Pfizer

Flu-like symptom reports

Female, 16 - 25 years

Age Reported Symptoms Notes
16 2021-01-07 headache Patient in clinic for chief complaint of possible side effect of the covid vaccine which she receive... Read more
Patient in clinic for chief complaint of possible side effect of the covid vaccine which she received yesterday. She states that she woke up at 0200 with chest tightness, achyness and headache. She rates the discomfort 7/10 last night and improved now to 5/10. She denies any worsening with any type of exertion and states that she can do simple things like take a shower, walk across the room, down the street or even stairs without any worsening. She denies any SOB or chest pain--just feels tight. Doesn't feel like she can't get a full breath or get the air out of her lungs either. She received her first of two doses of the Pfizer vaccine yesterday (4:23pm) and had no difficulty with the injection itself and then 9.5 hours later woke up from sleep with this chest tightness as well as achyness and headache.  She states that she had the exact same symptoms when she had positive covid test back in August of this year with the addition of fatigue which lasted for 5 days. At that time it was not felt necessary to do any further testing nor treat with steroids according to cardiology. She does have history of LV non-compaction cardiomyopathy and her last visit with cardiology was about 2 years ago and she had a normal EKG and echo only showed "mild LV non compaction at the apex" at that time. He did not need to see her again until she is 18 unless she has problems. She states that she generally does very well and other than this tightness she does not have any other significant symptoms.
16 2021-01-11 fatigue, headache C/O Tiredness, and Headache
16 2021-01-17 runny nose Runny and itchy nose, lasting for about a day.
16 2021-02-07 fatigue Shortness of breath, fatigue, tachycardia - persisting since vaccination
16 2021-02-10 fatigue Congestion, breathing abnormal, elevated heartrate , 02 lower then usual , tired , exhausted, fat... Read more
Congestion, breathing abnormal, elevated heartrate , 02 lower then usual , tired , exhausted, fatigue, not usual self , fussy , incosebale. Patient is a non verbal child
16 2021-02-17 headache Monday, Feb 15- Mild Headache, Feb 16 - mild body ache, Feb 17 - symptoms resolved
16 2021-02-18 headache, malaise, sweating Went to sit down and passed out; felt dizzy; nausious/nausia; sweaty; sick feeling; as she was ghost... Read more
Went to sit down and passed out; felt dizzy; nausious/nausia; sweaty; sick feeling; as she was ghost white; bad headache.; This is a spontaneous report from a contactable other Health Professional reported for herself. A 16-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318) via intramuscular on left arm on 02Feb2021 03:45 PM, at age of 16 years old at single dose for Covid-19 immunization. Patient was not pregnant at the time of vaccination. Medical history reported as allergies to medications, food, or other products was reported as none known. Prior to vaccination, patient was not diagnosed with COVID-19. Other medications the patient received within 2 weeks of vaccination included multivitamin and melatonin gummies. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via intramuscular at left arm on 12Jan2021 03:45 PM for Covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported morning after vaccine 03Feb2021 08:00 patient was felt dizzy and nausious. Told her mom and her mom ran over as she was ghost white. Went to sit down and passed out. Patient experienced sweaty, nausia, sick feeling and bad headache. Patient went to the emergency room (ER), they gave fluids and blood work. No heart issues noted. Felt better around 3 hours after. Headache was bad and continued on 05Feb2021 (reported today). Also, still feel nausious and had to lay down. All events occurred on 03Feb2021 08:00 AM. Patient was recovering. It was reported the adverse event result in emergency room/department or urgent care. The seriousness criteria were reported as not serious, no results in death, no life threatening, no caused/prolonged hospitalization, no disabling/incapacitating, no congenital anomaly/birth defect. Patient was received treatment for the adverse event included fluids and heart monitoring. The patient underwent lab tests and procedures which included blood work in Feb2021. Since the vaccination, patient had not been tested for COVID-19. Outcome of events bad headache and nauseous was not recovered, for felt dizzy, as she was ghost white, passed out, sweaty, sick feeling was recovering.; Sender's Comments: Based on the information provided and plausible temporal association, a contributory of the suspect drug to the reported events cannot be completely excluded. Case will be reassessed when additional information is available. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
16 2021-02-20 fever, headache, fatigue 10 hours post injection - fatigue 12 hours fever - 100° Held for 48 hours Fatigue, aches, headache ... Read more
10 hours post injection - fatigue 12 hours fever - 100° Held for 48 hours Fatigue, aches, headache for 72 hours Lymph node on injection arm swollen and painful 72 hours later
16 2021-02-24 headache, chills 1. 48 hours after the first vaccine dose, she developed a raised, red, bump ~4-5cm area on her back ... Read more
1. 48 hours after the first vaccine dose, she developed a raised, red, bump ~4-5cm area on her back with irregular borders. It was slightly itchy but not painful. 2. The area on her back worsened over the next 2-3 weeks and developed dark black scabs. 3. 24 hours after the second vaccine dose (which was given on 2/20/21), she developed scattered lesions on her neck, hairline, ear, face ? some with blisters, some with scabbed tops. Again slightly itchy but not painful. She also had a transient headache and chills that resolved on their own that same day.
16 2021-02-25 chills, throat pain, fatigue, headache The child was administered the vaccine at about 11:15 a.m on 2/7/2021. She woke up about 14 hours la... Read more
The child was administered the vaccine at about 11:15 a.m on 2/7/2021. She woke up about 14 hours later with vaccine side effects the family was prepared for, including headache, chills, nausea, vomiting and fatigue. This all resolved within 48 hours. Approximately one week later, the child woke up again in the night with severe chills in the middle of the night. It was a sudden onset following a week of feeling well. She had to sit in a warm/hot shower for an hour to get warm. She described it as "freezing to death." She has never experienced anything like this before.
16 2021-02-28 throat irritation Swelling in lips and burning in throat.
16 2021-03-03 fatigue, sweating My daughter became very dizzy, pale, and hot (sweating through her clothing) almost passing out aft... Read more
My daughter became very dizzy, pale, and hot (sweating through her clothing) almost passing out after receiving her first dose . Paramedics were called, vitals taken, and she was taken to an observation area. She started to feel a bit better after about 15 minutes. She was observed by paramedics and a nurse for another 30 mins and we were able to leave and go home. At home she was exhausted the remainder of the night.
16 2021-03-16 headache Patient mother reported patient began to shake and she was unable to speak or respond. Upon observat... Read more
Patient mother reported patient began to shake and she was unable to speak or respond. Upon observation patient was pale, awake, and clammy, responding appropriately . Pulse ox placed on patient O2 sats 98-100, pulse 57, BP 87/45. Patient oriented to person, place, and time. Patient reported feeling weak, complains of headache and neck hurting. Patient reported tingling in her left hand and reported her tongue was tingling. . At this time ambulance was called to transport the patient to the ED.
16 2021-03-18 malaise Patient is a 16 y.o. female who received the Pfizer-BioNtech Covid-19 Vaccine, mRNA, BNT162b2 (PF) 3... Read more
Patient is a 16 y.o. female who received the Pfizer-BioNtech Covid-19 Vaccine, mRNA, BNT162b2 (PF) 30 mcg/0.3 mL IM Susp, Lot ER2613 on 3/19/2021. The patient experienced the following reaction(s) during the immediate of observation: Patient received vaccine at 4:21pm and proceeded to recovery area where she verbalized to her mother that "I don't feel good." 4:23pm Patient had a witnessed syncopal episode and fell to the ground where she was attended to. Patient was treated/managed as follows: 4:25pm VS BP 118/88, HR 57, RR 18, O2 sat 98% on room air. Patient alert and verbal. 4:35pm: VS BP 144/80, HR 85, RR 18, O2 sat 97% on room air. Patient alert and oriented. Denies shortness of breath, difficulty breathing, or pain. Patient given educational material regarding vaccine and advised to continue to self-monitor per the CDC guidance. 4:37pm Paramedics arrived and care assumed by paramedics at this time. Patient mother present.
16 2021-03-21 chills, fatigue, fever Fever, chills, extreme fatigue, lightheadedness and very sore arm, but more importantly chest tightn... Read more
Fever, chills, extreme fatigue, lightheadedness and very sore arm, but more importantly chest tightness that became increasingly worse over 48 hours. My daughter dealt with the other symptoms but her asthma became less treatable over the two days since the second shot. I finally administered the nebulizer and inhaled steroid today after all other treatments failed to relieve her symptoms. She is doing better but I will follow up with the pediatrician.
16 2021-03-23 chills, headache headache, dizziness, weak, chills
16 2021-03-23 chills Patient briefly lost consciousness immediately following vaccine administration. Had shaking, chill... Read more
Patient briefly lost consciousness immediately following vaccine administration. Had shaking, chills, flushed and nausea. Pt had not eaten at all today. Administered oral water, snacks. VS within normal limits. Discharged with mother after 40 min of monitoring.
16 2021-03-26 sweating patient started sweating and feeling dizzy after the shot. she sat down for a while and recovered af... Read more
patient started sweating and feeling dizzy after the shot. she sat down for a while and recovered after sometime. Paramedics were called. they examined her vitals and everything was ok
16 2021-03-28 headache, throat irritation Approximately 15 minutes following vaccination, the patient complained of headache, dizziness, chest... Read more
Approximately 15 minutes following vaccination, the patient complained of headache, dizziness, chest pain and throat burning. I asked that she wait an additional 15 minutes so that we could monitor her. Approximately 30 minutes after vaccination, patient appeared to experience syncope or absence seizure (prev. history). we called 911 and paramedics transported her to hospital
16 2021-03-29 headache Within 30 minutes after the shot, my daughter had a headache and sore arm. Other than that she was ... Read more
Within 30 minutes after the shot, my daughter had a headache and sore arm. Other than that she was fine until midnight on Monday morning when her tremors increased and spread up from her legs to her torso and arms. The tremors persisted all day Monday even through her cranio-sacral therapy at Medical Center. Her therapist tried to calm down the tremors through frequency specific micro current with no success. Her therapist could tell that her whole system was in "overdrive" which was vastly different than her previous session a week ago. The tremors were so bad that my daughter wanted her wheel chair again. I took a video of her tremors after her therapy session. Her therapist told us to contact her DO, Dr. about it. I did. She was able to crash around 10pm on Monday. On Tuesday, when she woke up around 2:30pm, she still had the tremors but they weren't as severe. We had a telehealth appt with her sleep neurologist, Dr. at 3pm and showed her the video but she doesn't recall ever seeing her tremors in the past. When I spoke to Dr., I shared the video and she was going to discuss it with the therapist as they know each other. My daughter's tremors have never been this bad. She had one major tremor episode in her legs only over 2 years ago which we attributed to her meds at the time; but again, not this bad ever.
16 2021-04-01 fatigue Pain in injection area, sharp pain in underarm area, shortness of breath, chest pain, rapid heart pa... Read more
Pain in injection area, sharp pain in underarm area, shortness of breath, chest pain, rapid heart palpitations, dizziness, tiredness,
16 2021-04-01 headache, fatigue, chills, fever Experienced extreme onset of symptoms 12 hours after the 2nd dose w/ intense headache, severe leg pa... Read more
Experienced extreme onset of symptoms 12 hours after the 2nd dose w/ intense headache, severe leg pain, painful chills, fever and extreme fatigue and arm weakness in both arms, lasting approximately 12 hours and then subsiding for 12 hours for 4 days - extreme symptoms for 12 hours and then subsides - severity of the symptoms remains the same and doesn't lessen w/ each 12 hour episode. The leg pain is severe. Alternating Tylenol and Ibuprofen provides minimal relief and doesn't break the fever.
16 2021-04-01 headache On Tuesday late morning, she texted from school - that her heart was racing. shaking, headache, tum... Read more
On Tuesday late morning, she texted from school - that her heart was racing. shaking, headache, tummy ache. We brought her home from school. These symptoms - especially the severe headache, nausea, dizziness lasted for 3 days. She missed school as she stayed in bed.
16 2021-04-01 headache Immediate intense headache. Feeling faint. Lay down on floor, semi conscious. Ems staff moved her to... Read more
Immediate intense headache. Feeling faint. Lay down on floor, semi conscious. Ems staff moved her to sitting position where she completed blacked out. They struggled to hold her, so they lay her on the floor where she had convulsions similar to a seizure. Completely unconscious at this point.
16 2021-04-04 sweating, malaise Patient received her vaccination and stated that she was feeling lightheaded. Patient was cool and c... Read more
Patient received her vaccination and stated that she was feeling lightheaded. Patient was cool and clammy, sweating and stated she didnt feel good. EMS notified and hooked up to monitors. IV line was started and patient was transported to the hospital. Patients mother and sister were on site.
16 2021-04-05 body temperature increased Severe hives on arms, legs, and torso. Elevated temperature of between 99-100 F. Began at 11:00pm on... Read more
Severe hives on arms, legs, and torso. Elevated temperature of between 99-100 F. Began at 11:00pm on Apr 5, 2021, about 12 hours after vaccination. Hives severity continues to increase on Apr 6, 2021 as of about 24 hours after vaccination. Has not yet recovered. Monitoring.
16 2021-04-06 fatigue Feeling faint, extreme fatigue, vomiting without nausea (no warning)--foul/sour. Kept complaining th... Read more
Feeling faint, extreme fatigue, vomiting without nausea (no warning)--foul/sour. Kept complaining that she felt like she was crawling in her own skin, all through her arms and her chest, like an itch from the inside. NO HIVES. No difficulty breathing. Kept her home from school and she slept a lot. Only vomited the one time. She was fine by late afternoon and all symptoms seemed to have resolved by then.
16 2021-04-06 sweating Patient presented for her first COVID-19 vaccine. Approximately a minute after vaccine was given, sh... Read more
Patient presented for her first COVID-19 vaccine. Approximately a minute after vaccine was given, she was noted to be seated upright in the passenger seat of her car, with head bent forward and eyes open. She was unresponsive, stiff posture, and was placed into a reclined position. She then had some posturing with head turned to the left, no eye deviation or nystagmus, no tonic-clonic movement. Radial pulse was thready, bradycardia was noted, with normal respirations. She was noted to become diaphoretic and pale/ashen color noted to the face and arms. She became responsive within a few minutes, however initially was not able to answer questions clearly. She had no loss of bowel or bladder function. EMS assisted with evaluation. Initial blood pressure 78/31, HR 54, SpO2 100%. EMS then transferred her to the stretcher and she was transitioned from her car to the ambulance. She continued to improve spontaneously with BP 94/61 then 103/60 and HR 86 then 74. SpO2 remained stable at 100%. Skin color improved. She had normal responses to questions, no complaints of headache, dizziness, chest tightness, shortness of breath, numbness or tingling. She had some shaking/voluntary movement of the limbs and body noted, but she could control and stop this voluntarily, no myoclonic or tonic-clonic jerking noted. After syncopal event occurred, mom reported that the patient has a history of syncope routinely with blood draws and vaccines in the past, however this episode was slightly more prolonged and seizure-like activity was different. She has had some jerking movement previously with syncope which lasts 20-30 seconds, different from today's response. No known history of seizure disorder.
16 2021-04-06 sweating 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: Shakiness-Medium, Systemic: Tachycardia-Mild
16 2021-04-07 headache Upset stomach, headache, vomit,
16 2021-04-08 chills, headache Within a few hours of vaccine she began to have a very sore arm and headache. Around 1:00 A.M. on 0... Read more
Within a few hours of vaccine she began to have a very sore arm and headache. Around 1:00 A.M. on 04/09/2021 she began having chills and joint pain, but no fever as the headache continues. The event that concerns us was she began to have tingling in her fingertips both hands. This has been going on since 1:00 A.M. Her NP was notified and they said to watch it over the next few days and report to CDC/ FDA. Patient had Covid December 24, 2020. We waited the 90 days to get vaccinated and had clearance from her doctors.
16 2021-04-08 sweating Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mil... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Additional Details: 2 minutes post vaccine, pt complained of feeling hot and was unable to see. pt was feeling dizzy and faint. nurse had pt lay down at vaccination site, legs levated. bp 112/63, hr 67, regular and lungs clear and no difficulty breathing. @1449: 116/63, hr 67, 1453: gatorade and water intake, bp 111/69, hr 61. @1459 up in chair, no complaints from pt, sx has resolved. bp 116/72, hr 72. @1504 121/79, hr: 70. pt states feeling well and refused any er tx. pt wants to go home.
16 2021-04-08 sweating Pt syncopal episode post vaccination likely due to vaso vagal response. Diaphoretic and unresponsive... Read more
Pt syncopal episode post vaccination likely due to vaso vagal response. Diaphoretic and unresponsive slumped over at chair. Quickly regained consiousness was alert and oriented NAD, Given water allowed to lay down. Feeling much better. Discharged POV in NAD with father. Diaphoretic and unresponsive slumped over at chair Quickly regained consiousness was alert and oriented NAD
16 2021-04-08 fever, chills, headache Muscle and joint pain - 9:30pm 04/06/2021 - 6pm 04/7/2021 Headache - 9:30pm 04/06/2021 - 10am 04/9/2... Read more
Muscle and joint pain - 9:30pm 04/06/2021 - 6pm 04/7/2021 Headache - 9:30pm 04/06/2021 - 10am 04/9/2021 Chills - 3:30am 04/07/2021 - 6:00 am 04/7/2021 Fever - 3:30 am 04/07/2021 - 12pm 04/7/2021 Nausea - 9:30pm 04/06/2021 - 3pm 04/8/2021 Vomiting - one instance 7:30am 04/07/2021
16 2021-04-08 fever, fatigue By 4:30 started having chest pains and could not take deep breaths, by 7:00 she was running a high f... Read more
By 4:30 started having chest pains and could not take deep breaths, by 7:00 she was running a high fever of 102, body aches and extreme fatigue. She had a fever all day on 8th and experienced severe fatigue. She is still weak, having body aches and a low grade fever on Friday the 9th. Her chest pains stopped on Thursday.
16 2021-04-09 sweating Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Swe... Read more
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Systemic: Visual Changes/Disturbances-Mild, Systemic: Vomiting-Mild, Additional Details: Patient started feeling dizzy within 5 minutes after vaccine administration. Patient vomitted once during observation period. Patient also stated feeling ringing in ears and vision darkening right before throwing up. Patient felt better after throwing up. Patient was observed for total 30 minutes.
16 2021-04-10 sweating Immediately following administration of vaccine, patient was still in chair, became pale, diaphoreti... Read more
Immediately following administration of vaccine, patient was still in chair, became pale, diaphoretic, had pre-syncopal episode. Regained consciousness, did not fall. Placed in WC, transported to OBS area, completely alert and talking with parents and staff. Patient consumed gatorade, feels well. Finished 30 min obs period without incident. Left with parents feeling well.
16 2021-04-11 fatigue Pt received her covid vaccine, pt did not wait, was walking around withfather, she felt dizzy and d... Read more
Pt received her covid vaccine, pt did not wait, was walking around withfather, she felt dizzy and dad reported she fell. we did not see her fall. She was sitting on 20 when dad came toget us. Pt felt dizzy, ringing in ear, had her lay down on floor with feet elevated. BP pressure reading were 128/75 hr 70, 130/72, 75, pt now feeling better and sitting 108/76 64 108/76 64 and 118/76 76. Pt father declined ems. Pt waited until she felt normal, drank bottle of water, no longer dizzy, went home. Father instructed on emergency care. Followed up call with father at 5:08pm. Fahter reported she was tired, sometimes sob and advised to take pt to e.r. for evaluation.
16 2021-04-11 headache Within 1 minute of receiving vaccine, patient started to shake and appear to loose consciousness for... Read more
Within 1 minute of receiving vaccine, patient started to shake and appear to loose consciousness for about 30 seconds. She then came to and was disoriented for just a minute then could answer all questions asked of her (name, dob, where are you) She stated she had an intense headache, had trouble hearing but hear a buzzing sound. Mom was in the room as well, we gave her water and sat with her for about 10 minutes and she seemed weak but okay. They remained in the waiting area for another 15 minutes, she was feeling better and mom was comfortable to take her home as Mom is a Doctor.
16 2021-04-11 headache Patient has a history of dizziness, headaches and Tourette's syndrome. Immediate complaints of head... Read more
Patient has a history of dizziness, headaches and Tourette's syndrome. Immediate complaints of headache, nausea, arm tenderness and being dizzy. Patient was laid down, given water and a snack. She was discharged with her parents after 30 min of observation.
16 2021-04-11 sweating pt had first immunization , and within seconds pt felt dizzy, and sweaty. was brought to observatio... Read more
pt had first immunization , and within seconds pt felt dizzy, and sweaty. was brought to observation room #1. via w/c w/ mother . Pt given crackers and water . vs - 5:09 pm 100/74 79-18- pulse ox 100% 5:14 pm vs 127/76-65-18 pulse ox 100% 5;222PM VS 113/72 -76- 16 PULSE OX 99%. PT FEELING BETTER , VSS , PT REEASED TO MOTHER VIA W/C AND TAKEN TO EXIT .
16 2021-04-11 sweating Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unrespo... Read more
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Medium, Systemic: Hypotension-Medium
16 2021-04-11 sweating Systemic: Flushed / Sweating-Medium, Systemic: Seizure-Medium, Additional Details: was laid down, ep... Read more
Systemic: Flushed / Sweating-Medium, Systemic: Seizure-Medium, Additional Details: was laid down, epi given by imer, legs elavated once calmed down, ems called and treated, recovered soon after
16 2021-04-11 sweating Systemic: Flushed / Sweating-Medium, Systemic: Seizure-Medium, Additional Details: was laid down and... Read more
Systemic: Flushed / Sweating-Medium, Systemic: Seizure-Medium, Additional Details: was laid down and legs elavated once calmed down, ems were called and further treated by them
16 2021-04-11 malaise started vomiting the next day. We weren't concerned because this was expected and she recovered with... Read more
started vomiting the next day. We weren't concerned because this was expected and she recovered within two days. She improved the next day but became sick again the day after and every day since. We are now at day 19 and she is still nauseated every day. She vomits periodically about every second or third day. She vomited profusely today on day 19. I am reporting this because the symptoms shouldn't last this long.
16 2021-04-12 fatigue pt became very fatigued and has bouts of confusion. She has episodes where she doesnt know where sh... Read more
pt became very fatigued and has bouts of confusion. She has episodes where she doesnt know where she is or who she is with. She has had one episode that she didnt know who she was that lasted a few seconds. Most episodes last a couple of minutes. Her parents took her to Hospital ER i. They did an EKG and electrolytes- lab work. Test were normal. She was released to FU w/ PCP and Neurologist. She is scheduled to see a Neurologist today 4/13/2021 and is scheduled to have an EEG tomorrow on 4/14/2021. She has an appt to see her PCP on 4/14/2021.
16 2021-04-12 headache Dizziness, bad chest pain, headache
16 2021-04-13 chills, fatigue, headache uncontrollable shivers, chills, tiredness, muscle ache, headache, stomach ache, nauseous
16 2021-04-13 fatigue Patient stated in evaluation form that she had passed out once before after giving blood for labwork... Read more
Patient stated in evaluation form that she had passed out once before after giving blood for labwork. She and her mother decided to continue with the vaccination as it had never occurred before after getting a vaccine. A few minutes after the vaccine the patient lost consciousness. Mom stated that her face tensed up right before hand. The patient remained in her chair for the duration of the event. She regained consciousness about 30 to 60 seconds later, and within a few minutes she was conscious but still very shaky, pale, and hot. She was able to sip some water and we put a cool, wet paper towel on the back of her neck. The patient and her mother remained seated and under observation for an additional 15 to 20 minutes with no further issues, at which point they left the store. I followed up with the patients mother the next day and she said her daughter was exhausted last night, but this morning she woke up feeling well and went to school like normal.
16 2021-04-13 headache Patient received vaccine around 4:30pm. After 10 minutes patient reported that she was having a head... Read more
Patient received vaccine around 4:30pm. After 10 minutes patient reported that she was having a headache, felt like her breathing was a little bit heavy. Patient was brought to exam room with mother present. BP was 150s/100, O2: 99%, HR: 65, RR 20. No distress noted. Patient was slightly anxious, continued to complain about headache. Denied any blurred vision, changes in vision, nausea, vomiting. Around 4:45, patient was asked to lay down for a while to be observed further and to give her time to relax. Patient was given cold wash cloths for forehead. Patient suddenly became more increasing anxious at 4:49, complained of excruciating headache and bilateral arm pain. Oxygen remained at 100%. 911 called at 4:50pm. Paramedics arrived at 4:55pm. Paramedics checked patient's blood sugar: approximately 345. Patient reported last meal around 12:30pm. Patient was crying and continually stating that her head hurt. She was alert throughout the entire process and able to answer questions. Mother elected to have patient sent to ER for further evaluation. Followed up with family on 04/14/2021. Mother reported that patient was held at hospital for 5 hours, was given norco for headache. Diagnosed with panic attack. Mother reports that patient is doing better today.
16 2021-04-13 sweating Approximately 10 minutes after patient was given the vaccine, she reported feeling slight lump in he... Read more
Approximately 10 minutes after patient was given the vaccine, she reported feeling slight lump in her throat. We brought her into the clinic room and sat her down. Never had trouble swallowing and did not have any swelling. Felt hot and bit sweaty and light headed. Reports has felt similar ways in past when had blood drawn. We laid her down and she immediately started feeling better. Mom and sister were with her. Refused ambulance or transfer to physician. They were all comfortable her leaving on her own, after we have observed her for over 45 minutes from vaccine.
16 2021-04-14 chills, headache, fever Chills, moderate fever, headache and body (joint) pain from 6am through 2pm.
16 2021-04-14 fatigue Naeusa, abdominal pain, tiredness, general body aches
16 2021-04-14 headache Admitted to hospital on 4/10 with 2 day history of mydriasis, diplopia with blurry vision, dizziness... Read more
Admitted to hospital on 4/10 with 2 day history of mydriasis, diplopia with blurry vision, dizziness and balance difficulty. Found to have enhancement of 6th and 3rd CNs on MRI. Patient continued to have blurry and double vision during her stay and mild gait instability. She developed mild frontal headache managed with Tylenol. Her exam was remarkable for mydriasis, mild lateral gaze limitation R>L, mild dysmetria, dizziness and unsteady gait without notable ataxia. No papilledema. Her reflexes were 2+ in her BL UE and LEs. Pediatric Neurology and ophthalmology consulted and followed patient. Eye exam remarkable for bilateral cranial nerve 6 palsy but no other element of CN3 palsy and bilateral dilated but unreactive pupils. Patient treated with IVIG 1mg/kg/day x2 days for likely miller fisher syndrome variant of Guillain-Barre.
16 2021-04-14 headache 15 min after vaccine administration, pt experienced frontal headache, diffuse subjective weakness of... Read more
15 min after vaccine administration, pt experienced frontal headache, diffuse subjective weakness of LE, and gait instability. Admitted to medical center for monitoring and workup.
16 2021-04-14 sweating Pain between the breasts on the ribs. Started out as seconds of slight pain the day after shot until... Read more
Pain between the breasts on the ribs. Started out as seconds of slight pain the day after shot until about 9:30pm when the pain became consistent but was a slight pain. I woke up at 2:30am and my chest hurt really badly. It was a constant pain but the amount of pain was back and forth. It hurt more to lay down and if I bent down it was very painful. I stayed up for an hour and a half until the pain went away. When it did I had sweat a lot and was very hot. I then woke up with little discomfort until an hour after I woke up with slight pain. The pain then has gone off and on but not as painful as it was during the night.
16 2021-04-14 sweating Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild
16 2021-04-15 nasal discomfort, fatigue, headache Patient presented to the ER following her first COVID immunization. Symptoms started an hour after t... Read more
Patient presented to the ER following her first COVID immunization. Symptoms started an hour after the vaccine was administered. Stated her heart felt like it was racing, she had increased SOB, headache, was tired, nauseous, and had nasal burning.
16 2021-04-17 chills, fever, fatigue Fever, chills, tiredness
16 2021-04-18 headache, throat irritation, chills sx: dizziness, headache, chills, scratchy throat at 11:45am. started to have rash at 11:55am. BP che... Read more
sx: dizziness, headache, chills, scratchy throat at 11:45am. started to have rash at 11:55am. BP checked q 15 min since sx started with readings of 120/80, 118/80, 110/83 mmHg. patient drank sprite and was given 2 tablets of diphenhydramine 15 mg by mouth. At 12:11PM rash resolved and sx slowly disappearing. Patient left at 12:22PM with little headache.
16 2021-04-18 sweating Syncope, dizziness, flushing/sweating. BPs 92/52, 94/58 (pulse 77), O2 sat 98%.
16 2021-04-18 sweating Patient complained of feeling "dizzy and seeing black" at 1200. Patient assisted to zero gravity cha... Read more
Patient complained of feeling "dizzy and seeing black" at 1200. Patient assisted to zero gravity chair. Vital signs taken at 1200 (Blood Pressure 116/70, heart rate 65, SPO2 99%). Patient appeared diaphoretic. Patient offered water. Vital signs taken at 1210 (Blood pressure 116/74, Heart rate 72, SPO2 99%). Patient stated "I am feeling better." Vital signs taken at 1215 (Blood Pressure 110/64, Heart rate 74). Patient advised to follow up with primary care provider. Patient stated at 1230 that she is "feeling much better." Patient left facility unassisted with a steady gate.
16 2021-04-18 lethargy lethary and altered mental status 2.5 weeks after COVID vaccine. Found to be septic (hypotension, hy... Read more
lethary and altered mental status 2.5 weeks after COVID vaccine. Found to be septic (hypotension, hypothermia, suspected infection). Admitted to ICU. Required 15L vapotherm for respiratory support and several fluid boluses for blood pressure. Urine culture resulted positive for a bacterial infection. Started on antibiotics and improved. Concern for vaccine adverse event is low.
16 2021-04-18 malaise, fatigue No immediate response, approx 4 hours after dose started not feeling well passed out 3 times with 5... Read more
No immediate response, approx 4 hours after dose started not feeling well passed out 3 times with 5 minute time frame, EMS called, became coherent while they were route, continue to improve and vitals were checked and advised to monitor. Currently experiencing dizziness when standing from a seated position consistently with no improvement, also fatigued as well. In touch with Primary Care Physician and am monitoring .
16 2021-04-18 malaise, sweating, chills Day 0 (4/1/21) had mild arm soreness. On day 1 (4/2/21), she had chills and sweats and body aches. ... Read more
Day 0 (4/1/21) had mild arm soreness. On day 1 (4/2/21), she had chills and sweats and body aches. Took Tylenol and improved her symptoms. On day 2 (4/3/21) in the morning she felt well, but later that afternoon she had severe abdominal pain. She had worsening symptoms over the next few hours, with recurrence of sweats, nausea and then vomiting. She had resolution of symptoms after 15 minutes, but recurred about 1-2 hours later with vomiting and abdominal pain. Mom reports her pain was crippling, doubled over and on the floor due to pain. Took to urgent care for evaluation. UA and UPT negative. ED records show abdominal exam was normal except for "increased peristalsis". Treated with Zofran with resolution of vomiting. discharged home. Abdominal pain self-limited and resolved without further intervention within a few hours.
16 2021-04-18 malaise pt informed mom that she was not feeling well. nurse in observation lane witness seizure. pt was u... Read more
pt informed mom that she was not feeling well. nurse in observation lane witness seizure. pt was unconscious for 5-10 seconds. pt vomited as well. bp was 104/54 at 1154a, 107/52 at 11:52a, rest of vitals WNL. Md assessed, observed for additional 30 minutes. pt stated she was feeling well and was driven home by her mom
16 2021-04-19 chills, chills Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Hypertension-Mild, System... Read more
Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Hypertension-Mild, Systemic: Shakiness-Mild, Additional Details: pt complained of dizziness. lied down w/ feet elevated + used ice packs. stated this has not happened before. BP very high on 1 reading (233/108) and decided to call EMS out of precaution. begain shaking after a few minutes of ice packs but stopped after a few minutes of removal. EMS evaluated, sat pt up, and once pt was sitting up began shaking again and they decided to take to hospital to get checked out.
16 2021-04-19 fatigue, lethargy, chills Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy... Read more
Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Medium, Systemic: Seizure-Medium, Systemic: Weakness-Medium, Additional Details: Patient fainted in chair shortly after receving vaccine. She came to within a minute, but body became very rigid and she began to seize throughout her whole body. This lasted less than 30 seconds and she was very pale and lightheaded. Patient decsribed feeling extremely nauseous with chills, slowed breathing and lightheadedness. Moved patient to a new area to elevate feet, stated feeling better but was extremely nauseous and unaware that she had fainted or seized. 911 called per parents request
16 2021-04-19 headache, lethargy, fatigue, sweating Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting /... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Nausea-Mild, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Tinnitus-Mild, Systemic: Visual Changes/Disturbances-Mild, Systemic: Weakness-Mild, Additional Details: Tingling in face and legs
16 2021-04-19 sweating "Administered - 13:50 Adverse event started - 13:55 Patient had flushing/sweating, lightheaded. Pati... Read more
"Administered - 13:50 Adverse event started - 13:55 Patient had flushing/sweating, lightheaded. Patient states did not eat. BP 100/53 (63), HR 60, RR 16, O2 98%. Crackers, water given. Patient stable, released from vaccination site."
16 2021-04-19 sweating The patient passed out completely while sitting after having her 1st covid vaccine. She was alert s... Read more
The patient passed out completely while sitting after having her 1st covid vaccine. She was alert shortly thereafter but had blurry vision and low blood pressure. She said she was very hot and was sweating somewhat. We gave her some water and gradually she started feeling better. In the meantime, we had call 911 and when they evaluated her, they felt it was somewhat of a panic attack since she did have anxiety before getting the vaccine.
16 2021-04-20 chills, fever, headache, fatigue Fever, chills, muscle pain, joint pain, tiredness, headache, injection site pain, injection site red... Read more
Fever, chills, muscle pain, joint pain, tiredness, headache, injection site pain, injection site redness, nausea
16 2021-04-20 headache Pfizer-BiNTech COVID-19 Vaccine EUA: dizziness, that started the morning after the vaccine and stil... Read more
Pfizer-BiNTech COVID-19 Vaccine EUA: dizziness, that started the morning after the vaccine and still lasts for the 2nd day. Nausea on the morning after the vaccine. Headaches off and on.
16 2021-04-20 headache All night so far: Severe headache, body aches, excessive vomiting throughout night, dizziness, almos... Read more
All night so far: Severe headache, body aches, excessive vomiting throughout night, dizziness, almost passing out, confusion, weakness
16 2021-04-20 headache Pain and swelling in both feet and ankles, pain started evening of injection, swelling 2 days later.... Read more
Pain and swelling in both feet and ankles, pain started evening of injection, swelling 2 days later. Still tender/swollen 4 days later. Headache/Nausea on day 2.
16 2021-04-21 fatigue pt started feeling really dizzy and nauseated immediately after taking the vax. she started having ... Read more
pt started feeling really dizzy and nauseated immediately after taking the vax. she started having a seizure and made a growling type of noise and urinated on herself. The nurse at the vax site helped bring her back and was told to take her to a doctor. She was monitored and released from the vax clinic when her BP was 107/76. She was taken to medical center where she saw. She was told she had Syncope due to the stress of the situation of getting the vaccination. She is resting today and seems to have some fatigue.
16 2021-04-21 sweating Sweating, nausea, dizziness. BPs 88/60 (pulse 72), 104/90 (pulse 68). Water given. O2 sats 100%.
16 2021-04-21 fever, chills, headache Time of shot: 3pm Onset of reaction: 9pm Stomach ache and headache Hour later: fever (99.5) and chil... Read more
Time of shot: 3pm Onset of reaction: 9pm Stomach ache and headache Hour later: fever (99.5) and chills Difficulty sleeping Kept her home from school today (4/22/2021)
16 2021-04-21 fever Fever of 100.0 for 6 hrs.
16 2021-04-22 headache, chills, fever Headache/migrane, body aches, low grade fever, chills
16 2021-04-22 headache, fever Patient had fever, headache, body aches on 4/20/2021 by 4/21/2021 she had bloody urine, upon arrivin... Read more
Patient had fever, headache, body aches on 4/20/2021 by 4/21/2021 she had bloody urine, upon arriving in our office on 4/22/2021 she had 3+ blood in her urine analysis.
16 2021-04-22 headache Pt. received her second Pfizer dose at 3pm. By 11:30pm she had significant swelling on both of her e... Read more
Pt. received her second Pfizer dose at 3pm. By 11:30pm she had significant swelling on both of her eyes, mouth, and the start of red splotchy skin on arms and legs. We took her to ER. They gave her 50mg of hydroxizine and sent us home. 5min after leaving the ER at 12:30am on 4/23 she felt a golf ball sized lump in her throat and was having difficulty breathing. We brought her back to the ER. At this time they gave her an ekg, and at around 1:30am gave her an epi pin and an oral steroid. Within 5min of the oral steroid and epi pin she no longer had difficulty in breathing and the lump in her throat was gone as was the res splotches. By 5am the swelling in her face had reduced drastically to 90% normal in her left eye and 70% normal in her right eye and 70% normal in her lip. She was released from the ER at 5:45am and went home to sleep. At 11:30am on 4/23 her swelling in her face remains the same and she is complaining of a headache. She was given 50mg more of hydroxizine.
16 2021-04-22 sweating 16 y.o. female who received the Pfizer-BioNtech COVID-19 Vaccine, mRNA, BNT162b2 (PF) 30 mcg/0.3 mL ... Read more
16 y.o. female who received the Pfizer-BioNtech COVID-19 Vaccine, mRNA, BNT162b2 (PF) 30 mcg/0.3 mL IM Susp, Lot EW0158 on 4/23/2021.The patient experienced the following reaction(s) during the immediate of observation: Tinglings, blurry vision, diaphoretic. Patient was treated/managed as follows: Pt brought to treatment area to lay down on mat with legs elevated. VS: 4:15 pm BP: 100/80 R: 18 HR: 58 O2: 98% Pt reports feeling much better after laying down. 4:30 VS: BP: 105/78 HR:60 O2: 99% Patient given educational material regarding vaccine and advised to continue to self-monitor per the CDC guidance. Pt escorted to car with mom by nurse.
16 2021-04-22 fever, fatigue, headache, chills Low fever, chills, vomiting, disoriented, bad headache, adversion to light and sound, weakness, tire... Read more
Low fever, chills, vomiting, disoriented, bad headache, adversion to light and sound, weakness, tired
16 2021-04-22 fever, headache, throat pain Fever, headache, sores in the throat, serious difficulty swallowing
16 2021-04-22 fever, throat irritation My daughter was given her 2nd COVID shot at approximately 9:00am on 4-16-2021. We waited 30 minutes ... Read more
My daughter was given her 2nd COVID shot at approximately 9:00am on 4-16-2021. We waited 30 minutes after the shot. No issues. That evening at approximately 6:00pm, she had a red rash on her upper chest and throat. She stated that she was having a hard time breathing and swallowing. I gave her a Benadryl tablet and watched her for approximately 15-20 minutes. she continued to feel tightness in her throat and said it burned when she swallowed. She confirmed again that she felt her throat was swelling. I drove her to the closest ER located at. My daughter was seen and it was determined that she was having an allergic reaction. DR recommended continue Benadryl tab every 4 hours for the next 12-24- hours. We were discharged to home. I administered another does of Benadryl at approximately 10:15pm. My daughter went to sleep. I woke her up at 3:00am to check on her and she stated she did not have a rash and her throat was fine. She was running a low grade fever of 100.5. I gave her 500 mg of Tylenol for the fever. When my daughter woke later that morning at approximately 8:30am, she still did not have a rash or throat swelling. Her fever was gone.
16 2021-04-23 chills, fatigue, headache, fever Patient developed fatigue and headache within 24 hrs of receiving 1st vaccine, over the next several... Read more
Patient developed fatigue and headache within 24 hrs of receiving 1st vaccine, over the next several days she developed periorbital edema and cervical LAD. 6 days after vaccine she developed fever and chills and was febrile to 103. She went to the ER and labs revealed pancytopenia. She was admitted on the evening of 4/20 and was observed for 36 hrs. Symptoms improved without antibiotics
16 2021-04-24 headache, sleepiness I got the shot at around 4 in the afternoon and after sitting in the waiting area for around 15 minu... Read more
I got the shot at around 4 in the afternoon and after sitting in the waiting area for around 15 minutes I was allowed to leave. When I left I only had a slight headache, but nothing that seemed very noticeable. I felt a tad woozy but it was nothing serious so I went on with my day and went to my sports practice for an hour and a half. After I got home and had eaten, I was working and started to feel the effects. It started with an increasingly worse headache at around 9 and as the night went on it got worse and I constantly needed to lie down. My arm had started to feel sore but it was nothing much. I thought I could sleep it off but woke up feeling horrible. My stomach could not hold any food down and my headache had become really bad. I had to go to my sports game but on the car ride over (around 45 min) I got very nauseous. Throughout the course of the day my headache would get worse any time I tried to run and all I wanted to do was lie down and sleep. I was barely able to stand, let alone run and I felt sleepy all day. My arm had also gotten very sore and any contact on it made me flinch back. I was not able to eat or drink anything until about 4 in the afternoon and my stomach was not sitting right the entire time and I constantly was burping and feeling like I was going to vomit despite having only water in my stomach. After I was able to eat the stomach ache went away a bit but the headache lasted through the night and has finally started to subside two days later.
16 2021-04-24 sweating, chills Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic:... Read more
Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild
16 2021-04-24 sweating Syncope, flushing/sweating, vitals wnl. Given apple juice, graham crackers.
16 2021-04-25 headache, fatigue, fever Intense headache for 2 days 102 degree fever for 2 days light sensitivity for 2 days fatigue, nausea... Read more
Intense headache for 2 days 102 degree fever for 2 days light sensitivity for 2 days fatigue, nausea, and body aches for 2 days treatment: 500 mg acetaminophen every 6 hours while headache lasted, cold washcloth on forehead and eyes, lots of sleep and water
16 2021-04-25 headache, fatigue Friday : soreness at injection site,3 hours later severe migraines; fatigue Saturday - severe migrai... Read more
Friday : soreness at injection site,3 hours later severe migraines; fatigue Saturday - severe migraines, fatigue Sunday,- -Vomiting, severe migraines, joint aches Monday - awoke with swollen face - centered around eyes and cheeks area, achy headaches, fatigue - went to ER and received Steroid shot.
16 2021-04-25 throat irritation Pt received her first dose of Pfizer vaccine and at 1148 started to c/o tongue and throat "beginning... Read more
Pt received her first dose of Pfizer vaccine and at 1148 started to c/o tongue and throat "beginning to swell". Pt states hx of the same with penicillan. Pt is with mother. Pt was given 25mg Benedryl PO at 1200. EMTs called to evaluate Pt and released by medics home with mom. VS per medics at 1215 BP 114/68 HR 70 RR 16 O2 sat 98% RA
16 2021-04-26 fatigue First experienced heart racing, fatigue, dizziness and heaviness in your legs followed by hives that... Read more
First experienced heart racing, fatigue, dizziness and heaviness in your legs followed by hives that moved throughout the body including face, hairline, ears, legs, arms for the next 2.5 days.
16 2021-04-26 headache, fatigue Headache about a week, but decreasing during that week, tiredness for about 3-4 days, soreness at in... Read more
Headache about a week, but decreasing during that week, tiredness for about 3-4 days, soreness at injection site about 1-2 days, general itchiness most prominent between 2 - 5 days after, still there but I think that is due to the fact that I scratched it when it was most prominent.
16 2021-04-26 headache Tightness in chest, extreme nausea, dizziness, headache, shortness of breath. After receiving the va... Read more
Tightness in chest, extreme nausea, dizziness, headache, shortness of breath. After receiving the vaccine I had these symptoms for the rest of the day, as of this writing I am still feeling mostly nausea and the tightness in my chest has died down.
16 2021-04-26 sweating Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Additional Details: Patient has been fa... Read more
Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Additional Details: Patient has been fasting and did not mention to immunizer that she passed out twice today because she is not eating anything only water. Paramedics came and check on her and patient was stable and recovered at the time.
16 2021-04-26 fever, chills Fever, chills, severe body aches
16 2021-04-28 dehydration Within 2-minutes of vaccination, the patient experienced a syncopal episode. EMS evaluated the patie... Read more
Within 2-minutes of vaccination, the patient experienced a syncopal episode. EMS evaluated the patient on-site. The patient was hypotensive (84/44) with a FSBG of 59mg/dL. EMS administered 15g PO Glucose. IV access was attempted but not obtained. Upon re-evaluation, the patient was hypertensive (147/116) and tachycardic (117bpm). EMS transported the patient to Hospital Emergency Department. In the ED, the patient stated they became dizzy and passed out after vaccination. The patient noted that they did not eat anything all day. The patient was hypotensive (99/56). The patient's labs/tests indicated dehydration and the physician administered 1L IV normal saline. The patient was discharged with dehydration and vasovagal syncope.
16 2021-04-28 malaise Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Mild, Additional Details: After patient... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Mild, Additional Details: After patient was vaccinated she went to wait with her mother in the car (vaccinator did not specifiy to wait in the store). Patients mother came to alert us that the patient was not feeling well. I went to the car with the clinic nurse to check in on the patient. She was responsive however was feeling faint/dizzy/nauseas. Vitals were within normal limits however EMT was called by mother. Patient started to feel better and went home. Patient reports feeling fine now.
16 2021-04-28 fever, headache Got her COVID-19 2nd dose yesterday afternoon, woke up around 0300 hrs this morning with fever, chil... Read more
Got her COVID-19 2nd dose yesterday afternoon, woke up around 0300 hrs this morning with fever, chills, body aches, headache
16 2021-04-28 fever, throat pain, fatigue, headache From 2 days post vaccine, fever, fatigue, sore throat and headaches, lasting about a week. Persisten... Read more
From 2 days post vaccine, fever, fatigue, sore throat and headaches, lasting about a week. Persistent symptoms of headaches, dizziness, and blurring of vision still present at 19 day post vaccine.
16 2021-04-28 fever Fever, body aches, arm stiffness. Lasted approximately 12-15 hours.
16 2021-04-29 chills, fever, headache Fever, chills, dizzy, headache Fever over 101. Symptoms lasted just over 24 hours. Treatment: rest,... Read more
Fever, chills, dizzy, headache Fever over 101. Symptoms lasted just over 24 hours. Treatment: rest, ibuprofen, cold compress Same symptoms occurred after 1st shot as well.
16 2021-04-29 chills Severe diarrhea, chills, hot flashes, nausea. Evening of 4/2 and all day 4/3. Mostly okay in the mor... Read more
Severe diarrhea, chills, hot flashes, nausea. Evening of 4/2 and all day 4/3. Mostly okay in the morning of 4/4. Normal diarrhea treatments like plain diet, lots of water, and anti diarrhea meds (loperamide HCl 2mg pills and 3 were taken over the course of 4/3 with no relief). Severe stabbing abdominal pain that came in waves
16 2021-04-29 sweating Per EMT, patient became diaphoretic and pale suddenly approximately 5 minutes after receiving her fi... Read more
Per EMT, patient became diaphoretic and pale suddenly approximately 5 minutes after receiving her first dose of the Pfizer Covid-19 vaccine at a drive-through vaccination site. Patient was in car sitting in the observation area when incident occured. After becoming pale and diaphoretic, EMT lowered the seat and someone held the patient and patient became unconscious for approx. a minute. After consciousness regained, patient wanted to sit-up because she "felt naseous". Patient sat up and the RN called to incident. When this RN arrived, patient was consious and leaning over and appeared pale/grey and cyanotic. 911 called. This RN put pulse-ox on patient and told EMT to get O2. Patient's O2 saturations were in the low 80's and HR 46. Patient immediately layed back in seat of car and put feet up on dashboard and given 5L of oxygen. After approx. 5 minutes on 5L of O2 and laying back, patient's color improved and stated she "felt much better". O2 saturations improved to 100 after a couple minutes on oxygen and remained over 98% on RA X 5 minutes. Patient was not taken to the hospital and someone droved patient home with follow-up. Follou-up the next day: patient was febrile and given acetaminophen and was afebrile the rest of the night with no other adverse symptoms.
16 2021-04-29 sweating Patient fainted post-vaccination. Observed patient beginning to lean forward and RN was able to pre... Read more
Patient fainted post-vaccination. Observed patient beginning to lean forward and RN was able to prevent her from falling. Patient's eyes observed to roll upward while patient became unresponsive to stimuli and diaphoretic. No incontinence. EMS called while patient assisted simultaneously to gurney by multiple staff. Upon lying down, patient awoke and become alert and oriented to person, place, time, and situation, though stayed pale and diaphoretic for several minutes. VS @ 12:55: BP 120/80, P 59, SAO2 99%, resp unlabored. VS @ 13:00: BP 138/83, P 62, R 20, SAO2 99% VS @ 13:04: BP 123/73, P 54, SAO2 99% VS @ 13:10: BP 100/69, P 78, SAO2 98% Sitting at edge of bed without symptoms at 13:05, alert and conversing with staff and mother. EMS arrived at 13:07 - their monitor showed NSR, random blood sugar = 93. Ate a snack and drank juice, symptoms completely resolved. Mother declined transport to ED. Discharged home with mother with post-vaccination instructions, will receive 2nd dose while lying down.
16 2021-04-29 lethargy, fatigue Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Hypote... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Hypotension-Medium
16 2021-04-30 body temperature increased her right hand started twitching shaking uncontrollably; her right hand started twitching and shakin... Read more
her right hand started twitching shaking uncontrollably; her right hand started twitching and shaking uncontrollably; Her temperature also started rising but did not reach above 100*F; This is a spontaneous report from a contactable consumer (Parent). This consumer (patients mother) reported for a 16-year-old female patient (daughter). A 16-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via unspecified route of administration in left arm on 19Apr2021 (at the age of 16-year-old) for SINGLE DOSE for COVID-19 immunization. She received Pfizer vaccine on 19Apr2021 in left arm and within 2 minutes of receiving it left arm, her right hand started twitching and shaking uncontrollably on an unspecified date. The nurse and the fire department were with her and monitored her for 45 minutes until they suggested her to contact her primary care provider and go to the hospital. In those 45 minutes her right arm started twitching with her hand twitching more. It started going up and down with a flopping motion. Her temperature also started rising but did not reach above 100*F on an unspecified date. She was observed by several doctors in the hospital and was given Adavan (Ativan) for her symptoms which did not subside. She was dismissed from the hospital and was given Adavan (Ativan) again in the hopes that her symptoms would subside in the morning. This morning, only her right hand was still twitching. She is right-handed and could not use her right hand at all as she could not hold a pencil at all, which caused her to be absent from school today. She mentioned that her daughter was healthy, athletic, and had no underlying conditions. Her twin sister also had the vaccine yesterday and experienced nothing but nausea last night with some of the listed side effects. She is asking if there has been reports of this. Waiting to hear from hospital she may need to see a neurologist. Outcome of the event reported as recovering. Response: Referenced PI Section 6 and Section 18 LAB-1457-7.0 Revised: 06 April 2021 No follow-up attempts are needed; information about lot/batch number cannot be obtained.
16 2021-04-30 chills Chills and nausea within 15 minutes of vaccine administration
16 2021-04-30 sweating Fainted 48 hours after shot, sweats, slumped over. Luckily I was there to catch her. Complete loss o... Read more
Fainted 48 hours after shot, sweats, slumped over. Luckily I was there to catch her. Complete loss of color. Came on very suddenly. Could have been catastrophic if she was driving.
16 2021-04-30 malaise Patient Received her first dose Pfizer vaccine (LOT#: EW0173 EXP: 8/2021) at 1140 on 4/30/21. Mother... Read more
Patient Received her first dose Pfizer vaccine (LOT#: EW0173 EXP: 8/2021) at 1140 on 4/30/21. Mother of patient alerted EMT. Mother stated that patient wasnt feeling well. Patient stated that she felt weak and nauseous. Patient was moved to anti-gravity chair to make patient more comfortable. Patient then experienced a syncopal episode at 1155 which lasted about 30 seconds. Patient denied SOB. Patient did not hit head. EMT took patients vital signs at 1157. BP: unable to read, pulse: 70, O2: 100%. EMS was activated. EMS arrived on scene at 1205. EMT transported patient to outside area on wheelchair. EMS transported patient into AMR vehicle and put patient on a 12 lead. Paramedics stated that everything was within normal limits. Patients parents were informed on patients health. Patients parents denied care and signed AMA form. Patients parents stated that they would take patient to hospital themselves. Parents and patient were educated on worsening symptoms of syncopal episode. Patient left vaccination site with a steady gait, unassisted with her parents at 1215.
16 2021-04-30 throat pain, runny nose Runny nose; Sore throat; Body ache; This is a spontaneous report from a contactable consumer. This c... Read more
Runny nose; Sore throat; Body ache; This is a spontaneous report from a contactable consumer. This consumer (patients mother) reported that a 16-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, ER8732) at single dose via an unknown route on 12Apr2021 morning for Covid-19 immunization. She had a runny nose and sore throat before she got the vaccine on 12Apr2021 morning and was figured it was allergy but then the reporter was wondering if she was actually had Covid before she got the vaccine. Concomitant drug was not provided. Patient was very well might just feel badly because of the vaccine. She had a runny nose, sore throat and body ache. The reporter realized she just had a vaccine in the past 24 hours so patient not gotten a test. Outcome of the events was unknown. Reporter seriousness was unspecified. No follow-up attempts are needed: information about lot/batch number cannot be obtained.
16 2021-05-01 chills, fever, headache Fever, chills, body aches, headache, nausea
16 2021-05-01 fatigue 16 y/o female with NO PMH and no h/o similar prior experiences/syncope c/o "feeling tired" ~3 min af... Read more
16 y/o female with NO PMH and no h/o similar prior experiences/syncope c/o "feeling tired" ~3 min after receiving the 1st dose of pfizer vaccine. Pt LOC, "gently" falling onto the floor, landing on her face ~5 min after receiving the vaccine. Pt reported feeling tired before LOC, not associated with any other symptoms (dizziness, changes in vision/hearing). LOC lasted ~10 seconds, pt immediately returned to baseline. She was sat up with the help of her mother and nurse and the clinical lead was notified. Pt was laid down on a cot, VS were taken, ice was applied to her pressure points. Pt reported complete resolution of symptoms within ~5 min. Pt was progressively moved from lying down to sitting to standing. Pt denies eating or drinking anything today and was given fluids and snacks. Pt was monitored for a total duration of 45 min. Pt was driven home by parents. Pt was advised to eat and hydrate today and for the next dose. Pt and parents were advised to call PCP / 911 if symptoms return/persist/worsen or if pt develops concussive symptoms. Pt was instructed to inform the nurse that she fainted ater 1st dose and to prophylactically lay down prior to receiving prior to second dose vaccination.
16 2021-05-01 headache headache; no additional symptoms
16 2021-05-01 fever, fatigue, headache Headache, fatigue, fever (100)
16 2021-05-02 fatigue, fever, chills, headache My daughter developed a rash to her inner arms, inner legs, and hands. Warm to touch. Raised rough... Read more
My daughter developed a rash to her inner arms, inner legs, and hands. Warm to touch. Raised rough textured rash. The skin that is affected is swollen. Benadryl taken orally did not help decrease the rash, nor did topical Benadryl. She also complains of pain to her left leg from her hip to her knee that intermittently bothers her starting 4/30 and still continues to bother her. The day after the vaccine was given she had injection site pain, tiredness, extreme headache, fever of 101.8, nausea, chills, body aches. No swelling or redness to injection site. No lymph node swelling.
16 2021-05-02 headache, sweating 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: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Tingling at site of injection. Patient was seated after receiving the vaccine and suddenly collasped. Patient maintained consciousness throughout the episode and her symptoms have improved.
16 2021-05-02 sweating Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Confusion-Severe, Systemic: Dizziness / L... Read more
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe
16 2021-05-02 fever 100.7 fever, sensitive skin
16 2021-05-03 fatigue I was over heating, nauseous, fatigued, and sore.
16 2021-05-03 headache, fever, body temperature increased, fatigue FIRST VACCINE WAS ON 04/11/21 NO SIDE EFFECTS. SECOND VACCINE WAS ON 05/02/2021 AND HAD THE FOLLOWIN... Read more
FIRST VACCINE WAS ON 04/11/21 NO SIDE EFFECTS. SECOND VACCINE WAS ON 05/02/2021 AND HAD THE FOLLOWING SIDE EFFECTS: HEADACHE, STOMACH ACHE, HOT FLASHES, NAUSEA, FATIGUE, FEVER 101
16 2021-05-03 headache 0935- Vaccine recipient (VR) received 0.3ml dose of Pfizer vaccine that was reconstituted with the i... Read more
0935- Vaccine recipient (VR) received 0.3ml dose of Pfizer vaccine that was reconstituted with the incorrect amount of diluent (0.9mL). VR was asymptomatic during 30 minute observation. Immediately contacted program and was provided guidance and information. 1052 - Consulted School Nurse, VR was in nurses office with chief complaint of a headache, dizziness, and nausea. Left deltoid observed at injection site with no localized reaction found. Per school nurse: Nurse gave VR ibuprofen. Relayed information provided by program to VR. School nurse continued to observe. 1058- Contacted and spoke with VR's parent and relayed and emailed information provided from program (continued in next section) Additional information for Item 18: cont'd- which was the CDC Guidance for vaccine administration errors and deviations. Parent advised to contact primary care provider with any questions or concerns. 12:30 - Followed up with VR - headache and dizziness unchanged, nausea resolved, c/o "going the other way" bathroom. School nurses continued to observe. VR laying flat on bed, dim lights, and on phone.
16 2021-05-03 sweating, fatigue, headache, fever, chills Fatigue, nausea, body aches, chills, fever, hot/cold sweating, headache, ear ache and dizziness.
16 2021-05-03 sweating Pt complained of nausea and feeling dizzy immediately after vaccination. Patient became diaphoretic,... Read more
Pt complained of nausea and feeling dizzy immediately after vaccination. Patient became diaphoretic, pallor to face, patient assisted to wheelchair and taken to stretcher and laid flat since unable to stand. BP 108/67, HR 57, RR 14, o2 sat 99%. Patient later reported she left better, color returned to face and diaphoresis ceased. Updated vitals: BP 109/71, HR 52, RR 16, o2 sat 100%.
16 2021-05-03 sweating Patient reported feeling lightheaded status post first dose Pfizer COVID vaccine (Lot: EW0167, expir... Read more
Patient reported feeling lightheaded status post first dose Pfizer COVID vaccine (Lot: EW0167, expiration date: 08/31/2021) to medic. Medic noted that the client was CAOx4, her skin was pale, warm and slightly moist, pupils were equal, round, reactive to light and accommodating (PEARRL), respiration rate (RR) was 20. The client's sister stated the client had a history of anxiety and that "she gets this way whenever she gets a shot". Medic walked patient to the zero gravity chair. The client was given water to sip on. At 1213 baseline vitals were taken with client sitting: Blood pressure (BP): 110/82, heartrate (HR): 98, RR: 20, PEARRL. Medic reports she coached the client on her breathing to help alleviate her complaint of feeling lightheaded, mild nausea and anxiety. Client reported she felt anxious prior to her vaccination and that her last oral intake was 15 minutes prior to vaccine. Client denied headache, blurry vision and chest pain. At 1220 a second set of vitals were taken while standing: BP 108/80, HR 86, RR 16, CAOx4. Client stated her symptoms were diminishing. Client's RR slowed down to normal rate and rhythm, vital signs were trending to normal and client was negative for orthostatic pressures. Client was advised to stay for additional 30 minute observation. Client's symptoms resolved completely and she was able to ambulate away from observation site without assistance and with a steady gait.
16 2021-05-04 fatigue, headache Sore arm, vomiting, dizziness, fatigue, headache
16 2021-05-04 fatigue, headache In the morning I woke up with fatigue and it was difficult to get up. I also had body aches througho... Read more
In the morning I woke up with fatigue and it was difficult to get up. I also had body aches throughout the day. I had a bit of nausea and was dry heaving. Later in the day I had a headache
16 2021-05-04 sweating 16 yo female came into our injection site today 05/05/21 to receive her first pfizer vaccine. She wa... Read more
16 yo female came into our injection site today 05/05/21 to receive her first pfizer vaccine. She was accompanied by her father. Pt received vaccine IM to her left deltoid. Pt completed vaccine at 2:55pm at which she sat down for her 15 minute observation period. As soon as she sat down she called over the staff that administered the vaccine. She explained to her that she felt nausea and was breathing heavily. I then walked over to them and the attendee was very pale and breathing heavily. By that time I had RN getting attendees history from her father, She has no history of allergic reactions, not taking any medications and no current illness. She is "slightly asthmatic" but is not taking any rx. RN was helping me by putting cold pack behind attendees neck. Pt then proceeded to explain that she felt nauseas and starting dry heaving. RN then brought over trash can and attendee started to vomit. I then started to proceed and take her vitals. first set of vitals were taken at 2:58pm BP: 90/60 HR: 132 RR: 24 O2: 100%. Attendee at this point was diaphoretic, pale, breathing heavily and vomiting. We continued to monitor attendee in which she started to feel better by 3:08 pm. She was no longer pale, diaphoretic or vomitting and was breathing normally. We provided attendee with water and continued to monitor her. Now that pt was calm, I was able to ask her some questions. She stated that she had a smoothie and an avocado toast about an hour prior to vaccine. She explained to me that she does have a phobia to needles and was feeling very anxious prior to appointment. I then repeated her vitals at 3:16pm BP: 98/60 HR:89 RR: 20 O2: 99%. I had attendee stand up off chair and walk at 3:22pm. She felt fine and did not feel dizzy at all. No signs of distress noted. She was then discharged and walked out with her dad at 3:25pm.
16 2021-05-04 sweating Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Tachycard... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Tachycardia-Mild, Additional Details: pt released to her father. spoke with father a few hours later. pt is fine.
16 2021-05-04 fever Fever, body aches, nausea, vomiting
16 2021-05-05 cough Pt was asked to stay for 30min observation. Approximately 10-15mins post vaccination, client develop... Read more
Pt was asked to stay for 30min observation. Approximately 10-15mins post vaccination, client developed hives and began coughing which progressively got worse. Fire/EMS on-site and attended to client. Client was observed for an additional 45mins and given Benadryl. No relief from benedryl and pt transported to ER via squad where she was observed and released. 5/6/21-per mother, the clients pediatrician was notified and advised that the client not receive the second dose of vaccine unless in a controlled environment. Pediatrician. Additionally, client had continued with cough while in school which required a visit to the nurse and use of inhaler times 2.
16 2021-05-05 headache At approximately 1:04pm on 04/30/2021 patient during 10 minute observation had a syncopal episode an... Read more
At approximately 1:04pm on 04/30/2021 patient during 10 minute observation had a syncopal episode and fall from standing to floor with loss of consciousness. Trauma assessment found contusion to occipital region of skull. No bleeding, no other trauma findings. Pt moved to wheelchair, and then to cot without incident. Pt AA&Ox4, airway patent, breathing shallow and non-labored. Pulse strong and regular with delayed perfusion. Pt skin pale, cool and dry. Pt eyes PERRL bilaterally. Pt complains of pain 7/10, dull, localized, to the base of skull, and ringing of ears, as well as dizziness without nausea. Pt administered 650ml oral water with improvement to skin and respirations. Vitals and report continued on next page Pt however post oral hydration still stated no change to headache, and new onset tinnitus to left ear. Pt parent was consulted for transport to emergency department for assessment for potential injury post fall, and consented. EMS was contacted, who transported patient to hospital. Vital signs as follows 1312 108/68 93p 14r 98%RA 1323 106/62 82p 17r 98%RA 1335 104/60 74p 16r 97%RA
16 2021-05-05 sweating it seems like patient have vasovagal symptoms 5 minutes right after vaccinated. she was nauseated an... Read more
it seems like patient have vasovagal symptoms 5 minutes right after vaccinated. she was nauseated and sweat and almost faint. she said that she has hard time breathing. WE gave her 0.3mg epinephrine then she is ok and better. we called EMS over. and she is all fine after that. SHE did not need to go to hospital.
16 2021-05-05 sweating Accompany minor with dad received vaccine for first time. Pt complain of dizziness, diaphoretic, pa... Read more
Accompany minor with dad received vaccine for first time. Pt complain of dizziness, diaphoretic, pale to face, body stiffness and started jerking once on floor. Pt placed to floor for safety precautions. V/s obtained w/ b/p 80/54, HR 92 O2 98%. Jerking stopped with v/s obtained again w/ b/p 82/56 HR 95 O2 99%. EMS arrived and taken over care. Pt was more a/ox3. Taken to hospital via EMS.
16 2021-05-05 throat pain, headache At approximately 9 AM on the morning after receiving the second dose, the patient became dizzy at sc... Read more
At approximately 9 AM on the morning after receiving the second dose, the patient became dizzy at school. As she was walking to the teacher's desk, she lost consciousness and fainted, hitting her head on a desk, scraping her neck on a desk, and suffering several other minor injuries from the fall. She was immediately seen by school nurse and released to my care for the rest of the day. She rested at home and then was seen in at Walk-In Clinic to be evaluated for a concussion. On Day 2 after receiving the vaccine, the patient reported a sore throat, but no other symptoms. She was seen on the third day post-vaccine by our pediatrician's office for possible strep. She tested negative for strep and a concussion from her fainting episode was confirmed due to the lingering headache.
16 2021-05-06 cough, respiratory tract congestion Patient was seen at the urgent care clinic on 4/19/2021 having congestion for a couple of days as we... Read more
Patient was seen at the urgent care clinic on 4/19/2021 having congestion for a couple of days as well as cough, news throat the head and troubles breathing was noted to have normal oxygen saturation and was given an albuterol inhaler and told that she had a virus. She followed up in the PCP office on 4/21/2021 with worsening troubles breathing and was given Decadron in the office, 4days of prednisone, CXR and labwork. CXR showed possible reactive airway disease and was to do steroid and continue out albuterol every 4 hours. Had negative/normal lab work and positive Covid antibodies. History of Covid 10/2020. Felt almost completely back to normal by Sunday, her last day of steroids. On Monday had worsening of her breathing throughout the day, increased troubles breathing again after softball that night. Albuterol did seem to help up. Called the office as she woke up Tuesday morning with worsening and would started on Flovent. With no improvement return to PCP office on 4/29/2020 with marked inspiratory stridor. Was admitted to the hospital for work-up of return of stridor. Had a normal chest x-ray and neck/soft tissue x-ray. With continued troubles breathing and chest pains with decreased heart rate was elected to go to Hospital where she could have further work-up. When the ARNP came helicopter, was concerned about her airway and she intubated to fly to hospital. Was dx there with Sudden Acute Onset of Vocal Cord Dysfunction and is continuing with therapies.
16 2021-05-06 fatigue, chills, fever Fever, Chills, Fatigue
16 2021-05-06 fatigue Approximately after 1 minute from receiving her first pfizer vaccine the patient reported to her mot... Read more
Approximately after 1 minute from receiving her first pfizer vaccine the patient reported to her mother that she feels like she is going to pass out. This RN was alerted about the situation by the patients mother and when approaching the patient this RN noticed the patient losing consciousness and drawing her arms to chest and curling her hands with tremors throughout her body. This RN placed the patient on the floor for safety out of the chair and had other staff member contact 911. Tremors lasted approximately 30 seconds and patient regained consciousness however appeared tired and stated she is unware of what just happened. Vitals were taken which were within normal limits and continued to be taken frequently until EMS arrive to transport patient to Hospital
16 2021-05-06 headache, chills, fatigue Client stated she had chills, headache, tiredness, and felt dizzy. BP: 100/72 HR: 60 P:98 T:97.5
16 2021-05-06 headache, fatigue, chills Developed headache, chills, hot flashes, body aches, burning eyes, nausea, and fatigue 4 hrs after v... Read more
Developed headache, chills, hot flashes, body aches, burning eyes, nausea, and fatigue 4 hrs after vaccination. Symptoms wax and wane in severity, but have not resolved. She was seen by pediatrics and family practice by telemedicine. Treated with Tylenol and Advil. Then presented to Hospital ER 5/3/21 with worsening fatigue and weakness. ER work-up included normal/ negative CBC, d-dimer, monospot, CMP, ESR, CK, UPT, UA, RP Covid, and Influenza. Only noteworthy finding was mildly elevated CRP at 0.51. Treated with Zofran. Outpatient follow-up work-up included normal ECG, normal repeat CBC, CMP, CK, ESR, A1C. CRP 3. EBV, CMV, Parvovirus, Covid antibody, ANA, and RF pending. She briefly D/C'd Amitriptyline, so advised to resume.
16 2021-05-06 headache 16yoF was accompanied with an adult who was present for the vaccination. The COVID-19 Vaccine Pfizer... Read more
16yoF was accompanied with an adult who was present for the vaccination. The COVID-19 Vaccine Pfizer-BioNTech 0.3mL administered IM in right deltoid while patient was sitting. Patient remained sitting for 10 minutes after administered dose. Patient reported feeling well after the injection. Patient stood up while we continued to talk, after 2 more minutes passed out while standing. Suddenly, patient begain to go limp and her eyes crossed and rolled back. Patient fell backwards into the privacy curtain and into aisle 13 of the store. Patient's head bounced off the floor. Immunizer knelt next to patient. Patient was unresponsive until immunizer placed cold hand on back of neck and front of chest to check if she was breathing, immunizer calmly guided patient to breath, slow deep breaths into the belly and patient's eyes fluttered open. She said her head hurt really bad. Immunizer offered to the accompanying adult to call EMS because patient should be evaluated after hitting her head so hard. The accompanying adult denyed EMS, then stating that patient had previously fainted while walking and said that she would be fine. Immunizer advised patient to remain laying down while immunizer got some ice. Ice was then placed on the back of the head. Patient slowly stood up after laying for 10 minutes and was walked over to a sitting area to put feet up and continue with ice for another 5 minutes before the accomanying adult wanted to leave.
16 2021-05-06 headache Numbness in tongue, right sided facial droop, difficulty closing right eye, headache, jaw pain. dx ... Read more
Numbness in tongue, right sided facial droop, difficulty closing right eye, headache, jaw pain. dx with Bell's Palsy
16 2021-05-06 sweating Pt became dizzy and diaphoretic approximately 5 minutes after vaccination. She sat down and began to... Read more
Pt became dizzy and diaphoretic approximately 5 minutes after vaccination. She sat down and began to feel better. She reports fear of needles and not eating since 12pm that day. Approximately 10 minutes later she lost consciousness for approximately 30 seconds. Pt came to was given orange juice and left with her father around 20 minutes after vaccination.
16 2021-05-06 lethargy, fatigue Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-... Read more
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Nausea-Mild, Systemic: Seizure-Mild, Additional Details: Parents were with patient. says it happens every time she gets shots or blood work. possible NES and/or hypotension. says its happened in docs office before and they're testing her for pots and her sister has non epileptic seizures. She was fine after about 15 minutes. gave her a cold packet to put on the back of her neck and just monitored her for further symptoms.
16 2021-05-06 fever, headache, fatigue Nausea and fevers started at 4:30 am 14 hours after shot, had nausea, body aches, headache, fever up... Read more
Nausea and fevers started at 4:30 am 14 hours after shot, had nausea, body aches, headache, fever up to 101.2 , dizziness, fatigue. Nausea lasted 72 hours after the shot and has not stopped though has gotten better.
16 2021-05-08 headache, fever, chills Low-grade fever (100.5), chills, and headache; was managed with ibuprofen and had ceased in 24 hours
16 2021-05-08 fever 20 hours after receiving the vaccine I felt very dizzy and nauseous for a moment and then fainted an... Read more
20 hours after receiving the vaccine I felt very dizzy and nauseous for a moment and then fainted and was unconscious for a minute. I had developed a fever about 8 hours after receiving the vaccine, but by the time I fainted the fever was pretty much gone.
16 2021-05-09 fatigue Felt dizzy and nauseous at about 7:30pm following a workout 3 hours after I got the Pfizer vaccine. ... Read more
Felt dizzy and nauseous at about 7:30pm following a workout 3 hours after I got the Pfizer vaccine. Dizziness has increased and I feel fatigued.
16 2021-05-09 headache, fever Severe headache. Restricted neck movement. Fever. Body aches x 2 days
16 2021-05-09 headache, sleepiness Patient complained of feeling dizzy and blurred vision, headache and eyes hurting. Denies any c/o na... Read more
Patient complained of feeling dizzy and blurred vision, headache and eyes hurting. Denies any c/o nausea. BP 114/64 HR= 99 O2 Sat= 99% Patient/mom verbalized that she had a half of subway sandwich prior to her vaccination. Placed patient in supine position, took vital signs and instructed to remove her jacket since the observation area was warm. Gave her cold drinks, bar of candy and Tylenol 500 mg 1 tablet for headache. Continued to monitor patient then 30 minutes later RN walked her on the hallway. Still a little wobbly . Instructed to take some deep breaths. Mom did mention that her menstrual period is almost due. 10 minutes later she claims she is doing better but still have mild headache and sleepy. Discharged home with her mom and was instructed RN will follow up on her. Instructed if headache persists and start having dizziness to go to ER.
16 2021-05-10 fatigue The complaint is characterized as a skin rash. The onset of the symptoms have been rapid and they ha... Read more
The complaint is characterized as a skin rash. The onset of the symptoms have been rapid and they have been occurring for 3 days. The course has been decreasing (pain had improved by visit on 5/10). The skin complaint is described as moderate to severe. The location is described as on the right side of trunk. There has been associated itching. She has a history of chronic back pain: aches. She said this is occurring as well as the new and worse sharp pain. It was worst last night. She was achy Wednesday morning into Thursday after vaccine. She felt a little better Friday morning, Friday evening she became tired and her back was hurting again. The rash and itching started on Saturday morning, Sunday was worse. There was burning, sharp pains on her side with the rash. Diagnosis of Shingles (B02.9). Started Acyclovir 5%. Apply 3 times daily for 7 days. Follow up in office if symptoms don't subside or get worse.
16 2021-05-10 headache Severe headache for a week after the vaccine; This is a spontaneous report from a contactable consum... Read more
Severe headache for a week after the vaccine; This is a spontaneous report from a contactable consumer. A 16-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on Apr2021 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient did not received any other vaccine prior to COVID vaccine. The patient experienced severe headache for a week after the vaccine on Apr2021 which resulted in doctor's clinic visit. Prescription migraine medication was received as treatment for the event. Patient was not diagnosed with COVID prior to vaccination and had not been tested post-vaccination. Outcome of the event was not recovered.
16 2021-05-10 sweating Patient felt dizzy. Became pale and diaphoretic. 1215 - 98/52 HR 54, repeat at 1220 110/64 HR 78, ... Read more
Patient felt dizzy. Became pale and diaphoretic. 1215 - 98/52 HR 54, repeat at 1220 110/64 HR 78, repeat. 12/25 patient feels better, able to ambulate, alert and oriented. 1234 symptoms completely resolved and able to resume normal activity.
16 2021-05-11 fatigue Tiredness, migraine, dizziness, lower back pain
16 2021-05-11 sweating vomiting x1, dizziness, diaphoresis; patient felt immediately better after vomiting
16 2021-05-11 fever, headache, fatigue One day after the vaccine, feeling fatigued, feverish (99.5), headache Two days after the vaccine, f... Read more
One day after the vaccine, feeling fatigued, feverish (99.5), headache Two days after the vaccine, feeling some SOB w exertion, chest heaviness Mild chest heaviness 3 days after, resolved by end of day.
16 2021-05-11 fever pts arm hurt immediately after taking the vax. Later that night her legs were feeling very heavy, h... Read more
pts arm hurt immediately after taking the vax. Later that night her legs were feeling very heavy, her arm still hurts, joint pain in both hands, slight fever, has body aches and pains. On 5/12/21 they contacted her PCP and was told to give them a call back if her symptoms get worse.
16 2021-05-12 fatigue, fever, chills Sore arm with rash/swelling at injection site, lasted a week. Fever and chills that evening through... Read more
Sore arm with rash/swelling at injection site, lasted a week. Fever and chills that evening through the night. Extreme fatigue, slept for 18 hours. Abnormal menstruation (spotting for 8 days prior to actual period, started 2 days after vaccine)
16 2021-05-12 fatigue Patient chronic conditions (JIA, UC) previously controlled on adalimumab. Within several days of re... Read more
Patient chronic conditions (JIA, UC) previously controlled on adalimumab. Within several days of receiving COVID-19 vaccine dose #2, patient began experiencing worsening/flare of ulcerative colitis symptoms including stomach pain, diarrhea, fatigue, arthritis pain that lasted beyond the reasonable and known duration of vaccine related side-effects. Symptoms treated with dicyclomine and acetaminophen with no relief. Symptoms continued x 2 weeks. Patient ultimately required addition of budesonide to treatment regimen for ulcerative colitis and is currently having relief of symptoms.
16 2021-05-12 fatigue The patient felt tired and describes her eyes going dark, then passed out a few minutes after vaccin... Read more
The patient felt tired and describes her eyes going dark, then passed out a few minutes after vaccination. She was vaccinated and then left the immunization room to sit down for a 15 minute waiting period. When she went to sit down, she collapsed on the floor. Her mother assisted her into a chair. She continued to be incoherent and have her eyes rolling back into her head for a few minutes. We used a cool cloth on her forehead and the back of her neck. The parents requested that we call 911. EMS arrived shortly and evaluated her. Heart rate, blood pressure, pulse ox, blood sugar and chest sounds were all within normal range. The patient stated that her arm felt heavy and "funny". She then stated that her tongue felt funny. EMS evaluated her tongue and said it looked normal. To err on the side of caution, she was taken to the hospital to determine whether or not she was having a delayed onset anaphylactic reaction. This patient has no history of seizures.
16 2021-05-12 malaise pt was shaking and not feeling well at 3:10pm (10 minutes after vaccine was administered at 3:00pm).... Read more
pt was shaking and not feeling well at 3:10pm (10 minutes after vaccine was administered at 3:00pm). pt was given 2 oranges because pt describes having episodes of low blood sugar. Clinical staff spoke to mother and informed about event.
16 2021-05-13 chills, headache 12 hours post vaccine she had severe myalgia, rash on both arms and legs, headache, nausea, stomach ... Read more
12 hours post vaccine she had severe myalgia, rash on both arms and legs, headache, nausea, stomach pain, and mild swelling in legs. Over the next 48 hours the rash darkened and spread to the entire body causing pain in her skin. The myalgia became nearly unbearable and both Ibuprofen and Acetaminophen didn't put a dent in the pain. One side of her face swelled so that one eye could only partially open. The nausea and stomach pain worsened so that she couldn't eat. Headache became intense. By 48 hours post vaccine she became delirious - her speech was slurred and difficult to comprehend. She would fall asleep for a few minutes and wake up unaware of where she was or what was happening. She never got a fever but did have chills. Around this time I called a relative who is a doctor to seek advice and Diphenhydramine was recommended. Benedryl helped immensely. 30 minutes after taking it she could speak clearly, was more alert, pain became tolerable, and her appetite returned. Symptoms and swelling returned when the Benedryl wore off so she continued taking it every 4 hours for the next two days until it wasn't necessary any more. The myalgia, stomach pain and headache persisted for 7 days. At 8 days post vaccine (today) a mild headache, mild and intermittent stomach pain, and mild fatigue are her only remaining symptoms. Her pediatrician cannot see her until next week but we have an appt for the 22nd.
16 2021-05-13 sweating Within 5-10 mins post-injection pt became pallor, sweaty, dizzy and had a vasovagal episode while si... Read more
Within 5-10 mins post-injection pt became pallor, sweaty, dizzy and had a vasovagal episode while sitting in her chair. Pt exhibited jerking motions and then quickly had a syncope episode lasting <1 min. Pt was lowered to the ground during the episode. No trauma occurred. Pt mother beside pt entire time. During this time a pulse ox was put on pt and her legs were elevated. Pulse ox remained 96-98%. After waking, water and wet rag was given to pt and pt moved to reclined chair after 5 mins. Pt remained pallor and dizzy x15mins, after 40 mins pt was able to walk and leave the clinic. Mother stated in past that pt had a vasovagal episode after the Gardasil vaccine.
16 2021-05-13 malaise Right after patient received the vaccine she turned very pale and told the technician she felt light... Read more
Right after patient received the vaccine she turned very pale and told the technician she felt light headed. She remained seated in the room and closed her eyes a couple times but never appeared to lose consciousness. Her dad joined us in the room and confirmed she was really nervous before the vaccine. We kept her seated for several minutes and then she said she felt sick and vomited. After that she started to regain her color and was able to move to the waiting room. She sat there for about 5 more minutes and then felt well enough to leave with her dad.
16 2021-05-13 fever, chills, headache Pt developed chest pains and heart racing that night along with high fever 102 with very bad heada... Read more
Pt developed chest pains and heart racing that night along with high fever 102 with very bad headache. Chills and fever and weakness latest through Friday afternoon Fever started to go down Friday afternoon and weakness improved. Headache remains strong
16 2021-05-13 fever 16-year-old medically complex female, JIA, bronchiectasis and chronic nighttime oxygen requirement w... Read more
16-year-old medically complex female, JIA, bronchiectasis and chronic nighttime oxygen requirement who presented to the hospital on 5/6 with fever, increased stool output, and perianal skin breakdown. Her course was complicated by respiratory failure (requiring ICU admission for CPAP), pancytopenia, diarrhea with buttock skin breakdown requiring rectal tube for wound and stool management, and extensive workup which was unrevealing for an infectious cause. She clinically improved with respect to pancytopenia with discontinuation of felbamate, and completed a treatment course with Zosyn for suspected buttock SSTI.
16 2021-05-13 fever FEVER, BODY ACHES, NAUSEA AND VOMITING TREATED WITH TYLENOL FOR FEVER
16 2021-05-14 body temperature increased, headache, chills Thrombocytopenia noted; Elevated temps to 104; Associated chills; headaches; This is a spontaneous r... Read more
Thrombocytopenia noted; Elevated temps to 104; Associated chills; headaches; This is a spontaneous report from a contactable healthcare professional. A 16-year-old non-pregnant female patient received bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE), dose 1 intramuscular on 25Apr2021 (Lot Number: EWO171) as 1st dose, single for covid-19 immunization. Medical history included eczema, Pyle disease, food allergies, short stature, seasonal allergies, peanuts allergies and nuts allergies. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. The patient's concomitant medications were not reported. The patient did not have other vaccine in four weeks. On 26Apr2021, the patient had elevated temperatures to 104 [unspecified unit], 4-5 days post vaccination (pending clarification) with associated chills and headaches. Thrombocytopenia noted. The adverse events resulted in doctor or other healthcare professional office/clinic visit. No treatment was provided for the adverse events. The patient was tested post vaccination with a nasal swab test on 28Apr2021 and the result of negative. The reporter did not consider the events was serious. The outcome of the event was recovering. No follow-up attempts are needed. No further information is expected.; Sender's Comments: The reported event thrombocytopenia was observed only 1 day after vaccination. It is unlikely that thrombocytopenia is related to BNT162B2. It's more likely intercurrent medical condition. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
16 2021-05-14 fever, chills Fever, chills, body and joint pain
16 2021-05-15 body temperature increased, fatigue 101.2 Temperature and fatigue
16 2021-05-15 headache, respiratory tract congestion, throat pain Extreme abdominal pain/cramping. We ended up taking her to the ER department at the Hospital because... Read more
Extreme abdominal pain/cramping. We ended up taking her to the ER department at the Hospital because the pain was so extreme. In the course of the visit to the ER, they took a CT scan of the abdomen, and there saw evidence of Covid in the lungs. They did a nose swab test, and she tested positive. She had some mild symptoms (stuffy head, headache, mild sore throat) earlier in the week (May 8 - May 9), but we thought it was possibly allergies. Turns out it was Covid and we didn't know it. It seems that with the Covid virus already in the system, the shot caused an extreme reaction.
16 2021-05-15 sweating, chills Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic:... Read more
Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Systemic: Shakiness-Mild, Systemic: Weakness-Mild, Additional Details: Parademics/911 called, patient's parent refused transport to the hopsital. Patient waiting in recovery with NP and nurses, RPH to check
16 2021-05-16 chills, headache Immediately after the shot she had a bad headache and approximately 30 to 35 minutes later dizness, ... Read more
Immediately after the shot she had a bad headache and approximately 30 to 35 minutes later dizness, chills, and throat restriction (anaphlaxis), extreme muscle soarness( any sort of touch was extremely painful, and she couldn't move her neck, it hurt to move from side to side. Her legs began to feel extremely heavy and hard to move. These symptoms seemed to last for approx 30 minutes. Headache didn't subside until later in the day, it did lighten up.
16 2021-05-16 fever Patient presented to the ED with dizziness, fever and heavy vaginal bleeding around 24 hours after r... Read more
Patient presented to the ED with dizziness, fever and heavy vaginal bleeding around 24 hours after receiving her first dose of the Pfizer-BioNTech COVID-19 vaccine. She was tested for active COVID-29 infection via nasal swab PCR and tested positive. Upon presentation labs were drawn and her platelet count was found to be 8 on 5/15. Repeat labs were drawn that day to confirm low platelet count and confirmed diagnosis and thrombocytopenia secondary to an immune reaction to the vaccine was suspected. She was admitted and was started on tranexamic acid, medroxyprogesterone, dexamethasone and IV immunoglobulin (Ig) to help treat low platelet count and vaginal bleeding. As of writing, she is still admitted and her most recent platelet count on 5/17 was 16.
16 2021-05-17 fatigue, chills chills, body muscle aches, arm is sore, fatigue
16 2021-05-17 headache Patient received vaccine in her left arm. It was made aware to the immunizing technician prior to va... Read more
Patient received vaccine in her left arm. It was made aware to the immunizing technician prior to vaccinating that the patient had a history of dizziness after vaccines. Patient was seated when receiving shot and after stayed seat. About 30 seconds after the shot patient lost consciousness and fell out of the seat hitting her head on the way down. The pharmacist and mother helped patient back to her seat. As she came to consciousness patient reports a little headache and dizziness. Pharmacist took blood pressure which read 84/52, temp 97.9 and gave patient some water and 911 was called. As EMS arrived patient reported still some dizziness but was feeling better.
16 2021-05-17 headache At approximately 1:04pm on 04/30/2021 patient during 10 minute observation had a syncopal episode an... Read more
At approximately 1:04pm on 04/30/2021 patient during 10 minute observation had a syncopal episode and fall from standing to floor with loss of consciousness. Trauma assessment found contusion to occipital region of skull. No bleeding, no other trauma findings. Pt moved to wheelchair, and then to cot without incident. Pt AA&Ox4, airway patent, breathing shallow and non-labored. Pulse strong and regular with delayed perfusion. Pt skin pale, cool and dry. Pt eyes PERRL bilaterally. Pt complains of pain 7/10, dull, localized, to the base of skull, and ringing of ears, as well as dizziness without nausea. Pt administered 650ml oral water with improvement to skin and respirations. Vitals and report continued on next page
16 2021-05-17 headache Client received 1st COVID vaccine Pfizer (Lot#EW0185 expiration 05/22/21). At 4:28PM Client reports ... Read more
Client received 1st COVID vaccine Pfizer (Lot#EW0185 expiration 05/22/21). At 4:28PM Client reports headache, no dizziness, no lightheaded, no blurred vision, no chest pain, no shortness of breath. Client has already completed 20 minutes of observation. EMT obtained vital signs blood pressure 116/71, heart rate 87, oxygen saturation 98%. At 4:33PM, RN responded to the event. Client and father reports history of asthma and no known allergies. Offered supplemental nutrition and fluids. Client accepted. Client reports to RN about no chest pain, lightheaded was improving, headache is going down. At 4:39PM vital signs are blood pressure 130/84, heart rate 96, oxygen saturation 99%. Client reports lightheaded, blurred vision, no shortness of breath. RN educated Client and father in regards to ED precautions and common adverse effects of COVID vaccine. 4:44PM vital signs are blood pressure 121/79, heart rate 92, oxygen saturation 98%. Client reports no chest pain, no shortness of breath, lightheaded is improving, headache is going down, no blurred vision, no dizziness. Client remains sitting in a chair and eating/drinking supplemental nutrition and fluids. At 4:49PM vital signs blood pressure 118/78, heart rate 89, oxygen saturation 99%. Client reports all symptoms has resolved. Client has a steady gate and is waiting for other siblings to complete observation.
16 2021-05-17 fever, chills, fatigue Fever, chills, Fatigue, Shakiness
16 2021-05-17 fever Briefly, patient is an otherwise healthy 16-year-old female who presents with 12 days of epigastric ... Read more
Briefly, patient is an otherwise healthy 16-year-old female who presents with 12 days of epigastric pain in the setting of getting her 2nd COVID vaccine on 5/5. Did have fever and vomiting during the first 24 hours which has since subsided, but the abdominal pain has persisted. She has had a reassuring work up through her PCP but presents with continued pain. Labs overall reassuring with normal LFTs and lipase. Awaiting RUQ US and urine at this time. 0100: Family requesting discharge home. does not want to wait for US as they have an outpatient US scheduled for Thursday 5/20. Temperature: 36.6 DegC (05/18/21 01:14:00) Systolic Blood Pressure: 118 mmHg (05/18/21 01:14:00) Diastolic Blood Pressure: 60 mmHg (05/18/21 01:14:00) Heart Rate: 80 bpm (05/18/21 01:14:00) Respiratory Rate: 20 br/min (05/18/21 01:14:00) Oxygen Saturation (SPO2): 98 % (05/17/21 20:28:00) On re-evaluation, patient is awake, alert and well-appearing. She has remained afebrile, with normal vital signs for age. Reports improvement in symptoms, has tolerated PO and feel that she is appropriate for discharge home. Anticipated course of illness reviewed. Supportive care (rest, push fluids) discussed. Reasons to return to the emergency department discussed in detail. Written instructions provided. All questions answered. Parents expressed understanding and agreement with this plan. Patient was awake, alert and well-appearing upon discharge home from the emergency department. Final Diagnosis 1. Epigastric pain R10.13 2. Adverse reaction to vaccine constituent T50.A92A
16 2021-05-17 respiratory tract congestion, throat pain vomiting began 3 days after vaccination fever up to 102 began 4 days after vaccination sore throat, ... Read more
vomiting began 3 days after vaccination fever up to 102 began 4 days after vaccination sore throat, congestion, body aches persist 5 days after
16 2021-05-18 body temperature increased 10 minutes after receiving vaccination, attendee had complaints of feeling "dizzy and fuzzy" and int... Read more
10 minutes after receiving vaccination, attendee had complaints of feeling "dizzy and fuzzy" and intermittently staring off into space. Parent,(mother), present at bedside and states staring off into space occasionally is a baseline behavior for attendee but 'seemed worse' at this time. Vital signs at 4:10pm: blood pressure 130/90, heart rate 124, temp 99F, respirations 22. Blood glucose 93. EMT present. At 4:20pm attendee assisted to lie down on cot. Paramedics called as attendee felt she should go to hospital. Attendee transferred to gurney at approximately 4:30pm and was looking at her phone and requesting her headphones and drink of water. Pt seemed more attentive and appeared in no acute distress. She was able to stand and move her legs to transfer to gurney. Attendee transferred to hospital via fire station vehicle at 4:40pm.
16 2021-05-18 headache Severe head ache, severe nausea with vomiting ever since vaccine has been given.
16 2021-05-18 headache Lingering headache Called doctor - no appointment needed at this time
16 2021-05-18 sweating Patient felt lightheaded and dizzy after 2nd dose of Pfzier, was pale and diaphoretic but alert and ... Read more
Patient felt lightheaded and dizzy after 2nd dose of Pfzier, was pale and diaphoretic but alert and oriented x4. Had pt lay done supine and observed for an extra 15 minutes. Pt felt fine and symptoms resolved. Left with father feeling better
16 2021-05-18 sweating A few moments after receiving the vaccination, patient fainted and had some tremors afterwards. We p... Read more
A few moments after receiving the vaccination, patient fainted and had some tremors afterwards. We picked her up off of the floor and placed her in a chair. She was pale and had some discoloration around her nose area. She was able to speak to us. She felt cold and was sweating at the same time. Her body temp was 97 degrees F. According to her mom, she's had a previous reaction similar to this but not to this extreme with the HPV shot. We called 911 to have her assessed by the paramedics
16 2021-05-18 malaise, fever, throat irritation Swollen Lymph Nodes, 16 hours after injection, Rest, Fluids, Benedryl 10 mg - Symptom persists Itchy... Read more
Swollen Lymph Nodes, 16 hours after injection, Rest, Fluids, Benedryl 10 mg - Symptom persists Itchy Throat, 8 hours after injection, Rest, Fluids, Benedryl 10 mg - Symptom persists Low-Grade Fever, 30 hours after injection, One dose of Tylenol - Symptom persists Malaise, 8 hours after injection, Rest and Fluids - Symptom persists
16 2021-05-18 sleepiness PT HAD A SEIZURE APPROX. 30 MINS AFTER RECEIVING THE COVID VACCINE, PT FAINTED, STIFFENED UP, AND BE... Read more
PT HAD A SEIZURE APPROX. 30 MINS AFTER RECEIVING THE COVID VACCINE, PT FAINTED, STIFFENED UP, AND BEGAIN TO CONVULSE. PT WAS PLACED ON COTT IN THE RECOVERY POSITION, 911 WAS CALLED AND VS OBTAINED. P74, R22, BP118/80, O2SAT 98% ON RA. SEIZURE LASTED APPROX 10 SECONDS, AMBULANCE ARRIVED WITHIN 10 MINS, AND TOOK OVER PT'S CARE. PT'S COLOR REMAINED PINK THROUGHOUT, AND SHE WAS SLEEPY BUT ABLE TO ANSWER QUESTIONS APPROPRIATELY. VS: P83, R24,BP116/80, POX99% ON RA. PT TAKEN IN AMBULANCE TO HOSPITAL FOR FURTHER EVALUATION
16 2021-05-19 chills Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specif... Read more
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Chills-Mild
16 2021-05-19 dehydration Patient received first dose of Pfizer vaccine (lot EW0170) on 4/24/21 at University and received 2nd... Read more
Patient received first dose of Pfizer vaccine (lot EW0170) on 4/24/21 at University and received 2nd dose of Pfizer vaccine (lot EW0182) on 5/15/21 also at University. Came to hospital ED on 5/16 AM with diagnosis of acute chest pain, acute dehydration, and adverse reaction to vaccine administration. Was discharged to home and returned to ED on 5/17/21 for continued chest pain (central, throbbing, non-radiating chest pain). Medical tests and laboratory results revealed elevated troponin level (1.546 at peak, then declined to 0.585 prior to discharge home). Patient was admitted to PICU for close monitoring. CT angiogram of chest was negative, chest x-ray was negative, EKG showed normal sinus rhythm, echocardiogram was done and it was a normal study. Dr. discussed with the cardiology department at Hospital. Possible myocarditis due to vaccine. COVID-10 IgG IgM antibodies were positive for the patient which indicates good efficacy of the vaccine. Patient to have follow-up with outpatient pediatric cardiology Dr. Discussion with father on 5/20/21 indicates that patient's symptoms were improving.
16 2021-05-19 fatigue The patient had a Vasovagal response. She had a 15 second seizure ,blood pressure dropped, was flus... Read more
The patient had a Vasovagal response. She had a 15 second seizure ,blood pressure dropped, was flush, tired and nauseated. She has no memory of the event.
16 2021-05-19 fatigue arrhythmia, heart palpitations, pain in left arm, pain in chest (particularly left side) radiating i... Read more
arrhythmia, heart palpitations, pain in left arm, pain in chest (particularly left side) radiating into shoulder blade, fatigue, muscle aches
16 2021-05-19 headache, fatigue Patient started experiencing numbness and tingling on her right side and then all over on Sunday eve... Read more
Patient started experiencing numbness and tingling on her right side and then all over on Sunday evening 5/2/21. It affected her gait and the numbness and tingling in her legs caused her to have to catch herself and hold on to something to keep from falling. She described that her legs felt weak for a few seconds when walking. This sensation gradually decreased in intensity and duration. When I saw her at 5 pm on 5/3, she had normal gait and only felt the numbness and tingling very briefly. Her exam including her neuro exam was normal on 5/3 when I saw her. The sensation of numbness and tingling completely resolved by 5/4. She also experienced HA, nausea and fatigue, but did not have syncope, dizziness or fevers.
16 2021-05-19 headache, fever, runny nose Nausea; headache; soreness at injection point; fever; runny nose; This is a spontaneous report from ... Read more
Nausea; headache; soreness at injection point; fever; runny nose; This is a spontaneous report from a contactable Consumer (patient). A 16-year-old female non-pregnant patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EN5318, Expiration date not reported), via an unspecified route of administration in arm left on 27Jan2021 (at the age 16-year-old), as a single dose for COVID-19 immunization. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included escitalopram oxalate (LEXAPRO). The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EL3249, Expiration date not reported), via an unspecified route of administration in arm right on 06Jan2021, as a single dose for COVID-19 immunization. The patient did not receive any other vaccine in four weeks before vaccination. The patient experienced nausea, headache, soreness at injection point, fever and runny nose on 27Jan2021. The patient did not receive any treatment for the events. The outcome of the events was reported as recovering Follow-up attempts are completed. No further information is expected.
16 2021-05-19 sweating Shortly after vaccination became warm, diaphoretic and pale BP 78/96
16 2021-05-19 sweating pt began to fill light headed about 5 minutes after vaccination. She then had some vomiting. The roo... Read more
pt began to fill light headed about 5 minutes after vaccination. She then had some vomiting. The room was very warm. She was a little diaphoretic. The vomiting happened about 3 times then subsided. Patients color came back. She sat for a few additional minutes. Drank some water and left clinic completely stable. She has had a history of fainting with heat and with injections.
16 2021-05-19 throat pain, cough Within 15 minutes, pt complaining of chest pain, not radiating, in center of chest. Coughing, statin... Read more
Within 15 minutes, pt complaining of chest pain, not radiating, in center of chest. Coughing, stating sore throat. Given PO 50 mg Benadryl. Vital signs stable. No other s/s. Took private vehicle to hospital with RN.
16 2021-05-19 runny nose, cough, throat pain nausea within 1/2 hour. congested and runny nose within 1 hour. within 24 hours sore throat, cough... Read more
nausea within 1/2 hour. congested and runny nose within 1 hour. within 24 hours sore throat, cough, vomiting. Still has runny nose and cough.
16 2021-05-20 fatigue, chills Chills, Body Aches, Diarrhea, Nausea, Dry Heaving, Weakness, Dizziness, Fatigue, Loss of Appetite
16 2021-05-20 headache Developed severe headache 15 min after returning to class following vaccination . Approximately 30-4... Read more
Developed severe headache 15 min after returning to class following vaccination . Approximately 30-40 min post vaccination FAther came to school and will transport his daughter to an Urgent care center for evaluation
16 2021-05-20 sweating 6 days following vaccination, patient was exercising for the first time. started feeling dizzy. She... Read more
6 days following vaccination, patient was exercising for the first time. started feeling dizzy. She had some water and realized that her skin was red. She had a rash on face and puffy lips. Mom came to get her she stood up and was extremely dizzy. Mom did not notice that her lips were swollen but did notice that her skin was rashy and red. Mom, who is a nurse, also thought she appeared pale and diaphoretic. By the time they got the ED she was hypotensive. She got a cocktail of meds in the ED including a couple doses of EPI. She got IV fluids. She started to improve quickly after giving the medications.
16 2021-05-20 sweating Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-S... Read more
Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe, Systemic: Nausea-Severe
16 2021-05-20 throat pain, fatigue, headache SORE THROAT HEADACHE FATIGUE
16 2021-05-20 throat pain Covid vaccine administered on 5/20. 1704 - in observation room pt complained of feeling warm and a... Read more
Covid vaccine administered on 5/20. 1704 - in observation room pt complained of feeling warm and a sore throat. 1706 - 50 mg Benadryl PO given, VS HR 93, POX 99, BP 128/68 1710 - VS HR 97, POX 98 1712 - pt states throat feels better. 1715 - pt states throat feels okay. 1720 - pt states she feels fine. No dizziness, throat all better. 1723 - VS HR 97, POX 99 1725 - VS HR 93, POX 98 Pt monitored by 2 RNs for 30 minutes throughout this encounter prior to leaving observation.
16 2021-05-21 headache, fever I am her mother reporting and also an RN. She rarely complains of symptoms whenever I?ll. C/O 12 h... Read more
I am her mother reporting and also an RN. She rarely complains of symptoms whenever I?ll. C/O 12 hours post vaccination began feeling of throat closing- able to breath ok/safely but short of breath (O2 says 99% HR 60?s - WNL), feeling floaty and light- as if not on ground, body feels tingling and numb, difficulty sleeping, right pupil dilated greater than left but both pupils reacted to light appropriately with check. Pupil over dilation one side resolved by next morning. Other symptoms still continue. Other SE?s are common: HA, low grade fever 100.9, body aches. Currently 33.5 hours post vaccination at submission. Pfizer #1 on 4/30/21 Lot# EW0173 Pfizer #2 of 5/21/21. Lot# EW0187
16 2021-05-21 headache, fever Fever, body aches, headache, tingly limbs. Symptoms started around 4am, so about 17 hours later. Sym... Read more
Fever, body aches, headache, tingly limbs. Symptoms started around 4am, so about 17 hours later. Symptoms were gone by 48 hours later.
16 2021-05-21 throat pain, fatigue, headache Dizziness, headache, sore throat, tiredness Large painful lump near collarbone on left side notice t... Read more
Dizziness, headache, sore throat, tiredness Large painful lump near collarbone on left side notice the morning after when she woke up, still present.
16 2021-05-21 throat irritation, cough Patient received the vaccine at 4:00p. Her mother called us over at 4:05 as Shaelynn was feeling "we... Read more
Patient received the vaccine at 4:00p. Her mother called us over at 4:05 as Shaelynn was feeling "weird". She began to itch and cough, apparently trying to throw up, felt her throat was itching and swollen. She stated she couldn't swallow and was having a hard time breathing (although she was breathing). We administered an Epi Pen 0.3mg (only one) and called 911. Patient was transported to the hospital by ambulance.
16 2021-05-22 headache, throat pain Pfizer-BioNTech COVID-19 Vaccine EUA I woke up at about 4:30 AM and couldn?t fall back asleep, I kep... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA I woke up at about 4:30 AM and couldn?t fall back asleep, I kept feeling sleepy until I would get jolted back awake over and over. My joints were hurting, I had somewhat severe nausea, my head started throbbing. At about 6:40 AM my migraine started, my arm felt hot to the touch, and I got dizzy so I took some acetaminophen. At 10:00 PM I noticed the area under my left armpit was a little swollen and really sore, my throat and right tonsil was also sore and it hurt to swallow. The next day (today) I have another migraine, my throat and left armpit are still sore, and my muscles hurt. I?m getting better though.
16 2021-05-22 headache, fever 1. Headache - for 24 hours. Treated with acetaminophen & naproxen. 2. Nausea when standing - durati... Read more
1. Headache - for 24 hours. Treated with acetaminophen & naproxen. 2. Nausea when standing - duration 24 hrs 3. Dizziness when standing - duration 24 hrs 4. Fever up to 103 F - duration 18-24 hrs. Unknown due to taking acetaminophen & naproxen.
16 2021-05-22 sweating Vasovagal response immediately after vaccination. Dizzy, pale, lightheaded, diaphoretic, hypotensive... Read more
Vasovagal response immediately after vaccination. Dizzy, pale, lightheaded, diaphoretic, hypotensive. B.P. 64/25 @10:25 and @10:35 B.P. 110/60. Laid down in medical screening with good rebound Blood pressure. Remains for 30 minutes observation. Left in stable condition at 10:53.
16 2021-05-23 headache, fatigue, fever Vaccine administered at outside facility. Patient is a 16 yo girl, admitted on 4/19 with myocarditis... Read more
Vaccine administered at outside facility. Patient is a 16 yo girl, admitted on 4/19 with myocarditis, s/p IVIG (4/19) after presenting with progressive new onset chest pain. She was in usual state of health up until 2 days ago when she started developing body aches, and chest pain. Patient received her 2nd Pfizer COVID vaccine last week (4/15). No known history of COVID infection. Parents brought her to the ED yesterday after she complained of dizziness, SOB, chest pain, and had a near syncopal event. EKG showed non-specific ST abnormalities with labs showing elevated troponin, mildly elevated CRP, normal CXR, negative COVID PCR. Denies fever, GI symptoms, GU symptoms, headache, rash. Once transferred to our PICU, she was worked up for myocarditis vs MIS-C. Troponin has been trended q6 and is trending up (now 11). Of note, there have been no fevers. Patient is a 16 yo girl, s/p admission (4/19-4/23/21) with myocarditis, s/p IVIG (4/19), has now been readmitted on 5/10 with myocarditis after presenting with headache and neck pain for 2 days. Following discharge from the PICU on 4/23, patient states that symptoms have lingered (low grade fevers, feeling tired, on and off chest pain). After developing a progressive headache and neck pain, she came back to the ER for re-evaluation. Upon readmission, her troponin was elevated (2.06 on 5/10). Her CBC and CMP were reassuring. Blood culture collected on 5/11 and urine culture collected on 5/10. ID consulted for workup.
16 2021-05-23 headache Patient reporting worsening chest pain x 3 days, headache x 3 weeks, dizziness today
16 2021-05-23 lethargy, fatigue, sweating Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainti... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Seizure-Medium, Systemic: Shakiness-Medium, Additional Details: Patient had seizure with 1st vaccine, pediatritian informed mother to have patient lay down if it happens again. Patient said she felt out of it (at 11am) after administration of this vaccine so we helped her lay down on the floor with her head proped up. Gave her water and turned on the fan to try and make her more comfortable. Patient decidede to try sitting up slowly after 10-15 minutes, then after another 10 minutes she was able to stand and felt back to normal and left the store 11:30am.
16 2021-05-23 fever, sweating, chills hives developed in the evening after first vaccination, treated with otc oral benadryl. Hives of s... Read more
hives developed in the evening after first vaccination, treated with otc oral benadryl. Hives of scalp, neck, face and shoulders developed after the second vaccination on 5/19/2021, which was partially treated with otc oral benadryl. The day following the 2nd vaccination, the patient developed nausea with vomiting, fever, sweats, shaking and chills for one day.
16 2021-05-24 fatigue 16yo female pt had syncope episode approx 15 min after vaccination. Parents said they had just come... Read more
16yo female pt had syncope episode approx 15 min after vaccination. Parents said they had just come off of a long international flight and that pt was very tired and had not had anything to eat or drink. After vaccination, the family walked around the store, and pt fainted on other side of store. Emergency services were called. Pt was helped to sitting upright in a chair, and had a scraped knee.
16 2021-05-24 headache Started with a headache that over time worsened. Seen at PCP office on 5-4-2021 and then again on ... Read more
Started with a headache that over time worsened. Seen at PCP office on 5-4-2021 and then again on 5-5-2021. Sent to ER for further care.
16 2021-05-24 sweating Felt dizzy and like she would pass out Felt faint and nauseous and very sweaty. MOM noted she was ... Read more
Felt dizzy and like she would pass out Felt faint and nauseous and very sweaty. MOM noted she was obviously sweating and left wet marks from her arms on the table Did have a syncope episode
16 2021-05-24 throat irritation, chills With in 5 minutes patient began having throat itching, tongue tingling, and lips swelling. Face brok... Read more
With in 5 minutes patient began having throat itching, tongue tingling, and lips swelling. Face broke out in hives and patient was shivering.
16 2021-05-25 cough, fatigue, headache, sneezing 5 days after vaccination- loss of smell and taste, shortness of breath, sneezing, coughing, ear infe... Read more
5 days after vaccination- loss of smell and taste, shortness of breath, sneezing, coughing, ear infections, fatigue, and headache.
16 2021-05-25 fatigue This patient received the Pfizer vaccine on 5/24/21 at 4:30pm and was feeling fine until the next mo... Read more
This patient received the Pfizer vaccine on 5/24/21 at 4:30pm and was feeling fine until the next morning at 5:30am when she felt dizzy and passed out. She then was able to get back up and passed out again. Her guardian states that she was gray in color and was very weak. She was able to communicate but was very tired and stayed at home for 2 days. Today she is feeling fine and guardian was asking if she should get the 2nd dose. I said that she should contact her physician.
16 2021-05-25 headache Sharp, stabbing unilateral headaches lasting 1-3 seconds, initially 2/day, now 15/day. Different fr... Read more
Sharp, stabbing unilateral headaches lasting 1-3 seconds, initially 2/day, now 15/day. Different from baseline headache type. Started day after second dose.
16 2021-05-25 headache FEEL QUEASY; AWFUL HEADACHE; This is a spontaneous report from a non-contactable consumer, the patie... Read more
FEEL QUEASY; AWFUL HEADACHE; This is a spontaneous report from a non-contactable consumer, the patient. A 16-year-old non-pregnant female patient received 1st dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number/Batch Number: UNKNOWN), solution for injection via an unspecified route of administration in the left arm on 14March2021 at 10.30 am as a single dose for COVID-19 immunisation. The patient was allergic to gluten (celiac), Zithromax and Augmentin. The patient concomitant medications include Zoloft (Manufacturer unknown) , Junel birth control (Manufacturer unknown) and Claritin (Manufacturer unknown). On 14March2021, the patient experienced awful headache and queasy. The patient has recovering from the event headache and queasy at the time of reporting. Information about lot/batch number cannot be obtained. No further information is expected.
16 2021-05-25 sweating Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed ... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Severe, Systemic: Vomiting-Mild, Additional Details: Patient temp at time of incident was 96.8. About 8 mintues after vaccination was given patient became pale and passed out for several seconds. Patient was dizzy and vomited. No other symptoms. Called paramedics to make sure patient was okay. Gave patient some water and spoke to patient until the paramedics arrived. Paramedics took her vitals and after while they cleared her. She was able to walk out on her own and went home with her father and brother.
16 2021-05-25 sweating Pt has history of anorexia. When she arrived at 1:00pm stated she had only eaten 1/2 banana today. S... Read more
Pt has history of anorexia. When she arrived at 1:00pm stated she had only eaten 1/2 banana today. Stated she has lightheaded and dizziness frequently and right then. RN instructed her to go and eat something before her vaccine could be given. She returned at 2:15 after eating a whole roast beef sandwich. Vaccine was given and she immediately began feeling even more lightheaded than her norm, per her. She was assisted to lay flat on the floor and feet placed up on the chair. She stated that helped but still was feeling poorly. 911 was called. She was diaphretic and got a severe headache, stating she was blacking out and unable to see. She never lost consciousness. Mother remained at side. EMT took her to hospital.
16 2021-05-25 fever 103 degree fever, migraine, severe joint pain, GI got significantly worse (pain in stomach); went to... Read more
103 degree fever, migraine, severe joint pain, GI got significantly worse (pain in stomach); went to ER; admitted overnight to hospital since they could not get the fever and migraine resolved; spent two days in the hospital treated with various medications including Tylenol and magnesium
16 2021-05-26 headache The afternoon of May 4th, (the patient) had a headache at the back of her head. She took an Ibuprofe... Read more
The afternoon of May 4th, (the patient) had a headache at the back of her head. She took an Ibuprofen and went to bed. Over the course of the next 3 weeks, the headache would return, but was alieved with Ibuprofen. On the evening of May 23rd, 2021 (the patient) came to me and said she had a twitching in her neck. I looked, but did not see anything that was concerning. It was just a twitch. On the evening of May 24th, (the patient) went to dinner with her father. On the way to dinner, they were having a regular conversation when (the patient) began to stutter really bad. Her father pulled the car over and looked at her. He noticed her head was shaking uncontrollably and she could not talk. He immediately took her to the emergency room. When I arrived, it looked like she was having a seizure. (The patient) has never had any kind of speech problem, so she has never stuttered. the drs told us that they did not have a neurology dept, so we took her to another hospital. After numerous tests, we were told to take her home and it was probably something like stress and she should see mental health
16 2021-05-26 fever Patient had fever and nausea with some vomiting roughly 5-10 minutes after receiving vaccine. Patie... Read more
Patient had fever and nausea with some vomiting roughly 5-10 minutes after receiving vaccine. Patient also had some trouble breathing but it resolved within a five minutes. Gave patient cold compress over her neck and monitored her breathing and nausea. All symptoms resolved and she was able to leave facility.
16 2021-05-26 sleepiness Shortly after receiving vaccine (about 5 minutes), pt complained about difficulty breathing. I went ... Read more
Shortly after receiving vaccine (about 5 minutes), pt complained about difficulty breathing. I went to check on her and she appeared pale and seemed very drowsy and unresponsive to questions. She continued to complain about dizziness and nausea. Her parents grabbed some water for her and still there was no improvement. I called 911 to report the symptoms and was advised to administer EpiPen. When asked if her breathing improved, she nodded yes, but she did not appear to have improved. She continued to be unresponsive to questions and appeared extremely drowsy. Within 15 minutes, the ambulance arrived.
16 2021-05-27 cough, fatigue The patient was previously well then shortly after the first COVID vaccine she began experiencing fa... Read more
The patient was previously well then shortly after the first COVID vaccine she began experiencing fatigue slowing to her swim times ( she is an high level swimmer) and felt "Off". She presented to my office on May 6, 2021 three days after her second COVID vaccine I examined her and heard a slight hint of a wheeze and in addition to labs did a CXR which was Abnormal with evidence of a LLL consolidation and a pleural effusion. We then did a CT scan with contrast and started her on antibiotics and I called Pulmonology to get her in quickly since swimming trials were approaching and we had to do our best to get her in shape to compete. We also did a rapid COVID test which was negative at my office on May 7, 2021-- The pediatric pulmonologist repeated the CXR 5 days later and there was more fluid and she was now having more sx of cough and feeling worse so she was Admitted to the Hospital on May 11th and had a Chest tube placed and drained 950 cc of serous fluid . Pulmonology, oncology and rheumatology consulted to rule out various other causes of the pleural fluid in an otherwise healthy girl. Surgery did the procedure and followed up outpt. She was in the hospital for approximately 4 days. Proximity of sx onset to doses and other sources being essentially ruled out lead to concern for vaccine complication.
16 2021-05-27 fatigue Myocarditis. Chest pain started 2 days after the 2nd shot. Elevated troponin and went upto 20. Near ... Read more
Myocarditis. Chest pain started 2 days after the 2nd shot. Elevated troponin and went upto 20. Near syncope and tiredness.
16 2021-05-27 sweating Shortly after receiving vaccination client became pale and diaphoretic, c/o blurry vision and fell f... Read more
Shortly after receiving vaccination client became pale and diaphoretic, c/o blurry vision and fell from chair. She received a minor injury to her right knee which was treated on the scene by EMS. BP 91/50, 02 99%, HR 46
16 2021-05-27 sweating Approximately five minutes after injection, patient began feeling faint, nauseated and weak. Her pa... Read more
Approximately five minutes after injection, patient began feeling faint, nauseated and weak. Her parents had her sit down. She began vomiting and sweating. We called 911. Her Dad starting taking vital signs. He is an ER Dr at local hospital.
16 2021-05-27 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
16 2021-05-27 malaise Patient received the Pfizer vaccine. Patient left to sit in out waiting room after vaccine. Patient'... Read more
Patient received the Pfizer vaccine. Patient left to sit in out waiting room after vaccine. Patient's mother informed in a few minutes that the patient was not feeling well. She stated that the patient felt hot. I grabbed an ice pack on my way out to her. I put the ice pack behind her neck. Patient passed out within a minute of me getting to the patient. She came back to quickly and stated that she was having a hard time seeing and hearing. She then again passes out. At this point I made the decision to call 911. I delegated to my tech to call 911. She called 911. I asked my other tech to come help me thinking the patient my have needed to be lower to the ground. The patient again regained consciousness. At this point I asked tech to call our Store Director and inform them. I also asked that she get me a water for the patient. The patient was feeling better and drank some water. She then again passes out. This time we were struggling to get her to regain consciousness. I used sternal rubs to help the patient regain consciousness. I was having a hard time finding her pulse. This lasted for a minute or two and then she stared responding. Right then EMS arrived and took over. I gave them the information I had and they took her vitals. EMS decided that she was stable and could go home to be monitored by mom. I did call the Mother the next morning to check on the patient. The patient did well last night and was feeling good this morning.
16 2021-05-28 fatigue, headache, fever Fever 37.5C, fatigue, headache, swollen lymph nodes, back of the neck pain, stomach ache, pale compl... Read more
Fever 37.5C, fatigue, headache, swollen lymph nodes, back of the neck pain, stomach ache, pale complexion. Missed school, stayed in bed at home until symptoms resolved.
16 2021-05-28 fatigue Patient: Felt tired 5 minutes post vaccine administration. Treatment: no medication was given. patie... Read more
Patient: Felt tired 5 minutes post vaccine administration. Treatment: no medication was given. patient was under observation. Water improved symptoms Outcome: symptoms resolved and patient was sent to POV/Home.
16 2021-05-28 headache delerium; Severe myalgia; full body rash; swollen legs; facial swelling; slurred speech; stomach pai... Read more
delerium; Severe myalgia; full body rash; swollen legs; facial swelling; slurred speech; stomach pain and cramping; nausea; headache; injection for vaccine received same date; injection for vaccine received same date; injection for vaccine received same date; This is a spontaneous report from a contactable consumer (patient). A 16-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in left arm on 15Apr2021 (Lot Number: EP7533, at the age of 16-year-old) as single dose, and second dose via an unspecified route of administration, administered in right arm on 15Apr2021 (Lot Number: EW0171, at the age of 16-year-old) as single dose for covid-19 immunization. Medical history included post streptococcal reactive arthritis and bee sting allergy. The patient's concomitant medications were not reported. On 16Apr2021, the patient experienced severe myalgia, full body rash, swollen legs, facial swelling, slurred speech, delerium, stomach pain and cramping, nausea, headache. Headache and stomach pain have lasted 7 days. Rash and myalgia lasted 5 days. Delerium, facial swelling, leg swelling and slurred speech lasted 12-24 hours and were relieved by Benedryl. The treatment for the event included Ibuprofen, Acetaminophen, diphenhydramine. The injection for vaccine received same date on 15Apr2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient was not pregnant. The outcome of the events severe myalgia and full body rash was recovered on 21Apr2021, for events stomach pain and cramping and headache was recovered on 23Apr2021, for other events delirium, swollen legs, facial swelling, slurred speech, nausea was recovering.
16 2021-05-28 headache Patient reports immediately after receiving the vaccine she developed chest tightness and pain that ... Read more
Patient reports immediately after receiving the vaccine she developed chest tightness and pain that has continued to wax and wane the past two weeks. Has some intermittent difficulty breathing and fast heart rate that each last about 20- 30 minutes. Also accompanied by dizziness or lightheadedness. Reports her whole right leg feels tingly and her joints hurt, but denies weakness, redness or swelling of the joints or right foot. Also has a continuous headache that started within an hour of receiving the vaccine and worsened over the next few days. This too has waxed and waned.
16 2021-05-28 malaise I woke up not feeling well. I was pale in color and felt nauseous, light headed and my ears were rin... Read more
I woke up not feeling well. I was pale in color and felt nauseous, light headed and my ears were ringing. I took my blood pressure and the reading was 120/71 with a pulse of 54 which is really low. I went to the Dr. to be evaluated. Dr. felt it was a vasovagal response. I will continue to monitor myself and if it continues, I will see a cardiologist.
16 2021-05-30 chills, fatigue, headache Vomiting (6 times in 12 hours) Chills Headache Fatigue
16 2021-05-30 fever, headache, fatigue, chills, influenza like illness 1st dose: fatigue, slight headache, pain in left arm. during arm circles, would be pain during movem... Read more
1st dose: fatigue, slight headache, pain in left arm. during arm circles, would be pain during movement pain for a day or two. Took Tylenol 2 tablets 500mg each on the night of the vaccine. 2nd dose: received vaccine at 5pm, during night of vaccine day, got a fever and headache and chills. flu-like symptoms for 24 hours. fever of 101F. soreness of muscles. on second day, fever was almost gone. lasted 2 days total. most severe symptoms on first day. Took Tylenol 2 tablets 500mg in the morning, 2 tablets 500mg in the evening. Took 1 tablet of Advil 200mg on day 2.
16 2021-05-31 chills My daughter had a mild seizure 5 minutes or less after receiving her first vaccine. She fell out of ... Read more
My daughter had a mild seizure 5 minutes or less after receiving her first vaccine. She fell out of her chair, her eyes fluttered and rolled in the back of her head, her teeth were clocking and chattering and her body was shaking mildly. She lost consciousness for approximately 2 minutes. At 8:33 pm she felt a second seizure begin, her step father grabbed her before she could fall and again, her eyes fluttered and rolled in back of her head, her teeth were clicking and chattering and her whole body was shaking. The second episode lasted approximately 2 minutes as well, with her losing consciousness again. She was taken to the emergency room and stayed overnight for observation.
16 2021-05-31 dehydration, headache, fatigue Syncope x 3 in the early morning hours (around 3am) about 14-15 hours after vaccine. She had had hea... Read more
Syncope x 3 in the early morning hours (around 3am) about 14-15 hours after vaccine. She had had headaches that is intermittent, throbbing, phonophobia but no photophobia, from back of head to top of head and behind eyes, taking Advil or Excedrin intermittently with relief for a week prior to covid19 vaccine. Syncope, longest lapse was two minutes, her sister found her. She went to Medical Center ER at 0400, was assessed and scanned, neg CT scan of head, and was discharged home. Has felt some fatigue today due to not sleeping early the night before, has returned to school since concussion, with normal learning, and denies any exertional physical activity due to pre-existing torn ACL, torn medial meniscus L knee. After evaluation by ER, was given IV fluids, determined cause to be dehydration.
16 2021-05-31 fatigue At 15:05 voiced complaints of feeling tired and dizzy. Crying and scared. Her mother was in attendan... Read more
At 15:05 voiced complaints of feeling tired and dizzy. Crying and scared. Her mother was in attendance. They gave her some orange juice. No tachypnea or dyspnea. Skin warm and dry. 15:10 – Attendee stated that she "felt funny". Attendee assisted to the cot and given orange juice. 15:13 - HR: 78 BP: 120/80 O2Sat%: 99. 15:16 –Water given 15:20 -No voiced complaints- skin warm and dry. Attempted to sit her up and she reported dizziness, so she laid back down. HR: 75 BP: 110/70 O2Sat%: 100 Temperature 98.7 15:25 – Sat up on cot the and dangled her legs without dizziness 15:26 – Assisted to a chair and denies feeling funny or dizzy. 15:30 - discharged to home with her parents
16 2021-06-01 chills Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Chills-Mild, Systemic: Dizziness / Lighthea... Read more
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: blurry vision-Mild, Systemic: Shakiness-Mild, Systemic: Weakness-Mild, Additional Details: Patient reported leg weakness and blurred vision and dizziness/slight difficulty breathing upon getting ready to leave observation area. Said she hadn't eaten in a while and felt cold due to A/C in the store as well. BP was low and HR high, so called 911 to get her emergency help as she didn't feel like she could walk out of store safely. Felt strange and that her legs might give way. EMS arrived, vitals looked good, pt refused ambulance.
16 2021-06-01 headache At about 3pm on 05-01-2021, my daughter started acting crazy. She does have a history of leukemia wh... Read more
At about 3pm on 05-01-2021, my daughter started acting crazy. She does have a history of leukemia which was treated 07-03-2020. She has history of neurological problems from chemotherapy. She also has down syndrome. She has headaches since the vaccine. She is non speaking, non-verbal. After her Pfizer vaccine, my daughter repeat things over and over, at night she cries, moves her hands a lot, yells when she is at school. My daughter did not have a fever, body aches after her vaccine. I feed her, bathe her and take care of her and since receiving the Pfizer vaccine she is not the same person. Before the vaccine, my daughter was sociable, respected, educated but since the vaccine she has been out of control and acting crazy. My daughter received the Pfizer vaccine at a clinic and the doctors there said that she should not get the second dose. At this time, my daughter is scheduled for an MRI appointment on 06-18-2021.
16 2021-06-01 throat pain She was having a sore throat. I took her to the primary care doctor for it. They put her on antibiot... Read more
She was having a sore throat. I took her to the primary care doctor for it. They put her on antibiotics. She just got done with the medicine yesterday.
16 2021-06-02 fever, headache At the time of the vaccine daughter dizzy and started to fade out 20 minutes after the vaccine. She ... Read more
At the time of the vaccine daughter dizzy and started to fade out 20 minutes after the vaccine. She couldn?t see and it seemed like it was a Vaso Vagal response which resolved quickly. At 5am the woke up with a fever of 102 and extreme left arm pain. The fever was controlled with Tylenol. Two days after the vaccine she woke up complaining of chest pain and a knot under her left arm. It felt like something was pressing on her chest. We went to the ER and all tests were negative. The feeling lasted until the end of the day. Three days after the shot the next morning she got a headache for half of the day and resolved with Tylenol. The next day all symptoms were gone. Emergency Room Dr.
16 2021-06-03 fatigue 5/28 - swelling of right eyelid, 5/30 - swelling of left eyelid, burning eye pain, itchy, felt dizzy... Read more
5/28 - swelling of right eyelid, 5/30 - swelling of left eyelid, burning eye pain, itchy, felt dizzy, trouble focusing, fatigue
16 2021-06-03 sweating approximately 5 minutes after vaccine, patient experienced paleness, nausea, tingling throughout bod... Read more
approximately 5 minutes after vaccine, patient experienced paleness, nausea, tingling throughout body, stomach tightness and sweaty
16 2021-06-03 sweating Pt w/ hx of allergy to penicillins (rash) & HPV vaccine (unknown reaction). Pt had syncope, flushin... Read more
Pt w/ hx of allergy to penicillins (rash) & HPV vaccine (unknown reaction). Pt had syncope, flushing/sweating and dizziness. BP 119/76, HR 78, RR 18 -- > 107/61, 72, 18. Recommended to the patient to take 2nd dose supine. Pt stable and released from the vaccination site.
16 2021-06-03 malaise, sweating Bleeding & bruising happened instantly as the injection was given. Within 2 minutes (walking to the... Read more
Bleeding & bruising happened instantly as the injection was given. Within 2 minutes (walking to the waiting area) she was feeling dizzy. By the time we sat down she said she felt like she was going to be sick. She began sweating - it was dripping off her head and neck and her eyes kept closing. She was extremely pale and her lips were white. She was like this for approximately 10 minutes.
16 2021-06-05 fatigue Patient's mom reported that patient had chest pressure and felt tired on Saturday 6/5/2021 (pt got 2... Read more
Patient's mom reported that patient had chest pressure and felt tired on Saturday 6/5/2021 (pt got 2nd pfizer covid 19 vaccine dose on 6/4/2021) per mom. Pt's mom was advised to contact PCP or visit urgent care or ER if symptoms get worse. Called pt's mom next day to follow up on pt's adverse reactions. Pt felt better and chest pressure went away per pt's mom.
16 2021-06-06 fatigue My daughter experienced fatigue, GI issues, heart racing, anxiety, jittery (these are signs that her... Read more
My daughter experienced fatigue, GI issues, heart racing, anxiety, jittery (these are signs that her thyroid is not working). All her thyroid issues were off, her TSH value was up to 6. My daughter still has her symptoms of anxiety, GI issues and anxiety.
16 2021-06-06 sweating 3:40pm pt. c/o lightheadedness, ringing in ears and getting sweaty. Patient requested water. Water... Read more
3:40pm pt. c/o lightheadedness, ringing in ears and getting sweaty. Patient requested water. Water was provided. BP 117/66, HR 66, O2Sat 99% on RA.
16 2021-06-06 fever, chills Fever and chills on the 8th and 9th; Over the last couple of weeks, several times that I've gone to... Read more
Fever and chills on the 8th and 9th; Over the last couple of weeks, several times that I've gone to doctor. On May 18th, she had what was considered to be a pre-syncope event (almost passed out). And she had a pretty large migraine headache as well - the headache lasted for days - for probably three days. 18th, went to dr and they took her vitals. They were under the impression she passed out from having the migraine (her blood pressure is low but normal, in general). Dr was called on Monday 24th - doctor wanted tests. She had another pre-syncope event on May 1st in school and then had a fever the rest of the week. (From 6/1/2021 - 6/6/2021 - fever and threw up and bad headache - fever until yesterday). I did take her pediatrician. Negative for COVID and Strep on 2nd . She had another migraine on Tuesday. Pediatrician said it could be a viral infection of some sort. Neurologist believes the migraines were exacerbated by the viral infection as well. This one has lingered and it's the first time she had a migraine within a week or two weeks of each other. She was out of school was out 2 1/2 days last week and the week of the 18th she was out of school the 19th and got sick again the 20th and was out.
16 2021-06-07 fatigue, lethargy, sweating, headache, chills Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat T... Read more
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Chills-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Severe, Systemic: Hypertension-Medium, Systemic: Shakiness-Severe, Systemic: Tachycardia-Medium, Systemic: Visual Changes/Disturbances-Severe, Systemic: Weakness-Severe, Additional Details: Patient appeared weak, pale, sweaty, shaky about 5 minutes after the first dose was given to her. She complained of visual disturbances and progressive shortness of breath. Stated her throat felt a little tight but was not experiencing and swelling of of any parts of her face. She then complained of an intense headache that was getting worse. Patient was admitted to the hospital to make sure she was ok.
16 2021-06-07 head discomfort Pt was laying down for 2nd Covid vaccination as she fainted for 1st Covid vaccination. After 2nd vac... Read more
Pt was laying down for 2nd Covid vaccination as she fainted for 1st Covid vaccination. After 2nd vaccination was given- she had a vaso vagal reaction. BP 102/72 Pt has had 4 episodes of ears ringing & pressure both sides of head. Recommended to see her primary Dr. after leaving clinic.
16 2021-06-07 throat pain Patient admitted with myocarditis s/p dose #2 of the Pfizer COVID-19 vaccine. At the time of the re... Read more
Patient admitted with myocarditis s/p dose #2 of the Pfizer COVID-19 vaccine. At the time of the report, she is still hospitalized. From EHR note: Patient was in her usual state of health when she received her second dose of the Pfizer mRNA Covid vaccine on 6/3. She experienced mild myalgias in the day following the vaccine. However, on 6/5 she developed new severe substernal chest pain, dizziness, and dyspnea. Pain radiated to her throat. Given severity of pain, she presented to the emergency department. In the ED she was afebrile, tachycardic, and initially hypertensive. Labs demonstrated WBC 10.9 (N 49, L 27), Hb 11.7, PLT 315. ESR 25, CRP 7.61. Troponin T was mildly elevated at 0.08, consistent with mild cardiac inflammation. SARS-CoV-2 PCR and antibody testing were negative. An EKG was normal. However, an echo demonstrated low-normal LVEF (55%). Otherwise, patient denies nausea, vomiting, diarrhea, cough, runny nose, conjunctivitis, new rashes, arthralgias. Patient was admitted to the cardiology service for further monitoring. Following admission, she was started on ibuprofen. She notes that her substernal chest pain has improved somewhat since admission. Differential for patient's presentation includes infectious, post-infectious, and non-infectious causes of myocarditis. Although post-vaccination mild myocarditis seems likely, we agree with the infectious workup already undertaken, and recommend additional EBV and CMV PCR testing.
16 2021-06-07 fever Fever, urticarial rash to face, neck trunk, and extremities, arthralgias and swelling to hands, feet... Read more
Fever, urticarial rash to face, neck trunk, and extremities, arthralgias and swelling to hands, feet, ankles, left knee and left elbow occurring 4 weeks after vaccine lasting for 4 days in hospital after 2 days at home. still resolving slowly
16 2021-06-07 fever Fever and chest Pain
16 2021-06-08 fatigue, headache She experienced severe chest pains within the first 24 hours of the vaccine. The pains have lingered... Read more
She experienced severe chest pains within the first 24 hours of the vaccine. The pains have lingered on and off for a week after. She has severe fatigue, headaches, nausea, and bilateral arm pain in both arms like pain in her bones. They are giving her Zofran for the nausea which also causes headaches.
16 2021-06-08 headache, chills Patient felt dizzy, lightheaded, had chills, and a headache about 5-10 minutes after receiving her v... Read more
Patient felt dizzy, lightheaded, had chills, and a headache about 5-10 minutes after receiving her vaccine. Her feet were elevated, blood pressure taken (87/76), temperature taken(95F) at 5:15pm. She was given a cold compress. Since she hadn't eaten for several hours, she was given some orange juice. After approximately 10 minutes, her blood pressure was taken again and it had elevated (98/76). The patient said she felt better and was able to get up and move around without any other symptoms. She left with her mother at 5:38pm.
16 2021-06-08 headache, fatigue, malaise, chills, fever After the second dose a high fever onset overnight and lasting throughout next day. Temp of 102.2 wi... Read more
After the second dose a high fever onset overnight and lasting throughout next day. Temp of 102.2 with chills, headache, general malaise and exhaustion that slowly resolved over the course of hours until following morning. Overall 24 hours of symptoms.
16 2021-06-08 headache Patient had a headache this morning. At 11:30am she felt hot, so we took her temperature which was ... Read more
Patient had a headache this morning. At 11:30am she felt hot, so we took her temperature which was 100.0. She then walked into another room and had a febrile seizure lasting 30 seconds. Her face was pale white, her eyes were open and staring off, she moaned initially and then her jaw was stuck open with her tongue making a clicking sound. She urinated herself and then the seizure ended.
16 2021-06-08 headache After given Covid19 vaccine Pfizer 2nd dose to patient on 6/8/21, patient feels dizziness, headache ... Read more
After given Covid19 vaccine Pfizer 2nd dose to patient on 6/8/21, patient feels dizziness, headache and start to faint. We called 911 and paramedic came very quickly. Patient was conscious and we continue monitored patient for about 30 more minutes and she was ok at the store. Advice her dad to continue monitor patient when at home and report if any side effects. We called patient to follow up in the evening and patient is doing fine.
16 2021-06-09 chills Approximately 12 hours post vaccine, she started experiencing intense muscle spasms/twitching and ch... Read more
Approximately 12 hours post vaccine, she started experiencing intense muscle spasms/twitching and chills. This lasted approximately 3 hours. She stated she was unable to control her hands to work her phone to text or call for help. She stated she could not talk. After approximately 3 hours, she stated she got very flushed and then regained muscle control. She fell asleep amd felt fine when she awoke.
16 2021-06-09 sweating, malaise, body temperature increased Mom stated that patient reported she did not feel well about 6:30 pm (the same evening). She then sa... Read more
Mom stated that patient reported she did not feel well about 6:30 pm (the same evening). She then sat down, eyes rolled back in her head, speech was slurred and finally, became unresponsive for about 10 seconds. She was sweating uncontrollably, had a temperature of 99.1 F. afterwards. After she came to, she reported that she couldn't hear, eyesight became blurry just prior to incident. Mom stated that she was a little confused. Had some bottled water and felt better. Mom states that today (6/10), she is feeling better. She did not take any medications at that time. (The vaccine clinic was held as a drive-through, with people remaining in their cars). The weather was very warm. Unknown what activities patient was engaging in the rest of the day.
16 2021-06-09 throat irritation Patient came to college on 4/24/21 after she received her Pfizer COVID vaccine from hospital. She r... Read more
Patient came to college on 4/24/21 after she received her Pfizer COVID vaccine from hospital. She reported chest tightness and itchy throat. Her pulse ox was 98. Her lungs were clear. She accompanied her mother who was coming to college for her COVID vaccine. EMS spoke with patient as did Dr. Pt refused to go with EMS to the ED. She claimed if she had any problems she would go back to hospital.
16 2021-06-10 fever, fatigue, sleepiness Patient slept for about 16 hours a day; Severe fatigue; Vomiting; Nausea; Fever; This is a spontaneo... Read more
Patient slept for about 16 hours a day; Severe fatigue; Vomiting; Nausea; Fever; This is a spontaneous report from a contactable consumer (patient's mother). A 16-year-old female patient (daughter) received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 15May2021, as a single dose for COVID-19 immunization. The patient's medical history included ongoing asthma (gotten better in the past year or so but had it almost her whole life investigation assessment: No) and cold. Concomitant medications were not reported. The patient's mother reported that on 16May2021, the patient (daughter) developed nausea and vomiting for about 12 hours and treated with dramamine and went away, completely resolved. She also had fever of up to 102 Fahrenheit for about 3 days that went away and also presents severe fatigue that lasted from 9 to 10 days that started on 18May2021 and was only improving now and wanted to know if that would that be an allergic reaction, when she presented fatigue the patient slept for about 16 hours a day. The hours that she was awake she was normal, she was nor weak. Caller wants to know what can they expect "fatigue wise" with the second dose and why do patients develop fatigue. She also wants to know if a "severe fatigue" could last several days. A higher incidence was reported with the second dose of the vaccine with adults and adolescents. No information on how long the fatigue would last. The outcome of the events nausea and vomiting was resolved on 16May2021 and fever was resolved on an unknown date. Outcome of the severe fatigue was recovering and for the event patient slept for about 16 hours a day, it was unknown. Follow-up attempts are needed. Information on Lot/Batch number is requested.
16 2021-06-10 fever Pt. received COVID-19 vaccine on 06/05/21 and developed a mild fever on 06/06/21, but had not had a ... Read more
Pt. received COVID-19 vaccine on 06/05/21 and developed a mild fever on 06/06/21, but had not had a fever since that day when coming to the ED on 06/10/21. On 06/07/21 while the pt. was at school pt. became dizzy and pupils dilated. Pt. was picked up from school and rested for 3 hours and she did not remember how she got home or how she got to the school nurse..Pt.in ED for similar symptoms 6/7/21 and 6/9/21 before coming again on 06/10/21 with a negative work up. Pt. has been on school zoom meetings and has been looking at pillows and thinking they are people and they were moving and talking to her. Pt. walking into walls, trouble walking and intermittent confusion and multiple episodes of conversations that she does not recall and time periods which she can not remember. Pt. was transferred to a higher level of care in another facility.
16 2021-06-12 fatigue It could be that I?m just sixteen, but I started the worse period of my life today. It is really hea... Read more
It could be that I?m just sixteen, but I started the worse period of my life today. It is really heavy (more so than normal) and I?ve been having some pretty intense cramps. For the first time in my life I?m considering taking some sort of pain medication for my cramps. I didn?t have any of the usual signs that it was coming. As in, I normally cramp for maybe 2 days before my actual period starts. My cycles are normally quite long and irregular, but that ?pre-cramping? always happens. I?m also really tired, but that seems normal as everyone else in my family was super tired and their arm hurt.
16 2021-06-12 headache, fatigue Fatigue - rapid heart rate when standing up, exceeds 120bpm when walking or standing and then goes d... Read more
Fatigue - rapid heart rate when standing up, exceeds 120bpm when walking or standing and then goes down when lying, chest pain, severe headache, shortness of breath. All tests to rule out other causes negative
16 2021-06-12 headache Systemic: Fainting / Unresponsive-Medium, Systemic: Headache-Medium
16 2021-06-12 headache headache, ataxia, weakness, loss of DTR in lower extremites, treated with steroids. clinical improve... Read more
headache, ataxia, weakness, loss of DTR in lower extremites, treated with steroids. clinical improvement over 7 days. discharged home to follow up with pediatrician, pediatric neurology, pediatric infectious disease, and pediatric rehab. patient also found to have coronavirus (NOT COVID 19) acute infection during illness as well.
16 2021-06-12 malaise EVENT: 5 minutes after receiving 2nd Pfizer vaccine, patient reported she wasn't feeling good. she w... Read more
EVENT: 5 minutes after receiving 2nd Pfizer vaccine, patient reported she wasn't feeling good. she was already seated, so we had her bend forward with her head between her knees. That wasn't providing enough relief so we had her grip fingers into a fist and tense her arms. Got the patient cool water bottle to put on her neck. After approximately 2 minutes, patient was recovering and drank some water. She sat up again and her eyes started to lose focus and she said her ears were ringing. Had her put her head back down. She was too unstable to have lie down on the floor so we had her elevate her legs on another chair. Syncope symptoms resolved but patient said she was starting to have what she believed was a panic attack. Tried to have patient list 5 things she could see, hear, etc, but she was too anxious to do so. Asked patient about school/summer break and she started to relax. After 15 minutes of additional observation, patient was able to stand by herself. Guardian walked with her through the store for a few minutes before leaving.
16 2021-06-12 fever, fatigue, throat pain, respiratory tract congestion migraine, fever, sore throat, congestion, fatigue, body aches, nausea.
16 2021-06-13 headache vomiting for 4 days, head ache, hot flashes, loss of appetite, thirsty, achy, eye twitches
16 2021-06-13 sweating Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsiv... Read more
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Mild, Systemic: Nausea-Mild, Systemic: Tinnitus-Medium, Systemic: Weakness-Medium
16 2021-06-13 fever, fatigue Patient experienced fever to 103 and seizure about 28 hours after vaccine administration. Also had s... Read more
Patient experienced fever to 103 and seizure about 28 hours after vaccine administration. Also had some fatigue. Since vaccine notes ongoing fatigue and weakness. Having some chest discomfort without wheezing that has been responsive to albuterol.
16 2021-06-13 fever 16-year-old one day status post Pfizer vaccination #2. Other than the typical, known side effects o... Read more
16-year-old one day status post Pfizer vaccination #2. Other than the typical, known side effects of the vaccination, patient has right sided and fasciculations at rest and with movement. Additionally she reports numbness of the hands and feet although sensation is intact to light touch and remainder of exam is reassuring. The exam is not consistent with tardive dyskinesia, however in order to give patient symptomatic relief she was given Benadryl 25 mg by mouth ×1 with resolution of the fasciculations. Incidentally, the patient did develop a fever while in the urgent care, was given 650 mg of Tylenol. Patient was discharged from the urgent care in good condition, reassuring vital signs, well-appearing with instructions to take Tylenol and Benadryl as below as needed. Peds follow-up Monday
16 2021-06-14 fatigue I experienced fatigue upon waking up along with frequent heart palpitations. Heart was racing and t... Read more
I experienced fatigue upon waking up along with frequent heart palpitations. Heart was racing and then would come and go in fits.
16 2021-06-14 sweating Onset of diaphoresis, dizziness, and visual changes shortly after shot given. Dark vision described ... Read more
Onset of diaphoresis, dizziness, and visual changes shortly after shot given. Dark vision described without tunnel vision. No nausea or LOC. Initial BP 95/60, Pulse 74, O2 sat 96%. BP consistently 103-112 systolic thereafter without orthostasis. Returned to feeling normal. Patient dismissed with father feeling well. She stood while father made off-site 2nd vaccination arrangements at exit desk. Walking out the door she had sudden classic tunnel vision, and brief LOC. She was eased to the ground by her brother and had no injury. Second stay in Observation was for 40 minutes with resolution of symptoms and consistently normal vital signs. No orthostasis.
16 2021-06-15 fatigue Chest pain, heart racing, extreme vomiting , extreme fatigue
16 2021-06-16 fatigue My daughter had been battling migraines and joint pain and generalized fatigue for over three years.... Read more
My daughter had been battling migraines and joint pain and generalized fatigue for over three years. We started seeing a functional medicine specialist in April and radically altered her diet due to food sensitivities. Approximately two weeks prior to the Covid vaccine she had been free of migraines for over four weeks and free of generalized fatigue and joint pain for over two weeks. Within two hours of receiving the Covid vaccine her generalized fatigue and joint pain was back and has not yet resolved as of today.
16 2021-06-16 headache, fever headaches with dizziness; headaches with dizziness; felt feverish; itchiness we're I got my 2nd shot... Read more
headaches with dizziness; headaches with dizziness; felt feverish; itchiness we're I got my 2nd shot; Diarrhea; stomachache; This is a spontaneous report from a contactable consumer (patient). A 17-year-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 2 (Age at vaccination: 16 years) via an unspecified route of administration, administered in Arm Right on 03Jun2021 12:00 (Batch/Lot Number: EW0179 and Expiry date:Unknown) as 2ND DOSE, SINGLE for Covid-19 immunization. Medical history included allergy of big amounts of biotin. The patient concomitant medications was not reported. Historical vaccination included previously the patient received bnt162b2 (BNT162B2), dose 1 (Age at vaccination (years): 16) via an unspecified route of administration, administered in Arm Right on 13May2021 12:30 PM (Batch/Lot Number: EW0179 and Expiry date:Unknown) as 1st DOSE, SINGLE 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. Since the vaccination, the patient has not been tested for COVID-19. On 04Jun2021, after second dose, first day diarrhea and stomachache. On 05Jun2021 (2nd day) she felt feverish but was not too bad and also itchiness where she got her 2nd shot. On 06Jun2021,(on the 3-4 day) the patient had headaches with dizziness .The patient did not received treatment for the events. The outcome of the events was resolved on an unspecified date in 2021. Information on Lot/Batch number was available. Additional information has been requested.
16 2021-06-16 headache PT is a 16-year-old female with a history of dysmenorrhea and dyslexia who is otherwise healthy, and... Read more
PT is a 16-year-old female with a history of dysmenorrhea and dyslexia who is otherwise healthy, and is presenting after various neurologic symptoms after second Covid vaccine on 6/9/21. PT was in her usual state of health until she had her second Covid vaccine on June 9 around 2:30 PM. She reported that initially about 10 to 15 minutes after the vaccine she began experiencing a headache and blurry vision. However this resolved after 10 to 15 minutes of resting, and patient did not think much of it at the time. She thought it was likely either due to dizziness or to anxiety around the shot. For the rest of the day she felt like her typical self. On June 10 she woke up feeling normal and went to school. Around 1:30 PM she began experiencing a severe headache that she described as pounding. She did feel like this was the worst headache of her life and rated it about a 7 out of 10. This headache continued and she began experiencing also some numbness and tingling in her right thumb that then spread to her hand. During the symptoms she suddenly had an episode of abnormal speech. She was attempting to talk to friends when she began and having difficulties forming words. She remembers being able to think logically and could think about what sentence she wanted to say, but when she tried to speak the words came out as nonsensical sounds. Eve was confused and scared by this and immediately went to the school nurse. This lasted for about 2 minutes where she was having complete aphasia. The school nurse monitored her and suspected she was having a panic attack. After 2 minutes she began being able to form words properly but was still having difficulty forming sentences that were sense of call in finding words. This lasted for about 10 minutes, and then patient returned back to baseline. School nurse called mom and mom picked patient up and immediately took her to the pediatrician. Pediatrician saw her about an hour after this episode and by the time they examined her she was completely back to her baseline. Pediatrician then referred her to neurology. Since this episode on June 10 pt has experienced intermittent symptoms including: Periodic headaches, numbness and tingling of right forearm and thumb, muscle cramping and pain. She has not had any further events of blurry vision or aphasia. She has not had any weakness or clumsiness. She has been able to engage in normal life activities. However her intermittent symptoms have persisted and have been concerning to family. She was seen by neurology outpatient on June 11 who evaluated her and at that time suspected that her vaccine may have triggered a hemiplegic migraine. They recommended brain MRI to rule out other intracranial abnormalities. Family was waiting for this MRI but her symptoms were continuing and were concerning to family. Today on June 14, Eve was experiencing muscle cramping in bilateral lower extremities and upper extremities and continuing to experiencing numbness and tingling of bilateral forearms and thumbs intermittently. The pain from cramping was more severe today than prior days, and because of this family felt more comfortable presenting to the ED for further evaluation and not waiting for outpatient MR. PT has never had a blood clot or bleeding disorder that family is aware of. She does take OCPs. There is no family history of blood clots or strokes. She otherwise has been well. She has been afebrile emesis, diarrhea, URI symptoms, abdominal pain. Briefly, 16yoF otherwise generally healthy who p/w persistent HA and paraesthesias following 2nd COVID vaccine. Initially evaluated on Monday this week by Neuro who recommended outpt brain imaging, but presented tonight due to persistence of symptoms. Has been neurologically intact here, asymptomatic aside from mild HA that resolved with tylenol. Labs wnl. Neuro consulted in the ED, ddx cerebral venous sinus thrombosis vs. post-vaccine GBS vs. COVID vaccine-associated neuropathy. MRI/MRV brain w/ contrast and MRI entire spine w/ contrast revealed "Punctate principally bifrontal T2/FLAIR hyperintensities, of indeterminate significance at this point in time. This could relate to demyelination, migraine, or be nonspecific. Follow-up MRI may clarify as clinically desired. No evidence of prior or acute ischemic insult. Unremarkable intracranial MRV. No cerebral venous thrombosis. No significant abnormality seen of the spine." Per Neurology, these lesions are not in a pattern that would be consistent w/ MS, and more likely represent an incidental finding with no correlate on neurologic exam. They recommend follow-up MRI in 6 mos to 1 yr to evaluate for any interval change. They will also continue to follow her for headache management as needed. Discussed this plan with patient and family and they expressed understanding and agreement with this plan for discharge and follow-up. Patient was discharged to home in stable condition.
16 2021-06-16 sweating, fatigue felt exhausted; Blood pressure low, after the seizure: 73/49 and 68/42; skin pale and sweating, afte... Read more
felt exhausted; Blood pressure low, after the seizure: 73/49 and 68/42; skin pale and sweating, after the first vaccine; skin pale and sweating, after the first vaccine; Tired and weak, with some lightheadedness, after the first vaccine; Tired and weak, with some lightheadedness, after the first vaccine; Seizure: described as staring, passing out, stiffening of arms, talking like a toddler and giddy, after the first vaccine.; Seizure: described as staring, passing out, stiffening of arms, talking like a toddler and giddy, after the first vaccine.; Seizure: described as staring, passing out, stiffening of arms, talking like a toddler and giddy, after the first vaccine.; Seizure: described as staring, passing out, stiffening of arms, talking like a toddler and giddy, after the first vaccine.; Seizure: described as staring, passing out, stiffening of arms, talking like a toddler and giddy, after the first vaccine.; felt funny; This is a spontaneous report from a contactable consumer(mother, a nursing assistant, years ago) reported for a patient(daughter). The 16-year-old female patient received bnt162b2 (BNT162B2, Pfizer vaccination, Covid vaccine) at the age of 16-year-old, dose 1 via an unspecified route of administration, administered in Arm Left on 28May2021 11:52 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. Medical history included seizure from 28May2021 to an unknown date (doctor wants to schedule an EEG, for further evaluation of the seizure ,because they did not do that test in the hospital.), ongoing Feels down at times (Consumer states the doctor originally prescribed her daughter another medication. Because all the appointments were by video, Consumer felt the doctor was not understanding her daughter's issue. Consumer states the original medication for ADHD was helping her daughter, but it made her daughter uncomfortable, as her daughter had no problems with attention, or school. Caller states then the doctor changed the medication to Zoloft. Name of previous medication was Zenzedi.). No family Medical History. Concomitant medication included sertraline hydrochloride (ZOLOFT) taken for depressed mood from 19May2021 and ongoing. Consumer states that her daughter is not depressed, but just feels down at times, and it is not severe. Consumer states the doctor had her daughter on another medication before Zoloft, that is used for ADHD. Consumer states that her daughter has not been diagnosed with ADHD, and the doctor switched the medication once her issues were further understood, as clarified in later part of report. The patient experienced seizure: described as staring, passing out, stiffening of arms, talking like a toddler and giddy, after the first vaccine on 28May2021 with outcome of recovered, felt funny on 28May2021 with outcome of recovered , blood pressure low, after the seizure: 73/49 and 68/42 on 28May2021 11:52 with outcome of recovered , skin pale and sweating, after the first vaccine on 28May2021 with outcome of recovered , skin pale and sweating, after the first vaccine on 28May2021 with outcome of recovered, tired and weak, with some lightheadedness, after the first vaccine on 28May2021 with outcome of unknown, tired and weak, with some lightheadedness, after the first vaccine on 28May2021 with outcome of unknown, felt exhausted on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included blood pressure measurement: 73/49 on 28May2021 low , blood pressure measurement: 68/42 on 28May2021 low , blood pressure measurement: normal on 28May2021, heart rate: 55 on 28May2021, heart rate: 70 on 28May2021. The clinical course was reported as follows: Consumer states she took her daughter Friday, to have her first Pfizer vaccination, later reclarified as the Covid vaccine. Consumer states her daughter had a seizure after the vaccine. Consumer states Height maybe 5'8" or 5'9". Consumer states her daughter was weighed at the hospital. Consumer states that the experience was terrifying for her, to watch her daughter have the seizure. Consumer states her husband got the vaccine, and was fine. Consumer reports that her daughter got the vaccine at 11:52 am and within 30 seconds, her daughter said she felt funny, and then rolled her eyes and passed out. Consumer states after a minute, her daughter was conscious and the staff was rushing to her aid, as the Consumer called 911. Consumer states that for the next 25 to 30 minutes, her daughter was talking like a toddler, and was pale and sweating. Consumer states that the paramedics, told her daughter that she had a seizure, as they took her to the hospital. Consumer reports her daughters blood pressure, around the time of the event. Consumer states the first blood pressure, when her daughter awakened, after the seizure about 2 minutes later was 73/49, pulse 55, and a few minutes after that it was 68/42 and her pulse was 70. Seizure: Time: 11:52 am, almost immediately after the vaccine. Outcome: caller answers as she is monitoring her daughter closely. Consumer states that during her seizure, her daughter started to stare, and then passed out. Consumer states her daughter did have some stiffening of the arms with the seizure. Blood pressure low: Consumer states he daughter's blood pressure, began to elevate, before they transported her to the emergency room. Time: 11:52 am, almost immediately after the vaccine. Outcome: Consumer answers as her daughter's blood pressure was stabilized enough by the time she was transferred to the hospital, where it normalized. Consumer reports later that her daughter's skin was pale and she was sweating, at this time. Reclarified, Consumer states that when her daughter was talking to the medical staff, she was talking like a toddler, and giddy. Consumer states she was trying to tell the staff that this is not normal for her daughter. Consumer reports her daughter feels tired and weak after all the events. Consumer states she signed up for VSafe. Time: Consumer states sometime, after the vaccine. End: Consumer answers as her daughter is not as tired and weak, as she was the first day the event happened. Caller states that the next day, her daughter relaxed all day, and the day after that, her daughter went to work and felt exhausted, but felt that she could still go to work. Consumer states that yesterday at work, her daughter said she felt weak, and lightheaded. Consumer states that after having a snack and a break, her daughter felt better and worked the rest of her shift. Outcome: Unknown. Reclarified, Caller states she does not want to assume anything, and is monitoring her daughter, and that this event may be due to another reason, as well. Consumer clarifies her daughter went to the emergency room and then was released. Vaccination Facility Type was pharmacy. No Vaccine Administered at Military Facility. No History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available).No additional Vaccines Administered on Same Date of the Pfizer Suspect. The event Seizure required a visit to Emergency Room, not Physician Office. Prior Vaccinations (within 4 weeks), list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine was none. No AE(s) following prior vaccinations. Caller reports some prior vaccinations that her daughter had without any events. Consumer states that her daughter is not going to get the second vaccination. Consumer states that she does not know the potential risk, if her daughter gets another vaccination. Information about lot/batch number has been requested.
16 2021-06-16 sweating woke up sweating with hot flashes. Also dizzy
16 2021-06-16 lethargy, sluggishness Xeljanz (tofacitinib citrate) was given for Alopecia; First Dose: felt a little sluggish and letharg... Read more
Xeljanz (tofacitinib citrate) was given for Alopecia; First Dose: felt a little sluggish and lethargic; First Dose: felt a little sluggish and lethargic; This is a spontaneous report from a contactable consumer (patient's father) via a Pfizer sponsored program. A 16-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: not reported), dose 1 via an unspecified route of administration on 01Jun2021 (at the age of 16-years-old) as SINGLE DOSE for covid-19 immunisation; tofacitinib citrate (XELJANZ), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) and ongoing, at unspecified dose for alopecia. The patient medical history was not reported. The patient concomitant medications were none. It was reported that tofacitinib citrate was given for alopecia. She had no reaction except she felt 'sluggish' and lethargic. Caller did not want to file a report. She was currently on tofacitinib citrate and she was scheduled to receive her second dose of the Pfizer BioNTech COVID-19 vaccine in 1 to 2 weeks. Since tofacitinib citrate was an immunosuppressant and people who are taking immunosuppressants may have a lower response to the vaccine and therefore not produce enough antibodies, should her daughter get an antibody test done and how long after the second dose should she get it done. The caller's daughter was taking tofacitinib citrate for Alopecia and he wanted to know the reaction between tofacitinib citrate and the Pfizer COVID Vaccine. Caller stated his daughter has been taking tofacitinib citrate for a couple of years now and he was reading how the medication would interact with the COVID vaccine. Caller stated some reports stated that after the second vaccine, it might be wise to get an antibody test to make sure the body was producing antibodies. Caller stated the patient took the first dose, but she hasn't taken the second one. Caller stated there were no adverse events, other than she felt a little sluggish and lethargic for a day or two. The outcome of all event were unknown. Information on Lot/Batch number has been requested.
16 2021-06-17 headache Date of Vaccine: June 10th 2021 Onset of Symptoms: June 13th In the evening headache June 14th- thre... Read more
Date of Vaccine: June 10th 2021 Onset of Symptoms: June 13th In the evening headache June 14th- threw up 3 times during the day. In the late evening severe headache and light sensitivity during evening of the 14th severe throwing up, dizziness and weakness Early morning of June 15th-More throwing up(uncontrollable). weakness. room spinning, noise sensitivity and light sensitivity. LEFT TO GO TO EMERGENCY ROOM Admitted right away. Suspected Meningitis CT scan, Lumbar punch IV fluids. drugs to reduce vertigo symptoms. ADMITTED TO HOSPITAL IV continued, more medicines, continued room spinning 16 and 17th in hospital Released 10PM from hospital with severe Labyrinthitis and Vestibular Neuritis diagnosis. Continues to be weak and dizzy.
16 2021-06-17 lethargy, fatigue Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium
16 2021-06-17 malaise, headache Dose 1 (box 11) Pain injection site, reaction to previous exposure to vaccine Dose 2 sleep excessive... Read more
Dose 1 (box 11) Pain injection site, reaction to previous exposure to vaccine Dose 2 sleep excessive, nausea, headache, feeling unwell, injection site induration, injection site pain
16 2021-06-18 sweating, headache Site: Pain at Injection Site-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium,... Read more
Site: Pain at Injection Site-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Seizure-Mild
16 2021-06-18 sweating Pt began to feel dizzy, warm and faint within 10 minutes of her second pfizer vaccine. Pt did not l... Read more
Pt began to feel dizzy, warm and faint within 10 minutes of her second pfizer vaccine. Pt did not lose consciousness but was dizzy, clammy, sweaty, pale, faint feeling. Pt responded to commands but felt faint.
16 2021-06-19 headache, fever Felt nauseated, vomited, headache, low grade fever until 6/16/21 in the evening
16 2021-06-19 sweating Approximately 20 minutes after vaccine patient passed out, became pale and sweaty. She lost consciou... Read more
Approximately 20 minutes after vaccine patient passed out, became pale and sweaty. She lost consciousness briefly. I put her in a supine position on some chairs in waiting area. A technician called 911 while cool towels were applied and water was administered. She regained consciousness before EMTs arrived. She relayed while her that she disliked needles and did not eat breakfast that day.
16 2021-06-20 headache, fever, throat pain 16 y/o F with hx of autoimmune disorder and Tourette's syndrome BIB mom for dizziness s/p Pfizer COV... Read more
16 y/o F with hx of autoimmune disorder and Tourette's syndrome BIB mom for dizziness s/p Pfizer COVID-19 vaccine received yesterday. Pt endorses muscle pain, nausea, sinus pain, throat pain, and HA. Pt with fever (Tmax 100.2F) onset this AM. Denies chest pain and difficulty breathing. Pt reports she feels a little out of breath. Mom has a heart rate monitor at home and states pt's HR has been in the 140s. No medications taken. NKDA. Differential Diagnosis: vaccine reactions, myocarditis, pericarditis. After physical assessment and management, pt is well appearing, explained to mom on reassessment symptoms have improved, no longer dizzy or having trouble breathing. Pt still feels a little myalgia. Explained symptoms likely from vaccine reaction, explained normal heart enzymes and normal EKG, strict return precautions given including chest pain and persistent fever.
16 2021-06-20 fever Low grade fever, body aches and swollen lymph node in armpit of arm the vaccine was injected. The l... Read more
Low grade fever, body aches and swollen lymph node in armpit of arm the vaccine was injected. The lymph node has been swollen for 2-3 days. She has taken Tylenol and ibuprofen to decrease the swelling
16 2021-06-23 sweating DIZZINESS, PALE, DIAPHORETIC, BLURRED VISION, LAUGHING AND CRYING AT SAME TIME. ICE PACK APPLIED AND... Read more
DIZZINESS, PALE, DIAPHORETIC, BLURRED VISION, LAUGHING AND CRYING AT SAME TIME. ICE PACK APPLIED AND PT WAS FEELING FINE AFTER SOMETIME.
16 2021-06-23 lethargy Patient became lethargic within 5 minutes. Within 10 minutes she developed tightness in the chest, ... Read more
Patient became lethargic within 5 minutes. Within 10 minutes she developed tightness in the chest, difficulty breathing, and numbness in both hands. We administered an Epi-pen and symptoms began to improve in 10-15 seconds. She then was evaluated by emergency medical personnel and taken to a local hospital for follow up.
16 2021-06-23 runny nose Patient got the 1st dose of pfizer and was fine at the time of administration. However, as she sat ... Read more
Patient got the 1st dose of pfizer and was fine at the time of administration. However, as she sat down on the chair for observation, that was when she fainted and fell off but someone was there to catch her. After a minute, she regained her consciousness back. We took her BLOOD PRESSURE and it was normal. Ambulance came and took her to hospital. Yesterday, her sister came to pharmacy and asked if it was normal for her to keep having runny nose. We told her she might feel like flu-like symptom but to be safe, it's better she goes to see her primary doctor/urgent care.
16 2021-06-24 sweating Patient was fine when receiving vaccine,(350 pm) patient and parents were instructed to wait 30 and ... Read more
Patient was fine when receiving vaccine,(350 pm) patient and parents were instructed to wait 30 and to stay close in case there was a reaction. after a few minutes parent and patient started to walk to a nearby park bench and when she was sitting she "Looked like something was wrong" per parents, they (Parents walked her back over to mobile unit and the Nurse immediately called 911 at 3:56pm. Patient was talking at this time, she stated she lost hearing, appeared pale and Diaphoretic, patient was sat down and given water, her color started to return to her lips and face, patient stated after a few minutes she started to feel better. the emergency squad arrived at roughly 4:05 pm. Patent walked to squad car and they took her vitals. Patient and family refused to go the hospital. After squad left patient stated that "She only had coffee all day"
16 2021-06-25 chills, sweating Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Me... Read more
Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Severe
16 2021-06-25 headache Bad migraine in child. Throbbing headache
16 2021-06-25 headache 2d post receiving the second dose developed a nose bleed - lasted 10 minutes 2d post had headache al... Read more
2d post receiving the second dose developed a nose bleed - lasted 10 minutes 2d post had headache all day 3d post started her menses (would not have been typically due at that time)
16 2021-06-25 headache PT WAS GIVEN FIRST DOSE OF PFIZER IM LEFT ARM. APPROXIMATELY 3-5 MIN AFTER ADMINISTRATION PATIENT P... Read more
PT WAS GIVEN FIRST DOSE OF PFIZER IM LEFT ARM. APPROXIMATELY 3-5 MIN AFTER ADMINISTRATION PATIENT PASSED OUT. 911 WAS CALLED, PT BECAME ALERT, NO EPI-PEN NEEDED, COMPLAINE DOF HEADACHE AND NAUSEA. SHE USED HER ALBUTEROL INHALER. BP TAKEN 101/67 PULSE 85. EMS ARRIVED AND TOOK MORE VITALS. PT IMPROVED ENOUGH TO WALK TO CAR TO GO HOME FOR OBSERVATION. MOM WAS PRESENT AND OPTED NOT TO GO TO ER
16 2021-06-25 sweating 1455: Pt c/o of dizziness, diaphoresis with hx: of anxiety, NKA. Laid pt down to floor and elevated ... Read more
1455: Pt c/o of dizziness, diaphoresis with hx: of anxiety, NKA. Laid pt down to floor and elevated legs on chair. 1500 called EMS. 1st vitals: 102/60 02 99 HR 84. 1500 NP assess pt, she stated her face was pale. NP instructed her to deep breath and increase oral fluids. Pt states she was dizziness. Sat patient up 2nd vital 85/56 O2 97 HR92. 3 vital patient sitting on chair 101/66, O2 90, HR 92. NP assessed patient. Patient denies dizziness was able to stand and walk to car.
16 2021-06-25 throat pain Sore throat; Vomiting; Diarrhea; Anemia; This is a spontaneous report from non-contactable consumer ... Read more
Sore throat; Vomiting; Diarrhea; Anemia; This is a spontaneous report from non-contactable consumer (patient) via COVAES. This non-pregnant 16-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration in the left arm on 25May2021 at 10:45 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. Medical history included lymphocytic colitis from an unknown date and unknown if ongoing. The patient had no known allergies, had not been diagnosed with COVID-19 prior to vaccination and had not received any other vaccines in four weeks. Concomitant medications included calcium supplements, macrogol 3350 (MIRALAX), and nutrition shakes, all from unknown dates for unknown indications. The patient previously received the first dose of BNT162B2 (lot number unknown) on 04May2021 at 10:00 (at the age of 16-years-old) for COVID-19 immunisation. On 26May2021 the patient experienced sore throat, vomiting, diarrhea, and anemia, which the patient reported was confirmed with labs. The events resulted in an emergency room visit; no treatment was received for the events. The clinical outcomes of sore throat, vomiting, diarrhea, and anemia were recovering. It was also reported that since vaccination the patient had not been tested for COVID-19. No follow-up attempts are possible; information about lot number cannot be obtained.
16 2021-06-26 fatigue Vaccine administered without issue to pt (behavior & appearance normal, engaged in conversation). Pt... Read more
Vaccine administered without issue to pt (behavior & appearance normal, engaged in conversation). Pt agreed to wait 15 min. for observation and left vaccination area for monitoring area. Shortly thereafter, RPh heard what sounded like pt falling. RPh observed pt lying supine on tile floor of monitoring area. RPh assumed occurance of vasovagal syncope and went to aid pt; however, pt seemed to immediately (<1 sec.) regain consciousness, was breathing without difficulty and was able to shift to chair under own power. Tech who had been monitoring remarked pt had opted to stand rather than sit after exiting vaccination area and that she'd "hit her head" upon falling. RPh provided ice pack while pt's mother retrieved water bottle. Pt seemed alert and cognizant of situation (denied pain, was overheard saying to assumed male relative, "You didn't help me."). RPh strongly encouraged pt to wait 30 min. instead of 15 min. but family left after original time; mother remarked pt had vasovagal rxn after an unspecified vaccine in past (RX had not been previously made aware). About 1.5 hours later, RPh called mother to follow-up & advise on signs/symptoms of concussion. At the time, mother said she would monitor pt. Perhaps another half hour later, mother called RX to ask for advice: pt complaint of pain (took Tylenol) and tiredness (despite getting enough sleep the previous night & not usually tired around that time). RPh recommended taking pt to ER as soon as reasonably possible (mother denied any other S/S like uneven pupils, confusion or being difficult to rouse). Mother seemed receptive to that suggestion as well as warning staff of vasovagal syncope for all future vaccinations, though she could not be reached for confirmation of action the next morning.
16 2021-06-26 headache, dehydration 18 hours after the 1st vaccine shot... healthy female while in the shower....blacked out, couldn't ... Read more
18 hours after the 1st vaccine shot... healthy female while in the shower....blacked out, couldn't see, called for mother who she knew was not home, passed out, and was not coherent, felt dizzy, had a bad headache, and face was swollen, Called her doctor's office, told them about the vaccine and the incident, they said to go to the emergency room. Went to emergency room. She had a full list of tests. Was given a saline drip, hydration unit. Level V emergency code. Name vasovagal syncope, reaction to vaccine, electrolyte abnormalities, dehydration, dysthymia
16 2021-06-27 malaise, headache for first shot, got severe headache on day one and still has headaches every day even after second d... Read more
for first shot, got severe headache on day one and still has headaches every day even after second dose. wants to vomit every morning and headache starts between 12-3 everyday.
16 2021-06-28 fatigue Patient received vaccine and returned two hour later with complaints of fatigue and weakness. Patien... Read more
Patient received vaccine and returned two hour later with complaints of fatigue and weakness. Patient mother stated they went to the gym immediately after vaccination and patient began to feel these symptoms when they retuned to the car. Patient vital signs BP: 112/82, HR 75, O2 98%. Patient and mother informed of possibility of overworking after vaccination. Patient remained alert and oriented throughout care. Patient stated she ate very little before the gym. Patient was given orange juice and water and stated she felt a little better. Vital signs were repeated, BP: 116/84, HR 77, O2: 100%. Patient was instructed to try eating a meal and getting some rest. Also, if symptoms worsen to go to the hospital.
16 2021-06-28 headache an uncontrollable head movement/functional movement disorder; stuttering really bad; complain of a t... Read more
an uncontrollable head movement/functional movement disorder; stuttering really bad; complain of a twitch in her neck; a headache in the back of her head; This is a spontaneous report from a contactable consumer. A 16-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EW0176) via an unspecified route of administration on 04May2021 (age at vaccination 16-year-old) at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received first dose of BNT62B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: ER8731) via an unspecified route of administration on 13Apr2021 at single dose for covid-19 immunization. On 04May2021, patient stated that she had a headache in the back of her head after receiving their second dose of the vaccine. On 23May2021, patient complained of a twitch in her neck. On 24May2021, patient experienced stuttering really bad and developed an uncontrollable head movement. One physician indicated that it was a nervous tic while a neurologist indicated it was a functional movement disorder. However, she did not have these symptoms prior to the second dose. Adverse event resulted into Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care and hospitalization. Patient was hospitalized for 2 days. The outcome of event was unknown. No follow-up attempts are needed. No further information is expected.
16 2021-06-28 headache PATIENT RECEVIED VACCINES AT 1050 IN OUR OFFICE, PATIENT WAITED 30 MINUTES AFTER VACCINES WITH NO S/... Read more
PATIENT RECEVIED VACCINES AT 1050 IN OUR OFFICE, PATIENT WAITED 30 MINUTES AFTER VACCINES WITH NO S/SX OF REACTIONS. AT 1220 DAD CAME IN WITH PATIENT WHO WAS REPORTING FEELING DIZZY, HEADACHE, FEELING LIGHT HEADED. PATIENT WAS HAVING A HARD TIME KEEPING EYES OPEN. CLOSE TO PASSING OUT. PATIENT WAS SHAKING AND PALE. ALSO C/O ARM PAIN
16 2021-06-28 headache Client in clinic for school immunizations and mother consented to Pfizer/Covid vaccine. Review of pa... Read more
Client in clinic for school immunizations and mother consented to Pfizer/Covid vaccine. Review of patients health history reveals no current issues or complications today. Menactra and Bexsero given without incident. Pfizer vaccine mistakenly administered 0.5ml instead of recommended 0.3ml at 3:04 PM. Incident revealed to mother and patient of administration error. Patient remained for 45 minutes in clinic, no observation of adverse reactions observed or verbalized. Patient reported minor head lasting approximately 18 minutes. Patient left clinic with mother at 3:52. Mother educated concerning adverse signs and symptom to report immediately and seek medical attention. Mother verbalized understanding. Spoke with mother by phone at 5:45 PM and states patient reports headache. Reiterated to mother education concerning seeking medical attention if needed. All above information obtained with assistance of Health Department employee/interpreter.
16 2021-06-29 chills, headache, fever fever at 100.5; aching body; Chills; Headache; Nausea; This is a spontaneous report received from a ... Read more
fever at 100.5; aching body; Chills; Headache; Nausea; This is a spontaneous report received from a non-contactable consumer, the patient. A 16-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: unknown) via an unspecified route of administration in the left arm on 17Mar2021 at 02:30 (at the age of 16-year-old) as a single dose for COVID-19 immunisation. The patients medical history and concomitant medications were not reported and had no known allergies. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: unknown) via an unspecified route of administration in the left arm on 17Feb2021 02:30, as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Mar2021 at 02:30, the patient experienced fever at 100.5, aching body, chills, headache and nausea. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events fever at 100.5, aching body, chills, headache and nausea was recovered on an unknown date in 2021. No follow-up attempts are possible. Information about lot number cannot be obtained.
16 2021-06-30 headache, fatigue, fever The 1st vaccine my daughter had a sore arm (a few days) very tired (a few days) and very nauseous.... Read more
The 1st vaccine my daughter had a sore arm (a few days) very tired (a few days) and very nauseous. she was nauseous until her 2nd vaccine. about 12 hours after her 2nd vaccine she had a fever off & on for 3 days threw up off & on for 3 days had a headache off and on 4 days. extremely tired for 3 days, stomach ache and nauseous for almost 2 wks.
16 2021-06-30 headache Headache started within hours of vaccine dose given. Headache intermittent throughout the day for 1.... Read more
Headache started within hours of vaccine dose given. Headache intermittent throughout the day for 1.5 weeks. Treated supportively with Motrin and rest. Resolved after 1.5 weeks. Also report of right eye drainage, clear, present for 5 days. Currently resolved.
16 2021-07-02 headache Nausea; She was very limp, she was throwing up and very dizzy; She was very limp, she was throwing u... Read more
Nausea; She was very limp, she was throwing up and very dizzy; She was very limp, she was throwing up and very dizzy; She was very limp, she was throwing up and very dizzy; Severe Headache; Light sensitivity; This is a spontaneous report from a contactable consumer (patient's mother). A 16-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: Unknown) via an unspecified route of administration on 10Jun2021 (at the age of 16-year-old) as single dose for Covid-19 immunization at a Hospital. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The reporter stated that patient was very limp, she was throwing up and very dizzy and with a very severe headache and light sensitivity. Patient never had any of those type symptoms before and happened four days after she got the COVID shot. Reporter stated that, the evening of the 13Jun2021. It was headache and the headache got very severe through the next day. Reporter stated that, she had no idea and do not think it was anaphylactic reactions. She thought it was a severe headache which been reported and the MRI they were looking for blood clot as patient was experiencing severe headache that need her throw up, she did not know 100 times, and that end up in the hospital. There was light sensitivity when the CT scan and lumbar puncture was done to see if there was meningitis. CT-scan and spinal patch were done and patient was given nausea and dizzy medications and reporter and patient were waiting for the MRI. The events were serious (hospitalization) on 16Jun2021. The patient underwent lab tests and procedures which included computerised tomogram: unknown and lumbar puncture: unknown on an unspecified date in Jun2021. Therapeutic measures were taken as a result of events dizzy and nausea. Outcome of the events was unknown. Information about lot batch number has been requested.
16 2021-07-03 fatigue Prolonged lightheaded feeling Fatigue and exhaustion Migraine
16 2021-07-03 fever Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Genera... Read more
Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Fever-Mild
16 2021-07-04 fever, fatigue, chills, headache, sweating Tired Dizziness right after. 8 hours later tired. Next day fever chills sweating migraine headache ... Read more
Tired Dizziness right after. 8 hours later tired. Next day fever chills sweating migraine headache tired.
16 2021-07-07 dehydration Patient went to urgent care 1 day after vaccine for feeling tremors and pains in her lower extremiti... Read more
Patient went to urgent care 1 day after vaccine for feeling tremors and pains in her lower extremities. She also began to feel shaking in her entire body and had lightheadness, shortness or breath, and nausea. She vomited one time. EKG showed Sinus Ventricular Tachycardia/Sinus Tachycardia and was sent to ER by EMS. In ER fluids were given and all further testing normal. Discharged and told symptoms due to dehydration.
16 2021-07-07 fatigue Received 1st dose at 3pm on 7/7/21. Observed by facility staff for 30 minutes. Felt fatigued, but ... Read more
Received 1st dose at 3pm on 7/7/21. Observed by facility staff for 30 minutes. Felt fatigued, but otherwise no symptoms. On 7/8/21 at 7:45am went for a run outside. Mid-run felt generalized, severe itching and swelling in throat and facial swelling. Returned home within minutes, reported symptoms to me (mom). Called 911. Epi-Pen 0.3mg injection given in right thigh with no effect. Three minutes later, another Epi-Pen 0.3mg injection given in left thigh given. Benadryl 25mg PO given. Attempted 2nd Benadryl dose...unable to swallow. EMS arrived. Taken to ER. Symptoms slowly improved. Solumedrol IV given in ER. Monitored for 2.5hrs then discharged home with Prednisone PO for 5 days.
16 2021-07-07 headache, chills, fatigue, fever sore muscles all over entire arm in pain when used Extreme chills fever mood swings extreme fatigue ... Read more
sore muscles all over entire arm in pain when used Extreme chills fever mood swings extreme fatigue muscle pains headache dizziness hyperventilating
16 2021-07-07 throat pain Patient's mother reports patient c/o of chest pain with inhalation, swollen/sore throat, weakness, a... Read more
Patient's mother reports patient c/o of chest pain with inhalation, swollen/sore throat, weakness, and dizziness with change of position. Pt's mom was advised to take pt to ED or urgent care for evaluation.
16 2021-07-09 fever Chest pain, Shortness of Breath, high fever
16 2021-07-10 fatigue Chest pain, fatigue, sore arm
16 2021-07-10 malaise, lethargy No adverse effects after 1st shot. On Friday approximately 6 hours after 2nd shot at approximately ... Read more
No adverse effects after 1st shot. On Friday approximately 6 hours after 2nd shot at approximately 9pm CST, daughter started feeling depressed, body aches, lethargic. Saturday morning still not feeling well. Saturday afternoon she took about a 3 hour nap, felt 90% better. By Saturday evening, she was 100%.
16 2021-07-10 throat irritation full body onset of hives with severe itching in ears, throat. hives noted to neck, anterior and pos... Read more
full body onset of hives with severe itching in ears, throat. hives noted to neck, anterior and posterior torso, bilateral lower extremities. Benadryl 25 mg orally given. methylprednisone 4 mg given. Full recovery in 1 hour after medication administration Parent of the patient is a nurse practitioner who managed care in the home setting
16 2021-07-11 chills, fatigue, sweating, fever Fatigue 6 days Fever about 12 hours after 2nd dose, then again 6 days later (chills, sweating, shaki... Read more
Fatigue 6 days Fever about 12 hours after 2nd dose, then again 6 days later (chills, sweating, shaking) Racing heart, 6 days after 2nd dose. Shortness of breath, 6 days after 2nd dose. Acetaminophen and ibuprofen.
16 2021-07-11 malaise Patient felt ill and had syncope
16 2021-07-11 fever, fatigue Fever 102F, fatigue, slight muscle soreness, lasting 2 days after shot
16 2021-07-12 fever Low grade fever, seizure 25 hours after shot
16 2021-07-13 fatigue, respiratory tract congestion, headache vomited x1 yesterday and has been having nausea all day today. Patient c/o headache, congestion, los... Read more
vomited x1 yesterday and has been having nausea all day today. Patient c/o headache, congestion, loss of smell, and fatigue.
16 2021-07-13 sweating While completing paperwork in immunization room, patient's mother stated she thought her daughter wa... Read more
While completing paperwork in immunization room, patient's mother stated she thought her daughter was starting to react to the vaccine. It appeared patient was starting to pass out so pharmacist and mother lowered her down from the chair to the floor to prevent injury. Patient's pulse was very faint to the touch and patient was difficult to arouse. Pharmacist delegated pharmacy technician to obtain AED. Patient's mother stated patient was beginning to shake and was becoming very hot and sweaty. 911 was dialed. No health conditions or medications were noted that would cause this reaction. Pharmacist was beginning to take BP when EMS arrived. EMS continued taking vitals. BP 100/65, HR 84, SPO2 96%. Patient started to become alert again as vitals were being taken.
16 2021-07-15 cough, throat pain, nasal congestion, headache Sore throat, nasal congestion, cough, headache, body aches 24 hours after vaccine.
16 2021-07-17 dehydration Fainted; Mom thought maybe dehydration; This is a spontaneous report from a contactable consumer (pa... Read more
Fainted; Mom thought maybe dehydration; This is a spontaneous report from a contactable consumer (patient). A 16-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Leg Right on 06Jun2021 10:30 (at the age of 16 years old, not pregnant) (Lot Number: Ew0191) as single dose for covid-19 immunisation. Medical history was none. The patient's concomitant medications were not reported. No any other medications the patient received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 (Lot number: Ew0185) in Right arm on 16May2021 10:30 (at the age of 15 years old) for Covid-19 immunization and no events reported. Facility where the most recent COVID-19 vaccine was administered in Pharmacy or Drug Store. On 08Jun2021 at 18:30, the patient fainted in kitchen at night on day 3 after second dose, over 48 hrs after shot. Mom and dad caught her and put her on floor until she came back. Mom thought maybe dehydration so gave pedialyte but didn't know if that was reason. She slowly felt better. No treatment for fainted. The reporter considered the report as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. Outcome of the events was recovering. No follow-up attempts are needed. No further information is expected.
16 2021-07-17 fatigue, headache Migraine with aura; Burning pain along her right side; prolonged nosebleed; bruise developed under r... Read more
Migraine with aura; Burning pain along her right side; prolonged nosebleed; bruise developed under right eye; mouth ulcer; Joint pain; Stiffness; Stomach pain; headache; arm soreness; Severe fatigue; This is a spontaneous report from a contactable consumer, the patient. A 16-year-old non-pregnant female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP7534) via an unspecified route of administration in the left arm on 20Mar2021 at 12:00 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. The patients medical history included Bechet's disease. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination patient was not diagnosed with COVID-19. The patient was not tested for COVID-19 since having the vaccine. The patient experienced normal headache and arm soreness after 48 hours of vaccination and severe fatigue on 22Mar2021 and prolonged nosebleed, a bruise developed under her right eye, mouth ulcer, joint pain, stiffness, and stomach pain on 23Mar2021 and had another nose bleed on 24Mar2021 and migraine with aura and unusual burning pain along her right side on 25Mar2021. The patient did not receive any treatment for the reported events. The clinical outcome of the events headache, arm soreness, fatigue, nosebleed, bruising, mouth ulcer, joint pain, stiffness, stomach pain, migraine with aura and burning pain was not recovered. No follow-up attempts are needed. No further information is expected.
16 2021-07-17 headache, malaise Does not feel well; Headache; This is a spontaneous report from a contactable consumer. This consume... Read more
Does not feel well; Headache; This is a spontaneous report from a contactable consumer. This consumer (patient's parent) reported for a 16-year-old female patient (reporter's daughter) that: A 16-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW0198), via an unspecified route of administration on 09Jul2021 (at the age of 16-year-old) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter stated I have a question I got a new information about Pfizer that their vaccine is not as effective now because of the new variant. My daughter is 16, so the Pfizer vaccine is the only one she qualified for right now, yesterday she got her first vaccine. Reporter stated she does not feel well today on 10Jul2021, but she said she doesn't eat any Tylenol or anything, she also had a headache on unknown date in Jul2021 that's the only thing. No therapeutic measures were taken as a result of the events. The outcome of the events was reported as unknown.
16 2021-07-17 headache headache; Received the meningococcal B, Bexsero in the same right deltoid as the Covid vaccine and t... Read more
headache; Received the meningococcal B, Bexsero in the same right deltoid as the Covid vaccine and then received Menactra in the left deltoid today; received 0.5 ml instead of 0.3 ml of the Pfizer covid vaccine; This is a spontaneous report from a contactable other health care professional (Nurse). A 16-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0150; Expiration Date: Jul2021), via an unspecified route of administration, administered in Deltoid Right on 29Jun2021 15:04 as dose number unknown, 0.5ml single for covid-19 immunisation and meningococcal group b rlp2086 (MENINGOCOCCAL GROUP B RLP2086, Batch/Lot Number: ABXB29BA; Expiration Date: Jun2022), via an unspecified route of administration, administered in Deltoid Right on 29Jun2021 as 0.5 mL, single for an unspecified indication and meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA, Batch/Lot Number: U6690AB; Expiration Date: 23Aug2021), via an unspecified route of administration from 29Jun2021 to an unspecified date, at 0.5 mL for an unspecified indication. The patient medical history and concomitant medications were not reported. No prior Vaccinations (within 4 weeks) other vaccinations within four weeks prior to the first administration date of the suspect vaccine. It was reported that On 29Jun2021 the patient received 0.5 ml instead of 0.3 ml of the Pfizer covid vaccine and experiencing headache within an hour of administering. Caller just administered the Pfizer Covid vaccine to a (withheld) and gave her 0.5mL instead of 0.3mL, a vaccine error. They want to see if there is any concerns and what to tell mom about the vaccine error. States patient also received other vaccines today along with the Covid vaccine. Received the meningococcal B, Bexsero in the same right deltoid as the Covid vaccine and then received Menactra in the left deltoid today. No problems with vaccines in past and none given in the past 4 weeks. When providing product details for the Covid vaccine, caller takes off her glasses and provides details. Causality not provided. States patient has not been to emergency room or seen physician and is still there and doing just fine at the moment, hopefully. No further details provided. Yes patient took 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. Reporter seriousness for gave her 0.5mL instead of 0.3mL; vaccine error, received other vaccines today Medically significant. The outcome of the event was unknown. Information on Lot/Batch number was available. Additional information has been requested.
16 2021-07-17 headache Severe nausea; Severe headache; Dizziness; can't sleep; This is a spontaneous report from a contacta... Read more
Severe nausea; Severe headache; Dizziness; can't sleep; This is a spontaneous report from a contactable consumer (parent reporting for daughter). A 16-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration in left arm on 23Jun2021 10:00 as dose 2, single (at the age of 16-years-old) for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was reported as Doctor office/urgent care. Patient did not receive any other vaccines within 4 weeks, prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior to vaccination. Patient has not been tested for COVID-19, since the vaccination. Patient medical history included depression and exercise asthma. Patient had no known allergies. The concomitant medications included lithium, venlafaxine hydrochloride (EFFEXOR), mirtazapine. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration in left arm as dose 1, single for COVID-19 immunization. On 23Jun2021, several hours after the vaccine she was complaining of severe nausea, headache and dizziness. She also reported she could not sleep, even after taking Advil pm. We have not yet sought treatment but may if this continues or worsens. 3 of the 4 of her kids were reporting similar symptoms although 2 are effected much more. The reported case seriousness was non-serious. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Mother was unsure if they will go to the ER or urgent care. It was unknown if any treatment was received for the events nausea, dizziness and headache. The outcome of the events was not recovered. Information about lot/batch number has been requested.
16 2021-07-17 throat pain, fatigue, headache About 1 minute, or so, after her daughter received her COVID-19 Vaccine injection, her daughter pass... Read more
About 1 minute, or so, after her daughter received her COVID-19 Vaccine injection, her daughter passed out, and ended up in the ER; She said her daughter vomited twice after she passed out, and then vomited again in the Emergency Room; It was not normal for her daughter to gurgle like she was; Her daughter wet herself, clarifying her daughter involuntarily voided when she passed out.; Her daughter bit her lip really hard when she passed out; Her daughter had a really bad headache; Her daughter said she heard a nurse say as she was coming to that she was only breathing 6 breathes per minute; When her daughter received her 1st COVID-19 Vaccine, her daughter arched her back, and her daughter's arms drew in.; Her daughter may have been a little tired after getting her first COVID-19 Vaccine, but no more than normal; Her daughter said her throat was sore afterward (vomiting); This is a spontaneous report from a contactable Nurse. This Nurse (patients mother) reported for a female age 16 years old patient (reporters daughter) that patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number was EW0168), via unspecified route in right arm on 24Jun2021 13:21 as single dose for COVID-19 immunization. The patient medical history included mild asthma for a good 10 years. She did not even use an inhaler for the mild asthma, and the last time she used a rescue inhaler was in the last couple years and Dermatographia from 05Aug2020 and was ongoing she could be allergic to something, and then down the road, whether it be a few months or a few years, would not be allergic to it anymore. She had passed out from blood draws in the past, but that she would come to a few seconds afterwards. She would never get upset when she had blood draws. The patient concomitant medication included Cetirizine hydrochloride (ZYRTEC). On 24Jun2021 patient experienced for About 1 minute, or so, after she received her COVID-19 Vaccine injection, she passed out, and ended up in the Emergency Room and she vomited twice after, and then vomited again in the Emergency Room. It was not normal for her to gurgle like she was. She involuntarily voided and she bit her lip really hard when she passed out. She had a really bad headache. She heard a nurse say as she was coming to that she was only breathing 6 breathes per minute. When her daughter received her 1st COVID-19 Vaccine, she arched her back, and her daughter arms drew in. She might had been a little tired after getting her first COVID-19 Vaccine, but no more than normal and her throat was sore afterward. Patient was not given any treatment at the COVID-19 Vaccine facility but was taken by ambulance to the Emergency Room and the Emergency Room gave her daughter an Ativan 0.5mg tablet and placed an IV in her. An emergency Room ran an IV infusion of 999ml of Sodium Chloride 0.9%. On 24Jun2021 patient did an EKG, chest x-ray, urinalysis, and blood work and results of EKG, chest x-ray, urinalysis, and CBC were normal, but electrolytes were a little low. She had followed-up with her pediatrician after her Emergency Room visit. pediatrician scheduled an EEG for her daughter on 28Jul2021 because of her daughter losing her bladder control, and other things that happened when her daughter passed out. The outcome of event (sore throat, Fatigue) was unknown, event of (Passed out and bite wound) was unknown and event of (Dyskinesia, Respiratory rate decreased, Urinary incontinence and Abnormal behavior) was recovered on an unspecified date 2021 and event of (headache) was recovered on 25Jun2021.
16 2021-07-18 fatigue About 4 days after her 2nd COVID vaccine shot, my daughter was very fatigued. Then she started to ha... Read more
About 4 days after her 2nd COVID vaccine shot, my daughter was very fatigued. Then she started to have a higher than normal heart rate on runs - roughly 11 bpm higher (she runs cross country and track and tracks all her runs). We went to the doctor around the middle of June and they ran some tests. Several of her blood tests can back out of range but more starting was her TSH was extremely low. They started running several thyroid tests. It is important to note that she has a blood panel run in late March 2021 and her TSH level was normal, ~3.0 pg/mL.
16 2021-07-19 sweating Bradycardia, Syncope, diaphoresis, dizziness, pale skin
16 2021-07-20 body temperature increased, headache, throat pain, chills sore throat; had a 101.4F temperature starting on 17May2021 at 5am that gradually lowered to 98.6F o... Read more
sore throat; had a 101.4F temperature starting on 17May2021 at 5am that gradually lowered to 98.6F on 18May2021 at 6:45am after taking OTC acetaminophen; chills; headache; This is a spontaneous report from a contactable consumer (patient). A 16-year-old non-pregnant female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8736, Expiry date: not reported, age at vaccination: 16-year-old), via an unspecified route of administration, in Arm Left on 16May2021 at 14:15 as single dose for COVID-19 immunisation administered in Pharmacy or Drug Store. The patient medical history and concomitant medication was not reported. Previously the patient received first dose of bnt162b2 (Lot number ER8731), in Arm left on 25Apr2021 at 15:00 for COVID-19 immunization and there is no reaction on previous exposure to vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received OTC women's gummy vitamins received within 2 weeks of vaccination. The patient was not diagnosed with covid-19 prior to vaccination and was not tested for covid-19 since the vaccination. On 17May2021 at 5:00 Am, the patient had a 101.4f temperature that gradually lowered to 98.6f on 18may2021 at 6:45am after taking otc acetaminophen, resting at home and drinking a lot of water. The patient also had chills, headache and sore throat starting on 17May2021 at 5 Am that also gradually went away by taking OTC medicine, sore throat medicine, resting at home and drinking a lot of water. The outcome of event body temperature increased was recovered on 18May2021 while all other events recovered on an unknown date in May2021. Device Date : 30May2021 Follow-up attempts are completed. No further information is expected.
16 2021-07-20 chills, sweating During the patient's 15 minute waiting period, patient developed chills, hot sweats, vomiting, and d... Read more
During the patient's 15 minute waiting period, patient developed chills, hot sweats, vomiting, and dizziness. patient had stated that they had not eaten all day.
16 2021-07-20 fatigue extreme fatigue, nausea, ear pain, that persisted 7 days after the second dose especially ear pain a... Read more
extreme fatigue, nausea, ear pain, that persisted 7 days after the second dose especially ear pain and pressure and nausea
16 2021-07-20 sweating Patient was given her second covid19 vaccine at approximately 1045. She stood up and walked to a ch... Read more
Patient was given her second covid19 vaccine at approximately 1045. She stood up and walked to a chair in the waiting room. At 1048 she passed out and had a small seizure. Mom said she normally passes out after a shot for a short period of time but this was the first time she had a seizure. She was moved to the floor. She was sweating, eyes glossed over, said she felt like she couldn't breathe and couldn't feel her extremities. She stayed on the floor until EMS arrived approximately 10 minutes later. She was moved to a chair and once she tried to stand up she was moved back to the floor. She left in a wheelchair and was taken to her moms car.
16 2021-07-21 malaise The pain is just after the first vaccine and it gets worse, after the second one; 2-3 weeks before I... Read more
The pain is just after the first vaccine and it gets worse, after the second one; 2-3 weeks before I took her to the doctor she didn't feel better; This is spontaneous report from a contactable consumer. This consumer (patient's mother) reported for a 16-year-old female patient that: A 16-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot number: EW0168), via an unspecified route of administration on 15May2021 (at the age of 16-year-old) as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient's historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot number: EW0172), via an unspecified route of administration on 24Apr2021 (at the age of 16-year-old) as DOSE 1, SINGLE FOR COVID-19 immunisation and experienced the events the pain is just after the first vaccine, her body was the rash in her legs, by the knee and she have it on the back, her back was all rash, her legs all rash, knee and all joints was given a pain, she lose 8 pounds within two weeks, her face was just swollen and she fell sick. Patient's mother reported patient experienced pain was just after the first vaccine and it gets worse, after the second one and 2-3 weeks before I took her to the doctor, she did not feel better on unspecified date on 2021, so I took her again for blood work because I never had this. The outcome of the events was reported as unknown. Follow-up attempts are completed. No further information was expected.
16 2021-07-21 malaise Patient received the dose at 5:15pm. I was alerted by father at 5:25 that she was not feeling well. ... Read more
Patient received the dose at 5:15pm. I was alerted by father at 5:25 that she was not feeling well. I went to check on her and she had lost consciousness in her father's arms. I told the technician to call 911 at retrieved and epipen. I opened the epipen and checked the patient for response. She woke up and appeared very weak and confused. She responded that she could breathe. The epipen was not administered. EMS arrived and checked for vitals. Vitals were within normal range. The father decline transportation for further care. She remained sitting until 5:50 pm and she left on her own power with her family.
16 2021-07-21 malaise Her body, was the rash in her legs, by the knee and all joints is given a pain and she have it on th... Read more
Her body, was the rash in her legs, by the knee and all joints is given a pain and she have it on the back, her back is all rash, her legs all rash and her face is just swollen.; The rash is stopped right away but her face is still swollen.; She loose 8 pounds within two weeks because of after, she fell sick.; The pain is just after the first vaccine and it gets worse, after the second one.; Her body, was the rash in her legs, by the knee and all joints is given a pain and she have it on the back, her back is all rash, her legs all rash and her face is just swollen.; She loose 8 pounds within two weeks because of after, she fell sick.; This is a spontaneous report received from a contactable consumer. This consumer (mother) reported for a 16-year-old female patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0172) via an unspecified route of administration on 24Apr2021 (at the age of 16-year old) as dose 1, single for COVID-19 immunization. Relevant medical history was reported as none. The patient's concomitant medications were not reported. It was mentioned that patient did not receive other products and no investigation assessment was done. On an unknown date in Apr2021 the patient had a problem with vaccine, reporter just thought that this was because of the vaccine but after the second one it got worse. She had rash in her legs, by the knee and all joints had pain and she had it on the back, her back was all rash, her legs all rash and her face was just swollen. The rash had stopped right away but her face was still swollen. Reporter stated that she lost 8 pounds within two weeks after, she fell sick. Right after her first vaccine, about a week after patient start facing pain in her joints. The pain was just after the first vaccine and it got worse, after the second one. When probed for lab test: Reporter stated, she had not yet got them and was going to go tomorrow, because two weeks ago, the doctor said, it was allergy and was prescribed Zyrtec and Benadryl. It did not work so that was why they going to do blood work tomorrow because she took her again. It was mentioned that patient received Zyrtec one in the morning and Benadryl one in the night but she took like 3 days and it gave her headache (Further not clarify hence not captured as event) so she start taking it the other, she does not take it. The reported took her again and doctor took her blood to see what was wrong because they could not really tell, what could be better. The reporter mentioned that her daughter was a completely normal kid and after this vaccine just everything had become like another world. The split case was identified after the call hence no further relevant information for the patients could be probed. Limited information was available over the call. Follow-up attempts were completed. No further information was expected.
16 2021-07-22 body temperature increased Temperature 101.8 Body Ache Nausea
16 2021-07-22 headache The day following the vaccine, patient developed a headache with right sided head pain, mild photoph... Read more
The day following the vaccine, patient developed a headache with right sided head pain, mild photophobia and occasional nausea. Patient is treated with diphenhydramine, ketorolac, prochlorperazine and IV fluids. Her headache resolved completely.
16 2021-07-23 fatigue Fullbody aches and fatigue - ongoing Migraine - ongoing Nausea - ongoing
16 2021-07-23 headache, fatigue Pt reported hx of fainting to vaccines. Made sure she was comfortable sitting in her car. I attempte... Read more
Pt reported hx of fainting to vaccines. Made sure she was comfortable sitting in her car. I attempted to distract her, but she still fainted. She was out for approximately 3 seconds before recovering spontaneously. I applied ammonia inhalants as she was awaking, and she immediately came to. Afterwards, she complained of HA, lightheadedness, + fatigue. On exam, lungs: CTA B/L; Cardio: normal RRR, no murmurs, gallops, rubs; HEENT: no erythema or edema of face or throat. Denied CP, palp, SOB, pruritis, dizzy Ammonia inhalant used. Post-vaccination wait for 30 mins. HA, lightheadedness, and fatigue resolved w/in 30 min wait. Pt went home.
16 2021-07-23 lethargy, fatigue, sleepiness Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Hyperv... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Hyperventilation-Medium, Additional Details: Patient complained of sleepiness, lightheadedness and we contacted rescue at the parents request
16 2021-07-25 chills, headache, fatigue Headache, nausea, fatigue and chills. About 8 hours she took medicine and fell asleep. She said she ... Read more
Headache, nausea, fatigue and chills. About 8 hours she took medicine and fell asleep. She said she was just overall uncomfortable and doesn?t want to get her 2nd dose.
16 2021-07-25 fatigue, headache My arm hurt a lot right after the shot. A few hours after like about 5 my entire right side went nu... Read more
My arm hurt a lot right after the shot. A few hours after like about 5 my entire right side went numb and I couldn?t feel it. I also get intense headaches everyday after I got the shot. I was also very tired for the next 3 days.
16 2021-07-25 sweating Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / ... Read more
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Seizure-Mild, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: IMMEDIATELY AFTER VACCINE ADMINISTRATION, PT FAINTED FOR A FEW SECONDS, STARTED JERKY MOVEMENT. WHEN CAME BACK SHE DID NOT REMEMBER ANYTHING. THEN AGAIN SHE FAINTED TURNED EXTREMELY PAIL WITH EXCESSIVE SWEATING AND FEELING HOT, SHE SEEMED STUNNED GAZING TO ONE POINT NOT ABLE TO TALK OR MOVE. RPH ASKED TO CALL 911 IMM. PT TURNED BLUE WITH VERY LOW PULSE AND SHALLOW BREATHING. RPH ADMINISTERED EPIPEN TO THE UPPER OUTER RIGHT THIGH TO HELP RAISE BP AND PULSE. PUT PT IN SUPINE POS W/ ELEVATED FEET
16 2021-07-26 throat pain started sore throat on 7/26 and came for testing today 7/27
16 2021-07-27 fatigue had arm pain at injection site; her arm is numb to her hand on injection site side which is the left... Read more
had arm pain at injection site; her arm is numb to her hand on injection site side which is the left side.; From the injection site up to her neck is hurting; feels weak and tired; feels weak and tired; she can't feel her hand up to her fingers; This is a spontaneous report from a contactable consumer (patient's mother). A 16-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EW0198, Expiration Date: not reported) via an unspecified route of administration on 12Jul2021 as dose 1, single for COVID-19 immunization (at the age 16-year-old). The patient's medical history and concomitant medications were not reported. The patient experienced had arm pain at injection site, her arm was numb to her hand on injection site side which was the left side, from the injection site up to her neck was hurting, not horrible pain just aching, feels weak and tired, feels weak and tired, she can't feel her hand up to her fingers on an unspecified date in Jul2021. It was reported that, it was patient's first vaccine and getting the second dose on 02Aug2021. The outcome of the events was unknown. Information about lot/batch number is requested.
16 2021-07-27 fever, chills, fatigue, headache Very high heart rate over 120 for 8 hours; Fever.; Chills; Sore muscles; Headache; Dizzy; Very high ... Read more
Very high heart rate over 120 for 8 hours; Fever.; Chills; Sore muscles; Headache; Dizzy; Very high heart rate over 120 for 8 hours. Fever, chills, sore muscles, headache, dizzy, and tired.; This is a spontaneous report from a contactable consumer (patient). A 16-years-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left (at the age of 16 years old) on 12May2021 at 18:30 (Batch/Lot Number: EW0186) as DOSE 2, SINGLE for covid-19 immunization. Also reported 'Device Date:19May2021' no additional details provided. Facility where the most recent COVID-19 vaccine was administered was health facility. No other vaccines were given within 4 weeks. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. Medical history included attention deficit hyperactivity disorder. Concomitant medication(s) included methylphenidate hydrochloride (CONCERTA) 54mg. Historical Vaccine includes BNT162B2 Dose 1 (at the age of 16 years old) on 21Apr2021 at 18:30 Batch/lot number ER8736, Left arm Covid-19 immunization and not events were reported. The patient previously took amoxicillin and experienced drug hypersensitivity. On 13May2021 at 02:00 The patient experienced Very high heart rate over 120 for 8 hours, Fever, chills, sore muscles, headache, dizzy, and tired. The event Very high heart rate over 120 for 8 hours was considered medically significant. The patient underwent lab tests and procedures which included heart rate: high on 13May2021 (Very high heart rate over 120 for 8 hours). No Treatment was given and No hospitalization was involved. The clinical outcome of the events was recovered May2021. Follow-up attempts completed. No further information expected.
16 2021-07-27 fever, fatigue, chills difficulty breathing; strong internal chest pain that gradually subsided; chills; fever; body pain; ... Read more
difficulty breathing; strong internal chest pain that gradually subsided; chills; fever; body pain; exhaustion; This is a spontaneous report from a contactable health care professional (patient's mother). A 16-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number and expiration date were not reported) via intramuscular in the right arm on 14Jun2021 03:45 PM (at the age of 16-years-old) at single dose for covid-19 immunization. The patient medical history included that prior to vaccination, the patient was diagnosed with COVID-19. The patient was not pregnant. The patient was not pregnant at time of vaccination. There was no concomitant medication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient experienced approximately 24 hours of difficulty breathing and strong internal chest pain that gradually subsided, along with chills fever, body pain, and exhaustion on 15Jun2021 06:00 AM. No treatment was received for the events. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovered in Jun2021. The report was reported as non-serious. Information on the lot/batch number has been requested.
16 2021-07-28 headache, sweating Per witness, patient was sitting in the waiting room post vaccination w/ Pfizer vaccine. Patient's m... Read more
Per witness, patient was sitting in the waiting room post vaccination w/ Pfizer vaccine. Patient's mother got up and walked to counter to make 2nd dose appt. Patient started leaning over in chair and fell to the floor (witness reports patient bumped head). Per witness, mother ran to patient's side. This writer heard someone call for help. This writer was in the back assisting with immunization clinic. Patient was observed lying on the floor w/ mother at her side. Patient appeared confused and was actively trying to sit upright. This writer and patient's mother explained that she had experienced a vasovagal reaction after her COVID-19 vaccine. Patient was instructed to stay in lying position while vital signs were obtained. Patient was able to verbalize name, DOB, and place. Vital signs at 1040 (BP 98/55, HR 61, O2 98% on room air). Patient was diaphoretic and pale. Patient reported eating breakfast this morning. Patient was observed crying stating "I feel like I can't breathe." This writer continued to monitor vital signs (BP 120/72, HR 77, O2 99% on room air). Staff placed several ice packs on patient. She complained of headache and told staff that her head hurt. Mother of patient requested EMS to be called. Staff called EMS. Vital signs at 1050 (BP 101/64, HR 92, O2 98% on room air). Patient reported feeling better and was able to move to sitting upright position on the floor. Patient appeared less diaphoretic and color was returning to normal. Patient was moved to wheelchair w/ assistance from staff. Patient was provided with water and crackers. EMS arrived to the facility at 1050. EMS evaluated patient, but patient declined to be transported. V/S stable. Patient reports history of passing out unrelated to vaccine administration. Staff explained that mother/patient need to inform staff w/ the 2nd dose of vasovagal hx, so patient can receive vaccine lying down. Staff provided mother w/ concussion education and explained what S/S would indicate a need to go to the ER. Patient was also encouraged to f/u with pediatrician. Patient was taken out to car via wheelchair by staff at 1100.
16 2021-07-28 sweating sweating and racing heart noted on 09May21 Diagnosis of hyperthyroidism on 18Jun21
17 2021-01-04 chills, headache, fever DEVELOPED HEADACHE, FEVER, CHILLS, BODY ACHES, NAUSEA. RESOLVED BY MORNING OF 12/31/20
17 2021-01-16 headache, fatigue, chills 30 mins after IM injection: Left arm tingling 45 mins after IM injection: Left arm, Left shoulder, L... Read more
30 mins after IM injection: Left arm tingling 45 mins after IM injection: Left arm, Left shoulder, Left upper back tingling, Headache, chills, fatigue
17 2021-01-19 chills body aches, nausea, vomiting, and chills
17 2021-01-25 fever, chills, headache DEVELOPED BODY ACHES, FEVER, HEADACHE, AND CHILLS
17 2021-01-26 fever, fever DEVELOPED FEVER OF 103
17 2021-01-27 cough Systemic: Anaphylaxis-Medium, Systemic: Rash (other than injection site)-Mild, Systemic: Other- whee... Read more
Systemic: Anaphylaxis-Medium, Systemic: Rash (other than injection site)-Mild, Systemic: Other- wheezing, shortness of breath, coughing-Medium
17 2021-03-02 malaise Per paramedic, "Pt's mother told staff "my daughter's not feeling well." Paramedic was notified and ... Read more
Per paramedic, "Pt's mother told staff "my daughter's not feeling well." Paramedic was notified and pt was unc when he arrived. Pt was taken to the medical tent via w/c. Pt regained consciousness and was placed supine with legs elevated." RN was present when pt transferred to cot without assist. Pt was talking, accompanied by mother who states this happens every time she gets blood drawn or has a vaccine. B/P at time of incident 119/77 HR 91, 98% O2 Sat, at 5min 114/76 HR 77 100% O2 sat, at 10min. standing B/P 110/73, HR 76, O2 sat 99%. A/O speaking in full sentences, sitting up drinking water. Skin color pink. Pt monitored for 45 min. Stable at d/c by paramedic. Post vaccination instructions given.
17 2021-03-03 headache 17 yo F in post vac are reports nausea, dizziness, headache 4 mins after vaccination. Denies other s... Read more
17 yo F in post vac are reports nausea, dizziness, headache 4 mins after vaccination. Denies other s/s, speaks clear and complete. No respiratory distress noted. Two set of vitals taken, WNLs. . Monitored for 30 mins, s/s continued and have increased, post vac nurse recommended medical attention. Mom declined EMS transport. Mom stated she would take pt to a local urgent care.
17 2021-03-04 fever, headache, fatigue Fatigue; Headache; Fever; Dizziness; This is a spontaneous report from a non-contactable consumer (p... Read more
Fatigue; Headache; Fever; Dizziness; This is a spontaneous report from a non-contactable consumer (patient). A 17-year-old female patient (not pregnant) received the second dose bnt162b2 (BNT162B2, lot/batch number and expiry date were not reported), via an unspecified route of administration in left arm on 29Jan2021 13:00 at SINGLE DOSE for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. She had her first dose of bnt162b2 on 08Jan2021 in the left arm. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On 29Jan2021 17:00, the patient had deadache, fever, dizziness and fatigue. No treatment was reported. The outcome of events was recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
17 2021-03-07 sweating Flushing, sweating, anxious, tingling in ears, nausea, blurry vision. Vitals within normal limits. P... Read more
Flushing, sweating, anxious, tingling in ears, nausea, blurry vision. Vitals within normal limits. Patient stabilized.
17 2021-03-10 lethargy Written by the patient and guardian: " 8-10 minutes after shot, complaints of light head an throat ... Read more
Written by the patient and guardian: " 8-10 minutes after shot, complaints of light head an throat closing up. Removed mask for fresh air, no relief. Went to get up for water, immediately for light headed, pale face, checked-out look in eyes. Body went limp, set 17yo in chair, still was light headed and lethargic. Laid 17yo down on floor, administered water. Vision came back dizziness went away. remained seated for another 15minutes. Continued hydrating w/ water, other symptoms diminished." From Dr.: "Witnessed patient pass out in chair, within 10-20s was helping caregiver lower patient to the floor and patient had come to. Increasingly alert. Endorses above narrative, as well as not having eaten or drinking much today, "maybe an apple". She does not have a history of vasovagal syncope. Patient Pulse at 65, normal breathing, no distress, no signs of injury. Overall episode appears to be vasovagal syncope. Patient asked to drink water and remain at the vaccine center an additional 15-20 minutes for observation. After 15 min patient feeling back at baseline. No further medical intervention.
17 2021-03-11 chills, fever A few hours after I had chills and a really bad body ache. I could barely move without hurting. I co... Read more
A few hours after I had chills and a really bad body ache. I could barely move without hurting. I couldn't go to work. I had a low grade fever. Tylenol helped. It was better after the second day. For the second dose the symptoms were similar. My arm is still sore.
17 2021-03-11 headache Approx 3 hours after vaccination, patient did describe headache. About 12 hours after vaccination, ... Read more
Approx 3 hours after vaccination, patient did describe headache. About 12 hours after vaccination, patient was describing trouble swallowing and felt like her "throat was closing". No trouble breathing was noted. Patient went to local ER and was treated with ketorolac for HA and diphenhydramine. Patient was back to normal self 15-20 minutes after diphenhydramine. No further problems reported 12 hours after this.
17 2021-03-12 chills, fever Pt is complaining of shortness of breath and dizziness. As well as typical post-covid vaccination sy... Read more
Pt is complaining of shortness of breath and dizziness. As well as typical post-covid vaccination symptoms (i.e. aches, fever/chills). All symptoms started roughly noon - vaccination was around 4PM the previous evening.
17 2021-03-12 fever, fatigue, headache fatigue, headache, fever, body aches, nausea
17 2021-03-12 fever Fever of 103 F, received Tylenol, then developed tonic-clonic seizure activity for about 20 minutes ... Read more
Fever of 103 F, received Tylenol, then developed tonic-clonic seizure activity for about 20 minutes (received 10mg intranasal midazolam and 0.5mg buccal clonazepam while awaiting EMS)
17 2021-03-13 headache, fever, lethargy, sweating Fever ,Sweating,Lethargic Head ache
17 2021-03-14 chills Chills; body aches; This is a spontaneous report from a contactable consumer (patient parent). A 17-... Read more
Chills; body aches; This is a spontaneous report from a contactable consumer (patient parent). A 17-year-old (17-year-old age at vaccination) female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unknown route of administration on 27Jan2021 01:00 PM at single dose in left arm for COVID-19 immunization at clinic. Medical history was none. The patient was not pregnant at time of vaccination. No other vaccines received by patient within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. No Allergies to medications, food, or other products. Concomitant medication was not reported. The patient previously took (at age 17-year-old) first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: E1014D) on 06Jan2021 in left arm for COVID-19 immunization. The patient experienced chills, body aches on 28Jan2021 01:15 AM. No treatment received for the adverse events. Since the vaccination, it was unknown whether the patient been tested for COVID-19. The outcome of events was recovering. Information on the lot/batch number for 2nd dose has been requested.
17 2021-03-14 sweating Hard heart rate, sweating, nausea, fainting
17 2021-03-19 throat irritation itching one arm in one spot with brief throat itching. Pt felt much better with parents driving her... Read more
itching one arm in one spot with brief throat itching. Pt felt much better with parents driving her. Called family on phone daughter doing better went to store
17 2021-03-20 fatigue At approximately 49 hours after the first dose, patient experienced unusual sudden tiredness, sorene... Read more
At approximately 49 hours after the first dose, patient experienced unusual sudden tiredness, soreness at the injection site, visibly flushed face and sensation of heat emanating from the face. No treatment was given. All symptoms were resolved within 8 hours from onset.
17 2021-03-21 throat irritation Felt scratchiness in back of throat. Denied difficulty breathing. Chest clear, no wheeze. BP 118/76,... Read more
Felt scratchiness in back of throat. Denied difficulty breathing. Chest clear, no wheeze. BP 118/76, PO2 97%, Pulse 71. Patient given Benadryl 25 mg PO x 1. Within 15 minutes felt normal again.
17 2021-03-22 head discomfort Patient was dizzy and nauseous. She felt heaviness in her head. Her vitals WNL. She had not yet e... Read more
Patient was dizzy and nauseous. She felt heaviness in her head. Her vitals WNL. She had not yet eaten and was given Coke and a snack. Patient's symptoms resolved within 15 minutes.
17 2021-03-22 throat irritation, fatigue 17 YEAR OLD PATIENT: AFTER RECEIVING VACCINE PATIENT SAT IN OVERVATION AREA, UPON SITTING DOWN EXPER... Read more
17 YEAR OLD PATIENT: AFTER RECEIVING VACCINE PATIENT SAT IN OVERVATION AREA, UPON SITTING DOWN EXPERIENCED DIZZINESS, SHORTNESS OF BREATH, FATIGUE. PATIENT DEMONSTRTING RAPID EYE MOVEMENTS, RESPONSIVE TO DIRECET QUESTIONS AND TO PAINFUL STIMULI THOUGH UNABLE TO SPEAK IN FULL SENTENCES. DENIED CHEST PAIN, COUGH NAUSEA, VOMITING. MOTHER STATES SIMILIAR BEHAVIOR WHEN SHE DEVELOPED BLOOD CLOT IN THE PAST. PATIENT THEN STATED FELT LIKE THROAT WAS SCRATCHY.
17 2021-03-22 throat irritation After 2nd vaccination, client felt throat itchiness and swelling, and tongue swelling 15 minutes aft... Read more
After 2nd vaccination, client felt throat itchiness and swelling, and tongue swelling 15 minutes after. Client and guardian verbalized same adverse effects after 1st dose, and risks explained prior to 2nd dose vaccination. Client had difficultly swallowing and guardian gave client oral Benadryl which decreased some symptoms. No s/sx of resp distress, no SOB. client and guardian verbalized they did not need to be transferred to ER for further evaluation. Client and guardian left clinic @ 2:45 PM
17 2021-03-24 chills, throat pain, cough, headache The day after the vaccine- chills and headaches-lasted for 3 days The symptoms worsened slowly & on ... Read more
The day after the vaccine- chills and headaches-lasted for 3 days The symptoms worsened slowly & on 03/10/2021 presented: sore throat, cough, diarrhea, chest pains when coughing. Patient was tested for COVID-19 (PCR), for Strep (RST & THROAT CULTURE), Influenza A& B, EKG, CBC and Basic Metabolic. Patient was treated with AMOXICILLIN for possible Strep until culture was available, ALBUTEROL INHALER & DEXAMETHASONE for bronchitis. *** This patient was Positive for COVID-19 in August 2020. She had the same symptoms as in March.
17 2021-03-24 chills, fever Fever, body aches and chills
17 2021-03-24 fatigue, fever, chills Extreme chills, fever (lasted up to 24 hours), exhaustion, huge swollen bump over shot injection sit... Read more
Extreme chills, fever (lasted up to 24 hours), exhaustion, huge swollen bump over shot injection site, rash down left arm, swollen lymph node in left armpit where shot was administered
17 2021-03-24 headache, fever Began having seizures; Presented to the ER on 17 March 2021 for headache with blurry vision; Present... Read more
Began having seizures; Presented to the ER on 17 March 2021 for headache with blurry vision; Presented to the ER on 17 March 2021 for headache with blurry vision; Also had persistent nausea and subsequent vomiting; Also had persistent nausea and subsequent vomiting; Fever X1 to 100.4F on day of presentation/no further sz; This is a spontaneous report from a contactable physician. A 17-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly in right arm on 08Mar2021 (lot number: EN6206) at single dose for COVID-19 immunization. Medical history included headache and irregular periods, ongoing hospitalization. No known allergies. Concomitant medications included birth control pills. No other vaccine in four weeks. No COVID prior vaccination. Vaccine received during existing hospitalization. The patient began having seizures (hospitalization prolonged, life threatening) on 16Mar2021 12:00, presented to the ER on 17Mar2021 for headache with blurry vision (hospitalization prolonged, life threatening) on 16Mar2021 12:00, also had persistent nausea and subsequent vomiting (hospitalization prolonged, life threatening) on 16Mar2021 12:00, fever x1 to 100.4F on day of presentation/no further seizure (hospitalization prolonged, life threatening) on 16Mar2021 12:00. Clinical course: Presented to the ER on 17March2021 for headache with blurry vision. Patient reported symptoms for 1 day prior. Also had persistent nausea and subsequent vomiting. Presented to the ED at 23:00. Began having seizures. EEG shows localized to the occipital region. Fever X1 to 100.4F on day of presentation no further sz. LP shows 1 WBC, Gram stain negative. Cultures negative. HSV pending. On ceftriaxone and acyclovir. Continues to have focal sz on EEG now on 3 AEDs. MRI with contrast negative. CBC unremarkable. CRP elevated to 0.8 (normal less than 0.5). Tox screen negative. COVID tested post vaccination: Nasal Swab (SARS-CoV-2 Cepheid) with result of negative on 17Mar2021. Therapeutic measures were taken as a result of all the events which included treatment with IVIG, Antibiotics, Steroids, Antiepileptics. The outcome of the events was not recovered.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to the reported events cannot be completely excluded based on temporal association and known drug safety profile. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
17 2021-03-27 chills, body temperature increased Body aches, feelings of hot cold, dizziness, temp 101, chills, mild joint pain, resulting in loss... Read more
Body aches, feelings of hot cold, dizziness, temp 101, chills, mild joint pain, resulting in loss of sleep. She drank fluids(some electrolytes), and took two Advil.
17 2021-03-27 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: patient became nauseas, lightheaded, and had mild flushing post administration. patient was given water and was sat down. patient recovered fully 10 minutes later and left with no further issues.
17 2021-03-28 chills, fever Chills, nausea, vomiting, fever, head fog, all treated just with rest
17 2021-03-29 sweating Client felt light headed and diaphoretic within 15 minutes of vaccination. Was transported to Hospit... Read more
Client felt light headed and diaphoretic within 15 minutes of vaccination. Was transported to Hospital.
17 2021-04-01 headache Nauseous, severe headache, dizziness, and sores on tongue.
17 2021-04-01 influenza like illness Started to have typical flu symptoms night of 2nd vaccine, also followed with dizziness, nausea, and... Read more
Started to have typical flu symptoms night of 2nd vaccine, also followed with dizziness, nausea, and lastly small bumps of a rash developed over chest, neck and back.
17 2021-04-03 fever Fever 100 degrees F, nausea, abdominal pain, ongoing.
17 2021-04-04 headache Patient woke up in the middle of the night because her nose was spontaneously bleeding She had a sl... Read more
Patient woke up in the middle of the night because her nose was spontaneously bleeding She had a slight headache the next day. She has never had a nosebleed before.
17 2021-04-04 sweating Pt had reaction in the waiting room. Pt became pale, diaphoretic, passed out and had brief seizure ... Read more
Pt had reaction in the waiting room. Pt became pale, diaphoretic, passed out and had brief seizure x 3-5 seconds. She suddenly became aware again with no recollection of what happened. She continued to be pale and diaphoretic and c/o confusion and blurry vision. Pulse ox 98-100, HR dropped to 40's and BP 90/60. Squad was called, they assumed care and transported pt to ER with her mother present.
17 2021-04-04 sweating Fainted for 2 seconds. Sweating. Pale lips but the color got back on after few minutes. Tingling. Co... Read more
Fainted for 2 seconds. Sweating. Pale lips but the color got back on after few minutes. Tingling. Could not lift up her arm (but could feel squeezing thumb). Shaken hands and feet. Lied down on the ground around for 10 minutes and elevated feet. Had her to keep breathing in/out. Kept drinking water and gave orange juice. Called 911. EME arrived and took care of patent. Pt didn?t want to ride on the ambulance and said fine. Was able to walk in the end. Left the scene with her mom.
17 2021-04-05 fatigue, fever 6 am following day (4/6) after injection on 4/5/21, my 17-year-old daughter complained of sore right... Read more
6 am following day (4/6) after injection on 4/5/21, my 17-year-old daughter complained of sore right arm (injection site), tinnitus, syncope, nausea, fever. Day before had also been treated for vaginal yeast infection. Treated with miconazole and fluconazole (tablet and vaginal cream). Also complained that her ovaries hurt. She self-administered Motrin and applied heat. Went back to bed. Has rested without waking, suspect fatigue as well.
17 2021-04-05 sweating Presented at 0905 for vaccine. 0912: Staff were called to the patient vaccine area. Patient did see... Read more
Presented at 0905 for vaccine. 0912: Staff were called to the patient vaccine area. Patient did seem vaso vagal post vaccine (loss of color and diaphoretic), patient then appeared to have a Grand Mal type seizure with arm contracture and vomiting x4. Patient was unresponsive for around a minute. Only meds patient: BCP Patient accompanied by her mother. o2 98% HR 81 BP taken at 920 130/80. 0935: Patient seemed post-dictal, very sensitive to touch and disconnected. As per Mother, the patient had a history of a prior Grand Mal seizure 4 years ago; that was never worked up. Patient complaining that she is "Very Lightheaded." Spoke with patients primary PCP MD, she stated that it was not likely a seizure and that it was extreme vaso-vagal response and that the patient could go home if now drinking and responsive. Patients mother also spoke with PCP and I gave her the option to decline EMS or to go be evaluated. Patients mother chose for her to be evaluated. EMS was contacted by the local police who were working the vaccine clinic. Vitals taken by EMS: BP 127/61 Blood Glucose 97 0955: EMS arrived / Patient transported to ED.
17 2021-04-05 sweating Within 5 minutes of receiving vaccine, patient became lightheaded and diaphoretic. Patient vasovaga... Read more
Within 5 minutes of receiving vaccine, patient became lightheaded and diaphoretic. Patient vasovagal. Feet were propped up, patient returned to baseline with 5 minutes of episode. Was released into the care of her boyfriend.
17 2021-04-05 sleepiness Pt had itching about 50 minutes after getting the Pfizer covid vaccine. Pt waited the time requested... Read more
Pt had itching about 50 minutes after getting the Pfizer covid vaccine. Pt waited the time requested and was thankfully still shopping with her mother and brother in the store when the reaction developed. Pt was given 50mg of liquid diphenhydramine. I discussed calling 911 with the family and they said they would prefer we did not if possible. She has food allergies, which were discussed before giving the vaccine and she is used to having reactions, she also knows what anaphylaxis feels like and could tell that was not the reaction she was having. After discussing with the family and consulting with my market direction I decided to not call 911 immediately but let them know that if the diphenhydramine was not helping quickly I would make the call. I observed the patient for 30+ minutes with an EpiPen on my person in case she showed any signs of worsening. She improved visibly while getting drowsy from the antihistamine. After she had stabilized for some time and the patient and her family was also comfortable with her improvement I allowed her to depart the pharmacy with a request to keep her EpiPen close and call 911 if things worsen or the EpiPen became necessary.
17 2021-04-05 throat irritation Pt reported having an uncomfortable scratchy feeling in back of throat. Pt has experienced anaphylax... Read more
Pt reported having an uncomfortable scratchy feeling in back of throat. Pt has experienced anaphylaxis in past and was anxious about experiencing it again. Pt moved away from waiting area to be evaluated by RN. RN Assessed pt. Lung sounds clear, Pt denies having difficulty breathing, O2 sat remained 98% or better for the duration. BP initially 141/89 while sitting with HR at 75. Pt laid down with feet propped on chair. Vital signs reevaluated 15 min later: O2 98%, BP 118/89, HR 77. Pt still reports itchy throat but does not have difficulty breathing. Contacted on-call physician, recommended pt be evaluated at ED or urgent care. Pt parent refused ambulance; opted to drive pt to ED for further evaluation.
17 2021-04-05 throat irritation About ten minutes after injection, face and ears became flush and throat became itchy. Complained o... Read more
About ten minutes after injection, face and ears became flush and throat became itchy. Complained of mild dizziness and growing lump in her throat. Medical staff checked throat, blood pressure, O2, laid her down on cot with feet elevated. After 20 minutes of stable BP called the chief of immunology who recommended she go to Urgent Care for follow up. While waiting at Urgent Care for 30 minutes, her face, tongue, and throat became swollen, hives developed on face, and had increased difficulty in swallowing and felt short of breath. She was taken to a patient room, IV started and Epi-shot was given. Additional allergy meds were given (Benadryl and Solu-Medro). She the. Slept for the next 90 minutes. Swelling decreased and throat felt better. Monitoring for a couple hours and sent home.
17 2021-04-06 headache Mom called and reported headache, dizziness, and numbness/tingling in hands and feet.
17 2021-04-06 sweating At 1137am, 5 minutes after receiving Pfizer vaccine, pt c/o dizziness and lightheadedness. At 1139 p... Read more
At 1137am, 5 minutes after receiving Pfizer vaccine, pt c/o dizziness and lightheadedness. At 1139 pt became pale and diaphoretic, so EMT lifted her from chair, she then lost consciousness for approximately 30 seconds. Pt was placed on floor in trendelenburg position with her feet elevated on a chair. When she regained consciousness she did not recall being placed on the floor and stated she "blacked out" and was still dizzy. At 1138 EMT called 911. At 1145 EMT recorded the following vitals: BP 68/44, HR 58, and RR 16. At 1145 paramedics arrived and assumed care of pt. At 1150 paramedics took the following vitals: BP 70/50, HR 54, and blood glucose 95, and from these indications decided to start and IV and admininster a 500cc bolus. Pt O2 sat was 100% but she was placed on 2L O2 NC for comfort. At 1205 paramedics transported pt to Hospital for further evaluation.
17 2021-04-07 headache, sweating Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Tinnitus-Mild, Systemic: Vomiting-Mild
17 2021-04-07 headache Events happened about 5 mins after shot was given. Patient experienced lightheadedness, loss of cons... Read more
Events happened about 5 mins after shot was given. Patient experienced lightheadedness, loss of consciousness for a couple seconds, uncontrolled urination, hot flashes, headache. Patient was given water and a snack to consume. After about 10 minutes of resting and consuming food, she feeling better afterwards, said it could have been to fear of getting injections, and was able to go home with her family.
17 2021-04-07 sweating Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hyperventilat... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hyperventilation-Medium, Systemic: Shakiness-Mild, Systemic: Weakness-Mild
17 2021-04-08 fatigue Rash all over face and arms appeared 3 days later. It is now the 5th day and the rash has spread to ... Read more
Rash all over face and arms appeared 3 days later. It is now the 5th day and the rash has spread to my legs and stomach/very itchy and irritating; fatigue; This is a spontaneous report received from a contactable consumer (Reporting for herself). A 17-years-old female patient received Second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EM9810, Expiration date: not reported) via an unspecified route of administration in Arm Left on 13Feb2021 12:45 (At the age of 17 years-old) as single dose for COVID-19 vaccination. The patient medical history was not reported and no known allergies. The historical vaccine included first dose of BNT162B2 received via an unspecified route of administration in Arm Left on 23Jan2021 12:30 for COVID-19 vaccination. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No COVID prior vaccination. No COVID tested post vaccination. It was reported that patient had no symptoms after the 1st dose. On 16Feb2021 she had fatigue (the first 1-2 days after getting the 2nd dose of Pfizer) that got better. Rash all over face and arms appeared 3 days later. It is now the 5th day and the rash has spread to legs and stomach. It was beginning to get very itchy and irritating. Patient was treated with hydrocortisone 3-4 times a day and it was not of much help. The outcome of the events was not recovered.
17 2021-04-09 sweating Flushing/Sweating, Dizziness, Nausea. BP 84/50 HR65 RR18, then 3 minutes later improved to 104/64, H... Read more
Flushing/Sweating, Dizziness, Nausea. BP 84/50 HR65 RR18, then 3 minutes later improved to 104/64, HR88, RR18. Received water, symptoms resolved, discharged with father
17 2021-04-09 sweating Patient had anxiety prior to receiving vaccine and after. She said she felt very nauseas and wanted ... Read more
Patient had anxiety prior to receiving vaccine and after. She said she felt very nauseas and wanted to puke. Was having trouble breathing. Patient did end up puking a few times. She was sweating and overheating, her tongue was starting to go numb, but she said her throat was not closing up. Her lips started to become white and she said she was having trouble seeing. her vision came and went at different times. EMS arrived and did diagnose her with an allergic reaction, gave her benadryl, and an ice pack. And sent her home.
17 2021-04-10 fatigue Soreness in arm, general tiredness/body weakness
17 2021-04-10 sleepiness About 20 minutes after receiving the shot I got drowsy. About 30 minutes to an hour later I started ... Read more
About 20 minutes after receiving the shot I got drowsy. About 30 minutes to an hour later I started having mild stomach cramps similar to menstrual cramps. I later found out I had menstrual bleeding (about 2:30 PM). This was unnatural for me because I have an IUD and have had it for 9 months, so I haven't been getting PMS like cramps or my cycle for the past few months.
17 2021-04-11 cough Anaphylaxis (hives, oropharyngeal swelling, cough, shortness of breath) 20 mins following vaccine ad... Read more
Anaphylaxis (hives, oropharyngeal swelling, cough, shortness of breath) 20 mins following vaccine administration. Patient given epinephrine at vaccine site 20min after symptom onset with significant improvement in symptoms including improved pharyngeal swelling and resolution of hives. Patient presented to the emergency department 1.5 hours following onset of anaphylaxis with mild cough and mild pharyngeal swelling for observation.
17 2021-04-11 headache less than 10 minutes after vaccine administration patient was kneeled over on floor bent over on cha... Read more
less than 10 minutes after vaccine administration patient was kneeled over on floor bent over on chair . extremely pale, feeling lightheaded, head pounding, ears with sudden onset of lots of pressure. mother said never reacted to vaccine like this before. called EMTs they said her blood pressure was fairly low and wanted to take her to the ambulance for further evaluation.
17 2021-04-11 sweating Within about 20 minutes of administration, the patient reported feeling nauseous, hot, faint, and sw... Read more
Within about 20 minutes of administration, the patient reported feeling nauseous, hot, faint, and sweaty. She stated she could "hear the lights". Her temperature was normal at 96.2 degree Fahrenheit. She stated that these same symptoms have happened before with other vaccines, Within another 20 to 25 minutes she felt better and left with her mother. I checked in 5 hours later via the phone and she was feeling better. She only reported a sore arm at that time.
17 2021-04-12 headache Heavy sleeping, sore and stiffness in arm that was injected, chest pains and tightness of chest, ... Read more
Heavy sleeping, sore and stiffness in arm that was injected, chest pains and tightness of chest, nose bleeds and severe headaches
17 2021-04-12 fever, chills Body aches, Fever, Chills
17 2021-04-13 chills Fever, chills, achiness
17 2021-04-13 fatigue, fever She had COVID-19 infection on January 5. She received Pfizer vaccine 3.28.2021 - er8733 lot. she was... Read more
She had COVID-19 infection on January 5. She received Pfizer vaccine 3.28.2021 - er8733 lot. she was feeling well prior to the vaccine with no seasonal allergy symptoms. No nasal congestion or itchy eyes. No NSAIDs the day of vaccine. Tired 20 minutes later. She woke up 4 hour later with fever 101. Took Tylenol 5-6 hours later. No ocular swelling at that time. had some nausea that evening and some abdominal pain. No muscle pain. Some chest tightness that evening. The next miring was very hot and nauseated and then vomited. Two days later swelling around eyes, not too itchy. Swelling was more severe in April 4. the swelling is slightly improved over the last week. On April 4, antecubutal fossa were itchy and red. lasted 1-2 days. No runny nose, sneezing or itching. Low grade fever lasted 1 hour. fatigue lasted a few days. No muscle or GI symptoms. No NSAIDs, but Tylenol initially. no sore throat. No mucous membrane involvement. No leg swelling. No change in urine output. No joint pain. No headache. No vision change. No bleeding gums. No hives. No enlarged lymph nodes. No SOB. No chest pain. No change in bowel habits. Energy level good. No night sweats. SAR symptoms well controlled. Mild swelling at left arm injection sight that lasted 1 day. swelling is worse in the AM when waking up; both upper and lower eyelids.
17 2021-04-13 fatigue The shot was given on Friday around 1 pm. Blurry Vision immediately after vaccination, then felt fi... Read more
The shot was given on Friday around 1 pm. Blurry Vision immediately after vaccination, then felt fine until 7 pm. At 7 pm she fainted at Lacrosse practice. The following day, Saturday, she fainted at work and was sent home. Sunday, she slept most of the day. Monday, she fainted at school and was sent home. Symptoms have been feeling of her heart racing, blurry vision, fainting, weakness, and major fatigue. No fever.
17 2021-04-13 headache, malaise Patient arrived with mom for Covid vaccine at 12:48 pm. Mom reports a history of fainting so nurse d... Read more
Patient arrived with mom for Covid vaccine at 12:48 pm. Mom reports a history of fainting so nurse decided to administer vaccine with client lying down. Vaccine was administered and client immediately stiffened arms and appeared to seize while her eyes rolled back. Nurse reported she turned the client onto her side and she "came to within 20-30 seconds." She reported blurry vision but could read when asked to do so. She quickly became alert and oriented. Her mother reported that she had a previous episode one time in the past year with painful menses. Her vitals remained stable but each time she attempted to stand up, she reported feeling "sick." She developed a headache within minutes of the vaccine and took 2 Tylenol while still there. Client left with parent to follow up at hospital.
17 2021-04-13 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 fainted in waiting are 5 minutes after shot. Patient's muscles stiffened up and she hit back of head on shelf. Pharmacists lowered patient to recovery position on floor, where pt recovered consciousness and relaxed. Patient's mother said that patient has vaso-vagal responses to shots and that she was having one of those. Patient was well and was able to leave without further assistance.
17 2021-04-13 sweating Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unrespons... Read more
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Additional Details: Patient was close to vomiting, benadryl was given, patient recovered.
17 2021-04-13 fever Sore arm after shot. Fever, body aches same night into next day. (as expected) Breakthrough bleedin... Read more
Sore arm after shot. Fever, body aches same night into next day. (as expected) Breakthrough bleeding started 2nd night after shot with full blown period starting 3rd morning after shot. She is on the pill, did not miss a dose and has never had breakthrough bleeding. We are on day 3 so no known outcome resolution of bleeding.
17 2021-04-13 sleepiness At approximately 6:20pm on 03/30/2021 patient during 30 minute observation (high risk due to immunos... Read more
At approximately 6:20pm on 03/30/2021 patient during 30 minute observation (high risk due to immunosupression) had dizziness without syncopy. On assessment at 6:20 PM HR:121, BP:102/70 R:18 O2:99%, patient was AA&Ox4, answered questions correctly. 6:30 HR:83, BP:90/70, R:18, O:99%. Patient states: "I can not drink water." Patient appeared less alert and hard to rouse, Transportation to ER was advised repeatedly. Mother stated: "I don't want to take her to ER, because it is too dangerous for my daughter because she is on steroids. We have been in ER 3 weeks ago due to migraine and they check all labs." Mother refused to call 911 and said she would transport the patient to ER of Hospital.
17 2021-04-14 cough, respiratory tract congestion congestion and cough
17 2021-04-14 sweating, malaise 1325- Pt presented to observation room, mom was supporting her as she walked. I got to the patient a... Read more
1325- Pt presented to observation room, mom was supporting her as she walked. I got to the patient and supported her to the ground as she started to fall. Pt did not lose consciousness, appeared diaphoretic and pale, stated nauseated and didn't feel good. Mom said she has done this in the past when has had injections or blood draws. Laid pt with feet up on a chair. Ice pack placed on forehead. Answering questions appropriately. 1328- BP 112/72, HR 68, RR 20 1330- pt stated feeling better and sat up slowly 1333- felt well enough to sit on the chair 1338- pt and mom opted to leave premises, pt appeared neurologically intact, stable and walking independently
17 2021-04-14 sweating Dizziness, mild sweating, and a temporary loss of hearing a few minutes after the shot before brief ... Read more
Dizziness, mild sweating, and a temporary loss of hearing a few minutes after the shot before brief LOC. Mother reported "eyes rolling up" and a respiratory gasp. Rapid recovery with fully orientation on the floor. VS stable in observation. No nausea or visual changes reported by the patient. No orthostasis.
17 2021-04-14 sweating 1705- Pt passed out right after vaccine. Pt regained consciousness about 3-5 seconds later, stated t... Read more
1705- Pt passed out right after vaccine. Pt regained consciousness about 3-5 seconds later, stated that she couldn't hear anything. Pt moved to the observation area in a wheel chair. 1715- Pt passed out again, ammonia inhalants used. Regained consciousness 3 seconds later. Pt sweaty. Ice placed to back of neck. Pt moved to cart. First set of vitals @ 1717: Spo2: 100% HR: 53 BP: 83/42 Water and snack given to pt. Second set of vitals @ 1720: Spo2: 95% HR: 54 BP: 88/48 Third set of vitals @ 1726: Spo2: 97% HR: 64 BP: 102/64 Pt sitting up and talking with staff an mother, color in face improving. Pt states she is starting to feel better. Fourth set of vitals @1732: Spo2: 99% HR: 67 BP: 103/66 Pt sitting at 90 degrees, eating and drinking. States she does not feel nauseous. Last set of vitals @ 1537: Spo2: 100% HR: 62 BP: 94/63 Per mother she normally faints with vaccines. Pt states she is feeling much better. Reminded pt and mother to keep up with fluids.
17 2021-04-14 sweating immediately after vaccine patient asked if she "could sit for a minute"; became pale, diaphoretic an... Read more
immediately after vaccine patient asked if she "could sit for a minute"; became pale, diaphoretic and limp in the chair; responded immediately to spirits of ammonia and position change; patient given oral fluids and responded well; patient observed for 45 minutes before being allowed to leave vaccine clinic
17 2021-04-14 sweating pt looked pale 10 minutes after vaccine went out to check on him he was getting faint and lips looke... Read more
pt looked pale 10 minutes after vaccine went out to check on him he was getting faint and lips looked purple, was NOT having breathing problems and BP was normal at 104/54, called 911 patient was very clammy and sweaty, stayed with patient until paramedics arrived, patient was feeling much better a little before paramedics arrived, but they decided to take him to hospital
17 2021-04-14 sweating Patient is a 17 year old female who has completed a 30-minute observation period with the following ... Read more
Patient is a 17 year old female who has completed a 30-minute observation period with the following signs and symptoms of an adverse reaction: loss of consiousness. Pfizer-BioNTech COVID-19 vaccine # 1 in series administered. Parents states that patient become pale and dizzy 1 minute after she received covid vaccination , Patient had a syncopal episode in the hallway, unknown if patient hit her head against the floor, no bruises, soreness or redness notice Patient become alert and oriented x 4, pale, diaphoretic, Patient states that she didn't breakfast.Also Patient mentioned that she is afraid to needles. Action(s) taken: Vital sign at 0814: blood pressure ; 75/34, heart rate: 65, respiration ; 16, Spo2: 99 % Repeat Vital sign at 08:28: blood pressure ; 85/44, heart rate: 65, respiration ; 16, Spo2: 99 % Repeat Vital sign at 08:31: blood pressure ; 97/58, heart rate: 66, respiration ; 16, Spo2: 99 % - Patient denies chest pain ,shortness of breath, nausea vomiting, diarrhea, abdominal pain, difficulty swallow, headache, dizziness, or vision changes - Patient was able to tolerated fluids intake well. Action(s) taken: Transferred to higher level of care, ER Patient and parents advised to discuss second dose considerations with a clinician
17 2021-04-14 fever, chills, malaise On March 27, 2021 at 11:30pm started to not feel well, went to sleep woke up on and off through the ... Read more
On March 27, 2021 at 11:30pm started to not feel well, went to sleep woke up on and off through the night with chills, on march 28th felt nauseous on and off throughout the day, also had a slight fever of 101°F took tylenol and it helped
17 2021-04-15 chills, fever Very sore shoulder. Rash. Headache. Fever. Cold chills.
17 2021-04-15 head discomfort, headache She began to have a headache the day after the vaccine was given. The headache is on the top of her... Read more
She began to have a headache the day after the vaccine was given. The headache is on the top of her head. She reports that the area feels heavy. Doesn't normally have headaches like this.
17 2021-04-15 headache Severe headache, dizziness, nausea lasting approximately 45 minutes woke from sleep on night of 4/11... Read more
Severe headache, dizziness, nausea lasting approximately 45 minutes woke from sleep on night of 4/11/21. Improved with tylenol. Milder headache/dizziness for one day following, no medication needed.
17 2021-04-16 fatigue General fatigue, feeling slightly unable to speak or text in clear sentences (i.e., patient said she... Read more
General fatigue, feeling slightly unable to speak or text in clear sentences (i.e., patient said she feels "loopy"), coughing for a little while, chest (lungs) feels heavy
17 2021-04-16 sweating, cough Dizziness, Syncope; Cough abd pain, sweathing. BP 101/53, HR 60; RR 24 -- > 119/59, 67,20 -- > 94/6... Read more
Dizziness, Syncope; Cough abd pain, sweathing. BP 101/53, HR 60; RR 24 -- > 119/59, 67,20 -- > 94/67, 57. Given OJ and water, pt felt fine after drinking water and OJ. Patient stable and released from vaccination site.
17 2021-04-16 sweating Hx: Anxiety Allergy: Amoxicillin; Flushing/sweating, BP 104/61; HR 65; RR 18. Pt c/o "I feel like I... Read more
Hx: Anxiety Allergy: Amoxicillin; Flushing/sweating, BP 104/61; HR 65; RR 18. Pt c/o "I feel like I'm going to faint". Pt denies eating x24hrs. Pt D/C w/ , mother and no c/o @D/C, BP 112/61, HR68, RR16. Patient stable and released from vaccination site
17 2021-04-17 fatigue, fever, chills Pain at inject site immediately Fatigue setting in at 9PM Aches, chills, low fever (99.0) at 11PM
17 2021-04-17 headache, fatigue, chills, throat pain Headache, nausea, chills, fatigue, soreness at infection site, sore throat
17 2021-04-18 headache Woke up around 2AM the morning after the vaccine was administered and noticed pain in hands when was... Read more
Woke up around 2AM the morning after the vaccine was administered and noticed pain in hands when washing hands. Woke up officially around 9AM. Entire body hurt, most notably headache, backache, and neckache. Pain was intense, took Ibuprofen and muscle relaxer. Stayed in bed in the dark for most of the day because of pain. When standing, dizziness and weakness, fell over once. The pain finally subsided enough to function close to 7PM, disappeared completely by the following morning.
17 2021-04-18 throat irritation Ms. Young was observed post Covid-19 immunization for 15 minutes. During the observation period, she... Read more
Ms. Young was observed post Covid-19 immunization for 15 minutes. During the observation period, she experienced an adverse reaction with the following symptoms: Facial rash/bilateral checks. No itch. Warm to touch. Assessment : Patient left after check out in while in her car noticed the rash/flushed face on her face. Patient returned at 12:23pm and rash was noticed by RN to be red to the cheeks bilateral and warm to touch. It was noted that rash followed the outline of the patient's mask. Patient reports she has worn the mask before with no issues. Mask no washed in the past 2-3 days per patient. Alert and oriented. Patient reported itchy throat at 12:35. No difficulty swallowing. At 12:51 patient states she no longer has an itchy throat. Rash in still present. Not worsen in appearance. Patient reports no other symptoms. Patient stable and orientated x4. Walked patient out to door at 12:58 and gave Pfizer information sheet along with symptoms to look out for such as worsening in rash, difficulty breathing, swelling of the face and neck, fast heartbeat and dizziness or weakness. Actions taken: Vitals sign taken VAERS form completed Paramedic on site. Vitals Signs at 12:36, BP= 116/64 HR = 76, 02 = 100, Temp: 97.9F (Temporal) ,Vitals Signs at 12:55, BP= 119/54, HR = 72, 02 = 100. Medications administered: Loratadine (Claritin) 10 mg by mouth. Time: 12:25 pm. Administered by, RN. Famotidine (Pepcid) 20 mg by mouth. Time: 12:30. Administered by, RN, Disposition: Reports no further symptoms of adverse reaction after observation for 30 minutes. Discharged home. Instructed to follow up with PCP for evaluation for second dose. Instructed to call 911 for trouble breathing, rapid heart rate, dizziness, swelling of tongue or throat. The Patient was provided with Vaccine Information Sheet and instruction to access the system. Immunizations Administered, Name, Date Dose VIS Date, Route Pfizer COVID-19 Vaccine, 4/19/2021 12:00 PM, 0.3 mL 2/25/2020 Intramuscular, Manufacturer: Pfizer, Inc, Lot: EW0164, NDC: 59267-1000-2.
17 2021-04-19 chills, headache, fatigue Rashes all over the body with medium to large size blots, redness and raised. The skin has a rough t... Read more
Rashes all over the body with medium to large size blots, redness and raised. The skin has a rough texture to the touch. Headaches, tiredness, chills, and light nausea. Lack of air, and chest pressure, with difficulties to swallow.
17 2021-04-19 chills, fever, headache, fatigue Fever, headache, chills, fatigue
17 2021-04-19 fatigue, chills Chills, nausea, fatigue, right side chest pain, hard to breathe, excessive seizure like shaking.
17 2021-04-19 fever Felt dizzy at work the next day after the second shot. Passed out and then was sitting down and I fe... Read more
Felt dizzy at work the next day after the second shot. Passed out and then was sitting down and I felt nauseous. I threw up 5 times and my arms started to get numb. I had a fever when I got home and I couldn?t move because my body hurt so badly. Migraine and dizziness has been persistent ever since and is interfering with my daily life. Been treating with tylenol which helps a little but not completely. As soon as I stand up and move I feel like I?m going to pass out.
17 2021-04-19 throat irritation Scratchy throat
17 2021-04-19 throat irritation Tingling arms, itchy throat. Evaluated by EMS-Cleared
17 2021-04-20 chills, fever, malaise, sweating, fatigue, cough Patient not seen in office. History obtained via phone from father of patient and patient herself. ... Read more
Patient not seen in office. History obtained via phone from father of patient and patient herself. Very early on 4/19/2021, 8hrs after receiving her 2nd Pfizer COVID-19 vaccination, patient began developing nausea, chills, sweating, fever and malaise. Highest fever was 102.3', with symptoms treated with Advil 600mg. Had x1 episode of vomiting that day, none since. The next day 4/20, patient woke up with new-onset lip swelling, progressing to periorbital swelling and swelling of her facial cheeks & rash. She then began having a cough with some throat tightness with some mild discomfort with breathing in her throat, but no chest tightness or wheezing. Tongue not swollen per patient. Benadryl 25mg PO given multiple times and patient used her Albuterol MDI a few times as well, which helped. She continued to have fevers to 101' throughout the day, treated with Advil again. At night, patient then developed semi-itchy red "hives" on her legs. Per patient, she didn't feel she needed to go to ER for her symptoms or throat tightness/breathing issue. She was still drinking & urinating well and had been consuming light solids foods. The same day 4/20 in the afternoon, patient was prescribed over the phone Prednisone 60mg PO x1 which she first took after 5pm, with tapering dose over the next 4 days, in addition to increasing Benadryl to 50mg PO and starting Qvar 80 MDI BID, while using Albuterol prn. Via phone call to father this morning 4/21, patient reportedly slept well last night and woke up this morning with significantly less symptoms. No longer having throat tightness/breathing issues, with much less periorbital/facial swelling. Still fatigued but no longer having fevers, either.
17 2021-04-20 headache Patient received her 2nd dose of COVID (Pfizer). She walked out of the immunization room to wait in... Read more
Patient received her 2nd dose of COVID (Pfizer). She walked out of the immunization room to wait in the store, made it about 2 aisles over, and fainted. Patient's father and the Pharmacist immediately got to her side. She came to within less than 1 minute. In the meantime EMS was called and the Pharmacist waited with the patient until they arrived. EMS looked over the patient and patient was able to leave on her own after waiting out the nausea and dizziness that had occurred. Patient also reported a headache which was most likely from hitting her head on the way down.
17 2021-04-20 sweating 04/21/2021 11:48 AM Patient says she was lighted headed and dizziness. wasnt speaking dropped her ph... Read more
04/21/2021 11:48 AM Patient says she was lighted headed and dizziness. wasnt speaking dropped her phone and was not aware. BP WAS 79/37 Pupils were fixed with some movement.. mother was outside, called in. mother had stated earlier that she was afraid of needles. felt clamy and sweaty. patient taken to ER in wheelchair with mother for evaluation
17 2021-04-20 sweating emale client received her first dose of Covid Vaccine (Pfizer, Lot # ER8729, Expiration date: 07/31/... Read more
emale client received her first dose of Covid Vaccine (Pfizer, Lot # ER8729, Expiration date: 07/31/2021) at 1132. This minor client, accompanied by her mother proceeded to the observation room for her 15 minute wait period. Co-lead RN, was present in the observation room assessing another client. At 1137 this client's mother loudly voiced from the back of the room, "she's feeling dizzy" and co-lead observed client was hanging her head. Co-lead and EMT1 hurried to her side, and client stated she was feeling lightheaded and dizzy and was suddenly pale and diaphoretic. EMT1 immediately transferred her from chair to floor with full assistance to prevent a fall/injury. Client was placed in trendenlenburg position by elevating feet and placing them on the chair. Client was unresponsive for about 15 seconds until she regained consciousness and returned to baseline mentation. Client verbalized she "blacked out" and did not remember being placed on the floor. Client denied pain and respiratory distress. EMT1 called 911 at 1138. Client and her mother deny she has any medical issues, allergies, medications, or previous incidence of syncope. At 1145, first set of vitals taken by EMT1 indicate hypotension and bradycardia as follows: BP 68/44, HR 58, and RR 16. At 1145 paramedics arrived and assumed care after receiving report from EMT2. At 1150 medics took VS with BP 70/50, HR 54, and blood glucose 95, and determined they would start an IV to administer a 500cc bolus for dehydration and to improve BP. Client was also placed on 2L O2 for comfort, no desat noted. At 1200, medics advised client's mother and co-lead they would transport client to the Hospital for further evaluation. Medics departed at 1205 to transport client to the hospital.
17 2021-04-20 sweating Fell to floor from chair in observation area. OC related to vaccine administration. Pain in right ch... Read more
Fell to floor from chair in observation area. OC related to vaccine administration. Pain in right cheek. Pain level 2.5/10. Vaso-vagal response post vaccine injection. Vital Signs: BP 100/60 HR 85 Resp 20 O2Sat 98 , Skin Signs: Cool and dry, Clammy, Circulation: Cap refill <2sec, Respiratory: Breath sound clear bilaterally, Initial Treatment: Water/observation/elevated les bilateral. Assessed/evaluation by Dr. 10:25 AM, Vital Signs: BP 100/72 HR 85 Resp 20 O2Sat 72, Skin Signs: Cool and dry, clammy, Circulation: Cap refill <2sec, Respiratory: Breath sound clear bilaterally Follow up Treatment: Mask Oxygen administration for 10 min. 10:25-10:35 AM. Ice pack to right cheek, approx. 4 L and reduced to 2 L/min\, 10:35 AM\, Vital Signs: HR 98 Resp 20 O2sat 99, Skin Signs: Cool and dry, clammy, diaphoretic Circulation: Cap refill <2sec, Respiratory: Breath sound clear bilaterally 10:45 AM, Vital Signs: BP 120/82 HR 76 Resp 20 O2Sat 97, Follow up Treatment: 10:45 skin warm and dry, alert and oriented x3. Cap refill <2sec ,Notes: Recommended parent to contact peds office for injury to right cheek. Continue to maintain good hydration at home the rest of the day. Home with father at 10:55 AM
17 2021-04-20 throat pain she developed sore throat, aphtous ulcers and loss of appetite
17 2021-04-20 throat irritation itchy throat/skin, cleared, pt. left site
17 2021-04-21 headache, fatigue, lethargy Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Chest Tightness / Heaviness / Pain-Mild, ... Read more
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Severe, Systemic: Headache-Mild, Systemic: Hyperventilation-Medium, Systemic: Nausea-Severe, Systemic: Shakiness-Medium, Systemic: Tachycardia-Mild, Systemic: Visual Changes/Disturbances-Severe, Systemic: Weakness-Mild
17 2021-04-21 headache, fever Left arm ache, sore with slight bruising. Headache and mild fever. Pain ful menstrual cycle with abd... Read more
Left arm ache, sore with slight bruising. Headache and mild fever. Pain ful menstrual cycle with abdominal cramping and heavy bleeding with the cycle lasting for 6 days ( more than normal ).
17 2021-04-21 headache Left arm sore. Severe migraine headche with blurry vison in left eye( vision corrected later in the ... Read more
Left arm sore. Severe migraine headche with blurry vison in left eye( vision corrected later in the day) Onset of mentrual cycle with severe abdominal cramping , nausea, heav bleeding and headache.
17 2021-04-22 fatigue, fever, sweating Fever, super cold, sweating, fatigue, migraine, bossy aches and sore, sore arm
17 2021-04-22 fatigue EXTREME NAUSEA AND SEVERE FATIGUE AS WELL AS SHAKINESS
17 2021-04-22 sweating At 1143 - 17 year old female was sitting with her mom, pt advised staff that she was feeling dizzy. ... Read more
At 1143 - 17 year old female was sitting with her mom, pt advised staff that she was feeling dizzy. Pt states the room was spinning. Pt was assisted to wheelchair and escorted to designated private patient area. Pt was pale and diaphoretic but was alert and talking to staff, pt was assisted to remove her sweatshirt and assisted to lay down. Pt instantly stated she felt better after laying down. Pt provided wet cloth for comfort and skin color return to WNL . Pt had small sip of water and stated she felt much better. Pt advised she had only eaten two small donut holes and did not drink water prior to arrival at the clinic. Pt skin returned to normal warm and dry, VSS, AOx4 and pt stated she felt much better and was ready to go home. Pt mother will continue to monitor pt and ensure she continues to hydrate and eat after leaving the site. 1145 VS Bp 94/60 HR 51, 16RR 100% 1150 VS Bp 102/64 HR 60, 16RR 98% 1155 VS Bp 102/68 HR 69, 16RR 98% 1200 VS Bp 104/68 HR 73, 16RR 99% sitting
17 2021-04-22 sweating After receiving vaccine, patient became light headed and passed out sitting in chair. diaphoretic an... Read more
After receiving vaccine, patient became light headed and passed out sitting in chair. diaphoretic and clammy. Heartrate 60, BP 60/29,SPO2 100%. Medical response called, patient taken to ER, accompanied by mother
17 2021-04-22 fever, chills, fatigue Sore arm, chills, body aches, nausea, slight fever, tiredness
17 2021-04-22 sleepiness COLD SWEATS, DIZZINESS, DROWSINESS, BP WAS TAKEN 74/44, THEN 5 MINS LATER 99/60, PT WAS LAID DOWN TO... Read more
COLD SWEATS, DIZZINESS, DROWSINESS, BP WAS TAKEN 74/44, THEN 5 MINS LATER 99/60, PT WAS LAID DOWN TO PREVENT FALLING, PT WAS NERVOUS AND ANXIOUS
17 2021-04-23 sweating c/o feeling faint, pale and diaphoretic, seen by paramedic
17 2021-04-24 fatigue One day after the second dose I felt tired, weak, cold, and with a sore arm. After, I took 3 Tylenol... Read more
One day after the second dose I felt tired, weak, cold, and with a sore arm. After, I took 3 Tylenol capsules to feel better. Today my left arm which I got the vaccine in, feels itchy and my hand is swollen and red. Now my left feet is starting to feel itchy and swollen-red.
17 2021-04-24 headache, fever 2:00 am: chills 8:30 am: 102.2 fever with chills and throbbing headache fever continued throughout ... Read more
2:00 am: chills 8:30 am: 102.2 fever with chills and throbbing headache fever continued throughout day
17 2021-04-24 headache i couldnt sleep, woke up many times with chills and a really bad headache, the whole day ive been si... Read more
i couldnt sleep, woke up many times with chills and a really bad headache, the whole day ive been sick to my stomach and my head hurt. i even threw up a lot
17 2021-04-24 fever Daughter tested positive for covid on 2 separate tests.; fever 5 hrs later; This is a spontaneous re... Read more
Daughter tested positive for covid on 2 separate tests.; fever 5 hrs later; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer reported for his daughter. A 17-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 09Apr2021 as a single dose for COVID-19 immunization. On an unknown date, the patient started therapy with Trumenba (MENINGOCOCCAL GROUP B RLP2086; Suspension for injection, Lot# and expiration date not reported) via unknown route of administration as single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unknown date in Apr2021 (reported as 5 hr. later vaccination), the patient experienced fever. It was reported that the patient (daughter) tested positive for covid on 2 separate tests. Patient wanted to clarify whether she gets covid on Trumenba. The outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
17 2021-04-25 headache After only an hour outside in low 60s weather, I had felt symptoms similar to heat exhaustion. My vi... Read more
After only an hour outside in low 60s weather, I had felt symptoms similar to heat exhaustion. My vision got extremely spotty, and couldn?t see much. There was a loud ringing in my ears and everything else sounded muffled. I felt dizzy and my skin felt like tissue paper. It faded after I went inside and got water. However, I still have a headache, 6 hours later.
17 2021-04-25 sweating Patient had flushing/sweating, dizziness, anxious, sweating. Low BP 84/46 -- > 116/75 -- > 121/82. P... Read more
Patient had flushing/sweating, dizziness, anxious, sweating. Low BP 84/46 -- > 116/75 -- > 121/82. Patient stated did not eat since 4/24/21 6PM. Patient stable, released from vaccination site.
17 2021-04-25 sweating After vaccination patient described stomach hurting, nausea, sweating, and loss of hearing. Patient ... Read more
After vaccination patient described stomach hurting, nausea, sweating, and loss of hearing. Patient felt immediately better after moving up from chair and being transferred to Med OBVs at 17:18. First set of VS were taken at 17:21, HR:83, RR:20, BP: 121/68, SPO2: 98. Patient then stated that she had not eaten a meal before the vaccine, only a chewy bar. Second set of VS were taken at 17:28, HR: 89, RR: 20, BP: 116/67, SPO2: 98. Patient stated she felt fine and was comfortable heading home, last set of VS were taken at 17:45, HR: 82, RR: 20, BP: 112/63, SPO2: 98. Patient was released at 17:45 with her father.
17 2021-04-25 fever Mild SOB, fever, aches, rapid HR 130 and slightly irregular.
17 2021-04-26 chills, body temperature increased, malaise, headache At 2am 4/22 patient started to feel sick and sent a text that I didn't read until 630 as I was aslee... Read more
At 2am 4/22 patient started to feel sick and sent a text that I didn't read until 630 as I was asleep. She had severe muscle aches, hurt to move, hurt to breathe and felt like she was having a heart attack. She felt like she might pass out and had some blurred vision. At 630am, I saw her texts and immediately brought her 2 tylenol and a large glass of water. She went back to bed. She woke up around 10:45 and was feeling decent except for a headache but no fever or anything so we went to try on some Prom dresses. At the dress shop, she collapsed and had a seizure lasting around a minute. She lost her bladder and was completely confused and incoherent. She's never had a seizure before. I scooped her up, brought her to the ER where they ran every test and scan imagineable. Full blood work up and cultures, a chest xray, a CT scan of her brain and lungs. Her temp was high 103-104 and she had full body chills and a pounding headache. Her BP kept dropping and got as low as 81/36. They threw 2 bags of IV fluids into her and admitted her to the hospital. She had also developed a heart murmur. Over the course of the night, her BP stabilized but her temp continued to spike and come back down with Tylenol/Ibuprofen. She also had IV Tordahl for the headache. Her inflammatory markers were high at 15.3 which we were told should be less than 1. They reran labs in the morning but everything can back really low which they felt was a dilution effect from all the fluids so wanted us to follow up with her primary care on Monday. On Saturday night, he lymph nodes were swollen to the size of ping pong balls but have since slowly reduced in size although still there. Her labs were better from discharge and her white blood cell count was within range and her inflammatory marker was down to 1.7. Her blood sugar was a little low. She did pass out and have seizure like response to giving blood in the doctors office, lost bladder control again, shot pupils, etc. She is still stuttering over words, has some short term memory retention and has some motor function issues which they think is a result of the initial seizure and should resolve itself over time. Her liver function tests were totally normal in the hospital but are a high now so they will be checking her out again next week.
17 2021-04-26 fever, cough, chills, nasal congestion, fatigue ON 4/21/21, SHE BEGAN TO EXPERIENCE SHORTNESS OF BREATH, COUGHING, CONGESTION, SEVERE BACK ACHE, WEA... Read more
ON 4/21/21, SHE BEGAN TO EXPERIENCE SHORTNESS OF BREATH, COUGHING, CONGESTION, SEVERE BACK ACHE, WEAKNESS, FATIGUE, FEVER, CHILLS, VOMITING, DIARRHEA. I TOOK HER TO THE HOSPITAL WHERE WE WERE TOLD THAT IT WAS DUE TO VACCINE AND SHE WAS SENT HOME WITHOUT MEDS. SHE BECAME WORSE AND WORSE AND DEVELOPED HEART ATTACK SYMPTOMS: CHEST PAIN, WHEEZING, TIGHTNESS AND HEAVINESS IN CHEST, INTENSE BACK PAIN. WE RETURNED TO THE ER AND SHE WAS DIAGNOSED WITH PERICARDITIS. WE WERE ALSO TOLD THAT HER HEART WAS SLIGHTLY ENLARGED.
17 2021-04-27 fatigue Aches and sight nausea/fatigue the day of vaccine, on day of vaccine I was 142 pounds. Two days late... Read more
Aches and sight nausea/fatigue the day of vaccine, on day of vaccine I was 142 pounds. Two days later I was 145. Today, 5 days post vaccine, I was 147 pounds. My weight has never fluctuated this much in such a short period of time ever. There has been no change to my diet, activity level, medications or any other factors since vaccination. My weight was steady prior to vaccination. The vaccine in question was my second dose. I had no adverse reactions after my first vaccine.
17 2021-04-27 sweating Patient felt dizzy right after her vaccination, she was sweating a lot and wanted to throw up but ... Read more
Patient felt dizzy right after her vaccination, she was sweating a lot and wanted to throw up but didn't . No problem breathing . we called 911 and ambulance came and took patient to hospital for further evaluation. we called patient's dad at 3:00 pm, patient was feeling fine and got home already.
17 2021-04-27 sweating Pt received Pfizer COVID vaccine, was walking with father next to her, felt faint, and father eased ... Read more
Pt received Pfizer COVID vaccine, was walking with father next to her, felt faint, and father eased her to the floor, no head or body injury. Positive pallor and diaphoresis noted, legs elevated and pt color improved with pt now alert and oriented. Assisted to upright position, onto stretcher, given 1 small bottle water po, BP: 108/68, HR: 87, RR: 16 nonlabored, SaO2: 100% on RA. Pt currently has menses. 1023: drank 1 apple juice, feeling better. 1038: BP: 94/53, HR: 64, RR: 16 nonlabored, Sa02: 100% on RA. Sat upright on stretcher, legs dangling. 1044: BP 91/58, HR: 70, RR: 16 nonlabored, SaO2: 100% on RA, feeling well, drank 2 apple juice cups, standing up. 1049: standing up BP: 84/46, HR: 62, RR: 16 nonlabored, SaO2: 100% on RA. 1100: Pt feeling well, no c/o, escorted to front door of hospital, father at side. Pt aware to drink fluids today and especially during menses. Pt is also a dancer and practices every day. Discussed hydration needs prior to discharge from vaccine clinic. Pt aware to discuss vasovagal response from this injection at next visit so pt can lay down.
17 2021-04-27 sweating patient became very diaphoretic in the observation area, her head went back, eyes closed, extremitie... Read more
patient became very diaphoretic in the observation area, her head went back, eyes closed, extremities became very rigid and patient appeared to have lost consciousness for a brief moment. RN was present at side of patient, patient was hypotensive, vitals checked BP 71/48 and pulse 54. Patient states she felt like she went to sleep, started to feel better several minutes later. EMS was contacted to evaluate and transport patient to ED.
17 2021-04-28 fatigue, chills Passed out right after vaccine; muscle aches; tired; chills; migraine; This is a spontaneous report ... Read more
Passed out right after vaccine; muscle aches; tired; chills; migraine; This is a spontaneous report from a non-contactable consumer (patient). A 17-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in the left arm on 14Apr2021 at 14:15 (Batch/Lot number was not reported) as single dose for covid-19 immunization, administered at the Pharmacy or Drug store. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 17Mar2021 at 14:15 in the left arm for covid-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. The patient was not pregnant at the time of report and vaccination. The patient did not receive other vaccines in four weeks. The patient had no COVID prior to vaccination and was not tested for COVID post vaccination. The patient passed out right after vaccine, also experienced muscle aches, tired, chills, and migraine; all on 14Apr2021 with outcome of unknown. No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.
17 2021-04-28 malaise, fatigue, headache Arm pain, slight swelling in injection site area. Swollen lymph nodes on both sides of neck, overall... Read more
Arm pain, slight swelling in injection site area. Swollen lymph nodes on both sides of neck, overall malaise/body aches, fatigue, light-headedness resulting in fainting episode, headache
17 2021-04-28 fever Fever, headache, light headed, sore body, pain in shoulder where I got the shot all of which lasted ... Read more
Fever, headache, light headed, sore body, pain in shoulder where I got the shot all of which lasted for about 24 hours except the sore body which is still continuing on currently.
17 2021-04-29 chills, fatigue At 2am 4/30/2021 woke up with Nausea- fatigue-felt the chills.
17 2021-04-29 headache, cough, throat pain After receiving the vaccine on 4/26, she developed headache and temperature to max 99-100 as well as... Read more
After receiving the vaccine on 4/26, she developed headache and temperature to max 99-100 as well as muscle pain in the arm where she received the vaccine. Progressed to diffuse myalgias on 4/27 and 4/28. Was having a slight cough that is typical for her during this time of year due to allergies, no other respiratory symptoms. Then acutely developed severe jaw pain that radiated to the throat and into her chest when she woke up on 4/29 in the morning. She had 10 out of 10 crushing chest pain.
17 2021-04-29 headache Headache (4/10). Fear of needles, with history of fainting. O2 sat 100%. BP 91/74 (pulse 63).
17 2021-04-29 malaise Fainted- Started feeling sick and other common side effects after 7 hours continuing throughout the ... Read more
Fainted- Started feeling sick and other common side effects after 7 hours continuing throughout the next day, and passed out at 8pm about 30 hours after the shot. And continuing to feel common side effects throughout night 2 and next day (aprox. 48 hours after shot)
17 2021-04-30 body temperature increased, chills Not sleeping well at night due to pressure feeling in her chest up; Not sleeping well at night due t... Read more
Not sleeping well at night due to pressure feeling in her chest up; Not sleeping well at night due to pressure feeling in her chest up; shivers; jaw got paralyzed; she got shaky; feeling bad/ brain fog; burning sensation in her body; She couldn't talk; slight elevated temp (99.7F max); She has been off balance this week since getting her vaccine; This is a spontaneous report from a contactable physician. A 17-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Apr2021 (batch/lot number was not reported) as a single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome, panic attacks, migraines and acne. The patient was not pregnant at the time of vaccination. It was unknown if there were other vaccines in four weeks. The patient did not have Covid prior to vaccination and was not Covid tested post vaccination. Concomitant medications in two weeks included ondansetron hydrochloride (ZOFRAN) taken for anti-nausea, start and stop date were not reported; doxycycline taken for acne, start and stop date were not reported. The patient previously took glycerol (GLYCERIN) and experienced allergies. The patient got her vaccine on 12Apr2021. Two nights after her vaccine (14Apr2021), she got shaky and feeling bad and burning sensation in her body. No fever at that time, but slight elevated temp (99.7F max) the day after the vaccine (13Apr2021). Mother gave her anti-nausea medication (ondansetron hydrochloride 2 mg) and within 5 minutes her jaw got paralyzed. She couldn't talk. It lasted about 30 min. Mother called ambulance and patient was brought to ER. ER didn't do bloodwork or any evaluation. ER didn't know what happened per mother. She has been off balance this week since getting her vaccine (Apr2021). She feels better this morning but she still feels off balance. Not sleeping well at night due to pressure feeling in her chest up and she shivers to get the feeling away per patient (unspecified date). Slept better last night as of 17Apr2021. No facial drooping. She can smile and lift her eyebrows. Patient had "brain fog" this week as well after the vaccine. The adverse events "she got shaky", "feeling bad", "burning sensation in her body", "jaw got paralyzed" and "she couldn't talk" resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care visit. There was no treatment received for the adverse events. The outcome was recovered on an unspecified date for the events "jaw got paralyzed" and "she couldn't talk"; recovering for the event "not sleeping well at night"; not recovered for the event "off balance"; and unknown for the rest of the events. Information on the lot/batch number has been requested.; Sender's Comments: Based from temporal relation of event and vaccine administration, Trismus as an event in relation to suspected drug BNT162B2 cannot be totally excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
17 2021-04-30 fatigue, chills, fever fatigue; Fever; chills; aches in muscles; This is a spontaneous report from a contactable consumer (... Read more
fatigue; Fever; chills; aches in muscles; This is a spontaneous report from a contactable consumer (Parent). This is the 2nd of 2 reports, for the 2nd dose. A 17-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, at age of 17 years old, administered in Arm Left on 09Apr2021 09:00 (Lot Number: EP6955) at single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included depression. Concomitant medication(s) in two weeks included escitalopram, fexofenadine hydrochloride (ALLEGRA), bifidobacterium bifidum, bifidobacterium lactis, lactobacillus acidophilus, lactobacillus brevis, lactobacillus bulgaricus, lactobacillus casei, lactobacillus paracasei, lactobacillus plantarum, lactobacillus rhamnosus, lactobacillus salivarius (PROBIOTIC 10), all taken for an unspecified indication, start and stop date were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/lot number: EP6955) at age of 17 years old in Arm Left on 19Mar2021 09:00 for covid-19 immunisation and experienced Fatigue, chills and achy, zofran [ondansetron] and experienced hypersensitivity. The patient experienced Fever, chills, aches in muscles, fatigue on 09Apr2021 10:00. Tylenol received for events. And outcome of event was recovered on unknown date. The patient was not diagnosed with COVID-19 prior to vaccination, and Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No follow-up attempts possible. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021335679 same patient and vaccine, different AE and dose
17 2021-04-30 headache, chills nausea; headache; began having left eye twitches and they progressed to spasms and the nose and left... Read more
nausea; headache; began having left eye twitches and they progressed to spasms and the nose and left side of her face. It then included both sides of her face; pinching in her left shoulder; began having left eye twitches and they progressed to spasms and the nose and left side of her face. It then included both sides of her face; patient could not open her eye or control her face; her left leg had goosebumps and chills; her left leg had goosebumps and chills; This is a spontaneous report from a contactable consumer (patient's mother). A 17-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: ER8731) via an unspecified route of administration on 07Apr2021 at 15:15 (at the age of 17-years-old) as a single dose in the left arm for COVID-19 immunisation. Medical history included asthma from an unspecified date and unspecified if ongoing. Family medical history relevant to the adverse event was reported as none. Concomitant mediations included ethinylestradiol/levonorgestrel (JOLESSA) taken "to decrease her periods" from 2019 ("about two years ago") and ongoing and at an unspecified dose, cyclic, for three months straight with no placebo. Then takes a placebo pill for one week straight and biotin taken "for hair and nail growth" from an unspecified date ("she began taking within the last 6 months") and ongoing. There was no history of previous immunization with the Pfizer vaccine, there were no additional vaccines administered on the same date as the COVID-19 vaccine and there were no prior vaccinations within 4 weeks. It was not provided whether there were adverse events following prior vaccinations. On 07Apr2021 the patient experienced began having left eye twitches and they progressed to spasms and the nose and left side of her face. It then included both sides of her face, patient could not open her eye or control her face, her left leg had goosebumps and chills, pinching in her left shoulder, nausea and headache. The reporter called to report that her daughter had a severe reaction to the first dose of the COVID-19 vaccine. The clinical course was reported as follows: The patient received the first dose of the COVID-19 vaccine in her left arm. Less than an hour after receiving the COVID-19 vaccine, the patient developed goosebumps and chills in her left leg. The reporter was not very concerned about it at the time. About 9:00PM that same night, the patient started complaining of pinching in her left shoulder. The reporter was not too terribly concerned. By 9:30PM, that same night, the patient started to have left eye twitches. Then they increased to eye spasms, then the patient could not open her eye or control her face. Then, it progressed to patients nose and left side of her face. At that point, the reporter tried to contact a nurse with the health insurance advice line. She waited for 30 minutes. The patient's symptoms continued to get worse, so the reporter took the patient to the emergency room. While the patient was in the emergency room triage, while hospital staff were getting her blood pressure and temperature, her symptoms also started to involve the right side of her face. Around 10:15PM, that same night, the patient started to get nauseous and a headache kicked in. The emergency department took patient straight back to a room. The patient was not admitted to the hospital. The emergency department started an IV on the patient, and they administered Reglan, Benadryl, and Toradol to treat her symptoms. The emergency department ran blood tests, preformed a urinalysis and a CT scan. The reporter did not know what all blood testing that was done revealed; however, the reporter did know that they told her that none of the testing revealed anything and were all normal. The patient was eventually discharged from the emergency department at about 1:50AM. She was sent home with Butalbital, for headache and was advised to take ibuprofen. She was still having the twitching but not as bad when discharged. On 08Apr2021, the patient's symptoms had not completely subsided, but were significantly better. On 08Apr2021, the patient woke up with nausea, chills and a headache. The reporter expected the patient to have these side effects. The side effects continued until very late in the day on 10Apr2021. The patient never vomited, was only very nauseous. The reporter also stated that when the woman was administering the first dose of the COVID-19 vaccine, the woman said "oops" and it was not explained what "oops" meant. The reporter asked if it was possible that the patient received the dose subcutaneously and that was why she had these side effects. The reporter also stated that the second dose was scheduled for 28Apr2021 and she asked if the patient should receive the second dose. The clinical outcomes of the events began having left eye twitches and they progressed to spasms and the nose and left side of her face. It then included both sides of her face, patient could not open her eye or control her face, her left leg had goosebumps and chills, pinching in her left shoulder, nausea and headache all recovered/resolved on 10Apr2021. No follow-up attempts are needed; No further information is expected.
17 2021-04-30 headache Headache; This is a spontaneous report from a contactable nurse. A 17-year-old female patient receiv... Read more
Headache; This is a spontaneous report from a contactable nurse. A 17-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 intramuscular on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced headache on an unspecified date with outcome of not recovered. The reporter seriousness for headache was medically significant. Information about the Lot/batch number has been requested.; Sender's Comments: Based on the known product safety profile, a causal association between the reported event 'headache' and the suspect product 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.
17 2021-04-30 sweating Immediately after administration of vaccine, patient fainted. Patient assisted in to wheelchair and ... Read more
Immediately after administration of vaccine, patient fainted. Patient assisted in to wheelchair and wheeled to private observation area. Patient assisted to gurney. Patient has cool compress to forehead. Patient also nauseous, pale, and sweaty. Patient mother reports patient did not eat today. Given water and apple juice. Patient declined granola bar. Vital signs as follows: 0950-BP 88/59, P 86, RR 20, 95% RA, no pain. 0955-BP 92/60, P 69, 99% RA. 1000-BP 96/67, P 75, 100% RA. Education given to patient and mother regarding eating/drinking before next dose and to tell the vaccinator that patient passed out at last vaccine and to lay on gurney before second dose is given. Patient and mother acknowledged understanding. Patient back to baseline at 1010.
17 2021-04-30 malaise Within a couple of minutes of receiving the shot, my daughter felt hotness running down the length o... Read more
Within a couple of minutes of receiving the shot, my daughter felt hotness running down the length of her vaccinated arm and into her hand. Started feeling hot and started to produce a small patch of hives on the outside of the throat and chest. Did vigorous windmill motions with vaccinated arm. She had a feeling of slight unwellness that was followed by a rush of energy. As we leave the store and start to drive home her hives are a little bit worse and she says she feels a little lightheaded and has some heart palpations. But is still reporting a rush of energy. By the time we get home 10 minutes later hives, lightheadedness, and heart palpations have resolved. She feels great the rest of the day. Next day slight redness around the injection site and arm a bit sore. The following day redness is gone but a slight rash is starting to show up around the neck. 5 days later, the rash becomes inflamed, sore, hot and itchy, hives are full upper-body flareups. She takes Allegra 24 for hives control. Rash comes and goes daily. Acts more like hives. Allegra 24 controls hives mostly along with icing. After a few days, the effectiveness of the Allegra 24 is not as efficient with the neck rash. Switches to Zyrtec 24 which seems to provide better relief from both hives and rash around the neck. Sees Dr. April 29th. He advises not to take a second dose of Pfizer at this time and prescribes her an EpiPen.
17 2021-04-30 sleepiness, chills, fever fever 100.9; nausea; back pain; sleepiness; chills; fast heartbeat; This is a spontaneous report fro... Read more
fever 100.9; nausea; back pain; sleepiness; chills; fast heartbeat; This is a spontaneous report from a contactable consumer (parent) reporting for his daughter. A 17-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as single dose and had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as single dose for covid-19 immunization and stated was fine after the first dose. Patient was 17-years-old at the time of vaccination. The patient medical history and concomitant medications were not reported. The patient experienced fever 100.9, nausea, back pain, sleepiness, chills, fast heartbeat on an unspecified date. The outcome of event was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
17 2021-05-01 dehydration, fatigue dehydration migraine with aura myalgia fatigue
17 2021-05-01 fatigue, headache headache, muscle aches, pain at injection sight, fatigue, lightheaded
17 2021-05-01 headache, chills Woke up at 6:30 AM on May 2 with chills and moderate-severe headache, took 2 Ibuprofen at 7:00 AM. T... Read more
Woke up at 6:30 AM on May 2 with chills and moderate-severe headache, took 2 Ibuprofen at 7:00 AM. Took nap and then stood to speak to my mother, followed by a severe headache for a few seconds and then a seizure lasting less than 1 minute. Hospital released and recommended follow up with PCP for referral to neurologist. No further events as of May 2nd at 9:15 PM
17 2021-05-01 fever, chills, sleepiness, headache Fever, chills, aches, headache, groggy, itchy ears
17 2021-05-01 fever, sweating Patient said she was feeling dizzy, vision was blurry, sweeting. Was able to breath, asked for wat... Read more
Patient said she was feeling dizzy, vision was blurry, sweeting. Was able to breath, asked for water which was given to her. She had some rash on the face, provided diphenhydramine liquid 50mg. She was feeling feverish, took tylenol.
17 2021-05-02 sweating Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemi... Read more
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Seizure-Medium, Systemic: Vomiting-Mild
17 2021-05-02 sweating Sudden sweatiness, nausea and tunnel vision. Very brief LOC. Immediately better when placed supine... Read more
Sudden sweatiness, nausea and tunnel vision. Very brief LOC. Immediately better when placed supine. More scarred than anything else. No fall or injury. BP/pulse/O2 saturation all Normal Initial 126/89, 69, 100%. No orthostasis. Classic vasovagal reaction. Resolved.
17 2021-05-02 lethargy, fever, headache First 3 days, arm was sore, fever, nausea and day 3, vomiting. Every single day since, off and on th... Read more
First 3 days, arm was sore, fever, nausea and day 3, vomiting. Every single day since, off and on throughout the day: fever (99-101.9), nausea, headaches in the front part of the head, clammy feeling and lethargic. Starting 5/1, now been dizzy every day. We are on day 22 since the vaccine and this is still happening.
17 2021-05-02 nasal congestion, cough, headache ? Cough sx x 3 days ? Shortness of Breath ? Headache ? Nasal Congestion -consider use of OTC m... Read more
? Cough sx x 3 days ? Shortness of Breath ? Headache ? Nasal Congestion -consider use of OTC medications such as DayQuil/NyQuil, Robitussin or Delsym for cough - OTC nasal spray and decongestants may provide temporary relief. If you have hypertension, diabetes, thyroid disease, or are pregnant you should avoid using these products. - A mix of 1/2 honey and 1/2 lemon juice can be used to soothe the throat and help loosen thick mucus in the throat or use warm salt water gargles. Use of hard candy, or throat lozenges for sore throat or cough (sugar free if Diabetic) -Steam inhalation by standing in a hot shower or sitting in the bathroom when hot shower is running helps with nasal discomfort. Vaporizers and humidifiers are not recommended due to the risk of burns, bacterial growth in improperly cleaned equipment, and mold formation in the home -Saline nose drops help loosen secretions. Commercial or homemade may be used (1/4 tsp. salt dissolved in 8 ounces warm water distilled or boiled water, discard solution after 48-72 hours) -Consume extra fluids, maintain a nutritious diet, get adequate rest -Take Tylenol as needed for pain and/or fever.
17 2021-05-02 fever, chills, headache Fever, Chills, Nausea - lasted approx. 6 hours Headache - lasted approx. 2.5 days
17 2021-05-02 fever, chills Fainting; syncope Emergency room visit: low blood pressure, high heart rate, administered a bag of f... Read more
Fainting; syncope Emergency room visit: low blood pressure, high heart rate, administered a bag of fluids to hydrate High fever, chills and lightheadedness
17 2021-05-03 chills chest pain and chills 2 days after vaccination. seen in ED 2 days after for chest pain. normal lab... Read more
chest pain and chills 2 days after vaccination. seen in ED 2 days after for chest pain. normal labs and EKG. seen 6 days later in this office for continued chest pain and chills. no previous history of chest pain
17 2021-05-03 headache, fatigue Vomitting (cant keep anything down at all),headache, body ache to the point she was crying some of t... Read more
Vomitting (cant keep anything down at all),headache, body ache to the point she was crying some of the time, diarrhea, exhausted No fever so far It started at 3:00 am and it is now 7:30 am and she is finally able to fall asleep.... hopefully she improves throughout the day (still early)
17 2021-05-03 headache, sleepiness left-side facial drop with left mouth corner; stroke symptoms; transient mild headache; blurry visio... Read more
left-side facial drop with left mouth corner; stroke symptoms; transient mild headache; blurry vision; left side of tongue affected; slurring speech; felt confused; drowsy; This is a spontaneous report from a contactable consumer (patient). This 17-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8734), via an unspecified route of administration in the right arm at 17 years old on 30Mar2021 at single dose for COVID-19 immunization. Medical history included acquired brain injury (C-PVL) from pneumococcal strep infection, hypoxic ischemic encephalopathy, premature birth, quadriplegic dyskinetic cerebral palsy. Concomitant medications were none. The patient was not pregnant at time of vaccination. The patient previously received T-Dap vaccine at 10 years old and had prolonged migraine reaction. 12 days after, the patient developed stroke symptoms with transient mild headache, blurry vision, and left-side facial drop with left mouth corner and left side of tongue affected causing slurring speech also felt confused and drowsy which lasted for 8 hours. Events were started on 11Apr2021 at 03:30 PM. Events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient went to ER, they did stroke work-up. No evidence of stroke. The patient received treatment including CT scan, MRI, EKG, labs. The patient had no covid prior vaccination, no covid tested post vaccination. Outcome of the events was recovering.
17 2021-05-03 headache Full body aches, grueling and throbbing headache
17 2021-05-03 fever, fatigue White blister rash that started at injection site then spread quickly over back, chest, other arm, l... Read more
White blister rash that started at injection site then spread quickly over back, chest, other arm, legs. Light headedness, and tingling and numbness in lips and face. Was given Benadryl 25mg and 2 Tylenol. The rash and numb feeling persisted for 3-4 hours. Several hours later symptoms were followed with a fever and nausea. These symptoms remedied within 24 hours and she was just tired and sore.
17 2021-05-03 runny nose 03May21-daughter C/O obstruction in throat. upon view, left tonsil is enlarged, red, 'puffy', striat... Read more
03May21-daughter C/O obstruction in throat. upon view, left tonsil is enlarged, red, 'puffy', striated with white patches. Uncomfortable to swallow. slight runny nose, congested voice, puffy eyelids (slight). Went to urgent care, was tested for Mononucleosis and results positive.
17 2021-05-04 chills, fatigue, headache, lethargy, fever Site: Pain at Injection Site-Mild, Systemic: Chills-Severe, Systemic: Exhaustion / Lethargy-Mild, Sy... Read more
Site: Pain at Injection Site-Mild, Systemic: Chills-Severe, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Severe, Systemic: Fever-Medium, Systemic: Headache-Severe, Systemic: Unable to Sleep-Mild, Additional Details: mom called to report adverse reaction to 2nd dose of pfizer vaccine. pt had chills on monday, fever on tuesday, wed morning child passed out in the kitchen mom heard her fall, she did call 911. child was transported via ambulance to strong ER. pt was diagnosied with syncope. pt is now home with mild headache/lethargy and recovering. mom has called pcp waiting to talk to her.
17 2021-05-04 fatigue Fatigue
17 2021-05-04 headache, chills chills, muscle aches, joint pain, headache, nausea
17 2021-05-04 headache, fever, fatigue Fever, Headache, Body aches, Fatigue
17 2021-05-04 sweating Pt experienced full vaso vagal reaction post COVID vaccine. Cold packs were administered to back of... Read more
Pt experienced full vaso vagal reaction post COVID vaccine. Cold packs were administered to back of neck and forehead. Pt sweating resolved and color came back. Aided pt to stand until feeling came back in legs/feet. Called Dad into room. He stated he was a nurse and understood the situation. Everyone was calm. Had pt stay for additional time and offered snack once feeling better. Pt was not thirsty so allowed sip on water and gave reese cup. Dad walked around store for a bit before getting into the car.
17 2021-05-05 cough, headache Severe headache developed on evening of vaccine. The next morning, patient developed an itchy bumpy ... Read more
Severe headache developed on evening of vaccine. The next morning, patient developed an itchy bumpy raised red rash on her Right forearm while at school. Benadryl helped a little. A worsening headache, cough and wheeze started evening 4/27/21. She took Tylenol and used her Albuterol inhaler. She slept poorly due to itch, headache, bad cough & wheezing. On 4/29/21, 4 hrs after taking Benadryl, she developed an urticarial rash on her Left forearm (right arm improved by then). A pruritic, extensive petechial Left-sided facial rash began that evening which worsened the next am and spread to right side of face. Headache comes and goes. Rash spread to upper arms 5/3/21 despite daily Claritin. Facial rash is fading
17 2021-05-05 headache, chills headache,chills,nausea
17 2021-05-05 headache Patient arrived to post vaccine area after receiving second dose of Pfizer COVID 19 vaccine. Patient... Read more
Patient arrived to post vaccine area after receiving second dose of Pfizer COVID 19 vaccine. Patient reported to post vaccine nurse feeling lightheaded with tongue tingling, headache, nausea and feeling flushed/itchy. Initial vital signs 123/83 85bpm 99% O2. At 1730 patient given 25mg PO Benadryl per standing orders. Patient monitored by post vaccine nurse. Symptoms resolved at 6:15pm, and requested to leave. Last vitals: 117/78 HR 90 O2 99%. Patient had arrived with mother and agreed not to drive. Instructed to call 911/emergency services if symptoms return/worsen.
17 2021-05-05 sweating At 1130 pt reported feeling anxious. OxSat 94%, HR 55, BP 94/58, sweaty, clammy, At1142 Spoke to fa... Read more
At 1130 pt reported feeling anxious. OxSat 94%, HR 55, BP 94/58, sweaty, clammy, At1142 Spoke to father, informed him of reaction and treatment. Parent verbalized understanding. @1157 BP 110/68, HR 65, OxSat 98%
17 2021-05-05 sweating Client was lightheaded post vaccine--breathing was not in distress. Client was diaphoretic and pale.... Read more
Client was lightheaded post vaccine--breathing was not in distress. Client was diaphoretic and pale. Raised clients legs , propped her head up and applied ice packs to her neck. Client recovered in 10 minutes. No 911 call or meds received. Client walked out of clinic feeling "normal".
17 2021-05-05 fever, cough, respiratory tract congestion, fatigue Fever; Cough; Fatigue; Congestion; Body aches; Nausea; Shortness of Breath; Acetaminophen (TYLENOL) ... Read more
Fever; Cough; Fatigue; Congestion; Body aches; Nausea; Shortness of Breath; Acetaminophen (TYLENOL) tablet 650 mg Ondansetron ODT (ZOFRAN-ODT) disintegrating tablet 4 mg.
17 2021-05-06 chills Date and time of vaccination: (list both if they received both shots): 1st dose 4/6/2021 at 1100. 2n... Read more
Date and time of vaccination: (list both if they received both shots): 1st dose 4/6/2021 at 1100. 2nd dose 4/27/2021 at 1100. Date and time adverse event started: ~4/8/2021 (2 days post-vaccination), time unknown. Pt's mother reports that a couple hour post 1st dose vaccination, pt vomited right after. Couple days after 1st dose, pt had a breakthrough symptoms of hallucinations and delusions. Approx. a week later these symptoms gotten better and pt seems to return back to her normal self. Pt reports several hours post 2nd dose, pt vomited off and on and developed chills. In addition, pt's breakthrough symptoms appeared once again but seems worse than from the 1st dose. Today, pt is getting better but symptoms appears to lessen. ***NOTE*** Recommend pt's mom to see MD per these are not a common ADEs of the vaccine. Pt's mom advised pt have a follow up with MD on 5/4/2021. 5/5-Pfizer lot#EP7533, #ER8730. Patient no longer has symptoms, diminished on 5/3/21. No treatment was used to alleviate symptoms. Provider wrote a script for Ativan PRN yesterday but patient has not taking medication as of yet, has used non-pharmalogical coping skills to help alleviate symptoms.
17 2021-05-06 headache Approximately 15 min after the vaccine the patient c/o headache.pt history and vitals obtained. pt i... Read more
Approximately 15 min after the vaccine the patient c/o headache.pt history and vitals obtained. pt initially refused tylenol but did take 500mg tylenol 5 min later.pt monitored the rest of the time.pt stated she was feeling better and was released with advice to seek further medical attention if needed.
17 2021-05-06 sweating While sitting in vaccination chair, patient immediately started c/o of dizziness, and hearing soundi... Read more
While sitting in vaccination chair, patient immediately started c/o of dizziness, and hearing sounding muffled, diaphoretic and hot. Alert and oriented with BP 110/88 P52 and O2 99% on room air. Cold water given with gatorade insert. Cold compress also placed on patient. After 5 minutes, patient stated she "felt better." Alert and oriented x3. Left with mother. No acute distress noted.
17 2021-05-06 sweating Within a minute of administration, patient became diaphoretic, pale, vomited. Chair reclined. After ... Read more
Within a minute of administration, patient became diaphoretic, pale, vomited. Chair reclined. After vomiting, she immediately felt better. She was given water and monitored for 30 minutes. Upon assessment, it appeared as though patient was having a significant amount of anxiety at the time of injection, possibly causing aforementioned events.
17 2021-05-06 fever, throat pain The day after vaccine patient developed fever, myalgias, sore throat. Fever persisted 4-5 days. She ... Read more
The day after vaccine patient developed fever, myalgias, sore throat. Fever persisted 4-5 days. She developed rash on 4/30. Labs done showed low platelets (64k), low WBC with neutropenia. Fever resolved by 4/30 and rash resolved by 5/1/21. Platelets and WBC are recovering.
17 2021-05-07 fatigue Patient felt tired, light headache and developed rash at lower right abdomen. Given Benadryl and mon... Read more
Patient felt tired, light headache and developed rash at lower right abdomen. Given Benadryl and monitored 30 minutes. Itching stopped but continue to feel tired.
17 2021-05-07 fever, chills, headache Fever, headache, nausea, rash, sore near injection spot, cold chills.
17 2021-05-09 chills, malaise Patient received Pfizer Covid vaccine dose #1 at 4:07pm, 10 minutes later patient said that she was ... Read more
Patient received Pfizer Covid vaccine dose #1 at 4:07pm, 10 minutes later patient said that she was not feeling well. She felt her left arm was going numb, light headed, dizziness and chills. at 4:10 BP was 127/81 pulse 70. At 4:25 bp was 136/82 pulse 83. She was still feeling light headed, cold, and shaking. Pt given orange juice. At this point patient stated she has a hx of losing hearing and then a feeling of passing out. This has occurred more than one time. Pt also stated having lost feeling in both legs with no explanation as to why. 4:35pm bp 133/82 pulse 85, she was feeling cold and shaky. 4:42 pm patient stated she was getting colder and was still light headed. 4:56pm very cold, chills and dizziness. Pt was given another blanket. Both pt and father were asked if emergency services should be called. 5pm per parent;'s request were ok to give 480mg of tylenol, she was very dizzy and cold bp 132/85 pulse 89. Father approved of us calling for emergency services. Pt symptoms not improving. Emergency services arrived pt was able to get onto her feet and walk to the stretcher. Pt stated she is still very dizzy.
17 2021-05-09 cough, fever, productive cough, throat pain, headache, chills, sleepiness, sneezing Throwing up, headaches, abdomen pain, soar throat, chills, fever, sleepy, coughing violently, sneezi... Read more
Throwing up, headaches, abdomen pain, soar throat, chills, fever, sleepy, coughing violently, sneezing constantly, mucus coming up well coughing, wheezing, painful coughs, 05/06/2021
17 2021-05-09 headache, fatigue pt had headache, fatigue, and severe neck pain one day after receiving 2nd covid vaccine. Was seen i... Read more
pt had headache, fatigue, and severe neck pain one day after receiving 2nd covid vaccine. Was seen in ER on 05/06/21 . was seen in peds office 05/10/21 for follow up.
17 2021-05-09 headache, fever one week after covid #2 vaccine developed fevers, neck pain, headaches and vomiting, treated for lym... Read more
one week after covid #2 vaccine developed fevers, neck pain, headaches and vomiting, treated for lymphadenitis with oral antibiotics with continued fevers now x 9 days
17 2021-05-09 sweating Dizziness, followed by brief syncope, all resolved within 2 minutes. She fell out of chair on to gro... Read more
Dizziness, followed by brief syncope, all resolved within 2 minutes. She fell out of chair on to ground and immediately woke. Sweaty and pale, placed cool compress on back of neck and gave her a cold water to drink. She remained upright on the floor for approximately 5 minutes until she felt like she was fully recovered. Her father was present the entire time. She stated that she had no injuries or pain from falling out of chair. No rashes, bruising or bleeding observed. Mgr came over and patient's father declined to file a report for injury.
17 2021-05-09 lethargy, fatigue Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Tingling (... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild
17 2021-05-09 sleepiness, malaise, headache, fatigue When I first got the shot I had some soreness and some pain from mid upper are down to elbow. The ne... Read more
When I first got the shot I had some soreness and some pain from mid upper are down to elbow. The next day I could be rly wake up, my arm was incredibly sore and I felt sick to my stomach in waves. (rolling nausea) During the day I had off and on headaches that became a full on migraine my dinner. My arm stayed sore and hard to use all day and at night about 7:30 - 8:00 a sharp pain started lancing through my thigh to my knee, after a half hour or so it moved to include down to my ankle, then spaced out between the three randomly till about nine wen it moved to my side for about twenty minutes or so before becoming a dull throb in my leg till I fell asleep. The next day I felt a slight ickyness that last off and on all day as well as a light headache that got worse in the evening. The soreness in my arm dulled down and was just about gone by night, as well as rolling nausea all day though light. Today I woke up a little icky, very tired, and with a headache that has lasted all day and worened during the night, the soreness in my arm is gone.
17 2021-05-10 body temperature increased Had temperature of 101.8 degrees F at 8 PM. Gave Tylenol 650mg. Two hours later, temperature was 99.... Read more
Had temperature of 101.8 degrees F at 8 PM. Gave Tylenol 650mg. Two hours later, temperature was 99.7 and I gave Motrin 400mg. Temperature was 97.7 by the next morning at 07:10 AM.
17 2021-05-10 cough, runny nose 5 days ago her daughter had a runny nose and cough; 5 days ago her daughter had a runny nose and cou... Read more
5 days ago her daughter had a runny nose and cough; 5 days ago her daughter had a runny nose and cough; This is a spontaneous report from a contactable consumer (mother) received from Pfizer-sponsored program. A 17-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), dose 1 via an unspecified route of administration on 06Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. on Apr2021, the patient experienced 5 days ago her daughter had a runny nose and cough. Her daughter got the 1st dose 06Apr2021 and the 2nd dose schedule supposed to be on 27Apr2021, but they rescheduled the 2nd dose on 01May2021 because 5 days ago her daughter had a runny nose and cough. The action taken in response to the events for bnt162b2 was not applicable. The outcome of event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
17 2021-05-10 fatigue had pain at injection site; fatigue; This is a spontaneous report from a non contactable consumer. T... Read more
had pain at injection site; fatigue; This is a spontaneous report from a non contactable consumer. This consumer (sister of patients mother) reported for a 17-year-old female patient. A 17-year-old female patient received second dose of bnt162b2 (BNT162B2, Formulation: solution for injection, Lot number: not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, The patient had pain at injection site and fatigue. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
17 2021-05-10 headache dizziness, headache. Evaluated by EMS-Cleared
17 2021-05-10 sweating, fever, chills, malaise immediately felt tingling in her arm. About 3 hours later, she started having side effects. As of th... Read more
immediately felt tingling in her arm. About 3 hours later, she started having side effects. As of this report, it has been 28 hours since she received the 2nd dose. Her side effects are at their worse right now. They include: injection site pain, severe lymph node pain in her armpit, feeling unwell, nausea, low grade fever under 101 degrees, muscle pain in arms and legs, chills and sweats, some joint pain. dizziness and weakness and labored breathing.
17 2021-05-10 sweating While in observation, patient reports being lightheaded and hot. Patient became diaphoretic and pale... Read more
While in observation, patient reports being lightheaded and hot. Patient became diaphoretic and pale. Mother and patient state she does this after every injection. Ice pack, cold water, and snack provided. Pt feet propped on chair. Pt. waited additional 15 minutes and states she was feeling better and ready to go. ER/UC precautions given.
17 2021-05-10 throat irritation Immediate sever pain at injection site, immediately followed by flushed face, racing heartbeat, ting... Read more
Immediate sever pain at injection site, immediately followed by flushed face, racing heartbeat, tingling and inching of face, watering eyes, itchy throat that felt like it was closing in, lump in throat, difficulty breathing, unable to speak. Was able to speak after a couple minutes and the other symptoms started to gradually improve at that point. Most of the above symptoms subsided within around forty minutes. The lump in the throat remained for weeks eventually coming and going.
17 2021-05-11 chills, fatigue Per parent report: Friday 4-30-21. Vaccine was given at 1500, at 1730 client displayed a rash on fa... Read more
Per parent report: Friday 4-30-21. Vaccine was given at 1500, at 1730 client displayed a rash on face and chest with extreme fatigue and chills. client took Benadryl. Saturday 5-1-21. Rash gone, but extreme fatigue, crushing pain on chest and pain in arm. continued to take Benadryl. Sunday 5-2-21. Extreme fatigue. continued to take Benadryl. Monday 5-3-21. Still extremely fatigue, DC'd Benadryl. Tuesday 5-4-21. some improvement in fatigue, but experienced some brain fog. Wednesday 5-5-21. attended school where she presented to the health office with medical concerns, see quote taken from an email with the school nurse: "She missed school on Monday and Tuesday due to the reaction. On Wednesday, she presented to the health office with extreme redness to the face and chest. Emergency services was called and she was transported to the hospital. Benadryl was given in the rig to which she responded to well." parent reported that ER doctor ran many tests but did not determine cause. Tuesday 5-11-21. saw Primary Care provider. client is still having significant "brain fog". she is very confused more than half the day, not remembering things or events, and will zone out or fall asleep in inappropriate places with out realizing it.
17 2021-05-11 sweating lIght headed, tingling of fingers, pale, diaphoretic, c/o tingling of the throat briefly. sips of g... Read more
lIght headed, tingling of fingers, pale, diaphoretic, c/o tingling of the throat briefly. sips of gatorade. hypotensive: 80/40, 88; placed on stretcher semi-trendelenberg . BP: 120/P, No LOC.
17 2021-05-11 throat irritation hives along both arms and chest one hour after receiving injection. Sensation of throat swelling an... Read more
hives along both arms and chest one hour after receiving injection. Sensation of throat swelling and very slight difficulty breathing. Did not seek medical attention. Took benadryl and symptoms resolved within 40 minutes of taking benadryl
17 2021-05-12 fatigue, headache Headaches, dizziness, fatigue, injection site pain starting approximately 10 hrs after injection an... Read more
Headaches, dizziness, fatigue, injection site pain starting approximately 10 hrs after injection and lasting an additional 24 hours
17 2021-05-12 headache About 24 hours after shot: Nauseous, body ache, head ache About 42 hours after shot: head ache, stom... Read more
About 24 hours after shot: Nauseous, body ache, head ache About 42 hours after shot: head ache, stomach ache No treatment course taken
17 2021-05-12 fever Pfizer-BioNTech COVID-19 Vaccine EUA 101.9 F fever, severe right arm pain, not being able to move a... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA 101.9 F fever, severe right arm pain, not being able to move any part of body without my right shoulder hurting. Nausea, and mild fever for 24 hrs
17 2021-05-13 headache, fever fever and headache since second pfizer COVID vaccine that was given on 5/1/2021, noted at urgent car... Read more
fever and headache since second pfizer COVID vaccine that was given on 5/1/2021, noted at urgent care appt on 5/10/2021
17 2021-05-13 sweating Patient was sitting in observation for about 10 minutes and complained of feeling dizzy and fuzzy. P... Read more
Patient was sitting in observation for about 10 minutes and complained of feeling dizzy and fuzzy. Pt was pale and sweating. This RN assisted patient to wheelchair and escorted patient to EMS room. Pt was lying on the cot; ice pack was applied to Pt forehead and neck. BP 102/60, P 80. Pt refused drink and snacks when RN offered. Pt reported of feeling better after 15 minutes. Patient's mother was with Pt at all times. Pt and her mother left at 15:30 without any complications.
17 2021-05-13 influenza like illness Patient presented for second dose vaccination. Patient reported seeking medical attention for advers... Read more
Patient presented for second dose vaccination. Patient reported seeking medical attention for adverse effects. Patient sought medical attention due to swollen lymph nodes on neck (superficial cervical) and flu-like symptoms (fever, body aches, fatigue, nausea) following first dose vaccination. Lymph nodes prompted CT scan when checked at medical facility. Patient was not admitted as inpatient, no antibiotics were prescriber following encounter but anti-nausea medication was prescribed.
17 2021-05-14 lethargy, fever, chills faint; Fever; chills; body ache; diahhrhea; nausea; light headed ness; unable to move cause in so mu... Read more
faint; Fever; chills; body ache; diahhrhea; nausea; light headed ness; unable to move cause in so much pain- arms felt like lead weights; unable to move cause in so much pain- arms felt like lead weights; ring in ears; lethargic; This is a spontaneous report from a contactable consumer (patient). A 17-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration administered in left arm on 29Apr2021 13:00 (at the age of 17-year-old) (Batch/Lot Number: EW0172) as 2ND DOSE, SINGLE for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. 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 and has not been tested for COVID-19 since the vaccination. Medical history included seasonal allergies and known allergies to non-steroidal inflammatory drugs (NSAIDs), tree nuts, and pitted fruit. Concomitant medications included cetirizine hydrochloride (ZYRTEC ALLERGY) and mometasone furoate (ASMANEX). Historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, batch/lot number: EW0150), administered in left arm on 08Apr2021 at 01:00 PM for COVID-19 immunization and experienced foggy head and sore arm which was treated with Tylenol. On 29Apr2021 at 23:30, the patient experienced fever, chills, body ache, diarrhea, nausea, light headedness/faint, unable to move cause in so much pain- arms felt like lead weights, ring in ears, and lethargic. Therapeutic measures were taken as a result of all events. On an unspecified date, the patient recovered from all events.
17 2021-05-15 headache, fever, fatigue fever, headache, body aches, fatigue
17 2021-05-15 headache, runny nose, fatigue Fatigue, headache, loss of appetite, runny nose Medication - Tylenol, Benadryl Next day no symptoms
17 2021-05-16 chills, fever Woke up sore with a mild fever with chills, slightly nauseous and improved as the day went on, mostl... Read more
Woke up sore with a mild fever with chills, slightly nauseous and improved as the day went on, mostly back to normal by the day after.
17 2021-05-16 headache, fatigue, fever Fever - 24hrs Fatigue - 24hrs Vomiting - once around 7:00 PM on May 16 Headache - about 9 hours star... Read more
Fever - 24hrs Fatigue - 24hrs Vomiting - once around 7:00 PM on May 16 Headache - about 9 hours starting at 1 on May 16
17 2021-05-16 sweating PATIENT PASSED OUT IN DAD'S ARMS, CAME TO WHEN WE LAID HER DOWN SWEATINESS AND DIZZINESS RESOLVED ON... Read more
PATIENT PASSED OUT IN DAD'S ARMS, CAME TO WHEN WE LAID HER DOWN SWEATINESS AND DIZZINESS RESOLVED ON ITS OWN
17 2021-05-16 sweating THE PATIENT, AFTER RECEIVING ONE DOSE OF VACCINE, PASSED OUT AND WAS HAVING DIFFICULTY BREATHING, SH... Read more
THE PATIENT, AFTER RECEIVING ONE DOSE OF VACCINE, PASSED OUT AND WAS HAVING DIFFICULTY BREATHING, SHORTNESS OF BREATH, SWEATING. SHE WAS CONSCIOUS AT THE TIME THE EMS ARRIVED.
17 2021-05-16 pneumonia, cough, fever Patient received first COVID19 Pfizer vaccine on 4/18. At that time, had about 3 days of cough and ... Read more
Patient received first COVID19 Pfizer vaccine on 4/18. At that time, had about 3 days of cough and chest tightness. Subsequently began having neck pain on 5/8 and received second Pfizer vaccine on 5/9. Then began having fevers (Tmax 103F), cough. Admitted to Hospital on 5/15 with respiratory failure and shock. Unclear etiology of pneumonia vs multisystem inflammatory syndrome in children (MIS-C). Did not initially respond to antibiotics so treatment for MIS-C was initiated. Now slowly improving but still hospitalized.
17 2021-05-16 fever Diffuse hives and erythematous rash on arms, neck and chest. She had expected fever and muscle ache... Read more
Diffuse hives and erythematous rash on arms, neck and chest. She had expected fever and muscle aches for 24 hours after vaccine administration but this resolved.
17 2021-05-16 throat irritation The patient received her vaccine at 12:06pm. At around 12:40-12:45 she came back to the pharmacy co... Read more
The patient received her vaccine at 12:06pm. At around 12:40-12:45 she came back to the pharmacy complaining of her throat feeling strange. She was talking fine with no physical symptoms other than that complaint. She was given 2 teaspoonfuls of Benadryl and was monitored for 30 minutes. At her time of departure she said she was feeling better and was okay to go home. Her mom bought more Benadryl prior to leaving.
17 2021-05-17 cough, runny nose Tested positive for Covid19 on 18Apr2021, with symptoms starting on 16Apr2021, after receiving her f... Read more
Tested positive for Covid19 on 18Apr2021, with symptoms starting on 16Apr2021, after receiving her first dose of the Covid Vaccine on 07Apr2021; Cough; Runny nose; This is a spontaneous report from a Pfizer sponsored program. A contactable Nurse reported for her 17-year-old daughter (patient). A 17-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0150; Expiration Date: 31Jul2021), dose 1 via an unspecified route of administration, administered in left arm on 07Apr2021 at 09:50 (at the age of 17 years) as 1st dose, single for COVID-19 immunisation. The patient had no medical and familial history. The patient did not take any concomitant medications. The patient had no history of all previous immunization with the Pfizer vaccine considered as suspect. The patient had no other additional vaccines administered on same date of the Pfizer suspect. Patient had no prior vaccinations within 4 weeks. On 16Apr2021, evening, the patient started with a slight cough and runny nose and thought it was allergies. The reporter stated that the patient's friend tested positive on Thursday and they were also tested Thursday and she was negative and then Sunday, she tested again and was positive. On 18Apr2021, the patient was tested positive for Covid 19 and was clear now. The patient recovered from her symptoms by 23Apr2021 but she was isolated for the full 10 days. The reporter asked whether it was okay to take second dose after testing positive for COVID-19. The patient did not receive any treatment other than rest. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 18Apr2021 and negative on unspecified date in 2021. The outcome of the event Covid-19 was unknown, and outcome of the event cough and runny nose was recovered on 23Apr2021. No follow-up attempts are needed. No further information is expected.
17 2021-05-17 fever, chills fever, chills, muscle aches
17 2021-05-17 fever Fainting/syncope; high fever; lightheadedness; This is a spontaneous report from a contactable consu... Read more
Fainting/syncope; high fever; lightheadedness; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 17-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 29Apr2021 at 14:30 (at the age of 17 years old) (Lot Number: EW0171, unknown expiration) as 2nd dose, single for COVID-19 immunization. Medical history reported as none. No known allergies. The patient's concomitant medications were not reported. The patient also received first dose of BNT162B2 on 08Apr2021 at 16:30 in the left arm (at the age of 16 years old; Lot number: EW0150, unknown expiration) for COVID-19 immunization. The patient experienced fainting/syncope, high fever, and lightheadedness on 30Apr2021 at 06:45 AM. The events resulted in emergency room/department or urgent care visit. The patient received IV fluids as treatment for the events. No COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient is recovering from the events. Information on lot/batch number was available. Additional information has been requested.
17 2021-05-18 fatigue Patient was waiting in the waiting area for 6 minutes after getting the pfizer covid vaccine when sh... Read more
Patient was waiting in the waiting area for 6 minutes after getting the pfizer covid vaccine when she started to feel like she was going to faint. Her mom was with her. Her mom had already given her a snack when I was notified. Pt stated her vision was blurry and her hearing was "like she was in a tunnel". She was feeling cold and was feeling scared of that feeling. I asked if I could apply a cold pack and asked her to rest the back of her head against the wall and to close her eyes. I applied the cold pack to her forehead and observed her. She started to sweat and was calmer. She was feeling better and her hearing and vision was back to normal. I had her wait for a total of 30 minutes and had my technician stay with her at that time. She was feeling better and I asked her mom to hang on to her while walking to their car. I followed up with the patient 4 hours later and she was doing well. She said she was feeling well and her arm was not even sore just some fatigue.
17 2021-05-18 sweating patient experience dizziness after receiving immunization and later fainted . Patient sat on ground ... Read more
patient experience dizziness after receiving immunization and later fainted . Patient sat on ground before completely fainting to floor with help of mother and regained consciousness about 1 minute later. patient complained of muffled voices and trouble hearing for about 4 minutes, sweating , dizziness and shakiness. patient received water and Gatorade and cool cloth behind neck area. patient able to leave after approximately 20minutes in care of mother feeling better.
17 2021-05-18 sweating Patient began to feel faint within 2 minutes after receiving vaccine. Became pale and diaphoretic. ... Read more
Patient began to feel faint within 2 minutes after receiving vaccine. Became pale and diaphoretic. Patient was brought to floor and began to show improvement immediately. Patient remained in observation until 9:05 AM (25 minutes after vaccine administration) and was cleared to discharge home with father at that time.
17 2021-05-18 sweating 2nd dose Pfizer vaccine administered patient was in Observation Area and c/o of sweating and dizzine... Read more
2nd dose Pfizer vaccine administered patient was in Observation Area and c/o of sweating and dizziness. Patient fainted for about 2 seconds. Patient arousable and VS were within normal ranges, blood sugar was 68 when being cared for by EMS. Pt states she has had this history of reaction before to vaccines. She had not eaten or drank anything since around 8pm the night before. Patient given water and a food and stated she felt better. Patient remined in Obs area for an additional 40 minutes with EMT, RN and Physician oversight.
17 2021-05-18 sweating About 5 minutes after shot, the patient's mother alerted us to her daughter being unconscious. She ... Read more
About 5 minutes after shot, the patient's mother alerted us to her daughter being unconscious. She was sitting in a chair slumped forward, we pushed her back in the chair. The patient was tensed up, sweaty, with labored breathing. She was assessed to not to be in respiratory distress and held so she wouldn't slide out of the chair she was sitting in. She began to return to consciousness and pulse seemed relatively normal with breathing returning to normal after 3 minutes. Local EMS was activated. The patient was given cold water to hold on her neck and was alert. Local EMS assessed she was ok and the patient's mother refused transport to the ED. The patient left on her own.
17 2021-05-18 malaise 17 year old patient with no known allergies who was given 1st dose of Pfizer vaccine at 1655. At 170... Read more
17 year old patient with no known allergies who was given 1st dose of Pfizer vaccine at 1655. At 1700 during observation patient mentioned to the mother that she was not feeling well, was slumped over. The RN on observation noticed that she was apneic, whole body was rigid. Vital signs at 1701: BP 153/88, HR: 64. Oxygen saturation 99%. After 5 minutes a recheck of the vital signs: BP 115/74, HR: 64. Oxygen 97%. Patient did state that she gets anxious when she gets shots.The paramedics were called. Vital signs on arrival: 117/83, HR: 58, Oxygen saturation 100%. Blood sugar 70. After a few minutes patient stated that she was feeling a little better. Patient was able to walk to the ambulance for them to perform an EKG: Results were normal sinus bradycardia.(Patient is an athlete). Patient's mother declined further treated and signed AMA form.
17 2021-05-18 sleepiness Client received 1st COVID vaccine of Pfizer (Lot# EW0185 expiration 05/23/2021). At 1347, RN assiste... Read more
Client received 1st COVID vaccine of Pfizer (Lot# EW0185 expiration 05/23/2021). At 1347, RN assisted Client to stand up from vaccination chair. Client began to have unsteady gate. Both RN and RN assisted Client back to the gravity chair. At 1348, RN and PHN responded to the event. At 1348, vital signs are blood pressure 116/72, heart rate 64, oxygen saturation 100%. Client reported no blurry vision no headache, appearance is pale. Client is accompanied by mother. Per client's mother, Client has no medical history, allergies to dogs, and a history of syncope and lightheaded with needles/vaccines. At 1352, vital signs are blood pressure 118/82, heart rate 62, oxygen saturation 100%. Client reports lightheaded, feels tired, no shortness of breath, no headache. Supplemental nutrition and fluids provided to Client . Client accepted. At 1357, vital signs are blood pressure 116/76, heart rate 63, oxygen saturation 100%. Client reports no headache, no blurred vision, lightheaded improving, feels "sleepy", and skin tone returning to appropriate ethnicity. PHN educated client and mother ED precautions, common adverse effects of COVID vaccine, and emphasize a follow up with primary care provider. At 1400, vital signs are blood pressure 118/72, heart rate 63, oxygen saturation 100%. At 1402 Client stood up with no complains. At 1403 Client walked out of vaccination facility with a steady gait accompanied by mother.
17 2021-05-19 chills, fever Fever; chills; severe arm pain; nausea; This is a spontaneous report from a contactable consumer (pa... Read more
Fever; chills; severe arm pain; nausea; This is a spontaneous report from a contactable consumer (patient). A 17-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ER8736 and expiration date was not reported), via an unspecified route of administration in right arm, on 11May2021 at 19:15 (at the age of 17 years old) as second dose, single for COVID-19 immunization at a pharmacy or drug store. Medical history was reported as none. The patient had no known allergies. Concomitant medications included sertraline hydrochloride (ZOLOFT), loratadine (CLARITIN) and birth control (unspecified). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EW0170 and expiration date was not reported), via an unspecified route of administration in right arm, on 17Apr2021 at 13:00 (at the age of 17 years old) as first dose, single for COVID-19 immunization. The patient was not pregnant and 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 never tested for COVID-19. The patient experienced fever, chills, severe arm pain and nausea on 12May2021 at 05:00. No treatment was given to the patient for these events. The outcome of these events was recovering at the time of report. No follow up attempts are needed. No further information is expected.
17 2021-05-19 sweating Passed out; Vasovagal reaction; Dizzy; Skin was sweaty; Pale; This is a spontaneous report from cont... Read more
Passed out; Vasovagal reaction; Dizzy; Skin was sweaty; Pale; This is a spontaneous report from contactable Pharmacist. A 17-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Left on 06May2021 10:15 am (Lot Number: EW0171) at the age of 17-year-old as single dose for covid-19 immunisation. Medical history reported as none. No known allergies. The patient was not pregnant. The patient's concomitant medications were not reported. Vaccine was given, patient was sitting with her mother. Approximately 10 minutes after vaccine, she slumped to the side and passed out. When the reporter got to her she was just waking up. She still felt dizzy, skin was sweaty and pale. Paramedics arrived within 5-10 minutes to evaluate. They said they had seen this vasovagal reaction with the covid vaccine. Patient left on gurney with the paramedics. Adverse events start date was 06May2021. Events resulted in Emergency room/department or urgent care. The outcome of the events was unknown. The patient had no covid prior vaccination, no Covid tested post vaccination.; Sender's Comments: Based on a positive temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event of Loss of consciousness. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
17 2021-05-19 sweating Shot given 11:58am. Within 2 minutes symptoms began with feeling symptoms: nauseous, hot forehead. I... Read more
Shot given 11:58am. Within 2 minutes symptoms began with feeling symptoms: nauseous, hot forehead. I asked CVS for the nurse to help. By 12:01 patient was feeling extreme pain in her stomach, was sweating profusely, felt tingling sensation from head down to her stomach (including her arms and hands). Patient began screaming in pain. Her hands became rigid and paralyzed. She was completely unable to move both hands. Patient was able to feel if someone was touching her hands. Her face began tingling and feeling numb. Patient was lying down and almost passed our. I asked CVS to call 911 and if they should administer an epi pen. The epi pen was not administered. I (mother) went w/ child in the ambulance to Hospital. EMT monitored her vitals, which were normal. Patient was still unable to move her hands until after she was admitted to Hospital. Patient did not receive any IV r medication at Hospital. The sensation in her hands slowly came back with the numbness subsiding after about 1.5 hours in the ER. Patient was discharged at about 2:00pm on 5/16/2021.
17 2021-05-19 sweating Pt c/o feeling dizzy, muffled hearing & sweating. Pt escorted to observation and placed on cot in su... Read more
Pt c/o feeling dizzy, muffled hearing & sweating. Pt escorted to observation and placed on cot in supine position. Pt's VS obtained by clinical staff and (EMS) called. EMS assessed and monitored pt. VS WNL. Medical incident duration from onset to medically cleared by EMS was 7 minutes. Pt reports "I am feeling much better." Pt cleared by EMS that it was safe to go home and driven by her mother.
17 2021-05-19 malaise, runny nose customer states she took her second shot of the vaccine and she has been having eye inches and runni... Read more
customer states she took her second shot of the vaccine and she has been having eye inches and running noise and not feeling well. Called her and she is ok.
17 2021-05-19 throat irritation Patient was given dose at a vaccination site through County Health Department. Today in clinic she r... Read more
Patient was given dose at a vaccination site through County Health Department. Today in clinic she reported an allergic reaction to Pfizer vaccine. Approximately 30 minutes following vaccination had hives. Following morning had swollen lips and itchy throat with continued hives. Symptoms only treated with benadryl and improved. She then had hives again 4 days later. She did not report this to the vaccination clinic.
17 2021-05-20 cough Initially developed hives then swelling of lips, face and difficulty breathing with cough (anaphylax... Read more
Initially developed hives then swelling of lips, face and difficulty breathing with cough (anaphylaxis reaction). Treated by school nurse with epipen then ambulance paramedics arrived and administered nebulizer treatment, IM benedryl, dexamethasone and transported to ER for follow up stabilization. ER administered additional antihistamine. Patient was discharged from ER stable and in much improved condition.
17 2021-05-20 fatigue (Vasovagal Response) Felt tired and ?felt like fainting? immediately after shot. Pt laid down and e... Read more
(Vasovagal Response) Felt tired and ?felt like fainting? immediately after shot. Pt laid down and elevated feet. No additional treatment needed. (Initial BP 87/58)
17 2021-05-20 head discomfort dizzy, pale, fullness in ears. Increased monitoring. VSS and symptoms resolved
17 2021-05-21 headache Intense headache, large swollen lymph node in left arm, smaller swollen lymph node in right arm
17 2021-05-21 fever Tachycardia began at 27 hours after vaccine with hear rate up to the 160s . Fever developed after th... Read more
Tachycardia began at 27 hours after vaccine with hear rate up to the 160s . Fever developed after the tachycardia 31 hours after vaccine. Patient was monitored in the hospital on propranolol and was sent home on propranolol.
17 2021-05-23 body temperature increased After receiving dose, pt experienced Vasovagal response which she never had before when receiving a ... Read more
After receiving dose, pt experienced Vasovagal response which she never had before when receiving a shot. When they woke her she had a lot of jerky arm movement. About half an hour to 1hr after injection she said she had an odd taste in her mouth and her tongue was numb. Her chest felt tight but was not wheezing. About an hour later when she was home (~6pm) gave her "click it albuterol" and it relieved the tightness in the chest. She had pain in her left breast area. Around 6:30pm she continued to comment about her tongue being numb and pain in her breasts. She fell asleep right away and the next afternoon around 1pm she had a temperature of 99F. After motrin the temperature went back to normal and she felt better. No further chest tightness after that and she is feeling normal.
17 2021-05-23 chills, sweating Systemic: Chills-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Numbness (specify: facial ar... Read more
Systemic: Chills-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Weakness-Medium, Additional Details: patient was feeling cold, hot, shaky, weak, a heavy chest feeling, numbness in extremities a few minutes after her vaccine. Her pulse went from 80, 99, to 110 after 3 readings. Her BP was normal. Her brother said she just had a unspecified chest procedure. It wans't noted on her intake. She wasn't feeling after lying down for 30 minutes with legs propped up and wanted to paramedics to come. They sent her home after another 30 min. She doing well before she left.She went to school day after.
17 2021-05-23 headache Systemic: Fainting / Unresponsive-Mild, Systemic: Headache-Mild
17 2021-05-23 sweating Patient became light headed and fainted from a seated position about 10 minutes after her first Pfiz... Read more
Patient became light headed and fainted from a seated position about 10 minutes after her first Pfizer COVID-19 vaccination. She doesn't think she lost consciousness. Her skin was quite warm and sweaty after this event. I had her remain laying down on the ground while she recovered and I assessed her symptoms. She felt better almost immediately so I had her move to the pharmacy office for observation for an additional 15-20 minutes. She then reported that she has fainted with shots before and she hadn't eaten anything today. Her mother said this has happened before and drove her home once she felt well again.
17 2021-05-23 sweating Immediately light headed, sweaty, cold ALL over, vomit
17 2021-05-23 malaise Patient was extremely nervous prior to vaccine. Got shot, walked out of room to waiting area. about ... Read more
Patient was extremely nervous prior to vaccine. Got shot, walked out of room to waiting area. about 2-3 minutes post vaccine, realized did not feel well. Passed out. Mom said patient felt a touch rigid and twitched a couple times, then came too. Did hit head when patient fell to floor, although was not a major hit. Patient was worked up after coming to.
17 2021-05-24 cough Pt was swimming and started to cough (felt swallowed water) and upon getting out of water - collapse... Read more
Pt was swimming and started to cough (felt swallowed water) and upon getting out of water - collapsed and lost consciousness for a few seconds
17 2021-05-25 cough, sweating, headache, fever, chills Fever of 103; chills; sweating; body ache; nausea; vomiting; diarrhea; headache; couch; chest pain; ... Read more
Fever of 103; chills; sweating; body ache; nausea; vomiting; diarrhea; headache; couch; chest pain; This is a spontaneous report from a contactable consumer for herself. A 17-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 07May2021 17:00 (Lot Number: EW0176) at single dose for COVID-19 immunisation. Medical history was none. No allergies to medications, food, or other products. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant at the time of vaccination. The patient previously received first dose of BNT162B2 (lot number=EW0153) in left arm on 15Apr2021 04:00 PM for COVID-19 immunisation. The patient experienced fever of 103, chills, sweating, body aches, nausea, vomiting, diarrhea, headache, couch, chest pain on 08May2021 13:00 with outcome of not recovered. Events were resulted in doctor or other healthcare professional office/clinic visit. No treatment received. Patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient had not been tested for COVID-19.
17 2021-05-25 fatigue, fever, chills On 5/19 she got her first Covid Vacc (Pfizer). The following day she had mild fatigue and chills, bu... Read more
On 5/19 she got her first Covid Vacc (Pfizer). The following day she had mild fatigue and chills, but it did not interfere with activity. Then 5/21 PM she noted a discomfort in her chest. By yesterday she had marked chills, felt burning hot, c/o a mild ST and mild nausea and abd pain. Her chest discomfort (poorly characterized in location) worsened and she was brought to ER with concerns that she had another effusion. At the hospital, she had 24 hours of fever and hypotension.
17 2021-05-25 sweating Pt diaphoretic, pale, nauseas, blurred vision, difficulty hearing, lightheaded, SOB, 10 minutes afte... Read more
Pt diaphoretic, pale, nauseas, blurred vision, difficulty hearing, lightheaded, SOB, 10 minutes after receiving pfizer. Given water, vital signs obtained. HR low into the 50s, O2 sat 93-94%. Placed on a stretcher. After vitals obtained pt color returned and she stated she started feeling better. HR improved to 70s, O2 sat 97% on RA. BP stable throughout.
17 2021-05-25 sweating Pt felt lightheaded and sweaty and heart rate dropped to 50 and blood pressure dropped to 70/30. Pa... Read more
Pt felt lightheaded and sweaty and heart rate dropped to 50 and blood pressure dropped to 70/30. Paramedics were called 911 and arrived at 12:32 the episode happened at 12:30 by the time the paramedics arrived she was feeling better she had been put on the floor with her legs elevated on a chair and her blood pressure has come up since then she had refused to go to the hospital because she fell back to her normal.
17 2021-05-25 fever, headache, throat pain Fever headache body aches and sore throat
17 2021-05-25 fever Multisystem Inflammatory Response to the vaccine with fever for 5 days, elevated LFT's, low Na, low ... Read more
Multisystem Inflammatory Response to the vaccine with fever for 5 days, elevated LFT's, low Na, low platelets, elevated CPK. Patient hospitalized for 2 days.
17 2021-05-26 fatigue, headache, sweating Less than 1 minute after received the shot, patient became clammy and pale while sitting in chair. H... Read more
Less than 1 minute after received the shot, patient became clammy and pale while sitting in chair. Her eyes rolled back in her head and her body went slack. Myself (parent) and the nurse who had given the shot braced her on either side while she appeared to fade in and out of consciousness for several minutes (she seemed to occasionally interact with us, mumbling responses to 'yes' or 'no' questions). The nurse did not want to lower her to the floor, but wanted to keep her propped on the chair. Her head kept rolling to the side. At one point, she began to jerk rhythmically. Just as I was about to bring this to the attention of the nurse, the patient returned to consciousness. Patient was moved to a rolling recliner chair and taken to a recovery area where I (parent) did not see her for another 30 minutes as I was receiving my own shot. The chair she had sat in was wet, but it was assumed this was due to sweat (patient had sweated profusely). On the way out of the clinic, noticing a wet stain on the back side of patient's pants, I asked if she had wet her pants (quietly) two separate times. Patient denied it both times. However, upon returning home, patient confirmed that she had wet her pants. Patient was monitored during the evening for similar adverse events ; none noted. Patient ate lunch approximately 1 hour before receiving shot and was given crackers while at clinic. Patient is a well-hydrated individual, and also drank water while on-site. No fever either before or after shot. A slightly elevated BP the next day (135/83). However, patient complained of headache, fatigue, and pain at injection location; elevated BP may be related to headache and/or ordeal from day of the shot.
17 2021-05-26 head discomfort, fatigue, headache, sleepiness 1-20 minute bouts where tics appear "seizure-like," repetitive; many persistent involuntary tics inc... Read more
1-20 minute bouts where tics appear "seizure-like," repetitive; many persistent involuntary tics including coprolalia and violent motor tics; had one minor chronic tic before vaccination/many persistent involuntary tics including coprolalia and violent motor tics/Noticed increase in severity and frequency; many persistent involuntary tics including coprolalia and violent motor tics; Tics often include hitting oneself and banging head against things/violent; significant distress; persistent headache; chronic fatigue/sleepiness; lightheadedness; decrease in appetite; feeling of pressure in certain locations inside the head; intermittent earaches in both ears; persistent feeling of brain being "on fire," and "like a parasite has invaded the brain."; chronic fatigue/sleepiness; This is a spontaneous report from a contactable consumer (patient). A 17-year-old female non-pregnant patient received bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration, administered in Arm Right on 26Mar2021 as first single dose and on 16Apr2021 as second single dose (Batch/Lot number was not reported) for covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered: Other. Medical history included asthma, allergy to nuts, penicillin and ongoing chronic tic. No other vaccines within 4 weeks prior to the COVID vaccine. No covid prior vaccination. Concomitant medications included duloxetine; atomoxetine; hydroxyzine; loratadine. The patient previously took amoxicillin and experienced allergies. The patient experienced neurological symptoms included many persistent involuntary tics including coprolalia and violent motor tics. Smaller tics can be suppressed for minimal amounts of time before uncontrolled, violent/loud tics occur in rapid succession. Tics often include hitting oneself and banging head against things. The patient had one minor chronic tic before vaccination. Initial onset occurred nine days after vaccination from 04Apr2021. Noticed increase in severity and frequency approximately nine days after second dose of Pfizer vaccine. Symptoms cause significant distress. Additional symptoms included: persistent headache (from date of first vaccine to present); chronic fatigue/sleepiness; light-headedness; decrease in appetite; feeling of pressure in certain locations inside the head not related to the skull or skin; intermittent earaches in both ears; persistent feeling of brain being "on fire" and "like a parasite had invaded the brain, start date was 26Mar2021; and "1- 20 minute bouts where tics appear "seizure-like," repetitive, violent, and controlling". The patient underwent lab tests and procedures which included Spit test: negative (other) on 26Mar2021 and Apr2021, Covid test: negative on 26Mar2021 and on Apr2021. The events resulted in: Doctor or other healthcare professional office/clinic visit. No treatment received; the patient was not recovered. Information on lot/batch number has been request.
17 2021-05-26 sweating Site: Pain at Injection Site-Medium, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-M... Read more
Site: Pain at Injection Site-Medium, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: BP 103/65 Pulse 62-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Mild, Systemic: Shakiness-Mild, Additional Details: EMS was called but she went home with her mother and slept the rest of the day, she had a sore arm on Tuesday but was otherwise fine per mom.
17 2021-05-26 sweating Patient began to sweat, complained of blurred vision, and turned very pale in the face. We called 91... Read more
Patient began to sweat, complained of blurred vision, and turned very pale in the face. We called 911 and I stayed with the patient monitoring heart rate and symptoms. Patient was slightly tachycardic upon initial assessment. Once EMS arrived, patient had had resolution of blurred vision and the sweating. Her vitals were normal. Her mom refused further treatment to the hospital. I recommended to follow up with pediatrician.
17 2021-05-26 malaise, sweating Patient upon seated for the 15 minutes post-vaccination fainted. When she was coming through, she st... Read more
Patient upon seated for the 15 minutes post-vaccination fainted. When she was coming through, she started shaking as if she was having a seizure. When I reached the patient, she was shaking and then came through and stopped shaking. Patient was still pale, sweating, and didn't feel okay. 911 was already called once the patient was shaking. As I am checking in on the patient, the mom discloses that she has fainted at least twice before and when she comes through she shakes but it is not seizures. However, during the screening process, patient and mom stated the patient never had any problems when getting vaccinated. I got her BP checked and it was 102/61 and HR of 92. We had the patient sit still and drink water. When EMS arrived within 5-10 mins, they took her vitals and it was 112/70s and HR of 84 with 98% O2 sat. Patient and mom decided to be taken to the ED to make sure she is okay.
17 2021-05-26 fever, sweating, chills, throat pain Site: Pain at Injection Site-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Me... Read more
Site: Pain at Injection Site-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Fever-Medium, Systemic: JAW AND THROAT PAIN-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium
17 2021-05-26 fever High fever 1 day after vaccine of 102, SOB since vaccination (unresolved), chest 4 days after vaccin... Read more
High fever 1 day after vaccine of 102, SOB since vaccination (unresolved), chest 4 days after vaccination (resolved)
17 2021-05-27 fatigue, headache, chills, sweating Passed out/ got chills and sweats after receiving vaccine at the Pharmacy. Proceeding the vaccine sh... Read more
Passed out/ got chills and sweats after receiving vaccine at the Pharmacy. Proceeding the vaccine she had headaches and still gets them and it?s currently 05/27/2021 which it?s been 9 days since also for 3 days after vaccine was extremely exhausted.
17 2021-05-28 headache Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Head... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Headache-Mild, Systemic: Shakiness-Medium, Systemic: Weakness-Severe, Additional Details: Patient was given Pfizer vaccine, told to remain in waiting area for 15 minutes. Immediately after shot she seemed and and was conversing with me normally. 2-3 minutes later her dad noticed that she was tipping over and called for help. When I rushed over, pt was moved to the floor, close to passing out, very weak and shaky. We called 911 - she was responsive. she laid on the floor until ems arrived at which point they took over and took patient to get further checked out.
17 2021-05-28 sweating Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Confusion-Medium, Systemic: Dizziness... Read more
Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Weakness-Medium
17 2021-05-28 fever, headache She fainted and collapsed about 18 hours after receiving the second dose (6:30 am). She was confused... Read more
She fainted and collapsed about 18 hours after receiving the second dose (6:30 am). She was confused for about an hour after she fainted. She was on ibuprofen (400 mg taken at 5:30 am). Other than weakness, headache, and fever, she has had no other adverse reactions so far besides the single fainting episode.
17 2021-05-30 fatigue, headache Site: Pain at Injection Site-Mild, Systemic: mentrual changes-Mild, Additional Details: headaches, n... Read more
Site: Pain at Injection Site-Mild, Systemic: mentrual changes-Mild, Additional Details: headaches, no appetite, stomach ache, light sensitivity, fatigue, mentrual cycle distrupted. Patient states she got her period 2 weeks early. She takes an oral contraceptive pill, she did not miss any
17 2021-05-30 malaise Within 2-3 minutes she felt sick and dizzy, then became clammy and unresponsive. She was moved to th... Read more
Within 2-3 minutes she felt sick and dizzy, then became clammy and unresponsive. She was moved to the floor and regained consciousness within 1 minute. Was given water and a snack and felt better. She left happy and healthy, she does not like needles/vaccination - so she had anxiety from the vaccine.
17 2021-05-31 sweating became nauseous , light headed and started sweating
17 2021-05-31 sweating FELT DIZZY AND HAD A WITNESSED SYNCOPAL EPISODE, TRANSPORTED TO COT, APPEARED DIAPHORETIC AND PALE. ... Read more
FELT DIZZY AND HAD A WITNESSED SYNCOPAL EPISODE, TRANSPORTED TO COT, APPEARED DIAPHORETIC AND PALE. PARAMEDIC CAME, BP 86/51, HR 49, OFFERED HYDRATION, SX RESOLVED, NO TRANSPORT, AMA SIGNED.
17 2021-06-01 fatigue, chills, fever 2 hrs after vaccine started having chills and fever by Thursday April 22 her legs starting hurting p... Read more
2 hrs after vaccine started having chills and fever by Thursday April 22 her legs starting hurting pain moved from toes and all the way up to back then it stated moving to her hands and fingers. got admitted to hospital because they wanted to make sure she wasn't having syptoms of MS they did blood work, MRI, covid test, xrays, lupus test, physical therapy, nerves test, lime disease test and everything came back fine by sunday they sent her home and she started having stomach pains and had to go back to Dr. she has experience hair loss and it started her menstrual cycle early. was having alot of fatigue and its's been a month and she is now finally started to feel a little better but Dr dont know how long it will be before she is fully herself
17 2021-06-01 fatigue Patient reports muscle aches and significant fatigue for 3 weeks following the second vaccination. I... Read more
Patient reports muscle aches and significant fatigue for 3 weeks following the second vaccination. Initially just with sore arm, then a few day later developed the fatigue
17 2021-06-01 fatigue Roughly 2 minutes after receiving her I am Pfizer vaccine, patient told mother that she was feeling ... Read more
Roughly 2 minutes after receiving her I am Pfizer vaccine, patient told mother that she was feeling slightly lightheaded. She proceeded to lose consciousness. Mother honk the horn and alerted staff to come to help. Patient was in the car on the passenger side, patient was fully sitting up. I reclined her all the way down in her passenger seat, she was slightly gasping for air, Ambulance was called for evaluation. She had loss of consciousness for approximately 30 seconds. She regained consciousness and said she was feeling confused as to what it happened. Denies any feelings of needing to vomit, Or post ictal symptoms. EMS and fire we?re on scene by then, report given to paramedics on site. Patient declined further medical treatment and Ian made with the ambulance. after this stating she was a little tired. She continue to wait for 30 minutes, she had 1 episode of emesis and felt better. At the site with no issues.
17 2021-06-01 nasal congestion, fatigue tired, body aches, restricted breathing, upset stomach, vomiting, congestion
17 2021-06-01 throat pain, headache, fatigue Follow up report - The symptoms - severe headaches; shortness of breath; difficulty breathing; chest... Read more
Follow up report - The symptoms - severe headaches; shortness of breath; difficulty breathing; chest pain and throat pain with activities - even if he walked across the room he had this pain along with the shortness of breath; body aches and fatigue. He is an athlete and not able to do any of the sports - he starts breathing heavily when he walks across the room. He couldn't attend school for over a month. Has been to several physicians - a pulmonologist several times; cardiologist; gastroenterologist; his pediatrician. He got a steroid shot - 24th, given to him for the headaches. Last Monday, the 24th of May (the pulmonologist gave this to him). It (the headaches pain) was really bad on Tuesday, Wed, Thursday and he started feeling better with the headaches on Friday. He has been given an inhaler and Pepcid for acid reflux (gastroenterologist). These have given him a little relief - but he don't know if it's the steroid shot or the inhaler that is helping. Yesterday he tried to go to his Sports class and he couldn't do it - there was a problem with breathing; a lot of shortness of breath. The headaches and the breathing issues are still what are debilitating him the most.
17 2021-06-01 fever First on Saturday May 22 had sore arm, then pain that thought was possibly heartburn/indigestion, fe... Read more
First on Saturday May 22 had sore arm, then pain that thought was possibly heartburn/indigestion, fever over 100. Took acetaminophen and tried Tums. Then on Sunday May 23 chest pain that didn't feel quite like indigestion and fever over 100. Continued acetaminophen and Tums. Monday May 24 felt like heart was fast, hot flash type feeling like could faint and some light headedness/off feeling, continued chest pain. Pediatrician prescribed omeprazole to see if helped, did EKG. Checked in on Wed May 26, no change except no fever and light headedness improving. Referred to cardiology.
17 2021-06-01 sneezing Sneezing a lot, after the first and second vaccine; Right arm with rising and swelling: described as... Read more
Sneezing a lot, after the first and second vaccine; Right arm with rising and swelling: described as red in a crescent moon shape at injection area, after first vaccine; red in a crescent moon shape at injection area, after first vaccine; Vaccine poured and trickled out of arm, after first vaccine; Vaccine poured and trickled out of arm, after first vaccine; This is a spontaneous report from a contactable consumer. A 17-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm right on 21Apr2021 (caller states it was the evening) (Batch/Lot Number: EW0161) as 1st dose, single for covid-19 immunisation (Reported as because she is her daughter's mother, and told her daughter to get the vaccine. her daughter's school is making all the seniors get the shot to go back to school). Medical history included Birth control. Family Medical History relevant to AE was No. Concomitant medication included ethinylestradiol, ferrous fumarate, norethisterone acetate (LOESTRIN FE) from Mar2021 (two months ago) taken for birth control. Prior Vaccinations (within 4 weeks), no other vaccinations within four weeks prior to the first administration date of the suspect vaccine. AEs following prior vaccinations was None. Caller states she is calling for her daughter. Caller confirms she is calling about the Pfizer vaccine, confirmed as the Covid 19 vaccine. Caller states that when her daughter went and got the injection, some of the vaccine poured out of her arm, vaccine poured and trickled out of arm, after first vaccine was on 21Apr2021 3:20 pm. Caller states that 3 days later (in the morning), her daughter's arm started to get a rising, later clarified as swelling. Caller states that it was red, in a crescent moon shape, and raised up off her arm at the injection site. Caller states it was really huge. Caller states that she called the pharmacy and she was told to give her daughter Benadryl and Cortisone cream. Caller reports that this treatment was effective. caller then reports that her daughter had lasting effects, clarified as sneezing a lot, after the first injection and then it got more intense after the second injection. The event was not required a visit to Emergency Room and Physician Office. Relevant Tests was None. No Investigation Assessment. Treatment received for the events. Outcome of red in a crescent moon shape at injection area, after first vaccine was recovered on 26Apr2021 (also reported the area is still a little brown spot but not raised up off her arm). Outcome of Sneezing a lot was not recovered. Outcome of the events was unknown. Seriousness criteria is Medically Significant. Information on Lot/Batch number was available. Additional information has been requested.
17 2021-06-02 fatigue After receiving the shot she experienced the "Covid's bullseye", a circle on her arm at the site of ... Read more
After receiving the shot she experienced the "Covid's bullseye", a circle on her arm at the site of administration; tired; her arm was a little sore; the girl got a rash of the diameter of a lemon on her inner thigh, next day on both legs; This is a spontaneous report from a non-contactable consumer (patient grandmother). A 17-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 20May2021 (age at the time of vaccination 17-year-old) as 2nd dose, single for covid-19 immunisation. Medical history included allergic to sulfa drugs. Historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date as 1st dose, single for covid-19 immunisation. The patient concomitant medications were not reported. It was reported that after receiving the shot patient experienced after receiving the shot she experienced the "covids bullseye", a circle on her arm at the site of administration, tired, her arm was a little sore. On Saturday, the patient got a rash of the diameter of a lemon on her inner thigh, so the reporter told her to only use sunblock, next day (Sunday) both legs were covered in a rash. Reporter looked on the Pfizer's website and saw that rash was reported in 0.001 percent of people who had the vaccine. Also, on Sunday, reporter took the patient to the doctor but he was not there, so she called a service (reporter did not elaborate on this) and a person told them that the rash could be from a serious disease called "petechiae rash" and told them to take patient to ER where she got the shot. Once in the ER, they told them that it was not the serious condition "petechiae rash" but that it was a "rash" and that they had never heard before of anybody experiencing a "rash" after the administration of the vaccine. Reporter wanted to know if "rash" has been reported as an adverse event of the Pfizer's COVID-19 vaccine, how long after the administration of the vaccine appears and how long it lasts. She would also like to know if we can call the facility to let them know that "rash" was reported as a side effect of the vaccine, since she was upset because she does not understand how someone in the ER does not know that "rash" was an adverse reaction and they had them thinking for a couple of hours that patient could be suffering of a serious disease. Reporter does not want someone else to go through this situation. Reporter mentioned that in the ER told them to wait 2 days and give Benadryl to patient, so she wanted to confirm if this was the right treatment for patient and if she should wait those 2 days to see if the rash was gone before she calls the doctor. Reporter wanted to know how long after the administration of the vaccine the rash appears and how long the rash would last. The outcome of the event was unknown No follow-up attempts are possible. No further information is expected.
17 2021-06-02 fever Fever; Joint pain; facial and tongue swelling/broken out in a rash broken out in a rash that moved t... Read more
Fever; Joint pain; facial and tongue swelling/broken out in a rash broken out in a rash that moved to her face and lips/anaphylaxis/daughter's eye started to swell; Serum sickness; elevated CRP; Hives/an allergic reaction/lip and face swelling; This is a spontaneous report from a contactable consumer (the mother) reported for her daughter. A 17-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular, administered in left arm on 02Apr2021 10:00 (Batch/Lot Number: EN6207) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included Colitis ulcerative from 2014 and ongoing, Genetic immune deficiency, additional Information for other conditions: Caller describes it as "22q". patient was born with this but wasn't actually diagnosed until patient was 11 years old. They checked with patient's Immunologist before getting the vaccine especially with her daughter's history. Thyroid disease from 2015 to an unknown date, additional Information for other conditions: patient didn't have a thyroid- her thyroid was removed. Concomitant medications included cetirizine; famotidine; montelukast sodium (SINGULAIR); and epinephrine (EPIPEN) all taken for an unspecified indication, start and stop date were not reported; aloe vera, pramocaine hydrochloride (ATARAX ANTI ITCH LOTION) taken for itching, swelling and hives, start and stop date were not reported. The patient took first dose of Pfizer COVID vaccine on 12Mar2021 10:00 (Lot: EN6207) for COVID-19 immunization and patient had no side effects after the first dose. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations (within 4 weeks). The patient just saw her Immunologist and her Immunologist instructed her to report what is going on with patient. Caller clarifies patient's immunologist plans to call and report as well but also instructed her to call and report the side effects her daughter is experiencing. Her daughter was cleared to have the COVID vaccine. The caller explains they always check with her immunologist because of her daughter's immune issues. Her daughter received the second dose of the COVID vaccine on 02Apr2021. On the evening of 04Apr2021, her daughter broke out in hives. They didn't think it was a big deal, they thought it was just an allergic reaction. She tried Benadryl and several other things. They went and saw her daughters regular general practitioner and the doctor believed it was just a delayed skin reaction, which seems to be common with the Pfizer COVID vaccine. The doctor told her he's seen one other person with this delayed reaction. He gave her daughter a steroid injection, a Steroid Dose Pack and Pepcid. She was also placed on Benadryl as needed. About 2 weeks after this, her daughter and lip and face swelling and ended up in the Emergency Room (ER). At this ER visit, they initiated the allergic reaction protocol and it was not an anaphylactic reaction at that point. Her daughter received IV Benadryl and IV steroids, the caller is not sure what else. She confirms she has no NDC, Lot number and expiry dates for the medication her daughter received in the ER. The ER doctor contacted the Immunologist on call and the Immunologist had seen a few cases with a delayed reaction. Caller clarifies the ER doctor discussed her daughter's delayed skin reaction with the on-call Immunologist. The oncologist put her daughter on generic Zyrtec, 20mg in the morning and 20mg at night. The following week, her daughter woke her up with facial and tongue swelling. She clarifies further her daughter had fever, joint pain, and had broken out in a rash that moved to her face and lips. She immediately took her to the ER. The ER followed the whole anaphylaxis protocol and was given an EpiPen. She explains her daughter was diagnosed serum/covid sickness. This has been going on for over 6 weeks. The reaction will come and go. She was told as her daughter's body develops immunity, she is basically allergic to it. She clarifies at her ER visits, they checked her daughters liver and kidneys. It was noted her daughter had and elevated CRP, which is an inflammatory marker. The caller was told they thought her daughter had serum sickness from the vaccine which may last 4-6 weeks or it may be prolonged, so they just went with it. They told her as long as it didn't move to her lips or affect her daughters breathings, eventually it would wax and wane and go away. Her daughter started breaking out on her arms and legs and last Saturday, she woke up and her face was swelling. She clarifies her daughter's eye started to swell and her tongue. She took her straight to the ER and the ER followed the anaphylaxis protocol and injected her with an EpiPen. They contacted her Immunologist to check and make sure it wasn't anything else and consulted with the Covid Vaccine Clinic and it was found 3 other patients had this happen. No further details were provided regarding the 3 other patients. Right now, her daughter is on 4 different medications and an EpiPen. They contacted her insurance about her being placed on a biologic because not even the current medications her daughter is on is making everything going away. Caller verifies her daughter was never admitted into the hospital. When she was last seen in the ER Monday, she her daughter was monitored for 4 hours after the EpiPen was administered. The events require a visit to Emergency Room (total of three ER visits) and Physician Office. She known the last/third ER visit was Monday, 17May2021. The second ER visit was 04May2021. She believes the initial/first ER visit was probably a week or so before the second one. She clarifies she broke out in hives on 04 Apr2021 and went to the doctor on 07Apr2021 or 08Apr2021 so the ER visit was around the next week. Since her daughter had such a good response from the EpiPen the ER doctor took pictures before and after. She clarifies the name of the biologic they want to put her daughter on is Xolair, it is a monthly injection. She explains the current cocktail they have her daughter on is not working. She provides the following product information for these 4 medications and EpiPen. Relevant Tests included she knows they are testing for any other thing that it could be to rule it out. She knows they ran a CIS-tray, a complete CIQ , a Histamine release something and Tryptase. She knows they checked her CRP (inflammatory marker) because it was elevated. Every time her daughter went to the ER, they did a CBC and all of that was normal except for the CRP inflammatory marker, however her CRP was normal at the last ER visit. The outcome of events was unknown. No follow-up attempts are needed. No further information is expected.
17 2021-06-02 fever Fever 99.5 F in evening 102F next afternoon
17 2021-06-03 sweating Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed ... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Additional Details: Patient received 1st dose of pfizer vaccine. Less than 1 minute later patients mother alerted us that the patient had lost consciousness. She was immediately laid down and gained consciousness within 10 seconds. She stated feeling lightheaded, sweaty, looked pale and felt like she was in a trance. 1st BP reading (111/67), 2nd BP reading done 15 min later (106/59 & HR 65). After 30 min of monitoring patient was able to leave.
17 2021-06-05 malaise, fever, headache, chills 8 hours post vaccination, developed subjective fever, chills, headache, malaise 6/2: Around 32 hours... Read more
8 hours post vaccination, developed subjective fever, chills, headache, malaise 6/2: Around 32 hours post vaccination, developed acute chest pain, shortness of breath, difficulty breathing when laying flat. Required ibuprofen. 6/3: felt better, required ibuprofen. Presented to ED on 6/4 with continued symptoms (chest pain, shortness of breath), noted to have elevated troponins. Transferred to Hospital on 6/4 to ICU for monitoring. To the floor on 6/5. Clinically doing well just on NSAIDs with slowly decreasing troponins. Dx: probable acute myocarditis per cardiology based on clinical symptoms and troponin leak
17 2021-06-06 chills, sweating 5 mins after administering vaccine pt had difficulty breathing, chills, sweats, blurry vision, nause... Read more
5 mins after administering vaccine pt had difficulty breathing, chills, sweats, blurry vision, nausea, temp was 95, numbness in hands, and ringing ears. Possibly a seizure her mom said her arms were shaking a little I didn?t see anything
17 2021-06-06 fatigue, headache, fever Fever ranging from 99.8 to 102 for 54 hours. Fatigue (slept for 15 hours on first day); lower back ... Read more
Fever ranging from 99.8 to 102 for 54 hours. Fatigue (slept for 15 hours on first day); lower back ache, headache, muscle ache
17 2021-06-06 fatigue Patient tolerated administration of vaccine well and was monitored in observation room by two RN's f... Read more
Patient tolerated administration of vaccine well and was monitored in observation room by two RN's for 15 minutes and patient felt fine to leave. Patient left room and came back shortly after feeling very fatigued, nausea, and pain in both calf's- L leg worse than R , with red toes. Bilateral pedal pulses +2. Vitals: BP 130/67 HR 92 Sat 95% on room air. Gatorade given to sip on. RRT was ultimately called and patient was taken to ED.
17 2021-06-06 sweating, headache Systemic: Abdominal Pain-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Un... Read more
Systemic: Abdominal Pain-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Hypotension-Severe, Systemic: Nausea-Medium, Systemic: Shakiness-Mild, Systemic: Vomiting-Medium, Systemic: Weakness-Medium, Additional Details: Following 2nd covid-19 vaccination, patient became very lightheaded and fainted while seated in chair. After coming to again, she was very pale, having a hard time controlling her breathing and stated she couldnt see. 911 was called and upon the paramedics arriving, blood pressures both sitting and standing were taken, as well as a blood glucose reading. The patients blood pressure was low but stable, and her blood glucose reading was normal. Patient walked out of store with paramedics and Mom.
17 2021-06-06 lethargy patient was nervous/anxious about the shot. Sat in chair and received shot in the left deltoid with ... Read more
patient was nervous/anxious about the shot. Sat in chair and received shot in the left deltoid with no issue. Stood up to leave a minute later and told her mom that she felt dizzy and nauseous. We had her sit back down and she got a little shaky. Face seemed to loose all its color. she said everything went black and she was dizzy. she closed her eyes and laid her head back against the wall. I left the vaccine room to alert my pharmacist and as I walked out the door the patients brother said that she had started shaking like she was having a seizure and she passed out. She was seated and mom was supporting her while we called 911. patient came to within 30 seconds or so and was lethargic and dizzy still. Pharmacist too her blood pressure while waiting on emt and it was 102/52, heart rate 64. emt arrived and took over. emt was with the patient for about 10 minutes then left with her on a stretcher. emt left notes that her vitals while sitting were 93/56, heart rate 66, o2 100%. standing 80/50
17 2021-06-06 malaise, sweating After receiving the vaccine we moved to waiting area. Within minutes she told me she was not feelin... Read more
After receiving the vaccine we moved to waiting area. Within minutes she told me she was not feeling well she began sweating profusely, her skin became pale and clammy, her eyes rolled back she lost consciousness and began convulsing. She came to and said she could not hear well. She was taken to ED for observation and testing.
17 2021-06-06 malaise Patient told us that she has passed out and vomited after receiving vaccines in the past. After gett... Read more
Patient told us that she has passed out and vomited after receiving vaccines in the past. After getting the vaccine, she didn't feel well. We monitored her in the vaccine room for about 5 minutes. She had a drink of water, then when she was ready, her family helped her into the lobby I returned to the pharmacy, and continued to watch her. The patient's mom came to the window and said patient had fainted. I went to her, and said we need to lower her to the floor. At that point, mom said patient was not breathing I quickly lowered her to the floor, while dad supported her head. I didn't have time to verify that she wasn't breathing, because as soon as she touched the floor, she began convulsing, then sat up and w was immediately awake. She sat up, and we explained that she had passed out and I had her lie down. I stayed with her for a few minutes, asking if they wanted an ambulance (which mom and dad declined) while making sure she was ok. She was just resting at this point, so I returned to the pharmacy, and ask them to let me know if anything changed I continued to watch her from the pharmacy window, and the patient said she was nauseated. We gave mom a bag, and patient vomited in the bag. After a couple more minutes, she seemed to be recovering, and mom and dad helped her out of the store. I followed up with mom at 4:15pm, and mom said patient was still nauseated and had vomited a couple more times. I followed up one last time at 4:45pm, and patient was feeling a bit better, but mom was going to keep an eye on her I recommended that mom take her to a doctor to be evaluated, but mom said she would just keep an eye on her through the night. I told mom that I would follow up again in the morning.
17 2021-06-06 sleepiness, fatigue Swelling on the left hand (fingers) - a ring couldn't be taken off. The injection site was red and v... Read more
Swelling on the left hand (fingers) - a ring couldn't be taken off. The injection site was red and very itchy - that lasted for about three days. There was a lot of drowsiness; fatigue; upset stomach - lasted about a week. Went to Primary care doctor; he said it was a side affect. He told us to keep an eye on it. The swelling lasted three or four days.
17 2021-06-07 headache, fatigue Irregular Menstrual Period: short cycle (15-22 days), heavier than typical period pre-vaccine, prolo... Read more
Irregular Menstrual Period: short cycle (15-22 days), heavier than typical period pre-vaccine, prolonged period (12 days), no treatment given Extreme Fatigue: Sleeping 8-9 hours and can barely function through a typical day, irritable Frequent headaches lasting multiple days
17 2021-06-07 throat pain, malaise, fever, headache, chills, sweating see prior
17 2021-06-07 fever, headache Dose 1, headache. DOSE 2 Five hours later severe headache, extensive heat being generated from hea... Read more
Dose 1, headache. DOSE 2 Five hours later severe headache, extensive heat being generated from head, body not, then followed by high fever 101.8 with heart rate going up to 155, followed by twelve hour later breaking fever. Extensive headache continues. At 24 hour mark hives on face under eyes, big welts and red. Continued migraine. This is not safe!!!!!! I will sue the agency for this product, emergence use yet mandate by colleges and employers. SOMEONE NEEDS TO PAY FOR THIS!!!!! I WILL CONTACT A LAWYER.
17 2021-06-08 fatigue received the first dose of the Pfizer COVID-19 vaccine and also recently started taking Depo-Provera... Read more
received the first dose of the Pfizer COVID-19 vaccine and also recently started taking Depo-Provera. After receiving the first dose of the Pfizer COVID-19 vaccine her daughter developed a blood clot; tired and frail; feels lost and light headed; cramping pain; This is a spontaneous report from a contactable consumer (Patient's mother). A 17-year-old female patient received first dose of BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Right on 03May2021 15:00 (Batch/Lot number was not reported) as 1ST DOSE SINGLE for covid-19 immunization and medroxyprogesterone acetate (DEPO-PROVERA), route of administration, start and stop date, batch/lot number and dose were not reported for contraception. The patient's medical history and concomitant medications were not reported. The patient experienced received the first dose of the pfizer covid-19 vaccine and also recently started taking depo-provera. after receiving the first dose of the pfizer covid-19 vaccine her daughter developed a blood clot, tired and frail, feels lost and light headed and had cramping pain all on unspecified dates. It was reported that after receiving the first dose of the Pfizer COVID-19 vaccine her daughter developed a blood clot. Her daughter, who is currently on Depo Provera got her first dose of the Covid 19 vaccine. The daughter has been experiencing blood clotting and would like to further document this experience. Is also seeking medical advice to inform her daughter. Her daughter Has been on Depo Provera for 4 to 5 months. Since she had the Covid vaccine, she has been having bad blood clotting and has been having a continuous period. When she got the shot, she has been getting blood clots straight for three weeks. Patient is Tired and frail: She is a waitress, so all of this has made it hard. It started right when she got the shot and has pretty much stayed the same. She will feel like she is lost when she wakes up and is light headed from the loss of blood. It occurs when she is doing activities, like working. Patient took some Midol one day for cramping pain but it barely did anything. The action taken for medroxyprogesterone acetate was unknown. Outcome of tired and frail was not recovered. Outcome of all the other events was unknown. Information on Lot/Batch number was not available. Additional information has been requested.
17 2021-06-08 fatigue Arm hurt; Tired; Rash all over both of her legs; This is a spontaneous report from a contactable con... Read more
Arm hurt; Tired; Rash all over both of her legs; This is a spontaneous report from a contactable consumer (patient's grandparent). A 17-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration in the left arm on 20May2021 16:30 (Batch/Lot number was not reported), at the age of 17-years-old as 2nd dose, single for COVID-19 immunization. Medical history included allergic reaction of Sulphur drugs. The patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 on an unspecified date for COVID-19 immunization. The patient had her second Pfizer shot on Thursday 20May2021 at 4:30, the only side effect she seem to have, was her arm hurt and she was tired and the reporter don't know, her aunt was a pharmacist and said that circle that she developed at the site of the shot, and called it as a Covid bullseye. On Saturday 22May2021, the patient had rash about the size of a diameter of a lemon on the inside of her leg, the reporter didn't think anything out she has been out in the sun so they just observed until Sunday, 23May2021 she got the rash all over both of her leg. Previously she was has an allergic reaction of Sulphur drugs so with this rash all over both of her legs what they did was they called her doctors office Sunday and they haven't answering. They have a service that you can call about medical things, person that answers, there was a woman and said she know nothing about a rash they thought it would may be side effect from Pfizer because the reporter looked on the website and in the website rash was listed, usually rare. The patient does not have anaphylactic shock any of that there was a rash they think it was 0.001 they tried to explain this to the woman and she insisted it was something called Petechiae rash, which is a serious rash. She insisted not take the patient to the urgent care, she said they should take her to the ER and not urgent care, they took her to the ER they said they didn't know, it was definitely not the Petechiae rash which was a released that's a serious problem. They said it was okay to just give her Benadryl which they could have decided to give at home, but they didn't know if Benadryl was okay to take if the patient took the COVID vaccine. They were advised to bring her back to the doctor in 2 days if it doesn't go away. ER said they had never seen anyone who had a rash, they don't know any rash. The reporter tried to tell that it's on the website it's on a Pfizer website and thought she was thinking she should alert them about this because this was a lot of lot of gut ranching and anxiety that if this person calling from the doctor saying that the rash was a Petechiae rash which was a serious blood disease. The outcome of the events was unknown. Information on the lot/batch number has been requested.
17 2021-06-08 headache Woke up in morning around 8:00 with nausea and vomiting. Nausea most of the day. Headache, severe l... Read more
Woke up in morning around 8:00 with nausea and vomiting. Nausea most of the day. Headache, severe lower back pain
17 2021-06-08 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-Medium, Systemic: Nausea-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: PT fainted several minutes after vaccination and fell out of the chair. Pt regained conciousness immediatly after fall but suffered minor injuries to the face and knee (rug burn). She felt nauseous, light headed, dizzy and was pale and had cold clammy skin. She regained her complexion after 15 minutes and rested for 45 minutes before leaving.
17 2021-06-08 lethargy, fever Day after vaccination, patient reports intermittent fevers (Tmax 104F), neck pain that radiates down... Read more
Day after vaccination, patient reports intermittent fevers (Tmax 104F), neck pain that radiates down her back, and is interacting a lot less than usual, The following day, she was unable to walk at all and required being carried to use the bathroom. Patient denies and fevers, cough, gi distress. She does states that she is not feeling short of breath at this time, but is having weakness in her hands as well as her legs. Additionally patient states that she has been having chest pain today that comes and goes. On neuro exam Mental status: Appears to be distressed due to photophobia. Lethargy, however easily arousable, able to have a conversation, attention intact to spelling "globe" backwards, intact to high and low frequency words. Able to name and repeat. Speech: Mild dysphonia Cranial Nerves: II: Pupils equal, round reactive III/IV/VI: EOMI. Pupils move in all four cardinal directions VII: Face symmetric when talking, however limited effort to excursion on command VIII: Responds to voice IX/X: Voice normal XI: Turns head side-to-side XII: Tongue midline Motor: Normal bulk and tone. Resistance met to passive motion of BLE RUE/LUE: shoulder abduction 4/5, elbow flexion/extension 5/5, wrist flexion/extension with give-way weakness up to 4+/5, finger flexor 4/4 RLE/LLE: On command, 0/5 -however able to support her legs in a flexed position bilaterally, with encouragement 5/5 on dorsiflexion. Able to support her weight on her legs, however does not walk slowly sits back on the bed. Sensory: Intact to light touch, proprioception intact Coordination: No obvious dysmetria on FNF testing DTR: 2+ brachioradialis, bicep, patellar, ankle b/l. Plantars mute. Absent pathological reflexes: Hoffman, cross adductor
17 2021-06-08 sleepiness Client Received the 2nd dose of Pfizer COVID vaccine lot #ER8735 and expiration date 07/04/21 at 1:... Read more
Client Received the 2nd dose of Pfizer COVID vaccine lot #ER8735 and expiration date 07/04/21 at 1:34pm. At 1:34pm, client reports to vaccinator that she feels dizzy. Vaccinator offer client water and client starts drinking it. PHN 1 & PHN 2 arrive client reports she "feels weird" PHN asks client to explain and client is unable to describe. Client is alert and oriented X 4 and is already seated in zero gravity chair due to reporting history of syncope. Vaccinator offered client water and client starts drinking it. Client reports no headache, no shortness of breath, no blurred vision, no chest pain, just dizziness. At 1:34PM vitals heart rate taken manually by PHN :72 and blood pressure: 128/74, unable to get oxygenation due to long acrylic nails. PHN gets report from mother that client reports with the first dose something similar happened that she experienced dizziness after vaccine. Client was kept in observation and symptoms resolved prior to client going home. Clients mother reports no medical history, no medications and no history of allergies. At 1:36PM PHN gets called away for another adverse reaction and PHN stays with client. At 1:39pm client reports dizziness is resolving but still "feels weird", PHN asks client to clarify what weird means and she says "it feels like my heart is slower." At 1:40pm client reports she is feeling sleepy, PHN attempts to call 911 and gets disconnected. At 1:41pm vitals: blood pressure: 130/82 and pulse:134. At 1:42pm PHN calls 911 again to reconnect and observes clients lips look purple, closed eyes but able to answer questions and speak in complete sentences. Ask RN to get AED as instructed by 911 dispatcher. At 1:45pm, client reports having trouble breathing and RN placed zero gravity chair to laying position and assist client with coaching her to take slow deep breaths. Fire department paramedics arrived at 1:47pm and assumed care. Client was wheeled out on a gurney at 1:50pm.
17 2021-06-09 fatigue, lethargy Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainti... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: PT fainted and fell out of the chair several minutes after administration of vaccine. Pt regained conciousness immediately after fall. Suffered minor injuries to the face and knee (rug burn) and felt dizzy, lightheaded, and nauseas for at least 15 minutes before regaining complexion. PT discloses after incident that she has issues fainting with blood draw and some injections. PT rested for 45 minutes in the store before leaving. Vitals reviewed are normal before leaving the store
17 2021-06-09 headache, bronchitis J40 - Bronchitis, not specified as acute or chronic HEADACHE SHORTNESS OF BREATH CHEST PAIN
17 2021-06-09 headache, fever 17 y/o F with a hx of asthma and GBS presents to the ED for weakness and difficulty moving beginning... Read more
17 y/o F with a hx of asthma and GBS presents to the ED for weakness and difficulty moving beginning on 6/7/2021. Pt got her second COVID-19 vaccination on 6/6/2021 and has had an intermittent fever since (Tmax 104 F). Pt has been taking Motrin and Tylenol; last dose was at 07:00 today. Note, pt only had a fever after the first COVID-19 vaccination. Mother reports pt's baseline includes normal range of motion. However, in 2016 pt was diagnosed with GBS and was hospitalized for temporary paralysis for 1 month. Pt was also diagnosed with mononucleosis in 2017. Mother reports pt has also had neck pain that radiates down her back, and is interacting a lot less than usual. Pt denies any confusion, but admits to a mild headache. Differential Diagnosis: Guillain-Barre Syndrome, status post vaccine, tick paralysis, thyrotoxicosis, consider meningitis and other infectious causes like UTI, URI. Patient admitted to hospital.
17 2021-06-09 sleepiness Pt reported that she felt dizzy and sleepy and endorsing weakness after covid vaccine. Pt was sent ... Read more
Pt reported that she felt dizzy and sleepy and endorsing weakness after covid vaccine. Pt was sent to the emergency department. Pt felt better after eating and was able to ambulate with no dizziness or weakness. Pt stated she "feels better" and left.
17 2021-06-10 headache, lethargy, fever Severe Headache, fever, lethargic, dry throat.
17 2021-06-10 headache This was my daughters second shot. She experienced 90 minutes of uncontrollable shaking around midni... Read more
This was my daughters second shot. She experienced 90 minutes of uncontrollable shaking around midnight with whole body. Also, with headache and overall body aches and hot and cold spells.
17 2021-06-10 sweating, chills, fatigue, headache fatigue, headache, chills/sweats, dyspnea, left arm and axilla pain
17 2021-06-10 sweating PT WAS SITTING IN WAITING AREA, WAITING THE REQUIRED 15 MIN POST-VAX, JUST A FEW MIN AFTER ADMIN, PT... Read more
PT WAS SITTING IN WAITING AREA, WAITING THE REQUIRED 15 MIN POST-VAX, JUST A FEW MIN AFTER ADMIN, PT STARTED TO FEEL FAINT, LOOSE COLOR IN FACE AND BREAK OUT IN SWEAT. NO S/SX OF ANAPHYLAXIS. LOWERED PT TO THE FLOOR AND ELEVATED FEET. COLOR IMMEDIATELY RETURNED TO FACE AND PT REPORTED FEELING BETTER IMMEDIATELY. PT REMAINED CONSCIOUS THROUGHOUT. CHECKED BP 113/79 PULSE 69. HAD PT WAIT ANOTHER 15 MIN THEN LEFT WITH NO FURTHER COMPLAINTS.
17 2021-06-10 sweating Within seconds of receiving the 2nd PFizer covid vaccine, the patient slumped over sideways in her ... Read more
Within seconds of receiving the 2nd PFizer covid vaccine, the patient slumped over sideways in her chair, losing consciousness. Next, her arms went straight and locked, both her hands locked in a curled position. I looked up at her face and her eyes had rolled back into her head and her body started jerking. Shortly after, she sat upright in chair with her eyes open and didn't realize what had happened. She said a tingling sensation had gone up her arm. She was extremely pale. My tech called 911. I took her blood pressure which was 88/46 with a pulse of 45. As we were waiting for paramedics, she said she was sweaty and started getting abdominal cramps. Paramedics arrived and took over her care.
17 2021-06-10 fever 17 y/o F with a hx of asthma presents to the ED for weakness and difficulty moving beginning on 6/7/... Read more
17 y/o F with a hx of asthma presents to the ED for weakness and difficulty moving beginning on 6/7/2021. Pt got her second COVID-19 vaccination on 6/6/2021 and has had an intermittent fever since (Tmax 104 F). Workup including brain and spine MRI, and Lumbar puncture with CSF studies all normal. Of note patient had Guillan Barre Syndrome in 2016 which required 1 month of hospitalization.
17 2021-06-11 fever Passing out; Feeling very faint; high fever (103 degrees Fahrenheit); Body aches; This is a spontane... Read more
Passing out; Feeling very faint; high fever (103 degrees Fahrenheit); Body aches; This is a spontaneous report from a contactable consumer (patient). A 17-year-old female patient (not pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 27May2021 16:00 (at the age of 17years) (Batch/Lot number was not reported) as unknown, single for Covid-19 immunization. Medical history included ADHD (attention deficit hyperactivity disorder) and known allergies to Sulfate. Concomitant medication included tilactase (LACTAID) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28May2021 12:00, the patient experienced very high fever (103 degrees Fahrenheit) for at least more than 2 days, body aches, feeling very faint, passing out whenever she stands up for more than a couple of minutes. There was no treatment received for the adverse event. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. The outcome of events was not recovered. Information on the lot/batch number has been requested.
17 2021-06-11 throat irritation sporadic breakout of hives on face, torso and back for two days after vaccine, itchy throat, respond... Read more
sporadic breakout of hives on face, torso and back for two days after vaccine, itchy throat, responded to Benedryl and Sarna lotion
17 2021-06-13 fatigue, cough Received Pfizer vaccines on 3/18/21, 4/8/21 Tested positive for COVID 19 by PCR on 6/11/21. Hospital... Read more
Received Pfizer vaccines on 3/18/21, 4/8/21 Tested positive for COVID 19 by PCR on 6/11/21. Hospitalized 6/11-6/14/21. symptoms of fatigue, myalgias, diarrhea, dysgeusia, cough Received four doses of Remdesivir.
17 2021-06-13 headache She woke up this morning complaining of a severe headache, left sided neck pain. She reported she c... Read more
She woke up this morning complaining of a severe headache, left sided neck pain. She reported she could not see out of both eyes and then vomited. This episodes lasted~10 min and then resolved with residual neck pain.
17 2021-06-15 sweating Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unrespo... Read more
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Tinnitus-Medium, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Medium
17 2021-06-16 body temperature increased, headache Large (3 cm) painful supraclavicular lymph node x 1 on the same side as vaccine sight. The patient ... Read more
Large (3 cm) painful supraclavicular lymph node x 1 on the same side as vaccine sight. The patient also has headache and neck discomfort. Temp to 100.5.
17 2021-06-16 headache, malaise At around 9:25 am on Thursday, June 17th, 2021, seventeen-year-old patient walked into the vaccinati... Read more
At around 9:25 am on Thursday, June 17th, 2021, seventeen-year-old patient walked into the vaccination site. She was accompanied by two guardians, along with 14 other minors. The minors came in for their 2nd shot of Pfizer Covid-19 vaccines. Patient signed all necessary consent forms and pre-vaccination checklist requirements with guardian and entered the vaccination section at around 9:35 am. The Pfizer vaccine was administered at 9:39 am. Observation nurse reported that around 10:06 am the patient complained about having a severe headache, ?seeing stars?, feeling very dizzy, and not feeling well. Nurse assisted patient to lay down on the mat in case the patient may faint. Charge nurse obtained a pulse oximetry reading of 95% and a pulse of 96. Charge nurse checked if the patient experienced any symptoms of hives/redness, shortness of breath, or any difficulty breathing or swallowing. The patient complained to observation nurse that she was having a hard time breathing, severe headache, and chest pain. Observation nurse instructed patient to be calm and to relax. Charge nurse instructed the patient to take deep slow breaths to help increase O2 levels but the patient complained to the observation nurse that she cannot breathe through her nose. At 10:15 am charge nurse continuously monitored the patient?s B/P, pulse, and O2 level readings. The BP reading was 117/64 with a pulse of 78 and an O2 level of 100%. At approximately 10:16 am, patient started showing signs of change in LOC and lost consciousness for a few seconds. First responder paramedics from the first minor incident were still at the scene waiting for the 2nd ambulance to arrive. The first responder paramedic did a sternum rub using his knuckles with a closed fist to the center of the patient?s chest and immediately after the patient gasped for air and regained consciousness. The patient remained in a sitting position on the floor to be able to breathe easier. At approximately, 10:18 am charge nurse took another BP reading of 121/76, a pulse of 96, and O2 level of 99%. At approximately 10:20 am, patient started exhibiting a change in LOC and was very disoriented again. Observation nurse kept calling the patient?s name but did not get a response. This lasted for around 30 seconds while the patient gasped for air before becoming responsive again. At this time observation nurse observed that patient could not recall her name and did not know how she got there. At approximately 10:22 am, charge nurse took another BP reading of 165/133, a pulse of 122, and an O2 level of 96%. At around 10:24 am, the charge nurse took another BP reading of 112/78 and pulse of 112 with an O2 level of 96%. The second ambulance arrived at approximately 10:26 am and took over. The second ambulance?s first responder paramedics left with patient at approx. 10:29 am and took her to hospital for further observation.
17 2021-06-16 headache, fever, fatigue High fever; Tired; So cold; Headache; Sore arm/achy; This is a spontaneous report from a contactable... Read more
High fever; Tired; So cold; Headache; Sore arm/achy; This is a spontaneous report from a contactable consumer. A 17-years-old female patient received BNT162B2 (Pfizer COVID Vaccine: Solution for injection; Batch/Lot Number: EW0175), via an unspecified route of administration, administered in Arm Left on 11May2021 as 1ST DOSE, SINGLE DOSE and received BNT162B2 (Pfizer COVID Vaccine: Solution for injection; Batch/Lot Number: EW0182) via an unspecified route of administration, administered in Arm Left on 03Jun2021 at 13:00 as 2ND DOSE, SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously got a flu shot 6 or 7 or 8 years ago. She lost the pigmentation on her arm. She has not had a flu shot since. She gets allergy shots but that is weekly. She has not had one in over a month. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received her first vaccination last month and she did have a reaction of soreness, high fever, tired, and headache on an unspecified date of May2021. Yesterday she got her second dose and now she is back to the way she was with the first dose. Fever went as high as 99.3 which is not high, but the last time with first dose she got up to almost 103. It was 102.98 or something like that. Time of fever with first dose: it was within that night of getting it. Second dose was same thing. She got it yesterday at 1:00 and by 8:00 she was crying about being tired, so cold, achy, and fever. Caller clarified that all adverse events with second dose started at the same time around 20:00 the night of the 2nd dose. Patient had not received any treatment. Caller reported that the last time she did call the hospital and they said it would subside, which it did within 48-72 hours. Then she was back to being normal except with sore arm. Caller clarified it was left arm soreness. The outcome of the events was unknown. Information on lot/batch number was available. Additional information has been requested.
17 2021-06-16 headache At around 9:25 am on Thursday, June 17th, 2021, a seventeen-year-old Foreign-speaking patient walked... Read more
At around 9:25 am on Thursday, June 17th, 2021, a seventeen-year-old Foreign-speaking patient walked into the vaccination site. She was accompanied by two guardians, along with 14 other minors. The minors came in for their 2nd shot of Pfizer Covid-19 vaccines. Patient signed all necessary consent forms and pre-vaccination checklist requirements with guardian and entered the vaccination section at around 9:30 am. The Pfizer vaccine was administered at 9:37 am. Observation nurse reported that around 10:04 am the patient complained about having a severe headache. The observation nurse notified charge nurse that she needs assistance. The charge nurse immediately obtained a pulse oximetry reading of 99% and a pulse of 88. The charge nurse assessed if the patient is experiencing any symptoms of hives or redness, shortness of breath, or any difficulty breathing or swallowing. The patient stated to the observation nurse that she was having difficulty breathing. At 10:06 am the charge nurse called 911. While the charge nurse was standing and speaking with the 911 operator, the patient started to faint and laid her head on charge nurse's stomach while she was sitting. The patient looked like she was sleeping and making some whimpering sounds for about 2 minutes. At the same time, these events were taking place, observation nurse reported that another 17-year-old minor started complaining of a severe headache and ?seeing stars?. First responder paramedics came on the scene at around 10:09 am and took over care of the patient. At that point charge nurse attended to another patient, 17-year-old minor. Patient was also exhibiting a reaction to the Pfizer Covid-19 vaccine. First responder paramedics left with patient at around 10:15 am and she was taken to hospital for further observation.
17 2021-06-17 sweating Patient was given the second dose of Pfizer brand Covid-19 vaccine by our immunizing tech. and said ... Read more
Patient was given the second dose of Pfizer brand Covid-19 vaccine by our immunizing tech. and said patient was ok until she stood up to leave the immunization room and that is when she immediately fainted and slumped back into the chair. Within a few seconds she regained consciousness. Mom said she had not eaten anything before coming and has fainted before when having blood drawn. (patient does have a fear of needles) We had the patient sit the immunization room for around 20 minutes. We got her some juice and a wet cloth upon moms request as she was sweating and shaky feeling. After sitting for a while she said she was feeling better and mom declined further care and we advised she follow up with her PCP
17 2021-06-17 nasal congestion, headache, fatigue, throat pain Headache, stuffy nose, sore throat, nausea and vomiting. Sore arm. overall fatigue child had covid... Read more
Headache, stuffy nose, sore throat, nausea and vomiting. Sore arm. overall fatigue child had covid 19 in October 2020 confirmed positive with parents test
17 2021-06-18 headache I felt really dizzy. Every-time I bend down to get something or when I get up to fast, I get a rush ... Read more
I felt really dizzy. Every-time I bend down to get something or when I get up to fast, I get a rush to the head and get dizzy. I get headaches every now and then but it?s only happened when I had the shot
17 2021-06-20 fatigue Patient's mom reported hives starting around the mouth approximately 30 minutes after receiving the ... Read more
Patient's mom reported hives starting around the mouth approximately 30 minutes after receiving the vaccine. By 9 pm that evening, she reports that patient had hives over half her body. She was advised by pediatrician to give benadryl and go to the ER if hives didn't resolved. Hives responded to benedryl. Patient reports feeling fatigue the next 48 hours as well. Patient is now doing fine. No further followup at this time.
17 2021-06-20 headache Pt. with some SOB, headache, stomachache, nausea , decrease appetite 5 hrs after receiving 2nd C... Read more
Pt. with some SOB, headache, stomachache, nausea , decrease appetite 5 hrs after receiving 2nd Covid-19 Vaccine (Pfizer). Epi (111000)She improved after giving 0.3 mg and giving Prednisone . She was sent home on tab Prednisone 20 mg bid x 3 days
17 2021-06-20 lethargy 17 year old female received Pfizer COVID vaccine and was told to sit and wait 15 minutes for monitor... Read more
17 year old female received Pfizer COVID vaccine and was told to sit and wait 15 minutes for monitoring after the shot. Patient attempted to leave before the time elapsed with her father and collapsed in the aisle. She was able to be assisted to a nearby chair and 911 was called. I was told she did not hit her head or any other part of her body when she fell. I attempted to take her blood pressure, but it was too low. Patient appeared very pale and was responsive but stated she was seeing black and couldn't hear properly. She did not eat anything that morning. Patient continued to talk and answer questions updating me on her improvements but still appeared very lethargic and eyes were not focused. EMTs arrived and her BP was 81/46. EMTs, store management and health care ambassador remained with patient. Patient began to feel better and did not go to the hospital. EMTs left and management and associate remained with patient. Once patient felt better, she walked out of the pharmacy/store with her father.
17 2021-06-22 fatigue Chest pain, shortness of breath, fatigue, unable to take a deep breath
17 2021-06-22 fatigue About 5 minutes after receiving the Covid vaccine patient fainted, she was pale and reported feeling... Read more
About 5 minutes after receiving the Covid vaccine patient fainted, she was pale and reported feeling very tired and had tingling in her hands. After drinking water. Patient was feeling better but still felt tired. After 10 minutes paramedics arrived and took her vitals. Her blood pressure and pulse were normal.
17 2021-06-22 headache Client received the Pfizer COVID vaccine (lot #EW0187 and expiration date 7/15/21) at approximately ... Read more
Client received the Pfizer COVID vaccine (lot #EW0187 and expiration date 7/15/21) at approximately 3:30pm. Client came in for first dose Covid-19 vaccine and PHN submitted medical consult regarding concerns from mother due to client having a reaction to a vaccine at the age of 7 where she broke out in a rash and then had to go to the hospital. Mother of client reports she has no allergies and they never figured out what caused the reaction. When she was younger she had asthma and used an inhaler. Per Mother client has not needed an inhaler or had any asthma symptoms for a long time. Client reports she is just getting over a mild cold (runny nose) because her sister is a doctor and said it was not COVID and she's on antibiotics. Client states she "feels fine" today. Per Supervisor, client approved to receive first dose with 15 minute observation. Prior to arriving to the observation area client reports feeling a little nervous due to nearby emergency with another client. PHN walked client over to observation area and client reports "feeling fine." At 3:35PM EMT alerts PHN and PHN client is having reaction. PHN and PHN arrive at 3:38pm. Client reports headache 7/10, nausea and chest pressure. Client denies feeling throat closing, chest pain or shortness of breath. At 3:38 pm, pulse 75 and oxygen sat 95%. PHN calls 911 at 3:38pm. Current medications: ampicilina 500mg, guaifenesina clorfenamina metamizol 250mg. Vitals by EMT at 3:41pm: blood pressure 160/82, pulse 66, oxygen sat 98%. At 3:42pm client reports headache on temples. At 3:44 client reports headache radiating from temples to occipital area and pain level 7/10. Vitals at 3:45pm: blood pressure 140/70, pulse 66, oxygen sat: 98%. Client reports feeling a "pinching feeling in throat". PHN clarified with client if she felt swelling, closing of throat, itchiness or shortness of breath. Client denied all, stated just "pinching feeling". During assessment, mother of client reports client is allergic to nuts. At 3:47pm Fire department arrived and assumed care. Blood pressure done by paramedics at 3:50pm 165/108. Client transported to hospital via ambulance. Client left facility with paramedics at 4:01PM.
17 2021-06-22 sweating Patient developed syncope about 10 minutes after receiving the Pfizer vaccine. She had normal breat... Read more
Patient developed syncope about 10 minutes after receiving the Pfizer vaccine. She had normal breathing and mild sweating and lost consciousness for a brief moment. Patient was evaluated by EMT.
17 2021-06-22 malaise About 5 minutes after shot, pt felt extremely unwell, really hot, pale, blurry vision, confusion, a... Read more
About 5 minutes after shot, pt felt extremely unwell, really hot, pale, blurry vision