98%. Patient remained in the supine position for approximately 10 minutes and was then aided into a sitting position on the floor and then assisted into a chair. Patient was then observed for 30 minutes by staff where he continued to c/o lightheadedness and dizziness. VS at 1806 BP 115/68 HR 84 O2 Sat 97%. EMS was then called to assess patient for continued dizziness. VS by EMS sitting BP 122/77 and standing 117/70. Patient was offered to be taken by EMS for further assessment but patient and grandfather both declined further care at this time. Patient and grandfather were instructed to call 911 immediately for any change in mental status, nausea/vomiting, or any other reaction symptoms with verbalization of understanding and agreement. Patient was advised upon discharge to stay hydrated and rest for the remainder of the evening. Patient and grandfather were also encouraged to discuss reaction with patient's PCP prior to receiving second dose.
16 2021-05-26 feeling hot, pain in extremity Diagnosed with hemophagocytic lymphohistiocytosis on 5/7/2021 after bone marrow performed on 5/5/202... Read more
Diagnosed with hemophagocytic lymphohistiocytosis on 5/7/2021 after bone marrow performed on 5/5/2021. Presented to our office on 5/5/2021 for evaluation due to the finding of pancytopenia on 4/28. Mom states he received his second COVID vaccine on the 10th of April and since then he has been hurting head to toe, complaining of his throat, and feeling dizzy. He has had low grade temps mostly from 100-101, but it has gone as high as 103.6 deg F. They presented to urgent care 1 week after the vaccine and was told that it was likely due to the vaccine, he had fluid in his ears and he was prescribed an antihistamine. He went back to urgent care a few days later and saw the same NP who told them to go to their PCP. At their PCPs office he tested "faintly positive for Flu A" and was given tamiflu and zofran which has since completed. No bruising, bleeding, gum bleeding, nose bleeds. He has been having leg pain/difficulty walking and his friends brought him a cane to use. He has had possible night sweats, mom reports he "burns up constantly." Decreased appetite, lost 4lbs, hasn't eaten much since last week. Labs were performed at the PCPs office on 4/28/2021: WBC 1.7 Hgb 10.3 Hct 30.1 Plts 118K ANC 500 Mono was negative. A referral was placed to our office on 5/4/2021 and he was brought to our clinic today for evaluation.
16 2021-05-26 pain in extremity Developed arm soreness 1 day after vaccination, then developed axillary soreness and swelling 2 days... Read more
Developed arm soreness 1 day after vaccination, then developed axillary soreness and swelling 2 days after vaccination which progressed overnight before mostly resolving 3 days after vaccination. No systemic symptoms or injection site swelling/reaction noted.
16 2021-05-27 pain in extremity Received 2nd Pfizer COVID vaccine 5/9. On the evening of 5/10 he awoke with severe 7/10 CP located ... Read more
Received 2nd Pfizer COVID vaccine 5/9. On the evening of 5/10 he awoke with severe 7/10 CP located centrally and radiating down both arms. Not a distinct pain such as sharp, stabbing, burning, throbbing but located in center of chest and was really uncomfortable. No other associated CV symptoms (palpitations, SOB, syncope). Pain slightly worse supine. Pain self-resolved but recurred on 5/12. he had no symptoms of COVID disease.
16 2021-05-27 seizure My son had a mild seizure that lasted 1 - 2 minutes. He has never had a seizure before. He then vomi... Read more
My son had a mild seizure that lasted 1 - 2 minutes. He has never had a seizure before. He then vomited a few minutes after the seizure.
16 2021-05-27 seizure Patient began experiencing "tunnel vision" five minutes after receiving his first dose of Pfizer COV... Read more
Patient began experiencing "tunnel vision" five minutes after receiving his first dose of Pfizer COVID vaccine. Patient lost consciousness and began seizing for a few seconds. Patient regained consciousness after a couple minutes. Paramedics were called and patient was checked out. Vitals were good and parents decided to just monitor him and not send him to the hospital.
16 2021-05-27 seizure About 10 mins after shot, fainted with eyes rolling back in head, convulsions for a few seconds. Pat... Read more
About 10 mins after shot, fainted with eyes rolling back in head, convulsions for a few seconds. Patient helped to lay on floor. Showed confusion for a few seconds and then came to. EMTs checked vitals and blood sugar levels and said things were normal. Visited urgent care facility a few hours later where physician said episode was likely vasovagal syncope.
16 2021-05-27 tremor Patient was seen by me via telehealth for follow up after ED visit to Hospital on 5/26/21. On 5/26/2... Read more
Patient was seen by me via telehealth for follow up after ED visit to Hospital on 5/26/21. On 5/26/21 patient was riding his bike, felt like his legs were heavy and lost consciousness. He said that prior to losing consciousness his vision was blurry and sounds sounded distant. Mother witnessed event and stated he had shaking of his upper extremities for a few seconds woke up and then had repeat shaking and loss of consciousness with eyes rolling up. He was taken by EMS to Hospital where evaluation per report was normal (labs, CT head, EKG)
16 2021-05-28 unresponsive to stimuli Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient was very worked up and nervous before receiving vaccine. Seemed to calm down after vaccine administration. Within a few minutes patient fainted. Had patient lie down with feet up. Once patient could sit up, blood pressure reading 75/42. Patient was given water and laid down/sat for about 30 minutes. Feeling better and blood pressure reading of 98/69 before leaving store.
16 2021-05-29 pain in extremity 16 yo M w/ no known chronic medical conditions (but s/p ASD and mitral valve repair in 2015), presen... Read more
16 yo M w/ no known chronic medical conditions (but s/p ASD and mitral valve repair in 2015), presents w/ constant R-sided CP since yesterday; woke up w/ R shoulder pain that radiates to his R pinkie. The CP is worse w/ movement of the torso, specifically while bending forward. No shortness of breath, DOE, leg swelling, LH, diaphoresis, n/v/d, abd pain. No recent illnesses, fevers/chills, cough, nasal congestion. No h/o similar sx. No family h/o cardiac disease. He had congenital mitral prolapse and ASD that were repaired in 2015; he was told by his interventional cardiologist that the repairs were successful and that he does not need regular follow-up. Worked out heavily 2 days ago (mostly chest/arms weightlifting
16 2021-05-31 feeling hot 14 hours after the vaccination my son began to feel short of breath, warmth in the chest, very fast ... Read more
14 hours after the vaccination my son began to feel short of breath, warmth in the chest, very fast heartbeat, and chest pain. We immediately went to an emergency room and they detected pericarditis. Followed with a little milder symptoms. He will continue to visit his doctor.
16 2021-05-31 seizure Patient fainted and had convulsions for 5-10 seconds. He came to and was just fine.
16 2021-06-01 seizure Two days later my grandson fainted, had a seizure and was taken to the ER. At the ER a CT scan of th... Read more
Two days later my grandson fainted, had a seizure and was taken to the ER. At the ER a CT scan of the head was performed. Also while getting an IV, my grandson also had a seizure. I do not have his CT scan results at this time. My grandson is also prepping for a surgery coming in June.
16 2021-06-01 unresponsive to stimuli Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild
16 2021-06-02 discomfort 16-year-old male with no significant past medical history who presented on 5/25/2021 with 2-day hist... Read more
16-year-old male with no significant past medical history who presented on 5/25/2021 with 2-day history of chest pain. Patient had his second dose of Pfizer Covid vaccine on 5/22/2021 and on 5/23/2021 he developed headache and body aches. In the afternoon of that same day patient developed retrosternal chest pain that he described as a pressure and radiated to the back. He took 2 Tylenols and went to sleep and he reports improvement of the pain. He woke up the next day on 5/24/2021 without any pain and was most of the day doing well but in the afternoon early evening the pain returned stronger. He describes as at least 5 out of 10 in severity, no shortness of breath but the pain got worse when yawning or taking a deep breath. The pain would improved if he lay on his left side. Given the symptoms he was taken to outside hospital where he was found to have ST segment elevation and elevated troponin concerning for myo/pericarditis he was transferred from this facility for further management. He was given 2 aspirins and the pain improved down to a 1 out of 10 and has remained the same. Interval history 05/26/2021: No acute events overnight. Denies chest pain, SOB, or headache. Eating well. VSS. No emesis. Almost back to baseline very minimal residual discomfort
16 2021-06-02 grand mal seizure Tonic Clonic seizure
16 2021-06-06 weakness, tremor, seizure Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unrespo... Read more
Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Mild, Systemic: Seizure-Severe, Systemic: Shakiness-Severe, Systemic: Weakness-Severe, Additional Details: After confirming that the patient did not have allergies or any previous adverse reactions to any vaccines in general, immediately after the vaccine, the patient's eyes had rolled to the back of their head and he began to go limp. His body shook for a few seconds. He quickly regained consciousness but was very weak and confused. His sister stated that he has a fear of needles. He felt nauseous (did not vomit) and felt like his heart was racing but his pulse was normal.
16 2021-06-06 weakness It started around 10 PM, he stated with 102 degree fever, body aches, fatigue and he couldn't even g... Read more
It started around 10 PM, he stated with 102 degree fever, body aches, fatigue and he couldn't even get out of the bed. He was really weak and extremely tired. These symptoms last thur 06/04/2021 and his fever broke. I thought we was out of the woods. Saturday, Jun 05, 2021 he woke up with severe chest pains. He had an irregular heartbeat and rapid heart beat. He fever was back and it was 100.8. I called his PCP and he said to take him to the ER.
16 2021-06-06 pain in extremity Patient had a sore arm but no fever on the day the vaccine was given. The following day (4/29/2021) ... Read more
Patient had a sore arm but no fever on the day the vaccine was given. The following day (4/29/2021) patient was on a boat, in the sun, not drinking much water and noticed brown discoloration of urine. He drank more fluids and symptoms resolved. Patient received second COVID vaccine on 5/19/2021 and the following day (5/20/2021) he was again on a boat and in the sun all day long and noticed brown discoloration of his urine which resolved with increasing his fluid intake. On 6/2/2021, he noticed brown discoloration again that progressed to bright red blood in urine. Patient was seen in my clinic and labs showed acute kidney injury, hematuria, proteinuria, possible glomerulonephritis and/or acute tubular necrosis. He is being followed closely by Pediatric Nephrology now to monitor symptoms and will repeat labs to see if kidney function, hematuria, proteinuria has resolved. If it has not resolved, then he may need a renal biopsy to confirm diagnosis.
16 2021-06-06 pain in extremity Patient had the normal expected symptoms on the 2nd day following his shot ... with sore arm, fever ... Read more
Patient had the normal expected symptoms on the 2nd day following his shot ... with sore arm, fever to 101, fatigue & slight headache. He refused to take Tylenol that day, unlike his 14 year sister who had the same symptoms. On Sunday morning (the 3rd day) he woke up & told us he was having chest pain & shortness of breath. His sister was doing fine. So I gave him Tylenol at 10am to try to reduce any inflammation & he still had a fever of 100. About an hour later his fever had reduced to 99 but he was still having slight chest pain & shortness of breath ... mainly if he walked or moved around. He didn?t want to get it checked out but I called our insurance & they agreed that he should go to the ER for testing so we went there at around 3pm. He had testing done including EKG, chest X-ray & COVID-19 test which all came back negative & other lab tests that also came back negative. They gave him some meds & about 2 1/2 hours later diagnosed him with pleurisy. He still was having slight chest pain & shortness of breath when we left at 5:30pm but throughout the evening was getting better. We gave him Motrin before bed & another Motrin this morning before school, even though he said he was feeling better.
16 2021-06-06 unresponsive to stimuli Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Additional Det... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Additional Details: Patient fainted roughly 2 minutes after receiving COVID 19 vaccination
16 2021-06-07 nerve pain Persistent neuropathic pain and neurologic weakness in left arm
16 2021-06-07 seizure Patient passed out approximately 4 hours post shot and exhibited seizure like symptoms
16 2021-06-07 tremor, muscle spasms Mild muscle tremors/spasms in arms and legs. Occurs on daily basis, but is not constant. No treatm... Read more
Mild muscle tremors/spasms in arms and legs. Occurs on daily basis, but is not constant. No treatment to date. Visited Pediatric Dr. at Clinic to discuss during annual physical. Pediatric Dr. referred patient to Neurologist.
16 2021-06-07 unresponsive to stimuli Patient became unresponsive and bradycardic several minutes after the vaccine
16 2021-06-08 cold sweat, pain in extremity, weakness June 4: Vaccine received June 6 (AM): felt arm pain and mild chest pain not affected by breathing or... Read more
June 4: Vaccine received June 6 (AM): felt arm pain and mild chest pain not affected by breathing or moving. Continues on and off, but was relieved by ibuprofen. June 7: 1PM- chest pain became persistent, not relieved by ibuprofen. Describes as "squeezing" with palpitations. Accompanied by feeling clammy, weak, pale, subjective fever. Brought to ED and transferred to ICU 6/7 at 18:44 for labs and imaging consistent with myopericarditis. Started treatment on scheduled Ibuprofen (600 mg q8 hours). Chest pain improving, but serial troponin continued to rise. 6/9: NSAID changed to Toradol for continued chest pain with colchicine
16 2021-06-09 weakness Systemic: pale-Mild, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Mild, Addition... Read more
Systemic: pale-Mild, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Mild, Additional Details: Pt vision went dark within a few minutes after vaccine. Pt HR 40s, O2 93%, temp 97.1 and pt looking pale. UTA BP as pt is autistic teenager and was agitated and trying to leave during visit. Pt mother present and helped calm patient. 911 called due to vision change and low heart rate. EMS arrived and pt HR back up and no longer pale. EMS reassessed pt, per pharmacy on NP return, pt/guardian refused ER transport and condition stabilized. Pt vision returned. Further EMS services declined.
16 2021-06-09 unresponsive to stimuli Systemic: Fainting / Unresponsive-Mild
16 2021-06-10 flushing Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild
16 2021-06-10 pain in extremity complained of chest pain after having the vaccine; very fatigued; very sluggish; Sore arm; This is a... Read more
complained of chest pain after having the vaccine; very fatigued; very sluggish; Sore arm; This is a spontaneous report received from a contactable consumer (parent). A 16-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15May2021 (Lot Number: EW0177, at the age of 16-year-old) as single dose for covid-19 immunisation. Medical history included heart murmur. The patient's concomitant medications were not reported. Historical Vaccine included 2 vaccines in Mar2021 (Caller said that her son had 2 vaccines in Mar2021 on his annual doctor visit, she did not have the names of the vaccines and then had a booster for the vaccine 4 weeks later. The booster was 14 days prior to receiving the Covid vaccine), and meningococcal vaccine on 01May2021 (at the age of 16-year-old, Caller said that it was a meningococcal vaccine. She thought there were 2 different meningococcal vaccines). Caller was a consumer that was calling on behalf of her son that received his first dose of the Covid-19 Vaccine. She said that she saw on the news recently that Pfizer was looking into reports that teenagers were developing heart issues after receiving the vaccine. The caller said that her son was 16 years old and received his first dose on 15May2021. The caller said that her son had a really small heart murmur. When they got home later that day after he received the vaccine on 15May2021, he said that he had chest pain. She said that he did not have a fever, but was very fatigued and very sluggish for a couple of days. She said that this had been on her mind since she saw it on the news. She was concerned if he should get the second dose on 05Jun2021 with his pediatrician. The caller also said that because he turned 16 in Mar2021, he recently had 2 other vaccines and he had a booster. So he had 3 shots prior to having the Covid-19 Vaccine. The caller said that he received the Covid-19 Vaccine after 14 days of receiving the booster. The caller said that the fatigue and feeling sluggish lasted a couple of days, but stated that he was still tired a lot. The caller said that her son also reported that he had a sore arm. She said that he noticed it a couple of hours after his vaccination and lasted about 3 days. He had completely recovered from the sore arm. The outcome of the event chest pain was unknown, of event fatigue was not recovered, of event sluggish was recovering, of the event sore arm was recovered on 18May2021.
16 2021-06-10 seizure like phenomena Pt rec'd first dose of Pfizer vaccine at approximately 0950 and immediately after reported feeling n... Read more
Pt rec'd first dose of Pfizer vaccine at approximately 0950 and immediately after reported feeling nauseous and dizzy. MA retrieved a water bottle for pt and called for the RN. The RN, also responded, pt was pale, moist, coherent. At 0954, pt had seizure activity while sitting in chair, dad held pt, hands, arms, and legs stiffened and pt's head rolled back. Pt was secured by dad and activity lasted approximately 7-10 seconds. Immediately after this activity, pt was oriented to self, place, date, and situation, then reported increased nausea. At approximately 0958 pt started vomiting. 911 was called by the RN, at 0955 and provider, was retrieved immediately from COVID testing tent. During this time, pt started to report seeing purple lights at approximately 0957. Vitals were attempted at 0954 but pt started seizing. At 1001 pt reported total vision loss. At this time, EMT's arrived on site and began to obtain vitals. Pt's BP was 50/30, EMT's started an IV and prepared pt for transport to gurney. At 1008 pt reported sight returning. 8L of 02 were applied to pt via non-rebreather at approximately 1000 at which pt's 02 sats registered at 72%. EMT's placed pt on gurney at 1008 and started en route to Hospital. Prior to seizure activity, pt's medical hx, medication list, and allergies were confirmed with pt's father. Father reported pt has no medical hx, does not take any medications, and does not have any known allergies. Father denies pt having any seizure before, any hx of brain tumors, hx of epilepsy, hx of diabetes. Father remained with pt during duration of incident and accompanied pt and EMT's in ambulance to the hospital.
16 2021-06-10 tremor, seizure seizure happened; fainted; passed out or fainted; his face and lips became so pale; His body is shak... Read more
seizure happened; fainted; passed out or fainted; his face and lips became so pale; His body is shaking almost fell of the chair; his arm is so hard and straight (on the left arm where the vaccine was injected); This is a spontaneous report received from a contactable consumer (patient's father). A 16-year-old male patient received the 1st dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via unspecified route in the left arm on 26May2021 at 10:00 (at the age of 16-years-old) as a single dose for COVID-19 immunization. There was no medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no concomitant medications the patient received within 2 weeks of vaccination. After seconds of injecting the vaccine, on 26May2021 at 10:00, the patient passed out or fainted. His father slightly slapped his face to keep him awake. The patient responded slightly and his face and lips became so pale. His father thought he was okay, then he fainted again and the seizure happened. The father was holding his body and his arm is so hard and straight (on the left arm where the vaccine was injected). His body was shaking, almost fell of the chair. Then they called for emergency assistance from the hospital. The events resulted in Doctor or other healthcare professional office/clinic visit. Patient was to schedule a visit to the primary doctor. The clinical outcome of the events passed out or fainted, face and lips became so pale, seizure, arm is so hard and straight, and body was shaking was unknown. Since the vaccination, the patient has not been tested for COVID-19. The lot/batch number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.
16 2021-06-11 burning sensation 1 week later c/o intermittent burning pain in chest when eating or taking a deep breath. Sometimes f... Read more
1 week later c/o intermittent burning pain in chest when eating or taking a deep breath. Sometimes feels like heart is being squeezed. No fever, no chills. Does not feel like heart is beating funny. Has not stopped him from normal activities like working out or playing baseball.
16 2021-06-12 inability to speak Uvula Swelling Extreme throat pain Infection Difficulty talking, swallowing, eating Treated with A... Read more
Uvula Swelling Extreme throat pain Infection Difficulty talking, swallowing, eating Treated with Antibiotics and Steroids for 10 days.
16 2021-06-12 weakness Patient had a vasovagal reaction. Was sitting in a chair in our waiting area and fell off his chair ... Read more
Patient had a vasovagal reaction. Was sitting in a chair in our waiting area and fell off his chair and "passed out" for no more than a few seconds. After that he reported he felt weak and dizzy and nauseous
16 2021-06-13 pain in extremity WHILE SPEAKING WITH THE PATIENT, HE BECAME PALLOR IN COLOR AND DIAPHORETIC. HE BEGAN COMPLAINING OF ... Read more
WHILE SPEAKING WITH THE PATIENT, HE BECAME PALLOR IN COLOR AND DIAPHORETIC. HE BEGAN COMPLAINING OF CALF PAIN AND EXPRESSED PREVIOUS SYNCOPAL EPISODE AFTER RECEIVING THE FLU VACCINE LAST YEAR. I ASSISTED PATIENT TO RECLINE IN HIS SEAT IN THE CAR, PROVIDED A COLD BOTTLE OF WATER, PLACED AN ICE PACK ON THE BACK OF HIS NECK, AND BEGAN TO FAN HIM. PT REMAINED CONSCIOUS AND ABLE TO ANSWER NEUROLOGICAL QUESTIONS WITHOUT HESITATION. AFTER 2 MINUTES, PT BEGAN TO REGAIN COLOR AND WAS ABLE TO SIT UP. AFTER ANOTHER 5 MINUTES, PT WAS ABLE TO STAND AND WAS FEELING MUCH BETTER, SKIN COLOR RETURNED TO NORMAL.
16 2021-06-14 breast pain No immediate reaction. Starting around 48 hours after vaccination (Saturday 6/5), client noted swell... Read more
No immediate reaction. Starting around 48 hours after vaccination (Saturday 6/5), client noted swelling, redness and pain at site of injection that spread to left axillary and breast area. Swelling was significant enough that mother described it as "he looked like he had a breast". They sought medical attention on Monday 6/7 at pediatrician's office. Swelling had decreased but was still present. Pediatrician advised ibuprofen. Symptoms resolved within 5 days post vaccination.
16 2021-06-14 numbness Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: pt reported he fell... Read more
Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: pt reported he fell numbness(can not feel cold) on the anterior side of his left arm in 5 minutes after received vaccine. then in 15 minutes, they left, still have numbness. tried to contact parents several times. Finally, get hold-on the parents on 06/14/21. Mom said the numbness feeling lasted 2 days. Now he is fine. he will come to have 2nd dose on 06/15/21. will take benadryl and tylenol.
16 2021-06-15 night sweats Myocarditis Developed fevers, chest pain and hematuria. Fatigue started the next day, night sweets t... Read more
Myocarditis Developed fevers, chest pain and hematuria. Fatigue started the next day, night sweets the night after x 2 days, fever on 6/14, chest pain on 6/15. Troponin elevated, Echo with poor ventricular function, UA with hematuria. Improving on NSAIDs
16 2021-06-15 tingling The day following the second Pfizer shot the patient developed a fever to 101.5 that improved with T... Read more
The day following the second Pfizer shot the patient developed a fever to 101.5 that improved with Tylenol and did not recur. On that same day he felt tingling in the hands and feet and reported a floating sensation. This too resolved with resolution of fever. On the third day after the shot he developed chest pain, difficulty taking a deep breath. He woke up the following morning with nausea which resolved but the chest pain and a feeling that it was hard to take a deep breath worsened. The pain was significant enough that he went to the ER. In the ER, he was found to have an ECG consistent with acute pericarditis and his troponin was elevated (2.75, upper limits of normal 0.03). He was started on IV Toradol and admitted to the hospital. His troponin kept climbing so he was also given IVIG (80 gm). The following morning his Troponin started coming down and he no longer was reporting any symptoms.
16 2021-06-15 seizure, tremor Patient had a seizure in the parking lot after receiving second dose of vaccine and waiting in the o... Read more
Patient had a seizure in the parking lot after receiving second dose of vaccine and waiting in the observation room. Patient had bitten his tongue during the seizure and had blood on him. By the time the provider got to the car, the seizure had ended and the patient was post-ictal. They laid him down on his mother's lap while we waiting for EMS to arrive. He was breathing very deeply, but not tachypneic. Mom reported that the seizure lasted maybe 3 minutes and was full body shaking. She reported he had never had a seizure before, but has a history of autism and is basically non-verbal. He was able to maneuver himself from the car onto the EMS stretcher with assistance. Before he moved from the car, his breathing had returned to normal and he had O2 via nasal cannula running.
16 2021-06-16 cold sweat He kind of got sick; He felt lethargic; He felt feverish, he had a fever; He felt feverish, he had a... Read more
He kind of got sick; He felt lethargic; He felt feverish, he had a fever; He felt feverish, he had a fever; He felt clammy; He felt nauseated; This is a spontaneous report from a Pfizer sponsored program reported by consumer (patient mother). A 16-year-old male patient (reporter son) received bnt162b2(BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EW0182), via an unspecified route of administration on 02Jun2021 (at the age of 16-years-old) at 1ST DOSE SINGLE DOSE as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The reporter reported that the patient experienced he kind of got sick, he felt lethargic, for he felt feverish, he had a fever, for he felt clammy and for he felt nauseated on an unspecified date in Jun2021. The reporter stated that it took him 3 days to get better and she is not sure what to do and she does not if she, if her son should get the second dose even after experiencing these symptoms. The outcome of all the events was reported as resolving. Information on lot/batch number was available. Additional information has been requested.
16 2021-06-16 migraine also been experiencing a migraine which doesn't seem to be going away/ Intractable migraine, pain in... Read more
also been experiencing a migraine which doesn't seem to be going away/ Intractable migraine, pain in his head; pain in his head and neck; Fever; chills; This is a spontaneous report from a contactable consumer (patient's mother). A 16-years-old male patient received second dose of bt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0181), via an unspecified route of administration, administered in deltoid left on 04Jun2021 at 10:25 (at the age of 16-years-old) as single dose for COVID-19 immunization. The patient did not had ant medical history. The patient's concomitant medications were not reported. The patient previously received the first dose of bt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0182), administered in left deltoid muscle on 14May2021 as single dose for COVID-19 immunization. The patient did not receive any other vaccine within four weeks prior to the first administration date of the suspect vaccine. The patient did not administer any additional vaccines on same date of the Pfizer suspect. On 04Jun2021 at 18:25 (within 8 hours of being administered the second dose of Pfizer Covid-19 Vaccine), the patient experienced fever and chills. On 05Jun2021 at 20:00, the patient been experiencing a migraine which doesn't seem to be going away/ intractable migraine, pain in his head, and pain in his neck. The patient received treatment for the fever and chills which included Tylenol. The patient was also treated for the migraine and pain in his head and neck. Duration of the fever and chills was about 36 hours, after which patient recovered completely. The consumer explained that the fever and chills were the normal, expected side effect. The intractable migraine, pain in head and neck was persistent. The patient did not require a visit to emergency room or physician office but they were waiting to hear back from his doctor. The patient was not hospitalized and did not underwent relevant tests. The consumer wanted to know if that was normal and how long she should expect the headache to last. The outcome of the events fever and chills was resolved on 06Jun2021, and migraine and pain in his head and neck was not resolved.
16 2021-06-16 pain in extremity Too like Sore for the Arm; This is a spontaneous report from a contactable consumer (parent). A 16-y... Read more
Too like Sore for the Arm; This is a spontaneous report from a contactable consumer (parent). A 16-year-old male patient received second dose of bnt162b2 (BNT162B2- PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via intramuscular, administered in Arm Right on 09Jun2021( at the age of 16-year-old) as Second dose ,SINGLE DOSE for covid-19 immunisation. The patients Medical history and Concomitant medications were not reported. Patient was not received any other vaccine prior four weeks of vaccination. Patient's historical vaccine include first dose of BNT162B2 via intramuscular, administered in Arm Right (It was like 3 weeks before) for COVID-19 immunisation. On 10Jun2021 The patient experienced too like sore for the arm . Reporter stated, I am just calling because this past Wednesday when my son took the second dose of the Pfizer vaccine, but my son is too like Sore for the Arm . Reporter stated, it was started yesterday, and he just called us a little while ago and told that he was still having it in his right arm. Well, it started yesterday, and we noticed that from what he is telling is it is getting worse. he hasn't taken anything. That's why we were calling to see if we could give him some Ibuprofen. Therapeutic measures were not taken as a result of the events. The outcome of the event was reported as not recovered. Information on Lot/Batch number has been requested.
16 2021-06-16 pain in extremity Pain in the back of patient's right calf started after a flight on 6/2/2021. We ended up in the ER ... Read more
Pain in the back of patient's right calf started after a flight on 6/2/2021. We ended up in the ER on 6/7/2021. There he was diagnosed per ultrasound with DVT or having a blood clot in a vein in his right calf. He was prescribed Eliquis and counseled to follow up with his physician at home. Patient met with our family physician on 6/9/2021, the day we arrived home to follow-up. After receiving the medical records Dr. advised us to file this report. We understand that blood clots can happen on flights, but Dr. felt that this event was such an anomally for patient that it merited further reporting. Patient is a completely healthy 16 year old male who is an extremely active athlete who participates in basketball, track, cross-country and other physical activities daily. For him to develop a blood clot after a 4 hour flight is an exceptional, unexpected event. Dr. long term plan is to keep patient on Eliquis for 6 months, then take him off of the medicine and then run more blood tests after 2 weeks to fully investigate the incident.
16 2021-06-17 bell's palsy I got Bell's palsy; This is a spontaneous report from a contactable consumer (patient). A 16-years-o... Read more
I got Bell's palsy; This is a spontaneous report from a contactable consumer (patient). A 16-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Formulation: Solution for injection, Lot number: EW0177 and Expiration date: unknown), via an unknown route of administration, in left arm on 17May2021 at 15:45 (at the age of 16-years-old) as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. Medical history included I used to have Bell's Palsy and shellfish allergy. The patient's concomitant medications were not reported. 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. About 2 weeks later (may be on 02Jun2021 or 03Jun2021), the patient got bell's palsy. On 03Jun2021, the patient underwent nasal swab sars-cov-2 test and tested negative. Therapeutic measures were taken as a result of bell's palsy and patient received 21 Prednisone 20 mg and 10 Valacyclovir HCL 500 mg. The clinical outcome of event was recovering. Information on Lot/Batch number was available. Additional information has been requested.
16 2021-06-17 pain in extremity Pain in chest area around the heart and under the left arm, along the left side of the chest. Heada... Read more
Pain in chest area around the heart and under the left arm, along the left side of the chest. Headache, mild aching in the arms and legs, lack of desire to eat, and extreme tiredness also. Inflammation of the lining of the heart was the primary side effect and very concerning. Pain began the day after the immunization. It was significantly worse in the morning and mid-day. Pain would lessen during the day, but increase over night again. Most symptoms were gone within 5 days. Minor aches remain after 1 week.
16 2021-06-18 seizure like phenomena FAINTED, SEIZURE LIKE SYMPTOMS
16 2021-06-18 seizure Exactly seven days after patient second vaccine, he boarded a 9:10AM flight, with his Dad and sister... Read more
Exactly seven days after patient second vaccine, he boarded a 9:10AM flight, with his Dad and sister. Approximately 90 minutes into the flight, as patient watched a movie on his phone (which did not have a photosensitivity warning), he blacked out and doesn't remember anything else until after coming out of a seizure. What others saw, including his father (my husband), was a convulsing 16 year-old (nearly 6' tall and 155 pounds), who was sitting just in front of him, between two strangers. My husband quickly realized what was happening and was totally surprised and struck with some fear, as we have NEVER seen a seizure in our family or in patient before (we have six biological children). The airline called for medical help; a doctor and some other professionals came. My husband had EMT training many years ago, so didn't hold patient body, but did work a few times to keep his head up (patient was seated), so as not to allow the airway to close. Patient sister (age 18) was across the aisle, alone, watching all of the commotion take place, not knowing what to do or how to help, in tears, but handling it with poise and independence. After about 2-3 minutes, the intense convulsing stopped, and his seizure became quieter but still had movement. His eyes were rolled back and he was foaming a bit at the mouth. He was still not responsive. This went on for about 4-5 minutes. Then he stopped. His dad and the doctor asked him basic questions like, "who are you?" "how old are you?" "where are you?" He couldn't answer any other those. Another 3-5 minutes past, and finally he was able to answer "where are you?" with "I'm right here." Slowly, he came back to his "senses" but of course, was very tired and had a horrible headache afterward. The doctor and my husband decided it was best to have the plane divert to another city to get patient to a hospital as soon as possible. The three of them had to cancel their trip (work trip for my husband, which our 18- and 16-year-old children were accompanying him on for pleasure and travel). The Airlines was awesome about the whole thing. When the plane landed, they quickly escorted the three off the plane (patient walked slowly, then was put in a wheelchair when they got right off the plane). They were then transferred into an Ambulance and emergently sent to the Hospital. After several hours of waiting and testing, and patient not having any more seizure activity, his CT scan, blood tests, and chest x-ray were normal, so he was discharged with the instruction to get an MRI with and without contrast upon arrival back home, and then to follow up with a Neurologist. He has been home nearly a week now and feels like himself. He has had the MRI, which came back normal (yay!), but we are waiting to see a Neurologist at hospital. The ONLY thing in patient life that had changed for him in the days, weeks, months preceding this super surprising event, was his Covid #2 Pfizer vaccine. That is why we, and our supportive doctor, are suspicious that this may have been the cause. We are a little nervous about whether or not more seizures will take place, or perhaps his body is done dealing with his probably strong reaction to the immunologic/inflammatory variable. Maybe altitude could have played in, along with the vaccine, and been the straws that broke the camel's back of other things maybe brewing? But we don't think so. patient has had NO health issues, other than an appendix out 3 years ago! Thanks for listening. We want this variable to you as a data point.
16 2021-06-18 unresponsive to stimuli Within seconds after injection, the patient began to slump over and was unresponsive for approximate... Read more
Within seconds after injection, the patient began to slump over and was unresponsive for approximately 5 seconds. His dad and I were asking if he was ok and then he became responsive and said he was fine but had no memory of what just happened. He was completely normal after that except for not remembering what had happened. His father said he was going to take him to the hospital to get him checked out just in case.
16 2021-06-20 weakness Diabetic ketoacidosis CO2<10 A1C 13.4 Weak/sluggish/lethargic,/urinating a lot
16 2021-06-21 cold sweat, seizure Following with reaction like seizure; And after that faint; chest , neck and head pain with burning ... Read more
Following with reaction like seizure; And after that faint; chest , neck and head pain with burning sensation; chest , neck and head pain with burning sensation; chest , neck and head pain with burning sensation; After few minutes started to change the face skin color, cold skin and memory loss; After few minutes started to change the face skin color, cold skin and memory loss; After few minutes started to change the face skin color, cold skin and memory loss; This is a spontaneous report received from a contactable consumer (patient). A 16-year-old male consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19May2021 at 15:45 at single dose in left arm for COVID-19 immunisation at the age of 16-year-old. Lot number was Er8735. Medical history included Environmental allergies. Concomitant medications included calcium carbonate, colecalciferol (VITAMIN D 2000). On 19May2021 at 04:45, the patient experienced chest, neck and head pain with a burning sensation. Following with reaction like seizure. Then, patient started to change the face skin color, cold skin, and memory loss. And after that he faint. The patient was not treated for the events. The patient recovered from the events. Prior to vaccination, the patient was not diagnosed with COVID-19; since the vaccination, the patient has not been tested for COVID-19.
16 2021-06-21 sciatica After the vaccine couple hours exp headache and was very tired couldn't get out of bed. I contacted ... Read more
After the vaccine couple hours exp headache and was very tired couldn't get out of bed. I contacted chiropractic that day was seen that evening. He was placed on a treatment plan for sciatic nerve.
16 2021-06-22 feeling hot, flushing PMH: deniesALL: deniesVS: 96%, HR 54, BP 98/64 (intiial)99%, 49, 110/75 (after 30 min and full recov... Read more
PMH: deniesALL: deniesVS: 96%, HR 54, BP 98/64 (intiial)99%, 49, 110/75 (after 30 min and full recovery) Symptoms: This is Dose#216yM developed immediate dizziness, warm rush and darkening vision after injection that lasted about 3-5 minutes and improved without intervention apart from supine position. No medication given. Father reports pt has history of presyncope with blood donation. Assessment: slightly flushed appearing, complete sentences, coherent, alert and oriented. chest is clear, good air entry bilaterally, no respiratory distress or facial/oropharynegeal edema noted. Heart rate mildly decreased on auscultation but otherwise regular with normal S1S2. No distress. Treatment: none Patient observed for 30 minutes with snack and drink given. Symptom resolution and driven home by father. Patient is a high school athlete with slim build. Father reports heart rate is usually low/normal
16 2021-06-22 unresponsive to stimuli MOM SAID PT PASSED OUT PT WAS SEATED AND RESPONSIVE WHEN I SAW HIM
16 2021-06-23 weakness Next day on Saturday; developed fatigue & extreme tiredness. Slept most of the day. Did eat two meal... Read more
Next day on Saturday; developed fatigue & extreme tiredness. Slept most of the day. Did eat two meals with a slight headache. Sunday headaches worsened with ear aches, fatigue & slept all day. Gave Patient Tylenol, pushed fluids to tolerance & used cold compress towels on his head for his headaches. Monday symptoms persisted & taken to his primary MD & was given medication (Tylenol) & was instructed to administer Ibuprofen if symptoms of headache continue. Prior to MD visit he fainted & vomited attempting to use the toilet. Unable to tolerate any light from the house with sensitivity to his vision. Encouraged to hydrate with GatorAid & fluids with meals to tolerance. Was instructed to take patient to Emergency if symptoms persist till Tuesday to obtain IV hydration. Tuesday late afternoon 4:30 pm, took patient to Emergency & was assessed for blood work which was normal & given IV hydration while there. Wednesday- symptoms subsiding with no further headaches & is now able to walk by himself with improving strength. He ate 3 meals today & hydrating most of the day. Sitting up more & trying to improve his strength & endurance. Less sensitive to light.
16 2021-06-23 cold sweat Pt stated that he was feeling lightheaded and dizzy while sitting in post-vac after receiving Pfizer... Read more
Pt stated that he was feeling lightheaded and dizzy while sitting in post-vac after receiving Pfizer (EW0196) vaccine. Pt became pale and clammy to touch and sat down on floor. Pt's mother stated "he gets like this when he gets shots." Pt denies any SOB, itching, pain, or other discomfort. Pt has no orofacial swelling or visible hives/rash. Pt was given juice to drink and stated that he felt better afterward. Pt's skin returned to normal and he sat up in a chair. Pt was released at 12:40 into care of mother. Pt stated he was no long symptomatic and felt "back to normal." Pt left clinic with mother, walking with steady gait, and in no apparent distress.
16 2021-06-24 facial paralysis, slurring, severe one side paralysis, numbness 6/3/21 at 1230 pm: Sudden onset of right arm numbness progressing to transient blurry vision, diffic... Read more
6/3/21 at 1230 pm: Sudden onset of right arm numbness progressing to transient blurry vision, difficulty walking, right lower extremity weakness, difficulty moving his mouth, stuttering, imbalance, and right sided facial droop. He was admitted to hospital on 6/4/21. Found to have a demyelinating process (see imaging report below). He received IVIG treatment and IV steroids with some (but incomplet)e improvement and was discharged to Rehab on 6/16/21 on oral steroids. However, he had recurrence and progression of symptoms and was sent back to hospital on 6/19/21 with worsening right sided hemiplegia. He underwent repeat high dose IV steroids and initiation of plasmapharesis. He has currently (as of 6/25/21) completed 3 of 5 runs of plasmapharesis with marked improvement in symptoms but still has significant right sided motor deficits. Neurologists here now feel comfortable making a diagnosis of multiple sclerosis. He will likely be discharging home for ongoing therapy and treatment after he completes plasmapharesis on 6/28/21.
16 2021-06-25 unresponsive to stimuli We were sitting in the after-shot waiting area for the mandatory 15 minute wait period. Patient was ... Read more
We were sitting in the after-shot waiting area for the mandatory 15 minute wait period. Patient was getting restless and started asking to leave ~13 minutes after shot. I said ?no, we need to wait the full 15 minutes they recommend?. About on minute later, or ~14 minutes after shot, Patient said he felt like he was going to pass out. As I turned my head to look at him to began to slump towards me unconscious and I held him up by his shoulder and waved the paramedics over. He was unconscious with eyes closed for about 5 seconds and by the time the paramedics got there his eyes were fluttering, but he remained unresponsive for another ~10-15 seconds as they were calling his name, tapping his shoulder, and asking him questions. Then he finally came around and, while groggy, he was able to answer questions. He sat there a couple minutes talking to paramedics and they had wheelchair, but he said he could walk and got up slowly to walk slowly back to clinic area.
16 2021-06-27 bell's palsy Left Bells palsy abrupt onset on 6/21. House Brackmann scale 5 (severe dysfunction absent forehead m... Read more
Left Bells palsy abrupt onset on 6/21. House Brackmann scale 5 (severe dysfunction absent forehead movement, incomplete eyelid closure, no movement of the mouth
16 2021-06-27 unresponsive to stimuli Collapsed, unresponsive, low heart rate and blood pressure, vaccine staff attended and then felt 911... Read more
Collapsed, unresponsive, low heart rate and blood pressure, vaccine staff attended and then felt 911 should be called, paramedics attended, did EKG
16 2021-06-29 cold sweat After administration of the vaccine, the patient got light headed and clammy. The patient never load... Read more
After administration of the vaccine, the patient got light headed and clammy. The patient never loaded consciousness. His heart rate is normally in the 80s according to his mom, who is a nurse practitioner. His heart rate dropped to 69. The mom did not want an ambulance called. Monitored the patient for 20 minutes. He was completely alert and held a conversation the entire time.
16 2021-06-29 cold sweat When asked, patient states he did not eat or drink anything today. He noticed a tiny spot of blood a... Read more
When asked, patient states he did not eat or drink anything today. He noticed a tiny spot of blood at injection site, while his band-aid was being applied, he asked "Is this bad?". Shortly after after her complained of not feeling well. He complained of having blurry vision and the chills while his skin was warm and moist. Patient was laid down on the chaise lounge, and instructed to do isometrics with legs. Ice bags applied to back of neck and forehead. Vitals at 1152 were B/P - 108/58, SPO2: 99%, pulse: 66 bpm. Vitals at 1157 were B/P - 102/60, SPO2: 98%, pulse: 82 bpm. Patient was given water to drink and encouraged to drink lots of fluids today. Color was pink, skin was warm and dry when stood up to leave with mom and brother. Encouraged to eat and drink before second vaccination three weeks from now.
16 2021-06-29 seizure Breakthrough seizure; This is a spontaneous report from a contactable consumer. This consumer report... Read more
Breakthrough seizure; This is a spontaneous report from a contactable consumer. This consumer reported for a 16-year-old male patient (reporter's son) who received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number was EW0183 and expiration date was not reported), dose 1 via intramuscular route, administered in arm right on 08May2021 at 09:00 as dose 1, single and dose 2 via intramuscular route, administered in arm right on 29May2021 at 09:00 (lot number was EW0191 and expiration date was not reported) as dose 2, single for COVID-19 immunisation. Medical history included epilepsy. The additional information reported as: he had not a seizure in over an year until he got the vaccine. He was on medication and he has just got his level checked, a month before and they were fine, they were in range. The patient did not receive any other vaccination within 4 weeks prior to the first administration of the suspect vaccine. Concomitant medications included levetiracetam (KEPPRA) taken for an unspecified indication, start and stop date were not reported. On an unspecified date in May2021, the patient experienced breakthrough seizure. The clinical course of the event was reported as: The reporter was calling just to let know that, a week after each of the vaccine shot the reporter's son got, a week after each of those shots he had a bad seizure, a breakthrough seizure which was he was on his medication. His end level range and had seizure that whether it was the side effect from Pfizer or not the reporter just wanted to make aware it happened both times the first time was coincidence but happened twice, just wanted to make aware. 09 days after the first shot he got a seizure and then after his second shot, 12 days later he had a seizure. The reporter inquired if someone aware of it, in case someone else had the same thing. The outcome of the event was unknown. Information on lot/batch number was available. Additional information has been requested.
16 2021-06-30 pain in extremity Mild-moderate left arm pain; This is a spontaneous report from a contactable consumer, the parent. A... Read more
Mild-moderate left arm pain; This is a spontaneous report from a contactable consumer, the parent. A 16-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 01Mar2021 at 15:15 (at the age of 16-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not have any allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 23Mar2021 at 22:00, the patient experienced mild to moderate left arm pain. The patient did not receive any treatment for the event. The clinical outcome of event left arm pain was resolving at the time of this report. Information about lot/batch number has been requested.
16 2021-07-01 weakness Chest pain and weakness on evening of 7/1/21 after working for 8 hours and while taking a bath. Ches... Read more
Chest pain and weakness on evening of 7/1/21 after working for 8 hours and while taking a bath. Chest pain worsened and went to ER.
16 2021-07-01 tremor Took to ER at 5am because he was dry heaving, and vomiting. They did an EKG and a CT scan of the ab... Read more
Took to ER at 5am because he was dry heaving, and vomiting. They did an EKG and a CT scan of the abdomen and lab work. He was placed on hydratation, 6 bags of fluids as well as Zofran for the vomiting also he also had tachycardia. He also experienced chills to the point he was shakiness when he go the tachycardia. He also has fever of 108.F and he was given Tylenol for relief of pain. He was then transferred to Hospital at 4pm and stayed there till 11pm. He also received an EKG exam at the Hospital. They also did a Covid test which was negative. As far os today my son has recovered.
16 2021-07-02 flushing Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium
16 2021-07-04 slurring, facial paralysis, tingling, paralysis, bell's palsy Subsequently after having the vaccines on the 7/2, developed symptoms of left sided facial droop, he... Read more
Subsequently after having the vaccines on the 7/2, developed symptoms of left sided facial droop, hemiparalysis, decreased sensation to his left face, slurred speech and difficulty chewing. Symptoms and physical exam most suggestive of Bell's (facial nerve) palsy.
16 2021-07-05 seizure, feeling hot Patient received his 2nd dose of the Pfizer vaccine and fainted approximately minute after the dose... Read more
Patient received his 2nd dose of the Pfizer vaccine and fainted approximately minute after the dose was given. The patient's eyes rolled back as he fell to the floor where it appears that he had a mini seizure. We called for a code white and immediately began emergency procedures. I held the patient while he was sitting upright and kept speaking to him until he regain consciousness approximately 1 minute after he had syncope. The patient seemed very confused because he had asked the question "where am I," as he opened his eyes. He slowly became more alert as time passed by and was aware of his surroundings within the next 2 minutes. He then stated that he was hot and hungry and was given water (from me) and Gatorade from his mother at his request. It was not long after that that the patient fully recovered and was back to normal. I had them stay and observed him for at least 40 minutes just to make sure that he was ok. Statements were taken from a salaried member of management during this time. There was no medication needed and none given during this incident. Plans were made with patient's mother for a follow up and our contact information was given incase they needed to contact us for anything at all. I will reach out to them in the next 1-2 days to see how the patient is progressing.
16 2021-07-05 unresponsive to stimuli, flushing Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flus... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Additional Details: pt became very white, started to look like he was going to faint, got wet towels and applied to face, neck, arms. kept him conscious be talking to him, called ems but by the time they arrived, he had color and was ok
16 2021-07-06 pain in extremity Aches and pains in bilateral lower extremities. Small nodule next to left knee.
16 2021-07-06 unresponsive to stimuli, unresponsive to stimuli Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild
16 2021-07-08 pain in extremity Patient received vaccine on July 5 and had just a sore arm for 30 hours then began having headache o... Read more
Patient received vaccine on July 5 and had just a sore arm for 30 hours then began having headache on evening of July 6. July 7 headache worse and nausea. July 8 headache so severe could not walk without pain shooting down back and pain with neck motion. Vomited 4 times and had to wear sun glasses even inside due to eye sensitivity. Patient had no fever no sore throat or cough. When he presented to the ED his neurological exam was normal but had mild nuchal rigidity/photophobia/and moderate severe headache. As we worked him up the consideration was vaccine reaction versus viral meningitis. We gave him Toradol and Compazine as we awaited his test results and he felt significantly better. I was going to do a lumbar puncture if he was not improved. He ate and drank gatorade with no nausea and was discharged with orders to return if symptoms worsened. He was instructed to see his doctor if not well in 3-4 days.
16 2021-07-08 seizure Late in the evening on July 7 patient began having multiple seizures. EMTs were called and patient ... Read more
Late in the evening on July 7 patient began having multiple seizures. EMTs were called and patient was transferred to local hospital while seizing. Patient stabilized in ER with injections. But since patient was unconscious (postIcatal) he was transferred to ICU until stabilized on oral medication. Patient in hospital for 36 hours.
16 2021-07-08 tremor, unresponsive to stimuli Site: Pain at Injection Site-Mild, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-M... Read more
Site: Pain at Injection Site-Mild, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Mild
16 2021-07-09 flushing Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Me... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Medium, Additional Details: Patients BP was 120/87 after the 15 minute period. Symptoms resolved after giving the patient water.
16 2021-07-10 discomfort Pt stated he felt like his throat was closing up(severity scale 3/10 per patient). Mother happened t... Read more
Pt stated he felt like his throat was closing up(severity scale 3/10 per patient). Mother happened to have Benadryl so patient was given Benadryl 50mg. Pharmacist and mother observed the patient for about 45 minutes in the pharmacy. Pt felt better and left the pharmacy without incidence. followed up with the patient on 7-11-2010 again and spoke to the mother. Pt recovered from discomfort caused by throat closing but states his arm was sore.
16 2021-07-11 seizure Patient experienced vasovagal syncope 2 to 3 minutes post vaccine. He passed out for about 20 second... Read more
Patient experienced vasovagal syncope 2 to 3 minutes post vaccine. He passed out for about 20 seconds and his dad states he was convulsing. He was assisted to the clinic where he was provided 2 glucose tablets and had his vitals checked. Vitals were within normal limits. Throughout the next 30 minutes, patient continued to display cognitive awareness and finished about 12 oz of water. He was able to stand up on his own without feeling light headed. About 40 minutes post vaccine, he left to eat dinner. The family intends to see a physician prior to his second dose.
16 2021-07-16 numbness, bell's palsy, tingling 11 hours after 2nd dose of Pfizer COVID 19 mRNA vaccine patient developed tingling and numbness to R... Read more
11 hours after 2nd dose of Pfizer COVID 19 mRNA vaccine patient developed tingling and numbness to R side of face. Persisted another three days which prompted mother to page pediatrician. Recommended to be seen in ED
16 2021-07-16 pain in extremity Swelling on injection site 1 day after vaccine. Major pain when moving arm, almost unable to move in... Read more
Swelling on injection site 1 day after vaccine. Major pain when moving arm, almost unable to move in some directions due to pain.
16 2021-07-17 burning sensation Chin burning/ face on fire; This is a spontaneous report from a contactable consumer. A 16-years-old... Read more
Chin burning/ face on fire; This is a spontaneous report from a contactable consumer. A 16-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch Number/Lot: EW0162; Expiration Date: 31Jul2021), dose 1 via an unspecified route of administration, administered in Arm Left on 12May2021 as single dose for COVID-19 immunisation. Medical history included ongoing asthma. The patients concomitant medications were not reported. The patient not received any other vaccinations within four weeks prior to the COVID-19 vaccine. The patient experienced chin burning/ face on fire on 12May2021. She has 3 teenagers. One is 16, and he got the vaccine approximately 2 weeks ago. The other 2 teens got the vaccine last Tuesday. The 16 year old and 13 year old both had substantial side effects. She does not seem to be hearing about them. They both received their vaccines at the same medical facility. She is concerned about whether they should get the second dose based on their reaction. She asks what Pfizer recommends. Reporter stated that her son has severe allergies and they knew that when he went in there. They were watching him. Upon getting it, 15 minutes later his chin was burning. It was not significant and did not get any worse. Then for the next 4 days his face was on fire to the point where he could not even use soap or moisturize because it was really painful. She did not make the connection until her daughter had the same symptoms the night of her vaccine. The burning in his chin went away. She is not sure when it went away. It did not last that long and face on fire His face started the night he got the vaccine. It lasted for about 4 days. It has totally gone away. The patient did not visited Emergency Room and Physician Office. The outcome of the event was recovered.
16 2021-07-17 concussion, migraine Start Date/Time: [Pfizer] 02May2021 01:00 PM/ Start Date/Time: [Pfizer] 18Apr2021 01:45 PM; Fever; V... Read more
Start Date/Time: [Pfizer] 02May2021 01:00 PM/ Start Date/Time: [Pfizer] 18Apr2021 01:45 PM; Fever; Vomiting; Mild confusion; Extreme exhaustion; Body aches; Second dose brought back all concussion symptoms; Migraine; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 16-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via intramuscular, administered in right arm on 02May2021 13:00 (Age at Time of Vaccination: 16 years) (Batch/Lot number was not reported) as dose 2, single, the patient previously took first dose of bnt162b2 via intramuscular, administered in right arm on 11Apr2021 01:00 pm for covid-19 immunization. The patient medical history included attention deficit hyperactivity disorder (ADHD) and hypersensitivity. The patient concomitant medications included methylphenidate taken for attention deficit hyperactivity disorder, cetirizine hydrochloride (ZYRTEC) taken for hypersensitivity from Jan2021 and ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient received first dose on 18apr2021 and second dose on 02may2021 which led to (inappropriate schedule of product administration). The patient said Second dose brought back all concussion symptoms. Migraine, mild confusion, extreme exhaustion on 02May2021, 8:30 PM, vomiting at 9:30 PM. Body aches and fever on 03May2021, 8:00 PM and lasted for 7 days. The event migraine was reported as serious (disability). The patient received treatment for fever with Motrin. The outcome of the event inappropriate schedule of product administration was unknown and other events were resolved on an unspecified date on 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
16 2021-07-17 feeling hot, numbness Swelling in his tonsils; feels a little hot; last night he felt weird and then used the bathroom and... Read more
Swelling in his tonsils; feels a little hot; last night he felt weird and then used the bathroom and felt better; sleeping now and that is a warning flag for him sleeping a lot/he came home tired and fell asleep; he came home tired and fell asleep.; numbness in his arm; This is a spontaneous report from a contactable consumer (nurse, a CNA). A 16-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0196), via an unspecified route of administration on Left Arm(shoulder) on 14Jun2021 16:00 (age at vaccination: 16 years) as DOSE 1, SINGLE for just to get it to make sure he is fully protected. Vaccination Facility Type was reported as Pharmacy/Drug Store. The patient medical history included he had SVT and artery flutter that was diagnosed late in his 14 turning to 15. States they are fully resolved. Relays that he had 3 heart surgeries, each one you have to wait 6 months to get done. States the 1st one they couldn't find anything, the 2nd one they cauterized nerve endings, and the 3rd one they found another heart condition and did the same thing, they cauterized the nerve endings inside his heart. Additional Vaccines Administered on Same Date of the Pfizer Suspect was reported as none. Prior Vaccinations (within 4 weeks)or any other vaccinations within four weeks prior to the first administration date of the suspect vaccine was reported as none. Adverse events following prior vaccinations was reported as none. The patient Concomitant medications included ibuprofen(IBUPROFEN ABECE)taken for numbness from Jun2021. On 01Jul2021, the patient experienced Swollen tonsils at his appointment about 1:30pm, feels a little hot, last night he felt weird and then used the bathroom and felt better. On an unspecified date in Jul2021, the patient experienced sleeping now and that is a warning flag for him sleeping a lot, told to hold off and wait on getting the 2nd dose, he wants to have him evaluated 1st to see if it is an infection or an allergic reaction and he came home tired and fell asleep. On 15Jun2021, the patient experienced numbness in his arm. The other symptoms (except swollen tonsils) started around 8 PM-9 PM after their walk 1Jul2021.It was reported that he had heart complications(heart issues) 2 years ago which are resolved now. He received the first dose of the Pfizer-BioNtech Covid-19 vaccine on 14Jun2021 and he's scheduled for his second dose on 05Jul2021. Yesterday he went to his orthodontist and was diagnosed with swelling in his tonsils (first she said one of them and his tongue, then she explained that the swelling was in his tonsils). She would like to know if there are reports of any swollen glands and if she should be concerned about it. The reporter(who is patient's mom) stated that she just talked to the patients pediatrician and was told to hold off and wait on getting the 2nd dose, he wants to have him evaluated 1st to see if it is an infection or an allergic reaction. She states the lymph nodes are tonsils and they need to make sure it is not an allergic reaction and also not his heart and was told if it gets worse to take him to the Emergency Room and it's kind of off, like she saw them and they are really huge and it's just weird. She states he weighs about 205-210 pounds and is maybe 5 foot 7 inches tall. He just saw the orthodontist and received a letter to see his doctor and something clicked in her head that they are glands and basically anything like that vaccine have that type of reaction and he feels a little hot that started 01Jul2021 and last night he felt weird and then used the bathroom and felt better. Caller relays that he is sleeping now and that is a warning flag for him sleeping a lot. States that started recently and she tried to take him for exercising yesterday on nature walk and he came home tired and fell asleep. States he stayed up 1-2 hours and fell asleep. Caller states another orthodontist and pediatrician never have said anything about his tonsils before. Caller states she has to watch him, he will say he doesn't feel anything but that was the heart condition and he would go into shock and fall on the floor and she has to monitor him and he didn't know he was having episodes and they would reset his heart with paddles. Caller states she will probably take him to the ER and have tests run. The Relevant Tests was reported as None. Therapeutic measures were taken as a result of Swelling in his tonsils, numbness in his arm. The outcome of the event numbness in his arm, feels a little hot in his arm was unknown. The event "last night he felt weird and then used the bathroom and felt better" was recovered on Jul2021, while other events was not recovered. Relevant Med History (heart surgeries) notes: each one you have to wait 6 months to get done.1st one they couldn't find anything, the 2nd one they cauterized nerve endings, and the 3rd one they found another heart condition
16 2021-07-17 numbness Loss of feeling in left leg and foot; Foot drags when walking.; Nausea; shortness of breath; This is... Read more
Loss of feeling in left leg and foot; Foot drags when walking.; Nausea; shortness of breath; This is a spontaneous report from a contactable consumer, the patient. A 16-years-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection: Batch/Lot number: unknown), via an unspecified route of administration, administered in Arm Right on 18Jun2021 09:15 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient's medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 27Jun2021 13:00 Hour, the patient experienced loss of feeling in left leg and foot. Foot dragged when walking. Leg shook when still. Nausea and shortness of breath. The adverse event result in doctor or other healthcare professional office/clinic visit. The patient received treatment for the events. The outcome of the events was not recovered. Additional information has been requested and will be provided as it becomes available. ; Sender's Comments: Based on current information available, the events mostly represented intercurrent condition in this patient with young age, unrelated to Bnt162b2. Relevant medical history, concurrent disease, trauma history are missing for a medically meaningful assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate
16 2021-07-18 burning sensation, numbness, tingling patient initially had myalgias and then 5 days after second vaccination patient had acute onset of b... Read more
patient initially had myalgias and then 5 days after second vaccination patient had acute onset of burning, numbness and tingling of his feed and legs.
16 2021-07-19 cold sweat, tingling Immediately following 1st dose Pfizer COVID vaccine client turned pale and had a syncopal episode. C... Read more
Immediately following 1st dose Pfizer COVID vaccine client turned pale and had a syncopal episode. Client was assisted to a supine position on the floor. Client regained consciousness within 20 seconds of syncopal episode. Client skins were pale for ethnicity, clammy and cool. Vital signs were taken in supine position: BP 121/71, HR: 69, RR 12. Client's mother denied any medication use, stated client was positive for Asperger's syndrome, denied any NKDA or allergies to foods/ environment. Client was assisted to seated position in wheelchair vitals: BP 105/46, HR 60, RR 10, skins returning to normal color for ethnicity, dry and warm. Client was assisted to zero gravity chair without incidence. Client complained of nausea, dizziness and tingling of Left arm and hand. Denied SOB, CP or HA. EMS called. Client care transferred to EMS. EMS BP: 98/50, 12 lead EKG revealed NSR. Client's mother signed client AMA from EMS care. Client stayed at observation site an additional 30 minutes. Last set of vitals BP 117/69, HR 76 RR: 10. Client stated he felt much better and all symptoms were resolved. Client's mother instructed on ED protocols and advised to follow up with PCP. Client left observation site with his mother on his own accord and with a steady gait.
16 2021-07-20 pain in extremity slightly sore arm; This is a spontaneous report from a non-contactable consumer, the patient. A 16-y... Read more
slightly sore arm; This is a spontaneous report from a non-contactable consumer, the patient. A 16-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 23Mar2021 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not receive any medications within two weeks of COVID-19 vaccination. 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. On 23Mar2021, the patient experienced slightly sore arm. No therapeutic measures were taken as a result of the event. The adverse event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the event slightly sore arm was recovered on unknown date in 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
16 2021-07-21 tingling Itching on torso and back; Pins and needles on torso and back; This is a spontaneous report from a c... Read more
Itching on torso and back; Pins and needles on torso and back; This is a spontaneous report from a contactable consumer, the patient. A 16-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Apr2021 at 11:30 (at the age of 16-years-old), as a single dose for COVID-19 immunisation. Medical history included asthma and penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications were not reported. On 03Apr2021 at 01:00, the patient experienced itching on torso and back and pins and needles on torso and back. 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 itching on torso and back and pins and needles on torso and back was not recovered at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
16 2021-07-23 tremor, seizure Patient was given covid vaccine at approximately 8:15pm. About 5 minutes later, patient was sitting ... Read more
Patient was given covid vaccine at approximately 8:15pm. About 5 minutes later, patient was sitting outside with mother when the mother started calling the patients name saying that he just had a seizure or it looked like he was convulsing. I ran out to check on the patient whom at the time was back to alertness and conscious. He was slowly breathing but fully alert and slightly leaning on the chair next to him while holding onto his mom. Technician was told to call 911 at that time as well . About 2-3 minutes later as I turned to grab the phone the patient started to shake again for about 5 to 10 seconds and went back to full alertness. At this point I was checking the patient breathing & pulse while following the instructions of the operator on the phone. After which the paramedics arrived and took over to work up the patient.
16 2021-07-24 pain in extremity, feeling cold After getting the 2nd dose of the Pfizer vaccine at 1:45pm in his left arm, around 9pm, started to... Read more
After getting the 2nd dose of the Pfizer vaccine at 1:45pm in his left arm, around 9pm, started to get a headache. He went to sleep but felt cold at night and then started to get a cough. In the morning on Thursday July 22 his chest started to hurt in the upper area. He was feeling body aches. At 12:55pm he had a fever of 101.4 I gave him 2 Tylenol tablets. At 2:22 pm fever went down to 100.4 At 4:48pm his temperature was at 98.9. At 4:30pm he was complaining that his chest hurts, achy legs, headache. I call 911 and they tell me that he will need an ambulance to go to the hospital.
16 2021-07-26 weakness, flushing, numbness 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: Visual Changes/Disturbances-Medium, Systemic: Weakness-Medium
16 2021-07-28 pain in extremity Reaction to second vaccine (7/10/2021) -Vomiting -Fever for 24 hours -Pain; on vaccine site, entire... Read more
Reaction to second vaccine (7/10/2021) -Vomiting -Fever for 24 hours -Pain; on vaccine site, entire right arm and right side of back Took 4 doses of Tylenol (every 6 hours)
17 2021-01-12 weakness, flushing Patient described rapid onset sweating and flushing. Said he felt light headed as well. Gave Benadry... Read more
Patient described rapid onset sweating and flushing. Said he felt light headed as well. Gave Benadryl 25 mg with continued observation for 30 minutes and he said he felt mostly better, but still tired and weak. Followed up next day and his mother said he was doing better.
17 2021-02-24 tremor Patient was normal and little nervous before vaccination. After receiving vaccinations about 2 minut... Read more
Patient was normal and little nervous before vaccination. After receiving vaccinations about 2 minutes patient stated he could get up and was shaking. He was pale and sweating. Pharmacist Rima left the room to get another pharmacist. Patient mom reported she saw him passing out and eyes rolling. Patient was conscious after and had difficulty breathing but return to normal after a few minutes. We gave him a ice pack and called 911 to be ready on hand but was not dispatched. Patient rested in the room and left on their own.
17 2021-03-02 weakness Patient felt dizziness, weakness, and a fast heartbeat immediately after receiving injection. Patie... Read more
Patient felt dizziness, weakness, and a fast heartbeat immediately after receiving injection. Patient was observed by EMS onsite and then went to ED for visit. Patient discharged from ED with no issues.
17 2021-03-08 cold sweat 5 minutes post vaccination, patient became pale, cool, clammy, lethargic, lips blue with brief loss ... Read more
5 minutes post vaccination, patient became pale, cool, clammy, lethargic, lips blue with brief loss of consciousness (15 seconds). When regained consciousness pt. reports continued dizziness & ligh-headedness. Assisted to floor, legs elevated. V/S 110/70, 71-HR, 96%-O2, A&Ox4. EMS activated. Upon EMS arrival EKG, orthostatic VS, and FSBS taken, all reported to be WNL, with BS being low normal @ 66. EMS administered PO glucose tube, FSBS rechecked by EMS, 78. Patient reports to no longer feeling dizzy or lightheaded, declined to go to hospital, left site with mother.
17 2021-03-16 seizure After administering the covid 19 vaccine to patient, patient was observed for 15 minutes for any adv... Read more
After administering the covid 19 vaccine to patient, patient was observed for 15 minutes for any adverse reaction, then patient was taken back to his room and about 30 minutes after receiving the vaccine patient experienced seizure attack, felt and hit the wall. Seizure attack lasted for less than 1 minute as per staff who was monitoring him, 911 was called. Upon my arrival patient was back to normal and sitting on the chair. 911 arrived and took over. patient was transported to nearest ER.
17 2021-03-22 hot flush 1st Dose: only mild pain and swelling at injection site for a few days. 2nd night had heat flash and... Read more
1st Dose: only mild pain and swelling at injection site for a few days. 2nd night had heat flash and chills temporarily with constant brain fog for a week coming and going. 2nd Dose: after 4 hours, extreme fatigue throughout body, brain fog, confusion, and lethargic. Extreme brain fog 11 hours after vaccination. The next day strong fever and stronger symptoms from the day before. The 3rd day felt back to normal. 4th day had a mild brain fog moment.
17 2021-03-30 seizure seizure; This is a spontaneous report from a contactable consumer. A 17-year-old male patient receiv... Read more
seizure; This is a spontaneous report from a contactable consumer. A 17-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection Batch/Lot Number: EP6955; Expiration Date: 30Jun2021), via an unspecified route of administration on 17Mar2021 as single dose for covid-19 immunisation. Zonisamide, via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 800 mg, (600 mg at night and 200 mg on the morning) for an unspecified indication; cannabidiol (CBD OIL), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 7 mL, daily (4ml at night and 3 ml on the morning) for an unspecified indication. The patient medical history included ongoing seizure PMH of temporal epilepsy who has been having break through seizures since July 2020. The patient's concomitant medications were not reported It was reported that patient had received vaccine on Wednesday 17 2021 with no complaints after it until today Friday 19, 2021 at around 7 pm when he developed a seizure while working at his desk. We (the parents saw the end of it which looked more generalized than usual) and gave him 2 mg of Clonazepam, which is his usual rescue medication. He was awake after it and was able to do homework. The action taken in response to the events for Zonisamide and Cannabidiol was unknown. The outcome of the event was unknown.
17 2021-03-31 cold sweat Patient became Pale, Diaphoretic, clammy, Experienced N/V, and Dizziness. Patient vomited x1 , given... Read more
Patient became Pale, Diaphoretic, clammy, Experienced N/V, and Dizziness. Patient vomited x1 , given cold compress and escorted to cot. Vital signs obtained P: 67 , R: 18, B/P: 90/60, O2 sat 98% on R/A. Patient monitored for 30 minutes and symptoms improved , no medication required. Vitals P: 79, R: 18 , B/P: 102/70, O2 sat 98% on R/A. Patient color pink, lungs sound clear, no further distress noted, patient stated he felt better. Father advise to have second vaccine give with PCP. Discharged home.
17 2021-03-31 tingling, feeling hot 2 minutes after vaccination patient felt "warm, dizzy, lightheaded, nausea "and c/o tingling in hand... Read more
2 minutes after vaccination patient felt "warm, dizzy, lightheaded, nausea "and c/o tingling in hands and feet. Provided cooling measures and food and drink. Resolved within 15 minutes.
17 2021-04-02 seizure At 9:15 am on 3/31/21, patient experienced a seizure characterized by unconsciousness and full-body ... Read more
At 9:15 am on 3/31/21, patient experienced a seizure characterized by unconsciousness and full-body rigidity. He had never previously experienced a seizure. The episode lasted for approximately 5-8 minutes; the patient gradually regained consciousness, but was confused and complained of a headache, eye pain, and nausea for some time afterward. He does not remember the event or what preceded it. He visited the ER that morning. He received an injection of lorazepam and ondansetron. He was held for observation for about 4 hours. He was prescribed a 3 day supply of lorazepam 0.5 mg (taken every 12 hours) upon discharge.
17 2021-04-04 migraine April 2- woke up with extreme fatigue, achy, headache, had trouble sleeping. In afternoon had 100 fe... Read more
April 2- woke up with extreme fatigue, achy, headache, had trouble sleeping. In afternoon had 100 fever. April 3 - woke up with migraine type headache; fatigue; lack of energy; had trouble sleeping; had weird dreams. April 4 - work up with same headache; had trouble sleeping; had a neck ache and sore throat. Overnight, 230 am April 5, had severe stomach pain, breathlessness, pain in left elbow. Had headache after waking up, missed school, still feeling drained.
17 2021-04-05 unresponsive to stimuli, tremor, seizure Within 1-2 minutes my son passed out and started violently shaking/convulsing. His chin was pinned t... Read more
Within 1-2 minutes my son passed out and started violently shaking/convulsing. His chin was pinned to his chest, he struggled to breath and was making a sound as if he was loudly snoring but seemed to be struggling to breathe. I was unable to wake him. I'm not sure how long it lasted but maybe 2 minutes or so. He woke up and asked what was going on as we had all been standing over him trying to unsuccessfully wake him. He shared that he thought he'd been asleep and had been dreaming. He also shared that his throat hurt very much. He had the shakes for about 30 minutes after and was extremely exhausted. He slept for 14 hours as soon as we arrived home.
17 2021-04-07 weakness 4/8/2021 Patient was observed post Covid-19 immunization for 15 minutes . During the observation ... Read more
4/8/2021 Patient was observed post Covid-19 immunization for 15 minutes . During the observation period, he experienced an adverse reaction with the following symptoms: Feeling light headed and weak. Assessment : Time of assessment 0947, patient sloughing in chair feeling faint. Able to answer questions. Actions taken: Taken to stretcher, Vitals sign taken VAERS form obtained and completed by RN. 0947- 142/78, P- 88, RR- 16. O2- 100% 0957- BP127/66. P- 84, - 0952- CBG- 84 Water given. Medications administered: No medication administered. Disposition: Reports no further symptoms of adverse reaction after observation for 45 minutes. Discharged home. The Patient was provided with Vaccine Information Sheet and instruction to access the system. Mom with patient. Immunizations Administered Name Date Dose VIS Date Route Pfizer COVID-19 Vaccine 4/8/2021 9:42 AM 0.3 mL 12/11/2020 Intramuscular Manufacturer: Pfizer, Inc Lot: ER8729
17 2021-04-07 tremor After receiving vaccine client stated he was experinecing dizziness, having tremors. He was lowered ... Read more
After receiving vaccine client stated he was experinecing dizziness, having tremors. He was lowered to the ground by staff and mother, both legs elevated on chair. Mother stated " he has a way with needles and gets like this sometimes". MD on site and paramedics responded accordingly. Vitals taken by paramedics and assessment done by MD.Client is now verbally responsive , sitting in chair, hydration fluid given PO. Mother stated client has a hx of black out spells along with auto immune disease. Escorted to observation area in wheelchair with parents and MD. Last Vitals Bp 106/68 HR 73 O2 98% blood glucose 104
17 2021-04-07 unresponsive to stimuli, flushing Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Feve... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Fever-Mild, Systemic: Flushed / Sweating-Medium
17 2021-04-07 unresponsive to stimuli Systemic: Fainting / Unresponsive-Mild, Systemic: light headed, fainted after 5-10mins received vacc... Read more
Systemic: Fainting / Unresponsive-Mild, Systemic: light headed, fainted after 5-10mins received vaccine-Mild, Additional Details: After received vaccine 5-10mins, he started feeling light headed, fainted. RN notified him to floor leftside, cold water to back of neck and forehead. BP: 91/66 -90/70, HR 91-85 when left side lying, BP 123/87, Hr 100 when sitting on floor. BP 122/85- 117/83, HR 99-95 when sitting in chair. He went home acoompanied by his mother when feeling better. He has fainted in past with shots and blood draws
17 2021-04-07 unresponsive to stimuli Systemic: Fainting / Unresponsive-Mild
17 2021-04-07 unresponsive to stimuli Site: Redness at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting /... Read more
Site: Redness at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: FAINTED AND SCAR ON FACE-Mild, Additional Details: PATIENT SEATED AT SEAT 5 FELL AFTER FAINTING AND INJURED ON HIS FACE WITH BRUICE ON RIGHT SIDE AFTER HITTING GROUND WITH HIS GLASSES. PATIENT GOT CONSCIOUSNESS IMMEDIATELY AFTER. OFFERED MEDICAL HELP AND ATTENTION. GAVE WATER TO DRINK. HE WAS MONITORED FOR 30 MINUTES AND LEFT PHARMACY HIMSELF.
17 2021-04-08 feeling hot, flushing Shortly after receiving his Pfizer vaccine, patient began to feel lightheaded. He was accompanied b... Read more
Shortly after receiving his Pfizer vaccine, patient began to feel lightheaded. He was accompanied by his mother at the clinic and had come prior to going to the family business. Assisted in fanning patient and applying wet wipes to forehead and neck to cool down and he complained of being hot. His face began to become flushed. VS initially at 2:40 pm, BP=122/70-56 HR and regular-14-96% spot ox. Recovered after ingestion of fruit snacks and 1 bottle of H2). Stayed in observation for 30 minutes total and then left with mother. Contact information given to patient to reach if any further problems.
17 2021-04-08 feeling hot The patient started to feel nauseated and warm after his vaccination. His mother also reported that... Read more
The patient started to feel nauseated and warm after his vaccination. His mother also reported that he looked sweaty. They report that he has had the same reaction in the past with any sort of needle sticks (typically with blood draws). His symptoms resolved over a period of 5 minutes. He had some water and sat down and started to feel better.
17 2021-04-08 tremor Pt was given Pfizer first dose at 930. Walked to monitoring area. Sat down and c/o of visual disturb... Read more
Pt was given Pfizer first dose at 930. Walked to monitoring area. Sat down and c/o of visual disturbances light/blurry, ears sounding like drums. Bilateral hands shaking and holding parent's hands. Sweat running down face. Color draining from lips/face and began c/o trouble breathing. 9:31 epi given in right thigh. Began feeling better and breathing regular. 9:34 Benadryl given. Moved to exam room for monitoring. VS and monitoring continued for 4 hours. Pt released with epi rx and f/u instructions.
17 2021-04-10 flushing L forearm and hand flushing
17 2021-04-11 cold sweat 15 MINUTES AFTER VACCINATION PNT FELT CLAMY/SWEATY AND NAUSEOUS. PNT FELT LIKE HE WAS GOING TO FAINT... Read more
15 MINUTES AFTER VACCINATION PNT FELT CLAMY/SWEATY AND NAUSEOUS. PNT FELT LIKE HE WAS GOING TO FAINT TO HE LAID DOWN ON FLOOR. PATIENT DID NOT FAINT . BLOOD PRESSURE WAS MONITORED AND RANGED FROM 80/60 TO 90/60. 911 WAS CALLED TO CONTINUE MONITORING HIM
17 2021-04-11 muscle spasms Patient had an episode where he started stumbling, feeling diaphoretic, with diffuse muscle cramping... Read more
Patient had an episode where he started stumbling, feeling diaphoretic, with diffuse muscle cramping 100 m from finishing a 5K race. He reports a sore throat, headache, and some dyspnea. He reports no adverse reaction to the first COVID vaccine. The patient had great symptomatic improvement with hydration. Patient was recommended to follow up with PCP and cardiology.
17 2021-04-11 pain in extremity Pfizer covid 19 vaccine vial was mixed with 1.4 ml instead of 1.8 ml of diluent. Spoke to patient's ... Read more
Pfizer covid 19 vaccine vial was mixed with 1.4 ml instead of 1.8 ml of diluent. Spoke to patient's mother on 04/11/2021 and she reported that the patient had a sore arm. Provided counseling.
17 2021-04-12 flushing Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Itch (specify:... Read more
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Flushed / Sweating-Mild, Additional Details: epipen was not given by pharmacy, but given by paramedics after getting to the pharmacy
17 2021-04-13 weakness Systemic: Fainting / Unresponsive-Mild, Systemic: Headache-Mild, Systemic: Hypotension-Mild, Systemi... Read more
Systemic: Fainting / Unresponsive-Mild, Systemic: Headache-Mild, Systemic: Hypotension-Mild, Systemic: Weakness-Mild
17 2021-04-13 pain in extremity, migraine Severe, debilitating fatigue to the point of not being able to stay awake for more than a couple of ... Read more
Severe, debilitating fatigue to the point of not being able to stay awake for more than a couple of hours a day. This continues, although minimally improved, 1 month out from 2nd vaccine Migraine-type headache- daily, continues 1 month out Dizziness Thrombophlebitis Initial low-grade fever and arm soreness resolved within 2 days
17 2021-04-13 pain in extremity Blood clot in right calf. Noticed pain and knot in calf on Sunday 3/14/2021. It worsened over the ... Read more
Blood clot in right calf. Noticed pain and knot in calf on Sunday 3/14/2021. It worsened over the next few days. Went to Urgent care on 3/18 and they sent us straight to ER for Ultrasound. In hospital they found it was a clot identified as deep vein thrombosis, and started a treatment of blood thinner and pain medication.
17 2021-04-13 pain in extremity Throat had sensation of closing up and sore arm yesterday evening. Took Benadryl. Today muscle and b... Read more
Throat had sensation of closing up and sore arm yesterday evening. Took Benadryl. Today muscle and body aches, low grade 99.9 fever, dizziness.
17 2021-04-13 pain in extremity On 4/9 had sore left arm and fatigue, side effects lasted throughout the day and resolved. 4/13 woke... Read more
On 4/9 had sore left arm and fatigue, side effects lasted throughout the day and resolved. 4/13 woke up with bad nausea and headache (6/10 pain) stayed in bed and did not go to school, woke up 11 am and headache/nausea started to resolve throughout the day.
17 2021-04-14 feeling hot, tingling Patient was seen in the observation area together with his Mother who drove for him for his first do... Read more
Patient was seen in the observation area together with his Mother who drove for him for his first dose of Covid-19 vaccine.Patient stated that all of a sudden he felt heat all over his body, tingling sensation, felt nauseous then threw up. Applied cold compress on the back of the neck, lowered down the seat of the car and elevated his feet, encouraged to do pursed lip breathing, had him sip small amount of water. Extended their stay for to 30 minutes for further observation. Symptoms was resolve, left without any difficulties, Educated to call 911 if symptoms comeback and becomes worse. ER precaution initiated. Pt acknowledge understanding. Patient was seen in the observation area together with his Mother who drove for him for his first dose of Covid-19 vaccine.Patient stated that all of a sudden he felt heat all over his body, tingling sensation, felt nauseous then threw up. Applied cold compress on the back of the neck, lowered down the seat of the car and elevated his feet, encouraged to do pursed lip breathing, had him sip small amount of water. Extended their stay for to 30 minutes for further observation. Symptoms was resolve, left without any difficulties, Educated to call 911 if symptoms comeback and becomes worse. ER precaution initiated. Pt acknowledge understanding. Patient was seen in the observation area together with his Mother who drove for him for his first dose of Covid-19 vaccine.Patient stated that all of a sudden he felt heat all over his body, tingling sensation, felt nauseous then threw up. Applied cold compress on the back of the neck, lowered down the seat of the car and elevated his feet, encouraged to do pursed lip breathing, had him sip small amount of water. Extended their stay for to 30 minutes for further observation. Symptoms was resolve, left without any difficulties, Educated to call 911 if symptoms comeback and becomes worse. ER precaution initiated. Pt acknowledge understanding. Patient was seen in the observation area together with his Mother who drove for him for his first dose of Covid-19 vaccine.Patient stated that all of a sudden he felt heat all over his body, tingling sensation, felt nauseous then threw up. Applied cold compress on the back of the neck, lowered down the seat of the car and elevated his feet, encouraged to do pursed lip breathing, had him sip small amount of water. Extended their stay for to 30 minutes for further observation. Symptoms was resolve, left without any difficulties, Educated to call 911 if symptoms comeback and becomes worse. ER precaution initiated. Pt acknowledge understanding.n/a
17 2021-04-14 seizure After receiving first Pfizer vaccine, patient had a vasovagal episode. Patient states he became diz... Read more
After receiving first Pfizer vaccine, patient had a vasovagal episode. Patient states he became dizzy, lightheaded, and became diaphoretic prior to syncope. There were some mild seizure-type activity after the syncope. Patient was transferred to the ED In the ED, patient experienced no further episodes of seizure activities. Patient was evaluated, observed, and later discharged with PCP and neurology referral.
17 2021-04-15 weakness Systemic: Dizziness / Lightheadness-Mild, Systemic: Visual Changes/Disturbances-Mild, Systemic: Weak... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Visual Changes/Disturbances-Mild, Systemic: Weakness-Mild, Additional Details: After recieving vaccine within 10 minutes, patient complained of feeling light headed, dizzy, appeared pale. Assisted patient to lay down on the floor. Seen by EMS, Temp 98, Pulse 63, 90/70. Patient stated that he had taken medication for anxiety prior to vaccination. Per patients mother, he took \"Hydroxyzine 25 mg Tablet\". 2nd set of vital signs were taken, BP 100/60. Patient assisted back to chair and observed for an additional 10 mins. Refused transfer, patient went home with mother.
17 2021-04-15 weakness Patient c/o dizziness, temporary loss of hearing, weakness, nausea and sweating . Took vital signs B... Read more
Patient c/o dizziness, temporary loss of hearing, weakness, nausea and sweating . Took vital signs B/P was low 104/47. After 9 minutes B/P was up to 110/70 and patient's symptoms were resolved. He refused to be transported to ER to be evaluated and was taken home by his friend. Parents were notified of the event.
17 2021-04-15 flushing At 10:16 patient's mother brought him to our attention regarding how he was feeling. She states that... Read more
At 10:16 patient's mother brought him to our attention regarding how he was feeling. She states that patient was feeling hot and took off his sweatshirt and complained that he was starting to feel "dizzy" - then he started looking "grey" and not responding to any of her questions. States that he was progressively getting worse over time. Patient was flushed and hypotensive (80's/40's) initially followed by bp of 90/50 then before he left 102/60 at 10:45am. Initially his heart rate was 74 bpm and before he left it was 82 bpm. His temperature was around 97.5. Patient had not had anything to eat or drink prior to appointment. Patient was given a snack and water before leaving.
17 2021-04-15 numbness, tingling Approximately 5 minutes after vaccination was administered patient has numbness and tingling in both... Read more
Approximately 5 minutes after vaccination was administered patient has numbness and tingling in both hands in addition to nausea and dizziness. We gave him 50 mg of diphenhydramine with his mother's permission. By 10-15 minutes after the vaccination he was feeling much better and the numbness had gone away.
17 2021-04-15 tingling, numbness 2 minutes after receiving Covid vaccine- patient felt numbness in his left hand. About 1 min later ... Read more
2 minutes after receiving Covid vaccine- patient felt numbness in his left hand. About 1 min later he felt numbness in his right hand. About another minute later- his vision started to darken and he felt like he would faint (he was sitting down during this entire experience) and his face started to tingle. His vision went completely black but he did not lose consciousness. His eyes were very blood shot during this and he was very pale. He recovered from all symptoms after about 10 minutes. He felt very thirsty after this and throat felt dry.
17 2021-04-16 flushing Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Mi... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Mild, Additional Details: place in supine position on the floor with feet elevated. VS- @ 1839; BP 130/70, HR 40, RR 18, SPO2 95% RA; reassessment- VS- BP 122/78, HR 42, RR 18, SPO2 92% RA. Never loss consciousness but became very groogy. orange juice given, returned to baseline in < 15 minutes, sent home with mom as driver.
17 2021-04-16 numbness, weakness weak.numb, abdominal pain, dizzy, dry mouth, EMS evaluated, pt. refused transport.
17 2021-04-16 numbness, hot flush, tingling, tremor A few minutes after patient received dose this morning around 9:20am, he became pale, developed hot ... Read more
A few minutes after patient received dose this morning around 9:20am, he became pale, developed hot flashes, shaking, nausea, dizziness, and hands feeling numb/tingling. Provided the patient with a cold pack for the back of his neck and water to drink, and encouraged him to sit with his head lowered. The patient's father pointed out that he had not had anything to eat that morning, which could have contributed to his response. After a few minutes, most of the symptoms abated, and patient was feeling much better. His father left the store with him at that time. Called the father later that day, and he said patient was feeling better. Had taken nap and was only feeling a little tired. I explained possible side effects from vaccine and father thanked me for our time and concern.
17 2021-04-16 seizure like phenomena Pt sustained seizure like activity for approximately 20 seconds. Pt became postictal without interve... Read more
Pt sustained seizure like activity for approximately 20 seconds. Pt became postictal without intervention. Pt maintained an open airway and breathing during the seizure activity. Pt was able to ambulate after the activity. Pt's vitals were assessed and found to be within limits. Pt refused transport to a medical facility. Pt was released to parent.
17 2021-04-18 feeling hot Vasovagal, lightheaded, faint, pale, hot, diaphoretic. BPs 100/60 (pulse 55), 101/65. Given juice.
17 2021-04-19 weakness Near syncope, weakness 30 min after vaccine admin. Patient was C&A, self ambulatory & in no signs ... Read more
Near syncope, weakness 30 min after vaccine admin. Patient was C&A, self ambulatory & in no signs of immediate distress, strong regular bi lateral radial pulses w/ warm dry skin & regular respirations with good rate depth quality. Vital signs were obtained w/ no remarkable findings patients condition improved while in EMS care & was then released to patients father whom assumed responsibility of patients father. Patient was instructed to stay hydrated & eat food & Both patient & patients father where instructed to seek medical attention if symptom's worsened or reoccurred.
17 2021-04-19 tingling Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: light headed, sweaty... Read more
Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: light headed, sweaty, notable to respond verbally, closing eyes, unable to sit up by himself, pressure in ears. Paramedic team came. Patient recovered. Patient does not need to go to the hospital.
17 2021-04-19 sensory loss, numbness 1021: Patients mother alerted medic that son was experiencing respiratory distress. Medic immediatel... Read more
1021: Patients mother alerted medic that son was experiencing respiratory distress. Medic immediately radioed Personnel Personnel notified another Person and both arrived at car at 1022. 1022: Patient stated he felt like his throat was being to close up and appeared to be gasping for air. Pt also stated he was beginning to lose sensation in his extremities; extremities tense and contracting; denied changes in vision. Mother stated no food or medication allergies but pt had previous anxious reaction to Hep B two years prior. Initial vitals on arrival: BP: 80/52 SpO2: 89% Resp: 26 1025: 0.3 mg Epinephrine administer into left vastus lateralis by 2 personnel 1026: repeat vitals BP: 111/57 Sp
17 2021-04-19 sensory loss 1021: Patients mother alerted roving medic that son was experiencing respiratory distress. Medic imm... Read more
1021: Patients mother alerted roving medic that son was experiencing respiratory distress. Medic immediately radioed their another medic. Two other EMT arrived at car at 1022. 1022: Patient stated he felt like his throat was being to close up and appeared to be gasping for air. Pt also stated he was beginning to lose sensation in his extremities; extremities tense and contracting; denied changes in vision. Mother stated no food or medication allergies but pt had previous anxious reaction to Hep B two years prior. Initial vitals on arrival: BP: 80/52 SpO2: 89% Resp: 26 1025: 0.3 mg Epinephrine administer into left vastus lateralis by emt overseen by another emt 1026: repeat vitals BP: 111/57 Sp
17 2021-04-20 unresponsive to stimuli Patient walked into the observation area around 5:16pm after his vaccination. He was with his stepfa... Read more
Patient walked into the observation area around 5:16pm after his vaccination. He was with his stepfather. He was with normal mentation, walking on his own, and talking with his stepfather in the waiting room. Within 1-2 minutes in the waiting room, he leaned to the right in his chair, hit the glass (glass did not crack or shatter, no head injury), and was not responsive for about 5 seconds. His father called his name and grabbed his hand but no response. I rushed over and patient became responsive and endorses not remembering what happened. He does not remember the event. No body shaking, tongue biting, or incontinence. He was taken back to the vital room, and his first BP was 70/35, pulse in the 60s. He denied any symptoms, and physical exam including neurological exam were normal. He was speaking coherently and with good mentation. He was given a water to drink. Repeat blood pressure 5 minutes later improved to 96/59 with no medication. He was moved to a clinic room and was laid supine with his legs elevated. Orthostatic blood pressures were within normal limits (111/63 supine, 110/72 sitting, 109/69 standing). Patient was able to walk out on his own and was in normal mentation. No medications were given or interventions wee done.
17 2021-04-21 cold sweat pt fainted, lost LOC x 20 sec according to mom, upon arrival pt was awake, alert, clamy and pale, HR... Read more
pt fainted, lost LOC x 20 sec according to mom, upon arrival pt was awake, alert, clamy and pale, HR=85, laid pt in supine position, monitored HR x 15 mins, pt awake and alert, oriented, described a syncopal episode, stated he hadn't eaten yet today, engaged in conversation, then sat pt in sitting upright position x 15 mins, HR=85, gave pt juice = 50gms carb, pt continued stated he felt much better, still appeared pale, then 15 mins pt able to ambulate without dificulty, HR=85, mom refused to go to emergency room as counseled. mom states he has a history of syncopal episodes with blood draws, or getting shots.
17 2021-04-21 flushing pt with chronic idiopathic urticaria noted onset urticaria, flushing and itching 18 min after first ... Read more
pt with chronic idiopathic urticaria noted onset urticaria, flushing and itching 18 min after first covid no angioedema no stridor no globus no wheezing no shortness of breath no chest pain no palpitation . vital sign stable exam remarkable urticaria and flushing,o/w wnl pt given oral benadryl 50mg with resolution of sx
17 2021-04-21 flushing Flushing/sweating, dizziness, nausea, vision problems. BPs 122/64 (pulse 61), 88/47 (pulse 65), 106/... Read more
Flushing/sweating, dizziness, nausea, vision problems. BPs 122/64 (pulse 61), 88/47 (pulse 65), 106/62. O2 sat 100%.
17 2021-04-21 seizure My son developed headache, vomiting, nausea, and worst of all a 45 second seizure.
17 2021-04-21 seizure Systemic: Dizziness / Lightheadness-Mild, Systemic: Seizure-Mild
17 2021-04-22 tremor, seizure As soon as the injection was complete the patient started acting like he didn't feel well and that h... Read more
As soon as the injection was complete the patient started acting like he didn't feel well and that he might vomit. Then he started to seem like he might pass out. Then he was shaking for a few moments and his body straightened out on the chair and he seemed like he might be having a seizure. I had someone call 9-1-1. I stayed with him until the paramedics arrived. He kept seeming like he was nodding off, but when I spoke to him he was responsive. By the time the paramedics arrived he said he was feeling better, but they checked him out, BP and HR and blood O2 were normal. The paramedics offered transport to hospital but patient and his adult family member declined, and patient went home with his family member.
17 2021-04-24 weakness, flushing Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Mi... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Mild, Systemic: Visual Changes/Disturbances-Mild, Systemic: Weakness-Mild
17 2021-04-24 flushing Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Visual Changes/Disturbances-Severe, Additional Details: Patient received shot and vision went black after about 5 mins. Vision began to return blurry within 15 mins with paramedics.
17 2021-04-24 tingling Tingly, Dizzy, nausea , fainted
17 2021-04-24 tremor, weakness, unresponsive to stimuli Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mil... Read more
Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Shakiness-Mild, Systemic: Visual Changes/Disturbances-Mild, Systemic: Weakness-Mild, Additional Details: Family History: Both parents had sezuires after being immunized in the past and this was their son's first immunization. Otherwise, the patient was calm and healthy.
17 2021-04-25 flushing Patient had syncope (BP 100/59 -- > 97/63), flushing/sweating, dizziness, nausea. Stable -- released... Read more
Patient had syncope (BP 100/59 -- > 97/63), flushing/sweating, dizziness, nausea. Stable -- released from vaccination site.
17 2021-04-25 tremor Patient became very nervous five minutes after having vaccination, fainted to the floor with body tr... Read more
Patient became very nervous five minutes after having vaccination, fainted to the floor with body tremors, BP 81/38 P45, Resp. 18, EMT at side with nursing staff, was put on stretcher, and complained of dizziness, nausea and lightheadedness, Later BP 114/55, P67 Resp.17. Patient transferred to ER. Recovered, no medications administered.
17 2021-04-25 unresponsive to stimuli Systemic: Fainting / Unresponsive-Mild, Additional Details: Pt fainted about 5 min after admin. Had ... Read more
Systemic: Fainting / Unresponsive-Mild, Additional Details: Pt fainted about 5 min after admin. Had pt on the floor about 1/2 hour. He responded in a few seconds, but on multiple blood pressure checks he bp was low. Gave crackers and water. Took pulse which was normal. Had pt sit for additional 15 minutes. Eventually he was ok to lewave but mom was monitoring bp. Called pt at end of day and he was fine. Said he had fainted before with blood drawn in past.
17 2021-04-26 tremor, muscle twitching SEVERE FLU LIKE BODY PAIN IN ALL PARTS, SEVERE HEADACHE, SEVERE NECK PAIN, SEVERE CHILLS, FEVER, SEN... Read more
SEVERE FLU LIKE BODY PAIN IN ALL PARTS, SEVERE HEADACHE, SEVERE NECK PAIN, SEVERE CHILLS, FEVER, SENSITIVITY TO LIGHT/ SOUNDS/ SMELLS/ twitching/ shakey, extreme fatigue
17 2021-04-27 feeling hot PATIENT FELT HOT AND FAINTISH ABOUT 2 MINUTES AFTER RECEIVING THE IMMUNIZATION. PATIENT MOM SAID HE ... Read more
PATIENT FELT HOT AND FAINTISH ABOUT 2 MINUTES AFTER RECEIVING THE IMMUNIZATION. PATIENT MOM SAID HE KEPT LOOKING AT THE BLOOD AND THEN THE SYMPTOMS CAME ON. DURING THE OBSERVATION, THE PATIENHAD ON A SWEAT SHIRT, SKULL HAT AND HEAD BAND. ALL THREE ITEMS WERE REMOVED, PATIENT LIED DOWN ON THE FLOOR WITH FEET UP IN A CHAIR FOR 10 -15 MINUTES. AND A COLD COMPRESS TO THE NECK. PATIENT NEVER LOST CONSCIENCE AND ALWAYS KNEW HIS NAME A DOB WHEN ASKED. MOM AND SON SAID HE STARTED FEELING THIS WAY WHEN HE LOOKED AT THE BLOOD ON HIS BANDAGE. THE PATIENT NOR HIS MOM WANTED US TO SEEK MEDICAL 911 ATTENTION AND WALKED OUT ON HIS OWN LATER.
17 2021-04-27 flushing, unresponsive to stimuli Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: P... Read more
Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: Patient fainted after receiving his first dose of the shot. He was very pale and sweating but responsive to questions. Monitored his blood pressure and had him sit and drink water. After 15 minutes his color had returned, stopped sweating and was totally alert/oriented. Per patients mother he had just come from school and had not eaten much that day which she belived to be a contributing factor
17 2021-04-27 mild one side paralysis, tingling, inability to speak Right paresis, paresthesia, aphasia, fall and incontinence found to have left MCA occlusive CVA
17 2021-04-27 tingling Site: Pain at Injection Site-Medium, Systemic: Tingling (specify: facial area, extemities)-Mild
17 2021-04-28 tingling Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Mild tingling in the... Read more
Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Mild tingling in the arms 15 minutes after vaccination along with feeling uneasy. Benadryl given, pt felt well enough to leave store. Followup phone call on 4/28/21, pt had recovered fully.
17 2021-04-28 unresponsive to stimuli Systemic: Fainting / Unresponsive-Mild
17 2021-04-29 unresponsive to stimuli PT 7 MINS POST VACCINE BECAME DIAPHORETIC, A/Ox0, UNRESPONSIVE TO VERBAL STIMULI, EPISODE OF SYNCOPE... Read more
PT 7 MINS POST VACCINE BECAME DIAPHORETIC, A/Ox0, UNRESPONSIVE TO VERBAL STIMULI, EPISODE OF SYNCOPE LASTING LESS THAN 1 MINUTE. PT LAID ON FLOOR AND STERNAL RUB PERFORMED. PT RESPONSIVE TO PAINFUL STIMULI. V/S W/IN NORMAL LIMITS WITH SPO2 PRESENTING AT 93% BUT RESOLVED ONCE PT BECAME A/Ox3. PT GIVEN WATER TO SIP ON AND DISCHARGED IN NAD.
17 2021-04-30 weakness, tremor Patient given first dose of COVID vaccine today. After being vaccinated patient walked over where hi... Read more
Patient given first dose of COVID vaccine today. After being vaccinated patient walked over where his brother was sitting. Soon after siting he felt weak and fell to the floor, patient appeared to be shaking for 2 seconds, generalized, witnesses unsure if he hit his head. No eye rolling, no foaming of the mouth, no incontinence noted. Patient was monitored and assisted off the floor to a wheelchair. While being assessed at a nearby cot, while siting, the patient's eyes rolled back, upper limb shaking for 2 seconds. Patient does not remember either episode. Vitals: 120/70, HR 88, RR14, Oxygen 100%, Glucose 113, exam: patient alert and oriented x3, PERRLA, heart RRR, normal S1 and S2, no murmur, lungs cleared. Due to second episode occuring, 911 was called. Mother was on site and full report given to her. Patient was getting up and heart rated noted to drop to 56, he felt dizzy at this point and sat down, then laid down. The patient was evaluated by EMT and was taken to hospital for further evaluation.
17 2021-05-01 muscle spasms Spontaneous nose bleed approximately 24 hours after the injection. Lasted for approximately 30 mins ... Read more
Spontaneous nose bleed approximately 24 hours after the injection. Lasted for approximately 30 mins and resolved with pressure. Other expected side effects he has are fatigue, muscle cramps, body aches, headache.
17 2021-05-01 seizure 5 second seizure activity.
17 2021-05-02 weakness Visually observed patient looked faint for approximately 5 seconds Patient was reclined on cot, give... Read more
Visually observed patient looked faint for approximately 5 seconds Patient was reclined on cot, given juice & crackers, BP checked 1st 110/70 BP was weak Patient was observed for 30 minutes, patient verbally reported he was feel much better Left the facility with his father & told to go get food & water
17 2021-05-02 pain in extremity FEVER, CHILLS, FATIGUE, HEADACHE, ARM PAIN, CONGESTION, SWOLLEN & PAINFUL LYMPH NODE UNDER RIGHT AR... Read more
FEVER, CHILLS, FATIGUE, HEADACHE, ARM PAIN, CONGESTION, SWOLLEN & PAINFUL LYMPH NODE UNDER RIGHT ARM. THESE SYMPTOMS LASTED FOR SEVERAL DAYS AND WHILE NO LONGER SEVERE, CONTINUES TO BE FATIGUE AND HAVE PAIN WITH SWOLLEN LYMPH NODE.
17 2021-05-02 unresponsive to stimuli, weakness, flushing Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed/Sweating-Mild, Systemic: Weakness-Mild, Ad... Read more
Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed/Sweating-Mild, Systemic: Weakness-Mild, Additional Details: FOLLOWED UP WITH PATIENT AT 6:30P ON 05/02/2021. DAD SAID PATIENT IS DOING OK NOW. HE EATS AND TALK NORMALLY.
17 2021-05-04 weakness Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypotension-Medium, S... Read more
Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypotension-Medium, Systemic: Weakness-Medium
17 2021-05-04 cold sweat, numbness Approximately 25 minutes post vaccine, attendee began to complain of dizziness, clammy, nausea and a... Read more
Approximately 25 minutes post vaccine, attendee began to complain of dizziness, clammy, nausea and arm numbness. Patient's vitals were taken. 50Mg of Benadryl was given. The attendee was monitored for 45 minutes and released from site. He was accompanied by his older sister. No loss of consciousness was observed. The attendee remained alert and oriented the entire time.
17 2021-05-04 cold sweat During his 15 minute observation period after receiving his second shot, patient felt ill and starte... Read more
During his 15 minute observation period after receiving his second shot, patient felt ill and started turning pale. Pharmacy staff came to his side and gave him wet, cold compresses and water. He was feeling dizzy and clamy but never lost consciousness. The pharmacist could see that the patient was wearing a CGM. The patient was able to see his blood glucose levels on his receiver and they were high. We were able to rule out hypoglycemia. The patient threw up three times in the waste basket. After about 20-30 minutes he started feeling better.
17 2021-05-04 seizure Passed out and had seizure lasting 45-60 seconds.
17 2021-05-04 seizure increased seizure activity/mini seizures; increased seizure activity/mini seizures; confusion and me... Read more
increased seizure activity/mini seizures; increased seizure activity/mini seizures; confusion and memory issues; confusion and memory issues; fatigue/tired; This is a spontaneous report from a contactable consumer. A 17-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 17Apr2021 09:00 (Lot Number: EW1064) as SINGLE DOSE (at age of 17 years old) for covid-19 immunisation. Medical history included epilepsy (interactable epilepsy) from an unknown date and unknown if ongoing. There were no concomitant medications. Historical vaccine information included BNT162B2 dose 1 on 25Mar2021 09:00, lot number as ER8733, in the left arm for COVID-19 immunisation(at age of 17 years old). On 17Apr2021, the patient experienced increased seizure activity, fatigue/tired, confusion and memory issues. After the 2nd shot, about 4-5 hours, he experienced increased seizure activity and it has progressed to today, today he is a little bit better but it has progressed to point he is having a lot of confusion and memory issues. He has several different types of seizures but he has what are called mini seizures, the blank stare, the confusion. Nothing has stopped completely, he isn't back to his baseline as far as his seizures. He always has seizures, daily so she is calling about the increased activity and when she says his baseline she means he has not returned back to his baseline activity, but he is doing better than yesterday. Saturday, Sunday, and Monday were horrible. Today he started to get back to his normal self. The events did not require a visit to the Emergency Room or Physician Office. Outcome of the increased seizure activity/mini seizures, confusion and memory issues were recovering. Outcome of fatigue/tired were not recovered.
17 2021-05-05 feeling cold Patient is having fever, chills, nausea, and feeling of coldness now 5 days after receiving the seco... Read more
Patient is having fever, chills, nausea, and feeling of coldness now 5 days after receiving the second dose of Pfizer vaccine. He has been unable to eat much food and unable to sleep much due to feeling cold and having a fever.
17 2021-05-05 flushing, seizure, unresponsive to stimuli Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flus... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Seizure-Severe, Systemic: Vomiting-Medium, Additional Details: Patient began to seize/faint in chair within 5 minutes post-vaccination. Paramedics were called as I stabilized patient on floor. Consciousness regained within 60 seconds, patient confused/unaware of what had occured. Patient flush, lightheaded, vomiting. Paramedics arrived and confirmed patient was stable and safe to leave scene without further intervention.
17 2021-05-05 flushing, unresponsive to stimuli Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadedness-Medium, Systemic: Fainting / Unrespo... Read more
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadedness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Medium, Systemic: Visual Changes/Disturbances-Medium.
17 2021-05-05 flushing, unresponsive to stimuli Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unrespons... Read more
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Medium, Systemic: Visual Changes/Disturbances-Medium
17 2021-05-05 pain in extremity 8:30pm: pale, fever Overnight: chills, fever, difficulty sleeping 7:30am: headache, sore arm, stomac... Read more
8:30pm: pale, fever Overnight: chills, fever, difficulty sleeping 7:30am: headache, sore arm, stomach ache
17 2021-05-05 tremor 5 minutes following the vaccination, patient's BLE and BUE went into abnormal extension immediately... Read more
5 minutes following the vaccination, patient's BLE and BUE went into abnormal extension immediately followed by facial tics and shaking of the BUE. Pt was pale, diaphoretic, and verbalized " I am OK" three times in a row without being asked. Pt stated he was unaware of what had just happened then verbalized feelings of nausea. Airway, Breathing, Circulation intact. Pt was placed on gurney, side rails up x2, and transported to ED.
17 2021-05-06 tingling, numbness Patient feeling lightheaded, sweat and blurred vision. He also reported numbness, tingling bilater... Read more
Patient feeling lightheaded, sweat and blurred vision. He also reported numbness, tingling bilateral hands. dizziness and blurred vision subsided within 5 minute. Patient was encouraged to hydrate and wait full 15 minutes prior to leaving. Patient was feeling well enough to leave and mother was able to drive him home
17 2021-05-07 numbness, tingling After getting the 2nd dose of the Pfizer COVID-19 vaccine - patient's left arm (arm in which the vac... Read more
After getting the 2nd dose of the Pfizer COVID-19 vaccine - patient's left arm (arm in which the vaccine was administered) began to tingle all the way down to his hands, also included some numbness.
17 2021-05-07 sensory loss felt like his throat was being to close up; appeared to be gasping for air; lose sensation in his ex... Read more
felt like his throat was being to close up; appeared to be gasping for air; lose sensation in his extremities; extremities tense and contracting; respiratory distress; This is a spontaneous report from a contactable nurse, reporting for her son. A 17-year-old male patient received BNT162B2 ((PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 intramuscular, administered in the left arm on 20Apr2021 at 10:15 (Batch/Lot Number: EW0170) as a single dose (at the age of 17 years old) for covid-19 immunisation. Medical history included anxiety from an unknown date. There were no concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included anxious reaction to Hep B two years prior (2019). The patient experienced respiratory distress on 20Apr2021 at 10:21 with outcome of unknown, felt like his throat was being to close up on 20Apr2021 at 10:22 with outcome of unknown, appeared to be gasping for air on 20Apr2021 at 10:22 with outcome of unknown, lose sensation in his extremities on 20Apr2021 at 10:22 with outcome of unknown, and extremities tense and contracting on 20Apr2021 at 10:22 with outcome of unknown. Chronology of events was as follows: on 20Apr2021 at 1021: Patients mother alerted roving medic that son was experiencing respiratory distress. Medic immediately radioed and arrived at car at 10:22. At 10:22: Patient stated he felt like his throat was being to close up and appeared to be gasping for air. Patient also stated he was beginning to lose sensation in his extremities; extremities tense and contracting; denied changes in vision. At 10:25: 0.3 mg Epinephrine administer into left vastus lateralis. The patient underwent lab tests and procedures which included blood pressure measurement: 80/52 on 20Apr2021, blood pressure measurement: 111/57 on 20Apr2021 at 10:26, oxygen saturation: 89 % on 20Apr2021, and respiratory rate: 26 on 20Apr2021. The events resulted in Emergency room/department or urgent care. It was also reported that since the vaccination, the patient had not been tested for COVID-19; Sender's Comments: Based on current known drug safety profile, the reported events were assess as intercurrent medical events and thus assessed as not related to suspected drug BNT162B2 . Case will be reassessed pending new information. 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 2021-05-08 seizure, feeling hot Site: Pain at Injection Site-Mild, Additional Details: Patient was waiting after the his first covid... Read more
Site: Pain at Injection Site-Mild, Additional Details: Patient was waiting after the his first covid shot and he was talking with his parents, they had a conversation for 5 minutes and then the patient fainted, fell down, had seizure for few seconds and then woke up in few seconds. Patient was sweating, feeling hot. He was breathing normal. Face was red. .911 was called. Patient had no issues with needles. HR was 104. Patient felt better after 10-15 mins and left with his parents. No hospitalization needed.
17 2021-05-09 involuntary muscle movements Approximately 10 minutes after vaccination, patient began jerking and passed out. Patient was place... Read more
Approximately 10 minutes after vaccination, patient began jerking and passed out. Patient was placed on the floor and vitals were taken which were normal. After approximately 10 minutes, patient was brought to sitting position and after a few minutes began jerking movements and felt faint. After approximately 10 minutes, patient was walked to a chair but after a few minutes he again began jerking and felt faint. Patient was returned to the floor. Parents refused transport to the hospital. Father helped patient to the car and he was placed in the back seat lying down. Father stated he may take him to the ER if he seems like he needs it.
17 2021-05-09 seizure, tremor Systemic: Seizure-Mild, Systemic: Shakiness-Mild
17 2021-05-10 burning sensation Complained of nausea, next day, vomited. C/o burning and throbbing in opposite of vaccine injection ... Read more
Complained of nausea, next day, vomited. C/o burning and throbbing in opposite of vaccine injection site. 4pm low grade fever. C/o he can't breathe. C/o burning of chest. States better on Sunday after taking benadryl and nyquil mom stated. Administered by a nurse per record. Mom instructed to take to dr for evaluation but he is asymptomatic as of 4 pm 5/10/21/
17 2021-05-10 face paralysis, bell's palsy Bell's palsy on left, Patient is a 17 year old male who presents to ED today for left sided facial ... Read more
Bell's palsy on left, Patient is a 17 year old male who presents to ED today for left sided facial weakness involving the face and forehead. Patient says he received the Pfizer vaccine for COVID19 this past Saturday. Two days later on Monday, he developed these symptoms. He arrives well appearing in NAD. He has weakness of the left face involving the forehead, difficulty raising eyebrow and closing left eye.
17 2021-05-10 pain in extremity Continued headaches, soreness in arm and fatigue
17 2021-05-10 seizure, weakness Pt received vaccine to R arm and within 3mins collapsed and hit back of hit head. Pt had seizure lik... Read more
Pt received vaccine to R arm and within 3mins collapsed and hit back of hit head. Pt had seizure like activity for 1-2mins. Afterwards, pt was weak and confused. Pt taken to ER where he was given IVF and medication for nausea. Pt had neg head CT and CXR. Pt was discharged about 4hours later.
17 2021-05-11 bell's palsy At first(4/27/21) it felt like the left side of my face was acting spiritic but it was really the ri... Read more
At first(4/27/21) it felt like the left side of my face was acting spiritic but it was really the right side of my face not really doing anything so after a week of deducing and not knowing what it was I told my mom. She called the doctors office listed and they said to send me to the ER on 5/5/21. They said I have Bells Palsy and they put me on Prednisone and eye drops. We scheduled an appointment for our primary doctor which we went to on the 5/12/21. The doctor and I + my mom talked and they said we should report this because there was nothing else that could of caused the Bells Palsy.
17 2021-05-12 unresponsive to stimuli Pfizer vaccination administered into left deltoid at 0849. Reporter, RN arrived to patient at 0855 a... Read more
Pfizer vaccination administered into left deltoid at 0849. Reporter, RN arrived to patient at 0855 after being notified patient had fallen off his chair. Patient found to be laying facedown and unconscious near the chair he was sitting in. No initial response by patient to verbal and physical cues. Patient was pale in color and diaphoretic. Patient was placed into right side laying position. After about a minute of being in side laying position and continued verbal/physical cueing, patient awakened. Assisted patient to supine position, cool packs placed to armpit area, Excess sweat on face wiped. Two small abrasions noted to left side of face; nose and near top of mouth. Upper and lower extremities also had small abrasions. Patient reported he started to feel dizzy and tired shortly after receiving the Pfizer vaccination. Patient does not recall falling. Mother confirmed patient had eaten breakfast, no history of low blood glucose levels. Denied experiencing shortness of breath prior to fall and while nursing staff was present, No neurological deficits noted during assessment. No rash noted. Patient continued to be diaphoretic. Reported stomach was upset. Vitals taken at 0902; blood pressure 116/74, pulse 74, respirations 18, oxygen saturation 98% on room air. Permission by parent given to treat patient with epinephrine. Patient received 0.5 mg of epinephrine at 0900 and again at 0905. EMS arrived at 0912. Patient more alert at this time and diaphoresis subsided at this point. After EMS obtained further information, patient was assisted into a sitting position on the floor. Patient complained of stomach upset again and vomited two times. Ambulance arrived at 0935 and patient placed onto gurney. Ambulance departed at 0935 to transfer patient to Medical Center for further observation.
17 2021-05-13 difficulty speaking 17yo otherwise healthy male presents to clinic for worsening cough, runny nose congestion, and sweat... Read more
17yo otherwise healthy male presents to clinic for worsening cough, runny nose congestion, and sweats starting 4 days ago. He received the COVID vaccine 5 days ago in the afternoon and initially had what he expected to be normal side effects from the vaccine that evening. Symptoms included body aches, runny nose and general malaise. However, over the last few days he has felt worse and developed more congestion, cough, and sweating. He did improve a little bit 2 days ago but then started to feel worse yesterday and had a worsening cough that is resulting in some chest tightness. Cough is productive sounding. Mom describes it as barking. No appreciable wheezing but he sounds hoarse. He has some SOB after coughing repeatedly. He states it simply feels like it is hard to breathe for 10-20minutes after a coughing attack but then it resolves. He developed sweating yesterday as well. He states he will just start sweating for no reason. No measured fever. No chills. Today he has dried skin and cracked lips from blowing/wiping his nose all the time. No fevers. No vomiting. No diarrhea. No numbness/tingling. No redness/swelling at injection site. No rashes. No HA. EXPOSURE: No one at home is sick, No known exposures prior to vaccine CHRONIC: None, no hx of asthma or allergies, hx of eczema. PCP: None UTD on imms. Vitals: Wt 163.4, HR 60, RR 18, Temp 97.8, O2 sat % 98 Past Results: Examination: GENERAL APPEARANCE: alert, no acute distress, non-toxic, mildly diaphoretic, talking and cooperating throughout exam, sitting comfortably on exam bed, able to talk in complete sentences. HEAD: no visible lesions or abnormalities. EYES: no eye, eyelid, or orbital abnormalities identified. EARS: BILATERAL TMs pearly gray without erythema, effusion, or purulence; EAC with normal amount of cerumen bilaterally, no mastoid erythema or tenderness. NOSE: patent nares, congested, clear rhinorrhea. MOUTH/THROAT: moist mucous membranes, uvula midline, mild pharyngeal erythema without tonsillar exudate, no soft palate lesions, no trismus, no soft palate swelling or erythema, no difficulty swallowing or drooling. NECK: supple, non-tender, FROM. CHEST: normal shape, good expansion, no visible lesions/abnormalities, no tenderness, no retractions, no grunting, no stridor. HEART: no murmur, RRR. LUNGS: clear to auscultation, prior to administration of inhaler, diffuse wheezing and rhonchi throughout, post inhaler, improved air movement with focal rales in RIGHT poseterior middle lung field around T5. ABDOMEN: soft, no tenderness, no masses palpated, normoactive bowel sounds, non-distended. NEURO: alert, non-focal exam. SKIN: warm, dry without rash, petechiae, or purpura. Pneumonia of right middle lobe due to infectious organism Start Albuterol (Eqv-Proventil HFA) aerosol, 90 mcg/inh, 2 puff(s), inhaled, every 6 hours, 30 day(s), 1 Start amoxicillin tablet, 500 mg, 2 tab(s), orally, 3 times a day, 10 day(s), 60 Imaging:XR CHEST 2 VIEWS PA AND LAT Notes: History and exam are consistent with Community Acquired Pneumonia. CXR final read indicates RIGHT middle lobe bronchopneumonia. Suspect that pneumonia is unrelated to COVID vaccine. Pneumonia is an inflammation of the lungs caused by infection. Antibiotics are used to treat bacterial pneumonia. Other medications may help improve breathing and relieve symptoms in bacterial and viral pneumonia. Start and complete entire course of antibiotics. Increase fluids and restas much as possible. Patient informed to return if not improved or go to ER if worsening sympmtoms, SOB, or increased chest pain. Should be rechecked in 2-3 days by PCP. Discussed side effects and risks of medications with the patient. Patient expressed understanding and a willingness to participate in the plan. Patient left the UC in a stable condition with all questions answered at this time. Cough Imaging:XR CHEST 2 VIEWS PA AND LAT Notes: Discussed cough in clinic. Will plan to treat with albuterol PRN cough/wheezing every 4-6hrs and Stiolto Respimat 2 inhalations QD after discussion with Dr. First dose of Stiolto given in clinic with improvement in symptoms and improved aeration. Focal findings now appreciable. Discussed close follow-up and when to return to clinic. Will report symptoms to VAERS. All questions and concerns answered and addressed.
17 2021-05-13 tremor, seizure, involuntary muscle movements Seizure; Felt dizzy; Eye sight was blurry; Shake and jerk; Shake and jerk; Skin turned pale; Heart r... Read more
Seizure; Felt dizzy; Eye sight was blurry; Shake and jerk; Shake and jerk; Skin turned pale; Heart rate was high; Nauseous; This is a spontaneous report from a contactable consumer. A 17-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 28Apr2021 16:00 as unknown, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included fish oil; magnesium [magnesium citrate]; vitamin d [vitamin d nos]; probiotic [bifidobacterium lactis]; vitamin b complex (VITAMIN B). The consumer stated, approximately 20 minutes after receiving the vaccine (28Apr2021 16:15) the patient felt dizzy, eyesight was blurry, and he began to shake and jerk. It resembled a seizure. His skin turned pale, heart rate was high, and he felt nauseous. It took him approximately 5-10 minutes to feel "normal" again. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The adverse event result in emergency room/department or urgent care. There is no treatment for AE. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was resolving. Information about Batch/Lot no. has been requested.
17 2021-05-13 tremor Patient given vaccine, within 30 seconds became sweaty, shaky, pale, dizzy, complaining was dizzy an... Read more
Patient given vaccine, within 30 seconds became sweaty, shaky, pale, dizzy, complaining was dizzy and nauseous, had shallow breathing. EpiPen was administered within 2 minutes and 911 was called. Paramedics arrived, patient's BS and BP was good. Had nothing to eat or drink prior to the shot. Was deemed okay but taken to Salem Hospital anyways. Had no car but patient was taken with paramedics to hospital.
17 2021-05-13 unresponsive to stimuli Patient was the 4th person to receive today?s vaccine of Pfizer. This was his second dose. He did fi... Read more
Patient was the 4th person to receive today?s vaccine of Pfizer. This was his second dose. He did fine the first dose. Patient sat down in the chair and rolled sleeve up. Chose L deltoid for injection site. He was talking with a friend and writer gave injection. Placed band aid. Patient was quiet and looked like he was going to get up but fell forward out of the chair. He hit his L forehead on side of wall. Writer caught patient and sat him up on the ground. Eye?s were dilated, he was diaphoretic, zoned out and not responding initially to voice, but eyes were open. Eventually got patient up to a wheelchair and taken to office area to lay down and monitor. Father was notified and sat with us after he arrived at the school. Patient drank 1 full 120cc orange juice and approximately 6oz of water. Throughout monitoring patient gradually felt better. Pupils corrected to normal, wasn?t diaphoretic anymore, and vitals improved. He stated this has happened before with lab draws and shots, but not this severe. Writer and colleagues informed him to notify people that are going to give him shots or lab draws about his history. Also informed him to notify his teachers if he feels anything out the ordinary for the rest of the day. Make sure he hydrates. Patient then sat up and walked in the room. He stated he felt fine like before getting the shot. Patient left stable and under his own power.
17 2021-05-14 flushing Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Pt ... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Pt was repositioned in a charm with arms and head down. pt offered and consumed juice; symptoms resolved in 3 minutes
17 2021-05-14 tingling At 1249, 17-year old male client was administered Pfizer COVID-19 vaccine 2nd dose (Lot # EW0182, ex... Read more
At 1249, 17-year old male client was administered Pfizer COVID-19 vaccine 2nd dose (Lot # EW0182, expiring 08/2021) in the right arm by registered nurse (RN) vaccinator. Client accompanied by mother. RN vaccinator requested emergency medical technician (EMT) assistance due to client report of feeling sweaty, tingling in both hands, and client nearly falling forward. EMT responded and brought gravity chair to vaccinator table and assisted client into gravity chair. Vital signs at 1257: blood pressure 95/60, heart rate 50, oxygen saturation 97%. RN lead assessed client. Client reported feeling tired and tingling in both hands. Client reported not eating breakfast. Client?s Mother reported that client closed eyes and put his head down immediately after vaccine administration, then opened his eyes after 3 seconds. Client?s mother reported client does not have allergies or chronic conditions and had sore arm after 1st dose of Pfizer. Client denied any other side-effects to first dose. Client?s mother reported client has aversion to needles. Client and client?s mother were provided vaccine education, were encouraged to follow-up with client?s primary care provider, and encouraged to report side-effects on website. Client was advised that he will be observed for at least 30 minutes. At 1300, client stood up from chair unassisted, walked to observation area unassisted with steady gait, and sat down in gravity chair. Client was provided one bottled water and two granola bar snacks. Vital signs at 1307: blood pressure 125/63, heart rate 62, oxygen saturation 96%. Client reported tingling was resolving. Vital signs at 1317: blood pressure 125/72, heart rate 57, oxygen saturation 97%. Client reported side-effects resolved and feeling better. Client reported driving to vaccine site and felt safe to drive. At 1325, client stood up from gravity chair unassisted and walked out of vaccine site unassisted with steady gait accompanied by mother.
17 2021-05-14 unresponsive to stimuli, weakness Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Weak... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Weakness-Medium, Additional Details: patient felt dizzy and lightheaded and fainted off the chair. never lost consciousness. recovered after staying in laying down position with knees bent, then had a bottle of water and another drink. walked out after 40 minutes with mom
17 2021-05-15 unresponsive to stimuli Systemic: Fainting / Unresponsive-Mild, Additional Details: patient had second vaccine in series and... Read more
Systemic: Fainting / Unresponsive-Mild, Additional Details: patient had second vaccine in series and fainted. fell face forward from chair and hit cheek and left eyebrow area. patient was laid down and told to put feet on chair. blood pressure and heart rate were lower than noraml. patient was monitored for blood pressure and heart rate until vitals normalized. patient and careprovider declined emergency services offered.
17 2021-05-16 muscle spasms, facial paralysis, slurring, seizure, inability to speak, weakness Pt was seen at ED on5/8 for L sided weakness in the setting of a headache. Pt?s mother reports that ... Read more
Pt was seen at ED on5/8 for L sided weakness in the setting of a headache. Pt?s mother reports that these symptoms began 2 days after receiving second dose of Pfizer COVID-19 vaccination in R deltoid. She says that on 5/6, pt complained of L arm weakness during cooking class at school, which was followed by a mild L sided headache later in the day. Symptoms resolved without intervention but recurred on 5/8 with associated L sided facial droop, slurred speech, L arm spasms, and L foot drag. Pt was seen at ED for this and had a HA (5/10 in severity) at that time -- workup was unremarkable with a normal head CT, laboratory workup, and resolution of symptoms. Pediatric Neurology evaluated the pt, deemed no further workup necessary, and advised outpatient follow up. Pt presented again to the ED on 5/10 with concern for full tonic/clonic seizure, witnessed by pt?s mother. Mother reports that she heard pt fall and went upstairs to find pt seizing on his bed -- says that pt had shaking of bilateral upper extremities (in flexed position close to chest) and symmetric lower extremity shaking; eyes were closed without clear focality or eye deviation. Also some drooling, though no incontinence or tongue biting. Episode lasted for approximately 2 minutes; pt was confused and did not recall what happened immediately afterwards but improved within the next 8 minutes. He was taken to the ED by EMS. By the time he arrived in the ED, he had left sided weakness again. He was given Keppra 1g, placed on EEG, and was admitted. EEG overnight was read "normal" and additional workup was unremarkable. Pt had MRI brain completed showing cortical abnormalities in the R parietal lobe, suspected to be related to recent seizure. MRA showed patent intracranial cerebral vasculature. MRV showed no evidence of dural venous sinus thrombosis. Weakness resolved by the morning and pt was back to baseline on morning of 5/11/21. However, around 9 AM, L sided weakness (face, arm>leg) with associated headache recurred. Mom says that this event was captured on EEG. He was then transferred to our facility. He was placed on pEEG and had repeat labs, imaging completed. Pt did have L sided facial droop, L arm weakness, and slurred speech on arrival, but this resolved within 24 hours. Pt had one additional episode of "wave" of L sided weakness including L sided facial droop and slurred speech at one other time during the hospitalization, but no additional seizure like activity. He was discharged on 5/14 with a normal neuro exam-- some labs (including labs of Rheum and Id workup were pending at time of discharge.) Primary and consulting teams elected to forgo steroids but reconsider should symptoms worsen or return. Pt was readmitted on 5/16-- had an episode of expressive aphasia + headache while at a social gathering; states that he became overwhelmed by the noise. No additional seizure like activity.
17 2021-05-16 pain in extremity 17 y.o. male with non contributory PMHx presents with chest pain. Patient began not feeling well on ... Read more
17 y.o. male with non contributory PMHx presents with chest pain. Patient began not feeling well on Monday May 3rd with muscle aches, sore throat, dry cough, and headache. Received COVID vaccine on Apr 30. He woke up Friday May 7 he developed a fever to 102F. Went to urgent care yesterday was diagnosed with strep based on suspicion (negative rapid, culture pending) and started on amoxicillin. Rapid covid was negative at that time as well. Now presents for chest pain. He has woken up that last two mornings with chest pain (worse when laying flat), pain is substernal, sharp/throbbing, radiates to the left arm. Belching a lot. Palpitations and one episode of emesis prior to arrival. Suspected symptoms were from gas so took charcoal tablets prior to arrival without relief of symptoms. Has been taking ibuprofen for discomfort (400 mg every 4-6 hours for > 7 days). No shortness of breath. No abdominal pain. No diarrhea. No hematuria or dysuria. No family history of sudden cardiac death or significant for CAD. No known tick bite. Of note, received Pfizer dose 2 3d prior to symptoms starting. Presented to ED earlier tonight where exam was notable for: Low-grade temp, mildly hypertensive with otherwise stable vitals, appears uncomfortable, belching, neck is supple without meningismus, bilateral tonsils 1+ with exudate, oropharynx is erythematous, uvula midline, no trismus, no swelling, lungs clear, regular rhythm mild bradycardia, no murmurs rubs or gallops, abdomen is soft and nondistended with mild tenderness in epigastrium and right upper quadrant they did ECG, bedside Echo, Strep PCR, zofran, maalox, pepcid, IVF, tylenol, and labs which were notable for elevated troponin -> 13.58 d/w YSC Ped ED and tx Assessment: Patient is a 17 y.o. male previously healthy who presents with 1 week of malaise, and 3 days of intermittent substernal chest pain (now resolved), found to have elevated troponin and ST segment elevations in I and lateral leads c/f myopericarditis. Etiology is unclear at this time, likely viral vs post-vaccine. Exam notable for exudative pharyngitis, however Strep and CMV neg. EBV serology with positive EBNA only. Labs otherwise notable for elevated CRP 180, ESR 38, some transaminitis, ferritin/D-dimer wnl. COVID RNA neg, spike Ab positive c/w recent COVID vaccination. Normal function on ECHO. CRP continues to downtrend. Troponin has started downtrending again and pt remains asymptomatic. Plan Plan: #Myopericarditis - Repeat echo today - q8 troponin, AM CBC, CRP, ferritin - Motrin 400mg prn - steroid taper per Rheumatology recs 30mg PO BID for 7 days 30mg PO qday for 7 days 15mg PO qday for 7 days 7.5mg PO qday for 7 days 2.5mg PO qday for 7 days Off - f/u ID and rheum labs - continuous telemetry: patient at high risk of arrhythmia #FEN/GI - Regular diet - strict I/O - Pepcid 20mg BID #dispo - steroid taper sent for delivery to bedside - upon d/c start ASA - f/u cardiology - If echo today reassuring and troponin continuing to downtrend will plan for discharge this afternoon
17 2021-05-16 seizure PATIENT FAINTED FEW MINUTES AFTER RECEIVING THE VACCINE. HE LOOKED LIKE HE WAS HAVING A SEIZURE. IT ... Read more
PATIENT FAINTED FEW MINUTES AFTER RECEIVING THE VACCINE. HE LOOKED LIKE HE WAS HAVING A SEIZURE. IT LASTER FOR A BOUT 15-17 IN MY ESTIMATE. HE WAS ALERT AFTER AND ANSWERING QUESTIONS ABOUT HIS NAME, DOB AND WHERE HE WAS. TOOK HIS BLOOD PRESSURE TWICE-5 MIN APART AND IT WAS LOW. 113/58 AND THEN 102/50 TO MY RECOLLECTION. PARAMEDICS WERE CALLED IMMEDIETLY AND PATIENT HAD HIGHER BLOOD PRESSURE WHEN THEY WALKED IN. IT WAS "NORMAL". PATIENT TOLD US HE HAS A HISTORY OF VASOVAGAL SYNCOPE AND HE FAINTED BEFORE WHEN HIS BLOOD WAS DRAWN. HE SAID THAT IT SEEMED LIKE A SEIZURE BEFORE BUT CHECKED WITH NEUROLOGIST AND WAS NEVER DIAGNOSED WITH EPILIPSY. PT LEFT IN A STABLE CONDITION
17 2021-05-18 numbness within first few moments after injection- arm/hand numbness . the following day- lightheadedness an... Read more
within first few moments after injection- arm/hand numbness . the following day- lightheadedness and severe headache
17 2021-05-18 pain in extremity Sore arm for about a day
17 2021-05-18 unresponsive to stimuli Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient fainted a few minutes after getting shot but regained concisousness in less than a minutes
17 2021-05-19 burning sensation Fainted; Dizziness; Sweaty palms; Heart rate dropped; Weird burning sensation in the back of his nec... Read more
Fainted; Dizziness; Sweaty palms; Heart rate dropped; Weird burning sensation in the back of his neck with tension; Weird burning sensation in the back of his neck with tension; Disorientated; Lost his color; Weird sensation in throat; Headache; Had pressure in his ears; Gassy; This is a spontaneous report from a contactable consumer (mother of the patient). A 17-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8731; Expiration date was not reported) on 15Apr2021 (15:00) as a single dose, with route of administration unspecified, for COVID-19 immunization at the clinic (not a military facility). The patient had no relevant medical history and concomitant medications. On 15Apr2021, after the first dose of vaccination, the patient had fainted; dizziness; sweaty palms; heart rate has dropped; had weird burning sensation at the back of the neck with tension; was disorientated; and had lost his color. In Apr2021, the patient had weird sensation in the throat; headache; had pressure in his ears; and was gassy. The outcome of the events was unknown for 'lost his color'; was not recovered for 'headache'; and was recovered on an unspecified date in 2021 for all the other events. Information on lot/batch number was available. Additional information has been requested.
17 2021-05-19 tingling VOMITING (unsure if due to chronic condition though he hasn't vomited in at least 3 weeks) and 'TING... Read more
VOMITING (unsure if due to chronic condition though he hasn't vomited in at least 3 weeks) and 'TINGLY' LEGS- not quite pins and needles, no numbness, no pain, just aggravating tingling sensation
17 2021-05-20 feeling hot, cold sweat Within a few minutes of receiving the vaccine, the patient turned pale and clammy. He became confuse... Read more
Within a few minutes of receiving the vaccine, the patient turned pale and clammy. He became confused and lost consciousness for several seconds, his head fell back and he made gurgling noises. When he regained consciousness, he couldn't remember our conversation. He said he was hot and his head hurt for a few minutes, he remained pale and sweaty for several minutes. After 10-15 minutes he said he felt fine.
17 2021-05-20 flushing Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Mild
17 2021-05-21 unresponsive to stimuli Systemic: Fainting / Unresponsive-Mild, Systemic: Hypotension-Medium
17 2021-05-23 pain in extremity Patient was fine until sometime in the morning hours, approx. 12 hours after receiving vaccine. Bega... Read more
Patient was fine until sometime in the morning hours, approx. 12 hours after receiving vaccine. Began with a fever of 100.7, nausea, leg pain/joint pain. Patient took Motrin but fever rose to 102.5, continued with nausea, and leg pain. This lasted two full days.
17 2021-05-23 pain in extremity Symptoms of heart beating faster, louder and harder with mild pleuritic chest discomfort starting ab... Read more
Symptoms of heart beating faster, louder and harder with mild pleuritic chest discomfort starting about 5 days after second COVID vaccine, ongoing but improving. Got his second COVID vaccine on 5.13.2021. Feels like heart is beating out of his chest, constant throughout the day, worst when laying down. Heart rate up to 100 at home. intermittent shortness of breath. No chest pain. After the vaccine, he developed a high fever for 2 days, a sore arm and tiredness. vitals normal at time of clinic exam today, May 24, 2021 RX: slow breathing, albuterol inhaler, reading recommendation: Breathe by hcp
17 2021-05-23 seizure Patient reported they couldnt stand the sight of blood and had fainted during draws before. Father ... Read more
Patient reported they couldnt stand the sight of blood and had fainted during draws before. Father was present in the vaccine office as well. Immediately fooling the administration of the vaccine patients eyes glazed over and he fainted. A few seconds later he began to have a spastic seizure that was short in nature, followed by a voiding of his bladder before he regained consciousness. Patient was given water, glucose tablets, and instructed to lay on the floor of the room with his feet elevated while a member of the staff stayed with him to treat and watch him. Followed up with patient and doctor soon after to learn this was the only time it has happened, patient fully recovered.
17 2021-05-24 feeling cold, tremor, seizure like phenomena Patient fainted 10 minutes post-vaccination and reportedly had shaking/seizure-like activity. Patie... Read more
Patient fainted 10 minutes post-vaccination and reportedly had shaking/seizure-like activity. Patient felt cold and dizzy and requested transport to ER. Transported to medical center by EMS.
17 2021-05-24 pain in extremity Patient presented with one week of back, right leg and right groin pain. Right lower extremity swel... Read more
Patient presented with one week of back, right leg and right groin pain. Right lower extremity swelling and was diagnosed with deep vein thrombosis from right popliteal vein into IVC involving a renal vein. He is on anticoagulation currently and going for catheter-directed thrombolysis today. Patient has been in hospital two days and hospitalization is ongoing at the time of this report.
17 2021-05-24 seizure, pain in extremity -After receiving 2nd dose of Pfizer, the pt stated that his arm started to hurt, became light headed... Read more
-After receiving 2nd dose of Pfizer, the pt stated that his arm started to hurt, became light headed, the pt began to slump into the seat-assisted to the floor by administering nurse. The pt begun to seize for approx 30 min. Shortly afterwards, the pt became responsive, able to voice name, location and name. MOC was present at side. Client/MOC both verbally deny any previous sz.
17 2021-05-24 tension headache Patient received the Pfizer vaccine in the morning, then woke at about midnight. He went to get a dr... Read more
Patient received the Pfizer vaccine in the morning, then woke at about midnight. He went to get a drink of water, and was holding a glass of water in his hand. He started to feel as if the room was spinning, became very sweaty, had ringing in both ears, and lost consciousness, striking his head on the counter. The event was unwitnessed. He reports waking approximately 1 hour later with a bad headache. He had a headache and felt disoriented. He denies urinary/bowel incontinence or tongue biting. He was able to walk back to his room without difficulty, took ibuprofen, and went back to sleep. He woke the next morning with nausea and vomited, but this did not impact his headache. He has not had any notable neurologic symptoms since that time, but continues to have a minor headache. He has not had any further vomiting. Headache has not subsequently woken him from sleep and does not worsen with recumbent positioning. He denies visual changes, memory changes, difficulty swallowing, shortness of breath, ringing in his ears, or dizziness. He says his headache is located mostly around his forehead and at the top of his head that is now mild and feels like pressure ?like a tension type headache.? His mother is a nurse, and evaluated him the next day. The family did not feel that he needed to be seen in the emergency department, or prior to this visit. He has not had any previous episodes that were similar. Patient was evaluated in my clinic. Complete neurologic exam was within normal limits. He has been referred to neurology for further assessment.
17 2021-05-24 unresponsive to stimuli, muscle twitching, flushing, weakness Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flus... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Tachycardia-Mild, Systemic: Weakness-Medium, Additional Details: Patient and his father sat down in the observation area post vaccination. Within less than 5 min, the father called for help and pharmacy clerk notified the pharmacist that the patient needed attention. Patient had turned white and started to twitch lost consiousness for less than 30 seconds. Epipen was administered by pharmacist (pt was conscious, alert, and oriented nearly immediately after Epipen) and patient was reclined on his back on the floor. BP/ HR monitored while waiting for 911
17 2021-05-25 weakness Within about 5-6 hours of receiving the vaccine, the patient began to develop nausea, vomiting and d... Read more
Within about 5-6 hours of receiving the vaccine, the patient began to develop nausea, vomiting and diarrhea. He took OTC pepto bismol for relief of symptoms which lasted about 6-8 hours. The next day patient was weak and stayed home from work. Fully recovered by day 2.
17 2021-05-25 feeling cold, numbness DAY 1: shaking jaw and body, chills, feeling cold, numb hands all came on suddenly at 10pm. Next da... Read more
DAY 1: shaking jaw and body, chills, feeling cold, numb hands all came on suddenly at 10pm. Next day, headache and somache ache all day. Next day recovered except chest feeling weak and hard to breathe deeply.
17 2021-05-25 numbness, tingling Patient was seen on 5/19/21 complaining of numbness and tingling in both of his hands, face, and mou... Read more
Patient was seen on 5/19/21 complaining of numbness and tingling in both of his hands, face, and mouth, and stated that it started three days prior. He was not having any fevers and there was no known injuries. Dr. ordered a CBC w/ diff, CMP, ferritin, Hemoglobin A1C, iron and TIBC, and TSH, all of which came back normal. Patients' mom called hospital on 5/22/21 stating that he had an incident during a game on 5/21/21 where he became disoriented and felt like he became less alert. He went to the Emergency Department on 5/23/21 with numbness and tingling that was present for one week and a headache for one day. After evaluation it was decided that neurology would see him outpatient. Neurology saw him on 5/25/21 and he said he has had difficulty concentrating and maintaining attention. He has also had memory issues. They ordered an MRI and EEG which have not occurred yet.
17 2021-05-25 pain in extremity Arm pain, runny nose, fever, muscle aches. All symptoms resolved in 48 hours.
17 2021-05-25 pain in extremity Arm pain, runny nose, fever, muscle aches, headache. Second dose symptoms were less severe than firs... Read more
Arm pain, runny nose, fever, muscle aches, headache. Second dose symptoms were less severe than first dose. He had a severe headache after the second dose but not the first. All symptoms resolved within 24 hours, however first dose symptoms lasted longer than the first dose. He had a more severe reaction and longer duration to the first dose than he did the second dose.
17 2021-05-25 tremor BLE and BUE went into abnormal extension; facial tics; shaking of the BUE; Pt was pale, diaphoretic,... Read more
BLE and BUE went into abnormal extension; facial tics; shaking of the BUE; Pt was pale, diaphoretic, and verbalized "I am OK" three times in a row without being asked; Pt was pale, diaphoretic, and verbalized "I am OK" three times in a row without being asked; Pt was pale, diaphoretic, and verbalized "I am OK" three times in a row without being asked; nausea; This is a spontaneous report from a contactable consumer (patient). A 17-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in right arm on 05May2021 13:50 (Batch/Lot Number: EW0167) as single dose for covid-19 immunisation. Medical history were none. Prescriptions, over the counter medications taken were none. Allergies to medication, Food or other products were none. Other illness at the time of vaccination and up to one month prior were none. Chronic or long-standing health conditions were none. The patient's concomitant medications were not reported. 5 minutes following the vaccination, patients BLE and BUE went into abnormal extension immediately followed by facial tics and shaking of the BUE patient was pale, diaphoretic, and verbalized iam ok three times in a row without being asked. patient stated that he was unaware of what had just happened then verbalized feelings of nausea. Airway breathing, circulation intact. patient was placed on gurney, side rails upx2, and transported to ED. The patient never had an adverse event following any previous vaccine. Event start date was 05May2021. Medical tests and laboratory results related to the adverse events included: Vital signs, EKG, CT of the head. Emergency room/department or urgent care visit. Outcome was recovered. Follow-up attempts are needed. further information is expected.
17 2021-05-25 unresponsive to stimuli Site: Bruising at Injection Site-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Faint... Read more
Site: Bruising at Injection Site-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe
17 2021-05-26 cold sweat Approximately 15 mins after vaccination, patient had complaints of feeling lightheaded, nauseated, w... Read more
Approximately 15 mins after vaccination, patient had complaints of feeling lightheaded, nauseated, with diaphoresis. RN arrival at car noted skin of patient cool and clammy. Patient reported minimal dietary intake. Patient given OJ and gummies. VITALS: T 97.8, HR 72 , BP 122/82, O2 97% RA, RR 20. Lungs CTAB. No pruritis or SOB. 12:59 PM--patient reporting that symptoms resolved, patient had companion in car and did not drive home and left site in NAD.
17 2021-05-26 cold sweat Client became lightheaded and clammy. Responsive to verbal and tactile stimulation. No loss of con... Read more
Client became lightheaded and clammy. Responsive to verbal and tactile stimulation. No loss of consciousness. Alert, aware and responsive. Skin noted to be moist and clammy to touch. Pale complexion. Dad was present during event. Dad stated client was recovering from COVID-19. Had his last negative test on 5/14/2021. Dad did not want 911 services activated, however, he stated and nursing also advised that he take client to see his PCP. Upon exit, client was alert, verbal and ambulatory. No sign of acute distress. Exit at 3:47pm.
17 2021-05-26 tingling complained of chest pain, heart palpitation, jaw pain, tingling on fingers on both hands after wakin... Read more
complained of chest pain, heart palpitation, jaw pain, tingling on fingers on both hands after waking up at 7:00AM 05/26/2021, denied nausea/vomiting
17 2021-05-27 unresponsive to stimuli When patient arrived his guardian was not here so he sat and waited. When dad came, we registered pa... Read more
When patient arrived his guardian was not here so he sat and waited. When dad came, we registered patient as normal asking if he feels ill or not and he stated no. When I brought him back to the room we were talking about school and activities he is in and he seemed normal and answering normally just tired. I cleaned his arm and talked him through things that can happen with the second dose of Pfizer. He seemed just fine and once I injected and bandaged him he went stiff and I tried to talk to him and he did not respond. I called for help and they got his dad. he finally started coming too and was extremely warm. I sat with him for 10 to 15 minutes and rubbed his back and we got him water to drink. we started an incident report right away while talking to the dad. nothing further happened and he was told to go straight to the clinic to be checked out.
17 2021-05-28 facial paralysis, bell's palsy 6 days post vaccine patient presents to clinic with Left side facial paralysis, left blurred vision... Read more
6 days post vaccine patient presents to clinic with Left side facial paralysis, left blurred vision, and left ear pain. Bells Palsy.
17 2021-05-30 tremor, weakness Systemic: Dizziness / Lightheadness-Mild, Systemic: Shakiness-Mild, Systemic: Visual Changes/Disturb... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Shakiness-Mild, Systemic: Visual Changes/Disturbances-Mild, Systemic: Weakness-Mild, Additional Details: pt became lethargic , dizzy and visual disturbance. called ems laid pt on the ground and monitored vitals ok gave water and snack pt stayed extra and was ok with parent when left called later pt doing well and resting
17 2021-06-01 seizure, unresponsive to stimuli Systemic: Fainting / Unresponsive-Severe, Systemic: patient had a seizure about 5 mins following adm... Read more
Systemic: Fainting / Unresponsive-Severe, Systemic: patient had a seizure about 5 mins following adminstration-Severe, Systemic: Seizure-Severe, Additional Details: ems was called and patient was evaluated and pt was cleared with normal vitals and alert from ems parent refused to go to er i tried calling to follow up with patient and now answer on best contact number
17 2021-06-02 numbness Fever, nausea, headache, chills, hand numbness
17 2021-06-02 pain in extremity He had normal - tired, kind of sicky feeling when he woke up on Thursday. At 07:00pm, he had pain be... Read more
He had normal - tired, kind of sicky feeling when he woke up on Thursday. At 07:00pm, he had pain behind his right knee. I told him to drink more water and I gave him some Tylenol. I told him to keep me posted as to how he felt. The next morning, he said he hadn't slept all night - he had a dull pain that didn't go away when he moved. It traveled up his upper leg and up to his right hip. Moving and stretching didn't make it go away. Constant dull pain. I took him to ER. It took 36 -48 hours before it faded. He didn't wake up with it on Saturday.
17 2021-06-03 weakness, flushing Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy... Read more
Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Mild, Systemic: fast heartrate-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Weakness-Mild, Additional Details: patient was not feeling well sitting, so he laid on ground. went to check up on him, he felt clammy sweaty, but responsive. mom was there but not terrible concerned, declined 911 call. gave patient water and he was okay half hour later
17 2021-06-04 pain in extremity Accidently administered an undiluted dose of the Pfizer BioNTech Covid 19 vaccine; He has experience... Read more
Accidently administered an undiluted dose of the Pfizer BioNTech Covid 19 vaccine; He has experienced is a sore arm; He also had some diarrhea; Accidently administered an undiluted dose of the Pfizer BioNTech Covid 19 vaccine; This is a spontaneous report from a contactable pharmacist. A 17-year-old male patient (age at vaccination 17-year) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration on 20May2021 as unknown, single dose for COVID-19 immunization. Medical history included autism and bowel issues from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date the patient experienced he has experienced is a sore arm and he also had some diarrhea. Pharmacist accidently administered an undiluted dose of the Pfizer BioNTech Covid 19 vaccine on 20May2021. Mother reports that all that he has experienced is a sore arm. He also had some diarrhea a few days later but he has a history of bowel issues. The clinical outcome of the events was unknown. Information on the lot/batch number has been requested. Amendment (PSSR): This follow-up report is being submitted to amend the previously reported information which includes: Deleted the event "Vaccination site pain" since there was no indication the pain in injection site and removed the classification "At Risk".
17 2021-06-06 cold sweat Client became light headed and clammy. Responsive to verbal and tactile stimulation. No loss of co... Read more
Client became light headed and clammy. Responsive to verbal and tactile stimulation. No loss of consciousness. Alert, aware and responsive. Skin noted to be moist and clammy to touch. Pale complexion. Dad was present during event and stated client was recovering from COVID-19, had his last neg. test obtained on 5/14/21. Dad did not want 911 services activated, however, he stated and nursing also advised that he take client to see his PCP. When exit, client was alert, verbal and ambulatory; no sign of acute distress. Exit at 3:47pm.
17 2021-06-06 discomfort Reported by mother. When he got his vaccine, he went home and had no reaction. The next morning h... Read more
Reported by mother. When he got his vaccine, he went home and had no reaction. The next morning he had a fever of 103, and gave her Tylenol chewable. The following day he has no fever, in the early at 4:00 AM he woke up with pain on his chest. He said that he felt weird, tightness on his chest and he could not actually describe it, said it was in the middle of his chest. It was uncomfortable but uncomfortable and was worried. They observed him, the pain didn't go away, just on the chest. If he tried to sit up he felt better, but when he laid down the pain was always there. Around 3:00 PM she brought him to the ER and had tests run, and all tests were okay. His EKG showed ST-elevations and inflammation of the heart. He had an US of the heart and was discharged home this morning. He has to be seen by his PCP to be referred to a cardiologist. He was given some medications and is sleeping right now. He has an APT with his PCP on 6/9/21. He was sent home to take Ibuprofen.
17 2021-06-06 feeling cold, unresponsive to stimuli Approximately 4 minutes after the COVID vaccine the patient said he was cold then passed out while s... Read more
Approximately 4 minutes after the COVID vaccine the patient said he was cold then passed out while sitting in a chair in the pharmacy waiting area. His mom was nearby and tapped him and called his name. When I arrived Patient was pale, unresponsive and had a pulse of 66 and his skin was sweaty. His dad called 911. Over a four minute period Patient slowly began to regain color in his face. He knew where he was as well as the day of the week. 911 arrived and all of his vitals were good. The family declined going to the hospital because Patient felt much better.
17 2021-06-06 feeling hot pt complained of feeling hot, sweaty and lightheaded approximately 10 minutes after vaccine administ... Read more
pt complained of feeling hot, sweaty and lightheaded approximately 10 minutes after vaccine administration. pt was moved to a cool area and given the opportunity to lie down after drinking a few sips of water. pt very quickly calmed down and stated that he was feeling better, though he was kept for a 30 minute observation. at the end of the period, he was reassessed and found to be ok. pt was released to the care of his mother.
17 2021-06-06 feeling hot 6-4-2021 15:30. Subjective: This 17 y/o male pt presented to the vaccine administration site and was... Read more
6-4-2021 15:30. Subjective: This 17 y/o male pt presented to the vaccine administration site and was administered his first dose of the Pfizer Covid-19 vaccine. Prior to receiving the vaccine the patient had made a comment in regards to not liking needles. Following vaccine administration the pt stated that he began to feel dizzy and ?then things went dark.? The patient was seated vertically in a chair and had fallen forward onto the ground. Patient care was immediately administered and the patient was moved supine with his lower extremities elevated. The patient regained consciousness immediately and asked if he had ?fainted?? The patient then stated that he was very warm and had not eaten or drank very much today. The patient attempted to then sit up rapidly from a supine position causing him to have a second vasovagal syncopal episode. The patient was placed in a supine position following this and cold packs were administered as well as vitals were taken. The patient remained A&O X4 with a GCS of 15 for the remainder of patient contact. EMS was called and the patient was then transported with consent of his legal guardian to the nearest E.D. Objective: Pt was noted to have two consecutive vasovagal syncopal episodes following his first dose of the Pfizer Covid-19 vaccine. The patient stated he had not eaten or drank very much today. Assessment, PE,VS: The patient was noted to have a small abrasion to the right side of his face secondary to his glasses striking him after he had fallen. The patient's BP was noted to be 100/60 mmhg with a pulse of 64. The patient was A&O X4 with a GCS of 15 following his two separate syncopal episodes. HEENT: All findings normal, pt?s pupils PERRLA at 4mm. Cardiac: Normal Pulmonary: Normal, however verbal respiratory rate control was advised to the pt. Abdomen: Normal, cold compress applied. Extremities: Normal, Cold compress applied. Plan: Pt was continuously monitored and transferred to EMS care for transport to the nearest
17 2021-06-06 numbness, tingling First shot received on 4/3/21, and second received on 4/24/21. Symptoms of cold, tingling, and numb ... Read more
First shot received on 4/3/21, and second received on 4/24/21. Symptoms of cold, tingling, and numb left toes and left foot noticed about 2 weeks after 2nd Pfizer dose. Went to ER and blood clots were found in arteries in left knee and ankle, and clots in the vein in left calf. Four procedures performed by Intervention Radiology (IR) at Hospital on 5/25/21, and was treated with Heparin and TPA. Released from hospital with clot remaining in left calf vein and is taking Eliquis. Continuing treatment with hematologist post release from hospital.
17 2021-06-06 numbness, tingling Day 2 - fever and muscle aches Day 3 - chest tightness and discomfort; tingling and numbness in both... Read more
Day 2 - fever and muscle aches Day 3 - chest tightness and discomfort; tingling and numbness in both arms and hands
17 2021-06-07 weakness feeling exhausted/fatigue/he felt tired; not feeling well/feels crummy; body aches; fever/temperatur... Read more
feeling exhausted/fatigue/he felt tired; not feeling well/feels crummy; body aches; fever/temperature was 99.1; running nose; stuffy head; a little weak; barely could get out of bed; sore throat; This is a spontaneous report from a contactable consumer (parent) via medical information team reported for a 17-year-old male patient (son). A 17-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection) via an unspecified route of administration on 29May2021 11:00 as single dose for COVID-19 immunisation. Medical history and Concomitant medications were not reported. Patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) for COVID-19 immunisation. It was reported that caller was calling about his son who recently had his second covid vaccine. He had the first one, no issues and the second shot on Saturday at 11 am. Patient was feeling exhausted/fatigue/he felt tired on 30May2021, not feeling well, body aches, fever all in 2021, took Advil for it and felt normal. still has running nose, stuffy head, sore throat all in 2021. Since then he has felt worse. Each day, he has symptoms. He was feeling a little weak, body aches and temperature was 99.1 and he feels crummy all in 2021. He doesn't know what it seems like, we all had the vaccine. We had Moderna was it normal to have these symptoms. It didn't onset for a couple days later and now its Wednesday he received it on Saturday. He felt a little crummy then on Sunday worse. He wants to know if that's normal or if it continues for another day take him to the doctor. What should he be doing or looking for and today he barely could get out of bed in 2021. The outcome of event malaise was not recovered, for fatigue, general body pain, fever was recovering, for remaining events was unknown. Follow-up attempts not completed; information about lot/batch number cannot be obtained. No further information expected.
17 2021-06-07 numbness On 4/6 my son noticed changes with his vision which continued to 4/7 at which time we brought him to... Read more
On 4/6 my son noticed changes with his vision which continued to 4/7 at which time we brought him to his pcp. She referred us to his eye doctor. They got him in that afternoon, did an exam, told us to follow up that Friday. At the 4/9 follow up he was diagnosed with sixth nerve palsy on the left eye. We scheduled a MRI and lab work. Lab work came back fine. He went for the MRI on 4/16. The MRI showed several brain lesions pointing towards MS. We went to a medical center on 4/20 where they thought the finding lesion were incidental and not related to MS. We saw a neuro-opthamologist on 4/21, who said he felt my son did have MS with sixth nerve palsy. We saw a neurologist on the afternoon of 4/21 who said patient didn't meet the criteria of MS and to follow up another MRI in 3 months. That weekend patient started with areas on numbness. He was due for second covid injection which all providers agreed with us getting. He got his second dose on 4/24 during this flare of numbness. We went back the neurologist on 4/26. Patient was given a three day iv steroid infusion, lab work and follow up MRI. The follow up MRI showed more lesions in his brain which lead us to the neurologist in another state. Dr reviewed both MRIs, felt the lesions were incidental, the flare of numbness as well at the sixth nerve palsy of his eye were related to inflammation related to the vaccine he received.
17 2021-06-07 seizure seizure within 3 min of receiving vaccine, sent to hospital by ambulance.
17 2021-06-08 feeling hot after injection. patient stood up and fainted. the patient hit his head on the floor. staff elevated... Read more
after injection. patient stood up and fainted. the patient hit his head on the floor. staff elevated legs on chair. patient regained consciousness. LOCx4., responsive, warm to touch, Denies headache, SOB, lightness and dizziness. EMT arrived at 0906: vital within normal limits. 0910 Fire EMT arrived. patient's mother refuse to go hospital. Vitals: @0906 1st, 130/62, 96% O2, 77 HR and Glucose: 105. 2nd vitals @ 01917: 130/64, 99% O2, HR 93. NP; NP reassessed and released patient after 30 minutes inn observation.
17 2021-06-09 inability to speak Client started getting pale and sweating. He would not talk. Had his head down. Got him water. Took... Read more
Client started getting pale and sweating. He would not talk. Had his head down. Got him water. Took vitals his heart rate was in the 30's and at times oxygen sats were in the 70's. Put a cold wet wash cloth on his neck. No rash noted. Heart rate and oxygen slowly started to go up. He started talking and being "himself" again.
17 2021-06-09 flushing Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Dizzines... Read more
Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: LOSS OF VISION SHORT TERM-Mild, Systemic: Flushed / Sweating-Mild
17 2021-06-09 tremor, seizure within 1 minute of administration pt felt dizzy and was helped to a chair. He went pale and eyes ro... Read more
within 1 minute of administration pt felt dizzy and was helped to a chair. He went pale and eyes rolled back. He had trouble holding his head up, he continued to wobble his upper body around while seated. Mom reported he shook/seized. We gave him a bottle of water and monitored. He continued to appear pale and his head rolled back, and onto a merchandise shelf. 911 was called. In < 10 minutes from initial symptoms EMS arrived. Pt sysolic bp was 80 per EMT. pt was taken to ER for further evaluation
17 2021-06-10 weakness not able to function; sleeps all day; lost 14 pounds since the second dose of the vaccine/lost anoth... Read more
not able to function; sleeps all day; lost 14 pounds since the second dose of the vaccine/lost another 4 pounds over the weekend; chest hurt; Shortness of breath; fatigued and very weak; fatigued and very weak; Headache; cannot focus on school online; blood pressure goes up and down; heart rate goes up and down; Dizziness; muscle mass depleting; This is a spontaneous report from a contactable consumer (patient's parent). A 17-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 2 via an unspecified route of administration, administered in the right arm, at age 17 years, on 12Apr2021 (Batch/Lot Number: EW0158) as 2ND DOSE, SINGLE DOSE for COVID-19 immunisation. Medical history included pressure in his eye from an injury, asthma (diagnosed when the patient was about 2) and has family members with asthma and heart conditions. Patient is in perfect health, he works out 6 days a week, and does football conditioning 5 days a week. 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 none. Concomitant medication included timolol taken for pressure in his eye from an injury from an unspecified start date to 20May2021. Additional vaccines administered on same date of the Pfizer Suspect was none. The patient historically received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number: EP7534) at the left arm at age 17 years on 22Mar2021 for COVID-19 immunization. The patient got his second dose of the vaccine on 12Apr2021 and shorty after on 19Apr2021, he became very fatigued, very weak, his chest hurt, and he had shortness of breath. On Apr2021, patient had dizziness. The patient used to have bulky arms and now you can see his muscle mass depleting in Apr2021. The patient cannot focus on school online because of the headaches from 19Apr2021. The patient's blood pressure goes up and down from 19Apr2021. For days from 19Apr2021, the patient's heart rate will be fine in the 60s and it goes up to 120 or 130 with chest pain, it fluctuates depending on the day. The patient visited the emergency room on 05May2021, but was not admitted and no one knows what was going on with the vaccine. It was also reported that the patient lost 14 pounds on 25Apr2021 since the second dose of the vaccine. They knew the patient has already lost 10 pounds and then yesterday, 25May2021, the patient weighed himself and noticed he has lost another 4 pounds over the weekend. Patient had bloodwork on 20May2021 and it was all negative. The primary care provider was concerned about the weight loss so she ran a bunch of blood work. The patient is negative for COVID test and chest x-ray on 21May2021 and he has had multiple tests done. The patient went to his primary care provider on 25May2021 (yesterday from the time off reporting) and the reporter mentioned that maybe can they look at this as being a side effect from the vaccine. The patient's doctor laughed and said nothing has been proven yet about this. The reporter felt that this is a reaction to the vaccine. At the time of reporting on 26May2021, the patient was not able to function and sleeps all day. The patient also underwent lab tests and procedures that includes being tested negative for mono twice now (on unspecified dates). Clarified that they have not filed a safety report with Pfizer on the patient's events. The outcome of the events 'dizziness', 'lost 14 pounds since the second dose of the vaccine/lost another 4 pounds over the weekend', 'muscle mass depleting', 'cannot focus on school online', 'not able to function' and 'sleeps all day' was unknown; while for the other events, it was not recovered.
17 2021-06-10 burning sensation Approximately 24 hours after secondPfizer dose, 17 year old male awoke in the morning and was compl... Read more
Approximately 24 hours after secondPfizer dose, 17 year old male awoke in the morning and was complaining of intense throat pain radiating into the upper chest relieved by sitting up. NSAIDS not helpful, went to narcotic med to relieve, which it did with single tab of medication. Other symptoms, fatigue, body aches, low fever. Waxed and waned over 48 hour time period from onset, with another intense episode of throat/chest pain 24 hours in from onset requiring narcotic pain med to relief. Again this was in the morning. One episode of vomiting during second intense period with what looked like water that just hadn't gone down his throat, and following this he reported some relief from what he described as a radiating burning sensation up under the lower jaw and radiating into the upper chest. No shortness of breath ever. Burning sensation in throat and chest resolved by 72 hours with no more episodes of the acute throat and chest pain after the two episodes. While ED was considered due to the distress being experienced, we decided against since the narcotic med was helping and no shortness of breath was being experienced. I did try to get on with the CDC to report my concerns when it was happening to see if others were reporting this, then because it was a concerning reaction, but site was difficult to navigate and I was trying to monitor. I did not call the pediatrician at that time as I am a health care worker and felt I could assess and make decisions based on findings. Following the recent reports of myocarditis in teens, especially males, I felt obligated to report this experience. This child has no history of heart ailment. No tests were done to assess what might have been the cause. I assumed it was an outside-the-box reaction to the second Pfizer dose.
17 2021-06-10 flushing Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Dizzines... Read more
Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: LOSS OF VISION SHORT TERM-Mild, Systemic: Flushed / Sweating-Mild
17 2021-06-10 flushing Systemic: Fever-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: pt reported sweating, g... Read more
Systemic: Fever-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: pt reported sweating, gave him tylenol, and a glass of water
17 2021-06-11 tingling, muscle spasms, numbness Headache, body numbness ,muscle cramp,tingling all over the body, extreme pain, not able to walk As... Read more
Headache, body numbness ,muscle cramp,tingling all over the body, extreme pain, not able to walk As of today, june 12 2021, he still in pediatrics department, since June 7 2021.
17 2021-06-13 cold sweat Patient was thirsty and clammy and felt like he was going to faint. He got up and started to fall. ... Read more
Patient was thirsty and clammy and felt like he was going to faint. He got up and started to fall. He was laid down on floor with feet elevated. After about 5-7 minutes he felt better and sipped some water. He was helped up to chair and remained seated for an additional 10 minutes at which time his mother stated he was feeling like himself and the left the pharmacy
17 2021-06-13 discomfort He had the second shot, had very mild headache, and then woke up approx 48 hours after 2nd dose, com... Read more
He had the second shot, had very mild headache, and then woke up approx 48 hours after 2nd dose, complaining that his " chest hurt", I asked him to explain the " hurt", he said his chest felt tight, heavy pressure, like weight on his chest, uncomfortable. He said it went away after a few days... I didn't realize the inflammation of the heart was a side affect, until I recently heard that was coming up, so I put 2 and 2 together, and thought I had better report.
17 2021-06-14 seizure like phenomena Vaccine administered at 1215 pm. In waiting area around 1225 pt felt very faint sitting in chair nex... Read more
Vaccine administered at 1215 pm. In waiting area around 1225 pt felt very faint sitting in chair next to grandmother. Patient appeared to have seizure like activity and paramedic called immediately. After 1 to 2 minutes patient started responded well and just stated she felt very faint. Paramedics arrived and waiting for patient to fully recovered. They did state her blood pressure decreased to below baseline but quickly came back up to normal as patient started feeling better. They deemed patient to be stable and didn't think it was from the vaccine itself versus receiving an injectable vaccine as patient often feels faint after giving blood. They walked patient and grandmother to their personal car so she coudl be taken home.
17 2021-06-14 unresponsive to stimuli The pt received the Pfizer vaccine and after 1-2 minutes of sitting the pt fainted and bumped his he... Read more
The pt received the Pfizer vaccine and after 1-2 minutes of sitting the pt fainted and bumped his head on the concrete floor. The pt was sweating and not responding for about 5 minutes, after the pt was awake and the EMS saw him the pt started feeling much better and did not wan t to go to the hospital. The pt only had juice and it was after 1:00pm so this could have been a contributing factor. The pt stayed 30 more minutes with me after the EMS left and he was completely fine. I also think the pt since he was a minor was really nervous.
17 2021-06-15 unresponsive to stimuli Systemic: Fainting / Unresponsive-Mild, Systemic: Tinnitus-Mild, Additional Details: The patient fai... Read more
Systemic: Fainting / Unresponsive-Mild, Systemic: Tinnitus-Mild, Additional Details: The patient fainted about 3 minutes after receiving second dose of covid vaccine. He came around within 15 seconds then fainted again for a few seconds. An ambulance was called. He was given water and orange juice and let rest. She said his ears were ringing but that subsided quickly. The paramedics came and checked vital signs and all was normal so he did not go to the hospital. He said he was feeling fine and left after resting about 40 minutes.
17 2021-06-16 feeling hot Patient was administered the COVID19 vaccine and 5 minutes later, while in the observation chair, fa... Read more
Patient was administered the COVID19 vaccine and 5 minutes later, while in the observation chair, fainted and fell to the ground. His mother was present with him and the pharmacy staff rushed over to help. He came to after a minute or 2, but the paramedics were called immediately. Patient was a sweaty, hot. Paramedics arrived, did some test and said his blood pressure was low. They proceeded to take him to the hospital. Mom called around 3pm 6/17 and informed the pharmacy staff he was administered fluid, they ran more tests and he was waiting to be released.
17 2021-06-17 weakness, flushing Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Medium, Systemic: W... Read more
Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Medium, Systemic: Weakness-Medium
17 2021-06-17 feeling of body temperature change My son got both his 2nd dose of the Pfizer COVID-19 shot as well as a booster for Tdap. (Unsure of w... Read more
My son got both his 2nd dose of the Pfizer COVID-19 shot as well as a booster for Tdap. (Unsure of which Tdap or lot#) at 11:30 pm 6/18/2021 he was fine. About 30 mins later he was hit hard with side effects. Said he was very shaky and felt hot and cold at the same time. He did not let me know about this until this morning around 7:50 am 06/19/2021 about how he was feeling and he was still feeling very bad, advised him to take tylenol and he took that and went back to sleep. Around 12:00 PM 06/19/2021 I was finally able to check his temperature and other vitals. His temperature was normal, but his heart rate was 138 bpm. I made him sit down and relax for a bit and heart rate leveled out to normal. He also reported he is afraid to eat that he feels nauseous. As of this afternoon 06/19/2021 he seems to be feeling better.
17 2021-06-17 muscle spasms, pain in extremity He had sharp chest pains that would come and go in left side near ribs beginning around noon on 6/1... Read more
He had sharp chest pains that would come and go in left side near ribs beginning around noon on 6/17/2021. They seemed to worsen throughout day & with laying down. Then, increasing pain along left side of body into hip and leg around 5:30pm. He experienced very "bad, cramp-like" pain in left calf area around 6:30pm. Sharp Chest pains intermittent at "10 pain level" & lower left leg at "8 pain level". Some nausea and vomited once at this point. We called the urgent care line for our doctor's office and spoke with nurse who instructed us to go to the ER. They performed ECG and Chest XR. Labs were BMP, CBC, CK, D-dimer (quantitative), & Triponon-I. They gave 800mg Motrin, IV fluids and keterolac in IV. They said they "did not identify a specific problem" but to rest, take ibuprofen, and follow-up with doctor and cardiologist. They said it was most likely related to the Covid-19 vaccination but could not give causation. Patient seems fine so far today, but still has medication in system.
17 2021-06-18 feeling hot Patient received vaccination and shortly after patient started to feel dizzy. Patient then fainted f... Read more
Patient received vaccination and shortly after patient started to feel dizzy. Patient then fainted for about 30 seconds then regained conciousness. Patient reported to feel hot after waking up. Otherwise back to normal.
17 2021-06-18 night sweats night sweats; different things like that, joints; The initial case was missing the following minimum... Read more
night sweats; different things like that, joints; The initial case was missing the following minimum criteria: adverse event NOS. Upon receipt of follow-up information on 11Jun2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (Patient's mother). A 17-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and Expiry date was not reported) via an unspecified route of administration on an unspecified date as 1st dose, single dose (17-years age at the time of vaccination) for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, Consumer reported that patient received his first dose. Consumer does not remember the date. On an unspecified date, patient had symptoms (night sweats, different things like that, joints). Patient was sensitive to a lot of things, so consumer is nervous. Consumer heard of healthy people getting the vaccine and dying shortly after. Consumer further wanted to know if he should get the second dose. Consumer indicated he was to have his second dose on Monday but awaiting blood test from HCP, delayed until 14Jun2021. On an unspecified date, the patient underwent lab tests and procedures which included blood test with unknown result. The outcome of events was unknown. Information lot/batch number requested.
17 2021-06-20 weakness Woke up in the middle of the night with a fever around 101 Fahrenheit. Also had chills, severe heada... Read more
Woke up in the middle of the night with a fever around 101 Fahrenheit. Also had chills, severe headache, lack of energy, and no appetite. Condition significantly improved over the next 24 hours without seeing a doctor or taking any medication.
17 2021-06-21 weakness S/p COVID-19 vaccine and COVID-19 test uc reports "not feeling well" upon questions with Childcare t... Read more
S/p COVID-19 vaccine and COVID-19 test uc reports "not feeling well" upon questions with Childcare translator. UC verbalized feeling dizzy, rapid HR, and weak.
17 2021-06-23 seizure Patient had a syncopal episode within 15 minutes of vaccination. He then had seizure-like activity.... Read more
Patient had a syncopal episode within 15 minutes of vaccination. He then had seizure-like activity. He rested and felt better; patient was released to home.
17 2021-06-24 facial paralysis, bell's palsy 3 days after vaccine work up with unilateral facial paralysis
17 2021-06-24 pain in extremity dizziness, soar harm
17 2021-06-27 unresponsive to stimuli BP 101/60 (BP Location: LA-LEFT ARM, BP Patient Position: LYING, Cuff Size: Standard Adult) | Pulse... Read more
BP 101/60 (BP Location: LA-LEFT ARM, BP Patient Position: LYING, Cuff Size: Standard Adult) | Pulse 59 | Resp 16 | SpO2 99% Location of event Vaccine Center Description of Event: Pt appeared pale and nurse asked if he was ok. Pt slumped over and didn't respond to questions momentarily. When pt finally did respond he said he was ok but looked pale and diaphoretic. Interventions: Given water, juice, brought to gurney, assessed, vitals taken. Medications administered: None Response to interventions and/or medications given: Improved to baseline Additional information: Mom was present for whole event. Disposition: Home Treatment
17 2021-06-28 numbness initially numbness of right arm reported on day of second vaccine. noted to have muscle aches and pa... Read more
initially numbness of right arm reported on day of second vaccine. noted to have muscle aches and pains on day one after second vaccine dose. two days after vaccine, was complaining of severe chest pain, so was taken to ED.
17 2021-06-28 unresponsive to stimuli, seizure, tingling Patient had shallow breathing and mentioned pain with each breath, otherwise no other symptoms. Care... Read more
Patient had shallow breathing and mentioned pain with each breath, otherwise no other symptoms. Care team was in the room providing discharge assessment. Provider and patient verbally confirmed agreement to receive vaccine despite pain. Shortly afterwards, patient complained of shortness-of-breath but maintaining SATs and tachypneic, patient complained of not being able to feel upper extremities despite pressure on fingers. Non-rebreather was placed. Patient then became unconscious, sternal rubs were provided without response. The code team was called and patient began to seize. Ativan was administered and patient was prepared for intubation. Patient was intubated on the floor and subsequently transferred to PICU (Pediatric Intensive Care Unit).
17 2021-06-29 speech disorder Pt pale and diaphoretic, unable to speak for a few seconds, with shallow resp. 911 called Laid dow... Read more
Pt pale and diaphoretic, unable to speak for a few seconds, with shallow resp. 911 called Laid down on cot bed, obtained vs, and monitored pt. until paramedics arrived on scene. Pt evaluated returned to baseline with VSS on RA, released to mother, who took pt to urgent care for further evaluation via private vehicle
17 2021-06-30 unresponsive to stimuli Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unrespons... Read more
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Additional Details: pt fainted after getting second pfizer shot. was placed in supine position/water given later. bp,pulse was normal. emt/911 called and was checked in detain in ambulance.
17 2021-07-04 hot flush, cold sweat Woke up with cold sweats on 6/22/2021. By late morning spiked a fever (100.4) and was very tired. Sw... Read more
Woke up with cold sweats on 6/22/2021. By late morning spiked a fever (100.4) and was very tired. Switched between cold chills and hot flashes. Sent home from work and slept for about 3 hours in mid afternoon. Once awake, felt much better. Symptoms gone by dinner time. Took Ibuprofin.
17 2021-07-05 unresponsive to stimuli, seizure, tremor, flushing Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flus... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Medium, Systemic: Seizure-Medium, Systemic: Shakiness-Medium, Systemic: Visual Changes/Disturbances-Severe, Additional Details: Patient received pfizer covid vaccine in left deltoid. 5 minutes after shot he complained of visual changes. He sat down and said he could not see then lost conciousness and had mild convulsions for about 10 seconds. He regained counciousness but still could not see. pupals very dialated. 911 was called. Patient had temp of 97.8 and osat of 99. vision loss continued for 10-15 minutes but patient was concious. EMTs arrived on scene. blood glucose 102, BP 92/46. very low. recommended he go to ER.
17 2021-07-07 weakness, unresponsive to stimuli Systemic: Fainting / Unresponsive-Medium, Systemic: Weakness-Medium
17 2021-07-07 bell's palsy Patient visited primary doctor two weeks after receiving vaccine complaining of flu like symptoms, w... Read more
Patient visited primary doctor two weeks after receiving vaccine complaining of flu like symptoms, was diagnosed with viral infection, a week or so later he had trouble closing his eyelid, he went to urgent care where they diagnosed him with Bell's palsy.
17 2021-07-07 bell's palsy 17 yo male presented with Bell's palsy which started on 5/29/2021. First Pfizer dose 4/26/21, second... Read more
17 yo male presented with Bell's palsy which started on 5/29/2021. First Pfizer dose 4/26/21, second dose 5/17/21. Negative Lyme testing x2. No viral symptoms. No recent dental work. Treated w/prednisone 60 mg x 7 days. Symptoms improving but not resolved as of last office visit 6/24/21.
17 2021-07-08 tremor, flushing, weakness, unresponsive to stimuli, tingling Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainti... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Weakness-Medium, Additional Details: After recieving the pfizer covid-19 vaccine, Patient briefly passed out while sitting down less than 5 minutes after the vaccine. Subsequently his mother screamed out for help, I ran over took his pulse, which was present but slightly faint, and almost used the epipen but he came back to consciousness before it was injected. Upon inital observation when I came over the patient was very pale and sweaty. We called 911 and shortly thereafter the medics took him to emergency room.
17 2021-07-08 unresponsive to stimuli, weakness, tremor Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainti... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Shakiness-Medium, Systemic: Weakness-Medium
17 2021-07-09 tingling, tingling Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
17 2021-07-10 severe one side paralysis Patient presented with altered mental status, hemiplegia, headache and vomiting. Initially concernin... Read more
Patient presented with altered mental status, hemiplegia, headache and vomiting. Initially concerning for viral meningitis. Symptoms improved and then recurred 2 more times prompting further evaluation. Symptoms consistent with atypical hemiplegic migraine or atypical migraine. EEG with hemispheric slowing.
17 2021-07-11 numbness At 2:25pm patient c/o SOB, increasing heart rate, hard to breathe, numbness all over body, and high ... Read more
At 2:25pm patient c/o SOB, increasing heart rate, hard to breathe, numbness all over body, and high level anxiety. Nurse took his blood pressure and tried to help patient stabilize his breathing in brown bag. Requested EMS immediately and patient was transported to hospital. HR: 170 BP: 150/100 Resp: 26
17 2021-07-11 migraine A few hours after the vaccine he got chills and muscle aches. This continued into the next day and ... Read more
A few hours after the vaccine he got chills and muscle aches. This continued into the next day and he got a bad headache and couldn't go to school. Went to school Wednesday and came home with a migraine. He had migraines, congestion and extreme fatigue for next ten days. He was diagnosed with a sinus infections but could not break migraines so ended up in the ER and had an adverse reaction to Compazene. His heart rate dropped to below 42 beats per minute and his blood pressure was all over the place. He was basically sick for 6 weeks after getting the vaccine.
17 2021-07-11 pain in extremity PT is a 17 y/o previously healthy boy who presents with 3 days of moderate-severe, substernal chest ... Read more
PT is a 17 y/o previously healthy boy who presents with 3 days of moderate-severe, substernal chest pain, dyspnea, and nausea 2 days after receiving the 2nd dose of the Pfizer COVID-19 vaccine. On Tuesday (7/6), PT received the second Pfizer COVID-19 vaccine. The following day (Wednesday 7/7) PT had "flu-like symptoms" with chills, subjective fever, and a sore arm that resolved by Thursday (7/8). He was back to his baseline state of health on Thursday (7/8) and felt fine that whole day. On Friday afternoon (7/9) when he was at work washing dishes where he had some physical exertion he began to notice at 16:30-17:00 that he developed substernal, sharp, 7/10 chest pain that did not radiate, improve/worsen with deep breaths, sitting up, laying down or with movement of his upper extremities. It worsened towards the end of the night and peaked at 8/10 by 22:00-23:00 that same evening. His sister picked him up from work per his regular routine and he went home and took a shower which improved the pain to a 5-6/10 when he went to sleep. He woke up at 3 AM on Saturday (7/10) AM and had one episode of NBNB emesis associated with the chest pain. When he woke up later that morning he felt improved until 10-12 AM he developed mild chest pain again which he took Tums for. He also tried Motrin which did not help his pain at all. On the morning of admission (7/11), he woke up at 6-7 AM with upper right back pain, dyspnea, and nausea along with the persistent chest pain which prompted him to present to MFSH. He does endorse mild sore throat but denies any fevers, recent sick contacts, known COVID-19 exposure or previous history of COVID-19. There is a family history of cardiac disease including a fatal MI in his father. His mother's family also has a history of heart disease and both sides have a history of high cholesterol. He did add Whey Protein recently to his diet to for muscle building, but he DENIES any drug, alcohol, tobacco, vaping, marijuana, THC use. He does not play any sports regularly. He also denies any recent bug/tick bites or rashes.
17 2021-07-13 weakness 13:25 Patient received vaccination. 13:38 Observation staff noted patient looked fatigue and request... Read more
13:25 Patient received vaccination. 13:38 Observation staff noted patient looked fatigue and requested clinician to examine patient. 13:40 Clinician inquires about s/sx. Patient appeared not in distress. Speech cohesive and comprehensive. Patient noted body weakness 5 minutes post-vaccination. 13:42 Clinician asked scriber to obtain water for patient and RN to continue observing while clinician obtains sphygmomanometer and stethoscope. 13:43 Clinician obtained vital signs manually. BP: 132/84 P: 74 RRR. No adventitious sounds. Clinician continued to monitor for additional 15 minutes. 13:58 Patient informed clinician he feels better. Clinician observed patient completed one 8 fl oz water bottle. Clinician informed patient to rest and push fluids for rest of day however patient needs to return to work. So informed him to perform light duties if he needs to return to work. Clinician provided precaution to seek medical attention if patient develops difficulty breathing or chest pain/discomfort. Patient verbalizes understanding.
17 2021-07-13 tingling 4-5 days of a tingling sensation, chest tightness (mild, intermittent) post vaccination. Generaliz... Read more
4-5 days of a tingling sensation, chest tightness (mild, intermittent) post vaccination. Generalized macular rash on chest/back. Denies any shortness of breath or swelling. Vitals stable and within normal limits.
17 2021-07-13 tremor FIRST COVID VACCINE WAS SUCCESSFULLY ADMINISTERED & WHILE PATIENT STILL SEATED IN CHAIR, BEGAN TO FA... Read more
FIRST COVID VACCINE WAS SUCCESSFULLY ADMINISTERED & WHILE PATIENT STILL SEATED IN CHAIR, BEGAN TO FALL TO ONE SIDE. THE IMMUNIZER GRABBED HIS ARM SO THAT HE WOULDN'T FALL OVER AND NOTICED HE WAS SHAKING. HE QUICKLY GAINED CONCIOUSNESS AND WAS BREATHING NORMALLY AND AWARE. HE WAS VERY PALE AND SWEATING & WHEN WE CHECKED HIS BP IT WAS LOW. WE ALSO APPLIED ICE PACK TO HIS FOREHEAD, BACK OF NECK AND WRISTS & CALLED EMS. THEY ARRIVED AND CHECKED PATIENT AND EVERYTHING WAS NORMAL.
17 2021-07-13 tremor 10 Seconds after receiving the Vaccine the patient fell over in his chair and on how way to the grou... Read more
10 Seconds after receiving the Vaccine the patient fell over in his chair and on how way to the ground I caught him and laid him down on his back. During this time the patient's eyes rolled into the back of his head and had small tremors occuring throughout his body. This lasted approxiamtely 10 seconds before the patient regained consciousness. The patient has had no history of seizures or any issues with the first dose. The patient had reported that they had not ate anything all day and felt like their glucose was low. After observing the patient for 30 minutes after the incident they reporting feeling okay and just that they probably needed to eat something. A follow up call with the patients mother was completed 2 hours later and the patient was feeling better and eating. They were informed to call back with any issues.
17 2021-07-14 seizure Fever, seizure
17 2021-07-14 seizure Pt left room after vaccinating and passed out in store. Seized, Brought patient around, eyes rolled ... Read more
Pt left room after vaccinating and passed out in store. Seized, Brought patient around, eyes rolled back. Seized, called 911. Ambulance took to regional medical center per mom. Mom reported back thought may have been vasovagal syndrome associated with needle phobia.
17 2021-07-14 unresponsive to stimuli Systemic: Fainting / Unresponsive-Mild, Additional Details: PATIENT FAINTED A COUPLE OF MINUTES AFTE... Read more
Systemic: Fainting / Unresponsive-Mild, Additional Details: PATIENT FAINTED A COUPLE OF MINUTES AFTER RECIEVING PFIZER VACCINE; WHILE SITTING IN THE CHAIR, HE SLID OFF & HIT HIS HEAD ON THE OPPOSITE CHAIR. DID NOT FULLY LOSE CONSCIOUSNESS. NO EPIPEN NEEDED, EMS CALLED & NORMAL VITALS. PATIENT REFUSED TREATMENT/HOSPITALIZATION.
17 2021-07-15 inability to speak, tremor Four minutes after vaccination with 2nd dose of Pfizer Covid vaccine, mom and sister reported patien... Read more
Four minutes after vaccination with 2nd dose of Pfizer Covid vaccine, mom and sister reported patient's eyes rolled back, closed eyes, "shook for a moment", and slid down chair. Family yelled for help and I called 911. Patient's eyes reopened and was feeling dizzy; seemed to understand questions but unable to speak immediately after. Wet paper towel was provided to put on forehead and patient was monitored for anaphylactic, seizure, and other symptoms until emergency personnel arrived. Patient was evaluated and fireman stated that patient likely had "syncopal reaction".
17 2021-07-15 facial pain PATIENT STATES HE WAS PLAYING VIDEO GAMES WITH HIS FRIENDS YESTERDAY WHEN HIS NOSE STARTED TO BLEED.... Read more
PATIENT STATES HE WAS PLAYING VIDEO GAMES WITH HIS FRIENDS YESTERDAY WHEN HIS NOSE STARTED TO BLEED. HIS GRANDMOTHER TRIED MULTIPLE METHODS TO STOP THE BLEEDING. PATIENT'S NOSE CONTINUED TO BLEED FOR 2 HOURS WHEN HIS GRANDMOTHER CALLED EMS. PATIENT WAS TAKEN TO SCH ER WHERE A BALLOON WAS PLACED. 7/15/2021 THEY REPORT THEY WERE TOLD THE BALLOON WAS TO REMAIN IN PLACE UNTIL FRIDAY. PATIENT STATES HE HAS HAD PREVIOUS EPISODES OF EPISTAXIS, BUT NOTHING TO THIS DEGREE. PATIENT REPORTS INTENSE PAIN IN HIS NOSE, FACE AND PALATE. HE HAS HAD CLEAR NASAL DISCHARGE FROM AROUND THE BALLOON, BUT NO ACTIVE BLEEDING. PATIENT WAS PRESCRIBED ANTIBIOTIC, BUT HAS NOT FILLED THAT PRESCRIPTION YET. HE IS ASKING FOR THE BALLOON TO BE REMOVED DUE TO THE PAIN.
17 2021-07-15 tingling, numbness Pt we/ a hx of allergy to treenuts and "vaccine" (anaphylaxis). 35mins post vaccination, pt c/o che... Read more
Pt we/ a hx of allergy to treenuts and "vaccine" (anaphylaxis). 35mins post vaccination, pt c/o chest discomfort (stabing, brief), tingling in Left UE, and Left jaw ache/numbness. BP 121/70, HR 64, RR 16, O2 Sat 99% -- > 119/65, 63, 98%. NO rash, hives, angioedema noted. Numbness resolved. No further complaints of discomfort, numbness, or tingling. No further reports of abnormal symptoms. Pt stable and released from the vaccination site w/ dad @12:53.
17 2021-07-16 involuntary muscle movements Patient felt faint a few minutes after injection. Patient fainted in chair, after 15 to 20 seconds ... Read more
Patient felt faint a few minutes after injection. Patient fainted in chair, after 15 to 20 seconds he had some jerky movements and regained consciousness with a gasp. He lay on the ground for a few minutes and drank water I provided when he felt better. He ate a granola bar and left after 15 minute observation. Counseled mom on vasovagal syncope and prevention.
17 2021-07-17 night sweats night sweats; has a lot of allergies /sensitivities; This is a spontaneous report from a contactable... Read more
night sweats; has a lot of allergies /sensitivities; This is a spontaneous report from a contactable consumer (Patient). A 17-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation: Solution for injection), dose 1 via an unspecified route of administration on 2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unknown date in 2021, the patient got the first Pfizer Covid vaccine and started having night sweats and thinks he is past the time allowed for the second dose. It was believed he was 5 weeks out from the first dose. Wanted to know how much protection he has by the first dose and how that looked to protect him. Had a lot of allergies and does not want this to be another one. Caller stated she spoke with a nurse who said the 1st dose had an 85 percent protection. Due to the night sweats, caller got nervous to get the 2nd shot of the vaccine. Caller had taken her son to the doctor who ran tests wherein the results were fine. Caller had delayed the 2nd shot for her son due to the adverse event and because her son also had allergies and sensitivities. Wanted to know where they can get more information on how much antibodies he had because he had a lot of allergies and does not want this to be another one. This was a concern and knew it was a part of the side effects, but she really wanted to know if it was protecting him and not knowing makes her feel really concerned. The outcome of the events was not recovered. Information related to batch/Lot no. was requested.
17 2021-07-17 pain in extremity Intense left arm pain; Intense left arm pain resulting in aninability to move it; Body aches; Upset ... Read more
Intense left arm pain; Intense left arm pain resulting in aninability to move it; Body aches; Upset stomach; This is a spontaneous report received from a contactable consumer, the patient. A 17-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8732), via an unspecified route of administration in the left arm on 24Mar2021 at 15:45 (at the age of 17-years-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19, which was diagnosed prior to the vaccination. The patient was only allergic to Hazelnuts. Concomitant medication included sarecycline hydrochloride (SEYSARA) for unknown indication from unknown date. 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 25Mar2021 at 08:00, the patient experienced intense left arm pain resulting in an inability to move it or else there was excruciating pain. The patient also experienced full body aches and upset stomach. The patient did not receive any treatment for the events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the intense left arm pain, intense left arm pain resulting in an inability to move it, body aches and upset stomach were not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
17 2021-07-18 discomfort, pain in extremity Symptoms began morning after shot. Sore arm (left), headache, high fever, facial swelling, left axil... Read more
Symptoms began morning after shot. Sore arm (left), headache, high fever, facial swelling, left axillary lymph node inflammation, general discomfort and pain. Lasted approximately 2-3 days.
17 2021-07-18 tremor Around 4pm, the same day I got my vaccine, I got horrible heart palpitations, and my heart rate went... Read more
Around 4pm, the same day I got my vaccine, I got horrible heart palpitations, and my heart rate went up very high. I also started to get very shaky (not related to the chills). This lasted for hours at first, but now it is on & off.
17 2021-07-19 pain in extremity Horrible arm pain ( On a scale of 1-10it was an 11); Redness at injection site; Low grade fever; Thi... Read more
Horrible arm pain ( On a scale of 1-10it was an 11); Redness at injection site; Low grade fever; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 31Mar2021 at 08:15 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient had no allergies to medications, food, or other products. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 at 22:45, the patient experienced horrible arm pain (On a scale of 1-10, it was an 11), redness at injection site and low grade fever (all these reaction had started after 14 hours of injection). The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event painful arm, injection site redness and low grade fever was resolving at the time of this report. No follow-up attempts are needed. No further information is expected.
17 2021-07-21 weakness feeling faint, nauseated, weak
17 2021-07-22 weakness Ongoing dizziness, fog brain, weakness, fatigue, poor appetite, loss 7 pounds, heartburn, increase o... Read more
Ongoing dizziness, fog brain, weakness, fatigue, poor appetite, loss 7 pounds, heartburn, increase of anxiety, no motivation to do the things he once enjoyed
17 2021-07-22 pain in extremity So right after getting the shot, within an hour, he complained of a pain in his back and I thought i... Read more
So right after getting the shot, within an hour, he complained of a pain in his back and I thought it was left over from the arm pain from the shot. But then he complained of stomach ache as well. We went to the hospital in June and they have done so many tests on him though and he was referred to a GI DR as well. He gets a stomach ache after having full meals, like anything normal size he used to eat, he gets nausea. He passes stool that is yellow in color. The DRs are still working on him currently though. He has some sort of bug or something. We have tried Pepto bismol and other over the counter medications but they have not helped.
17 2021-07-23 feeling hot, tingling The patient received 1st dose, about 2 minutes after felt dizzy then fainted. The patient was accomp... Read more
The patient received 1st dose, about 2 minutes after felt dizzy then fainted. The patient was accompanied by mother and grandmother. He passed out for several seconds then came back and said he felt hot, fingers on right hand felt tingling. Looked like he might have passed out again but for only 1 second. My mom requested EMTs be called, EMTs called and patient taken by ambulance to hopital. Mother did call 2 hours later saying the patient was released and doing fine.
17 2021-07-23 unresponsive to stimuli, feeling cold Site: Itching at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Dizzi... Read more
Site: Itching at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Dizziness / Lightheadness-Mild, Additional Details: At the time I was administering another COVID vaccination, and heard the patient fall on the floor upon which I noticed he was lying flat on the ground not responsive. I had one of the customers call 911 and assessed his vitals, he was breathing and conscious and speaking. He told me he still had trouble breathing and he felt very cold. By the time the paramedics arrived on the seen and helped the patient sit up on the chair he was feeling better. He was taken to emergency services soon after
17 2021-07-24 seizure, tingling Within minutes of shot, my son had a seizure. He complained of tingling in left arm, then he couldn?... Read more
Within minutes of shot, my son had a seizure. He complained of tingling in left arm, then he couldn?t hear anything and had blurred vision, and said he had an extreme headache. Within moments he began convulsions that became stronger and his whole body was shaking. This lasted for about 45 seconds. He stopped shaking and began to wake up. He was groggy and confused and said he didn?t remember anything, but the pain in his head subsided. 911 was called and they took him to the hospital to check his vitals. They could not be sure what brought on Seizure. Suggested Vagol Response. We went home. That evening he felt tingles and needles in body, we thought side affect of vaccine. Today, he was in extreme pain from pins and needles sensations throughout his body.
17 2021-07-25 seizure My son had seizures 2 months after the vaccine and has now been diagnosed with Epilepsy.
17 2021-07-26 feeling hot Patient tolerated vaccine well and waited in the room for a phlebotomist to draw blood. As soon as ... Read more
Patient tolerated vaccine well and waited in the room for a phlebotomist to draw blood. As soon as the phlebotomist drew his blood, pt. started retching with very minimal vomitus. No facial swelling or hives noted. Not tachypneic, SPo2 97% RA. Pulse 77, Temp 98.6 Oral, Lungs clear. Patient stated he had felt hot and then nauseated. Patient reports he had not eaten that day. MD felt he had a vasovagal episode brought on by not eating. Vitals retaken at 3:40 pm and all were WNL. Left office at 1548 in NAD.
17 2021-07-27 feeling hot Patient passed out in the chair within seconds of receiving the first dose of the Pfizer covid vacci... Read more
Patient passed out in the chair within seconds of receiving the first dose of the Pfizer covid vaccine. I steadied him in the chair until he came back to, approx 20-30 seconds. When he awoke he said he felt nauseous, hot and sweaty. I provided him with a water and had him stay seated until he felt he could stand up, approx 10 minutes. He then left with his father, who was with him the entire time.
17 2021-07-28 seizure like phenomena syncope and mother reports seizure activty
18 2021-01-04 weakness Pt describes falling with onset of weakness below the hip level about 6 inches above the patella wit... Read more
Pt describes falling with onset of weakness below the hip level about 6 inches above the patella with missing clonus reflex. The pt cannot squat down with associated observable loss of strength, pt is not able to stand up. The pt has fallen 7 times since symptom onset around lunchtime between 1200 and 1300. Pt denies LOC.
18 2021-01-12 numbness Sx. Started with extreme fatigue. At around 16:00. Near 18:00 I had developed a fever, concurrent wi... Read more
Sx. Started with extreme fatigue. At around 16:00. Near 18:00 I had developed a fever, concurrent with aches and chills. Near 22:00 I had developed a headache, one of a dull nature, with Sharp throbs. Between 22:00 and 00:00 01/11/:12 I had developed tinnitus. Near 01:00 01/12/2021 I had developed swelling of the injection sight with contralateral numbness on the left arm and leg. Near 02:00 01/12I had loss sensation In my left arm and developed numbness in the face. From 20:00 01/11 to 22:00 01/12 I had developed episodes of tachycardia with a peak resting heart rate of 143bpm measured via Watch. Between 15:00 01/12 and 22:00 01/12 I had experienced terrible non radiating angina proximal to the sternum. I had developed pain while urinating at around 21:00 01/11 my last urination was at 23:00 01/12, I did not go again until 16:00 01/13. I had experienced lower back concurrent with that. From 22:00 01/11 to 23:00 01/12 I had terrible SOB, and chest pain upon exhalation. Fever and body aches did not subside until through the night of 01/12:13. I had not experienced any symptoms as the night of 01/12. I had developed a rash across my chest near 18:00 01/11 though it has subsided it is still present.
18 2021-02-09 pain in extremity, weakness Pt woke up 2 days later with excruciating pain in the knee throughout the day that has been semi rel... Read more
Pt woke up 2 days later with excruciating pain in the knee throughout the day that has been semi relieved by ibuprofen 600mg TID. His knee buckled twice while walking. 1st time the knee collapse and he fell backwards. The 2nd time his knee froze with excruciating pain and had to fall over because it locked. Tonight, he is resting with his knee elevated and will schedule an appointment with his primary for further evaluation. (Only on the right knee.) (Today is day 2 of the symptoms of the knee buckling and pain. Day 1 was the arm pain, slight headache, weakness.)
18 2021-02-19 seizure Hypothermia. Four days after second dose body temp dropped to 94 degrees F. Evaluation for sepsis w... Read more
Hypothermia. Four days after second dose body temp dropped to 94 degrees F. Evaluation for sepsis was unremarkable. CBC was normal, blood cultures were negative. Hypothermia was treated with warming devices. Increased seizure activity was noted. Keppra was started for increased seizure activity. Hypothermia resolved with resolution of the seizures.
18 2021-02-24 weakness Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Severe, System... Read more
Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Severe, Systemic: Vomiting-Mild, Systemic: Weakness-Medium
18 2021-02-28 seizure Fever of 102.5 and seizures
18 2021-03-05 numbness PT was in observation period and came up to the consultation window asking if a numb arm was a norma... Read more
PT was in observation period and came up to the consultation window asking if a numb arm was a normal side effect of the vaccines. At further inspection I noticed that he was having a rash . I had a sit for a few more minutes then his mom came up and we noticed that his arm started to swell. We gave him 2 capsules Benadryl 25mg and instructed him to go to urgent care. Called for a follow up later in the evening and found that urgent care send him to the ER. The rash was spread all over and well as the swelling. He swelled all the way to his toes. He also tuned white and became very lightheaded at the ER. They gave him IV Benadryl and dexamethasone and was sent home. It has been recommended by the ER doctors to not get the 2nd dose.
18 2021-03-07 cold sweat This is a 18 y.o. male who is generally healthy. He received a second dose of the SARS2-COV vaccine ... Read more
This is a 18 y.o. male who is generally healthy. He received a second dose of the SARS2-COV vaccine on 3/4. The following morning he felt feverish and achy with malaise. He stayed home, drank fluids and rested and felt well enough to come up to ski this weekend. During skiing he had some anterior chest pain, it resolved and he went about his day. Tonight at 2245 the pain became sharp and awakened him from sleep. He felt nauseated and clammy as well. Father brought him to the ER for evaluation. His emergency department evaluation showed ST elevations most notably in the inferior and lateral leads as well as in the lateral precordium.
18 2021-03-07 seizure Two days after receiving the vaccination, experienced two seizures about 2 hours apart; This is a sp... Read more
Two days after receiving the vaccination, experienced two seizures about 2 hours apart; This is a spontaneous report from a contactable consumer(patient). A 18-year-old male patient received the first dose of BNT162B2 (lot number: E13249), via an unspecified route of administration in right arm, on 15Feb2021 11:00 AM at single dose for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was Adult Residential Facility. The patient's medical history included developmentally disabled, seizures, malaria at birth. Known allergies included Shrimp, Penicillin and Amoxicillin. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient was not tested for COVID-19. Concomitant medications included aripiprazole 5 mg, aripiprazole 10 mg, escitalopram. Two days after receiving the vaccination, the patient experienced two seizures about 2 hours apart on 17Feb2021 14:00. The patient had not had a seizure in 6 months. No treatment was received for the event. The outcome of the event was recovered in Feb2021.
18 2021-03-15 feeling hot Left observation area post-vaccination and returned to the clinic area approx. 20 min after injectio... Read more
Left observation area post-vaccination and returned to the clinic area approx. 20 min after injection. Felt hot, had headache, and was shaky. VS WNL, administered IM Benadryl 25 mg and kept in observation for approx. 45 min.
18 2021-03-23 flushing after injection given pt became pale heart rate increased flushed nausea and sweats repotes this ha... Read more
after injection given pt became pale heart rate increased flushed nausea and sweats repotes this happens when blood is drawn onsite als notified and transfered care pt states i feel much better color came back family at side
18 2021-03-27 flushing Patient reported dizziness, lightheadedness, had progressive symptoms of diffuse flushing of the ski... Read more
Patient reported dizziness, lightheadedness, had progressive symptoms of diffuse flushing of the skin, fatigue. He was given 25 mg of Benadryl and placed on a caught to rest for about 30 minutes. After the dose of Benadryl and with time, his symptoms progressively improved. No itching of the throat, skin, no SOB or CP.
18 2021-03-30 weakness Soon after his vaccine, while in the waiting area, he slumped over in his chair losing consciousness... Read more
Soon after his vaccine, while in the waiting area, he slumped over in his chair losing consciousness and dropping his phone and papers. He recovered consciousness in seconds with his head down. He continued to complain of some "weakness" for 10-15 minutes while lying down and drinking water and eating crackers. He was fully recovered in about 15 minutes. He had not had anything to eat all day.
18 2021-03-30 feeling hot pt. c/o light headache immediate after the vaccine. Warmness of his face; dry mouth; symptoms re... Read more
pt. c/o light headache immediate after the vaccine. Warmness of his face; dry mouth; symptoms resolved & patient went home.
18 2021-03-31 flushing Patient felt flushed and had some "restricted breath." No rashes or wheezing. Vitals: BP 130/70, O2... Read more
Patient felt flushed and had some "restricted breath." No rashes or wheezing. Vitals: BP 130/70, O2 sat 100% on RA, HR 78. Patient given PO Benadryl 50 mg and famotidine 20 mg @ 0920. Patient felt better @1000 and left with parents.
18 2021-03-31 unresponsive to stimuli Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild
18 2021-04-03 pain in extremity Mild soreness when using shoulder on vaccine arm (left) at 7:58am Sudden headache, at 9:45pm Arm sor... Read more
Mild soreness when using shoulder on vaccine arm (left) at 7:58am Sudden headache, at 9:45pm Arm soreness increases substantially (cannot comfortably raise whatsoever) 9:45pm Chills at 9:50pm Fever 100 degrees F at 10:30pm Fever broke and chills stopped at around 3:00 am on 3/31 (the next day) Headache where it hurts to look to the side persists until 4/2 after which it gradually goes away becoming negligible by 4/4
18 2021-04-03 tingling Systemic: Dizziness / Lightheadness-Medium, Systemic: Tachycardia-Severe, Systemic: Tingling (specif... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Tachycardia-Severe, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Patient was having tachycardia after his dose. His heart rate went up to 142. We checked his blood pressure and heart rate 3 times. His vblood pressure was niormal but heart rate was consistenly elevated. WE called 911 and they took him to er
18 2021-04-05 pain in extremity, numbness, tremor My healthy 18-year old son had his first dose of Pfizer, and within a few minutes he felt dizzy. His... Read more
My healthy 18-year old son had his first dose of Pfizer, and within a few minutes he felt dizzy. His heart rate was also rapid. He didn't think much of it, but the dizziness persisted and so they had him lay down with feet up. After about 20 minutes, he began to vigorously shake (rigors I believe is what it is called.) He felt numb in both arms and also his tongue and mouth. We had 3 nurses attending to him, and after about 30 minutes they decided to send him to the ER for evaluation since the very strong shaking and other symptoms were worsening. The shaking, dizziness, numbness all subsided after about an hour. He was given a Zyrtec upon first symptoms about 15 minutes after dose. The ER doc doesn't believe it was an allergic reaction but potentially a strong vasovagal response and immune response. He felt tired after but was completely fine 2 hours later. We were discharged from the ER a few hours later after evaluation. Vitals were in normal range including blood sugar, blood pressure and oxygen. He was fully hydrated prior and had a turkey sandwich and orange prior to coming so was not low on food either. The shaking was very extreme and concerning. It has been almost 24 hours and he is feeling fine other than a sore arm.
18 2021-04-06 weakness Soar throat, headache, tiredness, weakness
18 2021-04-06 numbness Dizziness, tunnel vision, pectoral numbness
18 2021-04-07 seizure Pt. C/O feeling dizzy and nauseated. Had an episode of seizure that lasted for 5 sec, vomited small... Read more
Pt. C/O feeling dizzy and nauseated. Had an episode of seizure that lasted for 5 sec, vomited small undigested food particles and became diaphoretic afterwards. A pkt of 125 mls of apple juice and water offered. (11 call made. Pt. finished the apple juice but had few sips of water. Pt reported having had similar episodes whenever he got blood draws and confirmed the reaction was related to sensitivity to needles ( vaccination needle) than the vaccine. Paramedic team arrived at 3:25 p m. Pt. and mom refused the Ambulance services to the ER, but agreed to remain in the observation room for further observation.at about 4:05 p m. Pt and mom left the recovery hall .
18 2021-04-09 weakness, tremor Rapid heartbeat, dizziness, weakness, shaking (not chills), fainting, confusion
18 2021-04-09 pain in extremity, weakness feeling unwell; sick to stomach; vomiting; chest pains; hard to breath; chills/freezing; weak; 104 f... Read more
feeling unwell; sick to stomach; vomiting; chest pains; hard to breath; chills/freezing; weak; 104 fever; sore arm; sore muscles; This is a spontaneous report received from a contactable consumer (patient's mother). A 18-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 22Mar2021 14:00 (02:00 PM) (Lot Number: EP6955) at the age of 18 years old as single dose for covid-19 immunisation. Medical history included Known allergies Morphine and sulfa antibiotics; Marphans syndrome, autistic, severe scoliosis & kyphosis. The patient's concomitant medications received within 2 weeks of vaccination included too many to put down here not enuf room. Facility where the most recent COVID-19 vaccine was administered at Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The mother took care of the patient due to his sever disability iam filling this out for his as he was unable so he received shot (pending clarification), registered with v-safe, 22Mar2021 2pm. Fine, health check next 23Mar2021 day sore arm, kinda sore muscles, 24Mar2021, sore arm still sore muscles, 25Mar2021 13:00 (1pm), feeling unwell, sick to stomach started vomiting, chest pains, hard to breath, called 911 EMS advised him to stay home after vitals ok due to not wanting to expose the patient to actual Covid virus. At the time no fever 30 min after EMS left 104 fever sever chills, freezing coming in waves so weak. He can't get up to go to the bathroom. The reporter was worried and closely monitoring him. Treatment was received for the adverse event included Medication for vomiting, doctor apt in morning. The events were non-serious per the reporter. The patient underwent lab tests and procedures which included body temperature: no fever 25Mar2021, 104 30 min after EMS left on 25Mar2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was not recovered.
18 2021-04-12 weakness Ready for dc from OBS when he c/o "my legs feel weak". Denies dizzyness, lightheaded, SOB, trouble s... Read more
Ready for dc from OBS when he c/o "my legs feel weak". Denies dizzyness, lightheaded, SOB, trouble swallowing. Pt'c color good, feels warm to touch. He was able to ambulate independently to stretcher for further eval. VS 133/90 - 87-16-!00%. Pt given Water and asked to call parent. Pt. able to converse readily, states he is feeling better. Dad arrived, explained situation, VS122/77 76,18. Pt states he feels well enough to go home, parent agrees, left together with pt no longer c/o weakness.
18 2021-04-12 cold sweat Throat hurt, felt dizzy, heart rate 110, bp normal, clammy; occurred about 20 minutes after administ... Read more
Throat hurt, felt dizzy, heart rate 110, bp normal, clammy; occurred about 20 minutes after administration and was ok 40 minutes after administration
18 2021-04-12 feeling hot Hot, vision decreases Vital Signs: BP 108/58 HR 68 Resp 18 O2Sat 98 Skin Signs: Diaphoretic Circul... Read more
Hot, vision decreases Vital Signs: BP 108/58 HR 68 Resp 18 O2Sat 98 Skin Signs: Diaphoretic Circulation: Cap refill <2sec Initial Treatment: Supportive and observation 1:02 PM Vital Signs: BP 128/68 HR 70 Resp 16 O2Sat 99 Skin Signs: Warm and dry Circulation: Cap refill <2sec Respiratory: Breath sound clear bilaterally 1:17 PM Vital Signs: BP 132/72 HR 74 Resp 16 O2Sat 99 Follow up Treatment: Hydration and supportive Notes: Complete recovery reported by patient. Discharged to self. Continued to inform medical personal of this episode.
18 2021-04-12 flushing, unresponsive to stimuli, seizure 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: Seizure-Mild
18 2021-04-12 seizure like phenomena Patient fell from chair in waiting area and experienced seizure-like activity for 5 to 10 seconds. E... Read more
Patient fell from chair in waiting area and experienced seizure-like activity for 5 to 10 seconds. EMS was called and promptly arrived and took patient to hospital.
18 2021-04-13 weakness After administration of the COVID-19 1st dose, patient fainted and was caught by his father. Patient... Read more
After administration of the COVID-19 1st dose, patient fainted and was caught by his father. Patient then sat on a chair while pharmacy staff monitored patient. Approximately 5 minutes after the incident, patient continue to experience sweating and weakness.
18 2021-04-13 feeling hot, flushing Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / S... Read more
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Additional Details: 18 yo male fell out of chair and hit the left side of his head, ~5 min after receiving vaccine. The patient reported that he remembers becoming dizzy prior to falling out of chair. A nurse and pharmacist immediately placed him onto a sheet and elevated his feet. He was diaphoretic, warm to touch and awake. His initial blood pressure was 89/58. 2nd-4th readings were WNL. He was given water, an icepack for neck and abrasions on his face were treated. He reported that he was feeling much better.
18 2021-04-13 muscle spasms, seizure 5 minutes after getting the shot I fainted / had a seizure. I heard from people around me that my fa... Read more
5 minutes after getting the shot I fainted / had a seizure. I heard from people around me that my face had turned pale and that my hands were cramping up. I woke up not knowing what had happened, or where I was for a good 30 seconds. They had to call an ambulance and take me to the hospital to get checked on.
18 2021-04-14 slurring Patient received the Pfizer COVID vaccine (Lot EW0150, exp 7/2021) dose 1 at 1400. At 1405, EMT appr... Read more
Patient received the Pfizer COVID vaccine (Lot EW0150, exp 7/2021) dose 1 at 1400. At 1405, EMT approached patient who appeared pale and diaphoretic with his eyes closed. PHN approached to assess, patient had slow speech and pulse felt thready. Vital signs: O2 99%, pulse 56, respirations 24. Patient had thick sweatshirt on EMT had difficulty obtaining blood pressure. Paramedic approached to assist. At 1410, PHN, EMT, and paramedic transfered patient to zero gravity chair and placed in reclining position. Patient was offered water and he verbalized feeling better. Patient denied allergies, medical conditions, or medications. PHN assisted patient in removing sweatshirt partially to obtain blood pressure. Vital signs: O2 99%, pulse 51, blood pressure 92/60, respirations 24. PHN offered Benadryl but patient declined. PHN advised on when to call 911. At 1422, patient reported light sensitivity and blurry vision. At 1425, vital signs: pulse 52, respirations 18, O2 99%, blood pressure 118/84. At 1535, vital signs: O2 99%, pulse 58, respirations 18, blood pressure 110/66. Patient reported continued improvement in symptoms, only feeling tired. Patient reported working out, only sleeping 2 hours that night, and not eating before coming in. PHN called family member at patient's request to drive patient home. At 1439, patient assisted to seated position in zero-gravity chair by PHN and EMT. Patient reported symptoms had resolved and he felt back to baseline. At 1445, patient stood up, monitored closely by PHN and EMT. At 1449, patient left walking with steady gait to parking lot where family member was waiting to drive patient home.
18 2021-04-15 tingling, cold sweat Patient recieved vaccine without any issues on 4/16/21. Patient walked to waiting area with pharmaci... Read more
Patient recieved vaccine without any issues on 4/16/21. Patient walked to waiting area with pharmacist, was not having any issues or concerns, and was observed for several minutes by the RPH. Approximately 5 minutes after receiving the COVID-19 shot, the patient passed out, fell out of his chair, and hit his head. The patient immediately regained concousness and sat back in his chair. The RPH immediately had a pharmacy associate call 911 and observed the patient. Patient stated he felt a liquid tingle go down his arm from where he received his vaccine then passed out. Patient stated he had a headache and appeared clammy. RPH provided an instant ice pack and observed patient until EMS arrived. EMS provided care to patient and determined he did not need to go to the hospital. Patient was advised to go to hospital if he becomes nauseus. Patient claimed he was okay and just has a headache. Patient's mother took him home.
18 2021-04-15 unresponsive to stimuli, flushing Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / ... Read more
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium
18 2021-04-16 unresponsive to stimuli Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unrespo... Read more
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Nausea-Medium, Additional Details: Pt mother stated pt was nauseous and then that he was passing out. RN ran over to check on pt as pt eye rolled back and pt limbs fell limp. Pt moved to the floor by RN, rolled to the side by RN. Pt regained consciousness almost immediately and was laid on his back with feet elevated. Pt stated he felt fine, did not recall exactly what happened. Pt helped up into chair, given water and crackers. Pt stated he felt fine, observed by medical personnel for 30 min and pt was able to ambulate off site.
18 2021-04-18 pain in extremity Approximately 11 days after receiving my first dose, I began feeling dull pain in my left calf. By S... Read more
Approximately 11 days after receiving my first dose, I began feeling dull pain in my left calf. By Saturday, 4/17, the pain was severe enough to warrant a trip to the emergency room. After receiving an ultrasound of my leg, two blood clots were found in my left calf. One fully occluded a vein and another partially occluded a different vein.
18 2021-04-18 pain in extremity Soreness of arm, fatigue, back and body aches
18 2021-04-19 flushing 0.3ML COVID-19 VACCINE administered IM left deltoid AT 11:50AM today 4/20/2021 ... Read more
0.3ML COVID-19 VACCINE administered IM left deltoid AT 11:50AM today 4/20/2021 at 11:55 AM patient complained of Dizziness, patient was visibly Flushed, Pale looking; Sweating profusely, Water 4oz given to him. AT 12:04, he complained of DIFFICULTY BREATHING, 12:05 EPIPEN 0.3mg one dose administered (left thigh); 911 ACTIVATED; PARAMEDICS ARRIVED AT 1211pm BP 87/55 at 11:55am; 87/57 at 12:00pm; Epi-pen 0.3mg at 12:05pm; 12:10pm BP: 114/75 Pulse 51; 12:55pm 90/58; one bottle of Pediatric Electrolyte plain 32oz given, patient declined EMS pick up. 1:00PM bp 100/63; Pulse: 51. O2 sat at 99 the whole time period . Patient went home with mom.
18 2021-04-20 cold sweat, feeling hot Patient complained of lightheadedness, dizziness feeling hot. Patient noted to be clammy. BP 84/55, ... Read more
Patient complained of lightheadedness, dizziness feeling hot. Patient noted to be clammy. BP 84/55, HR 76, RR 24, O2 sat 97%. Pt given bottled water and graham crackers and tolerated well. BP 141/79, HR 85, RR 20, O2 sat 96%. Pt reported he felt improvement of symptoms and no longer clammy.
18 2021-04-21 weakness Pt was nervous before getting shot. After receiving shot he was in a monitor area. He raised hand ... Read more
Pt was nervous before getting shot. After receiving shot he was in a monitor area. He raised hand and stated he felt weak. He was pale and diaphoretic. Helped him to ground and allowed to rest. Felt better. Pt evaluated by paramedics. VS @ 1107 HR 68, OxSat 99%, BP 96/47. @1115 Sit in chair. BP 104/56, HR 70, OxSat 100%. @ 11:45 Pt ambulated w/o difficulty. Taking bus home. Told to call nurse when he arrives home.
18 2021-04-21 seizure SYNCOPAL EPISODE, SEIZURE ACTIVITY. Evaluated by EMS-Refusal to transport.
18 2021-04-22 flushing Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Severe, Systemic: Vomiting-Severe
18 2021-04-22 flushing Flushing, sweating, dizziness, vitals wnl.
18 2021-04-23 numbness Overnight, my (almost 19) son did not wake me, but reported to me in the morning that he had headach... Read more
Overnight, my (almost 19) son did not wake me, but reported to me in the morning that he had headaches, chills, numbness, thirst, and hallucinations. He was aware that they were not real during and after he had them, but it was a nonetheless disturbing experience. He described to me having the need to hydrate all night and he drank a lot of water. This morning he was still having a headache and numbness as well as overall malaise, but has taken advil and eaten a light breakfast. He is dressed and up and around and seems to be improving. Should the symptoms return or worsen, we plan to take him for medical care.
18 2021-04-23 seizure Patient had a seizure about 5 minutes after having the vaccination while they were in the waiting ar... Read more
Patient had a seizure about 5 minutes after having the vaccination while they were in the waiting area. The patient had the seizure for about 30 seconds and then regained their senses and were able to have a conversation with me, the pharmacist, and had a cup of water while we waited for the ambulance. The patient was then transferred to the hospital.
18 2021-04-25 feeling hot, cold sweat Patient complained of nausea and vomiting, headache, cold sweat but said he felt hot. Improved in 2... Read more
Patient complained of nausea and vomiting, headache, cold sweat but said he felt hot. Improved in 20 minutes. 2 hours afterwards he said he felt normal.
18 2021-04-25 feeling hot Patient received his first dose of Pfizer vaccine and waited 15 minutes in the observation area. Upo... Read more
Patient received his first dose of Pfizer vaccine and waited 15 minutes in the observation area. Upon rising from chair, patient reported feeling dizzy and faint. Patient called for assistance. Patient reported feeling hot and sweaty and being unable to hear and see correctly. Pulse and SpO2 were taken, Pulse was initially 54 bpm and rose to 68 bpm after drinking water. SpO2 was 94-95% RA. Patient refused EMS. Patient reported feeling better after about 20 minutes. Hearing and vision improved. Patient remained in observation area for another 20 minutes before leaving in stable condition.
18 2021-04-25 migraine with aura Migraine and constant aura...continues to this day!!
18 2021-04-25 tremor Patient states Saturday 4/17/21 he noticed "normal Pfizer symptoms" of fever, chills, "shakes," musc... Read more
Patient states Saturday 4/17/21 he noticed "normal Pfizer symptoms" of fever, chills, "shakes," muscle pains, especially in joints including shoulder and back, they got better after several hours, except that about midnight Saturday he still had the back pain, in the upper back, noticed severe chest pain in front and back, it hurt "with every heart beat," "like a heart attack," sometimes would have "attacks," sometimes better, sometimes worse, and it hurt in chest to breath, took Nyquil about 3am, was able to go to sleep, Sunday-Monday it was "pretty bad," but came in "attacks," sometimes it felt worse than others. Monday chest still hurt, went to urgent care, had EKG and scan, went home and did some school, that evening chest pain was severe "I froze," went to ER, was diagnosed with pericarditis. given an IV and Toradol. Was discharged home from ER with OTC Ibuprofen 200mg, to take 8 times a day. Patient states it is getting better, still continues to have some pain, taking ibuprofen daily at this point.
18 2021-04-26 flushing Patient had flushing/sweating, ringing in ears, nausea. Stable, released from vaccination site.
18 2021-04-26 seizure like phenomena Recipient received dose #2 vaccine today, and almost immediately had response with witnessed seizure... Read more
Recipient received dose #2 vaccine today, and almost immediately had response with witnessed seizure-like activity, with posturing, tonic-clonic movement of his upper extremities, and eye movement with lateral nystagmus. Loss of consciousness was noted. Symptoms lasted approximately 15-30 seconds, and patient was placed in a reclined position. He regained consciousness quickly and became pale and diaphoretic. He was normally responsive and answered questions appropriately. Initial BP 74/32, HR 38, SpO2 98%. He drank some Gatorade and had improvement of symptoms gradually over 15-20 minutes. Repeat BP 100/58, HR 78. No past history of seizures. One prior syncopal event after pain response with sports injury. No prior difficulty with dose #1. After recovery, patient reported immediate pain with vaccine administration, then vision went blurry and he lost consciousness. Mother was driving the vehicle, and she witness symptoms as well as nursing staff in the vaccine pod. After recovery, options for further medical evaluation were discussed given complicated vasovagal response with seizure-like activity, mother called pediatrician to see if he could be seen, they recommended ER. Mother chose to drive by personal vehicle, rather than EMS transport. Symptoms were fully resolved and patient was transported to ER for further evaluation by personal vehicle.
18 2021-04-27 migraine, pain in extremity completed Pfizer COVID vaccine 4/09/21, developed arm soreness 4/23/21 which resolved with Motrin, d... Read more
completed Pfizer COVID vaccine 4/09/21, developed arm soreness 4/23/21 which resolved with Motrin, developed fatigue, ?fever and migraine headache on 4/24/21; temp 100.4 on 4-25-21; on 4/27/21 feels ok, little tired; no uri sx's, no known contacts w/COVID, No rashes, vomiting, diarrhea, loss of taste, travel
18 2021-04-27 pain in extremity Soreness in arm that rapidly came on roughly 10 hours later, but subsided significantly following 24... Read more
Soreness in arm that rapidly came on roughly 10 hours later, but subsided significantly following 24 hours after the shot was given. All soreness subsided within 3 days. Sudden sensitivity to light developed about 26 hours after the shot was given. This side effect remained for about 8 days afterwards and still has some very slight residual effect (now 12 days after).
18 2021-04-28 flushing Within 15-minutes of vaccination, the patient experienced a syncopal episode. EMS evaluated the pati... Read more
Within 15-minutes of vaccination, the patient experienced a syncopal episode. EMS evaluated the patient on-site. The patient reported taking a marijuana edible prior to vaccination and stated he was anxious about the vaccine. The patient was normotensive (121/68). EMS administered 0.5L normal saline and 4mg IV Zofran. EMS transported the patient to Emergency Department. In the ED, the patient reported taking a marijuana edible at 1200 and that after their vaccination they experienced feeling flushed, nausea, vomiting, and near-syncope. After several hours waiting in the ED, the patient noted feeling improvement. The patient's labs and tests were unremarkable. Patient was discharged with vasovagal reaction and cannabis abuse.
18 2021-04-28 seizure like phenomena, unresponsive to stimuli Patient received Pfizer vaccine on left deltoid and immediately displayed seizure like activity whil... Read more
Patient received Pfizer vaccine on left deltoid and immediately displayed seizure like activity while sitting down. Patient eyes rolled back and was briefly unresponsive for a few seconds. EMS was notifed at this time. The patient was assisted and carried down to the matted floor and feet were elevated on a chair. Patient did become responsive and was alert and oriented but continued be dizzy. Patient did not have labored breathing or respiratory distress at this time. Patient's vital signs were taken at 14:50: 130/71, 80hr, 95% PsO2, 18rr The fire department arrived and transported patient to Hospital. Patient did have another seizure like activity and patient's heart rate dropped into the 40-50s. Peripheral IV on right hand was initiated and bolused. Patient's mother, was notified of event and patient's sister who was waiting outside was brought into facility. Patient's sister who is 14 years old was later picked up by mother.
18 2021-04-29 pain in extremity Injection was administered too high up on arm, within 1 fingerbreadth of acromion process. Mother of... Read more
Injection was administered too high up on arm, within 1 fingerbreadth of acromion process. Mother of client reported via email to Public Health. Spoke with mother on 4/29/21. She stated that last night client's arm was sore, this is not any worse. She has no other concerns, just wanted to ensure that the vaccinator received follow up education. She will report back with any other concerns should they arise. Advised mother that we do provide all our volunteers training on anatomical landmarks for IM injections, and that this will be reviewed with the vaccinator (and highlighted going forward with all volunteers).
18 2021-04-30 feeling cold, pain in extremity Around 10:30 I began to feel tired and a little sick. I went to sleep and at around 2 or 3 am I woke... Read more
Around 10:30 I began to feel tired and a little sick. I went to sleep and at around 2 or 3 am I woke up freezing cold and sweating, with my left arm (arm I got the shot in) hurting a ton. I didn?t fall asleep for a few hours and couldn?t get out of bed due to coldness, lethargy, and muscle soreness. Next day had a moderate headache throughout the day that Ibuprofen didn?t help with. By 10 pm Friday all symptoms other than arm soreness had disappeared.
18 2021-04-30 hot flush Severe headache, hot flashes, neck and body pain
18 2021-04-30 seizure % minutes after the patient was vaccinated he c/o abdominal discomfort, he told his mother that he f... Read more
% minutes after the patient was vaccinated he c/o abdominal discomfort, he told his mother that he felt like he was falling. Patient the fell to the floor and had a seizure the lasted approximately 5-10 seconds. Pt awoke postictal.
18 2021-04-30 seizure Loss of consciousness; Seizure; Drowsiness, couldn't stay awake; Vomiting; This is a spontaneous rep... Read more
Loss of consciousness; Seizure; Drowsiness, couldn't stay awake; Vomiting; This is a spontaneous report from a contactable consumer (patient). An 18-year-old male 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 12Apr2021 (11:30) as a single dose, with route of administration unspecified, for COVID-19 immunization at the pharmacy/drug store. Medical history included peanut and penicillin allergy. The patient's concomitant medications were not reported. On12Apr2021 (11:45), the patient had loss of consciousness; seizure; drowsiness/could not stay awake; and vomiting. The events had resulted in an emergency room/department for urgent care, and were assessed as serious (medically significant). The patient was hospitalized in Apr2021 due to loss of consciousness. The patient had received epinephrine (EPIPEN) as treatment for the reported events. The outcome of the events was recovered in Apr2021. The patient did no have COVID-19 prior to the vaccination, and had not been tested post-vaccination. Information on the lot/batch number has been requested.
18 2021-05-01 weakness Mid-grade fever for 18 hours, 2x325 mg acetaminophen about every 4 hours. Fever did not reduce after... Read more
Mid-grade fever for 18 hours, 2x325 mg acetaminophen about every 4 hours. Fever did not reduce after 4th dosage at 4pm 05/01/2021. General weakness, chills.
18 2021-05-01 pain in extremity 1st day was just a sore arm. Then on day 2, Fever and chills for 2 days, very tired. Then a dry co... Read more
1st day was just a sore arm. Then on day 2, Fever and chills for 2 days, very tired. Then a dry cough and nasal congestion began on days 4-8, including being very tired. This was shot 1.
18 2021-05-02 feeling hot I administered first dose of Pfizer covid 19 0.3 ml via intramuscular route to this patient. About 2... Read more
I administered first dose of Pfizer covid 19 0.3 ml via intramuscular route to this patient. About 2 minutes after the administration, the patient had syncope for a second. When I arrived to the scene, the patient was conscious. When he passed out, he felt and landed on his head. He had an abrasion. He stated ?he felt hot and dizzy?. He hasn?t had anything to eat all day. Due to the abrasion, he was rushed to the hospital About 3 hours later, I called to check on the patient. At the time of calling, the patient was discharged from the hospital in good condition. He stated he felt perfectly ok and wasn?t sure what had happened.
18 2021-05-02 feeling hot Sat in recovery for 30 minutes before stating to the monitor that he felt lightheaded, hot. His fac... Read more
Sat in recovery for 30 minutes before stating to the monitor that he felt lightheaded, hot. His face was reddened and noted heavy hoody jacket around his neck. He stated that he had not had much to drink today, so started to hydrate with water. At 1:42 pm, VSS: 122/82-112 Hr-97% on room air. His vitals were rechecked at 1:59 pm HR-107, O2 saturation: 97% on room air. States that he works at specific location and needs the evening off to finish a paper that is due. Attempted to call the place of employment as continues to feel lightheaded. Card with contact information given to patient to show work and continued to hydrate until his release at 2:30 pm. He was able to walk out on his own.
18 2021-05-03 feeling hot 18 yo WM c/o dizziness and feeling hot 15 minutes after receiving the 1st dose of the Pfizer vaccin... Read more
18 yo WM c/o dizziness and feeling hot 15 minutes after receiving the 1st dose of the Pfizer vaccine. Patient evaluated by NP/EMS; VS, 12 Lead EKG and IV fluids stated. 911 called; PT PMHX of Asthma and Seasonal Allergies. NKDA; FD arrived, re-assessed, and transferred PT to Medical Center for further medical evaluation.
18 2021-05-07 numbness extreme hallucinations; not feeling well; chills; aches and pains; headaches; slight numbness in his... Read more
extreme hallucinations; not feeling well; chills; aches and pains; headaches; slight numbness in his extremities; difficulty walking; he did not get much sleep; fever; This is a spontaneous report from contactable consumer (parent). An 18-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in left arm on 23Apr2021 at 12:45 (Lot Number: Ew0153) at the age of 18 years, as a single dose for COVID-19 immunization. Medical history included autism spectrum disorder, ADHD (Attention deficit hyperactivity disorder) combined, learning disabilities. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination included alfetamine aspartate/alfetamine sulfate/dexamphetamine saccharate/dexamphetamine sulfate (ADDERALL) taken for an unspecified indication. Historical vaccine included BNT162B2, dose 1 in left arm, on 02Apr2021, lot # EK5730. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Apr2021 at 21:00 the patient experienced extreme hallucinations, not feeling well, chills, aches and pains, headaches, slight numbness in his extremities, difficulty walking, he did not get much sleep, fever. The clinical course of events was reported as follows: My son reported to me at bedtime last night, the night of his second Pfizer vaccine dose, that he was not feeling well. I told him to take some Advil and go to bed. He had a very bad night with chills and aches and pains but most distressing was his description of having had extreme hallucinations. He said that he was aware they were hallucinations and not real during and after the experience, but it was nonetheless concerning. It is also concerning that he didn't wake me for help. At any rate, he did not get much sleep and I have to assume his fever went pretty high before morning. He described to me the need to hydrate during the night. He also relayed to me this morning an experience of headaches and slight numbness in his extremities, difficulty walking, but he is now feeling much better. He is dressed, has eaten, and is playing games on the computer. I am keeping a close eye on him today and should we return to that level of concern, we will take him to urgent care. The clinical outcome of the events was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
18 2021-05-10 speech disorder, pain in extremity 18M with no PMH s/p pfizer vaccination dose 2 on 5/4/21 who presented with chest pain. He initially ... Read more
18M with no PMH s/p pfizer vaccination dose 2 on 5/4/21 who presented with chest pain. He initially had chest pain the day prior to admission with pain in his back and down his left arm. This improved with Tylenol and resolved prior to bed. On the morning of 5/6 the chest pain returned and was so severe it woke him from sleep. He was difficult for him to characterize, but he said it was all over his chest, sometimes sharp and pressure-like, most severe in mid substernal region and was so substantial that he had difficulty speaking properly. He feels that the pain is most severe when lying flat and is best managed when he is resting at a 45 degree angle. Patient was at ED he was found to have an initial ECG with ST depressions in aVR and elevations in II, aVF, and V2 through V6 raising suspicion for pericarditis/myocarditis. Initial troponin was elevated at 4.35 as well. Cardiology Dr. was contacted by ED physician, case discussed, and EKGs reviewed and felt this was more likely pericarditis, but not STEMI. Of note, he reports a family history significant for his mother having a?hole in her heart.?He was given Toradol with improvement in his pain and upon arrival to hospital his chest pain was markedly improved. He was noted to have troponins peaking at 39.415 that down trended and an elevated CRP of 4.8 on admission. D-dimer was 0.26. Covid PCR was negative. He was evaluated by cardiology again here who upon review of his ECG and cardiac enzymes as well as presentation was consistent with pericarditis. Echocardiogram showed normal LV systolic function with trace posterior pericardial effusion and telemetry was monitored without any arrhythmias. He was started on low-dose beta-blockers, aspirin 650 mg 3 times a day, and colchicine 0.6 mg every 12 hours for 2 doses followed by 0.6 mg daily. He is planned to continue this for approximately 3 months and will need to follow-up with cardiology in 1 to 2 weeks for repeat monitoring and management with plan to taper off aspirin once his CRP normalizes. Later that night, he even had a similar episode of sudden onset chest pain for which she received IV Toradol with minimal relief and oral Tylenol with relief of symptoms after that. No telemetry abnormalities were recorded at that time. ECG the following day showed improving ST changes and troponin of 26.328 with CRP 4.2. He had no further symptoms for over 24 hours and is responding well to treatment. He is advised to take Tylenol as needed in addition to the above-mentioned medicines should he have any recurrent chest pain.
18 2021-05-11 tremor per mother, pt splayed out chair and body was shaking, which lasted a few seconds. Pt reports, that ... Read more
per mother, pt splayed out chair and body was shaking, which lasted a few seconds. Pt reports, that it felt like he was dreaming. Mother informed me immediately. Pt was oriented by the time I came. EMT was called and they took vitals. Pt was bradycardic and hypotensive. He also reported neck pain. He was then taken to the hospital.
18 2021-05-12 weakness Lack of energy- Attempted to sleep off with limited success Major pain in joints- Took Ibuprofen, mo... Read more
Lack of energy- Attempted to sleep off with limited success Major pain in joints- Took Ibuprofen, mostly ?treated? Still need to take it, or pain returns Stiffness- No actions can be taken to alleviate that I am aware of. Still present, but improved from yesterday and the night before Headaches- Took Ibuprofen, surprisingly ineffective . Relatively new symptom, just started today. Coughing- Did not treat, mostly disappeared by the next day. Only a very minor and sporadic cough still remains. Minor feeling of congestion- Did not treat, not serious enough to warrant action. Still present today.
18 2021-05-13 seizure Patient has history of vasovagal syncopy / seizure and told us in advance. When he was administered ... Read more
Patient has history of vasovagal syncopy / seizure and told us in advance. When he was administered the vaccine, he passed out for just a short period of time and had a minor seizure (approx. 5 seconds).
18 2021-05-17 concussion 5/15/2021 passed out while taking shower, and passed out 2nd time outside bathroom ( witnessed) , ... Read more
5/15/2021 passed out while taking shower, and passed out 2nd time outside bathroom ( witnessed) , hit head on side of door ,was seen in ER for head injury/ concussion Labs , EKG, Blood sugar , and Head CT scan done - normal results , referred to concussion doctor within 3-5 days
18 2021-05-18 unresponsive to stimuli, weakness Site: Pain at Injection Site-Medium, Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Dif... Read more
Site: Pain at Injection Site-Medium, Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Weakness-Severe, Additional Details: Patient lost conciousness a few minutes after dose was given. Patient was unresponsive for approximately 2 minutes. Neck felt tight, difficulty breathing, was not alert/oriented when finally awoken. Patient was given 1 shot of epi 0.3 due to a temporary interuption in breathing that lasted seconds. By the time paramedics arrived, he was becoming more alert. Was taken to the ER and discharged.
18 2021-05-19 seizure Patient is 18 year old male who received his first dose of Pfizer COVID 19 vaccine. graduate intern... Read more
Patient is 18 year old male who received his first dose of Pfizer COVID 19 vaccine. graduate intern, administered the dose and within the first minute, patient tensed up and passed out. He appeared to look like he had a seizure. Patient was passed out for less than a minute. When he came to, he said he fell asleep. He said he felt warm. We checked his Blood pressure and it 94/62 and pulse was 54. We called 911 and laid patient on a mat. He was given gatorade and a warm wash cloth. Paramedics arrived and rechecked BP. It was 110/66 and pulse was 66. They evaluated him and told him to have someone drive him home. Patient has not history of seizures and no history of adverse reaction to vaccine. He did receive a tetanus booster on 5/17/21. Only other medical history is asthma. He uses albuterol prn but has not had to use it for > 4 years.
18 2021-05-19 tremor Pt reported dizziness/lightheadedness, was pale & sweating. Began to shake as he was moved from whe... Read more
Pt reported dizziness/lightheadedness, was pale & sweating. Began to shake as he was moved from wheelchair to bed. Last meal was several hours prior (BP 93/48; HR 65). Similar sx w/previous vaccines, afraid of needles. Pt transferred to gurney, legs elevated. Ate crackers & juice. Able to walk w/out difficulty & waited for father to pick him up. Released in stable condition (BP 120/54; HR 87)
18 2021-05-20 tremor, unresponsive to stimuli Systemic: Fainting / Unresponsive-Severe, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Syste... Read more
Systemic: Fainting / Unresponsive-Severe, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Vomiting-Medium, Additional Details: Patient was administered first dose of Pfizer vaccine approximately 9:40am (MSD). Upon reviewing intake sheet there were no discrepancies to continue with the vaccination. Upon successful administration, patient was instructed to sit near Pharmacy in waiting area. Patient was standing next to wellness room where patient had fainted. Dr. and N.P. rushed to the scene to take control of the situation. Patient was assessed and asked a series of questions. He hadn't eaten in the morning.
18 2021-05-21 pain in extremity GAVE AN 18 YEAR OLD MALE HIS 1ST PFIZER COVID-19 VACCINE AND HAD HIM SIT DOWN FOR 15 MINUTES. ALMOST... Read more
GAVE AN 18 YEAR OLD MALE HIS 1ST PFIZER COVID-19 VACCINE AND HAD HIM SIT DOWN FOR 15 MINUTES. ALMOST 5 MINUTES AFTER THE VACCINATION, THE PATIENT WAS SLOUCHED IN HIS CHAIR, SWEATING, LOOKING PALE, AND COMPLAINING THAT HIS BODY WAS HURTING ALL OVER. I RAN OVER TO THE PATIENT AND ASKED IF HE WAS HAVING TROUBLE BREATHING, TO WHICH HE DENIED. I BEGAN TO ASK HIM WHERE EXACTLY DOES IT HURT TO WHICH HE MENTIONED HIS LEGS AND BODY. SINCE HIS BREATHING WAS FINE, I SUSPECTED IT WAS JUST A PANIC ATTACK BUT NONETHELESS I PROVIDED HIM AN ICE PACK AND WATER. WE ALSO MOVED HIM TO A MORE PRIVATE AREA TO ELEVATE HIS LEGS. I OFFERED TO CALL 911, BUT HE DENIED. WE KEPT HIM FOR 30 MORE MINUTES WATCHING OVER HIM TO SEE HOW HE PROGRESSED. HE FELT MUCH BETTER TOWARDS THE END. THE PATIENT ADMITTED HE WAS HAVING A PANIC ATTACK. MY TECHNICIAN OFFERED TO CALL A FAMILY MEMBER TO COME GET HIM, BUT HE DENIED AND SAID HE WAS OKAY TO DRIVE HIMSELF HOME.
18 2021-05-21 pain in extremity Sore Arm Stuffed Nose Headache Sneezing Sore throat
18 2021-05-21 tingling pericarditis; headache; fever; having trouble breathing; chest pain; tingling down his arms; This is... Read more
pericarditis; headache; fever; having trouble breathing; chest pain; tingling down his arms; This is a spontaneous report from a contactable consumer. An 18-year-old male patient received second dose of BNT162B2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 04May2021 at 16:00 (Batch/Lot Number: ER8736) as 2ND DOSE, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no Covid prior to vaccination and was not tested post vaccination. The patient experienced Pericarditis, headache, fever, having trouble breathing, chest pain and tingling down his arms all on 06May2021. It was reported that the patient had all the normal reactions to a significant extent, the headache, the fever, etc. But two nights after the vaccination he was having trouble breathing, he had chest pain, and tingling down his arms. The next day, patient was taken to urgent care and was diagnosed with pericarditis. The patient underwent lab tests and procedures which included EKG (electrocardiogram): pericarditis on 06May2021 (EKG showing Pericarditis and 10 days of medication). Therapeutic measures were taken as a result of all the events. The outcome of all the events was unknown.
18 2021-05-22 unresponsive to stimuli Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsiv... Read more
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension-Mild, Additional Details: Patient went to observation area after receiving Pfizer Covid-19 Vaccine. Patient became lightheaded and faint and fell to floor. Patient was unconscious for aproximately 30 sec. After being repositioned, patient did regain consciousness; however was a little confused as to what had happened. Patient did injure his lip during fall. Vitals were all within normal limits with a slightly low blood pressure reading. 911 was called immediately. Stated had not eaten today/slept night before either.
18 2021-05-24 tremor, flushing PATIENT FELT DIZZY AND FLUSHED WHICH PROCEEDED TO VOMITTING, DIFFICULTY BREATHING AND CHILLS AND SHA... Read more
PATIENT FELT DIZZY AND FLUSHED WHICH PROCEEDED TO VOMITTING, DIFFICULTY BREATHING AND CHILLS AND SHAKING THE PATIENT WAS MONITORED WHILE PARAMEDICS ARRIVED. PATIENT VITALS WERE NORMAL AND PATIENT WAS MONITORED BY PARAMEDICS AND PHARMACY STAFF FOR ABOUT HALF AN HOUR. PATIENT REFUSED FURTHER TREATMENT AND WENT HOME ON THEIR OWN AND WAS INSTRUCTED TO FOLLOW UP WITH THEIR DOCTOR, AN URGENT CARE CENTER OR CALL PARAMEDICS IF FURTHER CARE IS NEEDED OR THEIR STATUS CHANGES.
18 2021-05-25 pain in extremity Patient has pain that started 1 week after vaccine, pain in deltoid- when reported to doctor had bee... Read more
Patient has pain that started 1 week after vaccine, pain in deltoid- when reported to doctor had been 3 weeks, harder to lift things, painful. pain radiates from deltoid towards shoulder and down into forearm
18 2021-05-25 tingling Tingling in his right hand and then subsequently developed tingling in his right leg and down to his... Read more
Tingling in his right hand and then subsequently developed tingling in his right leg and down to his foot; Chest pain; This is a spontaneous report from a contactable physician (patient's father) via Medical Information Team. An 18-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration in the left arm on 30Apr2021 (at the age of 18-years-old), 1st dose, single, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The vaccine was administered at a pharmacy. On 30Apr2021, the patient developed tingling in his right hand and then subsequently developed tingling in his right leg and down to his foot, and then developed chest pain. The reporter stated that the patient went to the emergency room and an electrocardiogram was done on 30Apr2021 that came back normal, so he was sent home. The reporter would like to know if there was any guidance that could be provided on the safety of the patient getting the second dose of the vaccine. The outcome of the events was unknown. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
18 2021-05-25 unresponsive to stimuli 18 year old otherwise healthy male, with mild asthma, and history of vasovagal syncope with prior v... Read more
18 year old otherwise healthy male, with mild asthma, and history of vasovagal syncope with prior vaccinations, IV's and any type of injection on multiple occasions. He has no history of prior seizures or seizure disorder. He received his vaccine at about 9 AM and walked to our 15 minute observation area. Within 5 minutes of sitting down, he stated he was not feeling well, became unresponsive, and had a series of 3 very brief, witnessed tonic clonic seizure activity, each lasting 5 seconds or less, with only a few seconds between. Following this he was minimally responsive, still sitting up, eyes opened, and only mumbled in response to questions. He was pale, confused, mildly diaphorectic, BP was 119/99 pule was 61, O2 sat was 96% and resp rate was approximately 20. He was NOT incontinent of stool or urine. He was fully conscious and oriented to person place time and situation within 5 minutes. He soon regained his color and vitals continued to be stable. He does have a history of "low blood pressure" per his report. He was feeling well, but because of the history witnessed seizure activity the decision was made to transport to hospital. He was transported by Ambulance Service to Hospital. Prior to vaccination today was feeling well. He was accompanied by his girlfriend. Diagnosis per supervising MD, was Post vaso-vagal syncope seizure activity. Or seizure activity related to vaso-vagal syncope.
18 2021-05-26 weakness I'm really weak and grouchy; I'm really weak and grouchy; This is a spontaneous report from a contac... Read more
I'm really weak and grouchy; I'm really weak and grouchy; This is a spontaneous report from a contactable consumer (patient). An 18-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not reported), via an unspecified route of administration in left arm on 17May2021 at 14:00 (at the age of 18-years-old) as 1st dose, single for COVID-19 immunization. Medical history included shrimp allergy. Concomitant medication included Ibuprofen. The patient was vaccinated at Hospital. No other vaccine was given in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination has not been tested for COVID-19. The patient reported that he was really weak and grouchy on 17May2021 17:00. The events were reported as non-serious. The patient did not receive any treatment for the events. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
18 2021-05-27 weakness RAPID HEART RATE PERICARDITIS + MONO WEAKNESS
18 2021-05-27 unresponsive to stimuli, involuntary muscle movements While sitting in the recovery area, patient's family noticed patient was not responding. Pt was plac... Read more
While sitting in the recovery area, patient's family noticed patient was not responding. Pt was placed onto the floor by nurse and turned onto his left side. Patient had noticeable clenching and jerking. After approx. 5 mins, patient was alert and oriented x3. Vital signs obtained. BP 130/88 HR 108 SpO2 98% room air. Patient sat upright on his own. Gatorade water given. Cold compresses applied to neck and head. Vitals obtained again. BP 120/90 HR 91 SpO2 98% room air. Patient declined to have EMS called. Extended monitoring done. Patient ambulated from facility with mother and father. No acute signs of distress noted.
18 2021-06-01 hot flush, migraine, numbness, muscle twitching, tingling, feeling hot Severe fatigue; Right hand started twitching uncontrollably; Had pain but it did not go across chest... Read more
Severe fatigue; Right hand started twitching uncontrollably; Had pain but it did not go across chest like after first dose vaccine; Had numbness down arms and legs; Had vertigo really bad; Was very hot, no fever, but radiating heat; Muscle pain; Mind numbing migraine pain in the caller's son's head; Body was hot allover, and his skin turned red; had periodic pins and needles with the numbness; Dizziness; Difficulty sleeping; Chest tightness periodically, but not consistently; Chest pain; Ear ringing; General malaise; Can't walk to the end of the block without coming back in pain; Found it hard to concentrate; Cloudy head; This is a spontaneous report from a contactable consumer (patient's mother). An 18-years-old male patient received of bnt162b2 (BNT162B2, Formulation: Solution for injection) via an unspecified route of administration in left arm on 07May2021 12:10 (Lot Number: EW0183; Expiration Date: 31Aug2021) as 2nd dose, single dose for COVID-19 immunisation. Medical history included lyme disease ongoing from 2013 and it was reported that her son had no tick bite & was diagnosed through a blood test. Her son had fatigue, migraines, lethargy & the doxycycline made him sick as a dog. A chiropractor had success using various tinctures & after 1 to 1-1/2 years, her son went into remission. Her son has a low degree of pain & soreness & has learned to deal with the pain. When his immune system is triggered, his Lyme disease comes back & he takes tinctures for a week or 2 & his symptoms goes away. No further details provided. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (Lot number: EW0164 and Expiry date: 31Aug2021) administered in left arm for COVID-19 immunisation and experienced chest pain, headaches and light-headed. Patient also had his first HPV Vaccine, laid out flat for a week and had no problems with the meningitis. On 07May2021, after second dose of vaccine administration, the patient had pain but it did not go across chest like after first dose vaccine, numbness down arms and legs, really bad vertigo, was very hot, no fever, but radiating heat, muscle pain, dizziness, mind numbing migraine pain in head, body was hot allover, skin turned red and right hand started twitching uncontrollably. On an unspecified date in May2021, the patient had periodic pins and needles with the numbness, difficulty sleeping, chest tightness periodically, but not consistently, chest pain, severe fatigue, ear ringing, general malaise, can't walk to the end of the block without coming back in pain, found it hard to concentrate and cloudy head. It was reported that the caller's son had the pain but it did not go across his chest like after the first dose Pfizer Covid 19 vaccination. The caller's son had numbness down his arms and legs and her son's legs were real heavy. The caller's son had to help life his legs to get his legs to move. The caller's son had vertigo really bad. The vertigo was so bad the caller's son had to lay down on the stretcher as the vaccination site. Even sitting up, the caller's son's world was spinning. The caller's son had to lay down. It was very hot, no fever, but radiating heat: The caller's son was very hot, no fever, but radiating heat. Part of that was the vaccination centre was not air conditioned and the caller's son was already a little uncomfortably warm when he went in. Dry ice packs were placed on the caller's son's head, went through three dry ice packs melting on the caller's son. The dry ice packs were on the caller's son's forehead and back of his neck and the injection site. The caller was trying to give her son coolness the best she could. He stayed about 30 minutes at the vaccination site and nothing improved or got worse. He was still very heavily dizzy or whatever and got in the wheelchair and got home. The caller's son did nothing for the rest of the day or weekend. The caller's son was just in so much pain and so much dizziness, it was just too much to do anything. The caller's son's symptoms gradually improved but very minute. The amount of dizziness the caller's son had was a little less so he could sit up at the computer, but even that the caller's son had to take breaks and couldn't do it for more than 30 minutes before laying back down. Had pain but it did not go across chest like after first dose vaccine: The caller's son's pain was a little less intense. The caller's son's numbness by Monday, 10May2021, had subsided for the most part. The caller's son is still having numbness down his arm, the opposite arm the caller's son received the second dose Pfizer COVID-19 Vaccine. The caller's son is also having numbness in his thighs sometimes, but not constantly. Clarifies the thighs or upper legs. The caller took her son to a Chiropractor and the Chiropractor gave her son a couple supplements to detoxify. That seemed to actually make things worse. The caller also took her son to the doctor's office. The caller took her son to a Chiropractor and the Chiropractor gave her son a couple supplements to detoxify: The caller states these were Charcoal and Magnesium combination and Turmeric root extract. Reporter made her son hydrate and use the generic Acetaminophen 500mg Caplets, along with a pain tea. The pain tea was loose herbs of valerian root, peppermint, and skull cap and pain tea seemed to help her son more for his pain, and mask some of the general malaise, and allowed her son to study for his AP Calculus exam. Patient's pain went from an 11-12 and was now at a 6 or 7. patient had a high tolerance for pain, and could cope with the pain, but the pain made it difficult for him to concentrate. Patient's migraine pain was unbearable at times and made it difficult for him. The generic Acetaminophen 500mg caplet with the pain tea helped to manage so his migraine pain was not so extreme. Therapeutic measures included Liposomal Resveratrol 38mg Curcumin from turmeric root extract 100mg, dietary supplement (Lot: 00728B or 007288). She has reported that she had been giving her tylenol for muscular pain and migraine. Other treatment included: alternating between Advil (Liqui-Gels) and Tylenol (generic acetaminophen 500mg caplets), Advil Liqui-Gels 200mg Ibuprofen (UPC Number: 0573176914, Lot Number: R77157, Expiration Date: Mar2022), Generic Acetaminophen 500mg Caplets, NDC Number: 21130-111-90, Lot Number: 1AV1505 and Expiration Date: Nov2022). Reported in the evenings her son would take Advil PM (200mg Ibuprofen with Diphenhydramine Citrate 38mg), NDC/UPC Number: Unknown, Lot Number: EG1024 and Expiration Date: Jun2023. Reporter said that Advil didn't seem to work on her son's migraine headache like the Advil usually does. Outcome of the events pain but it did not go across chest like after first dose vaccine, numbness down arms and legs and vertigo really bad, muscle pain, mind numbing migraine pain in the caller's son's head, periodic pins and needles with the numbness, right hand started twitching uncontrollably, chest tightness periodically, but not consistently, chest pain and ear ringing as recovering, outcome of the event body was hot all over, and his skin turned red was recovered, outcome of the event difficulty sleeping as not recovered and outcome of the events dizziness, severe fatigue, general malaise, can't walk to the end of the block without coming back in pain, found it hard to concentrate and cloudy head as unknown. Information on Lot/Batch number was available. Additional information has been requested.
18 2021-06-02 pain in extremity 18 yo male with no significant PMH presented to the hospital on 6/2/2021 with c/o chest pain and SOB... Read more
18 yo male with no significant PMH presented to the hospital on 6/2/2021 with c/o chest pain and SOB. Per patient and his mother at bedside, he received the second dose of Pfizer vaccine on Sunday. Day after had mild headache, aches, arm pain and abdominal pain. Last night woke up with chest pain and SOB. They called his pediatrician who recommended they come to the ER for evaluation. In ED was found to have elevated troponin and EKG changes. CTA negative for PE. EKG showed ST elevations/ PR depressions inferior/ lateral leads concerning for pericarditis. Patient was seen by cardiology and diagnosis of myo/pericarditis was made. Patient was prescribed Aspirin 325 mg TID and Protonix 40 mg QD for GI prophylaxis. Patient will follow up with the cardiologist 1 week after discharge for further management and medication adjustments.
18 2021-06-04 weakness, pain in extremity First dose: His arm was sore; First dose: He was weak; This is a spontaneous report from a Pfizer sp... Read more
First dose: His arm was sore; First dose: He was weak; This is a spontaneous report from a Pfizer sponsored program COVAX US Support via a contactable consumer (patient, self-reported). A 18-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 20Apr2021, as a single dose for COVID-19 immunization. The reason for no lot number was he lost his vaccine record card. The patient taking Pfizer COVID vaccine because he could be able to go to events and participate in different things, so whenever he was around family, they were not worried and feeling unsafe. He was tired of wearing a mask. The patient's medical history and concomitant medications were not reported. The patient reported that on 20Apr2021, his arm was sore, and he felt weak, after first dose. He clarified that the first dose of the COVID vaccine actually hurt his arm more. After the first dose of the COVID vaccine, he was weak for 2 or 3 days. He did not have many side effects. He lost his vaccine record card. He and his step dad both received the COVID vaccine on the same day. He had his step dad's vaccine record card, so he was able to provide exact dates. Outcome of the events was recovered on 22Apr2021. Information about lot/batch number has been requested.
18 2021-06-04 pain in extremity His arm was only sore the same day he received the second dose of the covid vaccine, and the next mo... Read more
His arm was only sore the same day he received the second dose of the covid vaccine, and the next morning; He slept a lot that night; This is a spontaneous report from a contactable consumer (patient) from a Pfizer Sponsored Program COVAX US Support. A 18-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCIN, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 11May2021 (at the age of 18-years-old) as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCIN, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 22Apr2021 as single dose for covid-19 immunisation and had arm was sore and weak for 2 or 3 days. On 11May2021, on the same day of second dose of vaccine, patient arm was sore of the first day and the next morning, then it was fine. He slept a lot that night. He did not have nearly as much symptoms as most people say. He did not have many side effects. Outcome of the event pain in arm was recovered on 12May2021 and for other event was unknown. Information about lot/batch number has been requested.
18 2021-06-06 unresponsive to stimuli, tremor 14:08 While washing hands I heard commotion in the other section of the observation area. Noticed p... Read more
14:08 While washing hands I heard commotion in the other section of the observation area. Noticed pt. on the floor, next to his chair. He was having "shaky" movements, unresponsive, diaphoretic and very pale. Also noticed he was hitting head twice on wall. After protecting his head, he regained consciousness in approx. 15 sec. Staff had been called and 911 was activated. My oximeter read pulse of 40 to 45 and saturation between 96 to 98%. Pt. claimed it wasn't his first time after "needles" passing out. Said he had a good breakfast and lunch. He declined having his parents called.
18 2021-06-09 weakness, numbness, hot flush blackout; Shallow breathing; rapid heart rate; difficulty breathing or talking; dizziness; weakness;... Read more
blackout; Shallow breathing; rapid heart rate; difficulty breathing or talking; dizziness; weakness; feeling unwell; nausea; numb arm; heat flash; chills; This is a spontaneous report from a contactable consumer. An 18-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in left arm on 30Apr2021 at 14:30 (Batch/Lot number was not reported) (at the age of 18 years-old) as a single dose, for COVID-19 immunisation. There was no medical history. Concomitant medication included ibuprofen (IBUPROFEN) taken for an unspecified indication, start and stop date were not reported. No other vaccinations given within last 4 weeks. On 30Apr2021 at 1445, the patient experienced Shallow breathing, rapid heart rate, difficulty breathing or talking, dizziness and blackout, weakness, feeling unwell, nausea, numb arm, heat flash and chills. The outcome of the events was recovering. The patient did not have COVID prior to vaccination and was not tested post vaccination.
18 2021-06-09 numbness, feeling hot Patient became dizzy and heart began racing a few minutes after immunization. Increased dizziness an... Read more
Patient became dizzy and heart began racing a few minutes after immunization. Increased dizziness and then patient began having rigors that continued for 1 hour and 20 minutes post vaccination. He also experienced numbness in his body as well as warmth in his stomach and extremities. He was given Benadryl soon after vaccination. He was sent to the ER of to be monitored. Vitals and labs were deemed to be OK. Rigors ceased 20 minutes after arriving at the ER. He was monitored for a couple of hours and subsequently discharged. He has had severe fatigue. The day following immunization, he had another episode of rigors and numbness. Paramedics were called and evaluated patient at home. Patient then began having panic attacks and losing vision, brain fog, dizziness, and body numbness that have continued since that time. He has also had recurrent episodes of paranoia that started 3-4 days post vaccination and continue today. Patient has seen immunologist and is seeing psychologist weekly for counseling and EDMR. He has seen ophthalmologist as well as his primary care physician.
18 2021-06-10 seizure, tremor Pt received his 1st dose of the Covid19 (Pfizer-Biontech) vaccine in his left arm by myself on June ... Read more
Pt received his 1st dose of the Covid19 (Pfizer-Biontech) vaccine in his left arm by myself on June 11, 2021 around 9am at local pharmacy. About 5 minutes later while still being seated in the same seat, Pt started to look like he was going to pass out. His mother tried to keep him engaged and alert by talking to him. I raised his legs to see if it would help. Then, relatively soon after Pt's upper body and face began to shake and he started to foam from the mouth. We lowered him to the ground and placed him on his side. The "seizure" lasted less than 30 seconds. When Pt became alert and aware he stated he just had a "4 hour dream". When the paramedics arrived 5 minutes later we had Pt seated in a chair again and he had drank some water. About 5-10 minutes later he began to feel nauseated and vomited. The paramedics transported Pt to the hospital.
18 2021-06-10 seizure Approximately 3 minutes after receiving vaccination, patient experience seizure in waiting room. Sei... Read more
Approximately 3 minutes after receiving vaccination, patient experience seizure in waiting room. Seizure lasted approximately 45 seconds-1 minute. Regained consciousness. 2 inch laceration to chin and chipped tooth post seizure. EMS called. Patient transported to local ER for further treatment.
18 2021-06-11 unresponsive to stimuli Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild
18 2021-06-12 numbness Numbness in face both sides cheeks and jaw
18 2021-06-12 pain in extremity headache, sore arm could not lift arm very high, tired
18 2021-06-14 seizure As soon as vaccine administered, patient stated he felt like he was going to faint. RN grabbed his s... Read more
As soon as vaccine administered, patient stated he felt like he was going to faint. RN grabbed his shoulders, he fainted in chair and started snoring. RN lifted his head to open airway and pt started convulsing and turned bright red. RN yelled for help. RN leaned the chair back to lay on the floor, holding patents head so it would not hit hard. Pharmacy worker called 911. Pt stopped convulsions and started coming too then turned very pale. He said he was starting to feel better but wanted to remain laying on the floor. When paramedics arrived they assisted him up in a chair, took his vitals, he was stable. Then checked his blood sugar and pt immediately passed out again. RN again assisted to lay him back in the chair to be flat on the floor. He again became very pale. Paramedics placed him on the gurney and took him to ER to be evaluated.
18 2021-06-16 pain in extremity 5/4/21 Pt had first covid vaccine to right arm and aprox 5-6 hours later pt c/o sharp left upper bac... Read more
5/4/21 Pt had first covid vaccine to right arm and aprox 5-6 hours later pt c/o sharp left upper back pain the proceeded to radiate to right arm and chest, causing some sob due to pain with breathing. Pain cont. throughout night. Seen in office 5/6/21 for symptoms that persisted, but improving. Denied swelling, n/v/d, palpitations. Pulse ox 97% on RA, RR 20, HR 88. No acute distress. EKG and CXR done, no abnormal findings. Advised motrin for pain, f/u if worsening of symptoms occur.
18 2021-06-16 tingling Developed tingling in his right arm mostly the end and then he developed tingling in his right leg; ... Read more
Developed tingling in his right arm mostly the end and then he developed tingling in his right leg; Chest pain; This is a spontaneous report from a contactable physician. An 18-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number unknown), via an unspecified route of administration, administered in left arm on an unspecified date (at the age of 18 years old) at first dose, single dose for COVID-19 immunization at the pharmacy. There were no medical history and concomitant medications. On an unspecified date on the same day of vaccination, the reporter stated that the patient developed tingling in his right arm mostly the end and then he developed tingling in his right leg. The patient then developed chest pain; because of chest pain, the patient was brought to the emergency room on an unspecified date. The patient underwent electrocardiogram (EKG) that was reportedly normal. The physician brought up the concern that the patient's mother needed guidance as far as her son should get the second shot or not. The physician stated that patient had extensive treatment for chest pain which is that patient was brought to the emergency room and had an EKG. The outcome of events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
18 2021-06-18 feeling hot Patient had vaccine at 4pm stopped to eat after. Patient states was in air conditioning when returni... Read more
Patient had vaccine at 4pm stopped to eat after. Patient states was in air conditioning when returning home went to dinner in home approx 930 pm and felt warm and when stood up had syncopal episode felt warm and lost vision.
18 2021-06-18 tremor PATIENT WAS NERVOUS ABOUT VACCINE, HE INQUIRED ABOUT USING A NUMBING AGENT BUT WE DIDNT HAVE ANY THA... Read more
PATIENT WAS NERVOUS ABOUT VACCINE, HE INQUIRED ABOUT USING A NUMBING AGENT BUT WE DIDNT HAVE ANY THAT WE PROVIDED SO HE PROCEEDED WITH GETTING THE VACCINE. AFTER THE VACCINATION HE WAS OK, WAS TALKING AND WALKING FINE. I INFORMED HIS MOM AND HIM ABOUT WAITING AROUND FOR 15 MINUTES AND THEY WENT TO THE FRONT OF THE STORE WHERE HE SUBSEQUENTLY FAINTED. 911 WAS CALLED, PHARMACIST WENT TO PROVIDE SUPPORT BUT PATIENT WAS NOW CONSCIOUS, REACTIVE, AND SPEAKING. HE BEGAN TO TREMBLE AS THE PARAMEDICS SHOWED UP AND WAS CHECKED OUT BY THE PARAMEDICS. THE MOM LATER CAME BACK TO THE PHARMACY TO BUY TYLENOL AND LET US KNOW HE WAS FINE.
18 2021-06-20 hot flush, tingling, tremor, feeling cold 18 year old male with no known history of allergies presented to covid-19 vaccine pod for first dose... Read more
18 year old male with no known history of allergies presented to covid-19 vaccine pod for first dose of Pfizer. After vaccine administration patient sat during holding area and started to have dizziness, vision changes, tingles in left arm and hot flash. Patient appeared pale with no diaphoresis noted no change mental status. Alert and oriented x 3. Vitals BP 88/53 HR 88 Respirations 17 Pulse Ox 98% Patient admitted to eating only one bowl of cereal and one glass of water for the entire day. Patient denied any SOB, chest pain, swelling or tingling sensation around mouth or tongue however report heart racing. Patient observed for 15 minutes and given water and snack which patient noted to have improvement. Color returned to face. Vitals BP 110/67, HR 89, R 18, Pulse OX 98%. Notified family present of symptoms and at home education. Patient then started to feel cold, noted tremors of upper extremities and patient lips blue tinged. EMS called and spoke to mother on phone regarding patients status. EMS arrived on scene no visible improvements. Patient left via EMS to ED
18 2021-06-22 sensory loss 18yo M pt was nervous for vaccine, got vaccine, walked over to waiting area, sat for 5 minutes befor... Read more
18yo M pt was nervous for vaccine, got vaccine, walked over to waiting area, sat for 5 minutes before passing out and falling out of chair onto floor, dad yelled for help by the time I got over there he was coming to, sat on the floor was slightly hyperventilating, gave him water, complained about not being able to feel his hands, was white as a ghost, paramedics were already at store for a separate incident, came over, took his vitals, offered him a ride to hospital but didnt think it was needed, pt left with his father
18 2021-06-24 flushing, seizure, unresponsive to stimuli Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flus... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Seizure-Medium, Additional Details: patient fainted and hit head on chair when falling from sitting in chair to floor. bystander said that patient's entire body was convulsing. pharmacist ran out to patient and by the time rph was by his side he was awake and coherent. EMT came and checked patient out, advised patient to go to hospital for monitoring but patient refused. patient's mother came and picked him up.
18 2021-06-24 tremor, numbness Pfizer-BioNTech COVID-10 Vaccine EUA. Symptoms immediately started after vaccination. Patient repor... Read more
Pfizer-BioNTech COVID-10 Vaccine EUA. Symptoms immediately started after vaccination. Patient reports having chills, tremors, diaphoresis, numbness to his hands/stomach, palpitations, and light headedness. Nurse from the vaccine clinic reports giving the patient cetirizine prior to transferring to ED. Continued having numbness to the hands and slight light headedness. No further intervention.
18 2021-06-28 seizure Patient began to go pale and sweat about 3 minutes after receiving his first Pfizer shot. The patien... Read more
Patient began to go pale and sweat about 3 minutes after receiving his first Pfizer shot. The patient then passed out and had some convulsions. This last for about 5 seconds and happened twice about 30 seconds to a minute apart. Afterwards the patient stated that his tongue felt "funny" and looked a little swollen. The patient was observed and 911 was called. He was evaluated by EMT staff and seemed to be back to normal about 30 minutes later.
18 2021-06-29 weakness, pain in extremity, cold extremities, unresponsive to stimuli The day of the second shot (07JUN2021@11AM), my son complained his arm was sore and was not feeling ... Read more
The day of the second shot (07JUN2021@11AM), my son complained his arm was sore and was not feeling the best but was eating, drinking, and seemed fine. The next day (08JUN2021 @10AM) my son came down from his room to eat breakfast and still was not feeling the best but seemed fine after eating. Around 12PM my son came down the stairs to get some water in the kitchen and then shortly thereafter after passed out, fell against the wall and slid down to the floor. I was in the location and found him unresponsive, very cold, and eyes looking straight ahead -not moving. My older son and I then carried him to the couch where I laid him down and elevated his feet. He started coming around approx. two minutes later and broke out in a sweat but also had chills. At that point, I did not call an ambulance and started to hydrate. After an hour or so, he started feeling better and then ate some food but was weak most of day and rested. The next day he seemed fine.
18 2021-07-02 weakness patient reports feeling dizzy, sweaty and weak minutes after of the vaccine administration.
18 2021-07-06 seizure Two to three minutes after patient received COVID vaccine. Patient had a seizure. He was sitting in ... Read more
Two to three minutes after patient received COVID vaccine. Patient had a seizure. He was sitting in a chair while it happened. After a couple seconds patient said he was feeling okay just a little dizzy. Paramedics came and took him to a hospital to be monitored.
18 2021-07-11 feeling hot, weakness Dizziness, profuse sweating, felt hot,shortness of breath, felt like passing out, vision disturbance... Read more
Dizziness, profuse sweating, felt hot,shortness of breath, felt like passing out, vision disturbance (saw black spots) , weakness. This occurred immediately after shot was given. Medical personnel moved him to area to monitor his vitals, gave him ice packs, checked blood pressure, heart rate etc.
18 2021-07-11 numbness, tingling Adverse event: acute myocarditis/pericarditis. 2 days after receiving Pfizer #2, dev substernal ches... Read more
Adverse event: acute myocarditis/pericarditis. 2 days after receiving Pfizer #2, dev substernal chest pain, largely positional with positional dry cough. Also had left arm numbness/paresthesia after second vaccine. Treatments: 1 dose enoxaparin, IVF, ondansetron x 1, then placed on/discharged from hospital on colchine Never had fever or tachycardia
18 2021-07-12 tingling, numbness This is an 18-year-old male here complaining of pain in the left chest wall just inferior to the axi... Read more
This is an 18-year-old male here complaining of pain in the left chest wall just inferior to the axilla. Patient states it started 3 days ago 1 day after the Covid vaccine of Pfizer was given in the ipsilateral arm. Patient states he feels swollen with some numbness and tingling in that area and also in the left forearm. Mild tenderness to the left chest wall that is improving. Instructed patient to use anti-inflammatories as needed.
18 2021-07-14 pain in extremity Patient states that his arm has been and still is sore. He has lost mobility and it's painful (7 on... Read more
Patient states that his arm has been and still is sore. He has lost mobility and it's painful (7 on pain scale) when trying to raise his arm above his head. He can perform pull movements, but cannot perform any push movements.
18 2021-07-15 tingling Chest tightness, shortness of breath, tight jaw, tingling left foot, racing heart rate/arrhythmia, i... Read more
Chest tightness, shortness of breath, tight jaw, tingling left foot, racing heart rate/arrhythmia, irritability, inability to sleep more than 1 hour a night, excessive thirst? still waiting on treatment
18 2021-07-17 feeling hot Chest and back itch incredibly; Does feel hot; now swelling of his face or throat; now swelling of h... Read more
Chest and back itch incredibly; Does feel hot; now swelling of his face or throat; now swelling of his face or throat; This is a spontaneous report from a contactable consumer or other non-healthcare professional (Patient's father). An 18-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection, batch/lot number: EN0187 and Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 25Jun2021 14:30 (at the time of vaccination 18-years-old), as a single dose for COVID-19 immunization. The patient's medical history include sunburn and reported that he did have a sunburn 3 days ago. No concomitant medications were not reported. The caller provided other relevant medical history including but not limited to these conditions; diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. The patient did not have any other vaccination prior to COVID vaccine (within 4 weeks). No family Medical History Relevant to adverse events. On 25Jun2021, the patient experienced chest and back itch incredibly, does feel hot, and now swelling of his face or throat. It was reported that, today (25Jun2021) the caller 18-year-old son had the Covid-19 vaccination. He had the vaccine about 2 hours ago. Everything was fine up until about 30 minutes ago. He claims his chest and back itch incredibly. He had no other symptoms and no rash. He does feel hot. He had no difficulty breathing and now swelling of his face or throat. The caller wife was a nurse. She did not feel like it was an emergency at that point but being a nurse, she wanted him to check and see if they have any Benadryl. No relevant tests. Patient did not visit to emergency room, physician office and not hospitalized. The outcome for all the events was not resolved. Additional Information has been requested.
18 2021-07-17 muscle twitching Sore at injection site; Fatigue; Flu like symptoms; Twitching in my left arm; This is a spontaneous ... Read more
Sore at injection site; Fatigue; Flu like symptoms; Twitching in my left arm; This is a spontaneous report from a contactable consumer, the patient. A 18-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Ep7534), via an unspecified route of administration in the left arm on 29Mar2021 at 12:00 (at the age of 18-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient previously took erythromycin (MANUFACTURER UNKNOWN) and amoxicillin (MANUFACTURER UNKNOWN); experienced drug allergy. Prior to the vaccination, the patient was unknown if diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within 2 weeks of vaccination. On 30Mar2021 the patient experienced sore at the injection sight and felt super fatigued with flu like symptoms and twitching in the left arm. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatments for the events of vaccination site pain, fatigue, flu-like symptoms and twitching. The clinical outcomes of the events vaccination site pain, fatigue, flu-like symptoms and twitching were unknown at the time of the report. No follow-up attempts are needed. No further information is expected.
18 2021-07-19 pain in extremity sore arm; This is a spontaneous report from a contactable consumer (mother) reported for his son(pat... Read more
sore arm; This is a spontaneous report from a contactable consumer (mother) reported for his son(patient).A 18-year-old male patient received first dose of BNT162B2(Pfizer-Biontech Covid-19 Vaccine, Formulation: Solution for injection, batch/lot number not provided), via an unspecified route of administration on 18May2021 (at the age of 18 year) as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in May2021, the patient experienced sore arm.They were uncomfortable that he wasn't vaccinated," she said. So, he got the COVID vaccine without telling me." Withheld other son, now 16, had an adverse reaction to his measles-mumps rubella (MMR) vaccine when he was younger, and has not been vaccinated since. After (Withheld) first Pfizer dose on 18May2021experienced a Sore arm but was otherwise. The outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.
18 2021-07-20 seizure like phenomena 18 year old male started experiencing lightheadedness, muscle stiffness, sweating profusely within 1... Read more
18 year old male started experiencing lightheadedness, muscle stiffness, sweating profusely within 10 minutes of his first dose of Pfizer vaccine. Patient was made to lie down on the ground with ice applied to back of neck and forehead. His blood pressure reading was 77/64. Patient was coming in and out of consciousness for about 60 seconds then became alert and regained full consciousness. He also appeared to be experiencing an episode of muscle tightness (possibly a seizure) for a few seconds while he was unconscious. His mother who states that she is a nurse, was present with him as he experienced unconsciousness and prevented him from falling to the ground. She states he does not have a history of seizures or other conditions and has never had a reaction after an immunization. Paramedics arrived within 15 minutes, EKG and BP, blood glucose appeared normal. Patient was alert and able to stand unsupported prior to being taken to the hospital.
18 2021-07-21 flushing, unresponsive to stimuli Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mediu... Read more
Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Additional Details: pt was advised to wait 15 minutes after the vaccine but was in ahurry. He fainted in the front of the sore @115pm. vitals signs were taken and everything was okay. we also called 911 and he was transported to the hospital with mional injuries. Deviation of his nose and nose bleeding were the prmary effecs.
18 2021-07-22 weakness Throat was closing; Tongue swelled up; Heavy sweating; Fogging brain; Feeling of passing out; Lips s... Read more
Throat was closing; Tongue swelled up; Heavy sweating; Fogging brain; Feeling of passing out; Lips swelled up; Weak; This is a spontaneous report from a contactable consumer, the patient. An 18-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: er8733) via an unspecified route of administration in the left arm on 01Apr2021 at 13:45 (at the age of 18-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no allergies to medications, food, or other products. The patient did not receive any concomitant medication within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Apr2021 at 19:30, the patient felt that the throat was closing, lips and tongue swelled up, heavy sweating, fogging brain, feeling of passing out and weak. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measure taken as a result of the events experienced included benadryl (MANUFACTURER UNKNOWN). The clinical outcome of the events throat was closing, lips and tongue swelled up, heavy sweating, fogging brain, feeling of passing out and weak were resolving at the time of this report. No follow-up attempts are needed. No further information is expected.
18 2021-07-23 feeling hot Attendee received first dose Pfizer vaccine at 13:10 in the left arm. Lot# FA3780. Attendee was dir... Read more
Attendee received first dose Pfizer vaccine at 13:10 in the left arm. Lot# FA3780. Attendee was directed to observation area. At 13:15 voiced complaints of nausea and feeling hot. Chest discomfort 1/10. Attendee's skin was warm and dry. Attendee assisted to the wheelchair and was taken to the cot to lie down. Icepack applied to face and neck. 13:21 - Attendee still with nausea and feeling hot. No chest discomfort, at this time. HR: 63 BP: 100/60 RR: 20 O2Sat%: 99 Temp: 97.4 13:35 - No voiced complaints- skin warm and dry. HR: 82 BP: 102/60 RR: 18 O2Sat%: 99 13:45 -Denied complaints - skin warm and dry. 13:50 - Care Practitioner educated on home discharge/adverse reaction instructions and attendee was discharged to home with his partner. Attendee did not have any reported escalation of symptoms and was able to walk out of clinic independently.
18 2021-07-23 numbness Within 10 minutes of vaccination, the patient reported feeling numb in the left arm. It was not pai... Read more
Within 10 minutes of vaccination, the patient reported feeling numb in the left arm. It was not painful, there was not swelling or redness. I advised patient to contact doctor if the numbness persisted for 3 days, I advised the patient to take Tylenol or ibuprofen. I called the patient back 4 hours later and the patient's mom reported that the numbness was gone, but the arm was now itchy. I advised the patient to seek out his PCP if the feeling was still there after 3 days.
18 2021-07-29 unresponsive to stimuli Systemic: Fainting / Unresponsive-Medium, Additional Details: AFTER giving the vaccine, his mother t... Read more
Systemic: Fainting / Unresponsive-Medium, Additional Details: AFTER giving the vaccine, his mother told me he has vasovagel syndrome and she was expecting him to faint afterwards.
19 2021-01-07 difficulty speaking At time of vaccination ~5 minutes after the injection of the pfizer vaccine I developed a tightness ... Read more
At time of vaccination ~5 minutes after the injection of the pfizer vaccine I developed a tightness in my throat, I was still waiting in line and I did not think much of it, therefore I did not alert the medical personnel about the reaction. Approximately @15mins after the injection I left the site and developed a sense of something wrong and did not feel "right", my chest became tight, hoarseness in my throat and speach, lightheaded, and I remember taking a sip of my coffee thinking it was more difficult to swallow than usual. May I note I was in the passenger seat and not driving the vehicle. I alerted my mother of the reaction, both sceptical because of my hx of no known allergies. We both figured as long as I can breath and I was still conscious, with no signs of cyanosis I would be fine. At around 10:45 I took my BP: which was 106/62 I typically run low. I then took two 25mg Benadryl capsules which did help the throat tightness to an extent, however the tightness in the chest, lightheaded and dizziness still persisted. I was aware of the potential for Bi-phasic anaphylaxis so we had an Epi-pen on stand by just in case. I was stable for the rest of the day. At approximately 10pm I did notice a small erythematous non-pruritic rash across my chest. The symptoms of the reaction did subside within 24hrs. I remained in stable condition and recovered with time.
19 2021-01-12 pain in extremity Headache began around 8:00 pm on the day of the vaccination with worsening arm pain. The next mornin... Read more
Headache began around 8:00 pm on the day of the vaccination with worsening arm pain. The next morning around 7:00 am I had a fever of ~102 F, worsening headache, and nausea.
19 2021-01-22 feeling hot, tremor, feeling cold A little before bed I was feeling cold (I think it was a little after 10pm). I took a warm shower th... Read more
A little before bed I was feeling cold (I think it was a little after 10pm). I took a warm shower thinking the house was just cold, but when I went to bed after I started shaking with chills. I didn?t sleep well that night and during the day Thursday (01/21) I felt feverish and a throbbing headache. I tried sleeping throughout the day, still having the chills come and go. I took ibuprofen before heading the bed the next night and slept great other than feeling a little hot and sweaty. I showered the next morning and felt 100% again.
19 2021-02-10 feeling cold My right radial forarm felt cold, as if there was methane on it. The cap refill was under 2 seconds ... Read more
My right radial forarm felt cold, as if there was methane on it. The cap refill was under 2 seconds in both hands.
19 2021-03-04 involuntary muscle movements Patient ambulated to general observation, sat in chair and suddenly fell straight back and slammed b... Read more
Patient ambulated to general observation, sat in chair and suddenly fell straight back and slammed back of head on floor. Patient was unconscious, pale. Immediately turned onto left side. within a few seconds began having generalized rigid jerking for approx 5 sec, then patient came too, sat straight up, disoriented looking around. Able to recall name. states he was here for covid vaccine. Assisted to w/c by 2 EMT's and taken to private observation area. Patient c/o nausea and head pain. Color pale. Has an almond size swollen area at posterior base of head. Initial VS - BP 90/p; HR 53; O2 91% on room air. Responding to questions, but states he feels disoriented. Bilateral pupils 3cm with right reacting sluggish. Patient states he is a student. EMT attempted to contact patient's father and LVM. Patient's step mother returned called. Informed her that patient is being transported to Hospital downtown FW for further eval. She asked him what did she need to do. Nurse informed that his vehicle will be left at the vaccine location and he will need assistance pending hospital eval. Patient then called his boss to notify him that he will not be at work tonight. Patient states that he had a reaction to his first HPV - states he fainted, but completed the series without further problems. Repeat VS at 1550 BP 90/p; HR 67, O2 98%. Color remains very pale. EMS activated. patient states he needs to lie down. Assisted to stretcher per EMT, elevated legs, cushion under head with ice packs on back of head. 1602 EMS arrived, BP 121/75; HR 69 O2 100% on room air. Transferred to stretcher 1605 Patient transported to Hospital
19 2021-03-10 tremor Systemic: Fainting / Unresponsive-Mild, Systemic: Shakiness-Mild, Additional Details: THE PATIENT RE... Read more
Systemic: Fainting / Unresponsive-Mild, Systemic: Shakiness-Mild, Additional Details: THE PATIENT RECEIVED THE VACCINE AND WAS SEATED IN THE WAITING AREA . AFTER A FEW MINUTES, THE PATIENT BEGAN TO FAINT. THE PHARMACIST AND TECHNICIAN HELPED HIM TO THE FLOOR. HE STATED THAT THIS HAS HAPPENED TO HIM BEFORE WHEN HE HAD BLOOD DRAWN. HE ALSO CALLED HIS MOTHER AND SHE CONFIRMED THAT HE HAS A HISTORY OF SYNCOPE WHEN RECEIVING SHOTS. THE PATIENT DID NOT GO TO THE HOSPITAL, BUT HAD A FRIEND COME TO GET HIM. HE WAS CALLED LATER THAT NIGHT AND STATED THAT EVERYTHING WAS BACK TO NORMAL.
19 2021-03-15 seizure The patient had a seizure and vomited several times post-vaccine. 911 was called and EMS took him t... Read more
The patient had a seizure and vomited several times post-vaccine. 911 was called and EMS took him to the hospital for further evaluation.
19 2021-03-15 seizure 3-11-21 4:26PM CALLED TO VACCINE STATION. PARENT STATES PT HAS BEEN HAVING SEIZURES OFF & ON X ARPO... Read more
3-11-21 4:26PM CALLED TO VACCINE STATION. PARENT STATES PT HAS BEEN HAVING SEIZURES OFF & ON X ARPOX. 20MIN. SEIZURES STARTED BEFORE VACCINATION. 4:40PM PT POST ICTAL; PINK, W/D, RESP REG WITH EASE - NO RESP DISTRESS. TO EXIT PER W/C TO BE TAKEN HOME PER MOM. NO SEIZURES AT THIS TIME. 3-12-21 9:30AM MOM STATES PT IS '100% BETTER TODAY'.
19 2021-03-17 migraine Muscle soreness, achey feeling all over body, chills, migraine, and a lack of appetite paired with s... Read more
Muscle soreness, achey feeling all over body, chills, migraine, and a lack of appetite paired with slight upset stomach.
19 2021-03-22 feeling hot Per client post vaccine felt lightheaded and felt hot, and sob. Client states did not eat this morni... Read more
Per client post vaccine felt lightheaded and felt hot, and sob. Client states did not eat this morning, reports last meal was at 7pm last night. EMT and MD assessed, BP 132/90 @ 130pm, second BP 122/88 at 2pm , oxygenation 97%. Client remained in observation , left with parent without incident.
19 2021-03-22 cold extremities headache, dizzy, happens with every vaccine for him, sweaty cool skin 98/60, 86,18, 96%
19 2021-03-24 unresponsive to stimuli Client had a syncopal episode and fell from a sitting position to the floor. Pt was lying with eyes ... Read more
Client had a syncopal episode and fell from a sitting position to the floor. Pt was lying with eyes closed and non-verbal for 30 seconds or less. Tactile stimuli and deep sternum rub done to mid chest wall. Pt eyes open. A/O x3. LCTA. Medium size hematoma noted to left side of forehead with small abrasion noted to bridge of nose. Pt denies pain. EMS was notified. Once EMS arrived orthostatic v/s was obtained per EMS with last reading b/p 133/82 HR 72 RR 22 O2 99% RA. Pt refused further tx . Placed in w/c and pushed to lobby with family and RN at side. No acute distress.
19 2021-03-26 tremor A few seconds after vaccine was administered the vaccinator turned around to notice patient was unco... Read more
A few seconds after vaccine was administered the vaccinator turned around to notice patient was unconscious. Vaccinator describes 20-30 seconds of full body shaking. Patient then awoke and was Alert and oriented to people, place and time within 2 minutes. He was nauseas and anxious initially. Onsite EMS was alerted immediately and came to access the patient. 911 was also called quickly under the assumption it may have been a seizure. Patient denied any seizure history. Father arrived a few hours later to pick up patients vehicle and dog. Father informed me that patient was doing better at this point and was being prepared for departure.
19 2021-03-28 feeling cold Patient felt chilled and cold.
19 2021-03-30 seizure Pt had a seizure at 9:10 that lasted about 10 seconds. Pt.'s upper body stiffened and he turned pale... Read more
Pt had a seizure at 9:10 that lasted about 10 seconds. Pt.'s upper body stiffened and he turned pale. After the seizure pt. reported hx of seizures after vaccines that was not reported to the vaccinator. Pt was observed for an additional 30 minutes and left the observation area.
19 2021-04-02 feeling hot Became dizzy/lightheaded, overhead & nauseated. Had him lay down with feet up, offered water and par... Read more
Became dizzy/lightheaded, overhead & nauseated. Had him lay down with feet up, offered water and paramedics did vitals which were ok except low b/p 74/42. Drank some more water and b/p up to 105/65. BLS sugar 105. Felt better after about 1/2 hour. Wheelchairs to car.
19 2021-04-03 muscle spasms 45 minuted involuntary spasms rocking body, patient cons ious but immobilized making grunting chitte... Read more
45 minuted involuntary spasms rocking body, patient cons ious but immobilized making grunting chittering sounds, followed by several hours of heart palpitations and unsteadiness, nausea
19 2021-04-05 feeling hot Pt felt hot and became diaphoretic. He raised his hand and EMS responded.
19 2021-04-05 unresponsive to stimuli, feeling hot, flushing Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flus... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Additional Details: Immunization verified under (name), (name) administered, patient fainted during the 15 minute monitoring session. Patient was over-heated, fainited, responded immediately, had to prop patient up, continued to talk verbally to keep patient engaged. gave a cold water to rest behind neck, patient was sweaty, dizzy, propped a fan to cool patient, helped immediately, color returned to patient face. spoke with patient and mother of patient. counseled pt to be picked up. wfu with pt tomorrow.
19 2021-04-06 bell's palsy Bells Palsy that started 5 hours after vaccine administration
19 2021-04-07 weakness Feeling achy, weak, and tired. Also, have a cough.
19 2021-04-08 feeling hot patient started to feel hot and wheezing. wheezing appeared to worsen and he started reporting acid ... Read more
patient started to feel hot and wheezing. wheezing appeared to worsen and he started reporting acid reflux. patient had his asthmatic inhaler and took it with no resolution of symptoms. patient was given a cold compress for his head and neck to help cool him down. EMS came in and checked his vitals. He was cleared after patients symptoms resolved.
19 2021-04-09 unresponsive to stimuli Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient fainted about 2 minutes after ad... Read more
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient fainted about 2 minutes after administration. EMS was contacted and vitals were normal when checked by EMS personnel.
19 2021-04-10 unresponsive to stimuli Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient passed out about 2 minutes after... Read more
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient passed out about 2 minutes after vaccine administration. EMS was contacted and vitals were all normal as reported by EMS personnel.
19 2021-04-12 flushing Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Ligh... Read more
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Visual Changes/Disturbances-Medium
19 2021-04-12 pain in extremity 4/4 headache, chills, temp 102.8, sore arm, hard swollen lymph node in right axilla. Symptoms persis... Read more
4/4 headache, chills, temp 102.8, sore arm, hard swollen lymph node in right axilla. Symptoms persisted into 4/5 with addition of nausea. 4/6 tightness in chest, short of breath. Went to ER and was found to have elevated troponin level peaking at 9.6. Transferred to hospital, direct admit to CCU for suspected non STEMI. Hospital stay through 4/9 and diagnosed with myocarditis.
19 2021-04-12 pain in extremity Reporting back pain and arm pain
19 2021-04-12 tremor patient complained of dizziness on vaccine floor. patient brought to observation area. upon arrival ... Read more
patient complained of dizziness on vaccine floor. patient brought to observation area. upon arrival patient reports dizziness, sweating, "hard to hear", and shakiness. Vitals taken HR-71, RR-18, BP- 100/63, Pulse ox- 98%. Patient drank water bottle and apple juice cup. Vitals taken Q5min while under observation. 1455- HR-89, RR-18, BP- 117/75, Pulse ox- 100%, 1500-HR-72, RR-18, BP- 128/78, Pulse ox- 100%, 1505-HR-72, RR-18, BP- 123/77, Pulse ox- 99%, 1510 (while sitting upright)- HR-65, RR-18, BP- 116/72, Pulse ox- 99%, 1515 (while standing)- HR-79, RR-18, BP- 138/80, Pulse ox-100%. Patient reports feeling better and would like to leave.
19 2021-04-13 flushing Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Additional Details:... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: Patient started to feel dizziness after 15 minutes of the waiting period. He was told to lay down and lift his feet up. He mentioned that it was BP after 15 mins was 135/73. Water and orange juice were given. Patient laid on the floor with legs up for 15 mins. After that the BP down to 117/73. He was able to walk okay and he said he felt okay 100% before he left.
19 2021-04-13 pain in extremity Fatigue, arm pain(sore)
19 2021-04-15 flushing IMMEDIATELY FOLLOWING VACCINE DEVELOPED A HEADACHE, WITHIN 45 MINUTES DEVELOPED SKIN FLUSHING, SHORT... Read more
IMMEDIATELY FOLLOWING VACCINE DEVELOPED A HEADACHE, WITHIN 45 MINUTES DEVELOPED SKIN FLUSHING, SHORTNESS OF BREATH, FEELING OF THROAT CLOSING, AND DIZZINES.
19 2021-04-15 seizure Patient had a dizzy spell, fainted twice for about 15 seconds each. appeared to have seizure like ac... Read more
Patient had a dizzy spell, fainted twice for about 15 seconds each. appeared to have seizure like activity. Called 911 for furthur assistance. Patient was pale and cyanotic, became alert by the time paramedics got to the site.
19 2021-04-18 numbness, tremor Sympathomimetic Amines. Experiencing panic attack like symptoms. Started on Saturday at around 3:30 ... Read more
Sympathomimetic Amines. Experiencing panic attack like symptoms. Started on Saturday at around 3:30 am and present at the time of writing this. Experiencing shortness of breath, trouble breathing, accelerated heart rate, numbness throughout body, shaking, and tight cheats and throat.
19 2021-04-18 pain in extremity Patient had HA and fatigue after vaccine, but also had significant bilateral arm pain. On the am of... Read more
Patient had HA and fatigue after vaccine, but also had significant bilateral arm pain. On the am of 4/15 the right arm had resolved but he continued to have significant left arm pain and was seen in clinic. Was treated with ibuprofen. Sx resolved later in the day.
19 2021-04-18 unresponsive to stimuli Pt was found unresponsive on floor, pale, diaphoretic with BLEs elevated on chair. Pt became respons... Read more
Pt was found unresponsive on floor, pale, diaphoretic with BLEs elevated on chair. Pt became responsive in under 10 seconds. No head injury. VS laying down as follows: BP 111/66, HR 99, sats 99% on RA. Pt given water, snacks, cold compress applied to forehead. After 10 mins, pt was assisted to seated position on floor, VS as follows: BP 139/81, HR 85, sats 99% on RA. Pt recovered within 20 mins, ambulated out of clinic in NAD and was escorted to car by staff, driven home by friend.
19 2021-04-19 tremor Approximately 15 minutes after receiving the vaccination, pt came from our waiting area and said he ... Read more
Approximately 15 minutes after receiving the vaccination, pt came from our waiting area and said he was having trouble breathing and his hands were shaking. I had the patient sit down and he and I both agreed the pt was having an anxiety attack. No treatment was given. paramedics were called at [patients request.
19 2021-04-20 numbness Pt reports pain as soon as injection happened. Reports Numbness in Right shoulder and area around in... Read more
Pt reports pain as soon as injection happened. Reports Numbness in Right shoulder and area around injection site. Denies any redness or swelling. No other symptoms of covid 19. Discussed cold compress for 20 minutes and reaching out to PCP. Advised on s&s to monitor for and when to seek further medical treatment or call 911.
19 2021-04-23 cold sweat, weakness I have been feeling clammy and ache all over my body for 2 days at the time of reporting. I am also ... Read more
I have been feeling clammy and ache all over my body for 2 days at the time of reporting. I am also fairly weaker and have significantly less stamina. I take advil to help with the aching but it does not fully counteract the aching pain.
19 2021-04-23 seizure like phenomena SEVERAL MINUTES AFTER GETTING THE VACCINE THE PATIENT FAINTED AND SEEMED TO BE HAVING A SEIZURE. THI... Read more
SEVERAL MINUTES AFTER GETTING THE VACCINE THE PATIENT FAINTED AND SEEMED TO BE HAVING A SEIZURE. THIS HAPPENED 4 TIMES AND EACH EPISODE LASTED ABOUT 10 SECONDS. AMBULANCE CAME RIGHT AWAY. PT HAD SEVERLY LOW BLOOD PRESSURE, SWEATING, NAUSEA. MOM CAME AND PICKED UP PATIENT, HE REFUSED TO GO TO HOSPITAL.
19 2021-04-23 unresponsive to stimuli, tingling, flushing, numbness Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Letharg... Read more
Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic: Vomiting-Mild, Additional Details: numbess and tingling of the right arm
19 2021-04-24 unresponsive to stimuli, flushing, tremor Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flus... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Medium, Additional Details: Patient was sitting and suddenly things went black for a second. Patient thinks they passed out for a few seconds. Patient's first blood pressure reading was 90/64. Patient was shaking and sweating. After resting patient was feeling well and blood pressure returned to 122/72. Patient felt well after resting.
19 2021-04-26 numbness Chest hurting from shoulder to shoulder, arms going numb, hard time breathing. Start 1 day after sec... Read more
Chest hurting from shoulder to shoulder, arms going numb, hard time breathing. Start 1 day after second Pfizer shot, lasted for 3 days until taken to ER. Taken to ER, thought he was having a heart attack but heart was fine, just inflammation around the heart. Diagnosis was acute myopericarditis and demand is chemical myocardial.
19 2021-04-26 seizure 10 minutes post shot patient was feeling light headed. Pharmacist went out to check on them and his ... Read more
10 minutes post shot patient was feeling light headed. Pharmacist went out to check on them and his eyes rolled back in his head and he started having a seizure that lasted for just under 1 minutes. regained consciousness, started sweating . no history of seizure. Ambulance called and came within 5 minutes
19 2021-04-27 unresponsive to stimuli Systemic: Fainting / Unresponsive-Medium, Additional Details: After 10 minutes of getting vaccine pt... Read more
Systemic: Fainting / Unresponsive-Medium, Additional Details: After 10 minutes of getting vaccine pt told observer he was feeling light headed. pt was sipping on water. as we put pt down on back, pt passed out. we checked for pulse and could here pt slowly breathing. gave once dose of 0.3 epi and called 911. emt arrived within 5 minutes and took it from there. pt immediately felt fine after 1 dose of epi. pt bp was stable and hr. emt took care of pt who didnt need to go to hospital
19 2021-04-28 hot flush Sharp chest and back pain that gets worse with any movement and hurts to breathe. Hot flashes, nause... Read more
Sharp chest and back pain that gets worse with any movement and hurts to breathe. Hot flashes, nausea, fatigue, joint soreness, shortness of breath. All these symptoms started 2 days ago and have not subsided.
19 2021-04-28 unresponsive to stimuli Systemic: Fainting / Unresponsive-Medium
19 2021-04-29 pain in extremity 11:38 PSO298% pulse 113 reports throat feels tight and pain down his left arm to his elbow. 11:42 ... Read more
11:38 PSO298% pulse 113 reports throat feels tight and pain down his left arm to his elbow. 11:42 pain down left arm to wrist at this time. At vaccine site arm is blotchy red. Throat is feeling better. 11:52 left arm vaccine sight it itching at this time. Throat tightening is almost not noticeable. Ready to leave. PSO2 99% pulse 91. Informed to seek medical attention for further problems and to report the issue for today.
19 2021-04-29 seizure Received shot sitting down. All was fine. Walked down long hallway to observation room. Spoke to nur... Read more
Received shot sitting down. All was fine. Walked down long hallway to observation room. Spoke to nurse who told us to sit for 15 min. Sat down he started to sweat profusely. Told him to take his sweatshirt off. Continues to sweat his forehead his T-shirt was wet his back was wet. Then he tilted his head back his eyes rolled back into his head. I called the nurse. We got him to a wheelchair and behind the curtain. Before we had a chance to put him on the Exam Table he passed out and started to seize for the count of 3 or 4 seconds. Then he woke up. He said he saw white beautiful light. I am not kidding. He does not joke. Then he said he was fine. Insisted he was fine. His bp was low for the first two readings. Then It came back up to normal. He laid flat for 15 more min. Had some juice. Sat up when It was gone to go. Bp got super high. We waited till It was normal and left.
19 2021-04-30 depressed level of consciousness WHILE WAITING HERE AT PHARMACY FOR 15 MINUTES AFTER VACCINATION, HE STARTED FEELING NAUSEOUS AND DIZ... Read more
WHILE WAITING HERE AT PHARMACY FOR 15 MINUTES AFTER VACCINATION, HE STARTED FEELING NAUSEOUS AND DIZZY. PATIENT TRIED TO SIT DOWN ON THE CHAIR BUT BEFORE HE COULD REACHCHAIR HE JUST PASSED OUT AND FELL DOWN ON FLOOR, DID NOT LOOSE COMPLETE CONSCIOUSNESS, WOKE UP HIS OWN IN 30-45 SECONDS AND SAT DOWN ON CHAIR BY HIS OWN. EMS WAS CALLED, BY THE TIME HE DRANK SOME WATER AND ESM ARRIVED THEY EXAMINED HIM AND ASKED IF HE WOULD LIKE TO GO TO HOSPITAL BUT PATIENT DENIED AND WAS GETTING BETTER.
19 2021-04-30 tingling, muscle spasms I got my shot at around 2:50PM on 04/29/2021. I started experiencing symptoms at around 12 hours (3a... Read more
I got my shot at around 2:50PM on 04/29/2021. I started experiencing symptoms at around 12 hours (3am)after the shot. Basically chills, fever, headache, and just overall body cramps. Overall just felt super dizzy and could barely walk due to the dizziness and fatigue. About an hour later, I had trouble breathing and started hyperventilating. My body started cramping up all over to the point where I couldn?t move any part of my body and my entire body was tingly and it felt like I was having a heart attack but I believe it might have been a panic attack. I have not had many symptoms to vaccines in the past. Only meningitis B
19 2021-05-01 migraine, pain in extremity 36 hour-long fever (102.8°F), migraine, soar arms, heavy chest, dizziness, and nausea.
19 2021-05-02 migraine Migrane, fever, muscle pain, lasting more than 48 hours in varying degree.
19 2021-05-04 weakness Injection arm was really sore until around 4-5PM - a lot worse than the first vaccine I received and... Read more
Injection arm was really sore until around 4-5PM - a lot worse than the first vaccine I received and I had a 4/10 headache the whole day. Other symptoms started about 12 hours later which included: Whole body was sore and weak Sluggish/exhausted About 13-14 hours after injection: Sudden chills Treatments: I took two ibuprofen and took a warm shower and I was completely fine afterwards.
19 2021-05-04 involuntary muscle movements Patient fell from seated position in waiting area onto head approximately 5 minutes post injection p... Read more
Patient fell from seated position in waiting area onto head approximately 5 minutes post injection possibly due to brief loss of consciousness. Patient had brief episode of spastic movement after hitting head on floor of pharmacy waiting area. Patient awoke and was alert and oriented, but unsure what had happened. Patient had normal breathing and no apparent distress upon regaining consciousness from fall. Patient was comfortable and left pharmacy awake alert and oriented with no known issues and denied need for emergency services. Patient stated would follow up with medical care due to hitting head.
19 2021-05-04 flushing Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Medium, Additional Details: P... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Medium, Additional Details: Patient was sweating and light headed post vaccine, during observation period. Was given water and candy. Patient stated they had not eaten today. Observation period was extended 10 min and then patient was released after confirming "they felt fine" and was instructed to eat full meal ASAP. (Low blood glucose assumed)
19 2021-05-04 numbness The patient was crying at time of shot administration, came out to waiting area, after about 10-15... Read more
The patient was crying at time of shot administration, came out to waiting area, after about 10-15 minutes, we were asked to come help by his mom. He had passed out, we checked his pulse it was present., patient was very tense with head laid back. after about 30 seconds patient woke up and was agitated and was jerking his arms about . mom tried to calm him down. He was very pale , was sweating, and said he felt he had to throw up. We called 911 and has management staff come to area. He stated his arm was numb that he received shot in and was very emotional. We moved him to a more private area and got him a cold cloth and waited for ambulance to arrive. He refused to go in ambulance and mom was gonna take him to er in her vehicle.
19 2021-05-12 flushing Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Additional Details: Patient blacked out twice approximately 5 minutes following vaccine
19 2021-05-14 seizure like phenomena seizure like movements; passed out; dizzy; nausea; This is a spontaneous report from a non-contactab... Read more
seizure like movements; passed out; dizzy; nausea; This is a spontaneous report from a non-contactable healthcare professional (HCP). A 19-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (age at vaccination: 19 years old) (Batch/Lot Number: ew0167) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. The patient experienced dizzy, nausea, passed out, seizure like movements on an unspecified date. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
19 2021-05-15 hot flush, pain in extremity Fever about 10 hours after vaccination, hot flashes, chills, headache, muscle pain mostly in arm. Th... Read more
Fever about 10 hours after vaccination, hot flashes, chills, headache, muscle pain mostly in arm. This continued through the next evening as well
19 2021-05-16 flushing, unresponsive to stimuli, seizure Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unrespo... Read more
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Seizure-Severe, Additional Details: Difficulty seeing clearly. Difficulty hearing.
19 2021-05-17 unresponsive to stimuli patient was very anxious before getting vaccine. after vaccine administration patient felt dizzy rig... Read more
patient was very anxious before getting vaccine. after vaccine administration patient felt dizzy right away and could n t answer questions . patient was feeling very dizzy and was about to faint 911 called patient felt better after and was able to go home
19 2021-05-18 pain in extremity Patient is a 19 y.o. male with a variety of minor past medical problems but without any significant ... Read more
Patient is a 19 y.o. male with a variety of minor past medical problems but without any significant PMH who presents with 24h of acute onset chest pains. He reports yesterday morning he was woken from sleep at 3-4 am with severe substernal chest pains that radiated to his arm and neck. This was worsened by laying flat and better if he waked around/pacing. He took ibuprofen and it got better so he went back to sleep. The pain returned about 6 hours later and was getting more severe so he went to see his doctor. There an EKG was abnormal so he was referred to the ED where a work up showed ST elevations c/w pericarditis and an elevated trop I of 24. The night prior, he reported a low grade temperature. He has not had any more fevers for the past 12-18 hours. He denies any other symptoms such as palpitations, shortness of breath, cough syncope. He denies sick contacts but did have a sore throat 4-5 days ago without any other associated symptoms. He has had recent negative COVID tests while at college. Of note he did receive the 2nd dose of Pfizer on 5/15 about 24-36 hours before onset of symptoms. Of note, he does boxing at school and has been participating in work outs until about a week ago. ED course: EKG w/ diffuse ST segment elevation in V3-V6, I, II, II, AVF. Troponin I 24. Creatnine 1.2 with baseline of 0.5 but BUN WNL (11). CBC WNL, CRP mildly elevated to 3.1, Transferred to another ED. Second ED Course: BP 120/64 | Pulse 83 | Temp 36.7 °C (98.1 °F) (Temporal) | Resp 18 | Wt 76.3 kg | SpO2 97% exam non-focal, COVID ab notable for +spike neg nuclear capsid consistent with vax but no infection, D-Dimer, procal, ESR, ferritin, Coags all WNL, Trop T elevated to 1.46,, ECG with consistent diffuse ST seg elevations, seen by ped cards who did echo in ED and notable for EF ~50%, admitted to PCICU for further management and treatment Admitted to the PCICU in stable condition. Placed on telemetry monitoring for the duration of the admission. Started on IV steroids and given IVIG on hospital day 1. Continued on toradol which was switched to motrin on hospital day 2. Cardiac MRI did not show signs of fibrosis. Troponin downtrended throughout his stay. At the time of DC echo showed normal function, ekg showed T wave inverions, and troponin was down trending to 0.57. Pt to be restricted from physical activity until cleared by cardiology. Infectious workup also sent, most of which was pending at time of discharge.
19 2021-05-18 unresponsive to stimuli Systemic: Dizziness/Lightheadedness-Mild, Systemic: Fainting/Unresponsive-Mild, Additional Details: ... Read more
Systemic: Dizziness/Lightheadedness-Mild, Systemic: Fainting/Unresponsive-Mild, Additional Details: Patient passed out briefly during the 15-minute waiting period, after receiving the Pfizer COVID vaccine. We put patient on the floor; elevated his knees and feet; and called EMS. EMS arrived in just a few minutes. They monitored his blood pressure. EMS determined he was dehydrated and suffered an anxiety attack. Patient's mom was present and stated patient has a history of fainting due to anxiety. Patient stated he was fine. He walked out of the pharmacy on his own smiling with thumbs-up.
19 2021-05-19 tingling Patient started having blurred vision immediately after sitting down for the 15 minute wait. Afterwa... Read more
Patient started having blurred vision immediately after sitting down for the 15 minute wait. Afterwards he began experiencing muffled hearing, lightheadedness, tingling fingers, and was observed being pale and sweaty. Patient was instructed to lie down and place feet upon a chair and vitals were taken (BP: 110/61, Pulse: 75). Patient reported he had no food/water for some time and was immediately given something to eat and drink. Symptoms resolved within 5-10 minutes.
19 2021-05-20 weakness On May 14, patient developed fatigue and weakness. He took 2 tablets of acetaminophen 500mg and afte... Read more
On May 14, patient developed fatigue and weakness. He took 2 tablets of acetaminophen 500mg and after a couple of hours he felt better. Three days later on May 17, at 5 am patient developed chest pain. He visited a local health clinic patient presented high troponin levels 2533.4. At 6:58 pm he was transferred to the Emergency Department. Patient was admitted to the Pediatric Intensive Care Unit (PICU) at 8:00pm. The date of the event patient received Motrin 400mg, Toradol 30mg, Aspirin 81mg, Brilinta 180mg and Tridil 250mg/50ml (at 3 ml/hr). An acute myocardial event was rule out with a negative result of the catheterization procedure. Patient was diagnosed with myopericarditis. He still hospitalized, his troponins levels are decreasing and chest pain has been resolved.
19 2021-05-21 depressed level of consciousness Patient at 18:36 experienced a 1839 Syncopal episode 5-10 seconds, during 15min observation period. ... Read more
Patient at 18:36 experienced a 1839 Syncopal episode 5-10 seconds, during 15min observation period. While seated patient eyes rolled back, and fell out of his chair onto his left side onto the floor, face down. Patient rolled over, semi-conscious, some- what confused at this time. PCP and RN coordinator assessed patient. Irregular Pulse 48 noted, B/P 130/80 SPO2 88-90%. Patient extremely pallor but responsive. Confusion cleared after 5 minutes. Followed up vitals: Pulse 60 noted, B/P 128/86. Patient was walked out to vehicle.
19 2021-05-22 unresponsive to stimuli PATIENT WAS GIVEN VACCINATION & ASKED TO WAIT FOR THE REQUIRED 15 MINUTES. SHORTLY AFTER BEING SEATE... Read more
PATIENT WAS GIVEN VACCINATION & ASKED TO WAIT FOR THE REQUIRED 15 MINUTES. SHORTLY AFTER BEING SEATED, I AS WELL AS HIS MOHTER NOTICED HE TURNED VERY PALE & WAS UNRESPONSVIVE. I QUICKLY FELT HIS PULSE & IT WAS FAINT AS WELL AS HIS BREATHING. WE CALLED 911. WE MOVED HIM FROM A SEATED POSITION TO THE FLOOR. HIS COLOR CAME BACK QUICKLY & HE WAS RESPONSIVE TO VERBAL COMMANDS. EMT's CAME & CHECKED HIS VITALS, HIS VITALS WERE NORMAL. EMT's RELEASED HIM UPON THE PATIENT AGREEING
19 2021-05-24 weakness PT felt dizzy and weak, like they were going to pass out. Symptoms resolved before patient left
19 2021-05-25 tremor cold chills; sweating; joint pain; dehydration; headache; vomiting; tight chest; light sensitivity; ... Read more
cold chills; sweating; joint pain; dehydration; headache; vomiting; tight chest; light sensitivity; shaking; muscle pain; This is a spontaneous report from a non-contactable consumer. A 19-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE)(Batch/ Lot Number: Unknown), 2nd dose, via an unspecified route of administration in the left arm on 15Mar2021 at 10:00 AM for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient's past drug history included BNT162B2 (Lot/batch no: Unknown), 1st dose, via an unspecified route of administration on an unknown date for COVID-19 immunization. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with Covid-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to vaccination. On an unknown date in Mar2021, the patient experienced shaking, sweating, cold chills, vomiting, headache, muscle pain, joint pain, dehydration, tight chest and light sensitivity. The patient did not received any therapeutic measures for the adverse events. The clinical outcome of the events shaking, sweating, cold chills, vomiting, headache, muscle pain, joint pain, dehydration, tight chest and light sensitivity were recovering at the time of reporting. No follow up attempts are possible, information about batch number cannot be obtained. No further information is expected.
19 2021-05-27 cold sweat Patient is a 19yo male who experienced a near syncopal episode immediately after receiving his first... Read more
Patient is a 19yo male who experienced a near syncopal episode immediately after receiving his first dose of Pfzier covid 19 vaccine. Patient c/o dizziness and tinnitus, patient then noted altered level of conciousness, w/o complete loss of consciousness. Upon assessment patient noted with significant diaphoresis, noted generalized clammy skin, no skin lesions, rash or hives noted. respiratory rate WNL, respirations even and unlabored. Within less that 60 seconds patient started to regain alertness and was able to respond and answer questions appropriately. Reported feeling some anxiety prior to getting vaccine but denied being diagnosed or treated with anxiety. reported prior episode with similar less severe symptoms associated with "shots" within >2 minutes patient was A&O x4, verbal and able to make needs known. Respiration remained even and unlabored. Skin pink warm and intact with significantly decreased clamminess and diaphoresis. No sx/sx of allergic reaction. Chest is non-tender, initially bradycardia @ 43 BPM, noted irregular heart rhythm, no murmur or extra sounds noted. Pt reports playing football with practicing at least 4 days weekly. Denies significant past medical HX. No HX of allergies. Patient was assisted to yoga mat on ground, in supine position with lower extremities elevated. Physical assessment completed then past medical HX obtained from PT. Initial VS 100/50. HR 43, o2 96% ECG obtained by EMTS WNL. Spontaneous resolution of symptoms after 1-2 minutes. Patient was assisted to sitting position, then standing w/o return of symptoms. VS @ 5 mins 114/63 HR 63 RR 18 o2 98%. Patient escorted to observation area and sitting in chair. Patient was observed for 30 mins in observation area. After 30 minutes no acute distresss noted, pt denied pain, dizziness, tinnitus or other symptoms. Advised patient to abstain from strenuous activity for the rest of the day and advised against football practice today and against being alone today. Advised patient to seek emergency treatment by calling 911 should symptoms return, experience SOB, or any sx/sx of an allergic reaction. Patient verbalized understanding before leaving vaccine site @ 1610
19 2021-05-27 feeling of body temperature change Extreme dizziness, muscle pain especially at injection site, extreme hot and cold flashes
19 2021-05-31 pain in extremity Felt fatigued with arm soreness. Two days later developed left supraclavicular lymph node swelling. ... Read more
Felt fatigued with arm soreness. Two days later developed left supraclavicular lymph node swelling. Pt describes swelling as size of "ping pong ball" with tenderness. No axillary nodal swelling or tenderness. Progressive decrease in size of lymph node. Pt evaluated by clinician on 05/20/21. Non-tender palpable node measuring 2 cm X 1 cm. No axillary or cervical nodes noted. Recheck one week later, 05/27/21 - non-tender palpable node measuring 1 cm X 1 cm. CDC consultation sought 05/20 and 05/27.
19 2021-06-01 pain in extremity 19 year old with no significant past medical history presented to the ED with c/o chest pain. He was... Read more
19 year old with no significant past medical history presented to the ED with c/o chest pain. He was noted to have chest pain starting on 4/30. Patient stated that he had 2nd COVID vaccine on 4/29. He was noted to have one episode of vomiting and developed coughing. He has been c/o of sharp chest pain for the past two days. He was noted to have arm pain. He had chest pain when he breaths. He took advil and noted to have slight improvement in his pain. He was noted to have an elevated troponin and CK. Cardiology was consulted. His initial troponin came back 4.49 with a CPK of 294. Serial troponins were obtained. Troponin peaked to 44.8 and CPK to 1345, Echo showed newly reduced LVEF of 55%. Diagnosed with myopericarditis possibly related to the Covid vaccine and pt was transferred to the Hospital for cardiac MRI and further work-up. Upon transfer to the hospital, cardiac MRI was performed and showed acute myocarditis with no evidence of pericardial thickening or pericarditis. It also showed left ventricular function was at the lower limits of normal with a calculated left ventricular ejection fraction of 50% and no focal wall motion abnormality. He was treated with colchicine 0.6mg, pepcid 20 mg, and ibuprofen 600mg for the myocarditis and oral morphine 15mg and tylenol 1,000mg for chest pain. He was counseled on avoiding strenuous activity for the next 3 months and following up with cardiology upon discharge.
19 2021-06-03 pain in extremity At 1034, vaccinator reported to learn nurse "I think the needle may be in the client because I canno... Read more
At 1034, vaccinator reported to learn nurse "I think the needle may be in the client because I cannot find it." At 1034, co-lead nurse activated. Lead nurses assessed patient. Patient reported he felt 0/10 left arm pain and felt dizziness. Lead nurses examined syringe and confirmed that the needle was inside the syringe. Vaccinator confirmed that there was no spillage during administration of the vaccine and there was no vaccine left in the syringe. Patient reported no allergies, no medications, no medical conditions. At 1038, EMT assessed vitals: blood pressure 130/80 mmHg, pulse 85 beats/minute, and SpO2 99%. At 1046 paramedics arrived and assumed care. Paramedics confirmed there was no needle in patient's arm and patient refused to go to the hospital. Supervisor advised lead nurse to have patient wait in observation area for 30 minutes. Lead nurse was attending to vaccinator who stated she felt "traumatized" and "overwhelmed". Co-lead and EMT attended to another patient reaction in observation area. At approximately 1058, lead nurses realized patient already left observation area. Syringe used was 1mL Vanish Point syringe 25G x 1".
19 2021-06-03 seizure generalized seizure
19 2021-06-08 feeling hot chest pain; Caller stated the patient had an EKG showing irregular heartbeat.; diarrhea; Myocarditis... Read more
chest pain; Caller stated the patient had an EKG showing irregular heartbeat.; diarrhea; Myocarditis; fever; didn't feel well; warm; This is a spontaneous report from a contactable consumer (Patient's Parent). A 19-year-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: EW0187, NDC number and Expiration date are Unknown), via an unspecified route of administration, administered in Left arm on 22May2021 11:30 (at the age of 19-years-old) as 2ND DOSE, SINGLE for covid-19 immunisation. The Patient's medical history (including any illness at time of vaccination) was none and concomitant medications were not reported. The patient previously took first dose of historical vaccine, bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: EW0176, NDC number and Expiration date are Unknown) via an unspecified route of administration, administered in Left arm on 01May2021 10:30 (at the age of 19-years-old) as single dose for covid-19 immunisation. Additional vaccines administered on same date of the pfizer suspect were none. The patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. Adverse events following prior vaccinations were none. Family medical history relevant to adverse events was none. Relevant tests were unknown. It was reported that her 19-year-old son got the 2nd dose of the vaccine on 22May2021 and 2 days later on 24May2021, he wound up with chest pain and the caller took him to emergency room and the patient was diagnosed with myocarditis and admitted to the hospital. The Reporter clarified the patient's chest pain started when he woke up around 08:30-09:00. On an unspecified date in May2021 at 23:30, the patient had a fever starting about 12 hours from receiving the second dose and it lasted for 24 hours, and the patient didn't feel well on an unspecified date in May2021. At one point he didn't want to wake his parents up around 11:30 p.m. but he was warm on an unspecified date in May2021. At 0600am the next day, the caller took the patient's temperature, and his fever was 100.9 Fahrenheit. The caller carried the patient to the emergency room on 24May2021 due to his chest pain. It was reported that patient's EKG was extremely irregular and caller stated that if it was her or her husband's EKG, they would have been having an MI, but since the patient was only 19, the doctors didn't think MI was possible. The patient was then diagnosed with myocarditis. It was reported that the patient experienced diarrhea on 24May2021. Chest Pain required a visit to Emergency Room on 24May2021 and the patient was hospitalized from 24May2021 to 26May2021. It was reported that, the patient received treatment with Colchicine 0.6 mg (NDC number and Lot number: unknown, Expiration Date: 26may2022) one tablet by mouth twice a day. The patient came home from the hospital with this prescription on 26May2021 and he is still taking this medication. Prescribed to take it twice daily for a month. Famotidine, it is like a Pepcid. 20 mg (NDC number and Lot number: unknown, Expiration Date: 26Mayy2021) one tablet by mouth twice a day for 6 days, because of the heavy dose of ibuprofen and diarrhea. The patient had completed this medication. Ibuprofen 600 mg (NDC number, Lot number: unknown and Expiration Date: unknown) 1 tablet by mouth three times a day for six days and this has script had ended. Caller stated that her son was recovered but that he was still taking the treatment medications at this time. Caller stated that her son's symptoms are improved, he was not complaining of chest pain anymore, she assumes his myocarditis was improved because he was not complaining of the chest pain. The patient underwent lab tests and procedures which included body temperature: 100.9 Fahrenheit on an unspecified date in May2021, EKG (electrocardiogram): extremely irregular on 24May2021, PCR COVID test (sars-cov-2 test): negative on an unspecified date in May2021 while in the hospital. Caller stated the patient had an EKG showing irregular heartbeat.It was reported that the patient had tests but she didn't have results available and the patient had a PCR COVID test in the ER. Caller stated that all of this was related to the vaccine. Caller also stated that she is wondering if her son would have reacted differently if he had gotten the Moderna, but caller and her husband had gotten Pfizer and didn't have any problems. Reporter seriousness for Myocarditis, diarrhea and fever was unspecified. The outcome of the events, Myocarditis, chest pain, diarrhea and irregular heartbeat was recovering and for fever was recovered on an unspecified date in May2021 and for other events was recovered on an unspecified date in 2021. Additional information requested.
19 2021-06-08 migraine, feeling of body temperature change Day after second shot woke up with migraine like headache (pounding on both temples and forehead) se... Read more
Day after second shot woke up with migraine like headache (pounding on both temples and forehead) semi sensitive to light. body aches (felt very heavy) 100.4 degree fever. drastic temperature variation (very warm to cold) one nostril congested. very slight sore throat/ cough . self Treatment: slept most of it off after Tylenol and Benadryl. By late evening aprox 6:30 -7:00 pm headache subsided substantially, body aches almost gone. nose still slightly congested
19 2021-06-08 unresponsive to stimuli, seizure The patient was given the vaccination and told to wait 15 minutes in the recovery area to observe fo... Read more
The patient was given the vaccination and told to wait 15 minutes in the recovery area to observe for signs of adverse reactions. The patient had syncope about 2 minutes after sitting and fell from a seated position on his chair to the ground. He had a brief seizure (unresponsive, tense muscles, open eyes) for about 2-5 seconds. He then became responsive and was able to respond to prompts and questions. He was given water. an ice pack (for injured spot on forehead), and told to wait for 30 minutes for further observation. He arranged to have a friend pick him up to take him home from the pharmacy and was told that he could not drive himself home after this adverse reaction. The patient stated that he otherwise felt normal afterwards (aside from some ache from the forehead after falling).
19 2021-06-09 pain in extremity difficulty breathing; chest pain; environmental pneumonia; low grade fever/ fever 104.3; chills/ chi... Read more
difficulty breathing; chest pain; environmental pneumonia; low grade fever/ fever 104.3; chills/ chill were high; body ache; bumps that hurt on in front of his legs; erythema nodosum; hilar lymphadenopathy; This is a spontaneous report from a contactable consumer (patient himself). A 19-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: Unknown) via an unspecified route of administration, administered in left arm, on 01Apr2021 at 11:15 (at the age of 19 years old) as 1st dose, single dose, for COVID-19 immunisation. Medical history included asthma. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications received within 2 weeks of vaccination. On 06 to 08April2021 (as reported), the patient began with low grade fever, chills, body ache. Then on, 14Apr2021, the patient began to complain about chest pain went to the hospital. The patient was told that he had environmental pneumonia on right lung, and he was given with antibiotics. On 17Apr2021, the patient went to the emergency room as fever was 104.3 and chill were high, and he had difficulty breathing. The patient was admitted and transferred to a Hospital where he was given with antibiotics, azithromycin (ZITHROMAX) and intravenous fluids; he was discharge on 21Apr2021. Later that night, the patient noticed bumps that hurt on in front of his legs and went to the doctor. It was indicated that the patient had erythema nodosum and was prescribed with prednisone 2x a day for 5 days. The patient took an X-ray that showed he had hilar lymphadenopathy and will go see a pulmonary specialist. He was also told to take the 2nd dose of the vaccine; 2nd dose was taken on 28Apr2021. The patient underwent laboratory test for COVID-19 (nasal swab) on 12Apr2021, 15Apr2021 and 17Apr2021 which all showed negative results. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The adverse events: erythema nodosum, hair lymphadenopathy and pain in leg have resulted to doctor or other healthcare professional office/clinic visit; while for the other adverse events have resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The outcome of the events was not recovered.
19 2021-06-09 pain in extremity wrist and ankle pain; heel pain; bump re appeared however only on ankle and heel; This is a spontane... Read more
wrist and ankle pain; heel pain; bump re appeared however only on ankle and heel; This is a spontaneous report from a contactable consumer (patient). A 19-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were unknown), via an unspecified route of administration on 28Apr2021 (at the age of 19-years-old) at 2nd dose, single dose for COVID-19 immunization. Medical history included asthma. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication was reported as none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Past drug history was reported as none. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were unknown), via an unspecified route of administration in left arm on 01Apr2021 at 11:15 (at the age of 19-years-old) at 1st dose, single dose for COVID-19 immunization. On 06-08Apr2021 after the first dose, he experienced low grade fever, chills, and body ache. On 14Apr2021, he began to complain about chest pain. He went to a hospital in which he was told he has environmental pneumonia on right lung and was given antibiotics. On 17Apr2021, he went to the emergency room due fever at 104.3 and chills which were high, and he had difficulty breathing. He was admitted to a hospital and was eventually transferred. He was given antibiotics (ZITHROMAX) and IV fluids. The patient was discharged on 21Apr2021. Later that night, they noticed bumps that hurt in front of his legs. He went to the doctor and they indicated he had erythema nodosum and was prescribed prednisone 2 a day for 5 days. He took an X-ray that showed he had hilar lymphadenopathy on Apr2021, and they will go and see a pulmonary specialist. The patient was told it was ok to take the second dose of the Pfizer vaccine. He received the second dose on 28Apr2021 and on 01May2021, bump re-appeared however, it was only on his ankle and heel. On 15May2021, new symptoms he experienced were wrist, ankle, and heel pain. He was waiting to see a specialist. Facility where the most recent COVID-19 vaccine