Pfizer

Flu-like symptom reports

Female, 12 - 15 years

Age Reported Symptoms Notes
12 2021-05-14 sweating PT REPORTS FEELING LIGHTHEADED,DIZZY,NAUSEA AND SWEATY. NOTED TO BE DIAPHOREETIC AND PALE. DENIES SO... Read more
PT REPORTS FEELING LIGHTHEADED,DIZZY,NAUSEA AND SWEATY. NOTED TO BE DIAPHOREETIC AND PALE. DENIES SOB, DYSPNEA OR ITCHING. PATIENT IS ON THYROID MEDICATION AND TOOK A DOSE IN THE MORNING VS; O2 SAT 97% HR 83 PT ENCOURAGED TO LAY FLAT W FEET RAISE. ENCOURAGED TO DRINK WATER AND EAT BEFOR COMING TO THE NEXT APPT. PT HAD NOT EATING BEFORE COMING THIS MORNING. PATIENT FELT BETTER AFTER A CULE OF MINUTE. PT INSTRUCTED TO NOTIFY OBSERVATION TEAM IF SYMPTOMS WORSEN
12 2021-05-15 headache, sleepiness Headache, stabbing pain in left leg, sleepy Took Tylenol
12 2021-05-15 headache Approx 6-7 min after receiving vaccine in left arm. Patient's mother expressed concern about her dau... Read more
Approx 6-7 min after receiving vaccine in left arm. Patient's mother expressed concern about her daughters reaction. She complained of headache, stomachache, weakness in her legs and her eyes rolled back in her head and her head dropped.
12 2021-05-15 sweating About two minutes after she received her shot she told us she was seeing black spots. Then she told ... Read more
About two minutes after she received her shot she told us she was seeing black spots. Then she told me she couldn?t see and she passed out. She started to regain consciousness and a little bit of blurred vision and then she began dry heaving. She was clammy and sweaty at that point but continued to improve after she drank some water.
12 2021-05-16 sweating Patient received in RN triage area, post-COVID vaccination administration. Patient being observed fo... Read more
Patient received in RN triage area, post-COVID vaccination administration. Patient being observed for 15 minutes as recommended per CDC guidelines and facility policy on post-vaccination RN monitoring. Patient sitting in chair and reported feeling dizzy/lightheaded, blurred vision, ringing in the ears, patient noted pale, clammy, and diaphoretic, patient reporting feeling short of breath. Rapid response called. 14:05 Vitals: 75/34, HR: 54, 97% Patient placed on gurney, in the supine position. Patient and mother denies adverse reactions to vaccinations in past. Denies any medical history besides asthma. 14:10 Vitals: Bp: 105/53, Hr 83, 100% on 2L. Patient now denies any dizziness/lightheadeness, blurred vision, ringing in ears, and shortness of breath. 14;15 BP109/65, HR: 72, O2: 100%. COVID vaccination fact sheet and discharge information provided to patient on D/c from clinic, patient advised to review. Verbalized understanding. Appointment for 2nd COVID vaccination provided to patient. All questions and concerns addressed. Advised to follow up as needed. Patient departed with mother at 1435 symptom free.
12 2021-05-17 headache PATIENT HAD HEADACHE AND FELT PASSING OUT BUT NEVER PASSED OUT
12 2021-05-17 nasal congestion, fever, chills, headache fever to 102.6 day 3 after vaccine, chills, headache, increased nasal congestion
12 2021-05-17 fever Started having symptoms of fever and bodywide muscle aches. Fever reached 102 F. Sought care at m... Read more
Started having symptoms of fever and bodywide muscle aches. Fever reached 102 F. Sought care at medical clinic.
12 2021-05-18 sweating Pale diaphoretic, syncope witnessed loc Possible seizure Transported by ambulance with mother at11:4... Read more
Pale diaphoretic, syncope witnessed loc Possible seizure Transported by ambulance with mother at11:45am BP 67/30 P 46 14 99% at 12:00am BP 84/62 P 58 12 100%
12 2021-05-18 fever, fatigue, headache headache, lightheadedness, fatigue, and a fever of 100.4 - site of vaccine has a slight redness/tend... Read more
headache, lightheadedness, fatigue, and a fever of 100.4 - site of vaccine has a slight redness/tenderness (mom reports mild - consistent with vaccine localized reaction). Sxs have persistent through from 5/16/2021 to 5/18/2021, temperature has slightly improved at 99 with Motrin, but headache/fatigue persisting, and then patient woke 5/18/2021and vomited x 1. day 3 with slightly elevated temp, persisting headache, fatigue, and new onset sx of vomiting today. Motrin for fever, fluids, rest, and monitoring at home.
12 2021-05-19 headache, chills, fatigue Fatigue, chills and arm pain -18-48 hours Headache and nauseous 18 hours after and still present af... Read more
Fatigue, chills and arm pain -18-48 hours Headache and nauseous 18 hours after and still present after 5 days
12 2021-05-19 headache child became unresponsive, clenched teeth, unable to stand alone, vomited, eyes dilated, unable to s... Read more
child became unresponsive, clenched teeth, unable to stand alone, vomited, eyes dilated, unable to speak, headache, called 911 was transported to the hospital emergency room
12 2021-05-19 headache Pt c/o weakness, HA, dizziness, and Nausea. BP 121/76, HR 112, RR 22 -- > HR 98 -- > 108/62, 90. P... Read more
Pt c/o weakness, HA, dizziness, and Nausea. BP 121/76, HR 112, RR 22 -- > HR 98 -- > 108/62, 90. Patient stable and released from vaccination site.
12 2021-05-20 malaise On 5/15, at 4:00pm while in the shower, patient had a pre-syncopal episode with dizziness, and heav... Read more
On 5/15, at 4:00pm while in the shower, patient had a pre-syncopal episode with dizziness, and heaviness in her arms and legs. Before she fell I was able to assist her to a sitting position. Her skin was pale and clammy, pulse thready 90bpm, bp 80/50. Symptoms improved after 15 minutes. On 5/21, at 10:00am was outside at a school sports activity. She began to feel slightly dizzy. She ran a short race and the dizziness was worse. She was pale, hr 120, bp 100/60. She drank fluids and rested but still felt unwell and a headache started so she came home. The headache evolved into a severe migraine with several episodes of vomiting. She also felt heart palpitations, which is unusual with her migraines. Hr was 100 and regular. Bp 100/60. Discussed with pediatrician, who patient had seen 5/20. Appointment scheduled with cardiology 5/26
12 2021-05-21 sweating Sudden nausea, diaphoresis, lightheaded, shortness of breath, injection site pain for approx 10 min
12 2021-05-21 malaise, throat pain Patient began to experience symptoms consistent with an upper respiratory infection one day after ge... Read more
Patient began to experience symptoms consistent with an upper respiratory infection one day after getting 1st dose of COVID-19 vaccine. By day four, she developed an ear infection and began antibiotics. It is now exactly one week after the shot and 3 days after starting antibiotics and she still feels miserable. She?s losing her voice, throat is sore, and both ears feel infected.
12 2021-05-21 malaise Patient told her mom she was not feeling well right after the vaccine. Mom told her she would go bu... Read more
Patient told her mom she was not feeling well right after the vaccine. Mom told her she would go buy her an icepack to bring home to help her. The patient got up to follow her mom and fainted in the aisle. Her sister came and got the pharmacist and by the time I got to her she was already coming to. We did call an ambulance but by the time they paramedics arrived the patient was ok to leave on her own with her mom.
12 2021-05-22 head discomfort, headache My 12 year old daughter has reported having twitching of the head and right eye. She reports it star... Read more
My 12 year old daughter has reported having twitching of the head and right eye. She reports it started last week and continues to this day. The twitching of the head happens as often as every hour or more. The twitching of the right eye is rare. Depending on how fast the twitch happens with her head pain is associated with it.
12 2021-05-22 headache, lethargy The patient is a healthy 12 year old female with no medical history or problems, she received the CO... Read more
The patient is a healthy 12 year old female with no medical history or problems, she received the COVID Pfizer vaccine #1 on Wednesday, May 19th at 4pm and was asymptomatic at that time. Within about 5 hours, she began to experience extreme lethargy. By the following day, May 20th, she experienced profound lethargy that lasted 36hrs. During this time, she was asleep but arousable with effort, she described general myalgias, moderate left arm pain at injection site, mild headache, no other symptoms. Her profound lethargy lasted through midday on May 21st, upon which time she was able to keep her eyes open and began to regain her strength. By the evening of May 21st, she was fully recovered.
12 2021-05-22 fever, chills, fatigue, headache The night after her shot, patient had a hard time sleeping. She experienced "crazy dreams". She's... Read more
The night after her shot, patient had a hard time sleeping. She experienced "crazy dreams". She's had a fever, chills, headache, tiredness, pain at injection site, and a feeling of overall discomfort. She has been resting and sleeping all day.
12 2021-05-23 headache, chills Chills, headaches, nauseous, only for that date.
12 2021-05-24 sweating Complained of being light headed, diaphoretic Vital Signs: BP 108/72 HR 104 Resp 20 O2Sat 97 Skin S... Read more
Complained of being light headed, diaphoretic Vital Signs: BP 108/72 HR 104 Resp 20 O2Sat 97 Skin Signs: Diaphoretic Circulation: Cap refill <1sec Respiratory: Breath sound clear bilaterally Initial Treatment: Moved patient to triage, placed her in supine with feet elevated. Offered water and snacks. 3:04 PM Vital Signs: BP 108/61 HR 108 Resp 20 O2Sat 98 Skin Signs: Warm and dry Circulation: Cap refill <1sec Respiratory: Breath sound clear bilaterally Vital Signs: BP 104/64 HR 90 Resp 18 O2Sat 98 Skin Signs: Warm and dry Circulation: Cap refill <2sec Respiratory: Breath sound clear bilaterally Notes: Patient stated she was feeling better after 10 min. Advised patient to seek medical attention if symptoms re-occur or worsen. Home with parent.
12 2021-05-25 head discomfort, fatigue, sweating Pt w/ hx of allergy to amoxicillin (unknown rxn). Pt c/o flushing/sweating, feeling tired, "head he... Read more
Pt w/ hx of allergy to amoxicillin (unknown rxn). Pt c/o flushing/sweating, feeling tired, "head heavy", and right sided tiredness. BP 120/71, HR 80, RR 16. Pt stable and released from the vaccination site.
12 2021-05-25 sweating, lethargy Patient received covid vaccination. Became lethargic, diaphoretic and pale in observation. Patient... Read more
Patient received covid vaccination. Became lethargic, diaphoretic and pale in observation. Patient taken to ER for further evaluation. Pt left the ED after only being seen by triage RN; pt did not stay to see a provider.
12 2021-05-25 sweating AE: Diaphoretic, nervous, dizzy( at 4:01pm) Treatment: no medication was given. patient was under ob... Read more
AE: Diaphoretic, nervous, dizzy( at 4:01pm) Treatment: no medication was given. patient was under observation. Outcome: symptoms resolved with observation and patient was sent to POV/Home.
12 2021-05-27 fatigue My daughter is experiencing periodically nose bleeds, brain fog and bit distracted and losing hersel... Read more
My daughter is experiencing periodically nose bleeds, brain fog and bit distracted and losing herself in her thoughts after her first dose Pfizer vaccine. This is new from the initial report. Her mother also states she feels fatigue and not active for a few days now. At this time I have not been able to get an appointment to see her doctor and I am very concerned about her symptoms. I would like more research or documentation to be released about this type of group to figure out why this happened to her. Also, I would like to see if they are going to be monitored after her vaccine. I do not know what other side effects will be coming after her vaccine and I am concerned.
12 2021-05-27 headache Client received her first dose of the Pfizer Covid-19 Vaccine (lot # EW0185 exp. 08/2021) at 11:28 A... Read more
Client received her first dose of the Pfizer Covid-19 Vaccine (lot # EW0185 exp. 08/2021) at 11:28 AM. The client was brought to the EMT station by lead RN stating that the client was feeling "dizzy? at 11:46 AM. The client was a 12-year-old female alert and tracking with her eyes and appeared anxious. The client had a chief complaint of lightheadedness. The client stated that she ?began to feel lightheaded? after her initial 15-minute observation had completed. This was the client's first dose of the Pfizer Vaccine and she stated reluctance to receive her first dose. The client denied any allergies and her parents stated that the client had a history of unspecified behavioral disturbances that require her to see a therapist. The assessment revealed no hives, swelling, discoloration, shortness of breath, or other signs and symptoms of anaphylaxis. The client denied a headache or wanting to throw up. The client refused to have her vitals taken by EMTbut agreed at 1150 to remain lying down until she felt better. The client was encouraged to drink water while she waited. After 15 minutes and drinking a bottle of water, the client stated "I feel all better" but "I think I'm overthinking this" and stated that she was now experiencing a ?headache?. RN asked the client?s parents? permission to speak to the client. RN came over to reassess the client and that client finally agreed to have her vitals taken at 1208: 148/84 blood pressure, Pulse 94, 100% O2 on room air, Respirations 16, alert and oriented to person, place, date, and event. The client revealed to RN that she was experiencing anxiety from her vaccination but became much calmer after discussing her concerns further. Client also revealed that she engages in acts of self-harm but has no intent to end her life. The client's last set of vitals at 1216 were 128/76 BP, HR 96, O2 100%, Resp. 16. The client then stated that she was ?ready to go? after her last set of vitals. Lead RN asked to speak to client?s mother in private. Lead RN provided mother with crisis hotline. Mother informed lead RN that client was in therapy and already seeking help. The client's parents were instructed to seek emergency care if a significant allergic reaction occurred later in the evening and were provided with all relevant vaccine-related information by RN. The client departed at 1220 in a positive disposition with her parents.
12 2021-05-27 headache It was within 5 minutes, she started having hives that went down her arm and spread to other arm, fa... Read more
It was within 5 minutes, she started having hives that went down her arm and spread to other arm, face, trunk, legs, stomach. I went and got a nurse and she called a pediatric team - three nurses and one doctor - they took her vitals and gave her some Benadryl - 30 ML (children's). They had her sit and drink a bottle of water. We watched to see if the swelling and the hives would shrink and go away. It was probably about 20 minutes later where they went away, but she developed a headache and she was nauseated. We administered Benadryl (gave her regular 25 mg tablet every 6 hours) for the next 24 hors in the dosage times. She was nauseated the first day and she had headache for two days. The hives went away by the time she went to bed the evening of the vaccine.
12 2021-05-27 sweating Within 3-5 minutes, she was asking for water and feeling hot. Her back was sweaty. Her eyes looked ... Read more
Within 3-5 minutes, she was asking for water and feeling hot. Her back was sweaty. Her eyes looked like they were glazed- not responding; didn't look bright. She got some water and an ice pack on her back and removed her shoes and put her feet up. After drinking the water and keeping the ice pack on for the rest of those 15 minutes. Nurses were there watching her. And she was able to walk out of the clinic on her own power. It had looked like she maybe would have passed out without the intervention of water, ice pack and getting her feet up. She had muscle pain in her arm (of injection site) that day and into the next day. The muscle pain in her arm lasted for about 24 hours.
12 2021-05-27 throat irritation Shakes, redness, throat tightness and itch, given benedryl, and taken to hospital for observation
12 2021-05-28 chills, malaise developed a rash whole left arm; Feeling dizzy; dizziness was kind of severe dizziness where felt li... Read more
developed a rash whole left arm; Feeling dizzy; dizziness was kind of severe dizziness where felt like everything was moving around; weak; Shaking; Chilling; Does not feel ok; half an hour lying down; This is a spontaneous report from a contactable consumer reporting for their daughter (patient). A 12-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 at 12-years-old intramuscular, administered in arm left on 16May2021 (Batch/Lot Number: EW0177) as 1st dose, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that within 5 minutes after taking the vaccine on 16May2021, the patient started feeling dizzy, weak and little bit of shaking, chilling. Dizziness was kind of severe dizziness where felt like everything was moving around her. They took her to urgent care center because she does not feel ok after half an hour lying down there. The doctors were there and they gave medications as an injection of Promethazine 25 mg temporarily at first and also gave Ondansetron 4 mg and prescribed Meclizine 25 mg three times a day for 5 days as needed (treatment). The patient got the reaction at 1145 am within five minutes feeling dizziness. After 30 minutes waiting were advised to take her to the urgent care. She was prescribed Promethazine 25mg, Ondansetron 4mg, Meclizine 3 times a day for next five days. Reports adverse event (unspecified) still maintains. Then later developed a rash, whole left arm on an unspecified date. Therapeutic measures were taken as a result which included injection of Promethazine 25 mg temporarily at first and also gave Ondansetron 4 mg and prescribed Meclizine 25 mg three times a day for 5 days as needed. The outcome of the events was unknown.
12 2021-05-29 sweating About 5 minutes after the shot, patient's mom said that she didn't feel good. Patient was dizzy, sw... Read more
About 5 minutes after the shot, patient's mom said that she didn't feel good. Patient was dizzy, sweaty, nauseas and really hot. The arm that got the injection was also really hot. I had the patient lay down, and gave her an ice pack for her neck/arm. After a few minutes patient said that she felt better. I had her lay down for about 5 minutes. She then sat up and said she was much better. Wasn't dizzy or nauseous anymore. Arm felt better too. I had the patient sit and wait in total 30 minutes. Mom wanted to leave sooner but I asked if she wait so that we could make sure she was ok. THey waited 30minutes and left . patient was fine.
12 2021-05-29 sweating After receiving vaccination, syncopal episode while sitting in the chair. Mom held child from falli... Read more
After receiving vaccination, syncopal episode while sitting in the chair. Mom held child from falling to the ground and slowly placed her on the floor. LOC for less than 2 minutes. Alert and talking, ice pack to forehead and fluids offered. Placed in wheelchair and sent to med evaluation for further evaluation. Mom present at all times. VS taken 104/80 HR 72 Resp 16, diaphoretic with c/o's of lightheaded and foggy feeling. Lying on cot with Gatorade/water offered. Pt has never passed out with a vaccination in the past, had carrots for breakfast and little fluid intake. Very anxious with getting the shot. Discussion with mom & pt. importance of hydration eating when the next dose given, it will be in the med evaluation area lying down. Pt alert an ambulatory with 1/2 Gatorade and 1/2 eater prior to discharge with mom. Discussed s/s of reaction and call pediatrician with any further concerns. Verbalized understanding, discharged ambulatory with mom.
12 2021-05-30 fever, chills, headache, malaise, throat pain Headache for 3 days, arm pain at injection site for 3 days, fever 24hrs, chills for 2 days, general ... Read more
Headache for 3 days, arm pain at injection site for 3 days, fever 24hrs, chills for 2 days, general not feeling well, soar throat on 2nd day.
12 2021-05-31 headache, throat pain light headed, headache, dizzy, vomiting ,sore throat, ,hard to swallow, weak, felt like someone sit... Read more
light headed, headache, dizzy, vomiting ,sore throat, ,hard to swallow, weak, felt like someone sitting on her chest lost sense of smell and taste. Taken by medics to local hospital, , Placed on IV , GI cocktail, chest x rays 2 views, EKG,
12 2021-05-31 headache She had a rash after school - she noticed it about 2:00 - she started getting a headache and around ... Read more
She had a rash after school - she noticed it about 2:00 - she started getting a headache and around 03:00 - she noticed a rash (red marks - no bumps) on her knees and upper and thighs. About 3:20 - her right arm and a little bit on her left arm were almost like hives (bumps) - they were a little bit itchy off and on. The next morning, could still the bumps but not as bad, but on 19th after school it was back just like the day before. We gave Benadryl to see if that would help. In the morning it goes away - on her arms, she can see a little a bit of where the lumps are - not as bad; on legs it's just almost completely gone, and by afternoon it's back to full scale of where it had been the night before. Could see where the bumps were in her arm but it is not as bad as it was. Today, as far as I know from the last time I asked her, she said there are still some on her arms but not on legs.
12 2021-05-31 malaise, headache, chills, fever, throat pain Headache, sore throat, chills, low-grade fever, malaise
12 2021-05-31 runny nose, throat pain, headache, cough, respiratory tract congestion, fever She was taking Claritin for the few days before this event. She normally takes it every fall and ev... Read more
She was taking Claritin for the few days before this event. She normally takes it every fall and every spring. She had seasonal allergy symptoms on the days leading up to this event- she had sore throat, runny nose, a little headache and congestion and developed a cough; on the day of this symptoms she spiked a low grade fever - 100.5. I did a rapid test for COVID at home which was negative for her. Sudden onset: A bunch of knives poking her on the inside of her stomach - pokey from hips to ribs. She started to double over and bend over. Within 10 minutes, she couldn't stand up. She was telling me that something was really wrong. This isn't her character so I knew it was very wrong. I took her to ER. I was still concerned about appendicitis or COVID. This episode lasted for 90 minutes and then it came and went for the rest of the night and then after that - she had runny nose and congestion (normal allergies after that). She was better before they gave her the medication but it didn't seem like she really needed them. She was improving before she got either of the medications: Zofran; Levsin. They gave her a dosage of each there and sent home with a prescription but we never had them filled as she was feeling better. - As it started to improve - it ( being the pokey pain) it was located closer to her ribs and breastbone.
12 2021-06-01 throat pain, headache She started to get a sore throat and drainage the day after the first dose of the vaccine. That day ... Read more
She started to get a sore throat and drainage the day after the first dose of the vaccine. That day she had headache, sore arm with earache and joint pain. Those symptoms continued for several days with some loose stools which lasted for two to three days with abdominal pain which persisted for a little over two weeks. We visited the doctor because of ear and throat pain and nausea. All tests were negative, but the symptoms improved slowly but they are totally resolved right now.
12 2021-06-03 chills, headache, fever Client had chills, fever, headache and was throwing up after the 1st dose of the Pfizer vaccine. Sh... Read more
Client had chills, fever, headache and was throwing up after the 1st dose of the Pfizer vaccine. She was sick most of the day after the vaccine was administered.
12 2021-06-03 fatigue, fever, throat pain, headache, chills Fever of 101.5, chills, -body aches, stomachache, headache, high blood sugars 400-500 for 24 hours, ... Read more
Fever of 101.5, chills, -body aches, stomachache, headache, high blood sugars 400-500 for 24 hours, sore throat, tired, and sore muscles.
12 2021-06-03 headache, fatigue, sleepiness Patient awoke the morning after her 1st COVID vaccination. Reported she slept well. Her arm was sore... Read more
Patient awoke the morning after her 1st COVID vaccination. Reported she slept well. Her arm was sore from COVID shot. She was up for approximately 20 min and had brushed her teeth and did her hair. She was going to get dressed for the day and states she got a sudden pounding headache and felt nauseous. She was on her way out to the kitchen to tell us she didn't feel good when she blacked out. She face planted, hitting her forehead on the hardwood floor witnessed by both parents. She was out for approximately 30 seconds. Her blood pressure was 90/60, HR 120, O2 on rm air was 98%. She has no previous history of syncope. After spell heart rate ran in the 100-110s for about 30 min and then normalized around 88-95. Was tired and sleepy for 2 hours after. (No post ictal sx to suggest seizure) Patient also received Tdap and meningococcal vaccine in other arm at the time of 1st Covid vaccination. The night of her COVID shot patient had normal appetite and activity level.
12 2021-06-03 fever, fatigue, sweating Upon getting up, patient experienced brief spike in fever (felt very hot to touch), unsteadiness and... Read more
Upon getting up, patient experienced brief spike in fever (felt very hot to touch), unsteadiness and fainted. Temperature after fainting was 100 and patient was sweaty, fatigued and had 'wobbly' legs. About 5 minutes later, fever subsided and patient has generally recovered.
12 2021-06-05 sweating Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating... Read more
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Additional Details: I gave the COVID vaccine to patient in her left arm. Within 10 minutes, her mom asked me to come back there. I came and her daughter was very sweaty and feeling very dizzy. I asked one of the techs to grab her some apple juice and an ice pack. I had one of my techs call 911. As I said that, the daughter's mom started to pass out on me but I caught her. She passed out for less than a minute and then she was feeling better. I put ice packs on mom too. Paramedics took over
12 2021-06-05 sweating Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating... Read more
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Additional Details: I gave the COVID vaccine to pt in her left arm. Within 10 minutes, her mom asked me to come back there. I came and her daughter was very sweaty and feeling very dizzy. I asked one of the techs to grab her some apple juice and an ice pack. I had one of my techs call 911. As I said that, the daughter's mom started to pass out on me but I caught her. She passed out for less than a minute and then she was feeling better. I put ice packs on mom too. Paramedics took over
12 2021-06-05 fever 2nd pfizer covid vaccine....Fever the morning after that lasted only about 8 hours (and came down w/... Read more
2nd pfizer covid vaccine....Fever the morning after that lasted only about 8 hours (and came down w/ tylenol, but after 2 rounds of that, it never returned). Hives on the feet and ankles appeared the night after (about 36 hours after) and persist now that we are 48 hours out. Raised skin, redness and slight yellowing of the skin w/ the hives. Somewhat itchy hives. Administered Benadryl orally every 4 hours and topical hydrocortisone cream. It is still there, but not an emergency or causing problems. We will monitor and call the Dr. in the morning if it persists.
12 2021-06-06 body temperature increased did well acted right, felt right up until 5 AM this morning (6/4/21), she woke up throwing up over a... Read more
did well acted right, felt right up until 5 AM this morning (6/4/21), she woke up throwing up over and over again, she couldn?t keep even a dissolvable Zofran down. > I immediately contacted her Hematologist and he told me to take her to the E.R. > blood disorder, ?Hereditary Spherocytosis? came to life, flared up. >got extremely sick, where she could not walk or stand by 8:00 am this morning, when we arrived at the E.R. she had to be placed in a wheelchair because she was so weak. > Fluids, Pain medicine, Motrin, and nausea medication were given, plus rotating cool rags on her head to get her body temperature down. > CBC, was off the charts, she has developed Anemia and was diagnosed this morning. > blood pressure dropped to 91/42. > I spoke with two hematologist on top of speaking with the 2 E.R. Doctors. >reached over 110% immunity if not more. > Both Hematologist I spoke with plus the E.R. doctors determined she was at 100% immunity with just the first dose. > Due to her reaction her Oncologist/Hematologist are communicating with other hematologist in the U.S. about a reaction of a ?12 year old pediatric patient with Hereditary Spherocytosis?, further research will begin according to the Director of Onoccologist/Hematologist in the next few weeks to help other pediatric patients with Heriditary Spherocytosis in the U.S., the main point of this research is determining that one dose of Covid vaccine reaches 100% immunity vs 2 doses which would be equivalent to ?2 doses plus 2 booster shots of Covid vaccine? to someone with hereditary spherocytosis. > > After 8 hours of going through this, she was able to walk and stand. She was back to her old self. > If you can please reach out to CDC and let them know about a 12 year olds patient with Hereditary Spherocytosis reaction to second dose of Phizer Vaccine.
12 2021-06-06 chills, fever, headache Fever, headache, chills, body aches, nausea, vomiting
12 2021-06-06 headache, chills Achy 7hours after Chills/achy 11 hours after-ibuprofen given Headache/achy 17hours after- Tylenol gi... Read more
Achy 7hours after Chills/achy 11 hours after-ibuprofen given Headache/achy 17hours after- Tylenol given
12 2021-06-06 headache, runny nose, throat pain Headache, nauseas, sour throat, vomit; running nose
12 2021-06-06 headache first headache then nausea then 3 days after had chest pain and elevated troponins. Is being admitt... Read more
first headache then nausea then 3 days after had chest pain and elevated troponins. Is being admitted for ECHO and serial troponins
12 2021-06-06 fever Slight fever, all over aches for about 36 hours
12 2021-06-07 chills, fever Complaining of chest tightness in the morning, then it progressed to pain, subjective fever, chest, ... Read more
Complaining of chest tightness in the morning, then it progressed to pain, subjective fever, chest, rashes on arm and face, shivering. Feels throat is tightening.
12 2021-06-07 chills, fever 17 hours post dose, pt started with low grade fever, chill and nausea. 22 hours post dose she began... Read more
17 hours post dose, pt started with low grade fever, chill and nausea. 22 hours post dose she began vomiting and complaining of on and off stomach pain. 36 hours later on Sat June 6, she presented with severe lower right quadrant pain and we went to ER. Diagnosis was perforated appendix requiring emergency appendectomy and treatment for 72 hours with IV Cipro and Flagyl. She was discharged from hospital on Tues, June 7th on Cipro 500 mg BID po for 3 days.
12 2021-06-07 chills, runny nose Noticed on apple watch HR was going up to 120s/HR still elevated. Goes up to 120 when standing. Went... Read more
Noticed on apple watch HR was going up to 120s/HR still elevated. Goes up to 120 when standing. Went to take a shower and HR was 150; diarrhea; Developed rhinorrhea; Developed a pruritic rash on right side of back; chest heaviness; allergic reaction; SOB; chills; This is a spontaneous report from a contactable nurse. A 12-years-old female patient (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EW0168, expiry date not reported), intramuscular, administered in left arm on 15May2021 as first dose, single dose for covid-19 immunisation. Medical history included allergic rhinitis/conjunctivitis from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications included medications the patient received within 2 weeks of vaccination as cetirizine 5mg, and clotrimazole 1% topical cream. The patient previously took amoxicillin and experienced allergies. The most recent COVID-19 vaccine was administered in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient been tested for COVID-19 which included Covid 19-PCR (nasal swab) on 16May2021 as negative. On 15May2021, the patient received vaccine (Pfizer) and got chills a couple hours later. On 16May2021, patient developed a pruritic rash on right side of back and mom gave an allergy medicine (cetirizine), developed chest heaviness, and SOB (shortness of breath), no tongue/lip or throat swelling. Patient came to ED and received albuterol and decadron due to concern for an allergic reaction. On 17May2021, patient developed rhinorrhea; and chest and SOB improved, but continued to use albuterol. On 18May2021, patient had rhinorrhea and diarrhea; continued to use albuterol. On 19May2021, patient had diarrhea and noticed on apple watch HR (heart rate) was going up to 120s; last use of albuterol. On 20May2021, patient's diarrhea resolved, HR still elevated, went up to 120 when standing; and went to take a shower and HR was 150. The events were reported as serious medically significant, resulting in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures in response to the events included diphenhydramine, decadron, and albuterol. The patient recovered from the event diarrhea on 20May2021. The outcome of the other events reported was not recovered.; Sender's Comments: Based on temporal association and profile of the product, the events are considered related to BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EW0168, expiry date not reported).
12 2021-06-07 cough, throat irritation Received her 2nd dose of Pfizer approximately 12:15 PM. A couple of minutes later while sitting in o... Read more
Received her 2nd dose of Pfizer approximately 12:15 PM. A couple of minutes later while sitting in observation the pt started to c/o dry cough, itchy throat, and difficulty swallowing. The pt appeared flushed. Pt was laid down and assessed by staff. 911 called and asked for lights and sirens, 911 was called at 12:19 PM. Initial VS: 107/63 HR 106, O2sat 93%, pt began to c/o worsening difficulty swallowing, pt appeared flushed, O2sat dropped to 88%. Epi Pen autoinjector administered IM in the left thigh at 12:20 PM. About a minute after the Epi pen was administered the pt?s pulse ox came back up to 96% and the pt reported a strong relief of the difficulty swallowing and the itching in her throat. BP immediately post Epi was 103/78, HR 76 O2 Sat 96% Repeat BP; 109/79 HR 89 O2Sat 99% RR 16 Repeat BP 12:27 PM 106/63 HR 114 O2Sat 98% Staff continued to monitor pt?s O2sat and HR. At one point during observation while waiting for EMS the pt reported the difficulty swallowing seemed to be returning, pulse ox remained above 90%. Pt transported to ED. Pt has no medical history or allergies per mom. Pt is not taking any medications. Mom reports when the pt received her first dose she did experience flushing, dizziness, and a cough. The pt?s pediatrician happened to be present at clinic and told the pt she was fine and was cleared to get the 2nd dose per mom. RN followed up with mom later that day, pt was home and doing well.
12 2021-06-07 headache, chills, fever Headache, nausea, vomiting (2x), fever (~101F), chills. Lasted 36 hours.
12 2021-06-07 lethargy Patient became extremely lethargic. Vision was very blurry. Blood pressure registered 89/64 with pul... Read more
Patient became extremely lethargic. Vision was very blurry. Blood pressure registered 89/64 with pulse of 72bpm. Patient unable to move extremities
12 2021-06-08 body temperature increased, headache 10pm temp of 99.3, nausea, headache, body aches, dizziness 5am temp 100.3, headache, dizziness
12 2021-06-08 headache, fever, chills Chills, slight fever, under 100.00 deg. and headache.
12 2021-06-08 headache, fever The night of the vaccine, towards the middle of the night she had a fever 103.2; little bit of a hea... Read more
The night of the vaccine, towards the middle of the night she had a fever 103.2; little bit of a headache. Her fever went down through the night. In a.m., she was at 100 degrees. She started shaking and fainted when getting ready to go downstairs; Pulsometer - 147 for heart rate. She shook just a little. I thought she was going to have a seizure and I yelled for my husband and she regained consciousness. She hasn't had a fever since but we can't keep her heart rate down -it shoots up from 130- to low 150's. Still like that today. we took her to Dr. - he said it was reaction to vaccine. He referred her to cardiologist with an urgent designation. She's never had nay problems like this before. She will see cardiologist tomorrow. Rest and hydration is the current treatment. It hasn't gone away in the two or three days that they thought it would.
12 2021-06-08 headache Headache as described
12 2021-06-08 fever 6/8/21 -Presented with respiratory failure requiring intubation about 12 hours after 2nd dose of COV... Read more
6/8/21 -Presented with respiratory failure requiring intubation about 12 hours after 2nd dose of COVID-19 vaccine. Desaturated to the low 80's despite oxygen. Febrile to 38.8 after admission and had several breakthru seizures requiring loading doses of Keppra. 5/17/21-Had event of tachycardia into the 140s, and slight fever of 100.6, and 8 minute seizure after 1st dose.
12 2021-06-09 chills, fever, headache, fatigue Fever up to 103.5, chills, body ache, fatigue, headache
12 2021-06-09 chills, fever Nausea, vomiting, elevated heart rate, low grade fever, chills started next day. Weakness and mild n... Read more
Nausea, vomiting, elevated heart rate, low grade fever, chills started next day. Weakness and mild nausea day two.
12 2021-06-09 cough, fever My daughter presented with a fever of 101.9 and complaints of chest tightness about 24 hours after h... Read more
My daughter presented with a fever of 101.9 and complaints of chest tightness about 24 hours after her 2nd Pfizer vaccine. She also was coughing a very shallow, tight cough that was triggered by trying to take a deep breath. She rated the chest tightness a 7/10. By bedtime, fever down to 100.1 without any medication. Gave one ibuprofen for chest tightness. The next morning she was feeling much better and said she could barely feel chest tightness. As day progressed and over next several days, the symptom would come back, but was mild. Pediatrician saw her on 6/4 - no abnormal findings. Due to lingering , though mild symptoms over weekend, pediatrician made referral for cardiologist. Cardiologist performed EKG on 6/9 and results normal.
12 2021-06-09 fatigue, fever Chest pain and pressure; fever of 101 degrees F; shallow rapid breathing; rapid heart rate (120); fa... Read more
Chest pain and pressure; fever of 101 degrees F; shallow rapid breathing; rapid heart rate (120); fatigue and tiredness; feeling of being hot and unable to catch breath.
12 2021-06-09 headache, fatigue Patient had her #2 Pfizer vaccine 6/7/21. 6/8/21 pt describes waking up with mild headache and fatig... Read more
Patient had her #2 Pfizer vaccine 6/7/21. 6/8/21 pt describes waking up with mild headache and fatigue. Standing at bathroom sink brushing her teeth felt nauseous, then fainted. Woke seconds later when MOC (who heard "thud" of pt hitting ground) roused her. Pt woke with mild TTP at back of head assuming she hit her head on a door knob. During drive to The Hospital ER, pt reports drinking some juice started feeling a little better. Upon arrival, they advised Urgent Care instead of ER and again provided a juice box. The Hospital Urgent Care drew blood for BMP, performed EKG, and PE noting only abnls to be hyperglycemia at 166 and TTP at L occiput. Pt was dischg'd to home in good condition. 6/9/21 she woke with a slight headache that is since resolved despite walking to lunch in 90+ degree heat and working at library. MOC reports her complexion has returned to normal today (was pale yesterday). Pt reports she has been hydrating very well since visit. Currently pt reports feeling 100%.
12 2021-06-09 headache, fever Fever, headaches, aches throughout body.
12 2021-06-09 fever, headache, fatigue Next day: fever ranging 99-102 Vomiting: 2x Fatigue, headache Resolved about 30 -48 hours after do... Read more
Next day: fever ranging 99-102 Vomiting: 2x Fatigue, headache Resolved about 30 -48 hours after dose
12 2021-06-10 headache Neck pain and spasming - sharp shooting and progressing to ear and temporal pain. Initially occurri... Read more
Neck pain and spasming - sharp shooting and progressing to ear and temporal pain. Initially occurring a couple times a day and now more frequent. Also, originally started on just the left side of the neck and is now occurring on both sides.
12 2021-06-10 fever 102.5 fever day 1 poster vax 2; This is a spontaneous report from a contactable consumer (on behalf ... Read more
102.5 fever day 1 poster vax 2; This is a spontaneous report from a contactable consumer (on behalf of patient). A 12-years-old female patient received second dose of bnt162b2 (COVID VACCINE, formulation: solution for injection, Batch/Lot number: unknown, Expiry date: unknown), via an unspecified route of administration on an unspecified date (at the age of 12-years) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation.The patient received first dose of bnt162b2 (COVID VACCINE) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced 102.5 fever day 1 poster vax 2. The patient underwent lab tests and procedures which included body temperature: 102.5. Outcome of the events was unknown. Information on Lot/Batch number has been requested.
12 2021-06-10 fever Fever and gastrointestinal symptoms started on Wednesday. Gastrointestinal symptoms include strong c... Read more
Fever and gastrointestinal symptoms started on Wednesday. Gastrointestinal symptoms include strong cramps nausea and diarrhea. These are worsening to the present date.
12 2021-06-12 headache Headache, body and joint pain.
12 2021-06-12 sneezing, runny nose, fatigue, chills Vial of vaccine was reconstituted with 1.5ml of diluent instead of 1.8ml. Called patient on 6/12 to... Read more
Vial of vaccine was reconstituted with 1.5ml of diluent instead of 1.8ml. Called patient on 6/12 to ask how she was feeling. Starting 6/12 she had chills, was tired, sneezing, and had a runny nose.
12 2021-06-13 fatigue, headache Bad headache, upset stomach, very mild temp, extreme tiredness, started around 6 AM, got worse for ... Read more
Bad headache, upset stomach, very mild temp, extreme tiredness, started around 6 AM, got worse for about 5 hours. Headache first to go away. By 8 PM all but tiredness gone
12 2021-06-13 fatigue, fever, sweating Beginning Thursday night, fever onset reached 101. Patient reported extreme fatigue but aches and so... Read more
Beginning Thursday night, fever onset reached 101. Patient reported extreme fatigue but aches and sore arm made sleeping difficult. By 2 am on Friday, June 11th, vomiting and diarrhea began. Patient was given 200 mg of Tylenol and 25 mg of Benadryl. Arnaca gel was applied to the rash that formed on the vaccine site. The rash was approximately 3 cm wide and 5 cm tall oval shape. It was bright red and painful to touch (like a sunburn). Arm was also swollen from shoulder to elbow. Patient slept from 4 am - 8am on 6/11. All day on 6/11 patient had trouble keeping down fluids (tried water, juice, gatorade, and broth) and patient refused food (tried popsicles, rice, bananas, scrambled eggs, and plain noodles). Patient complained of throbbing pain in left arm. Patient refused to massage the area and would screen in pain and cry with tears if mom touched it at all. Cold packs and warm packs brought no relief. Patient continued to receive Tylenol every four hours. Fever would reach 102-102.5, break with sweats. Patient reported feeling very cold and then very hot. Fever break would last 30 min - 1 hour before climbing again. Sunday 6/12 continued the same as 6/11. Patient began alternating Advil 200 mg with Tylenol every four hours. Advil didn't seem to help any more than the Tylenol did. Parent called consulting nurse and was advised to take patient to urgent care where she received anti-nausea medication. Monday 6/13 patient continues to have difficulty with food and drink. The phenergan meds help with nausea but make patient so tired, there's little chance to get patient to eat or drink. Vomiting has stopped but diarrhea continues.
12 2021-06-13 headache, fatigue, fever Fever - Mild - start date 08Jun2021 - end date 08Jun2021 Fatigue - Moderate - start date 07Jun2021 ... Read more
Fever - Mild - start date 08Jun2021 - end date 08Jun2021 Fatigue - Moderate - start date 07Jun2021 - end date 09Jun2021 Headache - Moderate - start date 08Jun2021 - end date 09Jun2021 Body pain - Mild - start date 08Jun2021 - end date 09Jun2021 Nausea - Severe - start date 08Jun2021 - end date 09Jun2021 Emesis - Mild -start date 08Jun2021 - end date 08Jun2021 Con Med - Tylenol - 325mg
12 2021-06-13 malaise Patient felt "not right" and momentarily passed out after receiving vaccine, when she regained consc... Read more
Patient felt "not right" and momentarily passed out after receiving vaccine, when she regained consciousness she vomited but was then ok, possibly due to sight of needle and blood, since she bled. Paramedics called and arrived, took over.
12 2021-06-13 fever Fever, arm swelling, arm tenderness, body aches, and rash on legs lasted 2 days. Rash on legs is wh... Read more
Fever, arm swelling, arm tenderness, body aches, and rash on legs lasted 2 days. Rash on legs is what prompted reporting of symptoms.
12 2021-06-14 fatigue, sneezing, throat pain, headache She complained of a headache developing soon after receiving the shot on June 11th until June 13th. ... Read more
She complained of a headache developing soon after receiving the shot on June 11th until June 13th. She was tired most of the day on June 11th. On June 13th, she showed me where a red circle had developed around the injection site. On June 15th, she complained about sneezing a lot, a sore throat and having a headache throughout the day. Later that evening around 9:30 pm, she started vomiting (2 episodes) and stated her throat pain was an 8 out of 1 to 10. After vomiting her throat pain dropped to a 7.
12 2021-06-14 headache, fever, fatigue Fever noticed morning after shot at 99.3 then continued to rise to 102.1, controlled w/ibuprofen an... Read more
Fever noticed morning after shot at 99.3 then continued to rise to 102.1, controlled w/ibuprofen and then would rise again. At 10 am 6/11/21 she has a temp of 103.8. Given more ibuprofen. Also, with fatigue and headache. Following night temp at 103.4. 6/13-6/14 low grade temps at 99,100
12 2021-06-14 headache Headache and arm pain that makes difficult to move
12 2021-06-14 throat pain, headache Started vomiting 2hrs after vaccination. Went to ER who initially obtained CBC with stable Hgb and s... Read more
Started vomiting 2hrs after vaccination. Went to ER who initially obtained CBC with stable Hgb and sent home with Zofran. Patient continued to have bloody emesis so presented back to ER where they did CXR which was normal, gave IVF bolus, zofran, repeat CBC with Hgb 12.4 and transferred to another hospital for higher level of care. At the hospital, Initially made NPO and placed on IV fluids in preparation for possible endoscopy. Repeat labs showed stable hemoglobin compared to outside hospital. GI consulted and determined that hematemesis was most likely due to Mallory Weiss tear. Recommended carafate before meals, chloraseptic spray as needed for sore throat, continuing IV Protonix and IV zofran as needed, and gradually advancing her diet. On HD#3, she had another episode of hematemesis after eating solids. Overnight, tolerated liquids and solids without any further episodes of emesis. Tolerated transition from IV to PO meds and maintained hydration off of IV fluids. Due to symptom improvement, GI did not recommend endoscopy at this time and recommended that she be discharged on 1 week course of carafate, 2 month course of omperazole, and zofran as needed with plans for GI follow-up in 1-2 months. Had another episode of hematemesis at home after discharge. Went back to hospital and admitted again. The patient underwent upper endoscopy which showed no source of upper GI bleed. ENT was consulted and performed a nasopharyngolaryngoscopy which was negative for an ENT source of bleeding. She remained stable without an identifiable source of bleeding. Mom was comfortable with her being discharged home with close follow up by PCP. Pt seen on 6/7/21 at pediatrician's office for ER F/U. Pt reported she was still vomiting, 2x so far that day. The day before vomited 4x during the day and continued until the night. No more bright red blood in vomit. Describes vomit as blue and pink colors now. Pt does take a light green tablet that is her levothyroxine. Threw up the blue colored vomit immediately after taking this medication. Instructed to take zofran when feeling nauseous. Seen again by pediatrician on 6/10/21- Currently, per mom pt is still vomiting. Last time she vomited was last night. Pt is taking omeprazole. Pt vomited 5-6x yesterday. Decreased appetite, but has been eating some crackers and rice. Complaining of stomach pain after eating and vomiting. Pt used zofran once and it helped a little. Pt denies self induced vomiting. Pt has ben observed by family when vomiting and they do not report any self induced vomiting. Pt denies trying to lose weight. Pt never vomits up food, always liquid. Vomit is different colors, can be pink or blue. No more red color in vomit, only pink. Pt drinks water and gatorade. Pt denies feeling any burning before vomit, but feels burning sensation after vomiting. Pt has been having BMs, not regularly and hard. Taking one capful of miralax at night. Instructed for next five days, instructed to take zofran pill 1hr before dinner. F/U with GI. Seen again by pediatrician on 6/15/21- Per mom and pt she is still vomiting about 5-6 times a day. Pt went to GI yesterday, given lansoprazole 30mg qd and told to continue zofran.. Pt is now able to eat all her meals, takes zofran 1hr before dinner. Pt has vomited 1hr after dinner and has only vomited liquids. Hematemesis has resolved. Still has some blue colored vomit, most likely from levothyroxine medication she takes daily. Stopped taking Miralax 3 days ago. Pt had a soft BM earlier this morning. Pt states she has occasional stomach pains after vomiting, takes a while to calm down but then resolves. Described as lower abdominal. Pt has nausea before vomiting, after vomiting takes 15-30mins for nausea to resolve. Pt states she had a headache with a heavy sensation when vomiting. No headaches at night, but does vomit 3-4x overnight. LMP: 2wks ago. Recommended to go to ophthalmologist to r/o papilledema. WIll contact hospital to get results of any bloodwork done inpatient (reviewed - only CBC done inpt).. F/U in 1wk. Ordered MRI brain w/contrast. CMP. lipase, amylase, celiac disease panel. All results pending.
12 2021-06-14 fever, headache, fatigue After the second dose she had immediate pain at the injection site and over the next 24 hours she de... Read more
After the second dose she had immediate pain at the injection site and over the next 24 hours she developed: A fever of 101.4 severe abdominal pain and chest pain that made her feel like her heart was being pulled out painful electric shocks down her neck and spine that made her walk hunched over numbness and swelling in the arm she got the shot pain in her fingers and toes that turned white and were ice cold to the touch Over the next 2.5 months her abdominal, muscle and nerve pain became unbearable plus she developed new symptoms: Fatigue gastroparesis, nausea and vomiting Eventually she couldn?t even swallow food or liquids without immediately spitting it up. An itchy rash on her arms peeling skin on her feet Her menstrual cycle lasted a month with large clumps of blood She had unexplained painful cysts vision problems headaches erratic blood pressure and heart rate memory loss, mixing up words and brain fog Dizziness, fainting and then nonepileptic seizures that we suspect were from lyrica verbal and motor tics loss of feeling from the waist down, muscle weakness, abnormal gait and eventually she wasn?t able to walk at all urinary retention From the day she got her 2nd dose to today we took her to the ER nine (9) times and she was admitted to the hospital a total of 3 times totalling 2 months. The last time she was admitted to the hospital she could not walk, was unable to feel or move below her waist, threw up anything she tried to eat or drink, had tachycardia and her blood sugar was at 47. Once she got an NG tube and was stable they transferred her to Inpatient Rehabilitation and she was just discharged on June 1st. Today she is able to walk with a walker and take care of herself but she still has little to no feeling below her waist. She still has an NG tube for nutrition and continues to have GI and urinary retention problems.
12 2021-06-14 fever On 6/8/2021 patient c/o fever to 102.5 then at 1:15 PM woke up from a nap with upper left chest pain... Read more
On 6/8/2021 patient c/o fever to 102.5 then at 1:15 PM woke up from a nap with upper left chest pain described as burning. Parent treated with Tums and ibuprofen and pain lasted about 8 hrs. Also c/o nausea but no vomiting. Had dizziness earlier in the day but not when she had chest pain. No shortness of breath or palpitations. All symptoms resolved by the morning on 6/9/2021. Parents did not seek medical attention until 6/15/2021 when they learned about possible myocarditis as a vaccine side effect. Patient is currently asymptomatic but is not able to seek medical attention today. Recommended to go to nearest UC or ER to check a troponin and ECG.
12 2021-06-16 chills approx 24 hours after receiving 2nd pfizer vaccine, she developed behavioral changes including night... Read more
approx 24 hours after receiving 2nd pfizer vaccine, she developed behavioral changes including nightmares, shaking, nausea, chills, paranoia about being hurt by someone. She was up every hour and crying if mom left the room (not her typical behavior). She knew this was not how she normally was, but felt she couldn't control her fear. lasted for 36 hours and resolved. similar reaction when she received tamiflu for Influenza.
12 2021-06-16 sweating Patient was siting at the waiting area after about 10 minutes receiving first Covid19 Pfizer shot. M... Read more
Patient was siting at the waiting area after about 10 minutes receiving first Covid19 Pfizer shot. Mom reported to pharmacist staff that patient turned pale and felt dizzy. Pharmacist suggested patient to drink water and continued to rest while pharmacist monitored patient. Pharmacist tried to take patient's blood pressure but pharmacy didn't have the right cuff so she was unable to obtain patient's blood pressure. Patient then was sweating and mom continued to give her water while pharmacist checked patient's temperature (recorded 94.6'F). Few minutes later, patient vomited. Mom gave patient water after she was done vomiting. Patient reported she felt better afterwards. Patient was monitored for about 15 minutes and she was able to walk herself and left the pharmacy waiting area with mother. Pharmacist suggested mother to call doctor for follow up advice.
12 2021-06-16 sweating Patient was nervous about getting the vaccine. Patient felt dizzy as she stood up and started to fai... Read more
Patient was nervous about getting the vaccine. Patient felt dizzy as she stood up and started to faint. Her mother and I caught her to lower her to the ground and she came back out of it before we even got her to the ground. She became pale and sweaty.
12 2021-06-16 lethargy Patient was very nervous about the receiving the 2nd dose. We had a in depth conversation about side... Read more
Patient was very nervous about the receiving the 2nd dose. We had a in depth conversation about side effects because she had a headache with the 1st dose. Mom held her hand. A few minutes post, her sister saw that she was slumped over & her eyes had rolled to the back of her head. We tried to wake her up & she was very lethargic. I gave her 2 small bottles of water, pb crackers, 3 hard candies & elevated her feet. Mom said we didn't need to get medical attention. After about 10 minutes she was still very lethargic & mom said yes to EMS when asked again. Another mom came over & helped us lay her on the floor to elevate her feet above her head. Her husband came in & assessed patient. Her pulse was 60 & when he asked her to squeeze his fingers & press against his feet it was week. She told us that she hadn't eaten a full meal since the night before, only had watermelon as a snack. The ambulance came & took her.
12 2021-06-16 fever Fever of 100.4; This is a spontaneous report from a contactable consumer or other non hcp (Patient's... Read more
Fever of 100.4; This is a spontaneous report from a contactable consumer or other non hcp (Patient's father). A 12-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0217 and expiration date was not given), via an unspecified route of administration on 10Jun2021, as 2nd dose, single dose for covid-19 immunisation. Patient's medical history and concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number and expiration date was not given) for COVID-19 immunisation on an unspecified date. On 11Jun2021 patient experienced fever of 100.4. It was reported that, the reporter enquired My daughter got the second dose of the Pfizer on Thursday and today she has a fever of 100.4 and I was wondering if she could take Aleve. The patient underwent lab tests and procedures which included body temperature: 100.4 on 11Jun2021. The outcome of the event was unknown.
12 2021-06-16 fever Fever; She woke up before 6 in the morning feeling bad; when she stand up she felt weak; She woke up... Read more
Fever; She woke up before 6 in the morning feeling bad; when she stand up she felt weak; She woke up before 6 in the morning feeling bad; when she stand up she felt weak; This is a spontaneous report from a contactable consumer (patient's mother). A 12-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number was not reported) via an unspecified route of administration on 07Jun2021 14:45 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had received other products. The patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) on 17May2021 for COVID-19 immunization. Reporter stated, Exactly 3 weeks before second dose patient took 1st dose of vaccine. Reporter stated that, On 08Jun2021 patient woke up before 6 in the morning feeling bad and she had a fever and so they gave her Ibuprofen an hour ago and currently she still had the fever over 101 and she still feeling pretty badly like she did not like when she stand up she felt weak. Reporter was just wondering at what point they should get an alarmed the sheet said that a fever was a side effect but like at what point for a fever should be they worried; she enquired. Reporter further added, 'The sheet she received says that if experience severe reaction Call 911 but it's hard to know what is severe reaction is, you know. Reporter was informed about Pfizer Medical information department and was provided with the number. Therapeutic measures were taken as a result of fever, she woke up before 6 in the morning feeling bad; when she stand up she felt weak, she woke up before 6 in the morning feeling bad; when she stand up she felt weak as Ibuprofen was given to patient. The outcome of all events was unknown. Information on Lot/Batch number has been requested.
12 2021-06-17 fatigue, fever Fever of 102.7 at peak. Treated with ibuprofen a s acetaminophen regimen. Felt fatigued and ?heavy.... Read more
Fever of 102.7 at peak. Treated with ibuprofen a s acetaminophen regimen. Felt fatigued and ?heavy.?
12 2021-06-17 malaise Nausea and Significant Vomiting; Nausea and Significant Vomiting; Felt ill; This is a Spontaneous ca... Read more
Nausea and Significant Vomiting; Nausea and Significant Vomiting; Felt ill; This is a Spontaneous case report received from a contactable consumer. A 12-year-old female patient received first dose of BNT162B2 (Pfizer, Solution for injection) via an unspecified route of administration on an unspecified date (Lot number/NDC number/Expiry date: Unknown) (at age of vaccination) as single dose for Covid-19 immunization. Time the vaccination was given: afternoon. Anatomical location of vaccine: Unknown. The patient's medical history was not reported. Concomitant medications: Caller stated she knew the patient did take several medications because she had babysat her, but she did not know what they are. History of all previous immunization: none. On an unspecified date, the patient experienced nausea and significant vomiting and felt ill (afternoon). Caller was reporting what she heard about an adverse event in her daughter's friend with her first dose of the Pfizer Covid Vaccine in the newly approved age group, 12. Caller stated the patient had no other illness or notable cause for the nausea and vomiting. Caller stated the patient received the vaccine in the afternoon and then next morning she felt ill and then in the afternoon she had the nausea and vomiting. Caller stated dates were unknown, but she did know it was only on one occasion, she vomited a few times on that day and not any additional days. Caller stated she encouraged the girl's parents to call the number and she was hoping they would report it. Adverse event details: Provide the time of onset of AE(s): Morning. Treatment was unknown. Outcome of the events was recovered on an unspecified date. Communication: Caller provided with Report Reference Number. Information about the lot/batch number has been requested.
12 2021-06-17 nasal congestion, fever, chills, cough Seen in office 6/16/21 - Complaints of Shortness of breath, cough, nasal congestion X5 days. Receive... Read more
Seen in office 6/16/21 - Complaints of Shortness of breath, cough, nasal congestion X5 days. Received COVID #2 on 6/11/21. Got fever + chills w/in 24 hours of vaccine. Treated w/ Duoneb + prednisone, QVAR + albuterol at home. Seen in ED 6/16/21 -abnormal EKG; Murmur; Labs ordered; Albuterol + Atrovent nebs, chest xray; Home w/ Albuterol, prednisone
12 2021-06-17 fever, fatigue, chills, headache Status epilepticus in adolescent with well-controlled epilepsy, last seizure 9/2020. Seizures began ... Read more
Status epilepticus in adolescent with well-controlled epilepsy, last seizure 9/2020. Seizures began 31 hours after second dose of Pfizer Covid vaccine. Headache, chills, myalgias, fatigue began 15 hours after second dose. Tylenol had been given to manage headaches about three times before seizures began. Fever to 101 was noted by EMS and in ER, no fevers had been noted before then.
12 2021-06-17 fever, fatigue pain at the injection site, pain in the left arm - since after the injection - lasted for 2 days tir... Read more
pain at the injection site, pain in the left arm - since after the injection - lasted for 2 days tiredness, fatigue, low grade temp - 99.6 F orally - started on day 2, resolved on it's own by following morning.
12 2021-06-17 sneezing, runny nose, nasal congestion Stuffy nose; sneezing; runnynose; This is a spontaneous report from a Pfizer sponsored program. A co... Read more
Stuffy nose; sneezing; runnynose; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient's mother) reported for a 12-year-old female patient. A 12-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EW0191; Expiration date: unknown) via an unspecified route of administration on 27May2021 14:58 as single dose for COVID-19 immunization. The patient medical history was not reported. Patient's Medical History (including any illness at time of vaccination) was none. Patient had not History of all previous immunization with the Pfizer vaccine considered as suspect and not any additional Vaccines Administered on Same Date of the Pfizer Suspect. Family Medical History Relevant to Adverse event was not provided. Patient had not any other history and products. Prior Vaccinations within four weeks prior to the first administration patient had HPV booster shot. The patient's concomitant medications were not reported. Caller was asking question on behalf of her daughter. She had first dose of the Pfizer BioNTech COVID-19 vaccine on 27May2021; second dose was scheduled for 17Jun2021. On 12Jun2021 her daughter has been experiencing a lot of sneezing and a runny nose. It was clarified that patient had runny nose not red nose stated by transfer agent, who gave them their number to see if it was ok to give second dose. Wondering if there were any contraindications to that dose. All events started in the morning and progressed to like evening; exact time unknown by caller. A lot of sneezing it comes and goes. It was ongoing and had improved. Runny nose it was more like stuffy, ongoing, and it has improved. Stuffy nose was initially stated as it was started on Sunday, 13Jun2021. It was like sniffles now. Attempted to clarify. Runny nose and sniffling started the same day. Nose started running, then was sniffling, then stuffy all at the same time. Caller said the stuffy nose has improved and was ongoing. She did not think her daughter's symptoms were caused by the vaccine. She was just realized she did not think it was the vaccine. Caller just wanted to be sure it was ok to get the second dose for her daughter and agreed to be transferred to Pfizer Medical Information to see if they can help answer her question. Patient was taking vaccine to protect her from getting sick from COVID-19. Patient had not any adverse event prior vaccinations. The adverse event did not result into Emergency Room or Physician Office visit. Patient had not received any treatment. Patients had not any Relevant Tests. The outcome of all events was recovering. Follow attempts are needed. Further information is expected.
12 2021-06-18 headache Patient experienced pain and numbness in left arm after administration. Numbness and pain were repor... Read more
Patient experienced pain and numbness in left arm after administration. Numbness and pain were reported in lower arm extremity. Patient evaluated over the course of 30 minutes. During that course patient reported pain and numbness travelling down to wrist and fingers. She also reported a pounding headache once felt on forhead. Patient did report that it was getting better than worse over the course of observation. Mother was advised to contact pediatrician for further assistance if it progresses to worst.
12 2021-06-18 sweating Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushe... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Patient waited at pharmacy for 15 minutes after vaccination, then left to go get coffee with her mother. At coffee shop, patient complained of feeling hot then passed out and her head hit the floor. She immediately regained consciousness. We elevated her feet and stayed with her and monitored her until paramedics came. Paramedics assessed and stated that all vitals were good. After sitting for a bit, patient left to go home with her mother. Per patient's mother she had not eaten today.
12 2021-06-18 fever, body temperature increased had a fever of 104 and it subsided at 2am but it is back at 102; This is a spontaneous report from a... Read more
had a fever of 104 and it subsided at 2am but it is back at 102; This is a spontaneous report from a Pfizer-sponsored program. A contactable male consumer reported for his daughter (patient). A 12-year-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number: Unknown) via an unspecified route of administration, on 09Jun2021, as 1ST dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On 09Jun2021, patient had a fever of 104 (unit unspecified) and it subsided at 2am but it is back at 102(unit unspecified) on 10Jun2021. He wanted to report that and to make sure that he is doing the right thing by giving her Motrin. The outcome of the event was unknown.
12 2021-06-19 headache, chills, fever Fever, aches, chills, headache, and asthma/hard time breathing from morning of 6-17-21 until the mor... Read more
Fever, aches, chills, headache, and asthma/hard time breathing from morning of 6-17-21 until the morning of 6-19-21. She was in the yellow zone of her asthma action plan for about 48 hours.
12 2021-06-19 fever Fever on 6/9 night and body aches the next morning. Morning of 6/11 at 6-6:30am complained of chest... Read more
Fever on 6/9 night and body aches the next morning. Morning of 6/11 at 6-6:30am complained of chest pain. Fever of 99-100.5 F on 6/11 that resolved that morning without medication. Decreased appetite.
12 2021-06-20 body temperature increased, headache, chills Patient is a 12 yr/o child with a history of mobility, pots, factor VII deficiency, scoliosis who pr... Read more
Patient is a 12 yr/o child with a history of mobility, pots, factor VII deficiency, scoliosis who presents with chest pain and headache after receiving the second Covid vaccine. Mom reports patient got the second Pfizer Covid vaccine yesterday. After the vaccine the patient had some nausea and dizziness which he occasionally has at baseline. This morning when the patient woke up he was having chest pain with deep breathing and complaining of burning in the chest. Mom reports the patient had a temperature to 100.7 at home. Mom endorses decreased activity level and mom noted the patient to have a heart rate to the 130s at home. Patient endorses chills and nausea without vomiting, no diarrhea. Patient also endorses a poor appetite today. the patient has difficulty describing the exact location of the chest pain, mom reports that the patient has always had difficulty with pinpointing the exact location of pain.
12 2021-06-20 chills, sweating The patient was in extreme pain in her legs. this spread to her whole body. She had chills, shaking,... Read more
The patient was in extreme pain in her legs. this spread to her whole body. She had chills, shaking, sweating and stomach cramps. This event lasted almost 6 hours. We called the pediatricians on-call nurse and were told to start ibuprofen. The symptoms began residing about 5 hours after on-set and then by hour 6 the majority of the symptoms were gone. Patient still had body aches and chills for 12 hours more.
12 2021-06-20 fatigue Fatigue
12 2021-06-20 throat pain, fever, cough, respiratory tract congestion fever, sore throat, cough, congestion
12 2021-06-20 fever, chills Fever 101.3 lasting full day (treated with Motrin after vomiting) Projectile Vomiting 3 separate tim... Read more
Fever 101.3 lasting full day (treated with Motrin after vomiting) Projectile Vomiting 3 separate times - 5:15am, 7:30am, 9:15am (Fluoxetine was skipped this morning due to vomiting) Chills
12 2021-06-20 throat irritation hives on trunk, throat itchyness
12 2021-06-21 headache During the 15 minute observation period, patient experienced syncope or near syncope. Case reports ... Read more
During the 15 minute observation period, patient experienced syncope or near syncope. Case reports having a headache. Paramedics were called. Vitals were WNL. Patient was visiting from another country and was Spanish-speaking only. Little is known about her health history.
12 2021-06-21 headache Patient received her vaccine stood to wait for her sibling to receive the vaccine (per nurse admini... Read more
Patient received her vaccine stood to wait for her sibling to receive the vaccine (per nurse administering vaccine). She then passed out and hit her head on the ground from a standing position. (per nurse administering the vaccine, I did not witness this but responded.) Additionally the timeframes listed on this report are close approximations. The patient came to consciousness immediately. However, she had complaints of pain radiating from the back of her head to the front and down her spine. C-spine held. 911 called. C-collar placed on the patient. Patient transferred to the ER. No other symptoms or s/s of anaphylaxis noted.
12 2021-06-21 fever Diagnosed with acute promyelocytic leukemia within 48 hours of vaccine administration. Developed fev... Read more
Diagnosed with acute promyelocytic leukemia within 48 hours of vaccine administration. Developed fevers immediately after vaccine, thought to be appendicitis, but diagnosed with leukemia. Currently undergoing induction chemotherapy.
12 2021-06-22 headache Patient woke up and complained of a stomach ache and went to the bathroom Patient felt dizzy and com... Read more
Patient woke up and complained of a stomach ache and went to the bathroom Patient felt dizzy and complained of a headache. Had then started having a seizure. Patient does not have seizures.
12 2021-06-22 sweating AE: (Chief complain) : Patient was sweaty and dizzy upon vaccine administration. Treatment: Patient... Read more
AE: (Chief complain) : Patient was sweaty and dizzy upon vaccine administration. Treatment: Patient was under observation and was offered water to drink. The symptoms resolved after rest and drinking water. Outcome: Patient was discharged to POV/home with her mother.
12 2021-06-22 malaise A few minutes after the shot, patient told her mom she didn't feel well and fainted into her mother'... Read more
A few minutes after the shot, patient told her mom she didn't feel well and fainted into her mother's arms. She was put on the floor and she was conscious at that time. We put a blanket under her head. I took her BP and it was 111/67. After 5 minutes she wanted to sit up and she sat in a chair and passed out again. 911 was called at that point. We had her on the floor after that until the paramedics arrived. They retook her bp and it was 111/63. They checked her vitals and decided to take her to the ambulance just to give more privacy and have their equipment more readily available.
12 2021-06-23 chills, fever 6 days post 2nd COVID-19 Pfizer dose, developed a high fever, chills, very rapid heart rate at rest... Read more
6 days post 2nd COVID-19 Pfizer dose, developed a high fever, chills, very rapid heart rate at rest accompanied by chest pain. She was taken to the ER for evaluation. Initial EKG showed SVT. She was treated with IV fluids and Acetaminophen. All tests, including blood work-up, chest X-ray, COVID-19 test, strep , Flu and RSV done came back normal or negative. A repeat EKG was normal. She was discharged and has since recovered.
12 2021-06-23 headache, fatigue Red ring and bruising at injection site 12 after vaccination lasting about 2 weeks. other symptoms i... Read more
Red ring and bruising at injection site 12 after vaccination lasting about 2 weeks. other symptoms included lymph node swelling, fatigue, headaches and stomach for a day or two after vaccination.
12 2021-06-23 headache Patient reports she developed severe headache, chest pain and shortness of breath 3 days after recei... Read more
Patient reports she developed severe headache, chest pain and shortness of breath 3 days after receiving the vaccination. Her symptoms lasted for 2 days. She did not need to seek medical care.
12 2021-06-23 headache Polyuria, polydipsia, and headaches for one week, then altered mental status that prompted a visit t... Read more
Polyuria, polydipsia, and headaches for one week, then altered mental status that prompted a visit to the ED. Patient found to be in DKA and was treated per protocol, but altered mental status lasted 2 days. An MRI of the brain without contrast showed subependymal gray-white matter heterotopia along the left lateral ventricle.
12 2021-06-23 sweating Patient was a 12 year old female with a weight of 94 lbs who came into the clinic with her father fo... Read more
Patient was a 12 year old female with a weight of 94 lbs who came into the clinic with her father for her second dose of the Pfizer vaccine. During the interview, she stated that she did not have any adverse effects with her first dose. At 2:45 pm, after administering her second dose of 0.3 ml of Pfizer vaccine, I witnessed her having trouble standing up and assisted her back down into the seat. She vomited, was pale and diaphoretic. We elevated her legs up onto a bench and began fluid resuscitation. Her first BP was 71/55 and respiratory rate was unlabored. At 3:00 pm her second vitals were BP: 82/69, RR: unlabored, SPO2: 98, HR: 80. At 3:07 pm her third vitals were BP:83/64, RR: unlabored, SPO2: 99, HR:74. We changed her position from legs elevated to 90 degree angle. Fluids and crackers were still being administered. At 3:16 pm her fourth vitals were BP: 94/76, RR; unlabored, SPO2: 85, HR 67. At 3:30 pm her final vital signs were BP: 96/74, RR: 14, SPO2: 99, HR: 70. The patient was given a total of 60 oz of fluid and 1 pack of crackers. I reassessed that the patient's hemodynamic status improved and her skin was warm and dry. The patient was alert and oriented throughout the process. Her father stated that she no longer looked pale. She was brought to the observation room for another 15 minutes and her father was informed about the progression of her condition. He was informed to refer to her pediatrician if there were any other adverse effects related to the vaccine or changes in her condition.
12 2021-06-24 cough, fatigue, nasal congestion Worsening stuffy nose; Tiredness; Experienced coughing/Dry cough; This is a spontaneous report from ... Read more
Worsening stuffy nose; Tiredness; Experienced coughing/Dry cough; This is a spontaneous report from a contactable consumer (patient's mother) via Medical Information Team. A 12-year-old female patient received second dose of BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, Solution for injection) via an unspecified route of administration to her right arm on 03Jun2021 15:00 (Batch/Lot number: EW0181, NDC number/Expiry date: Unknown) as single dose for COVID-19 immunization. Age at vaccination was 12-year-old. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 via an unspecified route of administration to her right arm on 23May2021 (at the age of 12-years) (Batch/Lot number: EW0182) as single dose for Covid-19 immunization and no reaction was reported on previous exposure to vaccine. Mother called on behalf of her daughter who took the second dose of the Pfizer COVID 19 vaccine last 13Jun2021 and experienced coughing on the same day when she took the vaccine. Tiredness on the next day but it already went away. Worsening stuffy nose and cough was persisting. Asking if these were normal side effects of the vaccine or her daughter needs to see a doctor. DSU Potential duplicate AE Report E transmit. No zip code provided. First dose was given last 30May2021. Patient would turn 13-year-old on 20Jun2021. Stuffy nose and persisting cough were not listed as side effects of the vaccine. Side effect dry cough on 13Jun2021, tiredness on 14Jun2021 and stuffy nose on 15Jun2021. Stuffy nose was reported as worsened. Her daughter had her second dose on Sunday. Her daughter was almost 13-year-old. After the vaccine she started coughing. The next day she was tired. Now she was coughing with a stuffy nose. She stated that her daughter had no fever. Referred to HCP. Caller stated it was a dry cough that started the evening of the vaccine. States it was persisting. Regarding stuffy nose, caller stated it started yesterday and was worse today. Tired, states it was only an issue for the patient the day after the vaccine. Reporter seriousness for events was unspecified. Caller denied any medications, medical conditions, labs, testing or treatments for the patient relevant to the events. Outcome of the event tired was recovered on 14Jun2021, whereas other events was not recovered. No follow-up attempts are possible. No further information is expected.
12 2021-06-24 lethargy, fever stomach ache; lethargic; dizzy; 102 fever; This is a spontaneous report from a contactable consumer(... Read more
stomach ache; lethargic; dizzy; 102 fever; This is a spontaneous report from a contactable consumer(parent). This consumer (parent) reported for 12-years-old female (daughter) patient who received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection; Batch/Lot Number: ER8736) via intramuscular on 11Jun2021 at 03:15 in right arm as a single dose for Covid-19 immunization. Medical history was reported as none. The patient's concomitant medications, past drug history and known allergies were not reported. The patient did not receive any other vaccine within four weeks prior to the COVID or any other medications within two weeks of 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 historical vaccine included first dose of BNT162B2 (COVID Pfizer vaccine; lot number: EW0177) via intramuscular on 16May2021 at 12:00 in right arm for COVID-19 immunization. The patient experienced stomachache, 102 fever and she was lethargic and dizzy at 06:00 on 12Jun2021.The events were reported as non-serious. The patient did not receive any treatment. The patient underwent lab tests and procedures which included body temperature as 102 on 12Jun2021. The outcome of all events was resolved on an unspecified in Jun2021.
12 2021-06-24 malaise Patient slumped over in chair was not feeling well and possible having trouble breathing. We called ... Read more
Patient slumped over in chair was not feeling well and possible having trouble breathing. We called 911 and they came and checked her blood pressure and blood sugar. All were normal. Patient did not leave with the ambulance. She went home and ate something and was feeling much better.
12 2021-06-24 fever Fever; This is a spontaneous report from a Pfizer sponsored program . A contactable consumer reporte... Read more
Fever; This is a spontaneous report from a Pfizer sponsored program . A contactable consumer reported for a 12-year-old female patient (reporter's daughter). A 12-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 on an unspecified date for COVID-19 immunisation and no reaction. It was reported that mother calling on behalf of her 12-year-old daughter received the second dose of the vaccine yesterday and has been running a fever and taking Tylenol every 4 hours since this morning. Normally she keep her home from school for 24 hours until she was fever free. Because it generated as a reaction for the shot, does that rule still apply questioned. She has had a fever this evening. she last took her temperature at 4pm and her temperature was 101.8. If she feels fine in the morning should she send her to school Or should she keep her home until her fever breaks, was she contagious questioned by mother. Outcome of the event was unknown. Information about lot/Batch number has been requested. Follow-up attempts not completed; information about lot/batch number cannot be obtained. No further information expected.
12 2021-06-24 fever 6/12 - patient developed fever and cervical lymphadenopathy. Worsened gradually with difficulty swal... Read more
6/12 - patient developed fever and cervical lymphadenopathy. Worsened gradually with difficulty swallowing. 6/16 - presented to ED. Patient also reported rash in right lower extremity that is pruritic, 2 episodes of non-bloody non-bilious emesis daily since Saturday, intermittent chest pain and dyspnea, myalgias, diarrhea, generalized abdominal pain, and neck pain. Concern for infectious mononucleosis with lymphadenitis. Prescribed Augmentin and discharged home. 6/17 - returned to ED due to worsening rash (no longer pruritic) and diarrhea. Continued fever and neck pain. Hypotensive requiring 3L bolus and norepi. Large volume diarrhea. Mild AKI that resolved with fluid resuscitation. Treated broadly with antibiotics for toxic shock syndrome but rash was not consistent and cultures were negative, so eventually narrowed to ampicillin-sulbactam. Neck pain and swelling improved, but fever persisted through 6/19. Transferred to the floor on 6/20 and gradually improved without further intervention. Antibiotics were continued to target possible tonsillitis/lymphadenitis, but course did not seem to be truly responding to these antibiotics. CRP continued to increase despite antibiotics. Patient's presentation seemed most consistent with MIS-C; she also met criteria for incomplete KD with fever, rash, cervical lymphadenopathy and lab abnormalities, but this was felt less likely and she was not treated with IVIG or any other anti-inflammatories. Patient eventually improved and was discharged home 6/24.
12 2021-06-24 sleepiness Excessive sleep in absence of somnolence. 14-16 hours/day. Change from baseline 8-10 hours.
12 2021-06-25 headache, lethargy, fatigue Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Headac... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Headache-Mild, Systemic: Nausea-Mild, Systemic: Weakness-Medium, Additional Details: hypoglycemic event
12 2021-06-25 headache Client reported she self-medicated with Motrin and symptoms resolved the next day (2 days after vacc... Read more
Client reported she self-medicated with Motrin and symptoms resolved the next day (2 days after vaccination). Client denied having any allergies or chronic conditions and she did not follow-up with a physician regarding side-effects. Vaccine site lead provided education to client and mother on COVID-19 vaccine side-effects and encouraged to report any additional side-effects on VSAFE. Clinical coordinator was consulted and provided approval to administer 2nd dose with a 30-minute observation period.
12 2021-06-25 fever Low fever 98.3
12 2021-06-27 fatigue, headache Per Parent, Pt started on 06/26/2021 with headache, fatigue, and nausea at approx. 10 a.m.. Parent ... Read more
Per Parent, Pt started on 06/26/2021 with headache, fatigue, and nausea at approx. 10 a.m.. Parent called our office on Monday 6/28/2021 at approx. 10:54 am and said symptoms continue.
12 2021-06-27 headache With the first dose: Headache (came and went frequently) dizzy(2-3 days) nausea (2-3 days) sore arm ... Read more
With the first dose: Headache (came and went frequently) dizzy(2-3 days) nausea (2-3 days) sore arm (3-4 days) gave ibuprofen for about 2 days and most symptoms went away. She continued to complain about a headache every once in awhile. About a week later I noticed her eyes seemed a little yellow but it didn't seem to get worse and thought maybe she just need to drink more water and get some sleep. After second dose: Bad headache (3-4 days) dizzy and nauseous (3 days) gave ibuprofen for 2 days. Two days after the vaccine she was fully jaundice. Hadn't notice because she was feeling bad from the vaccine so I just let her sleep mostly. Next day we got into see her primary care dr who ordered stat bloodwork and stat ultrasound. That same day she got some blood work back and told us to go to the er because her platelets were really low. At the er they diagnosed her with autoimmune hemolytic anemia, which explained the jaundice. She was admitted and put on steroids. Her hemoglobin got as low as 5 and they cross matched her incase they needed to do a blood transfusion. They were concerned that there was a possibility that her immune system would attack the donor blood since it seemed to be attacking her platelets as well. Luckily the steroids started working and he levels creeped up a little. She also recieved 3 vitamin k transfusions and pain meds. When she was switched to oral steroids and her numbers were still rise they released her. She is still taking steroids and has weekly follow ups with Dr. . We are also in the process of getting a rheumatology referral to see if there is an underlying condition we didnt know about.
12 2021-06-27 nasopharyngitis Within minutes after receiving 1st dose of Pfizer-BioN Tech covid Vaccine 0.3 ml IM, patient complai... Read more
Within minutes after receiving 1st dose of Pfizer-BioN Tech covid Vaccine 0.3 ml IM, patient complained of dizziness and fell to the ground. Patient was very pale and cold to touch, not being responsive well. Patient was losing consciousness and having difficulty keeping her head up. Patient was moved to lie down on the floor with legs up. Cold water was offered and patient took a few sip. EMS was called. Patients eyes rolled back into her head and lost consciousness/possible anaphylactic shock and not being responsive. Epipen 0.3 MG IM administered. Patient regained consciousness. Nurse practitioner was called and vitals including BP and oxygen level was performed and found to be stable. EMS arrived in few minutes and vitals were checked again by EMS personnel and patient was transferred out to nearby ER. After 3 and 1/2 hours at the ER for observation, patient was discharged.
12 2021-06-27 runny nose Patient presented with positional chest pain that developed 1 day after the vaccine was administered... Read more
Patient presented with positional chest pain that developed 1 day after the vaccine was administered. Was found to have mild elevations in inflammatory markers and with T wave flattening on EKG. Admitted for observation for presumptive pericarditis. Did have URI symptoms w/ runny nose on admission and siblings with cough/runny nose at home
12 2021-06-28 chills, headache, fatigue Patient experienced chills, fatigue, headache on 6/10/21. On 6/11/21 she experienced shortness of b... Read more
Patient experienced chills, fatigue, headache on 6/10/21. On 6/11/21 she experienced shortness of breath, chest pain, and "feeling like she was going to die". Symptoms resolved by the following day. Suspect myocarditis.
12 2021-06-28 sweating Shortly after vaccination client became pale and diaphoretic and fell from chair possible short LOC,... Read more
Shortly after vaccination client became pale and diaphoretic and fell from chair possible short LOC, weak, HR 68, BP 79/50
12 2021-06-28 lethargy, fatigue Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: D... Read more
Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium
12 2021-06-29 headache Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Headache... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Headache-Mild, Additional Details: Mom stated pt felt lightheaded, her eyes rolled back, and fainted for a few seconds. When we observed her, pt was ok but a little shaky. The paramedics came and checked on her, but mother declined going to ER
12 2021-06-29 sweating, lethargy, fatigue Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion ... Read more
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Additional Details: Patient reported severe dizziness and nausea about 5 minutes after receiving the Pfizer vaccine. She ended up vomiting few times. Patient was given water and crackers. She did not end up feeling better even after resting for 15 minutes. The family called 911 and Emergency services took her to the hospital
12 2021-06-29 sweating Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweat... Read more
Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Medium, Additional Details: PATIENT REPORTED ARM PAIN AND PASSED OUT BRIEFLY (ABOUT 15-20 SECONDS) - GAVE WATER AND MONITORED FOR 30 MINS. TOOK BP 105/78 WHICH MOM REPORTS AS NORMAL FOR PT. FULL RECOVERY EXPECTED
12 2021-06-30 body temperature increased, lethargy, fatigue, chills My daughter experienced on day of her 2nd vaccine, feel nauseated in the evening time, then the seco... Read more
My daughter experienced on day of her 2nd vaccine, feel nauseated in the evening time, then the second day. Felt very lethargic, fatigue, laying in bed all day, sleeping. She still had nausea also experienced chills, highest temp 99.8F. Her arm pit on the right side where she got the vaccine was really sore. She basically like within a couple of days she started her period cycle again and it was very heavy and lasted one week and half almost two weeks. On 06-08-2021, at about 10pm, she was brushing her teeth when she saw black spots and she went to tell me. At about 11:30pm that night, she squatted to pat our dog and when she got up and she felt really dizzy, lightheaded so I got concerned. Her symptoms persisted and I scheduled an appointment with her pediatrician on 06-15-2021. The pediatrician ruled out anemia. Her pediatrician said she has Postural orthostatic tachycardia syndrome. Her pediatrician said that this is something manageable, she needs to strengthen her calf muscles and drink lots of water. They monitored her heart pressure and blood pressure. Her heart rate had increased to 40bpm. I also gave her Ibuprofen medication after the vaccine. Leading to today she has been having dizziness and light headiness every single day. My daughter is still experiencing symptoms, dizzy and light headed today. For her 1st vaccine- within few days after her 1st dose, she experienced when using the treadmill, she would feel very dizzy. I did not think anything of it at first and this happened three times then it stopped. She also had a sore arm.
12 2021-06-30 fatigue Sore left arm; tiredness; This is a spontaneous report from a contactable consumer (Parent). A 12-ye... Read more
Sore left arm; tiredness; This is a spontaneous report from a contactable consumer (Parent). A 12-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection, Batch/Lot Number: EN5318) via an unspecified route of administration, administered in Left Arm on 12May2021 (at the age of 12-years-old) as Dose 1, Single for COVID-19 immunization. The patient's medical history was not reported. The Concomitant medications included fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]) loratadine (CLARITINE) vaccine in two weeks. No other vaccine administered in four weeks. No Known allergies were reported. The patient did not test for covid post vaccination. The patient did not suffer from covid prior vaccination. On 12May2021, the patient experienced sore left arm and tiredness. Patient did not received ant treatment. Query included Pfizer Drug safety unit recently received the attached report submitted via pfizersafetyreporting.com. Please help to confirm the date that you became aware of the adverse events in this report as this effects regulatory reporting timelines. This awareness date is the date you became aware of the occurrence of the reported events. If you are the patient in the case, your awareness date would be the date that you became aware you were experiencing the reported events. If you are not the patient in the case, your awareness date would be the date you became aware of the occurrence of the reported events. This awareness date represents the Pfizer receipt date of the report and reflects the earliest date that any Pfizer colleague learned of the adverse event. If you learned of these events from another Pfizer colleague, please provide the date that the first Pfizer colleague became aware of the events reported, as regulatory reporting due dates are calculated based on the first day that a Pfizer colleague became aware of the adverse events. Response received I first became aware of this event on 12May2021. Please let me know if you need anything else. The outcome for the events was recovering.
12 2021-06-30 headache, malaise PATIENT, WAS GIVEN THE 1ST DOSE OF PFIZER VACCINE. FEW MINUTES AFTER THE VACCINE PATIENT REPORTED FE... Read more
PATIENT, WAS GIVEN THE 1ST DOSE OF PFIZER VACCINE. FEW MINUTES AFTER THE VACCINE PATIENT REPORTED FEELING DIZZY, PATIENT STATED SHE DID NOT FEEL VERY WELL, AND PATIENT HAS REPORTED HISTORY OF FAINTING AFTER VACCINATION. PATIENT WAS ADVISED TO LAY ON THE GROUND FOR WHILE SHE FELT LITTLE BETTER. HOWEVER SHE STATED SHE FEELING DIZZY, HAS HEADACHE AND REPORTED TINGLE /NUMBNESS IN HER LEGS. AMBULANCE WAS CALLED AND TOOK THE PATIENT. I FOLLOWED UP WITH THE PATIENT,. PATIENT WAS IN OKAY CONDITION, I SPOKE TO THE PATIENTS FAMILY MEMBER THEY STATED THAT THE DOCTOR SAID PATIENT FELT DIZZY DUE TO VASOVAGAL SYNCOPE. NO OTHER SIDE EFFECT WAS REPORTED.
12 2021-06-30 headache, fever, chills asthma/hard time breathing; Fever; aches; chills; headache; asthma/hard time breathing; This is a sp... Read more
asthma/hard time breathing; Fever; aches; chills; headache; asthma/hard time breathing; This is a spontaneous report from a contactable consumer (Patient) or other non hcp. A 12-years-old non pregnant female patient received bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number EP6955), dose 2 via an unspecified route of administration, administered in Arm Left on 16Jun2021 16:00 as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included asthma. Concomitant medications included fluticasone propionate (FLOVENT); albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]) as needed and Multivitamin. No relevant past drug history. No other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient not tested for COVID-19. On 17Jun2021 morning the patient had Fever, aches, chills, headache, and asthma/hard time breathing. The outcome for all events was recovered on 19Jun2021. Follow-up attempts are possible. Further information is expected.
12 2021-06-30 malaise throwing up; white as a ghost; wasn't feeling good; This is a spontaneous report from a contactable ... Read more
throwing up; white as a ghost; wasn't feeling good; This is a spontaneous report from a contactable consumer (Mother of patient). A 12-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EW0196 and expiration date: not reported), via an unspecified route of administration, on Right Arm, on 12Jun2021 in the afternoon (at the age of 12-year-old), as DOSE 1, SINGLE for covid-19 immunization at . The patient had no medical history and there were no concomitant medications. There were no other previous immunizations. No other vaccines administered on same date. The patient didn't receive any other vaccines within 4 weeks prior to the COVID -19 vaccine. There were no adverse events following prior vaccinations. Reporter stated that, the patient has an elderly grandmother and patient wanted to go see her and every time they go see her, they have to get tested for COVID. On 22Jun2021 patient experienced, throwing up. The patient went and got the milk and came back and wasn't feeling good, she was as a ghost on 22Jun2021. The reporter stated that patient is okay now, at the time of reporting, and wanted to know if it was normal after taking the shot, if it was a side effect from the shot or not. No test was taken. The outcome of the events was recovered on 22Jun2021.
12 2021-06-30 fever, fatigue, headache, chills headache; threw up; shallow quick breathing; fever; Injection site sore arm 4 hours after vaccine gi... Read more
headache; threw up; shallow quick breathing; fever; Injection site sore arm 4 hours after vaccine given; very tire 10 hours after; chills; shallow quick breathing; heart racing; very uncomfortable; dry throat; arm extremely sore; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 12-year-old female patient (non-pregnant) received second dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EW0187), via an unspecified route of administration, administered in Left arm on 06Jun2021 at 09:00 AM (at the age of 12-year-old), as single dose for covid-19 immunization. The patient's medical history was none. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection; Expiry Date: unknown, Lot number: EW0180), via an unspecified route of administration on 25May2021, 09:00 AM administered in left arm as single dose for COVID-19 immunization. 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 and since the vaccination the patient was not tested for COVID 19. On 15Jun2021 at 13:00, the patient experienced injection site sore arm four hours after vaccination/ arm extremely sore; she was very tire 10 hours after chills; had fever; experienced shallow quick breathing, heart racing, dry throat; and she was very uncomfortable. On the same day, she fell asleep about 11:30pm and threw up at 3:00 AM. On 16Jun2021 (on next day), she had headache and still on day 3. Therapeutic measures were taken with Tylenol, cool compress, hydration as a result of reported events. The outcome of event was resolving. Follow-up attempts are needed. Further information is expected.
12 2021-06-30 fever Myocarditis. 1d after vaccine with fever, tachycardia, chest pain. Abnormal ekg, elevated troponin... Read more
Myocarditis. 1d after vaccine with fever, tachycardia, chest pain. Abnormal ekg, elevated troponin. Admitted
12 2021-07-01 chills, fever, headache Fever 99.5-101 degrees for 12 hours, body aches, chills, severe headaches
12 2021-07-01 headache, fever June 26th- started getting a painful vesicular rash on her left arm- finger- spread up arm to axilla... Read more
June 26th- started getting a painful vesicular rash on her left arm- finger- spread up arm to axilla and then to L scapular area. + axillary lymphadenopathy. + fever and headache started 6/30/2021. Had a Dr. visit 6/30/2021. Diagnosed with shingles and started on acyclovir. No other areas of rash. No other symptoms. Fever and headache resolved mid day 7/1/2021. Rash on L arm continues- painful. Also had + rapid strep test that office visit on 6/30/2021- no throat pain- but still placed on antibiotics for strep- penicillin.
12 2021-07-01 fever Lipschutz Ulcer High fevers
12 2021-07-01 respiratory tract congestion, runny nose, cough Pericarditis. Patient was admitted on Monday night 6/28/21 with chest pain for 2 days- constant, ... Read more
Pericarditis. Patient was admitted on Monday night 6/28/21 with chest pain for 2 days- constant, pleuritic chest pain that was worse when supine, better when sitting up. EKG with T-wave abnormality. She was admitted for suspected pericarditis by EKG and history of chest pain. Her troponin was negative x2, no evidence of myocarditis by ultrasound. No pericardial effusion. Started on colchicine and ibuprofen. She improved and discharged the next morning 6/29/21. Of note, she also developed congestion, runny nose and mild cough since Sunday night 6/27/21. No fever. Her 2 younger siblings who are in daycare were sick first with colds. Patient RV panel was +enterovirus/rhinovirus on 6/29/21. Therefore the differential diagnosis of her acute pericarditis was upper respiratory viral infection associated pericarditis Vs. COVID-19 Vaccine associated pericarditis given the timing of onset.
12 2021-07-02 fatigue, headache Received the 1st dose of Pfizer Covid vaccine on 6/15/21. Patient had a headache, pain in left arm a... Read more
Received the 1st dose of Pfizer Covid vaccine on 6/15/21. Patient had a headache, pain in left arm and felt tired. On 6/16/21 she woke up around 10:00am and said her legs felt numb or asleep from the ankle to mid thigh. I contacted the pediatrician office and they advised us to wait and see if she had any other additional symptoms or changes. Patient said she could feel the sensation of pressure but could not feel what was touching her. She went to her usual swim team practice and seemed to be just fine except for the strange loss of sensation in her leg.s. On 6/17/21 her symptoms were unchanged upon waking up. She attended running club practice from 9-10:30am, and when I picked her up she said that now her left arm was experiencing the same loss of feeling from shoulder to her wrist. I took her to the pediatrician office, where they advised me to take her to the emergency room for further evaluation. She was seen by two different doctors in the ER at Hospital, and no other tests were done at the time. The doctors advised us to keep monitoring her symptoms of loss of sensation and return if any other symptoms occurred. Since that time Patient has had some improvement in feeling but overall it has stayed the same. Doctors could not find any other possible causes for the symptoms either. They did recommend getting the 2nd dose but warned that the loss of sensation could get worse.
12 2021-07-02 headache, chills Vomiting, chills, headache, short of breath at 3:00 pm on 7/2/2021
12 2021-07-02 headache, fever Immediate excessive pain in right arm/ infection site, fever 12 hours after dose 2. Around 24 hours ... Read more
Immediate excessive pain in right arm/ infection site, fever 12 hours after dose 2. Around 24 hours post vaccination, Nieve fainted and hit her head. She did not have prior dizzy or fainting spells. The emergency room physician diagnosed her with vasovagal syncope- fainting: vagal reaction, possibly caused by the pain in her arm. As of 7/3/21, Nieve has not gained again but still feels lightheaded, dizzy, and headache.
12 2021-07-02 sweating 12 year old patient received 1st dose of Pfizer COVID Vaccine. After receiving the vaccine and waiti... Read more
12 year old patient received 1st dose of Pfizer COVID Vaccine. After receiving the vaccine and waiting the 15 minutes, the patient and her father left the pharmacy area and began to shop in the store. While walking the patient stated that her stomach was hurting and she felt her eyes "look up and then down" and then she started to fall. Her father was able to catch her before falling and carried her back towards the pharmacy area. Patient was able to walk before completely reaching the pharmacy area. Once she was in the pharmacy area, the pharmacist was about to administer another vaccine heard a member state that she would call 911 for the patient. After then the pharmacy went over to the patient and her father and noticed the patient was sweating and immediately gathered a cool compress and provided care to the patient. Patient stated that she received her shot on an empty stomach and the father went to get the patient food. EMT were called and arrived and asked patient a series of questions in which the patient was able to respond to. After about 30-45 minutes, patient had eaten and stated that she felt better and her and father left the pharmacy.
12 2021-07-02 fever Mild chest pain starting day after shot (w fever, swollen lymph nodes, muscle pains). Went to ER, t... Read more
Mild chest pain starting day after shot (w fever, swollen lymph nodes, muscle pains). Went to ER, told she was ok, then phone call next day telling us her ekg had abnormalities (borderline high qtc and other non-specific findings). Told to follow up w cardiologist. Went to cardiologist on 6/30, qtc had normalized but other non-specific ekg findings remained. Echo normal except for occasional extra heart beat. Told to avoid exercise, was given 24 hr heart monitor (we are still waiting on results), and come back for new ekg on 7/7/2021.
12 2021-07-03 fever, headache She got a fever, muscle aches, severe headache. Then she started getting small patches of a raised r... Read more
She got a fever, muscle aches, severe headache. Then she started getting small patches of a raised rash. It started near the injection site, then on her wrist (same arm) then on her chin, same left side. After a few more days she started getting them all over: legs, chest etc. They itch her like crazy and burn when she tries not to itch.
12 2021-07-04 headache Loss of sight and hearing, headache, generalized weakness. No shortness of air, patient hadn?t eaten... Read more
Loss of sight and hearing, headache, generalized weakness. No shortness of air, patient hadn?t eaten breakfast before the vaccine.
12 2021-07-06 headache, fever, chills, throat pain Meningitis pain; she woke up and said her face felt funny; pressure on her chest; pressure behind he... Read more
Meningitis pain; she woke up and said her face felt funny; pressure on her chest; pressure behind her eyes; muscle pain; she had not slept,; fever; headache; the chills; sore throat; nauseous; Caller states she was assuming hives; inflammation stayed around awhile; body aches / pain through her head and back down her neck; trying to push her eyeballs out and it is really painful; she was slumpy; swelling from the digging and scratching; her hands began to swell yesterday; she was just not feeling right; couldn't walk by herself; lip swelling and numbness; lip swelling and numbness; itching on face, hands and feet / Caller states then her daughters hands and feet began to itch; This is a spontaneous report from a contactable consumer or other non health care professional. A 12-years-old female patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection, Lot Number: EW0178; Expiration Date: 31Aug2021), dose 2 via an unspecified route of administration, administered in Arm Right on 08Jun2021 16:00 (age at vaccination: 12 years) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included, meningitis from an unknown date and unknown if ongoing at 7 years old. The patient's concomitant medications were not reported. The historical vaccine include COVID-19 Vaccine on 18May2021 for COVID-19 Immunization (1st dose Expiry Date of Covid 19 vaccine: 31Aug2021, lot EW0168 ,anatomical location: Right arm) and had she had itching on the hands. And other vaccine includes flu shots (she does the flu shot every year) for immunization. The patient experienced Meningitis pain on unspecified date, lip swelling and numbness, itching on face, hands and feet / caller states then her daughters hands and feet began to itch in Jun2021. She has pressure on her chest on 09Jun2021. She had pressure behind her eyes, muscle pain,she had not slept, fever, headache, the chills , sore throat, nauseous, caller states she was assuming hives, inflammation stayed around awhile , body aches / pain through her head and back down her neck, trying to push her eyeballs out and it is really painful , she was slumpy, swelling from the digging and scratching, her hands began to swell yesterday in Jun2021. she woke up and said her face felt funny on 09Jun202. she was just not feeling right and couldn't walk by herself on Jun2021, Caller relays her daughter will be (withheld) . HCP: Caller states she called the pediatrician office and 1 was by phone and she was seen by this provider yesterday and she encouraged her to reach out to us as well. Mom states she was aware of the possible symptoms to occur and her daughter came home Tuesday perfectly fine and went to bed and woke up with the typical symptoms, she had not slept, fever, headache, the chills, sore throat, nauseous and had all the symptoms pretty much. States she didn't have anything weird going on during the observation time the day of the vaccine. Caller relays her daughter didn't have anything weird after her 1st dose. Caller states she took a nap Wednesday about 24 hours after her 2nd dose and she woke up and her lips had begun to swell and she woke up and said her face felt funny and it was itchy. Caller states she was assuming hives. Caller states that there was nothing concerning as it wasn't in that initial 15minutes to 4 hour and that this occurs 24 hours after and that was a concern. Caller states then her daughters hands and feet began to itch and that was kind of along the same lines and said hives and she would itch itch itch and there was swelling from the digging and scratching. Caller states she has numbness in her lip with the swelling. Caller states the other symptoms that are bizarre is more yesterday and it started some on Wednesday she had a pressure in her chest and this was a child, her daughter was very strong, she got up yesterday and tried to do school and had a fever of 102 and Wednesday evening was so sick with symptoms and she still tried. Caller states the pressure in her chest is concerning and told them yesterday and she needed to be seen. States her daughter described it to the doctor that it felt like someone was sitting on her chest sort of pressure and on a scale of 1-10 she was a 7. Caller provides that not at any time did she experience trouble breathing and she never saw her lose or get weird coloring. Caller states she called her doctor Wednesday afternoon and talked to another doctor, that she called the help line after hours as they close 4:30 or 5pm. States she was told it was good news that she did not have trouble breathing but to have it at this point was weird and no one knows what to expect and everyone is different. States she was told to do Benadryl and continue with pain medication for fever and discomfort. Caller states her daughter was miserable the rest of the evening. Caller relays that the swelling subsided and the inflammation stayed around awhile and yesterday she woke up better with no nausea and the common symptoms are better and she still had the fever. Caller relays that at about 9:00 she began to have a problem where she said that behind her eyes she had significant pressure and that scared the caller what with the brain and swelling. Caller states her hands began to swell yesterday, like her lip and her fingers are itchy and swelling and it's constant itching and the pressure on her chest yesterday, that those 3 things freaked the caller out and she called the pediatrician and they said to have her checked out to make sure as nobody wanted to rush her to the ER as she was not struggling to breathe she was just not feeling right. Caller states the pediatrician did her research about heart inflammation and listened to her heart a couple of times and said her best observation for rubbing sounds was she did not hear any. Caller states when her daughter was younger she had meningitis and went through a whole lot with that and caller states she does not immediately rush to the hospital as that brings back emotions with that. Caller states the doctor said she didn't see any immediate distress and would do an EKG or they could wait and see, that she thought the pressure might be like body aches and her daughter had laid in bed all day the day before and had a time with it. Caller states she couldn't walk by herself and she was out of it. Caller states she could do the EKG or wait until today and they chose to wait. States that today she seems better and the only thing today is the continuing pressure behind her eyes that her daughter described as it felt like someone had 2 spoons and was trying to push her eyeballs out and it is really painful. Caller relays her daughter has been through meningitis pain and has pain through her head and back down her neck and the concern is swelling. Caller states it could be a weird reaction and the doctor thinks it is a weird headache she is having and is still doing ibuprofen. Caller relays that her chest is not nearly as heavy today and she has taken Benadryl again for itching and swelling. States the doctor says they don't know what did it because the risk was there and the benefit and don't want to get reactions. Caller states she had no problem with getting the shot, that weird things happen and the pediatrician is saying it can happen but doesn't know. States it is kind of scary. Caller states they checked her out and they checked her oxygen and blood pressure and that made the caller feel better. States that 9:30-10 last night after she got home she was slumpy and her head was hurting and she had chest pressure. Caller states with the hand swelling, that the caller herself went through reaction and hives and the doctor had asked if her daughter had anything new introduced and no nothing was and her daughter didn't seem concerned to share this but after her 1st dose her hands itched and she didn't pay it any mind. States she had no face swelling. Caller states she is wondering if those little hand itches after the 1st dose she didn't tell about till now was that a little bit of a sign that something else was there. States she didn't mention it after the 1st dose and was good to go. States after the 2nd dose she said mommy my hands itched after the 1st dose, her lip didn't swell and she told the doctor it's not conditions on the list of symptoms and she didn't have breathing issues. Caller states it's a non severe reaction and is assuming to dose and said yesterday if she gets a booster what does Pfizer advise. Caller states they have all intention of getting what she needs in the future. Caller states she wants to make sure she doesn't have worse and the lip swelling was freaky. Caller states she thought her daughter was out of the woods after the 20 minutes waiting and was home and then turned. Caller states it was pretty straight forward and knew what the expected symptoms were and they were fine and knew she was having the exact ones on the list and was not feeling well and had a fever. States she was thrown for a loop when others came up and the fact that they were 24 hours out, that she got the 2nd dose 4-4:15 on Tuesday and these evolved well after that time. Caller said they said to report this and her hope is that they can help if someone else has this issue. States when she said she was laying there my hands did itch after the 1st but not like this to this degree. States she never said anything and caller didn't know. States she knows as a parent there are certain questions to ask and warning signs of potential allergic reactions. Caller states she is assuming this is some sort of allergic reaction, not the worst kind but pressure in the chest and other concerns about her heart having some sort of issue she knows have been reported.Caller states that today she could have done the EKG for more information but based on her listening and what she wanted to thinking the body aches and extensive issues with that she is glad she waited. States she was laying in bed at 6:30 and asked her if she wanted to get the EKG and she said she was afraid of going to the hospital and it's not fun but would give answers if there is something else and she laid in bed until 9:30-10 and gave her more Benadryl and Ibuprofen and continued with that for the discomfort behind her eyes and the doctor is thinking it's body aches. States the fever subsided yesterday.Caller states she would like to share that her daughter is a tough kid and tough kids can be taken down too and may not pay attention. Caller states she doesn't over react but she is aware and if she had told her about her hands she would have thought allergic reaction, mild one and brought her to the doctor or at the 2nd vaccine and she didn't say anything until after the fact. Caller relays her daughter has never been through hives and the caller has and has a lot of seasonal and environmental allergies and the caller was that kid. Caller states with her daughter not having seen her lip swell and her eyes started hurting and she started thinking the worst. States the doctor pushed on her and checked her lymph nodes and did a thorough exam that lasted about 30 minutes and nobody knows. States she appreciates all that Pfizer and the other companies have done, that we need this.Caller states her daughter goes to the pediatrician in 2 weeks for her annual check up. States the doctor yesterday said her body responded and had a hard time with it. States she does the flu shot every year and this was weird and she wanted us to know and hopes this report can help. Caller states her daughter is a tough kid nobody knows and today she is better, she has a headache behind her eyes still there.Caller relays that Friday she had her annual eye check up and it's not a vision thing, that was fine until Wednesday and other other stuff and yesterday with pressure and she is sure it's residual and her body adjusting and if she can help with letting other people know.Caller relays if it comes back she is going to do the EKG, that she is not the parent to say it is nothing and will follow through with Pfizer also. Caller states she didn't have anything weird for heart beat and no rubbing sound and no signs and she thinks it was issues from body aches and hopefully she is on the up and up and nobody will have to leave and go to the doctor today. And didn't think because it was not an immediate issue with her breathing and nothing like that and didn't think it would be an issue with a booster. Caller states it could be that instead of sitting for 20 minutes they keep her longer and that when she fills out the sheet if was not an option, she knows there is severe reaction listed, she will make notes and make the person giving the dose aware that she had the delayed what they are believing to be allergic reaction and make sure, that she may never have it again and it could have been her system was so under attack. Caller states she doesn't understand vaccines and knows it's the body's job to do something and she is not reluctant helping her be immune and she understands what to do in the event and doesn't have an epi pen and her daughter has no allergies and no reactions to anything. Caller states she didn't have the worry, that there is always a chance and you worry when something foreign goes in the body that there is a chance to react. Investigations: Caller states they listened to her heart and took her vitals and tests with her fingers checking her eyes to make sure her pupils were dilating correctly and move her eyes with a moving finger. Caller states she doesn't know the medical term but the basics and let them know she was not in dire straights to rush to the hospital immediately. The patient underwent lab tests and procedures which included blood pressure measurement, body temperature: 102 fahrenheit, electrocardiogram, oxygen saturation, vital signs measurement was unknown and unspecified date. Therapeutic measures were taken as a result of lip swelling and numbness, itching on face, hands and feet / caller states then her daughters hands and feet began to itch, pressure on her chest , fever, swelling from the digging and scratching. The outcome of the events was unknown.
12 2021-07-06 fever, headache, fatigue, sleepiness Fever, fatigue, headache, sleepiness, chest pain, and. pain during days 1-4 , after that she was not... Read more
Fever, fatigue, headache, sleepiness, chest pain, and. pain during days 1-4 , after that she was not herself. She had taken 9 tylenol and did not want to live anymore. She is admitted to hospital at this time.
12 2021-07-08 headache, fever Patient received her second Covid immunization on 6/27. On 6/28, she developed fever, myalgias, hea... Read more
Patient received her second Covid immunization on 6/27. On 6/28, she developed fever, myalgias, headache, and vulvar pain. On 6/30, she was diagnosed with acute vulvitis, which evolved by 7/2 to acute genital ulcers.
12 2021-07-08 fever Ruptured Ovarian Cyst, abdominal pain, fever on 6/29/2021
12 2021-07-09 headache Patient got her 2nd covid19 vaccine on July 2nd. starting from July 7th, after eating methimazole, s... Read more
Patient got her 2nd covid19 vaccine on July 2nd. starting from July 7th, after eating methimazole, she feel headache, nausea, want to vomit, but can't spit it out. she is lack of energy. she take methimazole for more than 2 years, never has this symptom before. all abnormal happened 1 week after her 2nd covid19 vaccine. I am worried about her.
12 2021-07-09 sweating, lethargy, fatigue Systemic: Abdominal Pain-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / ... Read more
Systemic: Abdominal Pain-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Severe, Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Systemic: Weakness-Medium, Additional Details: Patient's original BP was 91/57 and second reading was 92/72. She fainted for less than a minute and regained consciousness. She suffered from severe nausea/abdominal pain and vomited. Patient was given water and felt much better after throwing up. She also complained of feeling tired.
12 2021-07-13 sweating Vasovagal reaction to vaccine, dizziness, diaphoresis, pale. Had client lie down and raised legs. ... Read more
Vasovagal reaction to vaccine, dizziness, diaphoresis, pale. Had client lie down and raised legs. Lasted 4-5 minutes. Completely recovered
12 2021-07-14 headache Polyneuropathy in bilateral legs, headache, and weakness 24 hours after first dose of Pfizer with wo... Read more
Polyneuropathy in bilateral legs, headache, and weakness 24 hours after first dose of Pfizer with worsening over subsequent 48 hours - currently being admitted to hospital for evaluation.
12 2021-07-15 dehydration Approximately 3 days after the vaccine started with abd pain and vomiting, this lead to dehydration ... Read more
Approximately 3 days after the vaccine started with abd pain and vomiting, this lead to dehydration and hospitalization
12 2021-07-15 malaise Parent informed us that patient did not feel well via phone and will be taken to urgent care, but di... Read more
Parent informed us that patient did not feel well via phone and will be taken to urgent care, but did not specify symptoms
12 2021-07-16 influenza like illness Flu like symptoms
12 2021-07-17 headache, malaise, fatigue began seeing a scary image of a very distorted, grotesque person; pain in her arm; malaise; nausea; ... Read more
began seeing a scary image of a very distorted, grotesque person; pain in her arm; malaise; nausea; headache; fatigue; She is afraid to walk alone in the hallway. She has this fear that someone is gong to jump off and attack her; This is a spontaneous report from a contactable consumer. This consumer (patient's mother) reported for a 12-year-old female patient (reporter's daughter) that: A 12-years-old female patient received first dose of bnt162b2 (Solution injection; Batch/Lot Number: EW0181; Expiration Date: Aug2021), via an unspecified route of administration, administered in Arm Right on 18Jun2021 at 09:15 as single dose (at the age of 12-years-old) for covid-19 immunisation. Medical history included PFAPA syndrome, fever, and redness at the injection site. The patient's concomitant medications were not reported. Patient did not take any prior vaccinations within 4 weeks. On 18Jun2021, in the evening, patient had pain in arm, nausea, headache, fatigue and malaise. Reporter stated that, three days after receiving the vaccine, her daughter began seeing a scary image of a very distorted, grotesque person. She was afraid to walk alone in the hallway even during the day. Caller reported that it has gotten better, at least during the day. Caller reported that the patient doesn't tell her about the image, but the patient knows it's not real and not there. Caller reported that the patient says that she cannot shake this feeling of fear that something is going to jump out at her or attack her. Caller reported that the patient's feeling of fear comes and goes. Caller reported that what has gotten better it seems is during the day. Caller reported that the patient said that when she is busy or distracted, she doesn't think about it, but if the patient has more time on her hands she starts to go there. Caller reported that the patient is having kind of like this feeling, not necessarily paranoia, but a feeling like something is going to happen or jump out at her and she can't shake it. Caller reported that the patient knows that it is not real and not there. Caller reported that the patient received the Covid-19 vaccine because of school as they are not going to have a virtual option, as well as just to be safe and be able to travel. Caller reported that on night of 30Jun2021 was a little better but was a little worse at night on 01Jul2021. Caller reported that the patient was home schooled and was fully fine. Caller reported that the patient's grades were excellent and that she was happy to be home but missed her friends. Caller reported that this was very bizarre to her and that the patient's pediatrician advised the caller to call Pfizer and not to give the patient the second dose of the Covid-19 vaccine. Caller reported that although the patient's physician hadn't heard anything, she wanted to ask if Pfizer had heard anything. Caller stated that she reported the event to VAERS as well and made a submission. Caller stated that she does not know if Pfizer can give her that information or not but she just didn't know if this is something Pfizer has seen. On 19Jun2021, pain in arm, fatigue, nausea, headache and malaise was resolved. The outcome of She is afraid to walk alone in the hallway. She has this fear that someone is going to jump off and attack her and began seeing a scary image of a very distorted, grotesque person was unknown. Follow up attempts are needed. Further information has been requested.
12 2021-07-17 headache, fever in a lot of pain; Fever; Vomiting; Severe headache, very bad headache; This is a spontaneous report ... Read more
in a lot of pain; Fever; Vomiting; Severe headache, very bad headache; This is a spontaneous report from a contactable consumer (parent). A 12-years-old female patient (reporter's daughter) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and lot number and expiration date were unknown), dose 2 via an unspecified route of administration on 02Jul2021 02:30 (age at vaccination: 12-years-old) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 02Jul2021 at 02:30, the reporter's daughter just got her second dose of vaccine for the Covid-19 and at 03:00 in the morning, she started with the side effects which included fever since then, vomiting and severe headache, very bad headache. At 04:00 in the morning, the reporter further stated that She was in a lot of pain, her headache was killer her. The reporter thought that going to take her to the (unspecified, which was not clear) because she can't take the pain anymore. The outcome of the events was unknown. Follow-up attempts are needed; information about lot/batch number has been requested.
12 2021-07-18 headache Patient is a 12-year-old female who presents with rash, back pain, and pain with deep breaths follow... Read more
Patient is a 12-year-old female who presents with rash, back pain, and pain with deep breaths following her COVID-19 shot today. Patient has a history of having COVID-19 in September 2020. Mom states she is a long-haul her and has had migraines and developed POTS following having COVID-19. She is currently in enrolled in a study and has been seen and followed up there for the symptoms. It was recommended that she obtain a COVID-19 vaccine. Today she got her second vaccine and within 10 minutes she began having headache and then developed a generalized red rash with facial swelling about an hour later. Mom gave 25 mg of Benadryl and rash seemed to improve. Patient was complaining of pain to her mid back. She stated she had worsening pain when she took a deep breath. She denies any frontal chest pain. No shortness of breath. She did not take any Motrin or Tylenol at home. Mom states she also got a rash with COVID-19 shot. Patient denies any vomiting. No diarrhea. No cough. No difficulty breathing just pain when she takes a deep breath. No drooling. No difficulty swallowing.
12 2021-07-19 chills Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-M... Read more
Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Nausea-Mild, Additional Details: Pt was sitting down during 15 minute post vaccination on a chair when she began to slide out of it. Her grandfather called to us and helped her sit upright. She said all of a sudden she felt really lightheaded and nauseous and then she woke up in her grandfather's arms. her face was pale. she stated she had been "nervous" about getting her shot. after drinking some water and eating a piece of candy, patient regained color in her face and was able to walk out of the store normally.
12 2021-07-19 sweating Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Systemic... Read more
Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Mild, Additional Details: Rph gave first pfizer covid vaccine to patient and she felt nauseaus within a couple of minutes. Mother reports daughter lighter in color and needed a bag in case she needed to vomit. PT's mother declined to be brought into ER because daughter (patient) appeared to have recovered. Instructed by parametics to f/u with primary doctory.
12 2021-07-19 fever, fatigue Vaccine dilution error. The Pfizer vaccine was diluted with 1.5ml of the diluent NaCl 0.9% instead ... Read more
Vaccine dilution error. The Pfizer vaccine was diluted with 1.5ml of the diluent NaCl 0.9% instead of the recommended 1.8ml. The 0.3ml dose was given with this slightly higher concentration of vaccine. On 7/20/21, Leta's father reported that she felt tired and had a mild fever.
12 2021-07-20 chills, lethargy, sweating, fatigue Systemic: Chills-Mild, Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushed / Sweating-Medium, ... Read more
Systemic: Chills-Mild, Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Medium
12 2021-07-21 sweating Approximately 45 seconds after vaccination, patient began drooling and became diaphoretic, pale, an... Read more
Approximately 45 seconds after vaccination, patient began drooling and became diaphoretic, pale, and non-responsive, although she remained conscious. The patient's mother thought patient looked "blue." A Health Department nurse administered one EpiPen while another staff member called 911. Patient stopped drooling, regained normal color in her face, and began smiling almost immediately after epinephrine was administered. Nurse then took and recorded patient's blood pressure as 92/62, pulse as 64bpm, and respiratory rate as 24. Paramedics arrived approximately five minutes later and evaluated patient, who seemed to have returned to normal. Patient and her mother declined to have the patient transported to the hospital via ambulance for further observation. Patient was then driven home by her mother. Deputy COVID Operations Chief spoke with patient's mother over the phone around 6:30PM that same day to follow up with the patient. Patient's mother reported that the patient had returned to her normal self, had not experienced any further adverse events, and wished to move on from the incident.
12 2021-07-22 fever Had routine reaction immediately post vaccine (pain, redness, nausea, muscle aches, fever, etc) that... Read more
Had routine reaction immediately post vaccine (pain, redness, nausea, muscle aches, fever, etc) that recovered. Then, on 7/12/21, she started to experience pain, redness, and some swelling again but this time there was some pain on the right side as well. Pain originating from deltoid and radiating through arms and shoulders. On 7/16/21 the pain was worsening and she was no longer able to perform daily activities as well as would cry if her arms were even slightly touched. she was referred to the Urgent Care who did testing for illness and muscle conditions which came back normal. She was screaming through trying to get bloodwork due to the pain which is atypical for her and they sent us to the ER for pain with unknown origin. ER physician said all neurological processes were normal and was concerned for Complex Regional Pain Syndrome so he wanted an urgent follow-up with Primary Care. on 7/19/21 Primary Care suggested delayed response to the vaccine and referred her to Neurology. On 7/22/21 Neurology decided it was a delayed immune response to the Covid vaccine and prescribed Prednisone to start today 7/23/21.
12 2021-07-23 fatigue, fever, headache Prior to vaccine with a few weeks of weight loss, fatigue, and mild cough. Two days after vaccinatio... Read more
Prior to vaccine with a few weeks of weight loss, fatigue, and mild cough. Two days after vaccination with headache, self resolved. Then around 7/17 she developed tactile fevers, increasing fatigue, and headache. On 7/20 PM she had acute onset of altered mental status- she was screaming and disoriented. She was taken to the Hospital emergency department on 7/21 AM. Work up initially concerning for ADEM, although subsequent imaging consistent with miliary TB with CNS disease (tuberculomas). Patient was exposed to grandmother with MDR pulmonary TB in 2018. Patient was prescribed treatment for LTBI (QuantGold pos but negative CXR) but unclear if she took it. Currently started on therapy for MDR TB and remains hospitalized.
12 2021-07-23 headache, fever 1 day after receiving the COVID #2 vaccine, felt dizzy, body weakness, pain in stomach and head, fev... Read more
1 day after receiving the COVID #2 vaccine, felt dizzy, body weakness, pain in stomach and head, fever (tactile), 1x vomit - food contents, blood pressure low (unable to recall).
12 2021-07-24 fever, chills High fever that lasted two days (even with acetaminophen and ibuprofen), extreme chills with uncontr... Read more
High fever that lasted two days (even with acetaminophen and ibuprofen), extreme chills with uncontrollable shaking, face and neck rash.
12 2021-07-24 fever Lt arm pain same day. Next morning fever 102.6 and nausea, worsening arm pain.
12 2021-07-25 sweating Patient received vaccine at 17:00. At 17:04, she complained of nausea, of feeling 'hot" and had noti... Read more
Patient received vaccine at 17:00. At 17:04, she complained of nausea, of feeling 'hot" and had noticeable diaphoresis. At 17:06, patient started having emesis X 4. We placed cold packs on her neck, directed several floor fans toward her chair, offered her cold water and reassured her. At 17:20, patient was no longer diaphoretic and she said her stomach "felt better.' At 17:28, patient denied having any more symptoms. She felt better and wanted to go home with her mother who was with her. She had no dizziness upon standing and walked out of vaccination clinic on her own.
12 2021-07-25 malaise 12 year old daughter a few minutes after vaccine, says she didn't feel well and eyes closed and she ... Read more
12 year old daughter a few minutes after vaccine, says she didn't feel well and eyes closed and she dropped. I quickly grabbed and held her as she would have hit her head from passing out. The paramedics came and she lost 20 points of blood pressure and then ambulance took her to the hospital where she was released.
12 2021-07-26 fever Fever onset day after second vaccine dose, associated with gross hematuria, proteinuria and rhabdomy... Read more
Fever onset day after second vaccine dose, associated with gross hematuria, proteinuria and rhabdomyolysis (metabolic crisis due to Very long chain acyl carnitine dehydrogenase deficiency VLCAD). Admitted to the Hospital on 6/12 with hypertension and elevated creatinine. Renal biopsy c/w IgA nephropathy. She was discharged on 6/23 on prednisone 60 mg daily with plan for slow taper. Acute kidney injury, proteinuria, rhabdomyolysis and hypertension improved at discharge. She had 2 additional admissions for elevated CK on 6/29 and 7/6. CK improved with IV hydration and glucose, and both admissions were <48 hours. Of note, patient had transient episode of gross hematuria in 1/21. Creatinine normal, BP normal. Proteinuria and hematuria resolved spontaneously on repeat testing of urine 3 weeks later. Also of note, patient had multiple episodes of rhabdomyolysis as young child due to VLCAD, with most recent episode in 2016. Trigger was viral illness or fasting. Previous episodes had higher max CK >20,000, no prior history of acute kidney injury during these episodes.
12 2021-07-27 chills, headache Chills; Vomiting; Headache; Nausea and stomach cramps; Nausea and stomach cramps; Sore arm at the va... Read more
Chills; Vomiting; Headache; Nausea and stomach cramps; Nausea and stomach cramps; Sore arm at the vaccination site that was also a little bit warm; Sore arm at the vaccination site that was also a little bit warm; This is a spontaneous report from a contactable physician (parent). A 12-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration in Arm left on 19May2021 16:00 or around 15:15 pm (Batch/Lot Number: EW0185, Expiry date: unknown, Age at the vaccination: 12-years) as single for covid-19 immunization. Medical history included ongoing allergies, seasonal and environmental. Concomitant medications included fexofenadine hydrochloride (ALLEGRA) (she had been taking for a while), pseudoephedrine hydrochloride (SUDAFED 12 HOUR) (she only took it once) taken for hypersensitivity, ibuprofen (ADVIL 12 HOUR) (she had taken it here and there once or twice, not all the time) taken for an unspecified indication, fluticasone furoate (FLONASE SENSIMIST ALLERGY RELIEF) (she did not take it the day of the shot, but she took it the entire week prior) taken for hypersensitivity, seasonal allergy and azelastine (she was supposed to do one pump of spray twice daily per nostril) taken for an unspecified indication, start and stop dates were not reported. History of all previous immunization with the Pfizer vaccine considered as suspect was mentioned, additional vaccines administered on same date of the Pfizer suspect if applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect and prior vaccinations (within 4 weeks) if applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine was mentioned as none. When she was young, she had a fever after one of her shots. It was a high fever, only once. The reporter stated that his daughter got the vaccine on Wednesday in the afternoon at 4 pm, or around 3:15 pm. She was 12 years old. She had not been feeling well since then. On 19May2021, the patient had sore arm at the vaccine site that was a little bit warm, it was a little bit warm all day yesterday. It was still a little sore but maybe a little better. Left arm. It was quick it happened after the injection. On 20May2021, he stated that his daughter had chills started last night, Thursday night it was about the same, and just a lot of nausea and vomiting during the day along with stomach cramps. And now, it was Friday. She vomited like a dozen times and it was still going on. She had headache all day yesterday, it was better today. Relevant tests reported as none. Treatment in regard to the events was Advil for the headache, Pepto for the stomach, Pepcid for stomach discomfort, Benadryl to sleep, and rest. The outcome of event headache was recovered, vaccination site warmth and vaccination site discomfort were recovering, and other events was not recovered. Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
12 2021-07-27 lethargy Within 5 minutes of vaccine administration patient complained about feeling dizzy. Patient became pa... Read more
Within 5 minutes of vaccine administration patient complained about feeling dizzy. Patient became pale, appeared lethargic, felt clammy, dizziness, weakness, and threw up 3 times immediately. Patient was sitting in the chair, ice pack was applied to her neck and head, legs were elevated with a chair. Patient's blood pressure was taken after vomiting and was 60s/40s. Patient continued with the symptoms noted previously. Nurse assessed patient and administered Epipen 0.30mg. Blood pressure was taken again, 100/60, 911 was called and patient was taken to near by hospital, guardian left to meet at the hospital.
12 2021-07-27 malaise Chest pain; Not feeling well; This is a spontaneous report from a contactable consumer or other non ... Read more
Chest pain; Not feeling well; This is a spontaneous report from a contactable consumer or other non hcp. The consumer (mother) reported for (daughter) that 12-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported), dose 2 via an unspecified route of administration on 22Jun2021 as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route of administration on 01Jun2021 (Batch/Lot number: Not reported) as dose 1, single for covid-19 immunization. On an unknown date, the patient experienced chest pain and not feeling well. It was reported that caller was calling now on behalf of her daughter, she is 12 years old. She had her first dose Pfizer COVID 19 Vaccine 01Jun2021, second dose is 22Jun2021, that is yesterday. After having the second dose of Pfizer Covid 19 Vaccine she was experiencing chest pain and she was complaining about it. The clinical outcome of both events was unknown. Information regarding the lot/batch number has been requested.
12 2021-07-27 fever 24 hours after receiving the vaccine, my daughter experienced chest pain. Per the recommendation of ... Read more
24 hours after receiving the vaccine, my daughter experienced chest pain. Per the recommendation of her doctor, we took her to the ER. She had a rash on her back and chest. After 48 hours, a low-grade fever of 101 (lasted 1 day) and a swollen lymph node on her right armpit.
13 2021-01-05 fever, throat pain, chills, fatigue Late at night patient began having chills and extreme muscle pain all over her body, sore throat, na... Read more
Late at night patient began having chills and extreme muscle pain all over her body, sore throat, nausea, extreme fatigue. She also had a fever of 102.
13 2021-05-12 sweating Anxious, Pale, sweaty Seen by onsite EMTs. Discharged home with father on 5/13/2021 at 12:45 PM.
13 2021-05-13 cough Patient began coughing uncontrollably several hours after administration. Required ED visit for asth... Read more
Patient began coughing uncontrollably several hours after administration. Required ED visit for asthma treatment, but did not respond predictably to therapy. Did eventually get better after many hours.
13 2021-05-13 sweating Pt had a vasovagal reaction after receiving the first dose of the Pfizer vaccine. Pt was transported... Read more
Pt had a vasovagal reaction after receiving the first dose of the Pfizer vaccine. Pt was transported by wheelchair to a cot and assessed by the site paramedic. Pt reports feeling much better after eating crackers. 1448 Vitals: BP 108/64, HR 74, O2sat 99%, RR 18 Sx: pale/moist skin, re-assed 5mins later and found to be warm, dry PMH: Asthma Medications: Albuterol prn, Xyzal prn Allergies: Penicillin
13 2021-05-14 fatigue, lethargy, sweating Systemic: Body Aches Generalized-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lighthead... Read more
Systemic: Body Aches Generalized-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Additional Details: CALLED 911. AMR MONITORED PT FOR 30 TO 40 MINS AND RELEASED HER TO GO HOME AFTER THEY DID TALK TO HER MOM.
13 2021-05-14 headache PATIENT REPORT ANXIETY, DIZZINESS, HEADACHE. NO SHORTNESS OF BREATH. SYMPTOM START AS THE PT PULLE... Read more
PATIENT REPORT ANXIETY, DIZZINESS, HEADACHE. NO SHORTNESS OF BREATH. SYMPTOM START AS THE PT PULLED UP TO OBSERVATION PT APPEARED PALE. VS ; HR 65 O2 SAT 97% PT INSTRUCTED TO HYDDRATE AND LIE DOWN IN CAR PT STARTED FEELING BETTER AFTER ABOUT 5 MINS PT LEFT SITE FEELING WELL
13 2021-05-14 sweating Pt presented pale, diaphoretic, with cold clammy skin @ 12:18 PM, approx. 3 minutes after receiving ... Read more
Pt presented pale, diaphoretic, with cold clammy skin @ 12:18 PM, approx. 3 minutes after receiving her first Pfizer dose. Pt positioned changed to supine with her feet elevated. Vitals @ 12:18 are: BP: 90/67 P: 85 RR: 17 O2: 100% T: 97.3. At 12:21 Pt reported feeling better and no longer presented with any previously mentioned symptoms. Pt vitals @ 12:21 are: BP: 129/67 P: 97 RR: 20 O2: 100% T: 97.1. Pt remained in supine positioned and RN continued to monitor. At 12:36 pt position changed to sitting up, water was given upon pt request. Last set of vitals before discharge at 12:45 are BP: 113/67 P: 74 RR: 20 O2: 98% T: 98. Pt was discharged with her mom.
13 2021-05-14 sweating Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypervent... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Mild
13 2021-05-14 sweating Pt reports dizziness,sweating, Pt was transported to the clinic VS; BP 71/51 PULSE 78 O2 SAT 94% TEM... Read more
Pt reports dizziness,sweating, Pt was transported to the clinic VS; BP 71/51 PULSE 78 O2 SAT 94% TEMP 98.5 Pt laid down, leg raised and water was offered. VITAL became better VS; BP 101/65 O2 SAT 97%
13 2021-05-14 fever After the 1st dose, my child experienced Fever 102; chills, light-head ness; body aches
13 2021-05-15 headache PT REPORTED BEING DIZZY AND A HEADACHE. PATIENT REPORTED BEING NERVOUS BP: 140/80 HR:75 02:98
13 2021-05-15 headache pt experienced headache 3 minutes post vaccine. patient was given ice pack and had sit for 30 minute... Read more
pt experienced headache 3 minutes post vaccine. patient was given ice pack and had sit for 30 minutes, left feeling better
13 2021-05-15 headache client had syncope episode after receiving 1st dose Pfizer Covid Vaccine. Client received vaccine at... Read more
client had syncope episode after receiving 1st dose Pfizer Covid Vaccine. Client received vaccine at 1336 and was standing next to vaccine station and Father as sibling was receiving vaccine. Within 3 minutes of standing client had syncope episode and hit back of head on floor. RNs responded. PHN called 911 at 1340. Per RN client collapsed and hit back of head, Father tried to hold on but was unsuccessful. As PHN was speaking with paramedics, client regained consciousness. Client stated she remembered feeling dizzy and then woke up on the floor. Client alert and oriented, pale and stated blurry vision. RN elevated legs. Vitals: blood pressure 130/90, pulse 102, oxygen 99%. Father denied any relevant medical history, medications, allergies or history of syncope. Client stated feeling dizzy, denied pain on head or rest of body. Paramedics arrived approximately 1346 and assumed care. After assessment Father signed AMA with paramedics. Client sat in anti gravity chair after paramedics left. EMT stayed with client. Vitals at 1412: blood pressure 120/80, pulse 85, oxygen 96%. Client stated feeling dizzy and head hurts when she moves. Blurry vision resolved. PHN spoke with parents to review ER precautions and advised to make follow up appointment with primary doctor. After sibling was done with observation, client left facility at 1425 with steady gait.
13 2021-05-15 throat pain, fatigue Tired, minor sore throat, soreness at injection site (upper left arm)
13 2021-05-16 fatigue, headache HA vomiting Weakness Fatigue Injection site pain
13 2021-05-16 headache Fainted within minutes, hot. dizzy. Lasted approximately 15 minutes. Headache appeared about 8 hour... Read more
Fainted within minutes, hot. dizzy. Lasted approximately 15 minutes. Headache appeared about 8 hours later and soreness.
13 2021-05-16 headache After observation time was up, customer's mother asked for her to sit up to see how she was feeling.... Read more
After observation time was up, customer's mother asked for her to sit up to see how she was feeling. After customer sat up she got an instant headache. Code Red was called and EMS and nurse responded to call. BP 123/80, HR 81, O2 99%, 37.2 (Centigrade). Patient still had headache but stated she will be fine.
13 2021-05-16 sweating 10 minutes after her first dose she had been sitting in a chair & developed diaphoresis, warm skin, ... Read more
10 minutes after her first dose she had been sitting in a chair & developed diaphoresis, warm skin, loss of vision,& low blood pressure. Pt was initially not responsive, when transferred to a wheel chair to take her to a gurney, left arm & left leg jerk twice. Took her to lay down and check her blood pressure. En route, in the wheel chair within about 5 to 10 seconds, she became responsive and said she could not see. Her vision returned to normal within a minute. Her initial blood pressure was 97/64 with O2 Sat 100% on room air. Her skin temp was 95.5, and her HR was 95. She continued to be responsive with excellent oxygenation and When the EMTs arrived she had a blood sugar of 90 and improving blood pressure with a regular rate and rhythm. Her diaphoresis resolved, and she continued to improve, tolerating water. Had similar reaction last year to flu shot, no hx of seizures
13 2021-05-16 fever, chills, headache Pharmacist gave my daughter all six doses. She used an undiluted bottle and shot her full of it. Sh... Read more
Pharmacist gave my daughter all six doses. She used an undiluted bottle and shot her full of it. She has fever chills aches headaches green poop nausea
13 2021-05-16 fever, fatigue Patient is running 100 degree fever, feeling very disoriented and tired
13 2021-05-16 throat irritation Parent mother reported to staff, patient experiencing throat tingling, itchiness and mild SOB while ... Read more
Parent mother reported to staff, patient experiencing throat tingling, itchiness and mild SOB while in the observation area around 0909. Per patient symptoms started approx 15-20 post vaccine administration. Patient was brought back to triage area. 0910: VS BP 110/80, HR 63, Temporal temp 98.3 F, 100% RA. Monitoring continued, MD and mother at bedside. Patient given benadryl 25mg per MD order and water. Patient reported symptoms improved after medication administration. 0920: Vitals BP 111/74 HR 57 Temporal temp 98F, 98% RA. Per patient SOB resolved. Throat itchiness and tingling improving. Leader discussed with mother regarding second dose. MD continued to monitor and patient discharged from triage at 0940 with mother per MD.
13 2021-05-17 fatigue c/o of fatigue after vaccine. symptoms was resolved and pt. went home.
13 2021-05-17 headache, fatigue headache and fatigue
13 2021-05-17 headache Pt had been required to wait for 30 mins due to hx of allergy. Pt reported numbness in L upper arm t... Read more
Pt had been required to wait for 30 mins due to hx of allergy. Pt reported numbness in L upper arm that radiated to the neck and a headache. Vitals were normal and pt denied any other symptoms such as SOB, itching or swelling. Advised pt to wait longer till numbness resolved and to take tylenol or ibuprofen for headache. Numbness did resolve soon after and pt felt well enough to go home. Advised to go to walk in clinic if it did not fully resolve by tomorrow.
13 2021-05-17 headache @3:52pm pt c/o headache, dizziness and nausea. Pt. placed in gurney to restwith HOB elevated. V/S mo... Read more
@3:52pm pt c/o headache, dizziness and nausea. Pt. placed in gurney to restwith HOB elevated. V/S monitored. Vitals: 102/63 BP, P-62, RR-17, o2 - 98% RA Patient had sips of water with relief of nausea noted. Vitals monitored @4:18pm vitals BP: 100/70 , P-73, RR-17, o2 -99% RA @4:20pm - pt. verbalized recovered from symptoms. Pt. sent home. Advised to notify primary MD of recent COVID-19 S/E. #21: pt. stable and sent home
13 2021-05-17 sweating, malaise Patient came to the pharmacy to receive 1st dose of the Pfizer covid vaccine. About 5 minutes later ... Read more
Patient came to the pharmacy to receive 1st dose of the Pfizer covid vaccine. About 5 minutes later patient felt unwell. According to her mom she passed out for about 5 seconds then jerked up and passed out again for a few seconds and woke up. Mom was unsure but thought it looked like a mini seizure. Both pharmacist was informed and checked on patient. Patient was hot and sweating but breathing was fine. Patient was coherent and could talk. Patient was given water. Blood pressure check was 102/69. Patient remained sitting with head over legs as that made her feel better. EMT arrived at the scene and took patient away on a stretcher for further observation.
13 2021-05-17 malaise Patients is a 13 year old girl who came into facility to receive her Pfizer vaccine. She was nervous... Read more
Patients is a 13 year old girl who came into facility to receive her Pfizer vaccine. She was nervous upon receiving her vaccine and after the shot was administered she stated she feels a little warm. The vaccinating pharmacist told her to sit and wait in the sitting area for 15 minutes after receiving the vaccine. A couple minutes after her vaccine was administered the girl started not feeling well and fainted in the store and her father caught her. We immediately called 911 and checked in with the young girl. The ambulance came and did a physical exam. They offered to take her to the hospital but the patient declined. Patient left the store shortly after with her father.
13 2021-05-18 headache Patient developed changes in her vision that she reported as black dots on the left side of her visi... Read more
Patient developed changes in her vision that she reported as black dots on the left side of her vision that lasted roughly 2 minutes. She said she could not see out to the left side of her eye. This went away after 2 minutes and within 20-30 minutes she developed a severe headache and was in tears from the pain. She has no history of headaches and this has never happened before. She did not report light or sound sensitivity. She did not have any vomiting, but did not want to eat. We consulted her Optometrist and Pediatrician. I gave her Naproxen and caffeine and within 3 hours her headache resolved.
13 2021-05-18 headache On 5/19/2021 client received her first dose of the Pfizer Covid-19 Vaccine (lot #EW0185, expiration ... Read more
On 5/19/2021 client received her first dose of the Pfizer Covid-19 Vaccine (lot #EW0185, expiration 08/2022) at 12:42. Client was found sitting upright in her chair with her mother and appeared melancholy. Client was a 13-year-old female, alert and tracking with her eyes. Client had a chief complaint of headache at 12:48. EMT and RN responded. Client stated that she began to have a headache a few minutes after her observation had begun. This was the client's first dose of the Pfizer vaccine. Client's mother did not report any allergies or medical history. Assessment revealed no hives, rash, discoloration, shortness of breath or other signs of anaphylaxis. Client described a generalized headache with dizziness and stated that she had eaten breakfast this morning. Airway, breathing and circulation were intact. Client denied pain throughout the rest of her body. Vitals at 12:52 were blood pressure 122/74, pulse 84, respirations 18, O2 100% on room air, temperature 97.6*f, lung sounds clear bilaterally, and client was alert and oriented to person, place, date and time. Client's mother consented to allowing the client to lie down for 15 extra minutes but refused to remain for the entire 30-minute additional observation. Client's mother was instructed to seek emergency care or medical attention if condition becomes severe after leaving vaccination site. Client's final vitals were consistent at 13:07: blood pressure 118/78, pulse 84, O2 100% and respirations 18. Client's mother was provided with all vaccine related information and acknowledged that she already knew what signs and symptoms to look for as she was already vaccinated as well. departed facility with her mother at 13:07 with client's mother stating "I have another appointment."
13 2021-05-18 fever, chills, headache Sore arm, fever, chills, headache and dizziness. All symptoms resolved within 36 hours except headac... Read more
Sore arm, fever, chills, headache and dizziness. All symptoms resolved within 36 hours except headache and dizziness. Dizziness is the biggest complaint 4 days post vaccine.
13 2021-05-18 fever, fatigue pt had fever the night after taking the vax. The next day she when she woke up her entire right sid... Read more
pt had fever the night after taking the vax. The next day she when she woke up her entire right side of the body was sore and had diarhea. She had fatigue and developed a rash on her left arm. Three days later she still has a rash, sore arm, slight fever and diarhea. Pt will be going to urgent care today for treatment.
13 2021-05-19 sweating Pt w/ amoxicillin allergy unknown reaction. Flushing/sweating, dizziness, lightheadedness. Pt had a... Read more
Pt w/ amoxicillin allergy unknown reaction. Flushing/sweating, dizziness, lightheadedness. Pt had a near syncopal episode post vaccination. Pt has a hx of "passing out" w/ shots. Pt was laid down, given juice, and stable. VSS BP 101/52, HR 74, RR 20 -- > 99/65, 82, 20. Pt stable and released from the vaccination site.
13 2021-05-19 sweating Event occurred during COVID vaccination clinic of students at School, under direction of Hospital CO... Read more
Event occurred during COVID vaccination clinic of students at School, under direction of Hospital COVID Vaccination team. Syncopal event 5 minutes after injection. Fell backwards striking her head on the floor. Regained consciousness immediately. Pale, diaphoretic, reported lightheadedness and nausea. BP 86/50 HR 116 SpO2 99%. Consumed several ounces water and ice pack to head and neck while in observation. Released to parent after 30 minutes. BP 110/60 HR 90 SpO2 98% skin dry, color pink, denied nausea. Able to ambulate without assist. Presented to urgent care 5/18/21 for concussion evaluation reporting sensitivity to bright lights. Advised by provider to rest, avoid electronics and strenuous physical activity.
13 2021-05-19 fever dizziness and fever of 99.2, these symptoms lasted until 5/20/21 11:30am
13 2021-05-19 respiratory tract congestion, cough, sneezing, runny nose, throat pain Chest congestion runny nose sneezing sore throat coughing ear pressure
13 2021-05-20 throat irritation, malaise approx 15 mins post injection client's mother states client is not feeling well. Eval'd client, c/o ... Read more
approx 15 mins post injection client's mother states client is not feeling well. Eval'd client, c/o mild nausea and "throat feels a little scratchy" denies any other s/s. v/s remained stable throughout, Administered 5mg of Zyrtec to client, observed for another 30 mins, client states "feeling normal as always now" discharged from site, in stable condition.
13 2021-05-20 throat irritation Immediately began bleeding, which ran down arm from injection site. Approximately 4 minutes later, b... Read more
Immediately began bleeding, which ran down arm from injection site. Approximately 4 minutes later, back of entire arm that received injection was numb from underarm to pinky and ring finger; warm hives on front of both arms down to wrists; warm, rosy cheeks and cold hands/fingers; tickle in back of throat. Benadryl given at clinic. 2.5 hours later, numbness in arm reduced to upper arm only; hives on arms have reduced; tickle in throat gone. Continues to have pain at site of injection.
13 2021-05-21 sweating Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium
13 2021-05-22 cough, throat pain Cough then throat pain and trouble breathing, started about 1.5 hour after vaccine given. Hx of as... Read more
Cough then throat pain and trouble breathing, started about 1.5 hour after vaccine given. Hx of asthma, but no symptoms prior to vaccine given
13 2021-05-22 fatigue Pt woke up day after vaccine with dizziness, nausea/vomiting, fatigue and had syncope x 3
13 2021-05-22 fever, cough Fever, eye redness, body pain starting 1 day after vaccine cough, nausea, abdominal pain 3 days afte... Read more
Fever, eye redness, body pain starting 1 day after vaccine cough, nausea, abdominal pain 3 days after vaccine 1 episode of emesis 5 days after vaccine - Admitted to hospital with suspicion of MIS-C - As per ID and Hem/Onc, Started on IVIG and aspirin (5/23/21) - currently still admitted for management of MIS-C
13 2021-05-23 fatigue Fatigue, shortness of breath, trouble catching her breath, red face, lump in throat, dizziness, when... Read more
Fatigue, shortness of breath, trouble catching her breath, red face, lump in throat, dizziness, when exercising. Took rescue inhaler 5x , but did not see any improvement. Symptoms went away after an hour of rest.
13 2021-05-23 headache Fast onset of dizziness (head spinning, difficulty walking), nausea, temple pain, stomach pain. Some... Read more
Fast onset of dizziness (head spinning, difficulty walking), nausea, temple pain, stomach pain. Some chest ?burning? sensation.
13 2021-05-23 malaise, fever Fever, malaise. Given advil. Fever improved. Malaise persists today.
13 2021-05-23 fever Child's mom calls on 05/24/2021. States her daughter developed a rash to her torso and had a fever ... Read more
Child's mom calls on 05/24/2021. States her daughter developed a rash to her torso and had a fever of 101.0 F post vaccination. States they visited her physician today and their physician said it looked like a viral rash, but, recommended calling and reporting the event to the health department (VAERS Reporter). Went to physician office to get started on birth control. Mom says she just decided to mention the rash to the physician, but, wasn't concerned.
13 2021-05-24 fatigue, headache Immediately after the injection child experienced a severe headache, pain at injection site, and som... Read more
Immediately after the injection child experienced a severe headache, pain at injection site, and some fatique. The severe headache has continued for 3 days. Over the counter advil has not helped. Headache is so severe that child is crying from pain. Noises above a normal tone (including the sound of a piano playing) triggers the headache and worsens it.
13 2021-05-24 fatigue, headache the day following vaccination she described worsening of chronic fatigue, headache, chest/rib cage d... Read more
the day following vaccination she described worsening of chronic fatigue, headache, chest/rib cage discomfort, swelling of left arm and left face, hives under eyes and left face
13 2021-05-24 fatigue Systemic: Patient felt extremely tired soon after receiving her vaccination. I monitored patient for... Read more
Systemic: Patient felt extremely tired soon after receiving her vaccination. I monitored patient for 40 min. and then called to check on her later that night and then again after the weekend as well. Patient was recovered when I called to check on her on 5/24/21.-Mild, Systemic: Hypertension-Mild, Additional Details: The patient's blood pressure was elevated during the monitoring period, but I am unsure of her baseline/normal blood pressure. I recommended the patient and her caregiver to follow up with her primary care provider to be evaluated for pediatric hypertension.
13 2021-05-24 headache Site: Pain at Injection Site-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Patient stated s... Read more
Site: Pain at Injection Site-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Patient stated she felt weird.-Mild, Systemic: Headache-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Per the father, patient reported arm pain/soreness on 5/17/21, body aches on 5/18/21, and on 5/19/21 patient reported waking up with a mild headache and mild tingling of leg.
13 2021-05-24 headache c/o of slight headache after taking the first dose of vaccine. No medical history reported. no hi... Read more
c/o of slight headache after taking the first dose of vaccine. No medical history reported. no history of allergic reaction reported. vital signs stable. BP 129/74, O2 98, P 93, R 18. Pt. verbalized feeling better prior to mom driving her home. Advice mom to monitor pt. and report to PCP and abnormal changes.
13 2021-05-24 throat pain Chest pain shortly after the vaccination. Swallowing and throat. Long lasting and was sent to the em... Read more
Chest pain shortly after the vaccination. Swallowing and throat. Long lasting and was sent to the emergency room. Labs and EKG were normal. Sore throat lasting up to five days after the vaccine. Tightness in throat and chest experienced
13 2021-05-25 fatigue, cough, malaise, throat pain, productive cough, fever, respiratory tract congestion, sneezing The day after my daughter received her vaccine, she began to feel congested and tired. This was on S... Read more
The day after my daughter received her vaccine, she began to feel congested and tired. This was on Sunday, May 23. We got up for school on Monday, May 24, but she was complaining about a really bad sore throat. The school nurse called and I picked her up from school because she was also getting more congested. She began to cough and sneeze constantly and took a long nap. When she woke, she was saying that she was getting short of breath and it felt like her heart was racing, even though she was just sitting. The next day her throat felt better, but the congestion was the same - still coughing and sneezing but her shortness of breath started getting more obvious. I emailed her pediatrician to ask about bringing her in, and they said to report this to the CDC and bring her if if she's not better in the next few days. Today is Wednesday, May 26 and she is still congested, short of breath and overall feels lousy. She is coughing up lots of mucus - greenish and thick. Yuck. I just gave her one pill of a mucus reducer to see if that would help. My biggest worry is about the shortness of breath because that is exactly what I experienced after my first dose of the vaccine. Mine was Moderna and I have seen dr's about it - and actually ended up in the hospital, but they do not believe it to be connected to the vaccine. I will contact them and let them know about my daughter's shortness of breath and perhaps they will think differently. Oh, she's had a slight fever of 99 F on occasions during this.
13 2021-05-25 fever, headache Headache; fever of 102.6; This is a spontaneous report from a contactable consumer (patient). A 13-y... Read more
Headache; fever of 102.6; This is a spontaneous report from a contactable consumer (patient). A 13-year-old female (no pregnant) patient received the first dose of BNT162B2 via an unspecified route of administration on left arm on 14May2021 at 17:30 as single dose for COVID-19 immunization. Medical history was not reported. The patient not receive any other vaccines within 4 weeks prior to the COVID vaccine and not received the list of other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and hadn't been tested for COVID-19 since the vaccination. Concomitant medication was not reported. The patient experienced headache and fever of 102.6 on 15May2021. The outcome of events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
13 2021-05-26 fatigue Patient awoke from a nap with chest tightness, difficulty breathing, and nausea, symptoms have conti... Read more
Patient awoke from a nap with chest tightness, difficulty breathing, and nausea, symptoms have continued interimittently, and are associated w/fatigue.
13 2021-05-26 sleepiness, headache pt was dizzy - after 15 minutes of watching her she complained of a headache she could answer questi... Read more
pt was dizzy - after 15 minutes of watching her she complained of a headache she could answer questions but not with any enthusiasm. she was groggy - I got a blood pressure cuff and took three readings and they continued to increase the last reading was 148/120 I suggested to mom we need medical care and offered to call an ambulance - mom said she would take her to the er across the street
13 2021-05-27 fatigue She had an upset stomach and was feeling really tired. Then the next morning, she had a rash - itch... Read more
She had an upset stomach and was feeling really tired. Then the next morning, she had a rash - itchy and bumpy - torso, back arms and face. Went to the Doctor and she said it looked like an allergic rash. She told us that based on my daughter's genetics and her asthma - (I (her mother) had an anaphylaxis with my second Moderna shot - my entire body was giant hives.)- That he did not recommend her to have the 2nd shot. My daughter still has some of the rash - a little on her left cheek, stomach and back still. The itching is gone. She did take Benadryl for it.
13 2021-05-28 fatigue, headache, fever Swollen eye; low grade fever; slight headache; fatigue; 13-year-old female patient received BNT162B2... Read more
Swollen eye; low grade fever; slight headache; fatigue; 13-year-old female patient received BNT162B2; This is a spontaneous report from a contactable consumer (patient). A 13-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm on 13May2021 14:15 (batch/lot number: PFIZEREW0179) as 1st dose, single for COVID-19 immunization. Medical history included known allergies to amoxicillin. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No Covid prior to vaccination and was not Covid tested post vaccination. The patient experienced swollen eye, low grade fever (99.5 F), slight headache, fatigue; all on 14May2021 14:00. Treatment was received for the adverse events which included diphenhydramine hcl (BENADRYL). The outcome of the events was recovering. Information on lot/batch number was available. Follow-up attempts are completed. No further information is expected.
13 2021-05-28 malaise Patient had significant anxiety prior to administration. After administration, initially patient fel... Read more
Patient had significant anxiety prior to administration. After administration, initially patient felt fine. A few minutes after patient felt faint , hands and forehead were clammy. Mom was present. Blood pressure was checked, diastolic was slightly high at 90mmHg. Patient's eyes closed for a second but patient was never unconscious. Patient did not fall. Patient did not hit head on anything. Patient was given water and sat there for about 7 minutes. Then patient was walked outside next to Mom and Pharmacy Grad Intern. Patient was not feeling well initially outside but did feel better after a while. Mom refused an ambulance. Mom and patient left at 10:50am and patient was feeling much better
13 2021-05-29 malaise, headache She had troubles breathing. On the first day, she also had headaches and tummy pain. On the second d... Read more
She had troubles breathing. On the first day, she also had headaches and tummy pain. On the second day, she vomited in school. She also had a headache and troubles breathing. She had belly pain, as well. On Wednesday, around lunch break she called me to pick her up, she had troubles breathing and headache and feeling blah. Also on the first evening, Her arm was hurting and her left body side was hurting. (Wednesday this got a little bitter but she still had pain on her front left side -- especially her left leg.) I took her to primary care and he prescribed Prednisone. Prednisone started then. On Thursday, she still had troubles breathing and she stayed home from school. On Friday, it was okay for her to go to school.
13 2021-05-30 fever Prolonged Fever (over 103), ringing in ears, dizziness, rash over entire body and face. Some sorenes... Read more
Prolonged Fever (over 103), ringing in ears, dizziness, rash over entire body and face. Some soreness in legs but that went away.
13 2021-05-31 sweating fainted right away, pale, sweaty, eyes closed and then rolling back in the head. This never happene... Read more
fainted right away, pale, sweaty, eyes closed and then rolling back in the head. This never happened before.
13 2021-06-01 fatigue, headache headache; diarrhea; stomach ache; tired; This is a spontaneous report from a contactable consumer (p... Read more
headache; diarrhea; stomach ache; tired; This is a spontaneous report from a contactable consumer (patient's mother) via medical information team. A 13-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EW0182), via an unspecified route of administration in Arm Left on 25May2021 at 13:00 (13-years-old at the time of vaccination) as single dose for COVID-19 immunization. The patient's medical history included mental problem (reported that she takes a medicine for a mental problem that she has but the caller does not know the name of the medication or the condition). The patient had no family medical history relevant to adverse events. The patient did not receive other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient's concomitant medications were not reported. The patient's weight is 200 something. On 25May2021, the patient experienced headache, diarrhea, stomach-ache and was tired. Clinical course included: headache began after the shot yesterday (25May2021); diarrhea and stomach-ache began last night. Her daughter was also tired, she just said she was going to go take a nap now. The tiredness also started yesterday because she laid down with the headache, so it had to be yesterday. The tiredness was persisting about the same, caller's spouse can be heard in the background of the call saying everything was persisting about the same. The outcome of events was not recovered. Additional information is requested.
13 2021-06-01 headache, fatigue Patient is a 13 year old female who presents to the clinic today with her mother for a follow up ER ... Read more
Patient is a 13 year old female who presents to the clinic today with her mother for a follow up ER visit from 5/30/21. Patients mother reports that patient had received her first Pfizer COVID-19 vaccination on 5/26/21, and developed a headache on Thursday. On Friday, mother and patient report that she had a very active day at school, and in Phy-Ed she did a cardio work out, followed by a 10 minute run and then golf practice after school. Patient reports that she does not frequently go running. Saturday, mom reports that patient was fatigued and rested most of the day. Sunday, she was up at 5am and was working by 6am until noon at the family restaurant. Her mother reports that it was very busy at the restaurant. Later in the afternoon on Sunday, the family went to their lake house in New Auburn, MN. Mother reports that the patient ate a good supper and the patient was asked to take the dog for a walk around 8pm. Patient took the dog for a walk for about 5 minutes, and then came back and went to her room, and her older sister found her lying in her room with her arms flexed and legs extended. Mom reports that she was drooling, staring and her muscles were stiff, and she wouldn't bear weight on her legs. This lasted approximately 10 minutes and she was transferred by ambulance to the Bloomer ER for evaluation. Initial ER workup in Bloomer showed leukocytosis at 11.4, a CK of 333, and an alk phos of 263. Her CBC, Comp, CRP, Lactate, pregnancy, lymes, COVID and UA were all within normal limits. A head CT was negative as well. Given her symptoms, she was transferred from Bloomer ER to St. Mary's in Rochester to the general pediatric floor early Monday morning. Peds neurology consulted and diagnosed her with dissociative (non-epileptic) attack, and discharged her home around 5pm on Monday evening with family. Since discharge, she reports that she is still experiencing fatigue, a mild headache, and her quadricep muscles feel weak and ache. Mom reports that she has been monitored by family since discharge and she has not had another episode since. For pain, she is taking tylenol and ibuprofen with minimal relief. She has started her menses, her onset of menarche was January, 2021, and she did not have a menstrual cycle in February, March or April, and she began her menses on 5/24 through 5/30. Clinic recommends oupatient testing for an EEG, Echo, EKG and MRI and follow up with neurology.
13 2021-06-01 sweating About 5 minutes after the shot, the patient was in the waiting area and started feeling lightheaded ... Read more
About 5 minutes after the shot, the patient was in the waiting area and started feeling lightheaded and dizzy. She was sweating and sounded drowsy and said she couldn't see. She did not report to be hot or itchy. We had her lie down with her feet elevated and she immediately felt better and could see again. She remained in that position for 3-5 minutes before she sat up. She felt normal again at this time.
13 2021-06-01 fever, headache On 05-22-2021, participant's mother states her daughter pain started at about 1:00AM. I took her to ... Read more
On 05-22-2021, participant's mother states her daughter pain started at about 1:00AM. I took her to Urgent care because she was having chest pain, nausea and headaches. She also had 99.2F of fever but no congestion or cough. At the ER an EKG was done and it was a bit off, lab work was also performed, x-ray of the chest was also done and they gave her an Albuterol treatment. She was given IV fluids and steroids and a CT scan of the chest was also performed. After 9 hours, she was discharged home and could not find anything wrong. On 05-25-2021 I took her to her pediatrician who pushed on her chest and it hurt her when he did this, her pain level was between 5 and 8 out of 10 on VAS scale. EKG's were performed as well as lab work, x-ray of the chest at the pediatrician office. Her daughter also said her chest hurt her to exhale and inhale. The pediatrician said that her rib cage and breast bone where inflamed upon pressing on her daughter's chest and that she has s costochondritis. As of today my daughter still has nausea that comes and goes and also continues with the headaches and takes Ibuprofen as pain medication.
13 2021-06-02 cough, throat pain, fever, respiratory tract congestion, headache The morning after the vaccine she had a fever for 1/2 the day, a headache for two days, and body ach... Read more
The morning after the vaccine she had a fever for 1/2 the day, a headache for two days, and body aches for two days. Then, on Thursday, May 27th she had a swollen and painful armpit on the arm that the injection was in. The pediatrician thought it was probably swollen lymph nodes, but just did a teleconference with her, so she didn't see the swollen armpit. Patient took ibuprofen for the pain and swelling, put heat compresses on it occasionally, but it still stayed that way for All of Thursday and through the weekend. The swelling began to go down on Monday, May 31. Then on the morning of June 1 she had a sore throat, later developing a fever, headache, and congestion that lasted two days. She is a bit improved today, June 3rd, just still congested and has a cough but all other symptoms are gone.
13 2021-06-02 headache She had her first shot vaccine yesterday June 2, 21 and today she has sintoms off.. nausea, disines... Read more
She had her first shot vaccine yesterday June 2, 21 and today she has sintoms off.. nausea, disiness , can't eat , headache, and body illness, has well a lot of pain on the arm and body muscles, and difficulty on breathing..
13 2021-06-02 lethargy Face is swollen/face was puffy; complaining of pain in her throat glands/Glands under throat are pai... Read more
Face is swollen/face was puffy; complaining of pain in her throat glands/Glands under throat are painful; sleeping a lot; didn't really eat much; Very Lethargic; vomited once or twice/Vomiting; This is a spontaneous report from a contactable consumer. This consumer (patient's mother) reported for her daughter (patient). A 13-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at the age of 13-years-old via an unspecified route of administration on 15May2021 15:30 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. Medical history included ongoing reaction to bread. Concomitant medication included an unspecified anxiety medication. It was reported the patient received the first dose of the Pfizer COVID-19 vaccine on 15May2021, and the next day, 16May2021, she was sleeping a lot and vomited once or twice, didn't really eat much. This morning, 18May2021, she vomited and noticed face was puffy and complaining of pain in her throat glands, they will be taking her to her HCP this afternoon. Shee mentioned that she has had a reaction to bread, possible gluten intolerance, maybe yeast, and was asking if is there is yeast in the production of the vaccine. She got the vaccine on Saturday at 1530. It was further reported that for the first day or two she was very lethargic and vomiting on 15May2021. States they thought it was just a normal reaction. The reporter stated that today her daughter isn't in school again because she is vomiting, her face is swollen, and her glands under her throat hurt. States she is going to the doctor this afternoon. The patient did not recover from vomiting, was recovering from very lethargic while the outcome of the other events was unknown. Information on the lot/batch number has been requested.
13 2021-06-03 throat irritation Pfizer vaccine. Patient stated she was having some slight pain in her sternum area, then she stated ... Read more
Pfizer vaccine. Patient stated she was having some slight pain in her sternum area, then she stated it moved to her "belly" making her nauseas, then stated her throat felt like it was a little scratchy. Symptoms did not all happen at same time, the progressed. Patients blood pressure was115/75 pulse 81. Patient alert and oriented, appeared in no distress. Patients mom at side. Decided to drive her to the hospital. Did not want this RN to call 911.
13 2021-06-05 headache Patient felt dizzy, ringing in ear, headache within receiving COVID-19 Pfizer vaccine (first dose) w... Read more
Patient felt dizzy, ringing in ear, headache within receiving COVID-19 Pfizer vaccine (first dose) within 5 minutes. Ambulance arrived to take patient to hospital.
13 2021-06-05 fever She an a fever of over 102 all day on 6/4/2021 (day after 2nd dose) and then spiked to 103.4 at 11:3... Read more
She an a fever of over 102 all day on 6/4/2021 (day after 2nd dose) and then spiked to 103.4 at 11:30pm on 6/4/2021. She still ran a fever of between 100 and 101 the 2nd day after the vaccination (6/5/2021). Today 6/6/2021 the fever has come down to between 99 and 99.5.
13 2021-06-05 sleepiness About 5 minutes following immunization, parent came to alert pharmacist that patient was experiencin... Read more
About 5 minutes following immunization, parent came to alert pharmacist that patient was experiencing nausea and light-headedness. Pharmacist observed that patient had a drowsy appearance and her eyes would periodically roll to the back of her head. Patient was also warm to the touch. She was given a cold pack which we placed on her wrists and she said that seemed to help. Patient remained under observation for about 20 minutes before she felt comfortable to leave the store.
13 2021-06-06 chills, malaise, fatigue Patient blacked out and fell on the floor. I was alerted to what happened. When I went to investiga... Read more
Patient blacked out and fell on the floor. I was alerted to what happened. When I went to investigate what happened she was disoriented and laying on the floor. Afterwards she recovered from fainting and disorientation quickly. She had chills, a sore arm, and general feelings of tiredness and feeling unwell.
13 2021-06-06 dehydration Daughter stated she had diarrhea for 3 weeks while we were at the hospital on 6/2 for IV fluids and ... Read more
Daughter stated she had diarrhea for 3 weeks while we were at the hospital on 6/2 for IV fluids and severe dehydration. Her poop was mushy, and not diarrhea, however for her it was much softer than normal. She collapsed at home and was unresponsive, 911 was called, ER doctor determined she was severely dehydrated and administered 2 bags of IV fluids to stabilize her blood pressure.
13 2021-06-06 fatigue, lethargy Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Letharg... Read more
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Mild, Systemic: ears felt like they were clogged and difficulty hearing-Medium, Systemic: Hypotension-Medium, Additional Details: Monitored for 45+ minutes. Paramedics came and observed vitals were normal & offered ride to hospital. Pt's mom declined and paramedics walked with patient to car. Called mom around 6:55pm & she said patient felt worse on drive home and she took her to Hoag. They were watiting to be seen. Called again Saturday around 10:30am with no answer.
13 2021-06-06 fatigue There were no symptoms on the evening of the day of the injection and the morning of the next day. S... Read more
There were no symptoms on the evening of the day of the injection and the morning of the next day. So I went out with my daughter at 3:00 p.m. She and stood in line at clothing store after walking for an hour and a half and then suddenly she felt dizziness and 20 seconds later she lost consciousness. And then she woke up a minutes later while an employee called 911. She was fine and felt well but when we came back to our house, she was tired and slept 15 minute in my car. The next day, my daughter was fine, but after dinner we walk out near my house after 10 minutes she felt dizziness again. She sat there for 10 minutes and she was fine. After that day, there were no symptoms.
13 2021-06-06 fatigue Systemic: Fainting / Unresponsive-Medium, Systemic: Shakiness-Mild, Systemic: Tinnitus-Mild, Additio... Read more
Systemic: Fainting / Unresponsive-Medium, Systemic: Shakiness-Mild, Systemic: Tinnitus-Mild, Additional Details: 26hrs after 2nd shot, patient passed out & fell at home & brother caught her. 5 seconds later, she tried to get up but collapsed again & siblings saw her spasming for few seconds before regaining consciousness. She immediately complained of ringing in ears/fatigue/dizziness which resolved 40 minutes later. mother confirmed no history of seizures/fainting. menstruating now
13 2021-06-06 headache, lethargy, chills headaches, lethargy, chills, sweating through the night
13 2021-06-06 headache At 4:30 PM, the patient received the first dose of the COVID-19 vaccine in her right arm at facility... Read more
At 4:30 PM, the patient received the first dose of the COVID-19 vaccine in her right arm at facility. She developed a headache, along with dizziness and pain at the injection site. She also reports that her arm began tingling and felt heavy. She waited for an hour without resolution to her symptoms. Around 5:30 PM, she began having intermittent episodes of shaking her limbs. There was no seizure activity. She reports that she has had these episodes since the beginning of the school year, but hadn't told her Mom. She reports that it mostly happens when taking a test at school. The episodes are worse today since taking the vaccine. Vitals: HR 110 BP 134/75 Sat 99% on RA. An RRT was called and she was taken to the ED.
13 2021-06-06 sweating Post 2nd dose pt c/o nausea, pt was sweaty and poor color. Pt was assessed by medics low pulse/bp. ... Read more
Post 2nd dose pt c/o nausea, pt was sweaty and poor color. Pt was assessed by medics low pulse/bp. Pt vomited x1 Pt transported to ED "not getting better".
13 2021-06-06 sweating "Healthy 13 yo female with no significant PMH. No problem with the Pfizer vaccine dose #1. Today, 7 ... Read more
"Healthy 13 yo female with no significant PMH. No problem with the Pfizer vaccine dose #1. Today, 7 minutes after she received the Pfizer vaccine, she c/o dizziness. She was pale and sweaty. BP 96/61, HR 82, RR 16 -- > 102/62, 78, 16 She was supported by the nurses. She was alert with her eyes closed. Pt was given water. Pt stable, dizziness resolved. She is at baseline and verbalized readiness to go home. Pt stable and released from the vaccination site with her father."
13 2021-06-06 fever, influenza like illness, fatigue, headache, chills She woke me up in early morning - and she felt feverish and she had a headache. I gave her Tylenol a... Read more
She woke me up in early morning - and she felt feverish and she had a headache. I gave her Tylenol and she went back to sleep. When she woke up around 08:00 a.m. she felt like she had the flu - terrible headache, chills, 100 degree fever, body aches and nauseous and really restless. By the morning, her left arm at injection site was also sore. We gave Ibuprofen at 10 am to help with aches and pain. About 20 min later, she threw up a lot. I called the doctor and talked to nurse. Told me to wait four hours before giving pain meds again. We gave her Pedialyte. at 02:00 pm, I gave her a dose of Tylenol and in within 30 seconds after giving it to her she threw up again, a lot. I called the doctor again. Nurse said to give her more Tylenol when she was able to feel better. She took a bath and drank some Pedialyte and that helped rehydrate her and then we gave her Tylenols when she was feeling up to it. On Sunday, when she woke up, she had swollen and painful lymph nodes on armpit on her left side and those are still persisting - not as swollen but painful a bit. She was tired still on Sunday but feeling a lot better. Tiredness, sore arm and pain in lymph nodes under her left arm were what persisted on Sunday. She still has pain under her left arm with swollen lymph nodes but did go back to school today.
13 2021-06-06 fever Patient fainted in the bathroom around 2:00am. When we heard the thump, we ran to her and my husban... Read more
Patient fainted in the bathroom around 2:00am. When we heard the thump, we ran to her and my husband picked her up. She wasn't talking much, she started gagging and fainted again and her body started convulsing. We believe she was having a seizure. Patient has never had a seizure, her fever was high. It only lasted probably 20-30 seconds. When she stopped, she was able to walk with assistance back to her room. We quickly gave her some medicine to bring down her fever. Wet wash cloth and a fan on her. I failed to take her temperature. I was too concerned at what was going on.
13 2021-06-06 sleepiness, fatigue Client's Mother asked EMTs to assess daughter as she was falling asleep on chair. Vitals at 1819: b... Read more
Client's Mother asked EMTs to assess daughter as she was falling asleep on chair. Vitals at 1819: blood pressure 118/80, pulse 90, oxygen 99%. PHN joined shortly after. Upon arrival client sitting upright on chair, awake, alert and oriented x4. Mother stated not knowing if it was normal for client to feel fatigued shortly after vaccine. Per Mother client had already waited 15 mins and no reactions to first dose. Client currently on antibiotic treatment for throat infection. Mother stated client has been up since 0800, went to school and has been out all day. Client stated she just feels tired. Client denied shortness of breath, chest pain, headache, dizziness, or blurry vision. Client awake and alert x4 during time PHN was with client. Mother advised to monitor client at home, ER precautions also given. Last vitals at 1825: blood pressure 116/82, pulse 88, oxygen 99%. Client left facility with steady gait at 1830, Mother was driving client home
13 2021-06-07 body temperature increased Temperature 101.2 General body aches, difficulty focusing, standing. Weakness.
13 2021-06-07 headache, fatigue, fever Sore arm, headache, fever, fatigue and later hot red blotch on arm at injection site .
13 2021-06-07 malaise Patient became dizzy and generally not feeling well and laid down on the floor. The Pharmacist came ... Read more
Patient became dizzy and generally not feeling well and laid down on the floor. The Pharmacist came out to check on her. She was awake so he called store management over to bring her some juice and he checked her blood pressure. After a few minutes the patient was able to stand up and was ok to leave with her guardian.
13 2021-06-07 fever Lymph node on left side (same side as shot) was very painful and swollen. Swelling reduced in 24 hou... Read more
Lymph node on left side (same side as shot) was very painful and swollen. Swelling reduced in 24 hours, but still painful. Low-grade fever.
13 2021-06-08 fatigue, headache My daughter began having a headache a few hours after being vaccinated - that was on Sunday 6/6/21 a... Read more
My daughter began having a headache a few hours after being vaccinated - that was on Sunday 6/6/21 and we didn't think much of it. The headache (and fatigue) continued Monday and Tuesday as well. But by that Tuesday afternoon 6/8, she was complaining that her vision was impaired. She couldn't see things out of the right corner of her right eye. Example, when she looked at my face she could only see the left half, not the right half. When she looked down at her phone, some numbers on the right side of the screen seemed to be missing from her field of view. Additionally, she said she was having a hard time spelling easy words (ex. "because") and was processing information really slowly when reading -- she noticed she was going much slower than normal.
13 2021-06-08 fatigue sore arm; little fatigue; This is a spontaneous report from a contactable consumer via a Pfizer spon... Read more
sore arm; little fatigue; This is a spontaneous report from a contactable consumer via a Pfizer sponsored program. A contactable consumer reported for a 13-year-old female patient who received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on 20May2021 (Batch/Lot Number: EW0177) as a single dose for covid-19 immunization. Medical history included athletic induced asthma (she was diagnosed maybe 3 years ago, 2018 or maybe it was 2016) and horseshoe kidney (the patient was diagnosed with a horseshoe kidney a year or two ago, meaning when the patient was in the her mother's womb, her kidneys while they were developing never separated so she has to be careful not to get kidney infections and not to get hit in the stomach when she's playing sports). On 20May2021, the patient experienced sore arm, little fatigue. Caller (reporter) stated that there was a report that came out. Caller states her daughter got her first dose, she was 13, and had no reaction other than a sore arm and a little fatigue the first day. Caller states the reports says it's causing enlarged heart in a lot of teens; she asked her doctor about it and the doctor said the benefits of getting the vaccine outweigh the risks and advised the caller to still get it for her daughter. The outcome of the events was unknown. Pfizer Covid Vaccine: Caller confirms the patient received the Pfizer Covid Vaccine. NDC: Unknown; Expiry Date: Unknown; Unknown Dosage; Indication: Caller states they are pretty good about not going anywhere, but they certainly venture out more than she does. Caller states she wants to make sure she was protected. Caller states she learned a day or two before she scheduled the shot that her daughter's school is not offering school from home next year. Caller states it's called E classroom, they are also doing hybrid but her daughter opted to stay home. Caller states she learned they weren't doing any of that next year. Caller confirms her daughter is scheduled for her second dose on 10Jun2021. PSCC Communication: Report 2 of 7. Caller does not provide any further information on patient; therefore, no further information obtained or verified. Additional information has been requested.
13 2021-06-08 headache CC: headache, lightheaded 14 minutes after vaccine administration. Treatment: no medicine was given.... Read more
CC: headache, lightheaded 14 minutes after vaccine administration. Treatment: no medicine was given. Water and graham crackers improved the symptoms. Outcome: Patient condition improved and the patient was discharged to POV/Home.
13 2021-06-08 sweating, sleepiness Patient received her vaccine on 6/9/2021. after Vaccine was completed the patient was asked to sit i... Read more
Patient received her vaccine on 6/9/2021. after Vaccine was completed the patient was asked to sit in the lobby for 15 minutes so she could be monitored due to 1st dose. Within 5 minutes Patient stated to parent that she was thirsty, when parent grabbed a water and returned to see Patient fainting and sliding out of her chair. Went to assist patient to make sure she was OK. Patient was saying she felt sleepy and wanted to sleep. we kept her conscious but her words began to slur. Rescue came and assessed the patient who began to turn pale. She complained of her chest hurting and she started sweating. Rescue took patient to the local ER. Patient came back from ER with parent to let us know that she was OK. Her color had returned and she was no longer pale.
13 2021-06-08 sweating Patient DOB: 9/29/2007. Received her first dose of Pfizer (LOT#: EW0161 Exp: 8/2021) at 1144 on 6/08... Read more
Patient DOB: 9/29/2007. Received her first dose of Pfizer (LOT#: EW0161 Exp: 8/2021) at 1144 on 6/08/21. PHN noticed patients eyes rolling back. PHN got up and asked mother of patient if patient was okay. Mother stated that patient was feeling dizzy and that she had not eaten breakfast. PHN assessed patient. Patient was pale and diaphoretic. PHN asked patient if she had anything to eat before getting vaccinated. Patient stated she did not eat breakfast. PHN gave patient a snack and juice to drink. Patient finished snack and juice. EMT took patient vital signs. BP: 100/64, pulse: 82, O2: 97%. At 1158 patient stated that she was feeling better. Patient was no longer dizzy and was not diaphoretic or pale. Patient was moved to zero gravity chair. EMT retook vital signs and reassessed patient at 1215. BP: 100/60, pulse: 80, O2: 99%. Patient stated that she no longer felt any symptoms. EMT retook vital signs and reassessed patient at 1225. BP: 100/64, pulse: 73, O2: 97%. Patient stated that she did not feel any symptoms. Patient was educated on worsening signs and symptoms of side effects of the vaccine and when to call EMS or go to the ED/urgent care. Patient left with her mom unassisted and with a steady gait.
13 2021-06-08 lethargy Pt. accompanied by her mother arrived at site around 0845 to be vaccinated with her second of the Pf... Read more
Pt. accompanied by her mother arrived at site around 0845 to be vaccinated with her second of the Pfizer vaccination. Pt. and parent confirmed no adverse reactions after first dose, no known medication or other allergies, no known past medical conditions and the pt. indicated she was not pregnant. The pt. was given her second vaccination and as the vaccinating nurse turned away from the patient to move her cart out of the way and shut the patient's car door the patient was slouched over and nearly falling out of the car. The vaccinating nurse caught the patient and lowered her down to the ground from her vehicle. Charge Nurse was in prep directly across from the incident. Site lead brought over the E-Kit Charge Nurse utilized sternal rub to awaken patient which she was responsive to. Pt. was pale in color and stated she felt very lethargic. Pt. confirmed the last meal she had was over 13 hours ago. Upon initial evaluation of patient's vitals pt. was hypotensive 74/45 and bradycardic 45. EMS was called. Vitals reassessment BP increased to 81/54. Within two minutes of the syncopal episode the patient was able to talk and A&Ox4 after she was able to state full sentences she was given water, capri-sun and a sucker. After arrival by EMS the patient was reassessed. Vitals stabilized within normal limits. Parent informed the patient is stable and upon her choice she can be transferred to the hospital via ambulance for further evaluation. Parent decline. Pt. vitals and appearance within normal limits when driven from site by parent. Parent stated she will call the daughter's PCP to see if she can be further evaluated in her doctor's office today. Mother also stated pt. has an appointment 06/14/2021 for regular physical and follow-up.
13 2021-06-08 lethargy That afternoon, she was lethargic, achy and her arm was sore, so I gave her Tylenol. She had trouble... Read more
That afternoon, she was lethargic, achy and her arm was sore, so I gave her Tylenol. She had trouble sleeping that night. On Sunday morning, I gave her two Ibuprofen around 9 because her arm was still hurting. Around 9:30, she came in saying she was having chest pains and her pulse rate was over 120. I took her to the ER. Her heart rate was 128 when they triaged her. They gave her an IV and a saline drip, an EKG and chest x-ray, all of which were fine. Due to her being on birth control, they also did a d-dimer test, which was elevated at 442. They then did a lung scan to rule out a pulmonary embolism. Those results were negative as well. The chest pains resolved around 11 am. Since they ruled out the blood clot and nothing was found to be wrong with her heart, she was sent home. They figured that she maybe had an anxiety attack or heart palpations. I took her to her pediatrician the next day and she was cleared there as well.
13 2021-06-08 malaise Patient was given undiluted Pfizer vaccine straight out of the vial. When I spoke with her mother t... Read more
Patient was given undiluted Pfizer vaccine straight out of the vial. When I spoke with her mother today, she said her daughter had a sore arm yesterday and today she started feeling terrible - couldn't tell me any specific symptoms, as she was at work and her daughter was at home
13 2021-06-08 throat pain, runny nose Throat hurt 5/10, tearful, sniffling; Vital stable Resp rate 18-21 HR 70-82, PO2 100% Sitting up, d... Read more
Throat hurt 5/10, tearful, sniffling; Vital stable Resp rate 18-21 HR 70-82, PO2 100% Sitting up, drank water, calmed down with mom Discharged: 16:02 - stable Home by car with mom. Walking normally unassisted. Pain reduced 3/10. Relaxed
13 2021-06-08 fever Myalgias and low grade fever on first day. Chest pain requiring ER visit on second day. Exam, ECG,... Read more
Myalgias and low grade fever on first day. Chest pain requiring ER visit on second day. Exam, ECG, lab work, echo consistent with pericarditis
13 2021-06-08 fever Hospital tachycardia. No fever
13 2021-06-08 fever She had a high fever; This is a spontaneous report from a non-contactable consumer or other non hcp ... Read more
She had a high fever; This is a spontaneous report from a non-contactable consumer or other non hcp patient's mother). A 13-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in arm right on 02Jun2021 (Batch/Lot Number: EW0177) as a Single dose for covid-19 immunization. The patient medical history and concomitant medication was not reported. The patient previously took BNT162B2 on 12May2021 for COVID-19 Immunization (Dose: 1st, Batch/lot number: EW0179, anatomical site of injection for first vaccination: Left arm). On 03Jun2021, She had a high fever and the fever recorded 24 hours after the shot. The patient mother was interesting to patient about the fever was recorded 24 hours after the shot. So first she thought the patient didn't go to have any side effects at all but then she did get side effects 24 hours after the shot." The patient did not take any vaccination prior to second vaccination. The patient took Ibuprofen for fever reducing medicine. The outcome of the event was recovered in Jun2021. No follow-up attempts are possible. No further information is expected.
13 2021-06-08 throat irritation Anaphylactic reaction; left cheek started swelling; looking woozy; throat and tongue started swellin... Read more
Anaphylactic reaction; left cheek started swelling; looking woozy; throat and tongue started swelling; throat and tongue started swelling; having a hard time breathing; from the neck down, she had a temporary paralysis and she could not move./she could not feel anything from the waist down.; whole body was shaking; numbness and tingling all over.; numbness and tingling all over.; extreme pain in her back; When they would touch her hips, toes, spine, ankles, and knees she would complain of extreme pain, like joint pain.; When they would touch her hips, toes, spine, ankles, and knees she would complain of extreme pain, like joint pain.; When they would touch her hips, toes, spine, ankles, and knees she would complain of extreme pain, like joint pain.; very weak; chest was tight.; cannot walk without assistance; itching all over and in her throat; itching all over and in her throat; This is a spontaneous report from a contactable consumer (parent). A 13-years-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, 0.3 ML), at the age of 13-years-old , via an unspecified route of administration, administered in Arm Right on 21May2021 11:55 (Lot Number: EW0179; Expiration Date: Aug2021) as 0.3 ML SINGLE for covid-19 immunisation. Medical history included ongoing asthma, Diagnosed as a toddler. Had RSV as a baby. ongoing seasonal allergy, To like grass and pollen. ongoing constipation, Diagnosed about a year ago. allergic to shellfish because she gets sick. She said that it happened when her daughter was 4-5 years old. Whenever she has contrast for a MRI she throws it up. The patient's concomitant medications were not reported. The patient previously took Azithromycin and Amoxicillin and were allergic. The patient experienced anaphylactic reaction on 21May2021 with outcome of recovering, left cheek started swelling on 21May2021 with outcome of unknown, looking woozy on 21May2021 with outcome of unknown, throat and tongue started swelling on 21May2021 with outcome of unknown, having a hard time breathing on 21May2021 with outcome of unknown, from the neck down, she had a temporary paralysis and she could not move./she could not feel anything from the waist down on 21May2021 with outcome of unknown, whole body was shaking on 21May2021 with outcome of unknown, numbness and tingling all over on 21May2021 with outcome of unknown, extreme pain in her back on 21May2021 with outcome of unknown , when they would touch her hips, toes, spine, ankles, and knees she would complain of extreme pain, like joint pain on 21May2021 with outcome of unknown, very weak on 21May2021 with outcome of unknown , chest was tight on 21May2021 with outcome of unknown , cannot walk without assistance on 21May2021 with outcome of unknown , itching all over and in her throat on 21May2021 with outcome of unknown. Patient was in hospital from 21May2021 to 23May2021. AE(s) require a visit to Emergency Room. No AE(s) following prior vaccinations. No Family Medical History Relevant to AE(s). No Relevant Tests. Clinical courses as follows: It was reported they wanted her to wait for 30 minutes after her daughter received the vaccine. She said that after about 20 minutes, her daughter said that it felt like someone punched her in the face and her left cheek started swelling. She said that her husband said that their daughter started looking woozy and her eyes were closing. The staff laid her down on a mat on the floor. Then her daughter's throat and tongue started swelling and she was having a hard time breathing. Then her daughter complained that from the neck down, she had a temporary paralysis and she could not move. Her daughter asked if she asked if she was going to die. The nurse gave her an EpiPen and called a ambulance. Her whole body was shaking, probably from the EpiPen, like almost convulsing. She said that they got her onto the ambulance and her daughter was having trouble breathing. They gave her another dose of an EpiPen in the ambulance. They also gave her daughter a steroid and some Benadryl through an IV. Her daughter was rushed to the ER, having a hard time breathing and complaining she could not feel anything from the waist down. Caller said that her daughter was also complaining of numbness and tingling all over. She also started to complain about extreme pain in her back. When they would touch her hips, toes, spine, ankles, and knees she would complain of extreme pain, like joint pain. Her daughter had numbness from waist down. If they touched her foot she could not feel it. Her daughter was admitted to the hospital and got released yesterday 23May2021. She is still experiencing pain and numbness. The numbness is from the waist down and the tingling was up and down her arms. She said that her daughter was very weak and could not feed herself. They had to give her several albuterol breathing treatments in the hospital because her chest was tight. She was not wheezing, but they could tell it was constricted and treated her with Albuterol. She said that her daughter still cannot walk without assistance this morning. She was treated with Motrin, Benadryl and Atarax, and Prednisone in the hospital. The caller said that her daughter also complained about itching all over and in her throat. The caller said that her daughter did not have a rash though.
13 2021-06-09 chills, fever, sweating, headache Shot at 4 PM Monday. Woke up at 3:30 AM Tuesday feeling very hot and thirsty. Passed out in doorwa... Read more
Shot at 4 PM Monday. Woke up at 3:30 AM Tuesday feeling very hot and thirsty. Passed out in doorway of parents room when looking for assistance, Came to and began to vomit. Vomited several times. Passed out a second time. Ambulance called. Hot, sweaty. Fever and chills, massive headache and generally uncomfortable all day Tuesday. Woke up Wednesday morning feeling 100% fine.
13 2021-06-09 fatigue, dehydration Note- This patient did not receive the vaccine at our facility so I do not have further details on t... Read more
Note- This patient did not receive the vaccine at our facility so I do not have further details on the vaccine. 13 y/o female with hx of juvenille arthritis, migraines and anxiety, here for left sided CP, palpitations, fast HR, SOB since 6/8 receiving the 2nd Covid vaccine on 6/6/21. Pt states she is also having some nausea and fatigue. Pt has not taken any medications at home for pain. Pt currently taking methotrexate but no steriods. No family hx of blood clots or blood disorders. Differential Diagnosis: Electrolyte abnormality, dehydration, arrythmia, COVID vaccine reaction, myocarditis r/t COVID vaccine. EKG NSR. negative troponin.
13 2021-06-09 headache, lethargy Tics, lethargy, "skin is crawling," headache, stomach pains
13 2021-06-09 headache, fever She was observed for 30 minutes in the center of vaccination. At around 40 minutes, she started to s... Read more
She was observed for 30 minutes in the center of vaccination. At around 40 minutes, she started to smell a strange odor, later a strange laryngeal foreign body sensation, her voice changed tone to hoarse (dysphonia). Later she had difficulty breathing through her nose and in seconds general shortness of breath. Marked pallor of skin and lips. Strange sensation of the extremities. She does not remember what happened, she had for a few seconds cloudiness or a sensation of faintness. She spontaneously recovered from the shortness of breath around 5 minutes, time that we were able to get to the emergency room. We consulted the Clinic, emergency room. Where she was observed and monitored for two hours. She recovered well. The evening of 6/5/2021 she had fever up to 100.6, nausea, headache, mild myalgia.
13 2021-06-09 headache Earache, Headache, Pain in arm.
13 2021-06-09 fever, headache Woke up exactly 12 hours after vaccine with the following symptoms: Fever 99.5-100, red cheeks, sh... Read more
Woke up exactly 12 hours after vaccine with the following symptoms: Fever 99.5-100, red cheeks, shaking, body aches, nausea, headache, couldn't lift her arms much. Symptoms lasted 24hours and as fast as they came on, they went away the same. A severe headache remained the second day.
13 2021-06-10 chills, fatigue, headache During monitoring period post initial Pfizer COVID-19 vaccine, patient experienced headache, fatigue... Read more
During monitoring period post initial Pfizer COVID-19 vaccine, patient experienced headache, fatigue, dizziness. VS 141/97, P-157, O2-99% RA. Patient states she did not eat anything today and drank very little fluids prior to administration of vaccine today. Patient began to experience chills, flushing placed in Trendelenburg position. VS: 132/80, HR 105, 02 99%. Patient remained in Observation area for an extended period of time. Nurse remained with her and Mom for duration of observation. After an hour, VS: 130/85, P- 105, O2 100% RA, stated headache lessened.
13 2021-06-10 chills, headache, fever Dizzy; Fever; Headache; Chills; Nausea; This is a spontaneous report from a contactable consumer or ... Read more
Dizzy; Fever; Headache; Chills; Nausea; This is a spontaneous report from a contactable consumer or other non-health care professional. Reported regarding a 13-years-old female patient received second dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EW0165) via intramuscular route of administration and administered in left arm on 06Jun2021 as single dose for COVID-19 immunization. She took the first dose of Pfizer vaccine prior, that was the second shot. The patient medical history and concomitant medications were not reported. Reporters daughter gets the second dose of Pfizer vaccine yesterday (distorted voice) she had a fever, headache, chills and then she was dizzy. reporter called the doctors office he told me it was normal with the vaccine, then today patient called them and the person patient talked to said, because she is dizzy take her to the ER, taking her and they told me to call and report her side effect. It was unknown that Investigation Assessment performed or not. Therapeutic measures were taken as a result of fever, headache, chills, nausea with Tylenol. The outcome of events was unknown. Information on Lot/Batch number was available. Additional information has been requested.
13 2021-06-10 chills, fever, fatigue Patient originally enrolled in COVID19 vaccine trial but tested COVID19 Positive 1/7/2021 and loss s... Read more
Patient originally enrolled in COVID19 vaccine trial but tested COVID19 Positive 1/7/2021 and loss smell and taste. She has since been tested 1/21, 1/29, 2/17 & 5/19. Four of these tests were done during and with the Pfizer study for adolescents. She then came in 5/19 for her 1st Covid vaccine and came also came back positive and experienced a fever and chills after the injection, which mom associated it with her previously having Covid until that test came back positive too. Symptoms since after her vaccine include decreased appetite due to nausea, severe abdominal cramps and when she has a BM it is liquid. Patient reports when she touches cold metal her hands feel as if they are being shocked or burned. Having Headaches and very fatigued will sleep 12 hours+.
13 2021-06-10 lethargy, sweating Patient following administration of the vaccine became lethargic and pulse slowed down. Epinephrine ... Read more
Patient following administration of the vaccine became lethargic and pulse slowed down. Epinephrine was administered and patient was responsive. She did vomit and was hot to the touch and mildly sweaty.
13 2021-06-10 pneumonia Presented to ER with R sided chest pain during football practice. In ER, abnormal EKG with possible... Read more
Presented to ER with R sided chest pain during football practice. In ER, abnormal EKG with possible LVH, elevated troponin. Observed overnight. Her troponin normal by next day. She did have platelet 142K, not repeated (I have ordered). CTA showed incidental R sided pneumonia (she had no fever or cough at presentation). Cardiology consulted. They felt EKG was normal. Discharged on Amoxil. Follow up with cardio ordered, will need stress test.
13 2021-06-10 fever, chills, headache reported Fever, body aches. chills, Nausea, Severe headache which made me take her to Emergency Room... Read more
reported Fever, body aches. chills, Nausea, Severe headache which made me take her to Emergency Room on 6/11/21. Severe headache possibly from Covid Vaccine.
13 2021-06-10 fever, headache, fatigue The first day she had some arm pain, nothing significant. The day after, at 4pm, she had a nosebleed... Read more
The first day she had some arm pain, nothing significant. The day after, at 4pm, she had a nosebleed. The following day, she had 3 smaller nosebleeds. She never gets nosebleeds, so I took her into the Dr. to have labs done, just to make sure her platelet count was good. All tests came back normal. We are on day 3 after her 2nd Pfizer, and she has not had a nosebleed yet today, so I'm hopeful it's resolved. In addition to the nosebleed on day 2, she was exhausted, had a headache and had a low grade fever. These I expected, but not the nosebleeds.
13 2021-06-11 fever, chills, fatigue, malaise Feeling ill by 10 pm of vax date (6/8/2021). Experienced fever, chills, nausea, fatigue. Administe... Read more
Feeling ill by 10 pm of vax date (6/8/2021). Experienced fever, chills, nausea, fatigue. Administered alternating Tylenol/Advil for next 24 hours. Too ill for school on 6/9/2021. Symptoms lasted more than 24 hours; less than 30 hours.
13 2021-06-12 influenza like illness, chills Nauseous and chills (flu like symptoms for 20 hours) Still has body temperature issues. Gets very c... Read more
Nauseous and chills (flu like symptoms for 20 hours) Still has body temperature issues. Gets very cold and shakes periodically still Still has a sore arm
13 2021-06-12 sluggishness After a few minutes, patient stood up to walk around, and became light headed and fell down. Became ... Read more
After a few minutes, patient stood up to walk around, and became light headed and fell down. Became pale and sluggish
13 2021-06-13 fatigue, headache At first I was real tired and had headache. I notice my arm and leg was hives. When I went to doctor... Read more
At first I was real tired and had headache. I notice my arm and leg was hives. When I went to doctor my arms and legs had hives. I did not have hives on my feet and hand. I had took some Benadryl and next morning I had Claritin . It lasted for 24 hours.
13 2021-06-13 headache, body temperature increased Patient is a 13 Y female whose mother was called for adverse reaction to covid 2. Pt received the va... Read more
Patient is a 13 Y female whose mother was called for adverse reaction to covid 2. Pt received the vaccine and she started to get a headache that evening. She was given 2 tylenol (500mg x 2). Her last dose of Tylenol was 930am. She had body aches, temp to 101-104.
13 2021-06-13 sweating WITHIN 10 MINUTES OF VACCINATION, PATIENT EXPERIENCED NAUSEA AND SWEATING. PT DENIED ANY OTHER SYMPT... Read more
WITHIN 10 MINUTES OF VACCINATION, PATIENT EXPERIENCED NAUSEA AND SWEATING. PT DENIED ANY OTHER SYMPTOMS. PT HAD NOT YET EATEN THAT DAY. RPH PROVIDED PT ORANGE JUICE, WATER AND PEANUT BUTTER CRACKERS. PT DRANK ORANGE JUICE. PT DID NOT VOMIT. PT WAS PRESENT WITH PARENT AND PARENT STATED PATIENT WAS FEELING BETTER. PT AND PARENT LEFT AFTER OBSERVATION PERIOD.
13 2021-06-13 fever She woke up the next morning (approximately 14 hours after injection) complaining that she was havin... Read more
She woke up the next morning (approximately 14 hours after injection) complaining that she was having difficulty breathing. I?m an RN so I checked her sats and pulse. Sats were ok at 99% but pulse was 150. Mild fever of 100.5. Gave her water and rechecked pulse but it was still 140-150. Called her doctor
13 2021-06-14 fatigue Immediately after she exp fatigue and pain in left shoulder. Then when she woke up full body, heart ... Read more
Immediately after she exp fatigue and pain in left shoulder. Then when she woke up full body, heart palpitations and tightness in throat causing her having trouble breathing. Her Epipen shot to relieve her pain and she followed up at the hospital. The symptoms that are lingering which happened after 1st Dose sensation of throat(uncomfortable for her to swallow) and fatigue.
13 2021-06-14 headache Headache,dizziness, shoulder ache. Transported to medical screening via wheelchair for evaluation by... Read more
Headache,dizziness, shoulder ache. Transported to medical screening via wheelchair for evaluation by paramedics. Per medic, vitals within normal range. Left in stable condition at 12:35 p.m. Recorded by RN. Paramedic.
13 2021-06-14 fever, headache admitted to pediatric unit of hospital June 7th 2am with high fever over several days; severe headac... Read more
admitted to pediatric unit of hospital June 7th 2am with high fever over several days; severe headaches; projectile vomiting; started night of June 6th and symptoms ended June 9th. Triggered intense emotional distress as well requiring psychiatric hospitalization once medically stable.
13 2021-06-14 fever vomiting, abdominal pain, fever, hypotension; required ICU admission
13 2021-06-15 dehydration Patient fainted within a minute after receiving her COVID vaccine at the vaccine clinic on 6/5/2021.... Read more
Patient fainted within a minute after receiving her COVID vaccine at the vaccine clinic on 6/5/2021. Her father was watching the administration process and asked if the needle stayed in her arm after the needle retracted. The nurse answered, 'These needles retract back into the syringe.' Father continued, 'She did received the whole vaccine? It looked like it stayed in her arm..' The patient looked at the syringe and fainted when she didn't see the needle at the end of the syringe. The vaccinator noticed the patient's head tilt back and the vaccinator held her head and helped her to the ground and elevated her legs. Patient recovered within a minute after fainting. Patient was able to walk to the observation room with little to no assistance where vitals were taken. 102/80-87. Pulse Ox 96%. No respiratory symptoms,. Color good and felt back to normal by the time we got her back to the observation room. Drank 2 bottles of water. Patient had played soccer that morning, had eaten but admitted that she was dehydrated.
13 2021-06-15 headache, fever, chills got chills; fever; headache; This is a spontaneous report from a contactable consumer. A 13-year-old... Read more
got chills; fever; headache; This is a spontaneous report from a contactable consumer. A 13-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 14May2021 (Batch/Lot number was not reported) as first dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 14May2021 at night, patient got chills, fever, and headache. The patient's mother gave her 1 Tylenol. By 1:30 am, her fever was 103, her mother gave her two Tylenol and fever went to 100. At 7:30 am, 15May2021, her fever was back to 103 and her mother gave her two Tylenol again, fever went back to 100. At 3:25 am on 16May2021, fever was 103.5. Her mother gave her two Tylenol and went back to 100. Outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
13 2021-06-15 headache She woke up Sat with headache, body aches and muscle aches. Around 10:30 pm night she was became diz... Read more
She woke up Sat with headache, body aches and muscle aches. Around 10:30 pm night she was became dizzy passed out fell down the stairs. I took her to the ER she required stitches (chin) and had some test to rule of chest pain.
13 2021-06-15 fever, headache Fever of 102, headache.
13 2021-06-16 sweating Patient is a 12 year old female arrived to observation area complaining of nausea, weakness, noted t... Read more
Patient is a 12 year old female arrived to observation area complaining of nausea, weakness, noted to be diaphoretic. Instructed patient to remain calm, relax. arrived to scene for further evaluation. Vital signs rendered EKG rendered. Pt. denies any pain, discomfort. Pt. refused hospitalization. Pt. recovered from adverse event and left via personal vehicle with mother at 4:10pm.
13 2021-06-16 malaise Patient complained of not feeling well after being administered with pfizer vaccine, she said she wa... Read more
Patient complained of not feeling well after being administered with pfizer vaccine, she said she was cold, a little shaky, & nauseous. Checked her BP it was very low, elevated her feet, checked her BP several times after that and BP went up to 120/78. Called 911 because she was still not feeling well. EMS checked glucose level and it was low (patient did not have a meal all day). EMS said it was vasovagal syncope however patient did not pass out. Patient recovered while EMS was still on site.
13 2021-06-16 throat pain, fatigue, fever, headache Complained of SOB, "crampy, sharp" non-radiating substernal chest pain (fluctuating in severity, the... Read more
Complained of SOB, "crampy, sharp" non-radiating substernal chest pain (fluctuating in severity, the most severe becoming 8/10), fatigue, palpitations, HA, and sore throat which started on 6/14/21. Pt received her second Pfizer COVID19 immunization on 6/11/21. The first symptom to start was sore throat on 6/14/21, however Pt underwent negative strep and mono testing that same day. Pt's other sx began shortly thereafter, the most distressing symptom being the chest pain and SOB. ED Course: --febrile (39.3), tachycardic, and tachypneic which met SIRS criteria --received 20cc/kg fluid bolus --first doses of vancomycin, Zosyn started; Pt reported flushing and pruritis with vancomycin administration Currently hospitalized
13 2021-06-16 fever, fatigue nausea; vomiting; low grade temp 100; general tiredness; continuous stomach ache; This is a spontane... Read more
nausea; vomiting; low grade temp 100; general tiredness; continuous stomach ache; This is a spontaneous report from a contactable consumer. A 13-year-old non-pregnant female patient received BNT162B2 (PFIZER COVID-19 VACCINE, solution for injection, batch/lot number was not reported), via intramuscular route of administration, administered in arm left on 04Jun2021 17:30 (05:30 PM) (at the age of 13-year-old and non-pregnant at the time of vaccination) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. The patient experienced about 36 hours after the injection patient had nausea, vomiting, low grade temp 100, general tiredness continuous stomach ache on 06Jun2021 05:00 AM. The patient underwent lab tests and procedures which included low grade temp was 100 on 06Jun2021. The patient received Pepto bismol tablets and Tylenol as a treatment medication for the events nausea, vomiting, low grade temp 100, general tiredness continuous stomach ache. Outcome of the events was recovered on an unspecified date in 2021.
13 2021-06-16 fever Fever, arm pain, passing out
13 2021-06-16 fever Rash in the form of small raised bumps and hives on torso, itching appeared 2 days after vaccine was... Read more
Rash in the form of small raised bumps and hives on torso, itching appeared 2 days after vaccine was taken, after fever broke. Antihistamine (children's zyrtec) was administered for 3 days. Rash did not change in appearance, but itchiness went away.
13 2021-06-17 fatigue, fever Called by pharmacy staff to patient who was feverish and non responsive in a chair in the aisle. Pat... Read more
Called by pharmacy staff to patient who was feverish and non responsive in a chair in the aisle. Patient was lied on the floor, ice pack applied. She came to and wanted to sit in the chair. Was offered apple juice. After a few sips, she slumped and became unresponsive. Her breathing was shallow. Mother said she had not eaten or drunk anything today. She was lied on the floor again and remained non responsive and then said she was extremely tired. 911 was called, ice was continually applied. Patient did become responsive and drank 6 ounces of apple juice before EMS arrived. She was taken by stretcher by EMS for evaluation.
13 2021-06-17 headache, cough, fatigue, malaise 6/13 Sunday she was tired and achey, T 100. 6/14 Monday, she said her stomach hurt and headache at t... Read more
6/13 Sunday she was tired and achey, T 100. 6/14 Monday, she said her stomach hurt and headache at the end of the day. 6/14 during the night she woke up her Mom and said her chest hurt. She has mild exercise induced asthma. She said her chest felt tight, and it hurt to breathe. She went back to sleep in Mom's bed. She got up very early 6/15. She took a shower, and it helped. She does look like she has laboured breathing, she does seem uncomfortable or unhappy. No fever today, not checked, but does not feel warm. She does have an inhaler, she did use it, but didn't help. She did eat and drink 6/15. She ate cold cantaloupe, and it helped her feel better. Is not complaining of burning. She has not done anything strenuous at camp yesterday. She does not have a history of seasonal allergies. Not in distress. No runny nose, she has had a little cough, when she breathes deeply. No rash on her body. She did feel nauseated 6/15. No diarrhea. Evaluated at PCP's office . Chest pain/difficulty breathing resolved on 6/16
13 2021-06-17 headache Her period had advanced and the bleeding persisted; Headache; This is a spontaneous report from a co... Read more
Her period had advanced and the bleeding persisted; Headache; This is a spontaneous report from a contactable dentist (Patient's mother reported for her daughter) via medical information team. A 13-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), second dose via an unspecified route of administration on an unspecified date (at the age of 13-year-old), as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of vaccine bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date, as a single dose for COVID-19 immunisation and her period had advanced. Patient's mother reported that she was a dentist, and a mother of 13-year-old. She took her daughter to get the COVID-19 vaccine and noticed that she did not show any reaction during the first dose only her period had advanced. On arrival the second dose plus a reported headache the bleeding persisted. Patient's mother took the patient to doctor yesterday and learned that this was a severe vaccine reaction in her opinion. The patient's mother would like to know if this could compromise patient's health in the future (mainly reproductive) because patient's mother not calm in knowing. The patient's mother reported events as non-serious. The outcome of the event headache was reported as unknown and for another event outcome was reported as not recovered. Information regarding the lot/batch number has been requested.
13 2021-06-17 fever Mom noticed she experienced tremors last night after 2nd dose and it has gone away this morning. Whe... Read more
Mom noticed she experienced tremors last night after 2nd dose and it has gone away this morning. When she woke up, she had a 102.5 F fever and a massive migraine. Mom just gave her Advil 200mg one dose after she measured the fever. Pharmacist recommended mom to give her another 200mg Advil and to seek prompt medical attention if her fever does not break or she begins to experience any other symptoms.
13 2021-06-18 fatigue, fever Shortness of breath, near syncope, decreased hearing, fever 101.7 degrees F, fatigue, imbalance in s... Read more
Shortness of breath, near syncope, decreased hearing, fever 101.7 degrees F, fatigue, imbalance in standing but dizziness, soreness to right upper extremity( injection site), pallor lips and face Denies palpitation, nausea, headache.
13 2021-06-18 headache, sweating Very sore arm, headache, hot sweats Acetaminophen, water
13 2021-06-18 sweating, headache, fever, chills, cough, fatigue tired; chest heaviness; asthma like cough; shortness of breath; aches; sweating; shivering; feeling ... Read more
tired; chest heaviness; asthma like cough; shortness of breath; aches; sweating; shivering; feeling like she was "thinking really weirdly" like she was "dreaming but awake" during the night; dizzy; her heart feels really fast and pulse this morning; fever at 6am this morning 101.2. Now down to 99.7 after taking tylenol at 6am; She was up a lot of the night; headache; This is a spontaneous report from a contactable consumer (Patient Mother) reported for a 13-year-old patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 03Jun2021 09:30 (At the age of 13 year) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included, thrombosis (blood clots but not DVT's), mast cell activation syndrome (mast cell activation stuff especially near her periods), device malfunction, she also has a VP shunt. There were no concomitant medications. The patient previously took first dose of BNT162B2 for COVID-19 immunization. It was reported that Consumer calling on behalf of her 13-year-old daughter, birthday of DOB, who received the second dose of the Pfizer Covid 19 vaccine yesterday at 9:30am. She reports the following side affects her daughter has experienced: headache that started within an hour of getting the vaccine, by lunch she was tired, chest heaviness, an asthma like cough, a little bit of shortness of breath but her pulse ox is 98%, aches started when going to bed last night, sweating, shivering and feeling like she was "thinking really weirdly" like she was "dreaming but awake" during the night, very dizzy, head feels like it has a heart beat in it, her heart feels really fast and pulse this morning was 130 on the pulse ox, right now standing her pulse is 150, fever at 6am this morning 101.2. Now down to 99.7 after taking tylenol at 6am. It was reported that "She was up a lot of the night but did not want to bother us. It was reported that She has a history of "blood clots but not DVT's, mast cell activation stuff especially near her periods and she also have a VP shunt. Reporter want to know Is this an allergic reaction or could it be. Post Covid vaccine is anyone reporting pericarditis or chest heaviness, when would pericarditis occur. The patient underwent lab tests and procedures which included body temperature: abnormal Fever at 6am this morning 101.2. Now down to 99.7 after taking tylenol at 6 am, oxygen saturation: abnormal pulse this morning was 130 on the pulse ox, right now standing her pulse is 150. The outcome of events was unknown.
13 2021-06-18 sweating PATIENT FAINTED SOON AFTER VACCINE. PATIENT WAS HOT AND SWEATY AND NAUSEAOUS. PATIENT' S BLOOD PRES... Read more
PATIENT FAINTED SOON AFTER VACCINE. PATIENT WAS HOT AND SWEATY AND NAUSEAOUS. PATIENT' S BLOOD PRESSURE DROPPED
13 2021-06-18 fever, chills, throat pain Fever, chills, sore throat , nausea
13 2021-06-18 fever, headache On Day 3 evening, one hive appeared, with redness/swelling just below injection site. On Day 4 eveni... Read more
On Day 3 evening, one hive appeared, with redness/swelling just below injection site. On Day 4 evening, multiple hives (around 20) appeared, then merged into one larger mound (around 1.5" x 2"). Previously, on Day 1 evening, soreness of arm and fever started. Fever reached 103.4 degrees. Fever lasted 2 days but lower grade - 101 degrees or so. Day 2 saw bad headache and armpit pain. Day 5 seems to have recovered from hives, but will continue to watch.
13 2021-06-18 fever Super high fever. Severe chest pain. Trouble breathing. Patient taken to emergency room. X rays ... Read more
Super high fever. Severe chest pain. Trouble breathing. Patient taken to emergency room. X rays taken. Patient was given tylenol
13 2021-06-19 headache Right groin 2 CM lymph nodes swelling 2 days post Pfizer vaccine. Headache and muscle soreness at... Read more
Right groin 2 CM lymph nodes swelling 2 days post Pfizer vaccine. Headache and muscle soreness at injection site few minutes after the vaccine
13 2021-06-19 headache Systemic: Dizziness / Lightheadness-Severe, Systemic: Headache-Medium, Systemic: Hypertension-Medium... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Headache-Medium, Systemic: Hypertension-Medium, Systemic: Tachycardia-Medium, Additional Details: patient experienced syncope about 15 minutes after vaccine given...lasted around 30 minutes
13 2021-06-19 fever, headache chest pain, palpitations, and headache starting at 9am on 6/18 after receiving 2nd dose of pfizer va... Read more
chest pain, palpitations, and headache starting at 9am on 6/18 after receiving 2nd dose of pfizer vaccine on 6/13; noted to have a fever on arrival to ED, admitted to hospital and was noted to have sinus tachycardia without arrhythmia; underwent several tests including CT angio, echocardiogram; no clear identified etiology but per discussion with cardiology, suspected transient myopericardial or pleural inflammation from vaccine, improved with motrin
13 2021-06-19 fever 13 year old previously healthy female presenting with chest pain. Per patient, chest pain started t... Read more
13 year old previously healthy female presenting with chest pain. Per patient, chest pain started this AM on 6/18/21, described as substernal, pleuritic, unable to describe what it feels like. Was constant, sometimes radiating superiorly. Also reports light-headedness when standing quickly that preceded the chest pain. associated with shortness of breath. Had isolated low grade fever to 100.2 the night before, otherwise afebrile without cough, congestion, abdominal pain, N/V/D, rash, or leg swelling. Of note, patient received 2nd COVID vaccine 2 days prior to symptom onset (6/16/21). Patient seen at Hospital, got EKG which was normal. Troponin elevated at 0.83, elevated CK 701. Was transferred for concern for myocarditis, in the setting of recent 2nd dose COVID vaccine 2 days ago. Hospital (on 6/18/21): CBC WNL. Electrolytes WNL. AST, Bili mildly elevated. ESR, CRP elevated. Troponin 19. EKG normal. COVID neg. Received Tylenol and Motrin x1.
13 2021-06-20 fatigue 13-year-old otherwise healthy female presents to ED by ambulance for chest pain. Patient received he... Read more
13-year-old otherwise healthy female presents to ED by ambulance for chest pain. Patient received her second dose of the Pfizer vaccine on 6/18. The following day, patient had generalized fatigue, sore arm, and one episode of nonbloody nonbilious emesis. Yesterday, patient began to have intermittent midsternal chest pain which radiates to the back. Patient reports symptoms worsen with movement, walking, and deep inspiration. She denies any shortness of breath, or palpitations. She denies any headache, lightheadedness, fevers, chills, diarrhea, abdominal pain, or dysuria. No cardiac family history per mom. Patient did not have any symptoms after her first Pfizer vaccine. Differential Diagnosis: Chest pain, costochondritis, myocarditis secondary to vaccine.
13 2021-06-20 headache She had chest pain in her middle chest and to the left of middle. At first the pain was moving, it w... Read more
She had chest pain in her middle chest and to the left of middle. At first the pain was moving, it was up higher and down to ribs and is not upper chest, center chest and left of center of chest. hurts when breathing. She went to ER hour and half after pain started and then her leg, upper thigh, started hurting. elevating her leg helped the leg pain. The leg pain has gotten better. She also had a bad headache the first night and the night after the vaccine but the headaches have gotten better since.
13 2021-06-20 headache 13 y/o F with hx of exercise-induced asthma BIB mom for dizziness and chest pain s/p Pfizer COVID-19... Read more
13 y/o F with hx of exercise-induced asthma BIB mom for dizziness and chest pain s/p Pfizer COVID-19 vaccine received yesterday. Pt endorses nausea, HA, chest pain and SOB. No fever. Chest pain currently. Pt took albuterol 1.5 hours PTA. Pt usually only needs albuterol with physical activity. NO PMH/PSH. Vaccines UTD. NKDA. Differential Diagnosis: vaccine reaction, myocarditis, pericarditis, costochondritis. After assessment and treatment, pt is well appearing, explained to mom on reassessment symptoms have resolved, no chest pain currently. Explained symptoms likely secondary to vaccine reaction, explained normal heart enzymes and normal EKG, strict return precautions given including chest pain and fever.
13 2021-06-20 lethargy, fatigue Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainti... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Mild, Additional Details: patient passed out 3 times after giving the vaccine i checked her blood pressure and it was 92/62 i lift up her legs and offerd her the epipen but she refused.her parents tried to convience her to get epipen but she also refused.she spent about half hour in the store and she became good and went to home. i called her after 1 hour and she was fine
13 2021-06-22 fatigue, headache, head discomfort, fever, chills That evening patient stated that she was having body aches and chills. Patient passed out. Patient h... Read more
That evening patient stated that she was having body aches and chills. Patient passed out. Patient had fever. 911 was called. When patient stood up her heartrate increased. Headache was constant for nine days. Head felt funny. Patient experienced a high level of fatigue.
13 2021-06-22 sweating Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Pt.... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Pt. came into the pharmacy to get a 2nd dose of Covid-19 vaccine. 1st dose was on 6/1/21, with a hx of an adverse reaction of dizziness/pale Asked pt & her dad if she was fine after that incident-Pt. states she was totally fine when she got home so wanted to get 2nd dose. Shot was given ~4:15pm, and when I checked pt. if she's ok, she started to pale and told me she was dizzy. Called paramedic ~4:25pm and around 4:55pm paramedic teams walked pt. out, pt. seemed fine, and confirmed she was fine
13 2021-06-23 fatigue, fever Daily fever over 101 and fatigue starting the day after the vaccine and persisted for over 10 days. ... Read more
Daily fever over 101 and fatigue starting the day after the vaccine and persisted for over 10 days. fever of unknown origin work up was negative.
13 2021-06-23 sweating, headache Within minutes of receiving vaccine, pt verbalized feeling dizzy with a headache. Pt became pale and... Read more
Within minutes of receiving vaccine, pt verbalized feeling dizzy with a headache. Pt became pale and diaphoretic. Pt's lower extremities were elevated, ice pack applied to back of the neck and vital signs obtained. Juice and crackers were given. Within several minutes, Pt verbalized symptoms resolved and was ready to go home. Pt will lie down to receive second dose of Pfizer vaccine.
13 2021-06-23 malaise 13 YO F, 84 lbs, presented syncope, pt fainted 2 min after COVID vaccine, pt and mom corroborated th... Read more
13 YO F, 84 lbs, presented syncope, pt fainted 2 min after COVID vaccine, pt and mom corroborated that patient had not had breakfast or lunch, this event occurred at 3:30 pm. Patient verbalized being nervous prior to vaccination. Pt could not recall last time she had water. As soon as patient complained of feeling faint, patient was handed a water bottle and blood pressure was taken, reading on left arm was 62/47 83 bpm heart rate, pt was then given a Coca-Cola and a glucose tab. Patient reported feeling better after 5 min, then began complaining that she did not feel well again. Patient then fainted again, I popped an ammonium vial, and 2 ice packs. Took BP again and was 65/50, called 911, called a code white and let store manager know and once paramedics presented to patient, patient BP was 116/75 98 bpm, pt had regained color, and stated she felt better. Mom turned down offer to take patient to hospital, as patient stated they felt better.
13 2021-06-24 headache 1st night couldn't sleep 2nd day headache that wouldn't go away along with dizzy/light headedness 3r... Read more
1st night couldn't sleep 2nd day headache that wouldn't go away along with dizzy/light headedness 3rd day about an hour after her evening peanut immunotherapy dose of 4 peanuts her skin got very itchy, burning hot, red with some hives. She said her throat felt swollen. A couple hours after a double dose of benadryl and ice packs she began to improve. 4th day she was much better. We spoke with her allergist over the phone, and he said it was reasonable to chalk the reaction up to extra stress on her body due to the vaccine/her bodies response to the vaccine. We only did half her peanut dose. 5th day she was normal.
13 2021-06-24 fever, chills, fatigue fever; chills; fatigue; This is a spontaneous report from a non-contactable consumer (patient, self-... Read more
fever; chills; fatigue; This is a spontaneous report from a non-contactable consumer (patient, self-reported) via Pfizer sales representative. A 13-year-old female patient received second 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 unspecified date, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included 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 unspecified date, as a single dose for COVID-19 immunization. The patient reported that 2 sisters experienced similar symptoms. On an unspecified date, the patient experienced fever chills and fatigue which resolved in 24 hours. The events took place after use of product. The reporter did not wish to be contacted for follow-up. Outcome of the events was resolved on an unspecified date. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
13 2021-06-25 headache, chills, fever Fever, chill, headache
13 2021-06-26 sweating, malaise Patient said she felt immediate, strong pain in her arm from the jab the nurse gave her. She said t... Read more
Patient said she felt immediate, strong pain in her arm from the jab the nurse gave her. She said the needle was in her arm a lot longer than when she received her first shot. I also watched patient receive her first COVID shot from a different provider, different facility, and I was surprised by the force of the jab of this second COVID shot, and length of time the needle was in her arm. After the nurse left us in the room to wait 15 minutes, patient became more and more uncomfortable, hot, sweaty and nauseous. Within 5 minutes, she was lying down on the exam table - at which time I alerted staff at the nurse's station in hallway that patient wasn't well and we needed help. She said she would get "the provider" and be right in. When I walked back into the room, patient was curled up in a ball on the table, pale, clammy and not able to speak. I yelled down the hallway for help right away, and stepped back into the room. Patient then began to vomit. At least two nurses entered the room, and began to assess her vitals. Her blood pressure was low, but she was breathing fine. 'The provider" (I don't know his name) came in and I told him about how hard she was jabbed, and that she began to feel badly immediately afterward.
13 2021-06-27 headache Patient received COVID-19 shot and shortly after passed out hitting her head on the floor. Paramed... Read more
Patient received COVID-19 shot and shortly after passed out hitting her head on the floor. Paramedics were called to check her out. We did a wellness check patient had a headache but otherwise was fine.
13 2021-06-27 sweating A few minutes after the injection, she smelled a strange smell, started to sweat, felt like throat w... Read more
A few minutes after the injection, she smelled a strange smell, started to sweat, felt like throat was closing and couldn't breathe, and started panicking. An epi-pen was administered and 911 was called. The EMS team took her to the hospital by ambulance where she was monitored for a few hours until released.
13 2021-06-27 fever vomited diarrhea fever red marks everywhere extremely itchy pediatrician benedryl
13 2021-06-29 headache Shortness of breath, weakness, headache ? Vaccine RXN Orthostatic Hypotension Nausea
13 2021-06-30 headache 1530 - Patient received first dose of Pfizer vaccine, had syncopal episode and hit back of her head ... Read more
1530 - Patient received first dose of Pfizer vaccine, had syncopal episode and hit back of her head (in observation area). Stated she did not have anything to eat today and she feels anxious/nervous when she comes to the hospital or doctor's office. Mother assisted patient off the ground and onto a chair. Assisted patient onto gurney, vital signs taken 119/80, HR 90, 97% on RA, resp 18. Awake, alert and oriented, complains of pain on back of her head 4/10. Mother agreed to have paramedics called for transfer to emergency room. 1600 - Paramedics arrived, evaluated patient. Mother refused paramedic transport. Patient assisted onto wheelchair, mother stated she will take patient to emergency room in wheelchair. Risks/benefits explained. Mother gave verbal understanding.
13 2021-06-30 sweating Patient fainted/passed out approx 10 minutes after vaccine admin, was shaky and sweating
13 2021-07-01 fatigue Pain in chest, burning sensation in chest, shortness of breath and tired with normal walking and tal... Read more
Pain in chest, burning sensation in chest, shortness of breath and tired with normal walking and talking.
13 2021-07-01 headache Pt had syncope, headache about 18 hours s/p vaccination
13 2021-07-02 sweating PEDIATRIC PATIENT RECEIVED SHOT WHILST FATHER PRESENT AFTER SHOT HE STEPPED AWAY, THEN CHILD CLOSED ... Read more
PEDIATRIC PATIENT RECEIVED SHOT WHILST FATHER PRESENT AFTER SHOT HE STEPPED AWAY, THEN CHILD CLOSED HER EYE SHE LOOKED LIKE HER LIMS WERE SHAKING PER FATHERS OBSERVATION, THIS OCCURED FOR NO MORE THAN 2-5 SECONDS TECHNICIAN GAVE VACCINE. HE ALERTED ME AND I CAME OVER WITHIN 30 SECONDS. PATIENT WAS AWAKE LOOKED A BIT PALE AND HER PARENTS HAD LIFTED HER FEET UP. SHE TALKED TO ME EXPLAINING THAT SHE REMEMBERED THE BLOOD AND THE NEEDLED AND SHE DOESNT LIKE NEEDLES SHE THEN DOESNT REMEBER ANYTHING FROM WHAT SHE SAW THEN SHE DREAMED. SHE WAS ABLE TO WALK OUT THE CUBICLE AND SIT DOWN, AFTER 5 MINUTES SHE APEARED TO BE MORE SWEATY AND HOT LAYING ACROSS HER MOTHER , MOTHER GAVE HER SOME SODA-FLUID. I THEN CALLED EMERGENCY SERVICES, THEY CAME BY 5:25PM TO 5:30PM TOOK HER IN THE TRUCK TO OBSERVE, AFTER 15MINUTES OR MORE THE PARENTS CAME INTO THE DRIVE THRU AND SAID THEY WERE TAKING HER HOME SHE WAS FEELING BETTER.
13 2021-07-03 headache, fatigue Headache, chest pain, body aches, tired. Chest pain, in the ribcage area just started 33 hours afte... Read more
Headache, chest pain, body aches, tired. Chest pain, in the ribcage area just started 33 hours after the 2nd dose
13 2021-07-03 fever, fatigue Patient is a 13-year-old who was transferred from another hospital for chest pain in the setting of ... Read more
Patient is a 13-year-old who was transferred from another hospital for chest pain in the setting of Covid vaccination. She received her second dose of Pfizer vaccine on Tuesday, June 29. On Wednesday she developed fatigue chest pain shortness of breath weakness, nausea and mild abdominal pain. She also had a fever to 102.5 Fahrenheit. mom is a nurse and took her pulse and felt that it was 30 and fast. She then took 1 with her home equipment it was in the 120s. She called her neighbor who took her pulse and it was in the 130s. She then transferred her to another Hospital for further care at hospital her vital sinus evaluation was a temperature of 37.4 pulse 119 respiratory rate is 15 blood pressure 106/62 satting 98% on room air. On exam she was well appearing with tenderness to palpation of sternum heart rate normal rate and rhythm lungs clear bilaterally and abdominal exam benign. they obtain CBC with white count of 4.8 hemoglobin 12.9 Camm that was unremarkable LFTs are within normal limits troponin that was negative BNP 223 with a normal upper limit of 125 ESR 2 D-dimer 0.697 with upper limit of normal 0.5 and a CRP of 9 with upper limit of normal of 8.1. UA bland. She was given Toradol for chest pain EKG with sinus tachycardia . She was given 1/2 L normal saline bolus ondansetron Toradol and started on maintenance IV fluids of D5 NS. She was then transferred to another hospital for further care . Upon arrival here she notes improvement in her energy level and all of her pain except for her chest pain. She describes it as a pressure on top of her chest that is right in the center and is worse with movement and deep breaths. Of note she had a appendectomy a few years ago that was complicated by surgeons making the bowel and then required her to have a bowel resection. She has no dietary restrictions and eats by mouth, no GI complications in the long-term. PMH: as above PSH: No significant past surgical history FH: Reviewed and noncontributory to current presentation SH: Lives with caregivers Meds: None Allergies: No known drug allergies Immunizations: UTD Review of Systems Constitutional: fever, no chills, no sweats, fatigue Skin: no rash, no lesions, Eye: no redness ENMT: no ear pain, no sore throat, no congestion, no hoarseness Respiratory: + shortness of breath, no cough, no wheezing Cardiovascular: + chest pain, no palpitations, Gastrointestinal: + nausea, no vomiting, no diarrhea, no GI bleeding Genitourinary: no dysuria, no hematuria, Musculoskeletal: + muscle pain, Neurologic: no headache, no dizziness, no numbness, no weakness Psychiatric: no sleeping problems, Allergy/Immunologic: no recurrent infections, Additional ROS info: All other systems of a 10 system review are negative. Briefly, patient is presenting with chest pain, myalgias, and fever in setting of recent covid vaccine (2nd dose Pfizer 2 days ago). Seen at an outside hospital where labs were notable for mildly elevated BNP and D-dimer, negative troponin, normal LFTs and chemistries. Chest x-ray reportedly negative. EKG with T wave inversions in V1 through V4 (read as nonspecific ST changes by their physician), but otherwise normal. Given the possibility of post Covid vaccine myocarditis or PE, transferred for further management. Patient states that after Toradol that she received the outside hospital all of her other symptoms have resolved but she continues to have chest pain. My exam showed: Gen: tired but nontoxic appearing, no acute distress, alert and active; HEENT: PERRL, EOMI, normal conjunctiva, neck supple without LAN; Chest: significant reproducible chest pain; Card: RRR, no murmur, good perfusion, brisk radial pulses bilaterally; Lungs: CTAB, good air entry, no increased WOB; Abd: soft, non-tender, non-distended, no masses; Ext: warm and well perfused, moving all extremities; Skin: no rashes Chest pain. Overall well appearing with normal exam with reproducible tenderness. Given recent Covid vaccine, must consider myocarditis, although only mildly elevated BNP and negative troponin at the outside hospital are reassuring, especially given reproducible pain and reassuring EKG. Symptoms then may represent musculoskeletal etiology such as costochondritis or myositis related to vaccination. Less likely pneumonia or pneumothorax, but possible. Low suspicion for PE given lack of persistent tachycardia (tachycardia improved while in ED, currently HR 80s) or hypoxia. EKG obtained which showed T wave inversions in V1-V4 (normal for age). Bedside ultrasound with normal global function and lack of pericardial effusion. Labs obtained in BCH ED notable for negative BNP and troponin, along with reassuring lipase given abdominal pain. Thus, unlikely to be true myocarditis, more likely musculoskeletal etiology such as costochondritis or chest wall pain. Cardiology will discuss with mom for reassurance. Final Diagnosis 1. Chest pain R07.9 2. Fever R50.9 3. Fatigue R53.83 4. Shortness of breath R06.00 PLEASE NOTE: Since the patient is not from here, we do not have access to her vaccination records and cannot supply lot number, etc.
13 2021-07-04 chills, fever Patient received second dose of Pfizer vaccine on 6/10/21. 12 hours after administration she develop... Read more
Patient received second dose of Pfizer vaccine on 6/10/21. 12 hours after administration she developed fever (Tmax 103F), chills, myalgia. On 6/13/2021, she developed vaginal mucositis prompting hospital admission for evaluation and pain management. She was originally discharged with supportive care (Tylenol/ Motrin for pain) and if needed triamcinolone 0.1% cream. Per chart check, she was seen by PCP six days later and had not yet started triamcinolone cream and still in pain. PCP prescribed topical clobetasol, and oral prednisone 20mg BID for 5 days based on dermatology recommendations for treatment of Lipshutz ulcers.
13 2021-07-05 malaise, sweating About 2 mins after the vaccine was administered patient stated that she did not feel good. She was h... Read more
About 2 mins after the vaccine was administered patient stated that she did not feel good. She was hot, pale, sweaty, nauseas, almost passed out. We laid her on the floor and elevated her legs, then she started feeling better. The paramedics came. BP was 90/48. when they left her BP was 101/60. Her parents decided to take her home for observation. I called them at 7:58pm and mom said she was perfectly fine. Vaccine given at 4:55, paramedics left at 5:20.
13 2021-07-06 headache, chills, fatigue, fever 102 fever, chills, headache, body aches, nausea, fatigue, and hallucinations. Fever stayed between ... Read more
102 fever, chills, headache, body aches, nausea, fatigue, and hallucinations. Fever stayed between 99.8 and 102 and lasted 32 hours. Ibuprofen and Tylenol was given every 4-6 hours.
13 2021-07-07 cough Cough beginning day after vaccination and continuing now 7 weeks later; no chest pain, no shortness ... Read more
Cough beginning day after vaccination and continuing now 7 weeks later; no chest pain, no shortness of breath. possibly coincidental
13 2021-07-07 fever Patient has Pericardial Effusion and pericarditis and required a pericardial drain. This even happen... Read more
Patient has Pericardial Effusion and pericarditis and required a pericardial drain. This even happened 3 weeks after the vaccine and the symptoms the patient had following the vaccine were persistent fevers.
13 2021-07-08 sweating Approximatly 10min. after patient recieved her vaccine she was seen slumping over onto her mother an... Read more
Approximatly 10min. after patient recieved her vaccine she was seen slumping over onto her mother and hyperventilating. RN was then notified and arrived to help coach patient to slow her breathing down and to take even breaths. Vitals were taken at 0950:BP-110/70,HR-90,RR-20. Skin was pale and diaphoretic. Patient then was given water and crackers and transferred to lay down in a non-stimulating environment. At about 1015 her vitals were retaken:BP-115/80,HR-100,RR-18. Skin was normal pallor and non-diaphoretic. After a few minutes in the sitting position, then standing and soon she was ready to leave. mother was advised on when to seek medical attention for signs and symptoms of anaphylaxis.
13 2021-07-08 malaise Pfizer vaccine was administered on 6/30/21. On 7/1/21 mother reported that the patient was feeling f... Read more
Pfizer vaccine was administered on 6/30/21. On 7/1/21 mother reported that the patient was feeling fine, just a sore arm. On 7/9/21 mother reported that the patient is experiencing malaise and a sore arm.
13 2021-07-09 headache My daughter got an intractable headache the Tuesday after getting the vaccine. The headache was not... Read more
My daughter got an intractable headache the Tuesday after getting the vaccine. The headache was not treatable through normal pain relievers such as Tylenol and Ibuprofen. The pediatrician told us to take her to the ER. At the ER, they tested her for intercranial hypertension, as she had no history of migraines in the past. The tests turned out negative. They tried the normal migraine cocktail, Depakote, Decadron and magnesium. None of the typical treatments worked to relieve the headache. She was admitted to the hospital. She had a neurology consultation, which didn't show any neurological issues. The doctor also did an MRI. The MRI didn't show anything abnormal. The doctor started her on DHE (dihydroergotamine). The medication began to help relieve the headache. My daughter could not tolerate 0.5mg DHE, so the doctor gave her 2 more 0.4mg DHE treatments which eventually brought the headache down to a pain level of 0.
13 2021-07-10 sweating Systemic: Fainting / Unresponsive-Severe, Systemic: Sweating-Severe, Systemic: Nausea-Severe
13 2021-07-10 fever, headache Her temperature it was 101.5; Crashing headache; This is a spontaneous report from a non-contactable... Read more
Her temperature it was 101.5; Crashing headache; This is a spontaneous report from a non-contactable consumer or other non hcp. A 13-years-old female patient received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number EW0217) via an unspecified route of administration on 25Jun2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient received historical vaccine of first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number not reported) via unspecified route of administration on unspecified date as a dose 1 single for covid-19 immunisation. The patient experienced crashing headache on Jun2021, her temperature it was 101.5 on 26Jun2021. Therapeutic measures were taken as a result of crashing headache, her temperature it was 101.5. The patient underwent lab tests and procedures which included body temperature 101.5 on 26Jun2021. The outcome of the event headache was not recovered, and the outcome of the events pyrexia was unknown. No follow-up attempts are possible. No further information is expected.
13 2021-07-12 fatigue PT STATED SHE FELT TIRED AFTER WAITING 15 MINS.
13 2021-07-12 headache, throat irritation Within 15-20 seconds of receiving the injection, my daughter who has NO history of seizures or healt... Read more
Within 15-20 seconds of receiving the injection, my daughter who has NO history of seizures or health issues of any kind, , began having seizures. Her skin color becamee gray, her lips turned blue. The seizure last approximately 20 seconds and when she came out of it she was able to breathe but said her throat felt funny, scratchy, smaller - but she was still able to breathe. She was nauseous, head hurt and was very disoriented for approximately 20-30 minutes. The pharmacist called 911. 911 arrived and took her blood, did a multitude to tests which all came out ok. We opted not to take her to the hospital as she was breathing ok, and her color was returning.
13 2021-07-12 headache pain in bilateral eyes; left hand and left leg numbness; tongue numbness with fasciculation to the l... Read more
pain in bilateral eyes; left hand and left leg numbness; tongue numbness with fasciculation to the left side; tongue numbness with fasciculation to the left side; headache; nausea; This is a spontaneous report from a contactable consumer (parent). A 13-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number ew0186, expiration date was not reported) via an unspecified route of administration at the right arm on 16Jun2021 (at the age of 13-years-old) at single dose for covid-19 immunisation. Medical history included ADD (attention deficit hyperactivity disorder) from an unknown date. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant. The patient was not pregnant at time of vaccination. Concomitant medication included ibuprofen (ADVIL) and muscle relaxer taken for unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number ew0176,expiration date was not reported) via an unspecified route of administration on 27May2021 (at the age of 13-years-old) at single dose for covid-19 immunisation and no reaction on previous exposure to drug. The patient experienced pain in bilateral eyes, left leg numbness, left hand numbness, tongue numbness with fasciculation to the left side, headache, and nausea on 17Jun2021 17:30. No treatment was received for the events. The patient had not been tested for COVID-19 since the vaccination. The outcome of the events was recovered in Jun2021. The report was reported as non-serious.
13 2021-07-12 lethargy The patient, 13 y/o female, presented to clinic for the second dose at approximately 9:00 AM on 7/7/... Read more
The patient, 13 y/o female, presented to clinic for the second dose at approximately 9:00 AM on 7/7/2021. The patient denied contraindications to vaccination and reported that she experienced no adverse effects with the first dose of vaccine that was administered 3-weeks prior. The vaccine was administered by the public heath nurse to the patients left deltoid and the patient tolerated the injection well. After vaccination, the patient returned to the waiting area to sit with her mother for the 15 minute observation period. Approximately 5-10 minutes later, the patient's mother called for help and reported, along with front desk staff, the the patient started convulsing for a few seconds and then lost consciousness. At this point, front desk staff contacted EMS and I arrived at the side of the patient. The patient was pale and lethargic. She had no visible swelling or difficulty breathing. She reported feeling extremely hot and appeared to struggle to stay conscious. The patient responded accurately when asked her name and date of birth. The patient was given water and placed in the supine position. EMS arrived and transported the patient to a local hospital for evaluation. The patient's father was contacted on 7/8/2021 and he reported that the patient spent a number of hours in the hospital and that medical staff did not believe that she had a seizure and that the most likely etiology of her symptoms was vasovagal syncope. He reported that the patient was starting to feel better and was resting in bed. He was instructed to contact the health department with any questions/concerns and to report any additional side effects.
13 2021-07-12 throat pain abdominal cramping; throat started hurting and started tightening; throat started hurting and starte... Read more
abdominal cramping; throat started hurting and started tightening; throat started hurting and started tightening; This is a spontaneous report from a contactable consumer(patient). A 13-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number not provided), via an unspecified route of administration on 20May2021(at the age of 13-years-old) as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.it was reported that Complainant hung up abruptly/transfer incomplete. Reporter stated that I am just reporting a reaction my daughter had to the shot. It was the Pfizer Covid vaccine. On 20May2021, she had abdominal cramping and then her throat started hurting and started tightening. Her weight is approximately 135 pounds and she's probably 5'5. Product details and pharmacy details could not be probed as the caller hung up abruptly. Call back was done to gather further information however it was unsuccessful. Hence limited information available over the call. The outcome of the events was unknown. Information about lot/batch number has been requested.
13 2021-07-14 headache, fatigue Around 7PM on June 19th, she had chest pain and chest pressure. She also had a mild headache. She wa... Read more
Around 7PM on June 19th, she had chest pain and chest pressure. She also had a mild headache. She was taking a walk in the neighborhood and had to come home because she was experiencing shortness of breath and having difficulty breathing. She described it as an electric shock/shooting pain in her chest area, on both sides. I took her (the participant) to the ER. While at the ER, she started to feel experience pain and tingling in her left thigh. It would feel better if her leg was elevated. The leg pain subsided by the 20th. On the 21st, she was taken back to the ER because the chest pain and shortness of breath was not subsiding. They did another EKG which showed no abnormalities. Blood work came back with the same indication of virus/inflammation. They gave her a pain med (not sure of the exact name, but it is used for patients after surgery) and an IV. Also given a prescription for 27ml of ibuprofen with Tylenol in between. Two days later, on the 23rd, she had an appointment with the pediatrician. The doctor checked muscle tone and listened to her chest. My daughter gets fatigued by going up a single flight of stairs. Doctor referred her to a pediatric cardiologist. Later that night of the 23rd, she began to get a tingling sensation in her left arm that went down to her hands and lightheadedness. She was not able to move and had to lay down. Being upright made the pressure in her chest worse and she had to take shallow breaths. I took her to the ER. They did a chest x-ray that showed no abnormalities. Referred her for an echo cardiogram on the 24th. She was doing better after that until July 5th, when the pressure and pain started getting worse again. I took her to the pediatrician again and they referred her to rheumatologist on the 11th of July. The rheumatologist prescribed a steroid medication to calm her immune system. She said her immune system was activated and was inflamed, which is why she was experiencing the shortness of breath and pain. She prescribed her colchicine and Aleve. Since she has started to take the meds, she is doing better but she is still experiencing pressure at a lesser level. The pain is the same level that feels like static shock.
13 2021-07-15 sweating, dehydration Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unrespo... Read more
Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Shakiness-Severe, Systemic: Visual Changes/Disturbances-Severe, Additional Details: Vaccination was administered, within 10 min patient became unresponsive and appeared to lose conciousness. upon immediate assessment no signs of anaphylaxis were present, 911 was called. pt felt very warm to the touch and lost control of bladder. mother mentioned pt had passed out 7/14 at home but no prior history of any events. no reaction to any previous vaccines. paramedics arrived and took over pt was released under care of mother with suspision of dehydration
13 2021-07-15 sweating Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / S... Read more
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Severe, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Weakness-Severe, Additional Details: Patient presented about 10 min after vaccination as lightheaded and nauseous. Patient vomited one time. EMS was contacted, when they arrived the patient's BP was 90/60 and HR was 88 bmp. Parent of patient refused hospital transport after EMS gave all clear, and patient was able to talk, stand, etc on her own. Mother stated that patient was very anxious before and during the vaccine.
13 2021-07-15 fever Abdominal Pain, Nausea/Vomiting, Fever, and Body Aches after receiving 1st dose of COVID-19 vaccine ... Read more
Abdominal Pain, Nausea/Vomiting, Fever, and Body Aches after receiving 1st dose of COVID-19 vaccine (Pfizer) on Sunday. Acetaminophen given 1 hour prior to admission
13 2021-07-16 fever Rash on right side of face Low-grade fever
13 2021-07-17 fatigue had napped 2-3 different times, which was unusual for her daughter.; Her daughter immediately had ri... Read more
had napped 2-3 different times, which was unusual for her daughter.; Her daughter immediately had right arm injection site pain; Her daughter was really tired for 24-36 hours afterwards/Her daughter was really exhausted for 24-36 hours afterwards; This is a spontaneous report from a contactable Nurse. This Nurse (patient's mother) reported for a 13-year-old female patient (reporter's daughter) that: A 13-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW0168), via an unspecified route of administration, administered in Arm Right on 24Jun2021 at 13:21 (at the age of 13 year) as single dose for covid-19 immunisation. Medical history included ongoing heart disease congenital diagnosed prior birth, ongoing irregular heart rhythm. Patien''s family history includes her daughter's grandmother (patient's mother's mother) & her daughter's aunt (patient's mother's sister) all have holes in their hearts & they all have implantable defibrillators. History of all previous immunization with the Pfizer vaccine considered as suspect reported as none. Patient not received additional vaccines on same date of the Pfizer Suspect. Patient was not received any other vaccine four weeks prior vaccination. She stated her daughter (patient) didn't have an implanted defibrillator at this time & her daughter's doctor was waiting until her daughter was older. She reported her daughter's irregular heart rhythm had a genetic component, but she did not know if the irregular heart rhythm was related to her daughter's congenital heart disease. Patient's mother reported her daughter received her first COVID-19 Vaccine dose on 24Jun2021 at 01:21PM in her right arm, and immediately had right arm injection site pain on 24Jun2021. She said her daughter, was really tired and exhausted for 24-36 hours afterwards on unknown date in Jun2021. She said she was not sure if her daughter tiredness and exhaustion started on 24Jun2021, but her daughter took a nap that evening (24Jun2021), and on the next day (25Jun2021) had napped 2-3 different times, which was unusual for her daughter. She reported she offered her daughter Ibuprofen and an ice pack for her right arm injection site pain, and her daughter refused. Patient not visited to physician office or emergency room for the events. The outcome of the events her daughter was really tired for 24-36 hours afterwards/Her daughter was really exhausted for 24-36 hours afterwards was not recovered and had napped 2-3 different times, which was unusual for her daughter, her daughter immediately had right arm injection site pain was unknown. No follow-up attempts are possible. No further information is expected.
13 2021-07-17 headache Severe nausea; Headache; Dizziness; Can't sleep; This is a spontaneous report from a contactable con... Read more
Severe nausea; Headache; Dizziness; Can't sleep; This is a spontaneous report from a contactable consumer (parent). A 13-year-old non-pregnant female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and Expiry date: not reported, age at vaccination: 13-year-old), via an unspecified route of administration, in Arm Right on 23Jun2021 10:00 AM as dose 2, single for covid-19 immunisation administered in Doctor's office/urgent care. The patient medical history and concomitant medications were not reported. Previously, the patient received first dose of bnt162b2 (Lot number not reported), on an unspecified date for covid-19 immunization (age at the time of vaccination: 13-year-old). On 23 Jun2021, several hours after the vaccine, the patient complained of sever nausea, a headache and dizziness. She also cannot sleep, even after taking Advil pm. The treatment was not yet sought but may if this continues or worsens. The patient visited doctor or other healthcare professional office or clinic visit due to these adverse events. The patient did not receive any other vaccines within 4 weeks prior to covid vaccine and did not receive any other medications within 2 weeks of vaccination. The patient was not diagnosed with covid-19 prior or since the vaccination. The outcome of event was not recovered. Information on the lot/ batch number has been requested.
13 2021-07-17 headache severe nausea; headache; dizziness; cant sleep; This is a spontaneous report from a contactable cons... Read more
severe nausea; headache; dizziness; cant sleep; This is a spontaneous report from a contactable consumer (Parent). A 13-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown), via an unspecified route of administration on 23Jun2021 at 10:00 (at the age of 13-year-old), as dose 2, single in right arm, for COVID-19 immunization at Urgent Care Center. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine or any other medications within 2 weeks of vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration, on an unspecified date, as single dose for COVID-19 immunization. On 23Jun2021, several hours after the vaccine, the patient experienced severe nausea, a headache and dizziness. Patient also reported that she couldn't sleep, even after taking Advil pm. Reporter, stated they did not sought treatment but may if that continues or worsens. Adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The clinical outcome of all the events was not resolved. Information on the lot/batch number has been requested.
13 2021-07-17 throat pain Bell's palsy; Sore throat; This is a spontaneous report from a contactable Physician. A 13-year-old ... Read more
Bell's palsy; Sore throat; This is a spontaneous report from a contactable Physician. A 13-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; Lot number: LSW0196) via an unspecified route of administration on 05Jul2020 (at the age of 13-year-old) as single dose for COVID-19 immunisation. The patient's medical history, concomitant medications or past drug history were not reported. On 10Jul2020 (Saturday), the patient experienced sore throat and on 11Jul2020, patient experienced numbness of face on Sunday and was diagnosed with Bell's palsy. The patient was started on unspecified steroids as treatment medication after Bell's palsy diagnosis. The parent still wants child to receive second dose of vaccine and asked if this was okay. The outcome of the events was unknown.; Sender's Comments: Based on the available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported event Bell's Palsy cannot be fully assessed/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.
13 2021-07-18 malaise, fatigue, headache Headache starting 10 minutes after vaccine Extreme tiredness and malaise for two days Ringing in ear... Read more
Headache starting 10 minutes after vaccine Extreme tiredness and malaise for two days Ringing in ears Chest pain randomly since then.
13 2021-07-18 malaise Patient felt ill right after getting vaccine. She complained of temporarily losing vision and heari... Read more
Patient felt ill right after getting vaccine. She complained of temporarily losing vision and hearing. Patient became pale in appearance and vomited once. An ambulance was dispatched and patient was taken to an emergency room
13 2021-07-19 sweating Pt passed out after 2nd vaccine 2 minutes after administration she started to loose consciousness. R... Read more
Pt passed out after 2nd vaccine 2 minutes after administration she started to loose consciousness. RPh helped lay her on bench, eyes remained open patient was sweaty and answered immediately when her name was spoke. Arms were turning red, 911 was called. Assessed her breathing and pulse. Took blood pressure which was low, and took pulse ox; which was normal. Breathing was fine and color returned soon after. No swollen lips or tongue. Pt stated that she didn't eat anything all day and it was around 5pm. Mother stated that she has hx of syncope after any use of needles. EMS cleared pt, gave her a glucose tablet and he left on her own accord with her mother.
13 2021-07-20 sweating Site: Pain at Injection Site-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Weakness-Mild, Addit... Read more
Site: Pain at Injection Site-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Weakness-Mild, Additional Details: patient reported signs of feeling faint and lips turning white. temp was stable at 96.7 and breathing was normal. Parents refused 911 so I instructed them to seek medical attention immediately. Parents drove to hospital themselves. Called parents later in the evening and mom said daughter was doing ok and was told px reacted to pain of getting the vaccine and not the actual vaccine and she should continue vaccines series on 8/10/21. All vitals wore normal and she's being monitored at hospital
13 2021-07-20 malaise - Patient received 2nd dose pfizer accompanied by parent and family member. Reported loss of hearing... Read more
- Patient received 2nd dose pfizer accompanied by parent and family member. Reported loss of hearing in one ear and reported not feeling well. - Patient ambulated to the observation area and within a few minutes, she felt nauseous. Mother assisted patient to bathroom and patient became lightheaded. - Safety officer assisted patient to wheelchair and wheeled into Special Obs area and put into supine position - Vitals taken every 5 minutes for 15 minutes. Patient was able to sit up afterwards, felt better, and blood pressure was normal before leaving. - Counseled patient to contact PCP if any further reaction or call 911 if emergency.
13 2021-07-20 throat irritation, body temperature increased Patient received her first Pfizer dose at 4:06pm at 4:20 mom brought patient over to me to tell me s... Read more
Patient received her first Pfizer dose at 4:06pm at 4:20 mom brought patient over to me to tell me she was feeling like her neck and leg felt swollen, we all discussed that it could be swollen lymph nodes and they choose to go and check out up front. At 4:30 Mom brought patient back to the pharmacy and said she was feeling strange. Patient said her throat felt weird, she felt dizzy and was having ear pressure, but was not having difficultly breathing. I offered Benadryl and to call 911, Mom denied her needing that at the time. While we were asking patient questions her eyes started to roll and flutter and her head would fall back, but she was alert and talking and stated that she was seeing spots. I told Mom that we were going to call 911 at that time so they could come and check her out. I also go an ice pack and we placed it on her neck, her face was flushed and I took her temperature it was 99.2 at 4:42pm. Ambulance arrived at 4:45pm and they did her vitals and she walked out to the ambulance with them to be checked out. I called Mom at 6pm to check on patient and she was doing much better and did not have to go to ER.
13 2021-07-21 sweating Patient had Dizziness, Nausea and Sweating Beginning immediately after Vaccine was administered. Pat... Read more
Patient had Dizziness, Nausea and Sweating Beginning immediately after Vaccine was administered. Patient was given an ice pack and after 15-20 minutes felt well enough to leave with her father.
13 2021-07-21 throat pain, headache At first, waking up with difficulty breathing (around 4:30 AM), pain when breathing (throat), Chest... Read more
At first, waking up with difficulty breathing (around 4:30 AM), pain when breathing (throat), Chest pain. Headache. Very fast heartbeat. Took a lot of effort to walk, especially down stairs. Took Tylenol (around 5:00 AM) , went back to bed. After 7 hours of sleep, had no appetite. Headache. Symptoms faded after a couple more hours.
13 2021-07-22 headache Swollen lips after 4-6 hours Discoloration of top lip (purple in color) with redness on skin above... Read more
Swollen lips after 4-6 hours Discoloration of top lip (purple in color) with redness on skin above. Started peeling 2 days after, still with purple discoloration of top lip but improved. vomiting for 2 days after - vomiting that evening. With headaches which also resolved after 2 days.
13 2021-07-23 fever, headache Headache, fever 101
13 2021-07-24 fatigue, lethargy 13 year old female previously healthy, no chronic diseases,.10 days after the 1st dose of Pfizer COV... Read more
13 year old female previously healthy, no chronic diseases,.10 days after the 1st dose of Pfizer COVID19 vaccine, she developed fatigue, lethargy, paleness and dizziness. She was found to be profoundly anemic and was diagnosed with autoimmune hemolytic anemia; she was also found to have positive high-titer (1:1280) antinuclear antibody (ANA) testing (status prior to vaccination unknown). She was diagnosed with mixed cold/warm autoimmune hemolytic anemia. She received two units of packed red blood cells via blood transfusion and was treated with high-dose corticosteroids (both IV and oral). The anemia has resolved but the patient remains on oral corticosteroids (prednisone).
13 2021-07-25 sweating Patient had the normal injection of first dose in the series of Pfizer COVID-19 vaccine. The patient... Read more
Patient had the normal injection of first dose in the series of Pfizer COVID-19 vaccine. The patient waited in the facility for the standard 15 minutes when fainted (syncope). I rushed over within 10 seconds to turn the patient onto her back. I checked for a pulse and breathing. There was a faint pulse and breathing initially, which seemed to stabilize after about 2-3 minutes. She became conscious again after about 2 minutes of unconsciousness. Patient was diaphoretic with shallow and rapid breathing. EMT was called and arrived about 20 minutes later. Blood pressure read by the EMT: 105/56 about 30-40 minutes after the injection (20-25 minutes after the syncope). Patient was not given anything for treatment besides purified water. Patient was told to follow-up with primary care doctor for the second dose if required.
13 2021-07-26 sweating, sleepiness About 10 minutes after injection patient became dizzy, diaphoresis, flushed, hypotensive (100/80), d... Read more
About 10 minutes after injection patient became dizzy, diaphoresis, flushed, hypotensive (100/80), drowsy, nausea. Patient was seated and legs elevated. Cool water bottle placed behind neck, blood pressure obtained. She remained in this positi9on for about 15 minutes. No reaction noted at the injection site. When she began to stabilize we offered juice which she took and began to feel better. She was released to go home. I contacted her mother at about 7:30pm that evening and patient was feeling much better
13 2021-07-27 nasal congestion, cough acute onset of cough, chest tightness and shortness of breath starting 3 hours after vaccination. Pr... Read more
acute onset of cough, chest tightness and shortness of breath starting 3 hours after vaccination. Presented to urgent care facility. Took albuterol every 4 hours which improved symptoms. Developed body aches, nasal congestion in the following days.
13 2021-07-28 fever fever followed by genital aphthous ulcers on vulva
14 2021-02-17 headache Day of vaccination (Monday) - arm sore, Tuesday - body aches, muscles sore, headache, Wednesday- mus... Read more
Day of vaccination (Monday) - arm sore, Tuesday - body aches, muscles sore, headache, Wednesday- muscles less sore, headache, Thursday - symptom free
14 2021-05-12 throat irritation The patient have seasonal allergies and she already took Benadryl at night. She developed throat fe... Read more
The patient have seasonal allergies and she already took Benadryl at night. She developed throat feeling itchy about 30 minutes past vaccine administration. The patient drunk water ,ate crackers and offered to take another dose of Benadryl. She was unable to swallow the Benadryl for the first attempt then second attempt successfully swollen. At 12:00 she was feeling better and symptoms improved. Discharged to go home.
14 2021-05-13 headache, fatigue, lethargy Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Letha... Read more
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Headache-Medium, Systemic: Nausea-Medium, Additional Details: patient's mother told that pt has sickle cell's disease. As rph wasn't unsure the disease's effect on covid 19 vacicne. Rph asked pt to stay in resting area for 30 minutes. Approximately, 25 minutes after the patient got the shot, her mother reported her having allergic reactions. Patient reported as having dizziness, not being able to hear, nausea, and some eye blurness. I gave water, candy, and benadryl. Also 911 called just in case. By the time emergency team arrived, pt was doing fine back
14 2021-05-13 headache Patient started vomiting after administration of first dose of Pfizer. First dose was administered a... Read more
Patient started vomiting after administration of first dose of Pfizer. First dose was administered at 15:16 and patient felt dizzy, c/o of headache and started vomiting right afterwards. Charge RN, ANM, and onsite provider was notified. Moved patient to triage area and her VS were as follow: BP: 96/50; HR: 73, SPO2: 98%. Patient was given a peppermint gum to chew and water. Patient felt better five minutes later. Patient stable, and released into the observation area for 30 minutes. Patient was accompanied by father d/c to home stable steady gait. Pt advised to seek emergency services for any further sx.
14 2021-05-13 throat irritation Pt came to my office today for evaluation of itching and swelling around mouth starting 1 hour after... Read more
Pt came to my office today for evaluation of itching and swelling around mouth starting 1 hour after getting her first dose of Pfizer Covid 19 vaccine. She did not have hives but rather papules. In the office her rash had resolved with the exception of mild erythema. She also complained of an itchy throat but had onset of rhinorrhea and sneezing yesterday. She took benadryl yesterday which made no difference. She had no cough, wheezing, difficulty breathing, hives, vomiting or diarrhea.
14 2021-05-14 lethargy, fatigue Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting /... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild
14 2021-05-14 malaise 9:45am a 14 year old patient reported not feeling well, vital signs taken BP: 76/50, HR 60, then dro... Read more
9:45am a 14 year old patient reported not feeling well, vital signs taken BP: 76/50, HR 60, then dropped to 50s, 02 sat at 98% room air. Then patient became unresponsive with that 2 minutes, still with pulse of 52, Benadryl 50mg IM given to right arm, within 2 minutes patient became responsive and with color came back to her face. Ambulance came within 6 minutes, patient became responsive and vital signs stable. Report given to the ambulance. Patient and mom and sister went in the ambulance in stable condition.
14 2021-05-14 malaise Patient got up from receiving shot and fainted on the ground-patient hit his head. EMS was called. P... Read more
Patient got up from receiving shot and fainted on the ground-patient hit his head. EMS was called. Patient turned very pale and nausea, patients arms was swelling. Patient started to return to conscience but remined unwell. EMS did an evaluation. Father took son to hospital
14 2021-05-14 throat irritation, nasal congestion, malaise Patient was sitting in our recovery area when mom came and said she was having an "itchy" throat. S... Read more
Patient was sitting in our recovery area when mom came and said she was having an "itchy" throat. She said she felt like it was congestion, then said it just felt funny. We had her sit for 5 more minutes, no change. Gave her 2-25 mg benadryl with mom's approval and waited 10 more minutes. Patient said she was feeling better, mom not concerned anymore. Left after about 30 minutes recovery total
14 2021-05-14 throat irritation Patient received vaccine at Health dept 5/13/2021 at 4pm. Presented to our office 5/14/21. seen by ... Read more
Patient received vaccine at Health dept 5/13/2021 at 4pm. Presented to our office 5/14/21. seen by Dr 3:09 pm, complaint that had facial burning 1-2 hours after first dose COVID vaccine. School nurse called and reported face swollen and throat itching took Benadryl and did not help. no cough or wheeze, throat itchy called and spoke allergist who stated did not expect allergic run to last that long and people will idiopathic urticaria can have reactivation of urticaria- VAERS Report filed yesterday Patient returned to Saturday walk in clinic today 5/15/21 and saw me- woke up at 2 AM c/o difficulty breathing but didn't want to bother parents on arrival 09:29 P130 sat 98%- nurses state not in distress at arrival at my arrival in room 10:20 AM noted to have frank stridor and fair to good air movement- patient seems to have worsened while here 0.3 mg Epi given IM and felt better sent to ER by ambulance - Hospital for additional monitoring? in case more epi needed
14 2021-05-15 chills My daughter was fine that first 30 minutes. When we got home she had chills and had a rash on both h... Read more
My daughter was fine that first 30 minutes. When we got home she had chills and had a rash on both her legs above and below her knees. I bundled her up and within 20 minutes was okay. I monitored her and there was no other issues than diarrhea later
14 2021-05-15 headache Frontal Headache and Throat Tightness for 20 minutes. Symptoms resolved after mom gave Benadryl 37.... Read more
Frontal Headache and Throat Tightness for 20 minutes. Symptoms resolved after mom gave Benadryl 37.5mg orally.
14 2021-05-15 sleepiness Patient fainted about 10 minutes after receiving first dose of Covid-19 vaccine. She was instructed... Read more
Patient fainted about 10 minutes after receiving first dose of Covid-19 vaccine. She was instructed to remain seated in the waiting room but got up and walked around the store with her parents and felt faint after walking for a minute or two. She passed out and was caught by her dad and gently laid down on the floor. Paramedics were called to check vitals as patient continued to feel drowsy for a few minutes. She was assessed by paramedics and released to parents after checking vitals, blood glucose, heart. She stated she was feeling better after several minutes of sitting or laying down.
14 2021-05-16 malaise Vaccination was on Saturday, within 10 minutes of the vaccination, my child reported her ears felt l... Read more
Vaccination was on Saturday, within 10 minutes of the vaccination, my child reported her ears felt like they were popping, she felt dizzy, tight throat and jaw pain. On site nurses gave her apple juice and crackers. She reported feeling unwell, dizzy, light-headed, jaw pain and short of breath the following day, on Sunday. On Monday, we took her to urgent care for same symptoms - unwell, dizzy, light-headed, jaw pain, short of breath. Rapid COVID test and strep test were negative, EKG was normal. Urgent care doctor says it is vertigo.
14 2021-05-17 headache headache, throat closing, warm, rash on chest
14 2021-05-17 headache Systemic: Dizziness / Lightheadness-Medium, Systemic: Headache-Mild, Systemic: Hypotension-Mild, Add... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Headache-Mild, Systemic: Hypotension-Mild, Additional Details: 10 minutes after receiving vaccine patient felt lightheaded and dizzy. After being place on her back with legs elevated she started to feel better. Her blood pressure was 101/66. Patient felt better over some time and left feeling fine.
14 2021-05-17 malaise Patient received vaccine and within 5 minutes was not feeling well. Patient fainted and then when co... Read more
Patient received vaccine and within 5 minutes was not feeling well. Patient fainted and then when conscious began vomiting. Patient also became very pale and clammy. Patient has experienced vasovagal symptoms before when having blood work done but not during vaccination. Patient also stated afterwards that she had not eaten any food all morning prior to receiving the vaccine.
14 2021-05-17 sleepiness immediately after the injection, pt appeared to have fainted, eyes closed, still breathing, body sti... Read more
immediately after the injection, pt appeared to have fainted, eyes closed, still breathing, body stiffed and jerked for a brief moment then became slouchy on the chair. we called 911 - as we waited for ems, pt opened eyes, said very sleepy, i kept her awake by taking about greys anatomy - ems arrived - mom wanted pt to be monitored at a facility - ems took pt away on stretcher.
14 2021-05-18 sweating, chills Patient had syncope-type reaction, chills, sweating, and passing out. Started around 12:35-12:40pm, ... Read more
Patient had syncope-type reaction, chills, sweating, and passing out. Started around 12:35-12:40pm, lasted until 12:50pm after pharmacist intervention.
14 2021-05-19 headache Patient was administered the first Pfizer Covid 19 vaccine per protocol and was seated for observati... Read more
Patient was administered the first Pfizer Covid 19 vaccine per protocol and was seated for observation post administration. She became faint. Pharmacy staff broke an ammonia inhalant to help the patient recover. She responded quickly, but did require additional whiffs later. When questioned, she stated that she was having no difficulty breathing, swelling in throat, and no obvious rash. She was accompanied by her mother, who declined emergency medical care/911 assistance. The patient was not wearing constrictive clothing, so no adjustments were necessary, but she did recline further in the chair. She was also provided with cool, wet, paper towels for her forehead and neck. When she was feeling better, she had a few sips of water. Although offered a motorized cart to leave the store, she left with both parents walking with no assistance. On 5/20/21 we reached out to the family and spoke with her father. The patient did have a minor headache the evening of her vaccine administration, which has resolved. She does have a sore arm, which is a common side effect of the vaccine, Her father has reached out to her pediatrician to see whether she should get the second dose or not. He has not yet received a response.
14 2021-05-19 sweating, fatigue Pt appeared clammy and ashen in face 5 min after receiving 1st Pfizer vaccine . Had pt lay on floo... Read more
Pt appeared clammy and ashen in face 5 min after receiving 1st Pfizer vaccine . Had pt lay on floor in the event of passing completely out. Elevated pt's feet on the chair. Pt's hands where sweaty. Pt continued talking throughout process while laying on the floor. Pt stated she felt tired and tingly and hot. Monitored pt for next 15 minutes until she felt well enough to sit up. Pulse was normal and steady. After 15-20min pt had color returning to face. Pt felt well enough to sit up while still on floor. Had pt sit 5 min on floor and texted on phone. Pt felt well enough to sit on chair. Pt sat 5 min on chair. Pt felt well enough to stand and walk. Mom and I monitored pt walking and doing well. We sent pt home with mom.
14 2021-05-19 sweating Patient immediately became sweaty, dizzy,and experiencing hearing loss after receiving her first dos... Read more
Patient immediately became sweaty, dizzy,and experiencing hearing loss after receiving her first dose.Patient was seated on floor with elevated legs before she was wheeled back for observation. Patient was visually pale and sweaty.Patient denied any anxiousness before receiving her vaccine. Patient had vitals assessed and was given snacks and juice . Patient was reassessed after 15 minutes and reported feeling better and was sent home with parent. Patient and parent were advised to reach out to family doctor is any late onset of symptoms.
14 2021-05-19 sweating Vaccine Administered: Pfizer COVID-19 Patient reaction: Flushing Pale Skin Nausea/Vomiting Fainting... Read more
Vaccine Administered: Pfizer COVID-19 Patient reaction: Flushing Pale Skin Nausea/Vomiting Fainting Dizziness Action taken: Antihistamine given. Outcome: Patient recovered. Late charting for 5/17/2021 - 5ml Diphenhydramine given PO 10 minute after c19 vaccine - patient dizzy, diaphoretic, and nauseous. Emergency medication entered and signed.
14 2021-05-19 sweating Within first five minutes sudden ringing in ears, nausea, dizziness, sweating. An urge to pass out/f... Read more
Within first five minutes sudden ringing in ears, nausea, dizziness, sweating. An urge to pass out/faint. Symptoms subsided after 10 minutes.
14 2021-05-19 fever Fever 101 for 4 days, weakness in right arm started on day 4. Difficult to hold pencil doing homewor... Read more
Fever 101 for 4 days, weakness in right arm started on day 4. Difficult to hold pencil doing homework, right handed.
14 2021-05-20 fatigue, lethargy, sweating Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Flushe... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe, Systemic: Lymph Node Swelling-Severe, Systemic: Weakness-Severe, Additional Details: patient started feeling hypotensive, sweating, lethargic post covid 19 vaccination. paramedics called due to low blood pressure. patients symptoms resolved gradually and didn't necessitate ER trip.
14 2021-05-20 fatigue pts neck started swelling after taking the vax. she was having a hard time breathing due to the swe... Read more
pts neck started swelling after taking the vax. she was having a hard time breathing due to the swelling. she went to Hospital ER. pt was triaged and then left due to the situation at the hospital. Pts mother gave her Advil and was monitored all night. The swelling seemed to be better the next day. She had fatigue that lasted about 3 days. Parents called the Pediatrician. They were advised to call her Endocrinologist. They recommended her back to Pediatrician due it being a immune reaction. They called an infectious disease specialist which recommended her to an allergist. Pt has follow up appts next week for thyroid.
14 2021-05-20 headache Patient developed a headache similar to her chronic migraines (bifrontal, rated 4/10) with no associ... Read more
Patient developed a headache similar to her chronic migraines (bifrontal, rated 4/10) with no associated nausea/vomiting, altered mental status, LOC, shortness of breath. She preferred to leave with mom (who agreed that her symptoms were similar to chronic headaches) and were going to take medication when she got home. Mom was going to bring her back if the symptoms worsened or were not resolved with her regular medication.
14 2021-05-20 sweating Pt began to feel faint w/ flushing/sweating in observation area. RNs were waived over by parents. ... Read more
Pt began to feel faint w/ flushing/sweating in observation area. RNs were waived over by parents. Pt transferred via w/c to observation bay. NO loss of consciousness. Dad at bedside. BP 94/55, HR 51, RR 14 -- > 98/53, 60, 16. Pt feeling much better. Pt stable and released from the vaccination site.
14 2021-05-20 sweating Patient had syncopal episode with seizure. Diaphoretic and hives noted after regaining consciousness... Read more
Patient had syncopal episode with seizure. Diaphoretic and hives noted after regaining consciousness.
14 2021-05-20 lethargy Patient fainted two minutes after receiving vaccine. Loss of consciousness was not total. Patient wa... Read more
Patient fainted two minutes after receiving vaccine. Loss of consciousness was not total. Patient was pale, clammy, and lethargic. Patient's mother and myself held patient is place while she recovered in chair. Resolution was within 15 minutes from start of episode. Followed up with mother two and one-half hours post incident and mother said patient was completely recovered.
14 2021-05-20 malaise Patient stated she was not feeling well after her first dose of pfizer covid vaccine. Patient had s... Read more
Patient stated she was not feeling well after her first dose of pfizer covid vaccine. Patient had seizure like activity and was unconscious for a about 15-30 seconds. an ambulance was called vitals were taken. patient and patent family declined transport to medical facility.
14 2021-05-21 sweating Patient had vaccine and entered waiting area for monitoring period. Started feeling dizzy and start... Read more
Patient had vaccine and entered waiting area for monitoring period. Started feeling dizzy and started to sit on ground but passed out while transferring to ground. Patient came to confused, pale, sweating and then proceeded to pass out 2-3 additional times. EMS was called as a precaution since patient reported feeling confused, weak, heart palpitations. Patient was advised to remain on the ground while waiting for EMS and was given an ice pack, water, juice and crackers.
14 2021-05-22 sweating, headache 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: Headache-Severe, Systemic: Nausea-Medium, Additional Details: after getting vaccine, pt felt dizzy/lightheaded. pt has had hx of fainting after getting vaccines due to anxiety. pt was very sweaty/hot. laid pt on the ground and instructed her to put legs up on the chair. provided water stated that was helping. nurse, lpn came and checked pts vitals. while we called 911. ambulance came and took her away. mom came back and said daughter was feeling better and did not go to ER
14 2021-05-23 chills Site: Pain at Injection Site-Mild, Systemic: Chills-Medium, Systemic: Confusion-Medium, Systemic: Di... Read more
Site: Pain at Injection Site-Mild, Systemic: Chills-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Mild, Systemic: Shakiness-Medium, Systemic: Weakness-Medium, Additional Details: Pt received vaccine, spoke to her shortly after and decided to shop around the store. Shortly after walk pt started feeling light headed, and dizzy and fainted. Mom stated that this had happen to her before. Monitored patient for 30 min, gave water and a snack. Mom decided against calling 911.
14 2021-05-23 headache, sweating Approximately 2 hours after receiving her first covid vaccine, my 14 year old fainted. She was stand... Read more
Approximately 2 hours after receiving her first covid vaccine, my 14 year old fainted. She was standing in our kitchen at home and became dizzy and started falling backwards. She said her vision was black, she was hot, her head hurt, I could see sweat on her face and chest, and she said she was having tightness in her chest/not able to get full breaths. She didn't totally lose consciousness, but she was disoriented. These symptoms lasted a few minutes, then she felt fine.
14 2021-05-23 headache Horrible headache on Sunday, tears from pain, took rizatriptan and amitriptyline and did not help, M... Read more
Horrible headache on Sunday, tears from pain, took rizatriptan and amitriptyline and did not help, Monday could not lift head off pillow due to headache still there. Started day with 2 naproxen
14 2021-05-23 sweating, chills Systemic: Chills-Mild, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Syste... Read more
Systemic: Chills-Mild, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Weakness-Medium, Additional Details: pt passed out after about 10 minutes while in observation area. dad was next to her and she did not fall. emt were called to check her out and after 1/2 hr pt seemed to be ok
14 2021-05-24 fever Broke out in hives, had low grade fever, gave Benadryl and Tylenol after3 days seems to be gone
14 2021-05-25 headache, sweating Initial complaint at 1353: Lightheaded, hot, cold, headache on right side, diaphoretic to the touch... Read more
Initial complaint at 1353: Lightheaded, hot, cold, headache on right side, diaphoretic to the touch 1406 BP 110/70 HR 64 Denies SOB, tingling throat. Ate at 12 noon fruit and chips 1410 BP 122/72 HR 66 Worsening of headache on right side of head, room spinning. Hot/Cold flashes have passed. 1413 Spinning has stopped. Everything is bright. Clamminess has subsided 1417 R side of face numb. symmetrical grimace/smile 1419 Sitting up. Reports dizziness. Feeling melting down right side face. ***Documentation provided stops here.
14 2021-05-26 headache Started Tuesday evening with light headed, dizziness, headache, in the early morning hours pt said s... Read more
Started Tuesday evening with light headed, dizziness, headache, in the early morning hours pt said she felt as if her right side was going numb & asked to go to the hospital. Later in the afternoon she got worse along with bad chest pain & stomach & started vomitting
14 2021-05-26 lethargy Patient developed dizziness and coldness in extremities. She tried walking and fell down, but did no... Read more
Patient developed dizziness and coldness in extremities. She tried walking and fell down, but did not lose consciousness. She then alternated between feeling hot and cold and seeing "blurry spots". I noticed her lips turning white and she said she needed to lie down. I got her water and ice packs since she was sweating. We sat on the floor for about 10 minutes, then she was able to move to a chair for another 5-10minutes and then left the facility. Mom reports that she has been lethargic and napping most of the day. Patient ate a few cheez-its for breakfast and reports that she did not get a good nights sleep last night.
14 2021-05-27 dehydration, headache Participant's mother states her daughter received the vaccine around 3:30pm. PT mother states her da... Read more
Participant's mother states her daughter received the vaccine around 3:30pm. PT mother states her daughter felt a headache, felt dizzy and then had a syncope at around 6:00pm. 911 was called. PT mother states they went to the hospital where lab work was done. They told her that her daughter's potassium, iron and sodium was was low. The medical staff said she was excessively dehydrated. Her mother states as for today her daughter gets easily dizzy after she eats, and gets headaches, feels light headiness and I have been IV liquids to give her levels up.
14 2021-05-27 sweating Lightheaded and sweaty 3 mins post vaccination Water was provided, patient rested Patient discharged... Read more
Lightheaded and sweaty 3 mins post vaccination Water was provided, patient rested Patient discharged to home
14 2021-05-28 fatigue arm soreness, day after vaccine fatigue, two days after vaccine
14 2021-05-29 headache, fever Within 5 days of immunization, developed fever, abdominal pain, headache, elevated inflammatory mark... Read more
Within 5 days of immunization, developed fever, abdominal pain, headache, elevated inflammatory markers, DDimers, ferritin and BNP and coagulopathy. Admitted to Hospital and evaluated for MIS-C. Observed and treatment recommended for MIS-C with IVIG and steroids.
14 2021-05-29 sweating 5/30/2021 11:04 AM After 4 minutes of receiving vaccine, pt became weak, diaphoretic and fainted. 91... Read more
5/30/2021 11:04 AM After 4 minutes of receiving vaccine, pt became weak, diaphoretic and fainted. 911 was called. Pt's v/s HR 46,BP80/64. Pt woke up 2 minutes later, able to pronounce name and date of birth and able to drink 3 oz of apple juice. Pt's HR 65 BP 88/58. Transfer of care to ambulance personnel at 11:12. Ambulance record.
14 2021-05-30 sweating Systemic: Dizziness / Lightheadness-Medium, Systemic: patient cant control breathing; cant walk afte... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: patient cant control breathing; cant walk after 10 min administration-Medium, Systemic: Flushed / Sweating-Medium
14 2021-05-30 sweating Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unrespons... Read more
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Mild
14 2021-05-31 headache overall body aches, lightheadedness, shortness of breath, headache
14 2021-06-01 headache HPI: Patient is a * year old * who presents following administration of the first dose of Pfizer COV... Read more
HPI: Patient is a * year old * who presents following administration of the first dose of Pfizer COVID19 vaccine in the left deltoid. She states that immediately following administration of the vaccine, she started to feel lightheaded with ?fuzzy vision,? and pain with swallowing. She denies a history of anaphylaxis. She affirms seasonal allergies and confirms that she was feeling ?stuffy? this morning. She affirms that she ate and drank this morning without odynophagia. She relates that there was a big family argument that is causing her to feel stressed at this time as well. She affirms pleuritic chest pain, odynophagia, epigastric abdominal pain, headache, lightheadedness, and blurry vision. She denies chest pain, difficulty breathing, swelling of the face/lips/tongue/throat, skin rash/itching, cramping abdominal pain, nausea, and vomiting. Exam: GEN: Alert and oriented x 4, NAD. Patient appears to have a developmental delay secondary to eye contact avoidance, slow to respond, and speech impediment. HEAD: NCAT EYES: PERRL, EOMI ENT: Ears normal, Nose normal, OP normal, no evidence of angioedema NECK: Supple, without LAD. CV: RRR, no m/r/g PULM: Shallow, guarded breathing at rest, but clear to auscultation bilaterally with deep inspiration, no accessory muscle use ABD: Soft, no tenderness. SKIN: No rashes, skin warm and dry. No erythema or edema of the injection site. MSK: FROM, MS 5/5 NEURO: Alert and oriented x 4, CN 2-12 grossly intact, no ataxia, gait steady Clinical Impression/Field Tx: Vital signs stable and physical exam within normal limits, however, patient continued to report odynophagia, pleuritic chest pain, abdominal pain, lightheadedness, and blurry vision, even after giving patient snack/drink and reclining her with lower extremities above the level of heart and head. EMS called to the scene for further evaluation. Instructed patient and parent to consult their PCP regarding the post-vaccination reaction. Patient and parent instructed to go to emergency department should she develop chest pain, difficulty breathing, swelling of the face/lips/mouth/tongue/throat, or cramping abdominal pain with nausea/vomiting. Patient and parent demonstrated understanding of post-vaccination instructions. Medications administered: None Disposition: EMS contacted due to patient not improving. Care transferred to EMS . No workup was performed by EMS and they instructed the parent of the patient to take the patient to ER via private car for further evaluation. Father was amenable to plan and signed form.
14 2021-06-01 headache On the outset: There is no proven link of the vaccine with what happened, but I am filling this just... Read more
On the outset: There is no proven link of the vaccine with what happened, but I am filling this just in case you see a pattern emerge: She was vaccinated (pfizer, 1st dose) on Saturday, May 15 2021. A couple of hours later she started experiencing mild symptoms (moderate headache, which we thought as a normal reaction). These persisted on and off until Wednesday, May 19th, when patient started having swollen and painful glands at the back of her mouth. Long story short, after testing first for strep, followed by blood work, patient's blood test came back positive with mono on Monday, May 24. The reason for this report is that I have read that mRNA vaccines, great as they may be, may trigger a virus response for viruses that stay within a person - like shingles or herpes etc. The way I understand it, mono also stays with a person. Patient had never been diagnosed with mono before, but mono sometimes does not have symptoms. So, is it possible that she had mono sometime before the vaccine, and it got re-triggered due to the vaccine? Again, just in case you see a pattern, I am just reporting if helpful. Patient also developed a mono rash on Wednesday, May 26; treated with topical benadryl cream.
14 2021-06-01 sweating Diaphoretic History related to shots PR: 77 SPO2:96 B/P 124/82 Brought via wheelchair to med. screen... Read more
Diaphoretic History related to shots PR: 77 SPO2:96 B/P 124/82 Brought via wheelchair to med. screening room for evaluation by medic. Recorded by RN
14 2021-06-03 fatigue, headache vomiting several times since 8:00, it's now 11:16 headache sore arm fatigue NO DR VISIT YET
14 2021-06-03 headache Headache; This is a spontaneous report from a contactable consumer other non HCP (patient) received ... Read more
Headache; This is a spontaneous report from a contactable consumer other non HCP (patient) received via Pfizer-sponsored program. A 14-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0179) via an unspecified route of administration in arm left on 30May2021 (at the age of 14-year-old) as a 1st dose, single dose for COVID-19 immunization. The patient's medical history was reported as none. The patient's concomitant medications were not reported. No prior vaccinations within 4 weeks. It was reported that, whether patient could take a Tylenol. It was reported that, she needed to take a Tylenol and she mentioned that she was currently experiencing a headache, just a little headache. Patient was informed and provided the number of the Pfizer Medical Information Department. It was reported that, patient scheduled date of 2nd vaccination was on 01Jul2021, so they were actually going for June, so they scheduled it right when they would get back. she did not see expiration date of the vaccine, all she could see was the date given and date. Reported that, someone called her and tell her to take Tylenol. Treatment was not taken for event. The outcome of the event was unknown.
14 2021-06-05 fatigue, malaise Patient received 2nd shot and was standing nearby when she started feeling nauseous. She took a seat... Read more
Patient received 2nd shot and was standing nearby when she started feeling nauseous. She took a seat and started to become pale. She felt sick in her stomach and was responding to questions. Pharmacy staff gave her a bottle of water and bag to vomit in (but did not vomit). Staff also checked her blood pressure resulting in 109/68 HR 65. She felt better and left. Pharmacy staff called mom to follow up around 3:30pm. Mom said she was doing better, but feeling tired.
14 2021-06-05 sweating, sweating Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: patie... Read more
Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: patient passed out for abt 5sec and cameback, Her face was flushed and immediatly after turned white. She drank some water and after that she was feeliong okay. Mother reported she has fained before from the HPV vaccine. SHe didnt not want to call the ambulace. Sat for another 15 under observaction and then she was okay to go home
14 2021-06-06 fatigue Time: 3:00 PM Adverse event: Fatigue Treatment: bed rest for 8 hours Outcome: no longer fatigued
14 2021-06-06 sweating After administration, the patient became dizzy, shaky and sweaty. Her eyes were slowly closing and o... Read more
After administration, the patient became dizzy, shaky and sweaty. Her eyes were slowly closing and opening. I had her parent get juice and a candy bar while I monitored her. She stayed seated for at least 30 minutes and felt better after eating and drinking. She left with her parents after she felt better.
14 2021-06-06 sweating Approximately 11:10 am on 6/7/2021 Adverse event occurred during the 15 minute wait period following... Read more
Approximately 11:10 am on 6/7/2021 Adverse event occurred during the 15 minute wait period following the vaccination. Pt c/o SOB, weakness , diaphoresis and pale. Pt stated that she could not see and it was hard to breath. Pt stated that she has not eaten or had anything to drink today. Hx: was taken. Pt had no known medical hx or allergies to meds
14 2021-06-06 malaise, dehydration Patient presents to the ED with > 12 hours of vomiting the day after receiving Pfizer COVID-19 vacci... Read more
Patient presents to the ED with > 12 hours of vomiting the day after receiving Pfizer COVID-19 vaccine #2. From the ED note: 14-year-old previously well here for vomiting. Patient got her second Covid shot yesterday 230. 5:30 AM patient awakened with nausea and vomiting. She has vomited all day long (not bloody or bilious). Late afternoon they called primary care who called in prescription for Zofran. She took 4 mg at 6 PM but continued to feel unwell and vomit so came for evaluation. No fever. Some intermittent abdominal discomfort but no significant pain. No stool today. Decreased urine output. No fever, chills, dysuria, headache. No known ill contacts. Benign chem (elevated bun c/w dehydration). after fluids pt reports feeling much better:significantly improved appearance: good color, smiling, sitting up and able to walk around comfortably. improved hr, remains with nontender abd. Pt took po's without difficulty/N/V and voided in ED. Currently no evidence of bacterial infection, surgical abd/obstruction, significant dehydration/metabolic derangement, CNS process. May be related to vaccine vs possible viral vs food - although less likely given no known ill contact. Well appearing, taking po's well now. plan for discharge and outpatient f/u.
14 2021-06-06 malaise, fatigue, fever Extreme fever, 104.1 Temporel thermometer, nausea vomiting, malice fatigue, lightheaded dizziness, h... Read more
Extreme fever, 104.1 Temporel thermometer, nausea vomiting, malice fatigue, lightheaded dizziness, hallucinations with the fever, Vasoconstriction that included numbness of hands and extremities. Fever exceeds the 48 hour mark only brought down by ibuprofen and acetaminophen alternating Q3 hours then bringing the fever down to 100.1 on average between doses
14 2021-06-06 malaise She was not feeling well when she got up on Saturday morning. We went to the neighbors house and wer... Read more
She was not feeling well when she got up on Saturday morning. We went to the neighbors house and were outside for maybe 15 minutes (it was a warm day) when she passed out momentarily. We immediately got her some water and got her in the AC and she did fine since then. She did have mild finger swelling on the distal joint of both index fingers after the first injection on 5/14/2021(same lot #). We are not sure if the finger swelling was related to the vaccine. It started about 5 days after first vaccine.
14 2021-06-06 throat pain patient stated she had itching on both arms 5 minutes after receiving the vaccination and a sore thr... Read more
patient stated she had itching on both arms 5 minutes after receiving the vaccination and a sore throat, no further progression after 25 minutes. . there was no rash. Customer then took 50mg diphenhydramine liquid by mouth. 5 minutes after the diphenhydramine, the itching started to decrease. patient was observed for 40 minutes total.
14 2021-06-07 fatigue, headache Fatigue Shooting pain in legs Joint pain Weakness Headache Loss of appetite
14 2021-06-07 headache Patient had no reaction from her first Pfizer vaccine. A few minutes after her second dose, she stat... Read more
Patient had no reaction from her first Pfizer vaccine. A few minutes after her second dose, she stated itching on her injection arm and in her legs. 10 ml of Benadryl was administered at around 2:45 pm. She stated headache and pain in her neck and head, but no difficulty breathing. She took ibuprofen (given to her by her grandmother). She was monitored until 3:30 pm and indicated her symptoms had resolved and she was feeling much better. Counseled her grandmother to monitor her closely this evening and to administer another dose of Benadryl if needed.
14 2021-06-07 sweating Fainting 24 hours after receiving 2nd dose of Pfizer vaccine. Started feeling lightheaded, dizzy, br... Read more
Fainting 24 hours after receiving 2nd dose of Pfizer vaccine. Started feeling lightheaded, dizzy, broke out into a sweat and passed out for approximately 15 seconds. EMT called and observed at scene; transported to ER for additional observation. Received IV fluid and monitoring at ER and discharged later the same day.
14 2021-06-07 sweating Immediately following first does of covid vaccine patient became unresponsive, diaphortic. Pt did ha... Read more
Immediately following first does of covid vaccine patient became unresponsive, diaphortic. Pt did have a pulse and spontaneous breathing. Pt responded to ammonia capsule by opening her eyes . She complained of sudden onset of chest and abdominal pain . Pt states she became dizzy, lightheaded immediately following the injection. Then developed chest tightness and abdominal pain and nausea . Pt rated abdominal pain 10 0n 1-10 scale. Pulse 88 resp 36 Tx at mobile clinic: Ammonia capsule, benadryl 25 mg PO Pts weight 40.1 kg Tx in ED: Prevacid , Tylenol with great relief ,symptoms resolved
14 2021-06-07 pneumonia pneumonia; inflammation to the heart; Shortness of breath; chest pain; This is a spontaneous report ... Read more
pneumonia; inflammation to the heart; Shortness of breath; chest pain; This is a spontaneous report from a contactable consumer (patient). A 14-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0150, expiration date not provided), 1st dose via an unspecified route of administration, administered in Arm Left on 22May2021 08:00 at age of 14 years old as a single dose for covid-19 immunisation. Medical history included pericarditis with inflammation. The patient's concomitant medications were not reported. The patient previously took vancomycin and experienced allergies. The patient experienced pneumonia, inflammation to the heart, shortness of breath, chest pain, all on 23May2021 07:00. The outcome of the events was not recovered. The patient was not pregnancy at time of vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The adverse events resulted in emergency room/department or urgent care. The patient received treatment for the events included Antibiotics. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
14 2021-06-07 throat irritation Patient reported lip swelling, throat itching and a little hard to breath 30 minutes after injection... Read more
Patient reported lip swelling, throat itching and a little hard to breath 30 minutes after injection. 1.5 hours later, patient developed itchy rash on arms/cheeks/neck. No intervention needed. Symptoms resolved a few hours later on their own at home. Patient did not report to MD until 6/7/21
14 2021-06-08 cough, nasopharyngitis Heart rate on 5/20 of 204 until now still higher than normal between 97-116, when usually is around ... Read more
Heart rate on 5/20 of 204 until now still higher than normal between 97-116, when usually is around 80; diarrhea; cough; cold symptoms; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 14-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 19May2021 12:45 (Batch/Lot Number: EW0186) as 1ST DOSE, SINGLE for covid-19 immunization at the age at vaccination of 14 years old. Patient was not pregnant. Medical history included prior to vaccination, the patient was diagnosed with COVID-19. Past drug reported as none. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced heart rate on 5/20 of 204 until now still higher than normal between 97-116, when usually is around 80 (medically significant) on 20May2021 09:45 with outcome of not recovered; diarrhea, cough and cold symptoms (non-serious) on 20May2021 09:45 with outcome of not recovered. Reported as: Heart rate on 5/20 of 204 then we took her to the urgent care was given fluid and ekg and blood work, after that HR when down to 106, and until now still higher than normal between 97-116, when usually is around 80, also she had diarrhea on 5/20, and also cough from 5/20 until now like cold symptoms. The patient underwent lab tests which included blood test: unknown on 20May2021, electrocardiogram: unknown on 20May2021, heart rate: 204 on 20May2021, heart rate: 106 on 20May2021, heart rate: 97-116 on 20May2021 (still higher than normal, when usually is around 80), sars-cov-2 test: negative on 22May2021 (Nasal Swab; Test: Pcr). The events induced Emergency room/department or urgent care. The treatment received for the adverse event included: Fluids thru IV. Information on Lot/Batch number was available. Additional information has been requested.
14 2021-06-08 headache, chills HEADACHE, NAUSEA, RIGHT KNEE PAIN, LYMPH NODE ON LEFT SIDE (MARBLE SIZE), CHILLS, NO FEVER
14 2021-06-08 headache Headache and nausea
14 2021-06-08 lethargy, headache Projectile vomiting, double vision, confusion/ delirium No treatment just gave her time. All sympto... Read more
Projectile vomiting, double vision, confusion/ delirium No treatment just gave her time. All symptoms cleared within 6 hours of onset. Approximately 9 hours after vaccine administration. Other more expected immune response followed, sore arm, headache, body aches and lethargy. Theses all resolved 36 hours after vaccine administration.
14 2021-06-08 fever, chills fever, chills, vomiting, nausua, pain at injection site
14 2021-06-09 chills, fever Fever, chills, nausea, sore arm, dizziness
14 2021-06-09 chills, fever She started exp chills around midnight with 102 fever. Then she exp abdominal pain and that evening ... Read more
She started exp chills around midnight with 102 fever. Then she exp abdominal pain and that evening around 6pm had 105 temp. I (parent/guardian) reached out to the physician was informed to give her Tylenol.
14 2021-06-09 headache Tenderness at the site, headache, dizziness and nausea
14 2021-06-09 sweating Patient had a vagal response. She became sweaty, dizzy, her vision was impaired then she passed out... Read more
Patient had a vagal response. She became sweaty, dizzy, her vision was impaired then she passed out or seemed to.
14 2021-06-09 fever, chills fever (102/103) for 24 hours with chills vomiting for about 30 min, 36 hours after injection headach... Read more
fever (102/103) for 24 hours with chills vomiting for about 30 min, 36 hours after injection headache, moderate, 4 days
14 2021-06-10 fatigue, chills Mother received phone call that dose of vaccine was undiluted and received 3 doses at one time. Rece... Read more
Mother received phone call that dose of vaccine was undiluted and received 3 doses at one time. Received a phone call about 3-4 hours after the dose informing mother of the error. Since then about 12-18 hrs later pt is having fatigue, body aches, and chills. Arm soreness as well.
14 2021-06-10 sweating Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium
14 2021-06-10 sweating 0918 Called to front lobby. Found patient unconscious lying on floor. Unconscious 15-30 seconds. No ... Read more
0918 Called to front lobby. Found patient unconscious lying on floor. Unconscious 15-30 seconds. No facial swelling and no difficulty breathing. Per witnesses she fell. Code called. Pale and diaphoretic. C/O hot and dizzy/ VS Resp 14 HR 78 BP 106/66 O2 Sat 100% on room air. No history of syncope with vaccines or needles. Instructed parent to remind us this happened when returns for #2 so we can administer vaccine with her lying down. Verbalizes understanding. 0920 Cleared cspine by Dr. who was fist physician on scene. 0925 Transferred to gurney via walking with two person hands on assist. Transferred to ED accompanied by ED personnel and mother.
14 2021-06-10 sweating Pt became woozy and sweaty
14 2021-06-10 fever, cough, pneumonia Patient reports cough and fever since 5/22. Was seen by pediatrician in clinic on 5/25, diagnosed wi... Read more
Patient reports cough and fever since 5/22. Was seen by pediatrician in clinic on 5/25, diagnosed with pneumonia and prescribed azithromycin. Parent reported compliance with medication but reported that patient started to have coughing fits and fever of 104 at home. This prompted ER evaluation and subsequently admitted to hospital for observation. During admission, patient was treated with IV Ceftriaxone x 3 days and PRN Mucinex for pneumonia. No oxygen requirements, so no further intervention was needed per MD.
14 2021-06-10 fever child reports had low grade fever (99), injection site pain/swelling, developed red/blanchable whea... Read more
child reports had low grade fever (99), injection site pain/swelling, developed red/blanchable wheal like annular patches/plaques on sides of both feet of various sizes (1 cm to approx. 2 inch diameter) - describes as painful, denies itching
14 2021-06-10 fever Arm soreness, fever of 100.2, muscle aches in the legs all starting at 2am on 06/11/21. Administered... Read more
Arm soreness, fever of 100.2, muscle aches in the legs all starting at 2am on 06/11/21. Administered Tylenol and it didn?t help
14 2021-06-11 malaise Patient received vaccine at 3:17pm, following which they were instructed to have a seat in the waiti... Read more
Patient received vaccine at 3:17pm, following which they were instructed to have a seat in the waiting area. At 3:21pm, mother reports patient stating they were not feeling well, head tilted to the left and they slipped out from chair onto the floor, resulting in minor trauma to the mouth area. Pharmacy staff responded quickly, calling EMS, instructing patient to stay on floor in recovery position while help arrived. Patient was responsive and alert to questions during this time, mother was blotting mouth area with gauze and water. Patient quickly stabilized after. EMS arrived at 3:37pm and performed follow up tests including HR and blood glucose in EMS vehicle to which mother states results were normal, but patient was again light headed due to sight of blood. Mother and patient declined ride to additional medical facility.
14 2021-06-11 fever, fatigue, chills, body temperature increased 12 hrs post - severe headache, 100.5F fever, chills. Gave advil. Worsened over night. 6/10 vomited,... Read more
12 hrs post - severe headache, 100.5F fever, chills. Gave advil. Worsened over night. 6/10 vomited, nausea, 101F fever despite advil, body aches, severe headache, left arm pit/axillary lymph node pain, chills, shivering, muscle pain, continued advil and tylenol alternating, severe fatigue. Temp 101.6 at 8pm 6/10. 6/11 temp 99.4, headache improved, chills improved, able to eat 6/12 discontinued advil/tylenol, mild back ache, mild pain behind eyes, otherwise returning to normal
14 2021-06-12 influenza like illness Sore arm body aches flu feeling no fever
14 2021-06-13 fatigue Stated that he felt fine at first, recovered for the fifteen minutes and returned to class. Then sta... Read more
Stated that he felt fine at first, recovered for the fifteen minutes and returned to class. Then stated that he started to get really tired and his stomach hurt. Returned to clinic site, laid down for forty five minutes on stretcher, vital signs were stable throughout. Was released to go home with his mother.
14 2021-06-13 sweating Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Me... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Tinnitus-Medium, Systemic: Vomiting-Mild
14 2021-06-13 fever Starting early morning after vaccine, approximately 15 hours after vaccine, patient developed sever... Read more
Starting early morning after vaccine, approximately 15 hours after vaccine, patient developed severe chest pain, shortness of breath, and tachycardia. Her fever was high throughout the day (often 102.8 even after Tylenol and Ibuprofen). I am a physician and my husband is as well, we monitored her heart rate, oxygenation, temperature, and symptoms at home. We called her doctor and asked whether this could be myocarditis and whether we should go to the ER. She felt that we should just have her rest and monitor her vitals. I dosed her with two large doses of Ibuprofen (600 mg twice during the day), and by 6 pm on 6/4 her chest pain started to improve and her fever broke. The severe crushing chest pain lasted about 12 hours.
14 2021-06-14 headache The patient developed a severe headache. Grandmother (guardian) helped her sit in the car seat and s... Read more
The patient developed a severe headache. Grandmother (guardian) helped her sit in the car seat and she took 10 steps away from the car, when she looked back at the patient had began seizing. She was taken to the ER by rescue and diagnosed with having a grand mal seizure. Grandmother states her lips and around her mouth were blue and the seizure was severe. She was treated and released from the ER dept. The patient has been seizure free for 2 years.
14 2021-06-14 headache Vertigo with occasional headache
14 2021-06-14 sweating, headache After pt received vaccine, pt became diaphoretic, complained of headache and was pale. Pt sat down i... Read more
After pt received vaccine, pt became diaphoretic, complained of headache and was pale. Pt sat down in chair and feet propped up. Pt given juice and crackers. Pt laid down for the following 30 minuets to observe. pt discharged with mother with NAD, equal and unlabored breaths, warm, dry and pink.
14 2021-06-14 fever Fever onset 6/5/21. Vaginal Ulcer onset 6/6/21. 1st Pfizer dose received 5/14/21. 2nd Pfizer dose r... Read more
Fever onset 6/5/21. Vaginal Ulcer onset 6/6/21. 1st Pfizer dose received 5/14/21. 2nd Pfizer dose received 6/4/21.
14 2021-06-14 fever She received her 2nd Covid vaccine on 6/9/21. She felt 'crappy' for 2 days after, with low grade fev... Read more
She received her 2nd Covid vaccine on 6/9/21. She felt 'crappy' for 2 days after, with low grade fever. On 6/12/21 she had some vaginal itching. She was in the river that day. She isn't sure if the itching occurred before or after the river. Her LMP was one month ago. She is not sexually active. She has previously had a non-sexual inflammatory ulcer with influenza.
14 2021-06-14 fever 9 days of left upper quadrant abdominal pain and fever (starting 6/7/21), and splenic infarctions vi... Read more
9 days of left upper quadrant abdominal pain and fever (starting 6/7/21), and splenic infarctions visualized on CT abdomen/pelvis on 6/14
14 2021-06-15 headache, chills Caller stated that 12 hrs after shot his daughter had expected side effects...chills, headache and n... Read more
Caller stated that 12 hrs after shot his daughter had expected side effects...chills, headache and nausea which lasted 24 hrs. 2 days later she had a very painful very heavy period 2 wks early. (dad stated period has always been regular until after shot)
14 2021-06-15 fever Day 1 after vaccine abdominal pain started. Day 2 diarrhea started and still continues (day 8 today)... Read more
Day 1 after vaccine abdominal pain started. Day 2 diarrhea started and still continues (day 8 today) Day 4 vomiting started and still continues. Diarrhea is bloody. Low grade temperatures but no high fevers.
14 2021-06-15 sleepiness, sweating 9:52 Within 1 minute of being vaccinated, while seated in chair stated "I'm really lightheaded". E... Read more
9:52 Within 1 minute of being vaccinated, while seated in chair stated "I'm really lightheaded". Eyes were wide open and became unresponsive to verbal stimulation 9:53 Arms stiffened, no response, diaphoretic, pale 9:54 More responsive, groggy 9:56 Placed in supine position on floor mat with legs elevated. Stated she "could feel nurse holding me up" 9:58 BP 96/50 HR 70 laying flat 10:00 Call placed to mom 10:03 Mom arrived 10:05 Sitting up, eating snack with bottle of water 10:07 Felt "shaky" and laid down 10:09 BP 96/52 HR 80 10:15 BP 98/52 sitting up, HR 80 10:26 Seated in chair eating another snack. feels "a little lightheaded"10:25 Feels OK. DC with Mom
14 2021-06-16 chills, sweating Systemic: Chills-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Sys... Read more
Systemic: Chills-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium
14 2021-06-16 cough, malaise Extreme weakness in her arms and legs; Really bad cough; painful in arms and legs; not been feeling ... Read more
Extreme weakness in her arms and legs; Really bad cough; painful in arms and legs; not been feeling well; This is a spontaneous report received from a contactable consumer (Parent). A 14-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, via an unspecified route of administration in right shoulder on 23May2021 14:00 (Batch/Lot number was not reported) as 1st dose, single dose for covid-19 immunisation. Medical history was reported as none. There were no concomitant medications. Family history was reported as none, they were basically a healthy family. Patient was not vaccinated within 4 weeks and no additional Vaccines administered on same Date of the Pfizer Suspect. On 23May2021, the patient experienced extreme weakness in her arms and legs, really bad cough, on an unspecified date in May2021, she had severe pain in her legs and on an unspecified date in 2021, she was not been feeling well. Patient's father called on behalf of his 14-year-old daughter who received the first dose of the Pfizer COVID-19 vaccine about two weeks ago and had extreme weakness in arms and legs, 2 weeks ago, on Sunday 23May2021. She had not been to school since then, she went for a couple hours and then they send her back. His daughter also said that it had been painful but caller states that he does not know exactly what his daughter means by that, she said that her legs hurt her, that started probably 24May2021 or 25May2021 with the bad cough also and not been feeling well. Had all leveled out the past 10 days. Had blood work and the results came back Friday. Thought there was an outside chance based on the blood work that it was strep related. Her doctor had suggested that the parents call Pfizer to see if this type of reaction had been reported in her age group after receiving the Pfizer COVID-19 vaccine. She never really had a fever. This started the day after the vaccine, and they are not sure if it was related to the vaccine or not. A couple of results were off. The Streptolysins were 468. The antinuclear antibodies were 1 to 160, which was off. Everything else was negative. The patient underwent lab tests and procedures which included antinuclear antibody: 1 to 160, streptococcus test: 468. Patient received therapeutic measure to treat adverse events, they tried Amoxicillin, which had no impact, they thought maybe it was just a virus. They also tried Tylenol and Advil, which also had no impact. Stated that the Amoxicillin was 875mg twice a day and that the Tylenol and Advil were from different packages lying around the house. Patient was scheduled for the second dose this coming Sunday but they were holding off until she was better. The outcome of events was unknown. Information on the lot/batch number has been requested.
14 2021-06-16 headache On sunday night, about 36 hours after vaccination, she started to have numbness of her lower jaw and... Read more
On sunday night, about 36 hours after vaccination, she started to have numbness of her lower jaw and tongue. She started to have an incredible amount of drooling and could not swallow. She then started to have epigastric cramping and sharp abdominal pain that moved into the right lower quadrant. She had pretty severe headache that started the same time as numbness and drooling with photosensitivity. No fever. No vomiting but she was nauseous. she went to the ER late on 6/13. She was then transferred to the hospital for furthur care. She had a neurology consult that thought perhaps her headache, numbness and drooling could have been an atypical migraine-this resolved as of 6/14. Her abdominal pain resolved after appendectomy and now she just has muscular pain related to surgery.
14 2021-06-16 sweating, malaise, body temperature increased vaccine was given at the local high school (not by her doctor, the physician who is placing this rep... Read more
vaccine was given at the local high school (not by her doctor, the physician who is placing this report with mother's information) She told mother she did not feel right 10pm the night of the vaccination, felt hot and cold, sweating, could not sleep, rose up from bed at 4am to get a glass of water, mother heard a noise from kitchen, and found patient passed out on floor. She was out for 2minutes at the most Mother got her up and made her drink a lot of water. She continued to feel bad. Temp was close to 102. Around 5pm that evening she was feeling better. So this report is because of a syncopal episode about 19 1/2 hours after the Covid Pfizer vaccine #2.
14 2021-06-16 fever, chills, headache Fever, chills, headache Used Advil, fluids and rest
14 2021-06-16 fever The mom mentioned that the pt was experiencing fever of 102 which was not going down even after taki... Read more
The mom mentioned that the pt was experiencing fever of 102 which was not going down even after taking motrin. The pt fainted almost and the pts heart was having rapid heart beat. She had soreness as well and was concerned about heart conditions linked with this vaccine whether this was the situation.
14 2021-06-17 fatigue, fever Between 12-1am on 6/18/21 Complaints of extreme hypersensitivity of skin, felt ?weird? for her cloth... Read more
Between 12-1am on 6/18/21 Complaints of extreme hypersensitivity of skin, felt ?weird? for her clothing of bed sheets to touch her resulting in uncontrollable crying. Also fever of 101.3 Administration of ibuprofen by mouth for fever once able to calm the emotional reaction. Water intake & sleep. Awoke after 9am on 6/18, fever reduced, symptoms resolved except for tiredness.
14 2021-06-17 sweating Symptoms: Patient was sweaty, dizzy and nauseated 1 minute after the administration of the vaccin... Read more
Symptoms: Patient was sweaty, dizzy and nauseated 1 minute after the administration of the vaccine. Treatment: Patient laid down and symptoms improved . Outcome: Patient was discharged to POV/Home once the symptoms were improved.
14 2021-06-17 sweating Systemic: Flushed / Sweating-Mild, Additional Details: Patient complaint of being feeling hot after ... Read more
Systemic: Flushed / Sweating-Mild, Additional Details: Patient complaint of being feeling hot after the vaccination, gave her cold water to drink and made her lie down on the floor, fanned her, soon she was feeling better, got up and sat back on the chair, she was feeling good after wards and left.
14 2021-06-17 fever, malaise Fallen unconscious and collapsed; Fell down and she was not conscious/passed out; Had concussion lik... Read more
Fallen unconscious and collapsed; Fell down and she was not conscious/passed out; Had concussion like falling on the ground but it appears like a seizure, that was a immediate thing; Fallen unconscious and collapsed; Fell down and she was not conscious; Had concussion like falling on the ground but it appears like a seizure, that was a immediate thing; Low blood pressure; Fever; Shaking/She was shaking/still moving; She was not feeling well; She is still twitching; Eyes go back; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (mother) reported that a 14-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 03Jun2021 (Batch/Lot number was reported as EW 'O or 0' 186) at the age of 14-years-old as SINGLE DOSE for covid-19 immunisation. The patient medical history was none. There were no concomitant medications. No family medical history of seizure. The patient previously received the first dose of BNT162B2 on an unknown date at Arm Left for covid-19 immunisation. The reason for the transfer today (03Jun2021) was that her 14 year old daughter immediately after getting her second dose of the COVID vaccine started shaking, experiencing fever and fallen unconscious and collapsed and was taken to the hospital and she wanted to go ahead and report those adverse side effects for her. She (patient) was 14 year old and she got her second vaccination today and few minutes after she got it, she stood up and she said she was not feeling well and then the next thing reporter knew like her eyes go back, she do not seem conscious and she was shaking as if, looks like she was having a seizure and then she fell down and she was not conscious, so she fell down, she is still twitching. She has no history of like seizures but that is like twisting and now she was taken to the hospital. So, the hospital treated her as if she had a concussion. Reporter have reported to them that she looks like it was a seizure before she fell down, into her head. Reporter further stated "That day was her second shot and like I said she stood up, she got up from that, she said that she got funny and that I can see where she just kind of lost consciousness, eyes going back, shaking as if she was having seizures and then she fell down and she was unconscious and she is like still moving as if she is having a seizure and she was taken. Reporter stated, "it was a like a seizure but it is like over and she had concussion like falling on the ground but it appears like a seizure, that was a immediate thing." For treatment, reporter stated that "Any treatment, No. She was taken to the hospital and the hospital needs to write it down and I don't understand that, the hospital wrote down concussion but the hospital they took the vital signs and she had low blood pressure." For the date when patient went to the hospital, reporter stated "That was today, June 3rd and she is discharged. The reason she was taken was potential seizure and it was concussion and it was after she fell, she passed out and had low blood pressure. The outcome of the events was unknown. Information on the lot/batch number has been requested.
14 2021-06-17 fever familiar to a seizure; collapsed; unconscious; fever; shaking; they told possible sign of infection;... Read more
familiar to a seizure; collapsed; unconscious; fever; shaking; they told possible sign of infection; This is a spontaneous report from a Pfizer sponsored program. A non-contactable consumer reported that a 14-year-old female patient (consumer's daughter) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), the second dose via unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The relevant medical history was not reported. Concomitant medications were not reported. On an unspecified date, after getting the second dose of the Covid Vaccine immediately started experiencing fever, shaking; her eyes were back as she seemed unconscious and collapsed; it was familiar to a seizure; was taken to the hospital, they told possible sign of infection and she was advised to go ahead and just to report what had happened. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
14 2021-06-18 nasopharyngitis, malaise 14 yo female was anxious prior to and during vaccination given at 11:59am. The patient was told to ... Read more
14 yo female was anxious prior to and during vaccination given at 11:59am. The patient was told to sit for 30 mins due to an egg allergy. After waiting 30 minutes, the mother (who was shopping) retrieved child who was sitting in the pharmacy waiting area post vaccination. After 5 more mins, another customer got the RPH attention explaining the patient was passing out. The mother assisted patient to the pharmacy waiting area, in which the patient was given chairs to sit on and put feet up. Another shopper who said she was an ER nurse told the pharmacy staff to have the patient lay down across the chairs then left. The patient was weak, cold, clammy, and pale. The patient then told the pharmacist that she had left her mother at the check out section, went upstairs, used the bathroom, was coming down the stairs when her vision started to have black spots. She reached her mother when she said she didn't feel good and started to pass out. The mother stated she caught her daughter. At this point, the RPH initiated a 911 call. She called out for the technician to call the store managers for assistance and take over the 911 call. The RPh then stayed with the patient and the mother. The tech gave the mother a bottle of water for the pt. The store managers arrived at the scene and also assisted. The patient stated she was feeling a lot better after she laid down for a little bit. The RPh notice color coming back into the patient's lips and face. The patient stated that the adverse effects didn't start until she was walking down the stairs. After 10-15 mins, the Paramedics arrived and further assisted the patient and her mother. The paramedics took the patient via stretcher to the ambulance for further treatment around 12:55pm.
14 2021-06-18 fever Fever of 101.4 started Wednes evening, spiked to 103.4 by the following day. Administration of ibupr... Read more
Fever of 101.4 started Wednes evening, spiked to 103.4 by the following day. Administration of ibuprofen kept temp down to 99-101 throughout Thursday and Friday. Saturday at 5 am spiked to 102.9, administration of Tylenol got it back down to 98.9. Saturday evening at 5 pm (which is current date/ time) back up to 101.7. Tylenol administered.
14 2021-06-19 headache 14 yo Female client received Pfizer vaccine at 13:29. Client reported feeling dizzy and light heade... Read more
14 yo Female client received Pfizer vaccine at 13:29. Client reported feeling dizzy and light headed, appeared pale. Client escorted to the floow to lie down, father present BP 138/94, client reported feeling anxious Father gave client cookies, client reported feeling better but had a headache, color returned No EMS called Ambulatory upon leave with father
14 2021-06-20 chills, fever Fever 101.1 Chills with shaking
14 2021-06-20 headache Headache and dizzy
14 2021-06-21 chills, sweating, malaise, fever Patient is a 14 yo girl with PMH significant for migraines who presented with one day of chest pain ... Read more
Patient is a 14 yo girl with PMH significant for migraines who presented with one day of chest pain and nausea that woke her from sleep in the setting of multiple days of malaise. She states that after receiving the COVID-19 vaccine three days prior to admission she has not been feeling well. She reports subjective fevers and chills the day after receiving the vaccine, and intermittent feelings of her heart racing. She also has been feeling hot and generally unwell. + shortness of breath. The night of admission, she awoke from sleep with burning central anterior chest pain and nausea. She tried to stand up and felt generally weak, and then had tunnel vision and felt she was going to faint. Per mom, she was pale and diaphoretic at that time. The pre-syncopal symptoms resolved within about 10 minutes and the chest pain persisted for approx one hour. Parents called EMS and she was brought to the ED for evaluation. Of note, she reports a history of pre-syncopal sx however has never lost consciousness before. Also reports a history of intermittent palpitations. No hx chest pain prior to this episode. + fevers/chills as mentioned after receiving COVID vaccine three days PTA but no infectious sx prior to that. No cough/URI sx, no abdominal pain, no nausea. + diarrhea night of admission. No sick contacts. She is active in dance and has good exercise tolerance for that; does not spend much time outdoors. No known insect or tick bites. + FHx of sister with heart murmur as a baby that spontaneously resolved; unclear diagnosis. In the ED BP 94/62, T 97.4, P 84, R 16, SpO2 100% on RA EKG: sinus rhythm, no ST or PR changes CMP: unremarkable CBC: WBC 11.8, Hgb 11.5 Trop T 0.33 Bedside echo w/ reported good function UA wnl COVID neg CXR PA and lat unremarkable On arrival to the PCICU she reported feeling at her baseline and denied chest pain and shortness of breath.
14 2021-06-21 chills, fever Got the Vaccine on Sunday. On Monday had chills, fever, muscle aches. Tuesday started to feel vagina... Read more
Got the Vaccine on Sunday. On Monday had chills, fever, muscle aches. Tuesday started to feel vaginal pain and swelling of vulva. On Wednesday had more chills, episode of fingernails turning blue. Extreme vaginal pain. Thursday went to Gynecologist- diagnosed with ulcers. Sent pictures to dermatologist and diagnosis of Lipschutz ulcers was made. On Friday went to rheumatologist and ruled out any auto-immune disease. Monday- 6/21/21 seen by Dermatologist who confirmed the diagosis of Lipschutz ulcers, believes it came from the covid vaccine. No current treatment available, only supportive care available.
14 2021-06-21 sweating 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: Nausea-Medium, Additional Details: Patient did not have complaints during her 15 minute waiting period each time technician checked in on her. When the techinician told her her 15 minutes have elapsed, she complained of dizziness and fainted soon after. She regained consciousness after a few seconds and then complained of nausea. Paramedics were immediately called when she fainted. They arrived in about 5 minutes and transported her to ER.
14 2021-06-22 fever, chills Patient experienced fever and chills day following vaccine. On day two after receiving vaccine, pati... Read more
Patient experienced fever and chills day following vaccine. On day two after receiving vaccine, patient developed chest pain and presented to ED. Work up concerning for myocarditis due to chest pain in the setting of ECG changes and troponin elevation. Chest pain resolved prior to discharge from the hospital and patient was back to baseline.
14 2021-06-22 fever 1 day after 2nd shot had fever, abdominal pain, chest pain, shortness of breath, tachycardia.. Was... Read more
1 day after 2nd shot had fever, abdominal pain, chest pain, shortness of breath, tachycardia.. Was seen in ER. Fever. abdominal pain resolved in 2-3 days. Chest pain still present, and shortness of breath 5 days after
14 2021-06-22 fever 6/19/21 patient awoke with non-bloody, bright green emesis and abdominal pain. She endorses several ... Read more
6/19/21 patient awoke with non-bloody, bright green emesis and abdominal pain. She endorses several episodes of nonbloody diarrhea with continued abdominal pain. She endorses starting her menstrual period 3 days ago. Mom endorses fever at this time, T-max 102.9. Presented to an urgent care for further evaluation where they obtained a rapid strep test and COVID-19 swab that were both negative. 6/21/21 she presented to an ED for continued and worsening symptoms. She received a dose of antibiotics and saline boluses during transfer to another hospital. In route, she became hypotensive with minimal response to fluid resuscitation. She required vasopressors to maintain blood pressure. A CT of the abdomen showed nonspecific findings for enterocolitis. A urinalysis had 5-15 RBCs and 51-100 WBCs. She was started on antibiotics. She required ICU admission initially, but improved and became hemodynamically stable after about 16 hours in the PICU. Her urine culture grew 3 different organisms with low colony counts so antibiotics were discontinued on 6/22/21. An ECHO demonstrated normal biventricular size and systolic function (LFEF 62%), mild tricuspid regurgitation estimating mildly elevated RV pressure (30-40% systemic), mild flow accelration across normal appearing trileaflet aortic valve and borderline small aortic root and sinotubular junction, normal ascending aorta, no pericardial effusion, normal right, left main, and LAD coronary artery diameter z-score, and mild outpouching in the left main coronary artery that may represent an early appearance of an aneurysm. A repeat ECHO the following day revealed normal biventricular size and systolic function, mild tricuspid regurgitation estimating RV systolic pressure of 30mmHg, left main coronary artery appears slightly prominent but measures within normal limits. LMCA measurement is similar to previous, normal measurement of the proximal RCA and LAD, and trivial pericardial effusion. The patient also had an elevated CRP of 18.8 mg/dL, fibrinogen of 408 mg/dL, d-dimer of 0.98, and nt-pro BNP of 309. SARS CoV2 IgG was positive and IgM was negative. She received IVIG 100 gm on 6/23/21 and was started on rivaroxaban. CRP decreased to 8.2 mg/dL on 6/23/21.
14 2021-06-23 headache, fever Vomiting; Fever; Muscle aches; weakness; headache 24 hours
14 2021-06-23 fever, chills Got the Vaccine on Sunday. On Monday had chills, fever, muscle aches. Tuesday started to feel vagina... Read more
Got the Vaccine on Sunday. On Monday had chills, fever, muscle aches. Tuesday started to feel vaginal pain and swelling of vulva. On Wednesday had more chills, episode of fingernails turning blue. Extreme vaginal pain. Thursday went to Gynecologist- diagnosed with ulcers. Sent pictures to dermatologist and diagnosis of Lipschutz ulcers was made. On Friday went to rheumatologist and ruled out any auto-immune disease. Monday- 6/21/21 seen by Dermatologist who confirmed the diagosis of Lipschutz ulcers, believes it came from the covid vaccine. No current treatment available, only supportive care available.
14 2021-06-24 headache, malaise, fever Within 2 hours of the vaccine, patient was experiencing nausea and general feeling of unwellness. Wi... Read more
Within 2 hours of the vaccine, patient was experiencing nausea and general feeling of unwellness. Within 3 hours, patient had a fever of 99.9. At 11 pm, patient had a fever of 100. Mother administered Tylenol and patient went to bed. Patient woke up around 4:30 am with her whole body shaking uncontrollably. Mother heard her stirring and went to check on her. Her temperature was 100. Mother sat and talked with her and offered a snack, drink, and more Tylenol. Mother checked her pulse, which was normal. Patient was coherent and able to communicate. Mother left the room to get snack and drink and heard something fall over in patient's room and Mother called out and waited a few seconds for a response. Patient did not respond. Mother went back in the room, as it was unusual for patient not to respond, and found patient sitting back up and placing her head in her hands, stating in a panicked voice that she felt she was going to throw up and that she was very hot and that her head hurt really bad. Patient stated that her ears felt weird and everything went black and she somehow fell over from a sitting position on her bed to laying on her bed and had landed on the dog. Patient was unaware that she had knocked over her water bottle and had no recollection of the loud sound it made as it fell over (unusual because loud sounds are very startling for her). The shaking subsided to a tremor a few minutes after the black out. Patient then reported feeling very cold and her temperature had risen to 101. Patient complained of an extreme headache and continued nausea. Mother took patient to Urgent Care, who performed bloodwork and an EKG, and then referred patient to the Emergency Room for an EEG. ER repeated EKG and declined to do EEG and told patient to follow up with her doctor in 5 - 7 days.
14 2021-06-24 sweating 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, Systemic: Hypotension-Medium, Systemic: Vomiting-Severe, Systemic: Weakness-Severe
14 2021-06-24 fever, sleepiness, lethargy vomited; She developed a fever that night through morning of 12Jun2021; She was lethargic; slept for... Read more
vomited; She developed a fever that night through morning of 12Jun2021; She was lethargic; slept for 2 days; This is a spontaneous report received from a contactable consumer. A 14-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation; solution for injection, Lot number: unknown), via an unspecified route of administration on 10Jun2021 at 12:00 (at the age of 14-years old) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (lot number: unknown) via an unspecified route of administration on an unspecified date (at the age of 14-years) as single dose for covid-19 immunisation and had no reaction on previous exposure to vaccine. On 10Jun2021 at 12:00, the patient received second shot and developed a fever that night through morning of 12Jun2021. On an unspecified date in Jun2021, the patient was lethargic and slept for 2 days. On 11Jun2021, the patient vomited. Event took place after use of product. The outcome of the events was unknown. Information about lot/batch number has been requested.
14 2021-06-25 headache, fatigue, chills Hives, fatigue, headache, muscle aches and pain, chills
14 2021-06-25 sweating Became pale, diaphoretic, nauseous and had an emesis. B/P and pulse were stable. She was given water... Read more
Became pale, diaphoretic, nauseous and had an emesis. B/P and pulse were stable. She was given water and a granola bar. She was also leaned back and feet were put up in the chair to raise them above her heart.
14 2021-06-27 headache, fatigue, fever Received 2nd Dose on 6/22. On 6/23 & 6/24 she had "normal" reaction, for example- Headache, sore mu... Read more
Received 2nd Dose on 6/22. On 6/23 & 6/24 she had "normal" reaction, for example- Headache, sore muscles, low grade fever, tired. On Friday 6/25 she woke up with chest pain and the headache was still there. She had a hard time taking in a deep breath and when she did it hurt really bad. The chest pain hurt all the time, but worse when taking the deep breath. We call pediatrician and they told us to go to ER.
14 2021-06-27 sweating Diaphoretic, states can not see, Dropped BP, monitored for 30 minutes, BP improved, no loss of visio... Read more
Diaphoretic, states can not see, Dropped BP, monitored for 30 minutes, BP improved, no loss of vision
14 2021-06-27 malaise patient's mom yelled that she was having a reaction a few minutes after the vaccination. Patient wa... Read more
patient's mom yelled that she was having a reaction a few minutes after the vaccination. Patient was very pale, looked unwell. said she was feeling dizzy and bad. had her put her head between her knees. said she hadn't eaten anything that day, gave her some orange juice. we had called ED as a precaution because mom had at first thought she might be having a seizure. Paramaedics came and evaluated her. She was feeling better about 20 minutes later so mom took her home.
14 2021-06-27 throat pain Experienced lump formed in middle to base of throat and right cheek became swollen. Lump in throat w... Read more
Experienced lump formed in middle to base of throat and right cheek became swollen. Lump in throat was the size of a quarter but did not block her airway passage. Doctor checked her airway passage, heart, and pulse. Took one Zyrtec administered by mom, because she is allergic to Benadryl. The Zyrtec was given around 2:45 PM. After 10 minutes the lump in middle to base of her throat and right cheek did not reduce in size. She was able to drink water and her mom, and gave her another Zyrtec pill. This is an emergency plan for provided by her allergy doctor. This was an emergency event for her with all of her known allergies. After 20 minutes, she began to feel the lump in her throat slowly decrease in size. She was being monitored by Dr. and a Nurse, and additional nurses on staff. Dr. continued to check her heart, airway passage, and pulse. As the lump continued to reduce in size after 45 minutes to 1 hour after receiving the Pfizer vaccine, she was able to get up and walk around with a pulse monitor on her finger to monitor her heart rate and breathing. She did not have any concerns while walking nor while sitting in the office and was being watched by the staff. In the very beginning after giving her the Zyrtec she need to keep her mask off to ensure her breathing stayed under control. We were able to leave and did not need the EpiPen administered by staff nor by her mother. We were able to leave around 3:45PM. We received follow up calls from the Nurse at 4:54 PM and from Dr. around 5:30 PM to check on her. At 11:00 PM I did give her 1 Zyrtec before bed. I woke her up on June 17th at 6:15 AM and asked her to drink some water. After drinking water she noticed she had a lump in her throat. Her mom gave her another Zyrtec. She was watched closely throughout the remaining week and was in contact with her doctors office. Patient also experienced pain in her throat due to all the swelling/inflammation. Since receiving the vaccine, patient has noticed an increased difficulty in wearing her mask. This did occur prior to receiving the vaccine.
14 2021-06-28 fatigue, headache She is a soccer player and runner with high exercise tolerance. Today she went to track practice. Sh... Read more
She is a soccer player and runner with high exercise tolerance. Today she went to track practice. She experienced chest pain, dizziness, severe headache, nausea, and fatigue. She was not able to complete the workout. Heat was not a factor. She continues to have episodic chest pain, headache, and nausea the rest of the day.
14 2021-06-28 fatigue, sweating, lethargy Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection... Read more
Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Medium
14 2021-06-28 headache Pt had a witnessed fall post vaccination. Per mother, pt complained of being dizzy and fell. Staff w... Read more
Pt had a witnessed fall post vaccination. Per mother, pt complained of being dizzy and fell. Staff witnessed patient falling from standing to ground, and hit her head. Pt was awake and alert upon RN reaching at side. Pt was following commands. Pt stated she was dizzy and nauseated prior to syncopal episode. Maintaining C-spine precautions d/t posterior head and midline neck pain and tenderness. Team alert was called. To ED via stretcher with medics
14 2021-06-29 fatigue, lethargy, sweating Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection... Read more
Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe.
14 2021-06-29 fever, headache, chills, malaise Generalized rash, weakness, swollen lymph nodes, general malaise, fever, chills, one episode of diar... Read more
Generalized rash, weakness, swollen lymph nodes, general malaise, fever, chills, one episode of diarrhea and vomiting and headache.
14 2021-06-30 fever, lethargy Patient stated on 3 days post-dose on June 14, 2021, she began to feel lethargic. On June 15, 2021 p... Read more
Patient stated on 3 days post-dose on June 14, 2021, she began to feel lethargic. On June 15, 2021 patient started running low grade fever and treated with ibuprofen as needed. On Saturday, June 19, 2021 through Monday, June 21, 2021 pt was experiencing sharp chest pains with laying down and with movement as well as difficulty deep breathing. Patient continued to take ibuprofen to relieve symptoms. All symptoms resolved by Monday, June 21, 2021.
14 2021-06-30 throat irritation Mother assists with history that patient's throat felt "funny" once they return to their car after p... Read more
Mother assists with history that patient's throat felt "funny" once they return to their car after post-observation 15 mins observance. States that this is similar to when she eats certain foods namely cherry which is noted as an allergy in pt chart. Patient given 12.5mg diphenhydramine oral suspension with reported resolution of symptoms ("funny feeling in throat") after additional 15 mins observation. Patient discharged with mother.
14 2021-07-02 fatigue, fever, headache 100+ Fever & Headache for 6 days. Fatigue & Aches for 8 days and continuing.
14 2021-07-02 headache, runny nose, fever, chills, fatigue After 2nd vaccination at 10pm on 7/1/21 patient reported a headache. At 5am on 7/2/21 patient woke ... Read more
After 2nd vaccination at 10pm on 7/1/21 patient reported a headache. At 5am on 7/2/21 patient woke up with a fever of 100.4 temperature, headache, chills, and body aches, and feeling very tired. Later in the day her nose started to run and she felt like her chest was heavy when she took a deep breathe in. She slept all of the day. All symptoms continued throughout the day until early on 7/3/21 when the fever was gone but all the other symptoms remained mildly.
14 2021-07-03 sweating, headache, cough Patient had her first dose of Pfizer and after she sat down she became nauseous, head pounded, very ... Read more
Patient had her first dose of Pfizer and after she sat down she became nauseous, head pounded, very hot and sweaty, coughing, her lips, face and arms got tingly. She said her heartbeat was fast and she felt like she could faint. EMT was called but they did not take her to the hospital just suggested her parent get her checked out.
14 2021-07-04 fatigue, fever Fever and fatigue with a severe breast infection to follow
14 2021-07-04 fatigue My daughter developed a rash that has persisted for over 3 weeks now. She was originally misdiagnose... Read more
My daughter developed a rash that has persisted for over 3 weeks now. She was originally misdiagnosed as having poison ivy and was given 2 steroid shots. That helped for a few days. She then saw the regular Dr who said it was a virus and was given 5 days f oral steroids. The rash has persisted coming and going regularly in different locations all over the body. My daughter has also been much more tired than normal. The regular Dr has referred her to dermatology but she can?t get in to be seen for several weeks.
14 2021-07-04 fever I gave patient 0.3ml of an undiluted vial of vaccine. Later on, about an hour I realized what I had ... Read more
I gave patient 0.3ml of an undiluted vial of vaccine. Later on, about an hour I realized what I had done and called the Pfizer help line. They gave me a little information. I called the patients mom to let her know what had happened. I had talked to several other sources besides Pfizer about what to expect and informed mom of increased arm soreness and fever and feeling bad. I called the mom back the next day to see how she was doing and she had run fever that night and bad soreness in the arm. Mom said she was doing ok, nothing out of the ordinary. I also reported it through our compliance dept.
14 2021-07-05 sweating, malaise Per RN, patient "almost immediately" after receiving vaccine, stated she wasn't feeling well. Patien... Read more
Per RN, patient "almost immediately" after receiving vaccine, stated she wasn't feeling well. Patient became diaphoretic and pale. Patient assisted to supine position. Vitals at 1227 BP 113/78. 100% O2Sat, 61 HR. Placed cool compress on forehead. Continued to monitor. At 1235 BP 115/65, 99% O2Sat, HR 59. Offered Gatorade and given pretzels. Color improving, continued to lay supine. At 1240 BP 114/68, 99% O2Sat, HR 65. Patient slowly assisted to sitting position and assisted to chair. Remains slightly pale, awake & alert. Sipping Gatorade and eating pretzels, conversive with Mom and sister. Patient left Observation at 1:00pm, ambulatory with Mother and sister.
14 2021-07-06 fatigue After one week, loss of apetite. Then on 6/16/2021 in evening symptoms of nausea, fatigue, and sev... Read more
After one week, loss of apetite. Then on 6/16/2021 in evening symptoms of nausea, fatigue, and sever abdominal pain (pain described as an 8 in a scale of 1-10. CT scan of abdomen was negative foe appendicitis.
14 2021-07-07 headache, body temperature increased Headache, 102.2 temp, body aches, vomiting, nausea
14 2021-07-07 headache Headache for 5 weeks, found to have acute ischemic injury of L cerebellar hemisphere that likely pre... Read more
Headache for 5 weeks, found to have acute ischemic injury of L cerebellar hemisphere that likely precipitated symptoms, all starting after first dose of Pfizer COVID vaccine.
14 2021-07-07 sweating Dizzy, pale, diaphoretic, and syncopal event. Patient was caught by staff and parent, did not fall.... Read more
Dizzy, pale, diaphoretic, and syncopal event. Patient was caught by staff and parent, did not fall. Blood pressure taken, placed in a chair and then on a cot, cold compress, monitored for 20 minutes. Educated parent to have child in supine position during 2nd dose.
14 2021-07-07 malaise, fever Fever, nausea, arm/shoulder pain, generally feeling unwell
14 2021-07-07 throat pain Client received second dose of COVID19 vaccine at 2:28pm. While sitting in observation room with her... Read more
Client received second dose of COVID19 vaccine at 2:28pm. While sitting in observation room with her mom, she became dizzy, light headed and nauseous. Nursing staff evaluated client. She stated she had only had a muffin for breakfast. Staff provided juice, water and nutri-grain bar. Due to nausea, only able to drink a small amount of juice. Moved client to cot. EMS was called. Provided cold compress for forehead. She continued to drink the juice. Pulse ox was taken and was 98 continuously while she was on the cot. Nursing staff evaluated her for symptoms and improvement. She state she was still dizzy, lightheaded, and nauseous. She also stated her throat hurt/felt tight. EMS arrived. Interpreter used during event.
14 2021-07-07 pneumonia The differential diagnosis for this patient's chest pain includes PE, ACS, Dissection, Pericarditis,... Read more
The differential diagnosis for this patient's chest pain includes PE, ACS, Dissection, Pericarditis, Pneumothorax, Pleurisy, Pneumonia and musculoskeletal strain. Given the above history, physical exam and ancillary tests, the patient's symptoms are most consistent with: Acute myopericarditis. Should be noted the patient is post 2nd COVID 19 vaccine by 3 days ago. Case reviewed with the pediatric emergency medicine physician at healthcare facility who will accept the patient in transfer. Because this is highly likely a post vaccination myopericarditis will hold on aspirin or other treatments at this time. Patient was given Motrin 400 mg p.o. in the ED for pain.
14 2021-07-08 body temperature fluctuation weak pulse,changes in body temperature,clammy sweat, pale skin I called emergency services the emt f... Read more
weak pulse,changes in body temperature,clammy sweat, pale skin I called emergency services the emt firefighter came they checked her vitals her color returned and she was doing better but still shaky Mom wanted her to be checked out the emt took her to hospital
14 2021-07-08 fatigue, fever Fatigue 2 hours after vaccine Fever 101.2 ? 6:20 am 7/9/2021
14 2021-07-09 headache, fever Woke up with 101 degree fever, headache and muscle soreness
14 2021-07-09 lethargy Fainting, weakness, lethargy
14 2021-07-09 fever Patient developed an itchy rash on torso and upper body. They were red almost like pimples and very... Read more
Patient developed an itchy rash on torso and upper body. They were red almost like pimples and very itchy. Also developed a fever of 102, and arm was throbbing. Father alternated Ibuprofen and Tylenol for the fever , and Benadryl for the itchy rash. Today she is doing much better but still has a itchy rash on the arm. She no longer has a fever and seems to be much better.
14 2021-07-10 throat pain, sneezing, headache, runny nose, fever, fatigue She began feeling badly the day after 2nd dose. Sore throat, runny nose, sneezing, headache, fatigu... Read more
She began feeling badly the day after 2nd dose. Sore throat, runny nose, sneezing, headache, fatigue. Today is 4th day after 2nd dose and she feels pretty awful. Started running low fever and complaining of *chest pain* and *pain in back and shoulders* and pain upon *deep breaths*.
14 2021-07-10 sluggishness, fatigue, fever it was just mild fever; Pain in arm; sluggishness lasted for two days/sluggish for two days; she is ... Read more
it was just mild fever; Pain in arm; sluggishness lasted for two days/sluggish for two days; she is very tired; This is a spontaneous report from a contactable consumer (parent). A 14-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0196, 14-years-old at the time of vaccination), intramuscular, administered in arm left on 26Jun2021 10:30 as single for covid-19 immunisation. Medical history included asthmatic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included salbutamol sulfate (ALBUTEROL SULFATE) taken for asthma. Patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0186, at the age of 14-year-old), intramuscular, administered in arm left on 21May2021 12:30 as single for covid-19 immunisation and experienced four days late for her monthly menstrual cycle. On an unknown date in 2021 patient experienced mild fever, pain in her arm, sluggishness lasted for two days and she was very tired and sluggish for two days. Patient did not receive any treatment for the events. On an unknown date in 2021 events were resolved. Follow-up attempts are needed. Further information is requested.
14 2021-07-12 sweating Pt. Dizzy and sweating called emts checked vitals and released.
14 2021-07-12 sweating Site: Pain at Injection Site-Mild, Systemic: Abdominal Pain-Mild, Systemic: Confusion-Mild, Systemic... Read more
Site: Pain at Injection Site-Mild, Systemic: Abdominal Pain-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: passed out for 3-5 seconds-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Systemic: Vomiting-Mild, Additional Details: she passed out for 3-5 seconds, came to. Was very pale, maybe 5 minutes later threw up. Then she regained some color and was less confused. She was very anxious about getting the shot prior to getting the injection.
14 2021-07-12 fever, chills Lipschutz ulcers; episode of fingernails turning blue; vaginal pain; swelling of vulva; chills; feve... Read more
Lipschutz ulcers; episode of fingernails turning blue; vaginal pain; swelling of vulva; chills; fever; muscle aches; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 14-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EW0178), via an unspecified route of administration, administered in arm left on 13Jun2021 (at the age of 14-years-old) as dose 2, single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EW0183) via an unspecified route of administration, administered in arm left on on 23May2021, as dose 1, single for COVID-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination and since the vaccination the patient was not tested positive for COVID-19. It was reported that on Sunday 13Jun2021 the patient received second dose of vaccine and on Monday on 14Jun2021 patient had chills, fever, muscle aches and on Tuesday 15Jun2021 started to feel vaginal pain and swelling of vulva and on Wednesday 16Jun2021 she had more chills, episode of fingernails turning blue and had extreme vaginal pain. On Thursday 17Jun2021 she went to Gynaecologist-diagnosed with ulcers and sent pictures to dermatologist and diagnosis of Lipschutz ulcers was made. On Friday 18Jun2021 she went to rheumatologist and ruled out any auto-immune disease. Monday on 21Jun2021 seen by Dermatologist who confirmed the diagnosis of Lipschutz ulcers and believes it came from the covid vaccine. No current treatment available, only supportive care for pain management was available. On an unknown date in Jun2021, all blood tests came back normal, no other known cause for the ulcers. The outcome of the event vulval ulceration was unknown and patient was not recovered from rest of the other events.
14 2021-07-12 fever Swellenband painful lymph nodes behind ears. Fever rash over 100%of body . Started day two after v... Read more
Swellenband painful lymph nodes behind ears. Fever rash over 100%of body . Started day two after vaccine it is now day 7post vaccine rash getting worse
14 2021-07-12 upper respiratory tract infection, headache, sinusitis she developed a sinus infection; Within hours the typical symptoms of headache, body aches happened;... Read more
she developed a sinus infection; Within hours the typical symptoms of headache, body aches happened; Within hours the typical symptoms of headache, body aches happened; It has now turned into a Upper respiratory infection; This is a spontaneous report from a contactable consumer. A 14-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 09Jun2021 16:00 at age of 14-year-old (Lot Number: EW0178) as DOSE 2, SINGLE for covid-19 immunization. Medical history was none. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not received any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No concomitant medications were received. The patient previously received dose 1 via an unspecified route of administration, administered in Arm Left on 19May2021 16:00 at age of 14-year-old (Lot Number: ER8736) as DOSE 1, SINGLE for covid-19 immunization. The patient experienced she developed a sinus infection on 13Jun2021 with outcome of not recovered, within hours the typical symptoms of headache, body aches happened in Jun2021 with outcome of not recovered, it has now turned into a upper respiratory infection in 2021 with outcome of not recovered, the vaccine made her sick in 2021 with outcome of not recovered. Additional information included: Within hours the typical symptoms of headache, body aches happened. What is most important is exactly 4-5 days later, she developed a sinus infection and 3 weeks later and 2 antibiotics later, she is still sick. It has now turned into a Upper respiratory infection and had to spend a high amount of money on a CT scan of her lungs because she continues to get worse not better. Our Dr. is confident this is related to the vaccine. She was a perfectly healthy 14 yr. old girl and been sick ever since she got the vaccine. It is not a coincidence. The vaccine made her sick and we deserve answers. The reporter believe in vaccines and wanted to do the right thing to get the numbers down. Had the reporter known this would have been her body's response, reporter never would have had her get vaccinated. The patient underwent lab tests and procedures which included CT scan for her lungs: unknown results on unknown date. Therapeutic measures were taken as a result of all the events and the treatment included antibiotics. The events result in Doctor or other healthcare professional office/clinic visit.
14 2021-07-13 fever 24 hours after vaccine, she had a fever of 106. A week after, she began having breathing problems (... Read more
24 hours after vaccine, she had a fever of 106. A week after, she began having breathing problems (no history) and chest pain. Symptoms have continued still, and not getting better. We have been to urgent care, ED, pediatrician, and going to cardiologist soon. Now has 2 inhalers and OTC pain meds. I firmly believe the problems are connected to covid vaccine.
14 2021-07-14 sweating Shortly after vaccination (~15-20 minutes) patient became very faint and nauseous. Was pale in the f... Read more
Shortly after vaccination (~15-20 minutes) patient became very faint and nauseous. Was pale in the face and vomited. Patient was seen by several firefighters that happened to be in the store at the time. She mentioned to them having fuzzy hearing, heavy arms, and sweating. They checked vitals and gave oxygen supply. Patient was then taken via ambulance to hospital but was feeling much better.
14 2021-07-14 sluggishness Patient received the Pfizer Covid 19 vaccine and after waiting in the waiting room for a couple of m... Read more
Patient received the Pfizer Covid 19 vaccine and after waiting in the waiting room for a couple of minutes began having a seizure. The seizure lasted about 1 minute. 911 was called and the paramedics arrived shortly after. The patient was conscious and alert, but appeared very sluggish. The mother of the patient insisted that she be carted away to the hospital and the paramedics took her to the ambulance.
14 2021-07-15 headache patient was given a dose of pfizer that was diluted incorrectly. Pfizer was diluted with 0.9 mL of 0... Read more
patient was given a dose of pfizer that was diluted incorrectly. Pfizer was diluted with 0.9 mL of 0.9% NaCl instead of 1.8 mL of 0.9% NaCl. Patient experienced dizziness and headache. Headache started within 15 minutes of receiving dose and dizziness occurred within 24 hours of receiving vaccine.
14 2021-07-15 headache Patient presented to emergency center for evaluation of right sided headache for 12 hours with episo... Read more
Patient presented to emergency center for evaluation of right sided headache for 12 hours with episodic slurred speech day after 2nd dose of COVID vaccine. Per notes slurred speech already resolved at time of ER visit.
14 2021-07-15 fever Mother called to report that her child had been running a fever of 99.3 since having the 2nd COVID v... Read more
Mother called to report that her child had been running a fever of 99.3 since having the 2nd COVID vaccine. Today she was feeling bad and she was called by school to come and get her because she had vomitted. This according to the mother is unusual for her in that she does not vomit and generally has no problems with vaccines.
14 2021-07-16 sweating Immediately after administration, the patient slid off the chair and bumped her head on the trash ca... Read more
Immediately after administration, the patient slid off the chair and bumped her head on the trash can. She came to, but did not remember what happened. She was pale in color and started to perspire. We gave her water and was asked to lay on the floor. No medication was given and patient concentrated on breathing until she was able to get up. She layed on the floor for approximately 5 minutes until she was feeling better. We continued to monitor her until 4PM
14 2021-07-16 sleepiness Pericardial effusion on 6/19 s/p percardiocentesis. Ongoing hospitalization, associated complication... Read more
Pericardial effusion on 6/19 s/p percardiocentesis. Ongoing hospitalization, associated complications including pleural effusion and new pericardial effusion on 7/16. Initial rpesentation also with somnolence, decreased respiratory drive thought to be due to Onfi overdose. Was intubated now on room air.
14 2021-07-17 sweating 5 minutes after vaccination monitoring client had blurred vision, diaphoretic X@ altered pressure in... Read more
5 minutes after vaccination monitoring client had blurred vision, diaphoretic X@ altered pressure in ear, and alter mental status. Had eaten lunch- chick-fila and had no medical HX Vitals taken twice P48, BP 100/50, R16 O2 96% EKG sinus bradia, Near Syncopal P53, BP 88/51, R 20, O2 98%
14 2021-07-19 headache Tonic-Clonic seizures; Nausea; Vomiting; Severe body aches; Headache; Moderate - severe neurological... Read more
Tonic-Clonic seizures; Nausea; Vomiting; Severe body aches; Headache; Moderate - severe neurological events; Tics; Tremors; Confusion; Inability to speak or walk or use restroom on own; Inability to speak or walk or use restroom on own; Fine motor skills deficit; This is a spontaneous report from a contactable consumer (patient). A 14-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EW0876, Expiration Date: not reported), via an unspecified route of administration in left arm on 15May2021 at 15:00(Age at the of 14-years old)as dose 1, single for COVID-19 immunization at Pharmacy or Drug Store. The patient was not pregnant at time of Vaccination. Medical history was none. Known allergies was Nka. The patient received unspecified medications within 2 weeks of vaccination. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.On 17May2021,the patient experienced nausea, vomiting, severe body aches, headache, moderate - severe neurological events, tics, tremors, confusion, inability to speak or walk or use restroom on own, fine motor skills deficit and tonic-clonic seizures. Adverse events resulted in Emergency room/department or urgent care. The patient was hospitalized for 4 days. Hospitalization was not prolonged. The patient received treatment and stopped suspected interacting medicine. The patient also received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EW0191, Expiration Date: not reported), via an unspecified route of administration in left arm on 06Jun202114:00 as dose 2, single for COVID-19 immunization. The outcome of the events was recovering. ~~ No follow-up attempts are possible. No further information is expected.
14 2021-07-19 headache complained of seeing floaters and having headaches within days of 2nd dose. Optometrist visit reveal... Read more
complained of seeing floaters and having headaches within days of 2nd dose. Optometrist visit revealed optic nerve swelling and hemorrhaging behind eyes.
14 2021-07-19 headache Within seconds of getting vaccine, felt nauseous and headache. Within a minute, dizzy, extremely pa... Read more
Within seconds of getting vaccine, felt nauseous and headache. Within a minute, dizzy, extremely pale, nauseated and felt like she needed to vomit. She was excited to get this vaccine and has never had a reaction to any vaccine to include her allergy
14 2021-07-20 fatigue Patient light headed fainted tired nauseated
14 2021-07-20 malaise About 9pm on July 15, 2021, my daughter started to feel a tingling sensation on her face. Between 9:... Read more
About 9pm on July 15, 2021, my daughter started to feel a tingling sensation on her face. Between 9:30pm-10:30pm she gradually begin to have mild to severe numbness in her face, legs, chest and arms and her heart was beating rapidly. She told us she feels that she?s going to die. We took her to the emergency room where heart rate rose as high as 175bpm and the numbness got worse
14 2021-07-21 chills, sweating, fever Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Severe, Site: Pain at Injecti... Read more
Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Mild, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Abdominal Pain-Medium, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Chills-Severe, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fever-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hyperventilation-Severe, Systemic: Shakiness-Severe, Systemic: Tachycardia-Medium, Systemic: Unable to Sleep-Severe, Systemic: Visual Changes/Disturbances-Mild, Additional Details: PATIENT IS STILL FEELING CHEST PAIN AND STILL HAS RASH.
14 2021-07-21 headache Pt. had her 2nd Pfizer shot on July 14, 2021. Two days later, on July 16, 2021 approximately 4:58p... Read more
Pt. had her 2nd Pfizer shot on July 14, 2021. Two days later, on July 16, 2021 approximately 4:58pm, she developed chest pain and light headache. She took 2 Tylenol pills and the 10- 15 mins the pain went away.
14 2021-07-22 throat irritation ITCHY, SCRATCHY THROAT, DIFFICULTY SWALLOWING,
14 2021-07-23 sweating, chills Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Mild... Read more
Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium, Systemic: Vomiting-Medium, Additional Details: after 15mins pt vomited while walking out of store. she came back and stated she felt dizzy she was very pale. b/p was 88/86 pulse 107. had pt sit for 5 more mins. went out again and bp was 89/79 pulse 95. contacted ambulance as pt still felt faint. ambulance came 15 mins later. by that time pt had drank a whole bottle of water. pts vitals were within range. emts recommended she seek a physicians help at urgent care.
14 2021-07-27 headache, fever fever of 99.4 developed day 7; Headaches/strong recurring headaches past three nights/headaches alwa... Read more
fever of 99.4 developed day 7; Headaches/strong recurring headaches past three nights/headaches always around temple areas; This is a spontaneous report from a contactable consumer (mother). A 14-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Left on 13May2021 11:30 (Batch/Lot Number: ER8735) as DOSE 1, SINGLE (at the age of 14 years) for covid-19 immunisation. Medical history included seasonal pollen allergies from an unknown date, ongoing food allergy, ongoing Allergy to tree nuts, Cashew, pistachio, ongoing oral food allergy from an unknown date, ongoing seasonal allergy Pollen allergy -Rhinitis ongoing -pollen, adenotonsillectomy from an unknown date, removed tonsil adenoids at age 8 , anaphylactic shock from an unknown date, carries an epinephrine injector always, rhinitis from an unknown date and unknown if ongoing. Concomitant medication included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for seasonal allergy from an unspecified start date and ongoing. The patient experienced headaches/strong recurring headaches past three nights/headaches always around temple areas (reported as disability, medically significant) on 16May2021 20:00 with outcome of recovered, fever of 99.4 developed day 7 on 20May2021 with outcome of unknown. The patient underwent lab tests and procedures which included body temperature: 99.4 on 20May2021, body temperature: 101.5 on 04Jun2021. Therapeutic measures were taken as a result of headaches/strong recurring headaches past three nights/headaches always around temple area. Headaches are nightly and require Tylenol and ibuprofen at night to sleep, strong recurring headaches past three nights which seem to subside in the morning. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. No follow-up attempts possible. No further information expected.
14 2021-07-27 fever Fevers over 100; chest pain; hard time breathing.; Sore Joints; This is a spontaneous report from a ... Read more
Fevers over 100; chest pain; hard time breathing.; Sore Joints; This is a spontaneous report from a contactable consumer. A non-pregnant 14-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for inejction), dose 1 via an unspecified route of administration, administered in left arm on 23Jun2021 13:00 (Batch/Lot Number: EW0217) as dose 1, single (at the age of 14 years old) for COVID-19 immunisation. The patient had no medical history. The patient's concomitant medications were not reported. The patient experienced fevers over 100, chest pain, hard time breathing and sore joints on 23Jun2021. The patient received TYLENOL. Prior to vaccination, the patient was not diagnosed with COVID-19 and not been tested for COVID-19. The outcome of the events was recovered on an unspecified date in 2021.
14 2021-07-28 fever fever followed by genital aphthous ulcers on vulva
15 2021-05-12 fatigue Patient began to have a vasovagal response around 7:18 pm about 15 minutes after her vaccination. Be... Read more
Patient began to have a vasovagal response around 7:18 pm about 15 minutes after her vaccination. Began feeling nauseous, got pale, and stated that she felt very tired. B/P was 90/60 HR 84. Did not pass out or feel like she was going to. Mom was present with child the entire time. Gave patient water to drink during event. Patient began to feel better after 5 minutes with complete resolution of symptoms at 7:35 pm. Patient walked out with mom from the clinic.
15 2021-05-12 sweating She c/o dizziness about 5 minutes after vaccination, skin was pale, diaphoretic. She also c/o "not b... Read more
She c/o dizziness about 5 minutes after vaccination, skin was pale, diaphoretic. She also c/o "not being able to see," for a few seconds. She was brought to observation area, allowed to lie down on cot, vital signs taken, wnl. She was observed for 30 minutes, left with parent.
15 2021-05-13 headache Pt. sitting with mother and sister in observation area. Mother signed for assistance. Pt reported ... Read more
Pt. sitting with mother and sister in observation area. Mother signed for assistance. Pt reported feeling hot and having blurred vision. Able to state name throughout event. Pupils dilated, skin hot. Pt instructed to remove mask and breath deeply, cool pack applied to back of neck. After several minutes patient reported vision retuning to normal. Patient incontinent during episode. Pt transferred to private room. Water, peanuts, and fruit snacks provided. Sister very tearful and anxious. Water and snacks provided. Family remained 30 minutes. Verbalized feeling okay, reported slight headache. Mother made appointment for patient to see pcp today, family left clinic.
15 2021-05-13 sweating Vaso-vagal response. Nausea, dizzines, flushing/sweating, no loss of consciousness. Pt stabilized, V... Read more
Vaso-vagal response. Nausea, dizzines, flushing/sweating, no loss of consciousness. Pt stabilized, VS stable (95/57; HR 65; RR 16; O2 sat 100%), ambulates appropriately
15 2021-05-13 sweating Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, ... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Additional Details: Pt recovered after a few minutes of sweating and feeling nauseous.
15 2021-05-13 throat irritation Patient is a 15 year old female who has completed a 30-minute observation period with the following ... Read more
Patient is a 15 year old female who has completed a 30-minute observation period with the following signs and symptoms of an adverse reaction: other - itching throat and tonsil swelling. Pfizer-BioNTech COVID-19 vaccine # 1 in series administered. o Action(s) taken: Another drug administered - 25mg Benadryl cap o Allergy to COVID-19 vaccine documented in Allergies activity: No, Referral entered for allergy provider o Patient advised to discuss second dose considerations with a clinician o Patient held for observation for 30 minutes after administration of 25mg Benadryl capsule. o Dr. from urgent care contacted and instructed to d/c patient when 30 minute waiting period is completed after benadryl was given and if patient is feeling better. o Patient held for a total of 2 hours for observation and stated she was feeling better. o Patient left in stable condition with Mom Vital Signs: 1430: BP: 115/71 P: 82 Map: 81 O2: 99% R: 18 1455: BP: 108/63 P: 77 Map: 78 O2: 100% R: 18 1545 BP: 119/62 P: 87 Map: 81 O2: 100% R: 20
15 2021-05-14 sweating In 2-3 minutes after injection patent fainted, she was conscious but dizzy, she was sweating a lot... Read more
In 2-3 minutes after injection patent fainted, she was conscious but dizzy, she was sweating a lot, her skin was pale and clamy, she felt nauseated and threw up
15 2021-05-14 sweating syncope with bilateral tonic/clonic movements. per parents, patient has history of vasovagal synco... Read more
syncope with bilateral tonic/clonic movements. per parents, patient has history of vasovagal syncope following exposure to needles or lancets (vaccines, finger prick). approx 2 minutes following injection, patient lost consciousness, followed by several clonic movements bilaterally of upper and lower extremities. patient was transfered from chair to floor, legs were elevated. She regained consciousness quickly, was given water. When she felt better, she once again sat in a chair. After another 5 minutes (approx), she had another episode of loss of consciousness with increased tone of UE and LE bilaterally and also several clonic movements. She was again transferred to the floor, regained consciousness. She was more shaky and diaphoretic following the second episode but was otherwise aware and oriented. She was observed for another 30 minutes at the pharmacy and then left.
15 2021-05-15 chills Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsi... Read more
Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Shakiness-Medium
15 2021-05-15 headache Approximately 10 minutes after receiving her first Pfizer dose IM, Patient was experiencing a headac... Read more
Approximately 10 minutes after receiving her first Pfizer dose IM, Patient was experiencing a headache rated 4/10 on the pain scale as well as light headedness. Patients vehicle was directed to the ambulance on standby, paramedic crew assessed the patient. Vitals were stable and since the patient was a minor, the patient mother made a decision to refuse transport and exited the facility without issue. End of report.
15 2021-05-15 headache BP:128/76 HR:80 02:98 headache and jittery. strong pulse, alert, does not like crowds and the vaccin... Read more
BP:128/76 HR:80 02:98 headache and jittery. strong pulse, alert, does not like crowds and the vaccine. EMS REFUSAL
15 2021-05-16 chills Patient received a first dose of Pfizer vaccine around 10am on 05/16/2021. Around 6pm on 05/17/2021,... Read more
Patient received a first dose of Pfizer vaccine around 10am on 05/16/2021. Around 6pm on 05/17/2021, patient's mother called and stated that her daughter feels difficulty breathing, SPO2 at 94, heaviness in chest (she describes like an object was sitting on her chest) and chest pain (on scale 0-10, with 10 is the most intense pain, pt reported 8/10). In addition, pt has been experiencing chills since the day of the vaccination. Parent gave the child ibuprofen before calling pharmacy. Pt 's mother reported that her daughter dose not take any medication nor any herbal supplement. The daughter has a history of heart murmur. Based on the severity of the symptoms, we advised the mother to take her child to emergency care.
15 2021-05-16 sweating client felt lightheaded after receiving 1st Pfizer Covid Vaccine. Client received vaccine at 1717 an... Read more
client felt lightheaded after receiving 1st Pfizer Covid Vaccine. Client received vaccine at 1717 and RN kept client in chair a few mins as client stated feeling nervous. PHN brought client water. Per client had only ate snack prior to appointment. Client able to transfer by herself to anti gravity chair. 1722 vitals: blood pressure 122/68, oxygen 98%, pulse 81. Per client feeling nausea, RN gave emesis bag. Client appeared diaphoretic and pale. Per Mother only medical history is seasonal allergies and client takes Zyrtec as needed. No history of fainting with vaccines in the past or allergies. Vitals at 1728: blood pressure 118/72, pulse 82, oxygen 97%. Per client symptoms still there, but improving. Vitals at 1733: blood pressure 120/70, pulse 83, oxygen 100%. Client stated lightheaded resolved, nausea still same. Client denied blurry vision, headache, warmth feeling. Vitals at 1738: blood pressure 118/72, pulse 80, oxygen 99%. Per client all symptoms resolved. Last vitals at 1743: blood pressure 114/80, pulse 76, oxygen 99%. Mother driving client home. Advised to follow up with provider and ER precautions given. After completing 30 min observation client left facility with steady gait at 1750.
15 2021-05-16 sweating Flushing/sweating, dizziness, generalized weakness, nausea. BP 94/51; HR 60; RR 19. 17 min post vacc... Read more
Flushing/sweating, dizziness, generalized weakness, nausea. BP 94/51; HR 60; RR 19. 17 min post vaccination pt noted feeling much better. Denies pain/discomfort, no n/v. Fluid offered, seen by NP. Pt feeling better & released
15 2021-05-16 sweating Flushing/sweating, Dizziness, near syncopal event after witnessing brother have a syncopal event aft... Read more
Flushing/sweating, Dizziness, near syncopal event after witnessing brother have a syncopal event after his first dose. Pt did not have breakfast. BP 100/52, HR 59, RR 18 -- > 108/67, HR 77 -- > 110/67, 75. Improved after water, crackers, rest. Recommended patient eat and drink prior to next dose. Patient stable and released from the vaccination site.
15 2021-05-16 sweating Pt states had "tunnel vision and feeling of everything fading", ringing of ears and sweating immedia... Read more
Pt states had "tunnel vision and feeling of everything fading", ringing of ears and sweating immediately after receiving vaccine. Pt layed down for a few minutes and felt better. No LOC. Refused transport to ER. Father and family who were present took pt home.
15 2021-05-16 sweating AFTER COVID19 VACCINATION, PATIENT EXPERIENCED NUMBNESS, TINGLING, DIZZINESS, WEAKNESS, LIGHTHEADEDN... Read more
AFTER COVID19 VACCINATION, PATIENT EXPERIENCED NUMBNESS, TINGLING, DIZZINESS, WEAKNESS, LIGHTHEADEDNESS AND DIAPHORESIS AT FOREHEAD. NO LOC, NO DIB, NO SYNCOPE, NO CHEST PAIN. AFTER 15 MINUTES PATIENT WAS ASYMPTOMATIC. LEFT WITH FATHER TO HOME AT 11:16 AM. VITAL SIGNS: 1100 BP 72/36, HR 88, RR 20 1105 BP 86/46, HR 84, RR 20 1110 BP 88/62, HR 82, RR 20 1115 BP 96/68, HR 80, RR 20 1116 BP 102/70, HR 82, RR 20
15 2021-05-16 influenza like illness, headache, throat pain She got her vaccine, she was sitting in the chair and 4-5 minutes after the shot she started telling... Read more
She got her vaccine, she was sitting in the chair and 4-5 minutes after the shot she started telling her grandfather that she felt nauseated. She then started feeling dizzy and looked like she was going to pass out and he caught her and he laid on her on the floor on a pillow. There was a off-duty paramedic to assist her and they suggested to call 9-1-1 and they showed up 5-6 minutes later. She was then taken to Hospital. They ran a lot of laboratory tests, urinalysis and everything was negative. Her white blood cell count was high and her URC's and UBC's were high. Her albumin was also high. She was then released from the ER and was told to FU with PCP within 2 days. She is still having the symptoms of headache, sore throat, and achy bones, the typical flu-like side effects. She is taking Tylenol for the symptoms, as well as cough drops for her throat.
15 2021-05-16 malaise After administration of vaccine the patient stood up quickly and passed out. The patient fell down ... Read more
After administration of vaccine the patient stood up quickly and passed out. The patient fell down and came to rather quickly. After she came to we helped her to a chair and sat her down, advised her to put her head between her knees, and got her some water that she requested. After a few minutes she appeared rather pale and went to ask her if she was ok and she asked for a trash can because she felt like she was going to be sick. We gave her a garbage bag and she did get sick in the garbage bag. We kept an eye on her for another 15-20 minutes and she stated that she felt better and that she thought she was ok to leave. We offered her help to her car but she denied it saying she would be ok with she walked slowly. Her father was with her the entire time. While talking with them the father did state that she had incidents like that in the past where she stood up too fast and got light headed and passed out.
15 2021-05-16 fever, headache, fatigue Moderate headache, tiredness, fever
15 2021-05-16 sleepiness AFTER COVID19 VACCINATION, PATIENT EXPRIENCED DIZZINESS, WEAKNESS WITH DIFFICULTY MAINTAINING EYE CO... Read more
AFTER COVID19 VACCINATION, PATIENT EXPRIENCED DIZZINESS, WEAKNESS WITH DIFFICULTY MAINTAINING EYE CONTACT. PATIENT STATED SHE FELT SLEEPY WITH DIFFICULTY KEEPING EYES OPEN. AFTER 25 MINUTES, PATIENT WAS AAOX4, VITALS WNL, AMBULATING WITHOUT ASSISTANCE AND LEFT CLINIC WITH FATHER, DENYING ANY DIZZINESS OR WEAKNESS. VITALS: BP HR RR SPO2 12:45 138/80 100 16 99% 12:53 150/90 85 16 99% 12:58 138/90 81 14 99% 13:02 128/80 80 14 99% 13:07 122/86 75 16 99%
15 2021-05-16 throat irritation Tongue swelled up and her throat felt tight, itchy, and closed up. I have a dose of Benadryl withi... Read more
Tongue swelled up and her throat felt tight, itchy, and closed up. I have a dose of Benadryl within minutes, it didn?t seem to help. I gave a second dose of Benadryl and increased the amount and that helped. I also called the nurse line.
15 2021-05-16 throat irritation Itchy throat 2 hours after receiving the vaccination
15 2021-05-17 headache, fever, malaise Low grade fever - 5 days Malaise - 5 days Headache - 5 days
15 2021-05-17 sweating Patient started feeling dizzy/faint right after administration, she was sweating and felt hot to the... Read more
Patient started feeling dizzy/faint right after administration, she was sweating and felt hot to the touch, then she convulsed and shot up out of her chair for a few seconds before sitting back down. As she sat back down she vomited and then seemed to get better after. 911 was called and she was better by the time they arrived and blood pressure and vitals where all good.
15 2021-05-17 sweating Pt reported lightheadedness and was found to be diaphoretic and pale after vaccine administration. ... Read more
Pt reported lightheadedness and was found to be diaphoretic and pale after vaccine administration. She was laid down on a gurney with legs elevated, V/S monitored for 45 minutes and given apple juice po.
15 2021-05-17 sweating 1436 felt dizzy, was diaphoretic, pale, b/p 90/40, pulse 60 RR 40 99% 02 sat., MOC present. 1437 ass... Read more
1436 felt dizzy, was diaphoretic, pale, b/p 90/40, pulse 60 RR 40 99% 02 sat., MOC present. 1437 assisted to floor placed in Trendelenburg position feet elevated. 1439 B/P 110/p, pulse 80, RR 30 02 sat 99 %, alert and oriented , able to verbalize feeling better. No longer diaphoretic, skin color pink. 1444 assisted to sitting position in chair B/P 98/68 RR 32, 02 sat 100%, pulse 76. 1500 B/P 102/64 99% 02 sat 75 pulse respirations even and unlabored, per MOC stated she is feeling better, pt verbalized the same no longer requiring medical care, left with MOC, educated and encouraged to contact Primary MD if symptoms should return, verbalized understanding.
15 2021-05-17 throat pain, headache Pt was very anxious before shot given. Mother had to physically hold pt down for her to receive the ... Read more
Pt was very anxious before shot given. Mother had to physically hold pt down for her to receive the shot. Afterwards, pt reported headache, dizziness, and sore throat immediately after the shot. Pt was hyperventilating so I encouraged deep breathing and hydration. HEENT and Pulm exam were normal, as were the vitals. Pt eventually recovered without any other intervention. Pt waited for full 30 minutes after dose.
15 2021-05-17 throat pain, nasal congestion Sore throat and nasal congestion
15 2021-05-18 cough Pt started exhibiting a dry cough that progressed in frequency over the course of aprox. 15 mins. P... Read more
Pt started exhibiting a dry cough that progressed in frequency over the course of aprox. 15 mins. Patients father remained at her side, patients father administered two puffs of patients inhaler, Albuterol, for the coughing. Nurses attended at patients side, checked vitals which were stable with oxygen saturation of 100% and however, pulse noted to be elevated in the 130's. RN auscultated lung sounds, no wheezing noted, but pt exhibiting signs of anxiousness as well now. Pt assisted to wheelchair and to area to lie down for further evaluation. Pt was lain on her right side, RN remained at her side entire time. Pt advised to use inhaler again, two pufffs, and encouraged to slow her breathing, relax, and was advised that her vitals were stable. Pt was asked if she felt she needed additional support with her breathing and she stated yes. 911 was called and advised of the situation. Pts pulse did lower to 100-105 and breathing did become easier and more regular while we waited for EMS to arrive. Pt transferred to care of EMS with oxygen saturation of 100% and pulse of 104.
15 2021-05-18 headache Headache, body ache, nauseated, vomiting, weak
15 2021-05-18 headache Severe headache that turned into a migraine Vomiting
15 2021-05-18 sweating, headache First symptom was dizziness and nausea. Then, immediately began sweating profusely . Then began seei... Read more
First symptom was dizziness and nausea. Then, immediately began sweating profusely . Then began seeing spots that distorted her vision. Immediate pain in the ears, which felt as is the ears were very swollen and inflamed. It was difficult to talk because talking caused pain in the ears. Severe headache. Obviously her anxiety level escalated. We immediately found wet paper towels to place on her forehead and back of the neck to cool her. I found a hair tie and tied her hair up off her neck to keep her as cool as possible. She was sweating so much she soaked her t-shirt and was pouring sweat down her face, neck and body. We also moved patient from the chair, and placed her on the floor of the pharmacy, leaning against the wall with her legs stretched out. As a type 1 diabetic, the obvious concern was blood sugar during this reaction. Patient wears an insulin pump and Dexcom continuous glucose monitor. I was able to read her blood sugar levels during all the reaction time. Her blood sugar level spiked up. It then began to drop after a few minutes. I had an apple juice, and gave her the 15 carb apple juice.
15 2021-05-18 sweating Right after the shot, pt feels dizzy and went passing out for a few seconds, turn pale, then came b... Read more
Right after the shot, pt feels dizzy and went passing out for a few seconds, turn pale, then came back within seconds, start sweating and was laid on floor. Paramedics came and checked on her, she is alert and responding to questions. She went home with Mom after being checked by paramedics.
15 2021-05-19 sweating Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Dizziness / Lightheadn... Read more
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: tingling in fingers
15 2021-05-19 malaise Pt received vaccine...came out of vaccination room...sat down and started talking to mother...starte... Read more
Pt received vaccine...came out of vaccination room...sat down and started talking to mother...started to feel nauseous ? sat back and started to look limp...paramedics immediately contacted...pt never loss consciousness...looked pale... not feeling well...was responsive and breathing...respirations were being monitored...EMTs arrived and took over...did take pt to hospital...
15 2021-05-20 headache, fatigue, fever 3 days of severe abdominal and pelvic pain that was debilitating. Patient was hardly able to walk -... Read more
3 days of severe abdominal and pelvic pain that was debilitating. Patient was hardly able to walk - she had extreme pain with urination and defecation. She also had headache, fatigue, arm pain, fever and rash - hives, with pruritus of scalp.
15 2021-05-20 headache Per Dr. 1.Did the patient have an immediate allergic reaction of any severity such as urticaria, ang... Read more
Per Dr. 1.Did the patient have an immediate allergic reaction of any severity such as urticaria, angioedema, respiratory distress, or anaphylaxis (<4 hours following administration of the COVID vaccine)? Yes. 2, Did the patient previously have an immediate allergic reaction of any severity to polysorbate or polyethylene glycol? No. 3, Has the patient had prior anaphylactic reactions from another vaccine, medication or any other cause? Yes. 4, Did the patient have an allergic reaction >4 hours after administration? OR have an expected side effect of the COVID vaccine? No. Pt received COVID vaccine, Pfizer 1st dose. Approximate 5 minutes in the observation area pt complained of headache, throat discomfort, and stomach upset. She has a history of food additive allergy (dough additive), has an epi pen but has never needed to use it per mother at bedside. Initial VS: T 98.2 P 84 BP 119/70 RR 20 SpO2 99% on room air. She was monitored in the adverse reactions area. She was given Benadryl 25 mg oral x 2, and cetirizine 10 mg oral x 1. During observation period she had observed worsening oropharynx swelling, and stridor/inspiratory wheezing. VS prior to transfer was P 78 BP 102/69 RR 18 SpO2 100% on room air. EMS was called and pt transferred to ER for further monitoring, Tryptase level, and epinephrine if needed. Pt was recommended to see her pediatrician or allergist to discuss 2nd dose options prior to scheduling appointment. Signed: DO, 5/21/2021 2:59 PM".
15 2021-05-20 headache 11:38am c/o headache. 11:55am patient c/o feeling a little better. BP 110/60, HR 81, 99%.
15 2021-05-20 sweating, headache 15yo patient in observation parking lot c/o headache and laid down. honked horn because patient stat... Read more
15yo patient in observation parking lot c/o headache and laid down. honked horn because patient stated she had trouble breathing. RN's in observation area ran to the car. Patient tachypnic and couldn't talk, slightly pale with no signs of cyanosis. 911 called immediately and epi pen, 0.3mg administered at 1621. Patient layed down in the back of her car until ambulance arrived. BP stable, no pulse-ox available, respirations 66 bpm. Patient awake and alert, still unable to talk, lips pink, diaphoretic. Care turned over to Paramedics on site. No h/o allergies or anaphylactic reactions. H/O anxiety and on Prozac.
15 2021-05-20 sweating Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Tinnitus-Mild... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Tinnitus-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: Pt was flushed, stated she had ringing in her ears, and was seeing stars. She moved from her chair to sit on the floor and drank water and CapriSun. After a few minutes, she said she was feeling better. Mom states that she had a similar reaction to getting nose pierced not too long ago.
15 2021-05-21 sweating Patient fainted within a minute of receiving vaccine. Pale, diaphoretic, nauseated. No treatment. Re... Read more
Patient fainted within a minute of receiving vaccine. Pale, diaphoretic, nauseated. No treatment. Recovered without incident.
15 2021-05-21 sweating Client vaccinated, said it was good then slumped in chair, eyes rolled back. Responded to verbal com... Read more
Client vaccinated, said it was good then slumped in chair, eyes rolled back. Responded to verbal commands, opened eyes ,pupils dilated, diaphoretic, took a minute for her eyes to come into focus. Paramedic to cubicle, client transported to treatment area. Observed by paramedic for 45 minutes, departed for home with Mom and brother.
15 2021-05-21 malaise Vaccine was administered. The mom made a comment that her daughter has a tendency to pass out after... Read more
Vaccine was administered. The mom made a comment that her daughter has a tendency to pass out after vaccines after administering the vaccine to the patient. We kept the patient in the counseling room seated for observation to be on the safe side. Within 5 minutes, the patient got light headed and stated she didn't fell well. She passed out. We laid her down for about 10-15 minutes and gave her some candy since she stated she hadn't eaten all day. Pt regained consciousness and was fine after.
15 2021-05-23 chills Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Abdomina... Read more
Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Abdominal Pain-Mild, Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Medium, Systemic: Shakiness-Medium
15 2021-05-23 sweating patient fainted about 3 minutes after getting her vaccine injection. SHe was out for about 3 to 5 se... Read more
patient fainted about 3 minutes after getting her vaccine injection. SHe was out for about 3 to 5 seconds and then came to. she was sweaty but her temperature was ok and pulse seemed normal. THe pharmacy called 911 as a precaution. paramedics verified her vitals and gave mom the option to take her to the ER or just let her stay and be monitored. mom decided to have her stay. Mom and patient stayed by phramcy for 30 minutes as the child drank 2 bottles of water and ate a granola bar. when she felt 100% they left the store.
15 2021-05-23 fever, malaise Day 6 post vaccine patient began complaining of bilateral anterior ankle pain, and L hip pain. She ... Read more
Day 6 post vaccine patient began complaining of bilateral anterior ankle pain, and L hip pain. She had a low grade fever of 99.8 at that time. The following day Day 7, she had general fatigue, bilateral angle pain, and malaise. On Saturday, Day 8 she was unable to stand for periods of 15 minutes or longer due to pain in both ankles, and her knees, and elbows began to hurt. On this day she was given advil 400mg without relief, she then took Tylenol 650mg and the joint pain decreased from a 9 to a 6. We have had to continue alternating tylenol and advil since Saturday and she is unable to stand or walk for prolonged periods.
15 2021-05-23 throat irritation Dry, itchy throat with some throat swelling. Clamminess, dizziness and paleness. Local emergency ser... Read more
Dry, itchy throat with some throat swelling. Clamminess, dizziness and paleness. Local emergency services requested for assistance
15 2021-05-24 chills, sweating Site: Pain at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Severe, Systemic: Chills-Severe, ... Read more
Site: Pain at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Severe, Systemic: Chills-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Turning very pale, passed out and unresponsive, sweating-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Weakness-Medium, Additional Details: After 5 minutes of vaccination, mom called for help in the waiting area. The patient passed out for a few minutes and responded after we both called her several times. We called 911. She was feeling nauseous. She sipped a little water and was looking very pale and was starting to become unconscious again. Mother thought it was an allergic reaction and asked for Epipen. Epinephrine was administered, and patient became alert and less pale. EMS came and took her away due to low blood pressure
15 2021-05-24 headache, chills, fatigue, fever, lethargy lethargy, fever, chills, headache, fatigue up to 6 days post vaccination.
15 2021-05-24 headache, fatigue - Typical sore arm and fatigue in Day 1 & 2 - 4 days of severe headache from Day 1 through Day 4 - D... Read more
- Typical sore arm and fatigue in Day 1 & 2 - 4 days of severe headache from Day 1 through Day 4 - Day 4 severe diarrhea - Day 4 & 5 foggy "brain" - Muscle aches and weakness Day 2 - 4 - Potential menstrual period interruption
15 2021-05-24 sweating Patient was hot, sweaty and turned pale 5 minutes after vaccine. She felt like she was going to pas... Read more
Patient was hot, sweaty and turned pale 5 minutes after vaccine. She felt like she was going to pass out.
15 2021-05-24 sweating Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushe... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hyperventilation-Mild, Systemic: Hypotension-Mild, Systemic: Nausea-Mild, Systemic: Visual Changes/Disturbances-Medium, Systemic: Vomiting-Mild, Additional Details: Patient felt dizzy and blackout/ fainted for less than 10 seconds. Vommiting and blood pressure on the low 96/64
15 2021-05-24 lethargy, throat pain Very sore throat, rash on body, extreme lethargy
15 2021-05-25 fatigue, headache - severe aching - headaches - fatigue - joints popping out of sockets
15 2021-05-25 fatigue Sudden onset severe excruciating upper body pain including back, abdomen, chest, throat, neck causin... Read more
Sudden onset severe excruciating upper body pain including back, abdomen, chest, throat, neck causing difficulty moving, difficulty breathing, difficulty speaking, nausea. Severe pain lasted 20-25 minutes then slowly diminishing over next hour. After severe pain diminished, ongoing symptoms included severe fatigue, lack of fine motor coordination, brain fog, weaknesses.
15 2021-05-25 fatigue 2 days after administration of vaccine, the patient experienced 5 days of depressive symptoms includ... Read more
2 days after administration of vaccine, the patient experienced 5 days of depressive symptoms including low mood, fatigue, tearfulness, and social isolation/school avoidance. After 5 days, the patient returned to her previous baseline. No other clear stressors/triggers could be identified.
15 2021-05-25 headache About 5 minutes after receiving her vaccine, patient described feeling light headed, had hearing and... Read more
About 5 minutes after receiving her vaccine, patient described feeling light headed, had hearing and visual disturbances, felt like she might pass out. after several minutes of sitting with head between her leg, those symptoms went away but she said she had developed a headache. At time she left pharmacy she said she felt ok other than her headache.
15 2021-05-25 malaise, fatigue, fever, headache low grade fever; headache; fatigue; malaise; This is a spontaneous report from a contactable consume... Read more
low grade fever; headache; fatigue; malaise; This is a spontaneous report from a contactable consumer or other non hcp. A 15-years-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/lot number and expiry date: not reported) via an unspecified route of administration on 13May2021 (at the age of 15-years-old) as SINGLE DOSE for covid-19 immunisation. Patient medical history and concomitant medication were not reported. Mother stated that the side effects started the next day on 14May2021. She was experiencing low grade fever, headache, fatigue, and malaise (on 14May2021). The had talked to her Doctor and they did not seem to know much since the vaccine was so new for this age group. There were adults in their house hold who had gotten the vaccine and had not has side effects like this. It been Friday, Saturday, Sunday, Monday, and now Tuesday. It was enquired about how long were these side effects going to last. The outcome of the events was unknown E-transmitting for possible duplicate information. 15 year old female consumer. No follow up attempts possible. Information on lot/batch number cannot be obtained
15 2021-05-26 sweating, lethargy Pt came in to pharmacy with her mom for her 1st dose Pfizer vaccine appointment at 2pm on 5/26/21. W... Read more
Pt came in to pharmacy with her mom for her 1st dose Pfizer vaccine appointment at 2pm on 5/26/21. We checked her in and (pharmacist ) gave her shot with her mom present at 2 10pm and she was fine with no issues. Within 2 minutes in of her observation period, she started fainting and having seizure like for about 10 seconds, and regained conscious and said she felt dizzy and then blacked out. She was pale and sweating and asked for water. Our shift lead happened to be closed by her chair where she was sitting so she prevented pt from falling down from the chair and called pharmacist for help from inside the pharmacy. Pharmacist rushed to the patient and asked shift lead to call 911. Pt was consious, but lethargic, she could breath normally, no sign of obtruction airway. Pharmacist lift her legs up to opposite chair and started to take BP. Paramedic arrived within minutes and took her vitals which was normal. Mom agreed for paramedic took her out in stretcher to hospital for check up.
15 2021-05-26 sweating After the vaccine within second my child was sweating was taken out the waiting area before the 15 m... Read more
After the vaccine within second my child was sweating was taken out the waiting area before the 15 minutes and passed out on the floor .we have a broken jaw missing teeth and concussion there no protocol being followed my family is going through the worst right now this could have been avoided if guidelines were followed
15 2021-05-27 headache Approximately 10 minutes after the 1st dose, the patient fainted in the store and hit the back of he... Read more
Approximately 10 minutes after the 1st dose, the patient fainted in the store and hit the back of her head. She regained consciousness immediately. She was alert but pale and complained of pain on the back of her head.
15 2021-05-27 headache Patient received vaccine, then proceeded to faint and fall out of chair. She hit her head on the fl... Read more
Patient received vaccine, then proceeded to faint and fall out of chair. She hit her head on the floor. Mom was with her--patient was coherent and speaking to me. She said her head hurt--I told her I'd get an ice pack, which I did and gave to her. Mom was really worried so I asked her if she wanted me to call 911, which I did. 2 EMTs came and checked the patient out. Mom wanted her to go get checked out at the hospital so the patient and Mom went with the EMTs. I called Mom around 8:00pm 5/28/2021 and she said pt was checked out. The hospital doctor said it was a vaso-vagal reaction and released patient home with no restrictions.
15 2021-05-27 fever This 15 year and 11 month old female developed fevers, abdominal pain, diarrhea and constant wrenchi... Read more
This 15 year and 11 month old female developed fevers, abdominal pain, diarrhea and constant wrenching. She was seen in the ED and noted to be hypotensive and meeting SIRS criteria so was admitted to the PICU and started on norepinephrine pressor support. She had fevers to 39 degrees C and about a day into hospitalization developed acute mental status changes.
15 2021-05-28 headache Headache. Treatment was Tylenol.
15 2021-05-28 sweating SWEATING. BLURRY VISION. TUNNEL SOUNDS. DIZZY. HOT.
15 2021-05-29 fever, headache Fever, throwing up, diarrhea, headache
15 2021-05-31 sweating Syncope approximately 2 minutes after receiving COVID shot. Diaphoresis and pale in color.
15 2021-05-31 fever, chills Received vaccine 5/22/21 - had some local arm swelling & pain which resolved that night. 5/23 had fe... Read more
Received vaccine 5/22/21 - had some local arm swelling & pain which resolved that night. 5/23 had fever, chills, nausea, diarrhea x2 days with complete resolution. On 5/29, developed urticarial rash on legs & arms - no improvement with OTC Benadryl. No new foods/obvious exposure to other allergens other than family had tried a new scent of their brand of fabric softener. 5/31, developed nausea, vomiting, hand/feet swelling, & had a pre-syncopal episode. Presented to ER; tachycardic with symptomatic orthostatics though vitals otherwise normal. Received IV fluids, Pepcid, Decadron with improvement in HR/symptoms. Continued to be orthostatic with some extremity swelling so received IM Epinephrine - subsequent improvement in rash, nausea. Hospitalized for monitoring. Orthostatis/nausea resolved, vitals remained stable. Some intermittent itchiness/hives present that came & went still present at the time of discharge from hospital.
15 2021-06-01 lethargy, throat pain lethargic; sore throat; radh; This is a spontaneous report from a contactable consumer or other non ... Read more
lethargic; sore throat; radh; This is a spontaneous report from a contactable consumer or other non hcp. This consumer reported for a 15-years-old non-pregnant female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 14May2021 16:30 as 1ST DOSE, SINGLE for covid-19 immunisation . The patient's medical history was none. Patient's concomitant medications were not reported. Patient had no known allergies. On17May2021, 3 days after vaccine, she had a very sore throat, radh and was lethargic. Patient treatment was unknown. It was reported that most recent COVID-19 vaccine was administered at Public Health Clinic. Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not received any medications within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been not tested for COVID-19. The patient underwent lab tests and procedures which included sars-cov-2 test and strep: negative on 19May2021. The outcome of all event was recovering. Information on the batch/lot number has been requested.
15 2021-06-01 throat pain, fever, fatigue, headache May 14 started a low grade fever, headache, fatigue May 18 bad headache, still low grade fever May 2... Read more
May 14 started a low grade fever, headache, fatigue May 18 bad headache, still low grade fever May 23 complaining of sore throat May 25 fever elevating to 101 May 27 fever as high as 103, begin to have chest pain and tachycardia May 28 fever 103.5 tachycardic and chest pain May 29 fever 102 range tachycardic and chest pain May 30 fever 102.7 still exhibiting chest pain and tachycardic May 31 fever of 102 June 1 fever only 99.5
15 2021-06-01 fever, headache Headache, stomach ache, fever (101) and vomiting
15 2021-06-02 sweating RN vaccinated client and within 30 seconds noticed client started moving to the side. RN held client... Read more
RN vaccinated client and within 30 seconds noticed client started moving to the side. RN held client at chair, RN responded while two other RNs set up anti-gravity chair. Between all nurses, lifted client and laid in chair. PHN joined, client oriented to self and situation, pale, diaphoretic. Vitals at 1412: blood pressure 100/60 pulse 76, oxygen 97%. Client stated feeling dizzy, denied headache, blurry vision, nausea, shortness of breath, chest pain. Client given water and juice. Father present stated no reaction to first vaccine, allergies to peanuts and seafood. Vitals at 1414: blood pressure 106/70, pulse 79, oxygen 98%. Client alert and oriented x4, stated felt dizzy but did not lose consciousness. Per client same thing happened years ago when having blood drawn. Father informed we would observe for 30 mins. 1417: blood pressure 108/72, pulse 81, oxygen 98%. Client stated feeling better. Vitals at 1422: blood pressure 106/74, pulse 79, oxygen 97%. Client stated symptoms resolved. Alert and oriented x4, color normal for ethnicity. Per Father, client's blood pressure is on the lower end. Vitals at 1427: blood pressure 100/70, pulse 85, oxygen 99%. No complaints. Vitals at 1437: blood pressure 100/70, pulse 85, oxygen 98%. Per client feeling fine, everything resolved. Client and Father given ER precautions and advised to follow up with provider. Last vitals before client leaving blood pressure 106/78, pulse 87, oxygen 97%. Client able to stand up with no complaints. Client left facility with steady gait at 1444.44.
15 2021-06-03 headache, fever, chills Low- grade fever 99.3, body aches, chills, headache
15 2021-06-03 headache On 5/30/21, patient woke up around 10.30 am and complained of severe headache in back of head (pain ... Read more
On 5/30/21, patient woke up around 10.30 am and complained of severe headache in back of head (pain level 8-9/10). She was nauseous, unable to sit and even stand. She was getting rainbow circles in her vision. Rushed her to emergency to UCSF, drs ran various blood tests and brain MRI but everything was normal. It was also found that Bipasha had high BP 149/61. The drs could not make out what happened and they discharged her later on after giving some IV fluids and some pain medicine. On 5/31 and 6/1, at home, patient was seemingly okay. On 6/2, Wednesday, patient developed headache again, same symptoms like on 5/30. We rushed her to Urgent care in Fremont and saw her pediatrician dr and a pediatric neurologist. Her BP was high then also 144/87. No cause could be found why. The pediatric neurologist was suggesting it is possible that some Inflammation could be causing the blood fluctuations. Orthostatic testing resulted in major fluctuations of BP. Both neurologist and neurosurgeon have ruled out hydrocephalus. They are saying heart inflammation could be a cause.
15 2021-06-03 fever, fatigue It left her with migraines; A slight fever; Severe fatigue; This is a spontaneous report from a cont... Read more
It left her with migraines; A slight fever; Severe fatigue; This is a spontaneous report from a contactable consumer (caregiver) via a Pfizer sponsored program and medical information team. A 15-year-old female patient (reporter's daughter) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date in May2021 (at the age of 15-year-old) as a single dose for COVID-19 immunization. The patient's medical history included few immunity issues which were currently being treated. Concomitant medications were not reported. It was reported that patient has a few immunity issues which we are currently treating. Patient had her first vaccine last week, it left her with migraines, a slight fever with severe fatigue on an unspecified date in 2021. Reporter was concerned that the second would be more harsh. Please advise on your research if think that we should proceed or wait. The outcome of the events was unknown. Information on the lot/batch number has been requested.
15 2021-06-05 sweating, sweating Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Tinnitus-... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Tinnitus-Medium, Additional Details: After getting the Pfizer vaccine, patient started to feel fainted. Patient stated that she has lightheaded and ringing in her ear. Patient was helped to lie down on the ground with both feet elevated. After 20 minutes, patient was feeling better. Blood pressure at this moment was 101/69, and pulse was 74. Patient was able to stand up and walk around.
15 2021-06-05 sweating, sweating 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: Shakiness-Mild, Systemic: Tinnitus-Mild, Additional Details: After vaccine administration at approximately 09:10a, per mother stood up from vaccine area to walk to post-vaccination area with complaints of feeling light headed. Pharmacist notified & went to help pt in the post vaccination area. Pt was diaphoretic, pale, and appeared as though she was going to faint. Pts mother, pharmacist, and bystander assisted patient to the ground with legs bent, water, crackers, and ice pack provided. Patient was starting to become more responsive. Paramedics called.
15 2021-06-05 sweating, fever, headache Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unrespo... Read more
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Fever-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Nausea-Medium, Systemic: Vomiting-Medium, Additional Details: we called 911 3 emt arrived they took her vitals and stayed with her and her father for roughly 20 minutes and she left with her father
15 2021-06-05 fever, headache, fatigue She got the second shot of COVID-19 shot around 3 PM on 6/3. She had a sore arm, lower fever, and he... Read more
She got the second shot of COVID-19 shot around 3 PM on 6/3. She had a sore arm, lower fever, and headache on the second day (6/4), which was expected. On 6/5, she complained about chest congestion in the morning. She described that it felt like running after a mile. I asked her to drink more water and get some rest. The discomfort didn't get away, so I consulted her pediatrician over the phone. Her pulse and blood pressure were normal (86/103/75). She didn't feel short of breath. And her finger oximeter result was 99. In the afternoon, she described the discomfort as after some strenuous exercise and kept putting her hand over her heart. She felt tired and didn't have a good appetite for lunch or dinner, and only ate half meals. After dinner, around 9:30, she throws up and felt a little better. Then she took a capsule of Motrin liquid gel of 200 mg ibuprofen and went to bed. She slept well and felt OK this morning.
15 2021-06-05 fever, headache, sweating Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unrespo... Read more
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Fever-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Nausea-Medium, Systemic: Vomiting-Medium, Additional Details: we called 911, 3 EMT's arrived and they took her vitals and stayed with her and her father for roughly 20 minutes and she left with her father.
15 2021-06-06 cough, respiratory tract congestion 5/25 vaccine; 5/27 menstrual cycle began; 5/28 much heavier menstrual bleeding, 5/29 mild epistaxis ... Read more
5/25 vaccine; 5/27 menstrual cycle began; 5/28 much heavier menstrual bleeding, 5/29 mild epistaxis noted, sister sick with viral URI symptoms, 5/31 patient began to have cough, congestion, body aches; later noted bruising to right upper arm and right hip with no known trauma; 6/1 petechia to lower extremities; 6/2 started new oral contraceptive pack; 6/3 continue w/ menorrhagia & noticed many clots (very atypical, usually menstruation ceases at this point) 6/4 seen by PCR, CBC w/ platelet count 2,000, sent to hospital
15 2021-06-06 fatigue Patient was a 15 yo female. She came with her mother to get the 1st Pfizer vaccine. She was fine the... Read more
Patient was a 15 yo female. She came with her mother to get the 1st Pfizer vaccine. She was fine the vaccination room. However, after 15 minutes after the vaccine, she started to having a shortness of breath. Her face started to turn pale, she ended up passing out for 2 second which also led to 2-3 seconds of seizure. Two minutes after the event, she still look tired, mother ask to call 911. Paramedic came and check on patient as well as conducting a series of questions. After roughly 15 minutes, paramedic left and patient's mother refused to transport to the hospital. Paramedic inform patient to check with pediatric as soon as possible. Patient looked okay and back to normal state.
15 2021-06-06 sweating Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: I... Read more
Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: Immediately after I gave her the injection I looked at her face and her eyes rolled up and her pupils were dilated and I said to her Are You OK and that was when her head fell back and and it hit the back of the wall. I looked at the top of her head and it was red and she was sweating. Patient was still sitting and we called 911. Paramedics came and checked her out. She became aware and responsive within minutes. She stayed about 30 min.
15 2021-06-06 sweating Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mil... Read more
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hyperventilation-Mild, Systemic: Weakness-Mild
15 2021-06-06 sweating Patient fainted/passed out a few minutes after receiving the vaccine. Mom stated patient had a littl... Read more
Patient fainted/passed out a few minutes after receiving the vaccine. Mom stated patient had a little seizure. Patient retain consciousness after 1-2 minutes and did not recall what happened. She felt hot/sweaty and had minor vomiting. 911 was called. They arrived and left without any major concerns.
15 2021-06-06 sweating Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushe... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Systemic: Weakness-Mild, Additional Details: after immunization patient was sat down for observation. shortly after, patient felt weak in her chair. pharmacist was called to clinic. upon arrival patient continued to feel weak. while speaking with her mother next to her, patient fainted in her chair and was promptly brought tot he floor and legs raised. patient awoke shortly after and was given water. after a few minutes patient fully recoverd. patient stated for another 15 minutes for further observation. patient had no further issues
15 2021-06-06 malaise After the patient was vaccinated, she stating feeling ill. She was lightheaded and with problems bre... Read more
After the patient was vaccinated, she stating feeling ill. She was lightheaded and with problems breathing. We gave her Benadryl but still reported she was feeling bad and asked for an ambulance.
15 2021-06-06 malaise Patient received first dose of COVID19 Pfizer vaccine and stood up walked to a waiting room chair t... Read more
Patient received first dose of COVID19 Pfizer vaccine and stood up walked to a waiting room chair then within a minute or two experienced syncope for around a minute. Patient came 2 but was pale and still did not feel well. EMS was called and came to the scene checked blood pressure and released patient to care of the parent.
15 2021-06-07 chills, fatigue, lethargy Systemic: Chills-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Sys... Read more
Systemic: Chills-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Shakiness-Medium
15 2021-06-07 headache Patient received second COVID-19 vaccine on 06/06/2021 and on the next morning of 06/07/2021 she wo... Read more
Patient received second COVID-19 vaccine on 06/06/2021 and on the next morning of 06/07/2021 she woke up with a headache, large swollen bump on her left axillary that was red, warm and painful to touch and no fever.
15 2021-06-07 sweating Patient received 2nd dose of Pfizer vaccine today. The patient's mother asked for assistance as dau... Read more
Patient received 2nd dose of Pfizer vaccine today. The patient's mother asked for assistance as daughter was "having a reaction." Vitals/assessment at this time: 62, 16, 82/54, 99% on room air. Patient looks pale, diaphoretic, says "my vision is blurry". Questioned mother and patient, mother said "this is the first time this has happened." When asked about if she had anything to eat, she said she had not eaten breakfast. OJ given. Patient awake, alert, oriented X3. Sitting in chair. Skin warm to touch/ looks flushed. Vitals Reassessment- 72, 92/59, 95% room air. Repeat vitals taken x 2. Patient noted feeling better. Patient drank all orange juice, moving extremities, talking, walking with steady gait. Home with parent.
15 2021-06-07 sweating Patient received vaccine dose around 13:20. At approx. 13:25 patient began to audibly wheeze, became... Read more
Patient received vaccine dose around 13:20. At approx. 13:25 patient began to audibly wheeze, became pale, diaphoretic, and had mild circumoral swelling. Patient received 0.3 mg epinephrine via EpiPen at 13:26, and 911 was called. Patient lost consciousness at 13:27 and pt was lowered to floor from chair to prevent a fall. Patient immediately regained consciousness. Patient was transferred to a chair and vitals were obtained at 1330. BP 112/60, HR 86, SPO2 96% on rom air. Mild wheezes bilaterally over anterior bronchi, all other breath sounds clear throughout. EMS arrived, patient was still slightly pale and was transported to ED. Upon leaving, patient was AOx4, ambulatory, and without respiratory distress. Per ER note, patient was given Benadryl and solumedrol by EMS. At the ER, patient received NS bolus 1L, and Benadryl 25 mg orally. Patient was medically cleared by ED MD to go home at 17:58 pm on 5/21/21
15 2021-06-07 fever, headache, fatigue Symptoms? fever, head ache , fast heart rate, shortness of breath, body ache, fatigue, nausea
15 2021-06-07 fever Fever the following morning. Then, 38 hours after shot: abdominal cramping, rapid heart beat, dizzin... Read more
Fever the following morning. Then, 38 hours after shot: abdominal cramping, rapid heart beat, dizziness while laying in bed. Then, upon standing, passing out with loss of bowels and bladder and a tonic response.
15 2021-06-08 fatigue, cough tired; coughing; Breathing reaction; This is a spontaneous report from a contactable consumer. A 15-... Read more
tired; coughing; Breathing reaction; This is a spontaneous report from a contactable consumer. A 15-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 23May2021 (at the age of 15-year-old) (Batch/Lot number was not reported) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included allergic to amoxicillin where it was a couple of times when she was little and she would get blotches and red; and has been vaping without her parents knowing. Concomitant medication included etonogestrel (NEXPLANON). On 23May2021, the patient experienced breathing reaction. The mother stated that her daughter took the vaccine, she was 15, she was aware of the normal side effect problems and heart problems as she has been hearing in the news, she was concerned because she just figured out her daughter has been vaping without her parents knowing. The mother stated that she was a family therapist, and many teens vape age 12-15, parents don't have a clue about vaping and the chemicals in the vape that can cause heart and lung problems. She was contacting Pfizer because she wants to make sure this was in the radar, because of side effects. They should consider asking these types of things prior to administering the product. The mother was concerned watching her daughters breathing reaction. Her daughter was better today. The mother was reading side effects on vaping and there was some link to heart and lung issues, some even have lead in the chemicals or nicotine. The mother stated that she has also realized, in general when people ask if they are taking medications, especially for women they don't say anything about taking pills, or combination of pills. Her daughter experienced a Breathing reaction after the first dose. She was better today, she took the shot on Sunday, she was tired and coughing on an unspecified date but was better now. Her main concern was the age group and the Heart problems for this group. Her First Dose was on 23May2021, she was worse yesterday but today she was better. The breathing reaction started on the 23rd. Yesterday her daughter was in bed all day. Her daughter has made no physician office visit or went to the emergency room because of this. Treatment: Not to her knowledge, Unknown for breathing reaction. The mother again stated that she just wanted to express he concerns with this age group. The patient was recovering from all events. Information on the Lot/Batch number has been requested.
15 2021-06-08 fatigue, lethargy, sweating Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushe... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushed / Sweating-Severe, Additional Details: Patient started to feel dizzy and lightheaded and sweaty within 1 minute after getting the vaccine. We informed the clinic nurse who took over care. Patient drank some cold water and after about 15 minutes, patient started to feel better. Patient is going home with her mom. Patient is feeling much better now
15 2021-06-08 fatigue Patient experienced an anxiety/panic attack after vaccine administered. Patient stated her vision wa... Read more
Patient experienced an anxiety/panic attack after vaccine administered. Patient stated her vision was blurry and that she was "okay". Patients mom was beside her during this time and shared that this happened a month ago while giving blood. During this time patient was able to state her name but still appeared fatigued. Patients vital signs were taken at 1425, Bp: 110/70, HR: 65, O2: 99%. The patient was directed to focus on breathing in which she performed easily and stated that her vision was now clear again. Patient was also offered water in which she drank with no problem. At 1455 her vitals were taken again, Bp: 128/84, HR: 75, O2: 96%. Patient and her mom stayed for an additional 15 minutes for close observation. Patient fully recovered.
15 2021-06-08 nasal congestion, runny nose, fever, throat pain, pneumonia Pain at injection site, sore throat, fever, nasal congestion, runny nose, lose of taste and smell, ... Read more
Pain at injection site, sore throat, fever, nasal congestion, runny nose, lose of taste and smell, shortness of breath, high level blood clotting factor, pneumonia. Doctor visit on 5/26/21 OSF Virtual visit 5/27/21 , prescriptions prescribed consisted of: Montelukast , Levocetrizine DHCL , Azelastine HCI Nasal Spray , Fluticasone spray (was not administered because insurance would not allow scripts to be filled until 5/28-5/29/21). ER visit on 5/27/21 Treatment on 5/27/21-5/28/21 consisted of steroid via IV, Inhaler, antibiotic Prescriptions prescribed: Albuterol Sulfate , Azithromycin, Prednisone
15 2021-06-09 chills, fever Fever, chills, body aches and vomitting. Treating at home
15 2021-06-09 malaise patient felt sick and anxious ,was fine after 1/2 hr
15 2021-06-09 fever, cough, fatigue chest tightness and cough, no treatment thus far Other symptoms include: dizziness, tired, fever
15 2021-06-09 fever Fever 102 day of vaccination Fever 101 day 2 +3 post vaccination Fever 100 day 4+5 post vaccination
15 2021-06-10 fatigue, influenza like illness, headache Patient got her 2nd Pfizer Covid-19 shot at 5:45 PM on Tues 6/8. She had some of the typical side ef... Read more
Patient got her 2nd Pfizer Covid-19 shot at 5:45 PM on Tues 6/8. She had some of the typical side effects the next day- a sore arm, flu-like body aches, a headache and fatigue. In the middle of the night Wed night/Thurs morning at 3AM she woke up with chest pain and difficulty breathing. In her words, her "heart really hurts and it is hurts to breath." I gave her 1 (500 mg ) capsule of Tylenol. This was the first pain reliever she had received post shot. She also applied Frankincense oil over her heart. Patient was unable to go back to sleep for a few hours because it hurt too much. She did finally fall back asleep in the early morning hours. Yesterday (Thursday 6/10) she reported that she was feeling a lot better. Her heart was still a little painful but by today, Friday 6/11, she says she feels fine. When I heard on the news about a number of other children between 12-15 who reported heart pain, I thought we should let you all know. I am a little worried that there might be some kind of long term complication for her heart.
15 2021-06-10 fever, chills fever; nausea; vomiting; diarrhea; mild arm soreness; mild swelling at injection site; mild to moder... Read more
fever; nausea; vomiting; diarrhea; mild arm soreness; mild swelling at injection site; mild to moderate chills; mild to moderate muscle aches; This is a spontaneous report from a Pfizer Colleague from a contactable pharmacist (patient parent). A 15-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number and expiry date were not reported via an unspecified route of administration on 04Jun2021 (at the age of 15-years-old) as single dose for COVID-19 immunization. Patient did not have known drug allergies. Patient did not have any chronic medical conditions. Patient's medical history included the first dose of bnt162b2 vaccine. The patients concomitant medications were not reported. In Jun2021, patient experienced mild arm soreness, mild swelling at injection site, mild to moderate chills, mild to moderate muscle aches, and having a slight temp the day after her vaccine. On 07Jun2021, the patient started experiencing fever, nausea, vomiting, and diarrhea. The clinical outcome of all events was unknown. Information about batch/lot number has been requested
15 2021-06-10 fever, fatigue Patient received her second dose of the Pfizer COVID-19 vaccine Friday, June 4th, 2021. One day afte... Read more
Patient received her second dose of the Pfizer COVID-19 vaccine Friday, June 4th, 2021. One day after the second Pfizer Covid 19 shot, (Saturday, June 5th, 2021), Patient experienced fever, fatigue, weakness and swollen lymph nodes. Two days after the second Pfizer Covid 19 shot, (Sunday, June 6th, 2021), Patient still had those symptoms in addition to the break out of several painful genital laisons. She visited her pediatrician Tuesday, June 8th, 2021, and the laisons were tested for the herpes virus. Patient was also prescribed oral antiviral medication, and topical steroid creams. The results for the herpes test came out negative. Today, June 11th 2021, the laisons are still present and painful, and continue to be treated.
15 2021-06-12 bronchitis Bronchitis with wheezing, Chest wall pain, Costochondritis
15 2021-06-12 chills, fever, fatigue Fever chills fatigue achiness
15 2021-06-12 fatigue, fever Fever, vomiting, diarrhea, fatigue, sore muscles developed within 12 hours of vaccine administration... Read more
Fever, vomiting, diarrhea, fatigue, sore muscles developed within 12 hours of vaccine administration and were improving at approximately 24 hours later.
15 2021-06-12 fever, headache, chills 2nd Dose given at 830 am on June 5th. At 5pm sameday pt. Was having weak legs,dizzy, slight headache... Read more
2nd Dose given at 830 am on June 5th. At 5pm sameday pt. Was having weak legs,dizzy, slight headache trouble standing . By 9 pm pt. Was very weak, chills and she felt as if she had fever but temp was 97.3 , by 10pm she could not get out of bed because she felt so weak and achy,, her arm was so sore I couldn?t even touch it & she couldn?t lift it , had severe chills but also started to run a fever of 101.3. She could not sleep and was quite scared. I slept in her room with her to make sure she didn?t stop breathing. Gave sips of Gatorade and at 1130 gave her 1 pill tylenol rapid gel release for pain/fever sips of Gatorade through the night
15 2021-06-12 fever Sore arm and fever
15 2021-06-13 fatigue, headache Tightening around heart and chest area. Heart feels constricted and squeezed/tightening. Have a hard... Read more
Tightening around heart and chest area. Heart feels constricted and squeezed/tightening. Have a hard time trying to breath deeply. Headaches, felt fatigued, and heart hurts,, which lasted for 2 days.
15 2021-06-13 headache, chills, fatigue After administration of 2nd Pfizer vaccine, patient became dizzy/light headed. After laying down for... Read more
After administration of 2nd Pfizer vaccine, patient became dizzy/light headed. After laying down for 20 mins, patient began shivering, developed a headache, had numbness in hands, and was tired. After about 30 mins with no improvement of symptoms, 911 was contacted. Paramedics arrived and gave patient EKG, BP, Temp, and Glucose. All were within normal limits.
15 2021-06-13 headache, fatigue This patient received her 2nd Pfizer vaccine on 6/10/21 @1300. Upon waiting 15 minutes, patient was ... Read more
This patient received her 2nd Pfizer vaccine on 6/10/21 @1300. Upon waiting 15 minutes, patient was cleared of s/sx and reported feeling well to go home. The following day, mother called and reported her daughter was feeling nauseous, tired, and suffered a headache. She then proceeded to faint in the bathroom around 6am on 6/11/21. The reaction occurred approximately 12 hours after the vaccination. After the incident, patient slept until 14:30, and visited her primary care doctor, who then characterized her symptoms as a concussion.
15 2021-06-13 headache, fever, chills she had low grade fever, chills, headache, but next day she complain of pain on the left side of h... Read more
she had low grade fever, chills, headache, but next day she complain of pain on the left side of her body (not just the arm) I was told this was normal and to give her Tylenol or ibu. she has swelling in her left axilla. on Sunday she notice some blister on the inner corner of her mouth. I have messaged her PCP with no response
15 2021-06-13 headache Headache, vomiting, confusion, lost ability to speak, hypokalemia, tingling in arm all in evening of... Read more
Headache, vomiting, confusion, lost ability to speak, hypokalemia, tingling in arm all in evening of 6/12
15 2021-06-13 sweating Administration of vaccine began at 10:46am. At 10:48, patient was observed to be pale, complained o... Read more
Administration of vaccine began at 10:46am. At 10:48, patient was observed to be pale, complained of being light headed, and was observed to be diaphoretic. Pediatric resident was called at 10:48 and was in attendence through observation event. She was placed in a supine position on stretcher. BP 102/63; HR was 69. Improved quuickly; at 10:55; feet were placed down; BP was remeasured at 107/70; HR 77. She was positioned in sitting position on edge of stretcher; BP was 109/62 sitting. She was positioned to standing at 11:00; color was observed to be pink; standing BP was 109/66. She was discharged to home at 11:20am with parents.
15 2021-06-13 sweating Approx. 5 minutes after vaccine given Pt. felt weak and like she was going to pass out. She was sitt... Read more
Approx. 5 minutes after vaccine given Pt. felt weak and like she was going to pass out. She was sitting in chair and we gave her water and she put her head between her legs. After approx. 2-3 minutes she felt better and sat up drank water. After about 2 more minutes she felt dizzy and she went limp, she was diaphretic, pulse 50, bp 80/palp. Pt. arroused and was able to speak approx. 2 minutes later but was very weak and states "I cannot see anything". Squad was called they arrived and assumed care. Pt. was alert and oriented and was able to talk. Pt. Mom was with the patient the whole time
15 2021-06-13 malaise Pt presents for Covid 19 vaccination. Pfizer vaccine given per mothers consent. Pt tolerated well. P... Read more
Pt presents for Covid 19 vaccination. Pfizer vaccine given per mothers consent. Pt tolerated well. Pt observed in recovery area for 30 min due to history of allergy to Peanuts. Pt did well in recovery and was discharged home with mom. After approx 10 min, pt mother brought pt back into recovery area stating pt had abd pain, shaking and did not feel well. Pt placed in lying position. Sat up to vomit. Vomited small amount. Mother states pt has history of significant anxiety. Pt denies any sob or tingling. Resp easy and unlabored. Pt able to answer questions. A & O x 3. VSS Pulse ox 99 sat. bp 130 /80 hr 60-70. Mother requests EMS to be called. EMS called. Attempt to reassure pt and calm down. No progressive symptoms noted. Pt VSS remain stable. EMS arrives. Pt transported to hospital per EMS per moms request. Dr medical lead called per myself. No medications given. Pt was discharged that day from ED and refered to follow up at hospital
15 2021-06-13 throat pain, chills, headache, fatigue Headache starting that evening, chills, fatigue, nausea, muscle soreness/weakness, sore throat, musc... Read more
Headache starting that evening, chills, fatigue, nausea, muscle soreness/weakness, sore throat, muscle aches
15 2021-06-14 fever, headache, fatigue 5/18 - received Pfizer COVID Vaccine dose 1. 5/19-5/20 - very tired 5/20-5/21 - overall did okay 5/... Read more
5/18 - received Pfizer COVID Vaccine dose 1. 5/19-5/20 - very tired 5/20-5/21 - overall did okay 5/24 - woke up extremely nauseous, vomiting, fever to 100.6F -> increased to 102.5F, chills, near syncope in shower so ambulance called and went to Emergency Department 5/25 - similar symptoms as the day prior but also had headache, continued extreme fatigue. Fever continued. 5/26 - diarrhea started, vomiting resolved, continued headache and fatigue. Fever continued. 5/27 - last day of fever. Headache resolved 5/28 - diarrhea resolved.
15 2021-06-14 fever, lethargy Fever, lethargy, shortness of breath, chest pain, neck pain, swollen lymph nodes
15 2021-06-15 chills, headache Severe headache about 7 hours after vaccination, also severe body aches and chills responded to ibu... Read more
Severe headache about 7 hours after vaccination, also severe body aches and chills responded to ibuprofen
15 2021-06-15 chills, influenza like illness, fatigue Woke up with chills, muscle pain through out whole body, fatigued and just flu like feeling. Felt li... Read more
Woke up with chills, muscle pain through out whole body, fatigued and just flu like feeling. Felt like that, all day. Around 6:30pm she came outside to get some fresh air, trying to feel normal & got suddenly dizzy & then fainted. Her body kind of, rocked. She came to, after she heard her sister, calling her name a few times. So she was out for less than a minute. But she's never fainted before!
15 2021-06-15 chills, fever, headache patient received a 0.5 ml dose of vaccine instead of 0.3 ml resulting in high fever chills headache
15 2021-06-15 fatigue, fever The first shot threw her out of remission and into an IBD (Crohns) flare with liquid stool about one... Read more
The first shot threw her out of remission and into an IBD (Crohns) flare with liquid stool about one week after the shot and visible blood in her stool for a week. The second shot caused a fever of 102.5 for about 12 hours and tiredness the next day as well as throwing her into a worse flare where she had liquid stools at least 4 days with visible blood two days after the vaccination. We are still dealing with the flare, so I do not know how long it will last or if she will need steroids to get her back into remission.
15 2021-06-15 fatigue administered undiluted dose. as of 24 hours-sore arm, fatigue.
15 2021-06-15 headache, body temperature increased Temp >101 Headache all over aching vomiting
15 2021-06-15 headache Vaccine dose number 2 received on Saturday 06/05 and reoccurring and ongoing headache started Monday... Read more
Vaccine dose number 2 received on Saturday 06/05 and reoccurring and ongoing headache started Monday, 06/07. Treated with hydration rest, Tylenol and Ibuprofen. Some relief, but never fully went away. Persisted until at least Sunday, 06/14.
15 2021-06-15 throat pain, fatigue Two hours after the second dose of the vaccine my daughter developed a sore throat. The next day she... Read more
Two hours after the second dose of the vaccine my daughter developed a sore throat. The next day she felt better but her throat still hurt. On the fifth day she complained that she felt like she couldn't breathe so I took her to the ER. She was diagnosed with an Allergic reaction because her throat was swollen and she was prescribed some Prednisone. They gave her Benadryl and Steroids. It has been nine days and it seems to be a little better but her throat still hurts and she is very tired.
15 2021-06-16 fatigue, malaise About 10 minutes after receiving the Pfizer vaccine patient thought she was having an allergic react... Read more
About 10 minutes after receiving the Pfizer vaccine patient thought she was having an allergic reaction. She said her throat felt tight and like it was closing and she could not take a deep breath. I told the patient to take sips of water but she said that wasn't helping. Her throat still felt very tight and she couldn't breathe. I gave the patient 1 benadryl 25mg capsule. I continued to ask her to sip water and take deep breaths. After about 10-15 minutes she said she still felt like someone was choking her. I gave her another 25mg benadryl. The entire time the patient's mother was present and consented to provide Benadryl. After 10 more minutes, the patient said she still did not feel well, but did not want an Epi-Pen. Another pharmacist called WellNow (in our parking lot) and they said the patient could go there to be monitored. WellNow said the patient was just tired and they did not administer any further medication.
15 2021-06-16 headache Dizziness/lightheadedness; Nausea; Blurred vision; Terrible headache; a little palpitation; Clogged ... Read more
Dizziness/lightheadedness; Nausea; Blurred vision; Terrible headache; a little palpitation; Clogged throat; this heaviness (not clarified); This is a spontaneous report from a contactable consumer (parent). A 15-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 15May2021 16:00 (Batch/Lot Number: EW0182) as single dose for COVID-19 immunisation. Medical history included no other illness. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient previously received Amoxicillin, Azithromicin, Cefdinir, Gardasil(Pf) and had allergy. The patient had Nausea that does not go away with Gardasil. She also received HPV vaccine previously and experienced nausea and the dizziness for a month. Reporter stated, "she did not have any allergic 'condition' (not clear) but she was allergic, she had always had a rash when she had this Amoxicillin this antibiotic. She was allergic to Penicillin." The patient had the COVID Pfizer Vaccine on 15May2021 and as soon as she had her first dose she started to feel nausea and dizziness and from there 5 days later she had, she felt a terrible headache, 'this heaviness' (not clarified), headache, dizziness, palpitation. The reporter took her to the emergency room, they did all the test and they didn't really see anything in the results. From there she cannot stop to have nausea and dizziness and clogged throat so the reporter had to give allergy medication to her every day. She did have, she never had an allergic reaction to any vaccine but the HPV vaccine (captured as unspecified vaccine in tab) what was similar to what she is experiencing now. She had nausea and the dizziness for a month that she couldn't stay in school and she has this nausea and dizziness and clogged throat she has to run for this allergy medication what normally she never needed. So, she doesn't want to take this second dose and the reporter was wondering if it is Pfizer because she was just like (Height), a (Weight) pounds if because the reporter understand the vaccine is one for everybody, isn't this strong for a kid with that height that weight, that you do not needed the second dose. The patient could not she said she will not because she goes to school and she feel the nausea and dizziness and so. The reporter would like to report it because it maybe Pfizer's that she was thinking that 1 dose would be enough for kids. When asked about the start of experiencing adverse events, the reported stated that "Well the nausea and dizziness, she was a little bit not sure about like headache right after like her we stayed there like half hours because the doctor said to stay there because she has her reaction to which but then we just the reporter felt the nausea and everything was so bright you know, the reporter had the same effect but her went away and the patient after we received she was, the whole day but not too bad, 5 days after then she but she was already with this nausea, dizziness and 5 days after she got the palpitation, bad headache, nausea, dizziness and then I took her to the emergency room." Reporter stated, "No they have improved, the only thing now left is every day she has this nausea, dizziness and then she said about dizziness and then nausea and then clogged throat and then the reporter gave her the 'allergic pill I gave that, to this allergy' (not clarified further) really she gave only 1 tablet a day." Reporter stated, "On 20May2021, they did a blood test, they did urine test, they did a ECG, so the hospital did all and the doctor too, nothing new." The reporter had lab test result on chart, she stated they put on her chart but she also had the copy of the results. Okay, here they put the result is a line on the chart. Okay here they put like linear line lab test complete, she get all the line because here they didn't put results but screen for metabolic and kidney disorder they did, they did an 'urinary tract infection' (not clarified) they have marked in the ECG. Okay you going to ask for specific (incomplete sentence)." The patient had no other illness but reporter need to know what Gardasil and Covid 19 vaccine have in common because the symptoms were very similar. Nausea that does not go away. She asked if it is the preservative or what ingredients. Never had a reaction to any other vaccine. She just wanted to call the Medical Department if she should have the vaccine on Saturday or not. On 15May2021, 4:30 AM, the patient experienced dizziness, nausea, lightheadedness, blurred vision, headache, a little palpitation (as reported). The patient received treatment Children allergy medication. Adverse events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Outcome of the events clogged throat, heaviness was unknown and other events was not recovered.
15 2021-06-16 headache At around 9:25 am on Thursday, June 17th, 2021, a fifteen-year-old patient walked into the vaccinati... Read more
At around 9:25 am on Thursday, June 17th, 2021, a fifteen-year-old patient walked into the vaccination site. She was accompanied by two guardians, along with 14 other minors. The minors came in for their 2nd shot of Pfizer Covid-19 vaccines. Patient signed all necessary consent forms and pre-vaccination checklist requirements with guardian and entered the vaccination section at approx. 9:38 am. The Pfizer vaccine was administered at 9:45 am. Patient was one of the first minor patients of the group that complained of a severe headache to observation nurse. Observation nurse gave Gatorade to the patient and she took a sip of Gatorade and was calm afterward. One of the patient?s guardians instructed her to head back to the van with the rest of the group. At approximately 10:33 am observation nurse notified charge nurse that another minor patient was having a reaction to the vaccine in the parking lot area. One of our site specialists was the first to attend to patient. Site specialist stated that she saw the patient walking with one of her guardians in the parking lot and looked like she was about to faint. Charge nurse hooked up patient to the pulse oximetry and called 911 at approx. 10:34 am. The patient?s O2 level was 83 with a pulse of 107. The charge nurse observed that the patient was under a lot of stress and was hyperventilating and unable to verbalize how she was feeling. Shortly after, the patient fainted due to hyperventilation. Observation nurse advised the patient to calm down and take deep breaths but the patient did not comply and continued rapid breathing. The patient started to vomit and made some gurgling sounds in her mouth and the charge nurse with the help of site specialist laid the patient on her left side. Shortly after, the patient stopped breathing. Observation nurse administered the epi-pen on the patient?s right thigh. Immediately after administering the epi-pen, patient started to breathe again with an O2 level of 98 with a pulse of 110; but the patient was still unconscious and unresponsive. At approx. 10:36 am first responder paramedics arrived at the scene and took the patient to hospital for further evaluation.
15 2021-06-16 lethargy Client received her first dose of the Pfizer Covid-19 vaccine (Lot # EW0187 Exp. 08/2021) at 12:38 P... Read more
Client received her first dose of the Pfizer Covid-19 vaccine (Lot # EW0187 Exp. 08/2021) at 12:38 PM on Wednesday 6/16/21. EMTs and Lead RN responded to the incident. Lead nurse signaled over EMT at approximately 12:44 that she needed the gravity bed for a client. The client was found lethargic when EMTs arrived with a gravity bed. The client was a 15-year-old female with a chief complaint of dizziness. Client?s older brother was present during incident. Interpreter translated information between EMTs/RN and client/client?s brother. The client was alert and tracking to voice. Per the lead nurse, the client was complaining of dizziness after the administration of her first Pfizer vaccination. The client had no known allergies or medical history. The client also did not take any medication. The client's brother stated that ?she had chicken nuggets and a smoothie? to eat at approximately 10:00. The client's brother also stated that ?they had been standing at the border crossing under the sun? for an extended period of time. The client's airway, breathing, and circulation were intact. The client was negative for hives, swelling, shortness of breath, or other signs of anaphylaxis. The client was nauseous, dizzy and complained of numbness on both arms. The client was unable to bear weight and not following simple commands before she was assisted to gravity bed by EMT and RN. The client then briefly lost consciousness for less than a minute before becoming alert to person, place, date, and event. EMTs assessed vital signs every 5 minutes for a total duration of a 45-minute observation. Vital signs were taken by EMT with client lying supine immediately after losing consciousness (12:45) and were reported as follows: Blood Pressure (BP) 92/64, Pulse (P) 66, Oxygen Saturation (O2) 99%, Temperature (T) 98. Skin was intact, pale, and cool to touch immediately following patient regaining consciousness. Patient remained lying flat on gravity bed for approximately 10 minutes before she was assisted to a seated position. Patient was in a high-fowlers position when she was given a juice and granola bar. Client then stated that she was ?feeling better?. After an additional 10 minutes sitting on the gravity bed in high-fowlers position, the patient was assisted by RN and EMT from vaccination station to EMT/observation station. The client remained seated in the EMT/observation station for an additional 15 minutes. Vital signs were taken every 5 minutes during this time by EMT. They were reported as follows: 12:51- BP 112/78, P 69, O2 97%, T 98. 12:55- BP 108/78, P 77, O2 99%, T 97.9. 13:00- BP 104/78, P 66, O2 98%, T 98.1. 13:05- BP 96/62, P 83, O2 95%, T 98.1. 13:10- BP 92/68, P 76, O2 98%, T 98.1. 13:20- BP 90/70, P 92, O2 99%, T 97.6. 13:28- BP 92/72, P 93, O2 99%, T 97.9. After a 45-minute observation, client stated her condition was improving and was observed walking normally. Client?s skin color returned to a pale pink and became warm to the touch. Client denied dizziness or any other symptoms. Lead RN educated the client about what to do if symptoms returned. The client was provided with the V-Safe form and EUA form with highlighted portions pertaining to symptoms to be mindful of. The client was also instructed to call 9-1-1 if symptoms of anaphylaxis, also known as a severe allergic reaction, presented. These symptoms include difficulty breathing, shortness of breath, hives covering body, facial swelling and more. Client and client?s brother acknowledged understanding of information. The client?s brother stated that he would ?drive her straight home?. The client then left facility at approximately 13:33 with her older brother in positive disposition with steady gait.
15 2021-06-17 headache on 6/16/21 day after 2nd dose of vaccine, while at orthodontist appointment, was standing to get xr... Read more
on 6/16/21 day after 2nd dose of vaccine, while at orthodontist appointment, was standing to get xrays done and fainted for a few seconds. prior to fainting felt nauseous and dizzy, after that happened, went home and then slept for 5 hours. When work up had headache and vomiting x2 , and headache continued, medicine taken, the next morning 6/17/21 all resolved. felt completely normal. came to doctor for regular scheduled appointment not for syncopal episode, no cough, no fever, no chest pain, no heart palpitations,
15 2021-06-17 malaise 2nd Vaccine received at approx 10:38am. On arrival to observation area, mother reports patient state... Read more
2nd Vaccine received at approx 10:38am. On arrival to observation area, mother reports patient stated she was not feeling well. Pt passed out for brief period of time and was taken to pt care area for further evaluation. Mom denies hx of seizures or syncopal episodes. Daughter reports beginning her menses, last night. Reports she ate breakfast this morning and felt fine, before the vaccine. Denies any reaction or issue with 1st dose. BP initially: 88/42, P: 92 O2 Sat: 98% on RA, fluids given orally. Denies n/v. BP up to 124/104, P: 78 O2 Sat: 97% Pt became pale again; BP 81/48 . Call to emergency made services. 1 episode of emesis noted- Pt states she feels better after vomiting; color came back to face; BP:103/62. Paramedics arrived: BP: 108/69 and EKG: NSR @ 90. Mother of pt denied need to take pt to hospital.
15 2021-06-17 respiratory tract congestion, fever, headache Pfizer vaccine 2nd shot caused my daughter to have a fever that reached 101. She also experienced bo... Read more
Pfizer vaccine 2nd shot caused my daughter to have a fever that reached 101. She also experienced body aches, congestion and a headache.
15 2021-06-17 sleepiness A 15 yrs old female patient complained she could not see anything 10 minutes after receiving Pfizer ... Read more
A 15 yrs old female patient complained she could not see anything 10 minutes after receiving Pfizer vaccine. She seemed sleepy,and her face looked pale.She was responsive and conscious, She denied difficulty of breathing, She was hot to touch and asked for water. After approximately 5 minutes, her vision was back to normal,and her face color changed to its normal complexion. the patient has not received anything during this period. She was encouraged to be calm and breathe in and out slowly.Vitals not recorded. EMS arrived and patient went to the ER for further follow-up. Patient's mom confirmed patient remains stable an hour after the incident.
15 2021-06-18 headache, throat pain, fever Fever; Headache; A lot of pain in throat; Couldn't swallow; arm was hurting; This is a spontaneous r... Read more
Fever; Headache; A lot of pain in throat; Couldn't swallow; arm was hurting; This is a spontaneous report received from a contactable consumer (mother). A 15-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0168), via an unspecified route of administration, administered in arm (Unknown if right or left, but thinks right) on 24May2021 (age at vaccination: 15 years) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. On an unknown date in May2021 (was unsure of date, either 25May2021 or 26May2021), the patient experienced arm was hurting from the second day; on 13Jun2021 16:00, fever, headache, a lot of pain in throat and couldn't swallow. As the patient got sick and due to fever, she was sent to emergency room yesterday and they sent her home. The patient was due for second dose on an unknown date (reported as Monday, yesterday). She couldn't receive the second dose because she was sick, so she took her to the doctor yesterday because from Sunday she had a fever and Monday still having the fever so yesterday in the middle of the day, she took her to the doctor. She wasn't having symptoms from first dose, just arm was hurting, no fever or nothing else. She did not have fever after first dose until 13Jun2021 Sunday. The patient did not require a physicians' office visit. On 14Jun2021, the patient underwent test for throat infection which was negative and gave no antibiotics. The patient received the following treatment for the adverse events: Tylenol and Motrin, dose unknown, 2 pills for sore arm. For the Fever, pain in throat, headache, trouble swallowing received Tylenol every 6 hours and her daughter was getting better, no fever and headache. For swallowing: gargling with hot water, lemon, and salt, and was getting better. She no longer has the sore arm she is better now. The outcome of the event oropharyngeal pain and dysphagia was recovering, and all the other events were recovered on an unknown date in 2021. Information on Lot/Batch number was available. Additional information has been requested.
15 2021-06-18 fever, chills, malaise, headache High fever 102.7 to 103,2; general full body malaise; Chills; extreme soreness at injection site; Na... Read more
High fever 102.7 to 103,2; general full body malaise; Chills; extreme soreness at injection site; Nausea; Headache; body aches; This is a spontaneous report received from a contactable consumer (patient). A 15-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0217 and expiration date not provided), via an unspecified route of administration, in arm left, on 04Jun2021 15:45 (at the age of 15-year-old, not pregnant), at single dose, for COVID-19 immunization. Medical history and concomitant medications were reported as "none". Patient had no known allergies. No other medical history. Prior to vaccination, patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9264 and expiration date not provided), via an unspecified route of administration, in right arm, on 14May2021 15:45 (at the age of 15-year-old), at single dose, for COVID-19 immunization. On 05Jun2021 02:45, the patient experienced high fever 102.7 to 103.2, general full body malaise, chills, extreme soreness at injection site, nausea, headache, and body aches. The patient underwent lab tests and procedures which included body temperature: 102.7 to 103.2 on 05Jun2021 02:45. Since the vaccination, patient had not been tested for COVID-19. No treatment received for events. The outcome of evens was unknown.
15 2021-06-18 fever Felt very weak; Body ache; Body temperature of about 100.6F; This is a spontaneous report from a con... Read more
Felt very weak; Body ache; Body temperature of about 100.6F; This is a spontaneous report from a contactable consumer (patient's mother). A 15-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiration date: not reported), via an unspecified route of administration, on 15Jun2021 at 17:15 (at the age of 15-year-old), as 1ST DOSE, SINGLE for covid-19 immunization .The patient medical history was not reported. The patient's concomitant medications were not reported. On 15Jun2021, the patient felt very weak, body ache and body temperature of about 100.6F for over 24 hours now. The reporter would like to know what they need to do about it. Also wants to know if these has been reported side effects post-vaccination; and if so, how long does this usually lasts. The patient underwent lab tests and procedures which included body temperature: 100.6 Fahrenheit on 16Jun2021. The outcome of the events was unknown. Information about lot/batch number has been requested.
15 2021-06-19 fever, fatigue Painful vaginal ulcerations (Lipschutz ulcers) which began 2 days after second Covid vaccine. Had ... Read more
Painful vaginal ulcerations (Lipschutz ulcers) which began 2 days after second Covid vaccine. Had fever and fatigue 24 hours after receiving vaccine which resolved then developed vaginal ulcerations. Ulcerations very painful. Presented with pain and dysuria. Was treated with Ibuprofen and topical lidocaine
15 2021-06-20 malaise, fever Pt presented with painful vaginal ulcers bilaterally. HSV 1 and 2 swab was negative as was a bacte... Read more
Pt presented with painful vaginal ulcers bilaterally. HSV 1 and 2 swab was negative as was a bacterial culture. Ulcer consistent with Lipschutz Ulcer. Pt also had low grade fever and malaise. All symptoms started within 24 hours of second dose of the vaccine.
15 2021-06-20 sleepiness, sweating At 1443 EMT observed client leaning forward in chair and approached for further assessment. Client m... Read more
At 1443 EMT observed client leaning forward in chair and approached for further assessment. Client mentioned feeling dizzy. PHN arrived at 1445 and observed client sitting upright in chair, alert and oriented x4. PHN asked EM to bring anti-gravity chair. Client able to transfer to anti-gravity on her own. First vitals by EMT at 1445: blood pressure 148/86, pulse 92, oxygen sat 100%. Grandmother present with client. Client reported feeling dizzy and nauseous. Client denied headache, blurry vision, shortness of breath. PHN observed hives on neck, bilateral arms, chest and upper left back. PHN offered Benadryl, Grandmother accepted and stated she would go get Father who was outside. Father denied client having allergies, no pertinent medical history or current medications. At 1448 PHN administered 1ml/50mg Benadryl IM on right deltoid after checking dosage table and verifying weight with client. PHN called 911 at 1449. At 1452 client reported new onset of tingling on both hands. Client appeared pale and diaphoretic. Vitals at 1452 by EMT: blood pressure 150/90, pulse 108, oxygen sat 100%. Hives on bilateral arms improving, hives on upper left back resolved. Flushing of face and ears. 1456 PHN and EMT observe edema of lower lip. PHN on phone with 911 operator asked client if she was having trouble swallowing. Client unable to fully describe, drowsy, but was speaking in full coherent sentences. At 1456 pulse 95, oxygen sat 100%. Paramedics arrived at 1458 and assumed care. Client transported to
15 2021-06-21 chills, fatigue, headache Experienced a headache that has not went away. She is very fatigue, chills, enlarged lymph nodes beh... Read more
Experienced a headache that has not went away. She is very fatigue, chills, enlarged lymph nodes behind her ears and under armpits, dizzy spells, sensitive to light.
15 2021-06-21 headache Patient had Pfizer COVID-19 vaccines on 5/27/2021 and 6/17/2021. On the evening of 06/18/2021 she st... Read more
Patient had Pfizer COVID-19 vaccines on 5/27/2021 and 6/17/2021. On the evening of 06/18/2021 she started having headache with nausea and vomiting. Over that weekend she progressively got worse with slurred speech and then aphasia although she could still follow commands. She was then seen in the emergency department where she was then transferred to emergency department. There she was noted to have deterioration in her neurologic exam with inability to follow commands. She was then transferred to Hospital where she became more obtunded and encephalopathic and was transferred to the.
15 2021-06-21 sweating Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: brad... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: bradycardia-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Shakiness-Medium
15 2021-06-21 fever, headache 1st shot, no reaction. 2nd, fever, vomiting, headache, site redness and swelling . Took Tylenol fo... Read more
1st shot, no reaction. 2nd, fever, vomiting, headache, site redness and swelling . Took Tylenol for 48hrs and ibuprofen, alternating. Sips of water, but no food. By the 3rd day, she was if nothing happened.
15 2021-06-22 chills chills, muscle aches, nausea, chest pain
15 2021-06-22 fatigue, headache 4-5 days after dose # 1 she started with heavier than usual vaginal bleeding, passing clots, persist... Read more
4-5 days after dose # 1 she started with heavier than usual vaginal bleeding, passing clots, persisting in the 10-15 days following with dizziness, HA, fatigue, heart racing
15 2021-06-22 headache loss of consciousness; nausea; vomiting; stopped breathing several times for multiple seconds and th... Read more
loss of consciousness; nausea; vomiting; stopped breathing several times for multiple seconds and they described her to be gurgling when her pulse ox went down to 83%; Difficulty breathing; severe Headcahe; This is a spontaneous report received Support from a contactable nurse from Pfizer sponsored program via medical information team. This case pertains to patient 3 of 3. A 15-year-old female patient received bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: ER8727; Expiry Date: 31Jul2021), dose 2 via an unspecified route of administration on 17Jun2021 (at the age of 15-year-old) as a single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient historical vaccine included bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date as a single for COVID-19 immunisation and had no reaction. On 17Jun2021, after 15 minutes of observation, the patient had a severe headache, difficulty breathing, loss of consciousness and stopped breathing several times for multiple seconds and they described her to be gurgling when her pulse ox went down to 83%. On an unspecified date, the patient also had nausea and vomiting. The patient pulse ox (documented as provided by caller) went down to 83%, she had severe headache, nausea, vomiting and she was unconscious. When she was unconscious was when her pulse ox was 83% and she stopped breathing intermittently for 10 to 12 seconds at a time. Then she started breathing again but was not responsive after she received the epinephrine then her pulse ox steadily rose again but was not responsive. She was like this until EMS took her away. The reporter stated that the most severe case was for this particular patient. She had already been vaccinated and had already gone through the 15 minute observation. All these kids came in a bus together, but this patient was sitting in the vehicle after the observation when the guardian brought her back to the nurses saying that she was complaining of a severe headache and at that point she had difficulty breathing and lost consciousness. The nurses reported that it appeared that she stopped breathing several times for multiple seconds and they described her to be gurgling when her pulse ox went down to 83%. At that time they administered epi (epinephrine) and called EMS. Her pulse ox and her breathing improved after the administration of epi, however she remained unresponsive when she was on the way to the hospital with EMS. The patient was taken to the hospital and she did improve. This was the 2nd dose, she had the 1st dose and did not have a reaction to it. The seriousness of the events severe headache, difficulty breathing, loss of consciousness, stopped breathing several times for multiple seconds and they described her to be gurgling when her pulse ox went down to 83% was reported as medically significant. The reporter stated that it was very serious. This patient reaction was a little more intense than just an anxiety induced reaction. She says with a pulse ox of 83% if they had not intervened then this would of been life threatening. It is medically significant but if they had not intervened then it would have been life threatening especially when you're talking about gurgling and a pulse ox of 83%. The reporter tends to think that with that severe of a reaction, with the pulse ox that low and her being unresponsive, she believes that this was probably a true adverse event. Outcome of the events was reported as unknown. The reported causality for the events severe headache, had difficulty breathing and lost consciousness, stopped breathing several times for multiple seconds and they described her to be gurgling when her pulse ox went down to 83% was reported as related. Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events respiratory arrest, loss of consciousness, dyspnea and headache and the suspect drug. 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.
15 2021-06-23 chills, nasal congestion, fever, headache, fatigue, cough None stated.
15 2021-06-23 fatigue, headache, throat pain, cough 12 hours post vaccination she got a fever 102.9F, chest pain, chest tightness, shortness of breathe... Read more
12 hours post vaccination she got a fever 102.9F, chest pain, chest tightness, shortness of breathe, headache and achy. Fever last 24 hours, chest pain/tightness with shortness of breathe for 12 hours. Headache, sore throat, fatigue, cough lasted 48 hours.
15 2021-06-23 fatigue, headache Passed out for 20-30 min, fatigue, and headache
15 2021-06-23 fatigue, malaise, headache Daughter began having chest pain, severe fatigue, overall malaise, rapid heart beat, headaches
15 2021-06-23 headache, malaise Severe stomach pain/cramps 7/10, Nausea, general malaise, headache, weakness
15 2021-06-23 headache arm pain where the injection occured for 3 days, mild headache for 2 days
15 2021-06-23 sweating Complaints of seeing stars and feeling faint. Wheel chair and stretcher pad with legs up. Mom states... Read more
Complaints of seeing stars and feeling faint. Wheel chair and stretcher pad with legs up. Mom states she passed out with needle sticks or the sight of blood. 94/62, pulse 92, resp 14. Passed out a for few seconds. Mom declined EM. Pretty sweaty. 97/65, 92/14 states she feels better. Given water and cool cloth. 10:45 am 91/63, 97/14. Patient states no longer feels faint. Setting up . 11:00 Patient states she feels normal. Skin warm, dry and pink. Standing vital signs 116/86, 16. Mom and patient comfortable and walks without problems. Instructed to notify staff prior to vaccine so she can lay done before administration.
15 2021-06-23 throat pain Patient complains of shooting pain at the throat on one side, and pressure/pain in the chest one day... Read more
Patient complains of shooting pain at the throat on one side, and pressure/pain in the chest one day after receiving second dose of Pfizer covid-19 vaccine.
15 2021-06-23 fever, chills, headache First dose 5/28/21, second dose 06/17/21, "normal" second dose symptoms, fever, chills, headache, st... Read more
First dose 5/28/21, second dose 06/17/21, "normal" second dose symptoms, fever, chills, headache, stomach pain, after 3 days still feeling pain, worse vommiting, pain above spleen, change in cheek coloring. Mom took patient to ER and they did a CT and blood work, found nothing wrong and ruled out thrombocytopenia. Today she is feeling better still a headache and a bit nauseous. Mom called to make sure this incident was reported,
15 2021-06-24 headache, fever Vomiting; Had 103 Fever; Headache; Nausea; Body aches; This is a spontaneous report from a contactab... Read more
Vomiting; Had 103 Fever; Headache; Nausea; Body aches; This is a spontaneous report from a contactable consumer (Patient's parent). A 15-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EW0179; expiration date: 31Aug2021) via an unspecified route of administration in right arm on 12Jun2021 (at the age of 15-year-old) for COVID-19 immunization. Patient had no medical history and concomitant medications. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EW0183) in unspecified route of administration in left arm on 22May2021 (at the age of 15-year-old) for COVID-19 immunization and had no reaction. On 13Jun2021, one day after vaccination, the patient had 103 fever, headache, nausea, body aches and on 14Jun2021, two days after vaccination, the patient experienced vomiting. As per the reporter, patient was getting the side effect for 5 days now. She had 103 fever for day and half. She was experiencing severe headache. Now, she was experiencing headache, nausea, vomiting and body aches. Reportedly, It was started when she had the second vaccination, started on Sunday and Monday she had a fever and had experience headache and body aches and then on Tuesday fever went away and she started experiencing headache, nausea and vomiting still going on. Reporter's daughter received the vaccine shot, the second one, last Saturday, she was still experiencing side effects. She was having nausea, headache, body ache, and she had 103 fever for three days. Reporter mentioned that they were trying to find out what treatment should they give her. Outcome of the event 103 fever was resolved on 16Jun2021 and for the event headache, nausea, pain and vomiting were not resolved. No follow-up attempts are needed. No further information is expected.
15 2021-06-24 lethargy Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Det... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: Pt expressed she can pass out after vaccines and blood draws. i explained process, side effects and what to expect. I had pt look at her mom during admin. Patient did fabulous and told she did amazing as not even a speck of blood. About 5 mins later i asked pt hiow she was, which was good. About 15 mins later, she seemed lethargic and said she was dizzy. I asked questions, took Temp and got ice packs. I then called EMS as patient was not responding appropriastely. BP, O2, HR were perfect
15 2021-06-24 fever, chills Hives - itchy head started day of vaccination, then developed hives to chest, back, neck, face the d... Read more
Hives - itchy head started day of vaccination, then developed hives to chest, back, neck, face the days following. No SOB Also had fever, chills, body aches the day after
15 2021-06-24 fever, lethargy, headache Headache; lethargy; aches in large limbs; fever; injection site pain; This is a spontaneous report f... Read more
Headache; lethargy; aches in large limbs; fever; injection site pain; This is a spontaneous report from a contactable consumer or other non hcp. A 15-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular, in left arm on 16Jun2021 at 09:45 (Batch/Lot number: Not reported) (at the age of 15-years-old) as 2nd dose single for COVID-19 immunization. Medical history was not reported. Concomitant medication(s) included oxymetazoline hydrochloride (CLARITIN ALLERGIC) for seasonal allergy. Patient had no known allergies. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) intramuscular in left arm in May2021 as 1st dose single for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 16Jun2021 at 23:00, the patient experienced headache, lethargy, aches in large limbs, fever and injection site pain. Patient did not receive treatment for the events. The outcome of the events was recovering. Information on the batch/lot number has been requested.
15 2021-06-24 fever Symptoms: low fever, back and chest pain, mild nausea - started 6/4/21 and get worse over 4 days. U... Read more
Symptoms: low fever, back and chest pain, mild nausea - started 6/4/21 and get worse over 4 days. Urgent care seeked on 6/8/21, EKG shown normal, no treatment received. Symptoms abruptly disappeared on 6/10/21
15 2021-06-25 fever My daughter has developed a rash on her stocking; having high fever; This is a spontaneous report fr... Read more
My daughter has developed a rash on her stocking; having high fever; This is a spontaneous report from a contactable consumer or other non-HCP (patient mother). A 15-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration dates were not reported), via an unspecified route of administration in left arm on 08Jun2021 at 15:00 as dose 2, single (at the age of: 15-year-old) for COVID-19 immunization. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration dates were not reported), via unspecified route of administration in right arm. Medical history included migraine and asthma. The patient's concomitant medications were not reported. No other vaccine administered in last four weeks. The patient had diagnosed with COVID prior vaccination and not diagnosed post vaccination, patient had not tested with COVID. Prior to vaccination, the patient was diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. On 10Jun2021 at 15:00 The patient experienced she has developed a rash on her stocking and having high fever. Therapeutic measures were taken as Tylenol and benadryl as a result of she has developed a rash on her stocking, having high fever. Facility where the most recent COVID-19 vaccine was administered: Public Health Clinic/Veterans Administration facility. The outcome of all event was not recovered. Follow up attempts are needed, Information on lot/batch number has been requested.
15 2021-06-26 headache Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Un... Read more
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: tingling sensation on the arm that got the vaccine-Mild, Systemic: Headache-Mild, Systemic: Hypotension-Mild, Systemic: Weakness-Mild, Additional Details: as soon after giving vaccine, pt fainted. Woke up after 1-2 mins, pt was positioned flat on her back with legs elevated. Pt took apple juice and 25mg benadryl @7:30pm, watched pt for another 15 mins and took blood pressure before leaving. BP was low but mom states she always has low blood pressure. Followed up next day around 1pm, mom states pt has pain at the injection site, headache, no fever, and sleeping
15 2021-06-26 sweating AFTER vaccination and patient attempted to stand and fell backwards in seat. Patient was incoherent... Read more
AFTER vaccination and patient attempted to stand and fell backwards in seat. Patient was incoherent, hot, sweaty, loss color to face and lips and unresponsive. Blood pressure was check 100/46 65 heart rate and temp less the 85degrees. Patient was unresponsive for about 10 minutes. EMS was summoned and the patient was given water and juice to drink. Patient slowly returned to a normal state after about 30 minutes but was still slow to respond.
15 2021-06-26 sweating Client received dose 1 of the COVID19 Pfizer vaccine (Lot# EW0187 Exp 08/31/21) at 13:32 from RN1. ... Read more
Client received dose 1 of the COVID19 Pfizer vaccine (Lot# EW0187 Exp 08/31/21) at 13:32 from RN1. RN1 reported that within 5 seconds of receiving the vaccine, the client reported she felt dizzy and experienced a syncopal episode for 2-3 seconds. As the syncopal episode was occurring, ancillary staff, requested RN2 radio for a Lead Nurse & EMT. At 13:34 Lead RN arrived at station 6, radioed for an EMT, and observed client sitting up in the vaccination chair being held by her mother and RN1. Lead RN noted client?s head was down with her eyes open, exhibiting pallor and was diaphoretic. Lead RN asked client her name and how she was feeling. Client did not respond. Co-Lead RN entered the room at 13:35. RN1, Lead RN, Co-Lead RN, and client?s mother guided client to the floor, laid her in a supine position, lifting her legs and feet on a chair. Co-Lead RN removed client?s mask, continued to ask client her name. Within 2-3 seconds of repositioning client, she became responsive and alert & oriented to person, place, time, and event. Client also immediately stated, ?I?m fine.? EMT1, EMT2, and EMT3 came to the station at 13:36 with a zero-gravity chair. The EMTs assisted client into the zero-gravity chair. Client?s mother stated client has no underlying health conditions, no allergies, and that birth control is the only medication the client takes. The client confirmed this by nodding her head in agreeance. EMT2 gave client a bottle of water and the client immediately started drinking the water. Lead RN asked client if she had eaten or drank anything today. Client?s mother stated she did not realize her daughter had not eaten or drank anything prior to coming to get vaccinated. Client stated she was given a granola bar downstairs at check-in and ate it before receiving the vaccine. At 13:45 EMT1 took vitals. Both EMT1 & EMT2 were unable to obtain client?s blood pressure (HR:61, O2Sat: 97%). Lead RN asked client and her mother what the client?s normal blood pressure is. Client and her mother did not know, and client?s mother indicated that the client is an athlete in good shape. At 13:48, EMT3 took client?s blood pressure, which was 100/60. Client?s mother stated client was anxious about being vaccinated and has fainted when anxious in the past, but the last time was around 5 years ago. Client stated she was feeling better and no longer feeling dizzy. Client stated she just ?feels hot.? Lead RN brought client an ice pack to put behind her neck and damp paper towels to wipe her face with. At 13:59 EMT3 took client?s vitals (BP: 118/70, HR: 65, O2Sat 98%). Lead RN observed that client?s color was returning to her face and client was less diaphoretic. Client finished her bottled water and was given another by EMT2, which she started drinking. Lead RN asked client if she felt she could stand up. Client stood up and stated she was ?feeling fine.? At 14:05 all 3 EMTs escorted client and her mother to the observation room where she was monitored for an additional 30 minutes. At 14:30 Lead RN went to the observation room where EMT1was taking client?s vitals (BP: 110/70, HR: 60, SPO2 Sat 98%). Lead RN observed that client?s color had fully returned, and client was no longer diaphoretic. Client stated she ?felt fine? and was hungry. Client?s mother stated she would take client to get something to eat and EMT2 gave client an additional snack that client took with her when she left. Client and her mother left at 14:30. Client was walking with a steady gait when she exited the building.
15 2021-06-27 headache, fever 12 hours s/p vaccine The patient developed fever to 102.5 taken orally. She had body aches, Heada... Read more
12 hours s/p vaccine The patient developed fever to 102.5 taken orally. She had body aches, Headache, nausea and vomiting. By the second day the patient developed mild facial swelling bilaterally, this responded well to Zyrtec. There was no SOB, or dyspnea. There was no swelling of lips or oropharyngeal structures. Her symptoms persisted for 48 hours. Patient was treated at home by her mother, who is a pharmacist, with apap alternating with ibuprofen. She was also given Zyrtec as noted. The patient was seen by me this afternoon and was improved with no fever evident. However, Mom had given her 1 gram apap 1 hour prior to her visit.
15 2021-06-29 fever, fatigue Patient was given 0.3 mL of undiluted Pfizer Vaccine by pharmacist on duty. It was suppose to be th... Read more
Patient was given 0.3 mL of undiluted Pfizer Vaccine by pharmacist on duty. It was suppose to be the patients second dose. Patient received 6 times the dose. Patient developed severe fatigue and body aches about 12 hours later. Patient visited the urgent care overnight due to fever. Patient is currently resting at home and being monitored 24 hours after the administration of the vaccine.
15 2021-06-29 fever Patient was vaccinated on June 5, 2021 , one week later she developed fever and myalgia and on June ... Read more
Patient was vaccinated on June 5, 2021 , one week later she developed fever and myalgia and on June 27, she woke up with bruising and petechia on the legs and arms. she also had hematomas over the oral mucosa and subconjunctival hemorrhage. On June 27, she was seen in the ER, platelet count was 1000. She received IVIG on June 28 and 29
15 2021-06-30 fatigue, headache feeling like going to pass out; difficulty breathing; chest pain; Moderate headache; fatigue; modera... Read more
feeling like going to pass out; difficulty breathing; chest pain; Moderate headache; fatigue; moderate muscle aches; joint pain; This is a spontaneous report from a contactable consumer. A 15-years-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: EW0177 and Expiration date: unknown), via an unknown route of administration, in left arm on 06Jun2021 at 11:15 (at the age of 15-years-old) as dose 2 single for covid-19 immunisation. Medical history included ADHD (attention deficit hyperactivity disorder), mood disorder, asthma, NKA other than seasonal outdoor allergies and minor lactose intolerance from an unknown date. Concomitant medications included methylphenidate hydrochloride (CONCERTA); oxcarbazepine (TRILEPTAL) and salbutamol sulfate (PROAIR HFA) taken for an unspecified indication, start and stop date were not reported. Patient previously took first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: EW0185 and Expiration date: unknown), via an unknown route of administration, in left arm on 16May2021 at 11:00 (at the age of 15-years-old) for covid-19 immunisation. Patient did not receive any other vaccine within 4 weeks prior to covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19. On 06Jun2021 at 12:00, the patient experienced moderate headache, fatigue, moderate muscle aches, joint pain, chest pain, difficulty breathing and feeling like going to pass out. Lasted for exactly 48 hours. The case was assesses as non-serious. Patient received Ibuprofen and steroid inhaler as treatment for events. On an unspecified date in Jun2021, the events were recovered. Follow-up attempts are needed. Further information is expected.
15 2021-06-30 headache, fever Headache is really bother her; Head is hurting pretty bad; Nausea little bit; Fever; This is a spont... Read more
Headache is really bother her; Head is hurting pretty bad; Nausea little bit; Fever; This is a spontaneous report from a contactable consumer (grandparent). A 15-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number:EW0169, and expiration date was not reported), via an unspecified route of administration on 23Jun2021, as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), DOSE 1, SINGLE for covid-19 immunization. On 23Jun2021, the patient started feeling some side effects, she had a headache, little bit of nausea, and fever. At the morning of report, the patient still had a headache and it really bother her and her head was hurting pretty bad. The reporter would like to know what patient can take for her headache. The outcome of the event Headache was not recovered and of Nausea and pyrexia was unknown at the time of report.
15 2021-07-01 fatigue Her arm is just sore this time and she is tired; Her arm is just sore this time and she is tired; Hi... Read more
Her arm is just sore this time and she is tired; Her arm is just sore this time and she is tired; His daughter received twice the dose/ They put two and a half dosage given and they didn't diluted it correctly; They put two and a half dosage given and they didn't diluted it correctly; This is a spontaneous report from a contactable consumer (patient's father/ parent). A 15-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 07Jun2021 (9:00 or 09:10 this morning AM) (Lot Number: EW0180; Expiration Date: 01Aug2021) as single dose (at the age of 15-years-old) for COVID-19 immunization. Medical history included allergic to peaches. There were no concomitant medications. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 17May2021 16:00 (Lot Number: EW0167) as single dose (at the age of 15-years-old) for COVID-19 immunization. The patient received the second dose today (of the vaccine) and father was notified by the pharmacist that she received twice the dose of the vaccine today. The pharmacist called and said they put two and a half dosage given and they didn't diluted it correctly. Her arm is just sore this time and she is tired. She got her first shot and it was fine then. The patient underwent lab tests and procedures which included body temperature: fine on 07Jun2021. The patient did not receive any treatment for the events. The outcome of the events was unknown. The events were assessed as non-serious. The patient did not have any other vaccine after COVID vaccine.
15 2021-07-01 sweating Pt w/ hx of severe allergy to nuts. Hx of Fainting/feeling hot w/ allergy testing @ age 9. Pt c/o ... Read more
Pt w/ hx of severe allergy to nuts. Hx of Fainting/feeling hot w/ allergy testing @ age 9. Pt c/o flushing/sweating and dizziness 5mins after vaccination BP 114/70, HR 88, RR 16, O2 Sat 98% RA -- > 120/68, 86, 18, 100% RA. Pt VSS, extremities warm to touch. Pt stable and released from vaccination site ~35mins after vaccination. Pt transferred via wheelchair w/ Dad as a precaution.
15 2021-07-01 throat irritation Patient left the clinic and developed itching in throat with in four hours post vaccine, was taken t... Read more
Patient left the clinic and developed itching in throat with in four hours post vaccine, was taken to the emergency room for treatment, given benadryl.
15 2021-07-02 cough, headache, fever, respiratory tract congestion, fatigue tightness/pressure in chest, hard to breathe, feeling of congestion, cough after a couple of days. ... Read more
tightness/pressure in chest, hard to breathe, feeling of congestion, cough after a couple of days. All of this in addition to full body aches, headache, 4 days of extreme fatigue and fever. Chest pain last for days after all other symptoms cleared. (no reaction to first shot other than slight headache, soreness at injection sight and slight fatigue.)
15 2021-07-02 lethargy, malaise, sweating patient seemed to rapidly appear to begin to faint....sweating, nervous, lethargic, eyes remained op... Read more
patient seemed to rapidly appear to begin to faint....sweating, nervous, lethargic, eyes remained open, mom held her face and had patient focus on the mother. Gave patient water which she drink, applied cool wet cloths to both forehead, neck and face, to a while for patient to fully come around to the point of saying she felt ok, was smiling and laughing at one point....before this she did exhibit her body shaking, she had the dry heaves, felt like vomiting but nothing really came up, after which she was cold and put back on her sweatshirt....improved from that point on.We offered to call 911, which the mother was in favor of, but left it up to patient, who did not want to go to the hospital, just wanted to go home....which they did approximatey 4:57pm...an rx technician helped mom walk patient to the car.
15 2021-07-02 fever, headache Fever to 101.4 F, headache, chest pain, back pain
15 2021-07-03 malaise, headache APPROX AROUND 6:30P MY DAUGHTER COMPLAINED OF NOT FEELING WELL. SHE COMPLAINED OF ELEVATED HEART RAT... Read more
APPROX AROUND 6:30P MY DAUGHTER COMPLAINED OF NOT FEELING WELL. SHE COMPLAINED OF ELEVATED HEART RATE (138 AND 143), HEADACHE AND FEELING COLD
15 2021-07-04 fever At 10:30pm she developed fever of 101.5 , along with a very fast heart rate, and shortness of breath... Read more
At 10:30pm she developed fever of 101.5 , along with a very fast heart rate, and shortness of breath..
15 2021-07-04 fever She developed a fever around 10:46pm of 101.5 and a very fast heart rate over 137bpm. Shortness of b... Read more
She developed a fever around 10:46pm of 101.5 and a very fast heart rate over 137bpm. Shortness of breath and immediate chest pains..
15 2021-07-05 headache After vaccine, went to car, she felt a hot flash and reported dizziness, she then for about 15-20 s... Read more
After vaccine, went to car, she felt a hot flash and reported dizziness, she then for about 15-20 seconds had seizure like activity, pharmacist aware and pediatrician notified to which it is believed it was a vasovagal response. felt confused after the event with a headache, otherwise no other reaction at this time.
15 2021-07-05 fever, fatigue Patient developed fatigue 3 hrs post injection. The following day, developed fever to 103F, nausea a... Read more
Patient developed fatigue 3 hrs post injection. The following day, developed fever to 103F, nausea and vomiting, dizziness and pleuritic chest pain, difficulty breathing. fever last for 2 days. Went to ED for evaluation on day 3 (7/1). Symptoms ultimately resolved, but then developed facial hives and facial swelling on day 5 post vaccine.
15 2021-07-06 headache On 7/07/21 received her second dose Pfizer COVID vaccine (LOT#: EW0191 EXP: 7/29/21) at 1502. Patien... Read more
On 7/07/21 received her second dose Pfizer COVID vaccine (LOT#: EW0191 EXP: 7/29/21) at 1502. Patient alerted EMT's at 1503. Patient stated that she felt dizzy and nauseous. EMT took patients vital signs at 1500. BP: 110/60, HR: 72, O2: 99%. EMT reassessed and retook patients vital signs at 1508. BP: 100/60, HR: 80, O2: 99%. Patient stated that she had a headache 4/10 on the pain scale and was trembling. EMT reassessed and retook patients vital signs at 1513. BP: 116/60, HR: 79, O2: 99%. Patient stated that she no longer still had a headache but no longer felt dizzy anymore. EMT reassessed and retook patients vital signs at 1522. BP: 116/70, HR: 75, O2: 99%. Patient stated that her headache had gone down to a 1/10 on the pain scale. EMT reassessed and retook patients vital signs at 1530. BP: 110/60, HR: 78, O2: 99%. Patient stated that she was feeling better. Patient was educated by PHN on worsening signs and symptoms of covid vaccine and when to go to the emergency room/urgent care. Patient verbalized understanding of education. Patient left with mom and brother from vaccination site unassisted and with a steady gait at 1614.
15 2021-07-07 chills Rapid heartbeat, dizziness, chills, irregular period, difficulty breathing
15 2021-07-09 sweating, lethargy This patient began feeling faint approximately 2-3 minutes after vaccination. She did not lose consc... Read more
This patient began feeling faint approximately 2-3 minutes after vaccination. She did not lose consciousness at any point but was very clammy, sweaty and lethargic and feeling very weak and faint. We called 911 right away and EMS came and took her vitals which they reported as normal but took her to the ER to be evaluated. After speaking with mother that evening and the next day she reported it took her " a while" to feel better at the ER and the ER noted her blood sugar was also low. They ran some other tests but nothing else was remarkable according to mother. By the next day when we spoke 7/11 patient was feeling much better and back to normal according to mother.
15 2021-07-09 throat pain, fever, throat redness Pt developed fever, ST and presented to office with hives and edema of hands/feet> Pharynx red. Stre... Read more
Pt developed fever, ST and presented to office with hives and edema of hands/feet> Pharynx red. Strep neg and started on prednisone for presumed angioedema. EBV titers neg when ST persisted, inflammatory markers very high. Clinically did well and by day 3 steroids much improved. Of interest pt did have COVID in Jan 2021 with chest pain after that was evaluated with normal troponin and EKG/ECHO by cardiology and normal, though to be anxiety
15 2021-07-10 sweating, malaise 15-year-old female patient unwell after administering the vaccine. The patient is unconscious, prese... Read more
15-year-old female patient unwell after administering the vaccine. The patient is unconscious, presenting paleness and sweating. Vital symptoms blood pressure 90/60, dextrose 113, pulse 61, oxygenation room temperature 99, 16 breaths and cold temperature. Because the patient responds in time, place and space, she cannot move limbs or speak. The patient only shook her head to answer questions.
15 2021-07-10 sweating Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Seve... Read more
Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Severe, Systemic: Weakness-Severe, Additional Details: Reported yesterday with the details above for a different patient, but the incident was with this patient. I went back to the drug usage report to verify and called patient this morning but call went to voicemail. The COVID vacc was appropriately recon, dosed, timed and administered by my immunization certified technician. The paperwork errror is that I put the name on the "EVENT REPORTING SYSTEM" as this patient not other patient. Please make the correction accordingly.
15 2021-07-13 headache, sweating Around 9 AM, my daughter came downstairs and said her legs felt heavy. She sat down and then she sai... Read more
Around 9 AM, my daughter came downstairs and said her legs felt heavy. She sat down and then she said she was really hot. She was also sweating and pale. She said that she felt like she was about to pass out and that she couldn't see. She also said she couldn't focus, that she was seeing stars, and everything looked black. My husband and I told her to lay down on the couch. We gave her a rag to put on her head to cool her down and we got her some water to drink. She said she had a headache and we gave her some Tylenol.
15 2021-07-13 fever, fatigue Beginning on the day after thee 2nd shot:severe stomach pain, fever, fatigue, bloody loose stool, fe... Read more
Beginning on the day after thee 2nd shot:severe stomach pain, fever, fatigue, bloody loose stool, fever went away after several days but digestive problems persisted. Elevated heart rate gradually beginning to be noticeable and bothersome with a feeling of being "winded". This also was totally out of character for my daughter who is a runner. She has never had any symptoms like this before.
15 2021-07-14 sweating The patient started to feel dizzy almost right away, we had her sit, she was sweating and pale and h... Read more
The patient started to feel dizzy almost right away, we had her sit, she was sweating and pale and had black visions in front of her eyes. We gave her water and after a few minutes she started feeling better but we called 911 anyway. When they came her blood pressure was 80/54 and they gave her IV fluids right away and decided to take her to the ER for observation.
15 2021-07-15 fatigue, fever, headache Fever, swollen lymph node under arm, extreme fatigue, headache and nausea.
15 2021-07-15 malaise FAMILY MEMBER REPORTED VIA PHONE PATIENT NOT FEELING WELL AND WILL BE TAKEN TO URGENT CARE
15 2021-07-15 fever Started with chest pain the evening of 6/11/21. Also reported tachycardia the night of 6/11/21 with... Read more
Started with chest pain the evening of 6/11/21. Also reported tachycardia the night of 6/11/21 with a heart rate of 120 BPM. Tachycardia resolved by the morning of 6/12/21 and chest pain resolved on 6/13/21. Started with diarrhea, fever(101), and nausea 24 hours after receiving the vaccine and that lasted 2 days. No treatments were done due to patient not being seen by doctor for side effects.
15 2021-07-16 dehydration, fever, headache, chills At first had symptoms that are common including mild fever, chills, headache , etc.. then experience... Read more
At first had symptoms that are common including mild fever, chills, headache , etc.. then experienced extreme vomiting which required a prescription from her pediatrician to control so she could keep liquids down. Vomited about 10 times in a few hours then managed to stop after the medication was administered. She is a petite person and it took a long time after the vomiting stopped to get her fully hydrated and able to urinate properly
15 2021-07-16 fatigue, headache, fever Fever, headache, swollen lymph node under arm, extreme fatigue, nausea.
15 2021-07-16 sweating Less than 5 minutes after receiving the vaccine the patient began vomiting and sweating. After vomi... Read more
Less than 5 minutes after receiving the vaccine the patient began vomiting and sweating. After vomiting, sitting down with a cold compress on the forehead and a few sips of water the patient felt perfectly fine. Patient's mother stated that this has happened with previous vaccinations and even doctors appointments. She believes it was more nerves than an actual reaction to the vaccine.
15 2021-07-17 chills 12 hrs after vaccine administration reported chest pain upper retrosternal area with radiation to ja... Read more
12 hrs after vaccine administration reported chest pain upper retrosternal area with radiation to jaw .back with dizziness,feeling warm with chills and muscle aches and joint pains for next 36 hrs Admitted to Hospital 7/16/21 Symptoms resolved 7/18/21 at 10 am
15 2021-07-17 headache, fatigue passed out for 20-30 min 2 days after receiving covid vaccine; headache; fatigue; This is a spontane... Read more
passed out for 20-30 min 2 days after receiving covid vaccine; headache; fatigue; This is a spontaneous report from a contactable nurse. A 15-year-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0180), via an intramuscular route administration on 18Jun2021 (at the age of 15years) in right arm as DOSE 1, SINGLE for covid-19 immunization. Vaccine was administered at pharmacy or drug store. No medical history was reported. Patient had no known allergies. Concomitant medications included celecoxib (CELEXA) used for an unspecified indication. Patient was not diagnosed with COVID-19 prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID. Patient did not receive other vaccine within 4 weeks prior to the COVID vaccine. On 20Jun2021, the patient passed out for 20-30 min 2 days after receiving COVID vaccine and had headache and fatigue. Patient visited Doctor or other healthcare professional office/clinic visit/emergency room/department or urgent care. The patient had not taken any treatment for reported events. The outcome of the events was recovering.; Sender's Comments: Based on the information currently available,The casual association between the reported events and suspected vaccine BNT162B2 cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
15 2021-07-17 fever lost her hearing briefly for few minute this morning; Blurry vision; Fever; Nauseous/ she was sick t... Read more
lost her hearing briefly for few minute this morning; Blurry vision; Fever; Nauseous/ she was sick to her stomach and she was afraid she would throw up; This is a spontaneous report from a contactable consumer. This consumer reported for a 15-year-old female patient (reporter's daughter) And This is the first case of 2 split cases. A 15-year-old female adolescent patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER8729, Expiration date: 31July2021), via unspecified route, administered in right arm on 26Jun2021 09:30 am(at the age of 15-year-old) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 26Jun2021, after the vaccination in the night, the patient experienced Fever, Nauseous, she was sick to her stomach and she was afraid she would throw up. And on 27Jun2021 the patient experienced Blurry vision, lost her hearing briefly for few minutes this morning, no treatment options were used. Reported said that this is kind of a different side effect, she did read that someone had blurred vision, but she said she also lost her hearing. The event deafness assessed the as serious. The outcome of the events blurred vision was unknown, pyrexia and nausea are not recovered and deafness is recovered in 2021. No follow-up attempts possible. No further information expected.
15 2021-07-18 throat irritation impending doom, dizzy, nausea, chest pressure, itchy throat
15 2021-07-19 body temperature increased, malaise, headache At 4 hours ? headache, weakness, malaise, nausea She received 1st CoVid vaccine 7/9. She was ill wit... Read more
At 4 hours ? headache, weakness, malaise, nausea She received 1st CoVid vaccine 7/9. She was ill within 4 hours, peaked with 102.5 fever at 12 hours and was bedridden through Day 3 post vaccination. She has gained back some of her strength, but the nausea has remained and so severe that she is barely able to function or sleep at night. Three nights now she has not slept until 2 or 3 in the morning because nausea is at level 9 along with migraine and many hot flashes. She is vomiting 1x day. Through Day 8 post vaccine. Days 9 -12 no vomiting but continues to be bed ridden with severe debilitating nausea, migraine, weakness and multiple hot flashes.
15 2021-07-19 fatigue Patient started a heavy menstrual period the day after her 2nd dose of pfizer vaccine (she had alrea... Read more
Patient started a heavy menstrual period the day after her 2nd dose of pfizer vaccine (she had already had her regular period 6/10/21-6/16/21). The bleeding was very heavy (changing overnight pads every 1.5 hours) and caused patient to become pale, dizzy,- fatigue, nausea, and hard to concentrate. Sent for CBCs which showed drop in hemoglobin. Bleeding stopped 6/29 and restarted briefly on 7/3. Patient started on iron supplementation and recovered otherwise once bleeding stopped by 7/7.
15 2021-07-20 sweating Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: A... Read more
Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Medium
15 2021-07-20 fever platelet level at 9; fever up to 105F; This is a spontaneous report from a contactable consumer (pat... Read more
platelet level at 9; fever up to 105F; This is a spontaneous report from a contactable consumer (patient). A 15-year-old female patient received the second dose of bnt162b2 (BNT162B, Solution for injection, Lot Number: EW01872), via an unspecified route of administration, administered in Arm Left on 16Jun2021 (at the age of 15-years-old) as DOSE 2, SINGLE for COVID-19 immunisation. The patient had no relevant medical history or concomitant medications to report. There were no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. The patient was not pregnant at the time of vaccination and adverse events. The patient previously received the first dose of bnt162b2 (BNT162B, Lot Number: EW0187), via an unspecified route of administration, administered in Arm Left on 26May2021 (at the age of 15-years-old) as DOSE 1, SINGLE for COVID-19 immunisation. On 21Jun2021, the patient had fever up to 105F the day after 2nd dose of vaccine, which was managed and went away. She was scheduled for annual physical on 21Jun2021 and the doctor (withheld) ran a routine blood work. The resullts came back with platelet level at 9. the test was repeated the next day (22Jun2021) a few times, but the results came with numbers ranging at 6-7. She was admitted to (hospital name withheld) where she received steroid and IVig infusion. The adverse events resulted into Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient was not diagnosed with COVID-19 before vaccination and was not tested for COVID-19 post vaccination. Outcome of the event platelet level at 9 was not recovered, while fever up to 105F recovered on an unspecified date.
15 2021-07-22 fatigue, lethargy Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Letha... Read more
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Shakiness-Medium, Systemic: Weakness-Medium, Additional Details: 5 minutes after 1st covid vaccine, patient became lightheaded, pale and fainted. While unconcious, patient was shaking (not sure if it was a seizure or due to fainting) for about 1 minute. We called 911 and patient regained consiousness shortly after. She was confused and was weak. EMS arrived and took vitals but all vitals were within normal range. EMS thinks patient had a vaso-vagal response and cleared patient to leave. After 20 minutes, patient said she felt okay and left the building.
15 2021-07-24 dehydration After the vaccination, patient proceeded to sit on the chair. After about few minutes, patient faint... Read more
After the vaccination, patient proceeded to sit on the chair. After about few minutes, patient fainted. Patient eventually recovered after about 10 minutes. Upon my questioning afterward, before receiving the vaccine, patient felt dehydrated.
15 2021-07-24 sweating Visions went completely white. Ringing in ears. Clammy sweaty skin. Partially incoherent for 5-10 se... Read more
Visions went completely white. Ringing in ears. Clammy sweaty skin. Partially incoherent for 5-10 seconds.
15 2021-07-24 throat pain The symptoms happened after a few days my throat started to hurt a lot & I still have the throat pai... Read more
The symptoms happened after a few days my throat started to hurt a lot & I still have the throat pain as I keep continuing typing this & my throat pains gets worse at night, it?s hard to pass down saliva, eat, drinking or even talking. I feel like there?s a rock inside my throat.
15 2021-07-25 cough, throat pain continues cough, heavy body pain ,shortness of breath, dizziness, low blood pressure, high heart rat... Read more
continues cough, heavy body pain ,shortness of breath, dizziness, low blood pressure, high heart rate, pain full boils on body, sore throat,
15 2021-07-25 dehydration Mother called clinic to report two days after receiving Covid-19 vaccine pt. experienced syncope dur... Read more
Mother called clinic to report two days after receiving Covid-19 vaccine pt. experienced syncope during a sports practice. Mother reports pt was taken to hospital where she was given IV fluids for "severe dehydration".
15 2021-07-25 sweating Patient received vaccine at (13:22) directly afterwards, patient states "I feel hot, my eyes are tur... Read more
Patient received vaccine at (13:22) directly afterwards, patient states "I feel hot, my eyes are turning black, I cannot see." "I am sweating bad." Patient was noted to be pale and offered wheel chair. Patient was taken to private room and assisted to lie down at (13:30). Patient continued to be oriented (BP - 118/40) HR-76 / O2 -97. Patient complains of dizziness and black spots in vision. Continued to monitor. Cool rag applied to forehead (1:34 PM - BP -123/69 HR - 75 / O2-98) (1:36) (13:37) Patient assisted to sitting position. BP -114/59 Voiced feeling better. (13:40 PM) BP - 120 /75 / (13:40 - stood patient up and assisted to chair. Patient was normal and fine while sitting in chair. (13:50) Patient was clammy, stated she felt as though she would pass out. BP - 119/27 / HR - 89 O2 98 / assisted to lie down, continued to complain of dizziness. Clammy, (13:59) EMS called / BP -115/92 - HR -76. Ambulance arrived at (14:05). Before transfer of care BP - 125/71 - HR 107 / O2- 98
15 2021-07-26 headache 7-19-2021, five hours after receiving the vaccine, her mother states she developed a "severe headach... Read more
7-19-2021, five hours after receiving the vaccine, her mother states she developed a "severe headache" and vomited. 7-20-2021, in the afternoon, mother states patient became dizzy, passed out, hitting chin on concrete floor and became unconscious. Mother drove patient to ER, mother states that it took 20-30 mins before she regained consciousness. Patient was released from ER and followed up with PCP the next day.
15 2021-07-26 fever, chills, paranasal sinus discomfort, headache She started with a fever 102, chills, headache, body pain. As of today she still exp sinus pressure... Read more
She started with a fever 102, chills, headache, body pain. As of today she still exp sinus pressure, ear pain both sides (side going down gland to neck), headache and body pain. She was taken to the doctor informed to give Tylenol and Ibuprofen.
15 2021-07-27 chills, fever My child experienced dizziness and fainted within 24 hours of receiving the covid19 vaccine. That n... Read more
My child experienced dizziness and fainted within 24 hours of receiving the covid19 vaccine. That night, she experienced chills, fever and muscle aches. By the following morning (about 36 hours post vaccine), she was back to normal. No problems since then.
15 2021-07-27 headache Headaches and nausea 30 minutes after injection. Next day numbness sensation on hands and anxiety. ... Read more
Headaches and nausea 30 minutes after injection. Next day numbness sensation on hands and anxiety. Patient evaluated in the ER department. Ondansetron given for nausea. Patient recovered without complication afterwards.
15 2021-07-28 headache pt waited full observation period then left with parent. after about 15 minutes mom brought pt back... Read more
pt waited full observation period then left with parent. after about 15 minutes mom brought pt back, complained of headache, nausea, and dizziness. escorted patient to er for treatment.
15 2021-07-28 sweating Patient sitting for prescribed observation time. I noticed her blinking rapidly and stepped out to ... Read more
Patient sitting for prescribed observation time. I noticed her blinking rapidly and stepped out to ask if she was ok, she stated her vision was blurred and then proceeded to have what appeared to be a very brief seizure (5-10 seconds in length) then passed out briefly (10-15 seconds) when she came to she seemed completely normal again. We had her lie down on the bench and she drank some water, she was sweating more than normal. After 30 minutes or so she sat up for 5 minutes or so then stood and walked with mom out of store. Mom called pediatrician to see if they could have her seen.
15 2021-07-28 fever Fever followed by Genital aphthous ulcers of the vulva